mechanical expansion heart valve and device for its insertion

专利摘要:
The present invention relates to a device comprising a radially expandable and compressible annular frame, at least one frame coupled linear actuator device and at least one frame coupled locking mechanism. The linear actuator may be configured to apply a distally directed force and / or a proximal directed force to the frame to expand or compress the frame radially. The locking mechanism may comprise a first sleeve member attached to the frame at a first location, a second sleeve member provided with internal threads and attached to the frame at a second location, and a first screw configured to fit into the internal threads. of the second sleeve element in order to retain the structure in a radially expanded state.
公开号:BR112019010676A2
申请号:R112019010676
申请日:2017-12-06
公开日:2019-09-17
发明作者:Dvorsky Anatoly；Manash Boaz；Maimon David；Levi Schwarcz Elazar；Leiba Eyal；Bar-Or Jonathan；Tayeb Liron；Miller Noam；Witzman Ofir；Cohen Oren；Saar Tomer；A Neumann Yair；Yohanan Ziv
申请人:Edwards Lifesciences Corp；
IPC主号:

专利说明:

Descriptive Report of the Invention Patent for MECHANICAL EXPANSION HEART VALVE AND APPLIANCE FOR PLACING THE SAME.
FIELD OF THE INVENTION [0001] The present invention relates to implantable, mechanically expandable prophetic devices, such as prophetic heart valves, and methods and apparatus for the placement and inclusion of such prophetic devices.
BACKGROUND OF THE INVENTION [0002] The human heart can suffer from various valve diseases. These valve diseases can result in significant heart malfunction and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents and artificial valves), as well as several known methods for implanting these devices and valves in humans. Because of the inconveniences associated with conventional open heart surgery, percutaneous and minimally invasive surgical approaches are gaining attention. In one technique, a prophetic device is configured to be implanted in a less invasive procedure through catheterization. For example, a prophetic foldable transcatheter heart valve can be folded into a compressed state and introduced percutaneously into that compressed state through a catheter and expanded to a functional size in the desired position by means of mechanical expansion or using a self-expanding structure or a stent. Despite recent advances in percutaneous valve technology, there remains a need to improve transcatheter heart valves and valve placement devices. SUMMARY OF THE INVENTION [0003] Improved modalities of placement devices
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2/115 prosthetic implants and structures for them are described in this document, as well as the methods and related devices for such devices. In various embodiments, the devices described are configured to place replacement heart valves within a patient's heart.
[0004] In one aspect, the present invention provides a device for placing a prophetic implant. The delivery device can include a delivery device and a prophetic valve which can include a radially expandable and compressible expandable structure and a plurality of latch units coupled to the structure. The placement apparatus may include a plurality of elongated positioning elements releasably coupled to the locking units, and a plurality of release elements coaxially arranged with respect to, and engaged with, the locking units.
[0005] The positioning elements can be moved axially in order to selectively expand or contract the prophetic valve. When the prophetic valve is expanded to a desired size, the release elements may retract from the latch units, causing the latch units to lock the prophetic valve in the expanded state and causing the positioning elements to disengage from the prophetic valve.
[0006] In a representative embodiment, a prophetic valve placement device comprises a prophetic valve and a placement device. The prophetic valve may comprise a radially expandable and compressible expandable structure and a plurality of locking units coupled to the structure in circumferentially spaced positions. Each locking unit can comprise a respective first coupling element and a locking element. The placement apparatus may comprise a plurality of it
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3/115 elongated positioning elements, each of the positioning elements comprising a respective second coupling element at a distal end thereof, each second coupling element being removably coupled to a respective first coupling element. The placement apparatus may further comprise a plurality of elongated actuating elements, each of the actuating elements extending coaxially through one of the positioning elements and having a distal end portion coupled to the structure. The placement apparatus may further comprise a plurality of release elements, each of which among the plurality of release elements being engaged in, for example, extended over or through, one of the locking units. The movement of the positioning elements or actuation elements in an axial direction with respect to each other causes the structure to expand or contract. The retraction of the release elements proximal to the locking elements of the locking units causes the locking elements to move to a locked position in order to resist the contraction of the structure and to retract the release elements proximal to the first coupling elements of the units. locking element causes the first coupling elements to disengage from the second coupling elements, thereby allowing the positioning elements to disengage from the locking units.
[0007] In some embodiments, a handle may be attached to the proximal end portions of the first and second actuating elements. The handle can comprise a first actuator configured to produce an axial movement of the positioning elements. In some embodiments, the handle may comprise a second actuator configured to produce an axial movement of the release elements with respect to the
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4/115 positioning and performance elements.
[0008] In some embodiments, each locking element may comprise a pair of deformable locking claws arranged on one of the actuation elements. In some embodiments, each of the first coupling elements may comprise a tab and a notch and each of the second coupling elements may comprise a tab and a notch. The tab of the first coupling element can be accommodated in the notch of the second coupling element and the tab of the second coupling element can be accommodated in the notch of the first coupling element. In some embodiments, the tab of the second coupling element may comprise a groove extended in the axial direction.
[0009] In some modalities, the elements of action may comprise a plurality of strings. In some embodiments, a plurality of cutting elements can be configured in order to cut the actuation elements in locations proximal to the locking units. In some embodiments, each of the actuation elements may comprise a plurality of projections spaced apart in the longitudinal direction and configured so as to fit in one of the locking elements of one of the locking units.
[0010] In some embodiments, each locking unit may comprise a first elongated element coupled to a proximal end of the structure, and a second elongated element coupled to a distal end of the structure. The first and second elements can be axially movable with respect to each other.
[0011] In some embodiments, each of the first elements of the locking units can be removably attached to one of the positioning elements, and each of the second elements can be removably attached to one of the actuation elements.
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5/115
In some embodiments, the retraction of the release elements proximal to the locking units may be effective in the sense of uncoupling the second elements of the locking units from the actuation elements.
[0012] In some embodiments, each of the first elements of the latch units can comprise a first latch component and each of the second elements of the latch units can comprise a second latch component. In these embodiments, the retraction of the release elements proximal to the locking units can cause the first locking components to fit with the second locking components in order to resist the relative axial movement between the first and the second elements and the contraction of the structure .
[0013] In some embodiments, each of the first locking components may comprise a displaceable locking bar and each of the second locking components may comprise at least one opening dimensioned to accommodate a locking bar. In some embodiments, the first element of each lock unit can be pivotably connected to a vertex at the proximal end of the structure, and the second element of each lock unit can be pivotable to a vertex at the distal end of the structure. . In some embodiments, the structure may comprise a plurality of interconnected rods having a plurality of linear segments laterally offset from each other in a direction perpendicular to the lengths of the rods.
[0014] In some embodiments, the rods can be connected to each other at certain locations between the linear segments. In some embodiments, the rods can be articulated to each other by means of pins extended through the
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6/115 rods at the locations between the linear segments. In some modalities, each of the actuation elements can extend coaxially through one of the positioning elements. In some modalities, each of the release elements can extend through one of the locking units and coaxially between one of the positioning elements and one of the actuation elements. In some embodiments, the first coupling element of each of the plurality of locking units may comprise a radially outwardly tapered fin, wherein each of the release elements is arranged on a positioning element and a first coupling element.
[0015] In another representative embodiment, a method of placing a prophetic valve comprises inserting a distal end of an elongated delivery device into a patient, wherein the elongated delivery device is removably coupled to the prophetic valve, and that the prophetic valve comprises an expandable structure comprising a plurality of locking units. The method further comprises the axial movement of a plurality of elongated positioning elements of the placement apparatus in order to expand the prophetic valve to an expanded state of a desired size, and the removal of a plurality of elongated release elements from the plurality of locking units, causing the positioning elements to disengage from the structure and locking units in order to lock the structure in its expanded state. The elongated placement device can then be removed from the patient.
[0016] In some embodiments, removing the release elements from the locking unit may allow the first coupling elements of the actuating elements to disengage from the corresponding second coupling elements of the locking units. In
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7/115 some modalities, the axial movement of a plurality of elongated actuating elements of the placing apparatus may comprise the axial movement of a first plurality of actuating elements with respect to a second plurality of actuation elements of the placing apparatus in order to expanding the prophetic valve, and removing the release elements from the latch units may allow the first and second actuating elements to disengage from the structure.
[0017] In another representative embodiment, a prophetic valve comprises a radially expandable and compressible structure that comprises a plurality of interconnected rods. Each rod has a first end, a second end, and a length that extends from the first end to the second end. Each rod may comprise a plurality of linear segments laterally displaced from each other in a direction perpendicular to the lengths of the rods. The prophetic valve may further comprise a valve structure, such as a plurality of cusps mounted on the structure and configured to regulate blood flow through the prophetic valve.
[0018] In some modalities, each of the plurality of rods is connected in an articulated manner to at least one other rod of the plurality of rods. In some embodiments, the prophetic valve may also comprise a spacer arranged between a pair of connected rods. In some embodiments, the rods can be connected to each other by means of pins extended through the rods. In some embodiments, the structure may comprise a plurality of latch units circumferentially spaced and configured so as to lock the structure in an expanded state in the radial direction.
[0019] In another representative modality, a device can
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8/115 comprises a prosthetic heart valve comprising a radially expandable and compressible annular structure, at least one linear actuator device coupled to the structure, and at least one locking mechanism coupled to the structure. The at least one linear actuator device can be configured to apply a force directed in the distal direction and / or a force directed proximal to the structure in order to expand or compress the structure in the radial direction. The at least one locking mechanism may comprise a first sleeve element, a second sleeve element, and a first screw. The first sleeve element can be connected to the frame at a first location. The second sleeve element can have internal threads and can be connected to the structure at a second location. The first screw can be configured to fit the internal threads of the second sleeve element in order to retain the structure in an expanded state in the radial direction.
[0020] In some embodiments, at least one linear actuator device can be removably attached to the structure. In some embodiments, the at least one linear actuator device may comprise an actuator element configured to be removably coupled to the structure.
[0021] In some embodiments, the at least one linear actuator device may comprise a first threaded element connected to a distal end portion of the actuator element. The first threaded element can be configured so that it removably fits into a second threaded element connected to the structure.
[0022] In some embodiments, the first threaded element may comprise a second screw and the second threaded element may comprise an internal threaded nut. In some embodiments, the actuator element may comprise a cable. In some embodiments, the at least one linear actuator device can
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9/115 further comprise a sleeve positioned in an annular direction around the actuator element.
[0023] In some embodiments, the device may also comprise an annular stop connected to the structure. In these embodiments, the actuator element can extend through the stop, and the at least one linear actuator device can comprise a support tube positioned in an annular direction around the actuator element, and the stop can be configured to fit in a distal end of the support tube and prevent the support tube from moving in the distal direction and exceeding the stop in an axial direction.
[0024] In some embodiments, the device may also comprise a locking tool configured to be removably attached to the first screw. The locking tool may comprise a tool head configured to fit in and produce rotation of the first screw when the locking tool is coupled to the first screw such that the first screw moves axially through the first element of the glove and the second glove element.
[0025] In some embodiments, the first screw may have a screw head at its proximal end and the shape of the tool head may be configured to correspond to a shape of the screw head such that the tool head make it operable in the sense of coupling with the screw head in such a way that the rotation of the tool head causes the rotation of the first screw.
[0026] In some embodiments, the screw head and the first glove element can be configured in such a way that the screw head is prevented from moving in the distal direction beyond the first glove element in an axial direction.
[0027] In some modalities, the at least one mechanism of
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The 10/115 lock may further comprise an internal axis which extends partially within a lumen of the tool head. In these embodiments, the inner shaft may have a threaded surface at its distal end, the screw head may have inner threads, and the inner axis may be configured such that its threaded surface fits into the inner threads of the screw head.
[0028] In some embodiments, the first screw may further comprise a rigid portion and a flexible portion positioned between the screw head and the rigid portion. In some embodiments, the flexible portion of the first screw may comprise a braided cable. In some embodiments, the flexible portion of the first screw may comprise a hypotube.
[0029] In some embodiments, the first screw may further comprise a rigid portion connected to the screw head, a flexible portion connected to a distal end of the rigid portion, and a stop connected to a distal end of the flexible portion.
[0030] In some embodiments, the device may also comprise a spring lock fixed to the first glove element. In these embodiments, the spring lock can be configured to exert inward radial force against the screw head in order to resist rotation of the screw.
[0031] In some embodiments, the device may also comprise a spring lock fixed to the screw head. In these embodiments, the spring lock can be configured to exert a radial force directed inwards against the first sleeve element in order to resist rotation of the screw.
[0032] In some embodiments, the device may also comprise a flange attached to the screw head. In these embodiments, the flange can be configured to curve against the first sleeve element in order to resist rotation of the screw.
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11/115 [0033] In some embodiments, the device may also include a ratchet lock fixed to a proximal end of the first glove element. In these embodiments, the ratchet lock can include teeth configured to allow rotation of the screw head in a first direction and prevent rotation of the screw head in a second direction.
[0034] In some embodiments, the device may also include a click lock attached to a proximal end of the first glove element. In these embodiments, the click lock can comprise teeth configured to resist rotation of the screw by less than 90 degrees and click when the screw rotates 90 degrees.
[0035] In another representative embodiment, a device may comprise a prosthetic valve comprising a radially expandable and compressible annular structure and at least one expansion and locking mechanism. The at least one expansion and locking mechanism may comprise a linear actuator connected to the structure and a rotating element. The linear actuator can be configured to apply a force directed in the distal direction and / or a force directed proximal to the structure in order to expand or compress the structure in the radial direction. The rotating element can be coaxially positioned with respect to the linear actuator and can be configured to retain the structure in an expanded state in the radial direction.
[0036] In some embodiments, the device may further comprise a first glove element and a second glove element. In these embodiments, the first sleeve element can be connected to the structure at a first position, the second sleeve element can have internal threads and can be connected to the structure at a second location, the linear actuator can be removably attached to the structure,
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12/115 the rotating element can be a thread configured to fit the internal threads of the second sleeve element, and the linear actuator can extend through a screw lumen.
[0037] In some embodiments, the device may also comprise a locking tool configured to be removably attached to the screw and rotate the screw in such a way that the screw moves axially through the first sleeve element and the second sleeve element when the locking tool is attached to the screw.
[0038] In some embodiments, the locking tool and the first sleeve element can be configured in such a way that the locking tool is prevented from moving in the distal direction and exceeds the first threaded element in an axial direction.
[0039] In some embodiments, the screw may have a screw head at its proximal end. In these embodiments, the screw head and the first element can be configured in such a way that the screw head is prevented from moving in the distal direction beyond the first sleeve element in an axial direction.
[0040] In some embodiments, the linear actuator can be an actuator screw provided with external threads and can be connected to the structure in a first location, and the device can also comprise a sleeve connected to the structure in a second location. In these embodiments, the actuator screw can extend through a lumen of the sleeve, the rotating element can be a lock nut provided with internal threads configured to fit the threads of the actuator screw, and the glove and lock nut can be configured in such a way that the lock nut is prevented from moving distally beyond the sleeve in an axial direction.
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13/115 [0041] In some embodiments, the actuator screw may comprise a first portion and a second portion. In these embodiments, the diameter of the second portion may be smaller than the diameter of the first portion.
[0042] In some embodiments, the device may also comprise an annular actuator element provided with internal threads configured to fit the threads of the second portion of the actuator screw such that, when the internal threads of the actuator element fit into the threads of the second portion of the actuator screw, the axial movement of the actuator element results in the axial movement of the actuator screw.
[0043] In some embodiments, the device may also comprise a locking tool positioned within a lumen of the glove. In these embodiments, the locking tool may have a notched portion at its distal end configured to fit a corresponding notched portion at a proximal end of the locknut such that rotation of the locking tool in a clockwise direction rotation of the lock nut in a clockwise direction.
[0044] In some embodiments, the locking tool may have an internally threaded surface to fit the threads of the actuator screw. In some embodiments, the device may further comprise a support tube positioned in an annular direction around the locking tool. In these embodiments, a proximal end of the glove can be configured to fit at a distal end of the support tube such that the support tube is prevented from moving distally beyond the proximal end of the glove in an axial direction .
[0045] In some embodiments, the device may also comprise a skirt. In these modalities, the structure can comprise
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14/115 a plurality of rows of rods and the skirt can be positioned inside at least one row of rods and on the outside of at least another row of rods.
[0046] In some embodiments, the device may also comprise a skirt. In these embodiments, the structure can comprise a plurality of rows of rods and the skirt can be positioned inside at least one row of rods and on the outside of at least another row of rods.
[0047] In another representative embodiment, an implantable prophetic valve may comprise an annular structure and a skirt. The annular structure can comprise a plurality of rows of rods and can be foldable and radially expandable between a radially folded configuration and an expanded radial configuration. The skirt can be woven around the rods so that the skirt is positioned within at least one row of rods and on the outside of at least one other row of rods.
[0048] In another representative embodiment, a method of implanting a prophetic heart valve may comprise inserting the prophetic heart valve into a patient's vasculature, the prophetic heart valve being coupled to a distal end portion of a linear actuator, in which the prophetic heart valve comprises a structure in a compressed state in the radial direction, the linear actuator acting to expand the structure to an expanded state in the radial direction, and turning a screw so that it advances through the first and of the second elements of the structure in order to retain the prophetic valve in the expanded state in the radial direction.
[0049] In some embodiments, the act of turning the screw may comprise the rotation of a locking tool coupled to the stop
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15/115 spindle and then decoupling the screw locking tool after the screw advances through the first and second elements.
[0050] In some modalities, the method may also include decoupling the linear actuator from the structure. In some embodiments, the act of uncoupling the linear actuator may comprise unscrewing a threaded portion of the linear actuator from a corresponding threaded portion of the structure. In some embodiments, the actuation of the linear actuator may include the application of a force directed proximally to a distal portion of the structure using a cable.
[0051] The objects, characteristics, and advantages of the present invention explained above and still others will become more evident from the detailed description below, with reference to the attached Figures.
[0052] BRIEF DESCRIPTION OF THE DRAWINGS [0053] Figure 1 is a side elevation view of a modality of a prophetic valve placement device.
[0054] Figure 2 is a side elevation view of a prophetic valve, according to a modality.
[0055] Figures 3A and 3B are an enlarged perspective view and a side view, respectively, of a modality of coupled structure rods usable in the prophetic valve of Figure 2.
[0056] Figure 4 is a side elevation view of another modality of a structure that can be used in the prophetic valve in Figure 2.
[0057] Figure 5 is a side view of an embodiment of a stem for a structure of a prophetic valve, such as the structure of Figure 2 or the structure of Figure 4.
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16/115 [0058] Figure 6 is a side view of the structure of Figure 4 shown in a compressed state in the radial direction.
[0059] Figure 7 is a side view of a prosthetic valve incorporating the structure of Figure 4 shown in a compressed state in the radial direction.
[0060] Figure 8 is an enlarged perspective view of the distal end portion of the prosthetic valve placement device of Figure 1.
[0061] Figure 9 is an enlarged side view of a locking unit and the distal end portion of a positioning element of the prosthetic valve placement device of Figure 1.
[0062] Figure 10A is an enlarged side view of the locking and positioning element of Figure 9, illustrating the positioning element decoupled from the locking unit.
[0063] Figure 10B is an enlarged side view of the distal end portion of the positioning element of Figure 10A rotated 90 degrees from the orientation shown in Figure 10A.
[0064] Figure 11 is an enlarged side view of the locking unit and the positioning element of Figure 9 rotated 90 degrees from the orientation shown in Figure 9.
[0065] Figure 12A is a schematic diagram of an actuation element with the locking devices that can be used with the prosthetic valve placement device of Figure 1, according to an embodiment.
[0066] Figure 12B is a schematic diagram of another modality of an actuation element with the locking devices that can be used with the prosthetic valve placement device of Figure 1.
[0067] Figure 12C is a schematic diagram of another modality of an actuation element with the locking devices that
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17/115 can be used with the prosthetic valve placement device in Figure 1.
[0068] Figure 13 is an enlarged cross-sectional view of the handle of the prosthetic valve placement device in Figure 1.
[0069] Figure 14 is a perspective view of a portion of a prosthetic valve structure incorporating an alternative implementation of a locking unit.
[0070] Figure 15 is an enlarged side view of the lock unit of Figure 14.
[0071] Figure 16A is a cross-sectional view of the locking unit of Figure 14 shown in the fully contracted state corresponding to the fully expanded state in the radial direction of the prosthetic valve.
[0072] Figure 16B is an enlarged cross-sectional view of a portion of the latch unit shown in Figure 16A.
[0073] Figure 16C is a cross-sectional view of the locking unit of Figure 16A showing a retracted release element in order to release the locking unit from the placement apparatus and locking the locking unit in the implanted state.
[0074] Figure 16D is an enlarged cross-sectional view of a portion of the latch unit shown in Figure 16C.
[0075] Figure 17A is an enlarged cross-sectional view of a portion of a locking unit that can be used with the prosthetic valve placement device of Figure 1, according to one embodiment, showing the locking unit portion in a locked configuration.
[0076] Figure 17B is an enlarged cross-sectional view of the lock unit of Figure 17A, showing the lock unit in a release configuration.
[0077] Figure 18 shows the distal end of another system
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18/115 of exemplary prosthetic valve placement.
[0078] Figure 19A shows a top view of the prosthetic valve placement system in Figure 18.
[0079] Figure 19B shows a top view of another embodiment of a prosthetic heart valve placement system.
[0080] Figure 20A shows the structure of Figure 18.
[0081] Figure 20B shows the structure of Figure 20A with a force exerted on the structure.
[0082] Figure 20C shows the structure of Figure 20A in a locked configuration.
[0083] Figure 21 shows a portion of the placement system of Figure 18 with the expansion elements removed.
[0084] Figure 22 shows a portion of the placement system in Figure 18 with the locking elements in place.
[0085] Figures 23A and 23B show views of the expanded expansion mechanism.
[0086] Figures 24A to 24D show expanded views of the locking mechanism.
[0087] Figures 25A to 25D show exploded views of the locking mechanism.
[0088] Figures 26A and 26B show several views of another expansion mechanism and exemplary lock.
[0089] Figure 27 is a perspective view of a prosthetic valve structure, shown in a radial folded state, having a plurality of expansion and locking mechanisms, according to another embodiment.
[0090] Figure 28 is a perspective view of the structure and expansion and locking mechanisms of Figure 27, with the structure shown in an expanded state in the radial direction.
[0091] Figure 29A is a perspective view of a screw
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19/115 one of the expansion and locking mechanisms in Figure 27.
[0092] Figure 29B is a perspective view of one of the expansion and locking mechanisms of Figure 27.
[0093] Figure 29C is another perspective view of the structure and expansion and locking mechanisms of Figure 27, with the structure shown in an expanded state in the radial direction.
[0094] Figure 30 shows a cross-sectional view of one of the expansion and locking mechanisms of Figure 27 together with a portion of the structure.
[0095] Figure 31 is another perspective view of one of the expansion and locking mechanisms of Figure 27.
[0096] Figure 32 shows an exemplary flexible screw that can be implanted in a prosthetic heart valve.
[0097] Figure 33 shows a portion of the structure of a prosthetic valve locked in place with a rigid screw.
[0098] Figure 34 shows a portion of the structure of a prosthetic valve locked in place with the flexible screw of Figure 32.
[0099] Figure 35 shows another exemplary flexible screw that can be implanted in a prosthetic heart valve.
[00100] Figure 36A shows a portion of the structure of a prosthetic valve and the flexible screw in Figure 35 before locking the valve in place.
[00101] Figure 36B shows a portion of the structure of a prosthetic valve locked in place with the flexible screw of Figure 35.
[00102] Figures 37A to 37C show alternative modalities of a flexible screw that can be implanted in a prosthetic heart valve.
[00103] Figure 38 shows a portion of the structure of a prosthetic valve locked in place with a screw.
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20/115 [00104] Figures 39 to 41 show the structure and screw of Figure 38 with an exemplary spring lock in order to prevent accidental rotation of the screw after the structure is locked.
[00105] Figures 42 and 43 show the structure and screw of Figure 38 with another exemplary spring lock.
[00106] Figures 44 and 45 show the structure and screw of Figure 38 with an exemplary permanent fold lock.
[00107] Figure 46 shows the structure and screw of Figure 38 with an exemplary ratchet lock.
[00108] Figures 47A to 47D show several views of the ratchet lock of Figure 46.
[00109] Figure 48 shows the structure and screw of Figure 38 with a click lock.
[00110] Figures 49A to 49D show several views of the click lock of Figure 48.
[00111] Figure 50 shows an exemplary alternative structure of a prosthetic heart valve and a skirt.
[00112] Figure 51 is a perspective view of a prosthetic valve, according to another modality.
[00113] Figures 52A to 52F show various views of a stem for a prosthetic valve structure, such as the structure of Figure 51. Figure 52 A is an elevation view outside the stem. Figure 52B is an elevation view from the inside of the stem. Figure 52C is an end view of the rod. Figure 52D is an end view of the opposite end of the rod. Figures 52E and 52F are seen in top and bottom plan of the stem, respectively.
[00114] Figures 53A to 53D show several views of a prosthetic valve structure formed from several rods of the type shown in Figures 52A to 52F. Figure 53A is an elevation view
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21/115 front of the structure, which is symmetrical about a central longitudinal geometric axis. Figure 53B is a front elevation view of the structure with the rear half of the structure removed for purposes of illustration. Figure 53C is a top plan view of the structure. The bottom plan view is a mirror image of the top plan view. Figure 53D is a perspective view of the structure.
DETAILED DESCRIPTION OF THE INVENTION [00115] This document describes examples of devices for placing prophetic implants and their components that can improve a physician's ability to control the size of a mechanically expandable prophetic implant, such as prophetic valves (for example, valves cardiac or venous valves), stents, or grafts, as well as facilitating the separation of the prophetic implant from the placement device, during the implant procedure. The present invention also provides structures for use with such prophetic implants. The structures may comprise rods formed in order to reduce or eliminate compression of the soft components of the prophetic implant (for example, the implant cusps) when the implant is compressed in the radial direction for a placement configuration for placement in a patient.
[00116] Figure 1 shows an example of a prophetic implant placement device 10 according to an embodiment of the present invention. The delivery device 10 can include two main components: a prophetic heart valve 14 and a delivery device 18. The prophetic valve 14 can be removably coupled to the delivery device 18, as described in more detail below. It should be understood that the delivery device 18 and other delivery devices described in this document can be used in the placement of other prophetic devices in addition to the prophetic valves, such as stents or grafts.
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22/115 [00117] Figure 2 is a side elevation view of the prosthetic valve 14 shown in its implanted configuration, radially expanded. Although only one side of the prosthetic valve 14 is shown in the drawings, it should be understood that the opposite side is similar to the portion shown. Prosthetic valve 14 can include a stent or annular structure 22, and a valve structure 24 that can be coupled to structure 22. Structure 22 can have an inflow end portion 26, an intermediate portion 28, and an efflux end portion 30. The prosthetic valve 14 can define a longitudinal geometric axis that extends through the inflow end portion 26 and the efflux end portion 30.
[00118] Structure 22 can be made of any one of several suitable materials, such as stainless steel or a nickel titanium (NiTi) alloy, for example, Nitinol. The frame 22 may include a plurality of interlocking truss rods 32 arranged in a truss-like pattern and forming a plurality of vertices 34 at the efflux end 30 of the prosthetic valve 14. The stems 32 can also form similar vertices at the inflow end of the prosthetic valve (which are covered by a skirt 50 in Figure 2). The lattice rods 32 are shown positioned diagonally, or displaced at an angle to, or radially displaced from, the longitudinal geometric axis of the prosthetic valve. In other implementations, the truss rods 32 can be displaced in a different proportion than shown in Figure 2, or some or all of the truss rods 32 can be positioned parallel to the longitudinal geometric axis of the prosthetic valve 14.
[00119] The truss rods 32 can be pivotally coupled to each other. In the illustrated embodiment, for example, the end portions of the rods 32 that form the vertices 34 at the outflow end 30 and the inflow end 26 of the structure 22 can have a respective opening 36. The rods 32 can also be
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23/115 formed with openings 38 spaced apart along their lengths between the opposite ends of the rods. The respective joints can be formed at the vertices 34 and at the places where the stems 32 overlap each other between the ends of the structure by means of fasteners 40, which may comprise rivets or pins extended through the openings 36, 38. The joints may allow the stems 32 rotate with respect to each other when structure 22 is expanded or contracted, such as during assembly, preparation, or implantation of the prophetic valve 14. For example, structure 22 (and therefore the prophetic valve 14 ) can be manipulated in a compressed or contracted configuration in the radial direction (see, for example, Figures 6 and 7) and inserted into a patient for implantation. Once inside the body, the prophetic valve 14 can be manipulated to an expanded state (for example, Figures 2 and 4) and then released from the delivery device 18 (for example, Figure 1), as described in more detail below.
[00120] Structure 22 can be formed using any suitable technique. Suitable techniques may include the separate formation of individual components (for example, rods 32 and fasteners 40) of the structure and then the assembly and mechanical connection of the individual components to form structure 22. The rods and fasteners can be formed, for example, by laser cutting these components from metal sheets or tubes, or by electroforming (electroplating or electrodeposition) or by physical vapor deposition. In some embodiments, electroforming or physical vapor deposition may be used in order to form the subcomponents of structure 22 or the entire structure 22 with the pivotable connections between the rods. In an implementation, for example, electroforming or physical vapor deposition can be used to form rods 32 with integral fasteners 40. Individual rods can
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24/115 be assembled together in a structure by inserting the integral fasteners 40 of each rod through a corresponding opening of an adjacent rod. In some embodiments, electroforming or physical vapor deposition may be used to form the entire structure in its final, cylindrical shape. In other embodiments, electroforming or physical vapor deposition may be used to form the entire structure in a flattened configuration, after which the ends of the flattened structure are connected to each other in order to form the final cylindrical shape of the structure. .
[00121] In other embodiments, the truss rods 32 are not coupled to each other with their respective joints (for example, with fasteners 40), but are otherwise pivotable or foldable with respect to each other in order to allow for expansion and radial contraction of the structure. For example, structure 22 can be formed (for example, by laser cutting, electroforming or physical vapor deposition) from a single piece of material (for example, a metal tube).
[00122] In addition to the truss rods 32, the structure 22 may include one or more support rods extended in the longitudinal direction 42. The support rods 42 can be circumferentially spaced around the structure 22 and coupled, including pivotably coupled, to the truss rods 32. The support rods 42 can be positioned parallel to, and radially spaced from, the longitudinal geometric axis of the prosthetic valve. The support rods 42 can improve the rigidity of the structure 22 and help the structure 22 to maintain a uniform shape when it is expanded or contracted. In some implementations, the frame 22 does not include the support rods 42. The support rods 42 can be connected to the truss rods 32 in the articulation joints formed by the fasteners 40 that can extend through the respective openings in the truss rods and in the
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25/115 support rods.
[00123] With reference to Figures 3A and 3B, a spacer 46, such as a washer or bushing, may be arranged in a joint between the truss rods 32, or in a joint between the truss rods 32 and the support rods 42 (not shown). When the truss rods 32 and / or the support rods 42 are pivotally coupled to each other, the spacers 46 may assist the truss rods 32, or the truss rods 32 and the support rods 42 to move around with respect to the others. Spacer 46 may also act to space truss rods 32 from each other, or from support rods 42. In some implementations, frame 22 does not include spacers 46, or truss rods 32, or truss rods 32 and the support rods 42, are spaced differently.
[00124] In particular embodiments, fasteners 40 do not extend radially outward from their respective openings 36, 38 in the rods and can be fully contained within the openings. As shown in Figure 3B, for example, each of the openings 36 on the outermost rods in the radial direction 32 can include a recessed hole or an enlarged recessed portion 37 which is dimensioned to receive the head portion 41 from a respective fastener 40 (for example, a rivet). The head portion 41 can be fully accommodated within the recessed hole 37 and not extend radially out of the hole, for example, the head portion 41 may be aligned with the outer surface of the stem 32. Similarly, the openings 38 they can also be formed with the holes lowered to receive the head portions 41 of the fasteners. In this way, fasteners 40 do not increase or contribute to the overall crimped profile of the prophetic valve and do not interfere with or impose undesirable stresses on the valve placement sheath (e.g. sheath 82 in Figure 1).
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26/115 [00125] Referring to Figure 2, the prophetic valve 14 can include a valve structure 24 in order to regulate blood flow through the prophetic valve. The valve structure 24 can comprise, for example, a set of cusps 48 comprising one or more cusps made of a flexible material. The cusps of the cusp set 48 may be made of all or part of a biological material (for example, a pericardial tissue, such as a bovine or equine pericardium), biocompatible synthetic materials, or other similar materials, such as those described in United States Patent No. 6,730,118.
[00126] The prophetic valve may also include a skirt or annular sealing element 50 which can be attached to the external surface of the inflow terminal portion 26 of the structure 22, for example, with sutures 56 adjacent to the inflow terminal portion 26 of the structure 22. The inflow terminal portion of the cusp set 48 can be attached to frame 22 and / or to skirt 50, for example, by means of sutures 56. The skirt 50 helps to establish a seal with the native tissue at the implant site in order to prevent or minimize perivalvular leakage. In alternative embodiments, the prophetic valve may have a skirt or sealing element mounted inside the structure or a skirt or sealing element mounted inside and outside the structure. The skirt can be made of a natural fabric (for example, a pericardial fabric) or any one of several biocompatible synthetic materials, including biocompatible fabrics (for example, an ethylene polyterephthalate (PET) fabric.
[00127] Further details regarding the cardiac valve prophetic of catheter, including the manner in which the valve structure 24 can be coupled to the frame 22 of the prophetic valve 14 may be found, for example, in U.S. Patent ^Nos 6,730. 118, 7,393,360, 7,510,575, 7,993,394 and 8,652,202.
[00128] Figure 4 is a side elevation view of a portion
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27/115 of a structure 200 that can be used with a prosthetic valve in at least certain embodiments of the present invention. Although only one side of structure 200 is shown in Figure 4, it should be noted that the opposite side may be similar to the portion shown. The structure 200 is similar to the structure 22 presented above, but does not include the longitudinal rods 42. The structure 200 can include a plurality of truss rods 204. Each of the truss rods 204 may include a plurality of openings 208. The openings 208 they can be used in order to connect the truss rods 204 to each other using the fasteners 210, as described above for the truss rods 32 (Figure 2). In other implementations, openings 208 and fasteners 210 may be omitted. For example, the truss rods 204 can be fixedly connected to each other, for example, by welding or gluing, or by laser cutting the individual rods of the structure of a metal tube. Although not shown in Figure 4, a spacer may be included between the truss rods 204, for example, intermediate the portions of the truss rods 204 with the openings 208. In a particular example, the spacers can be configured as described above for the spacer 46. Likewise, if desired, frame 200 may include support rods (not shown) which can be analogous to support rods 42 (Figure 2).
[00129] As best shown in Figure 5, each truss rod 204 may have a displaced, or zigzag pattern, defined by a plurality of displaced linear portions or segments 218. The linear segments 218 in the illustrated embodiment are arranged end to end with tip with respect to each other, with its adjacent tips interconnected to each other by intermediate segments 220. The stem 204 may have extended end portions 224 that form the vertices at the inflow and outflow ends of the structure. Each
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28/115 linear segment 218 is slightly offset laterally from an adjacent linear segment 218 in a direction perpendicular to the total length of stem 204 in order to provide the zigzag pattern to the stem. Each of the intermediate segments 220 and the end portions 224 can have a respective opening 208 in its geometric center for receiving a fastener 210.
[00130] The amount of displacement of each linear segment 218 with respect to an adjacent linear segment along the length of the stem 204 can be constant such that an imaginary line 214 can pass through the opening 208 of each intermediate segment 220 along the entire length of the rod. In alternative embodiments, the amount of displacement between two adjacent linear segments 218 can vary over the length of the stem. For example, the amount of displacement between the linear segments 218 adjacent to the structure's efflux terminal may be greater than the amount of displacement between the linear segments 218 adjacent to the structure's inflow terminal, or vice versa.
[00131] The linear segments 218 may include at least substantially flat or linear longitudinal edges 226a, 226b extending between the curved or rounded edges 228 of the intermediate segments 220. In alternative embodiments, the opposite edges 228 of the intermediate segments 220 may be substantially edges flat or linear that extend at an angle between the respective ends of the edges 226a, 226b of the linear segments 218.
[00132] As best shown in Figure 5, the width W1 of each linear segment 218 is defined as the distance measured between the opposite edges 226a, 226b of a segment 218. In the illustrated embodiment, the width W1 is constant over the rod length 204. As such, each longitudinal edge 226a is laterally offset by
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29/115 an adjacent longitudinal edge 226a of an adjacent linear segment 218, and each longitudinal edge 226b is laterally offset from an adjacent longitudinal edge 226b of an adjacent linear segment 218. The width W2 of each intermediate segment 220 and the end portion 224 can be greater than the width W1 of the linear segments 218.
[00133] In alternative modalities, the width W1 of each linear segment 218 can vary along the length of a rod. For example, the width W1 of a linear segment 218 adjacent to the inflow terminal of the structure may be greater than the width W1 of a linear segment 218 adjacent to the efflux terminal of the structure, or vice versa. In addition, when the width W1 of the linear segments 218 varies along the length of a stem 204, a linear segment may have a longitudinal edge 226a or 226b collinear with a longitudinal edge of an adjacent linear segment on the same side of the stem, while the other longitudinal edge 226a, 226b is laterally displaced from the longitudinal edge of an adjacent linear stem on the same side as the stem. In other words, the stem 204 may have a general displaced or zigzag pattern due to the variable widths W1 of the linear segments.
[00134] The displaced or zigzag pattern of the stem segments 218 can help to space the stems 204 in the circumferential direction when the structure 200 is in a compressed state in the radial direction, as shown in Figures 6 and 7. As as shown, the open truss structure of structure 200 defines open cells 250 between the stems 204 may be preserved, even when structure 200 is fully compressed or contracted. For example, with reference to Figure 6, although the width of cells 250 along the length of structure 200 may vary between their adjacent stems, an opening 256 will remain in the middle of a cell 250 between two
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30/115 adjacent pivot joints 254.
[00135] When frame 200 is incorporated into a prosthetic valve (for example, prosthetic valve 14), the spaced nature of rods 204, including openings 256, can help protect the soft components of the prosthetic valve when frame 200 expands or contracts. Figure 7, for example, shows a prosthetic valve comprising structure 200, a skirt 266 mounted on the outside of structure 200 and a set of cusps 264 mounted inside structure 200. An internal skirt (not shown) can also be mounted inside the structure. The skirt 266 and the cusp set 264 can be coupled to the structure 200, for example, with sutures 270. The sutures 270 can extend through the material of the skirt 266 and / or the cusp set 264 and radially over the stems 204. The openings 256 created by the displaced configuration of stems 204 may prevent cusps 264, skirt 266, and / or sutures 270 from being tightened or cut between adjacent stems 204 when the prosthetic valve is compressed in the radial direction. In this way, the soft components of the prosthetic valve are protected against damage that can occur from contact with the metal rods of the structure. [00136] The placement apparatus 18 of Figure 1 is particularly suitable for placing the prosthetic valve 14 or any of the other prophetic valves described in this document. However, it should be noted that any of the prophetic valves described in this document can be implanted using other suitable placement devices. For example, any of the prophetic valves described in this document can be beaded over an inflatable balloon from a conventional balloon catheter. Once placed in the implant site, the balloon can be inflated in order to expand the prosthetic valve to its fully functional size.
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31/115 [00137] Again with reference to Figure 1, the placement apparatus 18 may include a handle 70, an elongated axis 72 that extended distally from the handle 70, a plurality of first actuating elements 76 (also referred to as positioning elements or elongated actuating elements), such as in the form of positioning tubes, extended across the axis and distally out of a distal end 78 of the axis 72, a plurality of release elements 106 (Figure 9) extended across of the respective positioning elements 76, and a plurality of second actuation elements 86 (also referred to as straps) that extend through the respective release elements 106. The positioning elements 76 can be at least partially arranged in the radial direction of, and extended axially through, one or more lumens of axis 72. For example, the positioning elements 76 can extend across central lumen of axis 72 or through the respective separate lumens formed on axis 72.
[00138] The shaft 72 may have a distal end portion 82 that can function as a sheath to contain or accommodate the prosthetic valve 14 in a radially compressed state for placement through a patient's vasculature. In this regard, the distal end portion 82 may have a lumen sized to receive the prosthetic valve 14 in a radially compressed state. As shown in Figure 13, the proximal end portion of axis 72 can extend into an axially extended hole 138 formed in the distal end portion of handle 70. The proximal end portion of axis 72 can be retained within of the axial hole 138 through a pressure or friction contact with the hole 138, using an adhesive, a clamp, a fastener, through the thermal connection of the catheter 72 in the hole 138, or by some other technique or mechanism.
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32/115 [00139] The positioning elements 76 have distal end portions that can be removably connected to the prophetic valve 14 through the respective release and lock units 94 (as best shown in Figure 8). As shown in Figure 13, the positioning elements 76 can extend through the axis 72, and proximally beyond a proximal end 140 of the axis, and into a central hole 142 of handle 70. A lead screw 144 can be arranged inside the central hole 142 of the handle 70. The proximal ends of the positioning elements 76 can be attached to the lead screw 144, for example, when they are received inside a hole (not shown) of the lead screw 144, in which they can be fixed by pressure or friction contact in the lead screw hole 144, using an adhesive, a clamp, a fastener, a thermal connection, or other suitable technique or mechanism.
[00140] As shown in Figures 8 and 9, each actuation element 86 can extend through a lumen of a respective positioning element 76. Actuation elements 86 can be coupled in their distal end portions to distal end 60 of structure 22. For example, the distal end portion of each actuating element 86 can be connected to a vertex 34 at the distal end 60 of the structure, such as by welding, an adhesive, or a mechanical fastener. Each actuating element 86 can also extend through a lumen of a respective locking unit 94 that can be coupled to the frame 22, for example, to a vertex 34 at the proximal end 62 of the frame. The actuation elements 86 can extend proximally inwards and through the handle 70. The proximal end portions 88 of the actuation elements 86 can be removed removably by a clamping element 182 mounted inside or on the handle 70 ( Figure 13).
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33/115 [00141] The actuating elements 86 operate in order to apply a pulling force directed proximally to the distal end 60 of the structure in cooperation with the positioning elements 76 which apply a pushing force directed towards the distal end. proximal 62 of the structure in order to carry out the radial expansion of the structure 22. In particular embodiments, the actuating elements 86 can comprise a relatively flexible material, but relatively non-elastic that can effectively transfer the tensile forces generated in the handle 70 towards the end distal from structure 22. For example, actuating elements 86 may comprise threads, sutures, ropes, or similar materials. In other embodiments, the actuating elements 86 can be a relatively more rigid component, such as an axle or rod, which can transfer the tensile forces directed proximally to the structure, as well as the impulse forces directed distally towards the structure.
[00142] The release elements 106 have distal end portions 107 that extend coaxially through the respective locking units 94 (Figure 9) and the proximal end portions 108 that extend into the handle 70 (Figure 13). The proximal end portions 108 of the release elements 106 can extend through the lead screw 144 and can be attached to a release button 168 inside handle 70.
[00143] Referring to Figures 1 and 13, a threaded actuator nut 148 can be arranged around the lead screw 144. The internal threads (not shown) of the threaded actuator nut 148 can fit into the threads 150 of the screw advance 144. An outer surface 152 of the threaded actuator nut 148 may extend through an opening or window 154 formed on the outer surface
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156 of handle 70. The outer surface 152 of threaded actuator nut 148 may include a texture, such as ridges 158, in order to assist a user to grasp and rotate threaded actuator nut 148.
[00144] Rotating the threaded actuator nut 148 in a first direction can cause the lead screw 144 to translate axially in the distal direction with respect to handle 70, thereby causing the positioning elements 76 to translate distally through the lumen from the shaft 72. Rotation of the threaded actuator nut 148 in the opposite direction can cause the lead screw 144 to translate in the proximal direction with respect to the handle, thereby causing the positioning elements 76 to retract or translate in the proximal direction through the lumen of shaft 72.
[00145] In particular implementations, the number and spacing of threads 150 of lead screw 144 (and thus the matching threads of threaded actuator nut 148), and the axial length of lead screw 144 can be selected from in order to provide a desired degree of displacement for positioning elements 76 and release elements 106. For example, the desired degree of displacement may be sufficient to allow structure 22 (and therefore the prophetic valve 14) to be manipulated between a fully expanded state (as shown in Figures 2 and 8) and a fully contracted or compressed state (as shown in Figures 6 and 7), including states between fully compressed or contracted or fully expanded, as described in more detail below.
[00146] The release and lock units 94 (also referred to as lock units) in the illustrated mode are configured so as to remove the positioning elements 76 to the structure 22 of the prophetic valve 14 in a removable way and selectively fix the elements
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35/115 of actuation 86 in order to retain the prosthetic valve 14 in an implanted and expanded state. With reference to Figures 8 to 11, the locking units 94 can comprise a generally cylindrical body 96 which can be attached to the structure 22 of the prosthetic valve 14 by a fastener 130 (for example, a pin or rivet). The fastener 130 can extend through an opening 132 (Figure 11) formed in the body 96 and through one or more corresponding openings 36 in the frame rods 32 that form the vertices 34 of the frame (Figure 8).
[00147] The body 94 may comprise a locking member, for example, in the form of a clamp 98, disposed adjacent to a distal end 100 of the locking unit 94 so as to selectively fit into an actuating element 86. The clamp 98 may comprise, for example, a pair of diametrically opposing claws 102 angled radially inward towards each other (as best shown in Figure 11). A release element 106 can be arranged within a lumen of each locking unit 94 in order to retain the clamps 102 of the clamp in an unhitched or unlocked state during the placement of the prosthetic valve 14 (Figure 9). Each release element 106 can extend proximally through a respective positioning element 76 to handle 70. As described above, the proximal end portions 108 of the release elements can be attached to a release button 168 on the handle ( Figure 13). Each actuating element 86 can extend proximally through a lumen of a respective release element 106 within handle 70.
[00148] In particular implementations, the release elements 106 can be made of any suitable biocompatible metallic material or polymeric material. In some examples, the material can be selected to allow the release elements 106 to become easily movable with respect to the claws 102 during placement
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36/115 of the valve, as described in more detail below. For example, the release elements 106 may be made of a lubricating or low-friction material (for example, PTFE) or may have an outer layer made of a lubricating or low-friction material (for example, PTFE).
[00149] When the release elements 106 are disposed within the locking units 94 that extend between the claws 102, the claws 102 are kept in an unlocked state and are prevented from coming into contact with the actuation elements 86. In the state unlocked, actuating elements 86 and positioning elements 76 can move freely in the axial direction with respect to each other in order to control the radial expansion and compression of the prophetic valve 14. When the prophetic valve 14 has to be released from the placing apparatus 18, the release elements 106 may be retracted proximally with respect to the locking units 94 and the positioning elements 76. As shown in Figures 10A and 11, once the release elements 106 are removed from the socket with the claws 102, claws 102 may move to a locked or engaged state in order to engage actuating elements 86, thereby preventing further movement of the actuating elements 86, and therefore retaining the structure 22 of the prophetic valve 14 in a desired expanded state.
[00150] Again with reference to Figure 10, the locking units 94 can be removably attached to the positioning elements 76 by means of the release elements 106. In the illustrated embodiment, for example, a distal end portion 110 of each positioning element 76 may include a coupling portion 112 which may include a tab 114 and a notch 116. Each locking unit 94 may include a corresponding notch 120 configured to accommodate the tab 114 of the positioning element
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76. Similarly, each locking unit 94 may include a flap 122 to be inserted into, and received by, the notch 116 of a respective positioning element 76. The flaps 114, 122 and the notches 120, 116, together with the release element 106, collectively they can form a releasable interlocking joint. The engagement of the flaps 114,122 in the notches 120,116 prevents the axial separation of the positioning element 76 from the locking unit 94, while the release element 106, which extends through the flaps 114, 122 in the locked state, prevents lateral separation of the positioning element 76 of the latch unit 94.
[00151] As shown in Figure 10B, the tab 114 of the positioning element 76 can include a groove extended in the axial direction 128. The groove 128 can be dimensioned to allow the tab 114 to be placed around the actuating element 86 or removed from the actuating element 86 when passing the actuating element through groove 128. However, groove 128 is desirably narrower than the diameter of the release element 106 in order to prevent lateral separation of the positioning element 76 of the latch unit 94 when the release element 106 is in an extended position through the tabs 114, 122, as shown in Figure 9. As indicated above, the retraction of the release element 106 from the claws 102 of the clamp 98 allows the claws to engage the actuation element 86. In addition, the retraction of the release element 106 until the distal end of the release element 106 is proximal to the flap 122 and the notch 116 allows the distal end portion 110 of the positioning element 76 to be separated from the locking unit 94 in a lateral direction (in a direction perpendicular to the length of the locking unit and the positioning element), as illustrated in Figure 10A. As the positioning element 76 moves in a lateral direction out of the lock unit 94, the
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38/115 actuating element 86 can pass through the groove 128 of the flap 114.
[00152] As still shown in Figure 10A, the flaps 114, 122 can be formed with the respective inclined meat surfaces 124,126, respectively, in order to facilitate the separation of the positioning element 76 from the latch unit 94. Each surface of meat 124.126 is inclined with respect to the longitudinal geometric axis of the positioning element 76 at an angle of less than 90 degrees. Therefore, the application of a force directed proximally to the positioning element 76 in the direction of arrow 134 (for example, when applying a tractive force to the positioning element in handle 70) causes the positioning element 76 to slide laterally out of the lock unit 94 in the direction of arrow 136.
[00153] The locking units 94 and / or the positioning elements 76 can include a cutting mechanism in order to cut the portions of the actuation elements 86 that extend proximally beyond the clamps 102 of the clamps 98 after the prosthetic valve expand and the release elements retract to actuate the clamps. For example, a blade, or other cutting surface, can be placed through the groove 128, such that the actuating elements 86 can be cut when they pass through the groove 128 during lateral separation of the positioning element 76 lock unit 94.
[00154] In another example, locking units 94 may include a clamping element which may include cutting jaws (for example, sharp or serrated jaws) positioned proximal to jaws 102. Cutting jaws, such as jaws 102 , can be held in an open position away from the actuating element by the release element 106. When the release element 106 is retracted out of engagement with the cutting jaws, the cutting jaws may move
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39/115 in the radial direction inward against the actuating element 86, thereby cutting it in that position. In other examples, a separate cutting device may be used to cut the actuating elements 86 in a desired position after the positioning elements 76 are released from the prosthetic valve 14, or, optionally, after the placing device 18 be removed from the body.
[00155] Again with reference to Figures 1 and 13, the lead screw 144 includes an extension portion 160 that extends proximally to the threaded portion of the lead screw. The extension portion 160 may comprise two leg portions 162 that define a U-shaped opening or slot 164 between the leg portions 162. The release button 168 may comprise a slide element 170 disposed between the leg portions 162 and a user insertable portion 172 extended radially out of the slide element 170. The proximal end portions 108 of the release elements 106 can be rigidly attached to the slide element 170, for example, with a suitable adhesive, such that a axial movement of the slide element 170 in the distal and proximal directions causes a corresponding movement of the release elements.
[00156] The release button 168 can be configured to move with, or even independently of, the lead screw 144. As noted above, the axial movement of the lead screw 144 causes a corresponding movement of the positioning elements 76. Therefore, when release button 168 is retained with respect to extension portion 160 of lead screw 144, axial movement of lead screw 144 will cause release button 168 and release elements 106 to move with the positioning elements 76, for example, during the implantation and the
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40/115 prosthetic valve expansion. When the release button 168 is not retained with respect to the extension portion 160 of the lead screw 144, the release button 168 can translate axially with respect to the extension portion, thereby performing the axial movement of the release elements 106 with respect to the positioning elements 76 in order to actuate the clamping mechanism 98 of the locking unit 94 and to release the positioning elements 76 from the structure 22 of the prosthetic valve.
[00157] Various mechanisms can be used in order to selectively or releasably release release button 168 in axial direction with respect to extension portion 160 of lead screw 144. For example, a movable pin or similar mechanism can be inserted through the slide element 170 or one or both leg portions 162 of the extension portion 160 in order to retain the axial position of the slide element 170 with respect to the lead screw 144. Removing the pin from the slide element 170 and / or of the leg portions 162 will allow axial movement of the release button 168 with respect to the lead screw.
[00158] In another embodiment, the slide element 170 can be configured to move between a first position in which it is engaged by friction by the extension portion 160 and a second position in which the slide element 170 no longer it is chained by the extension portion 160. In the first position, the axial movement of the lead screw 144 causes a corresponding movement of the release button 168. In the second position, the release button 168 can be moved in the axial direction independently of the screw advance 144 in the distal and proximal directions.
[00159] The actuating elements 86 can extend proximally beyond the proximal end portions 108 of the release elements 106 and through a hole or opening extended in the direction
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41/115 axial 178 formed at the proximal end portion 180 of the handle 70. The actuating elements 86 can be selectively fixed with respect to the handle 70 using a clamping or holding mechanism 182. The holding mechanism 182 can comprise a plug element 184, a screw element 186 connected to one end of the plug element 184, and a button 188 connected to the opposite end of the screw element 186. The plug element 184 can be positioned in a radial hole 184 made in the proximal end portion 180 of handle 70. Buffer element 184 may include a bottom triangular or trapezoidal surface that can be placed on or removed from, in contact with a corresponding formed surface 192 of radial bore 190. In other implementations, buffer element 184 may have a different way. The screw element 186 extends through a captured nut 194 in such a way that the rotation of the button 188 causes the plug element 184 to move towards or away from the surface 192 of the radial hole 190.
[00160] When the button 188 is fully depressed (such as by turning the button 188 in a first direction), the bottom surface of the plug element 184 can secure the actuating elements 86 against the surface 192, thereby fixing the locking elements actuation 86 against movement with respect to handle 70, axis 72, locking units 94, and structure 22 of the prosthetic valve. When the button 190 rotates in the opposite direction, the buffer element 184 can move off the surface 192 and the actuation elements 86, allowing the actuation elements to move with respect to the handle 70, the axis 72, the lock 94, and the structure 22 of the prosthetic valve.
[00161] To use the placement device 18 for placing and placing the prosthetic valve 14 in a desired position within the
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42/115 heart (for example, in the native aortic valve), the prosthetic valve 14 is connected to the positioning elements 76 using locking units 94 and release elements 106, as shown in Figures 8 and 9. The release 168 is fixed with respect to lead screw 144 in order to prevent a relative movement between the positioning elements 76 and the release elements 106. The prosthetic valve 14 can then be radially compressed or bent to a compressed state, as shown in Figure 7. The compressed prosthetic valve 14 can be loaded into sheath 82 of shaft 72.
[00162] Conventional techniques and devices can be used to insert and advance the placement device 18 and prosthetic valve 14 through a patient's vasculature to the desired implantation site. For example, a prosthetic aortic valve can be placed in a retrograde approach by advancing the delivery device through a femoral or aortic artery to the native aortic valve. At or adjacent to the implant site, the prosthetic valve 14 can be implanted from the sheath 82 by turning the actuator nut 148 in one direction so that the lead screw 144 moves distally with respect to the handle 70. This causes the positioning elements 76 and the release elements 106 to move distally with respect to the axis 72. The positioning elements 76 push the prosthetic valve 14 distally with respect to the axis 72. The actuator nut 148 can be rotated until the prosthetic valve is implanted from the distal end of sheath 82. In some implementations, the inherent resilience of structure 22 may cause the prosthetic valve to expand at least partially when advanced from sheath 82.
[00163] When prosthetic valve 14 is implanted from the sheath
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82, the retention mechanism 182 may be in a release position, allowing the actuating elements 86 to move distally with the prosthetic valve. In this way, the actuating elements 86 do not apply any expansion forces to the prosthetic valve when it is being implanted from the sheath. In order to apply an expansion force to the prosthetic valve, the retention mechanism 182 is tightened in order to retain the actuating elements 86 with respect to the handle 70. The continued rotation of the actuator nut 148 causes the positioning elements 76 continue to apply a force directed in the distal direction on the proximal end of the structure 22, while the actuation elements 86 (which at that moment are contained by the retention mechanism 182) apply a force directed proximally on the distal end of the structure 22. The application these forces causes the structure 22 to shorten in the axial direction and expand in the radial direction.
[00164] In some embodiments, the retaining mechanism 182 can be held in the locked position or engaged against the actuating elements 86 during implantation of the valve, as long as the actuating elements are long enough and have enough clearance to prevent application of any expansion force on the prosthetic valve when it is advanced from the sheath 82. For example, the lengths of the actuating elements 86 can be selected so as to prevent the application of any expansion force on the prosthetic valve when the it is advanced from the sheath 82 or after the prosthetic valve is fully implanted from the sheath, the actuating elements 86 are tightened and begin to apply an expansion force on the structure contrary to the expansion force of the positioning elements 76 in order to expand the prosthetic valve.
[00165] When repositioning or a complete withdrawal of
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44/115 body prosthetic valve is necessary, the user can turn the actuator nut 148 in the opposite direction, which will cause the positioning elements 76 to pull the prosthetic valve back into the sheath 82. The action of the portions distal end 110 of the positioning elements 76 which are retracted into the sheath 82 causes the prosthetic valve to compress in the radial direction. When desired or necessary, the prosthetic valve can be partially compressed without retracting into the sheath and then repositioned and expanded again by turning the actuator nut 148. In some cases, the prosthetic valve can be fully retracted back to inside sheath 82 for repositioning or complete removal of the prosthetic valve from the body.
[00166] When the prosthetic valve is expanded and positioned in the desired location, the release elements 106 can be retracted from the locking units 94. This can be achieved by releasing the release button 168 from the lead screw 144 and retracting the button release 168 in the proximal direction, which will cause the release elements 106 to retract from the locking units 94. When the distal ends of the release elements 106 are proximal to the claws 102 of the clamping mechanism 98, the claws may engage actuating elements 86 in order to retain the prosthetic valve in the expanded state. Greater retraction of the release elements 106 by the flaps 122 of the latch units 94 will allow the positioning elements 76 to disengage from the latch units. The retraction of the positioning elements 76 by rotating the actuator nut 148 or the retraction of the handle 70 will cause the distal end portions 110 of the positioning elements to disengage from the locking units 94. As described above, the portions the actuating elements 86 proximal to the clamping mechanisms 98 can be cut and removed from the body. The placement device can then be removed from the
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45/115 body.
[00167] In alternative embodiments, the distal end portions of the actuation elements 86 may have locking devices in order to promote the locking engagement of the claws 102 of the clamping mechanism 98 with the actuation elements 86. Figures 12A, 12B , and 12C, for example, show actuating elements 310, 320, 330, respectively, which can be used with locking unit 94 of Figure 9. With reference to Figure 12A, actuating element 310 may include locking devices on the in the form of a plurality of spaced ribs or protrusions 312 and slots 314 between ribs adjacent to the claws 102 of the clip 98 can extend into the slots 314, helping to secure the actuating element 86 against movement with respect to the clip 98 in a direction opposite to the voltage applied to the actuation element by the user. In other words, the actuating element 86 and the clamp 98 may act as a ratchet that allows the actuating element 86 to be pulled through the clamp 98 in a first direction in order to expand the structure 22, but the clamping 102 in the slots 314 it will prevent the movement of the actuation element 86 in a second opposite direction.
[00168] As shown in Figure 12B, an actuating element 320 may include a plurality of spaced angled burrs 322 which may engage the claws 102 of the clamp 98. Referring to Figure 12C, an actuating element 330 may include a plurality of spherical protrusions spaced apart 332, for example, spheres, which can fit in the claws 102 of the clamp 98. The burrs 322 and the protrusions 332, for example, the ribs 312, allow movement of the actuating element through the claws 102 in a first direction, but prevent movement in a second opposite direction.
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46/115 [00169] Figures 14, 15, and 16A to 16D illustrate an alternative release and locking unit 410 that can be used with a prosthetic implant placement device, including, for example, the prosthetic implant placement device 10 of Figure 1 unit. The locking unit 410 can be incorporated into any radially expandable structure of a prosthetic valve or other type of prosthetic implant, including, for example, structure 22 in Figure 2 or structure 200 in Figure 4.
[00170] With reference to Figure 14, the locking unit 410 can be coupled to a frame 412. The frame 412 can have a similar construction to the frame 200. One or more locking units 410 can be attached to the frame 412 in circumferential positions spaced apart, similar to the locking units 94 described above. In particular embodiments, frame 412 can have three of these locking units 412 connected to the frame, as shown in Figure 1 with respect to locking units 94.
[00171] The locking unit 410 can generally comprise an inner element 416, an inner tubular element, and an outer element 418, such as an outer tubular element, concentrically arranged around inner element 416. Inner element 416 and the outer element may be movable in the longitudinal direction with respect to each other in a telescopic manner in order to expand and contract the structure 412 in the radial direction, as further described below. As best shown in Figures 14 and 16A, the inner element 416 can have a distal end portion 420 coupled to a distal end 422 of the frame 412 with a coupling element 424. The outer element 418 can have a proximal end portion 426 coupled to a proximal end 428 of structure 412 with a respective coupling element 424.
[00172] The inner element 416 and the outer element 418 can be
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47/115 fit with respect to each other between a fully contracted state (as shown in Figure 15) corresponding to a fully expanded state in the radial direction of the prosthetic valve and a fully extended state (where the inner element 416 is fully extended to from external element 418) corresponding to a fully compressed state in the radial direction of the prosthetic valve. Locking unit 410 allows the prosthetic valve to fully expand or partially expand to different diameters and to keep the prosthetic valve in the partially or fully expanded state.
[00173] Each of the coupling elements 424 is desirably connected to a respective vertex 430 at the proximal or distal end of the structure. Each vertex 430 can be formed by the adjacent end portions of the two supports 432 which are pivotally connected to each other with a fastener 434 (for example, a rivet or pin) which extends through the corresponding openings of the rods. Each coupling element 424 can be pivotally connected to a respective vertex 430 by means of a corresponding fastener 434 that extends into an opening or hole 436 (Figure 16A) of the coupling element 424. The fastener 434 in the illustrated embodiment , therefore, connects the end portions of the rods 432 to a coupling element 424, while allowing the rods to rotate with respect to each other and to the coupling element 424.
[00174] In alternative embodiments, the end portions of the rods 432 can be attached to each other and to the coupling element without a pin connection. For example, the structure can be laser cut from a metal tube with no pin connections at each vertex, and the coupling elements or end portions of the inner and outer elements 416, 418 can be co
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48/115 connected to the structure at the vertices or the respective adjacent vertices, for example, by welding or sutures.
[00175] As still shown in Figure 16A, a proximal end portion 438 of the inner element 416 can be removably coupled to an inner actuating element, or axis, 440 that extends the length of the placement apparatus to a handle on the proximal end of the placement apparatus (the handle is not shown, but may be similar to handle 70 in Figure 1). The proximal end portion 426 of the outer element 418 can be removably coupled to an outer actuating element, or shaft, 442 that extends the length of the placement apparatus to the handle at the proximal end of the placement apparatus. The proximal end portions of the internal actuating element 440, and the external actuating element 442 can be operationally connected to the respective actuators or control mechanisms (for example, rotary or sliding buttons) of the handle in order to perform the longitudinal movement of the elements 440, 442 in relation to each other. The internal actuating element 440 can extend coaxially through the external actuating element 442. The pair of internal and external actuating elements 440, 442 can extend through an external axis (not shown, but may be similar to axis 72 of the Figure 1) together with other pairs of internal and external actuation elements extended from the other locking units 410. All pairs of internal and external actuation elements 440, 442 can be operationally connected to a common actuator or control mechanism over the handle.
[00176] The internal and external actuation elements 440, 442, respectively, are configured so as to apply forces directed proximally and distally to the internal and external elements 416, 418, respectively, in order to perform the expansion and contraction radial
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49/115 structure 412. For example, in order to expand the structure, the external actuating element 442 can be moved in the distal direction, while the internal actuating element 440 remains stationary, thus causing the external element 418 to move. in the distal direction over the inner element 416. As a result, a force directed in the distal direction will be applied to the proximal end 428 of the structure 412, causing the structure to shorten in the axial direction and expand in the radial direction. The expansion of structure 412 can also be obtained by moving the internal actuation element 440 in the proximal direction, while the external actuation element 442 remains stationary. Alternatively, the structure 412 can be expanded by moving the internal actuating element 440 in the proximal direction and, simultaneously, moving the external actuating element 442 in the distal direction. The structure 412 can be contracted in the radial direction by reversing the direction of movement of the internal and external actuation elements 440, 442.
[00177] A release element 444 can extend coaxially between the internal actuating element 440 and the external actuating element 442 along the length of the placing device. A distal end portion 446 of release element 444 can extend coaxially between inner element 416 and outer element 418 of latch unit 410. The proximal end portion of release element 444 (not shown) can be operationally connected to a corresponding actuator or control mechanism (for example, a rotary or sliding button) of the handle in order to perform the longitudinal movement of the release element with respect to the internal and external actuation elements 440, 442. The locking unit 410 may include a central tube 448 coaxially arranged between the inner element 416 and the outer element 418 distal from the releasing element 444. The central tube 448 helps to hold the outer element 418 in
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50/115 a coaxial alignment with respect to the inner element 416 and can be fixed, for example, by welding, to the outer element 418. The proximal end portions of the release elements 444 extended from all locking units 410 of the structure they can be operationally connected to a common actuator or control mechanism of the handle.
[00178] As mentioned above, the proximal end portion 426 of the outer element 418 can be removably coupled to the outer actuating element 442. As best shown in Figure 15, the removable coupling can be formed, for example, by a notch 454 and a flap 456 formed in the proximal end portion 426 of the outer element 418 and configured so as to removably fit in a corresponding flap 458 and in a notch 460 of the outer actuation element 442. During placement and expansion of the prosthetic valve, the release element 444 extends through the notches 454, 460 and flaps 456, 458, and may prevent the flap 456 from disengaging from the notch 460, and the flap 458 from disengaging from the notch 454, such such as flaps 114, 120 and notches 116, 120 of Figure 10A. When the prosthetic valve must be released from the placement device, the release element 444 can be moved proximally to the notches 454, 460 and the flaps 456, 458, allowing them to disengage and the outer element 418 and the element external actuator 442 disengage from each other.
[00179] The proximal end portion 438 of the inner element 416 can be removably coupled to the inner actuating element 440 in a similar manner. For example, inner element 416 can be coupled to inner actuation element 440 through a notch 462 and a guide 464 formed at the proximal end portion 438 of inner element 416 and configured to fit
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51/115 removably in a flap 466 and a corresponding notch 468 of the internal actuating element 440. During implantation and expansion, the release element 444 can extend in a coaxial direction along the notches 462, 468 and flaps 464, 466, preventing the inner element 416 and the inner actuation element 440 from decoupling. When the prosthetic valve must be released from the placement device, the release element 444 can be moved proximally to the notches 462, 468 and flaps 464, 466, allowing them to disengage and the inner element 416 and the 440 internal actuation disengage and disengage from each other.
[00180] The internal and external elements 416, 418 may include corresponding locking devices in order to retain the structure 412 in an expanded state. In the illustrated embodiment, for example, the inner element 416 may include one or more openings or recesses spaced in the longitudinal direction 470 arranged along the length of the inner element 416. The openings 470 can be configured to receive a locking element 472 of the outer element 418. locking element 472 may have a fixed end portion 474 attached to outer element 418, a tapered or reduced diameter intermediate portion 476, and a free end portion, or closure portion 478 configured to fit in one of the recesses 470. [00181] The locking element 472 can be tilted radially inwards towards the inner element 416, for example, by defining that the shape of the locking element 472 bends inwards towards the element internal. In certain embodiments, for example, the locking element 472 (and, optionally, the entire outer element 422) can be made of a shape memory alloy, such as a nickel titanium (NiTi) alloy, for example, Nitinol . When the release element 444 is disposed between the inner element 416 and the outer element 418 during placement and expansion of the prosthetic valve, the element
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52/115 of lock 472 is retained in an unlocked state with locking portion 478 radially spaced out of recesses 470 of inner element 416 (as best shown in Figure 16B). When the release element 444 is moved proximally beyond the locking element 472, the locking element 472 may take its pre-folded shape, indicated by position 480, and the locking portion 478 may extend into a recess selected 470 (as best shown in Figure 16D). When the locking portion 478 enters a recess 470, the inner element 416 and the outer element 418 may be prevented from relative axial movement, thereby resisting a radial contraction of the structure from its expanded state.
[00182] A rigid sleeve 490 can be mounted on the outer element 418 adjacent to the locking element 472 in order to resist deformation of the locking unit 410 in the area of the locking element 472. The rigid sleeve 490 can be at least so general annul and extend around at least a portion of the outer surface of the outer element 418. In some instances, the rigid sleeve 490 may extend fully over the outer surface of the outer element 418. In other examples, the rigid sleeve 490 may extend for less than the entire outer surface of the outer element 418. In some cases, the rigid sleeve 490 may be rigidly attached to the outer element 418, for example, by gluing or welding.
[00183] In use, the prophetic valve incorporating frame 412 and locking units 410 can be placed in a compressed state in a sheath of a delivery device, as described above with respect to prophetic valve 14. A physician may, then insert the prophetic valve into a patient. When the prophetic valve is at the desired location within the patient, the doctor can implant the sheath prophetic valve and then expand or contract the structure
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412 in order to obtain a desired size (diameter) of structure by manipulating the internal and external actuating elements 440, 442, as described above. The prosthetic valve can be unfolded from the sheath by retracting the sheath and / or by advancing the internal and external actuating elements in the distal direction in order to advance the sheath prosthetic valve.
[00184] In particular modalities, the prosthetic valve becomes fully functional as soon as it is unfolded from the sheath and at least partially expanded. In this way, the doctor can test the function of the prosthetic valve before releasing the prosthetic valve from the placement device. If necessary or desired, the prosthetic valve can be at least partially compressed in the radial direction, repositioned (for example, repositioned upwards or downwards) and then expanded again. If necessary or desired, the prosthetic valve can be fully compressed in the radial direction and recovered back into the sheath of the device for placing and removing the body.
[00185] When the desired size and position of the prosthetic valve are obtained, the doctor may retract the release element 444 proximally until it is positioned proximal to the locking element 472. The locking element 472 can then assume its pre-curved shape and fit into an opening 470 of the inner element 416 of the locking unit, thereby preventing another relative movement between the inner element 416 and the outer element 418 and retaining the prosthetic valve in its expanded state. As noted above, the handle of the placing apparatus may include a common actuator that controls the retraction of all release elements 444 that extend from the corresponding locking units 410 of the structure in embodiments that include several locking units.
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54/115 [00186] In order to release the prophetic valve from the delivery device, the doctor may further retract the release element 444 until it is located proximal to the notches 462, 468 and the flaps 464, 466 in order to decouple the inner element 416 from the inner actuation element 440, and proximal to the notches 454, 460 and the flaps 458, 456 in order to decouple the outer element 418 from the outer actuation element 442. Then the placement device can be removed of the body. [00187] It should be noted that the locking units 410 and the placement apparatus used with them can be modified without departing from the scope of the present invention. For example, in some implementations, outer element 418 may be axially movable with respect to a fixed inner element 416, in other implementations, inner element 416 may be axially movable with respect to a fixed outer element 416, and in still other implementations , the inner element 416 and the outer element 418 may both be axially movable with respect to each other. Although the inner element 416 is illustrated and described as connected to a distal end 422 of the frame 412, in other implementations, the position of the locking unit can be inverted such that the inner element 416 can be connected to the proximal end 428 of the structure 412, and the outer element 418 connected to the distal end 422 of the frame 412.
[00188] Similarly, inner element 416 is described as having openings 470, and outer element as having lock element 472. However, in other implementations, lock element 472 may be included in inner element 416, and the openings 470 may be formed in the outer element 422. Although illustrated and described as tubular, the inner element 416, the outer element 418, and the release element 444 may have other shapes or configurations. For example, in a particular implementation, the internal element
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416, the outer element 418, and the release element 444 can be made of flat strips of material, with one of the inner element 416 and the outer element 418 having the openings 470 and the other having the locking element 472. The strips planes that form the inner element 416, the outer element 418, and the release element 444 can be arranged in an elongated housing, for example, a shaft or tubular element.
[00189] The structures and / or placement devices of the present invention can provide numerous advantages. For example, a mechanically expandable structure as described in this document can be radially compressed in a laying configuration and loaded into a laying apparatus without the use of a crimping device. Since the structure can be fully expanded or expanded to a desired size smaller than the fully expanded state, at least in some embodiments, a prophetic valve, as described in this document, can be implanted in various ring sizes, and the ideal size of the prophetic valve can be obtained during its implantation. In some cases, a delivery device of the present invention may apply sufficient expansion force to open or enlarge a native calcified valve, which may reduce or eliminate the need for pre-balloon valvuloplasty.
[00190] In addition, as noted above, the prophetic valve can be fully functional during the implantation procedure, which may reduce or prevent blood flow occlusion and avoid the use of rapid stimulation during implantation. The modalities described in this document may also allow for a slow implantation of the prophetic valve, which may allow relaxation of tissue tension, as well as reducing the risk of aortic rupture.
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56/115 [00191] Figures 17A and 17B illustrate a proximal portion of an alternative release and locking unit 502 (locking unit) that can be used in embodiments of the present invention, for example, with the placement apparatus 18 of Figure 1, in order to release a prosthetic valve from a delivery device and / or lock the prosthetic valve in its expanded state. One or more of such units 502 may be mounted on the structure of a prosthetic valve in circumferentially spaced locations.
[00192] In some embodiments, a distal portion of the locking unit 502 (not shown; the distal portion to the left of the portion shown in Figures 17A and 17B) may be at least generally similar to a distal portion of the locking unit 94 of Figures 8, 9, 10A, 10B, and 11, and may include a locking device, for example, clamp 98, and opening 132 for receiving fastener 130 in order to secure locking unit 504 to a frame valve. According to other implementations, a distal portion of the latch unit 502 may at least be generally similar to a distal portion of the latch unit 410 of Figures 14, 15, and 16A through 16D.
[00193] The locking unit 502 can have an elongated internal body or shaft 504 (for example, a tube or shaft generally cylindrical), which can be arranged within a lumen of a release element 510. An positioning 516 can also be arranged within the lumen of the release element 510. The internal body 504 can be attached to the prosthetic valve structure. In some embodiments, the unit 502 may function only as a release unit in the sense of releasing the prosthetic valve from the placement apparatus, in which case the prosthetic valve may have another mechanism to lock the structure of the prosthetic valve in its expanded state.
[00194] The release element 510 and the positioning element 516 can be at least generally similar, respectively,
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57/115 to the release element 106 of Figure 9, or to the release element 444 of Figure 16C, and to the positioning element 76 of Figure 1. In at least some embodiments, for example, when the locking unit 502 includes a portion distal similar to that of the locking unit 94, the locking unit may include an actuating element 520, which may be at least generally similar to actuating element 86 of Figure 8. Actuating element 520 can be arranged within a lumen of body 504 of latch unit 502 and one lumen of positioning element 516. In other embodiments, for example, when latch unit 502 includes a distal portion similar to that of latch unit 410, actuating element 520 may be omitted. [00195] A proximal end portion 522 of body 504 of latch unit 502 may comprise a radially inwardly extending fin, or an inwardly facing edge portion 526. Fin 526 may be negatively angled, i.e. fin 526 it is angled distally towards the prosthetic valve (left, in the drawings). The fin 526 can be configured to overlap or extend into an angled notch or recessed portion 530 formed at a distal end portion 532 of the positioning element 516. The fin 526 and an extension portion 524 of the adjacent body 504 to the fin they can incorporate a predefined fold, such that they are radially skewed outwards. For example, locking unit 502 or at least fin 526 and extension portion 524 may be made of a shape memory alloy, such as a nickel titanium (NiTi) alloy, for example, Nitinol.
[00196] The body 504 and fin 526 can be hot consolidated in order to provide a desired degree of curvature. When positioned inside the release element 510, the fin 526 and the extension portion 524 are radially restricted, and the fin is kept in contact with the notch 530. Due to the diameter or width of the notch 530
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58/115 increases in a distal direction along the length of the positioning element 516, and the fin 526 which is negatively angled, the fin and the notch may fit together in order to prevent axial separation of the positioning element 516 of the inner body 504, thus maintaining the connection between the prosthetic valve and the placing device. When the prosthetic valve has to be released from the delivery device (for example, from the delivery device 18), for example, after being implanted into a patient's heart, the release element 510 may be proximally retracted, as shown in Figure 17B. No longer being restricted by the release element 510, the fin 526 and the extension portion 524 of the body 504 of the latch unit 502 can assume their predefined shape, bypassing radially outward, and thus disengaging the fin from the notch. 530. With the fin 526 released from the notch 530, the locking unit 502 and the positioning element 516 can disengage, thereby releasing the prosthetic valve from the placement device and allowing the placement device to be removed from the patient.
[00197] Figure 18 shows an alternative embodiment of a prosthetic valve placement device 600. The placement device 600 may include a prosthetic valve 602. Prosthetic valve 602 may include a radially expandable and foldable structure 604 and a valve structure 606 supported inside the structure (Figures 19A and 19B). Structure 604 can be constructed in a similar manner to structure 22 in Figure 2 and can be formed from a plurality of interconnected rods similar to rods 32. The valve structure can be constructed in a similar manner to the valve structure 24 in Figure 2 .
[00198] Placement device 600 may further include one or more linear actuator devices 608 and one or more locking mechanisms 610 attached to frame 602. The one or more actuator devices
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Linear 59/115 608 are configured to radially expand and compress structure 604, and the one or more locking mechanisms 610 are configured to lock or retain structure 604 in a given radially expanded state, as explained in more detail below. Placement device 600 may further include one or more locking tools 611 configured to advance one or more locking mechanisms 610 to a position for locking frame 604, as explained in more detail below.
[00199] In the illustrated embodiment of Figure 18, the placement device 600 includes two linear actuating devices 608 and a locking mechanism 610. Figure 19A shows a modality of the placing device 600 having two linear actuating devices 608 and a locking mechanism 610. Figure 19B shows an alternative embodiment of a prosthetic valve placement device 600 'equal to placement device 600, with the exception that the placement device 600' has a linear actuator device 608 and two locking mechanisms 610. In other embodiments, a prosthesis placement device can have any number of linear actuating devices and / or locking mechanisms.
[00200] The placement device 600 can be used in order to percutaneously implant prosthetic valve 602 into a patient's vasculature at a desired implantation site, such as in the native aortic valve. During implantation, structure 604 is in a radial folded state, similar to that of structure 200 in Figure 2. As soon as prosthetic valve 602 reaches the desired implantation site, one or more linear actuator devices 608 can be used in to expand the structure 604 in the radial direction. When frame 604 is expanded to a desired radially expanded size, one or more locking tools 611 may be used in order to position one or more locking mechanisms 610 towards
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60/115 to lock structure 604 in that expanded size in the radial direction such that structure 604 is prevented from further expansion and / or radial contraction. The one or more linear actuating devices 608 and one or more locking tools 611 can then be disconnected from the prosthetic valve 602 such that the structure 604 remains locked in an expanded state in the radial direction and the disconnected portion of the placement 600 can be removed from the patient. The operation of linear actuating devices 608, locking mechanisms 610, and locking tools 611 will be described in more detail below.
[00201] Figure 23A shows a linear actuator device 608 in the process of being disconnected from structure 604 after the structure has expanded in the radial direction. Referring to Figure 23A, linear actuator device 608 may include an internal actuator element 612 (which may also be referred to as an actuating element), a cover tube 614 extended coaxially along actuator element 612, a support tube or pusher element 616 extended coaxially along cover tube 614, a threaded screw 618, and a cap 620 fixedly mounted on frame 604. Figure 23B shows a perspective view of linear actuator device 608 without support tube 616. The element Actuator 612 can be, for example, a stem, a cable, or a wire. The actuator element 612 can be connected at its distal end to the threaded screw 618 in such a way that the rotation of the actuator element 612 causes the rotation of the threaded screw 618. The proximal end of the actuator element 612 can be connected to a handle or other control (not shown) that a doctor or operator of the placement device 600 can use to rotate the actuator element 612. Similarly, the proximal ends of each cover tube 614 and each support tube 616 can be connected to the handle.
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61/115 [00202] The screw 618 has a threaded outer surface that can fit into an internally threaded surface of a nut or sleeve 622, which is attached to the frame 604, for example, at the distal end of the frame. In the present invention, the term nut is sometimes used in general to refer to a glove that does not necessarily have internal threads. Therefore, reference to a nut does not necessarily require internal threads, unless the context determines otherwise. When the actuator element 612 is rotated in order to thread the screw 618 in the nut 622, the actuator element 612 is connected to the distal end of the structure 604 in such a way that a proximal or distal movement of the actuator element 612 causes a movement, respectively, proximal or distal from the distal end of structure 604.
[00203] The cover tube 614 annularly surrounds the actuator element 612. The cover tube 614 can be connected to the actuator element 612 in such a way that the actuator element 612 and the cover tube 614 can rotate together and move together in an axial direction. The actuator element 612 and the cover tube 614 extend through the stop 620, which can be attached to a proximal end of the structure. The support tube 616 surrounds the cap tube 614 in an annular manner. The stop 620 has an annular inner surface with an internal diameter larger than the outside diameter of the cover tube 614 and the screw 618 such that the cover tube 614 and the screw 618 can retract through the stop 620 when the structure 604 is expanded and as soon as the actuator is disconnected from the structure, as described in more detail below. The stop 620 is dimensioned to overlap or fit on the distal end of the support tube 616 in such a way that the support tube 616 is prevented from moving in the distal direction beyond the stop 620.
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62/115 [00204] In operation, before implantation in a patient, screw 618 is threaded on the actuator nut 622, thus connecting the linear actuator device 608 to the structure 604. The structure 604 can then be placed in a foldable state in the radial direction, and the placement device 600 may be inserted into a patient. Once the prosthetic valve 602 is at a desired implantation site, the structure 604 can be expanded radially, as described in this document.
[00205] In order to expand the structure 604 in the radial direction, the support tube 616 is firmly held against the stop 620. The actuator element 612 is then pulled in a proximal direction through the support tube 616, for example , when pulling the proximal end of the actuator element 612 or actuating a control button on the handle that produces the proximal movement of the actuator element 612. Once the support tube 616 is kept attached against the stop 620, which is connected to the proximal end of structure 604, the proximal end of structure 604 will be prevented from moving with respect to support tube 616 and the handle. Thus, movement of actuator element 612 in a proximal direction will result in movement of the distal end of structure 604 in a proximal direction, causing structure 604 to shorten in the axial direction and expand in the radial direction. Figure 20A shows structure 604 in a partially expanded state, while Figure 20B shows structure 604 in an even more expanded state when a force directed proximally is applied to the distal end of structure 604 while the proximal end of structure 604 stays in place. In the illustrated embodiment, there is a one-to-one relationship between the axial movement of the actuator element 612 and the increase in the diameter of the structure 604, which will allow a stable and controlled expansion of the structure.
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63/115 [00206] It should be understood that the structure 604 can also be radially expanded, pushing the proximal end of the structure towards the distal end of the structure by pushing the support tube 616 against the stop 620, while maintaining the actuator element 612 stationary with respect to the handle, or, alternatively, by simultaneously pushing the support tube 616 in the distal direction against the stop 620 and pulling the actuator element 612 in the proximal direction.
[00207] After the structure 604 is expanded to a desired radially expanded size, the locking mechanism 610 can be actuated to lock the structure 604 to the desired radially expanded size, as described in more detail below, and the actuator device linear 608 can be disconnected from structure 604, as described in this document. In order to disconnect the linear actuator device 608 from the structure 604, the actuator element 612 can be rotated to loosen the screw 618 of the nut 622. The actuator element 612 and the cover tube 614 can then retract proximally through from the stop 620, and the linear actuator device 608 (including the actuator element 612, the screw 618, the cover tube 614, and the support tube 616) can be removed from the patient. Cover tube 614 facilitates passage of screw 618 through stop 620. Figure 21 shows the placement device 600 after the linear actuator devices 608 are removed. In modalities that have more than one linear actuator device 608, the above procedure for expanding the structure 604 will be performed for each linear actuator device 608.
[00208] The locking of the structure 604 in a given expanded state in the radial direction can be obtained with the use of the locking mechanism 610 and the locking tool 611. With reference to Figure 18 and Figures 24A to 24D, the locking mechanism 610 can include a
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64/115 fixing screw 624 which has a threaded outer surface. Locking mechanism 610 may further include a proximal sleeve or nut 626 (also referred to as a proximal sleeve element) and a distal sleeve or nut 628 (also referred to as a distal sleeve element) connected to frame 604 at spaced apart from each other axially. Proximal nut 626 can be connected to a proximal end of structure 604 and distal nut 628 can be connected to structure 604 at an axially aligned and distally spaced location of proximal nut 626. Distal nut 628 can have internal threads that can fit on the external threads of the fixing screw 624 in order to connect the lock screw 624 to the structure 604 and prevent the radial contraction of the structure 604, as explained below. The proximal nut 626 can be dimensioned in such a way that the fixing screw 624 can slide freely within a lumen of the proximal nut. In alternative modalities, the proximal nut 626 may have internal threads that fit the external threads of the fixing screw 624 in order to connect the fixing screw 624 to the structure 604.
[00209] The fixing screw 624 may have a screw head 630 at its proximal end, having, for example, a square or rectangular shape. The screw head 630 can be dimensioned in such a way that the screw head cannot advance distally beyond the proximal nut 626. The locking tool 611 can be configured to operate the screw 624 after the prosthetic valve expands to desired size through linear actuators. Tool 611 can comprise an elongated shaft 634 and a tool head 632 connected to the distal end of shaft 634. The proximal end of shaft 634 (not shown) can be connected to the handle of the placing device 600, which may have an actuator (for example, a button on the handle) configured to rotate the axis after an action by a user. The axis
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634 may comprise, for example, a rod or cable with sufficient torsional rigidity for transferring torque from the proximal end of the shaft to the screw head 632.
[00210] The tool head 632 can have a square or rectangular opening 633 that corresponds to the shape of the screw head 630 such that the screw head 630 can accommodate itself inside the tool head 632. When the screw head 630 is accommodated within tool head 632, rotation of tool head 632 causes rotation of screw head 630. In alternative embodiments, screw head 630 and opening of tool head 632 may have several other non-circular shapes which allow tool head 632 to rotate screw head 630 when the tool head engages the screw head. [00211] With reference to Figures 25B and 25C, axis 634 may comprise an external axis, and tool 632 may further comprise an internal stem 636 (for example, a stem or cable) extending coaxially through the external axis 634. The distal end portion of the inner shaft 636 extends to the tool head 632 and is mounted on a fastener 638 configured to form a removable connection with the screw head 630. In the illustrated embodiment, for example, the element fixture 638 comprises external threads 640 configured to fit the internal threads 642 of an annular hole formed in the screw head 630 in order to connect the inner axis 636 to the screw head 630. The inner axis 636 can extend proximally to a handle or other device that a doctor or other operator of the placement device 600 can use to rotate the internal axis 636. The internal axis 636 can be rotated independently external shaft 634 and tool head 632.
[00212] Before implantation, tool 611 can be attached to the
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66/115 fixing screw 624 when placing tool head 632 around screw head 630, as shown in Figure 25C. The inner axis 636 is then rotated in a first direction (for example, in a clockwise direction) in order to thread the fastener 638 onto the screw head 630, as shown in Figure 25B. When retaining the inner shaft 636 with respect to the outer shaft 634 in the axial direction, fixing the fastening element 638 to the screw head 630 will retain the engagement of the tool head 632 on the screw head 630.
[00213] The fixing screw 624 can be initially positioned inside the proximal nut 626, but not threaded on the distal nut 628. This allows the structure to be radially expanded by the linear actuating devices 608. In this case, the placing device 600 may be inserted into a patient, and prosthetic valve 602 can be expanded to a desired radial size, as described above. In other embodiments, the screw 624 does not need to be previously inserted in the nut 626 and, instead, it can be positioned on the structure 604 in such a way that, when the screw is turned, the screw extends to the proximal nut 626 and to distal nut 628. In other modalities, in which proximal nut 626 has internal threads, screw 624 may initially be threaded on proximal nut 626, but not on distal nut 628. In other modalities, screw 624 does not need to be pre- mounted on the frame while the prosthetic valve is advanced to the implantation site. For example, screw 624 can be placed separately on the prosthetic valve (for example, using tool 611) after the prosthetic valve is expanded at the implantation site.
[00214] When prosthetic valve 602 is radially expanded to a desired size, external shaft 634 can be rotated (for example, clockwise) in order to rotate the tool head
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632, which in turn rotates the fixing screw 624 and advances the distal end portion of the screw 624 through distal nut 628, as shown in Figure 24B. The fixing screw 624 can be distally advanced so that the screw head 630 is juxtaposed with the proximal nut 626. When advanced, the threads of the fixing screw 624 fit into the inner threads of the distal nut 628. With the screw 624 connected to the distal nut 628, and the screw head 630 juxtaposed to the proximal nut 626, the screw is prevented from moving further in the distal direction in relation to the structure 604, thus avoiding the contraction of the structure 604 due to the external forces acting on structure 604.
[00215] However, since screw 624 can move freely within proximal nut 626, the proximal end of the screw may move in a proximal direction after the screw is placed in a locked position (fitting the distal nut 628 ), thereby allowing for further expansion of structure 604, either by using linear actuator device 608, as described above, or by continuing to turn screw 624 after screw head 630 is juxtaposed to proximal nut 626. This may allow a physician will further expand the structure 604 during implantation of the prosthetic valve 602 after advancing the fixing screw 624 to a locked position. This may also allow a doctor to expand the structure 604 days, months or years after following the implant procedure when implanting a new prosthetic valve inside the prosthetic valve previously implanted in a valve-to-valve procedure. If necessary, the valve previously implanted using a balloon valvuloplasty before implanting a new prosthetic valve.
[00216] Anatomical forces only apply a compressive force on the prosthetic valve 602 when it is implanted and,
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68/115 therefore, there is no risk of spontaneous expansion after valve 602 is locked with clamping screw 624. After another valve expansion is performed, clamping screw 624 can be rotated in order to advance distally the screw such that the screw head 630 is juxtaposed with the proximal nut 626 and again place the screw in a locked position. In the modalities in which the proximal nut 626 has internal threads that fit the fixing screw 624, any radial contraction and expansion of the prophetic valve 602 will be prevented, since the screw is inserted in the nuts 626, 628, without the rotation of the screw .
[00217] When the fixing screw 624 is screwed into the distal nut 628 in such a way that the screw head 630 is juxtaposed with the proximal nut 626, the inner axis 636 can rotate in a second direction (for example, in an anti-clockwise direction) clockwise), as shown in Figure 24C, in order to disconnect the fixing element 638 from the screw head 630, as shown in Figure 25C. The tool head 632 can then be pulled back and removed from the screw head 630, as shown in Figures 24D and 25D, in order to disconnect the locking tool 611 from the fixing screw 624 on the prophetic valve. The disconnected lock tool 611 can then be removed from the patient (for example, by removing the linear actuator devices 608 when the linear actuator devices and the lock tool are connected to a common handle), leaving the fixing screw 624 connected to structure 604, with structure 604 locked in a given state expanded in the radial direction, as shown in Figure 22.
[00218] Figures 26A and 26B show cross-sectional views of the expansion and locking mechanism 700, according to another modality. The expansion and locking mechanism 700 can be used both to expand and to radially lock a prophetic valve
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69/115 in an expanded state in the radial direction, for example, the prosthetic valve 602. Therefore, an alternative embodiment of a prosthetic valve placement device may be the same as the placement device 600, with one or more linear actuator devices 608 or one or more locking mechanisms 610 being replaced by one or more expansion and locking mechanisms 700. For example, instead of the placement device 600 of Figure 19A with two linear actuating devices 608 and a locking mechanism 610, or the device placement device 600 'of Figure 19B with a linear actuator device 608 and two locking mechanisms 610, a placement device may have three expansion mechanisms and locking 700. In other embodiments, the placement device 600 or the placement device 600' may have any number of linear actuating devices 608 and / or locking mechanisms 610 replaced by expansion and locking mechanisms 70 0. Exemplary placement devices may have any number of expansion mechanisms and lock 700.
[00219] Figure 26A shows the expansion and locking mechanism 700 and the structure 604 when the structure is in a radially folded or crimped configuration, and Figure 26B shows the expansion and locking mechanism 700 and the structure 604 when the structure is in an expanded configuration in the radial direction. As explained above, a placement device may have multiple expansion and locking mechanisms, but only one is shown in Figures 26A and 26B, for purposes of illustration.
[00220] The expansion and locking mechanism 700 can include a proximal nut or sleeve 702, a distal nut or sleeve 704, and an actuator nut 706 attached to frame 604. Nuts 702, 704, 706 can be axially spaced from each other others along the length of frame 604. Distal nut 704 and actuator nut 706 may have
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70/115 internal threaded surfaces. In alternative embodiments, the proximal nut 702 may also have an internally threaded surface. The proximal nut 702 can be attached to a relatively proximal portion of the structure 604, the actuator nut 706 can be attached to a relatively distal end of the structure, and the distal nut 704 can be attached to the structure 604 at an axial location between the proximal nut 702 and the actuator nut 706.
[00221] The expansion and locking mechanism 700 may also include an actuator element 708 (which functions as a linear actuator or an impulse and traction element in the illustrated mode), an actuator screw 710, a support tube 712, a tool for lock 714, and a fixing screw 716. Actuator element 708 can be, for example, a rod, cable, or wire. The actuator element 708 can be connected at its distal end to the actuator screw 710 in such a way that the rotation of the actuator element causes the rotation of the actuator screw 710. The proximal end of the actuator element 708 can be connected to a handle or other control device. control (not shown) that the doctor or operator of the placement device using the expansion and locking mechanism 700 can use to rotate the actuator element 708. Similarly, the proximal ends of the support tube 712 and the locking tool 714 can be connected to the handle.
[00222] Actuator screw 710 has a threaded outer surface that can fit into the internally threaded surface of actuator nut 706. When actuator element 708 is rotated to thread screw 710 on actuator nut 706, actuator element 708 it is connected to the distal end of the structure 604 in such a way that the proximal or distal movement of the actuator element causes the proximal or distal movement, respectively, of the distal end of the structure.
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71/115 [00223] The fixing screw 716 envelops the actuator element 708 in such a way that the actuator element extends through a lumen of the screw. The fixing screw 716 has a threaded outer surface that can engage the internally threaded surface of the distal nut 704. The fixing screw 716 can move in an axial direction within a lumen of the proximal nut 702, and the actuator element 708 can move freely in an axial direction with respect to the fixing screw 716. The fixing screw 716 has a screw head 718 at its proximal end, and the screw can lock the structure 604 in an expanded state particularly in the radial direction, such as explained in more detail below.
[00224] In the illustrated embodiment, the threads of the fixing screw 716 can be dimensioned to fit the internal threads of the proximal nut 702 such that the fixing screw 716 can move distally and proximally with respect to the proximal nut 702 after rotation of the fixing screw 716. In other embodiments, the threads of the fixing screw 716 can be spaced inside the proximal nut threads 702 in such a way that the screw threads do not match the threads of the nut, in which case the fixing screw 716 may be slid proximally and distally with respect to the proximal nut, at least until the fixing screw 716 fits into distal nut 704.
[00225] The support tube 712 annularly surrounds a proximal portion of the fixing screw 716. The support tube 712 and the proximal nut 702 are dimensioned in such a way that the distal end of the support tube is juxtaposed to or fits at the proximal end of the nut 702 such that the support tube 712 is prevented from moving distally beyond the proximal nut.
[00226] The locking tool 714 can be configured to be removably attached to the screw head 718 of the screw
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Clamping 72/115 716 and operating clamping screw 716 after the prophetic valve has been expanded to a desired size by means of actuator element 708, as explained below. The distal end of the locking tool 714 can be coupled to the screw head 718 in such a way that the rotation of the locking tool advances the fixing screw 716 through the proximal nut 702 and thread the fixing screw 716 in the distal nut 704. The distal end of the locking tool 714 and the screw head 718 can be of various shapes that allow the locking tool to rotate the locking screw 716 when the locking tool engages the screw. The locking tool 714 can be detached from the clamping screw 716 after the screw is threaded on the distal nut 704.
[00227] In operation, before implantation, the actuator element 708 is threaded on the actuator nut 706 and the fixing screw 716 is positioned inside the proximal nut 702, but it is not threaded on the distal nut 704. The structure 604 may, in this in this case, be placed in a radial folded state, and the placement device 600 can be inserted into a patient. Once the prophetic valve 602 is in a desired implantation site, the structure 604 can be expanded in the radial direction, as described in the present document. [00228] In order to expand the structure 604 in the radial direction, the support tube 712 is held firmly against the proximal nut 702. The actuator element 708 is then pulled in a proximal direction through the fixing screw 716, by example, by pulling the proximal end of the actuator element 708 or by pressing a control button on the handle that produces the proximal movement of the actuator element 708. Once the support tube 712 is held against the proximal nut 702, which is connected to a proximal end of structure 604, the proximal end of structure 604 is prevented from moving with respect to support tube 712 and the handle. Like this
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73/115 therefore, movement of actuator element 708 at a proximal end will result in movement of the distal end of structure 604 in a proximal direction, causing structure 604 to axially shorten and expand radially. Figure 26A shows the structure 604 in a radially folded state, while Figure 26B shows the structure in an expanded state in the radial direction.
[00229] It should be understood that the structure 604 can also be radially expanded by pushing the proximal end of the structure towards the distal end of the structure, by pushing the support tube 712 against the proximal nut 702 and at the same time maintaining the element actuator 708 stationary with respect to the handle, or, alternatively, by simultaneously pushing the support tube 712 in the distal direction against the proximal nut 702 and pulling the actuator element 708 in the proximal direction.
[00230] After the structure 604 is expanded to a desired radially expanded size, the fixing screw 716 can be actuated to lock the structure 604 to the desired radially expanded size. The locking of the structure 604 in a given radially expanded state can be obtained by using the locking tool 714 in order to advance the fixing screw 716 distally and by screwing the fixing screw 716 in the distal nut 704 until the screw 718 is juxtaposed with the proximal nut 702. This will make the threads of the fixing screw 716 fit into the internal threads of the distal nut 704. When the screw head 718 is also juxtaposed to the proximal nut 702, the screw 716 no longer will be able to advance in a distal direction, thereby preventing radial compression of structure 604. However, since screw 716 can move with respect to proximal nut 702 in a proximal direction after structure 604 is locked, an expansion
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74/115 of structure 604 is possible, either during the initial implantation procedure or later during a valve-to-valve procedure.
[00231] Further expansion of the structure can be achieved by pulling the fixing screw 716 proximally in order to move the distal nut 704 towards the proximal nut 702 (when the fixing screw 716 is sized so that it can slide freely in. proximal nut 702). Alternatively, when the fixing screw 716 is dimensioned to fit the threads of the proximal nut 702, the fixing screw 716 can unscrew the distal nut 704, which, in this case, will allow a greater expansion of the structure to the retract actuator element 708.
[00232] As soon as the structure 604 is locked in an expanded state in the radial direction, the locking tool 714 can be decoupled from the fixing screw 716, and the actuator element 708 can be rotated in order to unscrew the screw 710 from the lock nut. actuator 706. The element actuator 708, the support tube 712, and the locking tool 714 may, in this case, be removed from the patient, leaving the fixing screw 716 connected to frame 604 with frame 604 locked in a given expanded state in the radial direction.
[00233] Figures 27 and 28 show another modality of a prophetic valve that comprises the structure 604 and the expansion and locking mechanisms 800 (with the cusps and other soft components removed for purposes of illustration). As with the expansion and locking mechanism 700, the expansion and locking mechanism 800 can be used both to expand and lock the prophetic valve radially in an expanded state in the radial direction. Therefore, an alternative modality of a prophetic valve placement system may be the same as the placement device 600 with one or more linear actuating devices 608 or one or more locking mechanisms
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610 replaced by one or more expansion mechanisms and lock 800. In the example of Figures 27 and 28, three expansion mechanisms and lock 800 are connected to structure 604, however, in other exemplary placement devices, any number of expansion mechanisms and lock 800 can be used. Figure 27 shows the expansion and locking mechanisms 800 attached to the structure 604 when the structure is in a radially folded configuration, and Figure 28 shows the expansion and locking mechanisms attached to the structure when the structure is in a configuration. expanded in the radial direction. Figures 53A to 53D are various views of the basic structure 604 with other components of the prosthetic valve removed for purposes of illustration. Figures 52A to 52F are several views of one of the supports of the structure.
[00234] With reference to Figures 29A to 29C, the expansion and locking mechanism 800 in the illustrated embodiment may include an actuator screw 802 (which functions as a linear actuator or a thrust and traction element in the illustrated embodiment) comprising an upper portion or relatively long distal 804 and a relatively smaller proximal or lower portion 806 at the proximal end of screw 800, the lower portion having a smaller diameter than the upper portion. Both the upper and lower portions 804, 806 of screw 802 may have threaded outer surfaces.
[00235] The actuator screw 800 can have a distal fixture 808 attached to its distal end which has a distal valve connector extended in the radial direction 810. The distal fixture 808 can be fixed to the 802 screw (for example, welded together, or manufactured as a part). The distal valve connector 810 can extend through an opening at or near the distal end of the structure 604 formed at a location on the structure at which two or more rods intersect, as shown in Figure 29C. O
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76/115 distal valve connector 810 can be attached to frame 604 (for example, welded). Due to the shape of the rods, the distal end of structure 604 comprises an alternating series of distal junctions 650 and distal vertices 652. In the illustrated example, distal valve connectors 810 of the three expansion and locking mechanisms 800 are connected to structure 604 via distal junctions 650. In other examples, one or more distal valve connectors 810 can be connected to structure 604 via distal vertices 652. In other embodiments, distal valve connectors 810 can be connected to the junctions closest to the proximal end of the structure 604.
[00236] The expansion and locking mechanism 800 may further include a sleeve 812. Sleeve 812 may be positioned in an annular direction around the upper portion 806 of screw 802 and may contain axial openings at its proximal and distal ends through which the 802 screw can extend. The axial openings and the lumen in the sleeve 812 may have a diameter larger than the diameter of the upper portion 806 of the screw 802 such that the screw can move freely within the sleeve (the screw 802 can be moved proximally and distally with respect to to sleeve 812). Since the actuator screw 802 can move freely within the sleeve, it can be used to expand and / or contract the structure 604 radially, as described in more detail below.
[00237] Sleeve 812 may have a proximal valve connector 814 extended radially from its outer surface. The proximal valve connector 814 can be attached to sleeve 812 (for example, welded). The proximal valve connector 814 can be axially spaced from the distal valve connector 810 such that the proximal valve connector can extend through an opening at or near the proximal end of structure 604. The proximal end of structure 604 comprises a alternating series of proximal junctions 660 and
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77/115 proximal vertices 662. In the illustrated example, proximal valve connectors 814 of the three expansion and locking mechanisms 800 are connected to frame 604 via proximal junctions 660. In other examples, one or more proximal valve connectors 814 can be connected to structure 604 via proximal vertices 662. In other embodiments, proximal valve connectors 814 can be connected to the joints closest to the distal end of structure 604.
[00238] It should be understood that the proximal and distal connectors 810, 814 do not need to be connected to the opposite ends of the structure. The actuator 800 can be used to expand and compress the structure, as long as the proximal and distal connectors are connected to the respective joints of the structure that are axially spaced from each other.
[00239] A lock nut 816 can be positioned inside the sleeve 812 and can have an internally threaded surface that can fit on the externally threaded surface of the actuator 802. The lock nut 816 can have a notched portion 818 at its end proximal, the purpose of which is described below. The lock nut can be used in order to lock the structure 604 in an expanded state particularly in the radial direction, as described below.
[00240] Figure 30 shows a cross-sectional view of the expansion and locking mechanism 800 including the placement components not shown in Figures 29A to 29C. Referring to Figure 30, the expansion and locking mechanism 800 may further include a support tube 820, an actuator element 822, and a locking tool 824. The proximal end of support tube 820 can be connected to a handle or other control device (not shown) that a doctor or operator of the placement device uses to
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78/115 operate the expansion mechanism and lock 800, as described in this document. Similarly, the proximal ends of the actuator element 822 and the locking tool 824 can be connected to the handle.
[00241] The support tube 820 annularly surrounds a proximal portion of the locking tool 824 in such a way that the locking tool extends through a lumen of the support tube. The support tube 820 and the sleeve are dimensioned in such a way that the distal end of the support tube is juxtaposed with or fits in the proximal end of the sleeve 812 in such a way that the support tube is prevented from moving in the distal direction beyond of the glove.
[00242] The actuator element 822 extends through a lumen of the locking tool 824. The actuator element 822 can be, for example, a shaft, a rod, a cable, or wire. The distal end portion of the actuator element 822 can be removably connected to the lower portion 806 of the actuator screw 802. For example, the distal end portion of the actuator screw 802 may have an internally threaded surface that can engage the outer threads of the lower portion 806 of the actuator screw 802. Alternatively, the actuator element may have external threads that fit into an internal threaded portion of the screw. When actuator element 822 is threaded onto actuator screw 802, axial movement of the actuator element causes axial movement of the screw.
[00243] The distal portion of the locking tool 824 annulates the actuator screw 802 and extends through a lumen of the glove 812, and the proximal portion of the locking tool envelops the actuator element 822 and extends through one lumen of the support tube 820 for handling the delivery device. The locking tool 824 may have a surface internally
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79/115 threaded that can fit the externally threaded surface of the clamping screw 802 in such a way that the clockwise or counterclockwise rotation of the locking tool 824 causes the locking tool to advance distally or proximally along the screw, respectively.
[00244] The distal end of the locking tool 824 can comprise a notched portion 826, as can be better seen in Figure 31. The notched portion 826 of the locking tool 824 can have a locking surface 827 that is configured to engage a correspondingly formed locking surface 819 of the notched portion 818 of the lock nut 816 such that rotation of the lock tool (for example, a clockwise rotation) causes the nut 816 to rotate in the same direction (for example, clockwise) and advance distally along the clamping screw 802. The notched portions 818, 826 in the illustrated mode are configured in such a way that the rotation of the locking tool 824 in the opposite direction (for example, in the opposite direction counterclockwise) allows the notched portion 826 of the tool 824 to disengage from the notched portion 818 of the lock nut 816; that is, rotation of the locking tool in a direction that causes the locking tool to move proximally does not cause the corresponding rotation of the nut.
[00245] In alternative embodiments, the distal end portion of the locking tool 824 can have several other configurations adapted to fit the nut 816 and produce the rotation of the nut after the rotation of the locking tool in order to move the nut in the distal sense, just like any of the tool configurations described in this document. In some embodiments, the distal end portion of the locking tool 824 can be adapted to produce rotation of nut 816 in both directions to move the nut distally and proximally along the fixing screw
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80/115
802. For example, the distal end portion of the lock tool 824 may have the configuration of tool 634 shown in Figures 25A to 25D.
[00246] In operation, before implantation, the actuator element 822 is threaded on the lower portion 806 of the actuator screw 802, and the lock nut 816 is rotated in such a way that it is positioned at the proximal end of the screw. The structure 604 can then be placed in a radial folded state, and the placement device 600 can be inserted into a patient. Once the prosthetic valve is at a desired implantation site, the structure 604 can be expanded radially, as described in this document.
[00247] In order to radially expand structure 604, support tube 820 is held firmly against sleeve 812. Actuator element 822 is then pulled in a proximal direction through the support tube, for example, by pulling the proximal end of the actuator element or actuate a control button on the handle that produces the proximal movement of the actuator element. Since the support tube 820 is held against the sleeve 812, which is connected to a proximal end of the structure 604 by the proximal valve connector 814, the proximal end of the structure is prevented from moving with respect to the support tube. Thus, the movement of the actuator element 822 in a proximal direction causes the movement of the actuator screw 802 in a proximal direction (since the actuator element is threaded on the screw), thus causing the structure 604 to shorten in the axial direction and expand in the radial direction. Alternatively, the structure 604 can be expanded by moving the support tube 820 in the distal direction, while keeping the actuator element 822 stationary, or by moving the support tube in the distal direction, while moving the actuator element 822 proximally.
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81/115 [00248] After the structure 604 is expanded to a desired radially expanded size, the structure can be locked to that radially expanded size, as described herein. Locking the structure can be achieved by rotating the locking tool 824 in a clockwise direction, causing the notched portion 826 of the locking tool to engage the notched portion 818 of the locknut 816, thereby advancing the locking nut in the distal direction along the actuator screw 802. The locking tool 824 can therefore be rotated until the locknut 816 is juxtaposed to an internal protrusion at the distal end of the sleeve 812, and the lock nut 816 cannot go further distally (see Figure 31). This will prevent screw 802 from advancing distally from sleeve 812 and compress radially structure 604. However, in the illustrated embodiment, nut 816 and screw 802 can still move proximally through sleeve 812, thus allowing for expansion structure 604 either during implantation or later during a valve-to-valve procedure.
[00249] When the frame 604 is locked in the radially expanded state, the locking tool 824 may be rotated in one direction in order to move the locking tool proximally (for example, counterclockwise) in order to uncouple the notched portion 826 of the notched portion 818 of the locknut 816 and unscrew the locking tool of the actuator screw 804. In addition, the actuator element 822 can be rotated in one direction in order to unscrew the actuator element from the lower portion 806 of the actuator screw 802 (for example, the actuator element 822 can be configured to disengage from the actuator screw when turned counterclockwise). As soon as the locking tool 824 and the actuator element 822 are unscrewed from the actuator screw 804, they can be removed from the patient, together with the support tube 820, leaving
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82/115 the actuator screw and the sleeve 812 connected to the structure 604, as shown in Figure 29C, with the structure 604 locked in a certain expanded state in the radial direction.
[00250] In an alternative embodiment, the locking tool 824 may be formed without internal threads that fit into the outer threads of the actuator screw 802, which may allow the locking tool 824 to slide distally and proximally through the sleeve 812 and the actuator screw 802 to fit and unscrew nut 816.
[00251] Any of the placement devices described in this document may have several manipulation configurations, with one or more actuators or controls configured to produce the movement of the device components that expand and compress a prosthetic valve (or other type of implant). In some embodiments, as shown in Figures 1 and 13, the handle may have actuators that are manually operated by a user by manually turning and / or by manually pushing / pulling the actuators on the handle. In other modalities, the actuators on the handle and / or other components of the device may be electrically, pneumatically and / or hydraulically controlled.
[00252] For example, in some modalities, the handle may accommodate one or more electric motors actuated by a user in order to produce the movement of the components of the placing device, such as one or more motors operable in the sense of producing a linear movement actuator screws 802, and one or more motors operable to produce the rotational movement of the locking tools 824 (in order to turn the locknuts 816). In a specific embodiment, an electric motor is used to produce the linear motion of all 802 actuator screws mounted on the prosthetic valve, and an electric motor is used to produce the
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83/115 rotation movement of all 824 locking tools included in the device. In another implementation, an electric motor may be provided for each actuator screw and for each 824 locking tool. More details regarding the handle configurations that include electric motors for controlling the placement device components are presented in the United States Publication N. 2014/0296962.
[00253] In addition, any of the placement devices described in this document may include software and / or hardware operable to control the expansion of a prosthetic valve, as further described in United States Publication No. 2014/0296962 . In particular embodiments, a placement device may include a programmable controller (for example, accommodated in the handle) operable to radially expand a prosthetic valve according to a specific algorithm. For example, a placement device may include one or more motors (for example, electric motors) controlled by an electronic controller in order to expand a prosthetic valve in the radial direction according to a specific algorithm. In certain implementations, for example, the controller can be programmed to produce a pulsatile radial expansion in a prosthetic valve, as described in more detail in United States Publication No. 2014/0296962.
[00254] Figure 32 shows an exemplary flexible screw 900 that can be used to replace any of the screws described in the present invention, such as, for example, the fixing screw 624. As described above with respect to the valve device 600, before implantation in a patient, the prosthetic valve is crimped in a folded state in the radial direction. However, the presence of locking mechanism 610 and fixing screw 624 in the example illustrated in Figure 18, for example, may limit the degree to which the valve
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84/115 prosthetics can be radially bent. Specifically, the width of the fixing screw 624 extends within the profile of the structure, which may limit the degree to which the structure 604 can be crimped. Since a smaller beaded diameter is preferable for implantation in a patient, reducing the diameter of the 624 fixing screw is desirable.
[00255] However, the tensile force on the screw during valve expansion, the torque required to turn the screw, the fatigue stress of the screw during the valve's life cycle, and the bending moments due to lateral forces on the screw will limit the extent of the reduction of the diameter of the fixing screw 624. For example, the deformation of the structure during a crimping can exert bending forces on the screw, which can cause a plastic deformation of the screw. Therefore, the incorporation of a screw adapted to flex or bend along at least a portion of the screw without permanent deformation may allow the reduction of the diameter of the screw along all or a portion of the length of the screw.
[00256] The flexible screw 900 in the illustrated embodiment may comprise a relatively rigid threaded portion 902, a relatively flexible portion 904, and a screw head 906 connected to the end of the flexible portion, with the flexible portion 904 positioned between the threaded portion 902 and the screw head 906. The threaded portion 902 may have an externally threaded surface. The flexible portion 904 is relatively more flexible than the rigid threaded portion 902 and therefore can flex or bend with respect to the threaded portion. The flexible portion 904 may comprise, for example, a braided cable, a wire, a laser cut tube, or a hypotube. The threaded portion 902, the flexible portion 904, and the screw head 906 can be connected together by, for example, welding
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85/115 laser, a pressed connection, or integrating and machining all these parts as one part. The threaded portion 902, the flexible portion 904, and the screw head 906 can be made, for example, of titanium (for example, TÍ-6A1-4V ELI), cobalt chrome, stainless steel (for example, 316, 304) , PEEK, or other materials.
[00257] Figure 33 shows a portion of an exemplary valve device, in which a fixing screw 624 is used in order to lock structure 604 in a particular expanded state. Figure 34 shows a portion of an exemplary valve device in which a flexible screw 900 replaces rigid screw 624. Flexible portion 904 of thread 900 can bend and absorb bending forces after radial expansion and compression of the structure without deformation permanent or plastic screw. Therefore, flexible screw 900 may have a smaller diameter as possible with screw 624. In specific terms, the diameter of the threaded portion 902 of flexible screw 900 may be smaller than the diameter of rigid screw 624. Referring to Figure 32, in in some embodiments, the diameter D1 of the threaded portion 902 can be between 0.3 mm and 1 mm, and more desirably, between 0.4 mm and 0.6 mm, 0.5 mm being a specific example. In some embodiments, the D2 diameter of flexible portion 904 can be between 0.1 mm and 0.6 mm, and more desirably between 0.2 mm and 0.4 mm, 0.3 mm being a specific example. The flexible screw 900 can also operate in the same way as the fixing screw 624. [00258] Figure 35 shows an exemplary flexible screw 1000, according to another modality. Screw 1000 comprises a relatively rigid threaded portion 1002, a relatively flexible portion 1004 more flexible than the threaded portion, a screw head 1006 connected to the end of the threaded portion, and a stop 1008. Flexible screw 1000 is similar to flexible screw 900 , except that threaded portion 1002 is positioned between flexible portion 1004 and
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86/115 the screw head 1006 and the stop 1008 are connected to the distal end of the flexible portion 1004. An advantage of the flexible screw 1000 is that there is no need to transfer the torque through the flexible portion 1004 of the screw 1000 when tapping the screw in the frame.
[00259] Figures 36A and 36B show a portion of an exemplary valve device in which flexible screw 1000 can be used in order to lock structure 604 in a given state expanded in the radial direction. In the illustrated example in Figure 36A, the valve is shown in an expanded configuration prior to locking the valve. In the illustrated example in Figure 36B, the valve is shown after it has been locked in place with screw 1000. The exemplary valve device in Figures 36A and 36B can be produced by connecting stop 1008 to screw 1000 after positioning the screw within the proximal and distal nuts 626, 628. For example, the threaded portion 1002 of the screw 1000 may first be screwed into the proximal nut 626, followed by insertion of the flexible portion 1004 of the screw through the distal nut 628. The stop 1008 may then be welded or otherwise fixed to the distal end of the flexible portion 1008 in order to secure the proximal and distal nuts 626, 628 between the screw head 1006 and the anvil. Other manufacturing methods can also be used to ensure that nuts 626, 628 are positioned between screw head 1006 and stop 1008. When frame 604 is compressed in a crimped configuration prior to implantation in a patient (for example , from the configuration shown in Figure 36A), distal nut 628 is positioned closer to stop 1008. Therefore, flexible portion 1004 should be long enough so that structure 604 can be crimped to a desired extent without distal nut is juxtaposed to the stop.
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87/115 [00260] In the example in Figures 36A and 36B, the threaded portion 1002 of flexible screw 1000 can fit into the internal threads of proximal nut 626, and flexible portion 1004 can move freely within distal nut 628 in one direction axial. After the structure expands (for example, with one or more linear actuating devices 608 of Figure 18) to a desired radial expansion size, as shown in Figure 36A, screw 1000 can be used to lock the structure, as described in this document. The structure can be locked by rotating the screw in the direction of moving it in a proximal direction with respect to the nuts 626, 628 (for example, by turning the screw counterclockwise). The screw 1000 can then be turned until the stop 1008 is juxtaposed with distal nut 628, as shown in Figure 36B. From this configuration, further radial expansion of the structure will become possible by still shortening the structure and reducing the axial distance between proximal nut 626 and distal nut 628. However, radial compression of the structure will be prohibited in the configuration locked in Figure 36B, since the threaded portion 1002 that is threaded on the proximal nut 626 and the stop 1008 that is juxtaposed to the distal nut 628 will prevent the axial distance between the proximal ends and the distal nuts.
[00261] Figures 37A to 37C show alternative flexible screws 1100, 1200, and 1300. Each of these flexible screws 1100, 1200, 1300 has a relatively rigid threaded portion 1102, 1202, 1302, respectively, similar to the threaded portion 902 of the screw 900 and a screw head 1106, 1206, 1306, respectively, similar to screw head 906 of screw 900, connected to the end of the flexible portion opposite the threaded portion. In the example of Figure 37A, screw 1100 has a flexible portion 1104 comprising a cable (for example, a braided welded or pressed cable). In the example of
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88/115
Fig. 37B, screw 1200 has a flexible portion 1204 comprising a solid or tubular shaft that has a smaller diameter than threaded portion 1202. Screw 1200 can be manufactured by machining a part (for example, by machining solid shaft or hollow tube, for example, by laser cutting). In the example of Figure 37C, screw 1300 has a flexible portion 1304 comprising a metal hypotube that can be formed, for example, by laser cutting a metal tube.
[00262] The flexible screws 900, 1000, 1100, 1200, 1300 can also be used with the prophetic valves that have a mechanical expansion mechanism of the rotary or screw type, for example, with the prophetic valve 1800 of Figure 51, described in more detail below. In the example shown in Figure 51, screws 900 are shown, but can be replaced with any of the screws 1000, 1100, 1200, or 1300.
[00263] With reference to Figure 51, the prophetic valve 1800 comprises a structure 1802 which can have the same construction as structure 602 of Figure 18, and a valve structure 1804. In this embodiment, a proximal end portion of each screw 900 can be modified to include a fixture 1806 which can include a notch 1808 and a protrusion 1810 which can be removably coupled to a corresponding protrusion of a drive shaft of a placement device (not shown). The drive shaft can be attached to a motor or another device that can make it turn. When the drive shaft is therefore rotated while coupled to the 1806 fastener of a 900 screw, the force can be transferred to the screw, causing the screw to rotate.
[00264] A sleeve 1812 and a nut 1814 can be fixed to the structure 1802 in positions spaced in the axial direction. The 900 screw
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89/115 can be fixed axially with respect to sleeve 1812, while threaded portion 902 of the screw can fit into the internal threads of nut 1814 such that rotation of screw 900 causes the distance between the fixing positions of the sleeve 1812 and nut 1814 vary in such a way that the structure 1802 expands or contracts radially, based on the direction of rotation. The flexible portion 904 can extend along the screw at least partially between sleeve 1812 and nut 1814.
[00265] In other examples, the prosthetic valve 1800 can incorporate screws 1000, in which case each screw 1000 can be axially fixed to a sleeve 1814 (similar to nut 1814, but without internal threads), and the threaded portion 1002 of the screw it can fit into the internal threads of an 1812 nut (similar to sleeve 1812, but with internal threads), which will also result in the rotation of the screw and cause the expansion or contraction of the 1802 structure. More details regarding the prosthetic valve 1800 and the placement devices that can be used to implant the prosthetic valve are presented in pending United States Provisional Order No. 62 / 548,855.
[00266] Figure 38 shows a portion of structure 604 and a fixing screw 624 when the screw is threaded on the proximal nut 626 and distal nut 628 in order to lock the structure in a given expanded state in the radial direction, as described above with respect to Figures 24A to 24D. The use of a screw, for example, the fixing screw 624, in order to lock the structure is a robust and simple design due to the high tension force of the screws and the low torque required for locking. Figures 39 to 49 show several ways to further lock the position of a screw, for example, screw 624, under dynamic vibration loads.
[00267] Figures 39 to 41 show an example of an element of
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90/115 lock comprising an inclined spring lock 1400 that can be attached to a proximal nut 626 in order to resist rotation of the fixing screw 624 after the fixing screw moves to a position in order to retain the structure 604 in the expanded state. Figure 39 shows the frame 604, the clamping screw 624, and the tool head 632 before the frame is placed in the locked position. In Figure 39, tool head 632 is positioned around screw head 630 (not shown in Figure 39) in such a way that the tool head can rotate to advance clamping screw 624 to a locked position in which the screw head 630 is juxtaposed with the proximal nut 626.
[00268] Spring lock 1400 may be in the form of a laminated spring, as shown, and may have a fixed end portion 1402 attached to nut 626 and a free end portion 1404 angled inward in the direction of screw 624 of such that it exerts a force directed inwards in the radial direction towards the fixing screw 624. When the tool head 632 rotates and advances in the distal direction, the shape of the spring lock 1400 will be such that the tool head can slide under the free end portion 1404, pushing the spring lock out of the fixing screw 624, as shown in Figure 40. Although tool head 632 is positioned between screw 624 and spring lock 1400, the shape circular of the tool head will allow it to be easily rotated, despite the presence of the spring lock, since a very small surface area of the tool head is in contact with the lock spring
[00269] When tool head 632 fully advances screw head 630 against proximal nut 630, tool head 632 can be removed from the screw head, as shown in Figure 41. This causes the end portion free 1404
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91/115 of the spring lock 1400 is pressed against the screw head 630. Due to the flat surface of the screw head 630 and the pressure exerted against the screw head by the spring lock 1400, the torque required to turn the screw further 624 is increased. The pressure exerted by the spring against the screw head further resists the rotation of the screw (and the loosening of the screw) against the dynamic vibrational loads on the screw. The spring can be selected to have sufficient stiffness to withstand greater rotation of the screw under the load applied by the user in order to rotate the screw to the locked position.
[00270] In another example, the spring can be selected so that it has a stiffness that still allows an operator to turn the fixing screw 624 from its locked position with a predefined torque and at the same time still resist the rotation of the screw caused vibrational loads. In alternative embodiments, a spring lock can be fixed to a location on the structure other than nut 626. For example, a spring lock can be attached to a frame rod at a location where the spring lock can fit on the head. screw 630.
[00271] Figures 42 and 43 show an alternative example of an inclined spring lock 1410 that can be used to resist rotation of the fixing screw 624 after the prophetic valve expands and the fixing screw is moved to the locked position. In the example of Figures 42 and 43, the spring lock 1410 has a fixed end portion 1412 that is attached to the screw head 630 instead of the proximal nut 626, as in the example in Figures 39 to 41, and a portion of free end 1414. Spring lock 1410 is angled against nut 626. Spring lock 1410 is configured to be secured by tool head 632 in a first unattached location, outside nut 626 against the force of the locking nut. spring 1410
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92/115 and, when released from tool head 632, the spring lock may revert to a second engaged position, with the free end portion 1414 resting against nut 626.
[00272] Figure 42 shows the structure 604 and the clamping screw 624 when the tool head 632 is in a position to rotate the clamping screw to a locked position juxtaposed to the proximal nut 626. As shown, the Tool head 632 may include a slot or aperture 1416 sized to accommodate the free end portion of the spring lock and secure it in the non-engaged position. After the screw head 630 moves to a locked position juxtaposed with the proximal nut 626, the tool head 632 can be removed from the screw head, as shown in Figure 43 (and, as previously described). This causes the spring lock 1410 to be released from the tool head 632 and causes the spring lock to spring back and press against the proximal nut 626. The spring lock exerts sufficient pressure against nut 626 in order to resist the rotation of screw 624 caused by vibrational loads. The nut 626 can be formed with a flat surface 627 which is contacted by the spring lock in order to increase the resistance against rotation of the screw.
[00273] Figures 44 and 45 show an example of a plastically deformable locking element 1500 that can be used to resist rotation of the fixing screw 624. The locking element 1500 in the illustrated configuration comprises a flexible flange fixed to a end to screw head 630. Figure 44 shows screw 624 in a locked position with screw head 630 juxtaposed to proximal nut 626. When screw head 630 is in place, locking element 1500 can be bent against the proximal nut 626 under an external force, as shown in Figure 45. The locking element 1500 is plastically deformed when bent and,
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93/115 therefore maintains its shape against or adjacent to nut 626. When the locking element 1500 is bent to the position shown in Figure 45, the locking element 1500 resists the rotation of the fixing screw 624 caused by vibrational forces random.
[00274] The locking element 1500 may have a flat profile that corresponds to the flat surface 627 of nut 626. However, in alternative embodiments, the locking element and / or the nut may have other shapes. For example, the locking element 1500 can be dimensioned and shaped to fit in a recess or opening correspondingly formed in the nut.
[00275] The locking element 1500 can be bent by the locking tool 632 (not shown in Figures 44 and 45), for example, by pushing the locking tool or a separate thrust element against the flange while the screw head is juxtaposed with proximal nut 626. In other examples, other methods of flexing the flange 1500 may be used. The locking element may comprise a plastically deformable material, for example, stainless steel, and may be formed as a part of the screw head 630, or separately formed and fixed (for example, by welding) to the screw head. In alternative embodiments, the locking element may be attached to the nut 626 or in another convenient location on the structure and is then folded against the screw head 630 in order to resist the rotation of the screw.
[00276] In particular embodiments, a valve device may incorporate a ratchet lock system configured to allow the rotation of a fixing screw in one direction in order to place the screw in a locked position and resist the rotation of the screw in the opposite direction. Figure 46 shows an example of a ratchet lock 1600 configured to resist rotation of screw 624 after the screw is placed in a locked position after
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94/115 expansion of the valve. The ratchet lock 1600 in the illustrated embodiment is attached to the proximal end of a proximal nut 626 and positioned to fit the screw head 630. In some implementations, the proximal nut 626 and the ratchet lock 1600 may be manufactured as a single piece. In other implementations, the ratchet lock 1600 may be produced separately and then fixed to nut 626 (for example, by welding). In still other implementations, the ratchet lock 1600 may be mounted on the frame 604 away from nut 626; that is, the ratchet lock 1600 does not need to be directly mounted on the nut, as long as it is positioned to fit the screw head 630. The ratchet lock 1600 is formed with one or more ratchet devices configured according to in order to fit the screw head 630 and allow rotation of the fixing screw 624 in one direction to allow a user to move the fixation screw to its locked position, and, on the other hand, resist rotation of the screw in the opposite direction.
[00277] Figures 47A to 47D show several views of the proximal nut 626 and the ratchet lock 1600 fixed. The ratchet lock 1600 in the illustrated configuration can have a base element 1602 and one or more ratchet devices in the form of one or more ratchet teeth 1604 extended from the base element 1602. As best shown in Figure 47D , the ratchet teeth 1604 can be positioned at opposite corners of the base element 1602 and project outward from the base element and have angled surfaces that fit into the screw head 630.
[00278] The spacing between teeth 1604 can be slightly greater than the width of the screw head 630. In use, when the fixing screw 624 is turned towards its locked position (for example, clockwise), the screw head 630 will come into
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95/115 contact with teeth 1604. Due to the angled surfaces of teeth 1604, the screw head can be further rotated in the same direction to the locked position until the screw head is positioned between teeth 1604, as shown in Figure 46. Teeth 1604 can be dimensioned and formed in such a way that a predetermined torque applied to the screw by the user allows the screw to be placed in its locked position. As soon as the screw head 630 is between the teeth, rotation of the screw head (and therefore of the clamping screw) in the opposite direction (for example, counterclockwise) is prevented by contact between the teeth and the screw head. In this way, the ratchet lock 1600 will resist the rotational movement of the fixing screw 624 which may be caused by vibrational forces.
[00279] Although the two ratchet teeth are shown in the illustrated mode, a greater or lesser number of teeth may be used. In addition, in alternative embodiments, the screw head 630 may be formed with one or more ratchet devices (for example, teeth 1604) that fit on an adjacent surface of nut 626 or another component of the structure (without using ratchet lock 1600). In some embodiments, one or more ratchet devices on the screw head may be adapted to fit one or more ratchet devices on a 1600 ratchet lock or other component of the structure.
[00280] Figure 48 shows an example of a locking locking system that can be used in order to prevent the rotation of the fixing screw 24 after it is placed in a locked position. The exemplary latch locking system of Figure 48 is the same as the exemplary ratchet locking system of Figure 46, except that the ratchet lock 1600 is replaced by a locking socket 1650 which, in the illustrated configuration, comprises a base element 1652 it is a
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96/115 or more teeth or protrusions 1654, 1656. As described above with respect to the ratchet lock 1600, the lock socket 1650 may be integrally formed as part of nut 626, or it may be a separate component mounted on the nut or elsewhere on structure 604.
[00281] Figures 49A to 49D show several views of a proximal nut 626 and an attached locking insert 1650. As best shown in Figure 49D, each tooth has a convex surface that protrudes out of the base 1652. Teeth 1654 are dimensioned and formed to allow rotation of the screw head in both directions when a predetermined torque is applied to the screw by the user. In the illustrated example, after applying a predetermined torque to the screw, the screw head 630 can rotate on the surfaces of teeth 1654 in both directions, making a click every 90 degrees of rotation. However, the engagement of the teeth with the screw head will resist rotation of the screw when the predetermined torque is not exceeded. In this way, the rotational movement of the screw caused by vibrational loads can be prevented.
[00282] It should be understood that the lock fitting does not need to make an audible click when rotated. In the context of the present invention, a lock socket provides resistance to rotation in one or more rotational orientations of the lock socket with respect to a component that enters the lock socket (for example, the screw head), or vice versa. When the rotated component exceeds the resistance, the torque required to rotate the component decreases. The resistance that increases or decreases against the torque of the screw can offer a tactile response to the user with respect to the rotational orientation of the screw, whose response can be felt as the sound of a click when the screw is turned.
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97/115 [00283] Any of the locking mechanisms described above with respect to Figures 39 to 49 can be used in order to apply resistance against the rotation of a screw that is used in order to produce a radial expansion or compression in the structure of a prosthetic valve. For example, any of these locking mechanisms can be used with respect to screws 900 of prosthetic valve 1800 in Figure 51.
[00284] Figure 50 shows an alternative embodiment of a structure 1700 and a skirt 1702 of a prosthetic heart valve. The skirt 1702 can be made of any of the materials described above in relation to the skirt 50 of Figure 2. The skirt 1702 can function as a sealing element in order to help establish a seal with the surrounding fabric, as with the skirt 50. The skirt 1702 can also help to attach a set of cusps (for example, the set of cusps 48) inside the structure, such as when suturing the inflow edges of the cusps in the skirt 802.
[00285] Structure 1700 can be constructed similarly to structure 22 of Figure 2. Structure 1700 can have a plurality of parallel rods extending diagonally 1704, 1706, and 1708 pivotally connected to rods extending perpendicularly to the rods 1704, 1706, 1708, similar to structure 22 in Figure 2 and structure 200 in Figure 4. For purposes of illustration, only three rods 1704, 1706, 1708 of the structure are shown.
[00286] The skirt 1702 can be supported on the structure 1700 by weaving the skirt through the stems 1704, 1706, 1708 of the structure such that portions of the skirt are positioned on the internal surfaces of the stems, and portions of the skirt are positioned on the external surfaces of the rods. For example, in the illustrated embodiment, skirt 1702 is positioned on the inner surfaces of the stems 1704, 1708 and on the outer surface of the stems 1706.
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98/115 the skirt 1702 can be positioned on the outer surface of the stems 1704, 1708 and on the inner surface of the stems 1706.
[00287] The rods of structure 1700 can be connected together with the use of fasteners, such as fasteners 40 of Figure 2. Skirt 1702 can be placed between the rods during the rod assembly process in order to form the structure . In the embodiment illustrated in Figure 27, the fasteners used to connect the rods of the structure 1700 to a device can extend through the skirt 1702 in order to hold the skirt in place over the rods without the use of sutures. For example, skirt 1702 can be formed with holes that are precast and dimensioned to accommodate fasteners 40, or, alternatively, fasteners can be pressed and pierce the skirt material during the assembly process. Instead of or in addition to the use of fasteners, sutures may be made in the direction of fastening the skirt 1702 to the structure 1700.
[00288] Other examples:
[00289] 1. A prosthetic valve placement device, comprising:
[00290] - a prosthetic valve comprising an expandable compressible and radially expandable structure and a plurality of lock units coupled to the structure in circumferentially spaced locations, each lock unit comprising a respective first coupling element and a lock element; and [00291] - a placement apparatus comprising:
[00292] - a plurality of elongated positioning elements, each of the positioning elements comprising a respective second coupling element at a distal end thereof, each second coupling element being removably coupled to a respective first coupling element;
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99/115 [00293] - a plurality of elongated actuation elements, each of the actuation elements having a distal end portion coupled to the structure; and [00294] - a plurality of release elements, each one of the plurality of release elements coaxially arranged with respect to, or embedded in, one of the locking units;
[00295] - in which the movement of the positioning elements or the actuation elements in the axial direction with respect to each other causes the structure to expand or contract, and the retraction of the release elements proximal to the locking elements of the units locking element causes the locking elements to move to a locked position in order to resist the contraction of the structure, and the retraction of the release elements proximal to the first coupling elements of the locking units causes the first coupling elements to disengage from the second coupling elements, thereby allowing the positioning elements to disengage from the locking units.
[00296] 2. The placing device, according to example 1, further comprising a handle coupled to the proximal end portions of the first and second actuating elements, the handle comprising a first actuator configured so as to produce an axial movement of the positioning elements.
[00297] 3. The placing device, according to example 2, in which the handle comprises a second actuator configured to produce an axial movement of the release elements with respect to the positioning elements and the actuation elements.
[00298] 4. The placement device, according to any preceding example, in which each of the lock elements comprises a pair of deformable lock claws arranged on one of the actuation elements.
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100/115 [00299] 5. The placing device, according to any preceding example, in which each of the first coupling elements comprises a flap and a notch, and each of the second coupling elements comprises a flap and a notch. , the tab of the first coupling element being accommodated in the notch of the second coupling element, and the tab of the second coupling element being accommodated in the notch of the first coupling element.
[00300] 6. The placement device, according to example 5, in which the flap of the second coupling element comprises a slit extended in the axial direction.
[00301] 7. The placement device, according to example 1, in which the actuation elements comprise a plurality of straps.
[00302] 8. The placement device, according to any preceding example, further comprising a plurality of cutting elements configured in order to cut the actuation elements in places proximal to the locking units.
[00303] 9. The placement device, according to any one of examples 1 to 8, in which each of the actuation elements comprises a plurality of projections spaced apart in the longitudinal direction and configured so as to fit in one of the locking elements of one of the locking units.
[00304] 10. The placing device, according to any preceding example, in which each of the locking units comprises a first elongated element coupled to a proximal end of the structure and a second elongated element coupled to a distal end of the structure, the first and second elements being axially movable with respect to each other.
[00305] 11.0 placement device, according to example 10,
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101/115 in which each of the first elements of the locking units is removably coupled to one of the positioning elements, and each of the second elements is removably coupled to one of the actuation elements.
[00306] 12. The placing device, according to example 11, in which the retraction of the release elements proximal to the locking units is effective in the sense of uncoupling the second elements of the locking units from the actuation elements.
[00307] 13. The placing device, according to any of examples 10 to 12, in which each of the first elements of the latch units comprises a first component of latch, and each of the second elements of the latch units comprises a second locking component, and the retraction of the release elements proximal to the locking units causes the first locking component to engage the second locking component in order to resist the relative axial movement between the first and second elements and the contraction of the structure.
[00308] 14.0 placement device, according to example 13, in which each of the first locking components comprises a movable locking bar, and each of the second locking components comprises at least one opening dimensioned to accommodate a lock bar.
[00309] 15. The placement device, according to any of examples 10 to 14, in which the first element of each locking unit is pivotably connected to a vertex at the proximal end of the structure, and the second element of each locking unit is pivotally connected to a vertex at the distal end of the structure.
[00310] 16. The placement device, according to any preceding example, in which the structure comprises a plurality
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102/115 of interconnected rods having a plurality of linear segments laterally offset from each other in a direction perpendicular to the lengths of the rods.
[00311] 17.0 placement device, according to example 16, in which the rods are connected to each other in places between the linear segments.
[00312] 18.0 placement device, according to example 17, in which the rods are articulated coupled to each other by means of pins extended through the rods in the locations between the linear segments.
[00313] 19. The placement device, according to any of examples 1 to 9 and 16 to 18, in which each of the actuation elements extends coaxially through one of the positioning elements.
[00314] 20 The placement device, according to any of examples 1 to 9 and 16 to 18, in which each of the release elements extends through one of the locking units coaxially between one of the positioning elements and a performance elements. [00315] 21. The placing device, according to any of examples 1 to 9 and 16 to 18, in which the first coupling element of each of the plurality of locking units comprises a radially outwardly inclined fin, and in which each of the release elements is arranged on a positioning element and a first coupling element.
[00316] 22. A prosthetic valve, comprising:
[00317] - a radially expandable and compressible structure comprising a plurality of interconnected rods, each rod having a first end, a second end, and a length extending from the first end to the second
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103/115 end, each stem comprising a plurality of linear segments that are laterally displaced to one another in a direction perpendicular to the lengths of the stems; and [00318] - a valve structure mounted on the structure and configured to regulate blood flow through the prosthetic valve.
[00319] 23. Prosthetic valve, according to example 22, in which each of the plurality of rods is articulated to at least one other rod among the plurality of rods.
[00320] 24. Prosthetic valve, according to example 22 or 23, further comprising a spacer placed between a pair of connected rods.
[00321] 25. Prosthetic valve, according to any of examples 22 to 24, in which the rods are connected to each other by means of pins extended through the rods.
[00322] 26. Prosthetic valve, according to any of examples 22 to 25, in which the structure comprises a plurality of circumferentially spaced locking units configured to lock the structure in an expanded state in the radial direction.
[00323] 27. A method of placing a prosthetic valve, the method comprising:
[00324] - the insertion of a distal end of an elongated placement apparatus in a patient, the elongated placement apparatus being removably coupled to the prosthetic valve, the prosthetic valve comprising an expandable structure comprising a plurality of locking units;
[00325] - the axial movement of a plurality of elongated positioning elements of the placement apparatus in order to expand the prosthetic valve to an expanded state of a desired size;
[00326] - the removal of a plurality of release elements
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104/115 elongated from the plurality of locking units, causing the positioning elements to disengage from the structure and the locking units in order to lock the structure in its expanded state; and [00327] - removal of the patient's elongated placement device.
[00328] 28. The method, according to example 27, in which the removal of the release elements from the locking units allows the first coupling elements of the actuation elements to disengage from the corresponding second coupling elements of the locking units .
[00329] 29. The method, according to example 27 or 28, in which:
[00330] - the axial movement of a plurality of elongated actuation elements of the placing apparatus comprises the axial movement of a first plurality of actuation elements with respect to a second plurality of actuation elements of the placing apparatus in order to expand the prosthetic valve; and [00331] - removing the release elements from the locking units allows the first and second actuating elements to disengage from the structure.
[00332] 30. A device, comprising:
[00333] - a prosthetic valve comprising a radially expandable and compressible annular structure;
[00334] - at least one linear actuator device coupled to the structure and configured so as to apply a force directed in the distal direction and / or a force directed proximal to the structure in order to expand or compress the structure in the radial direction; and [00335] - at least one locking mechanism coupled to the structure comprising a first sleeve element connected to the structure at a first location, a second sleeve element provided with internal threads and connected to the structure at a second location, and a first
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105/115 screw configured to fit the internal threads of the second sleeve element in order to retain the structure in an expanded state in the radial direction.
[00336] 31. The device, according to example 30, in which the at least one linear actuator device is removably coupled to the structure.
[00337] 32. The device, according to example 30, in which the at least one linear actuator device comprises an actuator element configured so as to be removably coupled to the structure.
[00338] 33. The device, according to example 32, in which the at least one linear actuator device comprises a first threaded element connected to a distal end portion of the actuator element, the first threaded element being configured to fit removably engage a second threaded element connected to the frame.
[00339] 34. The device, according to example 33, in which the first threaded element comprises a second screw and the second threaded element comprises an internally threaded nut. [00340] 35. The device, according to any of the examples at 34, in which the actuator element comprises a cable.
[00341] 36. The device, according to any of the examples at 35, in which the at least one linear actuator device further comprises a sleeve positioned in an annular direction around the actuator element.
[00342] 37. The device, according to any of the examples at 36, further comprising:
[00343] - an annular stop connected to the structure, in which the actuator element extends through the stop;
Petition 870190048782, of 05/24/2019, p. 179/189
106/115 [00344] - where the at least one linear actuator device comprises a support tube positioned in an annular direction around the actuator element, and the stop is configured to fit at a distal end of the support tube and preventing the support tube from moving in the distal direction and exceeding the stop in an axial direction.
[00345] 38. The device of any of examples 30 to 37, further comprising a locking tool configured to be removably coupled to the first screw, the locking tool comprising a tool head configured to fit no and produce the rotation of the first screw when the locking tool is coupled to the first screw in such a way that the first screw moves axially through the first sleeve element and the second sleeve element.
[00346] 39. The device, according to example 38, in which the first screw has a screw head at its proximal end, and in which the shape of the tool head is configured to correspond to a shape of the head of screw in such a way that the tool head becomes operable in the sense of being coupled to the screw head in such a way that the rotation of the tool head causes the rotation of the first screw.
[00347] 40. The device, according to example 39, in which the screw head and the first sleeve element are configured in such a way that the screw head is prevented from moving in the distal direction beyond the first element sleeve in an axial direction.
[00348] 41. The device, according to any of the examples at 40, in which the at least one locking mechanism further comprises an internal axis which extends partially within a lumen of the tool head, the internal axis having a surface
Petition 870190048782, of 05/24/2019, p. 180/189
107/115 threaded at its distal end, the screw head having internal threads, and the internal axis being configured in such a way that its threaded surface fits into the internal threads of the screw head. [00349] 42. The device, according to any of the examples at 41, in which the first screw further comprises a rigid portion and a flexible portion positioned between the screw head and the rigid portion.
[00350] 43. The device, according to example 42, in which the flexible portion of the first screw comprises a braided cable.
[00351] 44. The device, according to example 42, in which the flexible portion of the first screw comprises a hypotube.
[00352] 45. The device, according to any of the examples at 41, in which the first screw further comprises a rigid portion connected to the screw head, a flexible portion connected to a distal end of the rigid portion, and a stop connected at a distal end of the flexible portion.
[00353] 46. The device, according to any of the examples at 45, further comprising a spring lock fixed to the first glove element, in which the spring lock is configured so as to exert a force directed inwards in the direction radial against the screw head in order to resist rotation of the screw.
[00354] 47. The device, according to any of the examples at 45, further comprising a spring lock fixed to the screw head, in which the spring lock is configured so as to exert a force directed inwards in the radial direction against the first sleeve element to resist rotation of the screw.
[00355] 48. The device, according to any of the examples at 45, further comprising a flange fixed to the screw head, in which the flange is configured to flex against the first glove element in order to resist the screw rotation.
Petition 870190048782, of 05/24/2019, p. 181/189
108/115 [00356] 49. The device, according to any of the examples at 45, further comprising a ratchet lock fixed to a proximal end of the first glove element, wherein the ratchet lock comprises teeth configured to allow the rotation of the screw head in a first direction and prevent rotation of the screw head in a second direction.
[00357] 50. The device, according to any of the examples at 45, further comprising a click lock fixed to a proximal end of the first glove element, wherein the click lock comprises teeth configured to resist rotation of the screw less than 90 degrees and sound a click when the screw is turned 90 degrees.
[00358] 51. A device, comprising:
[00359] - a prosthetic valve comprising a radially expandable and compressible annular structure; and [00360] - at least one expansion and locking mechanism comprising:
[00361] - a linear actuator connected to the structure, in which the linear actuator is configured in order to apply a force directed in the distal direction and / or a force directed proximal to the structure in order to expand or compress the structure in the radial direction ; and [00362] - a rotating element coaxially positioned in relation to the linear actuator configured to retain the structure in an expanded state in the radial direction.
[00363] 52. The device, according to example 51, further comprising:
[00364] - a first glove element connected to the structure in a first location; and [00365] - a second glove element with internal threads and connected to the structure in a second location;
Petition 870190048782, of 05/24/2019, p. 182/189
109/115 [00366] - in which the linear actuator is removably coupled to the structure;
[00367] - in which the rotating element is a screw configured to fit the internal threads of the second sleeve element; and [00368] - where the linear actuator extends through a screw lumen.
[00369] 53. The device, according to example 52, further comprising a locking tool configured to be removably attached to the screw and rotate the screw in such a way that the screw moves axially through the first sleeve element and the second sleeve element when the locking tool is attached to the screw.
[00370] 54. The device, according to example 53, in which the locking tool and the first glove element are configured in such a way that the locking tool is prevented from moving in the distal direction and exceeds the first element threaded in an axial direction.
[00371] 55. The device, according to any of the examples at 54, in which the screw has a screw head at its proximal end, and in which the screw head and the first element are configured in such a way that the screw head is prevented from moving in the distal direction beyond the first sleeve element in an axial direction.
[00372] 56. The device, according to example 51, in which the linear actuator is an actuator screw with external threads and is connected to the structure in a first location;
[00373] - in which the device also comprises a glove connected to the structure in a second location;
[00374] - in which the actuator screw extends through a lumen
Petition 870190048782, of 05/24/2019, p. 183/189
110/115 of the glove;
[00375] - in which the rotating element is a lock nut provided with internal threads configured to fit the threads of the actuator screw; and [00376] - in which the glove and lock nut are configured in such a way that the lock nut is prevented from moving in the distal direction beyond the glove in an axial direction.
[00377] 57. The device, according to example 56, in which the actuator screw comprises a first portion and a second portion, wherein a diameter of the second portion is less than a diameter of the first portion.
[00378] 58. The device, according to example 57, in which the device further comprises an annular actuator element provided with internal threads configured to fit the threads of the second portion of the actuator screw in such a way that, when the internal threads of the actuator element fit the threads of the second portion of the actuator screw, the axial movement of the actuator element results in an axial movement of the actuator screw.
[00379] 59. The device, according to any of the examples and 58, further comprising a locking tool positioned within a lumen of the glove, in which the locking tool has a notched portion at its distal end configured in a way to fit into a corresponding notched portion at a proximal end of the lock nut such that rotation of the lock tool in a clockwise direction causes the lock nut to rotate clockwise.
[00380] 60. The device, according to example 59, in which the locking tool has an internally threaded surface in order to fit the threads of the actuator screw.
Petition 870190048782, of 05/24/2019, p. 184/189
111/115 [00381] 61. The device, according to example 59, further comprising a support tube positioned in an annular direction around the locking tool, in which a proximal end of the glove is configured to fit at a distal end of the support tube such that the support tube is prevented from moving distally beyond the proximal end of the sleeve in an axial direction.
[00382] 62. The device, according to any of the examples at 61, further comprising a skirt, in which the structure comprises a plurality of rows of rods, and in which the skirt is positioned within at least one row of stems and on the outside of at least one other row of stems.
[00383] 63. An implantable prosthetic valve, comprising:
[00384] - an annular structure comprising a plurality of rows of rods and being radially foldable and expandable between a configuration folded in the radial direction and an expanded configuration in the radial direction; and [00385] - a skirt woven around the rods in such a way that the skirt is positioned within at least one row of rods and on the outside of at least one other row of rods.
[00386] 64. A method of implanting a prosthetic heart valve, the method comprising:
[00387] - the insertion of the prosthetic heart valve in the vasculature of a patient, the prosthetic heart valve being coupled to a distal end portion of a linear actuator, in which the prosthetic heart valve comprises a structure in a compressed state in the radial direction;
[00388] - the actuation of the linear actuator in order to expand the structure to an expanded state in the radial direction; and [00389] - the rotation of a screw in order to advance the screw
Petition 870190048782, of 05/24/2019, p. 185/189
112/115 through the first and second elements of the structure in order to retain the prosthetic valve in the expanded state in the radial direction.
[00390] 65. The method, according to example 64, in which the step of turning the screw comprises the rotation of a locking tool attached to the screw, and then the decoupling of the screw locking tool after the screw has advanced through the first and second elements.
[00391] 66. The method, according to any of examples 64 and
65, further comprising decoupling the linear actuator from the structure.
[00392] 67. The method, according to example 66, in which the step of uncoupling the linear actuator comprises unscrewing a threaded portion of the linear actuator from a corresponding threaded portion of the structure.
[00393] 68. The method, according to any of examples 64 to 67, in which the step of driving the linear actuator comprises the application of a force directed proximal to a distal portion of the structure with a cable.
[00394] General Considerations [00395] It should be understood that the described modalities can be adapted in order to provide and implant prosthetic devices in any of the native rings of the heart (for example, the pulmonary, mitral and tricuspid rings), and can be used with any one of several placement methods (for example, retrograde, anterograde, transeptal, transventricular, transatrial, etc.). The presented modalities can also be used in order to implant prostheses in other lumens of the body. In addition, in addition to prosthetic valves, the delivery device modalities described in this document can be adapted to provide and implant various other prosthetic devices, such as stents and / or other delivery devices.
Petition 870190048782, of 05/24/2019, p. 186/189
113/115 prosthetic repair.
[00396] For purposes of description, certain aspects, advantages and new features of the modalities of the present invention are described in this document. The methods, apparatus, and systems described are in no way to be construed as limiting. Instead, the present invention addresses all new features and obvious or non-obvious aspects of the various modalities presented, either alone or in various combinations or sub-combinations with each other. The methods, devices and systems are not limited to any specific aspect or feature or combination thereof, nor do the described modalities require that any one or more specific advantages be present for the problems to be solved. The technologies in any example may be combined with the technologies described in any one or more other examples. In view of the many possible modalities to which the principles of the presented technology can be applied, it must be recognized that the illustrated modalities are only preferred examples and should not be taken as limiting the scope of application of the presented technology.
[00397] Although the operations of some of the described modalities are described in a particular sequential order for presentation purposes, it should be understood that this form of description covers rearrangements, unless special ordering is required by the specific language presented below . For example, the operations described in sequence can in some cases be rearranged or performed simultaneously. In addition, for the sake of simplicity, the attached figures may not show the different ways in which the methods described can be used in conjunction with other methods. In addition, the description sometimes uses terms such as providing or obtaining to describe the methods presented.
Petition 870190048782, of 05/24/2019, p. 187/189
114/115
These terms are high-level abstractions from the actual operations that are performed. The actual operations that correspond to these terms may vary, depending on your particular implementation, and will be easily discernible by a person with simple knowledge in the art.
[00398] As used in the present application and in the claims, the singular forms one, one, and o, a include their plural forms unless the context clearly determines otherwise. In addition, the term includes means comprises. In addition, the terms coupled and associated generally mean electrical, electromagnetic, and / or physically (for example, mechanically or chemically) coupled or related and do not exclude the presence of intermediate elements between the coupled or associated elements, unless a specific language determine otherwise.
[00399] As used in this document, the term proximal refers to a position, direction, or portion of a device that is closest to the user or furthest from the implantation site. As used herein, the term distal refers to a position, direction, or portion of a device that is further from the user or closer to the implantation site. Thus, for example, the proximal movement of the device will be a movement of the device towards the user, while the distal movement of the device will be a movement of the device away from the user. The terms longitudinal and axial refer to a geometric axis that extends in the proximal and distal directions, unless otherwise expressly defined.
[00400] As used in this document, the terms integrally formed and unitary construction refer to a construction that does not include any welds, fasteners, or other means for attaching separately formed pieces of material to each other.
Petition 870190048782, of 05/24/2019, p. 188/189
115/115 [00401] As used herein, operations that occur simultaneously or concurrently generally occur at the same time with respect to one another, although delays in the occurrence of one operation with respect to another, due, for example, to , to a spacing, play or gap between components in a mechanical joint, such as threads, gears, etc., are expressly within the scope of the above terms, in the absence of a specific language to the contrary.
[00402] Taking into account the many possible modalities to which the principles of the present invention can be applied, it should be recognized that the illustrated modalities are only preferred examples and should not be taken as limiting the scope of the present invention. Otherwise, the scope of the present invention is defined in the following claims.

权利要求:
Claims (28)
[1]
1. Prosthetic valve, characterized by the fact that it comprises:
- a radially expandable and compressible structure comprising a plurality of interconnected rods, each rod having a first end, a second end, and a length extending from the first end to the second end, each rod comprising a plurality of linear segments which they are laterally deflected to each other, in a direction perpendicular to the lengths of the rods; and
- a valve structure mounted on the structure and configured to regulate blood flow through the prosthetic valve.
[2]
2. Prosthetic valve, according to claim 1, characterized by the fact that each of the plurality of rods is articulated to at least one other rod of the plurality of rods.
[3]
3. Prosthetic valve, according to any of the preceding claims, characterized by the fact that it also comprises a spacer placed between a pair of connected rods.
[4]
4. Prosthetic valve according to any of the preceding claims, characterized by the fact that the rods are connected to each other by means of pins extended through the rods.
[5]
5. Prosthetic valve according to any one of the preceding claims, characterized by the fact that the structure comprises a plurality of latch units circumferentially spaced and configured so as to lock the structure in an expanded state in the radial direction.
[6]
6. Device, characterized by the fact of understanding:
- a prosthetic valve comprising a radially expandable and compressible annular structure;
Petition 870190048782, of 05/24/2019, p. 67/189
2/7
- at least one linear actuating device coupled to the structure and configured so as to apply a force directed in the distal direction and / or a force directed proximal to the structure in order to expand or compress the structure in the radial direction; and
- at least one locking mechanism coupled to the structure comprising a first sleeve element connected to the structure at a first location, a second sleeve element provided with internal threads and connected to the structure at a second location, and a first screw configured to fit into the internal threads of the second sleeve element in order to retain the structure in an expanded state in the radial direction.
[7]
7. Device according to claim 6, characterized by the fact that the at least one linear actuator device comprises an actuator element configured to be removably coupled to the structure.
[8]
8. Device according to claim 7, characterized in that the at least one linear actuator device comprises a first threaded element connected to a distal end portion of the actuator element, the first threaded element being configured to fit removably on a second threaded element connected to the frame.
[9]
Device according to claim 8, characterized in that the first threaded element comprises a second screw, and the second threaded element comprises an internal threaded nut.
[10]
10. Device according to any one of claims 7 to 9, characterized in that the at least one linear actuator device further comprises a sleeve positioned in an annular direction around the actuator element.
Petition 870190048782, of 05/24/2019, p. 68/189
3/7
[11]
11. Device according to any one of claims 7 to 10, characterized in that it further comprises:
- an annular stop connected to the structure, in which the actuator element extends through the stop;
- wherein the at least one linear actuator device comprises a support tube positioned in an annular direction around the actuator element and the stop is configured to fit at a distal end of the support tube and prevent the support tube move in the distal direction and pass the stop in an axial direction.
[12]
12. Device according to any one of claims 6 to 11, characterized in that it also comprises a locking tool configured to be removably coupled to the first screw, the locking tool comprising a tool head configured so as to to engage and produce rotation of the first screw when the locking tool is coupled to the first screw in such a way that the first screw moves axially through the first sleeve element and the second sleeve element.
[13]
13. Device according to claim 12, characterized by the fact that the first screw has a screw head at its proximal end, and by the fact that the shape of the tool head is configured to correspond to a shape of the screw head in such a way that the tool head becomes operable in the sense of being coupled to the screw head in such a way that the rotation of the tool head causes the rotation of the first screw.
[14]
14. Device according to claim 13, characterized in that the screw head and the first sleeve element are configured in such a way that the screw head is im ~
Petition 870190048782, of 05/24/2019, p. 69/189
4/7 requested to move in the distal direction beyond the first glove element in an axial direction.
[15]
Device according to any one of claims 12 to 14, characterized in that the at least one locking mechanism further comprises an internal axis which extends partially within a lumen of the tool head, the internal axis having a threaded surface at its distal end, the screw head having internal threads, and the internal axis being configured such that its threaded surface fits into the internal threads of the screw head.
[16]
16. Device according to any one of claims 6 to 15, characterized in that the structure comprises a plurality of interconnected rods, each rod having a first end, a second end, and a length extending from the first end to the second end, each rod comprising a plurality of linear segments laterally displaced from each other in a direction perpendicular to the lengths of the rods.
[17]
17. Device, characterized by the fact of understanding:
- a prosthetic valve comprising a radially expandable and compressible annular structure; and
- at least one expansion and locking mechanism comprising:
- a linear actuator connected to the structure, in which the linear actuator is configured so as to apply a force directed in the distal direction and / or a force directed proximal to the structure in order to expand or compress the structure in the radial direction; and
- a rotating element coaxially positioned in relation to the linear actuator configured to retain the structure in an expanded state in the radial direction.
Petition 870190048782, of 05/24/2019, p. 70/189
5/7
[18]
18. Device, according to claim 17, characterized by the fact that it also comprises:
- a first glove element connected to the structure at a first location; and
- a second glove element provided with internal threads and connected to the structure in a second location;
- where the linear actuator is removably coupled to the structure;
- where the rotating element is a screw configured to fit the internal threads of the second sleeve element; and
- where the linear actuator extends through a screw lumen.
[19]
19. Device according to claim 18, characterized by the fact that it also comprises a locking tool configured to be removably coupled to the screw and rotate the screw in such a way that the screw moves axially through the first sleeve element and the second sleeve element when the locking tool is attached to the screw.
[20]
20. Device according to claim 19, characterized by the fact that the locking tool and the first sleeve element are configured in such a way that the locking tool is prevented from moving in the distal direction and exceeds the first threaded element in an axial direction.
[21]
21. Device according to any one of claims 18 to 20, characterized by the fact that the screw has a screw head at its proximal end, and the fact that the screw head and the first element are configured in such a way that the screw head is prevented from moving in the distal direction beyond the first sleeve element in an axial direction.
Petition 870190048782, of 05/24/2019, p. 71/189
6/7
[22]
22. Device, according to claim 17, characterized by the fact that the linear actuator is an actuator screw with external threads and is connected to the structure in a first location;
- in which the device also comprises a sleeve connected to the structure in a second location;
- in which the actuator screw extends through a glove lumen;
- in which the rotating element is a lock nut provided with internal threads configured to fit the threads of the actuator screw; and
- in which the sleeve and lock nut are configured in such a way that the lock nut is prevented from moving in the distal direction beyond the sleeve in an axial direction.
[23]
23. Device according to claim 22, characterized in that the actuating screw comprises a first portion and a second portion, wherein a diameter of the second portion is less than a diameter of the first portion.
[24]
24. Device according to claim 23, characterized in that the device further comprises an annular actuator element provided with internal threads configured to fit the threads of the second portion of the actuator screw such that when the internal threads of the actuator element fit the threads of the second portion of the actuator screw, the axial movement of the actuator element results in the axial movement of the actuator screw.
[25]
25. Device according to any one of claims 22 to 24, characterized in that it further comprises a locking tool positioned within a lumen of the glove, in which the locking tool has a notched portion at its distal end configured in a way to fit a corresponding notched portion at a proximal end of the lock nut in such a way
Petition 870190048782, of 05/24/2019, p. 72/189
7/7 that turning the locking tool in a clockwise direction causes the locking nut to rotate clockwise.
[26]
26. Device according to claim 25, characterized by the fact that the locking tool has an internally threaded surface to fit the threads of the actuator screw.
[27]
27. Device according to claim 25, characterized by the fact that it also comprises a support tube positioned in an annular direction around the locking tool, in which a proximal end of the glove is configured to fit at one end distal from the support tube such that the support tube is prevented from moving distally beyond the proximal end of the sleeve in an axial direction.
[28]
28. Device according to any one of claims 17 to 27, characterized in that the structure comprises a plurality of interconnected rods, each rod having a first end, a second end, and a length extending from the first end to the second end, each rod comprising a plurality of linear segments laterally displaced from each other in a direction perpendicular to the lengths of the rods.

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同族专利:

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公开号 | 公开日

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CN109952077A|2019-06-28|

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JP2019536576A|2019-12-19|

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EP3551129A1|2019-10-16|

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AU2017370680A1|2019-05-30|

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CR20190248A|2019-09-19|

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ZA201903351B|2020-02-26|

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US10603165B2|2020-03-31|

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CA3044062A1|2018-06-14|

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IL266626D0|2019-07-31|

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MX2019006064A|2019-08-12|

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WO2018106837A8|2019-04-25|

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WO2018106837A1|2018-06-14|

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EP3551129A4|2019-12-25|

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US20200297482A1|2020-09-24|

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KR20190085145A|2019-07-17|

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CN209751295U|2019-12-10|

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US20180153689A1|2018-06-07|

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WO2022011212A1|2020-07-10|2022-01-13|Edwards Lifesciences Corporation|Prosthetic heart valves with expansion and locking assemblies|

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CN113925646A|2020-07-13|2022-01-14|爱德华兹生命科学公司|Clamp for coupling expansion and locking assembly to frame of prosthetic valve|

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WO2022015910A1|2020-07-15|2022-01-20|Edwards Lifesciences Corporation|Devices and methods for adjusting the tensions of leaflets mounted within prosthetic valves|

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CN113940789A|2020-07-16|2022-01-18|爱德华兹生命科学公司|Expansion and locking assembly with wound wire|

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WO2022016059A1|2020-07-17|2022-01-20|Edwards Lifesciences Corporation|Expandable introducer for dilating the distal tip of an introducer sheath|

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WO2022040188A1|2020-08-18|2022-02-24|Edwards Lifesciences Corporation|Prosthetic heart valve including an expansion and locking mechanism transitionable between locked and unlocked states|

法律状态:
2021-10-05| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201662430810P| true| 2016-12-06|2016-12-06|

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US15/831,197|US10603165B2|2016-12-06|2017-12-04|Mechanically expanding heart valve and delivery apparatus therefor|

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PCT/US2017/064962|WO2018106837A1|2016-12-06|2017-12-06|Mechanically expanding heart valve and delivery apparatus therefor|

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