Medical device delivery system

The medical device delivery system addresses stabilization and deployment challenges by using a flexible tubular stabilizer and coupling members to securely hold and deploy implantable devices, ensuring precise placement in complex anatomical paths.

WO2026096427A1PCT designated stage Publication Date: 2026-05-07SCITECH MEDICAL INC
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
SCITECH MEDICAL INC
Filing Date
2025-10-28
Publication Date
2026-05-07

AI Technical Summary

Technical Problem

Existing medical device delivery systems face challenges in stabilizing and deploying implantable devices, such as vascular stents, particularly in navigating curved anatomical paths and preventing unwanted displacement during deployment.

Method used

A medical device delivery system featuring an elongated tubular body with a flexible stabilizer and coupling members that include retaining features to securely hold the device, combined with an outer sheath that can compress and expand the device, allowing for stable navigation and controlled deployment.

Benefits of technology

The system effectively stabilizes and deploys implantable devices, mitigating displacement and ensuring precise placement, even in complex anatomical structures.

✦ Generated by Eureka AI based on patent content.

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Abstract

One described example provides a stent delivery system that includes an elongated tubular body and a device coupling mechanism. The tubular body includes an inner tubular member and a tip portion extending distally from the inner tubular member. A tubular stabilizer has a flexible cylindrical sidewall and a device coupling mechanism extends between the tip portion and the tubular stabilizer. A proximal coupling member extends distally from a distal end of the tubular stabilizer. The proximal coupling includes one or more retaining channels in the sidewall of the proximally coupling member extending proximally from a distal edge of the proximal coupling member to terminate at an intermediate location between the proximal and distal ends of the distal coupling member, in which the one or more retaining channels are configured to releasably receive therein a proximal retaining feature of an implantable medical device.
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Description

MEDICAL DEVICE DELIVERY SYSTEMCross-Reference to Related Application

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 712,799, filed on October 28, 2024, which is incorporated herein by reference in its entirety.Technical Field

[0002] This disclosure relates to a medical device delivery system, such as for implanting a stent or other implantable medical device.Background

[0003] Medical devices are widely used in various medical procedures to access remote anatomical locations and / or deploy therapeutic devices, such as vascular stents. Vascular stents can be implanted to treat various forms of peripheral or cardiovascular diseases. For example, a delivery system can be used to carry an expandable stent or other medical device through a patient’s vasculature and to a delivery site where it can be implanted at a desired location.Summary

[0004] This disclosure relates to a medical device delivery system, such as for implanting a stent or other implantable medical device.

[0005] One example provides a delivery system that includes an elongated tubular body, which includes an inner tubular, a tip portion and a tubular stabilizer. The inner tubular member includes an elongated sidewall defining a central lumen that extends through the elongated tubular body. The tip portion extends distally from the inner tubular member to define a distal end of the elongated tubular body. The tubular stabilizer includes a flexible cylindrical sidewall, extending over a proximal portion of the inner tubular member, and terminating a distal end. A device coupling mechanism is at a distal end portion of the tubular body between the tip portion and the tubular stabilizer. The device coupling mechanism includes a proximal coupling member having proximal and distal ends spaced apart from each other by a length of a sidewall thereof and extending distally from a distal end of the tubular stabilizer. The proximal couplingmember can include one or more retaining channels in the sidewall of the proximal coupling member extending proximally from a distal edge of the proximal coupling member to terminate at an intermediate location between the proximal and distal ends of the proximal coupling member, in which the one or more retaining channels are configured to releasably receive therein a proximal retaining feature of an expandable medical device. The delivery system can also include at least one retaining sleeve extending radially outwardly from an outer surface of the inner tubular member at an axial location between the tip portion and the proximal coupling member.

[0006] Another example delivery system includes an elongated tubular stabilizer having a flexible cylindrical sidewall extending between proximal and distal ends thereof, in which the tubular stabilizer comprises a circular helix defining at least a distal portion of the sidewall of the tubular stabilizer. An inner tubular member includes an elongated sidewall extending longitudinally through the tubular stabilizer, in which a distal portion of the inner tubular member extends distally from the distal end of the tubular stabilizer to terminate in a distal end of the inner tubular member, and the inner tubular member has a central lumen extending through the elongated sidewall of the inner tubular member. A tip portion extends distally from the inner tubular member. A first device coupling member includes a tubular sidewall extending from the distal end of the tubular stabilizer to terminate in a distal end thereof that is spaced proximally from the tip portion, in which a length of the distal portion of the inner tubular member extends between the distal end of the first device coupling member and a proximal end of the tip portion. The tubular sidewall of the first device coupling member can also include a plurality of retaining recesses arranged along the tubular sidewall of the first device coupling member. An expandable medical device can be provided around the distal portion of the inner tubular member between the tip portion and the first device coupling member, in which a proximal end portion of the medical device includes proximal retaining features arranged and configured to be received within respective retaining recesses of the first device coupling member. An outer sheath can be provided around the inner tubular member and movable axially relative to the inner tubular member. The outer sheath can be configured to hold each proximal retaining feature within a respective retaining recess and the medical device in a compressed condition responsive to being positioned over the medical device and the device coupling member.

[0007] Yet another example delivery system includes an elongated tubular stabilizer having a flexible cylindrical sidewall extends between proximal and distal ends thereof, in which the cylindrical sidewall of the tubular stabilizer comprises a circular helix defining at least a distal portion of the cylindrical sidewall of the tubular stabilizer. An inner tubular member includes an elongated sidewall, defining a central lumen, extending longitudinally through the tubular stabilizer. A distal portion of the inner tubular member, defining a stent mount region, can extend distally from the distal end of the tubular stabilizer to terminate in a distal end of the inner tubular member. At least one retaining sleeve can be provided around and extend radially outwardly from an outer surface of the inner tubular member at an axial location within the stent mount location. The at least one retaining sleeve can have an outer diameter that approximates or is smaller than an inner diameter of an expandable stent when mounted around the stent mount region in a compressed condition. A tip portion can extend distally from the inner tubular member. A stent coupling member includes a tubular sidewall extending from the distal end of the tubular stabilizer to terminate in a distal end that is spaced proximally from the tip portion, such that the stent mount region of the inner tubular member extends between the distal end of the stent coupling member and a proximal end of the tip portion, the tubular sidewall of the stent coupling member including a plurality of retaining recesses arranged along the tubular sidewall of the stent coupling member, hi some examples, the delivery system can also include an outer sheath around the inner tubular member and movable axially relative to the inner tubular member, in which the outer sheath is configured to hold proximal retaining features of a stent or other medical device within a respective retaining recess in a compressed condition responsive to being positioned over the stent coupling member and the stent or other medical device.

[0008] Other examples can provide a method of using any of the example delivery systems.Brief Description of the Drawings

[0009] FIG. 1 is a broken view of an example stent delivery system.

[0010] FIG. 2 is a cross sectional view of part of the stent delivery system of FIG. 1.

[0011] FIG. 3 is a partial exploded view of the stent delivery system showing the stent separate from the delivery system.

[0012] FIGS. 4-7 depict various views of an example distal coupling member.

[0013] FTG. 8 depicts part of a stent being retained in a compressed condition with the distal coupling member.

[0014] FIGS. 9-10 depict various views of an example proximal coupling member.

[0015] FIG. 11 depicts part of a stent being retained in a compressed condition with the proximal coupling member.

[0016] FIG. 12 depicts part of an example tubular sidewall of the delivery system of FIG. 1.

[0017] FIG. 13 is a cross-sectional view of a portion of the tubular sidewall of FIG. 12.

[0018] FIG. 14 is a cross-sectional view of another part of the delivery system showing a tip portion, the proximal coupling member, and a portion of the stent.

[0019] FIG. 15 is a broken view of another example stent delivery system.

[0020] FIG. 16 is a partial exploded view of the stent delivery system of FIG. 15 showing the stent separate from the delivery system.

[0021] FIG. 17 is a cross sectional view of part of the stent delivery system of FIG. 15.

[0022] FIG. 18 is a side isometric view of a tubular stabilizer and integral coupling for a stent.

[0023] FIG. 19 is a cross-sectional view of the stabilizer and coupling of FIG. 18.

[0024] FIG. 20 is a partial exploded view of part of another example stent delivery system showing a stent separate from the delivery system.

[0025] FIG. 21 is a partial exploded view of part of yet another example stent delivery system showing the stent separate from the delivery system.Detailed Description

[0026] This disclosure relates to a medical device delivery system, such as for implanting a stent or other implantable medical device.

[0027] As an example, the delivery system includes an elongated tubular stabilizer having a flexible, pliant cylindrical sidewall extending between proximal and distal ends thereof. For example, the tubular stabilizer includes a circular helix (e.g., a coil winding or helically cut hypotube) defining at least a distal portion of the sidewall of the tubular stabilizer. The delivery system also includes an inner tubular member having an elongated sidewall that includes one or more lumens extending through the delivery system, such as can be configured to receive a guidewire or other elongated device therein. The tubular stabilizer can be fixed to the innertubular member, and the inner tubular member can extend longitudinally through the tubular stabilizer such that a distal portion of the inner tubular member extends a distance (e.g., a predetermined distance) distally from and beyond the distal end of the tubular stabilizer. The delivery system can also include a distal tip portion extending distally from the inner tubular member, such as having a tapered end and of a pliant material to facilitate movement through a patient’s vasculature. The lumen of the inner tubular member can continue through a passage of the tip portion.

[0028] The delivery system further can include one or more coupling members configured to releasably hold a portion of an implantable medical device (e.g., an expandable stent) to inhibit axial movement of the device as it moved within an anatomical structure. For example, a first coupling member includes a tubular sidewall that extends from the distal end of the tubular stabilizer to terminate in a distal end that is spaced proximally from the tip portion, such that a length of the inner tubular member extends between the distal end of the first coupling member and a proximal end of the tip portion. The first coupling member can be coupled to the distal end of the tubular stabilizer. Alternatively, or the coupling member can be monolithic with the tubular stabilizer to provide an integrated structure. The tubular sidewall of the first coupling member can include a plurality of retaining recesses arranged along the tubular sidewall of the first coupling member and configured to couple to mating features of the implantable medical device (e.g., stent).

[0029] The implantable device can be placed around the distal portion of the inner tubular member, such as extending over a mounting region between the tip portion and the first coupling member. A proximal end portion of the implantable medical device (e.g., stent) can include a set of retaining features arranged and configured to be received within respective retaining recesses of the first coupling member. In examples where a second coupling member is included distally from the first stent coupling member, the implantable device can be releasably coupled and extend between the first and second coupling members. An outer sheath can be mounted around and be movable axially over the inner tubular member and tubular stabilizer. The outer sheath further can be advanced over the implantable device, when in a compressed condition over the mounting region, and hold the implantable device in its compressed condition with each proximal retaining feature of the expandable device in a respective retaining recess of the first coupling mechanism. Further, the outer sheath can be retracted proximally to enable theexpandable device to expand to its expanded condition, automatically and / or through application of radially outward force. The flexibility of the tubular stabilizer, which is coupled to the implantable device through its connection with the coupling member, individually and / or in combination with the retaining sleeves, helps to stabilize the implantable medical device within the delivery system, particularly as the sidewall of the elongated tubular device is bent along one more curves.

[0030] FIGS. 1-14 depict a first example stent delivery system 100 (also referred to herein as a system or delivery system). The delivery system 100 includes an elongated tubular body 102, which can include one or more portions that extend between a distal end 104 and a proximal end 106 of the tubular body. One or more lumens, including a central lumen 107, can extend through the entire tubular body 102 or a portion thereof according to a desired end use application. Various tubes, wires, or the like can be inserted into, advanced and retracted axially within the lumen(s) 107. As shown, the delivery system 100 can include a tip portion 108, a stent coupling mechanism 110, a tubular stabilizer 112, an outer sheath 114, and a handle assembly 116. The tip portion 108 can be implemented as a soft (e.g., compliant or flexible) tip configured to facilitate insertion and withdrawal of the tubular body 102 with tubular anatomic structures, such as the vasculature. A distal portion of the outer sheath 114 can be optically translucent (e.g., clear) to allow visual inspection of the stent after it has been loaded on to the delivery system 100. A distal portion of the outer sheath 114 can be opaque or clear.

[0031] The tip portion 108 can be coupled to a distal portion of an elongated inner tubular member (or tube) 118 (e.g., by an adhesive, mechanical coupling, and / or other bonding mechanism). The inner tubular member 118 can extend through the tubular body 102, such as between the tip portion 108 and the handle assembly 116. The handle assembly 116 further can be configured to enable manipulation and steering of the tubular body 102. The inner tubular member 118 can be formed of a flexible material (e.g., a polymer or metal) and include the central lumen 107 extending longitudinally therethrough. One or more other device (e.g., guidewires, catheters, or the like) can move through the tubular body 102 axially within the central lumen 107 of the inner tubular member 118. In other examples, the tip portion 108 can be coupled to a distal end 120 of the stent coupling mechanism 110 or be omitted from the delivery system 100.

[0032] In the example of FIGS. 1-14, the stent coupling mechanism 110 includes first and second coupling members 122 and 124 (also referred to herein as distal coupling member 122 and proximal coupling member 124). The distal coupling member 122 and proximal coupling member 124 are spaced apart axially from each other by a distance generally corresponding to a length of a stent (or other medical device) 126 to be delivered by the system 100. While the examples here are described with respect to delivering or deploying a stent, other types of medical devices can be implanted or deployed using the systems and methods described herein. Each of the distal coupling member 122 and the proximal coupling member 124 can be coupled to an outer surface of the inner tubular member 118. For example, each of the distal coupling member 122 and the proximal coupling member 124 can be fixed to the inner tubular member 118 by an adhesive (e.g., a UV activated glue or cyanoacrylate glue), a mechanical coupling, and / or other bonding mechanism. For instance, a portion of the inner tubular member 118 within the stent coupling mechanism 110 can define a device mounting region along the inner tubular member 118. which can be set based on the distance between coupling members 122 and 124. In examples herein, where the distal coupling member 122 is omitted, an axial length of the device mounting region can be defined based on the distance between the proximal coupling member 124 and the tip portion 108.

[0033] As an example, the coupling members 122 and 124 can be made of metal and alloys thereof (e.g. L605, stainless steel 316L, Nitinol, or another biocompatible alloy) or made from polymer (e.g., Nylon, PEBAX, polycarbonate, polyurethane, or any other biocompatible polymer suitable for use in medical devices). In some examples, the polymer can also include a sufficient amount of radiopaque material to render the coupling member(s) 122, 124 or one or more portions thereof visible in a medical imaging modality (e.g., X-ray, ultrasound, intraoperative computed tomography, etc.).

[0034] The coupling members 122 and 124, which define the stent coupling mechanism 110 along the outer surface of the inner tubular member 118, are configured to help hold the stent in place as well mitigate unwanted displacement of the stent 126 responsive to deployment of the stent 126. For example, as the outer sheath 114 is retracted axially, the distal coupling member 122 helps reduce contact as well as frictional and other forces being applied from the outer sheath 114 to the distal end portion of the stent 126, thus mitigating shortening of the stent. The proximal coupling member 124 can be configured to facilitate release of the stent 126 as well ascan reduce potential jumping and / or unwanted stent displacement until full release from the stent coupling mechanism 110.

[0035] As shown in FIG. 3, the stent 126 (shown separate from the delivery system 100) has a generally cylindrical body and is expandable from a compressed condition to an expanded condition. The expansion can be automatic (e.g., a self-expanding stent), such as responsive to axial retraction of the outer sheath 114. Also, or alternatively, the expansion of the stent 126 can be provided responsive to inflation of a balloon within an interior of the stent or by another expansion mechanism configured to apply radially outward force to the stent 126. The central body of the stent 126 can include a mesh structure and, in some examples, include a polymer coating. As an example, the stent 126 can be one of the Solaris stents available from Scitech Produtos Medicos SA of Brazil. Other stents and other medical devices can be used in other examples.

[0036] As a further example, the stent 126 includes a number of distal retaining features 130 at a distal end portion of the stent. The stent 126 can also include a number of proximal retaining features 132 at a proximal end portion of the stent. The retaining features 130 and 132 are shown as having a circular shape but can have other shapes, such as rectangular, triangular, T- shaped, etc. (even different shapes relative to other retaining features). In some examples, one or more (e.g., all) of the retaining features 130 and 132 include a radiopaque marker 128, such as at a central part of the retaining features. The radiopaque markers 128 can be radiopaque tantalum or other material configured to render the marker visible in x-ray, CT angiography, or other imaging modalities.

[0037] As best shown in the examples of FIGS. 3-8, the distal coupling member 122 has distal and proximal ends 134 and 136 spaced apart from each other by a length defined by a sidewall thereof. Respective outer surfaces of one or both of the distal and proximal ends 134 and 136 can be curved or chamfered to facilitate axial movement of an outer sheath over the respective ends. For example, the sidewall of the distal coupling member 122 can be tubular and include a central lumen 138 extending therethrough, such as for enabling inner tubular member 118 (or other structures) to traverse axially through the coupling member 122. For example, the lumen 138 is defined by distal and proximal cylindrical portions 139 and 141, respectively, in which the distal cylindrical portion has a diameter that is greater than the proximal cylindrical portion. A ring of radiopaque material (e.g., a marker band) 143 can be coupled within the distalcylindrical portion, such as shown in FIG. 6. The ring of radiopaque material 143 can have an inner diameter that is equal to or approximates the inner diameter of the proximal cylindrical portion 141, and the surface of the proximal cylindrical portion can be coupled (e.g., by an adhesive, mechanical coupling, and / or other bonding mechanism) to the inner tubular member 118.

[0038] The distal coupling member 122 includes one or more retaining slots 140 in the sidewall at an intermediate location between the proximal and distal ends 136 and 134 of the tubular sidewall. In the examples shown, the distal coupling member 122 includes three retaining slots 140. A greater or lesser number of retaining slots 140 can be used in other examples. The retaining slots 140 are shown as having a circular shape configured to receive respective distal retaining features 130 of the stent. In other examples, the retaining slots 140 can have other shapes such as triangular, rectangular or linear slots for receiving corresponding retaining features 130 of the stent therein.

[0039] In some examples, each retaining slot 140 extends radially completely through the tubular sidewall of the distal coupling member 122 to define an inner periphery surface 142 of the respective retaining slot. In other examples, the slots 140 can extend partially into the tubular sidewall of the distal coupling member 122 an amount that is less than the thickness of the sidewall to define a partial version of the slot (e.g., a groove or notch or receptacle). Opposing sides of the inner periphery surface 142 of the retaining slots can taper toward each other (e.g., radially inwardly) so that a radially inner edge of the slot’s inner periphery surface has a smaller cross-sectional dimension than a radially outer edge thereof, such as shown in FIG. 5. The shape of the slot 140 thus can facilitate receiving the distal retaining feature 130 therein but can inhibit (or prevent) the retaining feature from passing into the central lumen 138 of the coupling member 122.

[0040] The distal coupling member 122 can also include a retaining channel 144 extending proximally from the respective retaining slot 140 to terminate at and extend through (e.g., forming an opening in) a proximal edge of the tubular sidewall. As mentioned, the retaining slot 144 is configured to releasably receive a distal retaining feature 130 of the stent 126 therein, and a corresponding portion of the stent extending proximally from the distal retaining feature 130 can be received within the retaining channel 144. The retaining channel 144 can extend completely through the sidewall like the respective retaining slot 140 from which it extends. Theinner surfaces of the retaining slot 140 and the retaining channel 144 thus can define a continuous (integral) receptacle through the sidewall having a generally keyhole shape (or spoon shaped) receptacle configured to receive the distal end retaining feature 130 of the stent 126, such as shown in FIG. 8. Other shape receptacles can be provided in other examples, which can be configured to receive the distal end retaining feature 130 of the stent 126. Distal parts of the stent 126, which are arranged between the distal retaining features 130, can rest on the curved sidewall surface of the proximal end 136, such as shown in FIG. 8.

[0041] As shown in the examples of FIGS. 9-11, the proximal coupling member 124 has a tubular sidewall extending between proximal and distal ends 146 and 148 thereof. The sidewall of the proximal coupling member 124 also includes a number of retaining recesses, which can include slots 150 at circumferentially spaced apart locations along a periphery of the sidewall arranged to receive corresponding proximal features of the stent 126 (or other medical device). A respective retaining channel 152 further extends in the sidewall axially from a respective one of the retaining slots to terminate at and extend through the distal end of the sidewall. As shown in FIG. 11, the proximal retaining features 132 of the stent 126 is received within a respective retaining slot 150 of the proximal coupling member 124 and extends distally therefrom in the respective channel 152.

[0042] As described herein, the outer sheath 114 can be placed over and around the tubular body 102 and be configured to be axially movable (through the control handle 154 and / or through another control within the handle assembly 1 16) relative to the tubular body, in which the outer sheath is configured to hold each retaining feature within a respective retaining slot responsive to the sheath extending over the retaining features of the coupling members 122 and 124.

[0043] As shown in the example of FIGS. 1-3, 11, 12, and 13, the elongated tubular stabilizer 112 is implemented as a tubular coil that extends proximally from the proximal coupling member 124 of the stent coupling mechanism 110. The tubular stabilizer 112 can be implemented as includes a helically (or spirally) wound coil defining the cylindrical sidewall of the tubular stabilizer 112. A central lumen can extend axially through the tubular stabilizer (e.g„ coil sidewall). As shown in FIG. 13, the sidewall of tubular stabilizer 112 has a thickness that approximates an outer diameter of the coil windings as the sidewall of the tubular stabilizer includes one layer of the coil windings arranged axially stacked on each other. The windings ofthe tubular stabilizer 112 can be arranged axially to contact each other along the length of the coil member when in a linear (e.g., straightened configuration) to define a circular helix. A distal end portion (e.g., one or more of the windings at the distal end) of the tubular stabilizer 112 can be coupled (e.g., by an adhesive, mechanical coupling and / or other bonding mechanism) to outer surface of the inner tubular member 118, which extends coaxially through the lumen of the coil member.

[0044] The tubular stabilizer 112 can be formed of a flexible and resilient metal material(e.g., copper, aluminum, alloys, polymers, etc.) to facilitate bending of the tubular body along its length. The tubular stabilizer 112, distal coupling member 122, stent (in its compressed condition) 126, and the proximal coupling member 124 can have a common outer diameter (e.g., approximates or slightly smaller than the inner diameter of the outer sheath 114) to enable the outer sheath 114 to move axially (by operation of the control handle along the tubular body 102 formed by the respective parts 112, 122, and 126.

[0045] In some examples, the proximal coupling member 124 can be monolithic with the tubular stabilizer 112 (e.g., the proximal coupling member and tubular stabilizer are integrated into a single, unified tubular structure). For example, the monolithic structure, which defines the proximal coupling member 124 and the tubular stabilizer 112 can be formed (e.g., by laser welding, etching, laser cutting, and / or other machining technologies) from a unified starting tube or block of material. Such structure can help increase stabilization of the stent 126 (or other medical device) being carried by the delivery system, particularly along curved paths like an individual’s vasculature. As an example, the proximal coupling member and tubular stabilizer can be formed of one or more metals, such as stainless steel, nitinol, inconel, cobalt chrome, platinum I iridium, gold, tungsten, and / or titanium. Alternatively, the proximal coupling member and tubular stabilizer can be formed of one or more polymeric materials, such as fluoropolymers (e.g., PTFE, FEP, PFA, etc.), implantable grade elastomers, and / or engineered polymers (e.g., pebax, peek, polyimide).

[0046] In other examples, the proximal coupling member 124 can be an independent component that is coupled to the distal edge of the tubular stabilizer 112. For example, a proximal edge of the proximal coupling member 124 is coaxially aligned with and coupled (e.g., affixed or bonded by an adhesive, a mechanical coupling, and / or other bonding mechanism) to the distal edge of the tubular stabilizer 112 (see, e.g., FIG. 11). Also, or alternatively, an innersidewall or other surface of the proximal coupling member can be fixed to the inner tubular member 118 (e.g., by an adhesive, a mechanical coupling, and / or other bonding mechanism). Also, or alternatively, in this example embodiment, the proximal coupling member 124 and the tubular stabilizer 112 can be formed of different materials or they can be formed of the same material.

[0047] FIGS. 15-19 depict a second example stent delivery system 200 (also referred to herein as a system or delivery system). The delivery system 200 can be similar to the example of FIGS. 1-14 and reference can be made to the description of such FIGS, for information about such similar features and materials. The delivery system 200 includes an elongated tubular body 202 extending distally from a handle assembly 216. The tubular body 202 can include one or more portions that extend between a distal end 204 and a proximal end 206 of the tubular body. As shown in FIGS. 15-19, the tubular body 202, which extends from the handle assembly 216, includes a tip portion 208, a coupling mechanism 210, a tubular stabilizer 212, and an inner tubular member 218. As shown, the delivery system 200 can also include an outer sheath 214 and a stent 226. One or more lumens, including a central lumen 207, can extend through the entire tubular body 202, such as including through the inner tubular member 218 and through the tip portion 208. The tip portion 208 can be implemented as a soft (e.g., compliant or flexible) tip or include a pliant coating. The inner tubular member 218 can extend through the tubular body 202, such as between the tip portion 208 and the handle assembly 216. One or more other device (e.g., guidewires, catheters, or the like) can move through the tubular body 202 axially within the central lumen of the inner tubular member 218, as described herein.

[0048] In the example of FIGS. 15-19, the stent coupling mechanism 210 includes a distal coupling member 222 and a proximal coupling member 224, which are spaced apart from each other by a length of the inner tubular member 218. For example, the distal coupling member 222 can be fixed to the inner tubular member 218 by an adhesive, a mechanical coupling, and / or other bonding mechanism. Also, or alternatively, the proximal coupling member 224 likewise can be fixed to the inner tubular member 218. The distal coupling member 222 can be configured and arranged in the system 200, such as described with respect to FIGS. 1-14,. Each of the coupling members 222 and 224 can also include retaining recesses of the distal and proximal coupling members, which can be in the form of respective slots 250 and channels 252,arranged and configured to hold retaining features of the stent 226 (or other implantable medical device).

[0049] As shown in FIGS. 15 and 16, the stent 226 has a generally cylindrical body and can be configured as described with respect to FIGS. 1-14. For example, the stent includes a body portion, a number of distal retaining features 230 at a distal end portion of the stent, and a number of proximal retaining features 232 at a proximal end portion of the stent. One or more (e.g., all) of the retaining features 230 and 232 include a radiopaque marker 228, such as at a central part of the retaining features.

[0050] As shown in the examples of FIGS. 15-19, the proximal coupling member 224 has a tubular sidewall extending from a distal end 248 thereof. The sidewall of the proximal coupling member 224 also includes a number of retaining recesses, which can include retaining slots 250 and respective channels 252 at circumferentially spaced apart locations along a periphery of the sidewall. As shown in FIG. 18, the proximal retaining features 232 of the stent 226 is received within a respective retaining slot 250 of the proximal coupling member 224 and extends distally therefrom in the respective channel 252. The outer sheath 214 can be placed over and around the tubular body 202 and be configured to be axially movable relative to the tubular body, in which the outer sheath is configured to hold each retaining features of the stent 226 within a respective retaining recesses responsive to the sheath extending over the retaining features of the coupling members 222 and 224. The coupling members 222 and 224, which define the stent coupling mechanism 210, are thus configured to help hold the stent in place as well mitigate unwanted displacement of the stent 226 responsive to use of the delivery system as well as during deployment of the stent 226. For example, as the outer sheath 214 is retracted axially the distal coupling member 222 helps reduce contact as well as frictional and other forces being applied from the outer sheath 214 to the distal end portion of the stent 226, thus mitigating shortening of the stent. The proximal coupling member 224 can be configured to facilitate release of the stent 226 as well as can reduce potential jumping and / or unwanted stent displacement until full release from the stent coupling mechanism 210. In some examples, such as shown in FIGS. 20 and 21, the distal coupling member 222 can be omitted from the delivery system 200.

[0051] In the example of FIGS. 15, 16, and 18 the elongated tubular stabilizer 212 is implemented as a circular helix, such as a helically cut hypotube, in which a pattern (e.g., helical or spiral) of helical cuts 254 are formed in or through the sidewall thereof. The flexibility of thetubular stabilizer can be defined according to design parameters thereof (e.g., helical angle, pitch, cutting depth into the sidewall, distance between successive turns, thickness of the sidewall, material properties, etc.).

[0052] As shown in FIGS. 15-19, the proximal coupling member 224 can be integral with the sidewall of distal end portion of the tubular stabilizer 212 (e.g., a monolithic structure formed from a single tubular part (e.g., by laser welding, etching, laser cutting, and / or other machining technologies). For example, the proximal coupling member 224 can be defined as a distal portion of the tubular sidewall that extends from a distalmost of the helical cuts 254 (e.g.. the proximal coupling member is free of helical cuts). As an example, the proximal coupling member 224 and tubular stabilizer 212 can be formed as a unified monolithic structure of one or more metals, such as stainless steel, nitinol, inconel, cobalt chrome, platinum / iridium, gold, tungsten, and / or titanium. Alternatively, the proximal coupling member and tubular stabilizer can be formed as a unified monolithic structure of one or more polymeric materials, such as fluoropolymers (e.g., PTFE, FEP, PFA, etc.), implantable grade elastomers, and / or engineered polymers (e.g., pebax, peek, polyimide).

[0053] In other examples, the proximal coupling member 224 can be an independent component that is coupled to the distal edge of the tubular stabilizer 212. For example, a proximal edge of the proximal coupling member 224 can be coaxially aligned with and coupled (e.g., affixed or bonded by an adhesive, a mechanical coupling, and / or other bonding mechanism) to the distal edge of the helically cut tubular stabilizer 212, which can thus transfer forces from the sidewall of the tubular stabilizer to the proximal coupling member for stabilizing the stent 226 (or other device) during use of the system 200. Also, or additionally, the inner sidewall of the tubular stabilizer 212 and / or the inner sidewall of the proximal coupling member 224 can be fixed to an outer surface of the inner tubular member 218 to maintain a relative axial alignment between the cylindrical sidewall of the tubular stabilizer and the inner tubular member.

[0054] As shown in FIGS. 16 and 17, the example delivery system 200 further can include one more retaining sleeves 256 around and extending radially outwardly from an outer surface of the inner tubular member at an axial location between the tip portion and the proximal coupling member. Each retaining sleeve 256 can have an outer diameter that approximates or is smaller than an inner diameter of the implantable medical device at the axial location. In the example ofFIGS. 16 and 17, each retaining sleeve has an axial length along the inner tubular member 218 that is less than half (e.g., less than 1 / 3, or less than 1 / 4) the length of the device mounting region. While three retaining sleeves 256 are shown, other numbers less than three (e.g., none, one or two) or greater than three can be used in other examples. The number and axial length of the retaining sleeves 256 can depend on the axial length of the stent 226 and thus the axial length of the device mounting region.

[0055] The sidewall and ends of each retaining sleeve 256 can have various configurations. In one example, the sidewall of one or more retaining sleeves 256 has a right circular cylinder (e.g., a constant diameter). In another example, the diameter of one or more retaining sleeves 256 has a variable diameter along its length. Also, or alternatively, the proximal and distal ends of each retaining sleeve 256 can define a plane that is normal to the longitudinal axis of the inner tubular member 218 (e.g., the sleeve has flat ends). In another example, the proximal and distal ends of one or more retaining sleeves 256 can taper in an axial direction away from the sleeve from a maximum diameter of the sleeve, such as tapering to the surface of the inner tubular member 218 or to some diameter that is between the diameter of the retaining sleeve and the diameter of the inner tubular member.

[0056] Each retaining sleeve 256 can be implemented as a flexible, pliant material that is fixed at the axial location along the inner tubular member. For example, the retaining sleeve(s) 256 can be formed of a polymer having different flexibility or hardness, such as curable polymers like silicon. The outer diameter of the retaining sleeve(s) 256 can be calibrated to form a gap between the retaining sleeve and the inner surface of the compressed stent 226 so sufficient support is provided for the stent during curved deployments. The inner surface (e.g., radially inner surface) of the retaining sleeve(s) 256 can be coupled to the outer surface of the inner tubular member 218, such as by laser welding, hot air gun, adhesive bonding, etc. While the example sleeves are shown as tubular segments that extend completely circumferentially (e.g., 360 degrees) around the inner tubular member 218, in other examples, shorter angular segments could be distributed along the inner tubular member to provide friction and stability.

[0057] FIG. 20 is a partial exploded view of another example stent delivery system 300. In FIG. 20, a stent 326 is shown separated (exploded) from the delivery system 300. The stent delivery system 300 is similar to the example system 200 of FIGS. 15-19 except the distal coupling member has been omitted. Accordingly, one may refer to the description of FIGS. 15-19 (as well as to FIGS. 1-14). For example, the delivery system 300 includes an elongated tubular body 302 that includes an elongated tubular stabilizer 312, an inner tubular member 318, a distal tip 308. The delivery system also includes an expandable medical device (e.g., a stent) 326, a proximal coupling member 324, and an outer sheath 314.

[0058] The elongated tubular stabilizer 312 has a flexible cylindrical sidewall that includes a circular helix defining at least a distal portion of the cylindrical sidewall of the tubular stabilizer. The circular helix of the cylindrical sidewall of the tubular stabilizer 312 can thus be implemented as a helically cut hypotube having a number of turns of helical cuts 354 along at least the distal portion of the sidewall of the tubular stabilizer, such as described herein.

[0059] The inner tubular member 318 has an elongated sidewall, which can define a central lumen for the elongated body of the delivery system 300. The proximal coupling member 324 is arranged at a distal end of the tubular stabilizer 312 and configured to releasably coupled to proximal retaining features of the stent 326, as described herein. The stent coupling member 324 can include a tubular sidewall extending from the distal end of the tubular stabilizer 312 to terminate in a distal end that is spaced proximally from the tip portion 308, such that a stent mounting region along the inner tubular member extends between the distal end of the stent coupling member 324 and a proximal end of the tip portion 308. The tubular sidewall of the coupling member 324 including a plurality of retaining recesses arranged along the tubular sidewall of the stent coupling member for releasably connecting to retaining features of the stent 326. The proximal coupling member 324 can be monolithic with the tubular stabilizer 312 or be a separate part that is coupled to the distal end of the tubular stabilizer. A distal end of cylindrical sidewall of the tubular stabilizer 312 and / or the proximal coupling member 324, which is coupled together end-to-end, can be affixed to an outer surface of the inner tubular member 318.

[0060] The stent delivery system 300 can also include one or more retaining sleeves 356. Each retaining sleeve 356 extends radially outwardly from an outer surface of the inner tubular member at an axial location within the stent mount location. The retaining sleeve(s) can further have an outer diameter that approximates or is smaller than an inner diameter of an expandable stent when mounted around the stent mount region in a compressed condition.

[0061] The outer sheath 314 can be placed around the inner tubular member and be movable axially relative to a central longitudinal axis of the inner tubular member. The outer sheath 314 is configured to hold each one or more retaining features of the stent 326 (or other medical device) within a respective one or more of the retaining recesses of the proximal coupling member 324 responsive to being positioned over the stent coupling member and the stent or (other medical device).

[0062] FIG. 21 is a partial exploded view of yet another example stent delivery system 400. In FIG. 21, the stent delivery system 300 is similar to the example system 300 of FIGS. 20 except the tubular stabilizer is the type and configuration described with respect to FIGS. 1-14; though, like FIG. 20, a distal coupling member has been omitted. The delivery system 400 includes an elongated tubular body 402 that includes a tip portion 408, an inner tubular member 418, a flexible elongated tubular stabilizer 412, and an outer sheath 414. The delivery system 400 also includes a proximal coupling member 424 extending from a distal end of the tubular stabilizer 412 and configured to couple to respective retaining features of the stent 426 (shown exploded from the mounting region). The delivery system 400 also includes a number of retaining sleeves arranged along the inner tubular member 418. Accordingly, one may refer to the description of FIGS. 1-14 for further description of the proximal coupling member and tubular stabilizer and to FIGS. 15-20 for the other parts.EXAMPLE EMBODIMENTS:

[0063] Several aspects of the present technology are set forth in the following numbered examples.Example 1. A delivery system, comprising: an elongated tubular body comprising: an inner tubular member having an elongated sidewall defining a central lumen that extends through the elongated tubular body: a tip portion extending distally from the inner tubular member to define a distal end of the elongated tubular body; and a tubular stabilizer having a flexible cylindrical sidewall, extending over a proximal portion of the inner tubular member, and terminating a distal end; anda device coupling mechanism at a distal end portion of the tubular body between the tip portion and the tubular stabilizer, wherein the device coupling mechanism comprises: a proximal coupling member having proximal and distal ends spaced apart from each other by a length of a sidewall thereof and extending distally from a distal end of the tubular stabilizer, the proximal coupling member comprising: one or more retaining channels in the sidewall of the proximal coupling member extending proximally from a distal edge of the proximal coupling member to terminate at an intermediate location between the proximal and distal ends of the proximal coupling member, in which the one or more retaining channels are configured to releasably receive therein a proximal retaining feature of an expandable medical device.Example 2. The system of example 1, wherein the proximal coupling member further comprises a retaining slot in the sidewall of the proximal coupling member and intersecting the one or more retaining channels at the intermediate location between.Example 3. The system of example 1 or 2, further comprising at least one retaining sleeve around and extending radially outwardly from an outer surface of the inner tubular member at an axial location between the tip portion and the proximal coupling member, the at least one retaining sleeve having an outer diameter that approximates or is smaller than an inner diameter of the implantable medical device at the axial location.Example 4. The system of example 3, wherein the at least one retaining sleeve comprise a plurality of retaining sleeves around the inner tubular member spaced axially apart at respective locations between the tip portion and the proximal coupling member. Example 5. The system of example 3, wherein the at least one retaining sleeve is a flexible, pliant material that is fixed at the axial location along the inner tubular member. Example 6. The system according to any one of the preceding examples, wherein the sidewall of the proximal coupling member is monolithic with the sidewall of the tubular stabilizer.Example 7. The system according to any one of examples 1 through 5, wherein a proximal edge of the proximal coupling member is coupled to a distal edge of the tubular stabilizer.Example 8. The system according to any one of examples 1 through 5, wherein sidewall of the tubular stabilizer defines a circular helix.Example 9. The system of example 8, wherein the sidewall of the tubular stabilizer comprises a cylindrical coil spring along at least a distal portion of the sidewall of the tubular stabilizer.Example 10. The system of example 8, wherein the sidewall of the tubular stabilizer comprises a helically cut hypotube having a number of turns along at least a distal portion of the sidewall of the tubular stabilizer.Example 11. The system of example 10, wherein the proximal coupling member is monolithic with the helically cut hypotube of the tubular stabilizer.Example 12. The system according to any one of the preceding examples, wherein the device coupling mechanism further comprises: a distal coupling member spaced distally from the proximal coupling member along the inner tubular member and having proximal and distal ends spaced apart from each other by a length of a sidewall thereof, the distal coupling member comprising: a retaining slot in the sidewall at a respective location between the proximal and distal ends of the distal coupling member; and a retaining channel extending proximally from the retaining slot to terminate at and extend through a proximal edge of the sidewall of the distal coupling member, in which the retaining slot and / or the retaining channel are configured to releasably receive therein a distal retaining feature of the implantable medical device.Example 13. The system according to any one of the preceding examples, further comprising: the medical device around the tubular body and extending between the tip portion and the proximal coupling member, in which a proximal end portion of the medical device includes a set of proximal retaining features adjacent a proximal end of the medical device, each of the set of proximal retaining features is arranged and configured to be received within a respective retaining slot of the proximal coupling member; and an outer sheath that is axially movable along the tubular body over the distal and proximal coupling members, and over the medical device when in a compressed condition.Example 14. The system of example 13, wherein the medical device comprises a stent.Example 15. A delivery system, comprising: an elongated tubular stabilizer having a flexible cylindrical sidewall extending between proximal and distal ends thereof, in which the tubular stabilizer comprises a circular helix defining at least a distal portion of the sidewall of the tubular stabilizer; an inner tubular member having an elongated sidewall extending longitudinally through the tubular stabilizer, in which a distal portion of the inner tubular member extends distally from the distal end of the tubular stabilizer to terminate in a distal end of the inner tubular member, and the inner tubular member has a central lumen extending through the elongated sidewall of the inner tubular member; a tip portion extending distally from the inner tubular member; a first device coupling member comprising a tubular sidewall extending from the distal end of the tubular stabilizer to terminate in a distal end thereof that is spaced proximally from the tip portion, in which a length of the distal portion of the inner tubular member extends between the distal end of the first device coupling member and a proximal end of the tip portion, and the tubular sidewall of the first device coupling member includes a plurality of retaining recesses arranged along the tubular sidewall of the first device coupling member; an expandable medical device around the distal portion of the inner tubular member between the tip portion and the first device coupling member, in which a proximal end portion of the medical device includes proximal retaining features arranged and configured to be received within respective retaining recesses of the first device coupling member; and an outer sheath around the inner tubular member and movable axially relative to the inner tubular member, in which the outer sheath is configured to hold each proximal retaining feature within a respective retaining recess and the medical device in a compressed condition responsive to being positioned over the medical device and the device coupling member.Example 16. The system of example 15, further comprising at least one retaining sleeve around and extending radially outwardly from an outer surface of the inner tubular member at an axial location between the tip portion and the first coupling member, the at least one retaining sleeve having an outer diameter that approximates or is smaller than an inner diameter of the medical device at the axial location when in the compressed condition.Example 17. The system of example 16, wherein the at least one retaining sleeve comprise a plurality of retaining sleeves around the inner tubular member spaced axially apart at respective locations between the tip portion and the first coupling member.Example 18. The system according to any one of examples 15, 16, or 17, wherein the sidewall of the tubular stabilizer comprises a cylindrical coil spring along at least the distal portion of the sidewall of the tubular stabilizer to define the circular helix.Example 19. The system according to any one of examples 15, 16, or 17, wherein the cylindrical sidewall of the tubular stabilizer comprises a helically cut hypotube having a number of turns along at least the distal portion of the sidewall of the tubular stabilizer to define the circular helix.Example 20. The system according to any one of examples 15, 16, 17, 18, or 19. wherein the first coupling member is monolithic with the tubular stabilizer.Example 21. The system of example 15, further comprising a second device coupling member comprising a tubular sidewall extending from the proximal end of the tip portion to terminate in a proximal end thereof that is spaced distally from and substantially coaxially with the first device coupling member, in which the tubular sidewall of the second device coupling member includes a plurality of respective retaining recesses arranged and configured to receive distal retaining features of the medical device, such that the medical device surrounds the distal portion of the inner tubular member and is releasably coupled between the first and second device coupling members.Example 22. The system according to any one of examples 15 through 21, wherein the medical device comprises a stent that is compressible and expandable between compressed and expanded conditions.Example 23. A stent delivery system, comprising: an elongated tubular stabilizer having a flexible cylindrical sidewall extends between proximal and distal ends thereof, in which the cylindrical sidewall of the tubular stabilizer comprises a circular helix defining at least a distal portion of the cylindrical sidewall of the tubular stabilizer; an inner tubular member having an elongated sidewall, defining a central lumen, extending longitudinally through the tubular stabilizer, in which a distal portion of the innertubular member, defining a stent mount region, extends distally from the distal end of the tubular stabilizer to terminate in a distal end of the inner tubular member; at least one retaining sleeve around and extending radially outwardly from an outer surface of the inner tubular member at an axial location within the stent mount location, the at least one retaining sleeve having an outer diameter that approximates or is smaller than an inner diameter of an expandable stent when mounted around the stent mount region in a compressed condition; a tip portion extending distally from the inner tubular member; a stent coupling member comprising a tubular sidewall extending from the distal end of the tubular stabilizer to terminate in a distal end that is spaced proximally from the tip portion, such that the stent mount region of the inner tubular member extends between the distal end of the stent coupling member and a proximal end of the tip portion, the tubular sidewall of the stent coupling member including a plurality of retaining recesses arranged along the tubular sidewall of the stent coupling member; and an outer sheath around the inner tubular member and movable axially relative to the inner tubular member, in which the outer sheath is configured to hold each one or more retaining features of a stent or other medical device within a respective one or more of the retaining recesses responsive to being positioned over the stent coupling member and the stent or other medical device.Example 24. The system of example 23, wherein the circular helix of the cylindrical sidewall of the tubular stabilizer comprises a coil winding of a wire having a circular or rectangular cross-section.Example 25. The system of example 23, wherein the circular helix of the cylindrical sidewall of the tubular stabilizer comprises a helically cut hypotube having a number of turns along at least the distal portion of the sidewall of the tubular stabilizer to define the circular helix.Example 26. The system according to any one of examples 23, 24, or 25, wherein the stent coupling member is monolithic with the tubular stabilizer.Example 27. The system according to any one of the preceding examples, wherein the cylindrical sidewall of the tubular stabilizer is fixed to an outer surface of the inner tubular member to maintain a relative axial alignment between the cylindrical sidewall of the tubular stabilizer and the inner tubular member.Example 28. The system of example 23, wherein the stent coupling member is a first stent coupling member, and the system further comprises a second stent coupling member having a tubular sidewall extending from the proximal end of the tip portion to terminate in a proximal end thereof that is spaced distally from and substantially coaxially with the first stent coupling member, in which the tubular sidewall of the second stent coupling member includes a plurality of respective retaining featuresExample 29. The system of example 28, further comprising: an expandable stent around the distal portion of the inner tubular member between the tip portion and the stent coupling member, in which a proximal end portion of the stent includes proximal retaining features and a distal end of the stent include distal retaining features, each arranged and configured to be received within respective retaining recesses of the first and second stent coupling members, and a body of the stent is dimensioned and configured to surround the stent mount region of the inner tubular member and opposing end features of the stent are releasably coupled between the first and second stent coupling members when surrounded by the outer sheath.Example 30. A method of using the delivery system according to any one of the preceding examples, comprising: placing the medical device or stent around the distal portion of the inner tubular member; releasably coupling retaining features of the medical device or stent with one or more retaining recesses of the coupling member; and advancing the outer sheath distally along the tubular stabilizer and over the medical device or stent to hold the medical device or stent in a compressed condition coupled with the coupling member.Example 31. The method of example 29, further comprising: retracting the outer sheath proximally along the tubular stabilizer to uncover the medical device or stent such that the medical device or stent is allowed to expand.

[0064] It is contemplated that the outer surface of the various parts of the delivery systems described herein further could include one or more coatings (e.g., a lubricant coating and / or other coating) as desired for a particular use environment.

[0065] There also may be any desired seals, gaskets, connectors, and / or other components provided to the delivery systems 100, 200, 300, 400 as appropriate for a particular use environment and can readily be provided by one of ordinary skill in the art taking into account, for example, durability, affordability, sterilizability, ease of manufacture, and / or any other desired factors or combinations thereof.

[0066] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items. It will be understood that when an element is referred to as being “on,” “attached” to. “connected” to, “coupled” with, “contacting”, “adjacent”, etc., another element, it can be directly on, attached to, connected to, coupled with, contacting, or adjacent the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on,” “directly attached” to, “directly connected” to, “directly coupled” with, “directly contacting”, or “directly adjacent” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “directly adjacent” another feature may have portions that overlap or underlie the adjacent feature, whereas a structure or feature that is disposed “adjacent” another feature might not have portions that overlap or underlie the adjacent feature.

[0067] Spatially relative terms, such as “under,” “below,” “lower,” “over,” “upper”, “proximal”, “distal”, and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms can encompass different orientations of a device in use or operation, in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features.

[0068] While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the artcould readily determine any number of tools, sequences of steps, or other means / options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and / or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for many applications. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment.

[0069] The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified— a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Unless expressly specified, substantially means + / - 5% of a stated condition or quality.

[0070] Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. For example, any of the delivery systems disclosed herein can include one or more of the various configurations of retaining sleeves and / or any of the various configurations of tubular stabilizers. A device or method incorporating any of these featuresshould be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof.

[0071] Other aspects, objects, and advantages can be obtained from a study of the drawings, the disclosure, and the appended claims.

Claims

CLAIMS1. A delivery system, comprising: an elongated tubular body comprising: an inner tubular member having an elongated sidewall defining a central lumen that extends through the elongated tubular body; at least one retaining sleeve around and extending radially outwardly from an outer surface of the inner tubular member at an axial location between the tip portion and the proximal coupling member a tip portion extending distally from the inner tubular member to define a distal end of the elongated tubular body; and a tubular stabilizer having a flexible cylindrical sidewall, extending over a proximal portion of the inner tubular member, and terminating a distal end; and a device coupling mechanism at a distal end portion of the tubular body between the tip portion and the tubular stabilizer, wherein the device coupling mechanism comprises: a proximal coupling member having proximal and distal ends spaced apart from each other by a length of a sidewall thereof and extending distally from a distal end of the tubular stabilizer, the proximal coupling member comprising: one or more retaining channels in the sidewall of the proximal coupling member extending proximally from a distal edge of the proximal coupling member to terminate at an intermediate location between the proximal and distal ends of the proximal coupling member, in which the one or more retaining channels are configured to releasably receive therein a proximal retaining feature of an expandable medical device; and at least one retaining sleeve around and extending radially outwardly from an outer surface of the inner tubular member at an axial location between the tip portion and the proximal coupling member.

2. The system of claim 1, wherein the proximal coupling member further comprises a retaining slot in the sidewall of the proximal coupling member and intersecting the one or more retaining channels at the intermediate location between.

3. The system of claim 1 or 2, wherein the at least one retaining sleeve has an outer diameter that approximates or is smaller than an inner diameter of the implantable medical device at the respective axial location of the at least one retaining sleeve.

4. The system according to any one of claims 1, 2 or 3, wherein the at least one retaining sleeve comprise a plurality of retaining sleeves around the inner tubular member spaced axially apart at respective locations between the tip portion and the proximal coupling member.

5. The system according to any one of claims 1, 2 or 3, wherein the at least one retaining sleeve is a flexible, pliant material that is fixed at the axial location along the inner tubular member.

6. The system according to any one of the preceding claims, wherein the sidewall of the proximal coupling member is monolithic with the sidewall of the tubular stabilizer.

7. The system according to any one of claims 1 through 5, wherein a proximal edge of the proximal coupling member is coupled to a distal edge of the tubular stabilizer.

8. The system according to any one of claims 1 through 5, wherein sidewall of the tubular stabilizer defines a circular helix.

9. The system of claim 8, wherein the sidewall of the tubular stabilizer comprises a cylindrical coil spring along at least a distal portion of the sidewall of the tubular stabilizer.

10. The system of claim 8, wherein the sidewall of the tubular stabilizer comprises a helically cut hypotube having a number of turns along at least a distal portion of the sidewall of the tubular stabilizer.

11. The system of claim 10. wherein the proximal coupling member is monolithic with the helically cut hypotube of the tubular stabilizer.

12. The system according to any one of the preceding claims, wherein the device coupling mechanism further comprises: a distal coupling member spaced distally from the proximal coupling member along the inner tubular member and having proximal and distal ends spaced apart from each other by a length of a sidewall thereof, the distal coupling member comprising: a retaining slot in the sidewall at a respective location between the proximal and distal ends of the distal coupling member; and a retaining channel extending proximally from the retaining slot to terminate at and extend through a proximal edge of the sidewall of the distal coupling member, in which the retaining slot and / or the retaining channel are configured to releasably receive therein a distal retaining feature of the implantable medical device.

13. The system according to any one of the preceding claims, further comprising: the medical device around the tubular body and extending between the tip portion and the proximal coupling member, in which a proximal end portion of the medical device includes a set of proximal retaining features adjacent a proximal end of the medical device, each of the set of proximal retaining features is arranged and configured to be received within a respective retaining slot of the proximal coupling member; and an outer sheath that is axially movable along the tubular body over the distal and proximal coupling members, and over the medical device when in a compressed condition.

14. The system of claim 13, wherein the medical device comprises a stent.

15. A delivery system, comprising: an elongated tubular stabilizer having a flexible cylindrical sidewall extending between proximal and distal ends thereof, in which the tubular stabilizer comprises a circular helix defining at least a distal portion of the sidewall of the tubular stabilizer; an inner tubular member having an elongated sidewall extending longitudinally through the tubular stabilizer, in which a distal portion of the inner tubular member extends distally fromthe distal end of the tubular stabilizer to terminate in a distal end of the inner tubular member, and the inner tubular member has a central lumen extending through the elongated sidewall of the inner tubular member; a tip portion extending distally from the inner tubular member; a first device coupling member comprising a tubular sidewall extending from the distal end of the tubular stabilizer to terminate in a distal end thereof that is spaced proximally from the tip portion, in which a length of the distal portion of the inner tubular member extends between the distal end of the first device coupling member and a proximal end of the tip portion, and the tubular sidewall of the first device coupling member includes a plurality of retaining recesses arranged along the tubular sidewall of the first device coupling member; an expandable medical device around the distal portion of the inner tubular member between the tip portion and the first device coupling member, in which a proximal end portion of the medical device includes proximal retaining features arranged and configured to be received within respective retaining recesses of the first device coupling member; and an outer sheath around the inner tubular member and movable axially relative to the inner tubular member, in which the outer sheath is configured to hold each proximal retaining feature within a respective retaining recess and the medical device in a compressed condition responsive to being positioned over the medical device and the device coupling member.

16. The system of claim 15, further comprising at least one retaining sleeve around and extending radially outwardly from an outer surface of the inner tubular member at an axial location between the tip portion and the first coupling member, the at least one retaining sleeve having an outer diameter that approximates or is smaller than an inner diameter of the medical device at the axial location when in the compressed condition.

17. The system of claim 16, wherein the at least one retaining sleeve comprise a plurality of retaining sleeves around the inner tubular member spaced axially apart at respective locations between the tip portion and the first coupling member.

18. The system according to any one of claims 15, 16, or 17, wherein the sidewall of the tubular stabilizer comprises a cylindrical coil spring along at least the distal portion of the sidewall of the tubular stabilizer to define the circular helix.

19. The system according to any one of claims 15, 16, or 17, wherein the cylindrical sidewall of the tubular stabilizer comprises a helically cut hypotube having a number of turns along at least the distal portion of the sidewall of the tubular stabilizer to define the circular helix.

20. The system according to any one of claims 15, 16, 17, 18, or 19, wherein the first coupling member is monolithic with the tubular stabilizer.

21. The system of claim 15, further comprising a second device coupling member comprising a tubular sidewall extending from the proximal end of the tip portion to terminate in a proximal end thereof that is spaced distally from and substantially coaxially with the first device coupling member, in which the tubular sidewall of the second device coupling member includes a plurality of respective retaining recesses arranged and configured to receive distal retaining features of the medical device, such that the medical device surrounds the distal portion of the inner tubular member and is releasably coupled between the first and second device coupling members.

22. The system according to any one of claims 15 through 21, wherein the medical device comprises a stent that is compressible and expandable between compressed and expanded conditions.

23. A stent delivery system, comprising: an elongated tubular stabilizer having a flexible cylindrical sidewall extends between proximal and distal ends thereof, in which the cylindrical sidewall of the tubular stabilizer comprises a circular helix defining at least a distal portion of the cylindrical sidewall of the tubular stabilizer; an inner tubular member having an elongated sidewall, defining a central lumen, extending longitudinally through the tubular stabilizer, in which a distal portion of the innertubular member, defining a stent mount region, extends distally from the distal end of the tubular stabilizer to terminate in a distal end of the inner tubular member; at least one retaining sleeve around and extending radially outwardly from an outer surface of the inner tubular member at an axial location within the stent mount location, the at least one retaining sleeve having an outer diameter that approximates or is smaller than an inner diameter of an expandable stent when mounted around the stent mount region in a compressed condition; a tip portion extending distally from the inner tubular member; a stent coupling member comprising a tubular sidewall extending from the distal end of the tubular stabilizer to terminate in a distal end that is spaced proximally from the tip portion, such that the stent mount region of the inner tubular member extends between the distal end of the stent coupling member and a proximal end of the tip portion, the tubular sidewall of the stent coupling member including a plurality of retaining recesses arranged along the tubular sidewall of the stent coupling member; and an outer sheath around the inner tubular member and movable axially relative to the inner tubular member, in which the outer sheath is configured to hold each one or more retaining features of a stent or other medical device within a respective one or more of the retaining recesses responsive to being positioned over the stent coupling member and the stent or other medical device.

24. The system of claim 23, wherein the circular helix of the cylindrical sidewall of the tubular stabilizer comprises a coil winding of a wire having a circular or rectangular crosssection.

25. The system of claim 23. wherein the circular helix of the cylindrical sidewall of the tubular stabilizer comprises a helically cut hypotube having a number of turns along at least the distal portion of the sidewall of the tubular stabilizer to define the circular helix.

26. The system according to any one of claims 23, 24, or 25, wherein the stent coupling member is monolithic with the tubular stabilizer.

27. The system according to any one of the preceding claims, wherein the cylindrical sidewall of the tubular stabilizer is fixed to an outer surface of the inner tubular member to maintain a relative axial alignment between the cylindrical sidewall of the tubular stabilizer and the inner tubular member.

28. The system of claim 23. wherein the stent coupling member is a first stent coupling member, and the system further comprises a second stent coupling member having a tubular sidewall extending from the proximal end of the tip portion to terminate in a proximal end thereof that is spaced distally from and substantially coaxially with the first stent coupling member, in which the tubular sidewall of the second stent coupling member includes a plurality of respective retaining features29. The system of claim 28, further comprising: an expandable stent around the distal portion of the inner tubular member between the tip portion and the stent coupling member, in which a proximal end portion of the stent includes proximal retaining features and a distal end of the stent include distal retaining features, each arranged and configured to be received within respective retaining recesses of the first and second stent coupling members, and a body of the stent is dimensioned and configured to surround the stent mount region of the inner tubular member and opposing end features of the stent are releasably coupled between the first and second stent coupling members when surrounded by the outer sheath.

30. A method of using the delivery system according to any one of the preceding claims, comprising: placing the medical device or stent around the distal portion of the inner tubular member; releasably coupling retaining features of the medical device or stent with one or more retaining recesses of the coupling member; and advancing the outer sheath distally along the tubular stabilizer and over the medical device or stent to hold the medical device or stent in a compressed condition coupled with the coupling member.31 . The method of claim 29, further comprising: retracting the outer sheath proximally along the tubular stabilizer to uncover the medical device or stent such that the medical device or stent is allowed to expand.

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