Delivery device for occlusive implant

Abstract

Delivery devices for occlusive implants and methods of manufacturing and using the delivery devices are disclosed. An example delivery device can include a delivery sheath having a proximal region, a distal tip region, and a lumen formed therein. A core wire can be slidably disposed in the lumen. The core wire can include a central shaft, a first region having a first coil assembly disposed along the central shaft, a second region having a second coil assembly disposed along the central shaft, and a distal implant securement region. An occlusive implant can be coupled to the distal implant securement region.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 594,149, filed October 30, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to medical devices and methods of manufacturing medical devices. More specifically, this disclosure relates to delivery devices for occlusive implants. Background Technology

[0004] Various medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include guidewires, catheters, etc. These devices are manufactured using any of a variety of different manufacturing methods and can be used according to any of these methods. Each known medical device and method has its own advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using these devices. Summary of the Invention

[0005] This disclosure provides designs, materials, manufacturing methods, and alternatives for use in medical devices. A delivery device for an occluded implant is disclosed. The delivery device includes: a delivery sheath having a proximal region, a distal terminal region, and a lumen formed therein; a core wire slidably disposed in the lumen; wherein the core wire includes a central axis, a first region having a first coil assembly disposed along the central axis, a second region having a second coil assembly disposed along the central axis, and a distal implant fixation region; and an occluded implant coupled to the distal implant fixation region.

[0006] As an alternative to or supplement to any of the above embodiments, the central shaft comprises stainless steel.

[0007] As an alternative to or supplement to any of the above embodiments, the central shaft comprises a nickel-titanium alloy.

[0008] As an alternative or supplement to any of the above embodiments, the central shaft includes a stainless steel component and a nickel-titanium alloy component fixed to the stainless steel component.

[0009] As an alternative or supplement to any of the above embodiments, the first region includes an outer sheath disposed on the first coil assembly.

[0010] As an alternative to or supplement to any of the above embodiments, the first region includes a braid connected to the first coil assembly.

[0011] As an alternative to or supplement to any of the above embodiments, the first coil assembly includes a single coil.

[0012] As an alternative to or supplement to any of the above embodiments, the first coil assembly includes two or more coils.

[0013] As an alternative to or supplement to any of the above embodiments, the second coil assembly includes two or more coils.

[0014] As an alternative or supplement to any of the above embodiments, it further includes one or more bead members disposed adjacent to the first region.

[0015] As an alternative or supplement to any of the above embodiments, it further includes one or more beaded components disposed between the first region and the second region.

[0016] As an alternative or supplement to any of the above embodiments, the first region has a first outer diameter, and wherein the second region has a second outer diameter different from the first outer diameter.

[0017] A delivery device for an occlusion implant is disclosed. The delivery device includes: a delivery sheath having a proximal region, a distal terminal region, and a lumen formed therein; a core wire slidably disposed in the lumen; wherein the core wire includes a central axis, a first region having a coil assembly disposed along the central axis, a second region having a spacer assembly disposed along the central axis, and a distal implant fixation region; and an occlusion implant coupled to the distal implant fixation region.

[0018] As an alternative to or supplement to any of the above embodiments, the spacer assembly includes one or more bead members.

[0019] As an alternative to or supplement to any of the above embodiments, the spacer assembly includes a support-like structure.

[0020] As an alternative to or supplement to any of the above embodiments, the spacer assembly includes a helical tube disposed around the central axis.

[0021] As an alternative to or supplement to any of the above embodiments, the central shaft comprises stainless steel.

[0022] As an alternative or supplement to any of the above embodiments, the central shaft includes a stainless steel component and a nickel-titanium alloy component fixed to the stainless steel component.

[0023] As an alternative to or supplement to any of the above embodiments, the delivery sheath has an inner diameter, and wherein the spacer member has an outer diameter very close to the inner diameter.

[0024] A method for implanting an occlusion implant into the left atrial appendage is disclosed. The method includes: advancing a delivery device to a position adjacent to the left atrial appendage, the delivery device comprising: a delivery sheath having a proximal region, a distal terminal region, and a lumen formed therein; a core wire slidably disposed within the lumen, wherein the core wire includes a central axis, a first region having a first coil assembly disposed along the central axis, a second region having a second coil assembly disposed along the central axis, and a distal implant fixation region, and an occlusion implant connected to the distal implant fixation region; and advancing the core wire such that the occlusion implant is ejected from the distal terminal region of the delivery sheath.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation of this disclosure. The accompanying drawings and detailed descriptions below illustrate these embodiments in more detail. Attached Figure Description

[0026] This disclosure will be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1 This is a side view of an example delivery system.

[0028] Figure 2 This is a side view of an example delivery system.

[0029] Figure 3 This is a side view of a portion of the example delivery system.

[0030] Figure 4 This is a side view of a portion of the example delivery system.

[0031] Figure 5 It is along Figure 4 The sectional view taken from line 5-5 in the figure.

[0032] Figure 6 This is a cross-sectional view of a portion of the example delivery system.

[0033] Figure 7 This is a cross-sectional view of a portion of the example delivery system.

[0034] Figure 8 This is a side view of a portion of the example delivery system.

[0035] Figure 9 This is a side view of a portion of the example delivery system.

[0036] Figure 10 This is a side view of a portion of the example delivery system.

[0037] Figure 11 This is a side view of a portion of the example delivery system.

[0038] Figure 12 This is a side view of a portion of the example delivery system.

[0039] Figure 13 This is a side view of a portion of the example delivery system.

[0040] While this disclosure is adaptable to various modifications and alternatives, its details have been illustrated by example in the accompanying drawings and will be described in detail. However, it should be understood that the invention is not limited to the specific embodiments described. Rather, the invention encompasses all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0041] The terms defined below shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0042] All numerical assumptions made herein are modified by the term “approximately”, whether explicitly stated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the term “approximately” may include numbers rounded to the nearest significant figure.

[0043] The numerical range represented by the endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0044] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless expressly stated otherwise. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless expressly stated otherwise.

[0045] It should be noted that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily imply that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with an embodiment, it should be understood that, unless explicitly stated to the contrary, these features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether explicitly described or not.

[0046] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered the same. The drawings (not necessarily to scale) depict illustrative embodiments and are not intended to limit the scope of the invention.

[0047] Figures 1-2 Selected components and / or arrangements of an occlusion implant system are schematically illustrated. It should be noted that, for simplicity, some features of the occlusion implant system may not be shown in any given figure, or may be shown schematically. Further details regarding some components of the occlusion implant system may be shown in more detail in other figures. Occlusion implant systems can be used to deliver and / or deploy a variety of medical implants (e.g., cardiovascular implants, occlusion implants, etc.) to one or more sites within an anatomical structure, including, in some embodiments, the heart and / or left atrial appendage. For clarity, the following description refers to occlusion implants; however, occlusion implant systems may use and / or consider other medical implants.

[0048] An occlusion implant system may include a delivery system 10 comprising a delivery sheath 14 having a delivery lumen 12 extending proximally from a distal end of the delivery sheath 14. In one example, the delivery lumen 12 extends from a proximal opening of the delivery sheath 14 to a distal opening. 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 contemplated. 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 contemplated. In some embodiments, the delivery system 10 and / or the delivery lumen 12 may include a proximal segment (not shown) extending within and / or through the intermediate hub 18, the intermediate shaft 20, and the proximal hub 16. In some embodiments, the proximal segment may be in fluid communication with the delivery lumen 12 of the delivery sheath 14 and / or may be an extension of the delivery lumen. In some embodiments, the side port 22 may be in fluid communication with the proximal segment and / or the delivery lumen 12.

[0049] The occlusion implant system and / or delivery system 10 may include a core member or core wire 24 slidably and / or rotatably disposed within a delivery lumen 12 (and a proximal segment, if present). The occlusion implant system may include an occlusion implant 26 configured for implantation within the left atrial appendage, releasably engaging with and / or releasably attaching 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 proximally to the proximal end of the delivery sheath 14 and / or the proximal opening of the delivery lumen 12 for manual manipulation by a clinician or practitioner. In at least some embodiments, the delivery sheath 14 may include a polymeric material and / or may be formed of a polymeric material. In some embodiments, the delivery sheath 14 may include multiple polymeric materials and / or may be formed of multiple polymeric materials. In some embodiments, the delivery sheath may include a combination of metallic and polymeric materials and / or may be formed of a combination of metallic and polymeric materials. In some embodiments, the delivery sheath 14 may include reinforcing elements, such as a mesh, coil, braid, etc., formed therein, embedded therein, attached thereto, etc., along at least a portion of the length of the delivery sheath 14. Other configurations may also be considered. Suitable but non-limiting examples of materials for the occlusion implant system, the core wire 24, and / or the delivery sheath 14, etc. (including, but not limited to, metallic materials, polymeric materials, etc.) will be discussed below.

[0050] The occlusion implant 26 may include an expandable frame 28 (e.g., Figure 2 This extensible framework is configured to deliver constructs (e.g., Figure 1 ) and expansion construction (e.g., Figure 2 The delivery configuration can be switched between the occlusion implant 26 and the delivery lumen 12, for example, when the occlusion implant 26 is positioned within the delivery lumen 12 near the distal opening and / or within the distal portion of the delivery lumen 12, and the deployment configuration can be used when the occlusion implant 26 is not constrained by the delivery sheath 14.

[0051] In some embodiments, the expandable frame 28 may include a plurality of interconnected struts. In some embodiments, the expandable frame 28 may be compliant or semi-compliant and may conform substantially to the shape and / or geometry of the left atrial appendage in the unfolded configuration and / or be configured to sealably engage with the shape and / or geometry of the left atrial appendage.

[0052] In some embodiments, the proximal end of the expandable frame 28 may be configured to be releasably attached, connected, coupled, engaged, or otherwise connected to the distal end of the core wire 24 (e.g., Figure 2In some embodiments, the proximal end of the expandable frame 28 may include a proximal hub that is coupled and / or non-releasably attached thereto. In some embodiments, the proximal hub may be configured and / or adapted to be releasably coupled, connected, mated, or otherwise engaged with the distal end of the core wire 24. Other methods of releasably coupling and / or engaging the expandable frame 28 to the distal end of the core wire 24 may also be considered.

[0053] In some embodiments, the occlusion implant 26 may include an occlusion element 30 (e.g., a membrane, fabric, or tissue element) connected to at least a portion of the expandable frame 28, disposed on at least a portion of the expandable frame, sleeved on at least a portion of the expandable frame, or disposed around or covering at least a portion of the expandable frame. In some embodiments, the occlusion element 30 may be connected to at least a portion of the outer (or outward-facing) surface of the expandable frame 28, disposed on at least a portion of the outer surface of the expandable frame, sleeved on at least a portion of the outer surface of the expandable frame, or disposed around or covering at least a portion of the outer surface of the expandable frame.

[0054] 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 comprise a polymer membrane, a metal or polymer mesh, a porous or semi-porous filter-like material, or other suitable construction. In some embodiments, the occlusion element 30 prevents thrombi (e.g., blood clots) from passing through the occlusion element 30 and exiting the left atrial appendage into the bloodstream. In some embodiments, the occlusion element 30 facilitates post-implantation endothelialization, thereby effectively removing the target site (e.g., the left atrial appendage) from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusion element 30 are discussed below.

[0055] In some embodiments, the expandable frame 28 and / or the plurality of interconnected struts may be integrally formed and / or cut from a single component. In some embodiments, the expandable frame 28 and / or the plurality of interconnected struts may be integrally formed and / or cut from a single tubular component and subsequently formed and / or heat-set into a desired shape in the unfolded configuration. In some embodiments, the expandable frame 28 and / or the plurality of interconnected struts may be integrally formed and / or cut from a single flat component or sheet and then rolled or formed into a tubular structure and subsequently formed and / or heat-set into a desired shape in the unfolded configuration. Some exemplary ways and / or methods of manufacturing and / or forming the expandable frame 28 include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical melting, etc. Other ways and / or methods are also contemplated.

[0056] In use, the delivery sheath 14 can be advanced and / or guided to the left atrial appendage to deliver the occlusion 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 can be advanced into the patient's left atrium, with the distal end positioned adjacent to the left atrial appendage, and the occlusion implant 26 in the delivery configuration positioned in the distal end. In some embodiments, the delivery sheath 14 may include a steering capability. After the distal end of the delivery sheath 14 is positioned adjacent to and / or at the left atrial appendage, the core wire 24 can be advanced distally relative to the delivery sheath 14 to eject the occlusion implant 26 from the delivery sheath 14, at which point the occlusion implant 26 can be converted to an unfolded configuration.

[0057] Although not explicitly shown, in some embodiments, the occlusion implant system may further include an access device. In some embodiments, the access device may be a bidirectional steerable catheter and / or an intravascular catheter. Examples of intravascular catheters may include, but are not limited to, balloon catheters, atherosclerotic resection catheters, device delivery catheters, drug delivery catheters, diagnostic catheters, and guiding catheters.

[0058] In some embodiments, the access device may be advanced and / or guided to a left atrial appendage. In one example, the access device may be advanced and / or guided to a left atrial appendage using and / or via a guidewire. For example, the access device may be advanced into the patient's left atrium, with the distal end positioned adjacent to the left atrial appendage. In some embodiments, the access device may include steering capability. 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 be advanced within the access device, with the occlusion implant 26 disposed therein in a delivery configuration. After the distal end of the delivery sheath 14 is positioned adjacent to the distal end of the access device and / or at the distal end, the core wire 24 may be advanced distally relative to the delivery sheath 14 and / or the access device to eject the occlusion implant 26 from the delivery sheath 14 and the access device, at which point the occlusion implant 26 may be converted to an unfolded configuration.

[0059] In some embodiments, the delivery system, delivery sheath 14, and / or access device may be sized according to their intended use. For example, the length of the delivery system, delivery sheath 14, and / or access device may range from about 10 to about 150 cm, about 25 to about 125 cm, about 50 to about 100 cm, about 25 cm to about 50 cm, about 50 to about 75 cm, about 75 to about 100 cm, etc. Other lengths, including but not limited to subsets of the ranges disclosed herein, are also considered. It is also contemplated that the outer diameter of the delivery system, delivery sheath 14, and / or access device may vary depending on the use or application. In some examples, the outer diameter of the delivery system, delivery sheath 14, and / or access device may be about 2 mm, about 3 mm (or 9 French), about 3.5 mm, about 4 mm (or 12 French), about 4.5 mm, about 5 mm (or 15 French), about 5.33 mm, about 5.5 mm, about 5.66 mm (or 17 French), about 6 mm, about 6.5 mm, about 7 mm (or 21 French), about 8 mm, or other suitable dimensions. In some embodiments, the outer diameter of the delivery system, delivery sheath 14, and / or access device is at most 5.66 mm (17 French), and preferably less than 5.66 mm (17 French). Other configurations are also contemplated. 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.

[0060] In some cases, it may be necessary to recapture and / or reposition the occluded implant 26 during the procedure. For example, the initial placement of the occluded implant 26 may be inappropriate and / or improper. Therefore, the delivery sheath 14 and / or access device may be configured to allow for recapture and / or repositioning of the occluded implant 26. This document discloses a delivery system including a delivery sheath, which, for example, has a proximal region, a parking region, and a distal terminal region. These and / or other structures can help make the delivery sheath easier to recapture and / or reposition the occluded implant. Additional details regarding these and other structures are disclosed herein.

[0061] It is understood that delivery of occluded implants may involve pushing the occluded implant through a delivery sheath using a core wire. For efficient delivery of the occluded implant, it may be desirable to manufacture the core wire to include a desired level of pushing support (e.g., scalability). Furthermore, because the inner diameter of the delivery sheath may be larger than the outer diameter of some core wires, the core wire may shift or bend within the delivery sheath. This can reduce control and / or accuracy in delivering the occluded implant and / or increase spurts in the occluded implant. The systems and core wires disclosed herein are designed to contribute to increased deliverability of occluded implants. Additional details regarding the features and advantages of such systems (and / or core wires) are disclosed herein.

[0062] Figure 3 The core wire 24 is shown. Generally, the core wire 24 is designed to have a desired level of push support (e.g., maneuverability) to enhance the delivery system 10's ability to deliver the occluded implant 26 effectively and accurately. As can be seen here, the core wire 24 may include a proximal shaft region 36 having a proximal end region 32. A handle member 34 may be coupled to the proximal end region 32. The proximal shaft region 36 may include a central shaft 42 formed of a relatively rigid material, such as stainless steel, a nickel-titanium alloy (e.g., which may include a hyperelastic or linearly elastic nickel-titanium alloy), and / or the like. The relatively rigid central shaft 42 can provide the core wire 24 with a desired level of push support (e.g., maneuverability). Other materials, including those disclosed herein, are also considered. In some cases, the central shaft 42 may include a first or proximal segment and a second or distal segment coupled to the first segment. For example, the central shaft 42 may include a proximal stainless steel section that is coupled (e.g., by thermal bonding, mechanical bonding, adhesive bonding, welding, forging, or a combination thereof) to a distal nickel-titanium alloy section.

[0063] The core wire 24 may also include a distal shaft region 38. For example... Figure 3As shown, the distal axis region 38 may include a coil or coil assembly 44. The coil or coil assembly 44 may include a single coil. Alternatively, the coil assembly 44 may include two or more coils (e.g., opposing coils). In at least some cases, the coil 44 may be configured around a central axis 42. In other words, the central axis 42 may extend along the distal axis region 38, and the coil 44 may be configured around the central axis 42 along the distal axis region 38. The coil 44 may provide a higher level of push support along the distal axis region 38 while remaining highly flexible. Furthermore, the coil 44 may increase the outer diameter of the core wire 24 along the distal axis region 38. For example, the coil 44 may define an outer diameter close to the inner diameter of the delivery sheath 14. This can help reduce the likelihood of the core wire 24 shifting, jumping, or otherwise shortening within the delivery sheath 14. Although not explicitly shown, an external coating or sleeve may be provided along the coil 44. The sleeve or coating may include a smooth coating / sleeve. In some cases, the proximal end region of coil 44 may be coupled to the central shaft 42 at a transition section or transition member 37 and / or serve as a transition section or transition member. The transition member 37 may take the form of a sleeve, solder, adhesive bonding, a combination thereof, and / or similar methods. The distal connector 40 may be coupled to the distal shaft region 38. In at least some cases, the distal connector 40 may be configured to secure the core wire 24 to the occlusion implant 26.

[0064] Figures 4-5 Another example core wire 124 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 124 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. Generally, core wire 124 is designed to have a desired level of push support (e.g., scalability) to enhance the delivery system 10's ability to deliver the occluded implant 26 effectively and accurately. It can be seen here that core wire 124 may include a proximal shaft region 136 having a proximal end region 132. Handle member 134 may be coupled to the proximal end region 132. Core wire 124 may include a central shaft 142 formed of a relatively rigid material, such as stainless steel, nickel-titanium alloy (e.g., which may include hyperelastic or linearly elastic nickel-titanium alloy) and / or the like (e.g., see...). Figure 5 A relatively rigid central shaft 142 can provide the core wire 124 with a desired level of push support (e.g., maneuverability). Other materials, including those disclosed herein, are also considered. In some cases, the central shaft 142 may include a first or proximal segment and a second or distal segment coupled to the first segment. For example, the central shaft 142 may include a proximal stainless steel segment coupled (e.g., thermally bonded, mechanically bonded, adhesively bonded, welded, forged, or a combination thereof) to a distal nickel-titanium alloy segment.

[0065] The core wire 124 may also include a distal axis region 138. This distal axis region 138 may include a coil 144 (e.g., a coil or coil assembly 144, which may include a single coil or a coil of two or more coils). In at least some cases, the coil 144 may be configured around a central axis 142 (e.g., see...). Figure 5 In other words, the central axis 142 may extend along the distal axis region 138, and the coil 144 may be arranged around the central axis 142 along the distal axis region 138. The coil 144 may provide a higher level of push support along the distal axis region 138 while remaining highly flexible. Furthermore, the coil 144 may increase the outer diameter of the core wire 124 along the distal axis region 38. For example, the coil 144 may define an outer diameter close to the inner diameter of the delivery sheath 14. This can help reduce the likelihood of the core wire 124 shifting, jumping, or otherwise shortening within the delivery sheath 114. Although not explicitly shown, an external coating or sleeve may be provided along the coil 144. The sleeve or coating may include a smooth coating / sleeve. In some cases, the proximal end region of the coil 144 may be coupled to the central axis 142 at a transition or transition member 137 and / or serve as a transition or transition member. The transition member 137 may take the form of a fitting, weld, adhesive bonding, a combination thereof, and / or similar forms. The proximal axial region 136 may also include a coil or coil assembly 139. In some cases, the coil assembly 139 may include one or more coils (e.g., a pair of opposing coils). Although not explicitly shown, an outer coating or sleeve may be provided along the coil assembly 139. The distal connector 140 may be coupled to the distal axial region 138. In at least some cases, the distal connector 140 may be configured to secure the core wire 124 to the occlusion implant 26.

[0066] Figure 6 A portion of another example core wire 224 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 224 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a portion of the distal shaft region 238 is shown. The distal shaft region 238 may include a central shaft 242, a coil 244 configured to surround the central shaft 242, and a braided member 246 disposed on the coil 244. A sleeve 248 may be disposed on the coil 244 and the braided member 246. For example... Figure 6 The components shown can be used for the distal and / or proximal shaft sections of suitable core wires disclosed herein.

[0067] Figure 7A portion of another example core wire 324 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 324 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a portion of the distal shaft region 338 is shown. The distal shaft region 338 may include a coil 344 and a braided member 346 disposed on the coil 344. A lumen 349 may be defined within the coil 344. A sleeve 348 may be disposed on the coil 344 and the braided member 346. Figure 7 The components shown can be used for the distal and / or proximal shaft sections of suitable core wires disclosed herein.

[0068] Figure 8 A portion of another example core wire 424 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 424 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a portion of a distal shaft region 438 is shown. The distal shaft region 438 may include a central shaft 442 and a helical / coil 446 disposed along the central shaft 442. The helical / coil 446 may increase the outer diameter of the core wire 424 along the distal shaft region 438. For example, the helical / coil 446 may define an outer diameter close to the inner diameter of the delivery sheath 14. This may help reduce the likelihood of the core wire 424 shifting, sputtering, or otherwise shortening within the delivery sheath 14. Although not explicitly shown, an external coating or sleeve may be disposed along the helical / coil 446.

[0069] Figure 9 A portion of another example core wire 524 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 524 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a portion of distal shaft region 538 is shown. The distal shaft region 538 may include a central shaft 542 and one or more bead members 548 disposed along the central shaft 542. The bead members 548 may increase the outer diameter of core wire 524 along distal shaft region 538. For example, the bead members 548 may define an outer diameter close to the inner diameter of delivery sheath 14. This may help reduce the likelihood of core wire 524 shifting, sputtering, or otherwise shortening within delivery sheath 14. Although not explicitly shown, an external coating or sleeve may be disposed along helix / coil 546.

[0070] Figure 10A portion of another example core wire 624 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 624 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a portion of a distal axis region 638 is shown. The distal axis region 638 may include a central axis 642 and a support-like structure 650 disposed along the central axis 642. The support-like structure 650 may increase the outer diameter of the core wire 624 along the distal axis region 638. For example, the support-like structure 650 may define an outer diameter close to the inner diameter of the delivery sheath 14. This may help reduce the likelihood of the core wire 624 shifting, splintering, or otherwise shortening within the delivery sheath 14. Although not explicitly shown, an external coating or sleeve may be disposed along the support-like structure 650.

[0071] Figure 11 A portion of another example core wire 724 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 724 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a portion of a distal axis region 738 is shown. The distal axis region 738 may include a central axis 742 and a slotted tubular member 752 disposed along the central axis 742. The slotted tubular member 752 may increase the outer diameter of the core wire 724 along the distal axis region 738. For example, the slotted tubular member 752 may define an outer diameter close to the inner diameter of the delivery sheath 14. This may help reduce the likelihood of the core wire 724 shifting, snapping, or otherwise shortening within the delivery sheath 14. Although not explicitly shown, an outer coating or sleeve may be provided along the slotted tubular member 752.

[0072] Figure 12 A portion of another example core wire 824 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 724 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a distal shaft region 838 and a distal connector 840 are shown. The distal shaft region 838 may include a central shaft 842. One or more bead members 848 may be arranged along the central shaft 842 (e.g., along a coil). In this example, at least some bead members 828 may be arranged adjacent to each other (e.g., in contact). Bead members 828 may increase the outer diameter of core wire 824 along the distal shaft region 838. For example, bead members 828 may define an outer diameter close to the inner diameter of delivery sheath 14. This can help reduce the likelihood of core wire 824 shifting, snapping, or otherwise shortening within delivery sheath 14. Although not explicitly shown, an external coating or sleeve may be provided along bead members 828.

[0073] Figure 13 A portion of another example core wire 924 is shown, which is similar in form and function to other core wires disclosed herein. Core wire 924 can be used with delivery system 10 and / or other similar systems, including those disclosed herein. In this example, a distal shaft region 938 and a distal connector 940 are shown. The distal shaft region 938 may include a central shaft 942. One or more bead members 948 may be arranged along the central shaft 942 (e.g., along a coil). In this example, at least some bead members 928 may be spaced apart from each other. Bead members 928 may increase the outer diameter of core wire 924 along the distal shaft region 938. For example, bead member 928 may define an outer diameter close to the inner diameter of delivery sheath 14. This can help reduce the likelihood of core wire 924 shifting, snapping, or otherwise shortening within delivery sheath 14. Although not explicitly shown, an external coating or sleeve may be provided along bead members 928.

[0074] Materials that can be used for various components of delivery system 10 (and / or other delivery systems disclosed herein) may include materials typically associated with medical devices. For simplicity, the following discussion refers to delivery system 10. However, this is not intended to limit the apparatus and methods described herein, as the discussion can be applied to other delivery systems disclosed herein.

[0075] Delivery system 10 and / or other components of delivery system 10 may be made of metal, metal alloys, polymers (some examples of polymers are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene 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., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer or Elf...). CRISTAMID® (available from Atochem), elastic polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under the PEBAX® brand), ethylene vinyl acetate copolymers (EVA), silicone, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyether imide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., available from EMS) The sheath may be made from materials such as GRILAMID® (obtained from American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, 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 thereof. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6 percent LCP.

[0076] Some examples of applicable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low-carbon steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium alloys; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®; other HASTELLOY® alloys, etc.); and nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, N...). ICKELVAC® 400, NICORROS® 400, etc.; nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.); nickel-molybdenum alloys (e.g., UNS: N10665, such 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel, titanium, combinations thereof, etc., or any other suitable material.

[0077] In at least some embodiments, part or all of the delivery system 10 may be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be capable of producing a relatively bright image on a fluorescent examination screen or other imaging technique during medical procedures. This relatively bright image helps the user of the delivery system 10 determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the design of the delivery system 10 to achieve the same result.

[0078] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is provided in the delivery device 10. For example, the delivery system 10 or its components may be made of materials that substantially do not distort the image or produce significant artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they can produce artifacts in MRI images. The delivery system 10 or its components may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), nitinol, and others.

[0079] It should be understood that this disclosure is illustrative in many respects. Changes in details, particularly in the shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include the use of any feature of an exemplary embodiment used in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A delivery device for occlusion implants, the delivery device comprising: A delivery sheath having a proximal region, a distal terminal region, and a lumen formed therein; A core wire that can be slidably disposed in the cavity; The core wire includes a central axis, a first region having a first coil assembly disposed along the central axis, a second region having a second coil assembly disposed along the central axis, and a distal implant fixation region. and An occluded implant connected to the distal implant fixation region.

2. The delivery device according to claim 1, wherein, The central shaft is made of stainless steel.

3. The delivery device according to any one of claims 1-2, wherein, The central shaft is made of nickel-titanium alloy.

4. The delivery device according to any one of claims 1-3, wherein, The central shaft comprises a stainless steel component and a nickel-titanium alloy component fixed to the stainless steel component.

5. The delivery device according to any one of claims 1-4, wherein, The first region includes an outer sheath disposed on the first coil assembly.

6. The delivery device according to any one of claims 1-5, wherein, The first region includes a braided fabric connected to the first coil assembly.

7. The delivery device according to any one of claims 1-6, wherein, The first coil assembly includes a single coil.

8. The delivery device according to any one of claims 1-6, wherein, The first coil assembly includes two or more coils.

9. The delivery device according to any one of claims 1-8, wherein, The second coil assembly includes two or more coils.

10. The delivery device according to any one of claims 1-9, further comprising one or more bead members disposed adjacent to the first region.

11. The delivery device according to any one of claims 1-10, further comprising one or more bead members disposed between the first region and the second region.

12. The delivery device according to any one of claims 1-11, wherein, The first region has a first outer diameter, and the second region has a second outer diameter that is different from the first outer diameter.

13. A delivery device for an occlusive implant, the delivery device comprising: A delivery sheath having a proximal region, a distal terminal region, and a lumen formed therein; A core wire that can be slidably disposed in the cavity; The core wire includes a central axis, a first region having a coil assembly disposed along the central axis, a second region having a spacer assembly disposed along the central axis, and a distal implant fixation region. and An occluded implant connected to the distal implant fixation region.

14. The delivery device according to claim 13, wherein, The spacer assembly includes one or more beaded components, a support structure, or a helical tube arranged around the central axis.

15. The delivery device according to any one of claims 13-14, wherein, The central shaft comprises a stainless steel component and a nickel-titanium alloy component fixed to the stainless steel component.

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