Delivery device with stabilizing tube with compressible region

Abstract

A catheter prosthetic heart valve delivery device includes an inner shaft assembly having a coupling structure configured to selectively engage a prosthetic heart valve; a delivery sheath assembly having a balloon and slidably disposed on the inner shaft assembly; and an outer stabilization tube coaxially received on the delivery sheath assembly and having a compressible region. When the balloon retracts, the balloon contacts the distal end of the outer stabilizing tube, and as the balloon further retracts to the proximal side, the balloon applies a force to the distal end of the outer stabilizing tube, which force ultimately overcomes the biasing force of the compressible region, causing the outer stabilizing tube to retract with the balloon, allowing the outer stabilizing tube to be longer, and allowing the outer stabilizing tube to be longer. Higher stability is provided than when the compressible region is absent.

Description

Technical Field

[0001] The present technology generally relates to transcatheter prosthetic heart valve delivery devices. Background Art

[0002] The human heart includes four heart valves that define the path of blood flow through the heart: the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. The mitral valve and tricuspid valve are atrioventricular valves, which are located between the atria and ventricles, while the aortic valve and pulmonary valve are semilunar valves, which are located in the arteries leaving the heart. Ideally, when the valve is in the open position, the native leaflets of the heart valve move apart from each other, and when the valve is in the closed position, these native leaflets meet or "close together". Possible problems with the valve include stenosis that causes the valve to be unable to open normally and / or insufficiency or regurgitation that causes the valve to be unable to close normally. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or regurgitation typically causing relatively severe physiological consequences for the patient.

[0003] Diseased or otherwise defective heart valves can be repaired or replaced using a variety of different types of heart valve surgery. One conventional technique involves an open-heart surgical approach performed under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine.

[0004] Recently, minimally invasive methods have been developed to facilitate the implantation of prosthetic heart valves or prostheses onto a beating heart in a catheter-based manner, thereby aiming to avoid the need to use traditional sternotomy and cardiopulmonary bypass. Generally speaking, an expandable prosthetic valve is compressed around or within a catheter, inserted into a patient's body cavity (such as the femoral artery), and delivered to the desired location in the heart.

[0005] The heart valve prosthesis adopted by catheter-based surgery or transcatheter surgery generally includes an expandable multi-level framework or stent, which supports a valve structure with multiple leaflets. The framework can be contracted during percutaneous intraluminal delivery and expand when deployed at or in the native valve. A type of valve stent can be initially provided in an expanded or uncurled arrangement, and then curled or compressed around the balloon portion of the catheter. The balloon is then inflated to expand the prosthetic heart valve and deploy it. In the case of other stented prosthetic heart valve designs, the stent frame is formed to self-expand. In the case of these systems, the stent with valve is curled to the desired size and is kept in the sheath in this compressed state for transluminal delivery. Retracting the sheath from the stent with valve allows the stent to self-expand to a larger diameter, thereby being fixed at the native valve site. Once the prosthetic valve is positioned at the treatment site, such as in a functionally deficient native valve, the stent frame structure can be expanded to firmly hold the prosthetic valve in place.

[0006] The present disclosure addresses problems and limitations associated with the related art. Summary of the invention

[0007] The technology of the present disclosure generally relates to transcatheter valve delivery / deployment systems and devices including an outer stabilizing tube. Such a delivery device generally includes a handle assembly, a delivery sheath assembly, an inner shaft assembly, and an outer stabilizing tube. The delivery sheath assembly includes a capsule that is used to sheath a prosthetic heart valve maintained on the inner shaft assembly during delivery. In the delivery state, the prosthetic heart valve is compressed on the inner shaft and within the capsule. The outer stabilizing tube is disposed on the delivery sheath assembly. The outer stabilizing tube isolates the delivery sheath assembly from an introducer located at the farthest end of the delivery device, and when the delivery sheath assembly is retracted to unsheath the prosthetic heart valve and deploy the prosthetic heart valve, the outer stabilizing tube stabilizes the inner shaft assembly and the delivery sheath assembly while anchoring the delivery device relative to the patient's anatomy.

[0008] The outer stabilizing tube is sized so that its distal end is proximally spaced from the capsule (in the delivery state) by a distance approximately equal to the length of the capsule itself. This allows the delivery sheath assembly and the capsule to be fully retracted to release and deploy the prosthetic heart valve. If the outer stabilizing tube is extended closer to the capsule (e.g., if the outer stabilizing tube is sized so that its distal end is proximally spaced from the capsule (in the delivery state) by a distance approximately less than the length of the capsule itself), improved device stability can be provided during deployment of the prosthetic heart valve. Therefore, aspects of the present disclosure include providing an outer stabilizing tube having a compressible region biased to an uncompressed state. By this method, the distal end of the outer stabilizing tube can be positioned close to or adjacent to the capsule in the delivery state. When the capsule is retracted, the capsule contacts the distal end of the outer stabilizing tube, and as the capsule is further retracted proximally, the capsule applies a force to the distal end of the outer stabilizing tube, which eventually overcomes the biasing force of the compressible region, thereby causing the outer stabilizing tube to move proximally and retract with the capsule.

[0009] In one aspect, the present disclosure provides a transcatheter prosthetic heart valve delivery device, which includes: an inner shaft assembly having a coupling structure configured to selectively engage a prosthetic heart valve; a delivery sheath assembly that is slidably disposed on the inner shaft assembly; and an outer stabilizing tube that is coaxially received on the delivery sheath assembly and has a first portion and a compressible region. The axial compressive strength of the compressible region is less than the axial compressive strength of the first portion. The device further includes a handle assembly that maintains the inner shaft assembly, the delivery sheath assembly, and the outer stabilizing tube. The handle assembly includes a housing fixed to the inner shaft assembly, and an actuator mechanism maintained by the housing and connected to the delivery sheath assembly. The actuator mechanism is operable to selectively move the delivery sheath assembly relative to the inner shaft assembly.

[0010] In another aspect, the present disclosure provides a transcatheter prosthetic heart valve delivery device, the transcatheter prosthetic heart valve delivery device comprising: an inner shaft assembly configured to selectively engage a prosthetic heart valve; an outer stabilizing tube; and a handle assembly that maintains the inner shaft assembly and the outer stabilizing tube. The handle assembly has a housing fixed to the inner shaft assembly and a biasing member connecting the outer stabilizing tube to the housing.

[0011] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in the disclosure will become apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1is a partially exploded perspective view of a delivery device for delivering a prosthetic heart valve, the delivery device including an outer stabilizing tube having a compressible region within a handle assembly.

[0013] Figure 2A yes Figure 1 A cross-sectional view of a delivery device in a delivery state with the prosthetic heart valve omitted for clarity.

[0014] Figure 2B yes Figure 2A A cross-sectional view of a delivery device in a deployed state with the prosthetic heart valve omitted for clarity.

[0015] Figure 3 is a cross-sectional view of an alternative delivery device for delivering a prosthetic heart valve, the delivery device including an outer stabilizing tube having a compressible region adjacent a handle assembly.

[0016] Figure 4 is a cross-sectional view of yet another delivery device for delivering a prosthetic heart valve, the delivery device including an outer stabilizing tube having a compressible region between two sheath portions of the outer stabilizing tube. DETAILED DESCRIPTION

[0017] The specific embodiments of the present disclosure will now be described with reference to the accompanying drawings, wherein identical reference numerals indicate identical or functionally similar elements. In the following description, the terms "distal" and "proximal" are used relative to the position or direction of the treatment clinician. "Distal" or "distalward" is a position away from the clinician or on the direction away from the clinician. "Proximal" and "proximal" are positions near the clinician or on the direction towards the clinician.

[0018] Figures 1 to 2B Components of a non-limiting example of a delivery device 10 are shown in FIG. The delivery device 10 is arranged and configured for percutaneous delivery of a cardiac prosthesis 12, such as a stented prosthetic heart valve or stent. Figure 1 , which shows an exploded perspective view, the delivery device 10 includes an outer stabilizing tube assembly 14 , a delivery sheath assembly 16 , an inner shaft assembly 18 , and a handle assembly 20 .

[0019] The inner shaft assembly 18 includes a proximal inner shaft 17 and a distal shaft 22 having a nose cone 30 disposed at the distal end of the distal inner shaft 22. The nose cone 30 may be conical or otherwise adapted to promote non-traumatic contact with body tissue. The distal inner shaft 22 may be continuous with the proximal inner shaft 17, or may be optionally coupled to the proximal inner shaft 17 via a retainer 24. For example, the retainer 24 couples the proximal end of the distal inner shaft 22 to the distal end of the proximal inner shaft 17. In addition to coupling the proximal inner shaft 17 to the distal inner shaft 22, the retainer 24 may also have one or more recesses oriented to retain one or more protrusions of the prosthesis 12 to secure the prosthesis 12 to the inner shaft assembly 18 in a radially compressed configuration for percutaneous delivery to a treatment site (e.g., a patient's heart).

[0020] The delivery sheath assembly 16 includes a delivery tube 25 and a balloon 26 disposed at the distal end of the delivery tube 25. The balloon 26 extends distally from the delivery tube 25 a distance L1 and has an internal volume that is oriented to encapsulate the prosthesis 12 in a radially compressed configuration for percutaneous delivery to a treatment site. The outer stabilizing tube assembly 14 includes an outer stabilizing tube 40 and a compressible member 42, the outer stabilizing tube having a distal end 28. The inner shaft assembly 18, the delivery sheath assembly 16, and the outer stabilizing tube assembly 14 are sized to be concentrically arranged, with the proximal inner shaft 17 concentrically positioned within the delivery tube 25, and the delivery tube 25 concentrically positioned within the outer stabilizing tube 40. Any one or more of the outer stabilizing tube assembly 14, the delivery sheath assembly 16, and the inner shaft assembly 18 may be a single integrally formed component, or may alternatively include multiple interconnected components.

[0021] The handle assembly 20 includes a housing 34 and an actuator 32 that is configured to move one or more of the inner shaft assembly 18, the delivery sheath assembly 16, and the outer stabilizing tube assembly 14. For example, the actuator 32 can be configured to move the delivery sheath assembly 16 proximally and / or distally relative to the inner shaft assembly 18. Proximally moving the delivery sheath assembly 16 relative to the inner shaft assembly 18 causes the balloon 26 to move proximally relative to the distal inner shaft 22, thereby unsheathing the radially compressed prosthesis 12. When the prosthesis 12 is unsheathed by the proximally moving balloon 26, the prosthesis 12 radially expands until the entire prosthesis 12 is unsheathed and deployed at the treatment site. Distally moving the delivery sheath assembly 16 relative to the inner shaft assembly 18 causes the balloon 26 to move distally relative to the distal inner shaft 22, thereby re-sheathing or recapturing the radially expanded portion of the prosthesis 12.

[0022] like Figure 2A and Figure 2B As shown, it shows the delivery device 10 in the delivery state ( Figure 2A ) and deployment status ( Figure 2B), the proximal inner shaft 17 of the inner shaft assembly 18 extends axially along the delivery tube 25 of the delivery sheath assembly 16 and within the delivery tube from the handle assembly 20 to the distal side. Similarly, the delivery tube 25 extends axially along the outer stabilizing tube 40 of the outer stabilizing tube assembly 14 and within the outer stabilizing tube from the handle assembly 20 to the distal side. The capsule 26 extends distally from the delivery tube 25 along the distal inner shaft 22 toward the nose cone 30 and encapsulates the compressed prosthesis 12 (not shown) and the retainer 24. The proximal end of the capsule 26 is axially spaced from the distal end 28 of the outer stabilizing tube 40.

[0023] Once the prosthetic heart valve 12 is loaded, compressed and covered by the balloon 26 of the delivery sheath assembly 16 in the delivery state, the prosthetic heart valve can be delivered to the target site, such as the native heart valve. During the deployment of the prosthetic heart valve 12 at the target site, the outer stabilizing tube 40 improves the stability of the delivery sheath assembly 16 and the inner shaft assembly 18 by inhibiting the tendency of these components to move from the outer curvature of the anatomical structure to the inner curvature (for example, when traveling along the aortic arch). When the prosthetic heart valve 12 is located at the target site, the delivery sheath assembly 16 and the balloon 26 are withdrawn proximally relative to the distal inner shaft portion 22 of the inner shaft assembly 18 and the prosthetic heart valve 12 loaded thereon, so that the proximal end of the balloon 26 contacts the distal end 28 of the outer stabilizing tube assembly 14. When the balloon 26 is withdrawn proximally in the deployed state, the prosthetic heart valve 12 is allowed to expand to the expanded arrangement, so that the prosthetic heart valve 12 is partially released from the distal inner shaft portion 22 of the inner shaft assembly 18 and the retainer 24 and finally fully deployed. In some embodiments, the prosthetic heart valve 12 can be expanded using any known technique, such as using an expandable balloon, or if the prosthetic heart valve 12 is made of a shape memory material that is configured to be biased toward the expanded arrangement, it can be expanded naturally. If it is desired to recapture the prosthetic heart valve 12 for repositioning the prosthesis or repair surgery, the balloon 26 can be advanced distally before the prosthesis is fully deployed.

[0024] In addition, in the deployed state, the delivery sheath assembly 16 applies a longitudinal force to the outer stabilizing tube assembly 14 at the interface between the balloon 26 and the distal end 28 of the outer stabilizing tube 40 when it is proximally retracted relative to the handle assembly 20. The distal and proximal movement of the delivery sheath assembly 16, including the delivery tube 25 and the balloon 26, relative to the prosthetic heart valve 12 can be actuated by the handle assembly 20. The handle assembly 20 can adopt many configurations to support the delivery sheath assembly 16 and the inner shaft assembly 18, and also control the movement of each of these components. In one example, the handle assembly 20 can include an actuator mechanism 32 that is rotatable so that the rotational movement of the actuator mechanism 32 about the central longitudinal axis of the handle assembly 20 corresponds to the translational movement of the delivery sheath assembly 16 to move the balloon 26 relative to the inner shaft assembly 18, thereby sheathing or unsheathing the prosthetic heart valve 12. Any other actuator mechanism capable of controlling the movement of the balloon 26 is considered to be within the scope of the present disclosure.

[0025] In one example, the compressible region or member 42 of the outer stabilizing tube assembly 14 is positioned within the housing 34 of the handle assembly 20 such that the compressible region 42 abuts the inner surface 36 of the housing 34 (which, in some examples, can be considered a component within the housing 34). The compressible region 42 can provide a biasing force to push the distal end 28 of the outer stabilizing tube 40 to a distal-most position during delivery of the prosthetic heart valve 12, and can also be compressed against the inner surface 36 to reduce its length. For example, Figure 2A The compressible region 42 is shown having a first length L2 in a relatively uncompressed configuration, thereby biasing the outer stabilizing tube 40 in a distal direction toward the balloon 26 so that the distal end 28 of the outer stabilizing tube 40 is in a distal-most position during delivery of the prosthetic heart valve 12. Figure 2B , when the delivery sheath assembly 16 is retracted proximally, the balloon 26 abuts the distal end 28 of the outer stabilizing tube 40, thereby applying an axial compressive force to the outer stabilizing tube assembly 14, thereby causing the compressible region 42 to compress to a shorter second length L3. The compressible region 42 of the outer stabilizing tube assembly 14 has a relatively low axial compressive strength compared to the relatively high axial compressive strength of other portions of the outer stabilizing tube 40. In some examples, the compressible region 42 has a lower axial compressive strength than adjacent portions of the outer stabilizing tube 40. Therefore, when subjected to an axial compressive force greater than the biasing force of the compression region 42 imparted by the proximal retraction of the delivery sheath assembly 16, the compression region 42 is configured to compress and decrease in length from L2 to L3.

[0026] In some embodiments, the outer stabilizing tube 40 may be sized such that the distal end 28 is proximally spaced from the balloon 26 (in the delivery state) by a distance approximately equal to or greater than the longitudinal length L1 of the balloon 26 itself to ensure that the outer stabilizing tube assembly 14 does not obstruct full retraction of the balloon 26. Such sizing allows the delivery sheath assembly 16 and the balloon 26 to be fully retracted to release and deploy the prosthetic heart valve 12. During prosthesis deployment, improved stability is provided when the outer stabilizing tube 40 is extended closer to the balloon 26 and the distance between the distal end 28 of the outer stabilizing tube 40 and the balloon 26 is less than the length L1 of the balloon 26. Thus, compared to prior embodiments in which the distance between the distal end 28 of the outer stabilizing tube 40 and the balloon 26 is approximately equal to or greater than the length L1 of the balloon 26, embodiments of the present disclosure include increasing the length of the outer stabilizing tube 40 such that the distal end 28 of the outer stabilizing tube 40 is closer to the balloon 26 by a predetermined distance defined as less than the length L1 of the balloon 26. When the balloon 26 is retracted to deploy the prosthetic heart valve 12, the balloon 26 contacts the distal end 28 of the outer stabilizing tube 40, and as the balloon 26 is further retracted proximally, the balloon 26 applies a force to the distal end 28 of the outer stabilizing tube 40. This force eventually overcomes the biasing force of the compressible region 42, thereby allowing the outer stabilizing tube 40 to be retracted together with the balloon 26. The handle assembly 20 can be configured to allow the outer stabilizing tube 40 to be retracted proximally relative to the handle assembly 20 when the compressive force applied to the outer stabilizing tube 40 overcomes the biasing force of the compressible region 42. For example, by spacing the distal end 28 of the outer stabilizing tube 40 from the balloon 26 by a distance less than the length L1 of the balloon 26, the delivery sheath assembly 16 applies a force to the outer stabilizing tube 40 that overcomes the biasing force of the compressible region 42 when the inner shaft assembly 18 is retracted proximally.

[0027] The compressible region 42 of the embodiments disclosed herein can take many forms. In the illustrated example, the compressible region 42 is formed at least in part by a biasing member (such as a compression spring) connected to the outer stabilizing tube 40. The compressible region 42 can optionally be hollow, tubular, or otherwise define a longitudinal opening through which other components of the delivery device 10 (e.g., one or more of the delivery tube 25, the inner shaft 17, a guidewire (not shown), and one or more irrigation lumens (not shown)) can be positioned and / or moved. In other examples, the compressible region 42 can be made of one or more materials (such as foam or other elastic compressible materials) capable of applying a biasing force. Some non-limiting examples of compressible materials include polymers, foams, rubbers, braid / coil constructions, laser-cut hypotubes, or other structures with compressible geometries, all of which have a compressive strength less than the comparable compressive strength of the outer stabilizing tube 40, such that the compressible region 42 is configured to compress before the outer stabilizing tube 40 is subjected to the applied compressive load.

[0028] Figure 3 A cross-sectional view of another delivery device 110 is shown, which, unless otherwise indicated, is similar to Figures 1 to 2B The same or similar to the delivery device 10 of the present invention. In this example, the delivery device 110 includes an outer stabilizing tube assembly 114, which is coaxially positioned on the delivery sheath assembly 16 and has a compressible region 142 and an outer stabilizing tube 140. The compressible region 142 is at least partially (if not completely) positioned outside the housing 34 of the handle assembly 20. In this example, the compressible region 142 is positioned to abut the outer surface 136 of the housing 34, so that the compressible region 142 is directly or indirectly compressed against the outer surface 136 of the housing 34. For example, in some embodiments, the compressible region 142 can be directly compressed against the outer surface 136, but in other examples, unspecified elements can be positioned between the outer surface 136 and the compressible region 142. The compressible region 142 can take any form disclosed herein. It is further contemplated that the compressible region 142 can optionally include a covering 144 to prevent anatomical structures or operating materials (including but not limited to surgical drapes, operator gloves, etc.) from being pinched. In some examples, the outer diameter of the compressible region 142 is equal to the outer diameter of the outer stabilizing tube 140 to provide a substantially seamless transition from the outer stabilizing tube 140 to the compressible region 142 in the delivery state (ie, when the compressible region 142 is not compressed).

[0029] Figure 4 A cross-sectional view of another alternative delivery device 210 is shown, which, unless otherwise noted, is similar to the Figures 1 to 2BThe delivery device 210 is the same or similar to the delivery device 10 of the present invention. In this example, the delivery device 210 includes an outer stabilizing tube assembly 214 having a compressible region 242. The compressible region 242 is positioned completely outside the housing 34 of the handle assembly 20, between the distal portion 240a of the outer stabilizing tube 240 and the proximal portion 240b of the outer stabilizing tube 240. The compressible region 242 can optionally be positioned so that it is located within the patient's body during delivery of the prosthetic heart valve 12. The proximal portion 240b of the outer stabilizing tube 240 can have sufficient stiffness along its length to allow the compressible region 242 to effectively compress against the proximal portion 240b without compressing the proximal sheath portion 240b. Alternatively, the proximal portion 240b can be constructed to have a varying stiffness from the compressible region 242 to the handle assembly 20. For example, the proximal sheath portion 240b can have a compressive stiffness that increases in a direction defined from the compressible region 242 toward the handle assembly 20, thereby providing a variable stiffness that allows the compressible region 242 and a portion of the proximal sheath portion 240b to compress when subjected to an applied load. The compressible region 242 can take any form disclosed herein and can optionally include a covering (e.g., covering 144) as disclosed above. In some examples, the outer diameter of the compressible region 242 is equal to the outer diameter of the distal portion 240a and / or the proximal portion 240b of the outer stabilizing tube 240 and is a seamless transition. The outer stabilizing tube assembly 214 can be a sheath having multiple interconnected portions that have variable compressibility. The outer stabilizing tube assembly 214 can be made of one or more materials to provide variations in compressibility and biasing force in one or more regions.

[0030] As mentioned herein, the prosthetic heart valves used with the various devices and methods of the present disclosure can adopt a variety of configurations (e.g., bioprosthetic heart valves with tissue leaflets, or synthetic heart valves with polymer leaflets, metal leaflets, or tissue engineered leaflets), and can be particularly constructed for replacing valves of human hearts. The prosthetic heart valves of the present disclosure can be self-expanding, balloon-expandable, and / or mechanically expandable, or a combination of the above. The prosthetic heart valves of the present disclosure include a stent or stent frame having an inner cavity that maintains a valve structure (tissue or synthetic), wherein the stent frame has a normal expanded state or arrangement, and can be folded to a compressed state or arrangement for loading in a delivery device. For example, the stent or stent frame is a support structure comprising a plurality of struts or wire segments, which are arranged relative to each other to provide the desired compressibility and strength to the prosthetic heart valve. The support or wire segments are arranged so that they can automatically change from a compressed or folded state to a normal radially expanded state, or are forced to change from a compressed or folded state to a normal radially expanded state. The support or wire segments can be formed by a shape memory material, such as a nickel-titanium alloy (e.g., Nitinol). The stent framework can be laser cut from a single piece of material, or can be assembled from a plurality of discrete components.

[0031] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, according to examples, certain actions or events of any process or method described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., all described actions or events may not be necessary to implement these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the technology of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

Claims

1. A transcatheter prosthetic heart valve delivery device comprising: an inner shaft assembly including a coupling structure configured to selectively engage a prosthetic heart valve; a delivery sheath assembly slidably disposed on the inner shaft assembly; an outer stabilizing tube coaxially received on the delivery sheath assembly and having a first portion and a compressible region; wherein the axial compressive strength of the compressible region is less than the axial compressive strength of the first portion; and A handle assembly, the handle assembly holding the inner shaft assembly, the delivery sheath assembly, and the outer stabilizing tube, the handle assembly comprising: a housing secured to the inner shaft assembly; and An actuator mechanism is maintained by the housing and coupled to the delivery sheath assembly, wherein the actuator mechanism is operable to selectively move the delivery sheath assembly relative to the inner shaft assembly.

2. The transcatheter prosthetic heart valve delivery device of claim 1, wherein: The compressible region includes a biasing member.

3. The transcatheter prosthetic heart valve delivery device of claim 2, wherein: The handle assembly is configured to allow the outer stabilization tube to be proximally retracted relative to the housing when a force applied to the outer stabilization tube overcomes a force of the biasing member.

4. The transcatheter prosthetic heart valve delivery device of claim 3, wherein: The handle assembly is configured such that the biasing member applies a force to the outer stabilizer tube to resist movement of the outer stabilizer tube relative to the housing.

5. The transcatheter prosthetic heart valve delivery device of claim 3, wherein: The transcatheter prosthetic heart valve delivery apparatus is configured such that proximal retraction of the delivery sheath assembly relative to the inner shaft assembly applies a force to the outer stabilization tube.

6. The transcatheter prosthetic heart valve delivery device of claim 5, wherein: The delivery sheath assembly comprises a proximal shaft and a distal balloon, the distal balloon being configured to house the prosthetic heart valve, and further wherein the transcatheter prosthetic heart valve delivery device is configured to provide: a delivery state in which the balloon is distally spaced apart from a distal end of the outer stabilizing tube; and and a deployed state in which the balloon is proximally retracted from the delivery state and contacts the distal end of the outer stabilizing tube.

7. The transcatheter prosthetic heart valve delivery device of claim 6, wherein: The transcatheter prosthetic heart valve delivery apparatus is configured such that in the deployed state, proximal retraction of the delivery sheath assembly relative to the handle assembly applies a longitudinal force to the outer stabilizing tube at an interface between the balloon and the distal end.

8. The transcatheter prosthetic heart valve delivery device of claim 1, wherein: The compressible region abuts an outer surface of the housing.

9. The transcatheter prosthetic heart valve delivery device of claim 1, wherein: The compressible region is positioned within the housing.

10. The transcatheter prosthetic heart valve delivery device of claim 1, wherein: The compressible region includes a spring.

11. A transcatheter prosthetic heart valve delivery device comprising: an inner shaft assembly configured to selectively engage a prosthetic heart valve; External stabilizing tube; as well as A handle assembly, the handle assembly holding the inner shaft assembly and the outer stabilizing tube, the handle assembly comprising: a housing secured to the inner shaft assembly, A biasing member connects the outer stabilization tube with the housing.

12. The transcatheter prosthetic heart valve delivery device of claim 11, wherein: The handle assembly is configured to allow the outer stabilization tube to be proximally retracted relative to the housing when a force applied to the outer stabilization tube overcomes a force of the biasing member.

13. The transcatheter prosthetic heart valve delivery device of claim 12, wherein: The handle assembly is configured such that the biasing member applies a force to the outer stabilizer tube to resist movement of the outer stabilizer tube relative to the housing.

14. The transcatheter prosthetic heart valve delivery device of claim 12, further comprising a delivery sheath assembly; wherein The transcatheter prosthetic heart valve delivery apparatus is configured such that proximal retraction of the delivery sheath assembly relative to the inner shaft assembly applies a force to the outer stabilization tube.

15. The transcatheter prosthetic heart valve delivery device of claim 14, wherein: The delivery sheath assembly comprises a proximal shaft and a distal balloon, the distal balloon being configured to house the prosthetic heart valve, and further wherein the transcatheter prosthetic heart valve delivery device is configured to provide: a delivery state in which the balloon is distally spaced apart from a distal end of the outer stabilizing tube; and and a deployed state in which the balloon is proximally retracted from the delivery state and contacts the distal end of the outer stabilizing tube.

16. The transcatheter prosthetic heart valve delivery device of claim 15, wherein: The transcatheter prosthetic heart valve delivery apparatus is configured such that in the deployed state, proximal retraction of the delivery sheath assembly relative to the handle assembly applies a longitudinal force to the outer stabilizing tube at an interface between the balloon and the distal end.

17. The transcatheter prosthetic heart valve delivery device of claim 11, wherein: The biasing member includes a spring.

18. The transcatheter prosthetic heart valve delivery device of claim 11, wherein: The handle assembly includes an actuator mechanism maintained by the housing and coupled to the delivery sheath assembly, wherein the actuator mechanism is operable to selectively move the delivery sheath assembly relative to the inner shaft assembly.

19. The transcatheter prosthetic heart valve delivery device of claim 11, wherein: The inner shaft includes a coupling structure configured to selectively engage the prosthetic heart valve.

20. The transcatheter prosthetic heart valve delivery apparatus of claim 11, further comprising a delivery sheath assembly slidably disposed on the inner shaft assembly and at least partially within the outer stabilization tube.

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