• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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    • 专利摘要:
    CARDIAC STIMULATION DEVICES WITHOUT DERIVATION These are implantable non-shunt stimulation devices and medical device systems that include an implantable non-shunt stimulation device. An exemplary implantable lead-free stimulation device may include a stimulation capsule. The stimulation capsule can include a housing. The housing may have a proximal and a distal region. A first electrode can be placed along the distal region. One or more anchoring members can be coupled to the distal region. The anchoring members can each include a region with a composite curve.
    公开号:BR112016003148B1
    申请号:R112016003148-2
    申请日:2014-08-06
    公开日:2021-01-12
    发明作者:J. Haasl Benjamin；Sachs Dana；R. Maile Keith
    申请人:Cardiac Pacemakers, Inc.；
    IPC主号:
    专利说明:

    TECHNICAL FIELD
    [001] The present disclosure pertains to medical devices and methods for making medical devices. More particularly, the present disclosure pertains to non-shunt cardiac pacing devices. BACKGROUND
    [002] A wide variety of medical devices have been developed for medical use, for example, cardiac use. Some of these devices include catheters, leads, pacemakers and the like. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Among the medical devices and known methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for making and using medical devices. SUMMARY
    [003] This disclosure provides design, material, method of manufacture and alternative uses for medical devices. An exemplary medical device may include a stimulation device without implantable shunt. The stimulation device without implantable shunt may include a stimulation capsule. The stimulation capsule can include a housing. The housing may have a proximal and a distal region. A first electrode can be placed along the distal region. One or more anchoring members can be coupled to the distal region. The anchoring members can each include a region with a composite curve.
    [004] A stimulation device system without implantable shunt may include a delivery catheter that has a proximal region, a distal retention section and a lumen formed therein. A pressure member can be slidably disposed within the lumen. A non-shunt stimulation device can be received slidingly within the distal retention section. The non-shunt stimulation device may include a housing that has a proximal and a distal region. A first electrode can be placed along the distal region. A plurality of anchoring members including a first anchoring member can be coupled to the distal region. The first anchoring member may have the ability to switch between a first configuration when the non-tapping stimulation device is disposed within the distal retention section and a second configuration when the non-tapping stimulation device is advanced from the distal retention section ; The distal retention section can have a longitudinal geometric axis. The first anchoring member can be arranged substantially parallel to the longitudinal geometry axis when the first anchoring member is in the first configuration. The first anchor member can include a region with a composite curve when the first anchor member is in the second configuration.
    [005] Another exemplary implantable lead-free stimulation system may include a delivery catheter that has a proximal region, a distal retention section and a lumen formed therein. A pressure member can be slidably disposed within the lumen. A non-shunt stimulation device can be received slidingly within the distal retention section. The non-shunt stimulation device may include a housing that has a proximal and a distal region. A first electrode can be placed along the distal region. A plurality of anchoring members including a first anchoring member can be coupled to the distal region. The first anchoring member may have the ability to switch between a first configuration when the non-tapping stimulation device is disposed within the distal retention section and a second configuration when the non-tapping stimulation device is advanced from the distal retention section ; A contact section of the first anchor member may come into contact with an inner wall surface of the distal retaining section when the first anchor member is in the first configuration. The contact section can be positioned proximally to a distal end of the first anchoring member. The first anchor member can include a region with a composite curve when the first anchor member is in the second configuration.
    [006] The above summary of some modalities is not intended to describe each revealed modality or each implementation of the present disclosure.
    [007] The Figures and Detailed Description, below, exemplify more specifically these modalities. BRIEF DESCRIPTION OF THE DRAWINGS
    [008] The disclosure can be more fully understood taking into account the following detailed description in connection with the attached drawings, in which:
    [009] Figure 1 is a plan view of an exemplary non-shunt stimulation device implanted within a heart;
    [010] Figure 2 is a perspective view of an exemplary non-shunt stimulation device;
    [011] Figure 3A is a cross-sectional view taken through Line 3A-3A;
    [012] Figure 3B is an alternative cross-sectional view;
    [013] Figure 3C is an alternative cross-sectional view;
    [014] Figure 4 is a partial partial cross-sectional side view of an exemplary medical device system positioned adjacent to cardiac tissue;
    [015] Figure 5 is a side view in partial cross-section of an exemplary non-shunt stimulation device attached to cardiac tissue;
    [016] Figure 6 is a partial cross-sectional side view of another exemplary medical device system positioned adjacent to cardiac tissue; and
    [017] Figure 7 is a partial cross-sectional side view of another exemplary medical device system positioned adjacent to cardiac tissue.
    [018] Although the disclosure is favorable to various modifications and alternative forms, specifications of the same have been shown by way of example in the drawings and will be described in detail. It must be understood, however, that the intention is not to limit the invention to the particular modalities described. Otherwise, the intention is to cover all modifications, equivalents and alternatives that are included in the spirit and scope of the revelation. DETAILED DESCRIPTION
    [019] For the following defined terms, these definitions should apply, unless a different definition is given in the claims or elsewhere in this specification.
    [020] All numerical values in this document are presumed to be modified by the term "about," whether it is explicitly stated or not. "The term" about "generally refers to a number range that one skilled in the art would consider equivalent to the recited value (that is, that has the same function or result.) In many cases, the terms "about" may include numbers that are rounded to the nearest significant number.
    [021] Recitation of numeric ranges by commas includes numbers within that range (for example, 1 to 5 include 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5),
    [022] As used in this specification and the appended claims, the singular forms of "one", "one", "o" and "a" include plural referents unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense that includes "and / or" unless the context clearly indicates otherwise.
    [023] It is noted that the references in this specification to "one modality", "some modalities", "other modalities", etc., indicate that the described modality may include one or more resources, structures, and / or particular characteristics. However, such recitations do not necessarily mean that all modalities include particular resources, structures, and / or characteristics. In addition, when particular features, structures, and / or features are described in connection with one modality, it should be understood that such features, structures, and / or features can also be used in connection with other modes whether or not they are explicitly described unless. that the opposite is clearly indicated.
    [024] The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered in the same way. The drawings, which are not necessarily to scale, depict illustrative modalities and are not intended to limit the scope of the invention.
    [025] Cardiac pacemakers provide electrical stimulation to cardiac tissue to cause the heart to contract and thus pump blood through the vascular system. Conventional pacemakers typically include an electrical lead that extends from a pulse generator implanted subcutaneously or submuscularly to an electrode positioned adjacent to the inner or outer wall of the cardiac chamber. As an alternative to conventional pacemakers, self-contained or lead-free cardiac pacemakers have been proposed. A cardiac pacemaker without a bypass can take the form of a relatively small capsule that can be attached to an intracardiac implant site in a cardiac chamber. It can be readily understood that the implantation of a non-shunted stimulation device within a pulsating heart could become dislodged as the heart works. Consequently, it may be desirable for a non-shunt pacing device to include an anchoring mechanism and / or one or more anchoring members to help secure the pacing device to the heart.
    [026] Figure 1 illustrates a cardiac pacing device without exemplary implantable shunt 10 implanted in a chamber of an H heart, such as the right ventricle RV. The device 10 can include a housing or housing 12 that has a distal region 14 and a proximal region 16. One or more anchoring members 18 can be arranged adjacent to the distal region 14. Anchoring members 18 can be used to secure the device 10 to a tissue wall of the heart H, or otherwise anchor the implantable device 10 to the patient's anatomy. A locking member 20 can be disposed adjacent to the proximal region 16 of the housing 12. The locking member 20 can be used to facilitate the delivery and / or recovery of the implantable device 10.
    [027] Figure 2 is a perspective view of the device 10. In the present context, it can be seen that the engaging member 20 may extend from the proximal region 16 of the housing 12. In at least some embodiments, the member of socket 20 may include a head portion 22 and a neck portion 24 extending between housing 12 and head portion 22. Head portion 22 may have the ability to engage a delivery and / or retrieval catheter. For example, if it is desired to retrieve device 10 from the patient, a recovery catheter can be advanced to a position adjacent to device 10. A recovery mechanism such as a loop, rope, arm, or other suitable structure can extend to from the recovery catheter and engage the head portion 22. When properly engaged, the device 10 can be pulled from the cardiac tissue and finally removed from the patient.
    [028] The implantable device 10 can include a first electrode 26 positioned adjacent to the distal region 14 of the housing 12. A second electrode 28 can also be defined along the housing 12. For example, the housing 12 can include a conductive material and can be isolated over a portion of its length. A section along the proximal region 16 can be exempt from insulation in order to define the second electrode 28. The electrodes 26/28 can be detection and / or stimulation electrodes to provide electrotherapy and / or detection capabilities. The first electrode 26 may have the ability to be positioned against or otherwise come into contact with the cardiac tissue of the heart H while the second electrode 28 may be spaced from the first electrode 26, and therefore spaced from the cardiac tissue.
    [029] Device 10 may also include a pulse generator (e.g., electrical circuitry) and a power source (e.g., a battery) within housing 12 to provide electrical signals to electrodes 26/28. The electrical communication between the pulse generator and electrodes 26/28 can provide electrical stimulus to the cardiac tissue and / or detect a physiological condition.
    [030] As the name suggests, anchoring members 18 can be used to anchor device 10 to target tissue. A suitable number of anchor members 18 can be used with device 10. For example, device 10 can include one, two, three, four, five, six, seven, eight, or more anchor members. In at least some embodiments, the anchoring members 18 may take the form of anchor points that have the ability to pierce the cardiac tissue, cycling a portion of the cardiac tissue, and then extending externally from the cardiac tissue. In doing so, it may be desirable for the anchoring members 18 to have relatively shallow penetration into the heart tissue. In addition, it may be desirable for the anchoring members 18 to be arranged to be spaced from the first electrode 26. Other configurations are contemplated.
    [031] In order to achieve these and other goals, the anchoring members 18 may have a composite curved structure. For the purposes of this disclosure, a composite curved structure can be understood as a structure that includes a plurality of different curved regions. For example, at least some of the anchoring members 18 may include a base region 30, a first curved region 32, a generally straight region 34, a second curved region 36, and an end region 38. The base region 30 can be positioned at the junction between the anchoring members 18 and the housing 12. In some embodiments, the base region 30 can be attached to the housing 12. In other embodiments, the base region 30 can be pivotally attached to the housing 12.
    [032] According to these modalities, the base region 30 can have a certain freedom of movement in relation to the housing 12. In some cases, an actuation mechanism can be coupled to the anchoring members 18 so that a clinician can pivot members anchor 18 during an implantation procedure. For example, a translatable mechanical resource such as a wire, rope, or the like can be attached to the housing 12 which has the capacity to transmit movement to the anchoring members 18.
    [033] The first curved region 32 can curve in the opposite direction to the housing 12. In other words, the curvature of the first curved region 32 can result in at least a portion of the anchoring members 18 becoming progressively positioned radially further away housing 12. For example, it may be desirable for anchoring members 18 to extend or otherwise be positioned laterally as far from the first electrode 26 as possible in order to minimize irritation of tissue adjacent to where the first electrode 26 comes into contact. contact with the heart wall. In addition, the curvature of the first curved region 32 (and / or another region of anchoring members 18) may have the ability to secure the retention device to the heart wall while having a relatively shallow penetration into the tissue. Superficial penetration can help reduce irritation and / or injury to local tissue in the cardiac wall.
    [034] In some embodiments, the radius of curvature of the first curved region 32 may be constant. In other embodiments, the radius of curvature may vary along the first curved region 32. For example, the first curved region 32 may include a parabolic curve, hyperbolic curve, exponential curve, a curve defined by a first polynomial order, a defined curve by a second polynomial order, a curve defined by a third polynomial order, a curve defined by a fourth or greater polynomial order, etc. The first curved region 32 can be completely within a single plane (for example, the first curved region 32 can extend in only two dimensions) or the first curved region 32 can be within more than one plane (for example, the first curved region 32 can extend in three dimensions). These are just examples. Other curves, shapes, configurations, etc. are contemplated.
    [035] The generally straight region 34, as the name suggests, can be substantially free of a curve. The generally straight region 34 may be of suitable length. For example, in some embodiments, a greater separation between the first curved region 32 and the second curved region 36 may be desirable. In such embodiments, it may be desirable for the generally straight region 34 to have a relatively longer length. In other embodiments, less separation may be desired between the curved portions 32/36 and, therefore, the generally straight region 34 can be relatively short. In still other embodiments, the anchoring members 18 may lack a generally straight region 34. In other words, the first curved region 32 can be attached directly or otherwise to the second curved region 36.
    [036] The second curved region 36 can curve towards housing 12. In at least some embodiments, the curvature of the second curved region 36 can be oriented in the opposite direction to the first curved region 32. Like the first curved region 32, the second curved region 36 can have a constant or variable radius of curvature.
    [037] End region 38 may be generally straight or end region 38 may include a curve. In at least some embodiments, the end region 38 may have a relatively sharp point or end that may have the ability to penetrate the tissue.
    [038] In addition to allowing device 10 to be securely anchored to a patient's heart, anchoring members 18 can also allow acute repositioning of device 10. For example, device 10 can be attached to the heart of a patient. patient via anchor members 18. If it is desired to relocate device 10, a retrieval and / or repositioning device can be used to engage device 10 so that it can be repositioned (for example, by removing anchor members 18 tissue and moving device 10 to another desirable location) and resuscitated.
    [039] The cross-sectional shape of the anchoring members 18 may vary. For example, at least some of the anchoring members 18 may have a generally rectangular cross-sectional shape as shown in Figure 3A. According to these modalities, the width W of the anchoring member 18 can be greater than the thickness T.
    [040] However, in other embodiments, the thickness T may be greater than the width W. In other embodiments, at least some of the anchoring members 18 may have a generally circular cross-sectional shape with a diameter D as depicted in Figure 3B. Other cross-sectional formats are contemplated. For example, anchoring members 18 may have an oval cross-sectional shape (for example, as depicted in Figure 3C), a semicircular cross-sectional shape, a polygonal cross-sectional shape (for example, triangular, square, quadrilateral, pentagonal, hexagonal, octagonal, etc.), combinations thereof (for example, a polymeric shape with rounded edges or corners), or any other suitable shape. The anchoring members 18 can have the same cross-sectional shape essentially along the entire length thereof. Alternatively, the cross-sectional shape may vary over the length of the anchoring members 18. For example, the portions of the anchoring members 18 may have a generally non-circular cross-sectional shape and other portions of the anchoring members 18 may have a generally circular cross-sectional shape. In addition, in some embodiments, all anchoring members 18 may have the same cross-section and / or profile shape. In other embodiments, the various anchoring members 18 of a given device 10 can be different from each other.
    [041] Figure 4 illustrates a delivery catheter 100 that can be used, for example, to deliver device 10 to a suitable location within the anatomy (e.g., the heart).
    [042] Catheter 100 can include a limb or proximal region 140 and a distal limb or retention section 146. A pressure member 142 can be arranged (for example, slidably arranged) within proximal region 140. A region of head 144 of pressure member 142 can be arranged within distal retaining section 146. Head region 144 may have the ability to engage locking member 20 of device 10. Pressure member 142 can be used to "push" device 10 out of distal retention section 146 for the purpose of driving and anchoring device 10 within a target region 148 (e.g., a region of the heart such as the right ventricle). Catheter 100 can be advanced through the vasculature to the target region 148. For example, catheter 100 can be advanced through a femoral vein, into the inferior vena cava, into the right atrium, through the tricuspid valve, and into the right ventricle. Target region 148 may be a portion of the right ventricle. For example, target region 148 may be a portion of the right ventricle close to the apex of the heart. Target region 148 could also be other regions that include other regions of the heart (for example, the right atrium, left ventricle, left atrium), blood vessel, or other suitable targets.
    [043] Anchor members 18 may have the ability to switch between a first configuration and a second configuration. For example, when device 10 is disposed within distal retention section 146 of delivery catheter 100, anchor members 18 may be in the first configuration. When configured in this way, the anchoring members 18 can extend distally from the device 10 in a generally straighter configuration. In other words, the anchoring members 18 can be oriented in the distal direction. For example, catheter 100 may have a longitudinal geometric axis X and anchoring members 18 may correspond to longitudinal geometric axis Y which is generally parallel to longitudinal geometric axis X of catheter 100. However, anchoring members 18 do not need to extends exactly parallel to the longitudinal geometric axis X of catheter 100 and, instead, can be genetically oriented in the distal direction.
    [044] When device 10 is properly positioned adjacent target region 148, pressure member 142 can be advanced distally to push device 10 distally so that anchor members 18 engage target region 148. Making if so, the anchor members can switch to the second configuration as shown in Figure 5. When in the second configuration, the anchor members 18 can have the composite curved configuration. The composite curve of the anchor members 18 can help orient the anchor members 18 in the direction opposite to the tissue entry point and then back out of the tissue at a location that is laterally spaced from the entry point.
    [045] In at least some embodiments, the anchoring members 18 can still maintain a composite curvature (for example, although in a changed shape) when in the most rectified configuration. For example, when device 10 is disposed within a delivery catheter, the anchoring members 18 can still maintain the composite curve. In other embodiments, one or more of the curves formed in the anchoring members 18 can be substantially rectified so that the anchoring members 18 can be considered to have no more a composite curve when in the most rectified configuration. When switching to the second configuration (for example, which can be considered a triggered, implanted, delivered, or "not tilted" configuration), the anchoring members 18 may have or otherwise return to a shape that includes the curve composed.
    [046] When in the first configuration, a portion of the anchoring members 18 may engage an inner wall surface of the distal retaining section 146. The portion of the anchoring member 18 that engages the inner wall surface of the distal retaining section 146 may be positioned proximally to the distal end of the anchoring member 18. For example, the second curved region 36 can engage the inner wall surface of the distal retention section 146, as shown in Figure 4. Other arrangements are contemplated. For example, Figure 6 illustrates device 110 (which may be similar in shape and function to the other devices disclosed in the present document) including anchoring member 118 and locking member 120. In the present context, it can be seen that the first curved region 132 can engage the inner wall surface of the distal retaining section 146.
    [047] Figure 7 illustrates device 210 (which can be similar in shape and function to the other devices disclosed in this document) including anchor member 218 and locking member 220. In this embodiment, a section of anchor member 218 extending from the second curved region 232 to the tip 238 may rest against the inner wall surface of the distal retention section 146.
    [048] Materials that can be used for the various components of device 10 and catheter 100 (and / or other devices / catheters disclosed herein) may include those commonly associated with medical devices. For example, device 10 and / or catheter 100 can be produced from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like , or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated propylene ethylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether ester block, polyurethane (for example , Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butiene / poly (alkylene) ether) phthalate and / or other polyester elastomers such as HYTREL® available from DuPont), polyamide (eg DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, polyamide block / ethers, amide block polyether (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate (EVA) copolymers, silicones, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, polyethylene linear low density no. (eg REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polymethylene terephthalate, polyethylene naphthalate (PEN), polyetherethercetone (PEEK), polyimide (PI), polyetherimide (PET), polyphenylene sulfide (PPS), polyphenylene oxide (PPG), poly paraphenylene terephthalamide (eg KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro ( propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly (styrene-b-isobutylene-d-styrene) (eg SIBS and / or SIBS 50A), polycarbonates , ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, and the like. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.
    [049] Some examples of suitable metals and metal alloys include stainless steel, such as stainless steel 304V, 304L and 316LV; sweet steel; nickel-titanium alloy as linear-elastic and / or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (for example, UNS: N06625 as TNCONEL® 625, UNS: N06022 as HASTELLOY® C-22®, UNS: N102.76 as HASTELLOY® C276®, other HASTELLOY® alloys , and the like), nickel-copper alloys (for example, UNS: N04400 such as MONEL, ® 400, NICKELVAC® 400, NICQRROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (for example, UNS: R30033 as MP35- ® and the like), nickel-molybdenum alloys (eg UNS: N10665 as HASTELLOY © ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (for example, UNS: R30003 as EL GILO Y®, PHYNOX®, and the like); platinum-enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.
    [050] As mentioned in this document, within the family of commercially available nickel-titanium or nitinol alloys, there is a category called "linear elastic" or "non-superelastic" that, although it may have chemistry similar to the memory varieties of conventional shape and super elastic, can exhibit useful and distinct mechanical properties. Linear elastic and / or non-superelastic nitinol can be distinguished from super elastic nitinol in that linear and / or non-superelastic nitinol does not exhibit a "superelastic plateau" or "flag region" in its stress curve / tension as the super elastic nitinol does. Instead, in linear elastic and / or non-superelastic nitinol, as the recoverable stress increases, stress continues to increase in a substantially linear relationship, or one in some way, but not necessarily, completely linear until the deformation of plastic starts or at least in a relationship that is more linear than the super elastic plateau and / or flag region that can be seen with super elastic nitinol. Therefore, for the purposes of this disclosure the linear elastic and / or non-superelastic nitinol can also be called "substantially" linear and / or non-superelastic nitinol.
    [051] In some cases, linear and / or non-super-elastic nitinol can also be distinguishable from super-elastic nitinol in that linear and / or non-super-elastic nitinol can accept up to about 2 to 5% of tension while remaining substantially elastic (for example, before deforming plastically) whereas super elastic nitinol can accept up to about 8% of tension before deforming plastically. Both of these materials can be distinguished from other linear elastic materials like stainless steel (which can also be distinguished based on their composition), which can only accept about 0.2 to 0.44 percent stress before plastically deforming.
    [052] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show any martensite / austenite phase changes that are detectable by differential scanning calorimetry (DSC) and thermal analysis dynamic metal (DMTA) over a large temperature range. For example, in some embodiments, there may be no martensite / austenite changes detectable by DSC and DMTA analysis in the range of about -60 degrees Celsius (° C) to about 120 ° C in the linear elastic nickel-titanium alloy and / or not super-elastic. The mechanical folding properties of this material can therefore be generally inert to the effect of temperature across this very wide temperature range. In some embodiments, the mechanical folding properties of the linear elastic and / or non-superelastic nickel-titanium alloy at room or ambient temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not exhibit a super-elastic plateau and / or flag region. In other words, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear and / or non-superelastic elastic characteristics and / or properties
    [053] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy can be in the range of about 50 to about 60 weight percent of nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent of nickel. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel-titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, which are incorporated by reference in this document. Other suitable materials may include ULTANRJM ™ (available from e-Metrics) and GUM METAL ™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve the desired properties.
    [054] In at least some embodiments, portions or the entire device 10 and / or catheter 100 may also be doped with, produced from, or otherwise include radiopaque material. Radiopaque materials are understood to be materials that have the ability to produce a relatively clear image on a fluoroscopy screen or other set of imaging procedures during a medical procedure. This relatively clear image assists the user of device 10 and / or catheter 100 in determining its location. Some examples of radiopaque materials may include, without limitation, gold, platinum, palladium, tantalum, tungsten alloy, polymeric material charged with a radiopaque charge, and the like. In addition, other radiopaque marker coils and / or bands can also be incorporated into the design of the device 10 and / or catheter 100 to achieve the same result.
    [055] In some modalities, a degree of compatibility of Magnetic Resonance Imaging (MRI) is conferred on device 10 and / or catheter 100. For example, device 10 and / or catheter 100 (or portions thereof) can be produced from a material that does not substantially untwist the image and creates substantial artifacts (that is, gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they can create artifacts in an MRI image. Device 10 and / or catheter 100 (or portions thereof) can also be produced from a material that the MRI machine can imagine. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (for example, UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (for example , UNS: R30035 as MP35-N® and the like), nitinol, and the like, and others.
    [056] It must be understood that this revelation is, in many ways, only illustrative. Changes can be made in detail, particularly in terms of the shape, size and arrangement of the steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of an exemplary modality that is used in other modalities. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.
    权利要求:
    Claims (11)
    [0001]
    1. Stimulation device without implantable derivation, characterized by the fact that it comprises: a stimulation capsule that includes a housing, the housing having a proximal region and a distal region; a first electrode disposed along the distal region; and one or more anchoring members coupled to the distal region, each anchoring member including a region with a composite curve; in which the anchoring members have the ability to switch between a first configuration and a driven configuration, in which the members extend distally from the stimulation device without shunt in a generally straighter configuration in the first configuration, in which the members of anchorages include the region with the composite curve when in the driven configuration; and wherein the region with the composite curve includes a first curved section oriented in a first direction and a second curved section oriented in a second direction opposite the first direction.
    [0002]
    2. Stimulation device without implantable bypass, according to claim 1, characterized by the fact that a straight region is arranged between the first curved section and the second curved section.
    [0003]
    3. Stimulation device without implantable bypass, according to claim 1, characterized by the fact that each of the anchoring members includes a sharp point section.
    [0004]
    4. Stimulation device without implantable bypass, according to claim 1, characterized by the fact that the first curved section, the second curved section, or both, have the ability to cause the anchoring members to move laterally in the direction opposite the first electrode when the anchoring members extend into a target tissue.
    [0005]
    5. Stimulation device without implantable bypass, according to claim 1, characterized by the fact that the first curved section, the second curved section, or both, have a variable radius of curvature.
    [0006]
    6. Stimulation device system without implantable derivation, the system characterized by comprising: a delivery catheter that has a proximal section, a distal retention section and a lumen formed therein; a pressure member slidably disposed within the lumen; a non-shunt stimulation device received slidingly within the distal retention section, the non-shunt stimulation device comprising: a housing having a proximal region and a distal region, a first electrode disposed along the distal region, and a plurality anchoring members that include a first anchoring member coupled to the distal region; wherein the first anchoring member has the ability to switch between a first configuration, when the non-shunt stimulation device is disposed within the distal retention section, and a second configuration, when the non-shunt stimulation device is advanced outward to from the distal retention section; wherein the distal retention section has a longitudinal geometric axis; wherein the first anchoring member is disposed substantially parallel to the longitudinal geometric axis when the first anchoring member is in the first configuration; wherein the first anchor member includes a region with a composite curve when the first anchor member is in the second configuration; wherein the region with the composite curve includes a first curved section and a second curved section; wherein the first curved section is oriented in a first direction and the second curved section is oriented in a second direction different from the first direction; and where the first direction is opposite to the second direction.
    [0007]
    7. System according to claim 6, characterized by the fact that a contact section of the first anchoring member comes into contact with an inner wall surface of the distal retaining section when the first anchoring member is in the first configuration.
    [0008]
    8. System according to claim 7, characterized by the fact that the contact section is positioned proximal to a distal end of the first anchoring member when the first anchoring member is in the first configuration.
    [0009]
    9. System according to claim 8, characterized by the fact that the contact section extends between the distal end of the first anchoring member and a point arranged proximally to the distal end when the first anchoring member is in the first settings.
    [0010]
    10. System according to claim 6, characterized by the fact that the first curved section, the second curved section, or both, have the ability to cause the first anchoring member to move laterally in the direction opposite to the first electrode when the first anchoring member extends into cardiac tissue.
    [0011]
    11. Stimulation device system without implantable derivation, the system characterized by comprising: a delivery catheter that has a proximal section, a distal retention section and a lumen formed therein; a pressure member slidably disposed within the lumen; a non-shunt stimulation device received slidingly within the distal retention section, the non-shunt stimulation device comprising: a housing having a proximal region and a distal region, a first electrode disposed along the distal region, and a plurality anchoring members that include a first anchoring member coupled to the distal region; wherein the first anchoring member has the ability to switch between a first configuration, when the non-shunt stimulation device is disposed within the distal retention section, and a second configuration, when the non-shunt stimulation device is advanced outward to from the distal retention section; wherein a contact section of the first anchor member comes into contact with an inner wall surface of the distal retaining section when the first anchor member is in the first configuration; wherein the contact section is positioned proximally to a distal end of the first anchoring member; wherein the first anchor member includes a region with a composite curve when the first anchor member is in the second configuration; wherein the region with the composite curve includes a first curved section and a second curved section; wherein the first curved section is oriented in a first direction and the second curved section is oriented in a second direction different from the first direction; and where the first direction is opposite to the second direction.
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    同族专利:
    公开号 | 公开日
    RU2661754C2|2018-07-19|
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    EP3033141A1|2016-06-22|
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    US10179236B2|2019-01-15|
    US20150051616A1|2015-02-19|
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    CN105916544B|2019-11-12|
    AU2014306940A1|2016-03-03|
    US10857353B2|2020-12-08|
    WO2015023488A1|2015-02-19|
    AU2014306940B2|2017-09-07|
    CN105916544A|2016-08-31|
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    法律状态:
    2020-07-21| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-11-24| B09A| Decision: intention to grant|
    2021-01-12| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/08/2014, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201361866799P| true| 2013-08-16|2013-08-16|
    US61/866,799|2013-08-16|
    PCT/US2014/049914|WO2015023488A1|2013-08-16|2014-08-06|Leadless cardiac pacing devices|
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