SYSTEM AND METHOD FOR MECHANICALLY POSITIONING INTRAVASCULAR IMPLANTS

专利摘要:
system and method for mechanically positioning intravascular implants. The present invention relates to systems and methods for the distribution of intravascular implants that are described. This system conducts an implant by retaining a locking element that engages the implant in a position near an opening at a distal end of the delivery system. the locking element is retained near the opening by a drawstring that obstructs the movement of the locking element through the opening. the engaging member is free to rotate and moves within an area defined by the delivery system, allowing the implant to react to forces transmitted to the implant by movement of the delivery system and to implant through of a delivery catheter. Once the implant is in a desired implant position, the cord is moved away from an opening and the engaging member is allowed to move away from the delivery system.
公开号:BR102012024803A2
申请号:R102012024803-4
申请日:2012-09-28
公开日:2018-02-27
发明作者:Slee Earl；Moret Oliver；Shrivastava Sanjay
申请人:Tyco Healthcare Group Lp；
IPC主号:

专利说明:

(54) Title: SYSTEM AND METHOD FOR MECHANICALLY POSITIONING INTRAVASCULAR IMPLANTS (51) Int. Cl .: A61B 17/12 (30) Unionist Priority: 30/09/2011 US 13 / 251,021 (73) Holder (s): TYCO HEALTHCARE GROUP LP (72) Inventor (s): EARL SLEE; OLIVER MORET; SANJAY SHRIVASTAVA (74) Attorney (s): DANNEMANN, SIEMSEN, BIGLER & IPANEMA MOREIRA (57) Summary: SYSTEM AND METHOD FOR MECHANICALLY POSITIONING INTRAVASCULAR IMPLANTS. The present invention relates to systems and methods for delivering intravasoular implants that are described. This system conducts an implant by retaining a locking element that fits the implant in a position close to an opening at a distal end of the delivery system. The locking element is held close to the opening by a cord which obstructs the movement of the locking element through the opening. The locking element is free to rotate and moves within an area defined by the distribution system, allowing the implant to react to the forces transmitted to the implant by the movement of the distribution system and implant through delivery catheter. Once the implant is in a desired implant position, the cord is moved away from an opening and the locking element is allowed to move away from the delivery system.

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Invention Patent Report for SYSTEM AND METHOD FOR MECHANICALLY POSITIONING INTRAVASCULAR IMPLANTS.
Background
The present description relates to therapeutic implant delivery and retrieval systems and, more particularly, to a system with a limb that mechanically fits an implant to be positioned in a body. Positioning includes distributing and using an implant at a target site or removing an implant from the target site. The exhibition also refers to implants and, more particularly, to implants adapted to be retained, mechanically, by a distribution and recovery system.
Sometimes, a body cavity, such as an aneurysm, is located in a surgically remote, delicate and torturously formed region, such as within the cerebral vasculature, which requires a specialized distribution system to navigate the region and distribute it safely and reliably. , a coil implant.
summary
The positioning system includes an actuator operated by an operator, a positioner fitting the actuator and an implant interface at the distal end of the positioner that fits a complementary portion of an implant.
The positioner provides the operator with the ability to move the implant, controllably, through a microcatheter or delivery tube and position the implant properly in a target location. The positioner provides a mechanical system to selectively fit the implant, while maintaining a narrow profile and sufficient flexibility to navigate tortuous paths within the body, which are navigated to reach the target site. While providing a small, flexible profile, the positioner is strong enough to allow the operator to move the implant, controllably, through the microcatheter and the mechanical fit with the implant remains functional and controllable when
2/97 subjected to high tortuosity near the target site. The mechanical fit of the positioner with the implant also maintains proper implant orientation throughout the positioning procedure by allowing the implant to rotate and release any torsional forces induced during the movement of the implant to the target location. The positioner also allows the operator to control the movement of the positioner and the implant through proper translation of the control by the operator in predictable and responsive movements near the target site.
The positioner achieves an advantageous performance and sells problems that are believed to be limiting the performance of existing systems by providing a mechanical locking system with the implant, which allows free rotating movement, while retaining the implant and providing minimal direct contact with the implant, in order to minimize the accumulation of torsional forces between the positioner and the implant, when the implant is twisted and rotated during movement through the microcatheter. Contact between the positioner and the implant is minimized and completely rotatable, so that the implant would maintain an acceptable orientation as it progresses to the target site, while reacting, independently, to any forces acting on the implant. implant when navigating the tortuous path to the target location. Minimizing contact and torsional forces between the positioner and implant improves the operator's ability to control the positioner and improves the accuracy in positioning the implant at the target location. The positioner also achieves advantageous performance by providing a mechanical locking system with the implant that is narrow, flexible and controllable. The positioner provides a narrow profile through the use of a mechanical fitting system with the implant in which the implant moves in an axial direction, when fitting or detaching the positioner, without the need for transverse movement of the implant. The positioner provides improved flexibility through the use of a support structure that has variable flexibility along its length, with greater flexibility corresponding to the most tortuous portions of the curing up to the
3/97 target location. The positioner provides improved controllability through the use of materials and surfaces that provide selected friction coefficients with respect to the tortuosity of the path to the target location and which are used in the positioner to correspond to the most tortuous portions of the path to the target location . The positioner also provides improved control through the most complete and accurate communication of the control movements exerted by the operator for the movement of the positioner at the target location. The positioner also provides a system that allows the mechanical insertion or disengagement of the implant, without the use of hydraulic, thermal, electrical or chemical energy.
The implant implant allows the operator to mechanically control the placement and disengagement of the implant in the positioner and allows the positioner to retain the implant in a way that minimally contacts the implant, allowing movement in all directions of movement and rotation15 and that allows the implant to move axially and without radial movement, when fitting and detaching the implant interface. The implant interface provides mechanical control of implant placement and disengagement by retaining a limb that fits the implant. The limb is introduced into the implant interface through an opening in the positioning system and retained in the implant interface by obstructing the opening at least in part, or completely, in order to physically prevent the complete exit of the limb back through the opening. Obstruction is achieved with a movable elongated member arranged along the length of the positioning system with a distal end that obstructs the opening. By obstructing the opening and not restraining the implant, the implant remains free to move according to the limitations defined by the implant interface, which includes movement in the axial and radial directions, compared to the geometric axis of the positioning system, rotational movement around an geometrical axis of the implant and angular movement that disposes the implant at an angle compared to the geometric axis of the positioning system. In addition, by obstructing the opening and not directly restricting the implant, contact between the implant interface and the implant is minimized.
The therapeutic implant can be any implant that can be retained and positioned by the positioning system. The implant is retained by the implant interface with an extension fitting the implant. The extension can be a part of the implant, when the implant is made, a modified portion of the implant manufactured or attached to the implant after initial fabrication. The extension provides an end that is arranged at a distance from the implant body and allows the implant interface to fit and secure the implant by fixing the end of the extension. The implant body itself, however, is not connected to the implant interface. The end of the extension can be a sphere, but it can take other shapes.
The positioning system facilitates unimpeded rotation of the ball and the implant, thus avoiding the sudden or uncontrolled release of energy transmitted to the system by the movement of the system to the target location. The free rotation of the implant and the ball allows the implant to be used from the microcatheter at the target site much more smoothly than with existing systems having a connection that is rigid or that limits, partially or totally, movement and rotation between the implant and the delivery system and free rotation also reduces the force applied to the vasculature during use and the positioning of the implant at the target site.
The implant interface also advantageously provides unrestricted axial movement of the ball within a cavity of the implant interface. The movement of the sphere within the cavity is related to the longitudinal length of the cavity and the length of the stem that fits the implant and is arranged in the cavity. When the implant and the positioner are both advanced in the distal direction, friction against the implant surface will cause the ball to move axially to an extreme proximal position in the cavity and the proximal surface of the implant will support the distal surface of the positioner. When the positioner is advanced in the proximal direction, friction against the implant surface will cause the ball to move distally5 / 97 to an extreme distal position in the cavity and there will be minimal or no frictional contact between the positioner and the implant. The different frictional characteristics, related to the axial movement of the ball in the cavity, and the degree of contact between the implant and the implant interface, provide a frictional push and a frictionless push to the positioning system that calls the operator because it provides a additional tactile sensation related to the movement of the system.
The axial movement of the sphere in the cavity advantageously allows the implant to assume an angled orientation, compared to the geometric axis of the positioner, and to articulate or rotate around the sphere. Angled orientation and articulation advantageously assist in relaxing and discharging potential energy or spring forces in the implant, or between the implant and the positioner, while the implant is moved through the microcatheter.
The positioner advantageously also captures or recaptures an implant already located at or near the target site.
The actuator interface provides the operator with the ability to control the movement of the implant as it is positioned by the positioning system and to mechanically control the selective fitting and undocking of the implant and the implant interface.
The actuator interface controls the movement of the implant by providing a surface over which the operator can exercise control, so that the operator's control movements are transferred precisely to the implant interface and the implant through the positioner. The actuator interface provides a relatively stiff proximal end of the positioner that transfers the axially directed and rotational forces exerted on the actuator interface by the operator to the relatively flexible distal end of the positioning system, with minimal loss due to flexion and torsion positioning system. The actuator interface provides control of implant placement and disengagement from the implant interface with a sliding mechanism that moves, controllably and predictably, the implant interface between the
6/97 embedded and undocked orientations. The actuator interface also connects to an actuator that allows the operator to move, controllably and predictably, the cursor. In addition, the actuator interface establishes and maintains a compressive thrust of the implant interface so that the implant interface remains in the embedded orientation through the cursor arrangement in a distally advanced position.
The actuator provides a mechanism that removably fits the actuator interface and causes controllable and predictable movement of the actuator interface. The actuator achieves this function by providing a structure that holds the outer tube in a fixed position in relation to the actuator body and a tongue and anvil that grips the cursor and pulls the cursor in the proximal direction for a predetermined distance with a force and then disengages the cursor to allow the actuator to disengage. The actuator also provides a design that allows the operator to hold the actuator firmly in place in order to maintain the positioner position in relation to the target location and allows the operator to use the actuator in a controlled manner, which minimizes the movement of the positioner;
In order to minimize the required force of the operator and to reduce the potential for failure of the instrument components, the positioning system advantageously obtains improved pushing capacity. The force applied to the proximal end of the positioner translates to an equal or almost equal force at the distal end of the positioner. The positioning system also advantageously obtains improved pushing capacity through the reduction of friction between the cord and the positioner and between the positioner and microcatheter. Advantageously, the force transfer ratio is obtained by reducing the average friction coefficient in the portions of the positioning system subject to the greatest tortuosity. This can be achieved by selecting specific materials and corresponding surface characteristics in the portions of the positioning system subject to the greatest tortuosity.
The positioning system can achieve an appropriate level of
7/97 flexibility by providing a relatively rigid structure in the proximal portion of the positioner, a relatively flexible structure in the distal portion of the positioner and a transition region in the middle of the positioner, which provides a change in flexibility between the proximal and distal portions. The proximal portion of the positioner can provide flexibility (or stiffness) that remains almost constant over the length of that section of the positioner. The almost constant flexibility of the proximal portion is achieved by using a tube structure. The distal portion and the transition region achieve malleability with a combination of structural changes in the tube structure, which increases flexibility, the increase in the degree of those structural changes along the length of the tube structure in the distal direction and the structural support provided to the positioner through reinforcement structures. The flexibility of the distal portion increases along the length of that section, with the greatest malleability obtained near or at the most distal end of the positioner. The almost constant flexibility of the proximal portion is also achieved by a completely closed tube structure of the positioner, without the use of scraping. The variable flexibility characteristics of the distal portion and the transition region are achieved by a combination of a scraped tube, the increase in the degree of scraping along the length of the tube in the distal direction and the structural support provided to the positioner by the tube sleeve positioner.
The positioning system achieves a mechanically operated implant fit and unplug with an appropriate profile, or size, through the use of materials and surfaces with variable friction coefficients, resistances and flexibilities appropriate for a positioner subjected to a tortuous path. The outer diameter of the distal end of the positioner is small enough to reach the target site, while allowing proper operation of the implant interface of a mechanical system by connecting the implant interface to the proximal end of the positioning system.
The positioner avoids or minimizes the development of ten8 / 97 related to fatigue at the interface between the positioner and the implant by allowing the implant's unrestricted movement in relation to the positioner, within the limitations defined by the implant interface. The development of stresses at the implant interface is minimized or prevented because the ball, stem and implant are able to move in the axial and radial directions, compared to the geometric axis of the positioning system, to rotate around a geometric axis the stem or the implant and to move angularly, so that the implant is at an angle when compared to the geometric axis of the positioning system.
The positioning system does not require an additional step of preparing a coil separation mechanism because the positioner and implant are already in an embedded orientation when removed from the package and before insertion into a patient. The positioner and implant thus provide a system that is ready for use outside the packaging. The positioning system also provides a direct connection between the actuation of a separation mechanism and the separation of the implant from the distribution system, without an intermediate process to initiate and complete the separation of the coil. The positioning system thus achieves a quick preparation and / or separation time, which represents a short period of time between opening the package and using the implant. The positioning system can be prepared for use without delay regarding the preparation of the coil separation mechanism and can achieve the separation of the implant from the positioning system, without delays resulting from an intermediate process to initiate and complete the separation. The absence of these delays and the connection of the separation mechanism provide a system that allows a quick and efficient use of the implant in a target site. The reduction in the length of time required to prepare the positioning system advantageously increases the efficiency of the procedure because a step of preparing the coil separation mechanism is not necessary, thus allowing the physician to attend to other assignments during the invasive medical procedure. . The time
9/97 of reduced use advantageously allows the duration of the invasive medical procedure to be shortened because there is no time for the separation mechanism to achieve the separation of the coil. The short employment time also allows the positioner employed to be removed shortly after separation and allows the next implant to be inserted and positioned within a given time interval.
Additional features and advantages of the technology in question will be presented in the description below and, in part, will be evident from the description, or can be learned by practicing the technology in question. The advantages of the technology in question will be realized and achieved by the structure particularly noted in the written description and its claims, as well as attached drawings.
It should be understood that the foregoing general description and the following detailed description are exemplary and exploratory and are intended to provide additional explanation of the technology in question, as claimed.
The technology in question is illustrated, for example, according to several aspects described below. Several examples of aspects of the technology in question are described as clauses (1, 2, 3, etc.) for convenience. These are provided as an example and do not limit the technology in question. It is noted that any of the dependent clauses can be combined in any combination and placed in a respective independent clause, for example, clause_The other clauses can be presented in a similar way.
Clause 1. Set for placing an implant in an aneurysm in a vessel, comprising:
- a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis and a distal portion having a transverse sectional dimension and a distal end;
- a coil implant having an enlarged proximal end; and
- a core wire that extends into the lumen and counts 10/97 with the enlarged end in one point,
- in which a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross-sectional dimension, so that the extended end is blocked or prevented from moving within the distal lumen and entirely beyond the distal end, when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen;
- and in which at least a portion of the core wire is attached to the wall in its distal portion, so that while the core wire and the tubular element are attached, relative axial movement between the core wire and the tubular element is substantially prevented.
Clause 2; Assembly, according to clause 1, in which at least a portion of the core wire is attached to the wall by at least one of an adhesive, a spot weld, a circumferential weld, a pin, a crimp in the tubular element, solder and a frangible connection.
Clause 3: Assembly, according to clause 1, in which at least a portion of the core wire is attached to the wall by a fixation that can be broken when the core wire is subjected to a predetermined force.
Clause 4: Assembly, according to clause 1, in which at least a portion of the core wire is attached to the wall in a portion proximal to a location where the core wire and the extended end are radially adjacent to each other in relative to the geometric axis.
Clause 5: Set, according to clause 1, in which the coil implant still comprises: a coil comprising a proximal portion and a distal portion; a stretch-resistant member extending through the coil and having a proximal end and a distal end, the distal end of the stretch-resistant member coupled to the distal coil portion; wherein the enlarged proximal end is arranged on the proximal end of the stretch-resistant member and, otherwise, is free from the proximal portion of the coil.
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Clause 6. Assembly, according to clause 1, in which a coil of the coil implant is disposed entirely outside the lumen.
Clause 7: Set, according to clause 1, in which the enlarged proximal end is spaced from a coil of the coil implant.
Clause 8: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis, the lumen comprising: (i) a distal portion having a internal cross-sectional dimension and a distal end and (ii) a reduced portion, close to the distal portion, having a reduced cross-sectional dimension; a coil implant having an enlarged proximal end close to the distal end and distal to the reduced portion; and a core wire extending into the lumen, the core wire contacting the enlarged end at one point and having an enlarged region, close to the reduced portion, having an extended cross-sectional dimension transverse to the geometric axis and greater than the dimension cross-section enlarged across the geometric axis and larger than the reduced cross-sectional dimension; wherein, a piece of a line segment extending from an outer surface of the extended end, through the point and to an outer surface of the core wire is greater than the internal cross-sectional dimension, so that the extended end is impeded movement within the distal lumen and entirely beyond the distal end, when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen; and wherein the core wire is substantially prevented from axial movement distal from the enlarged region beyond the reduced portion.
Clause 9: Assembly, according to clause 8, in which a portion of the core wire near the enlarged region is compressively driven towards the reduced portion, so that the distal movement of the core wire in relation to the tubular element is restricted .
Clause 10: Set, in accordance with clause 8, in which the
12/97 enlarged region rests on the wall.
Clause 11: Set, according to clause 8, in which the reduced portion extends through an obstruction member within the lumen;
Clause 12: Set for use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis from a proximal end to a distal end, a wall defining a lumen along the geometric axis, and a distal portion having an internal cross-sectional dimension; a coil implant having an enlarged proximal end; and a core wire extending into the lumen and contacting the enlarged end at one point; wherein a length of a line segment extending from an external surface of the extended end, through the point and to an external surface of the core wire is greater than the cross-sectional dimension, so that the extended end is prevented from move within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen; wherein, prior to the release of the tubular element coil implant and when the enlarged end is unable to move within the lumen distally beyond the distal portion of the tubular element, the core wire extends through the lumen and beyond the distal end.
Clause 13: Assembly, according to clause 12, in which the core wire extends in the coil.
Clause 14: Assembly, according to clause 12, in which the core wire extends at least the distance from the extended proximal end of the coil to the distal end of the tubular element.
Clause 15: Assembly, according to clause 12, in which the core wire is positioned eccentrically through the lumen.
Clause 16: Assembly, according to clause 12, in which the core wire rests on the wall.
Clause 17: Set, according to clause 12, in which the
13/97 core wire extends beyond a more distal portion of the lumen.
Clause 18: Set, according to clause 12, in which the coil implant still comprises: a coil comprising a proximal portion and a distal portion; a stretch-resistant member extending through the coil and having a proximal end and a distal end, the distal end of the stretch-resistant member coupled to the distal coil portion; wherein the close, enlarged end is disposed at the proximal end of the stretch-resistant member and is otherwise free from the proximal portion of the coil.
Clause 19: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis; a wall defining a lumen along the geometric axis, and a distal portion having an internal cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire, having a distal end, extending into the lumen and contacting the enlarged end at one point; wherein a length of a line segment extending from an external surface of the extended end, through the point and to an external surface of the core wire is greater than the cross-sectional dimension, so that the extended end is prevented from move within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen; and wherein the core wire is compressively driven towards the distal portion of the tubular element, so that the axial movement of the core wire with respect to the tubular element is restricted.
Clause 20: Assembly, according to clause 19, in which the distal end of the core wire rests axially on the distal portion of the tubular element.
Clause 21: Assembly, according to clause 19, in which the core wire is compressively driven against the distal portion of the tubular element, so that the proximal movement of the nucleus wire in relation to the tubular element is substantially prevented until the core wire is subjected to a predetermined force.
Clause 22: Assembly, according to clause 19, in which the core wire is compressively driven against the distal portion of the tubular element, so that the distal movement of the core wire in relation to the tubular element is restricted.
Clause 23: Set, according to clause 19, in which the coil implant still comprises: a coil comprising a proximal portion and a distal portion; a stretch-resistant member extending through the coil and having a proximal end and a distal end, the distal end of the stretch-resistant member coupled to the distal coil portion; wherein the enlarged proximal end is arranged on the proximal end of the stretch-resistant member and, otherwise, is free from the proximal portion of the coil.
Clause 24: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis; a wall defining a lumen along the geometric axis, and a distal portion having an internal cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire, extending into the lumen and contacting the enlarged end at one point; and a restraining element, disposed within the lumen proximal to the enlarged end, configured to limit a non-axial translational movement of the core wire within the lumen; wherein a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is prevented to move within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 25: Assembly, according to clause 24, in which the core wire extends through the restraining element.
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Clause 26: Assembly, according to clause 24, in which the restraining element extends within the lumen by a distance of a greater part of a length of the tubular element.
Clause 27: Assembly, according to clause 24, in which the restraining element provides a smaller internal cross-sectional dimension than an internal cross-sectional dimension of the tubular element.
Clause 28: Set, according to clause 24, in which the restriction element comprises polytetrafluoroethylene.
Clause 29: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis; a wall defining a lumen along the geometric axis, and a distal portion having an internal cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire, extending into the lumen and contacting the enlarged end at one point; and a limiting element extending radially into the wall near the enlarged end and a limiting element configured to receive a proximal region of the core wire and to limit the non-axial translational movement of the core wire within the lumen; wherein a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is prevented to move within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 30: Set, according to clause 29, in which, in the distal portion, the wall comprises at least one section that extends at least partially through the wall.
Clause 31: Set, according to clause 30, in which at least one section is selected from the group consisting of a section
16/97 roughened, a crack, a gap, a hole, a spiral cut and a reduced thickness in the tubular wall.
Clause 32: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis; a wall defining a lumen along the geometric axis, and a distal portion having an internal cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire, extending into the lumen and contacting the enlarged end at one point; the core wire comprising a region having a cross section that has, in a plane transverse to the longitudinal geometric axis and intersecting the point, a first concave side; wherein a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is prevented to move within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 33: Set, according to clause 32, in which the cross section has a second convex side facing away from the enlarged end.
Clause 34: Set, according to clause 33, in which the second side contacts the wall.
Clause 35: Set, according to clause 32, in which the first side contacts the enlarged end.
Clause 36: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis and a distal portion having an internal cross-sectional dimension and an end distal; a coil implant comprising: (i) a coil having an enlarged proximal end, a proximal portion and a distal portion; (ii) a stretch-resistant member extending through the coil and having a proximal end and a distal end, the distal end of the stretch-resistant member coupled to the distal coil portion; (iii) fixing member disposed at the proximal end of the stretch-resistant member and otherwise free from the proximal portion of the coil; the fixation member being disposed within the lumen, so that the coil implant is configured for at least one of (i) to move axially with respect to the tubular element a distance of at least one length of the fixation member and (ii ) tilt around the fixing member within a range of angles in relation to the longitudinal geometric axis.
Clause 37: Assembly, in accordance with clause 36, still comprising: a core wire that extends into the lumen and contacting the fixation member at one point.
Clause 38: Assembly, according to clause 37 in which a length of a line segment extending from an external surface of the fixing member, through the point, and up to an external surface of the core wire is greater than the cross sectional dimension, so that the fixing member is prevented from moving within the distal lumen and entirely beyond the distal end of the tubular element, when the core wire and the fixing member are positioned radially adjacent to each other within the lumen .
Clause 39: Assembly, according to clause 38, in which the coil implant is configured to move axially in relation to the tubular element the distance of at least the length of the fixation member, while the core wire is contacting the member fixing point.
Clause 40: Assembly, according to clause 38, in which the coil implant is configured to tilt around the fixation member within the range of angles in relation to the longitudinal geometric axis, while the core wire is contacting the member fixing point.
Clause 41: Set, according to clause 36, in which the
18/97 proximal portion of the coil is spaced from the distal portion of the tubular element.
Clause 42: Set, according to clause 36, in which the coil implant is configured to rotate around the longitudinal geometric axis
Clause 43: Set, according to clause 38, in which the coil implant is configured to rotate around the longitudinal geometric axis, while the core wire is contacting the fixation member at the point.
Clause 44: Set, according to clause 36, where the range of angles is about 10 to about 50 degrees.
Clause 45: Set, according to clause 36, in which the coil is arranged entirely outside the lumen.
Clause 46: Set, according to clause 36, in which the coil implant is configured to (i) move axially in relation to the tubular element a distance of at least one length from the fixation member and (ii) tilt it around the fixing member within a range of angles to the longitudinal geometric axis.
Clause 47: Set, according to clause 46, in which the coil implant is configured to rotate around the longitudinal geometric axis.
Clause 48: Set for use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis and a distal portion having an internal cross-sectional dimension and an end distal; a coil implant comprising: (i) a coil having an enlarged proximal end, a proximal portion and a distal portion; (ii) a stretch-resistant member extending through the coil and having a proximal end and a distal end, the distal end of the stretch-resistant member coupled to the distal coil portion; (iií) fixing member disposed on the proximal end of the stretch-resistant member and otherwise free from the proximal portion of the coil; the fixing member being disposed within the
19/97 lumen, so that the coil implant is configured to tilt around the fixation member within a range of angles with respect to the longitudinal geometric axis.
Clause 49: Set, in accordance with clause 48, still comprising: a core wire that extends into the lumen and contacting the fixation member at one point.
Clause 50: Set, according to clause 49, in which a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the fixing member is prevented from moving within the distal lumen and entirely beyond the distal end of the tubular element, when the core wire and the fixing member are positioned radially adjacent to each other within the lumen.
Clause 51: Assembly, according to clause 50, in which the coil implant is configured to tilt around the fixation member within a range of angles in relation to the longitudinal geometric axis, while the core wire is contacting the fixing member at one point.
Clause 52: Assembly, according to clause 48, in which the proximal portion of the coil is spaced from the distal portion of the tubular element.
Clause 53: Set, according to clause 48, in which the coil implant is configured to rotate around the longitudinal geometric axis.
Clause 54: Assembly, according to clause 50, in which the coil implant is configured to rotate around the longitudinal geometric axis while the core wire is contacting the fixation member at the point.
Clause 55: Set, according to clause 48, in which the range of angles is about 10 to about 50 degrees;
Clause 56: Set, according to clause 48, in which the coil is arranged entirely outside the lumen.
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Clause 57: Assembly, according to clause 48, in which the coil implant is configured to move axially in relation to the tubular element a distance of at least one length of the fixation member.
Clause 58: Assembly, according to clause 50, in which the coil implant is configured to move axially with respect to the tubular element a distance of at least one length from the fixation member, while the core wire is contacting the member fixing point.
Clause 59. Set for use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis; a wall defining a lumen along the geometric axis, and a distal portion having an internal cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire, extending into the lumen and contacting the enlarged end at one point; and wherein a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is prevented from moving within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen; and wherein, when the widened end is disposed within the lumen, the core wire extends distally beyond a distal end of the widened end to the distal portion of the tubular member.
Clause 60: Assembly, according to clause 59, in which the core wire extends beyond a more distal portion of the lumen.
Clause 61: Set, according to clause 59, in which the coil implant still comprises a coil having a proximal portion and a distal portion.
Clause 62: Set, according to clause 61, in which the
The coil implant further comprises a stretch-resistant member that extends through the coil and having a proximal end and a distal end, the distal end of the stretch-resistant member coupled to the distal portion of the coil.
Clause 63: Assembly, according to clause 62, in which the enlarged proximal end is disposed on the proximal end of the stretch-resistant member and is otherwise free from the proximal portion of the coil.
Clause 64. A set for placing an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis and a distal portion having a transverse sectional dimension and a distal end ; a coil implant, comprising: (i) a coil; (ii) an enlarged proximal end spaced from the coil; a core wire extending into the lumen and contacting the enlarged end at one point; and wherein a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross-sectional dimension, so that the extended end is impeded movement within the distal lumen and entirely beyond the distal end, when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 65: Set, according to clause 64, in which the coil still comprises a proximal portion and a distal portion.
Clause 66: Set, according to clause 65, wherein the coil implant further comprises a stretch-resistant member that extends through the coil and having a proximal end and a distal end, the distal end of the coupled stretch-resistant member distal portion of coil.
Clause 67: Assembly, according to clause 66, in which the enlarged proximal end is disposed on the proximal end of the stretch-resistant mem22 / 97 bro and is otherwise free from the proximal portion of the coil.
Clause 68: Assembly, according to clause 54, in which, when the core wire and the extended proximal end are positioned radially adjacent to each other in relation to the geometric axis, the extended proximal end rests on the wall.
Clause 69: Set, according to clause 64, in which, in the distal portion, the wall comprises at least one section that extends at least partially through the wall.
Clause 70: Set, according to clause 69, in which at least one section is selected from the group consisting of a rough section, a gap, a gap, a hole, a spiral cut and a reduced thickness in the tubular wall.
Clause 71: Assembly, according to clause 64, wherein the core wire comprises at least one segment that tapers from one of a first cross-sectional dimension to a second minor cross-sectional dimension.
Clause 72. Set for placing an implant in an aneurysm in a vessel, comprising:
- a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis and a distal portion having an internal cross-sectional dimension and a distal end; a coil implant comprising:
- (i) a coil disposed entirely outside the lumen; (ii) an enlarged proximal end, disposed within the lumen; a core wire extending into the lumen and contacting the enlarged end at one point; and
- in which a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is prevented movement within the distal lumen and entirely beyond the extremity
23/97 distal, when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 73: Set, according to clause 72, in which the coil still comprises a proximal portion and a distal portion.
Clause 74: Set, according to clause 73, wherein the coil implant further comprises a stretch-resistant member that extends through the coil and having a proximal end and a distal end, the distal end of the coupled stretch-resistant member distal portion of coil.
Clause 75: Assembly, according to clause 74, in which the enlarged proximal end is disposed on the proximal end of the stretch-resistant member and is otherwise free from the proximal portion of the coil.
Clause 77: Assembly, according to clause 72, in which, in the distal portion, the wall comprises at least one section that extends at least partially through the wall.
Clause 78: Set, according to clause 77, in which at least one section is selected from the group consisting of a rough section, a gap, a gap, a hole, a spiral cut and a reduced thickness in the tubular wall.
Clause 79: Assembly, according to clause 72, in which the core wire comprises at least one segment that tapers from a first cross-sectional dimension to a second minor cross-sectional dimension.
Clause 80: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis and a distal portion having an internal cross-sectional dimension and an end distal; a coil implant comprising: (i) a coil having a proximal portion and a distal portion; (ii) a stretch-resistant member extending through the coil and having a proximal end and a distal end, the distal end of the
24/97 stretch-resistant member coupled to the distal coil portion; (iii) an enlarged proximal end disposed at the proximal end of the stretch-resistant member and otherwise free from the proximal portion of the coil; a core wire extending into the lumen and contacting the extended end at a point, a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the wire core length is greater than the cross sectional dimension, so that the extended end is prevented from moving within the distal lumen and entirely beyond the distal end, when the core wire and the extended end are positioned radially adjacent to each other within the lumen.
Clause 81: Assembly, according to clause 80, in which, when the core wire and the extended end are positioned radially adjacent to each other in relation to the geometric axis, the extended proximal end rests on the wall.
Clause 82: Set, according to clause 80, in which, in the distal portion, the wall comprises at least one section that extends at least partially through the wall.
Clause 83: Set, according to clause 82, in which at least one section is selected from the group consisting of a rough section, a gap, a gap, a hole, a spiral cut and a reduced thickness in the tubular wall .
Clause 84: Assembly, according to clause 80, in which the core wire comprises at least one segment that tapers from a first cross-sectional dimension to a second cross-sectional dimension.
Clause 85: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis; a wall defining a lumen along the geometric axis, and a distal portion having an internal cross-sectional dimension and a distal end; a coil implant having an enlarged proximal extremity; and a core wire, extending into the lumen and contacting the enlarged end at one point; the core wire comprising a region having a cross section which has, in a plane transverse to the longitudinal geometric axis and intersecting the point, substantially crescent shaped, in which a length of a line segment extending from an external surface of the widened end, through the point, and even an outer surface of the core wire is greater than the cross sectional dimension, so that the widened end is prevented from moving within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 86: Assembly, according to clause 85, in which the cross section has a first concave side facing the enlarged end.
Clause 87; Assembly, according to clause 86, in which the first side contacts the widened end, when the core wire contacts the widened end.
Clause 88: Set, according to clause 85, in which the cross section has a second convex side facing away from the enlarged end.
Clause 89; Assembly, according to clause 88, in which the second side contacts the wall, when the core wire contacts the enlarged end.
Clause 90: Assembly, according to clause 85, in which the core wire comprises at least one segment that tapers from a first cross-sectional dimension to a second minor cross-sectional dimension.
Clause 91: Set for use of an implant in an a30 neurism in a vessel, comprising: a tubular element having a longitudinal geometric axis; a wall defining a lumen along the geometric axis, and a distal portion having a cross-sectional dimension
26/97 internal and a distal end; a coil implant having an enlarged proximal end; and a core wire, extending into the lumen and contacting the enlarged end at one point; wherein a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is prevented to move within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen and where a region of the wall has a non-circular cross-sectional shape in a perpendicular plane to the longitudinal geometric axis and intersecting the point, where the core wire is restricted by the wall from moving around a circumference of the lumen, while the core wire is contacting the enlarged end.
Clause 92: Set, according to clause 91, in which the region has a substantially oval cross-sectional shape in the plane.
Clause 93: Assembly, according to clause 91, in which the tubular element has an external profile with a cross-sectional shape substantially circulating in the plane.
Clause 94: Set, according to clause 91, in which the thickness of the tubular element varies in the region.
Clause 95: Set, according to clause 91, in which the coil implant still comprises (i) a coil having a proximal portion and a distal portion and (ii) a stretch-resistant member that extends through the coil and having a proximal end and a distal end, the distal end of the stretch-resistant member coupled to the distal coil portion, where the enlarged proximal end is arranged at the proximal end of the stretch-resistant member and is otherwise free from the proximal portion the coil.
Clause 96: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having (i) a longitudinal geometric axis; (ii) a wall defining a lumen along the
27/97 geometric axis, (iii) an opening through the wall; (iv) an arm extending from an edge of the opening, covering at least a portion of the opening and curving radially into the geometric axis: and (v) a distal portion having an internal cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire, extending into the lumen and contacting the enlarged end at one point; wherein a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is prevented to move within the distal lumen and entirely beyond the distal end when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 97: Assembly, according to clause 96, in which no part of the arm extends a radial distance from the geometric axis greater than an external radius of the tubular element.
Clause 98: Set, according to clause 96, in which a portion of the arm extends inward, towards the longitudinal geometry axis up to a radial distance from the geometry axis less than an external radius of the tubular element.
Clause 99: Assembly, according to clause 96, in which the arm is in contact with the widened end, when the widened end is inside the opening and contacting the core wire.
Clause 100: Set for use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis, the lumen comprising: (i) a distal portion having a internal cross-sectional dimension (ii) and a distal end and (iii) a reduced portion, close to the distal portion, having a first non-circular cross-sectional profile; a coil implant having an enlarged proximal end; and a core wire extending into the 28/97 men lumen through the reduced portion and contacting the enlarged end at one point, the core wire comprising an enlarged region having a second cross-sectional profile, in which (i) the displacement of the enlarged region through the reduced portion is limited while in a first rotational state in relation to the reduced portion and (ii) the displacement of the enlarged region through the reduced portion is allowed while in a second rotational state in relation to the reduced portion: where a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the enlarged end is prevented from moving in. of the distal lumen and entirely beyond the distal end, when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 101: Set, according to clause 100, in which the second cross sectional profile is geometrically similar to the first cross sectional profile.
Clause 10 2: Set, according to clause 100, in which the second cross sectional profile is congruent to a uniform scale of the first cross sectional profile.
Clause 103: Set, according to clause 100, in which the second cross-sectional profile has substantially the same shape as the first cross-sectional profile.
Clause 104: Set, according to clause 100, in which the second cross sectional profile and the first cross sectional profile comprise non-square rectangles.
Clause 105: Assembly, according to clause 100 „in which a portion of the core wire near the enlarged region is compressively driven towards the reduced portion, so that the distal movement of the core wire in relation to the tubular element is restricted while the enlarged region is in the first rotational state.
Clause 106: Set, according to clause 100, in which
29/97 the reduced portion extends through an obstruction member within the lumen.
Clause 107: Set, according to clause 106, in which a proximal surface of the enlarged region is substantially parallel to a distal surface of the obstruction member.
Clause 108: Set, according to clause 100, in which the first rotational state comprises a first position of rotation of the enlarged region around the longitudinal geometric axis.
Clause 109: Set for the use of an implant in an aneurysm in a vessel, comprising: a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis, an opening through the wall and a distal portion having a dimension internal cross section and a distal end, a coil implant having an enlarged proximal end, the enlarged end having (i) a primary portion residing in the lumen and (ii) a secondary portion extending from the primary portion at the opening and fitting an edge of the opening and a core wire extending into the lumen and contacting the enlarged end at one point. Where a length of the line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross-sectional dimension, so that the extended end is prevented from move within the lumen, distally and entirely beyond the distal end, when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
Clause 110: Set, according to clause 109, in which a surface distal from the secondary portion fits a surface distal from the edge.
Clause 111: Set, according to clause 109, in which the primary portion is substantially non-spherical.
Clause 112: Set, according to clause 109, in which the secondary portion is substantially non-spherical.
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Clause 113: Set, according to clause 109, in which the secondary portion is substantially cylindrical.
Clause 114: Set, according to clause 109, in which a first width of the secondary portion distal from the primary portion is greater than a second width of the secondary portion close to the primary portion.
Brief Description of Drawings
The attached drawings, which are incorporated here and form part of this report, illustrate exemplary modalities of the exhibition and, together with the general description given above and the detailed description given below, serve to explain the characteristics of the exhibition.
Figure 1A shows a plan view of the positioning system and a plan view of an exemplary implant.
Figure 1B shows a closer view of a portion of figure 1A.
Figure 2A shows a plan view of the positioning system of figure 1A within the human body.
Figure 2B shows a closer view of a portion of figure 2A, showing the partial cross-sectional positioning and system and an exemplary implant in a position within the human body.
Figure 2C shows a closer view of a portion of figure 2A, showing the partial cross-sectional positioning system and an exemplary implant in another position within the human body.
Figure 3 shows a cross-sectional plan view of the positioner of the embodiment illustrated in Figure 1 and a plan view of a portion of an exemplary implant.
Figure 4 shows an isometric view of the example positioner and implant shown in Figure 3, with the positioner shown in partial view.
Figure 5A shows a plan view of the positioner tube of the embodiment of figure 3.
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Figure 5B shows a cross-sectional view of a portion of figure 5A.
Figure 6A shows a cross-sectional plan view of the implant interface of another embodiment and a plan view of a portion of an exemplary implant.
Figure 6B shows an isometric view of the implant interface of figure 6A, with the implant interface shown in a particular section room.
Figure 7A shows an isometric view of portions of the positioner and implant of figure 3, with the positioner in an embedded orientation and with the positioner shown in a partial section room.
Figure 7B shows an isometric view of portions of the positioner and implant of figure 3, with the positioner in an undocked orientation and with the positioner shown in a partial section room.
Figure 8A shows a cross-sectional plan view of the positioner and a plan view of the implant of figure 7A.
Figure 8B shows a cross-sectional plan view of the positioner and a plan view of the implant of figure 7B.
Figure 8C shows a cross-sectional plan view of portions of the positioner and the implant of figure 3, with the implant removed from the positioner.
Figure 9 shows an isometric view of the implant interface of another embodiment and an isometric view of an exemplary implant.
Figure 10 shows a cross-sectional plan view of the implant interface and partial plan view of the implant of Figure 9.
Figure 11A shows a cross-sectional view of an embodiment of the implant interface shown in figure 8A.
Figure 11B shows a cross-sectional view of an embodiment of the implant interface shown in figure 8A.
Figure 11C shows a cross-sectional view of an embodiment of the implant interface shown in Figure 8A.
Figure 12 shows a cross-sectional plan view
32/97 a portion of the embodiment of figure 3 in an orientation.
Figure 13 shows a cross-sectional plan view of a portion of the embodiment of Figure 3 in another orientation.
Figure 14 shows a cross-sectional plan view of a positioner and a plan view of a portion of an exemplary implant.
Figure 15 shows a cross-sectional view of a positioner embodiment.
Figure 16 shows a cross-sectional view of a positioner modality.
Figure 17A shows a plan view of an embodiment of an implant.
Figure 17B shows a plan view of an embodiment of an implant.
Figure 18 shows a cross-sectional plan view of another embodiment of the actuator interface of Figure 3.
Figure 19 shows a cross-sectional plan view of yet another embodiment of the actuator interface of Figure 3.
Figure 20A shows a cross-sectional plan view of 20 yet another embodiment of the actuator interface of figure 3 in a first orientation.
Figure 20B shows a cross-sectional plan view of yet another embodiment of the actuator interface of figure 3 in a second orientation.
Figure 21A shows a partial cross-sectional piano view of the actuator of figure 3 in an off position
Figure 21B shows a partial cross-sectional plan view of the actuator of figure 3 in an activated position.
Figure 22A shows an iso30 metric partial cross-sectional view of a portion of the actuator of Figure 21A
Figure 22B shows a partial isometric cross-sectional view of a portion of the actuator of figure 21B.
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Figures 23A, 23B and 23C show flexibility profiles for the existing systems and the positioner illustrated in figures 3 and 4.
Figure 24 shows a plan view of another embodiment of the positioning system of Figure 1 with partial cross-sectional views and with a partial cross-sectional plan view of a preferred implant.
Figure 25 shows a cross-sectional plan view of another embodiment of the actuator interface of Figure 3.
Figures 26A and 26B show schematic plan views of another embodiment of the actuator interface of figure 3 and the actuator of figures 21 A-22B.
Figure 27 shows a partial cross-sectional plan view of another embodiment of the actuator of figure 3 in an activated position.
Figure 28 shows an isometric view, partially exploded, of the actuator of figure 27.
Figure 29 shows a cross-sectional side elevation view of another embodiment of a separation system according to the exposure.
Figure 30 shows a top view of the embodiment of figure 29.
Fig. 31 shows a bottom view of the embodiment of Fig. 29 with a core wire shown in partial shading.
Figure 32 shows a cross-sectional side elevation view of the embodiment of figure 29, following a step in the separation of the embolic coil.
Fig. 33 shows a cross-sectional side view of the embodiment of Fig. 29, then the separation of the embolic coil.
Figure 34 shows a cross-sectional view in side elevation of a modality according to the exposure.
Figures 35A and 35B show cross-sectional views of an embodiment of a coil distribution system.
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Figures 36A and 36B show cross-sectional views of an embodiment of a coil distribution system.
Fig. 37 shows a cross-sectional view of an embodiment.
Figures 38A and 39B show partial cross-sectional side elevational views of a modality of a coil distribution system.
Fig. 39 shows a side elevation view of a pull cord having an enlarged region.
Figures 40A and 40B show final views of a pull cord having an enlarged region.
Fig. 41 shows a side elevation view of a sphere having a projection.
Fig. 42 shows a side elevation view of a sphere having a projection.
Detailed Description
In the following detailed description, numerous specific details are presented in order to provide a complete understanding of the technology in question. It will be evident, however, to someone of ordinary skill in the technique that the technology in question can be put into practice without some of these specific details. In other cases, well-known structures and techniques will not be shown in detail so as not to obscure the technology in question.
A phrase, like an aspect, does not imply that that aspect is essential to the technology in question or that that aspect applies to all configurations of the technology in question. An exposure relating to an aspect can apply to all configurations or one or more configurations. One aspect can provide one or more examples of the exposure. A phrase, like a modality, does not imply that that modality is essential for the technology in question or that that modality applies to all configurations of the technology in question. An exhibition referring to a modality can apply to all modalities or to a
35/97 or more modalities. One embodiment can provide one or more examples of the exhibition. A sentence, such as a modality, can refer to one or more modalities and vice versa. A phrase such as a configuration does not imply that that configuration is essential for the technology in question or that that configuration applies to all configurations of the technology in question. An exposure referring to a configuration can apply to all configurations, or to one or more configurations. A configuration can provide one or more examples of the exhibit. A phrase, such as a configuration, can refer to one or more configurations and vice versa.
The US patents ^Nos 5122136 and 5423829 describe some existing electrolyte distribution system having a pusher attached to a platinum coil through separation implantable segment can be etched by an electrolytic process.
The coil is advanced by the pusher through a microcatheter to the desired target location within the vasculature and an electric current is applied to the pusher in the separation segment which results in the coil being separated from the pusher and the coil being released at the target location. It is believed that there are numerous disadvantages and difficulties with these electrolytic systems. A disadvantage of this design is that the separation segment must be positioned distally from the microcatheter for release (ie, the operator cannot pre-release the coil into the microcatheter, if desired). Another disadvantage is believed to be that these systems require electrical insulation and isolation from the separation system to reduce the release of metal particles created during separation, which can cause unwanted embolization downstream of the target site. Another disadvantage is believed to be that these systems require the physician to wait for an unknown amount of time, typically 10-180 seconds, until the implant coil is released, with the release monitored by feedback from a specialized system using electrical actuators. complex. It is also believed that another disadvantage is that these systems generate false positives quite frequently, in
36/97 a rate of 3 - 10%, which falsely indicates that the coil was released when in fact it was not. Also, as with any electrochemical reaction in solution, the system must be within ionic fluids to function and it is believed that undesirable gases are formed in both the anode and the cathode. Additionally, it is believed that there are limitations on the size of the guide wire and the distribution system because these systems require a constant flow of electrolytes, such as saline through the microcatheter to speed up the coil separation time. Because of this need with electrolytes, it is believed that the outside diameter of an electrolytic distribution system is optimized for the flow of saline rather than for considerations of coil distribution capacity, pushability and pusher force transfer. and the flexibility of the distal end of the distribution system.
The US patents ^Nos 6063100 and 6607538 disclose hydraulic distribution system having a pusher attached to an implantable platinum coil with a frictional fit between a pressure cuff at the distal end of the pusher and a solid cylindrical proximal end of the coil. The platinum coil is advanced through a microcatheter by the pusher on the target side. Hydraulic pressure is applied to the proximal end of the pusher, creating hydraulic pressure at the distal end of the pusher and causing the solid cylindrical proximal end of the coil to be pushed out of the pressure cuff in order to cause the coil to separate from the pusher. A disadvantage of this design is believed to be that these systems require complex catheter construction and rigorous purging, to prevent air piston distribution. Even after purging, it is believed that some air plungers are usually left in the system and will inevitably be injected into the patient during the separation process. Another disadvantage is believed to be that these systems are time consuming when using because of the pusher preparation and because of the filling and separation of the pressure syringes. These systems are believed to be less safe than electrolytic systems and have sometimes failed to release the coil or prematurely bitten the coil; In addition, with this type of design, it is believed that the distribution system is optimally dimensioned for hydraulic separation and not dimensioned to facilitate the distribution of the coil or the action of the pusher - coil interface. These distribution systems, in general, have hollow ducts designed for high hydraulic pressures and, as a result, are rigid. The coil - pusher interface, likewise, is hard because part of the proximal end of the coil is pressed tightly at the distal end of the pusher.
U.S. Patent No. 5234437 describes a mechanical delivery system with a pusher that is attached to an implantable platinum coil by a threaded portion at the distal end of the pusher, which screws into the inner coil windings. The coil is advanced by the pusher through a microcatheter at the target location. Once positioned, the operator twists the proximal end of the pusher a number of times to unscrew the distal pusher end of the coil implant. It is believed that a disadvantage of this design is that the system will not work well in highly tortuous anatomy due to the pusher's reduced transmission and torque, that is, the pusher's body itself twists with little or no rotation of the threaded portion. It is also believed that the operation of unscrewing the pusher causes undesirable movement of the entire system, which could cause misalignment with the target site and cause the coil to be positioned undesirably within the target vessel. Also, it is believed that the thread design requires the operator to hyperextend the pusher beyond the tip of the microcatheter to effect the release and be non-recoverable at that point.
U.S. Patent No. 5895391 and United States Patent Publication No. 2006/0276823 describe mechanical delivery systems. United States Patent No. 5895391 describes a corresponding member attached to a vaso-occlusive member that is held in an opening with an interference wire. The interference wire compresses the corresponding member in an opening through the wall of a support element. United States Patent Publication No. 2006/0276823 describes a mechanical interlocking mechanism with a locking member attached to a distal end of a pusher member and extending through a retaining ring at a proximal end of an embolic device . A separating member extends through an opening at the distal end of the locking member to lock the embolic device in the pusher member.
As a result, there is a need for an implant delivery system that is easier to use and more secure than the systems currently on the market and that requires fewer steps and faster separation.
There is another need for a technique for treating a vascular defect or injury with platinum coils, without creating metallic or gaseous particles during the separation process.
There is another need for an implant delivery system that has increased reliability, measured by less false positive separations and less premature separations.
There is another need for a coil-to-pusher interface that is less rigid than those of existing systems.
There is another need for an implant delivery system with superior propulsion capability with a flexible distal flexibility profile.
As shown in figures 1A and 1B, the positioning system 10 can include an actuator 20 operated by an operator, a positioner 40 engaging with the actuator 20 and an implant interface 80 at the distal end of the positioner 40. A portion of the implant interface 80 fits a complementary portion of an implant 90.
In the embodiment illustrated in figures 1A and 1B, an operator uses a guide tube or guide catheter 12 to position a delivery tube or microcatheter 14 in a patient's vasculature, as shown in figure 2A. The procedure involves inserting the guide catheter 12 into a patient's vasculature through an access point, such as the groin and
39/97 directing the distal end 12a of the guide catheter 12 through the vascular system until reaching the carotid artery, after removing a guide wire (not shown from the guide catheter 12, a microcatheter 14 is inserted into the guide catheter 12 and from the distal end 14a of the microcatheter 14, subsequently, the distal end of the guide catheter 12a comes out and is positioned close to the target site 16, such as an aneurysm in the patient's brain. As shown in figures 2B and 2C, the microcatheter 14 includes microcatheter markers 15 and 15a that facilitate imaging of the distal end 14a of microcatheter 14 with common imaging systems and, in the illustrated embodiment, microcatheter markers 15 and 15a are made of a radiopaque material. distal 14a reaching target site 16, the positioning system 10 of the illustrated embodiment is then inserted into the microcatheter 14 to position the implant interface 80 at the end distant from positioner 40 near target site 16, as shown in figure 2C. If implant 90 is being delivered in the procedure, implant 90 is attached to implant interface 80, before inserting positioning system 10 into microcatheter 14. This implant delivery mode is illustrated in figures 2A - 2C. The distribution of the implant 90 is facilitated by placing the microcatheter marker 15a close to the target site 16 and aligning the microcatheter marker 15 with a positioner marker 64 on the positioner 40 which, when the two markers (markers 15 and 64) are aligned with each other the other, as shown in figure 2C, indicates to the operator that the implant interface 80 is in the proper position for releasing implant 90 from the positioning system 10. After depositing implant 90 at target site 16, a second implant 90 can be deposited at target site 16 by removing the positioning system 10 from the microcatheter 14 and inserting a second positioning system 10 with a second implant attached 90 to the microcatheter 14 in a manner similar to the method used with the insertion of the first implant 90. The same procedure can be used for a third implant 90 and subsequent implants, if necessary, clinically. If implant 90 is already in the patient's body to be recovered or repositioned, positioning system 40/97 ma 10 is inserted into microcatheter 14, without implant 90. Positioner
The positioner provides the operator with the ability to move the implant controllably through the microcatheter and position the implant properly in the target location. The positioner provides a mechanical system to selectively fit the implant, while maintaining a narrow profile and sufficient flexibility to navigate the tortuous paths within the body to reach the target site. While providing a small, flexible profile, the positioner is strong enough to allow the operator to move the implant, controllably, through the microcatheter and the mechanical fit with the implant remains functional and controllable when subjected to high tortuosity near the target location. The mechanical fit of the positioner on the implant also maintains proper implant orientation throughout the positioning procedure by allowing the implant to rotate and discharge any torsional forces induced during the movement of the implant to the target location. The positioner also allows the operator to control the movement of the positioner and the implant by properly translating the control exercised by the operator into predictable and responsive movements near the target site.
The positioner achieves advantageous performance and overcomes problems that are believed to be limiting the performance of existing systems by providing a mechanical implant fitting system that allows free rotating movement while retaining the implant and providing minimal direct contact with the implant to minimize the accumulation of torsional forces between the positioner and the implant, when the implant is twisted and rotated during movement through the microcatheter. Contact between the positioner and the implant is minimized and completely rotatable, so the implant will maintain an acceptable orientation as it progresses to the target site, while independently reacting to any forces acting on the implant when navigating the tortuous path to the target location. Minimizing contact and torsional forces between the positioner and the implant improves the operator's ability to control the positioner and improves the accuracy in positioning the implant at the target location.
The positioner also achieves advantageous performance by providing a mechanical implant fitting system that is narrow, flexible and controllable. The positioner provides a narrow profile through the use of a mechanical implant fitting system in which the implant moves in an axial direction, when fitting or detaching the positioner, without the need for transverse movement of the implant. The positioner provides enhanced flexibility through the use of a support structure that has variable flexibility along its length, with greater flexibility corresponding to the most tortuous portions of the path to the target location. The positioner also provides improved control by communicating more fully and precisely from the control movements exerted by the operator to the movement of the positioner at the target location. The positioner also provides a system that allows the mechanical insertion or disengagement of the implant without the use of hydraulic, thermal, electrical or chemical energy.
The positioner is an elongated, flexible structure that transfers the control force applied by the operator at the proximal end to the implant interface at the distal end. As shown in figures 3 and 4, positioner 40 can include a positioner tube 42 which is an elongated tube containing a lumen 44. At the proximal end of positioner tube 42 is an actuator interface 46 that has an external tube 48 attached to the proximal end of the positioner tube 42. The proximal end of the outer tube 48 encloses a distal end of a slider 50, which slides into the outer tube 48. The slider 50 receives the proximal end of the strand 52 and pulls or pushes the strand 52 when moved by the operator. Next to the cursor 50 is an end weld 51, connecting the end closest to the bead 52. The distal end of the positioner tube 42 fits the implant interface 80 and ends in an end cap 82 has an orifice 84 through which the lumen 44 communicates with the outer medium of positioner 40 or the interior of micro42 / 97 catheter 14, depending on the position of positioner 40 relative to microcatheter 14. End cap 82 also provides an opposing end cap surface 83 to the cord 52 and which prevents the implant 90 from disengaging from the implant interface 80. As shown in figure 24, the proximal edges of the end cap 82 in the hole 84 can be rounded or chamfered.
As also illustrated in figures 3 and 4 and illustrated in figures 5A - 5D, the positioner tube 42 has a central axis 54 and a wall 56 that extends the length of the positioner tube 42. At the proximal end 42a and the distal end 42b of the positioner tube 42, the wall 56 is circumferential and forms a completely enclosed tube around the lumen 44. A middle portion 58 of the positioner tube 42 has a wall 56 that is trimmed over most of the length of the middle portion 58, where the wall 56 does not completely and circumferentially surround the lumen 44, as shown in figures 5A, 5C and 5D. Roughed out can also include a cut-out or chiseled opening or channel in the wall 56 of the positioner tube 42. In the roughed sections 60 of the middle portion 58, the wall 56 surrounds the lumen 44 only partially and forms a longitudinal opening exposing the lumen 44. the wall 56 in the roughed sections 60 of the median portion 58 has less material, is more flexible than the completely closed wall 56 of the proximal and distal ends of the positioner tube 42, when subjected to a bending force, bending the geometric axis 54 of the positioner tube 42, or rotational force, twisting the positioner tube 42 around the geometry axis 54. The thickness of the wall 56 also varies across the length of the positioner tube 42, with a relatively thick wall 56 towards the end proximal 42a and a relatively thin web 56 towards the distal end 42b, as shown in figures 5B and 5C. As shown in figures 5A and 5D, the degree of roughing in the roughed section 60 also varies along the length of the positioner tube 42.
At two points 62 along the length of the median portion
43/97 there are areas where wall 56 transitions from a partial wall to a full wall circumferentially enclosing lumen 44, similar to wall 56 at the proximal and distal ends of positioner tube 42. Between these two points 62 is a marker of positioner 64, as illustrated in figures 3 and 4, which is detectable by means of common image formation systems. The positioner marker 64 has an outside diameter that is larger than the inside diameter of the lumen 44, in order to maximize the visibility of the positioner marker 64, when viewed with common imaging techniques. The two points 62 provide a precise location along the length of the positioner tube 42 for positioning the positioner marker 64 and preventing the positioner marker 64 from migrating during assembly or use. In use, the positioner marker 64 assists in the proper alignment of the positioner 40 with a microcatheter marker 15, as shown in figure 2C and indicates when the positioner 40 is in the correct position in relation to the microcatheter 14 for disengaging the implant 90. One or both two points 62 can be arranged at a predetermined distance or distances from each other, from the end cap 82, from the end of the positioner tube 42 and / or from a positioner marker, such as a marker 124. The predetermined distance may be within a tolerance of 0.2 mm.
Referring to Figures 3 and 4, enclosed around the longitudinal length of the positioner tube 42 is a positioner tube sleeve 66 that provides a sliding outer surface for the positioner tube 42 that facilitates the insertion and sliding of the positioner tube 42 in and through the microcatheter 14. The sleeve 66 of the positioner tube increases the lubricity between the positioner tube 42 and the inner lumen surface of the microcatheter 14 by one third distant from the positioning system 10 as that more distal portion is subjected to the tortuous anatomy that causes additional friction between the moving components. The wall thickness of the sleeve 66 of the positioner tube varies along its longitudinal length and, as best illustrated in figure 3,
44/97 in general, has a relatively thick wall thickness towards the distal end 42b of the positioner tube 42, oppositely disposed, when compared to the variable wall thickness 56 of the positioner tube 42. The combination of the wall thickness of the sleeve 66 of the positioner tube and the thickness disposed opposite the wall 56 of the positioner tube 42 provides a consistent outer diameter of the positioner 40 along the length portions of the positioner 40 and a profile that slidably fits the interior of the microcatheter 14 As shown in figure 24, portions of sleeve 66 of the positioner tube can conform to the shape of the structure contained within the sleeve, thus having a smaller outside diameter where the sleeve 66 covers the roughed sections of the positioner tube 42, when compared with the largest outside diameter where sleeve 66 covers uncut parts of positioner tube 42. As also shown in figure 24, sleeve 66 of positioner can cover only the distal half of positioner 40. As further illustrated in figure 24, the roughed sections 60 can include multiple roughed sections 60 which are identified as roughed sections 60a, 60b and 60c, with one or all of the roughed sections arranged in one predetermined distance from each other, end cap 82, both ends of positioner tube 42 and / or a positioner marker, such as 124.
A bead liner 68 may be disposed on the inner surface of the positioner tube 42 within the lumen 44 encloses the bead 52 to provide a sliding surface that guides the bead 52 along geometry axis 54. The bead liner 68 also passes through inside the 64, reducing the diameter where it fits the 64. It is advantageous to insert a low-friction material between the surface of the cord 52 and the positioner tube 42 in order to reduce the frictional drag acting on the cord 52, when moved inside the positioner tube 42. It is particularly advantageous to reduce the friction in the distal third of the positioner tube 42 and the cord 52 as these more distal portions are subjected to tortuous anatomy causing additional friction between the cord 52 and the coating of
45/97 cord 68.
The cord 52 slides inside the lumen 44 and the lumen of the cord lining 68, from the actuator interface 46 to the implant interface 80. As shown in figures 3 and 4, at the implant interface 80, the positioner tube 42 encloses a plug 70 fixed inside the positioner tube 42 near where the positioner tube 42 transitions from a roughed portion to a completely closed portion. The plug 70 works to guide and control the movement of the distal portion of the cord 52. Just next to the plug 70, the cord 52 is again limited to the distal movement within the positioner tube 42 by an area of coining 72, which is an enlarged portion the cord 52, which is too large to pass distally through the central lumen of the plug 70. The configuration of the plug 70 and the coinage area 72 allows the cord 52 to be compressively pushed in the distal direction against the plug 70, which helps in assembly and keeps the distal end of the cord 52 in a position distally forward. Compression of the cord 52 can cause a portion of the cord 52 to flex and assume a position that is adjacent to the geometry axis 54 and possibly against the inner surface of the positioner tube 42.
Positioner tube 42 can be made of a material that is flexible and strong enough to transfer forces applied by the operator at the end proximal to the implant interface 80, such as 304 stainless steel hypotube, polymeric extrusion, braided extrusion or polymeric material from non-elongation, which has an outer diameter of (0.010 - 0.018 inch) and an inner diameter of (0.005 - 0.012 inch), with a length of 10 - 60 cm from the distal end of the positioner tube 42 to an outer diameter of (0.008 - 0.016 inch) to reduce circumference and increase flexibility. The outer tube 48 can be made of 304 stainless steel hypotube, polymeric extrusion, braided extrusion or non-elongation polymeric material, with an outer diameter of (0.012 - 0.020 inch) and an inner diameter of (0.010 - 0.018 inch) and an length of 1 -15 cm, adapted through 1 - 50 mm proximal to the tube 46/97 positioner 42 and circumferentially welded to the positioner tube 42. The slider 50 can be made of a 304 stainless steel tube, polymer extrusion or alloys made of steel and crimped at the proximal end of the cord 52, with an outer diameter of (0.010 - 0.018 inch), an inner diameter of (0.001 - 0.016 inch) and a length of 1 - 15 cm. End cap 82 can be made of 304 stainless steel (0.001 - 0.005 inch) thick, polymeric material or an alloy steel retaining ring with an outer diameter of (0.008 - 0.018 inch) and a hole with (0.003 - 0.009 inch), welded or attached to the distal end of positioner tube 42. Positioner marker 64 can be a platinum / iridium or platinum / tungsten radiopaque coil, arranged in lumen 44 and has an outer diameter of (0.008 - 0.018 inch ), an internal diameter of 0.005 - 0.015 and a length of 1 - 6 mm. The sleeve 66 of the positioner tube can be made of polytetrafluoroethylene (PTFE) or low-friction polymeric material, having a friction coefficient of 0.2 or less, shrunk by the heat in the whole or at least in the most distal portion of the tube. positioner 42. The cord liner 68 can be made of PTFE or other low-friction materials and has an inner diameter of (0.002 - 0.006 inch) and an outer diameter of (0.004 - 0.008 inch). The strand 52 can be a strand, wire, rod, tube, thread or filament made of a metal or polymer with a circular cross section and an outer diameter of (0.001 - 0.005 inch) in outer diameter. The plug 70 can be made of 304 stainless steel, polymeric extrusion, braided extrusion or non-elongation polymeric material with an internal diameter of approximately (0.001 - 0.012 inch) internal diameter and is welded to the inside of the positioner tube 42. The coinage area 72 can be (0.0015 - 0.0120 inch) wide. The length of the cord 52 near the plug 70 (for example, between the proximal end of the positioner tube 42 and the proximal end of the plug 70) may be slightly longer than the corresponding length of the structure adjacent to the length of the cord 52 (for example, example, the length of the positioner tube 42 corresponding to the length of the cord 52) by (0.001 - 0.040 pole47 / 97 g), thus, compressively pushing the cord 52 so that it holds the coinage area 72 against the plug until that the cord 52 is moved in the proximal direction.
Positioner tube 42 can be made of 304 stainless steel hypotube and has an outer diameter of (0.012 inch) and an inner diameter of (0.007 inch) and 50 - 60 cm in length from the distal end of positioner tube 42 is carried to an outside diameter of (0.010 in.) to reduce circumference and increase flexibility. The outer tube 48 can be made of 304 stainless steel hypotube with an outer diameter of 0.016, an inner diameter of (0.0122 in.) And a length of 6 cm, adapted about 5 mm proximal to the positioner tube 42 and welded , circumferentially, in positioner tube 42. Cursor 50 may be made of a 304 stainless steel hypotube segment crimped at the proximal end of bead 52, such as an outer diameter of (0.012 inch), an inner diameter of (0.003 inch) and a length of 4 cm. End cap 82 may be a 304 stainless steel retaining ring (0.002 - 0.003 inch) thick with an approximate outside diameter of (0.010 inch) and a hole with (0.043 inch) in diameter, welded at the distal end of the positioner tube 42. Positioner marker 64 can be a platinum / tungsten radiopaque coil disposed in lumen 44 and having an outer diameter of (0.008 in.), an inner diameter of (0.006 inch) and a length of 3 mm. Positioner tube sleeve 66 can be made of heat shrunk PTFE over most of the length of positioner tube 42. The cord liner 68 can be made of PTFE and has an inner diameter of (0.003 inch) and an outer diameter of (0.005 inch).
Cord 52 may be a 304 Hyten ™ stainless steel cord, sold by Fort Wayne Metals, Indiana, with a circular cross section and an outer diameter of (0.00185 inch). The plug 70 can be made of 304 stainless steel with an internal diameter of (0.0022 in.) And is sold inside the positioner tube 42. The coinage area 72 can be (0.0028 inch) wide. The length of cord 52 between
48/97 the proximal end of the positioner tube 42 and the proximal end of the plug 70 can be longer than the corresponding length of the positioner tube 42 by (0.027 inch), thereby compressively pushing the cord 52 so that holds the coinage area 72 against the plug 70 until the cord 52 is moved in the proximal direction.
Although specific materials, dimensions and characteristics are described in relation to the illustrated modalities, it is appreciated that other designs can achieve the same operational objectives as the described components and structures. For example, to control the flexibility of the positioner tube 42, instead of rough sections 60 of the wall 56 in the middle portion 58, the wall 56 may completely or partially enclose the lumen 44 and include a plurality of slits or clearances to increase the flexibility of the wall. The cracks or gaps can have a depth that reaches through the entire wall 56 to form holes that communicate with the lumen 44, or the cracks and gaps can have a depth that reaches only partially in the surface of the wall 56. The cracks or gaps they can be longitudinal and parallel with the geometric axis 54, transverse or orthogonal to the geometric axis 54 or at an angle to the geometric axis 54, instead of cracks or clearances, the wall 56 can have circular or oval holes partially or completely through the wall 56 According to some embodiments, the median portion 58 of the wall 56 may have a spiral cut across all or part of the length of the median portion 58 to increase the flexibility of the wall. According to some embodiments, the thickness of all or part of the wall 56 in the middle portion 58 can be reduced to increase flexibility. In yet another embodiment, instead of a tube or a thinned tube, the positioner tube 42 can have a series of tubes and / or partial tubes longitudinally aligned with a stiffening element between the tubes and / or partial tubes. Likewise, the end cap 82 can be replaced by a partial or total loop or opening defining a hole 84 and / or driven by a stiffening element disposed at a distance from the positioner tube 42.
49/97
According to some embodiments, instead of the end cap 82, the distal end of the positioner tube 42 can be formed to have an end crimp, cone shape or dome shape to reduce the diameter of the distal end of the positioner tube 42 and form the orifice 84 and also form a surface that fits the cord 52 and the implant 90 90 to prevent the implant 90 from disengaging from the implant interface 80. An embodiment in which the end cap 82 is replaced by an end dome 81, made by crimping the distal end of the positioner tube 42, is illustrated in figures 6A and 6B.
According to some embodiments, instead of a positioner tube sleeve 66, the exterior of the positioner tube 42 or the interior of the microcatheter 14 can be coated with a lubricating material or a lubricant. Also, instead of being disposed on the inner surface of the lumen 44, the cord lining 68 can be disposed on a portion of the cord 52. According to some embodiments, the exterior of the cord 52 or the surface of the lumen 44 can be coated with a lubricating material or a lubricant.
According to some modalities, instead of the coinage area 72, the outside diameter of the cord 52 in the position of the coinage area 72 can be made larger than the lumen of the plug 70 by attaching a bushing to the cord 52. According to with some modalities, instead of modifying the dimensions of the cord 52 in the coinage area 72 to limit its distal movement through the lumen of the plug 70, the cord 52 may, instead of having a curvature or torsion that prevents distal movement of the cord 52 in the lumen of the plug 70. In yet another embodiment, the cord 52 is fixed in a position distally forward by an adhesive that can be broken when the cord 52 is subjected to sufficient force.
Another aspect of the compressively driven arrangement that holds a portion of the cord 52 in a position distally forward, in the coinage area 72 and its various modalities, is that the positioner tube 42 is strong enough to maintain the disposition of mo50 / 97 than the distal end of the cord does not leave its position close to the hole 84 or allow premature release of the ball 96 from the cavity 86. The positioner tube 42 can maintain the position of the cord 52 in relation to the hole 84, when subjected to a stretching force more than 3
Newtons or an elongation force of more than 2 Newtons. According to some embodiments, an enlarged proximal end (e.g., sphere 96) of the coil implant 90 can be of any size, shape or geometry. For example, the enlarged end may be a sphere, a cube, a hexahedron, another polyhedron, a cylinder or a hook.
Implant Interface
The implant interface allows the operator to mechanically control the placement and disengagement of implant 90 in relation to positioner 40 and allows positioner 40 to retain implant 90 in a way that minimally contacts implant 90, which allows movement in all directions15 of movement and, rotationally, which allows the implant 90 to move axially and without radial movement, when fitting and detaching the implant interface. The implant interface provides mechanical control of implant placement and detachment 90 through the retention of an element that fits the implant 90. The element is introduced into the implant face through an opening in the positioning system and retained in the implant interface by obstructing the opening, at least in part, or completely, so as to physically prevent the complete exit of the element back through the opening. The obstruction is achieved with an elongated movable element arranged along the length of the positioning system with a distal end that obstructs the opening. By obstructing the opening and not restraining the implant, the implant 90 remains free to move according to the limitations defined by the implant interface, which includes movement in the axial and radial directions, compared to the geometric axis of the position system30 positioning, rotational movement around a geometric axis of the implant 90 and angular movement that disposes the implant in an Angle, when compared with the geometric axis of the positioning system. Beyond
51/97 In addition, by blocking the opening and not directly restricting the implant 90, the contact between the implant interface and the implant 90 is minimized.
As shown in figures 3 and 4, the cord 52 can be disposed at the implant interface 80. A distal end 88 of the cord 52 is positioned at or 84 of the end cap 82 so that it partially obstructs the hole 84 when the cord 52 is in its most distally advanced position on the positioner tube 42. The distal tip 88 can be deformable so that it can be displaced from the geometric axis 54 of the positioner tube 42 and enter hole 84 near the edge of the hole. The positioner tube 42, the end cap and the distal surface of the plug 70 define a cavity 86 within the implant interface 80.
The cord 52 can have fitted and disengaged orientations illustrated, respectively, in figures 7A and 7B. In the embedded orientation illustrated in figure 7A, the cord 52 is in an advanced position more distally in the positioner tube 42, in the illustrated mode, with the area wedge 72 supporting the plug 70. The distal tip 88 of the cord 52 is disposed within the hole 84 in the end cap 82 and the cord 52 is maintained in the orientation engaged by the actuator interface 46. In the disengaged orientation shown in figure 7B, the cord 52 was moved in the proximal direction in relation to the positioner tube 42, with the wedge area 72 arranged proximal to the plug 70. The distal tip 88 of the cord 52 is proximal to the hole 84 in the end cap 82 and no more completely obstructing or obstructing the orifice 84 and the cord 52 is maintained in the orientation disengaged by the implant interface 46. After obtaining the disengaged orientation, a ball 96 guided by a shaft te 94 and fitting the implant 90 90 is free to move distally through the hole 84 or the positioner tube 42 or the entire positioner 40 can be moved in the proximal direction to allow the ball 96 to exit the positioner tube 42. A snapped orientation, snapped orientation and ball exit 96 from implant interface 80 are illustrated in figures 8A, 8B and 8C, respectively, As shown in figure 24, the proximal edges
52/97 of end cap 82 in orifice 84 can be rounded or chamfered to facilitate the exit of ball 96 from implant interface 80.
In an embodiment illustrated in figures 9 and 10, the distal end 88 of the cord 52 is not disposed in the hole 84 of the end cap 82, but actually rests against the surface 83 of the proximal end cap of the end cap 82 in the embedded orientation illustrated in figures 9 and 10. The diameter or thickness of the distal tip 88 is sufficient to obstruct the orifice 84 in the embedded orientation and the proximal movement of the distal tip 88 removes the obstruction of the proximal edge of the orifice 84 to assume the disengaged orientation illustrated in figure 7B. Since the end cap 82 provides a support surface 83 for the end cap that opposes the distal movement of the cord 52, the obstruction of the orifice 84 can be achieved with or without the plug 70 and the coinage area 72 and the cord liner 68 can be arranged more distally at the implant interface 80, as shown in figures 9 and 10. The compressive thrust of the cord 52 can be maintained by compressing the distal tip 88 against the end cap surface 83 of the end cap. end 82 and cavity 87 can be defined by positioner tube 42, end cap 82, end cap surface 83 and the distal surface of the cord lining 68.
According to some embodiments, the cord 52 extends into the lumen or cavity 87 and contacts the sphere 96 at one point. A length of a line segment extending from an outer surface of the ball 96, through the point and to an external surface of the cord 52 is greater than the cross-sectional dimension of a distal portion of a tubular element (for example, the end cap 82), so that ball 96 is prevented from moving within a distal lumen and entirely beyond end cap 82, when strand 52 and ball 96 are positioned radially adjacent to each other within the lumen.
Implant
The implant can be any implant that can be retained and positioned by the positioning system. The implant is retained by the interface
53/97 implant with an extension that fits the implant. The extension can be a part of the implant 90 when the implant is made, a modified portion of the implant manufactured or attached to the implant 90 after initial fabrication. The extension provides an end that is arranged at a distance from the implant body 90 and allows the implant interface to fit and secure the implant 90 by fixing the end of the extension. The implant body itself, however, is not connected to the implant interface.
According to some modalities, as shown in figures 1A - 1B and 2B -4, implant 90 is a neurological coil. The neurological coil implant 90 shown in figures 1A - 1B is shown in a spiral orientation before insertion into the microcatheter 14 and the neurological coil implant 90 shown in figures 2B-4 is shown in a truncated form for simplicity and arranged in alignment with the geometric axis 54 inside the microcatheter 14 (not shown in figures 2B-4). The neurological coil implant 90 shown in figure 2C is shown in an implanted state, arranged in an aneurysm. The implant 90 can have a stem 94 engaging the implant 90 in the proximal direction, with the stem 94 including an orifice 110 engaging a stretch-resistant member 112, as shown in figure 24. The stretch-resistant member 112 can pass through orifice 110 and wrap orifice 110 to form a knot or to form a latch knot.
The neurological coil implant 90 may comprise (i) a coil 116 having a proximal portion and a distal portion; (ii) a stretch-resistant member 112 that extends through the coil 116 and having a proximal end and a distal end, the distal end of the stretch-resistant member 112 coupled to the distal portion of the coil 116; (iii) an enlarged proximal end (e.g., ball 96) disposed at the proximal end of the stretch-resistant member 112 and otherwise free from the proximal portion of coil 116. Ball 96 can be spaced from coil 116. A ball 96 can be arranged entirely within a lumen of the distribution tube and coil 116 can be arranged entirely outside the lumen.
54/97
As shown in figures 3-4, when fitting the implant interface 80, the stem 94 is arranged in the hole 84 in the end cap 82 and ends with the ball 96 disposed close to the end cap 82 in the cavity 86. The ball 96 has a cross-sectional area that is smaller than a cross-sectional area of the orifice 84, which allows the ball 96 to pass freely through the orifice 84, when the positioner 40 is in the undocked orientation, shown in figure 7B. When in the embedded orientation shown in figures 3 - 4 and 7A, the distal tip 88 of the cord 52 obstructs a portion of the hole 84 in the end cap 82, with another portion of the hole 84 blocked by the stem 94. The obstruction of the hole 84 by the end distal 88 reduces the available area of hole 84, so that ball 96 cannot pass through hole 94. Although physically obstructed from passing through hole 84, when cord 52 is in the engaged orientation, ball 96 and shank 94 are otherwise unrestricted and free to move and rotate within cavity 86 and orifice 84. Also, shank 94 is retained at implant interface 80, but not connected to any portion of the positioning system 10. The 96 is thus free to move in the direction parallel or radial to the geometric axis 54 of the positioner tube 42, free to move to a position where a central geometric axis of the implant 90 is at an angle to the geometric axis 54 and free to rotate around the central geometric axis of the implant 90.
The freedom to rotate the ball 96 and the implant 90, facilitated by the illustrated embodiment, is advantageous. In existing systems, it is believed that the implant or a portion of the implant is firmly held by the delivery system and is not free to rotate, and when the implant and delivery system are advanced distally to the target site via a microcatheter, the implant surface (especially the helical surface of some neurological coils) can induce torque within the implant when moved along the inner surface of a microcatheter. That torque is stored as a potential energy in a spring compressed within the implant itself 90 and within the connection between the implant 90 and the
55/97 distribution system. When the implant then emerges from the microcatheter at the target site, it is believed that the potential energy can be released suddenly and cause the implant to twist unpredictably and deposit in an undesirable location. The positioning system 10 facilitates the unimpeded rotation of the ball 96 and the implant 90, thus avoiding the problem that is believed to exist with the existing distribution systems. The free rotation of implant 90 and ball 96 allows implant 90 to be used from microcatheter 14 at target site 16 much more smoothly than with existing systems having a connection that is rigid or that limits, partially or totally, movement and the rotation between the implant and the delivery system and the free rotation also reduces the force applied to the vasculature during use and the positioning of the implant 90 at the target site 16.
The relationship between the implant interface and the implant 90 establishes some of the dimensions of these components. The implant interface provides an opening having a first opening area and a second opening area. The implant provides an extension that is arranged at the implant interface through the opening and has a portion (such as sphere 96) that can pass through the first opening area, but cannot pass through the second opening area. The extension portion has an obstruction dimension that defines a structural arrangement that prevents the portion from passing through the structure defining the second opening area in the opening. The obstruction dimension also defines the structural arrangement that allows the portion to pass through the structure defining the first opening area. This relationship can be expressed as follows:
first dimension second obstruction opening area opening area
Equation (1)
The implant interface and the implant extension use this relationship because it has the implant interface structure that forms the second opening area being smaller than the obstruction dimension of the implant extension, to physically block the passage of the portion of the implant. extension
56/97 through the opening and the structure of the implant interface that forms the first opening area being larger than the obstruction dimension, to allow the extension portion to pass through the opening.
In the modality illustrated in figure 11 A, the principles of Equation (1) can be applied to relate the size of sphere 96 with the dimensions of hole 84 and distal tip 88 of cord 52 by the following relationship:
p> b> (p - w) (Equation 2) where p is the cross-sectional dimension of orifice 84, b is the cross-sectional dimension of sphere 96 and p - w is the cross-sectional dimension of orifice 84 minus the cross-sectional dimension of distal end 88 of cord 52. In the illustrated modality, the relation of Equation (2) is applied to structures having circular cross sections. However, it is appreciated that the principles of Equation (1) can be applied to structures having non-circular geometries, such as a rod 95, with a triangular cross section, or holes 85 and 89, with a non-circular shape, as illustrated in the figures 15 and 16.
According to some embodiments, the ball 96 can be replaced by another structure that can effectively pass through an unobstructed orifice 84, but does not pass through an obstructed orifice 84, such as a disk, hook or ring structure. Likewise, distal tip 88 can be modified to block only selected portions of orifice 84 or to lean more closely against the inner surface of positioner tube 42 within cavity 86 to provide greater space for ball 96 to rotate freely or otherwise move within the cavity 86. According to some embodiments, the distal tip 88 may have a cross-sectional shape that is non-circular. For example, as shown in figure 11B, the cross-sectional shape of distal tip 88 can be ovoid and, as shown in figure 11C, the cross-sectional shape of distal tip 88 can be arched. Also, according to some modalities, the stem 94 can fit the implant 90 at an angle to a central geometric axis of the implant 90 or in a
57/97 angle to the geometric axis 54 of the positioner tube 42.
The illustrated embodiment advantageously provides the unrestricted axial movement of the ball 96 within the cavity 86 of the implant interface 80. The movement of the ball 96 within the cavity 86 is related to the longitudinal length of the cavity 86 and the length of the stem 94 engaging the implant 90 in the cavity 86. As shown in figure 12, the stem 94 is of sufficient length to allow axial movement of the ball 96 and the implant 90 in the direction of the geometric axis 54 of the positioner tube 42. When the implant 90 and the positioner tubes 42 are both advanced in the distal direction, as shown in figure 12, it can be appreciated that the friction against the implant surface 90 will cause the ball 96 to move axially to an extreme proximal position in the cavity 86 and the proximal surface of the implant 90 will support the distal surface of the end cap 82 and align the implant 90 with the geometry axis 54 of the positioner tube 42. When advanced diastally, with the implant 90 supporting the end cap 82, there is a slight frictional adhesion where the implant 90 and the end cap 82 contact each other. When positioner tube 42 or implant 90 and positioner tube 42 are advanced in the proximal direction, as shown in figure 13, it can also be appreciated that friction against the surface of implant 90 will cause ball 96 to move diastally to a extreme distal position in cavity 86 and that there will be minimal or no frictional contact between end cap 82 and implant 90. The different frictional characteristics related to the axial movement of ball 96 in cavity 86 and the degree of contact between implant 90 and the implant interface 80, provides a frictional push and a frictionless pull to the positioning system 10 which is appealing to the operator because it provides an additional tactile sensation related to the movement of the system. It is believed that existing systems that do not allow axial movement of the implant or that do not provide a frictional interaction or without reduced or variable friction between the implant and the distribution system, provide the operator with less tactile sensation when moving these systems. distri58 / 97 existing contribution.
Also, the axial movement of the ball 96 in the cavity 86 advantageously allows the implant 90 to assume an angled orientation, compared to the geometric axis 54 of the positioner tube 42, and to articulate, tilt or rotate around the ball 96. As shown in figure 13, the stem 94 can be arranged at an angle 98 with respect to the geometric axis 54 of the positioner tube 42 and that the angle 98 be increased as the ball 96 approaches an extreme distal position in the cavity 86 That angled orientation and the articulation advantageously assist in relaxing and discharging potential energy or spring forces on the implant 90 or between the implant 90 and the positioning system 10, as the implant is moved through the microcatheter 14 The angle can be approximately 10-80 degrees between the center line of the stem 94 and the geometric axis 54 of the positioner tube 42. In one embodiment, the angle can be approximately 30 degrees. According to other modalities, angulations of about 0, 10, 20, 40, 50, 60, 70 and about 80 degrees are considered. Also, when it is observed that the implant 90 has an angled orientation with an imaging system, the operator can readily determine that the implant 90 is not experiencing potential energy or girl forces, which could be released later, when implant 90 is deposited at target site 16. It is believed that existing delivery systems that do not allow the angulation or articulation of implant 90 do not provide this information to the operator.
According to some embodiments, as shown in figures 14-15, the hole 85 of the end cap 82 can be non-circular or have a notch that advantageously allows for an angle or articulation greater than that which can be obtained with the shaped hole. circular 84, allowing an angle 99 between the center line of the stem 94 and the geometric axis 54 of the positioner tube 42. Similarly, the stem can have several cross-sectional shapes, such as a triangular shape of the stem 95, as shown in figure 16 , which interfaces with a 59/97 plementary 89 shaped hole in order to maintain a specific joint (by aligning the triangular shape of the nail 95 with a triangular notch in the hole 89) when the implant interface 80 is operated to orient the nail 95 so that implant 90 is arranged in a specific direction. It can be appreciated that a slight proximal movement of the positioner 40 40 may be necessary to maintain sufficient contact between the stem 95 and the orifice 89 shown in figure 16. As can also be appreciated from figures 13-16, the angle can also be increased or decreased by adjusting the inner diameter of orifice 84 or adjusting the thickness of end cap 82. Specifically, a larger inner diameter of orifice 84 will allow stem 94 to assume a greater angle 98 and a thinner end cap 82 will allow the ball 96 takes a more distal position in cavity 86 and will allow a greater angle of stem 94 through hole 84; As can still be appreciated, a desired angulation can be preset in the design of the implant interface 80 by controlling the length and cross-sectional dimensions of the stem 94, the diameter of the hole 84 and the thickness of the end cap 82. Also, for example , orifice 84 may have a conical shape or a shape in which one end of orifice 84 is wider than the other end of orifice 84, so that stem 94 can take a larger or predetermined angle with respect to positioner 40.
The positioning system 10 of the illustrated modality also advantageously captures or recaptures an implant 90 already located at or near the target site 16. As can be seen in the reverse sequence of figures 8A - 8C, in the order of 8C to 8B to 8A , with the directional arrows in figures 8B and 8C inverted, positioner tube 42 can be advanced distally through microcatheter 14 (without implant 90) to an implant 90 already positioned at target site 16 or, if implant 90 has already been implanted released from implant interface 80, positioner tube 42 can be maneuvered close to implant 90 already released. As can also be seen from figure 8C, end cap 82 can be moved through ball 96 so that ball 96 passes through hole 84 and into cavity 86 of the inter60 / 97 implant face 80 and the distal tip 88 of the cord 52 can be advanced distally to obstruct orifice 84 to retain ball 96 and assume the engaged orientation. The implant 90 can then be moved or removed entirely from the target location 16. According to some embodiments, the ball 96 and the end cap 82 can be made of a material that can be imaged with standard forming technologies imaging, such as radiopaque material, to assist with positioning end cap 82 in relation to sphere 96. Commercially available embolic coils suitable for use with delivery system 10, when modified to include sphere 96 or a combination of stem 94 and ball 96, include Sapphire®, NXT® and Nexus® embolic coils, commercially available from EV3, Inc of Plymouth, Minnesota USA. Although implant 90 of the illustrated embodiment is a neurological coil, implant 90 can be any implant that can be inserted with a catheter, such as a stent or stent 90a, as shown in figure 17A or an embolic filter 90b, as shown in figure 17B. Commercially available stents suitable for use with the delivery system 10, when modified to include ball 96 or a combination of rod 94 and ball 96, include commercially IntraCoil®, IntraStent®, ParaMount®, PRIMUS®, and PROTÉGÉ® stents available from EV3, Inc. of Plymouth, Minnesota USA. A commercially available embolic protection device suitable for use with the delivery system 10 when modified to include ball 96 or a combination of stem 94 and ball 96 is the SpideRX® embolic protection device, commercially available from EV3, Inc of Plymouth, Minnesota USA.
Actuator Interface
The actuator interface provides the operator with the ability to control the movement of the implant 90 as it is positioned by the positioning system 10 and mechanically control the placement and selective disengagement of the implant 90 from the implant interface. The actuator interface controls the movement of the implant by providing a surface on which the operator can exercise control, so that the operator's control movements are transferred precisely to the implant and implant interface via the positioner. The actuator interface provides a relatively rigid proximal end of the positioner that transfers the axially directed and rotational forces exerted on the actuator interface by the operator to the relative and flexibly distal end of the positioning system with minimal loss due to system bending and torsion positioning. The actuator interface provides control of implant fitting and detaching from the implant interface 90 with a sliding mechanism or cursor that moves the implant interface controllably and predictably between the fitted and undocked orientations. The implant interface also connects to an actuator that allows the operator to move, controllable and predictably, move the cursor. In addition, the actuator interface establishes and maintains a compressive thrust of the implant interface so that the implant interface remains in the orientation engaged by the cursor arrangement in a position distally forward.
The compressive thrust of the cord 52 which compresses the coinage area 72 distally against the proximal end of the plug 70 can be established at the actuator interface 46. In the embodiment illustrated in figure 3, the proximal end of the positioner tube 42 is fixed to the outer tube 48 by a circumferential weld. The slider 52 is then slidably engaged in the lumen of the outer tube 48 of the proximal end of the outer tube 48. The cord 52 is then preloaded or pushed in the distal direction to create compression in the cord 52 in the coinage area 72 against the plug 70 and the slider 50 are spot welded with spot weld 49 to the outer tube 48 while preloaded, to temporarily attach the slider 50 and the outer tube 48 and keep the implant interface 80 in the engaged orientation. When undocked orientation is desired, the operator slides the cursor 50 in the proximal direction, relative to the outer tube 48, with enough force to break the weld by points 49 and release the cursor 50 so that it can move in. of the outer tube 48. The tensile strength in the range of approximately 200 - 500 grams can be
62/97 required to break the weld by points 49 and little or no particulate matter is released by breaking the weld by points 49. As shown in figure 24, outer tube 48 may include a strip 105 visible by the actuator operator indicating when the actuator is properly inserted into actuator 20, in the direction of arrow 106. Specifically, when outer tube 48 is inserted into actuator 20, a correct insertion depth is indicated when marker 105 is completely inside actuator 20 and is no longer visible by the actuator operator, as shown in figures 26A and 26B.
According to some embodiments, the thrust, fixation and movement of the cord 52 within the positioner 40 can be achieved with a variety of designs. The slider 50 can be threaded and received on the corresponding threads of the outer tube 48, with the slider 50 axially held in place in relation to the outer tube 48 by the threads and with the thrust and movement of the slider 50 controlled by the rotational movement of the slider 50 in in relation to the outer tube 48. According to some modalities, instead of spot welding 49, the thrust of the bead 52 and the fixation of the slider 50 can be obtained with a removable locking pin fitted through a common hole through the outer tube 48 and the slider 50, temporarily fixed together with an adhesive or the pin can be breakable or foldable with a force that is similar to the force applied when the weld breaks through points 49. The slider 50 can also be temporarily fixed in place by a deformable strip in the outer tube 48 that compresses the outer tube 48 against the surface of the slider 50, to hold the slider 50 in place in relation to the outer tube 48.
According to some modalities, as illustrated in figure 18, the cursor 50 is fixed to the outer tube 48 with a circumferential weld 74 instead of the spot weld 49 and the end weld 51 is replaced by an end cap 75 with a weld similar to spot weld 49 similar to spot weld 49. The proximal end of bead 52 is disposed close to hole 76. Spot weld 77 secures corset 52 to end cap 75 and keeps positioner 40 in the locked orientation until
63/97 that a predetermined force, proximally directed, be applied to the closest portion of the bead 52, which is sufficient to break the spot weld 77. Alternatively or in combination, end cap 75 and spot weld 77 can be replaced by a ratchet mechanism, which controls or limits the movement of the cord 52 in the distal direction to keep the orientation engaged and which allows the cord 52 to move in the proximal direction after the cord 52 is pulled in the proximal direction by a predetermined force similar to the force required to break spot weld 77.
According to some modalities, as shown in figure 19, instead of spot welding 49, the cursor 50 is connected to the outer tube 48 with a circumferential weld 74. The bead 52 is kept in the center of the positioner tube 42 along the geometry axis 54 for the entire length of the proximal end of the positioner tube 42, with the proximal end of the cord 52 completely enclosed and held in the location of the geometry axis 54 by the cursor 50, the positioner tube 42 and the cord liner 68. In the embodiment of figure 19, the external components of the proximal end of the positioner 40 are fixed to each other, but the internal bead 52 remains slidably disposed along the geometric axis 54, except at the end closest to the bead 52 where it is fixed in the end weld. 51. Actuator interface 46 is of sufficient length so that the operator can hold and bend actuator interface 46 around a cylindrical object (not shown) , such as the operator's finger or a cylindrical object of a predetermined diameter. When the actuator interface 46 is held against and wrapped around the cylindrical object, the cord 52 is forced to conform to an arcuate stroke that has a radius that is greater than a radius of a corresponding arcuate stroke defined by the outer surfaces of the positioner tube 42 and outer tube 48 supporting the cylindrical object, as measured from a center of the cylindrical object. As can be appreciated, the arcuate stroke of the cord 52 around the cylindrical object is greater than the corresponding arcuate stroke on the outer surfaces of the positioner tube 42 and the external tu64 / 97 bo 48a supporting the cylindrical object, which induces a movement of the cord 52 (and a movement of the distal tip 88) in the proximal direction with respect to the actuator interface 46 (and relative to the end cap 82) without using the actuator 20. The appropriate number of times es that the proximal end of the positioner tube 42 can be wrapped around the cylindrical object to cause sufficient movement of the distal tip 88 and obtain the undocked orientation can be determined by trial and error or calculated for various sizes of the positioning system 10. According to some modalities, as illustrated in figure 18, the outer tube 48 and the slider 50 can be omitted and the positioner tube 42 and the bead 52 can directly fit the butt weld 51.
In the embodiment illustrated in figures 20A and 20B, the outer tube 48 48, the outer tube 48 encloses bushings 101, 102 and 103, which are arranged inside the outer tube 48 and around the cursor 50 and the positioner tube 42. As illustrated , the bushing 101 is fixed to the inner surface of the outer tube 48 with a circumferential weld at the proximal end of the outer tube 48 and the slider 50 is slidably arranged inside the inner surface of the bushing 101, but temporarily fixed to the bushing 101 with a weld by points 104 at the proximal end of bushing 101. Spot welding 104 works similarly to spot welding 49 described in the embodiment illustrated in figure 3; The bushing 102 is slidably arranged inside the outer tube 48 and the distal end of the cursor 50 is arranged inside the bushing 102 and fixed to the bushing 102 with a circumferential weld at the distal end of the outer tube 48 and the proximal end of the positioner tube 42 is arranged inside the internal surface of the bushing 103 and fixed to the bushing 103 with a circumferential weld at the distal end of the bushing 103. The characteristics that are identical to those of the other modalities are not identified again.
When the implant interface 80 is in the engaged orientation, the cursor 50 is disposed in a distal position within the outer tube 48 and is temporarily held in place by the spot weld 104, as shown in figure 20A. When desired by the operator, a terminated pre-65/97 force is applied to the cursor 50 in the proximal direction with respect to the outer tube 48 and the spot weld 104 is broken to release the cursor 50 to slide in the proximal direction within the sleeve 101. The operator then moves the cursor 50 to a proximal position illustrated in figure 20B. which corresponds to the orientation disengaged in the implant interface 80. The cursor 50 is retained in the external tube 48 by the interface between the sleeve 102 and the sleeve 101, thus preventing the removal of the cursor 50 from the external tube 48. According to some modalities, the bushing 102 can be replaced by an enlarged distal end of the cursor 50, having an outer diameter that is greater than the inner diameter of the bushing 101. According to some embodiments, the bushing 101 can be replaced by a crimped proximal section of the tube outer 48 that has an inner diameter that is less than the outer diameter of the bushing 102 and spot welding 104 can actually temporarily fix the proximal end of the outer tube 48 to the outside of the slider 50. According to some modalities, a crimp can be added to the outer tube 48 exactly distal from the bushing 101 to establish a support surface that will prevent the proximal movement of the bushing 102.
According to some embodiments, as shown in figure 24, the outer tube 48 may have a groove 120 that forms an inner surface with a diameter that is less than the outer diameter of a portion of the cursor 50, so that when the cursor moves in the proximal direction, an edge 122 supports the inner surface formed by the frieze 120 and for the new proximal movement of the cursor 50. As also illustrated in figure 24, positioner 42 can include one or more markers 124 in a sleeve 126, which can be fluoro-safe markers. Figure 25 illustrates another modality working similarly to the modality of Fig. 24. The characteristics that are identical to those of the other modalities are not identified again in Figures 24 and 25.
Actuator
The actuator provides a mechanism that removably fits the actuator interface and causes controllable and predictable movement
66/97 of the actuator interface. The actuator achieves this function by providing a structure that holds the outer tube in a fixed position in relation to the actuator body and a tongue and anvil, which presses the cursor and pulls the cursor in the proximal direction for a predetermined distance with a force predetermined and then detaches from the cursor to allow the operator to hold the actuator firmly in place in order to maintain the positioner position in relation to the target location and allows the operator to use the actuator in a controlled manner, which minimizes the movement of the positioner .
As shown in figure 1, the proximal end of positioner 40 can engage a distal end of actuator 20. As shown in figures 21A - 22B, actuator 20 includes a body 21, a receiver section 22, a tongue 23, a stop 24 , a slide return spring 25, a slide frame 26, and a clamp 27. The body 21 can be tubular and provides support for the proximal portion 26a of the slide frame 26, the receiver section 22, and the slide return spring 25 Closing part of the body 21 is the clamp 27, which has two claws that are pulled by the operator in the proximal direction, when operating the actuator 20. The clamp 27 is fixed on a pin 28 that passes radially through the clamp 27, through the slot 29 on the body 21 and is attached to the proximal portion 26a of the sliding frame. The proximal portion 26a of the sliding frame is also movably connected to the proximal end of the body 21 by the cursor return spring 25. As can be seen from figures 21A - 22B, the sliding frame 26, the clamp 27 and the pin 28 are fixed one to the other and move as one when the operator grips the two claws of the clamp 27 and the proximal end of the body 21 and slides the clamp 27 in the distal direction relative to the body 21 from the position shown in figure 21A to the position illustrated in figure 21B.
Figures 21A and 22A illustrate the actuator 20 in a disabled position that allows the insertion of the actuator interface 46 in the actuator 20. Figures 21B and 22B illustrate the actuator 20 in an activated position in which the cursor 50 was pulled in the proximal direction in relation to the outer tube 48 to make the implant interface 80 move from the engaged orientation to
67/97 the orientation disengaged.
As shown in figures 21A and 22B, the body 21 can be tubular and has a distal end connected to the receiver section 22 and an inner lumen, slidably containing the partially cylindrical sliding frame 26. The receiver section 22 has a distal surface that includes a funnel that directs the insertion of the actuator interface 46 to a central lumen 31. The central lumen 31 has two internal diameters adjacent to each other along the length of the central lumen 31 corresponding to the outer diameters of the cursor 50 and the outer tube 48 and an edge between the two diameters that acts as a stop when supporting the proximal end of the outer tube 48. The edge of the central lumen 31 limits the proximal movement of the actuator interface 46 when inserted in the central lumen 31 and orientates the cursor 50 so that it is arranged in a proximal direction of the central lumen 31 to a predetermined position between the tongue 23 and the stop 24. The proximal end of the body 21 has a closed end containing the spring cursor return 25 under compression. The closed end of the body 21 also provides a surface that the operator can hold in place when moving the gripper claws 27 to move the actuator 20 from the disabled position to the activated position. The cursor return spring 25 also serves to return the actuator 20 to the deactivated position once the operator releases the gripper clamps 27.
The receiving section 22 also includes a holder 32 fixed in a channel directed radially towards the receiving section 22 and in the central lumen 31. The holder 32 includes a sphere positioned in the channel that is driven into the central lumen 31 by an internal spring. A portion of the ball of the detent 32 is compressed in the central lumen 31 by the internal spring and when the actuator interface 46 is inserted in the central lumen 31, the ball compresses against the outer surface of the outer tube 48 and, reticently, retains the outer tube 48 in the central lumen 31.
Slidably disposed within the body 21 is the sliding frame 26. The proximal portion 26a of the sliding frame 26 is dimension 68/97 not to conform to the inner surface of the body 21, to align and guide the movement of the sliding frame 26 within the body 21 The sliding frame 26 is pushed in the body 21 to move in the distal direction by the slider return spring 25. The distal portion 26b of sliding frame 26 fits the proximal portion 26a (behind the tongue 23 and the stop 24 in the cross-sectional views shown in figures 21A - 22B) and supports the proximal surface of the receiving section 22 and provides a generally flat surface that is parallel and adjacent to the portion of the cursor 50 disposed proximal to the central lumen 31. The distal portion 26b of the sliding frame 26 fits the proximal portion 26a (behind the tongue 23 and the stop 24 in the cross-sectional views shown in figures 21A - 2B and supports the proximal surface of the receiving section image 22 and provides a generally flat surface that is parallel and adjacent to the portion of the cursor 50 disposed proximal to the central lumen 31. The distal portion 26b of the sliding frame is composed of two opposing elements extending from the proximal portion 26a of the cylindrical sliding frame, with each element disposed on opposite sides of the tongue 23 and the stop 24, to keep the tongue 23, the stop 24 and the tongue spring 30 in position between the two opposite elements. In the cross-sectional views shown in figures 21A - 22B, only the rearmost (of the shown view) of the two opposite elements of the distal portion 26b of the sliding frame is illustrated.
A hinge 33 is also arranged on the flat surface of the distal portion 26b of the sliding frame (between the two opposite elements of the distal portion 26b) and engages the tongue 23 and the tongue spring 30 pushes the proximal end of the tongue 23 away from the proximal portion 26a of the sliding frame pivotally around the hinge 33 and compresses the proximal end of the tongue 23 against the proximal end of the receiving section 22. The stop 24 is guided by the flat surface of the distal portion 26b of sliding frame (between the two opposite elements of the portion distal 26b) and, in the deactivated position shown in figures 21A and 22A, a space is maintained between the tongue 23 and the stop 24 sufficient to allow insertion of the cursor 50 between the tongue 23 and the stop 24.
69/97
Referring to figures 21B and 22B, when the sliding frame 26 is moved a predetermined distance in the proximal direction in relation to the body 21 and away from the receiving section 22, the tongue 23 and the stop 24 also move because they are engaged in the portion distant 26b of sliding frame. The proximal movement of the sliding frame 26 also causes the proximal end of the tongue 23 to rotate around the hinge 33 because of the push of the tongue 23 to compress the cursor 50 against the stop 24, thus pressing and holding the cursor 50. The cursor 50, now stuck between the tongue 23 and the stop 24, is pulled in the proximal direction by the proximal movement of the sliding frame 26, while the outer tube 48 is retained by the edge within the central lumen 31 of the receiving section 22, thus making the spot weld 49 breaks and moves the implant interface 80 in the undocked orientation. As shown in figures 21B and 22B, the cursor 50 is finally moved in the proximal direction in relation to the outer tube 48, almost the same distance displaced by the stop 24 and by the sliding frame 26 in the proximal direction in relation to the body 21 and the receiving section 22.
The receiving section 22 can be made of polycarbonate or ABS and the tongue 23, the stop 24, the cursor return spring 25 and the tongue spring 30 are made of steel. The funnel of the receiving section 22 can be a cone with an angle of 10 - 20 degrees and the central lumen 31 has a diameter of (0.0010 - 0.030) of an inch to receive the outer tube 48 and a diameter of (0.006 - 0.026) of an inch to receive the cursor 50.
The receiving section 22 can be made of polycarbonate and the tongue 23, the stop 24, the cursor return spring 25 and the tongue spring 30 are made of stainless steel. The funnel of the receiving section 22 can be a cone with an angle of 30 degrees and the central lumen 31 has a diameter of 0.018 of an inch to receive the outer tube 48 and a diameter 0.014 of an inch to receive the outer tube 48 and a diameter of 0.014 of an inch to receive the cursor 50.
The interface surface manipulated by the operator, used by the
70/97 operator to move actuator 20 from the deactivated position, illustrated in figure 21A to the activated position, illustrated in figure 21B, can be implemented with a variety of replaceable designs that provide structure for moving the sliding frame 26 closely in relation to to the receiving section 22 (i.e., the clamp 27 and the claws arranged on the clamp 27 can be replaced by structures that can move the internal components controllably within the clamp 27, as shown in figures 21A and 22B). In the embodiment illustrated in figure 1 and as illustrated in figures 21A - 22B, the actuator 20 involves the operator who compresses the actuator 20, so that the claws of the clamp 27 (fixed on the sliding frame 26) are moved proximally in relation to the proximal end body 21 (fixed in receiving section 22). According to some modalities, instead of the operator compressing the actuator 20 with the clamp 27, the internal components (that is, the components inside the clamp 27) of the actuator 20 remain essentially the same, but the external components interfacing with the operator they are adapted to facilitate a variety of actuation movements, such as actuation movements, such as actuation movements of pulling a trigger, sliding a switch, turning a wheel, pressing a button or moving a lever. Another modality of the actuator 20 is illustrated in figures 27 and 28, with characteristics identical to those of the other modalities are not identified again. As shown in figure 27, the body 21 is held by the operator and the clamp 27 is slid in the proximal direction to move the actuator 20 from the disabled position to the activated position illustrated in figure 27.
Pushing Ability
The vasculature of the brain is more tortuous than the vasculature that leads to the brain from the groin, a typical access point in a patient's body. An instrument placed on a patient's body between the groin and the brain thus experiences the most tortuous path at the distal end of the instrument. This tortuous path forces the instrument to bend and suddenly raises the instrument's body to increased tensions. Also, any sliding element, moved slidably within the instrument, such as a string, is subjected to greater frictional forces against the sides of the instrument when the instrument is turned or bent. These increased frictional forces require the instrument operator to exert additional force to move the slider through the instrument and increased stresses in the instrument from bending or bending can cause permanent instrument deformation or failure of the instrument body or slider. Also, high frictional forces at the distal end of the instrument body can prevent movement of the instrument through a catheter or the movement of a string through the instrument. Namely, high frictional forces at the distal end of the instrument can cause the median and proximal portions of the sliding element or strand to deform, that is, to have the axial movement of the sliding element or strand redirected in a non-axial direction or undesirable radial, instead of a desired axial direction or form folds in the sliding element or cord.
In order to minimize the required force of the operator and decrease the potential for failure of the instrument components, the positioning system advantageously obtains improved pushing capacity. Specifically, the ability to push can be characterized by a relation of the force applied to the positioner or cord by the operator at the proximal end of the system (F1) and the force observed at the distal end of the system (F2). Ideally, when the ratio of F1 to F2 approaches the unit, this indicates that the force applied to the proximal end becomes an equal or almost equal force at the distal end. As can be appreciated, the curvature or bending of the positioner 40 or bead will produce a ratio of F1 to F2 that is not or almost not the unit. The ratio of F1 to F2 can also be represented as a percentage, indicating that a certain percentage of the force at the proximal end has been observed at the distal end. As shown in Table 1, positioning system 10 can provide a push capability that is closer to the unit (100%) than that seen with an existing distribution system (Nexus / NXT Pusher refers to a
72/97 pusher used with commercially available Nexus® and NXT® 'reels from EV3, Inc., Plymouth, Minnesota USA).
TABLE 1
Sample System Average Standard Positioning system 94.6% 1.9% Nexus / NXT pusher 79% 4.6%
The positioning system also achieves the ability to push or improved sliding ability by reducing the friction between the bead 52 and the positioner tube 42 and between the positioner tube 42 and the microcatheter 14. The following equation is a characterization of the frictional forces referring to a flexible internal cylindrical element enclosed within a flexible external cylindrical element, with the external element conforming to a curved surface defining a tortuous path and with the internal element moved, slidingly, inside the external element:
Fi / F ₂ = β ^μ θ Equation (3) where:
F1 is the force applied to the inner element at a proximal end of the interface between the inner and outer tubes through the length of the tortuous path;
F2 is the resistance force exerted by the outer element at a distal end of the interface between the inner and outer tubes through the length of the tortuous path:
and it is the basis of natural algorithms;
μ is the average friction coefficient along the length of the interface between the inner and outer tubes through the length of the tortuous path; and
Θ is the total tortuosity across the length of the tortuous path, that is, the sum of the angular contact between the inner element and the outer element, in radians.
The smallest possible force transfer ratio (F1 / F2) is desired, so that there is only a small related frictional loss
73/97 with the movement between the inner and outer tubes. As it is well known that e ° = 1, it can be appreciated that, in order for the force transfer ratio to be as small as possible, the product of μ and Θ is likely to be a small value.
When the principles of Equation (3) and the knowledge of the anatomy of the vasculature are applied in the various modalities, an advantageous force transfer relation is obtained by reducing the average friction coefficient in the portions of the positioning system 10 subject to the greatest tortuosity. This can be achieved through the selection of specific materials and surface characteristics of corresponding surfaces in the portions of the positioning system 10 subject to the greatest tortuosity, for example, in the most distant third of the positioner 40. The positioning system 10 can act within a 900 - 4000 degree tortuosity range, with a force transfer ratio of 16 or less and an average friction coefficient of 0.045 or less across the 4000 degree tortuous path length.
Materials capable of providing a friction coefficient of 0.045 or less are limited. The strand 52 can be a stainless steel strand with a roughness of less than (50 microinches) and the strand coating 68 is a polymer with a roughness of less than (200 microinches), the strand coating 68 and the strand 52 have a hydrophilic coating or the type between the cord coating 68 and the cord 52 is loaded with a liquid polysoloxane containing a concentration of stearic acid in the range of 2 -10%. The strand 52 can be a 304 stainless steel strand with a roughness of less than (50 microinches) and the cord liner 68 is PTFE with a roughness of less than (200 microinches).
The materials for cord 52 and cord liner 68 can be used for all lengths of cord and cord liner. However, preferred materials can be provided in the portions of positioner 40 which are subjected to 4000 degrees of tortuosity, which is the most distant third of positioner 40. For the pro74 / 97 maximal two thirds of positioner 40, a wider selection of materials is available because that portion of positioner 40 is subjected to less tortuosity (less than 2000 degrees) than the distal third of positioner 40. For the proximal two thirds of positioner 40, positioner 40 can act with a force transfer ratio 15 or less and an average friction coefficient of 0.11 or less across a tortuous path of 2000 degrees or less in the two proximal thirds of positioner 40. Materials capable of providing a friction coefficient of 0.11 or less are not so limited with the distal third of positioner 40. Preferable materials suitable for use in the proximal two thirds of positioner 40 include polyethylene, acetal or fluorope polymer for bead coating 68 and a steel or polymeric material with a surface roughness of less than (50 microinches) for bead 52. Materials can be polyethylene for bead coating 68 and steel with a surface roughness less than (50 microinches) for cord 52.
An advantageous force transfer ratio is also obtained on another corresponding surface of the positioning system 10, that is, where the sleeve 66 of the positioner tube moves slidably inside the microcatheter 14. Applying the same principles of Equation (3) as described above for bead 52 and bead liner 68, the preferred material for sleeve 66 of the positioner tube is a heat shrunk PTFE material and the preferred material for microcatheter 14 is a polymer with a relatively smoother surface.
Flexibility
The flexibility of the positioning system along the length of the system can affect the design and performance of the system, as the flexibility of the system refers to the operator's ability to control the positioner and the sensitivity of the proximal end system manipulated by the operator. Also, the malleability of the distal tip of the positioner refers to the operator's ability to direct the positioner to the desired position. Maintaining the desired flexibility of a
75/97 system with a mechanical implant fitting and detaching system is particularly difficult because the length of the system provides a mechanical connection between the proximal and distal ends of the system that is small in size but strong enough to cause the fitting and the detachment of the implant from the system.
The positioning system 10 can achieve the appropriate level of flexibility by providing a relatively rigid structure in the proximal portion of the positioner, a relatively malleable structure in the distal portion of the positioner and a transition region in the middle of the positioner that provides a change in flexibility between the proximal and distal portions.
The proximal portion of the positioner can provide flexibility (or stiffness) that remains quite constant over the length of this section of the positioner. The almost constant flexibility of the proximal portion is achieved by using a tube structure. The distal portion and the transition region obtain a degree of malleability with a combination of structural modifications in the tube structure which increases flexibility, the increase in the degree of those structural modifications along the length of the tube structure in the distal direction and the support structural strength provided to the positioner by the reinforcement structures. The predetermined flexibility increases along the length of this section, with the greatest malleability obtained near or at the most distal end of the positioner. The almost constant flexibility of the proximal portion can be achieved through a completely closed structure of the positioner, without the use of thinning. The variable flexibility characteristics of the distal portion and the transition region are obtained through a combination of a thinning tube, the increase in the degree of thinning along the length of the tube in the distal direction and the structural support provided for the positioner by the glove. of positioner tube.
Figure 23A illustrates the flexibility of the positioner of the modality illustrated in figures 3 and 4 (identified as 3G / FX - 0.012 Prox Pusher, in figures 23A and 23C). The horizontal geometric axis in figure 23A
76/97 (labeled distance from the target site) corresponds to the positioner length, with end cap 82 (close to or within the target site area, as shown in figure 2C), defining the zero point on the horizontal geometric axis and each mark on the horizontal geometric axis identifying a distance from the end cap 82 in the proximal direction. The horizontal geometric axis also corresponds to the anatomical areas in the human body, illustrated in figure 2A, when the end cap 82 is located close to the target site 16, with distances close to the end cap 82 and the target site 16 corresponding to the various anatomical features identified in figure 23A until the proximal end of positioner 40 finally exits the human body in the groin, as shown in figure 2A. The vertical geometric axis in figure 23A (labeled moment) corresponds to the amount of resistance provided by the positioner 40 along its length, when subjected to a 20 ° deflection.
When subjected to a 20 ° deflection, the positioner 40 resists deflection, which corresponds to flexibility, through the generation of a moment. As shown in figure 23A, the moment observed in the proximal portion of positioner 40 is approximately constant near the portion of positioner 40 disposed near the aorta, indicating an almost constant flexibility in this portion of positioner 40. The moment observed in the distal portion of positioner 40 decreases distal to the portion of the positioner 40 disposed in the carotid artery, indicating a variable flexibility in this portion of the positioner 40 that increases in the distal direction. As also illustrated in figure 23A, the moment changes at an approximately linear rate in the transition region of positioner 40 which corresponds to a length of positioner 40 disposed between the aorta (approximately) and the carotid artery (approximately), indicating an approximate linear change in the flexibility in this portion of the positioner 40, from lesser flexibility to greater flexibility in the distal direction. The almost constant flexibility in the proximal portion of the positioner 40, and the approximately linear change in the positioner's flexibility in the transition region, provides a combined flexibility that is interpreted as a good
77/97 sensation for the operator manipulating the external tube 48. The flexibility profile illustrated in figure 23A also advantageously provides a relatively malleable distal end in the tortuous anatomy within the brain and distal to the carotid artery. The relatively stiff proximal end provides the operator with the ability to control positioner 40. Also, the portion of positioner 40 where the largest transition from rigid to malleable occurs (in the transition region) is arranged as distally as possible in positioner 40, but exactly close to the carotid artery, where the anatomy begins to become more tortuous towards the brain and where increased maleabildiade is desired.
As also shown in figure 23A, positioner 40 provides a profile of variable flexibility across the length of positioner 40.
As also illustrated in figure 23A, positioner 40 provides a variable flexibility profile across the length of positioner 40. In the proximal portion of positioner 40, the measured moment can be (0.01 - 0.50 in - Ibs) at 20 ° of deflection between the proximal end of the positioner 40 and the portion of the positioner 40 disposed near the aorta, between 55 cm and 80 cm proximally to the target site 16. In the distal portion of the positioner 40, the measured moment can be * (0.0001 - 0.0100 in - Ibs) at 20 ° of deflection between the portion of positioner 40 disposed in the carotid artery and end cap 82, between 0 cm and 35 cm proximally to the target site 16. In the transition region of positioner 40 between the proximal and distal portions, the measured moment can change from (0.001 in - Ibs to 0.100 in - Ibs) in 20 ° of deflection between 35 and 50 cm from the target site 16.
The flexibility of the proximal portion can be approximately (0.045 in - Ibs) at 20 ° of deflection, the flexibility of the transition region changes from (0.0005 to 0.045 inch - Ibs) at 20 ° of deflection and the flexibility of the distal portion is approximately (0.0005 in - Ibs) at 20 ° deflection.
As further illustrated in figure 23A, the flexibility of the positioner 40 changes at specific rates across the entire length of the positioner 40, as determined from the moment measurement at
78/97 positioner 40. In the proximal portion of the positioner 40, flexibility can remain close between the proximal end of the positioner 40 and the portion of the positioner 40 arranged near the aorta, between 55 cm and 80 cm proximally to the target location 16. distal portion of positioner 40, flexibility can change at a rate of 100 - 800% between the portion of positioner 40 disposed in the carotid artery and end cap 82 between 0 cm and 35 cm proximally to the target location 16. In the region of positioner 40 transition between the proximal and distal portions, the flexibility can change at a rate of 100 - 1000% between 35 cm and 55 cm from the target site 16. The flexibility of the proximal portion can be constant, the flexibility of the transition region changes at a rate of approximately 800% and the flexibility of the distal portion changes at a rate of approximately 700%.
As illustrated in figure 23B, the flexibility profiles of existing thermal, electrolytic and hydraulic systems are comparable with the flexibility profile of the modality illustrated in figures 3 and 4 (in figures 23B and 23C, Cordis refers to Cordis Corporation of Miami Lakes, Florida USA, MTI refers to Micro Therapeutics, Inc. of Irvine, California USA, GDC refers to Guglielmi Detachable Coil or GDCID® Detachable Coil, commercially available from Boston Scientific Corporation of Natick, Massachusetts, USA, and Micrus refers to Micrus Endovascular Corporation of San Jose, California USA). As can also be seen from a comparison of figures 23A and 23B, the illustrated embodiment has a less flexible proximal portion between the proximal end of the positioner 40 and the positioner portion disposed close to the aorta, than the existing thermal, electrolytic and hydraulic systems .
Figure 23C is a closer and more detailed view of the information presented in Figures 23A and 23B, between the distances of 0 and 40 cm (on the x-axis) and between the moments of * (0.000 and 0.005 in-lbs) (in the y-axis). As can be seen in figure 23C, in the distal portion of the positioner 40, between 0 and 35 cm from the end cap 82 (or the distal ends of the respective existing systems) the observed moment decreases (and the flexibility of the positioner 40 increases) continuously until reach the last 4
79/97 cm, where measurements become less reliable. As can also be seen in figure 23C, the existing non-mechanical systems in figure 23B produce a moment that does not change between 10 and 35 cm and that quickly reduces to a minimum moment between 0 and 10 cm. It is believed that this comparatively abrupt change at the moment in the distant 10 cm of existing devices demonstrates that existing devices do not have continuously variable flexibility in their respective distal portions. The positioner 40 of the illustrated embodiment, however, has a flexibility that changes continuously along the length of the distal portion and especially along the 5 - 35 cm near the end cap 82. As can also be seen from figure 23C, the distal end of positioner 40 provides flexibility that changes in the distal direction by 100 - 800% between 35 cm and 0 cm from end cap 82, for example, by approximately 700%. As can also be seen from figure 23C, the distal end of positioner 40 provides a degree of flexibility that changes in the distal direction between 35 cm and 10 cm from end cap 82, decreasing by 100 - 900%, for example, by 500% . Referring to figure 23C, it is believed that existing non-mechanical systems do not provide distal portions with flexibilities that change as significantly as seen with the positioner 40 and it is also believed that existing non-mechanical systems do not provide distal portions with flexibilities that change between 10 and 35 cm from the most distal end of these systems.
The flexibility of the tip of the positioner 40 can be important for proper positioning of the implant 90 in the target site 16. It has been demonstrated that the flexibility of the distal tip of the modality illustrated in figures 3 and 4 provides a more flexible tip, when compared with other systems , when submitted to a longitudinally compressive force, as shown in Table 2.
TABLE 2
Sample System Curvature Force Positioning System 1.0 g Micrus Pusher 3.0 g
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Profile
A mechanically operated positioning system can be flexible and small enough to reach the target site, but remain strong enough to allow the operator to control the operation and positioning and mechanics of the implant interface. The positioning system obtains a mechanically operated implant fitting and detaching system with a profile, or size, appropriate through the use of materials and surfaces with variable friction coefficients, resistances and flexibilities suitable for a positioner subject to a tortuous path. The outer diameter of the distal end of the positioner 40 at the distal end of the pusher tube 42 can be small enough to reach the target site 16 while allowing proper operation of the implant interface 80 of a mechanical system connecting the implant interface 80 to the proximal end of the positioning system 10. The outer diameter of the distal end of the positioner 40, at the distal end of the pusher tube 42, can have an outer diameter of (0.008 - 0.018 inches) for 304 stainless steel hypotube or steel alloy. The outer diameter of the distal end of the positioner 40, at the distal end of the pusher tube 42, can have an outer diameter of (0.012 inches) for 304 stainless steel hypotube.
Fatigue Resistance
When implanting multiple neurological coils in an aneurysm, it is believed that a common practice is to place multiple coils within the aneurysm sufficient to fill the void created by the aneurysm and promote the formation of thrombi. It is believed that a satisfactory result can be obtained when an aneurysm accommodates as many coils as possible, within the operator's discretion. However, in this procedure, it is possible that the first implanted coil or coils will interfere with or prevent subsequent coil placement. Also, this interference from already implanted coils can possibly make it difficult for the operator to determine whether the aneurysm can accommodate additional coils. Few coils may possibly result in rupture of the aneurysm or
81/97 the displacement of a coil from a desired position at the target location.
It is further believed that, when placing an additional coil at the target location, the operator can repeatedly move the additional coil back and forth (by moving the distribution system) in order to house the coil within the aneurysm between the coils already implanted and evaluate if the aneurysm can accommodate the implantation of more coils. It is also believed that the repeated movement of the distribution system and the additional coil causes the system and the coil to experience friction where the system and the coil move slidably inside a distribution catheter and where the additional coil contacts coils already implanted . It is believed that the friction of the repeated movement of the system and the coil can cause the connection point between the system and the coil to experience significant stresses and, when combined with the repeated movement back and forth, possibly causes fatigue. of the material and fracture of the connection point, resulting in premature disengagement of the system coil. It is also believed that existing distribution systems that rigidly or firmly fit the additional coil, or that prevent the movement or free rotation of the coil in relation to the system, allow the development of stresses related to the repeated movement back and forth of the system and the coil.
The positioner of the various modalities prevents or minimizes the development of stresses at the interface between the positioner and the implant by allowing the implant's unrestricted movement in relation to the positioner, within the limitations defined by the implant interface. The development of stresses at the implant interface is minimized or prevented because the ball, stem and implant are able to move in axial and radial directions compared to the geometry axis of the positioning system 10, to rotate about an axis the stem or implant and move angularly, so that the implant 90 is at an angle when compared to the geometric axis of the positioning system.
Referring to figure 13, when moved back and forth (or push - pull) during an implantation procedure, a proximal (or pulling) movement of the positioner 40 causes the implant interface 80 fit and pull the ball 96 and pull the implant 90 in a proximal direction, which can cause tension in the ball 96 and the stem 94, when the implant 90 resists the proximally directed movement because of the friction of contact with the interior of the microcatheter 14 or with the implants already implanted. However, as ball 96 and stem 94 are able to move within end cap 82, implant 90 is capable of assuming an orientation, angled or rotational position, which prevents or minimizes the development of curvature stresses or of the rotation of the implant 90 in relation to the positioner 40.
Referring to figure 12, a distal movement (or pushing) of the positioner 40 causes the distal surface of the implant interface 89 (the end cap 82) to engage and push the proximal surface of the implant 90 and push the implant itself in the direction distal, without applying axially directed forces to ball 96 or stem 94. Ball 96 and stem 94 are thus not subjected to significant stress when implant 90 is moved in the distal direction because all or most of the force transmitted from positioner 40 to implant 90 is transmitted directly to implant 90, without the involvement of ball 96 or stem 94, although there may be some radially directed forces applied to ball 96 or stem 94 by contact with end cap 82 or the positioner 40. In the distal movement of the positioner 40 and the implant 90, the implant 90 remains capable of assuming an orientation or rotational position responsive to the forces resulting from the contact of the i implant 90 with end cap 82, with the inside of the microcatheter 14 or with implants already implanted. Also, as the implant 90 supports the end cap 82, the operator is endowed with a tactile sensation regarding the degree of resistance resulting from attempts to insert or harbor the implant 90 within the aneurysm or between the implants already implanted.
As shown in Table 3, when measured, it was observed that the fit between the stem 94 and the positioner 40 can resist a force
83/97 higher than the interfaces between the implants connected to the existing systems. (Implant positioner / interface refers to the modality described Sapphire / NXT / Nexus refers to Sapphire®, NXT® and Nexus® products commercially available from EV3, Inc. of Plymouth, Minnesota USA and GDC refers to Guglielmi Detachable Coil or GDC ® Detachable Coil commercially available from Boston Scientific Corporation of Natick, Massachusetts, USA).
TABLE 3
System Implant Positioner / Interface Sapphire /NXT / Nexus GDC - Electrolytic Average strength 1.71 N 1.62 N 1.02 N Standard deviation 0.06 N 0.18 N 0.17 N 95/95 1.53 N 0.95 N 0.38 N
Separation Time
The embodiment illustrated at least in figures 3 and 4 provides a coil positioning system 10 that can already be in the fitted orientation, when removed from the package and before insertion into a patient, as shown in figure 8A, for example. The illustrated positioner 40 and implant 90 thus provide a system that is ready for use outside the packaging, subject to the necessary steps common to these mechanical procedures that are performed before the use of the coil, for example, the insertion of a microcatheter in the patient and the insertion of the delivery system in the microcatheter.
The modality illustrated at least in figures 3 and 4 also provides a coil positioning system that directly connects the actuation of the separation mechanism with the separation of the implant from the distribution system, without an intermediate process to initiate and complete the separation of the coil. As illustrated in figures 3 - 4 and 8A 8C, the direct connection between the cursor 50 and the cord 52 causes the movement of the cursor 50 to move the 62 away from the orifice 84, thus reaching a separate state because the implant 90 is no longer held firmly by positioner 40, while ball 96 is free to pass through hole 84.
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Also, the illustrated coil structure of the implant 90 still facilitates the movement of the ball 96 through the hole 84 because the coil structure expands or adjusts to the anatomy of the target site 16, which causes the implant 90 to move distally away of the end cap 82 and thus facilitate the movement of the ball 96 through the hole 84. The illustrated embodiment can achieve a preparatory time out of the package of approximately 15 seconds and a separation time of less than 1 second.
It is believed that the preparatory and separation times of the illustrated modality provide a system that allows a quick and efficient use of implants in a target location. The advantageous preparatory and separation times reduce the length of time required to prepare the positioning system 10 and advantageously increase the efficiency of the procedure, thereby allowing the physician to fulfill other responsibilities during the invasive medical procedure.
Side Wall Opening
Reference is made to United States Patent Publication No. 2010/0174269, published on July 8, 2010 and corresponding to United States Order No. Serial 12 / 498,752, filed on July 7, 2009, all of which is incorporated by reference, as presented here, completely.
Figures 29 - 33 illustrate modalities of a separation system. Figures 29, 32 and 33 illustrate the separation system 200 following the successive steps to separate the embolic coil 206 also referred to here as implant 90, from the insertion tool 214. Starting with figure 29, a cross sectional view in side elevation the distal end of the insertion tool 214 is shown. The insertion tool 214 comprises an elongated pusher tube 216, also referred to herein as tube 42, a distal tubular tip 218, having a distal opening 219 and a side wall 204 defining the lumen 208, also referred to here as cavity 86. The opening distal 219 may have a cross-sectional dimension substantially similar to a cross-sectional dimension of tube 216 or, as disclosed with respect to orifice 84, me85 / 97 nor than a cross-sectional dimension of tube 216. Pusher tube 216 can be understood of the same materials and manufactured using the same processes as those previously described for the positioner tube 42. The distal tubular tip 218 can be comprised of metal, ceramic, polymer or other materials known in the art. The pusher tube 216 can be permanently attached to the distal tubular tip 218 by welding, adhesives, crimping or other means. In one or more embodiments, the distal end of the pusher tube 216 is inserted into a socket within the proximal end of the distal tubular tip and is affixed by epoxy adhesive. Side wall 204 is cut, molded or otherwise configured to define a driver 240, partial opening 244 surrounding a portion of driver 240 and shoulder 246. Driver 240 and partial opening 244 can be of various sizes and / or shapes. An example of a suitable shape for the driver 240 can be seen in a top view in figure 30, which also reveals a possible position of ball 232, also referred to here as ball 96, prior to the use of system 200. Other shapes, positions and sphere 232 orientations are considered, including, but not limited to, out of egg and polyhedron. As explained in greater detail below, prior to using system 200 to release coil 206, ball 232 has freedom of movement within lumen 208, axially, rotationally and through articulation (tilt). For example, the ball 232 can be arranged within the lumen 208, so that the coil implant 206 is configured for at least one of: (i) moving axially with respect to the elongated pusher tube (216); (ii) tilting around sphere 232 within a range of angles to the longitudinal geometric axis of the elongated pusher tube 216 and (iii) rotating about its own longitudinal geometric axis, while the pulling wire 226 is contacting sphere 232. The exact position of sphere 232 may, as a result, vary from that illustrated in figure 30.
Also cut or otherwise configured or arranged on a side wall 204 is the alignment element 228, shown in the example of figure 29 as the opposite driver 240. As seen from a
86/97 bottom view of the device in figure 31, an alignment element is illustrated as a loop cut from side wall 204. Alternatively or in combination, an alignment element can be formed by placing one or more circumferential cuts and / or longitudinal on the side wall to define a strip and curving the strip inward into the lumen. It will be appreciated that the alignment element 228 can be, for example, a hook, a flap or any other suitable structure to guide the position of the pull wire 226, also referred to herein as cord 52. The pull wire 226 can be comprised of the same materials and manufactured using the same processes as those previously described for cord 52. In some embodiments, the pull wire may be comprised of one or more tapering segments 226A or 226B, in order to provide increased flexibility in the distal or other region of the insertion tool 214, eliminating interference for smooth sliding between the pulling wire and roughness or bumps on the internal surface of the wall 204 and other advantages. The tapering segments 226A or 226B can provide one or more smooth or uninterrupted transitions from a first segment of pulling wire 226 having a first cross-sectional dimension to a second segment of pulling wire 226 having a second cross-sectional dimension. For example, a segment can taper from a first cross-sectional dimension to a second, smaller cross-sectional dimension. The taper can occur in a proximal or distal direction. The pulling wire 226 is axially movable within the alignment member 228; however, the alignment member 228 helps prevent unwanted circumferential translation of the pulling wire 226.
In preparation for use of system 200, the pull wire 226 is loaded through the alignment element 228 until it reaches the ball 232 or the coil 206. Before loading the coil 206, the pull wire 226, which can be tapered , can be threaded through the distal end of the insertion tool 214 to allow the ball 232 to be loaded and then retracted or advanced to freely loosen the coil 206. When positioned within the distal tip 218 via the
87/97 alignment 228 and occupying the lumen 208, the pulling wire 226 pushes the ball 232 against the driver 240 and the ball has freedom of movement inside the opening 244. The partial opening 244 allows the driver 240 to be pushed slightly outward of the side wall plane 204 and the actuator 240, in turn, puts some pressure on the ball 232. The axial movement of the ball 232 in a distal direction is prevented by the shoulder 246, thus preventing the ball 232 from leaving the distal tip 218. Although the ball 232 is retained within the distal tip of the insertion tool 214 before the use of the system 200. The ball 232, advantageously, has freedom of axial, rotational and articulation movement within the distal tip 218 of the insertion tool 214 prior to retraction of the pulling wire 226 by an operator.
As shown in figure 32, when using the separation system 200, the pull wire 226 is retracted proximally from the ball 232. Alternatively, or in combination, the insertion tool 214 can be moved distally to the pull wire 226. Once as long as the pull wire 226 is close to ball 232, ball 232 is driven by the driver 240 into the lumen 208 of the insertion tool 214. The axial movement of ball 232 is no longer restricted in a distal direction by the shoulder 246 and the ball 232 (and, in some embodiments, coil 206) is free to exit distal tip 218. Figure 33 illustrates coil 206 following its exit from distal tip 218.
Figure 34 illustrates a similar separation mechanism, which operates in general according to the same principles of the modality described in relation to figures 29 - 33 above. According to the modalities, the separation system 300 provides mechanisms for separating the embolic coil 306 from an insertion tool. The insertion tool comprises an elongated pusher tube and has a driver 340 covering at least a portion of a side wall opening. In the embodiment illustrated in figure 34, the driver 340 can be oriented parallel or transverse (for example, perpendicular) to the longitudinal geometric axis of the insertion tool. Alternatively, no cir88 / 97 opening surrounds actuator 340 and actuator 340 can be a portion of the tube that protrudes radially outward, providing a recess within which the fixing element 332 can reside when in contact with the pulling wire 326. Other trigger configurations 340 are also possible according to the exposure. The embolic coil 306 is attached to the fastener 332, which initially resides inside the tube, for example, near the driver 340. The fastener 332 can be any of a variety of shapes, including spherical, ovoid, polyhedron , cylindrical, etc. Also cut or otherwise configured or arranged on a side wall is the alignment element 328, shown in the example of figure 34 as the opposite driver 340.
According to modalities, in preparation for the use of the system 300, the pulling wire 326 is loaded through the alignment element 328 until it reaches the fixing element 332, or the coil 306, or beyond the coil 306. The wire the pull element 326 drives the fastener 332 against the driver 340 or into the recess (not shown) The axial movement of the fastener 332 in a distal direction is prevented by a portion of the distal tube to the driver 340 or the recess, thus, preventing the fastener 332 from leaving the distal end of the tube. When using the separation system 300, the pulling wire 326 is retracted close to the fastener 332. The axial movement of the fastener 332 is then no longer restricted in a distal direction and the fastener 332 (and , in some embodiments, coil 306) is free to exit the tube.
Cross-sectional profile of the Lumen
According to some embodiments, as shown in figures 35A, 35B, 36A and 36B, an elongated pusher tube 216, or a portion thereof (for example, the distal tubular tip 218) can be preformed, so that an inner wall it defines a lumen having a non-circular profile in order to prevent, limit or reduce the lateral movement of the pulling wire 226 in relation to the longitudinal geometric axis of the tube 216. For example, as shown in figure 35A, a region of the
89/97 inner wall defining a lumen has a non-circular cross-sectional shape in a plane perpendicular to the longitudinal geometric axis of distal tip 218, the plane intersecting a point of contact between the pulling wire 226 and the ball 232. The inner wall can be formed, for example, using extrusion, thermosetting, stamping, die forming or other techniques.
According to some embodiments, the wall thickness of a distal tip 218 can be varied. For example, as shown in figure 35A, a lumen with a non-circular cross-sectional dimension could define voids V not occupied by the pulling wire 226, by portions of sphere 232 within the lumen or other structures. Where the sphere 232 extends at least partially through an opening 244 or recess, voids are defined by the open space between portions of the sphere and the pulling wire 226 remaining within the lumen and the wall surface of the lumen.
According to some embodiments, as shown in figure 35B, an elongated pusher tube 216 or a portion thereof (for example, the distal tubular tip 218) can be toothed into what would otherwise be empty, in order to reduce the size voids or eliminate them. The distal tip 218 can be manufactured in conjunction with a forming mandrel inside the tube which preserves the desired lumen shape. In this case, the outer surface of the distal tip 218 has concave regions 217A at least across the distal region of the distal tip and corresponding convex regions 217B, on the inner surface of the distal tip to restrict the lateral movement of the pulling wire 226. Toothed tubes can be formed, for example, using the techniques listed above, crimping or other techniques.
According to some modalities, as shown in figure 36A, voids in the vicinity of the pulling wire 226 can also be filled with space-occupying material 227 in order to prevent, limit or reduce the lateral movement of the pulling wire 226 in relation to the longitudinal geometric axis of tube 216.
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Alternatively, as shown in figure 36B, a distal tip 218 with variable wall thickness can be formed using the techniques listed above. A distal tip 218 with variable wall thickness can provide an outer profile of substantially circular or non-circular cross-sectional dimension and an internal profile of circular or non-circular cross-sectional dimension. The internal profile can be smaller than the external profile, the two profiles sharing or not sharing a common center or central geometric axis. For example, as shown in figure 36B, the internal profile can be configured to have a central point away from a central point of the external profile, so that the thickness of a region of the distal tip 218 near the pulling wire 226 is greater than that a distal tip region 218 opposite pull wire 226. Each of the inner and outer profiles can vary or be consistent along the length or a portion of the length of the tube 216. For example, the inner profile may have a first configuration along a distal segment of tube 216 and a second configuration along a proximal segment of tube 216. Likewise, the external profile can have a first configuration along a distal segment of tube 216. Any of the said settings can be as described here.
According to some embodiments, an inner wall defining a lumen of a tube 216 can be shaped to receive a sphere 232 and a pull wire 226, having a region of a crescent or other non-circular cross-sectional shape. For example, the lumen of the tube 216 can provide a lumen size and shape to which the ball 232 and the pulling wire 226 conform when placed together within the lumen.
According to some modalities, an inner wall, defining a lumen of a tube 216 having non-circular cross sectional geometry can reduce or eliminate voids in the lumen of the tube 216 around and between the pulling wire 226 and the ball 232. This configuration reduces the lateral movement of the pulling wire 226, especially the lateral movement, due to the limitations of manufacturing tolerances and thus reduces the unwanted premature release of the ball 232.
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Pull Wire Geometry
According to some embodiments, as shown in figure 37, the pulling thread 226, or a portion thereof, may have a non-circular cross-sectional shape. For example, a region of the pull wire 226 may have a non-circular cross-sectional shape in a plane perpendicular to the longitudinal geometric axis of the elongated pusher tube 216, the plane intersecting a contact point between the pull wire 226 and the ball 232 The cross-sectional shape of the region can fill at least a substantial portion of the lumen not otherwise occupied by sphere 232. For example, as shown in Figure 37, a region of the pull wire 226 has a substantially cross-sectional cross-sectional geometry. growing. The region of the pull wire 226 can have a first concave side facing ball 232. The first side can contact ball 232. The region of pull wire 226 can have a second convex facing away from ball 232. The second side the elongated pusher tube 216 may contact the wall. The molded wire with crescent cross section can be formed, for example, by means of engraving, crimping, stamping, forging, plating, EDM, welding or other techniques. According to some embodiments, a distal portion of the pull wire 226 has a non-circular cross section and a proximal portion of the pull wire 226 has a substantially circular cross section. According to some embodiments, an entire length of the pull wire 226 has a non-circular cross section. In some embodiments, the radius of curvature on the concave side may correspond to the radius of curvature on ball 232. In some embodiments, to reduce the friction of the pull wire 226 against ball 232, the radius of curvature on the concave side may be less than that the radius of curvature of the ball 232 so that the contact between the two is limited to the two lines or points instead of having contact across the entire concave surface of the pulling wire 226. In some embodiments, to reduce the friction of the wire of pulling 226 against ball 232, the radius of curvature of the concave side can be greater than the radius of curvature of ball 232 so that the contact between the two is limited to one point rather than having contact
92/97 through the entire concave surface of the pull wire 226.
According to some embodiments, a pull wire 226 having non-circular cross-sectional geometry can reduce or eliminate voids in the lumen of the elongated pusher tube 216 around and between the pull wire 226 and the ball 232. This configuration reduces movement lateral pull wire 226, especially lateral movement due to limitations in manufacturing tolerances and thus reduces unwanted premature release of ball 232.
Atraumatic Trigger
According to some modalities, the driver 240 can be curved inwardly, towards the central geometric axis of the elongated pusher tube 216 by means of excess curvature of the driver 240 beyond the elastic limit of the material from which the driver 240 is made, so that the driver 240 acquires a permanent adjustment in an inwardly curved position. As shown in figures 38A and 38B, actuator 240 covers at least a portion of an opening 244 through the extension of tube 216 (for example, distal tubular tip 218) at one edge of opening 244. According to some embodiments, no part of driver 240 extends a radial distance from the geometric axis of tube 216 greater than the outer radius of tube 216. According to some embodiments, a portion (e.g., a distal portion) of driver 240 extends inward , towards the longitudinal geometric axis of the tube 216 to be a radial distance below the outer surface of the tube 216. This inward turn or curvature can be provided by curvature, thermosetting or other means. The amount of applied curvature can be controlled by die casting, crimping or other techniques, optionally in conjunction with the use of an internal mandrel during manufacturing.
According to some embodiments, the driver 240 can be thermoset in an inwardly curved position by applying heat to at least the driver portion 240 of the tube 216, while the driver portion 240 is at or nearly in the desired inward curved position93 / 97 da. Local application of heat can be done using, for example, laser energy, CO2 laser energy, heated dies, RF heating or other techniques. The amount of applied curvature can be controlled by means of heated dies, thermally conductive molds or other techniques, optionally in conjunction with the use of an internal mandrel during manufacture. Materials that have shape memory properties, such as Nitinol, are particularly suitable for thermosetting techniques. Swivel Cap
According to some embodiments, as shown in figures 39, 40A and 40B, a pulling wire 226 may include a plug 226A, forming an enlarged region along its length. A plug 226A may have a cross sectional shape and size distinct from the cross sectional shape and the size of other portions of the pull wire 226. For example, pull wire 226 can have a substantially circular cross sectional shape in proximal or distal portions of the plug 226A . A plug 226A may have a non-circular cross-sectional shape, such as square, rectangular, triangular, oval or other shapes.
According to some embodiments, a pull wire 226 may extend into a lumen through a reduced portion 229 of the lumen. Pull wire 226 can be aligned within the reduced portion 229 to allow portions of pull wire 226 to be arranged against a side wall of tube 216 or away from a side wall of tube 216. Pull wire 226 can extend for any length within tube 216 and contact sphere 232, which may be within or near an opening or otherwise arranged within a lumen of tube 216. The reduced portion 229 may be formed by an aligning element 228 extending of a wall of tube 216 (e.g., distal tubular tip 218). Alternatively, or in combination, the reduced portion 229 may be a portion of a tube lumen 216 having a tapered or reduced cross-sectional dimension in relation to the other portions of the lumen. According to some embodiments, a plug 226A can be arranged on the pulling wire 226 distal to the reduced portion 229. The pulling wire 226 can have a profile
94/97 cross sectional along a proximal portion or distance to plug 226A, where plug 226A has a different cross sectional profile. For example, the pull wire 226 may have a substantially circular cross-sectional profile along a proximal or distal portion to the plug 226A and the plug 226A may have a non-circular cross-sectional profile along its length. The reduced portion 229 can have a cross sectional profile that corresponds to the cross sectional profile of the plug 226A. For example, the cross-sectional profile of the reduced portion 229 may be geometrically similar to the cross-sectional profile of the plug 226A. As another example, the cross sectional profile of the reduced portion 229 may have substantially the same shape as the cross sectional profile of the plug 226A.
The second cross-sectional profile of the plug 226A can have at least one cross-sectional dimension that exceeds at least one cross-sectional dimension of a proximal portion of the pull wire 226. The second cross-sectional profile of the plug 226A can have at least one cross-sectional dimension which exceeds at least one cross-sectional dimension of the reduced portion 229 through which the pulling wire 226 extends.
According to some modalities, as shown in figure 40A, the displacement of the plug 226A through the reduced portion 229 is limited, while the plug 226A is in a first rotational state in relation to the reduced portion 229. According to some modalities, the displacement of buffer 226A through the reduced portion 229 is allowed while in a second rotational state relative to the reduced portion 229 (figure 40B). Where the rotational states of the plug 226A are controlled by a user, the displacement of the plug 226A through the reduced portion 229 and the proximal displacement of the pull wire 226 can be reduced or prevented until a given rotational state of the plug 226A is selected controllably by the user. . As a result, the premature proximal displacement of the pull wire 226 can be reduced or eliminated, thereby reducing the unwanted longitudinal retraction of the pull wire 226 and the
95/97 premature release of ball 232.
A plug 226A can be formed by adding material to the pulling wire 226, such as by means of welding, electrodeposition, attaching a tubular component, for example, by welding, brazing or adhering or by other means, alternatively, or in In combination, a plug 226A can be formed by removing material from the pulling wire 226, such as by grinding, stamping, crimping, EDM or other means. A plug 226A can be formed by sliding an additional component through the pull wire 226, followed by stamping or crimping the supplementary component to form a frictional connection (e.g. interference fit) between the two. A plug 226A can be formed by coining a region of the pull wire 226 so as to flatten the pull wire 226 so that the plug 226A is wider than the diameter of the wire in a different direction, normal to the geometric axis the wire.
According to some embodiments, as shown in figure 39, a plug 226A may have a proximal surface 230 that is parallel to a distal surface 231 of alignment element 228, so that when the distal surface 231 is not normal to the geometric axis of the pull wire 226, the pull wire 226 will tend to align in a preferred rotational state with respect to alignment element 228. Said rotational state can be an orientation that does not allow the plug to pass through the hole in alignment element 228 The alignment element 228 can be oriented at many angles to the geometric axis of the pull wire 226. In some embodiments, angles from 45 degrees to 135 degrees are considered.
Opening interface
According to some embodiments, as shown in figures 41 - 42, a sphere 232 can have a projection 232A that is configured to extend at least partially into an opening 244 of a tube 216 (e.g., distal tubular tip 218). The projection 232A on sphere 232 can have a cross sectional shape such as square, rectangular,
96/97 triangular, oval or other shapes. The height of the protrusion may vary, but desirably it is equal to the wall thickness of the tube 216, so that the projection 232A does not extend beyond the outer surface of the tube, which could undesirably become housed against stents, deposits of calcium or other luminal roughness during the positioned distribution.
The projection 232A can be formed by adding material to sphere 232, such as by means of welding, electrodeposition, fixing a tubular component, for example, by welding, brazing, brazing or bonding or by other means. Alternatively, or in combination, a projection 232A can be formed by removing material from sphere 232, such as through grinding, stamping, crimping, EDM or other means. A projection 232A can be formed by coining a region of a sphere 232 in order to elevate the projection of the surface of the sphere. In some embodiments, the fabrication of the projection 232A will deform the sphere 232 so that the sphere 232, without considering the projection 232A, is no longer spherical, but rather has a flattened shape, an egg shape or other shapes.
According to some embodiments, as shown in figure 41, one or more protrusions 233 of a projection 232A are considered to be substantially normal to the geometric axis of the catheter. According to some modalities, as shown in figure 42, one or more protuberances 233 can form non-orthogonal angles with the geometric axis of the catheter. These angles can be between about 60 degrees and about 120 degrees. In some embodiments, as shown in figure 42, a width of a projection 232A on a surface farther from sphere 232 will be wider than a width of projection 232A in the region of contact with sphere 232, so that the shoulder 246 of the tube 216, when forced against the projection 232A, tends to move the ball 232 to a position of greater fit within the opening 244, thereby enhancing the safety of the ball 232. A shoulder surface 246 can be parallel to a protruding surface 233 to enhance the security of the ball 232.
97/97
To the extent that the term include, have or the like is used in the description or in the claims, that term is intended to be inclusive in a similar way to the term understand how to understand is interpreted when used as a transition word in a claim.
The word example is used here to mean serving as an example, case or illustration. Any modality described here as an example should not necessarily be constructed as preferred or advantageous over other modalities.
A reference to an element in the singular is not meant to mean one and only one, unless specifically mentioned, but rather one or more. Pronouns in the masculine (for example, his) include the feminine and the gender neutral (for example, her and its) and vice versa. The term some refers to one or more. Underlined and / or italic headings and subtitles are used for convenience only, do not limit the technology in question and are not referred to in connection with the interpretation of the description of the technology in question. All structural and functional equivalents to the elements of the various configurations described throughout this exhibition that are known or will become known later on by those of ordinary skill in the art are here expressly incorporated by reference and are intended to be involved by technology in question. In addition, nothing disclosed herein is intended to be dedicated to the public, regardless of whether this exhibition is explicitly cited in the description above.
Although certain aspects and modalities of the invention have been described, they have been presented by way of example only and are not intended to limit the scope of the invention. In fact, the new methods and systems described here can be realized in a variety of other ways, without departing from your spirit. The attached drawings and their equivalents are intended to cover these terms or modifications, as they fall within the scope and spirit of the invention.
1/3

权利要求:
Claims (15)
[1]
1. Set for placing an implant in an aneurysm in a vessel, comprising:
- a tubular element having a longitudinal geometric axis, a wall defining a lumen along the geometric axis and a distal portion having a transverse sectional dimension and a distal end;
- a coil implant having an enlarged proximal end; and
- a core wire extending within the lumen and contacting the enlarged end at a point, the core wire comprising a region having a cross section, that is, in a plane transverse to the longitudinal geometric axis and intersecting the point, substantially at crescent shape;
- in which a length of a line segment extending from an external surface of the extended end, through the point, and to an external surface of the core wire is greater than the cross sectional dimension, so that the extended end is blocked from movement within the distal lumen and entirely beyond the distal end, when the core wire and the enlarged end are positioned radially adjacent to each other within the lumen.
[2]
An assembly according to claim 1, wherein the first side contacts the widened end, when the core wire contacts the widened end.
[3]
An assembly according to claim 1, wherein the second side contacts the wall when the core wire contacts the enlarged end.
[4]
Assembly according to claim 1, in which a region of the wall has a non-circular cross-sectional shape in a plane perpendicular to the longitudinal geometric axis and intersecting the point, where the core wire is restricted by the moving wall around a lumen circumference, while the core wire is contacting the enlarged end.
2/3
[5]
Assembly according to claim 4, wherein the region has a substantially oval cross-sectional shape in the plane.
[6]
6. Assembly according to claim 4, wherein the thickness of the tubular element varies in the region.
[7]
7. Assembly according to claim 1, wherein the tubular element has an opening through the wall and an arm that extends from one edge of the opening, covering at least a portion of the opening and curving radially inwardly to the geometric axis.
[8]
An assembly according to claim 7, wherein no part of the arm extends a radial distance from the axis greater than an external radius of the tubular element.
[9]
An assembly according to claim 7, wherein a portion of the arm extends inwardly, towards the axis, to a radial distance from the axis less than an external radius of the tubular element.
[10]
An assembly according to claim 7, wherein the arm is in contact with the enlarged end, when the enlarged end is within the opening and contacting the core wire.
[11]
11. Assembly according to the claim in which the tubular element has a reduced portion, proximal to the distal portion, having a first non-circular cross-sectional profile and in which the core wire extends through the reduced portion and comprises an enlarged region having a second cross-sectional profile, in which (i) the displacement of the enlarged region through the reduced portion is limited while in a first rotational state in relation to the reduced portion and (ii) the displacement of the enlarged region through the reduced portion is allowed, while in a second rotational state in relation to the reduced portion.
[12]
12. Assembly according to the claim, wherein a portion of the core wire proximal to the enlarged region is compressively inclined towards the reduced portion, so that the distal movement of the core wire in relation to the tubular element is restricted while the enlarged region is in the first rotational state.
[13]
An assembly according to claim 1, wherein the enlarged end has (i) a primary portion that resides in the lumen and (ii) a secondary portion that extends the primary portion in the opening and fitting an edge of the opening.
[14]
An assembly according to claim 13, wherein a distal surface of the secondary portion engages a distal surface of the edge.
[15]
An assembly according to claim 13, wherein a first width of the secondary portion distal from the primary portion is greater than a second width of the secondary portion close to the primary portion.
1/39

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同族专利:

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公开号 | 公开日

---

EP2574289A2|2013-04-03|

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US20120041470A1|2012-02-16|

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CN103251436A|2013-08-21|

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US8777979B2|2014-07-15|

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EP2574289A3|2013-06-05|

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JP2013078584A|2013-05-02|

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EP2574289B1|2016-09-14|

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CN103251436B|2016-01-20|

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法律状态:
2018-02-27| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|

---

2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2020-05-19| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2020-09-15| B11B| Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements|

优先权:

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申请号 | 申请日 | 专利标题

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US13/251,021|US8777979B2|2006-04-17|2011-09-30|System and method for mechanically positioning intravascular implants|

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US13/251,021|2011-09-30|

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