Delivery device for occlusive implants

Abstract

A delivery device for occlusive implants, and a method for manufacturing and using the delivery device are disclosed. An exemplary delivery device may include a delivery sheath having a proximal region, a garage region, and a distal tip region. The proximal region may have a proximal inner diameter. The garage region may have a garage inner diameter larger than the proximal inner diameter. Reinforcing members may extend along the proximal region, along the garage region, or along both. A core member may be slidably disposed within the delivery sheath. An occlusive implant is releasably connected to the core member.

Description

Technical Field

[0001] The present disclosure relates to medical devices and methods for manufacturing medical devices. More specifically, the present disclosure relates to delivery devices for occlusive implants.

Background Art

[0002] A wide variety of medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include guidewires, catheters, 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. Each of the known medical devices and methods has specific advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0003] The present disclosure provides alternatives for the design, materials, manufacturing methods, and methods of use for medical devices. A delivery device for an occlusive implant is disclosed. The delivery device includes a delivery sheath having a proximal region, a garage region, and a distal tip region, wherein the proximal region has a proximal inner diameter, the garage region has a garage inner diameter that is larger than the proximal inner diameter, a reinforcing member extending along the proximal region, along the garage region, or along both, a core member slidably disposed within the delivery sheath, and an occlusive implant releasably coupled to the core member.

[0004] Alternatively or additionally to any one of the above embodiments, the proximal region has a proximal outer diameter and the garage region has a garage outer diameter that is substantially equal to the proximal outer diameter. Alternatively or additionally to any one of the above embodiments, the proximal region has a proximal outer diameter and the garage region has a garage outer diameter that is different from the proximal outer diameter.

[0005] In addition to or alternative to any one of the embodiments described above, the reinforcing member includes a braid. Alternatively, or in addition to, any of the embodiments described above, the reinforcing member includes a tubular member having a plurality of slots formed therein.

[0006] Alternatively, or in addition to, the reinforcing member extends along the garage area in any one of the embodiments described above. In any of the embodiments described above, either as an alternative or additional measure, the proximal region does not include a reinforcing member.

[0007] Alternatively, or in addition to, any of the embodiments described above, the reinforcing members are arranged along the garage area, and the proximal area further includes reinforcing braids. Alternatively, or in addition to, any of the embodiments described above, a plurality of axial slits are formed in the distal tip region.

[0008] Alternatively, or in addition to any one of the embodiments described above, the core member has an outer diameter with a difference of 0.01 inches (0.254 millimeters) or less from its proximal inner diameter. A delivery device for an occlusive implant is disclosed. The delivery device comprises a delivery sheath having a proximal region, a garage region located distal to the proximal region, and a distal tip region located distal to the garage region, wherein the proximal region has a proximal inner diameter and the garage region has a garage inner diameter larger than the proximal inner diameter; a garage reinforcing member located along the garage region; and a proximal reinforcing member located along the proximal region.

[0009] Alternatively, or in addition to, any one of the above embodiments, the proximal region has a proximal outer diameter, and the garage region has a garage outer diameter substantially equal to the proximal outer diameter. Alternatively, or in addition to, any one of the above embodiments, the proximal region has a proximal outer diameter, and the garage region has a garage outer diameter different from the proximal outer diameter.

[0010] In addition to or alternative to any one of the embodiments described above, the proximal reinforcing member includes a braid. Alternatively, or in addition to, any of the embodiments described above, the garage reinforcement member includes a tubular member having a plurality of slots formed therein.

[0011] In addition to or alternative to any one of the embodiments described above, the proximal reinforcing member is continuous with the garage reinforcing member. Alternatively, or in addition to, any one of the above embodiments, the present invention further comprises a core member slidably disposed within a delivery sheath and an occlusion implant releasably connected to the core member.

[0012] A method for implanting an occluding implant in the left atrial appendage is disclosed. The method includes advancing a delivery device to a position adjacent to the left atrial appendage, wherein the delivery device is a delivery sheath having a proximal region, a garage region and a distal tip region, the proximal region having a proximal inner diameter and the garage region having a garage inner diameter greater than the proximal inner diameter; a reinforcing member extending along the proximal region, along the garage region or both; a core member slidably disposed within the delivery sheath; and an occluding implant releasably connected to the core member; and advancing the core member such that the occluding implant advances outward from the distal tip region.

[0013] Alternatively, or in addition to, any of the above embodiments, the further step includes resheathing the occluding implant into the distal tip region by retracting the occluding implant proximal to the distal tip region.

[0014] Alternatively, or in addition to, any of the embodiments described above, the step of resheathing the occluded implant further includes retracting the occluded implant proximal to the garage area.

[0015] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following drawings and detailed description illustrate these embodiments more specifically.

Brief Description of the Drawings

[0016] The present disclosure can be more fully understood by considering the following detailed description together with the accompanying drawings. [Figure 1] It is a side view of an exemplary delivery system. [Figure 2] It is a side view of an exemplary delivery system. [Figure 3] It is a side view of a part of an exemplary delivery system. [Figure 4] It is a perspective view of a part of an exemplary delivery system. [Figure 5] It is a schematic side view of a part of an exemplary delivery sheath. [Figure 6] It is a schematic side view of a part of an exemplary delivery sheath. [Figure 7] It is a schematic side view of a part of an exemplary delivery sheath.

Modes for Carrying Out the Invention

[0017] The present disclosure can accept various modified forms and alternative forms, the details of which are shown as examples in the drawings and described in detail. However, it should be understood that the intention is not to limit the present invention to the specific embodiments described. On the contrary, the intention is to encompass all modified forms, equivalents, and alternative forms within the spirit and scope of the present disclosure.

[0018] For the terms defined below, these definitions shall apply unless different definitions are given in the claims or elsewhere in this specification. All numerical values are assumed, in this specification, whether or not explicitly indicated, to be modified by the term "about." The term "about" generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent (e.g., having the same function or result) to the recited value. In many cases, the term "about" may include a value rounded to the nearest significant digit.

[0019] The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0020] Note that references in this specification to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment(s) may include one or more particular features, structures, and / or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and / or characteristics. Additionally, when a particular feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in relation to other embodiments, whether or not explicitly described, unless clearly stated to the contrary.

[0021] The following detailed description should be read with reference to the drawings in which like elements in different drawings are numbered the same. The drawings are not necessarily to scale and are illustrative of exemplary embodiments and are not intended to limit the scope of the invention.

[0022] Figures 1 and 2 schematically illustrate selected components and / or arrangements of an occlusive implant system. Note that in any given figure, some features of the occlusive implant system may be omitted or schematically illustrated for simplification. Additional details regarding some components of the occlusive implant system may be shown in more detail in other figures. An occlusive implant system may be used to deliver and / or deploy various medical implants (e.g., cardiovascular implants, occlusive implants, etc.) to one or more locations within anatomical structures, including, but not limited to, the heart and / or left atrial appendage in some embodiments. For clarity, the following description refers to occlusive implants, but other medical implants may be used and / or considered in conjunction with an occlusive implant system.

[0023] An occlusive implant system may include a delivery system 10, which includes a delivery sheath 14, and the delivery sheath 14 has a delivery lumen 12 extending proximal to the distal end of the delivery sheath 14. In one example, the delivery lumen 12 extends from the proximal opening to the distal opening of the delivery sheath 14. The delivery system 10 may include a proximal hub 16. In some embodiments, the delivery system may include an intermediate hub 18. In some embodiments, the delivery system 10 may include an intermediate shaft 20 extending from the proximal hub 16 to the intermediate hub 18. In some embodiments, the delivery sheath 14 may extend distally from the intermediate hub 18. Other configurations are also possible. In some embodiments, the delivery system 10 may include a side port 22. In some embodiments, the side port 22 may communicate with the intermediate shaft 20. Other configurations are also possible. In some embodiments, the delivery system 10 and / or delivery lumen 12 may include a proximal segment (not shown) extending within and / or through an intermediate hub 18, an intermediate shaft 20, and a proximal hub 16. In some embodiments, the proximal segment may be in fluid communication with and / or an extension thereof of the delivery lumen 12 of the delivery sheath 14. In some embodiments, a side port 22 may be in fluid communication with the proximal segment and / or the delivery lumen 12.

[0024] The occlusion implant system and / or delivery system 10 may include a core member or core wire 24 slidably and / or rotatably disposed within the delivery lumen 12 (and proximal segment, if present). The occlusion implant system may include an occlusion implant 26 configured to be implanted in the left atrial appendage and releasably engaged with and / or releasably attached to the distal end of the core wire 24. In at least some embodiments, the occlusion implant 26 may be a left atrial appendage closure device. In some embodiments, the proximal end of the core wire 24 may extend proximal to the proximal end of the delivery sheath 14 and / or proximal opening of the delivery lumen 12 for manual manipulation by a clinician or operator. In at least some embodiments, the delivery sheath 14 may be composed of and / or formed from a polymer material. In some embodiments, the delivery sheath 14 may be composed of and / or formed from a plurality of polymer materials. In some embodiments, the delivery sheath may be composed of and / or formed from a combination of metallic and polymer materials. In some embodiments, the delivery sheath 14 may include reinforcing elements such as mesh, coils, or braids formed, embedded, or attached inside it along at least a portion of its length. Other configurations are also conceivable. Some suitable but non-limiting examples of materials for the occlusion implant system, core wire 24, and / or delivery sheath 14, etc. (including, but not limited to, metallic materials and polymer materials) are described below.

[0025] The occluding implant 26 may include an expandable framework 28 (e.g., Figure 2) configured to shift between a delivery configuration (e.g., Figure 1) in which the occluding implant 26 is positioned within and / or within the distal portion of the delivery lumen 12, close to the distal opening, and an unfolded configuration (e.g., Figure 2) in which the occluding implant 26 is not constrained by the delivery sheath 14.

[0026] In some embodiments, the expandable framework 28 may include a plurality of interconnected struts. In some embodiments, the expandable framework 28 may be compliant or semi-compliant and may be configured to conform in its deployed form to the shape and / or geometry of the left atrial appendage and / or to engage with it in a sealed manner.

[0027] In some embodiments, the proximal end of the expandable framework 28 may be configured to be releasably attached, joined, coupled, engaged, or otherwise connected to the distal end of the core wire 24 (e.g., Figure 2). In some embodiments, the proximal end of the expandable framework 28 may include a proximal hub coupled to and / or non-releasably attached thereto. In some embodiments, the proximal hub may be configured and / or adapted to be releasably coupled, joined, mated, or otherwise engaged with the distal end of the core wire 24. Other means for releasably connecting and / or engaging the expandable framework 28 to the distal end of the core wire 24 are also conceivable.

[0028] In some embodiments, the occlusion implant 26 may include an occlusion element 30 (e.g., a membrane, fabric, or tissue element) that is connected to, positioned on, above, around, or covers at least a portion of the expandable framework 28. In some embodiments, the occlusion element 30 may be connected to, positioned on, above, around, or cover at least a portion of the outer (or outward-facing) surface of the expandable framework 28.

[0029] In some embodiments, the occlusion element 30 may be permeable or impermeable to blood and / or other fluids such as water. In some embodiments, the occlusion element 30 may include a polymer membrane, a metal or polymer mesh, a porous or semi-porous filter-like material, or other suitable structure. In some embodiments, the occlusion element 30 prevents a thrombus (e.g., a blood clot) from passing through the occlusion element 30 and flowing out of the left atrial appendage into the bloodstream. In some embodiments, the occlusion element 30 promotes post-implantation endothelialization, thereby effectively removing the target site (e.g., the left atrial appendage) from the patient's circulatory system. Some preferred but non-limiting examples of materials for the occlusion element 30 are described below.

[0030] In some embodiments, the expandable framework 28 and / or a plurality of interconnected struts may be integrally formed and / or cut from a single member. In some embodiments, the expandable framework 28 and / or a plurality of interconnected struts may be integrally formed and / or cut from a single tubular member and then formed and / or heat-set to a desired shape in an unfolded form. In some embodiments, the expandable framework 28 and / or a plurality of interconnected struts may be integrally formed and / or cut from a single flat member or sheet and then wound or formed into a tubular structure and subsequently formed and / or heat-set to a desired shape in an unfolded form. Some exemplary means and / or methods for manufacturing and / or forming the expandable framework 28 include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical dissolution, and the like. Other means and / or methods are also conceivable.

[0031] During use, the delivery sheath 14 can be advanced and / or guided to the left atrial appendage to deliver the occlusive implant 26 to the left atrial appendage. In one example, the delivery sheath 14 can be advanced and / or guided to the left atrial appendage using and / or via a guidewire. For example, the delivery sheath 14 may be advanced to the patient's left atrium, with its distal end positioned adjacent to the left atrial appendage, and the occlusive implant 26 may be positioned inside the left atrial appendage in delivery configuration. In some embodiments, the delivery sheath 14 may include a steering function. After the distal end of the delivery sheath 14 is adjacent to and / or positioned in the left atrial appendage, the core wire 24 is advanced distal to the delivery sheath 14, and the occlusive implant 26 is advanced outside the delivery sheath 14, where the occlusive implant 26 may transition to an unfolded configuration.

[0032] Although not explicitly illustrated, in some embodiments the occlusion implant system may further comprise an access device. In some embodiments, the access device may be a bidirectional steerable catheter and / or an intravascular catheter. Examples of intravascular catheters include, but are not limited to, balloon catheters, atherectomy catheters, device delivery catheters, drug delivery catheters, diagnostic catheters, and guide catheters.

[0033] In some embodiments, the access device may be advanced and / or guided to the left atrial appendage. In one example, the access device may be advanced and / or guided to the left atrial appendage using and / or through a guidewire. For example, the access device may be advanced to the patient's left atrium, with its distal tip positioned adjacent to the left atrial appendage. In some embodiments, the access device may include a steering function. In some embodiments, the delivery system 10 may be inserted through the access device. In some embodiments, the length of the delivery sheath 14 may be substantially equal to the length of the access device. In some embodiments, the length of the delivery sheath 14 may be slightly longer than the access device. During use, the delivery sheath 14 may advance within the access device with the occlusive implant 26 positioned inside in a delivery configuration. After the distal end of the delivery sheath 14 is adjacent to and / or positioned at the distal end of the access device, the core wire 24 is advanced distally to the delivery sheath 14 and / or the access device, and the occlusion implant 26 is advanced outside the delivery sheath 14 and the access device, where the occlusion implant 26 can transition to an unfolded state.

[0034] In some embodiments, the delivery system, delivery sheath 14, and / or access device may be dimensionally set according to their intended use. For example, the delivery system, delivery sheath 14, and / or access device may have lengths in the range of about 10 to about 150 centimeters, about 25 to about 125 centimeters, about 50 to about 100 centimeters, about 25 to about 50 centimeters, about 50 to about 75 centimeters, about 75 to about 100 centimeters, etc. Other lengths are also envisioned, including but not limited to a subset of the ranges disclosed herein. It is further envisioned that the outer diameter of the delivery system, delivery sheath 14, and / or access device may vary based on use or application. In some examples, the outer diameter of the delivery system, delivery sheath 14, and / or access device may be approximately 2 mm, approximately 3 mm (or 9 French), approximately 3.5 mm, approximately 4 mm (or 12 French), approximately 4.5 mm, approximately 5 mm (or 15 French), approximately 5.33 mm, approximately 5.5 mm, approximately 5.66 mm (or 17 French), approximately 6 mm, approximately 6.5 mm, approximately 7 mm (or 21 French), approximately 8 mm, or other appropriate sizes. In some embodiments, the outer diameter of the delivery system, delivery sheath 14, and / or access device is a maximum of 5.66 mm (17 French), and preferably less than 5.66 mm (17 French). Other configurations are also conceivable. In some embodiments, it is desirable that the outer diameter of the delivery system, delivery sheath 14, and / or access device be as small as possible.

[0035] In some cases, it may be necessary to retrieve and / or reposition the occlusive implant 26 during the procedure. For example, the initial placement of the occlusive implant 26 may be inaccurate and / or inappropriate. Therefore, the delivery sheath 14 and / or access device may be configured to allow for the retrieval and / or repositioning of the occlusive implant 26. This specification discloses, for example, a delivery system including a delivery sheath having a proximal region, a garage region, and a distal tip region. These and / or other structures may help to make the delivery sheath more suitable for the retrieval and / or repositioning of the occlusive implant. Some further details relating to these and other structures are disclosed herein.

[0036] Figure 3 shows a portion of another exemplary delivery device 110, which may be similar in form and function to other delivery devices disclosed herein (for example, for delivering occlusive implants such as occlusive implant 26). The delivery device 110 may include a delivery sheath 114 having a proximal region 152, a garage region 154, and a distal tip region 156. A marker member 166 (e.g., Pt-Ir, Ta, Au, radiopaque filler, etc.) may be positioned adjacent to the distal tip region 156. In some cases, the delivery sheath may include a first tubular member or an inner tubular member 158. The inner tubular member 158 may also be called a liner. The inner tubular member 158 may be formed from a suitable material such as polytetrafluoroethylene. Other materials, such as those disclosed herein, may also be used. A lumen 160 may be defined by the inner tubular member 158. An outer tubular member 162 may be positioned around the inner tubular member 158. The outer tubular member 162 may be formed from a suitable material such as polyether block amide. Other materials, such as those disclosed herein, may also be used. In some cases, a filler material 170 (e.g., polymer filler) may be placed between the inner tubular member 158 and the outer tubular member 162. The filler material 170 may help support the inner tubular member 158, for example, when the delivery sheath 114 transitions from the proximal region 152 to the garage region 154. The filler material 170 may also help provide structural support to the proximal region 152, thereby improving the pushability of the proximal region 152 (and / or the entire delivery sheath 114).

[0037] The delivery sheath 114 may include a reinforcing member 164 extending along at least a portion of the length of the delivery sheath 114. The reinforcing member 164 may extend along the garage region 154, along the proximal region 152, or along both. In some cases, the outer tubular member 162 may include the reinforcing member 164. In some of these and other cases, the inner tubular member 158 may include the reinforcing member 164 (and / or separate reinforcing members). The reinforcing member 164 is generally configured to help reduce damage to the delivery sheath 114, for example, during resheathing / retrieval and / or repositioning procedures. In this example, the reinforcing member 164 may take the form of a braid. The braid may have about 40–80 picks / inch, or about 60–70 picks / inch. Other reinforcing members are envisioned, including coils, notched tubular members / slotted tubular members, and / or equivalents thereof.

[0038] Lumen 160 along the proximal region 152 corresponds to the proximal inner diameter ID P It may have. Garage area 154 is garage inner diameter ID G It may include an enlarged inner diameter region 168 having the following characteristics: Garage inner diameter ID G This is the proximal internal diameter ID P It can be larger than that. For this reason, the garage area 154 may be adapted to accommodate the occlusion implant 26 during the delivery process, for example, when the occlusion implant 26 is delivered to the target site (e.g., the left atrial appendage). In addition, the garage area 154 may also be suitable for accommodating the occlusion implant 26 during the resheathing / retrieval and / or repositioning process. A larger size may help prevent damage to the delivery sheath 114 during the resheathing / retrieval and / or repositioning process. In at least some cases, the proximal inner diameter ID P The difference from the outer diameter of the core member 24 may be approximately 0.03 inches (0.762 millimeters) or less, or approximately 0.02 inches (0.508 millimeters) or less, or approximately 0.01 inches (0.254 millimeters) or less.

[0039] Proximal internal diameter ID PA relatively tight tolerance between the core member 24 and the proximal inner diameter ID can be desirable for several reasons. For example, the proximal inner diameter ID P The relatively tight tolerance between the core member 24 and the occlusion implant 26 may reduce the likelihood of the core member 24 moving laterally within the lumen 160. This may help prevent the core member 24 from dislocating, bouncing, or otherwise moving while being guided to the target site. As a result, the occlusion implant 24 is more likely to remain stable during delivery and is less likely to dislocate, bounce, or otherwise move, for example, during delivery and / or deployment. In addition, the relatively tight tolerance may help reduce torsion of the proximal region 152 when delivering the occlusion implant 26, for example.

[0040] In the example shown in Figure 3, the garage region 154 and the proximal region 152 may have substantially the same outer diameter. Therefore, the delivery sheath 114 may have a substantially constant diameter along its length. Other arrangements are also conceivable. Several examples of delivery sheaths in which the outer diameter may vary along its length are disclosed herein.

[0041] Figure 4 shows a portion of another exemplary delivery device 210 (for delivering occlusive implants, such as occlusive implant 26) which may be similar in form and function to other delivery devices disclosed herein. The delivery device 210 may include a delivery sheath 214 (see, for example, Figure 5) having a proximal region 252, a garage region 254, and a distal tip region 256. In this example, a transition region 278 may be located between the proximal region 252 and the garage region 254.

[0042] The distal tip region 256 may have a plurality of slits 274 formed in the distal tip region 256. The plurality of slits 274 may form or define a plurality of flaps 276 in the distal tip region 256. The plurality of slits 274 and flaps 276 may allow the distal tip region 256 to be expandable. For example, the distal tip region 256 may be expandable to allow the occluded implant 26 to be more easily guided within the distal tip region 256 and / or the delivery sheath 214 during resheathing / retrieval and / or repositioning procedures. Other distal tip regions disclosed herein may similarly include slits (e.g., similar to slits 274) and flaps (e.g., similar to flaps 276), even if not expressly illustrated or described.

[0043] In this example, the garage area 254 may include a reinforcing member 264 in the form of a slotted tubular member. The slotted tubular member may be formed from a suitable material such as stainless steel, nickel-titanium alloy, and / or other materials listed herein. The slots in the slotted tubular member may be arranged in a manner that allows for an appropriate level of flexibility while maintaining compression resistance, extension / tensile resistance, and / or desired torque transmission.

[0044] In some cases, the garage region 254 may have a different outer diameter than the proximal region 252. For example, the garage region 254 may have a larger outer diameter than the proximal region 252. This may allow the garage region 254 to be made larger to accommodate the occluding implant 26 during delivery. In addition, the enlarged garage region 254 may help to accommodate the occluding implant 26 during the resheathing / retrieval and / or repositioning process.

[0045] Figures 5–7 show exemplary delivery sheaths 314, 414, and 514, which may be similar in form and function to other delivery sheaths disclosed herein. These figures, which are essentially schematic, are intended to show different arrangements of reinforcing members along delivery sheaths 314, 414, and 514. These configurations may be used in any of the delivery sheaths disclosed herein. For example, in Figure 5, delivery sheath 314 may lack reinforcing members. In other words, the proximal region 352, garage region 354, and distal tip region 356 may all lack reinforcing members. In Figure 6, reinforcing member 464 may be arranged along the distal tip region 456, garage region 454, and transition region 478 (if any). The proximal region 452 may lack reinforcing member 464. In Figure 7, the reinforcing member 564 may be positioned along the distal tip region 556, the garage region 554, the transition region 578 (if any), and the proximal region 552.

[0046] Numerous additional design configurations are envisioned. For example, delivery sheaths (e.g., delivery sheaths 314, 414, 514) may include a liner or inner tubular member (e.g., similar to inner tubular member 158). This may include designs in which part of the delivery sheath region includes a liner or inner tubular member, and part of the delivery sheath region lacks a liner or inner tubular member. For example, the proximal region may lack a liner or inner tubular member. Other delivery sheaths (e.g., delivery sheaths 314, 414, 514) may lack a liner or inner tubular member (e.g., similar to inner tubular member 158). In some cases, the transition region between the proximal region and the garage region may be described as relatively short (e.g., the transition occurs over a length of less than about 5 cm, and / or the transition region is about 5 cm or less in length). In other cases, the transition region between the proximal region and the garage region can be described as relatively long (for example, the transition occurs over a length of more than approximately 5 cm, and / or the transition region is approximately 5 cm or longer).

[0047] Materials that can be used for various components of the delivery device 10 (and / or other delivery systems disclosed herein) may include materials commonly associated with medical devices. For simplicity of explanation, the following description refers to the delivery device 10. However, this is not intended to limit the devices and methods described herein, and the description may also apply to other delivery systems disclosed herein.

[0048] In some embodiments, the delivery device 10 and / or other components of the delivery device 10 may be made from metals, metal alloys, polymers (some examples of which are shown below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf available from Bayer). Available from Atochem: CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS AmericanThe materials may include perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath may be formulated with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6 percent LCP.

[0049] Some examples of suitable metals and metal alloys include stainless steel such as 304V stainless steel, 304L stainless steel, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, and nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10 such as HASTELLOY® C276®). 276, other nickel alloys such as other HASTELLOY® alloys and similar ones, nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and similar ones), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and similar ones), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY This includes UNS:N10665, such as B2 (trademark), 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 similar materials, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, and similar materials), platinum-enriched stainless steel, titanium, combinations thereof, and similar materials, or any other suitable material.

[0050] In at least some embodiments, part or all of the delivery device 10 may also be doped with, fabricated from, or contain radiopaque material. Radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopic screen or with another imaging technique during a medical procedure. This relatively bright image assists the user of the delivery device 10 in determining its location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials loaded with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils may be incorporated into the design of the delivery device 10 to achieve the same result.

[0051] In some embodiments, a certain degree of magnetic resonance imaging (MRI) compatibility is imparted to the delivery device 10. For example, the delivery device 10 or part thereof may be made of a material that does not substantially distort the image and does not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they can produce artifacts in MRI images. The delivery device 10 or part thereof may also be made of a material that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nitinol, and others.

[0052] It should be understood that this disclosure is, in many respects, merely illustrative. Modifications may be made in detail, particularly with respect to shape, size, and step arrangement, without departing from the scope of this disclosure. This may include, to a suitable extent, the use of any feature of one exemplary embodiment in other embodiments. The scope of the invention is, of course, defined by the language in which the appended claims are expressed.

Claims

1. A delivery device for occlusive implants, A delivery sheath having a proximal region, a garage region, and a distal tip region, The aforementioned proximal region has a proximal inner diameter, The garage region has a garage inner diameter larger than the proximal inner diameter, and the delivery sheath is A reinforcing member extending along the proximal region, along the garage region, or both, A core member slidably disposed within the delivery sheath, A delivery device comprising an occlusion implant releasably connected to the core member.

2. The delivery device according to claim 1, wherein the proximal region has a proximal outer diameter, and the garage region has a garage outer diameter substantially equal to the proximal outer diameter.

3. The delivery device according to claim 1, wherein the proximal region has a proximal outer diameter, and the garage region has a garage outer diameter different from the proximal outer diameter.

4. The delivery device according to any one of claims 1 to 3, wherein the reinforcing member includes a braid.

5. The delivery device according to any one of claims 1 to 3, wherein the reinforcing member includes a tubular member having a plurality of slots formed therein.

6. The reinforcing member extends along the garage area, as described in any one of claims 1 to 5.

7. The delivery device according to any one of claims 1 to 6, wherein the reinforcing member is not present in the proximal region.

8. The delivery device according to any one of claims 1 to 7, wherein the reinforcing member is arranged along the garage region, and the proximal region further includes a reinforcing braid.

9. The delivery device according to any one of claims 1 to 8, wherein a plurality of axial slits are formed in the distal tip region.

10. The delivery device according to any one of claims 1 to 9, wherein the core member has an outer diameter that is no more than 0.01 inches (0.254 millimeters) different from the proximal inner diameter.

11. A delivery device for occlusive implants, A delivery sheath having a proximal region, a garage region located distal to the proximal region, and a distal tip region located distal to the garage region, The aforementioned proximal region has a proximal inner diameter, The garage region has a garage inner diameter larger than the proximal inner diameter, and the delivery sheath is Garage reinforcing members arranged along the aforementioned garage area, A delivery device comprising a proximal reinforcing member arranged along the proximal region.

12. The delivery device according to claim 11, wherein the proximal region has a proximal outer diameter, and the garage region has a garage outer diameter substantially equal to the proximal outer diameter.

13. The delivery device according to claim 11, wherein the proximal region has a proximal outer diameter, and the garage region has a garage outer diameter different from the proximal outer diameter.

14. The delivery device according to any one of claims 11 to 13, wherein the proximal reinforcing member includes a braid.

15. The delivery device according to any one of claims 11 to 14, wherein the garage reinforcing member includes a tubular member having a plurality of slots formed therein.

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