Prosthetic implants, delivery systems and delivery devices

Abstract

A prosthetic implant including an anchor member, at least one elastic tethering strut extending from the anchor member, a junction structure coupled to an end of the at least one elastic tethering strut, and a tensioning unit extending between the anchor member and the junction structure, the tensioning unit including a flexible hollow tube and a tensioning wire extending through the flexible hollow tube, the tensioning wire having a first end fixed to a junction between the first end of the flexible hollow tube and the junction structure and a second end extending from the second end of the flexible hollow tube, the second end of the tensioning wire being retractable from the second end of the flexible hollow tube to bend the flexible hollow tube and the at least one elastic tethering strut and move the junction structure relative to the anchor member.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. US63 / 084,477, filed September 28, 2020, and Singapore Patent Application No. 10202100895W, filed January 27, 2021, the entire contents of which are incorporated by reference into this application for all purposes. [Technical field]

[0002]

[0002] Various embodiments relate generally to prosthetic implants, delivery systems for prosthetic implants, and delivery devices for prosthetic implants. In particular, various embodiments relate generally to prosthetic valve implants, delivery systems for prosthetic valve implants, and delivery devices for prosthetic valve implants. [Background technology]

[0003] Historically, valvular insufficiencies such as tricuspid regurgitation (TR) were repaired using open-heart surgery. These high-risk procedures, performed under general anesthesia, typically involve providing circulatory support via a heart-lung machine while the patient's heart is stopped during surgery. The risks are significant, and recovery is painful and difficult.

[0004]

[0004] Thus, the preferred valve repair procedure for TR is increasingly performed using significantly less invasive percutaneous transluminal valve replacement procedures, as these procedures dramatically reduce the risks of open heart surgery. In principle, the replacement valve is constructed to function nearly identically to the diseased valve being replaced, including the leaflets. Thus, when using a mechanical replacement valve, the procedure includes sizing the replacement valve for a patient-specific fit.

[0005]

[0005] Delivery of a replacement valve, such as a tricuspid valve, involves loading the valve onto a delivery device, such as an on-the-wire or over-the-wire catheter in a compressed configuration, passing it percutaneously to the diseased area, positioning and securing it, and then removing the delivery device to complete the deployment. The replacement valve can then be sutured to secure it in place.

[0006]

[0006] Therefore, there is a need for a simpler and easier solution for heart valve replacement. Summary of the Invention

[0007]

[0007] According to various embodiments, a prosthetic implant (or artificial valve implant) is provided. The prosthetic implant may include an anchor member. The prosthetic implant may include at least one resilient tethering strut extending from the anchor member. The prosthetic implant may include a junction structure coupled to an end of the at least one resilient tethering strut remote from the anchor member. The prosthetic implant may include a tensioning unit extending between the anchor member and the junction structure. The tensioning unit may include a flexible hollow tube extending between the anchor member and the junction structure, and a tensioning wire extending through the flexible hollow tube, a first end of the tensioning wire being secured to a junction between the first end of the flexible hollow tube and the junction structure, and a second end of the tensioning wire extending from the second end of the flexible hollow tube. The second end of the tensioning wire may be extendable relative to the flexible hollow tube such that it can be pulled away from the second end of the flexible hollow tube to bend the flexible hollow tube and correspondingly bend the at least one elastic tethering strut, thereby moving the joint structure relative to the anchor member.

[0008]

[0008] According to various embodiments, a prosthetic implant delivery system is provided. The prosthetic implant delivery system may include a prosthetic implant and a delivery device as described herein. The delivery device may include an outer sheath within a first end of which the prosthetic implant is compressed and constrained. The delivery device may include a tensioning rod enclosed within the outer sheath. The tensioning rod may have a first end removably coupled to a second end of a tensioning wire of a tensioning unit of the prosthetic implant. The delivery device may include a control handle at the second end of the outer sheath. The control handle may include a first control interface associated with the second end of the outer sheath and operable to retract the outer sheath to deploy the prosthetic implant. The control handle can include a second control interface associated with the second end of the tensioning rod and operable to retract or extend the tensioning rod relative to the control handle to move the second end of the tensioning wire relative to the flexible hollow tube to adjust the displacement of the second end of the tensioning wire from the second end of the flexible hollow tube and correspondingly adjust the degree of bending of the flexible hollow tube and the degree of bending of the at least one elastic tethering strut to position the joint structure relative to the anchor member. The control handle can include a third control interface associated with the second end of the tensioning rod and operable to decouple the first end of the tensioning rod from the second end of the tensioning wire of the tensioning unit of the prosthetic implant.

[0009]

[0009] According to various embodiments, there is provided a delivery device for the prosthetic implant described herein. The delivery device may include an outer sheath at a first end thereof for compressing and constraining the prosthetic implant. The delivery device may include a tensioning rod enclosed within the outer sheath. The tensioning rod may have a first end removably connectable to a second end of a tensioning wire of a tensioning unit of the prosthetic implant. The delivery device may include a control handle at the second end of the outer sheath. The control handle may include a first control interface associated with the second end of the outer sheath and operable to retract the outer sheath to deploy the prosthetic implant. The control handle can include a second control interface associated with the second end of the tensioning rod and operable to retract or extend the tensioning rod relative to the control handle to move the second end of the tensioning wire relative to the flexible hollow tube to adjust the displacement of the second end of the tensioning wire from the second end of the flexible hollow tube and correspondingly adjust the degree of bending of the flexible hollow tube and the degree of bending of the at least one elastic tethering strut to position the joint structure relative to the anchor member. The control handle can include a third control interface associated with the second end of the tensioning rod and operable to decouple the first end of the tensioning rod from the second end of the tensioning wire of the tensioning unit of the prosthetic implant.

[0010]

[0010] In the drawings, like reference characters generally refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments are described with reference to the following drawings: [Brief description of the drawings]

[0011] [Figure 1A] 1 shows a schematic diagram of a prosthetic implant (or artificial valve implant or valve implant) according to various embodiments. [Figure 1B] 1B shows a schematic diagram of the prosthetic implant of FIG. 1A with the attachment structure moved relative to the anchor member according to various embodiments; [Diagram 2] 1B illustrates an artificial valve implant as an example of the prosthetic implant of FIG. 1A according to various embodiments. [Figure 3A] 3 illustrates the prosthetic valve implant of FIG. 2 with an expanded view of the tensioning unit according to various embodiments. [Figure 3B] 3B illustrates an example of the tensioning unit of FIG. 3A according to various embodiments. [Figure 3C] 3B illustrates another example of the tensioning unit of FIG. 3A according to various embodiments. [Figure 4] 13A-13D show three tensioning units having different amounts of curvature according to various embodiments. [Figure 5A] 3 illustrates an assembled view of the leaflet prosthesis of FIG. 2, the coupler, at least one elastic tethering strut, and a tensioning unit of an artificial valve implant according to various embodiments. [Figure 5B] 5B illustrates an exploded view of FIG. 5A according to various embodiments. [Figure 5C] 1 illustrates a close-up view of a coupler according to various embodiments. [Figure 6A] 3 shows an enlarged view of a connection between a tensioning unit and a stent of the prosthetic valve implant of FIG. 2 according to various embodiments. [Figure 6B] 6B shows cross-sectional views of FIG. 6A illustrating different stages of operation of the locking part of the tensioning unit according to various embodiments. [Figure 6C] 6B shows cross-sectional views of FIG. 6A illustrating different stages of operation of the locking part of the tensioning unit according to various embodiments; [Figure 6D] 6B-6C show cross-sectional views of FIG. 6A illustrating further different stages of operation of the locking parts of the tensioning unit according to various embodiments; [Figure 6E] 6B shows cross-sectional views of FIG. 6A illustrating further different stages of operation of the locking parts of the tensioning unit according to various embodiments; [Figure 6F] 3 shows a perspective view of a stent of the prosthetic valve implant of FIG. 2 according to various embodiments. [Figure 6G] 6F shows a cutaway view of the stent of FIG. 6F to illustrate locking components according to various embodiments. [Figure 7] 1 illustrates a delivery device according to various embodiments. [Figure 8A] 8 illustrates a side view of a control handle with a tensioning rod to illustrate the tensioning mechanism of the delivery device of FIG. 7 according to various embodiments. [Figure 8B] 8B shows a top view of FIG. 8A according to various embodiments. [Figure 8C] 8C shows details of the feature marked in circle A in FIG. 8B according to various embodiments. [Figure 8D] 8B shows a perspective view of the feature marked by circle B in FIG. 8A according to various embodiments. [Figure 8E] 8C shows a detail of a first end of the tensioning rod marked with circle C in FIG. 8B according to various embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012]

[0030] It will be appreciated that embodiments described below in relation to an apparatus are equally valid for the respective methods and vice versa. Furthermore, it will be understood that the embodiments described below may be combined, e.g., parts of one embodiment may be combined with parts of another embodiment.

[0013]

[0031] As used in the following description, it should be understood that terms such as "on," "over," "top," "bottom," "down," "side," "back," "left," "right," "front," "lateral," "side," "up," "down," and the like are used for convenience and to aid in the understanding of relative location or orientation, and are not intended to limit the orientation of any device, or structure, or any portion of any device or structure. In addition, the singular terms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Similarly, the word "or" is intended to include "and" unless the context clearly dictates otherwise.

[0014]

[0032] Various embodiments generally relate to prosthetic implants, delivery systems for prosthetic implants, and delivery devices for prosthetic implants. In particular, various embodiments generally relate to prosthetic valve implants, delivery systems for prosthetic valve implants, and delivery devices for prosthetic valve implants. According to various embodiments, the prosthetic implant may be a prosthetic valve implant. According to various embodiments, the prosthetic valve implant may function as a replacement valve used, for example, in replacing a diseased valve in a heart. According to various embodiments, the prosthetic valve implant may be used in a valve replacement procedure for tricuspid regurgitation (TR). According to various embodiments, the delivery system may be configured to percutaneously deliver the prosthetic implant (or prosthetic valve implant) into a patient's body, for example, into the patient's heart for replacing a diseased valve. According to various embodiments, the delivery device may be configured to control the deployment and / or positioning and / or orientation of the prosthetic implant (or prosthetic valve implant). Various embodiments may also relate to respective methods. For example, various embodiments may also relate to methods of deploying and / or positioning and / or orienting a prosthetic implant (or artificial valve implant or valve implant), methods of operating a delivery device to implant a prosthetic implant (or artificial valve implant or valve implant), or methods of implanting a prosthetic implant (or artificial valve implant or valve implant) using a delivery system.

[0015]

[0033] According to various embodiments, a prosthetic implant (or artificial valve implant or valve implant) may include an attachment structure for attachment with at least one native leaflet and / or providing a surface against which at least one native leaflet may attach, an anchor member for fixing or attaching the prosthetic implant (or said artificial valve implant or valve implant) to one or more tissue sites, and a tensioning unit extending between the attachment structure and the anchor member, and a relative position and / or orientation of the attachment structure with respect to the anchor member may be adjusted by adjusting the tension of the tensioning unit. For example, the tensioning unit may include a flexible tube that may bend or flex upon application of a pulling force to adjust the tension of a tensioning wire within the flexible tube to move the attachment structure with respect to the anchor member to position and / or orient the attachment structure. Thus, the tensioning unit may provide a simple, efficient and effective solution for precise control or adjustment of the position and / or orientation of the attachment structure to achieve a desired or optimal placement or arrangement of the attachment structure during implantation.

[0016]

[0034] According to various embodiments, the delivery device may include a tensioning mechanism, and the prosthetic implant (or artificial or valvular implant) may be connectable to the tensioning mechanism of the delivery device. Additionally, the delivery device may include an adjustable user input element or control interface (e.g., a tension dial) for adjusting the tension of a tensioning wire of a tensioning unit of the prosthetic implant (or artificial or valvular implant) via the tensioning mechanism, and another adjustable user input element or control interface (e.g., a release knob) for disconnecting the tensioning mechanism of the delivery device from the prosthetic implant (or artificial or valvular implant).

[0017]

[0035] According to various embodiments, the delivery system can include various embodiments of a prosthetic implant (or artificial or valve implant) and various embodiments of a delivery device.

[0018]

[0036] The following examples relate to various embodiments.

[0019]

[0037] According to various embodiments, a prosthetic implant (or artificial valve implant) is provided. The prosthetic implant may include an anchor member. The prosthetic implant may include at least one elastic tethering strut extending from the anchor member. The prosthetic implant may include a junction structure coupled to an end of the at least one elastic tethering strut remote from the anchor member. The prosthetic implant may include a tensioning unit extending between the anchor member and the junction structure. The tensioning unit may include a flexible hollow tube extending between the anchor member and the junction structure, and a tensioning wire extending through the flexible hollow tube, a first end of the tensioning wire being secured to a junction between the first end of the flexible hollow tube and the junction structure, and a second end of the tensioning wire extending from the second end of the flexible hollow tube. The second end of the tensioning wire may be extendable relative to the flexible hollow tube such that it can be pulled away from the second end of the flexible hollow tube to bend the flexible hollow tube and correspondingly bend the at least one elastic tethering strut, thereby moving the joint structure relative to the anchor member.

[0020]

[0038] According to various embodiments, the prosthetic implant described in the paragraph above may optionally include a coupler coupling the joining structure to an end of at least one elastic tethering strut. The coupler may have a first connection end for receiving the joining structure and a second connection end for receiving an end of the at least one elastic tethering strut. A major axis of the coupler may extend between the first and second connection ends. The joining structure may be fitted to the first connection end of the coupler with rotational play about the major axis of the coupler and pivotal play about a transverse axis perpendicular to the major axis of the coupler.

[0021]

[0039] According to various embodiments, the prosthetic implant described in the above paragraph may optionally include that the joining structure may include a pair of L-shaped connecting legs having feet pointing in opposite directions. The coupler may include a hollow coupler body with a first opening at a first connecting end and a pair of side holes in opposing wall portions of the hollow coupler body. The pair of side holes may be coaxial with the horizontal axis. A height of the first opening in a height direction perpendicular to the main axis and the horizontal axis may be greater than a thickness of the pair of L-shaped connecting legs. The pair of L-shaped connecting legs of the joining structure may be inserted into the first opening of the first connecting end of the coupler with the feet of the pair of L-shaped connecting legs respectively fitted into the pair of side holes.

[0022]

[0040] According to various embodiments, the prosthetic implant described in the paragraph above may optionally include that each of the pair of side holes may be a slot parallel to the height direction of the first opening of the first connection end.

[0023]

[0041] According to various embodiments, the prosthetic implant according to any one of the two previous paragraphs above may optionally include that the end of the at least one elastic tethering strut may include a pin hole or key hole. The hollow coupler body of the coupler may include a second opening at the second connection end and a corresponding pin hole or key hole in the wall portion of the hollow coupler body. The end of the at least one elastic tethering strut may be inserted into the second opening at the second connection end of the coupler, and a locking pin or key may be inserted through the corresponding pin hole or key hole in the hollow coupler body of the coupler and into the pin hole or key hole of the end of the at least one elastic tethering strut to lock the at least one elastic tethering strut to the coupler.

[0024]

[0042] According to various embodiments, the prosthetic implant as described in the paragraphs above may optionally include that a locking pin or key may have a spacer portion inserted between the pair of L-shaped connecting legs of the joining structure to hold the pair of L-shaped connecting legs apart and hold the feet of the pair of L-shaped connecting legs respectively engaged with the pair of side holes of the hollow coupler body.

[0025]

[0043] According to various embodiments, the prosthetic implant described in any one of the six previous paragraphs above may optionally include a first end of the flexible hollow tube of the tensioning unit being coupled to an end of at least one elastic tethering strut and a second end of the flexible hollow tube of the tensioning unit being coupled to an anchor member.

[0026]

[0044] According to various embodiments, the prosthetic implant described in any one of the seven previous paragraphs above may optionally include that the tensioning unit may further include a locking component secured to the second end of the tensioning wire. The locking component may be movable relative to the anchoring member to pull the second end of the tensioning wire relative to the flexible hollow tube to pull the second end of the tensioning wire away from the second end of the flexible hollow tube. The locking component may be lockable to the anchoring member to secure the second end of the tensioning wire when a desired displacement from the second end of the flexible hollow tube is reached such that the curvature of the flexible hollow tube, the curvature of the at least one elastic tethering strut, and the relative positioning of the joint structure relative to the anchoring member may be fixed.

[0027]

[0045] According to various embodiments, the prosthetic implant described in the paragraph above may optionally include that the anchor member can include a slider strut and the locking component can include a lock housing having a slider bracket having a gap therebetween for fitting the slider strut such that the locking component is in sliding engagement with the slider strut.

[0028]

[0046] According to various embodiments, the prosthetic implant described in the paragraph above may optionally include that the slider strut of the anchor member may include a plurality of locking holes spaced longitudinally along the slider strut. The locking component may include a spring-biased locking pin oriented perpendicular to the slider strut. The locking component may be operable to hold the spring-biased locking pin in a retracted position within the lock housing to allow the locking component to slide relative to the slider strut, and may be operable to release the spring-biased locking pin to extend from the lock housing to an extended position for engagement with at least one of the plurality of locking holes to lock the locking component to the slider strut of the anchor member.

[0029]

[0047] According to various embodiments, the prosthetic implant described in the paragraph above may optionally include that the spring-loaded locking pin may include a pin and a leaf spring. The pin may be coupled to a free end of the leaf spring, and the other end of the leaf spring may be fixedly coupled to a lock housing of the locking component.

[0030]

[0048] According to various embodiments, the prosthetic implant described in any one of the two paragraphs above may optionally include that in the extended position, the spring-loaded locking pin can extend from the lock housing into a gap between the slider bracket and the lock housing.

[0031]

[0049] According to various embodiments, the prosthetic implant as described in any one of the twelve paragraphs above may optionally include that the flexible hollow tube may include a slotted tube, a ribbed tube, a corrugated bellows tube, an interlocking tube, a mesh tube, or a braided tube.

[0032]

[0050] According to various embodiments, the prosthetic implant described in any one of the thirteen paragraphs above may optionally include that the flexible hollow tube may have directional flexibility.

[0033]

[0051] According to various embodiments, the prosthetic implant described in the paragraph immediately above may optionally include that the flexible hollow tube may include a first sector that extends continuously from a first end of the flexible hollow tube to a second end of the flexible hollow tube forming a spine portion, and a second sector in which a plurality of spaced apart ribs are arranged at regular intervals from the first end of the flexible hollow tube to the second end of the flexible hollow tube forming a ribbed portion.

[0034]

[0052] According to various embodiments, the prosthetic implant described in the paragraph above may optionally include that the multiple spaced apart ribs may be formed by multiple parallel transverse cuts along the second sector of the flexible hollow tube.

[0035]

[0053] According to various embodiments, the prosthetic implant described in the paragraph above may optionally include that each of the multiple transverse cuts may have a V-shaped or U-shaped cut segment.

[0036]

[0054] According to various embodiments, the prosthetic implant as described in any one of the 17 paragraphs above may optionally include that the anchor member may include a stent and that the coaptation structure may include a leaflet prosthesis.

[0037]

[0055] According to various embodiments, a prosthetic implant delivery system is provided. The prosthetic implant delivery system may include a prosthetic implant and a delivery device as described in any of the 18 paragraphs above. The delivery device may include an outer sheath within a first end of which the prosthetic implant is compressed and constrained. The delivery device may include a tensioning rod enclosed within the outer sheath. The tensioning rod may have a first end removably coupled to a second end of a tensioning wire of a tensioning unit of the prosthetic implant. The delivery device may include a control handle at the second end of the outer sheath. The control handle may include a first control interface associated with the second end of the outer sheath and operable to retract the outer sheath to deploy the prosthetic implant. The control handle can include a second control interface associated with the second end of the tensioning rod and operable to retract or extend the tensioning rod relative to the control handle to move the second end of the tensioning wire relative to the flexible hollow tube to adjust the displacement of the second end of the tensioning wire from the second end of the flexible hollow tube and correspondingly adjust the degree of bending of the flexible hollow tube and the degree of bending of the at least one elastic tethering strut to position the joint structure relative to the anchor member. The control handle can include a third control interface associated with the second end of the tensioning rod and operable to decouple the first end of the tensioning rod from the second end of the tensioning wire of the tensioning unit of the prosthetic implant.

[0038]

[0056] According to various embodiments, the prosthetic implant delivery system described in the paragraphs above may optionally include, when the prosthetic implant includes a spring-biased locking pin and a lock housing, a first end of the tensioning rod may include a retaining element that engages with the spring-biased locking pin of the locking component to hold the spring-biased locking pin in a retracted position. The retaining element may be retractable to disengage from the spring-biased locking pin of the locking component to release the spring-biased locking pin for engagement with the slider strut.

[0039]

[0057] According to various embodiments, the prosthetic implant delivery system described in the paragraph immediately above may optionally include that the first end of the tensioning rod may include a coupling element that engages with the locking part to releasably couple the first end of the tensioning rod to the locking part.

[0040]

[0058] According to various embodiments, the prosthetic implant delivery system described in any one of the two previous paragraphs above may optionally include that the retention element may include an insertion tip. The insertion tip may be inserted perpendicular to the spring-biased locking pin to retain the spring-biased locking pin in a retracted position. The insertion tip may be retractable to release the spring-biased locking pin for engagement with the slider strut.

[0041]

[0059] According to various embodiments, the prosthetic implant delivery system described in the paragraph above may optionally include that the coupling element may include a threaded stem portion adjacent the insertion tip. The threaded stem portion may be threaded into the lock housing of the locking component with the insertion tip inserted perpendicularly into the spring-loaded locking pin in the retracted position. The threaded stem portion may be partially unscrewed from the lock housing of the locking component to withdraw the insertion tip from the spring-loaded locking pin, thereby releasing the spring-loaded locking pin, and completely unscrewed from the lock housing of the locking component to disconnect the first end of the tensioning rod from the locking component.

[0042]

[0060] According to various embodiments, the prosthetic implant delivery system described in any one of the five previous paragraphs above may optionally include that the second control interface may include a rotatable dial. The rotatable dial may be rotatable about a longitudinal axis of the control handle. The control handle may include a rotational-linear motion mechanism interconnecting the rotatable dial and the tensioning rod to convert rotational motion of the rotatable dial into linear translational motion of the tensioning rod.

[0043]

[0061] According to various embodiments, the prosthetic implant delivery system described in the paragraph above may optionally include that the rotatable dial may include an internal thread. The rotary-linear motion mechanism may include a lead screw having an external thread that engages with the internal thread of the rotatable dial such that the rotatable dial translates linearly along the longitudinal axis of the control handle when rotated about the longitudinal axis of the control handle. The second end of the tensioning rod may be coupled to the lead screw such that the tensioning rod may be linearly translatable with the lead screw.

[0044]

[0062] According to various embodiments, the prosthetic implant delivery system described in the above paragraph may optionally include that the control handle may include an indicator plate fixedly coupled to the lead screw and an elongated window aligned longitudinally with respect to the control handle for viewing the indicator plate as the lead screw translates linearly along the longitudinal axis of the control handle.

[0045]

[0063] According to various embodiments, the prosthetic implant delivery system described in any one of the two previous paragraphs above may optionally include that the third control interface may include a knob for rotating a transmission shaft extending longitudinally within the control handle. A first end of the transmission shaft may be coupled to the knob and a second end of the transmission shaft may be coupled to a second end of the tensioning rod to impart rotation of the shaft to rotate the tensioning rod about a rod axis of the tensioning rod.

[0046]

[0064] According to various embodiments, the prosthetic implant delivery system described in the paragraph immediately above may optionally include that the lead screw is hollow and may have a through channel extending longitudinally therethrough. The control handle may include a shaft coupling interconnecting the second end of the transfer shaft and the second end of the tension rod via the through channel of the lead screw. The shaft coupling may include an elongate body having a bore extending longitudinally into the elongate body from a first end of the elongate body and a longitudinal slot along a wall of the bore. The second end of the transfer shaft may be inserted into the bore with a pin protruding perpendicularly from the second end of the transfer shaft into the longitudinal slot to form a slidable pin-slot joint. The second end of the tension rod may be fixedly coupled to the second end of the elongate body of the shaft coupling. The control handle may include a shaft coupling support bracket fixed to an inner wall surface of the lead screw. The shaft coupling may be mated via a shaft coupling support bracket such that the shaft coupling may be rotatable about its longitudinal axis to rotate the tensioning rod about the rod axis, but may be immovable along the longitudinal axis of the shaft coupling relative to the lead screw such that the tensioning rod may be linearly translatable with the lead screw.

[0047]

[0065] According to various embodiments, a delivery device for a prosthetic implant as described in any one of paragraphs

[0030] to

[0047] is provided. The delivery device may include an outer sheath at a first end thereof for compressing and constraining the prosthetic implant. The delivery device may include a tensioning rod enclosed within the outer sheath. The tensioning rod may have a first end removably connectable to a second end of a tensioning wire of a tensioning unit of the prosthetic implant. The delivery device may include a control handle at a second end of the outer sheath. The control handle may include a first control interface associated with the second end of the outer sheath and operable to retract the outer sheath to deploy the prosthetic implant. The control handle can include a second control interface associated with the second end of the tensioning rod and operable to retract or extend the tensioning rod relative to the control handle to move the second end of the tensioning wire relative to the flexible hollow tube to adjust the displacement of the second end of the tensioning wire from the second end of the flexible hollow tube and correspondingly adjust the degree of bending of the flexible hollow tube and the degree of bending of the at least one elastic tethering strut to position the joint structure relative to the anchor member. The control handle can include a third control interface associated with the second end of the tensioning rod and operable to decouple the first end of the tensioning rod from the second end of the tensioning wire of the tensioning unit of the prosthetic implant.

[0048]

[0066] According to various embodiments, the delivery device described in the above paragraph may optionally include that, when the prosthetic implant includes a spring-biased locking pin and a lock housing, the first end of the tensioning rod may include a retaining element for engaging the spring-biased locking pin of the locking component of the prosthetic implant to retain the spring-biased locking pin in a retracted position. The retaining element may be retractable to disengage from the spring-biased pin of the locking component to release the spring-biased locking pin for engagement with a slider strut of the prosthetic implant.

[0049]

[0067] According to various embodiments, the delivery device described in the above paragraph may optionally include that the first end of the tensioning rod may include a coupling element for engaging a locking component of the prosthetic implant to releasably couple the first end of the tensioning rod to the locking component.

[0050]

[0068] According to various embodiments, the delivery device according to any one of the two previous paragraphs above may optionally include that the retention element may include an insertion tip that is insertable perpendicular to the spring-loaded locking pin of the locking component of the prosthetic implant and capable of retaining the spring-loaded locking pin in a retracted position. The insertion tip may be retractable to release the spring-loaded locking pin for engagement with the slider strut.

[0051]

[0069] According to various embodiments, the delivery device described in the above paragraphs may optionally include that the coupling element may include a threaded stem portion adjacent the insertion tip. The threaded stem portion may be threaded into the lock housing of the locking component with the insertion tip inserted perpendicularly into the spring-loaded locking pin in the retracted position. The threaded stem portion may be partially unscrewed from the lock housing of the locking component to withdraw the insertion tip from the spring-loaded locking pin, thereby releasing the spring-loaded locking pin, and completely unscrewed from the lock housing of the locking component to disconnect the first end of the tensioning rod from the locking component.

[0052]

[0070] According to various embodiments, the delivery device described in any one of the two previous paragraphs above may optionally include that the second control interface may include a rotatable dial. The rotatable dial may be rotatable about a longitudinal axis of the control handle. The control handle may include a rotational-linear motion mechanism interconnecting the rotatable dial and the tensioning rod to convert rotational motion of the rotatable dial into linear translational motion of the tensioning rod.

[0053]

[0071] According to various embodiments, the delivery device described in the above paragraphs may optionally include that the rotatable dial may include an internal thread. The rotary-linear motion mechanism may include a lead screw having an external thread that engages with the internal thread of the rotatable dial such that the rotatable dial translates linearly along the longitudinal axis of the control handle when rotated about the longitudinal axis of the control handle. The second end of the tensioning rod may be coupled to the lead screw such that the tensioning rod may be linearly translatable with the lead screw.

[0054]

[0072] According to various embodiments, the delivery device described in the paragraph immediately above may optionally include that the control handle can include an indicator plate fixedly coupled to the lead screw and an elongated window aligned longitudinally with respect to the control handle for viewing the indicator plate as the lead screw translates linearly along the longitudinal axis of the control handle.

[0055]

[0073] According to various embodiments, the delivery device described in any one of the two previous paragraphs above may optionally include that the third control interface may include a knob for rotating a transmission shaft extending longitudinally within the control handle. A first end of the transmission shaft may be coupled to the knob, and a second end of the transmission shaft may be coupled to a second end of the tensioning rod to impart rotation of the shaft to rotate the tensioning rod about a rod axis of the tensioning rod.

[0056]

[0074] According to various embodiments, the delivery device described in the above paragraph may optionally include that the lead screw is hollow and may have a through channel extending longitudinally therethrough. The control handle may include a shaft coupling interconnecting the second end of the transfer shaft and the second end of the tension rod via the through channel of the lead screw. The shaft coupling may include an elongate body having a bore extending longitudinally into the elongate body from a first end of the elongate body and a longitudinal slot along a wall of the bore. The second end of the transfer shaft may be inserted into the bore with a pin protruding perpendicularly from the second end of the transfer shaft into the longitudinal slot to form a slidable pin-slot joint. The second end of the tension rod may be fixedly coupled to the second end of the elongate body of the shaft coupling. The control handle may include a shaft coupling support bracket fixed to an inner wall surface of the lead screw. The shaft coupling may be mated via a shaft coupling support bracket such that the shaft coupling may be rotatable about its longitudinal axis to rotate the tensioning rod about the rod axis, but may be immovable along the longitudinal axis of the shaft coupling relative to the lead screw such that the tensioning rod may be linearly translatable with the lead screw.

[0057]

[0075] 1A illustrates a schematic diagram of a prosthetic implant 100 (or artificial or valve implant) according to various embodiments. According to various embodiments, the prosthetic implant 100 can include an anchor member 110. According to various embodiments, the anchor member 110 can be configured to be secured or secured to one or more tissue sites. According to various embodiments, the anchor member 110 can include, but is not limited to, a stent, a clamp, a hook, a fixation ring, a screw, a tine, or a barb.

[0058]

[0076] According to various embodiments, the prosthetic implant 100 can include at least one elastic tethering strut 120 extending from the anchor member 110. Thus, one or more elastic tethering struts 120 may protrude from the anchor member 110 to extend or reach beyond the anchor member 110. According to various embodiments, the at least one elastic tethering strut 120 may be an elongated structural member of a length of material used as a support. Thus, the at least one elastic tethering strut 120 may be in the form of a strip, or stripe, or bar, or beam, or stick, or spoke, or pole, or spar, or rod of elastic material. According to various embodiments, the at least one elastic tethering strut 120 may be straight and may have a natural tendency to return to a straight shape after being bent or flexed. According to various embodiments, the at least one elastic tethering strut 120 may be integral with the anchor member 110. Thus, the at least one elastic tethering strut 120 may be integrally molded, integrally printed, integrally cast, or integrally formed with the anchor member 110 as a single, unitary part. According to various embodiments, the at least one elastic tethering strut 120 and the anchor member 110 may be separate pieces that are joined, bonded, attached, secured, mated, or coupled to one another.

[0059]

[0077] According to various embodiments, the prosthetic implant 100 may include an attachment structure 130. According to various embodiments, the attachment structure 130 may be configured to attach to at least one native leaflet and / or provide a surface against which at least one native leaflet may attach. According to various embodiments, the attachment structure 130 may include, but is not limited to, a leaflet prosthesis, a neo-leaflet, a flap, a membrane, a balloon, an occlusion member, or a blocker. According to various embodiments, the attachment structure 130 may be coupled to an end 120a of at least one elastic tethering strut 120 remote from the anchor member 110. Thus, the at least one elastic tethering strut 120 may interconnect the anchor member 110 and the attachment structure 130 such that the anchor member 110 may be at one end 120b of the at least one elastic tethering strut 120 and the attachment structure 130 may be at an opposite end 120a of the at least one elastic tethering strut 120. Thus, the anchoring members 110 and joining structures 130 may be at the two ends 120b, 120a of at least one elastic tethering strut 120, respectively.

[0060]

[0078] According to various embodiments, bending or flexing at least one elastic tethering strut 120 can move the joining structure 130 relative to the anchor member 110 to change or adjust or change the position and / or orientation and / or placement of the joining structure 130 relative to the anchor member 110. According to various embodiments, the at least one elastic tethering strut 120 can limit the range of relative movement between the joining structure 130 and the anchor member 110.

[0061]

[0079] According to various embodiments, the prosthetic implant 100 can include a tensioning unit 140. According to various embodiments, the tensioning unit 140 can extend between the anchoring member 110 and the joining structure 130. Thus, the anchoring member 110 can be at one end of the tensioning unit 140, and the joining structure 130 can be at an opposite end of the tensioning unit 140. Thus, the anchoring member 110 and the joining structure 130 can be at two ends of the tensioning unit 140, respectively.

[0062]

[0080] According to various embodiments, by applying a pulling or tensile force to the tensioning unit 140, the tensioning unit 140 can bend to correspondingly bend the at least one elastic tethering strut 120 to move the joint structure 130 relative to the anchor member 110 to position and / or orient the joint structure 130 relative to the anchor member 110. According to various embodiments, the at least one elastic tethering strut 120 and the tensioning unit 140 can function as a counter pair to move the joint structure 130 relative to the anchor member 110. Thus, the tensioning unit 140 can bend by applying a pulling or tensile force to move the joint structure 130 relative to the anchor member 110, and upon releasing some or all of the pulling or tensile force to the tensioning unit 140, the at least one elastic tethering strut 120 can provide a counter force to partially or fully reverse the movement or partially or fully return the joint structure 130 to its initial position and / or orientation, respectively.

[0063]

[0081] According to various embodiments, the tensioning unit 140 may include a flexible hollow tube 142. According to various embodiments, the flexible hollow tube 142 may extend between the anchor member 110 and the junction structure 130. Thus, the flexible hollow tube 142 may extend from the anchor member 110 to the junction structure 130. Thus, the anchor member 110 may be at one end 142b of the flexible hollow tube 142, and the junction structure 130 may be at the opposite end 142a of the flexible hollow tube 142. Thus, the anchor member 110 and the junction structure 130 may be at the two ends 142b, 142a of the flexible hollow tube 142, respectively.

[0064]

[0082] According to various embodiments, the tensioning unit 140 can include a tensioning wire 144. According to various embodiments, the tensioning wire 144 can extend through a flexible hollow tube 142. The flexible hollow tube 142 can thus function as a trunking or a conduit or duct between the anchor member 110 and the joint structure 130, such that the tensioning wire 144 extends through or within the flexible hollow tube 142. Thus, a length of the tensioning wire 144 can be surrounded or enclosed by the flexible hollow tube 142.

[0065]

[0083] According to various embodiments, the first end 144a of the tensioning wire 144 may be fixed to the junction 132 between the first end 142a of the flexible hollow tube 142 and the junction structure 130. Thus, the first end 144a of the tensioning wire 144 may be rigidly attached or fixed to a point or node where the first end 142a of the flexible hollow tube 142 and the junction structure 130 meet, converge, or come together. Thus, the first end 144a of the tensioning wire 144 may be in a fixed arrangement relative to the first end 142a of the flexible hollow tube 142. According to various embodiments, the tensioning wire 144 may be threaded, passed or inserted through the flexible hollow tube 142 to secure the first end 142a of the tensioning wire 144 at the joint 132 between the first end 144a of the flexible hollow tube 142 and the joint structure 130.

[0066]

[0084] According to various embodiments, the second end 144b of the tensioning wire 144 can extend from the second end 142b of the flexible hollow tube 142. Thus, the tensioning wire 144 can be longer than the flexible hollow tube 142 such that a segment of the tensioning wire 144 toward the second end 144b of the tensioning wire 144 can extend outside the flexible hollow tube 142 beyond the second end 142b of the flexible hollow tube 142. Thus, the second end 144b of the tensioning wire 144 can protrude from the second end 142b of the flexible hollow tube 142 by an amount equivalent to the additional length of the tensioning wire 144 relative to the flexible hollow tube 142. According to various embodiments, the second end 144b of the tensioning wire 144 can be aligned with the anchor member 110.

[0067]

[0085] 1B shows a schematic diagram of the prosthetic implant 100 of FIG. 1A with the joint structure 130 moved relative to the anchor member 110, according to various embodiments. According to various embodiments, the second end 144b of the tensioning wire 144 can be pulled relative to the flexible hollow tube 142 away from the second end 142b of the flexible hollow tube 142 to bend the flexible hollow tube 142 to correspondingly bend at least one elastic tethering strut 120 and move the joint structure 130 relative to the anchor member 110. Thus, the second end 144b of the tensioning wire 144 can be pulled in a direction away from the second end 142b of the flexible hollow tube 142. Thus, a pulling or tensile force can be applied to the second end 144b of the tensioning wire 144 to generate tension along the tensioning wire 144. Because the first end 144a of the tensioning wire 144 is fixed, the tension in the tensioning wire 144 can bend or flex the flexible hollow tube 142. The bending or flexing of the flexible hollow tube 142 can correspondingly bend or flex the at least one elastic tethering strut 120. As the flexible hollow tube 142 and the at least one elastic tethering strut 120 are bent or flexed, the joint structure 130 at the second end 142b of the flexible hollow tube 142 and the end 120b of the at least one elastic tethering strut 120 can move relative to the anchor member 110.

[0068]

[0086] According to various embodiments, when the pulling force or tension is partially or completely relieved, the tension in the tensioning wire 144 can be reduced or released, respectively. Thus, the at least one elastic tethering strut 120 can provide a counter force to partially or completely reverse the bending or bending of the at least one elastic tethering strut 120 and partially or completely return to a straight line. When the at least one elastic tethering strut 120 is unbent or unbent, the flexible hollow tube 142 can also be unbent or unbent. With the flexible hollow tube 142 and the at least one elastic tethering strut 120 in an unbent or unbent state, the joint structure 130 at the second end 142b of the flexible hollow tube 142 and the end 120b of the at least one elastic tethering strut 120 can partially or completely return to their initial positions and / or orientations.

[0069]

[0087] According to various embodiments, the flexible hollow tube 142 may include, but is not limited to, a slotted tube, a ribbed tube, a corrugated bellows tube, an interlocking tube, a mesh tube, or a braided tube. Thus, the flexible hollow tube 142 may have the necessary flexibility such that the flexible hollow tube 142 may bend or flex by applying a pulling or tensile force to the tensioning wire 144.

[0070]

[0088] According to various embodiments, the flexible hollow tube 142 can have directional flexibility. Thus, the flexible hollow tube 142 may be flexible in a particular direction. According to various embodiments, the flexible hollow tube 142 may be flexible in a predetermined direction such that applying a pulling force or tensile force to the tensioning wire 144 can always cause the flexible hollow tube 142 to bend or flex in a predetermined direction.

[0071]

[0089] According to various embodiments, the flexible hollow tube 142 can include a first sector (see, e.g., 242c in FIG. 4 ) that extends continuously from the first end 142a of the flexible hollow tube 142 to the second end 142b of the flexible hollow tube 142 to form a spine portion. Thus, the first longitudinal wall portion along the first sector of the flexible hollow tube 142 can be continuous without interruption to form a continuous longitudinal wall that extends from the first end 142a of the flexible hollow tube 142 to the second end 142b of the flexible hollow tube 142. The continuous longitudinal wall can function as a backbone or spine of the flexible hollow tube 142.

[0072]

[0090] According to various embodiments, the flexible hollow tube 142 may include a second sector (see, for example, 242d in FIG. 4 ) in which a plurality of spaced ribs are arranged at regular intervals from the first end 142a of the flexible hollow tube 142 to the second end 142b of the flexible hollow tube 142 to form a spaced ribbed portion. Thus, the second longitudinal wall portion of the flexible hollow tube 142 along the second sector may be composed of a plurality of spaced ribs, whereby each rib may be oriented transversely with respect to the flexible hollow tube 142, and the plurality of spaced ribs may be parallel to each other. Thus, each rib may resemble a C-shaped link having two ends joined or fixed or attached or connected, respectively, to two longitudinal sides of the first sector of the flexible hollow tube 142 having a continuous longitudinal wall.

[0073]

[0091] According to various embodiments, the flexible hollow tube 142 having a continuous longitudinal wall along a first sector and a plurality of spaced ribs along a second sector can exhibit directional flexibility. According to various embodiments, when a pulling force or tension is applied to the tensioning wire 144, the plurality of spaced ribs along the second sector can fold toward each other, causing the continuous longitudinal wall along the first sector to bend or flex toward the second sector. Thus, the flexible hollow tube 142 may always flex toward the second sector having the plurality of spaced ribs.

[0074]

[0092] According to various embodiments, the plurality of spaced apart ribs of the flexible hollow tube 142 may be formed by a plurality of parallel transverse cuts or slots along the second sector of the flexible hollow tube 142. Thus, the remaining uncut transverse portions may form a plurality of spaced apart ribs having open spaces or gaps therebetween. Thus, when a pulling or tensile force is applied to the tensioning wire 144, the uncut transverse portions forming the plurality of spaced apart ribs may fold together.

[0075]

[0093] According to various embodiments, the plurality of spaced apart ribs of the flexible hollow tube 142 may be formed by a series of corrugated bellows with alternating peaks and roots along the second sector of the flexible hollow tube 142. The peaks of the corrugated bellows may thus form the plurality of spaced apart ribs. Thus, when a pulling or tensile force is applied to the tensioning wire 144, the roots may collapse such that the peaks collapse together.

[0076]

[0094] According to various embodiments, the multiple spaced apart ribs of the flexible hollow tube 142 may be formed by alternating lateral strips of thicker material with lateral strips of thinner material. The lateral strips of thinner material may be in the form of a thin sheet or film or membrane. Thus, the lateral strips of thicker material may form multiple spaced apart ribs. Thus, when a pulling force or tension is applied to the tensioning wire 144, the lateral strips of thinner material may fold over such that the lateral strips of thicker material may fold over together.

[0077]

[0095] According to various embodiments, the flexible hollow tube 142 may be formed by a series of interlocking rings. The axial width of a first sector of each ring may be greater than the axial width of a second sector of each ring. Thus, the series of interlocking rings may be interlocked or interconnected along a first sector of the series of rings to form the flexible hollow tube 142. Thus, the first sector of the flexible hollow tube 142 may be composed of first sectors of the series of interlocking rings interlocked or interconnected in series. The second sectors of the series of interlocking rings may then be spaced apart from one another with gaps or empty spaces between them along the second sector of the flexible hollow tube 142. Thus, a plurality of spaced apart ribs of the flexible hollow tube 142 may be formed by the second sectors of the series of interlocking rings. When a pulling force or tension is applied to the tensioning wire 144, the second sectors of the series of interlocking rings may collapse together.

[0078]

[0096] 2-8D, a prosthetic valve implant 200 (or valve implant or tricuspid implant) and a delivery device 260 (or delivery system handle) are shown as an example of the prosthetic implant 100 of FIGS. 1A and 1B. According to various embodiments, the prosthetic valve implant 200 can include all of the features and limitations of the prosthetic implant 100 of FIGS. 1A and 1B and will be described below with like reference numbers referencing the same / common parts throughout. Further details of the illustrated prosthetic valve implant 200 are also described below.

[0079]

[0097] According to various embodiments, the prosthetic valve implant 200 may be used to replace a diseased valve in the heart. According to various embodiments, the delivery device 260 may be used to percutaneously deliver the prosthetic valve implant 200 into the heart to replace the diseased valve.

[0080]

[0098] Various embodiments relate to aspects and / or capabilities of the prosthetic valve implant 200 positioned within the tricuspid valve (TV) of the heart in the treatment of tricuspid regurgitation (TR) via a tensioning system. The tensioning system may include a tensioning unit 240 (or tensioner) of the prosthetic valve implant 200 and a tensioning mechanism 261 of a delivery device 260.

[0081]

[0099] FIG. 2 illustrates a prosthetic valve implant 200 according to various embodiments. According to various embodiments, the prosthetic valve implant 200 can include a stent 210 that functions as an anchor member of the prosthetic implant 100, similar to the anchor member 110 of the prosthetic valve implant 200 of FIGS. 1A and 1B. According to various embodiments, the stent 210 can be an inferior vena cava (IVC) stent. According to various embodiments, the stent 210 can be made of Nitinol. When the prosthetic valve implant 200 is deployed in the heart, the stent 210 can be positioned in the IVC near the junction of the right atrium (RA) and the IVC. Thus, the stent 210 can fix or anchor the prosthetic valve implant 200 to the IVC.

[0082]

[0100] According to various embodiments, the prosthetic valve implant 200 can include a leaflet prosthesis 230 (or neo-leaflet or sail) that functions as the attachment structure of the prosthetic implant 100, similar to the attachment structure 130 of the prosthetic valve implant 200 of FIGS. 1A and 1B. According to various embodiments, the leaflet prosthesis 230 can include a support frame 234 (or leaflet frame or sail frame) and a leaflet blade panel 236 (or fabric or fabric panel) that covers, is supported by, is attached to, or is secured to the support frame 234 to form the prosthetic leaflet or sail. For example, the support frame 234 of the leaflet prosthesis 230 can be a Nitinol frame, and the leaflet blade panel 236 can be a medical grade surgical fabric that is sewn or attached or secured to the support frame 234. Additionally, polyester sutures can be used to attach the leaflet blade panel 236 to the support frame 234 (or Nitinol frame). According to various embodiments, the leaflet prosthesis 230 may be connected to the stent 210. For example, the support frame 234 of the leaflet prosthesis 230 may be permanently attached to the stent 210. When the artificial valve implant 200 is deployed in the heart with the stent 210 in the IVC, the leaflet prosthesis 230 with the leaflet blade panel 236 covering the support frame 234 (or the fabric covering the sail frame) may extend into the tricuspid valve (TV) and function as a coaptation structure for the native TV leaflets.

[0083]

[0101] According to various embodiments, the prosthetic valve implant 200 can include a coupler 250 connecting the stent 210 and the leaflet prosthesis 230. According to various embodiments, the coupler 250 can be configured to allow limited, multi-rotational movement of the leaflet prosthesis 230 relative to the coupler 250 to allow blood "in" from the right atrium into the right ventricle and resist "out" (regurgitation) from the TV.

[0084]

[0102] According to various embodiments, the prosthetic valve implant 200 may include a tensioning unit 240 (or tensioner). The tensioning unit 240 may be an adjustable component that can move the coupler 250 toward the TV when the internal structure is tightened to help position the leaflet prosthesis 230 in the native TV annulus. A locking component 246 (or tension anchor) of the tensioning unit 240 may be connected to the coupler 250 and slide along the struts of the stent 210. The movement of the locking component 246 of the tensioning unit 240 may be controlled by a tensioning mechanism 261 inside the delivery device 260. The locking component 246 of the tensioning unit 240 may be securely locked in place on the stent 210 during the implantation procedure, and the tensioning mechanism 261 of the delivery device 260 may be disconnected to complete the delivery of the prosthetic valve implant 200.

[0085]

[0103] FIG. 3A illustrates the prosthetic valve implant 200 zoomed in on the tensioning unit 240, according to various embodiments. FIGS. 3B and 3C illustrate an example of the tensioning unit 240, according to various embodiments. According to various embodiments, the tensioning unit serves to provide a means for positioning the leaflet prosthesis 230 within the TV to promote coaptation of the leaflet prosthesis 230 with the native TV leaflets, ultimately reducing TR. According to various embodiments, the tensioning unit 240 can include a flexible hollow tube 242 and a tensioning wire 244. According to various embodiments, the flexible hollow tube 242 can be made of metal or plastic. According to various embodiments, the tensioning wire 244 can be a tension wire or a suture. According to various embodiments, the tensioning wire 244 can be disposed inside the flexible hollow tube 242. According to various embodiments, the tensioning wire 244 can connect the coupler 250 to a locking component 246 of the tensioning unit 240. According to various embodiments, the flexible hollow tube 242 can have a laser cut pattern (see FIG. 3B) in the tube wall that allows it to preferentially bend when the locking component 246 of the tensioning unit 240 is pulled along the axis of the stent 210. This tensioning action can bend or flex the flexible hollow tube 242 and reposition the leaflet prosthesis 230 from the right atrium of the heart toward and into the TV. According to various embodiments, the tensioning wire 244 can be encapsulated in a polytetrafluoroethylene (PTFE) tube to reduce frictional forces and improve the repositioning response time of the leaflet prosthesis 230.

[0086]

[0104] 4 shows three tensioning units 240 having different amounts of curvature according to various embodiments. Depending on the amount of tension applied to the tensioning wires 244, different amounts of curvature may be possible according to various embodiments.

[0087]

[0105] According to various embodiments, the prosthetic valve implant 200 can include at least one elastic tethering strut 220 extending from the stent 210. Thus, the one or more elastic tethering struts 220 can protrude from the stent 210 and extend or reach beyond the stent 210. According to various embodiments, the stent 210 can be cylindrical in shape and formed by a plurality of stent struts 212. According to various embodiments, the at least one elastic tethering strut 220 can extend from a longitudinal end of the stent 210. According to various embodiments, the at least one elastic tethering strut 220 can be an elongated structural member of a length of material used as a support. Thus, the at least one elastic tethering strut 220 can be in the form of a strip, or stripe, or bar, or beam, or stick, or spoke, or pole, or spar, or rod of elastic material. According to various embodiments, the at least one elastic tethering strut 220 may be straight and may have a natural tendency to return to a straight shape after being bent or flexed. According to various embodiments, the at least one elastic tethering strut 220 may be integral with the stent 210. For example, the at least one elastic tethering strut 220 may be one of the stent struts 212 of the stent 210 extending from the stent 210. Thus, the at least one elastic tethering strut 220 may be integrally molded, printed, cast, or formed with the stent 210 as a single, integral part. According to various embodiments, the prosthetic valve implant 200 may include two elastic tethering struts 220 extending from the stent 210.

[0088]

[0106] According to various embodiments, the leaflet prosthesis 230 of the artificial valve implant 200 may be coupled to an end 220a of at least one elastic tethering strut 220 (or each of the two elastic tethering struts 220) that is remote from the stent 210. According to various embodiments, the end 220a of at least one elastic tethering strut 220 (or each of the two elastic tethering struts 220) may be coupled to the leaflet prosthesis 230 via a coupler 250. Thus, at least one elastic tethering strut 220 (or two elastic tethering struts 220) may interconnect the stent 210 and the leaflet prosthesis 230 such that the stent 210 may be at one end 220b of the at least one elastic tethering strut 220 (or each of the two elastic tethering struts 220) and the leaflet prosthesis 230 may be at the opposite end 220a of the at least one elastic tethering strut 220 (or each of the two elastic tethering struts 220). Thus, the stent 210 and the leaflet prosthesis 230 may each be at the two ends 220b, 220a of the at least one elastic tethering strut 220 (or each of the two elastic tethering struts 220).

[0089]

[0107] According to various embodiments, bending or flexing at least one elastic tethering strut 220 (or two elastic tethering struts 220) can move the leaflet prosthesis 230 relative to the stent 210 to change or adjust or alter or change the position and / or orientation and / or placement of the leaflet prosthesis 230 relative to the stent 210. According to various embodiments, the at least one elastic tethering strut 120 (or two elastic tethering struts 220) can limit the range of relative motion between the leaflet prosthesis 230 and the stent 210.

[0090]

[0108] According to various embodiments, the tensioning unit 240 of the prosthetic valve implant 200 may extend between the stent 210 and the leaflet prosthesis 230. Thus, the stent 210 may be at one end of the tensioning unit 240 and the leaflet prosthesis 230 may be at the opposite end of the tensioning unit 240. Thus, the stent 210 and the leaflet prosthesis 230 may be at two ends of the tensioning unit 240, respectively.

[0091]

[0109] According to various embodiments, by applying a pulling or tensioning force to the tensioning unit 240, the tensioning unit 240 can bend to correspondingly bend the at least one elastic tethering strut 220 (or two elastic tethering struts 220) to move the leaflet prosthesis 230 relative to the stent 210 to position and / or orient the leaflet prosthesis 230 relative to the stent 210. According to various embodiments, the at least one elastic tethering strut 220 (or two elastic tethering struts 220) and the tensioning unit 240 can function as a counter pair to move the leaflet prosthesis 230 relative to the stent 210. Thus, the tensioning unit 240 may be bent by applying a pulling force or tension to move the leaflet prosthesis 230 relative to the stent 210, and upon releasing some or all of the pulling force or tension on the tensioning unit 240, at least one elastic tethering strut 120 (or two elastic tethering struts 220) can provide an opposing force to partially or completely reverse the movement or partially or completely return the leaflet prosthesis 230 to its initial position and / or orientation, respectively.

[0092]

[0110] According to various embodiments, the flexible hollow tube 242 of the tensioning unit 240 of the artificial valve implant 200 may extend between the stent 210 and the leaflet prosthesis 230. Thus, the flexible hollow tube 242 may extend from the stent 210 to the leaflet prosthesis 230. Thus, the stent 210 may be at one end 242b of the flexible hollow tube 242, and the leaflet prosthesis 230 may be at the opposite end 242a of the flexible hollow tube 242. Thus, the stent 210 and the leaflet prosthesis 230 may be at two ends 242b, 242a of the flexible hollow tube 242, respectively. According to various embodiments, the end 242b of the flexible hollow tube 242 may be connected to the stent 210. According to various embodiments, the end 242 a of the flexible hollow tube 242 may be connected to the prosthetic valve implant 200 via a coupler 250 .

[0093]

[0111] According to various embodiments, the tensioning wire 244 of the tensioning unit 240 of the prosthetic valve implant 200 may extend through the flexible hollow tube 242. Thus, the flexible hollow tube 242 can function as a trunking or a conduit or duct between the stent 210 and the leaflet prosthesis 230, as the tensioning wire 244 extends or extends through the flexible hollow tube 242. Thus, the length of the tensioning wire 244 may be surrounded or enclosed by the flexible hollow tube 242.

[0094]

[0112] According to various embodiments, the first end 244a of the tensioning wire 244 may be fixed to the junction between the first end 242a of the flexible hollow tube 242 and the leaflet prosthesis 230. Thus, the first end 244a of the tensioning wire 244 may be rigidly attached or fixed to a point or node where the first end 242a of the flexible hollow tube 242 and the leaflet prosthesis 230 meet, converge, or come together. Thus, the first end 244a of the tensioning wire 244 may be in a fixed arrangement relative to the first end 242a of the flexible hollow tube 242. According to various embodiments, the junction between the first end 242a of the flexible hollow tube 242 and the leaflet prosthesis 230 may be a coupler 250. According to various embodiments, the tensioning wire 244 may be threaded, passed through, or inserted into the flexible hollow tube 242 to secure the first end 242a of the tensioning wire 244 to the coupler 250 between the first end 244a of the flexible hollow tube 242 and the leaflet prosthesis 230. Thus, the first end 244a of the tensioning wire 244 may be secured to the coupler 250, or to the first end 242a of the flexible hollow tube 242 connected to the coupler 250, or to the end 220a of at least one elastic tethering strut 220 (or each of the two elastic tethering struts 220) connected to the coupler 250, or to a portion of the leaflet prosthesis 230 connected to the coupler 250.

[0095]

[0113] According to various embodiments, the second end 244b of the tensioning wire 244 can extend from the second end 242b of the flexible hollow tube 242. Thus, the tensioning wire 244 can be longer than the flexible hollow tube 242 such that a segment of the tensioning wire 244 toward the second end 244b of the tensioning wire 244 can extend outside the flexible hollow tube 242 beyond the second end 242b of the flexible hollow tube 242. Thus, the second end 244b of the tensioning wire 244 can protrude from the second end 242b of the flexible hollow tube 242 by an amount equivalent to the additional length of the tensioning wire 244 relative to the flexible hollow tube 242. According to various embodiments, the second end 244b of the tensioning wire 244 can be aligned with the stent 210. According to various embodiments, the second end 244b of the tensioning wire 244 may be coupled to a locking component 246 of the tensioning unit 240. According to various embodiments, the locking component 246 of the tensioning unit 240 may be along the stent 210.

[0096]

[0114] According to various embodiments, the second end 244b (or locking component 246) of the tensioning wire 244 may be retractable relative to the flexible hollow tube 242 such that it is pulled away from the second end 242b of the flexible hollow tube 242 to bend the flexible hollow tube 242 in order to correspondingly bend at least one elastic tethering strut 220 (or two elastic tethering struts 220) and move the leaflet prosthesis 230 relative to the stent 210. Thus, the second end 244b (or locking component 246) of the tensioning wire 244 may be pulled in a direction away from the second end 242b of the flexible hollow tube 242. Thus, a pulling force or tensile force may be applied to the second end 244b of the tensioning wire 244 (or locking component 246) to generate tension along the tensioning wire 244. Because the first end 244a of the tensioning wire 244 is fixed relative to the coupler 250, tension in the tensioning wire 244 can bend or flex the flexible hollow tube 242. The bending or flexing of the flexible hollow tube 242 can correspondingly bend or flex the at least one elastic tethering strut 220 (or two elastic tethering struts 220). With the flexible hollow tube 242 and the at least one elastic tethering strut 220 (or two elastic tethering struts 220) bent or flexed, the leaflet prosthesis 230 connected via the coupler 250 to the second end 242b of the flexible hollow tube 242 and the end 220b of the at least one elastic tethering strut 220 (or each of the two elastic tethering struts 220) can be moved relative to the stent 210.

[0097]

[0115] According to various embodiments, when the pulling force or tension is partially or completely relieved, the tension in the tensioning wire 244 may be reduced or released, respectively. Thus, the at least one elastic tethering strut 220 (or two elastic tethering struts 220) may provide a counter force to partially or completely reverse the bending or bending of the at least one elastic tethering strut 220 (or two elastic tethering struts 220) and partially or completely return to a straight line. Unbending or unbending the at least one elastic tethering strut 220 (or two elastic tethering struts 220) may also unbend or unbend the flexible hollow tube 242. With the flexible hollow tube 242 and the at least one elastic tethering strut 220 (or two elastic tethering struts 220) in an unbent or unflexed state, the leaflet prosthesis 230 connected to the second end 242b of the flexible hollow tube 242 and the end 220b of the at least one elastic tethering strut 220 via the coupler 250 can partially or completely return to its initial position and / or orientation. According to various embodiments, a reduction or release of the pulling or tensioning force may be required to reposition or retrieve the prosthetic valve implant 200. Thus, at least one elastic tethering strut 220 (or two elastic tethering struts 220) providing a counterforce may be used to allow for repositioning and / or retrieval of the prosthetic valve implant 200.

[0098]

[0116] According to various embodiments, the flexible hollow tube 242 may be a slotted or ribbed tube, as shown, to provide the necessary flexibility so that the flexible hollow tube 242 can bend or flex upon application of a pulling or tension force to the tensioning wire 244.

[0099]

[0117] According to various embodiments, the flexible hollow tube 242 can have directional flexibility. Thus, the flexible hollow tube 242 may be flexible in a particular direction. According to various embodiments, the flexible hollow tube 242 may be flexible in a predetermined direction such that applying a pulling force or tensile force to the tensioning wire 244 can always cause the flexible hollow tube 242 to bend or flex in a predetermined direction.

[0100]

[0118] According to various embodiments, the flexible hollow tube 242 can include a first sector 242c that extends continuously from the first end 242a of the flexible hollow tube 242 to the second end 242b of the flexible hollow tube 242 to form a spine portion. Thus, the first longitudinal wall portion along the first sector 242c of the flexible hollow tube 242 can be continuous without interruption to form a continuous longitudinal wall that extends from the first end 242a of the flexible hollow tube 242 to the second end 242b of the flexible hollow tube 242. The continuous longitudinal wall can function as a backbone or spine of the flexible hollow tube 242.

[0101]

[0119] According to various embodiments, the flexible hollow tube 242 may include a second sector 242d in which a plurality of spaced ribs 242e are arranged at regular intervals from the first end 242a of the flexible hollow tube 242 to the second end 242b of the flexible hollow tube 242 to form a spaced ribbed portion. Thus, the second longitudinal wall portion of the flexible hollow tube 242 along the second sector may be composed of a plurality of spaced ribs 242e, whereby each rib 242e may be oriented transversely with respect to the flexible hollow tube 242, and the plurality of spaced ribs 242e may be parallel to each other. Thus, each rib 242e may resemble a C-link with two ends joined or fixed or attached or connected, respectively, to two longitudinal sides of the first sector 242c of the flexible hollow tube 242 having a continuous longitudinal wall.

[0102]

[0120] According to various embodiments, the flexible hollow tube 242 having a continuous longitudinal wall along the first sector 242c and a plurality of spaced apart ribs 242e along the second sector 242d may exhibit directional flexibility. According to various embodiments, when a pulling force or tensile force is applied to the tensioning wire 244, the plurality of spaced apart ribs 242e along the second sector 242d may collapse toward each other, causing the continuous longitudinal wall along the first sector 242c to bend or flex toward the second sector 242d. Thus, the flexible hollow tube 242 can always bend toward the second sector 242d having the plurality of spaced apart ribs 242e.

[0103]

[0121] According to various embodiments, the plurality of spaced apart ribs 242e of the flexible hollow tube 242 may be formed by a plurality of parallel transverse cuts or slots along the second sector 242d of the flexible hollow tube 242. Thus, the remaining uncut transverse portions may form the plurality of spaced apart ribs 242e with empty spaces or gaps therebetween. Thus, when a pulling force or tension is applied to the tensioning wire 244, the uncut transverse portions forming the plurality of spaced apart ribs 242e may collapse together. According to various embodiments, each of the plurality of transverse cuts may have a V-shaped or U-shaped cut segment 242g.

[0104]

[0122] FIG. 5A shows an assembled view of the leaflet prosthesis 230, the coupler 250, at least one elastic tethering strut 220 (or two elastic tethering struts 220), and the tensioning unit 240 according to various embodiments. FIG. 5B shows an exploded view of FIG. 5A according to various embodiments. FIG. 5C shows a close-up view of the coupler 250 according to various embodiments. According to various embodiments, the coupler 250 can connect the stent 210 to the leaflet prosthesis 230 and provide a predetermined or predetermined free movement of the leaflet prosthesis 230. Thus, the coupler 250 can connect at least one elastic tethering strut 220 (or two elastic tethering struts 220) extending from the stent 210 to the leaflet prosthesis 230.

[0105]

[0123] According to various embodiments, the coupler 250 may include a locking pin 252 (or locking key or coupler pin). According to various embodiments, the end 220a of the at least one elastic tethering strut 220 may include a pin hole 222 (or key hole or hole). Thus, the locking pin 252 may be inserted through the coupler 250 into the pin hole 222 of the end 220a of the at least one elastic tethering strut 220 when the end 220a of the at least one elastic tethering strut 220 is inserted into the coupler 250. According to various embodiments, the locking pin 252 may have an interference fit with the pin hole 222 at the end 220a of the at least one elastic tethering strut 220. According to various embodiments, the support frame 234 of the leaflet prosthesis 230 may include a pair of L-shaped connecting legs 236 (or angled legs). According to various embodiments, the locking pin 252 of the coupler 250 can have a spacer portion 252b that can be inserted between the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230 when the pair of L-shaped connecting legs 236 are inserted into the coupler 250. Thus, the locking pin 252 of the coupler 250 can lock the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230 into the two opposing side holes 254 of the coupler 250.

[0106]

[0124] According to various embodiments, the shape or configuration of the locking pin 252 can maintain the relationship between the components, namely the coupler 250, the end 220a of the at least one elastic tethering strut 220, and the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230, to allow some freedom of movement of the leaflet prosthesis 230. According to various embodiments, by varying the size and / or dimensions and / or positions of the first opening 251a and the side holes 254 of the coupler 250 into which the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230 are inserted, various combinations of rotational play (torsional play) about the main axis (or longitudinal axis) of the coupler 250 and pivotal play about the hole axis of the side holes 254 can be achieved.

[0107]

[0125] According to various embodiments, the support frame 234 of the leaflet prosthesis 230 may be made from a flat sheet cutting or may be made from a wire having a circular cross section. According to various embodiments, the support frame 234 of the leaflet prosthesis 230 and / or the coupler 250 and / or the at least one elastic tethering strut 220 (or two elastic tethering struts 220) and / or the tensioning unit 240 may be made from a plastic material to prevent metal-to-metal contact so that corrosion and premature wear can be minimized.

[0108]

[0126] According to various embodiments, the coupler 250 can couple the leaflet prosthesis 230 to the end 220a of the at least one elastic tethering strut 220. According to various embodiments, the coupler 250 may include a first connection end 250a for receiving the leaflet prosthesis 230 and a second connection end 250b for receiving the end 220a of the at least one elastic tethering strut 220. Thus, the leaflet prosthesis 230 may be connected or mated to the first connection end 250a of the coupler 250, and the end 220a of the at least one elastic tethering strut 220 may be connected or mated to the second connection end 250b of the coupler 250. According to various embodiments, a main axis of the coupler 250 may extend between the first connection end 250a and the second connection end 250b. According to various embodiments, coupler 250 may have an elongated shape, the first longitudinal end may be first connecting end 250, the second longitudinal end may be second connecting end 250b, and the longitudinal axis may be the main axis of coupler 250.

[0109]

[0127] According to various embodiments, the leaflet prosthesis 230 can be connected or mated to the first connecting end 250a of the coupler 250 with rotational play (or torsional play) about the major axis of the coupler 250 and pivotal play about a transverse axis perpendicular to the major axis of the coupler 250. Thus, the leaflet prosthesis 230 can be connected or mated to the first connecting end 250a of the coupler 250 with some room for rotational and / or pivotal movement about two orthogonal axes of the coupler 250, including the major axis of the coupler 250 and a transverse axis perpendicular to the major axis of the coupler 250. Thus, the leaflet prosthesis 230 can have some rotational and / or pivotal movement relative to the coupler 250.

[0110]

[0128] According to various embodiments, the support frame 234 of the leaflet prosthesis 230 may include a pair of L-shaped connecting legs 236 having feet 236a pointing in opposite directions. Thus, the pair of L-shaped connecting legs 236 may be mirror images of each other with the feet 236a facing outward.

[0111]

[0129] According to various embodiments, the coupler 250 may include a hollow coupler body 251. According to various embodiments, the hollow coupler body 251 may have an elongated shape. According to various embodiments, the hollow coupler body 251 may include a first opening 251a at the first connecting end 250a. The leaflet prosthesis 230 may be connected or mated to the coupler 250 with the pair of L-shaped connecting legs 236 inserted into the first opening 251a at the first connecting end 250a. According to various embodiments, the hollow coupler body 251 may include a pair of side holes 254 in opposing wall portions of the hollow coupler body 251. Thus, the pair of side holes 254 may be aligned with each other. According to various embodiments, the pair of side holes may be two through holes. According to various embodiments, the pair of side holes 254 may be coaxial with a transverse axis perpendicular to the main axis of the coupler 250. Thus, the pair of side holes 254 may be aligned with the transverse axis of the coupler 250 .

[0112]

[0130] According to various embodiments, the height of the first opening 251a in a height direction perpendicular to the major axis and the lateral axis of the coupler 250 may be greater than the thickness of the pair of L-shaped connecting legs 236. The height direction of the coupler 250, the major axis of the coupler 250, and the lateral axis of the coupler 250 may be perpendicular to each other. Therefore, since the height of the first opening 251a is greater than the thickness of the pair of L-shaped connecting legs 236, a certain amount of play can be provided between the pair of L-shaped connecting legs 236 of the valve leaflet prosthesis 230 and the first opening 251a of the coupler 250.

[0113]

[0131] According to various embodiments, the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230 can be inserted into the first opening 251a of the first connecting end 250a of the coupler 250 with the feet 236a of the pair of L-shaped connecting legs 236 respectively fitted into the pair of side holes 254 of the coupler 250. Thus, the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230 can be inserted into the first opening 251a and the feet 236a of the pair of L-shaped connecting legs 236 can be inserted into the pair of side holes 254 to connect the leaflet prosthesis 230 to the coupler 250. Thus, when the height of the first opening 251a is greater than the thickness of the pair of L-shaped connecting legs 236, the leaflet prosthesis 230 can have rotational play around the feet 236a of the pair of L-shaped connecting legs 236 (or the pair of side holes 254).

[0114]

[0132] According to various embodiments, each of the pair of side holes 254 may be a slot parallel to the height direction of the first opening 251a at the first connecting end 250a of the coupler 250. The slot may therefore extend perpendicular to a plane containing the major and lateral axes of the coupler 250. When the pair of side holes 254 are perpendicular slots, the leaflet prosthesis 230 may have rotational (or twisting) play about the major axis of the coupler 250.

[0115]

[0133] According to various embodiments, the hollow coupler body 251 of the coupler 250 may include a second opening 251b at the second connection end 250b. At least one elastic tethering strut may be connected or mated to the coupler 250 with the end 220a of the at least one elastic tethering strut 220 inserted into the second opening 251a at the second connection end 250a. According to various embodiments, the hollow coupler body 251 of the coupler 250 may include a pin hole 252a (or key hole) in a wall portion of the hollow coupler body 251. The pin hole 252a in the wall portion of the hollow coupler body 251 may correspond to the pin hole 222 in the end 220a of the at least one elastic tethering strut 220 and may correspond to the lock pin 252. Thus, the locking pin 252 can be inserted through the pin hole 252a in the wall portion of the hollow coupler body 251 and into the pin hole 222 of the end 220a of the at least one elastic tethering strut 220 when the end 220a of the at least one elastic tethering strut 220 is inserted into the coupler 250. Thus, the locking pin 252 can be inserted through the corresponding pin hole 252a in the hollow coupler body 251 of the coupler 250 and into the pin hole 222 of the end 220a of the at least one elastic tethering strut 220 to lock the at least one elastic tethering strut 220 to the coupler 250.

[0116]

[0134] According to various embodiments, the locking pin 252 can have a spacer portion 252b. According to various embodiments, the spacer portion 252b of the locking pin 252 can be inserted between the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230 to hold the pair of L-shaped connecting legs apart and to hold the feet 236a of the pair of L-shaped connecting legs 236 respectively fitted into the pair of side holes 254 of the coupler body 251 of the coupler 250. According to various embodiments, when the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230 are inserted into the first opening 251a of the first connecting end 250a of the hollow coupler body 251 and the end 220a of the at least one elastic tethering strut 220 is inserted into the second opening 251a of the second connecting end 250a of the hollow coupler body 251, the foot 236a of the pair of L-shaped connecting legs 236 may abut the end 220a of the at least one elastic tethering strut 220 in the hollow coupler body 251. Thus, when the locking pin 252 is inserted into the hollow coupler body 251, a portion of the locking pin 252 may be inserted into the pin hole 222 of the end 220a of the at least one elastic tethering strut 220, and the spacer portion 252b of the locking pin 252 may be inserted between the pair of L-shaped connecting legs 236 of the leaflet prosthesis 230.

[0117]

[0135] According to various embodiments, a first end 242a of the flexible hollow tube 242 of the tensioning unit 240 may be coupled to the end 220a of the at least one elastic tethering strut 220. According to various embodiments, the flexible hollow tube 242 may extend along the at least one elastic tethering strut 220 from the end 220a of the at least one elastic tethering strut 220 to the stent 210. According to various embodiments, a second end 242b of the flexible hollow tube 242 of the tensioning unit 240 may be coupled to the stent 210. According to various embodiments, a first end 244a of the tensioning wire 244 of the tensioning unit 240 may be fixed to the end 220a of the at least one elastic tethering strut 220. According to various embodiments, the first end 244a of the tensioning wire 244 of the tensioning unit 240 can be secured by various fastening methods, including but not limited to knotting, tying, bonding, or welding.

[0118]

[0136] FIG. 6A shows a close-up view of the connection between the flexible hollow tube 242 of the tensioning unit 240 of FIG. 2 and the stent 210 of the prosthetic valve implant 200, according to various embodiments. FIGS. 6B-6E show cross-sectional views of FIG. 6A illustrating different stages of operation of the locking element 246 of the tensioning unit 240, according to various embodiments. FIG. 6F shows a perspective view of the stent 210, according to various embodiments. FIG. 6G shows a cut-away view of the stent 210 of FIG. 6F to show the locking element 246, according to various embodiments. According to various embodiments, the locking element 246 of the tensioning unit 250 functions to lock onto the stent 210 and maintain the amount of tension in the tensioning wire 244 after the leaflet prosthesis 230 is positioned and the stent 210 is fully deployed (or released). According to various embodiments, the locking element 246 and the flexible hollow tube 242 may be attached to the stent 210 as shown in FIGS. 6A-6E.

[0119]

[0137] As shown, the flexible hollow tube 242 may be attached to the stent 210 via a tube support 242f and a tube connector 242g. Also as shown, the locking component 246 may include a spring-loaded locking pin 246a, a lock housing 246b, and a spring 246c. According to various embodiments, the tensioning rod 269 of the delivery device 260 may be removably coupled to the locking component 246.

[0120]

[0138] As shown in Figure 6A, in Stage I, the prosthetic valve implant 200 and delivery device 260 may be preassembled during manufacturing. Additionally, Stages II-V in Figures 6B-6E show the locking component 246 in different positions along the stent 210 in cross-sectional views.

[0121]

[0139] As shown in FIG. 6B, in stage II, the tension rod 269 may be inserted into the spring-loaded lock pin 246a, which is threaded into the lock housing 246b and held in place by the spring 246c. The spring 246c may be a leaf spring. Note that the spring 246c is not shown bent in stage II in FIG. 6B. However, in an actual implementation, the spring 246c is bent. According to various embodiments, in this configuration, the tension rod 269 and the locking part 246 may be translatable (see arrow 602) along the stent 210 (or in a direction parallel to the axis of the stent 210) to change the amount of curvature of the flexible hollow tube 242 of the tensioning unit 240.

[0122]

[0140] As shown in FIG. 6C, in stage III, the tensioning rod 269 and locking component 246 may be translated along the stent 210 away from the second end 242b of the flexible hollow tube 242 to change the amount of curvature of the flexible hollow tube 242 of the tensioning unit 240.

[0123]

[0141] 6D, in stage IV, once the tensioning unit 240 is in the desired position and / or orientation (i.e., the leaflet prosthesis 230 is positioned within the TV), the tensioning rod 269 may be partially threaded to allow the spring-loaded locking pin 246a to engage with the hole 214a of the slider strut 214 of the stent 210 while maintaining tension in the tensioning unit 240. According to various embodiments, before proceeding to disengage the tensioning rod 269 from the locking component 246, additional tension or pulling force may be applied to the tensioning rod 269 to ensure that the locking component 246 is locked in place.

[0124]

[0142] 6E, in stage V, the tensioning rod 269 can be fully disconnected by fully disengaging it from the locking component 246. According to various embodiments, this allows the stent 210 along with the prosthetic valve implant 200 to be fully deployed and the delivery device 260 to be removed. According to various embodiments, the spring 246c can keep the spring-loaded locking pin 246a engaged with the slider strut 214 of the stent 210.

[0125]

[0143] According to various embodiments, the stent 210 can include a slider strut 214, and the locking component 246 of the tensioning unit 240 can include a lock housing 246b having a slider bracket 246d with a gap therebetween. The slider strut 214 can thus be fitted through or inserted through the gap between the locking housing 246b and the slider bracket 246d of the locking component 246 such that the locking component 246 can slidably engage with the slider strut 214 of the stent 210. The locking housing 246b and the slider bracket 246d of the locking component 246 can thus surround the slider strut 214 of the stent 210 such that the slider strut 214 of the stent 210 can slide along the slider strut 214 of the stent 210.

[0126]

[0144] According to various embodiments, the slider strut 214 of the stent 210 may include a plurality of locking holes 214a. According to various embodiments, the plurality of locking holes 214a of the slider strut 214 may be spaced longitudinally along the slider strut 214. Thus, the plurality of locking holes 214a may be in a linear longitudinal row along the slider strut 214. According to various embodiments, the spring-loaded locking pin 246a of the locking component 246 of the tensioning unit 240 may be oriented perpendicular to the slider strut 214. Thus, the load direction of the spring-loaded locking pin 246a may be perpendicular to the slider strut 214. According to various embodiments, the locking component 246 may be operable to hold the spring-loaded locking pin 246a in a retracted position within the lock housing 246b to allow the locking component 246 to slide relative to the slider strut 214. Thus, when the spring-loaded locking pin 246a is in the retracted position, the spring-loaded locking pin 246a may be fully enclosed within the lock housing 240b such that the locking component 246 may be slidable along the slider strut 214. According to various embodiments, the locking component 246 may be operable to release the spring-loaded locking pin 246a to protrude from the lock housing 246b to an extended position for engaging at least one of the plurality of locking holes 214a of the slider strut 214 to lock the locking component 246 to the slider strut 214 of the stent 210. Thus, when the spring-loaded locking pin 246a is in the extended position, the tip of the spring-loaded locking pin 246a may protrude from the lock housing 246b to engage or be inserted into at least one of the multiple locking holes 214a of the slider strut 214 to lock the locking component 246 against sliding relative to the slider strut 214 of the stent 210.

[0127]

[0145] According to various embodiments, the spring biased locking pin 246a can include a pin 246e and a spring 246c in the form of a leaf spring, where the pin 246e can be coupled to a free end of the spring 246c, the other end of which can be fixedly coupled to the lock housing 246b of the locking component 246. Thus, the spring 246c can provide a biasing force to urge the pin 246e from the retracted position toward the extended position. Thus, the spring 246c can bias the pin 246e in a direction perpendicular to the slider struts 214 of the stent 210.

[0128]

[0146] According to various embodiments, in the extended position, the spring-biased locking pin 246a can protrude from the lock housing 246b into a gap between the slider bracket 246d and the lock housing 246b. Thus, the spring-biased locking pin 246a may be aligned with the slider bracket 246d such that when the spring-biased locking pin 246a is in the extended position, the spring-biased locking pin 246a protrudes from the lock housing 246b and extends between the lock housing 246b and the slider bracket 246d. Thus, the spring-biased locking pin 246a may extend across the gap between the slider bracket 246d and the lock housing 246b. Thus, the spring-loaded locking pin 246a may be inserted or fitted through one of the multiple locking holes 214a in the slider strut 214 between the lock housing 246b and the slider bracket 246d to lock the locking component 246 to the slider strut 214 of the stent 210.

[0129]

[0147] FIG. 7 illustrates a delivery device 260 (or delivery system handle) according to various embodiments. According to various embodiments, the delivery device 260 can provide multiple functions during preparation and implantation of the prosthetic valve implant 200 and can provide controlled implantation that allows for retrieval if necessary. According to various embodiments, the delivery device 260 can include a nose cone 262. The nose cone 262 can guide the delivery of the prosthetic valve implant 200 to a predetermined location, for example, within the RA via a guidewire. According to various embodiments, the delivery device 260 can include an outer sheath 264. The outer sheath 264 can constrain the prosthetic valve implant 200 and can surround an inner catheter (not shown). According to various embodiments, the delivery device 260 can include an irrigation port 266. The irrigation port 266 can allow the delivery device 260 to be flushed with saline to remove any air from the inner catheter and the prosthetic valve implant 200. According to various embodiments, the delivery device 260 can include a control handle 270 (or handle body). The control handle 270 can provide support during use. According to various embodiments, the control handle 270 can include a sheath control interface 272 (or a user adjustable input element for the sheath) in the form of, for example, a dial (or a sheath dial). The sheath control interface 272 in the form of a dial can retract the outer sheath 264 when rotated to slowly expose the prosthetic valve implant 200. According to various embodiments, the control handle 270 can include a limit control interface 274 (or a user adjustable input element for removing the restriction) in the form of, for example, a release button. When the limit control interface 274 is not activated, it can prevent accidental release of the prosthetic valve implant 200 by limiting or preventing the outer sheath 264 from fully retracting. Only when the limit control interface 274 is activated (or the release button is pressed) can the restriction be released and the outer sheath 264 can be fully retracted to expose the prosthetic valve implant 200.According to various embodiments, the control handle 270 can include an elongated window 275 (or tension window) for providing a visual indication or display as an indication of the amount of tension present in the tensioning unit 240. According to various embodiments, the control handle 270 can include a tension control interface 276 (or a user adjustable input element for controlling tension), for example in the form of a tensioning dial. According to various embodiments, the tension control interface 276 can adjust the amount of tension in the tensioning unit 240 when rotated. According to various embodiments, the control handle 270 can include a detachment control interface 278 (or a user adjustable input element for detaching the delivery device 260), for example in the form of a release knob. According to various embodiments, the detachment control interface 278 can detach the delivery device 260 from the locking component 246 of the tensioning unit 240 of the prosthetic valve implant 200. According to various embodiments, the delivery device 260 can include a guidewire luer 268, for example in the control handle 270, to allow for flushing of air within the guidewire lumen.

[0130]

[0148] FIG. 8A shows a side view of the control handle 270 with the tensioning rod 269 to illustrate the tensioning mechanism 261 of the delivery device 260 according to various embodiments. FIG. 8B shows a top view of FIG. 8A according to various embodiments. FIG. 8C shows a detail of the mechanism marked with circle A in FIG. 8B according to various embodiments. FIG. 8D shows a perspective view of the mechanism marked with circle B in FIG. 8A according to various embodiments. FIG. 8E shows a detail of the first end 269a of the tensioning rod 269 marked with circle C in FIG. 8B according to various embodiments. According to various embodiments, the tensioning mechanism 261 functions to apply a precise amount of tension to the tensioning rod 269 and provide a way to safely detach the locking member 246 from the tensioning rod 269. According to various embodiments, the tensioning mechanism 261 can facilitate an implantation procedure that maintains the position of the leaflet prosthesis 230 during and after implantation of the prosthetic valve implant 200.

[0131]

[0149] According to various embodiments, the tensioning mechanism 261 may be housed within the delivery device 260. According to various embodiments, the tensioning mechanism 261 may include a tensioning rod 269 having a first end 269a (or distal end) and a second end 269b (or proximal end), a tensioning rod tube 269c, an indicator plate 263, a shaft coupling support bracket 284 (or tension plate), a lead screw 282 (or tension driver), a tension control interface 276 (or tension dial), a shaft coupling 286 (or tension interface), a transmission shaft 288 (or gear shaft), a release gear assembly 290 (or release gear), and a separate control interface 278 (or release knob).

[0132]

[0150] According to various embodiments, the tensioning rod subassembly may include a tensioning rod 269 having a first end 269a (or distal end) and a second end 269b (or proximal end), a tensioning rod tube 269c, a shaft coupling 286 (or tension interface), a transmission shaft 288 (or gear shaft), a release gear assembly 290 (or release gear), and a separate control interface 278 (or release knob). According to various embodiments, the transmission shaft 288 may include a pin 288c that slides axially within a slot 286e of the shaft coupling 286. Thus, when the separate control interface 278 rotates, the rotation is transmitted through all connected components of the tensioning rod subassembly. Thus, the first end 269a of the tensioning rod 269 may or may not be threaded from the locking piece 246.

[0133]

[0151] According to various embodiments, the shaft coupling support bracket 284 may be attached to the lead screw 282. Additionally, the shaft coupling support bracket 284 may be coupled to the second end 269b of the tensioning rod 269, allowing the shaft coupling 286 to rotate freely. Thus, as the tension control interface 276 rotates, the lead screw 282 may be translated along the control handle 270 to translate the tensioning rod 269 along the rod axis of the tensioning rod 269 to adjust the tension of the tensioning unit 240.

[0134]

[0152] According to various embodiments, the outer sheath 264 of the delivery device 260 can compressively constrain the prosthetic valve implant 200 within a first end 264a (or distal portion) of the outer sheath 264. Thus, the prosthetic valve implant 200 can be fitted and inserted into the outer sheath 264 of the delivery device 260 in a compressed or uncompressed state and disposed at the first end 264a (or distal portion) of the outer sheath 264. The first end 264a (or distal portion) of the outer sheath 264 can be inserted into the patient.

[0135]

[0153] According to various embodiments, the tensioning rod 269 of the delivery device 260 may be enclosed within the outer sheath 264. Furthermore, the tensioning rod 269 may have a first end 269a removably coupled to the second end 244b of the tensioning wire 244 of the tensioning unit 240 of the prosthetic valve implant 200. For example, the first end 269a of the tensioning rod 269 may be coupled to the second end 244b of the tensioning wire 244 of the tensioning unit 240 via the locking part 246. Thus, the first end 269a of the tensioning rod 269 may be removably connected to the locking part 246 of the tensioning unit 240 and the second end 244b of the tensioning wire 244.

[0136]

[0154] According to various embodiments, the delivery device 260 can include a control handle 270 at the second end 264b (or a proximal portion) of the outer sheath 264. As such, the second end 264b of the outer sheath 264 can be coupled to the control handle 270. For example, the second end 264b of the outer sheath 264 can be connected to a sheath retraction mechanism in the control handle 270. As such, the sheath retraction mechanism of the control handle 270 can retract the outer sheath 264 relative to the control handle 270.

[0137]

[0155] According to various embodiments, the control handle 270 can include a sheath control interface 272 associated with the second end 264b of the outer sheath 264. The sheath control interface 272 can be operable to retract the outer sheath 264 to deploy the prosthetic valve implant 200. Thus, the sheath control interface 272 can be operated to move the second end 264b of the outer sheath 264 further into the control handle 270 to retract the outer sheath 264 relative to the control handle 270.

[0138]

[0156] According to various embodiments, the control handle 270 can include a tension control interface 276 associated with the second end 269b of the tensioning rod 269. The tension control interface 276 can be operable to retract or extend the tensioning rod 269 relative to the control handle 270. Thus, the tension control interface 276 can be operated to move the second end 269b of the tensioning rod 269 to retract or extend the tensioning rod 269 relative to the control handle 270. According to various embodiments, the first end 269a of the tensioning rod 269 is connected to the second end 244b of the tensioning wire 244 via the locking member 246, so that by moving the tensioning rod 269, the second end 244b of the tensioning wire 244 can be moved relative to the flexible hollow tube 242 of the tensioning unit 240 to adjust the displacement of the second end 244b of the tensioning wire 244 from the second end 242b of the flexible hollow tube 242, and accordingly adjust the degree of bending of the flexible hollow tube 242 and the degree of bending of the at least one elastic tethering strut 220 for positioning the valve leaflet prosthesis 230 relative to the stent 210. Thus, by operating the tension control interface 276, the tensioning rod 269 of the delivery device 260 can be moved, which in turn moves the tensioning wire 244 of the artificial valve implant 200 to bend or flex the flexible hollow tube 242 and at least one elastic tethering strut 220 of the tensioning unit 240 to position the valve leaflet prosthesis 230 relative to the stent 210.

[0139]

[0157] According to various embodiments, the control handle 270 can include a detachment control interface 278 associated with the second end 269b of the tensioning rod 269. The detachment control interface 278 can be operable to detach or remove or disconnect the first end 269a of the tensioning rod 269 from the second end 244b of the tensioning wire 244 of the tensioning unit 240 of the prosthetic valve implant 200. Thus, the detachment control interface 278 can be operated to allow the first end 269a of the tensioning rod 269 to be detached or removed or disconnected from the locking piece 246 secured to the second end 244b of the tensioning wire 244 of the tensioning unit 240.

[0140]

[0158] According to various embodiments, in a lock component 246 having a spring-loaded lock pin 246a and a lock housing 246b, a first end 269a of the tension rod 269 can include a retaining element 269d that engages with the spring-loaded lock pin 246a of the lock component 246. Thus, when the retaining element 269d engages with the spring-loaded lock pin 246a of the lock component 246, the retaining element 269d of the tension rod 269 can retain the spring-loaded lock pin 246a in a retracted position. In the retracted position, the spring-loaded lock pin 246a can be completely within the lock housing 246b. According to various embodiments, the retaining element 269d can be withdrawn to disengage from the spring-loaded lock pin 246a of the lock component 246 to release the spring-loaded lock pin 246a for engagement with the slider strut 214. Thus, the retaining element 269d can be removed from the spring-loaded locking pin 246a of the locking part 246 so that the spring-loaded locking pin 246a of the locking part 246 can move from a retracted position to an extended position to engage with the slider strut 214 to lock the locking part 246 to the slider strut 214.

[0141]

[0159] According to various embodiments, the first end 269a of the tension rod 269 may include an insertion tip 269e that functions as a retention element 269d. According to various embodiments, the retention element 269d may be in the form of an insertion tip 269e. According to various embodiments, the insertion tip 269e may be inserted perpendicularly to the spring-loaded locking pin 246a to retain the spring-loaded locking pin 246a in the retracted position. Thus, the pin 246e of the spring-loaded locking pin 246a may include a transverse hole. The insertion tip 269e of the tension rod 269 may be inserted into the transverse hole of the pin 246e of the spring-loaded locking pin 246a to maintain or retain the spring-loaded locking pin 246a in the retracted position when the spring-loaded locking pin 246a is in the retracted position. According to various embodiments, the insertion tip 269e of the tensioning rod 269 may be retractable to release the spring biased locking pin 246a for engagement with the slider strut 214. Thus, the insertion tip 269e of the tensioning rod 269 can be removed from the cross hole of the pin 246e of the spring biased locking pin 246a of the locking piece 246 such that the pin 246e of the spring biased locking pin 246a of the locking piece 246 can move from a retracted position to an extended position to engage the slider strut 214 to lock the locking piece 246 to the slider strut 214.

[0142]

[0160] According to various embodiments, the first end 269a of the tensioning rod 269 can include a coupling element 269f that engages with the locking component 246 to removably couple the first end 269a of the tensioning rod 269 to the locking component 246. According to various embodiments, the coupling element 269f of the tensioning rod 269 can be configured to removably couple with the locking component 246. According to various embodiments, the first end 269a of the tensioning rod 269 can include a threaded stem portion 269g that functions as the coupling element 269f. According to various embodiments, the threaded stem portion 269g can be adjacent to the insertion tip 269e. Thus, the threaded stem portion 269g can be next to or immediately adjacent to the insertion tip 269e along the first end 269a of the tensioning rod 269. According to various embodiments, the threaded stem portion 269g may be threaded into the lock housing 246b of the lock component 246 to removably couple the tensioning rod 269 to the lock component 246. According to various embodiments, when the threaded stem portion 269g is threaded into the lock housing 246b, the insertion tip 269e of the tensioning rod 269 may be inserted perpendicularly to the spring-biased locking pin 246a in the retracted position. Thus, with the threaded stem portion 269g threaded into the lock housing 246b, the insertion tip 269e of the tensioning rod 269 may be inserted into the transverse hole of the pin 246e of the spring-biased locking pin 246a.

[0143]

[0161] According to various embodiments, the threaded stem portion 269g can be partially unscrewed from the lock housing 246b of the locking component 246 to withdraw the insertion tip 269e from the spring biased locking pin 246a and release the spring biased locking pin. Thus, when the threaded stem portion 269g is partially unscrewed from the lock housing 246b of the locking component 246, the insertion tip 269e can be fully withdrawn from the transverse hole of the pin 246e of the spring biased locking pin 246a such that the pin 246e of the spring biased locking pin 246a can be moved from a retracted position to an extended position for engaging the slider strut 214 to lock the locking component 246 to the slider strut 214. The threaded stem portion 269g is partially unthreaded when a portion of the threaded stem portion 269g remains threaded into the lock housing 246b and a portion of the threaded stem portion 269g is not threaded or engaged with the lock housing 246b. For example, the threaded stem portion 269g may be partially unthreaded when approximately half of the threaded stem portion 269g remains threaded into the lock housing 246b and half of the threaded stem portion 269g is not threaded into or is outside of the lock housing 246b.

[0144]

[0162] According to various embodiments, the threaded stem portion 269g can be fully unscrewed from the lock housing 246b of the locking part 246 to disconnect the first end 269a of the tensioning rod 269 from the locking part 246. Once the threaded stem portion 269g is fully unscrewed from the lock housing 246b, the tensioning rod 269 can be fully disconnected or removed or separated from the locking part 246 such that they no longer contact each other. Thus, once the threaded stem portion 269g is fully unscrewed from the lock housing 246b of the locking part 246, the threaded stem portion 269g can be completely outside of the lock housing 246b of the locking part 246.

[0145]

[0163] According to various embodiments, the tension control interface 276 of the control handle 270 of the delivery device 160 may be a rotatable dial 276a. The rotatable dial 276a may be rotatable about the control handle 270. According to various embodiments, the control handle 270 may be elongated in shape. Thus, the rotatable dial 276a may be rotatable about the longitudinal axis of the control handle 270. According to various embodiments, the control handle 270 may include a rotation-linear mechanism 280 interconnecting the rotatable dial 276a and the tension rod 269 to convert a rotational motion of the rotatable dial 276a into a linear translational motion of the tension rod 269. According to various embodiments, the rotation-linear mechanism 280 may connect the rotatable dial 276a to the second end 269b of the tension rod 269. Thus, the rotary / linear mechanism 280 can linearly translate or move the second end 269b of the tensioning rod 269 upon receiving a rotational input from the rotatable dial 276a.

[0146]

[0164] According to various embodiments, the rotatable dial 276a, which functions as the tension control interface 276 of the control handle 270, can include an internal thread. Thus, the internal thread can be along an inner wall of the rotatable dial 276a. According to various embodiments, the rotary-linear mechanism 280 can include a lead screw 282 having an external thread. Thus, the external thread of the lead screw 282 can engage with the internal thread of the rotatable dial 276a. According to various embodiments, the engagement between the external thread of the lead screw 282 and the internal thread of the rotatable dial 276a allows the lead screw 282 to translate or linearly move along the longitudinal axis of the control handle 270 as the rotatable dial 276a rotates about the longitudinal axis of the control handle 270. Thus, the rotational motion of the rotatable dial 276a can be converted into a linear translational motion of the lead screw 282 by the threaded engagement between the rotatable dial 276a and the lead screw 282. According to various embodiments, the second end 269b of the tensioning rod 269 may be coupled to the lead screw 282 such that the tensioning rod 269 may be linearly translatable with the lead screw 282. Thus, with the second end 269b of the tensioning rod 269 coupled to the lead screw 282, the linear translational motion of the lead screw 282 may be imparted to the tensioning rod 269.

[0147]

[0165] According to various embodiments, the indicator plate 263 of the control handle 270 can be fixedly coupled to the lead screw 282 of the rotary-linear mechanism 280. According to various embodiments, the elongated window 275 of the control handle 270 can be aligned longitudinally with respect to the control handle 270. According to various embodiments, the indicator plate 263 can be disposed below the elongated window 275. Thus, as the lead screw 282 translates linearly along the control handle 270, the indicator plate 263 can move along the elongated window 275. Thus, the elongated window 275 can be for viewing the indicator plate 263 as the lead screw 282 translates linearly along the longitudinal axis of the control handle 270. Thus, the linear movement of the lead screw 282 can be observed by viewing the movement of the indicator plate 263 through the elongated window 275. When the tensioning rod 269 is coupled to the locking member 246 and the rotatable dial 276a is rotated to move the lead screw 282 to move the tensioning rod 269 and apply tension to the tensioning unit 240, the indicator plate 263 and the elongated window 275 can provide a visual indication or display as an indication of the amount of tension present in the tensioning unit 240.

[0148]

[0166] According to various embodiments, the separate control interface 278 of the control handle 270 may be a knob 278a. The knob 278a may be coupled to a transmission shaft 288 extending longitudinally within the control handle 270. The knob 278a may thus be rotatable to rotate the transmission shaft 288. According to various embodiments, a first end 288a of the transmission shaft 288 may be coupled to the knob 278a, and a second end 288b of the transmission shaft 288 may be coupled to a second end 269b of the tensioning rod 269. Thus, rotation of the transmission shaft 288 may be imparted to the tensioning rod 269 to rotate the tensioning rod 269 about the rod axis of the tensioning rod 269. According to various embodiments, the second end 269b of the tensioning rod 269 may be coaxially coupled to the second end 288b of the transmission shaft 288. According to various embodiments, the knob 278a may be coupled to a first end 288a of the transmission shaft 288 via a release gear assembly 290. According to various embodiments, the release gear assembly 290 may include two or more gears. For example, the release gear assembly 290 may include at least two gears arranged side-by-side with parallel axes of rotation.

[0149]

[0167] According to various embodiments, the lead screw 282 of the rotary-linear mechanism 280 may be hollow. Thus, the lead screw 282 may include a through channel 282a extending longitudinally therethrough. Thus, the through channel 282a may completely longitudinally pass through the lead screw 282 from one longitudinal end to the other longitudinal end. According to various embodiments, the control handle 270 may include a shaft coupling 286. The shaft coupling 286 may be arranged to be surrounded by the lead screw 282. Thus, the shaft coupling 286 may be introduced into the through channel 282a of the lead screw 282. Thus, the shaft coupling 286 may extend into or within the through channel 282a of the lead screw 282. According to various embodiments, the shaft coupling 286 may interconnect the second end 288b of the transmission shaft 288 and the second end 269b of the tensioning rod 269 via the through channel 282a of the lead screw 282. Thus, the tensioning rod 269, the shaft coupling 286, and the transmission shaft 288 may be connected to one another to extend through the through channel 282a of the lead screw 282. Thus, when the tensioning rod 269, the shaft coupling 286, and the transmission shaft 288 are coupled to one another, the lead screw 282 may surround at least a portion of the coupling.

[0150]

[0168] According to various embodiments, the shaft coupling 286 may include an elongated body 286c having a first end 286a and a second end 286b. According to various embodiments, the elongated body 286c of the shaft coupling 186 may include a bore 286d extending longitudinally into the elongated body 286c from the first end 286a of the elongated body 286c. According to various embodiments, the elongated body 286c of the shaft coupling 186 may include a longitudinal slot 286e along a wall 286f of the bore 286d. Thus, the longitudinal slot 286d may be parallel to the bore 286d and may provide access to the bore 286d along the length of the bore 286d. According to various embodiments, the second end 288b of the transmission shaft 288 may be inserted into the bore 286d from the first end 286a of the elongated body 286c. According to various embodiments, the second end 288b of the transmission shaft 288 may include a pin 288c that protrudes perpendicularly from the second end 288b of the transmission shaft 288. According to various embodiments, the pin 288c may protrude or fit or be inserted into the longitudinal slot 286e to form a slidable pin-slot joint. Thus, the shaft coupling 286 and the transmission shaft 288 may be slidably connected to one another.

[0151]

[0169] According to various embodiments, the second end 269b of the tensioning rod 269 may be fixedly coupled to the second end 286b of the elongated body 286c of the shaft coupling 286. Thus, the tensioning rod 269 may be rigidly attached or rigidly fastened to the shaft coupling 286. Thus, the shaft coupling 286 and the tensioning rod 269 may move together.

[0152]

[0170] According to various embodiments, the shaft coupling support bracket 284 of the control handle 270 may be fixed to an inner wall surface of the lead screw 282. Thus, the lead screw 282 and the shaft coupling support bracket 284 can be rigidly attached or fastened. According to various embodiments, the shaft coupling 286 can fit through the shaft coupling support bracket 284 such that the shaft coupling 286 is rotatable about its longitudinal axis to rotate the tensioning rod 269 about the rod axis, but is immovable along its longitudinal axis relative to the lead screw 282 such that the tensioning rod 269 is linearly translatable with the lead screw 282. Thus, the shaft coupling 286 is coupled to the shaft coupling support bracket 284 such that the shaft coupling 286 is rotatable about its longitudinal axis but is immovable along its longitudinal axis relative to the shaft coupling support bracket 284.

[0153]

[0171] According to various embodiments, the elongated body 286c of the shaft coupling 186 may include a smaller diameter neck 286f or circumferential groove. The shaft coupling support bracket 284 may include a break or opening that fits into the neck 286f or circumferential groove of the shaft coupling 186 to rotate about the neck 286f or circumferential groove such that the shaft coupling 186 can rotate about its longitudinal axis within the break or opening in the shaft coupling support bracket 284. Additionally, the shaft coupling 186 may not be able to translate along its longitudinal axis relative to the shaft coupling support bracket 284 because the sides of the shaft coupling support bracket 284 may abut the side walls of the neck or circumferential groove of the shaft coupling 186.

[0154]

[0172] According to various embodiments, a prosthetic implant delivery system is provided that includes a prosthetic valve implant 200 and a delivery device 260.

[0155]

[0173] In various embodiments, the delivery system provides the ability to align the leaflet prosthesis relative to the TV, control the movement of the leaflet prosthesis to maximize reduction in TR, and provide a safe and controlled method of maintaining the position of the leaflet prosthesis upon removal of the delivery device.

[0156]

[0174] The above disclosure enables a person skilled in the art to practice the present invention. The present disclosure provides disclosure of embodiments of the present invention. However, the embodiments do not limit the present invention to the exact structure, dimensional relationship, and operation shown and described. Those skilled in the art can easily conceive and appropriately use modifications, alternative structures, changes, and equivalents without departing from the scope of the present invention. Therefore, the above description and examples should not be interpreted as limiting the scope of the present invention. Therefore, the scope of the present invention is indicated by the accompanying description, and therefore, it is intended to embrace all modifications that are within the meaning and scope of the equivalents of the description.

Claims

1. Face An anchor member; at least one resilient tethering strut extending from the anchor member; a joining structure coupled to an end of the at least one elastic tethering strut remote from the anchor member; a tensioning unit extending between the anchor member and the joining structure; 1. A prosthetic implant comprising: The tension applying unit is a flexible hollow tube extending between the anchor member and the joining structure; a tensioning wire extending through the flexible hollow tube, a first end of the tensioning wire being secured to a junction between the first end of the flexible hollow tube and the junction structure, and a second end of the tensioning wire extending from the second end of the flexible hollow tube; Equipped with A prosthetic implant, wherein the second end of the tensioning wire is extendable relative to the flexible hollow tube such that the second end of the tensioning wire is pulled away from the second end of the flexible hollow tube to bend the flexible hollow tube and correspondingly bend the at least one elastic tethering strut, thereby moving the joint structure relative to the anchor member.

2. a coupler coupling the joint structure to the end of the at least one elastic tethering strut; the coupler having a first connection end for receiving the joining structure and a second connection end for receiving the end of the at least one elastic tethering strut; a main axis of the coupler extends between the first connection end and the second connection end; 2. The prosthetic implant of claim 1, wherein the joining structure is fitted to the first connecting end of the coupler with rotational play about the main axis of the coupler and with pivotal play about a transverse axis perpendicular to the main axis of the coupler.

3. The joining structure includes a pair of L-shaped connecting legs having legs pointing in opposite directions; the coupler comprises a hollow coupler body having a first opening at the first connection end, and a pair of side holes in opposing wall portions of the hollow coupler body, the pair of side holes being coaxial with the horizontal axis, and the height of the first opening in a height direction perpendicular to the main axis and the horizontal axis is greater than a thickness of the pair of L-shaped connection legs; 3. The prosthetic implant of claim 2, wherein the pair of L-shaped connecting legs of the joining structure are inserted into the first opening of the first connecting end of the coupler with the feet of the pair of L-shaped connecting legs respectively fitted into the pair of side holes.

4. The prosthetic implant of claim 3 , wherein each of said pair of side holes is a slot parallel to said height direction of said first opening of said first connecting end.

5. the end of the at least one elastic tethering strut includes a pin hole or a key hole; the hollow coupler body of the coupler includes a second opening at the second connection end and a corresponding pin hole or key hole in a wall portion of the hollow coupler body; 5. The prosthetic implant of claim 3 or 4, wherein the end of the at least one elastic tethering strut is inserted into the second opening at the second connection end of the coupler, and a locking pin or key is inserted through the corresponding pin or key hole in the hollow coupler body of the coupler and into the pin or key hole in the end of the at least one elastic tethering strut to lock the at least one elastic tethering strut to the coupler.

6. 6. The prosthetic implant of claim 5, wherein the locking pin or key has a spacer portion inserted between the pair of L-shaped connecting legs of the joining structure to hold the pair of L-shaped connecting legs apart and to hold the feet of the pair of L-shaped connecting legs respectively fitted into the pair of side holes of the hollow coupler body.

7. 7. The prosthetic implant of claim 1, wherein the first end of the flexible hollow tube of the tensioning unit is coupled to the end of the at least one elastic tethering strut and the second end of the flexible hollow tube of the tensioning unit is coupled to the anchor member.

8. the tensioning unit further comprises a locking component fixed to the second end of the tensioning wire, the locking component being movable relative to the anchor member to retract the second end of the tensioning wire relative to the flexible hollow tube to pull the second end of the tensioning wire away from the second end of the flexible hollow tube; 8. The prosthetic implant of claim 1, wherein the locking component is lockable to the anchor member to secure the second end of the tensioning wire when a desired displacement from the second end of the flexible hollow tube is reached such that the curvature of the flexible hollow tube, the curvature of the at least one elastic tethering strut, and the relative positioning of the joining structure to the anchor member are fixed.

9. 9. The prosthetic implant of claim 8, wherein the anchor member comprises a slider strut, and the locking component comprises a lock housing having a slider bracket having a gap therebetween for receiving the slider strut so that the locking component slides in engagement with the slider strut.

10. 10. The prosthetic implant of claim 9, wherein the slider strut of the anchor member comprises a plurality of locking holes spaced longitudinally along the slider strut, and the locking component comprises a spring-biased locking pin oriented perpendicular to the slider strut, the locking component operable to hold the spring-biased locking pin in a retracted position within the lock housing for sliding the locking component relative to the slider strut and operable to release the spring-biased locking pin to extend from the lock housing to an extended position for engaging at least one of the plurality of locking holes to lock the locking component to the slider strut of the anchor member.

11. 11. The prosthetic implant of claim 10, wherein the spring biased locking pin comprises a pin and a leaf spring, the pin being coupled to a free end of the leaf spring and the other end of the leaf spring being fixedly coupled to the lock housing of the locking component.

12. 11. The prosthetic implant of claim 9 or 10, wherein in an extended position, the spring biased locking pin extends from the lock housing into the gap between the slider bracket and the lock housing.

13. The prosthetic implant of any one of claims 1 to 12, wherein said flexible hollow tube comprises a slotted tube, a ribbed tube, a corrugated bellows tube, an interlocking tube, a mesh tube or a braided tube.

14. The prosthetic implant according to any one of claims 1 to 13, wherein said flexible hollow tube has directional flexibility.

15. 15. The prosthetic implant of claim 14, wherein the flexible hollow tube comprises a first sector that extends continuously from the first end of the flexible hollow tube to the second end of the flexible hollow tube forming a spine portion, and a second sector that comprises a plurality of spaced ribs arranged at regular intervals from the first end of the flexible hollow tube to the second end of the flexible hollow tube forming a ribbed portion.

16. 16. The prosthetic implant of claim 15, wherein said plurality of spaced apart ribs are formed by a plurality of parallel transverse cuts along a second sector of said flexible hollow tube.

17. 17. The prosthetic implant of claim 16, wherein each of said plurality of transverse cuts has a V-shaped or U-shaped cut segment.

18. The prosthetic implant of any one of claims 1 to 17, wherein the anchor member comprises a stent and the coaptation structure comprises a leaflet prosthesis.

19. A prosthetic implant according to any one of claims 1 to 18, Delivery device and 1. A prosthetic implant delivery system comprising:

20. The delivery device, an outer sheath within a first end of the outer sheath within which the prosthetic implant is compressed and constrained; a tensioning rod enclosed within the outer sheath and having a first end removably coupled to the second end of the tensioning wire of the tensioning unit of the prosthetic implant; a control handle at a second end of the outer sheath; and Equipped with The control handle comprises: a first control interface associated with the second end of the outer sheath and operable to retract the outer sheath to deploy the prosthetic implant; a second control interface associated with a second end of the tensioning rod and operable to retract or extend the tensioning rod relative to the control handle to move the second end of the tensioning wire relative to the flexible hollow tube to adjust the displacement of the second end of the tensioning wire from the second end of the flexible hollow tube and correspondingly adjust the degree of bending of the flexible hollow tube and the degree of bending of the at least one elastic tethering strut to position the joint structure relative to the anchor member; a third control interface associated with a second end of the tensioning rod and operable to decouple the first end of the tensioning rod from the second end of the tensioning wire of the tensioning unit of the prosthetic implant; A prosthetic implant delivery system comprising:

20. 20. The prosthetic implant delivery system of claim 19, wherein the first end of the tensioning rod comprises a retaining element that engages with the spring biased locking pin of the locking part to retain the spring biased locking pin in the retracted position, the retaining element being withdrawable to disengage from the spring biased locking pin of the locking part to release the spring biased locking pin for engagement with the slider strut, when the prosthetic implant is as described in any one of claims 10, 11, 12 or 13-18 in combination with claim 10.

21. 21. The prosthetic implant delivery system of claim 20, wherein the first end of the tensioning rod comprises a coupling element that engages with the locking part to releasably couple the first end of the tensioning rod to the locking part.

22. 22. The prosthetic implant delivery system of claim 20 or 21, wherein the retaining element comprises an insertion tip that is inserted perpendicular to the spring-loaded locking pin to retain the spring-loaded locking pin in the retracted position, and the insertion tip is retractable to release the spring-loaded locking pin for engagement with the slider strut.

23. 23. The prosthetic implant delivery system of claim 22, wherein the coupling element comprises a threaded stem portion adjacent the insertion tip, the threaded stem portion threaded into the lock housing of the locking component with the insertion tip inserted perpendicularly to the spring biased locking pin in the retracted position, the threaded stem portion being partially unscrewed from the lock housing of the locking component to withdraw the insertion tip from the spring biased locking pin to release the spring biased locking pin, and being fully unscrewed from the lock housing of the locking component to decouple the first end of the tensioning rod from the locking component.

24. the second control interface comprises a rotatable dial, the rotatable dial being rotatable about a longitudinal axis of the control handle; 24. The prosthetic implant delivery system of any one of claims 19 to 23, wherein the control handle comprises a rotational-linear motion mechanism interconnecting the rotatable dial and the tensioning rod to convert rotational motion of the rotatable dial into linear translational motion of the tensioning rod.

25. the rotatable dial having an internal thread; the rotary-linear motion mechanism comprising a lead screw having external threads that engage the internal threads of the rotatable dial such that the rotatable dial translates linearly along the longitudinal axis of the control handle when rotated about the longitudinal axis of the control handle; 25. The prosthetic implant delivery system of claim 24, wherein the second end of the tensioning rod is coupled to the lead screw such that the tensioning rod is linearly translatable with the lead screw.

26. 26. The prosthetic implant delivery system of claim 25, wherein the control handle comprises an indicator plate fixedly coupled to the lead screw and an elongated window aligned longitudinally with respect to the control handle for viewing the indicator plate as the lead screw translates linearly along the longitudinal axis of the control handle.

27. 27. The prosthetic implant delivery system of claim 25 or 26, wherein the third control interface comprises a knob for rotating a transmission shaft extending longitudinally within the control handle, a first end of the transmission shaft coupled to the knob and a second end of the transmission shaft coupled to the second end of the tensioning rod to impart a shaft rotation for rotating the tensioning rod about a rod axis of the tensioning rod.

28. the lead screw is hollow with a through channel extending longitudinally therethrough; the control handle includes a shaft coupling interconnecting the second end of the transfer shaft and the second end of the tensioning rod through the through channel of the lead screw; the shaft coupling comprises an elongate body having a bore extending longitudinally into the elongate body from a first end thereof and a longitudinal slot along a wall of the bore, the second end of the transfer shaft being inserted into the bore with a pin protruding perpendicularly from the second end of the transfer shaft into the longitudinal slot to form a slidable pin-slot joint; the second end of the tensioning rod is fixedly coupled to a second end of the elongate body of the shaft coupling; 28. The prosthetic implant delivery system of claim 27, wherein the control handle comprises a shaft coupling support bracket secured to an inner wall surface of the lead screw, the shaft coupling being mounted through the shaft coupling support bracket such that the shaft coupling is rotatable about its longitudinal axis to rotate the tensioning rod about the rod axis, but is immovable along the longitudinal axis of the shaft coupling relative to the lead screw such that the tensioning rod is linearly translatable together with the lead screw.

29. A delivery device for a prosthetic implant according to any one of claims 1 to 18, comprising: an outer sheath within a first end of the outer sheath within which the prosthetic implant is compressed and constrained; a tensioning rod enclosed within the outer sheath and having a first end removably connectable to the second end of the tensioning wire of the tensioning unit of the prosthetic implant; a control handle at a second end of the outer sheath; and Equipped with The control handle comprises: a first control interface associated with the second end of the outer sheath and operable to retract the outer sheath to deploy the prosthetic implant; a second control interface associated with a second end of the tensioning rod and operable to retract or extend the tensioning rod relative to the control handle to move the second end of the tensioning wire relative to the flexible hollow tube to adjust the displacement of the second end of the tensioning wire from the second end of the flexible hollow tube and correspondingly adjust the degree of bending of the flexible hollow tube and the degree of bending of the at least one elastic tethering strut to position the joint structure relative to the anchor member; a third control interface associated with a second end of the tensioning rod and operable to decouple the first end of the tensioning rod from the second end of the tensioning wire of the tensioning unit of the prosthetic implant; A delivery device comprising:

30. 30. The delivery device of claim 29, wherein when the prosthetic implant is according to any one of claims 10, 11, 12 or 13-18 in combination with claim 10, the first end of the tensioning rod comprises a retaining element that engages with the spring biased locking pin of the locking part of the prosthetic implant to retain the spring biased locking pin in the retracted position, the retaining element being withdrawable to disengage from the spring biased locking pin of the locking part to release the spring biased locking pin for engagement with the slider strut.

31. 31. The delivery device of claim 30, wherein the first end of the tensioning rod comprises a coupling element that engages with the locking part to releasably couple the first end of the tensioning rod to the locking part.

32. 32. The delivery device of claim 30 or 31, wherein the retaining element comprises an insertion tip that is inserted perpendicular to the spring-biased locking pin to retain the spring-biased locking pin in the retracted position, and the insertion tip is retractable to release the spring-biased locking pin for engagement with the slider strut.

33. 33. The delivery device of claim 32, wherein the coupling element comprises a threaded stem portion adjacent the insertion tip, the threaded stem portion being threadable into the lock housing of the locking component with the insertion tip inserted perpendicularly to the spring-biased locking pin in the retracted position, and the threaded stem portion being partially unscrewed from the lock housing of the locking component to withdraw the insertion tip from the spring-biased locking pin to release the spring-biased locking pin, and being fully unscrewed from the lock housing of the locking component to decouple the first end of the tensioning rod from the locking component.

34. the second control interface comprises a rotatable dial, the rotatable dial being rotatable about a longitudinal axis of the control handle; 34. The delivery device of any one of claims 29 to 33, wherein the control handle comprises a rotational-linear motion mechanism interconnecting the rotatable dial and the tensioning rod to convert rotational motion of the rotatable dial into linear translational motion of the tensioning rod.

35. the rotatable dial having an internal thread; the rotary-linear motion mechanism comprising a lead screw having external threads that engage the internal threads of the rotatable dial such that the rotatable dial translates linearly along the longitudinal axis of the control handle when rotated about the longitudinal axis of the control handle; 35. The delivery device of claim 34, wherein the second end of the tensioning rod is coupled to the lead screw such that the tensioning rod is linearly translatable with the lead screw.

36. 36. The delivery device of claim 35, wherein the control handle comprises an indicator plate fixedly coupled to the lead screw and an elongated window aligned longitudinally with respect to the control handle for viewing the indicator plate as the lead screw translates linearly along the longitudinal axis of the control handle.

37. 37. The delivery device of claim 35 or 36, wherein the third control interface comprises a knob for rotating a transmission shaft extending longitudinally within the control handle, a first end of the transmission shaft coupled to the knob and a second end of the transmission shaft coupled to the second end of the tensioning rod to impart a shaft rotation for rotating the tensioning rod about a rod axis of the tensioning rod.

38. the lead screw is hollow with a through channel extending longitudinally therethrough; the control handle includes a shaft coupling interconnecting the second end of the transfer shaft and the second end of the tensioning rod through the through channel of the lead screw; the shaft coupling comprises an elongate body having a bore extending longitudinally into the elongate body from a first end thereof and a longitudinal slot along a wall of the bore, the second end of the transfer shaft being inserted into the bore with a pin protruding perpendicularly from the second end of the transfer shaft into the longitudinal slot to form a slidable pin-slot joint; the second end of the tensioning rod is fixedly coupled to a second end of the elongate body of the shaft coupling; 38. The delivery device of claim 37, wherein the control handle comprises a shaft coupling support bracket secured to an inner wall surface of the lead screw, the shaft coupling being mounted through the shaft coupling support bracket such that the shaft coupling is rotatable about its longitudinal axis to rotate the tensioning rod about the rod axis, but immovable along the longitudinal axis of the shaft coupling relative to the lead screw such that the tensioning rod is linearly translatable together with the lead screw.

Images