CN115734770A

CN115734770A - Delivery system for prosthetic heart valves

Info

Publication number: CN115734770A
Application number: CN202180039420.9A
Authority: CN
Inventors: C·乔巴努; T·麦斯威尔; E·伯明翰; N·克罗斯比; E·基恩; F·格林; S·K·布莱克; T·吉尔森; P·金; S·A·蒙哥马利; R·乌纳德卡特; N·福克斯; J·邓利娅; T·D·法雷尔; A·伯格
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2020-12-07
Filing date: 2021-12-07
Publication date: 2023-03-03
Also published as: WO2022125512A1

Abstract

A system for delivering an implantable medical device to an implantation location includes a control handle portion, a cannula portion coupled to the control handle portion, and a distal portion configured to receive the implantable medical device. The cannulation portion includes an outer shaft including an inner braid extending axially along the outer shaft, an outer braid extending axially along the outer shaft, and an axial spine located between the inner braid and the outer braid and extending axially along the outer shaft, wherein the outer braid has a lower braid density relative to the inner braid.

Description

Delivery system for prosthetic heart valves

Cross Reference to Related Applications

This application claims priority from U.S. provisional application No. 63/122,440, filed on 7/12/2020 and U.S. patent application No. 17/543,230, filed on 6/12/2021, each of which is incorporated herein by reference in its entirety.

Technical Field

The present technology relates generally to medical devices. And more particularly to delivery systems and methods for stents, prosthetic heart valves, and other implantable medical devices.

Background

Patients suffering from various medical conditions or diseases may require surgery to install an implantable medical device. For example, valve regurgitation or stenotic calcification of heart valve leaflets may be treated with heart valve replacement surgery. Conventional surgical valve replacement procedures require a sternotomy and cardiopulmonary bypass, which can be highly traumatic and uncomfortable to the patient. Traditional surgical valve procedures may also require long recovery times and may lead to life-threatening complications.

One alternative to traditional surgical valve replacement procedures is to use minimally invasive techniques to deliver implantable medical devices. For example, prosthetic heart valves can be delivered percutaneously and translumenally to an implantation site. In such methods, the prosthetic heart valve can be compressed or crimped over a delivery cannula for insertion into the vasculature of a patient; advancing to an implantation location; and re-expanded for deployment at the implantation site. Devices that are commonly used to access blood vessels and other locations in the body and perform various functions at those locations have medical cannulas or delivery cannulas that are adapted to deliver and deploy medical devices (such as prosthetic heart valves, stent grafts, and stents) to selected target sites within the body. Such medical devices are typically releasably carried within the distal region of the delivery cannula in a radially compressed delivery state or configuration as the cannula is guided to the target treatment/deployment site and positioned at this point. In many cases, such as those involving cardiovascular issues, the route to the treatment/deployment site may be tortuous and may present conflicting design considerations, requiring compromises between size, flexibility, material selection, operational control, etc.

Typically, the advancement of the delivery cannula within the patient is monitored by fluoroscopic methods to enable the clinician to manipulate the cannula to steer its distal end and guide it through the patient's vasculature to the target treatment/deployment site. Such tracking movement requires that the distal end of the delivery cannula be safely guided to the target treatment/deployment site by manipulation of the proximal end by the clinician. Such manipulation may include pushing, retracting, and twisting forces or a combination of the three together. It is therefore desirable that the distal end of the delivery cannula be able to withstand all of these forces.

Desirably, the delivery cannula has a low profile/small outer diameter to facilitate navigation through tortuous vasculature; however, small outer diameter cannulas present various design difficulties due to conflicting considerations, resulting in design tradeoffs. For example, such a delivery cannula must be flexible enough to be guided within the tortuous vasculature or anatomy of a patient. However, typical configurations of delivery cannulas must attempt to balance the necessary flexibility with axial strength/stiffness (a characteristic that permits the delivery cannula to be pushed and pulled) and torsional strength/stiffness (a characteristic that permits the delivery cannula to be rotated about its longitudinal axis). It is particularly important to balance these characteristics in the distal portion of the delivery cannula that houses the prosthesis in its radially compressed delivery state.

There remains a general need in the art for an improved cannula configured to be guided through or within the anatomy of a patient.

Disclosure of Invention

The technology of the present disclosure relates generally to delivery systems for implantable medical devices.

In one aspect of the disclosure, a system for delivering an implantable medical device to an implantation location includes a control handle portion, a cannula portion coupled to the control handle portion, and a distal portion for receiving the implantable medical device. The cannulation portion includes an outer shaft including an inner braid extending axially along the outer shaft, an outer braid extending axially along the outer shaft, and an axial spine extending axially along the outer shaft between the inner and outer braids, wherein the outer braid has a lower braid density relative to the inner braid.

In another aspect of the present disclosure, in a system according to any other aspect thereof, the axial spine includes a single wire that extends axially the length of the outer shaft.

In another aspect of the present disclosure, in a system according to any other aspect thereof, the outer shaft includes a proximal portion including a first jacket layer surrounding an inner braid, an outer braid, and an axial spine, a distal portion positioned distal to the proximal portion and including a second jacket layer surrounding the inner braid, the outer braid, and the axial spine, and an intermediate portion positioned between the proximal and distal portions and including a third jacket layer surrounding the inner braid, the outer braid, and the axial spine, and surrounding the inner braid, the outer braid, and the axial spine.

In another aspect of the present disclosure, in a system according to any other aspect thereof, the first jacket layer, the second jacket layer, and the third jacket layer comprise different materials.

In another aspect of the present disclosure, in the system according to any other aspect thereof, the cannula portion further includes a stabilization shaft coupled to the control handle portion and surrounding the outer shaft, wherein the stabilization shaft extends from the control handle portion to a distal position on the outer shaft.

In another aspect of the present disclosure, in a system according to any other aspect thereof, the distal position is approximately 36 inches from the control handle portion.

In another aspect of the present disclosure, the system according to any other aspect thereof further comprises a capsule coupled to the distal end of the outer shaft, wherein the capsule is actuatable to move axially from the distal portion to expose the implantable medical device.

In another aspect of the present disclosure, in a system according to any other aspect thereof, the capsule includes a flexible region having a stiffness less than a stiffness of other regions of the capsule.

In another aspect of the present disclosure, in a system according to any other aspect thereof, the flexible region of the capsule is positioned approximately 43.5mm from the proximal end of the capsule.

In another aspect of the present disclosure, in the system according to any other aspect thereof, the cannula portion further includes an intermediate shaft extending from the control handle portion and positioned within the first lumen formed by the outer shaft, and an inner shaft extending from the control handle portion and positioned within the second lumen formed by the intermediate shaft.

In another aspect of the disclosure, in the system according to any other aspect thereof, the distal portion includes a mandrel coupled to the intermediate shaft and a tip coupled to the inner shaft, wherein the tip is positioned distal of the mandrel to define a space for receiving the implantable medical device between the mandrel and the tip.

In another aspect of the disclosure, in the system according to any other aspect thereof, the tip is frustoconical and tapers linearly from the proximal end of the tip to the distal end of the tip.

In another aspect of the disclosure, the system according to any other aspect thereof further comprises an introducer slidably positioned on the outer shaft, wherein the introducer comprises an inline shield, a hub coupled to a proximal end of the inline shield, and a stop cock coupled to the hub, wherein the stop cock is configured as a three-way stop cock.

In another aspect of the disclosure, a system for delivering an implantable medical device to an implantation site includes: controlling the handle portion; a cannula portion coupled to the control handle portion at a proximal end of the cannula portion; and a distal portion configured to receive the implantable medical device. The cannula portion includes an outer shaft, a capsule coupled to a distal end of the outer shaft, and an inner shaft. The capsule can be actuated to move axially from the distal portion to expose the implantable medical device. The capsule includes a ribbed member, a sheath laminated to the ribbed member, and a flexible region having a stiffness less than other regions of the capsule due to delamination of the sheath from the ribbed member in the flexible region.

In another aspect of the present disclosure, in the system according to any other aspect thereof, the flexible region of the capsule is positioned approximately 43.5mm from the proximal end of the capsule.

In another aspect of the disclosure, in the system according to any other aspect thereof, the sheath is delaminated from the flexible region of the ribbed member by bending the capsule.

In another aspect of the present disclosure, in a system according to any other aspect thereof, the outer shaft further comprises: an inner braid extending axially along the outer shaft; an outer braid extending axially along the outer shaft; an axial spine extending axially along the outer shaft between the inner braid and the outer braid. The proximal portion of the outer shaft includes a first jacket layer surrounding the inner braid, the outer braid, and the axial spine. The distal portion of the outer shaft includes a second jacket layer surrounding the inner braid, the outer braid and the axial spine. An intermediate portion of the outer shaft between the proximal and distal portions includes a third jacket layer surrounding the inner braid, the outer braid and the inner braid, a surrounding inner braid, the outer braid and the axial spine, and a surrounding inner braid, the outer braid and the axial spine.

In another aspect of the present disclosure, a method of manufacturing a capsule for a delivery system comprises: forming a capsule comprising an inner liner, a ribbed member, and an outer jacket, wherein the outer jacket is laminated to the ribbed member; and bending the capsule at the predetermined location, wherein the bending delaminates the outer sheath from the ribbed member in an area surrounding the predetermined location.

The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in the disclosure will be apparent from the description and drawings, and from the claims.

Drawings

The foregoing and other features and advantages of the present disclosure will be apparent from the following description of the embodiments of the present disclosure, as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the disclosure. The figures are not necessarily to scale.

Fig. 1A-1D depict illustrations of a delivery system for an implantable medical device according to an embodiment thereof.

Fig. 2A-2C depict illustrations of different enlarged views of the distal end and delivery cannula of the delivery system of fig. 1A-1D, according to an embodiment thereof.

Fig. 3A and 3B depict illustrations of enlarged views of the tip and inner shaft of the delivery system of fig. 1A-1D, according to embodiments thereof.

Fig. 4A, 4B, 4C, 5A, and 5B depict illustrations of several views of a capsule 112 according to an embodiment thereof.

Fig. 6A-6E depict illustrations of several views of an outer shaft of the delivery system of fig. 1A-1D, according to an embodiment thereof.

Fig. 7A-7F depict illustrations of several views of the stabilizing shaft of the delivery system of fig. 1A-1D, according to an embodiment thereof.

Fig. 8A-8C depict an illustration of several views of an introducer of the delivery system of fig. 1A-1D, according to an embodiment thereof.

Fig. 9 depicts an illustration of a side view of the control handle portion 106 of the delivery system of fig. 1A-1D, according to an embodiment thereof.

Fig. 10A-10C depict illustrations of a prosthetic heart valve that can be used with the delivery system of fig. 1A-1D, according to embodiments thereof.

Detailed Description

Specific embodiments of the present disclosure will now be described with reference to the accompanying drawings. The following detailed description describes examples of embodiments and is not intended to limit the present technology or the application and uses of the present technology. Although the embodiments of the present disclosure are described in the context of a delivery system, the present techniques may also be used in other devices. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

The terms "distal" and "proximal" when used in the following description to refer to a delivery system or cannula are with respect to position or orientation relative to the clinician performing the treatment. Thus, "distal" and "distally" refer to positions away from or in a direction away from the clinician performing the treatment, while the terms "proximal" and "proximally" refer to positions closer to or in a direction toward the clinician.

Fig. 1A-1D illustrate examples of a delivery system 100 according to embodiments thereof. Those skilled in the art will appreciate that fig. 1A-1D illustrate one example of a delivery system, and that existing components illustrated in fig. 1A-1D may be removed and/or additional components may be added to the delivery system 100.

As shown in fig. 1A, the delivery system 100 generally includes a cannula portion 102, a distal portion 104, and a proximal control handle portion 106, the distal portion 104 being effectively controlled by the proximal control handle portion. The delivery system 100 also includes an introducer 107 configured to slide over a portion of the cannula portion 102. The cannula portion 102 is preferably of a length and size to permit controlled delivery of the distal portion 104 to a desired implantation location, such as a patient's heart. The distal portion 104 provides a means by which an implantable medical device (e.g., a prosthetic heart valve) can be mounted for delivery to an implantation site, and further provides or allows for expansion of the implantable medical device for effective deployment thereof. Introducer 107 operates to provide an access lumen for introducing delivery cannula 102 and distal end 104, including an implantable medical device, into a patient. Control handle portion 106 preferably controls the movement of the elongated structure of cannula portion 102 in translation to distal portion 104. Preferably, functions controlled by the control handle portion 106 are provided to permit expansion and deployment of the implantable medical device at a desired location, such as a heart valve annulus, and to facilitate delivery and retrieval of the delivery system through the patient's vasculature.

As illustrated in fig. 1B, which is an enlarged view of the cannula portion 102 and distal portion 104 with the introducer 107 removed, the cannula portion 102 of the delivery system 100 also preferably includes an outer shaft 108 that is also operably connected to the control handle portion 106 and that surrounds one or more inner shafts, such as an intermediate shaft 120 and an inner shaft 122, as discussed in further detail below in fig. 2A-2C. In an embodiment, the outer shaft 108 includes one or more lubricious inner layers (e.g., high density polyethylene HDPE or polytetrafluoroethylene PTFE), one or more stainless steel intermediate braided layers, an axial spine, and one or more flexible plastic outer layers, such as Pebax 7233, pebax 6333, nylon 12, vestamid ML24, as described in further detail below with reference to fig. 6A-6C. The outer shaft 108 extends from the control handle portion 106 and facilitates advancement of the delivery system 100 along a guidewire and through the vasculature of a patient by improving pushability of the delivery system 100 and by improving flexibility by including only a single axial spine.

The outer shaft 108 is operably coupled at a proximal end with the control handle portion 106 so as to be movable by operation of the handle control portion, and is connected with a shroud or capsule 112, as described in further detail below with reference to fig. 4A and 4B. In some embodiments, the capsule 112 may be a separate component coupled to the outer shaft 108. In some embodiments, the capsule 112 may be formed as an integral extension of the outer shaft 108. The capsule 112 is configured for retaining an implantable medical device (e.g., a prosthetic heart valve) in a radially collapsed configuration for delivery to a desired implantation location, as described in more detail below. That is, telescoping movement of the outer shaft 108 by operation of the control handle portion 106 causes the capsule 112 to undergo longitudinal translational movement proximally away from the distal portion 104, thereby exposing an implantable medical device, such as a self-expanding prosthetic heart valve 150, as illustrated in fig. 1C. The control handle portion 106 is further designed to control the advancement and withdrawal of the capsule 112.

In an embodiment, as shown in fig. 1B, the cannula portion 102 of the delivery system 100 further comprises a stabilizing shaft 109. A stabilization shaft 109 is operably coupled to a distal end of the control handle portion 106 and extends over a portion of the length of the outer shaft 108. In an embodiment, stabilizing shaft 109 includes a lubricious inner layer (such as high density polyethylene HDPE or polytetrafluoroethylene PTFE), a stainless steel intermediate braid, and a flexible plastic outer layer, such as composed of Vestamid Care ML24, green PMS 368, pebax 7233, or nylon 12. The stabilization shaft 109 extends from the control handle portion 106 to a desired length of the cannula portion 102 of the delivery system 102, as described in further detail below with reference to fig. 7A-7E. The stabilization shaft 109 facilitates advancement of the delivery system along a guidewire through the vasculature of a patient by improving the pushability of the delivery system 100. Also, the stabilization shaft 109 may add some stiffness to the proximal end of the cannula portion 102 to translate into a more supportive structure of the cannula portion 102. This stiffness of the stabilization shaft 109 minimizes movement of the cannula portion 102 within the anatomy during deployment of the implantable medical device, as described below. For example, the stabilizing shaft 109 as described herein assists the user in more accurately deploying the self-expanding prosthetic heart valve 150 by limiting movement of the cannula portion 102 within the anatomy during deployment.

Fig. 2A-2C illustrate various enlarged views of the distal end 104 and the delivery cannula 102 with the outer shaft 108, capsule 112, and stabilizing shaft 109 removed. As illustrated, in addition to the outer shaft 108 being operably coupled to the control handle portion 106, the delivery device 100 further includes an intermediate shaft 120 slidably disposed within the outer shaft 108 and operably coupled to the control handle portion 106. As used herein, "slidably" means along or generally parallel to the central longitudinal axis L of the delivery system 100 _A To and fro (proximally and distally) in the longitudinal direction of. The inner shaft 122 is disposed within the intermediate shaft 120. Like outer shaft 108, intermediate shaft 120 and inner shaft 122 each extend distally from within control handle portion 106.

As illustrated in fig. 1D, which isbase:Sub>A cross-sectional view of the delivery cannula 102 taken along linebase:Sub>A-base:Sub>A of fig. 1C, the outer shaft 102 defines the inner lumen 124 and is slidingly and concentrically disposed on the intermediate shaft 120. The intermediate shaft 122 defines an inner lumen 126 and is concentrically disposed over the inner shaft 122. The inner shaft 122 defines a lumen 128 such that the delivery system 100 can be slidably disposed over and moved along a guidewire 129.

The inner shaft 122 has a proximal end (not shown) terminating within the control handle portion 106, and a distal end 130, as illustrated in fig. 2B, which is a cross-sectional view taken along line B-B of fig. 2A. A tapered flexible nose cone or distal tip 132 may be coupled to the distal end 130 of the inner shaft 122. In some embodiments, the distal end 130 of the inner shaft 122 may be located within a channel 134 extending from a proximal end 136 to a distal end 138 of the distal tip 132.

Returning to fig. 2A, the intermediate shaft 120 has a proximal end (not shown) disposed within the control handle portion 106, and a distal end 121 disposed inside the capsule 112 when the capsule 112 is disposed on the implantable medical device. The distal end 121 of the intermediate shaft 120 may include a mandrel 140 to which one end of an implantable medical device is releasably coupled. In some embodiments, the distal end 121 of the intermediate shaft 120 and the mandrel 140 may include mating male and female threads to attach the mandrel 140 to the distal end 121 of the intermediate shaft 120. The inner shaft 122 is coupled to the intermediate shaft 120 at the mandrel 140 such that the inner shaft 122 and the intermediate shaft 120 are slidably disposed as an assembly within the capsule 112.

The mandrel 140 is a tubular member having at least one recess 142, such as two recesses 142, formed on an outer surface thereof, the recesses configured to receive attachment devices (e.g., paddles) extending proximally from the implantable medical device, as described in further detail below with reference to fig. 10. The at least one depression 142 may be sized and shaped to closely correspond to the size and shape of an attachment device of an implantable medical device (e.g., a paddle of a prosthetic heart valve). The attachment device fits within or mates with the recess 142 of the mandrel 140 such that the implantable medical device is releasably coupled to the intermediate shaft 120. Although only one recess 142 is visible in fig. 2A, one of ordinary skill in the art will appreciate that the mandrel 142 may include two or more recesses for receiving mating paddles of an implantable medical device, such as first and second recesses at opposing circumferential locations on the mandrel 140.

In embodiments, inner shaft 122 is configured to receive an implantable medical device, such as self-expanding prosthetic heart valve 150, on a distal portion thereof, and capsule 112 is configured to compressively retain self-expanding prosthetic heart valve 150 on the distal portion of inner shaft 122 during delivery. That is, the capsule 112 surrounds and constrains the self-expanding prosthetic heart valve 150 in a radially compressed or delivered configuration. As previously described, the distal end 121 of the intermediate shaft 120 includes a mandrel 140 to which the self-expanding prosthetic heart valve is releasably coupled. During in situ deployment of the self-expanding prosthetic heart valve, the capsule 112 is proximally retracted relative to the self-expanding prosthetic heart valve 150 via the control handle portion 106, thereby gradually exposing the self-expanding prosthetic heart valve 150 until the self-expanding prosthetic heart valve 150 is fully exposed and thus released from the delivery device 100 (e.g., mandrel 140). That is, as the outer shaft 108 and capsule 112 are retracted proximally, the intermediate shaft 120, inner shaft 122, and self-expanding prosthetic heart valve remain stationary. When the capsule 112 is proximally retracted beyond the mandrel 140, the attachment devices of the self-expanding prosthetic heart valve 150 are no longer retained within the depressions 142 of the mandrel 140, and the self-expanding prosthetic heart valve 150 is permitted to self-expand to its deployed configuration.

As further illustrated in fig. 2A, in some embodiments, the intermediate shaft 120 can include a step 123 leading from a distal portion of the intermediate shaft 120 with a larger diameter than a proximal portion. The flush tube 160 may be positioned on the smaller diameter proximal portion of the intermediate shaft 120 such that at one end of the flush tube 160 abuts the step 123. The proximal end of the irrigation tube 160 may be coupled to an irrigation hub located in the control handle portion 106. The intermediate shaft 120 may also be coupled to an irrigation hub located in the control handle portion 106. For example, the irrigation tube 160 can have an inner diameter relative to the outer diameter of the middle shaft 120 to form an annular lumen between these respective surfaces so that irrigation fluid can be delivered distally from the irrigation hub. By connecting the irrigation hub of the control handle portion 106 to the irrigation tube 160, the irrigation fluid can enter the lumen between the irrigation tube 160 and the middle shaft 120 to flow distally from that point of the delivery system 100.

For example, the irrigation tube 160 may include openings 162 that are preferably disposed near the step 123 of the intermediate shaft 120. The openings 162 may allow fluid to flow out of the lumen between the irrigation tube 160 and the middle shaft 120 through the openings 162. Thus, the opening 162 may provide fluid communication with the lumen 124 formed between the intermediate shaft 120 and the outer shaft 108. Accordingly, the flushing fluid may be delivered to the interior of the capsule 112. This fluid path allows the entire length of the delivery system 100 to be flushed through the implantable medical device to remove air from the system. With respect to each connection of the stabilization shaft 109, outer shaft 108, inner shaft 122, and irrigation tube 160 with other components of the system, an adhesive bond connection may be utilized to secure the shaft or tube ends in place. However, those skilled in the art will recognize that other bonding or securing techniques and processes may be utilized instead.

Fig. 3A and 3B show enlarged views of the tip 132 and the inner shaft 122. As shown in fig. 3A, the tip 132 may include a distal portion 302 and a proximal portion 304. The distal portion 302 of the tip 132 may include a proximal end 306 coupled to the proximal portion 304, and a distal end 308 at the distal end of the delivery system 100. In certain embodiments, the distal portion 302 and the proximal portion 304 are formed from a single piece, such as by molding. The proximal portion 304 of the tip 132 may be formed such that its diameter allows the capsule 112 to slide over the proximal portion 304 of the tip 132 and abut the proximal end 306 of the distal portion 302. The distal portion 302 of the tip 132 may have a frustoconical or tapered shape that decreases in diameter linearly from the proximal end 306 to the distal end 308 of the tip 132. The frusto-conical shape of the distal portion 302 of the tip 132 increases the ease of insertion of the distal end 104 of the delivery system 100, thereby increasing deliverability. In an embodiment, the distal portion 302 may be formed of a soft polymeric material to allow engagement with tissue of the vascular system during insertion, removal, and manipulation. In some embodiments, the distal portion 304 of the tip may be coated with a hydrophilic material. The tip 132 is shaped like an access dilator because it is longer and has a smaller taper angle. This provides for smoother insertion into the access site and artery (e.g., femoral/iliac).

In embodiments, the distal portion 302 and the proximal portion 304 can be formed in various sizes to accommodate different types and sizes of implantable medical devices. For example, in the first configuration, the proximal portion 304 may be formed to have a diameter D of approximately 0.190 inches ₃₃ And a length L of approximately 0.492 inches ₃₃ As illustrated in fig. 3B, which is a cross-sectional view taken along line C. In the first configuration, the distal portion 302 may be formed to have a diameter D of approximately 0.233 inches at the proximal end 306 ₃₁ And has a diameter D of approximately 0.07 inches at the distal end 308 ₃₂ . The distal portion 302 may also be formed such that its length L is from the proximal end 306 to the distal end 308 ₃₁ Is approximately 0.984 inches and has a length L from the distal end 308 to the distal end 130 of the inner shaft 122 ₃₂ Is approximately.0496 inches. In another example, in the second configuration, the proximal portion 304 may be formed to have a diameter D of approximately 0.251 inches ₃₃ And a length L of approximately 0.495 inches ₃₃ . In the second configuration, the distal portion 302 may be formed to have a diameter D of approximately 0.289 inches at the proximal end 306 ₃₁ And has a diameter D of approximately 0.07 inches at the distal end 308 ₃₂ . The distal portion 302 may also be formed such that its length L is from the proximal end 306 to the distal end 308 ₃₁ Is approximately 1.063 inches, and has a length L from distal end 308 to distal end 130 of the inner shaft ₃₂ Is approximately.0984 inches. One skilled in the art will recognize that any of the examples of dimensions described herein are approximate and may vary, for example +/-5.0%, based on manufacturing tolerances, operating conditions, and/or other factors.

Fig. 4A, 4B, 5A, and 5B illustrate several views of the capsule 112. As illustrated in fig. 4A, which is a side view, capsule 112 includes a body portion 402 having a proximal end 408 and a distal end 406. Capsule 112 also includes a tapered proximal portion 404 coupled to a proximal end 408 of body portion 402. The tapered proximal portion 404 is also adapted to be coupled to the outer shaft 108. The tapered proximal portion 404 of the capsule 112 tapers from the larger diameter capsule 112 to the smaller diameter outer shaft 108. As illustrated in fig. 4B, which is a cross-sectional view taken along line D-D of fig. 4A, the body portion 402 is formed into a tubular shape and includes a ribbed member 411, a capsule sheath 409, and a capsule liner 410. The ribbed member 411 is shown in more detail in fig. 4C and includes a tapered proximal portion 413, a central portion 415, and a flared distal portion 417. The plurality of slots form pillars or ribs in the ribbed member 411. The central portion 415 of the ribbed member 411 includes two spines 416, although only one spine 416 is shown in fig. 4C.

In embodiments, the capsule sheath 409 may be formed from a polymeric material or a combination of polymeric materials. For example, for some configurations, the capsule sheath 409 may be formed from a material composition comprising 66% elastic fiber 80A, 20% silicone MB50-017, 10% Orevac, and 4% Foster Medibatch White. In an embodiment, the ribbed member 411 may be formed from a rigid or semi-rigid material (such as a metal or metal alloy). For example, the ribbed member 411 may be formed from a nickel titanium alloy (e.g., nitinol). The capsule liner 410 may be formed from a polymeric material or a combination of polymeric materials. For example, for some configurations, capsule liner 410 may be formed from, for example, high density polyethylene HDPE or polytetrafluoroethylene PTFE.

The capsule sheath 409 and capsule liner 410 may be reflow soldered during manufacture, and the openings in the ribbed member 411 allow reflow soldering material (the material of the capsule sheath 409 and capsule liner 410 in semi-liquid form) to pass therethrough. Thus, the capsule sheath 409 and capsule liner 410 fuse or join together during the reflow process to enclose the ribbed member 411.

In embodiments, the capsule 112 may be formed in various sizes to accommodate different types and sizes of implantable medical devices. For example, in an embodiment, the capsule 112 may be formed to have a length L ranging between 3.3 inches to 3.8 inches ₄₁ . Also, in a second example, the capsule 112 may be formed to have a length L ranging between 4.25 inches to 4.75 inches ₄₁ 。

In an embodiment, as the distal portion 104 of the delivery system 100 tracks to the implantation location, the capsule 112 needs to undergo bending to track movement through the native anatomy. However, the capsule 112 may be formed of a material that is resistant to bending. Thus, as illustrated in fig. 5A, the capsule 112 may be adjusted to create a flexible region 500 in the capsule 112 prior to use in the delivery system 100. The flexible region 500 has been adjusted to reduce the stiffness of the flexible region 500 relative to other portions of the capsule 112. As illustrated in FIG. 5B, to adjust the capsule 112, the capsule 112 may be at an angle θ with respect to a central axis of the capsule 112 ₅₁ And (4) bending. In some embodiments, the angle θ ₅₁ May range between 45 degrees and 60 degrees, preferably 53 degrees. As described above, because the capsule 112 is formed from multiple layers of fused polymer layers, for example, the capsule sheath 409 is fused to the capsule liner 410 by the ribbed members 411, bending the capsule 112 in the flexible region 500 causes the fused polymer material to delaminate from the ribbed members 411 of the capsule 112, thereby reducing the stiffness of the capsule 112 in the flexible region 500. In an embodiment, the linear length of the adjusted portion of the capsule is in the range of 16.5 mm. Additionally, the linear length may begin approximately 43.5mm from the proximal end of the tapered proximal portion 404 of the capsule 112. The capsule 112 is bent in two directions, e.g., to the left and right, to create the flexible zone 500. In an example, the flexural rigidity of the flexible region 500 decreases in the range of 10% to 40%, or 15% to 35%, or 20% to 30% after bending as compared to the same region of the capsule prior to bending to create the flexible region 500.

Fig. 6A-6C illustrate several views of the outer shaft 108. As illustrated in fig. 6A, the outer shaft 108 is formed into a tubular shape extending from the control handle portion 106 to the capsule 112. The outer shaft 108 includes a proximal portion 602 coupled to the actuator of the control handle portion 106, a distal portion 606 positioned adjacent to the capsule 112, and an intermediate portion 604 between the proximal and

distal portions

602, 606.

As illustrated in fig. 6B, which is a cross-sectional view taken along line E-E, the outer shaft 108 is formed from a series of concentric layers that form the wall of the outer shaft 108, the inner surface of which defines the inner lumen 126. In an embodiment, the outer shaft 108 includes one or more lubricious inner layers (e.g., high density polyethylene HDPE or polytetrafluoroethylene PTFE) formed adjacent to the inner lumen 126 to allow the outer shaft 108 to move easily relative to the intermediate shaft 120. For example, the outer shaft 108 can include a first liner layer 610 and a second liner layer 612. To provide structure to the outer shaft 108, the outer shaft includes an inner braid 614 and an outer braid 616, as illustrated in fig. 6B. An intermediate backing layer 616 is formed between the inner and

outer braids

614, 616. Additionally, to provide support, a single axial spine 620 is positioned within the intermediate backing layer 616 between the inner 608 and outer 610 braided layers. Those skilled in the art will recognize that the outer shaft 108 may include one or more additional lining layers between the lubricious inner layer, the inner braid 614, the axial spine 620, and the outer braid 616.

As illustrated in fig. 6B, the outer shaft 108 includes a jacket layer 622 formed as an outermost layer. As illustrated in fig. 6A, the outer shaft 108 may also include the following jacket layers 622: it may comprise three sections: a proximal sheath layer 630 formed on proximal portion 602, an intermediate sheath layer 632 formed on intermediate portion 604, and a distal sheath layer 634 formed on distal portion 606. In an embodiment, proximal jacket layer 630, intermediate jacket layer 632, and distal jacket layer 634 may be formed of different materials. For example, proximal sheath layer 630 may be formed of Vestamid, middle sheath layer 632 may be formed of Pebax 72D, and distal sheath layer 634 may be formed of Pebax 63D. In this example, the use of Pebax 63D for the distal sheath layer allows for greater flexibility at the distal end of the outer shaft 108, while the use of Vestamid for the proximal sheath layer reduces compression in the outer shaft 108.

As illustrated in fig. 6C, which is a side view with the liner layer removed, the inner braid 614, the outer braid 616, and the axial spine 620 extend the length of the outer shaft 108 axially from the control handle portion 106 to the capsule 112. In an embodiment, the single axial spine 620 may be formed of a material that provides structural support to the outer shaft 108. For example, the unitary axial spine 620 may be formed from a metal or metal alloy (such as stainless steel). A single axial spine 620 improves trackable mobility/deliverability as compared to having multiple spines (e.g., two spines spaced 180 from each other).

Fig. 6D illustrates a side view of the outer braid 616, while fig. 6E illustrates a side view of the inner braid 914. As illustrated, the outer and inner

woven layers

616, 614 are configured to form interlocking strips of material or wires 650 of a web of material, with a first series of strips or wires 650 oriented in a first direction and a second series of strips or wires 650 oriented in a second direction. For example, the outer braid 616 and the inner braid 614 may be constructed of interlocking strips 650 of metal or metal alloy (such as stainless steel). In an embodiment, to improve stability of the outer shaft 108, the inner braid 614 may be formed with a higher density of strips or wires 650 (higher or greater braid angle) relative to the outer braid 616. For example, the inner braid 614 may be formed to have a braid density of approximately 40 Picks Per Inch (PPI) with a braid angle θ ₆₂ In the range from approximately 130 degrees to 140 degrees. The outer braid 616 may be formed to have a braid density of approximately 20PPI at a braid angle θ ₆₁ In the range from approximately 70 degrees to 80 degrees. The larger braid angle of the inner braid 614 maintains the flexibility of the shaft. The smaller braid angle of the outer braid 616 increases shaft stiffness and resists compression of the polymer in the axial direction.

In embodiments, the outer shaft 108 may be formed in various sizes to accommodate different types and sizes of implantable medical devices. For example, as illustrated in fig. 6A, in some configurations, the outer shaft 108 may be formed to have a length L of 46.81 inches ₆₁ The combination of distal portion 606 and intermediate portion 604 may be formed to have a length L of 9.8 inches ₆₂ While the distal portion 608 may be formed to have a length L of 3.9 inches ₆₂ 。

Fig. 7A-7D illustrate several views of the stabilizing shaft 109. As illustrated in fig. 7A, the stabilization shaft 109 includes a body portion 702 having a proximal end 704 and a distal end 706. As illustrated in fig. 7B, the stabilization shaft 109 may include a shaft tip 710 formed at the distal end 706. As illustrated in fig. 7C, which is a cross-sectional view taken along line F-F, the body portion 702 of the stabilizing shaft 109 includes a braid 714 having a backing layer 712 formed on an inner surface of the braid 714 and a jacket layer 716 formed on an outer surface of the braid 714. The backing layer 712 may be formed of a lubricious material, such as PTFE. The braid 714 may be formed of a metal or metal alloy, such as stainless steel. The jacket layer 716 may be formed from Vestamid.

In embodiments, the stabilizing shaft 109 may be formed in various sizes to accommodate different types and sizes of implantable medical devices. In an embodiment, the stabilizing shaft 109 is formed with a length to improve stability of the cannula portion 102 to different anatomical structures. For prosthetic heart valve deployment, ventricular motion during the initial stage of deployment may be common, requiring the user to correct by manipulating the delivery device 100. For example, for delivery and deployment of a prosthetic aortic heart valve, the delivery cannula 102 of the delivery system 100 experiences significant bending as it travels through the aorta, as illustrated in fig. 7E, which is a simplified representation of the delivery cannula path. As illustrated in fig. 7E, friction of the capsule 112 along the anatomical structure may prevent movement of the capsule 112. As the outer shaft 108 is retracted, the cannula portion 102 moves toward the inner curvature of the aorta. In other words, instead of retracting, the outer shaft 108 moves inward and the capsule 122 remains stationary. Because the intermediate shaft 120 can move relative to the outer shaft 108, the intermediate shaft 120 pushes forward to compensate for the new path, thereby making it possible for the tip 132 to enter the heart.

As illustrated in fig. 7F, the increased stiffness and length of the stabilizing shaft 109 counteracts this movement. That is, the increased stiffness and length of the stabilizing shaft 109 resists movement toward the inner curvature. In embodiments, as illustrated in fig. 7A, in some configurations, the stabilizing shaft 109 may be formed to have a length L of 36.5 inches ₇₁ . Likewise, the braid 714 may be formed to have a braid size of 0.0003 inches by 0.005 inches. In an embodiment, the stabilizing shaft 109 is about 80% of the length of the outer shaft 108 away from the handle portion 106. The stabilizing shaft 109 provides increased stiffness within the geometric constraints of the fit between the outer shaft 108 disposed within the stabilizing shaft 109 and the in-line shroud 802, as described below. Testing has shown that the increased stiffness and length of the stabilizing member 109 results in a longitudinal extent of the inflow end of the cannulated heart valve prosthesis for a delivery system for a 29mm nominal valveThe reduction in vessel movement is about 70% and results in about 40% reduction in longitudinal vessel movement at the inflow end of the cannulated heart valve prosthesis for a delivery system for a 34mm nominal valve, enabling more accurate placement of the cannulated heart prosthesis.

Fig. 8A-8C illustrate several views of the introducer 107. As illustrated in fig. 8A, the introducer 107 includes an inline shroud 802, a hub 804, and a tip ring 810. Introducer 107 may also include stop cock 806 coupled to hub 804 by tube 808. As further illustrated in fig. 8C, which is a cross-sectional view, stop cock 806 may include a valve 820 coupled between

input ports

822 and 824 and output port 826. Stop cock 806 may be actuated to place input port 822 or input port 824 in fluid communication with output port 826. Stop cock 806 may also be actuated to seal output port 826 from

input ports

822 and 824. Thus, fluid may be selectively directed to the hub 804 from either the input port 822 or the output port 824.

In an embodiment, the in-line shield 802 may be slidably disposed about the stabilization shaft 109 and/or the outer shaft 108 to extend from the control handle portion 106 to the distal portion 104. The in-line shield 802 may be made of any suitable material, such as, but not limited to, a biocompatible plastic. In an embodiment, the in-line shield 802 may include a flexible portion and a rigid portion. For example, in some embodiments, the proximal and distal portions of the inline shield 802 may be rigid, while an intermediate portion of the inline shield 802 between the proximal and distal portions may be flexible. In an embodiment, the in-line shield 802 may be made of, for example, a coil reinforced shaft with a biocompatible polymer jacket, although this is not meant to be limiting. In some embodiments, the coil reinforcing element may be a flat wire, but this is not meant to be limiting. The flexibility variability described above can be achieved by varying the pitch of the coils. In certain embodiments, the inline shield 802 may include a solder coil end to prevent flaring.

In an embodiment, the in-line shield 802 may be formed of a material that reduces friction between components, which may allow the in-line shield 802 to slide easily along the stabilization shaft 109 and/or the outer shaft 108. As illustrated in fig. 8C, which is a cross-sectional view, the in-line shroud may include a lining on its inner surface to reduce friction with the stabilizing shaft 109 and/or the outer shaft 108. In an embodiment, a tip ring 810 may be located at the distal end of the in-line shroud 802 to form an atraumatic transition with the stabilization shaft and capsule.

Fig. 9 shows a side view of the control handle portion 106. As illustrated, the control handle portion 106 includes a base 902 and an actuator 904. The actuator 904 may be used to advance and retract the outer shaft 108, thereby advancing and retracting the capsule 112. For example, during in situ deployment of the self-expanding prosthetic heart valve, the actuator 904 may be rotated to proximally retract the outer shaft 108 and capsule 112 relative to the self-expanding prosthetic heart valve 150. The actuator 904 can be incrementally rotated to incrementally expose the self-expanding prosthetic heart valve 150 until the self-expanding prosthetic heart valve 150 is fully exposed and thereby released from the delivery device 100 and the prosthetic tab 1010 has been released from the mandrel 140. Likewise, the outer shaft 108 and the capsule 112 may be advanced by rotating the actuator 904 in the opposite direction.

In addition, as shown, the control handle portion includes a proximal irrigation hub 906 and a distal irrigation hub 908. The proximal irrigation hub 906 may be in fluid communication with an irrigation tube 160 having an inner diameter related to the inner diameter of the intermediate shaft 120 to form an annular lumen between the intermediate shaft and the inner shaft such that irrigation fluid may be delivered distally from the irrigation hub 908. By connecting the proximal irrigation hub 906 of the control handle portion 106 to the irrigation tube 160, the irrigation fluid can enter the lumen between the irrigation tube 160 and the intermediate shaft 120 to flow distally from that point of the delivery system 100.

In an embodiment, an implantable medical device that may be used with the present disclosure may be available from mayonney under the trade name

Sold under the trade name Evolt available from Meindon force ^TM Pro +, and others. FIGS. 10A-10C illustrate implantable medical devices for use with the systems, devices, and methods of the present disclosureAre described herein. In particular, fig. 10A illustrates a side view of the prosthetic heart valve 1000 in a normal or expanded (uncompressed) arrangement. Fig. 10B illustrates the prosthetic heart valve 1000 in a compressed arrangement (e.g., when compressively retained within a delivery system, such as the distal portion 104 of the delivery system 100). The prosthetic heart valve 1000 includes a stent or frame 1002 and a valve structure 1004. The stent 1002 may take any of the forms described above, and is generally configured to be expandable from a compressed arrangement (fig. 10B) to an uncompressed arrangement (fig. 10A). In some embodiments, the stent 1002 is self-expanding. The valve structure 1004 is assembled to the stent 1002 and provides two or more (typically three) leaflets 1006, as shown in further detail below with reference to fig. 10C and 10D. The valve structure 1004 can be assembled to the stent 1002 in various ways, such as by suturing the valve structure 1004 to one or more wire sections or commissural posts defined by the stent 1002.

The prosthetic heart valve 1000 of fig. 10A and 10B can be configured to replace or repair an aortic valve. Alternatively, other shapes are also contemplated that are suitable for the particular anatomy of the valve to be repaired (e.g., a stent-type prosthetic heart valve according to the present disclosure may be shaped and/or sized to replace a native mitral, pulmonic, or tricuspid valve). By way of example in fig. 10A and 10B, the valve structure 204 extends less than the entire length of the stent 1002, but may extend along the entire length or nearly the entire length of the stent 1004 in other embodiments. A wide variety of other configurations are also acceptable and within the scope of the present disclosure. For example, the stent 1002 may have a more cylindrical shape when in the normal, expanded arrangement.

The stent 1002 includes support structures that include a plurality of strut or wire portions 1008 arranged relative to one another to provide the valve structure 1004 with a desired compressibility and strength. The stent 1002 can also include one or more paddles 1010 that removably couple the prosthetic heart valve 1000 to a delivery system, such as the delivery system 100. Although fig. 10A and 10B illustrate blade 1010, one skilled in the art will recognize that blade 1010 may be replaced with other components, such as eyelets, rings, slots, or any other suitable coupling member. The paddle 1010 can include one or more radiopaque markers that assist in the positioning and orientation of the prosthetic heart valve 1000. The strut or wire portion 208 forms a lumen having an inflow end 1012 and an outflow end 1014. Radiopaque markers may be included, such as adjacent the inflow end 1012 to aid in depth alignment and/or rotational orientation. The strut or wire portion 1008 may be arranged such that the strut or wire portion 1008 is capable of transitioning from a compressed arrangement to an uncompressed arrangement. The wires are arranged in a manner such that the stent 1002 is allowed to fold or compress or crimp into a compressed arrangement having an inner diameter that is smaller than an inner diameter in an uncompressed arrangement. In the compressed arrangement, such a stent 1002 with attached valve structure 1004 can be mounted to a delivery system, such as distal portion 104 of delivery system 100. The braces 1002 are configured such that they can be brought into an uncompressed arrangement when desired, such as by relative movement of one or more shrouds with respect to the length of the braces 1002.

In an embodiment, the wires of the support structure of the stent 1002 in embodiments of the present disclosure may be formed from a shape memory material, such as a nickel titanium alloy (e.g., nitinol). Due to the material, the support structure may self-expand from the compressed arrangement to the normal expanded arrangement, such as by application of heat, energy, or the like, or by removal of an external force (e.g., a compressive force). The stent 1002 may also be compressed and re-expanded multiple times without significantly damaging the structure of the stent framework. Further, the bracket 1002 of such an embodiment may be laser cut from a single piece of material, or may be assembled from a number of different components, or manufactured by various other methods known in the art.

In an embodiment, the stent 1002 can be a generally tubular support structure having an interior region in which the leaflets 1006 can be secured. The leaflets 1006 can be formed from a variety of materials, such as autologous tissue, xenograft material, or synthetic materials as are known in the art. In some embodiments, leaflets 1006 can be provided as a homogeneous biological valve structure (e.g., a porcine, bovine, or equine valve). In some embodiments, the leaflets 1006 can be provided separately from one another and subsequently assembled to the support structure of the stent 1002. In some embodiments, the stent 1002 and leaflets 1006 can be fabricated simultaneously, such as can be achieved using high strength nano-fabricated NiTi films produced by Advanced Bioprosthetic Surfaces (ABPS). The stent 1002 can be configured to house at least two (typically three) leaflets 1006, but more or less than three leaflets 1006 can be incorporated.

Fig. 10C is an end view of fig. 10A and illustrates an exemplary tricuspid valve having three leaflets 1006, although a mitral valve configuration may alternatively be used in embodiments thereof. More specifically, if the prosthetic heart valve 1000 is configured to be placed within a native valve having three leaflets (such as an aortic valve, a tricuspid valve, or a pulmonary valve), the cannulated valve prosthesis 1000 includes three valve leaflets 1006. If the cannulated valve prosthesis 1000 is configured to be placed within a native valve having two leaflets (such as a mitral valve), the prosthetic heart valve 1000 includes two valve leaflets 1006.

The leaflets 1006 can be made of pericardial material; however, the leaflets may instead be made of another material. The native tissue for replacement of valve leaflets can be obtained from, for example, a heart valve, aortic root, aortic wall, aortic leaflets, pericardial tissue (e.g., pericardial patch), bypass graft, blood vessels, intestinal submucosal tissue, umbilical cord tissue, and the like, from a human or animal. Synthetic materials suitable for use as leaflets 1004 include those commercially available from Invista North America s.a.r.l. of wilmington, terawal

Polyester, other cloth materials, nylon blends, polymeric materials, and vacuum deposited nitinol fabrication materials. One polymeric material that can be made into leaflets is an ultra high molecular weight polyethylene material, which is commercially available under the tradename DYNEEMA from DSM, royal, the Netherlands. For certain leaflet materials, it may be desirable to cover one or both sides of the leaflet with a material that prevents or minimizes overgrowth. It is further desirable that the leaflet material be durable and not stretch, deform or fail.

Delivery of the prosthetic heart valve 1000 can be accomplished via a percutaneous transfemoral or transapical approach via an open chest procedure directly through the apex of the heart, or can be positioned within a desired region of the heart via different delivery methods known in the art for accessing the heart valve. During delivery, if self-expanding, the prosthetic valve remains compressed until it reaches the targeted diseased native heart valve, at which point the prosthetic heart valve 1000 can be released from the delivery cannula and permitted to expand in place via self-expansion. The delivery cannula is then removed and the prosthetic heart valve 1000 remains deployed within the native target heart valve.

In embodiments herein, the stent 1002 is self-expanding to return from a compressed or constricted delivery state to an expanded deployed state and may be made of stainless steel, pseudoelastic metals (such as nitinol or nitinol, etc.), or so-called superalloys (which may have a base metal such as nickel, cobalt, chromium, or other metals). As used herein, "self-expanding" refers to a structure/component having a mechanical memory to return to an expanded or deployed configuration. Mechanical memory may be imparted to the wire or tubular structure forming the stent 1002 by heat treatment to achieve spring tempering in, for example, stainless steel or to provide shape memory in susceptible metal alloys such as nitinol or polymers such as any of the polymers disclosed in U.S. patent application publication No. 2004/0111111 issued to Lin, the entire contents of which are incorporated herein by reference. Alternatively, the prosthetic heart valve 1000 can be balloon expandable, as will be appreciated by those of ordinary skill in the art.

Although the components of the delivery system 100 are described above with the relative terms "first," "second," "proximal," and "distal," one skilled in the art will recognize that the use of these terms is intended only to identify the components of the delivery system 100 and does not define any preferred or sequential arrangement of the components of the delivery system 100.

As used herein, the term "substantially" when referring to a dimension refers to plus or minus 10% of the dimension.

It is to be understood that the various embodiments disclosed herein may be combined in different combinations than those specifically presented in the description and drawings. It will also be understood that, according to an example, some acts or events of any process or method described herein may be performed in a different order, may be added, merged, or not performed at all (e.g., all described acts or events may not be necessary for performing the technique). Further, while certain aspects of the disclosure are described as being performed by a single device or component for clarity, it should be understood that the techniques of the disclosure may be performed by a combination of devices or components associated with, for example, a medical device.

Claims

1. A system for delivering an implantable medical device to an implantation site, the system comprising:

controlling the handle portion;

a cannula portion coupled to the control handle portion at a proximal end of the cannula portion, the cannula portion including an outer shaft, wherein the outer shaft includes:

an inner braid extending axially along the outer shaft;

an outer braid extending axially along the outer shaft, wherein the outer braid has a lower braid density relative to the inner braid; and

an axial spine located between the inner braid and the outer braid extending axially along the outer shaft; and

a distal portion configured to receive the implantable medical device.

2. A system as in claim 1, wherein the axial spine comprises a single wire that extends axially a length of the outer shaft.

3. The system of claim 1, wherein the outer shaft further comprises:

a proximal portion comprising a first jacket layer surrounding the inner braid, the outer braid and the axial spine;

a distal portion positioned distal of the proximal portion and comprising a second jacket layer surrounding the inner braid, the outer braid, and the axial spine; and

a middle portion between the proximal and distal portions and including a third jacket layer surrounding the inner braid, the outer braid and the axial spine, surrounding the inner braid, the outer braid and the axial spine.

4. The system of claim 3, wherein the first jacket layer, the second jacket layer, and the third jacket layer comprise different materials.

5. The system of claim 1, wherein the cannula portion further comprises:

a stabilizing shaft coupled to the control handle portion and surrounding the outer shaft, wherein the stabilizing shaft extends from the control handle portion to a distal position on the outer shaft.

6. The system of claim 5, wherein the distal position is approximately 36 inches from the control handle portion.

7. The system of claim 1, further comprising:

a capsule coupled to a distal end of the outer shaft, wherein the capsule is actuatable to move axially from the distal portion to expose the implantable medical device.

8. The system of claim 7, wherein the capsule comprises a flexible region having a stiffness less than other regions of the capsule.

9. The system of claim 8, wherein the flexible region of the capsule is positioned approximately 43.5mm from the proximal end of the capsule.

10. The system of claim 1, wherein the cannula portion further comprises:

an intermediate shaft extending from the control handle portion and positioned within a first lumen formed by the outer shaft; and

an inner shaft extending from the control handle portion and positioned within a second lumen formed by the middle shaft.

11. The system of claim 9, wherein the distal portion comprises:

a spindle coupled to the intermediate shaft; and

a tip coupled to the inner shaft, wherein:

the tip is positioned distal to the mandrel to define a space for receiving the implantable medical device.

12. The system of claim 11, wherein the tip is frustoconical, tapering linearly from a proximal end of the tip to a distal end of the tip.

13. The system of claim 1, further comprising:

an introducer slidably positioned on the outer shaft, wherein the introducer comprises:

an inline shroud;

a hub coupled to a proximal end of the inline shield; and

a stop cock coupled to the hub, wherein the stop cock is configured as a three-way stop cock.

14. A system for delivering an implantable medical device to an implantation site, the system comprising:

controlling the handle portion; and

a cannula portion coupled to the control handle portion at a proximal end of the cannula portion, the cannula portion comprising an outer shaft, a capsule coupled to a distal end of the outer shaft, and an inner shaft; and

a distal portion configured to receive the implantable medical device between the inner shaft and the capsule,

wherein the capsule is actuatable to move axially from the distal portion to expose the implantable medical device, and wherein the capsule is tubular and comprises:

a ribbed member;

a jacket laminated to a portion of the ribbed member; and

a flexible region having a stiffness less than other regions of the capsule due to delamination of the sheath from the ribbed member in the flexible region.

15. The system of claim 14, wherein the flexible region of the capsule is positioned approximately 43.5mm from the proximal end of the capsule.

16. The system of claim 14, wherein the sheath is delaminated from the ribbed member in the flexible region by bending the capsule.

17. The system of claim 14, wherein the outer shaft further comprises:

an inner braid extending axially along the outer shaft;

an outer braid extending axially along the outer shaft; and

an axial spine located between the inner braid and the outer braid extending axially along the outer shaft;

wherein:

the proximal portion of the outer shaft further comprises a first jacket layer surrounding the inner braid, the outer braid, and the axial spine;

a distal portion of the outer shaft positioned proximal of the capsule comprises a second jacket layer surrounding the inner braid, the outer braid, and the axial spine; and is

The intermediate portion of the outer shaft between the proximal and distal portions further includes a third jacket layer surrounding the inner braid, the outer braid and the axial spine, surrounding the inner braid, the outer braid and the axial spine.

18. The system of claim 17, wherein the first jacket layer, the second jacket layer, and the third jacket layer comprise different materials.

19. A system as in claim 17, wherein the axial spine comprises a single wire that extends axially a length of the outer shaft.

20. The system of claim 14, wherein the cannula portion further comprises:

21. The system of claim 20, wherein the distal position is approximately 36 inches from the control handle portion.

22. A method of manufacturing a capsule of a delivery system for delivering an implantable medical device to an implantation site, the system comprising:

forming the capsule comprising an inner liner, a ribbed member, and an outer jacket, wherein the outer jacket is laminated to the ribbed member; and

bending the capsule at a predetermined location, wherein the bending delaminates the outer sheath from a ribbed member located in a surrounding area of the predetermined location.