Frame with varied strut widths for prosthetic implant

Abstract

To provide prosthetic implants, such as self-expanding prosthetic heart valves and support structures, and associated delivery apparatuses.SOLUTION: A prosthetic implant has a self-expanding frame with an inflow end, an outflow end, and a plurality of struts interconnected at junctions. At least a portion of the plurality of struts has, at at least one junction, a reduced strut width configured to reduce or prevent infolding of the frame during recapture into a delivery cylinder of a delivery apparatus.SELECTED DRAWING: Figure 37

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 942,704, filed on Dec. 2, 2019. The entire disclosure of U.S. Provisional Patent Application No. 62 / 942,704 is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to prosthetic implants, such as self - expanding prosthetic heart valves and support structures, and related delivery devices.

Background Art

[0003] Prosthetic heart valves have been used for many years to treat diseases of the heart valves. Native heart valves (such as the aortic valve, pulmonary valve, and mitral valve) play important functions in ensuring the proper forward flow of blood through the cardiovascular system. These heart valves can lose their effectiveness due to congenital, inflammatory, or infectious conditions. Such damage to the valve can potentially result in severe cardiovascular disorders or death. Over the years, the most certain treatment for such diseases has been surgical repair or replacement of the valve during open - heart surgery, but such surgeries can cause many complications. More recently, transvascular techniques have been developed to introduce and implant prosthetic heart valves using flexible catheters in a less invasive manner than open - heart surgery.

[0004] In this technique, the prosthetic valve is mounted in a collapsed state at the distal end of a flexible catheter and advanced through the patient's blood vessels until the prosthetic valve reaches the implantation site. The prosthetic valve at the catheter tip is then expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the prosthetic valve is mounted. Alternatively, the prosthetic valve can have an elastic self - expanding stent or frame that expands the prosthetic valve to its functional size as it is advanced from a delivery sheath at the distal end of the catheter.

[0005] Balloon-expandable prosthetic valves are typically preferred for replacing calcified native valves because a catheter balloon can apply sufficient expansion force to anchor the frame of the prosthetic valve to the surrounding calcified tissue. On the other hand, self-expanding prosthetic valves can also be used for replacing stenotic valves, but may also be preferred for replacing non-failing, non-stenotic (non-calcified) native valves.

[0006] During implantation of a self-expanding implant, such as a prosthetic valve or valve support stent, a surgeon can partially advance the implant from a delivery cylinder or sheath containing the implant to evaluate the positioning of the implant before fully deploying it. If adjustment of the position is required, the surgeon can partially or fully retract the prosthetic implant back into the delivery sheath, which is a process known as "recapturing" the prosthetic implant. During implant recapture, the distal end portion of the delivery sheath can be advanced or guided to return the prosthetic implant to a compressed state as the prosthetic implant is drawn back into the delivery sheath. Partial deployment and recapture of the implant may be performed multiple times to achieve the desired positioning before the prosthetic implant is fully deployed. However, certain self-expanding prosthetic implants, such as relatively large-diameter prosthetic heart valves and support stents, may cause inward folding where one or more struts bend, deform, or buckle radially inward during recapture. Such inward folding can result in creases, wrinkles, or depressions on the outside of the frame and may require replacement of the prosthetic implant and / or balloon valvuloplasty to fully expand the prosthetic implant after deployment.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

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Patent Document 12

Summary of the Invention

Problems to be Solved by the Invention

[0008] Therefore, there is a need for an improvement in the frame for self-expanding prosthetic implants such as prosthetic heart valves and support stents.

Means for Solving the Problems

[0009] Certain embodiments of the present disclosure relate to a self-expanding frame for a prosthetic implant with varying strut widths, thicknesses, junction widths, and other parameters configured to reduce or prevent inward folding of the frame during recapture into the delivery cylinder of the delivery device. In a representative embodiment, the prosthetic implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, and at least a portion of the plurality of struts having a reduced strut width at at least one junction.

[0010] In any or all of the disclosed embodiments, at least some of the plurality of struts have a strut width that is reduced at both joints.

[0011] In any or all of the disclosed embodiments, at least some of the plurality of struts have a strut width that is reduced at their inlet-side joints.

[0012] In any or all of the disclosed embodiments, at least some of the plurality of struts have a strut width that is reduced at their outlet-side joints.

[0013] In any or all of the disclosed embodiments, at least the struts of the second row of struts have a strut width that is reduced at their outlet-side joints.

[0014] In any or all of the disclosed embodiments, at least the struts of the second row of struts have a strut width that is reduced at their inlet-side joints.

[0015] In any or all of the disclosed embodiments, the struts define a first row of struts at the inlet end of the frame, a second row of struts at the outlet end of the frame, and at least one row of struts between the inlet end and the outlet end of the frame.

[0016] In any or all of the disclosed embodiments, at least the struts of the first row of struts have a strut width that is reduced at their inlet-side joints.

[0017] In any or all of the disclosed embodiments, at least the struts of the first row of struts have a strut width that is reduced at their outlet-side joints.

[0018] In any or all of the disclosed embodiments, the strut includes an inlet end portion, an outlet end portion, and an intermediate portion between the inlet end portion and the outlet end portion. The inlet end portion of the struts in the first row of struts has a first strut width, the outlet end portion of the struts in the first row of struts has a second strut width, and the intermediate portion of the struts in the first row of struts has a third strut width that is greater than the first strut width.

[0019] In any or all of the disclosed embodiments, the third strut width is greater than the first strut width and greater than the second strut width.

[0020] In any or all of the disclosed embodiments, the first strut width and the second strut width are substantially equal.

[0021] In any or all of the disclosed embodiments, the ratio of the first strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95.

[0022] In any or all of the disclosed embodiments, the ratio of the second strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95.

[0023] In any or all of the disclosed embodiments, the thickness of the strut is greater than the third strut width.

[0024] In any or all of the disclosed embodiments, the ratio of the third strut width to the strut thickness is 0.65 or more, or is 0.65 to 0.85.

[0025] In any or all of the disclosed embodiments, the joint has a joint width, and the joint width is greater than the third strut width.

[0026] In any or all of the disclosed embodiments, the ratio of the joint width to the third strut width is 0.3 to 0.5.

[0027] In any or all of the disclosed embodiments, the strut has a strut thickness and the junction width is greater than the strut thickness.

[0028] In any or all of the disclosed embodiments, the ratio of the junction width to the strut thickness is 2.1 or less, or is between 1.5 and 2.1.

[0029] In any or all of the disclosed embodiments, when 80% of the total length of the patch implant is deployed from the delivery cylinder of the delivery device, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less, or is between 5.0 and 6.0.

[0030] In any or all of the disclosed embodiments, the inflow end portion of the struts in the second row of struts has a first strut width, the outflow end portion of the struts in the second row of struts has a second strut width, and the middle portion of the struts in the second row of struts has a third strut width.

[0031] In any or all of the disclosed embodiments, each junction has a curved inflow surface that defines a radius, and the ratio of the second strut width at the outflow end of the strut to the radius of the curved inflow surface is between 4.0 and 7.5.

[0032] In any or all of the disclosed embodiments, all struts of the frame have a first strut width, a second strut width, and a third strut width.

[0033] In any or all of the disclosed embodiments, all struts of the frame have a first strut width, a second strut width, and a third strut width.

[0034] In any or all of the disclosed embodiments, the patch implant is a prosthetic heart valve comprising a plurality of valve leaflets coupled to the frame and configured to regulate blood flow through the frame.

[0035] In any or all of the disclosed embodiments, the patch implant is a docking station configured to be implanted in the annulus of a native heart valve and configured to receive a prosthetic heart valve.

[0036] In another representative embodiment, a method includes advancing a patch implant of any of the embodiments described herein from a delivery cylinder of a delivery device in which the patch implant is held in a radially compressed state such that the inflow end of the patch implant at least partially expands, and retracting the patch implant back into the delivery cylinder such that the patch implant returns to a radially compressed state.

[0037] In another representative embodiment, a patch implant delivery device includes a catheter having a handle portion at a proximal end portion and an elongate shaft extending from the handle portion, the catheter further including a delivery cylinder having an inner diameter at a distal end portion of the shaft, and a self-expanding patch implant according to any of the embodiments described herein held in a radially compressed state within the delivery cylinder.

[0038] In any or all of the disclosed embodiments, the patch implant has a specific design diameter of at least 29 mm, and when the patch implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the patch implant is withdrawn, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less.

[0039] In another representative embodiment, the patch implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts. The struts are interconnected at the joints. The struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame. Each strut comprises an inflow end portion, an outflow end portion, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the struts in the first row of struts has a first strut width, the outflow end portion of the struts in the first row of struts has a second strut width, and the intermediate portion of the struts in the first row of struts has a third strut width that is greater than the first strut width and greater than the second strut width.

[0040] In another representative embodiment, the patch implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts. The struts are interconnected at the joints. Each strut comprises an inflow end portion coupled to each joint, an outflow end portion coupled to each joint, and an intermediate portion between the inflow end portion and the outflow end portion. The strut width of the intermediate portion of the strut is different from the strut width of the inflow end portion of the strut and different from the strut width of the outflow end portion of the strut. The strut has a strut thickness. The ratio of the strut width of the intermediate portion of the strut to the strut thickness is 0.65 or more, or is 0.65 to 0.85.

[0041] In another representative embodiment, the patch implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts. The struts are interconnected at the joints, and the joints have a joint width. Each strut comprises an inflow end portion coupled to each joint, an outflow end portion coupled to each joint, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the strut has a first strut width, the outflow end portion of the strut has a second strut width, and the intermediate portion of the strut has a third strut width that is greater than the first strut width and greater than the second strut width. The joint width is greater than the third strut width of the intermediate portion of the strut.

[0042] In another representative embodiment, the patch implant delivery device is a catheter comprising a handle portion at the proximal end portion and an elongated shaft extending from the handle portion, and further comprising a delivery cylinder having an inner diameter at the distal end portion of the shaft. A self-expanding patch implant is held in a radially compressed state in the delivery cylinder. The patch implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, and the struts are interconnected at joints. The patch implant has a specific design diameter of at least 29 mm. When the patch implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the patch implant is withdrawn, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less.

[0043] The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Appendix 1] A patch implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, wherein the struts are interconnected at joints, and at least a portion of the plurality of struts have a reduced strut width at at least one joint. [Appendix 2] The patch implant according to Appendix 1, wherein the at least a portion of the plurality of struts have a reduced strut width at both joints. [Appendix 3] The patch implant according to Appendix 1, wherein the at least a portion of the plurality of struts have a reduced strut width at their inflow-side joints. [Appendix 4] The patch implant according to Appendix 1, wherein the at least a portion of the plurality of struts have a reduced strut width at their outflow-side joints. [Appendix 5] The struts define a first row of struts at the inflow end of the self-expanding frame, define a second row of struts at the outflow end of the self-expanding frame, and define at least one row of struts between the inflow end and the outflow end of the self-expanding frame, the patch implant according to any one of claims 1 to 4. [Claim 6] At least the struts of the first row of the struts have a reduced strut width at their inflow side joints, the patch implant according to claim 5. [Claim 7] At least the struts of the first row of the struts have a reduced strut width at their outflow side joints, the patch implant according to claim 5 or 6. [Claim 8] At least the struts of the second row of the struts have a reduced strut width at their inflow side joints, the patch implant according to any one of claims 5 to 7. [Claim 9] The struts include an inflow end portion, an outflow end portion, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the struts of the first row of the struts has a first strut width, the outflow end portion of the struts of the first row of the struts has a second strut width, and the intermediate portion of the struts of the first row of the struts has a third strut width greater than the first strut width, the patch implant according to claim 5. [Claim 10] The third strut width is greater than the first strut width and greater than the second strut width, the patch implant according to claim 9. [Claim 11] The first strut width and the second strut width are substantially equal, the patch implant according to claim 9 or 10. [Claim 12] The ratio of the first strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95, the patch implant according to any one of claims 9 to 11. [Claim 13] The thickness of the struts is greater than the third strut width, the patch implant according to any one of claims 9 to 12. [Additional item 14] When 80% of the total length of the patch implant is deployed from the delivery cylinder of the delivery device, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less, or 5.0 to 6.0. The patch implant according to any one of claims 1 to 13. [Additional item 15] The inflow end portion of the struts in the second row of the struts has the first strut width, the outflow end portion of the struts in the second row of the struts has the second strut width, and the intermediate portion of the struts in the second row of the struts has the third strut width. The patch implant according to any one of claims 9 to 14. [Additional item 16] All struts of the self-expanding frame have the first strut width, the second strut width, and the third strut width. The patch implant according to any one of claims 9 to 15. [Additional item 17] The patch implant is a prosthetic heart valve including a plurality of valve tips coupled to the self-expanding frame, and is a prosthetic heart valve configured to regulate the flow of blood through the self-expanding frame. The patch implant according to any one of claims 1 to 16. [Additional item 18] The patch implant is a docking station configured to be implanted in the valve ring of a native heart valve and to receive a prosthetic heart valve. The patch implant according to any one of claims 1 to 17. [Additional item 19] Advancing the patch implant according to any one of claims 1 to 18 from the delivery cylinder of the delivery device in which the patch implant is held in a radially compressed state such that at least a portion of the inflow end of the patch implant expands; Retracting the patch implant back into the delivery cylinder so that the patch implant returns to the radially compressed state; A method comprising. [Additional item 20] A catheter, comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, and further comprising a delivery cylinder having an inner diameter at a distal end portion of the shaft. The self-expanding patch implant according to any one of claims 1 to 18, which is held in a radially compressed state in the delivery cylinder. A patch implant delivery device comprising the same. [Claim 21] The patch implant has a specific design diameter of at least 29 mm. When the patch implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the patch implant is withdrawn, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less. The patch implant delivery device according to claim 20. [Claim 22] A self-expanding frame having an inflow end, an outflow end, and a plurality of struts, wherein the struts are interconnected at joints. The struts define a first row of struts at the inflow end of the self-expanding frame, a second row of struts at the outflow end of the self-expanding frame, and at least one row of struts between the inflow end and the outflow end of the self-expanding frame. The struts comprise an inflow end portion, an outflow end portion, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the struts in the first row of struts has a first strut width, the outflow end portion of the struts in the first row of struts has a second strut width, and the intermediate portion of the struts in the first row of struts has a third strut width that is greater than the first strut width and greater than the second strut width. A patch implant. [Claim 23] The first strut width and the second strut width are substantially equal. The patch implant according to claim 22. [Claim 24] The ratio of the first strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95, the patch implant according to claim 22 or 23. [Claim 25] The thickness of the strut is greater than the third strut width, the patch implant according to any one of claims 22 to 24. [Claim 26] The inflow end portion of the strut of the second row of the struts has the first strut width, the outflow end portion of the strut of the second row of the struts has the second strut width, and the intermediate portion of the strut of the second row of the struts has the third strut width, the patch implant according to any one of claims 22 to 25. [Claim 27] All struts of the self-expanding frame have the first strut width, the second strut width, and the third strut width, the patch implant according to any one of claims 22 to 26. [Claim 28] The patch implant includes a plurality of valve tips coupled to the self-expanding frame and is configured to regulate blood flow through the self-expanding frame, or is configured to be implanted in the valve annulus of a native heart valve and to receive a patch heart valve, the patch implant according to any one of claims 22 to 27. [Claim 29] A catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, and further comprising a delivery cylinder having an inner diameter at a distal end portion of the shaft. A self-expanding patch implant held in a radially compressed state in the delivery cylinder. A self-expanding frame having an inflow end, an outflow end, and a plurality of struts, wherein the struts are interconnected at joints. Having a specific design diameter of at least 29 mm. A self-expanding patch implant. Comprising. A prosthetic implant delivery device, wherein when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the prosthetic implant is withdrawn, the ratio of the diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is 6.0 or less. BRIEF DESCRIPTION OF THE DRAWINGS

[0044]

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DETAILED DESCRIPTION OF THE INVENTION

[0045] Described herein are embodiments of a self-expanding frame for a patch implant with varying strut widths, thicknesses, junction widths, and / or other parameters configured to reduce or prevent inward folding of the frame during recapture of the delivery device into the delivery cylinder / sheath. For example, in certain embodiments, the struts of the frame described herein may have a strut width that is smaller than the strut width near the center of the strut at or near the junction between adjacent struts. In certain embodiments, the ratio of the strut width at or near the junction to the strut width in the middle portion of the struts within a specific range can reduce the occurrence of inward folding during recapture of the frame. In certain embodiments, the struts can have a reduced strut width at their inflow-side junctions, outflow junctions, or both. In certain embodiments, the struts of the row of struts at the inflow end of the frame may have a varying strut width as described herein. In certain embodiments, varying the strut width as described herein can maintain the ratio of the inflow-side diameter of the partially deployed frame to the inner diameter of the delivery cylinder within a specific range to reduce inward folding. For example, certain frame embodiments described herein can be withdrawn from the delivery cylinder by more than 80% of the full length of the frame and recaptured into the delivery cylinder without inward folding. In a specific example, this can reduce the risk that the implant may be damaged and require replacement during the procedure, thereby reducing the time of the procedure and improving the patient's outcome.

[0046] First representative embodiment Referring initially to FIG. 1, a prosthetic aortic heart valve 10 according to one embodiment is shown. The prosthetic valve 10 includes an expandable frame member or stent 12 that supports a flexible leaflet region 14. The prosthetic valve 10 is radially compressible into a compressed state for delivery to a deployment site through the body and is expandable at the deployment site to its functional size as shown in FIG. 1. In certain embodiments, the prosthetic valve 10 is self-expanding, i.e., the prosthetic valve can expand radially to its functional size when advanced from the distal end of a delivery sheath. Devices particularly suitable for the percutaneous delivery and implantation of self-expanding prosthetic valves are described in detail later. In other embodiments, the prosthetic valve can be a balloon-expandable prosthetic valve adapted to be mounted in a compressed state on a balloon of a delivery catheter. The prosthetic valve can be expanded to its functional size at the deployment site by inflating the balloon, as is known in the art.

[0047] The illustrated prosthetic valve 10 is adapted to be deployed at the native aortic valve annulus, but may be used to replace other native valves of the heart. Further, the prosthetic valve 10 can be adapted to replace other valves in the body, such as venous valves.

[0048] Figures 3 and 4 show the stent 12 without the valve tip region 14 for purposes of illustration. As shown, the stent 12 can be formed from a plurality of frame members or struts 16 that extend longitudinally and are generally in the shape of a sine wave. The struts 16 are formed by alternating bends and are welded or otherwise fixed to each other at the knot points 18 formed from the tops of adjacent bends so as to form a braided structure. The struts 16 can be made of a suitable shape memory material such as nickel-titanium alloy known as nitinol that is compressed to a reduced diameter for delivery in a delivery device (such as those described later) and then expanded to its functional size in the patient's body when deployed from the delivery device. If the prosthetic valve is an expandable prosthetic valve adapted to be collapsed onto an inflatable balloon of the delivery device and expanded to its functional size by inflation of the balloon, the stent 12 can be made of a suitable ductile material such as nickel-chromium alloy or stainless steel.

[0049] The stent 12 has an inflow end 26 and an outflow end 27. The mesh structure formed by the struts 16 generally includes a cylindrical "upper" or outflow end portion 20, an outwardly arcuate or expanded intermediate region 22, and an inwardly arcuate "lower" or inflow end portion 24. The intermediate region 22 is desirably sized and shaped to extend into the aortic sinus at the origin of the aorta to assist in anchoring the prosthetic valve in place when implanted. As shown, the mesh structure desirably has a curved shape with a diameter that gradually increases from the outflow end portion 20 to the intermediate region 22, then gradually decreases from the intermediate region 22 to the location at the inflow end portion 24, and then gradually increases in diameter to form a flared end portion that terminates at the inflow end 26 along its entire length.

[0050] When the prosthetic valve is in its expanded state, the intermediate region 22 has a diameter D1, the inflow end portion 24 has a minimum diameter D2, the inflow end 26 has a diameter D3, and the outflow end portion 20 has a diameter D4, where D2 is smaller than D1 and D3, and D4 is smaller than D2. Also, D1 and D3 are preferably larger than the diameter of the native valve annulus into which the prosthetic valve is implanted. In this approach, the overall shape of the stent 12 assists in holding the prosthetic valve at the implantation site. More specifically, referring to FIGS. 5A and 5B, the prosthetic valve 10 can be implanted into the native valve (the aortic valve in the illustrated example) such that the lower region 24 is positioned within the aortic valve annulus 28, the intermediate region 22 extends upward above the aortic valve annulus and into the sinus of Valsalva 56, and the flared lower end 26 extends downward below the aortic valve annulus. The prosthetic valve 10 is held within the native valve by the radially outward force of the lower region 24 against the tissue surrounding the aortic valve annulus 28 and by the shape of the stent. Specifically, the intermediate region 22 and the flared lower end 26 extend radially outwardly from the aortic valve annulus 28 to better resist axial displacement of the prosthetic valve in the upstream and downstream directions. Depending on the condition of the native valve leaflets 58, the prosthetic valve is typically deployed within the native valve annulus 28 in a compressed state with the native valve leaflets 58 folded upwardly and between the outer surface of the stent 12 and the wall of the sinus of Valsalva, as depicted in FIG. 5B. In some cases, it may be desirable to excise the valve leaflets 58 prior to implanting the prosthetic valve 10.

[0051] Known prosthetic valves having self-expanding frames typically have additional anchoring devices or frame portions that extend into the vasculature and are to be secured in a disease-free area of the vasculature. Since the shape of the stent 12 assists in holding the prosthetic valve, no additional anchoring device is required, and the overall length L of the stent can be minimized such that the upper portion 20 of the stent does not extend into a disease-free area of the aorta, or at least minimizes the extent to which the upper portion 20 extends into a disease-free area of the aorta. Avoiding disease-free areas of the patient's vasculature helps avoid complications if future therapeutic interventions are required. For example, the prosthetic valve can be more easily removed from the patient since the stent is primarily anchored to the diseased portion of the native valve. Further, in certain embodiments, shorter prosthetic valves can be more easily guided around the aortic arch.

[0052] In a specific embodiment, for a prosthetic valve intended for use at a valve annulus of 22 mm to 24 mm, the diameter D1 is from about 28 mm to about 32 mm, with 30 mm being a specific example, the diameter D2 is from about 24 mm to about 28 mm, with 26 mm being a specific example, the diameter D3 is from about 28 mm to about 32 mm, with 30 mm being a specific example, and the diameter D4 is from about 24 mm to about 28 mm, with 26 mm being a specific example. The length L in a specific embodiment is from about 20 mm to about 24 mm, with 22 mm being a specific example.

[0053] Referring to FIG. 1, the stent 12 can have a plurality of holding arms or projections 30 spaced angularly apart and extending from the upper portion 20 of the stent in the form of posts (three in the illustrated embodiment). Each holding arm 30 has an opening 32 sized to receive a projection of a valve holding mechanism that can be used to form a releasable connection between the prosthetic valve and a delivery device (described later). In an alternative embodiment, the holding arms 30 need not be provided if a valve holding mechanism is not used.

[0054] As best shown in FIGS. 6 and 7, the valve leaflet assembly 14 in the illustrated embodiment includes three valve leaflets 34a, 34b, 34c made of a flexible material. Each valve leaflet has an inflow end portion 60 and an outflow end portion 62. The valve leaflets can include any suitable biologic (e.g., pericardial tissue such as bovine or equine pericardium), a biocompatible synthetic material, or other such materials such as those described in U.S. Patent No. 6,730,118, which is incorporated herein by reference. The valve leaflet assembly 14 can include an annular reinforcing skirt 42 that is fixed to the outer surface of the inflow end portions of the valve leaflets 34a, 34b, 34c at a suture line 44 adjacent to the inflow end of the prosthetic valve. The inflow end portion of the valve leaflet assembly 14 can be fixed to the stent 12 by suturing the skirt 42 to the struts 16 in the lower region 24 of the stent (best shown in FIG. 1). As shown in FIG. 7, the valve leaflet assembly 14 can further include an inner reinforcing strip 46 that is fixed to the inner surface of the inflow end portion 60 of the valve leaflets.

[0055] Referring to FIGS. 1 and 2, the outflow end portion of the valve leaflet assembly 14 can be fixed to the upper portion of the stent 12 at three angularly spaced attachment joints of the valve leaflets 34a, 34b, 34c. As best shown in FIG. 2, each attachment joint can be formed by winding a reinforcing area 36 around the adjacent upper edge portion 38 of a pair of valve leaflets at the joint formed by the two valve leaflets and securing the reinforcing area 36 to the edge portion 38 with suture 48. Next, the sandwiched layer of the reinforcing material and the valve leaflets can be fixed to the struts 16 of the stent 12 with suture 50 adjacent to the outflow end of the stent. Thus, the valve leaflets preferably extend from the inflow end 26 to the outflow end 27 for the full or substantially the full length of the stent. The reinforcing area 36 reinforces the attachment of the valve leaflets to the stent so as to minimize stress concentration at the suture line and to avoid "stitch marks" in the portions of the valve leaflets that flex during use. The reinforcing area 36, the skirt 42, and the inner reinforcing strip 46 are preferably made of a biocompatible synthetic material such as polytetrafluoroethylene (PTFE) or a woven fabric material such as woven polyester (e.g., polyethylene terephthalate (PET)).

[0056] Figure 7 shows the operation of the patch valve 10. During diastole, the valve leaflets 34a, 34b, 34c collapse to effectively close the patch valve. As shown, the curved shape of the intermediate region 22 of the stent 12 defines a space mimicking the sinus of Valsalva between the intermediate region and the valve leaflets. Thus, when the valve leaflets close, backflow into the "sinus" creates a turbulent flow of blood along the upper surface of the valve leaflets, as indicated by arrow 52. This turbulent flow helps to wash over the valve leaflets and the skirt 42 and minimize the formation of blood clots.

[0057] The patch valve 10 can be implanted in a retrograde approach in which the patch valve, mounted in a collapsed state at the distal end of a delivery device, is introduced into the body via the femoral artery and advanced through the aortic arch to the heart, as further described in U.S. Patent Application Publication No. 2008 / 0065011, which is incorporated herein by reference.

[0058] Figures 8 and 9 show a delivery device 100 according to one embodiment that can be used to deliver a self-expanding prosthetic valve 10, such as the prosthetic valve described previously, through a patient's vasculature. The delivery device 100 includes a first outermost or main catheter 102 (shown alone in FIG. 10) having an elongate shaft 104, and the distal end of the elongate shaft 104 is coupled to a delivery sheath 106 (see FIG. 18; also referred to as a delivery cylinder). The proximal end of the main catheter 102 is coupled to the handle of the delivery device. FIGS. 23-26 show an embodiment of a handle mechanism having an electric motor for operating the delivery device. The handle mechanism is described in detail later. During delivery of the prosthetic valve, the handle can be used by a surgeon to advance and retract the delivery device through the patient's vasculature. Although not required, the main catheter 102 can be provided with a guiding catheter configured to allow a surgeon to guide or control the amount of bending or deflection of the distal portion of the shaft 104 when the shaft 104 is advanced through the patient's vasculature, such as that further described later. Another embodiment of the guiding catheter is disclosed in U.S. Patent Application Publication No. 2008 / 0065011, which is incorporated herein by reference.

[0059] As best shown in FIG. 9, the delivery device 100 also includes a second intermediate catheter 108 (also referred to herein as a torque shaft catheter) having an elongated shaft 110 (also referred to herein as a torque shaft) and an elongated screw 112 coupled to the distal end of the shaft 110. The shaft 110 of the intermediate catheter 108 extends coaxially through the shaft 104 of the primary catheter 102. The delivery device 100 may also include a third nose cone catheter 118 having an elongated shaft 120 and a nose piece or nose cone 122 fixed to the distal end portion of the shaft 120. The nose piece 122 may have a tapered outer surface as shown for non-invasive tracking through a patient's vasculature. The shaft 120 of the nose cone catheter extends through the prosthetic valve 10 (not shown in FIGS. 8 - 9) and the shaft 110 of the intermediate catheter 108. In the illustrated configuration, as described in more detail later, the innermost shaft 120 is configured to be axially movable and rotatable relative to the shafts 104, 110 to effect valve deployment and release of the prosthetic valve from the delivery device, and the torque shaft 110 is configured to be rotatable relative to the shafts 104, 120. Also, the innermost shaft 120 may have a lumen for receiving a guide wire (FIG. 8C) such that the delivery device can be advanced over the guide wire inside the patient's vasculature.

[0060] As best shown in FIG. 10, the outer catheter 102 may include a deflection control mechanism 168 at the proximal end to control the amount of bending or flexure of the distal portion of the outer shaft 104 as the shaft 104 is advanced through the patient's vasculature, such as those described in more detail later. The outer shaft 104 may include a proximal section 166 extending from the deflection control mechanism 168 and a distal section 126 including a slotted metal tube that increases the flexibility of the outer shaft at this location. The distal end portion of the distal section 126 may include an outer fork 130 of a valve holding mechanism 114 configured to releasably secure the prosthetic valve 10 to the delivery device 100 during valve delivery, as described in more detail later.

[0061] Figure 28A is an enlarged view of a portion of the distal segment 126 of the outer shaft 104. Figure 28B shows a cutting pattern that can be used to form the distal segment 126 by laser cutting the pattern into a metal tube. The distal segment 126 comprises a plurality of interconnected circular bands or rings 160 that form a slotted metal tube. A tension wire 162 can be positioned inside the distal segment 126 and can extend from location 164 (Figures 10 and 12) of the distal segment 126 to a deflection control mechanism. The distal end of the tension wire 162 can be fixed to the inner surface of the distal segment 126 at location 164, such as by welding. The proximal end of the tension wire 162 can be operably connected to a deflection control mechanism 168, which is configured to apply and release tension to the tension wire to control the bending of the shaft, as will be described further below. The rings 160 of the shaft and the gaps between adjacent rings are shaped to permit bending of the shaft in the application of a light tensile force in the tension wire 162. In the illustrated embodiment, as best shown in Figure 12, the distal segment 126 is fixed to a proximal segment 166 having a different structure (e.g., one or more layers of a polymer tube). In the illustrated embodiment, the proximal segment 166 extends from the deflection control mechanism 168 to the distal segment 126 and thus makes up most of the length of the outer shaft 104. In an alternative embodiment, all or substantially all of the length of the outer shaft 104 can be formed from a slotted metal tube comprising one or more sections of interconnected rings 160. In either case, the use of a main shaft having such a structure can render the delivery device highly maneuverable, particularly when used in combination with a torque shaft (described below) having the structure shown in Figures 40 and 41.

[0062] The width of the loop 160 may be varied to vary the flexibility of the distal segment along its length. For example, the loop in the distal end portion of the slotted tube may be made relatively narrow to increase the flexibility of the shaft at that location, while the loop in the proximal end portion of the slotted tube may be made relatively wide so that the shaft has relatively poor flexibility at that location.

[0063] Figure 29A shows an alternative embodiment of the distal segment, indicated by reference numeral 126', which can be formed, for example, by laser cutting a metal tube. Segment 126' may comprise the distal segment of the outer shaft of the delivery device (shown in FIG. 12), or substantially the entire length of the outer shaft may have the structure shown in FIG. 29A. FIG. 29B shows the cutting pattern for forming segment 126'. In another embodiment, the delivery device may comprise a composite outer shaft comprising a laser-cut metal tube laminated with a polymeric outer layer fused within the gaps in the metal layer. In one example, the composite shaft may comprise a laser-cut metal tube having the cutting pattern of FIGS. 29A and 29B and a polymeric outer layer fused within the gaps between the loops 160 of the metal tube. In other examples, the composite shaft may comprise a laser-cut metal tube having the cutting pattern of FIGS. 28A and 28B and a polymeric outer layer fused within the gaps between the loops 160 of the metal tube. The composite shaft may also comprise a polymeric inner layer fused within the gaps between the loops 160 of the metal tube.

[0064] Referring to FIGS. 8A and 11, the deflection control mechanism 168 may include a rotatable housing or handle portion 186 that houses a slide nut 188 mounted on the rails 192 / 190. The slide nut 188 is prevented from rotating within the housing by one or more rods 192, each of which is partially disposed in a corresponding recess in the rail 192 and a slot or recess inside the nut 188. The proximal end of the tension wire 162 is fixed to the nut 188. The nut 188 has a male thread that engages the female thread of the housing. Thus, rotating the housing 186 moves the nut 188 axially proximally or distally within the housing, depending on the direction of rotation of the housing. Rotating the housing in a first direction (e.g., clockwise) advances the nut proximally, which applies tension to the tension wire 162, which bends or deflects the distal end of the delivery device. Rotating the housing in a second direction (e.g., counterclockwise) advances the nut distally, which releases the tension in the tension wire 162 and deflects the distal end of the delivery device back to its pre-deflected configuration under its own elasticity.

[0065] As best shown in FIG. 13, the torque shaft catheter 108 includes an annular projection in the form of a ring 128 (also referred to as a tether disc) mounted on the distal end portion of the torque shaft 110 adjacent to the screw 112. The ring 128 is fixed to the outer surface of the torque shaft so that it cannot move axially or rotationally relative to the torque shaft 110. Features such as slots or recesses are formed in the inner surface of the outer shaft 104, and these features receive the ring 128 in such a way that the ring 128 and the corresponding feature on the inner surface of the outer shaft 104 rotate the torque shaft 110 relative to the outer shaft 104 but prevent the torque shaft from moving axially relative to the outer shaft. The corresponding feature of the outer shaft 104 that receives the ring 128 can be an inwardly extending tab portion formed in the distal section 126, such as that indicated by reference numeral 164 in FIG. 12. In the illustrated embodiment (best shown in FIG. 14), the ring 128 is an integral part of the screw 112 (i.e., the screw 112 and the ring 128 are part of a single component). Alternatively, the screw 112 and the ring are separately formed components, but both are firmly fixed to the distal end of the torque shaft 110.

[0066] The torque shaft 110 is preferably configured to be rotatable relative to the delivery sheath 106 in order to effect a progressive and controlled advancement of the plug valve 10 from the delivery sheath 106. To that end, according to one embodiment, the delivery device 100 may comprise a sheath retaining ring in the form of a threaded nut 150 that mounts on the male threads of the screw 112. As best shown in FIG. 16, the nut 150 includes female threads 152 that engage the male threads of the screw, and axially extending legs 154. Each leg 154 extends into an opening 172 at the proximal end of the sheath 106 and / or has a raised distal end portion that forms a snap-fit connection with the opening 172 (as best shown in FIG. 18) to secure the sheath 106 to the nut 150. As shown in FIGS. 17B and 18, the sheath 106 extends over the plug valve 10 and holds the plug valve in a radially compressed state until the sheath 106 is retracted by the user to deploy the plug valve.

[0067] As best shown in FIGS. 21 and 22, the outer fork 130 of the valve holding mechanism includes a plurality of protrusions 134, each of which protrusions extends through a region defined between two adjacent legs 154 of the nut so as to prevent rotation of the nut relative to the screw upon rotation of the screw 112. Thereby, rotation of the torque shaft 110 (and thus of the screw 112) causes corresponding axial movement of the nut 150. The connection between the nut 150 and the sheath 106 is configured such that axial movement of the nut along the screw 112 (in the distal or proximal direction) causes the sheath 106 to move axially in the same direction relative to the screw and the valve holding mechanism. FIG. 21 shows the nut 150 in a distal position where the sheath 106 (not shown in FIG. 21) extends over the prosthetic valve 10 and holds the prosthetic valve 10 in a compressed state for delivery. Movement of the nut 150 from the distal position (FIG. 21) to the proximal position (FIG. 22) moves the sheath 106 in the proximal direction, thereby deploying the prosthetic valve from the sheath 106. Rotation of the torque shaft 110 to effect axial movement of the sheath 106 can be accomplished by a motorized mechanism (such as those shown and described later in FIGS. 23 - 26), or by manually turning a crank or wheel.

[0068] FIG. 17 shows an enlarged view of a nose cone 122 that is fixed to the distal end of the innermost shaft 120. The nose cone 122 of the illustrated embodiment comprises a proximal end portion 174 sized to fit inside the distal end of the sheath 106. The intermediate region 176 of the nose cone is positioned adjacent to the end of the sheath during use and has a plurality of longitudinal grooves or recesses 178 formed therein. The diameter at the proximal end 180 of the intermediate region 176 is desirably slightly larger than the outer diameter of the sheath 106. The proximal end 180 can be held in close contact with the distal end of the sheath to protect the surrounding tissue from contacting the metal edge of the sheath 106. The grooves 178 can radially compress the intermediate region when the delivery device is advanced through the introducer sheath. This allows the nose cone to be slightly larger than the inner diameter of the introducer sheath. FIG. 17B shows a cross-sectional view of the nose cone 122 and the sheath 106 in the delivery position with the prosthetic valve held in a compressed delivery state inside the sheath 106 (only the stent 12 of the prosthetic valve is shown for purposes of illustration). As shown, the proximal end 180 of the intermediate region 176 can abut against the distal end of the sheath 106, and the tapered proximal face 182 of the nose cone can extend into the distal portion of the stent 12.

[0069] As previously described, the delivery device 100 can comprise a valve holding mechanism 114 (FIG. 8B) for releasably holding the stent 12 of the prosthetic valve. The valve holding mechanism 114 can comprise a first valve fixing component (best shown in FIG. 12) in the form of an outer fork 130 (also referred to as an "outer trident" or "release trident") and a second valve fixing component (best shown in FIG. 17) in the form of an inner fork 132 (also referred to as an "inner trident" or "locking trident"). The outer fork 130 cooperates with the inner fork 132 to form a releasable connection with the holding arm 30 of the stent 12.

[0070] The proximal end of the outer fork 130 is coupled to the distal segment 126 of the outer shaft 104, and the distal end of the outer fork is releasably coupled to the stent 12. In the illustrated embodiment, the outer fork 130 and the distal segment 126 may be integrally formed as a single component (e.g., the outer fork and the distal segment may be laser cut or otherwise machined from a single piece of metal tubing), although these components may be formed separately and subsequently coupled to one another. The inner fork 132 may be mounted on the nose catheter shaft 120 (best shown in FIG. 17). The inner fork 132 couples the stent to the distal end portion of the nose catheter shaft 120. The nose catheter shaft 120 can be axially moved relative to the outer shaft 104 to release the prosthetic valve from the valve retaining mechanism, as described further below.

[0071] As best shown in FIG. 12, the outer fork 130 includes a plurality (three in the illustrated embodiment) of projections 134 spaced angularly in a direction corresponding to the retaining arms 30 of the stent 12, and the projections extend from the distal end of the distal segment 126. The distal end portion of each projection 134 includes a respective opening 140. As best shown in FIG. 17, the inner fork 132 includes a plurality (three in the illustrated embodiment) of projections 136 spaced angularly in a direction corresponding to the retaining arms 30 of the stent 12, and the projections extend from a base portion 138 at the proximal end of the inner fork. The base portion 138 of the inner fork is firmly fixed to the nose catheter shaft 120 (e.g., with a suitable adhesive) to prevent axial and rotational movement of the inner fork relative to the nose catheter shaft 120.

[0072] Each projection of the outer fork cooperates with a corresponding projection of the inner fork to form a releasable connection with the holding arm 30 of the stent. In the illustrated embodiment, for example, an opening 140 is formed in the distal end portion of each projection 134. When the patch valve is fixed to the delivery device (best shown in FIG. 19), each holding arm 30 of the stent 12 extends inwardly through the opening 140 of the projection 134 of the outer fork, and the projection 136 of the inner fork is inserted through the opening 32 of the holding arm 30 so as to hold the holding arm 30 so as to retreat outward from the opening 140. FIG. 42 also shows the patch valve 10 fixed to the delivery device by the inner and outer forks before the patch valve is mounted on the sheath 106. Retracting the inner projection 136 proximally (in the direction of arrow 184 in FIG. 20) to remove the projection from the opening 32 has the effect of releasing the patch valve 10 from the holding mechanism. When the inner fork 132 is moved to the proximal position (FIG. 20), the holding arm 30 of the stent can move radially outwardly from the opening 140 in the outer fork 130 under the elasticity of the stent. In this approach, the valve holding mechanism 114 forms a releasable connection with the patch valve sufficient to hold the patch valve firmly against the delivery device to allow the user to finely adjust or regulate the position of the patch valve after the patch valve is deployed from the delivery sheath. When the patch valve is positioned at the desired implantation site, the connection between the patch valve and the holding mechanism can be released by retracting the nose catheter shaft 120 relative to the outer shaft 104 (which retracts the inner fork 132 relative to the outer fork 130).

[0073] Techniques for compressing the prosthetic valve 10 and loading it into the sheath 106 are described later. Once the prosthetic valve 10 is loaded onto the delivery sheath 106, the delivery device 100 can be inserted into the patient's body for delivery of the prosthetic valve. In one approach, the prosthetic valve can be delivered in a retrograde procedure, in which the delivery device is inserted into the femoral artery and advanced through the patient's vasculature to the heart. Prior to insertion of the delivery device, an introducer sheath is inserted into the femoral artery, followed later by a guide wire, which is advanced through the patient's vasculature through the aorta to the left ventricle. The delivery device 100 can be inserted through the introducer sheath and advanced over the guide wire until the distal end portion of the delivery device, which includes the prosthetic valve 10, is advanced to a location adjacent to or within the native aortic valve.

[0074] Thereafter, the prosthetic valve 10 can be deployed from the delivery device 100 by rotating the torque shaft 110 relative to the outer shaft 104. As described later, the proximal end of the torque shaft 110 can be operably coupled to a manually rotatable handle portion or a motorized mechanism that can cause rotation of the torque shaft 110 relative to the outer shaft 104 by the surgeon. Rotation of the torque shaft 110 and the screw 112 moves the nut 150 and the sheath 106 in a proximal direction toward the outer shaft (FIG. 22), thereby deploying the prosthetic valve from the sheath. Rotation of the torque shaft 110 moves the sheath in an accurately controlled manner relative to the prosthetic valve as the prosthetic valve advances from the open distal end of the delivery sheath and begins to expand. Thus, unlike known delivery devices, as the prosthetic valve advances and begins to expand from the delivery sheath, the prosthetic valve is retained against uncontrolled movement from the sheath caused by the expansion force of the prosthetic valve against the distal end of the sheath. Also, when the sheath 106 is retracted, the prosthetic valve 10 is held in a stationary position relative to the end of the inner shaft 120 and the end of the outer shaft 104, thanks to the valve retention mechanism 114. Thereby, the prosthetic valve 10 can be held stationary relative to the target location in the body when the sheath is retracted. Further, after the prosthetic valve has been partially advanced from the sheath, it may be desirable to retract the prosthetic valve back into the sheath, for example, to reposition the prosthetic valve or to withdraw the prosthetic valve entirely from the body. The partially deployed prosthetic valve can be retracted back into the sheath by reversing the rotation of the torque shaft, which advances the sheath 106 distally over the prosthetic valve.

[0075] In known delivery devices, the surgeon must apply pushing and pulling forces to the shaft and / or sheath to extract the prosthetic valve. As a result, it is difficult to transmit force to the distal end of the device without distorting the shaft (e.g., compressing or stretching the shaft axially), which in turn causes uncontrolled movement of the prosthetic valve during the extraction process. To mitigate this effect, the shaft and / or sheath can be made more rigid, which is undesirable because it makes the device more difficult to maneuver through the vasculature. In contrast, the method of extracting the prosthetic valve described above eliminates the application of pushing and pulling forces to the shaft as required in known devices, and thus relatively large and accurate forces can be applied to the distal end of the shaft without sacrificing the flexibility of the device. In certain embodiments, a force of up to 20 pounds can be transmitted to the end of the torque shaft without adversely affecting the extraction process. In contrast, prior art devices that utilize a push-pull mechanism typically cannot exceed a force of about 5 pounds during the extraction process.

[0076] The prosthetic valve 10 is advanced from the delivery sheath and, after expanding to its functional size (the expanded prosthetic valve 10 fixed to the delivery device is depicted in FIG. 42 of U.S. Patent No. 9,867,700, which is incorporated herein by reference), the prosthetic valve remains coupled to the delivery device via the retention mechanism 114. As a result, after the prosthetic valve is advanced from the delivery sheath, the surgeon can reposition the prosthetic valve relative to the desired implantation position in the native valve by moving the delivery device proximally, distally, or laterally, or by rotating the delivery device, which causes a corresponding movement of the prosthetic valve. The retention mechanism 114 preferably provides a sufficiently firm and rigid connection between the prosthetic valve and the delivery device to hold the position of the prosthetic valve relative to the delivery device against the blood flow while the position of the prosthetic valve is adjusted relative to the desired implantation position in the native valve. When the surgeon positions the prosthetic valve at the desired implantation position in the native valve, the connection between the prosthetic valve and the delivery device can be released by retracting the innermost shaft 120 proximally relative to the outer shaft 104, which has the effect of retracting the inner fork 132 and pulling its projection 136 out of the opening 32 in the retention arm 30 of the prosthetic valve (FIG. 20). Some retraction of the outer shaft 104 allows the retention arm 30 of the prosthetic valve to be withdrawn from the outer fork 130, and the retention arm 30 slides outwardly through the opening 140 in the outer fork to completely disconnect the prosthetic valve from the retention mechanism 114. The delivery device is then withdrawn from the body, leaving the prosthetic aortic valve 10 implanted in the native valve (as shown in FIGS. 5A and 5B).

[0077] The delivery device 100 has, at its distal end, a semi-rigid section consisting of relatively rigid components used to convert the rotation of the torque shaft into axial movement of the sheath. Specifically, this semi-rigid section in the illustrated embodiment consists of a patch valve and screw 112. An advantage of the delivery device 100 is that since the nut 150 is used instead of the female thread on the outer shaft to act on the translation of the sheath, the overall length of the semi-rigid section is minimized. The reduced length of the semi-rigid section increases the overall flexibility along the distal end portion of the delivery catheter. Further, the length and location of the semi-rigid section remain constant since the torque shaft does not translate axially relative to the outer shaft. Thereby, the curved shape of the delivery catheter can be maintained during valve deployment, which can improve the stability of deployment. A further benefit of the delivery device 100 is that the ring 128 prevents the transmission of axial loads (compression and tension) to the region of the torque shaft 110 distal to the ring.

[0078] In an alternative embodiment, the delivery device can be adapted to deliver a balloon-expandable patch valve. As previously described, the valve holding mechanism 114 can be used to secure the patch valve to the end of the delivery device. Since the stent of the patch valve does not self-expand, the sheath 106 can be optional. The holding mechanism 114 enhances the pushability of the delivery device and patch valve assembly passed through the introducer sheath.

[0079] Figures 23-26 show the proximal end portion of a delivery device 100 according to one embodiment. The delivery device 100 may include a handle 202 configured to be releasably connectable to the proximal end portion of a catheter assembly 204 that includes catheters 102, 108, 118. For various reasons, it may be desirable to disconnect the handle 202 from the catheter assembly 204. For example, disconnecting the handle can allow other devices, such as a valve retrieval device or a device to assist in maneuvering the catheter assembly, to slide over the catheter assembly. It should be noted that any of the features of the handle 202 and the catheter assembly 204 can be implemented in any of the disclosed embodiments of the delivery device herein.

[0080] Figures 23 and 24 show the proximal end portion of a catheter assembly 204 partially inserted into the distal opening of the handle 202. The proximal end portion of the main shaft 104 is formed with an annular groove 212 (best shown in FIG. 24) that cooperates with a retaining or detent mechanism 214 inside the handle. As shown in FIGS. 25 and 26, when the proximal end portion of the catheter assembly is fully inserted into the handle, the engaging portion 216 of the retaining mechanism 214 extends at least partially into the groove 212. One side of the retaining mechanism 214 is connected to a button 218 that extends through the housing of the handle. The opposite side of the retaining mechanism 214 is contacted by a spring 220 that biases the retaining mechanism into engagement with the main shaft 104 in the groove 212. Engagement of the retaining mechanism 214 in the groove 212 prevents axial separation of the catheter assembly from the handle. The catheter assembly can be released from the handle by depressing the button 218, thereby moving the retaining mechanism 214 out of engagement locking it to the main shaft. Further, a flat surface portion may be formed in the groove 212 in the main shaft 104. The flat surface portion is positioned in contact with a corresponding flat surface portion of the engaging portion 216. This engagement holds the main shaft 104 stationary relative to the torque shaft when the torque shaft 110 is rotated during valve deployment.

[0081] The proximal end portion of the torque shaft 110 may have a driven nut 222 (FIG. 26) that is slidably received within a drive cylinder 224 (FIG. 25) mounted within the handle. The nut 222 may be fixed to the proximal end of the torque shaft 110 by securing the nut 222 across a coupling member 170 (FIG. 15). FIG. 26 is a perspective view of the interior of the handle 202 with the drive cylinder and other components removed to show the driven nut and other components positioned within the drive cylinder. The cylinder 224 has an opening (or lumen) that extends the length of the cylinder shaped to correspond to the plane of the nut 222 such that rotation of the drive cylinder is effective to rotate the nut 222 and the torque shaft 110. The drive cylinder may have an enlarged distal end portion 236 that houses one or more seals (e.g., O-ring 246) that form a seal with the outer surface of the main shaft 104 (FIG. 25). The handle may also house a fitting 238 that has a cleaning port that communicates with the lumen of the torque shaft and / or the lumen of the main shaft.

[0082] The drive cylinder 224 is operably coupled to an electric motor 226 through gears 228 and 230. The handle may also house a battery compartment 232 that contains a battery for powering the motor 226. Rotation of the motor in one direction rotates the torque shaft 110, which further retracts the sheath 106 to remove the cover from over the occluder valve at the distal end of the catheter assembly. Rotation of the motor in the opposite direction rotates the torque shaft in the opposite direction, which moves the sheath back over the occluder valve. An operator button 234 on the handle activates the motor for the user, and the motor can be rotated in either direction to extract the occluder valve or to restore an expanded or partially expanded occluder valve.

[0083] As described above, the distal end portion of the nose catheter shaft 120 can be fixed to the inner fork 132 that is moved relative to the outer fork 130 to release the patch valve fixed to the end of the delivery device. Movement of the shaft 120 relative to the main shaft 104 (which secures the outer fork 130) can be effected by the proximal end portion 240 of a handle that is slidable relative to the main housing 244. The end portion 240 is operably connected to the shaft 120 such that its movement axially translates the shaft 120 relative to the main shaft 104 (releasing the patch valve from the inner and outer forks). The end portion 240 can have flexible side panels 242 that are normally biased outwardly in a locked position to hold the end portion against the main housing 244 on both sides of the handle. During deployment of the patch valve, the user can push down on the side panels 242, which disengage from corresponding features in the housing and allow the end portion 240 to be pulled proximally relative to the main housing, which causes a corresponding axial movement of the shaft 120 relative to the main shaft. Proximal movement of the shaft 120 disengages the protrusion 136 of the inner fork 132 from the opening 32 in the stent 12, which further radially outwardly deflects the retaining arm 30 of the stent from the opening 140 in the protrusion 134 of the outer fork 130, thereby releasing the patch valve.

[0084] FIG. 27 shows an alternative embodiment of a motor, indicated by reference numeral 231, that can be used to drive a torque shaft (e.g., torque shaft 110). In this embodiment, the catheter assembly can be directly connected to one end of the motor shaft 233 without gears. The shaft 233 includes the innermost shaft of the catheter assembly (e.g., shaft 120), a guide wire, and / or a lumen that allows passage of fluid for flushing the lumen of the catheter assembly.

[0085] Alternatively, the power source for rotating the torque shaft 110 may be a hydraulic power source (e.g., a hydraulic pump) or a pneumatic (air-operated) power source configured to rotate the torque shaft. In another embodiment, the handle may have a manually movable lever or wheel operable to rotate the torque shaft 110.

[0086] In another embodiment, the power source (e.g., an electrical, hydraulic, or pneumatic power source) can be operably coupled to a shaft, and the shaft is further coupled to the repair valve 10. The power source is configured to reciprocate the shaft longitudinally in the distal direction relative to the valve sheath in an accurate and controlled manner to advance the repair valve from the sheath. Alternatively, the power source may be operably coupled to the sheath to reciprocate the sheath longitudinally in the proximal direction relative to the repair valve to deploy the repair valve from the sheath.

[0087] Figure 30 shows another exemplary stent 300 for use in a prosthetic heart valve. For purposes of illustration, the bare stent 300 is shown, but other components of the prosthetic valve, including valve leaflets and skirts, are omitted. However, in use, the prosthetic valve may comprise valve leaflets 34a, 34b, 34c and a skirt 42 mounted on the stent 300, as previously described in connection with prosthetic valve 10. The stent 300 may have the same overall shape and configuration as the stent 12 of the prosthetic valve 10 previously described, except that all the tops 302 at the outflow end of the stent 300 each have a respective opening 304. The stent 300 may further comprise three junction posts 306 (also referred to herein as "tops") with small holes 308, also at the outflow end. The delivery device can engage the stent by winding a loop of suture around the top at one end of the stent (e.g., the outflow end). In some embodiments, the stent may have a notch, passage, or other narrow portion formed in or adjacent to the top to stably hold the loop of suture at each top. The frame 300 may be configured for delivery using any of the delivery devices described herein. Additional embodiments of delivery devices that can be used to deliver the stent 300 are described in U.S. Patent No. 9,867,700, which is incorporated herein by reference, and U.S. Patent Application Publication No. 2015 / 0305867, which is incorporated herein by reference.

[0088] Second exemplary embodiment During the deployment of a self-expanding prosthetic heart valve such as prosthetic valve 10, the prosthetic valve can be partially deployed or withdrawn from the delivery cylinder while the surgeon has access to the placement of the prosthetic valve. If it is desirable to reposition the prosthetic valve, the prosthetic valve can be drawn or "recaptured" back into the delivery cylinder partially or fully to reposition the prosthetic valve at the native valve annulus. Depending on factors including the diameter of the prosthetic valve, the diameter of the delivery cylinder, the percentage of the total length of the prosthetic valve that is outside of the delivery cylinder before recapture is attempted, the number of times recapture is attempted, etc., the frame of the prosthetic heart valve can potentially collapse back uniformly into a substantially cylindrical shape when recaptured.

[0089] For example, FIG. 31 shows a self-expandable prosthetic valve frame 400 that is partially deployed from a delivery cylinder 402. In FIG. 31, approximately 80% of the total length of the frame has been withdrawn, leaving 20% of the frame length within the delivery cylinder 402. FIGS. 32-35 show the recapture of the frame 400 after partial (e.g., 80%) deployment from the delivery cylinder. In FIGS. 31 and 32, the inflow end 404 of the frame forms a flared or conical shape extending distally from the delivery cylinder 402. In FIG. 32, the inflow end 404 of the frame has a circular or substantially circular shape. For example, in the illustrated configuration, adjacent struts 406 can form a plurality of inflow side apices 408 at the junctions where they intersect. In the state shown in FIG. 32, the distance or diameter measured between pairs of diametrically opposed apices 408 can be constant or substantially constant for any pair of diametrically opposed apices around the perimeter or circumference of the inflow end 404.

[0090] When the frame is drawn back into the delivery cylinder, or "re-covered", the inlet end should preferably maintain the profile of a circle or substantially a circle with a constant or substantially constant diameter measured at each top 408 around the inlet end. However, in certain cases, when the frame is drawn back into the delivery cylinder 402, one or more struts may bend, deform, buckle, or break radially inwards towards the frame longitudinal axis. This phenomenon is shown in FIG. 33, where one or more struts in the lower right quadrant of the inlet end 404 have started to deform and the inlet end has lost its circular or substantially circular shape. In FIG. 34, the deformation has progressed further and the inlet side top 408A has deviated radially inwards towards the guide wire 410. In FIG. 35, one or more struts that were previously located in the lower right quadrant of FIGS. 32-34 have moved or buckled, causing the inlet side top 408A and adjacent struts to move into the upper right quadrant of FIG. 35. This phenomenon forms wrinkles or internal folds in the frame, which are referred to herein as "internal folds" or "indentations" of the frame. Such internal folds can potentially result in the need to discard the implant and insert a new replacement valve during the implantation procedure.

[0091] Figure 36 shows another embodiment of a self-expanding frame 500 for a prosthetic heart valve configured to reduce the likelihood of an infolding event during recapture. For clarity, only the front half of the frame is shown. The frame 500 may comprise an inflow end 502 and an outflow end 504. The frame 500 may be formed from a plurality of diagonal strut members 506 arranged end-to-end to form a plurality of rows or tiers of strut members extending circumferentially around the frame. For example, the frame 500 may comprise a first or lower row I of diagonal strut members 506 forming the inflow end 502 of the frame, a second row II of strut members above the first row, a third row III of strut members above the second row, a fourth row IV of strut members above the third row, and a fifth row V of strut members above the fourth row forming the outflow end 504 of the frame. The struts 506 may be interconnected at nodes or junctions 530 that can define the boundaries of the respective rows I-V. When traced in a direction along the longitudinal axis 510 of the frame, the struts 506 can be combined to form members generally in the shape of a sine wave at the apexes formed by the junctions 530 so as to provide a braided structure.

[0092] The frame may, similar to the frame of FIG. 1, comprise generally cylindrical "upper" or outflow end portion 512, an outwardly arcuate or expanded intermediate or belly portion 514, and an inwardly arcuate "lower", constricted, or inflow end portion 516. The intermediate portion 514 may be sized and shaped to extend into the sinus of Valsalva at the origin of the aorta to assist in anchoring the prosthetic valve as in the previously described embodiments.

[0093] When the frame is in its expanded state, the intermediate portion 514 can have a diameter D1, the constriction of the inflow end portion 516 can have a minimum diameter D2, the inflow end 502 can have a diameter D3, and the outflow end portion 512 can have a diameter D4, where D2 is smaller than D1 and D3, and D4 is smaller than D2. Similar to the embodiments described above, D1 and D3 can be larger than the diameter of the native valve annulus into which the prosthetic valve is implanted to assist the frame in holding the prosthetic valve at the implantation site. In certain embodiments, this configuration can also reduce or prevent perivalvular leakage.

[0094] The struts 506 can be made of a shape memory material such as nitinol or other nickel-titanium alloy that compresses to a reduced diameter for delivery of the prosthetic valve with a delivery device (such as those described above) and then expands to its functional size within the patient's body when deployed from the delivery device. In other embodiments, the frame can also include a ductile material such as nickel-chromium alloy or stainless steel and can be configured for use with a balloon-expandable valve.

[0095] FIG. 37 shows a representative row of struts 506 of the frame 500 in a radially compressed state. Each of the struts 506 includes an inflow end portion 518, an outflow end portion 520, and an intermediate portion 522 that extends between the inflow end portion and the outflow end portion. In certain embodiments, the dimensions of the struts 506 can vary along the length of the strut between the inflow end and the outflow end of the strut. In certain embodiments, the dimensions of the various portions of the struts in one row of struts can be different from the dimensions of the corresponding portions of the struts in an adjacent row of struts.

[0096] For example, the strut may have a thickness or dimension, herein referred to as the "strut width" W, that is generally measured in the plane of the curved outer surface of the frame. Referring again to FIG. 36, each of the struts 506 may have a surface 524 that is generally oriented in the direction of the inlet end 502 when the frame is in the expanded state, and a corresponding surface 526 on the opposite side of the strut that is generally oriented in the direction of the outlet end 504 when the frame is in the expanded state. Each strut may further comprise an outer surface 528 that is perpendicular to surfaces 524 and 526. The thickness of the strut 506 measured between the inlet side surface 524 and the outlet side surface 526 is herein referred to as the strut width W. Stated another way, the strut width W is the dimension of the outer surface 528 of the strut 506 measured in a direction perpendicular to the longitudinal axis of the strut. Each of the struts 506 may have a strut width as defined above. The corresponding dimension of the surface of the strut member facing radially inward opposite the outer surface 528 may be the same as or different from the strut width of the outer surface 528, depending on the specific desired characteristics.

[0097] Referring again to FIG. 36, the strut 506 may also have a wall thickness, radial thickness, or strut thickness T that is measured radially from the inner surface of the frame strut to the outer surface 528 of the strut. In embodiments where the frame 500 is formed from a tube (e.g., by laser cutting), the struts of the frame may have a thickness T that corresponds to the wall thickness of the tube from which the frame is cut. In other embodiments, the wall thickness of the tube and / or frame after laser cutting may be varied (e.g., by machining, reaming, etching, etc.), which can result in a change in the radial thickness of the strut.

[0098] Returning to FIG. 37, the strut 506 can define a first strut width W1 at the inflow end portion 518, a second strut width W2 at the outflow end portion 520, and a third strut width W3 at the intermediate portion 522. These measurements are indicated on a representative strut member 506A that extends between a joint 530A (e.g., the outflow side joint of strut 506A) and a joint 530B (e.g., the inflow side joint of strut 506A). FIG. 38 shows joint 530B in more detail. Referring to FIG. 38, in certain embodiments, the joint 530 between strut rows can extend between adjacent strut members and can define a curved surface having a radius r. For example, a representative joint 530B can include a curved or concave surface 532 on the inflow side and a curved or concave surface 534 on the outflow side. In certain embodiments, each of the joints 530 can include similar curved surfaces in the inflow side aspect and the outflow side aspect of the joint.

[0099] Referring to FIG. 38, in certain embodiments, the strut width W1 can be measured at or adjacent to the edge of the outflow side curved surface 534 of joint 530B. In certain embodiments, the strut width W2 can be measured at or adjacent to the edge of the inflow side curved surface 532 of joint 530B. In certain embodiments, the strut widths W1 and W2 can be measured at the midpoint between the edge of the curved surface of each joint and the location where the strut width reaches a particular strut width W3. In certain embodiments, the strut width W1 can gradually increase to the strut width W3 in a direction along the longitudinal axis of the strut. Similarly, at the opposite end of the strut, the strut width W3 can gradually decrease to the strut width W2. In other embodiments, some or all of the joints need not include curved surfaces in the inflow side aspect and the outflow side aspect of the joint, and instead can include flat surfaces and / or convex surfaces.

[0100] In certain embodiments, the third strut width W3 can be greater than the strut widths W1 and W2. In certain embodiments, the strut widths W1 and W2 may be the same or different depending on the desired specific characteristics. In certain embodiments, the strut widths W1 and W2 can be equal or substantially equal. As used herein, the strut widths W1 and W2 are substantially equal if their values differ by 10% or less. In certain embodiments, reducing the strut width at the junction can advantageously reduce the radial force required to collapse the valve for delivery, as further described later.

[0101] In certain embodiments, each strut 506 of strut columns I - V can be configured similarly to a representative strut member 506A. In certain embodiments, the strut width of various portions of the struts may vary between columns. For example, in certain embodiments, the struts of column I, or columns I and II, at the inlet end portion of the frame may have the varying strut width configuration shown in FIGS. 37 and 38, while the struts of the remaining columns may have a different configuration (e.g., a uniform strut width along the length of the strut, or another configuration).

[0102] For example, FIG. 57 shows a joint 530 of another embodiment of a frame in which struts 506A and 506B (e.g., on the outflow side of the joint) have varying strut widths W1, W2, and W3, and struts 506C and 506D (e.g., on the inflow side of the joint) have a constant or substantially constant strut width along their lengths. In a particular example, struts 506C and 506D may have a strut width (e.g., W1 or W2) smaller than the strut width W3 as shown in FIG. 57, or a strut width equal to, substantially equal to, or greater than W3. For example, FIG. 58 shows another configuration in which struts 506C and 506D have a third strut width W3 (or a different strut width) substantially along their entire lengths, but struts 506A and 506B on the outflow side of joint 530 have a reduced strut width W1 at the joint. FIG. 59 shows a reverse configuration in which struts 506C and 506D on the inflow side of joint 530 have varying strut widths at the joint, and struts 506A and 506B have a constant or substantially constant strut width (e.g., W3 or a different strut width) along their lengths.

[0103] Any two columns of struts integrally joined at a joint such as joint 530 may have either the varying strut width configuration or the constant strut width configuration described herein. For example, in a particular embodiment, at least a portion of the struts of the frame may have a reduced strut width (e.g., W1 or W2) at at least one of their respective joints, such as their inflow-side joints (e.g., joint 530B in FIG. 37), their outflow-side joints (e.g., joint 530A in FIG. 37), or both. In a particular embodiment, the first column I (FIG. 36) of struts at the inflow end of the frame may have a reduced strut width at their inflow-side joints, outflow-side joints, or both. In a particular embodiment, two or more columns of struts, such as columns I and II, or columns I - III, or a column configured to be deployed first from the delivery sheath, may have a reduced strut width at one or both of the inflow-side joint and / or the outflow-side joint.

[0104] In certain embodiments, the length L of the strut member 506 can be from 4 mm to 6 mm. In certain embodiments, the length L of the strut member 506 can vary based on a particular design diameter of the frame. For example, in a particular example, a frame configured as described herein to have a particular design diameter of 26 mm in this specification can have a strut length L of 4.33 mm. A frame having a particular diameter of 29 mm can have a strut length L of 4.79 mm, and a frame having a particular design diameter of 32 mm can have a length L of 5.3 mm.

[0105] Returning to FIG. 38, the junction 530B can define an inflow side curved surface 532 and an outflow side curved surface 534, as described above. Both curved surfaces 532 and 534 can have a radius r, although in other embodiments, the radius on the inflow side of the junction can differ from the radius on the outflow side of the junction. The junction 530B can define a thickness dimension A that extends along the y-axis between the top 536 of the inflow side curved surface 532 and the top 538 of the outflow side curved surface 534. The junction 530B can also define a dimension B of the junction width that extends between edges 540 and 542 that are oriented in the longitudinal direction of the junction.

[0106] The inventor has discovered that a self-expandable frame for a prosthetic heart valve comprising one or more of the parameters described herein in embodiments, individually and / or in various combinations, can provide surprisingly excellent performance, particularly when recapturing the prosthetic valve without inward folding. The parameter and frame embodiments described herein can also provide improved performance with respect to the radial force required to collapse the valve for delivery and the "persistent" radially outward force applied to the surrounding biological structure by the frame when deployed at the treatment site.

[0107] For example, in certain embodiments, the ratio of strut width W1 and / or W2 to strut width W3 can be 0.7 to 0.95, 0.75 to 0.95, 0.8 to 0.95, or 0.90 or less. In a specific embodiment, strut widths W1 and W2 can be 0.29 mm to 0.32 mm, and strut width W3 can be 0.33 mm to 0.37 mm. Narrowing the strut width near the junction 530 can reduce the tendency of the frame to buckle during recapture while reducing the radial force required to constrict the valve for delivery.

[0108] In certain embodiments, the ratio of strut width W3 to strut thickness T can be 0.5 to 0.9, 0.6 to 0.85, 0.65 to 0.8, or 0.65 or more. In a specific embodiment, strut width W3 can be 0.33 mm to 0.37 mm, and strut thickness T can be 0.47 mm to 0.50 mm. The ratio of strut width W3 to strut thickness T within the ranges provided above can reduce the tendency of the frame to buckle during recapture.

[0109] In certain embodiments, the ratio of the joint width B of the joint 530 to the strut thickness T can be from 1.4 to 3.2, such as from 1.5 to 2.5, from 1.5 to 2.1, or from 1.5 to 2.0. In certain embodiments, the ratio of the joint width B to the strut thickness T can be 1.5 or more or 2.1 or less. In a specific embodiment, the joint width B of the joint 530 can be from 0.7 mm to 1.5 mm, such as from 0.8 mm to 1.0 mm, or from 0.85 to 1.0 mm. In a specific embodiment, the joint width B can be 0.91 mm, and the strut thickness T can be from 0.47 mm to 0.50 mm. The ratio of the joint width B of the joint to the strut thickness T within the ranges provided above can provide the values of the radial force and the compression resistance within the specifications for implantation in the heart such as the native aortic valve. For example, in certain embodiments, the frame configured as described herein applies a maximum radial force of 145 N or less, such as 121 N or less, during crimping and a continuous outward force of 30 N or more after expansion to a specific design diameter. These frames also exhibit a compression resistance of 5 N to 8 N. In certain embodiments, the strut thickness T can have a relatively large effect on the compression resistance and a relatively small effect on the radial force, while the joint width B and / or the inflow-side strut width W1 and the outflow-side strut width W2 can have a relatively large effect on the radial force exerted by the compressed frame.

[0110] In certain embodiments, the ratio of the strut width W3 to the joint width B can be from 0.25 to 0.7, such as from 0.3 to 0.6, from 0.3 to 0.5, or from 0.3 to 0.45. In certain embodiments, the ratio of the strut width W3 to the joint width B can be 0.3 or more or 0.45 or less. In a specific embodiment, the strut width W3 can be from 0.33 mm to 0.37 mm, and the joint width B can be from 0.7 mm to 1.5 mm, such as 0.91 mm as described above.

[0111] In certain embodiments, the ratio of the strut width W1 and / or W2 to the joint width B can be from 0.2 to 0.5, such as from 0.25 to 0.45, or from 0.3 to 0.4. In certain embodiments, the ratio of the strut width W1 and / or W2 to the joint width B can be 0.3 or more or 0.4 or less. In a specific embodiment, the strut width W1 and / or W2 can be from 0.29 mm to 0.32 mm, and the joint width B can be from 0.7 mm to 1.5 mm, such as 0.91 mm as described above.

[0112] In certain embodiments, the ratio of the strut width W2 at the outflow end 520 of the strut to the radius r of the curved inflow surface 532 of the joint can be from 4.0 to 7.5, such as from 4.1 to 7.1. The ratio of the strut width W1 at the inflow end 518 of the strut to the radius r of the outflow side curved surface 534 can have a similar value. In a specific embodiment, the radius r of the curved surface 532 and / or 534 of the joint 530 can be from 0.04 mm to 0.08 mm, such as from 0.044 mm to 0.07 mm. The radius within these ranges can improve the manufacturability and accuracy of the resulting surface, especially when using laser cutting techniques where the diameter of the laser beam can be 0.04 mm. A larger radius of the joint can promote more uniform heat distribution through the metal of the frame during laser cutting and can also reduce the formation of microcracks at the joint due to repeated shrinkage.

[0113] In certain embodiments, after the frame is cut from the tube, the frame can be electropolished, electrochemically polished, and / or etched with an etching solution. These processes can change the parameters of the strut width, thickness, and / or junction radius of the frame when cut. Thus, in certain embodiments, the mass of the frame can be used to infer whether the parameters of the strut width, strut thickness, and / or junction radius are within a particular range. For example, in certain embodiments of the frame 500 configured as described herein, the mass of the frame can vary between 800 - 1,100 mg, such as between 875 mg and 1,000 mg, or between 950 mg and 990 mg. In a specific embodiment, the mass of the frame 500 configured as described herein can be 975 mg.

[0114] In certain embodiments, the flared inflow end portion 516 can define an angle Q with respect to the longitudinal axis 510. In certain embodiments, configuring the inflow end portion such that the angle Q is within a particular range can reduce the tendency of the frame to kink during recapture. Maintaining the angle Q within a particular range can also reduce the likelihood that the inflow end portion 516 contacts the His bundle and interferes with electrical signal transmission in the heart after implantation. In a particular example, an angle Q of less than 30°, such as 25° or less or 21° or less, reduces the risk of kinking and / or contact with the His bundle during recapture while providing sufficient flare of the inflow end portion 516 to anchor the prosthetic valve to the native valve annulus. In a specific embodiment, an angle Q of 21° in combination with positioning the frame such that 5 mm of the inflow end portion 516 extends into the left ventricle can reduce the risk of contact with the His bundle.

[0115] Another parameter that can reduce the likelihood of inward folding during recapture is the ratio of the inner diameter of the delivery cylinder to the diameter of the inflow end of the flared end of the frame when the frame is partially deployed from the delivery cylinder. In certain embodiments, the frame can be configured to expand to a specific design diameter (also referred to as the specific diameter, design diameter, or deployment diameter). The specific design diameter of the prosthetic valve can, for example, be tailored to the size and shape of the anatomy of the individual into which the prosthetic valve is implanted. For a self-expanding frame configured as described herein, the specific design diameter can be measured between the inner surfaces of the frame at the narrowest location of the inflow end portion 516. In other embodiments, the specific design diameter can be measured at the location of the minimum inner diameter of the frame anywhere along its length when the frame has been expanded to its functional size. The specific design diameter D of the frame 500 SPEC is shown in FIG. 36. For example, in certain embodiments, a prosthetic heart valve configured as described herein can be provided with specific design diameters of 23 mm, 26 mm, 28 mm, 29 mm, and 32 mm or greater.

[0116] Typically, the specific design diameter of a prosthetic heart valve is selected to be slightly larger than the patient's native annulus (e.g., a 32 mm prosthetic valve may be selected to treat a patient with a native annulus diameter of 30 mm). In certain embodiments, a prosthetic heart valve with a specific design diameter of at least 29 mm or more may be more prone to inward folding during recapture after partial deployment. In certain embodiments, the ratio of the diameter of the inflow end of a partially expanded prosthetic valve to the inner diameter of the delivery cylinder may affect the tendency of the frame to inward fold or buckle during recapture. For example, FIG. 39 shows a frame 500 partially deployed from a delivery cylinder 544. For purposes of illustration, a portion of the frame 500 inside the delivery cylinder 544 is schematically shown in dashed lines. The delivery cylinder 544 has an inner diameter D5, and the flared inflow end 502 of the frame may have a diameter D6. In certain embodiments, the inner diameter D5 of the delivery cylinder 544 can be 6.35 mm for a prosthetic valve with a specific design diameter of 32 mm, 6.1 mm for a prosthetic valve with a specific design diameter of 29 mm, and 5.85 mm for a frame with a specific design diameter of 26 mm.

[0117] Figure 40 shows a portion of the frame 500 located outside the delivery cylinder when 60% of the full length Y of the frame is deployed and when 80% of the full length of the frame is deployed. As used herein, the full length Y of the frame 500 can be the length of the frame measured between the inlet end 502 and the outlet end 504 when the frame is expanded to its specific design diameter. Thus, the latitude line 546 corresponds to 60% of the full length Y of the frame, and the latitude line 548 corresponds to 80% of the full length Y of the frame. In the illustrated embodiment, the latitude line 546 is just above the junction 530' that separates the strut row III from the strut row IV (Figure 36). In other words, when 60% of the full length Y of the frame is deployed from the delivery cylinder (schematically shown at reference numeral 544 in Figure 40), the junction 530' has just emerged from the distal end of the delivery cylinder to the surface. In the illustrated embodiment, the latitude line 548 is just above the junction 530'' that separates the strut row IV from the strut row V (Figure 36). Thus, as used herein, deploying 80% of the full length of the frame refers to the location 548 in the frame that is 80% of the distance between the inlet end 502 and the outlet end 504 when the frame is at its specific design diameter, or a position outside (e.g., distal to) the delivery cylinder. In the illustrated configuration, 80% of the full length Y of the frame is deployed when the junction 530'' has emerged from the delivery cylinder 544 to the surface.

[0118] The following Table 1 provides exemplary dimensions for 29 mm frames and 32 mm frames configured similarly to the frame 500 of Figure 36. Embodiments of these frames were tested and were successfully recaptured into the delivery cylinder after a partial deployment where 80% of the full length of the frame was withdrawn.

[0119]

Table 1

[0120] In certain embodiments, when 80% of the overall length Y (FIG. 40) of the frame 500 is deployed from the delivery cylinder 544, the ratio of the diameter D6 of the inflow end 502 of the frame to the inner diameter D5 of the delivery cylinder 544 can be greater than 4.5, such as 4.5 - 8.0, 5.0 - 7.0, 5.0 - 6.0, 5.2 - 6.2, or 5.5 - 6.0. In certain embodiments, for a frame with a specific design diameter of 29 mm or more, the ratio of the diameter D6 of the inflow end 502 of the frame to the inner diameter D5 of the delivery cylinder 544 can be 6.0 or less when 80% of the overall length Y of the frame is deployed from the delivery cylinder. In a specific embodiment, the ratio of the diameter D6 of the inflow end 502 to the inner diameter D5 of the delivery cylinder 544 when 80% of the overall length of the frame is deployed from the delivery cylinder can be 5.7 - 6.0. In certain embodiments, the ratio of D6 to D5 within the previous ranges can significantly reduce the likelihood of inward folding during recapture, particularly for valves with a larger design diameter where recapture is attempted with more than 80% of the overall length of the frame deployed from the delivery cylinder.

[0121] In certain embodiments, any of the delivery cylinders and / or devices described herein can be configured to deliver other types of self-expanding implants, such as any of the repair heart valve docking stations, stents, etc., described later.

[0122] In addition to reducing the potential for kinking, the frame embodiments described herein also meet specification values for parameters including resistance to axial forces (also known as compressive forces or compression resistance), the radial forces required during initial constriction of the valve, and the radial forces applied by the frame to the surrounding tissue after implantation (also known as "persistent outward forces"). FIG. 41 shows the force curve as a function of frame diameter for a frame having a particular design diameter of 32 mm and configured as previously described. The natural, unconstrained diameter of the frame before constriction is approximately 37 mm. When the frame is constricted, the diameter and force follow the upper curve 602 to a minimum diameter of 6-7 mm. At this diameter, the radial force exerted by the frame on the delivery cylinder (e.g., the force required to keep the frame radially constrained) is approximately 135 N. When the frame expands, the force / diameter relationship follows the lower curve 604. Generally, a self-expanding frame is sized 1-2 mm larger than the target valve annulus. Thus, at a diameter of 30 mm, a 32 mm frame exerts a persistent outward radial force of approximately 30 N. Existing 32 mm self-expanding frames exert a maximum radial force of approximately 145 N and a persistent outward radial force of 30 N.

[0123] The different embodiments of the self-expanding frame described herein can provide one or more corresponding advantages over existing self-expanding frames. For example, certain embodiments of the frames described herein can allow repeated partial deployment and recapture of frames having a particular design diameter that is relatively large, without infolding or collapsing. For example, a self-expanding frame configured as described herein having a particular design diameter of 32 mm was successfully recaptured without infolding after deploying 80%, 90%, 95%, and 98% of the total length of the frame. The ability to repeatedly and partially deploy and recapture a large-diameter self-expanding valve can provide significant advantages when attempting to place a prosthetic valve in a relatively large anatomical structure, and can reduce the risk that a new prosthetic valve may be needed during the procedure. The frames described herein also meet the specifications for a radial collapsing force (e.g., 145 N or less) and a sustained outward force (e.g., 28 N to 30 N, or more) when expanded at the treatment site.

[0124] Figures 42-44 show successful recapture of an embodiment of frame 500 having a particular design diameter of 32 mm into a delivery sheath 544 having an inner diameter of 6.35 mm. In Figure 42, 80% of the total length of the frame is deployed from the delivery cylinder 544. In Figure 43, recapture is in progress, and Figure 44 shows that the frame was completely recaptured into the delivery sheath 544 without infolding.

Examples

[0125] In a representative embodiment, testing and measurement of the radial force and the continuous outward force of the frame 500 were performed using the radial expansion force measuring device 700 shown in FIG. 45. The device 700 includes a main body 702 and a throttle assembly 704 having a plurality of wedge members or mandrels 706. The member 706 defines a central opening or lumen 708 configured to receive the frame 500. The member 706 can be actuated to controllably and uniformly reduce the diameter of the lumen 708 along the length of the frame to radially crush the frame.

[0126] The test device 700 is calibrated, for example, by ensuring that the device 700 is horizontal and that the device is at a specific temperature. In this example, the test was performed at 37°C. To calibrate the temperature reading of the device 700, a calibrated temperature sensor such as a thermocouple, and / or a calibrated digital thermometer was inserted into the environmental chamber head of the device, such as the lumen 708, to a depth of 50.8 mm to 76.2 mm. After a specific period of time (e.g., 5 minutes), a temperature correction value was entered so that the temperature reading of the device matched the temperature sensor.

[0127] To calibrate the diameter of the throttle assembly 704, a 6 mm diameter gauge pin was inserted into the lumen 708 at least 40 mm, and a calibration routine was executed. Next, a 40 mm diameter gauge pin was inserted into the throttle assembly at least 40 mm, and a calibration routine was executed. To calibrate the load cell of the device 700, a calibration yoke 710 was attached to or hung on the screw 712 when the specific screws 712 in the device 700 were horizontal (e.g., at a diameter of 10 mm). Weights 714 of varying mass were attached to the yoke 710 to calibrate the load cell.

[0128] Next, the friction of various elements of the throttle assembly 704 was checked. In this example, the measured friction was within the range of a radial force of ±1.5 N.

[0129] During the test, a pre-set routine was selected for a 32 mm frame that starts at a first diameter of 37 mm and radially contracts at a rate of 0.5 mm / s to a second diameter of 6.35 mm (corresponding to the inner diameter of the delivery cylinder). The frame was inserted into the lumen 708 and acclimated for 2 minutes before the test was started. Next, the radial force exerted by the compressed frame was measured, and the results are shown in a graph of radial force versus diameter as shown in Figure 41.

[0130] The third representative example The variable strut widths, junction widths, junction radii, etc. described previously can also be implemented in frames for other types of prosthetic implants, such as a docking station or system configured to receive a prosthetic heart valve. One representative example of such a docking station is shown in FIGS. 47A - 51.

[0131] FIGS. 47A and 47B show an exemplary embodiment of the frame 800 or body of the docking station 802. The frame 800 or body can take a wide variety of different forms, and FIGS. 47A and 47B show only one of many possible configurations. In the example shown by FIGS. 47A and 47B, the docking station 802 has a relatively wider proximal inflow end 804 and distal outflow end 806, and a relatively thinner portion 808 that forms a seating portion 810 between the ends 804, 806. In the example shown by FIGS. 47A and 47B, the frame 800 of the docking station 802 is preferably a wide stent consisting of a plurality of metal struts 812 that form cells 814. In the example of FIGS. 47A and 47B, the frame 800 has a generally hourglass shape with a thinner portion 808, and the thinner portion 808 forms a valve seat 810 when covered by an impermeable material between the proximal end 804 and the distal end 806. As described later, the prosthetic valve expands at the thinner portion 808 that forms the valve seat 810.

[0132] Figures 47A and 47B show the frame 800 in its unconstrained, expanded state. In this exemplary embodiment, the retaining portion 816 includes the ends 818 of the metal struts 812 at the proximal end 804 and the distal end 806. The sealing portion 820 is between the retaining portion 816 and the constriction 808. In the unconstrained state, the retaining portion 816 generally extends radially outwardly and is radially outside of the sealing portion 820. The frame 800 can be compressed radially for delivery and expansion by a catheter. The docking station can be made of an elastic or compliant material to accommodate a number of deformations in the biological structure. For example, the docking station can be made of a highly flexible metal, metal alloy, polymer, or closed-cell foam. An example of a highly flexible metal is nitinol, but other materials and non-metallic materials with flexibility or compliance at other hardnesses can be used. The docking station 802 can be self-expanding, manually expandable (e.g., expandable via a balloon), or mechanically expandable. A self-expanding docking station 802 can be made of a shape memory material such as nitinol, for example.

[0133] FIG. 48 shows a prosthetic valve 822 embedded in a frame 800. The valve 822 can optionally expand slightly around either side of the valve seating portion when docked within the docking station. This configuration, sometimes referred to as a “dog bone” (e.g., due to its shape formed around the valve seating portion or band), can also help hold the valve in place. In certain embodiments, the prosthetic valve 822 can be a SAPIEN® 3 balloon-expandable transcatheter heart valve available from Edwards Lifesciences Corporation. Details regarding the SAPIEN® 3 transcatheter heart valve can be found in U.S. Patent No. 9,393,110, which is incorporated herein by reference. Additional embodiments of balloon-expandable prosthetic heart valves that can be used in combination with the docking system 802 can be found in U.S. Patent Application Publication No. 2018 / 0028310, which is incorporated herein by reference. The docking system 802 can also be used in combination with a mechanically expandable prosthetic valve. Representative examples of mechanically expandable prosthetic valves can be found in U.S. Patent Application Publication No. 2018 / 0153689 and U.S. Patent Application Publication No. 2019 / 01056153, which are incorporated herein by reference.

[0134] Figures 49 and 50 show the docking station 802 of FIG. 47A embedded in a circulatory system such as the pulmonary artery. The sealing portion 820 provides a seal between the docking station 802 and the inner surface 824 of the circulatory system. In the examples of FIGS. 49 and 50, the sealing portion 820 is formed by providing an impermeable material 826 (see FIG. 50) over the frame 800 or a portion thereof. Specifically, the sealing portion 820 may comprise a rounded radially outwardly extending portion 828 below the frame 800. In an exemplary embodiment, the impermeable material 826 extends from at least a portion 828 of the frame 800 to the valve seat 810. This renders the docking station impermeable from the sealing portion 820 to the valve seat 810. Thereby, all blood flowing at the inflow end 804 towards the outflow end 806 is directed towards the valve seat 810 (and, when installed or deployed at the valve seat, the valve 822).

[0135] In a preferred embodiment of the docking station 802, the inflow portion has a wall that is impermeable to blood, while the outflow portion wall is relatively open. In one approach, the inflow end portion 804, the intermediate region 808, and a portion of the outflow end portion 806 are covered with a blood-impermeable fabric 826, which can be sewn to the stent or attached by techniques known in the art. The impermeability of the inflow portion of the stent helps to direct blood into the docking station 802 and ultimately helps to flow blood through the valve that expands and is secured within the docking station 802.

[0136] From another perspective, this embodiment of the docking station is designed to seal the proximal inflow region 804 to create a conduit for blood flow. However, the distal outflow region generally remains open, thereby allowing the docking station 802 to be placed higher in the pulmonary artery without restricting blood flow. For example, the permeable portion 830 may extend into the branches of the pulmonary artery and can be made not to obstruct or significantly obstruct the blood flow across the branches. In one embodiment, a blood-impermeable fabric such as a PET fabric, or other materials cover the proximal inflow region but do not cover any or at least a portion of the distal outflow region 806. As one non-limiting example, when the docking station 802 is placed in the pulmonary artery, which is a large blood vessel, a significant volume of blood flowing through the artery is directed into the valve 822 by the fabric covering 826. The fabric 826 is fluid-impermeable so that blood cannot pass through. Again, various other biocompatible covering materials can be used, such as a foam or fabric treated with a coating that is impermeable to blood, polyester, or a biologically derived material treated such as pericardium.

[0137] In the example shown in FIG. 50, more of the docking station frame 800 is provided with the impermeable material 826, forming a relatively large impermeable portion 832. In the example shown by FIG. 50, the impermeable portion 832 extends from the inflow end 804 and stops one row before the cells 814 from the outflow end. Thereby, the outermost distal row of the cells 814 forms the permeable portion 830. However, more rows of the cells 814 may not be covered by the impermeable material to form a larger permeable portion. The permeable portion 830 can allow blood to flow into and out of the region 834, as indicated by the arrow 836. With respect to the inflow end 804, it should be noted that since the cells 814 are generally diamond-shaped, blood can flow between the docking station 802 and the surface 824 until it reaches the sealing portion 820. That is, blood can flow into and out of the region 838 in one exemplary embodiment.

[0138] The valve seat 810 can provide a support surface for embedding or deploying the valve 822 in the docking station 802. The holding portion 816 can hold the docking station 802 at the embedding position or deployment site in the circulatory system. The illustrated holding portion has an outwardly curved flared end that helps hold the docking station 802 intra-arterially. As used herein, "outward" means extending away from the central longitudinal axis of the docking station. As shown in FIG. 49, when the docking station 802 is compressed by the inner surface 824, the holding portion 816 extends substantially radially outwardly (e.g., α (the angle perpendicular to the surface 824 with respect to the tangent of the midpoint of the surface of the holding portion 816) is between 0 and 20 degrees or about 10 degrees), rather than at an angle α that can be between 30 and 60 degrees, such as about 45 degrees, and engages the surface 824. This inward bending of the holding portion 816, as indicated by the arrow 840, acts to hold the docking station 802 in the circulatory system. The holding portion 816 is at the wider inflow end portion 804 and outflow end portion 806 and presses against the inner surface 824. The flared holding portion 816 engages the surrounding biological structures in the circulatory system, such as the pulmonary space. In one exemplary embodiment, the flare acts as a stop to lock the device in place. When an axial force is applied to the docking station 802, the flared holding portion 816 is pushed into the surrounding tissue by the force to resist the movement of the stent, as will be described in more detail later. In a particular embodiment, the docking station generally has an hourglass shape, with a wider distal end portion and proximal end portion having a flared holding portion, and a narrow band-like constriction between the ends into which the valve expands.

[0139] FIG. 51 shows a docking station 802 deployed in a circulatory system and a valve 822 deployed in the docking station 802. After the docking station 802 is deployed, the valve 822 is in a compressed form and is introduced into a valve seat 810 of the docking station 802. The valve 822 is expanded in the docking station so as to engage with the valve seat 810. In the example shown by FIG. 51, the docking station 802 is longer than the valve. However, in one embodiment, the docking station 802 can be of a length equal to or less than the length of the valve 822.

[0140] The patch valve 822 can be expanded at the location of the docking station via means including balloon or mechanical expansion, or by self-expansion. When expanded, the valve 822 is nested in the valve seat of the docking station 802. In one embodiment, the band-like constriction is somewhat elastic and exerts an elastic force on the patch valve 822 to help hold the patch valve in place.

[0141] As described above, the struts of the docking station frame 800 can have the variable strut widths, joint widths, joint radii, etc. described above. For example, any of the struts of the various strut rows of the frame 800 can have a narrower strut width adjacent to the joint or a tapered strut width according to any of the ratios described herein, and a wider intermediate strut width in the portion located between the joints. The width of the joint can also be greater than the intermediate strut width according to any of the ratios described herein. The ratio of the diameter of the inflow end of the docking station 802 to the inner diameter of the delivery cylinder in which the docking station is deployed can also be 6.0 or less as described above. Any or all of these features can, individually and / or in combination, reduce the tendency of the docking station frame 800 to fold inwards during deployment and recapture. Additional details regarding the docking station 802 can be found in U.S. Patent Application Publication No. 2017 / 0231756, which is incorporated herein by reference.

[0142] Fourth Representative Embodiment Figs. 52 - 53B show another embodiment of a docking system 900 configured to receive a prosthetic heart valve and that can have any of the varying strut widths, junction widths, junction radii, etc. described herein in various combinations. Fig. 52 shows an exemplary embodiment of a frame 902 of the docking system 900 comprising a plurality of strut members 903 arranged in a lattice pattern. In certain embodiments, the struts 903 may vary in length and / or thickness as described in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference. The frame 902 can take a wide variety of different forms, and Fig. 52 shows only one of many possible configurations. In certain embodiments, the frame 902 may comprise an elastic material, a superelastic material, or a metal such as nitinol.

[0143] The frame 902 may comprise a retaining portion 904 having an annular outer portion or wall 906 with a toroidal end face 908. The shaping of the annular outer portion 906 (e.g., the programmed shape of a shape memory material) can bias the wall 906 radially outward to contact the inner surface of a blood vessel (e.g., the aorta) to hold the docking station 900 and a prosthetic valve received in the docking station 900 in an implanted position. The frame 902 may further comprise legs or members 910 extending from around the frame to a lumen for supporting a valve seat 912, which can be configured to receive a prosthetic heart valve, such as any of the prosthetic heart valves described herein.

[0144] Referring to FIGS. 53A and 53B, in certain embodiments, the frame 902 may include a sealing material or coating 914 disposed at the end 908 of the frame to provide a seal between the prosthetic heart valve received in the valve seat 912 and the surrounding biological structure. The coating 914 may be configured as a cylinder that is partially wound back onto itself. The coating 914 may comprise one or more sheets of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), any other polymer, or a biocompatible material. In certain embodiments, the coating 914 may comprise a woven or knitted fabric comprising any of the foregoing materials. Further details of the coating 914 can be found in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated by reference above.

[0145] FIG. 60 shows another embodiment of a docking system frame 1200 configured to receive a prosthetic heart valve and which may also comprise any of the varied strut widths, junction widths, junction radii, etc. described herein. Frame 1200 may comprise an inflow end portion 1204 and an outflow end portion 1206. Frame 1200 may comprise a plurality of longitudinal strut members 1208 spaced from each other circumferentially about frame 1200. The frame may further comprise a plurality of rows of struts 1210 arranged alternately in a zigzag pattern. The rows of struts 1210 may be axially spaced from each other along the longitudinal axis 1212 of the frame. For example, in the illustrated embodiment, frame 1200 may comprise 11 rows I-XI of struts 1210, with a first row I located at the inflow end portion 1204 and an eleventh row XI located at the outflow end portion 1206. Struts 1210 are arranged such that a first end portion of the strut is coupled to longitudinal strut member 1208 at junction 1220 and a second end portion of the strut is coupled to a second end portion of an adjacent strut 1210 to form a "free" top 1218. The outflow end portion 1206 may comprise a plurality of struts 1222 coupled to the junctions 1220 of the eleventh row XI of struts. Struts 1222 may extend in a downstream direction and may be angled radially inwardly towards longitudinal axis 1212 to define a valve receiving portion or valve seat generally designated by reference numeral 1228, which may be coaxial with frame 1200 and configured to receive a prosthetic valve. Further details of docking station frame 1200 can be found in U.S. Provisional Patent Application No. 63 / 073,643, which is incorporated herein by reference.

[0146] As described above, any of the struts of the docking station frames 900 and / or 1200 can have the changed strut widths, joint widths, joint radii, etc. described above. For example, any of the struts in the various strut rows of frames 900 and / or 1200 can have a thinner strut width adjacent to the joint or a tapered strut width according to any of the ratios described herein, and a wider intermediate strut width in the portion located between the joints. The width of the joint can also be larger than the intermediate strut width according to any of the ratios described herein. The ratio of the diameter of the inlet end of the docking station frames 900 and / or 1200 to the inner diameter of the delivery cylinder in which the docking station is deployed can also be 6.0 or less as described above. The struts and joints can also be configured such that the ratio of the various strut widths to the radius of the curved surface of the joint is within any of the ranges described herein. Any or all of these features, individually and / or in combination, can reduce the tendency of the docking station frames 900 and 1200 to fold inward during deployment and recapture.

[0147] The Fifth Representative Embodiment FIG. 54 shows another embodiment of a frame 1000 of a prosthetic heart valve comprising a plurality of diagonal struts 1002 integrally joined at a joint 1004. The frame 1000 can be configured as a self-expanding frame comprising any of the self-expanding materials described herein and can be movable between a collapsed delivery configuration and an expanded functional configuration. The frame can comprise an inlet end 1006 and an outlet end 1008. The diameter of the frame 1000 can vary along its longitudinal axis 1010 as shown.

[0148] Figure 55 shows a selected portion of the frame 1000. The struts 1002 may each include a first or inlet end portion 1012 and a second or outlet end portion 1014 adjacent to respective joints 1004. The struts may further include a third or intermediate portion 1016 located between the inlet end portion 1012 and the outlet end portion 1014. The inlet end portion 1012 can have a strut width W1, and the outlet end portion 1014 can have a strut width W2. The struts are shown as tapering from the joints towards the middle of the struts, but in certain embodiments, the intermediate portion 1016 can have a strut width W3 that is greater than the strut widths W1 and W2 as previously described. The strut widths W1, W2, and W3 can have any of the values and ratios described herein.

[0149] The joint 1004 can also include a joint width B. The joint width B can be greater than the intermediate strut width W3, as previously described. The ratio of the intermediate strut width W3 to the joint width B can be any of the ratios described herein. The struts 1002 can also have a strut thickness configured according to any of the dimensions and a ratio described herein. In certain embodiments, the frame 1000 can be configured such that when 80% of the total length of the frame is deployed from the delivery cylinder, the ratio of the diameter of the flared inlet (or outlet) end of the frame to the inner diameter of the delivery cylinder is 6.0 or less. The struts and joints can also be configured such that the ratio of the various strut widths to the radius of the curved surface of the joint is within any of the ranges described herein. In certain embodiments, these features, alone and / or in various combinations, can reduce the tendency of the frame 1000 to buckle during loading, deployment, and / or recapture of the patch valve.

[0150] FIG. 56 shows another embodiment of a frame 1100 for a self-expanding prosthetic heart valve comprising a plurality of diagonal strut members 1102, an inflow end 1104, and an outflow end 1106. The frame struts 1102 can be configured according to any of the embodiments described herein to reduce the tendency of the frame 1100 to fold inwards during loading, deployment, and / or recapture of the prosthetic valve.

[0151] The Sixth Representative Embodiment Any of the frame strut configurations, junction width configurations, etc. described herein can be implemented in combination with a prosthetic device that includes a plurality of frames, such as an inner frame and an outer frame, or a plurality of layers of a frame. Also, for a prosthetic implant where the outflow end is deployed from the delivery sheath first, the concept of varying strut widths described herein can be implemented at least for the struts at the outflow end of the frame. Such an implementation can include a prosthetic heart valve configured for implantation (e.g., transseptally) in a native mitral valve. For example, FIGS. 61-64 show another embodiment of a self-expanding prosthetic implant configured as a prosthetic heart valve 1300 configured for implantation in a native mitral valve. Referring to FIG. 61, the prosthetic heart valve 1300 can include an inner frame 1302 and an outer frame 1304. The prosthetic heart valve 1300 can also have an inflow end 1303 and an outflow end 1305. The outer frame 1304 can have an upper region 1306, an intermediate region 1308, and a lower region 1310. In some situations, such as when the implant 1300 is positioned within a native mitral valve, the upper region 1306 can generally be positioned annularly above, the intermediate region 1308 can generally be positioned annularly within, and the lower region 1310 can generally be positioned annularly below. The outer frame 1304 is depicted separately in FIG. 63.

[0152] A representative embodiment of the inner frame 1302 is shown in FIG. 62. The inner frame 1302 may have an upper region 1312, a middle region 1314, and a lower region 1316. As shown, the middle region 1314 may have a diameter smaller than the upper region 1312, the lower region 1316, or both. This allows the middle region 1314 to form an hourglass shape that is thinner in diameter than both the upper region 1312 and the lower region 1316. In some embodiments, the upper region 1312 and the lower region 1316 may have approximately the same diameter. In certain embodiments, the inner frame 1302 may include an inner frame anchoring feature that includes a plurality of individual anchoring members 1318 that extend in a curved state from the lower region 1316 in a radially outward direction and have tips configured to contact / engage the intraluminal tissue in the implantation of a native mitral valve. The inner frame 1302 may also include a plurality of locking tabs 1320 configured to couple the prosthetic valve to the delivery system.

[0153] Referring to FIG. 63, the outer frame 1304 may include a plurality of struts that at least partially form cells 1322. The cells 1322 can have an irregular octagon shape, such as a "teardrop" shape, and can be formed through a combination of struts. As shown in the illustrated embodiment, the upper portion of the cell 1322 can be formed from a set of circumferentially expandable struts 1326 that form a zigzag or undulating shape that repeats in the form of a "V". The circumferentially expandable struts 1326 can be inclined or curved radially outward from the longitudinal axis of the prosthesis 1300 such that the upper portion of the strut 1326 is positioned closer to the longitudinal axis of the prosthesis 1300 than the lower portion of the strut 1326. The bottom portion of the cell 1322 can be formed from a set of struts 1328 that extend downward from each or generally the center of the "V" shape. The struts 1328 can extend with a plane parallel to the longitudinal axis of the prosthesis 100 and / or a plane that extends through its longitudinal axis. The shape of the cell 1322 can allow the cell 1322 to be reduced when the outer frame 1304 is expanded, and that expansion can be used to secure the prosthesis to the native valve or the intraluminal tissue around it.

[0154] Any or all of the struts of the inner frame and / or outer frame of the prosthetic heart valve 1300 may include any of the varying strut width concepts described herein. For example, FIG. 64 shows the outer frame 1304 in a flat configuration. In certain embodiments, the strut 1328 of the outer frame 1304 may comprise an inflow end portion 1330 and an outflow end portion 1332. The inflow end portion 1330 may define an arcuate / rounded / circular top or junction 1334. At or near the junction 1334, the strut 1328 may have a reduced strut width. For example, the inflow end portion 1330 of the strut can have a strut width S1, and the outflow end portion and the intermediate portion between the inflow end portion and the outflow end portion can have a strut width S2 that is greater than the strut width S1. In certain embodiments, this can reduce the likelihood of inward folding during recapture of the prosthetic valve 1300. In other embodiments, both the inflow end portion and the outflow end portion of the strut 1328 can have a reduced strut width compared to the intermediate portion of the strut. The junction 1334 can also have any of the radius and / or width dimensions described herein, and / or the width of the strut 1328 can be defined by the width and / or radius of the junction 1334 in any of the ratios described herein. In certain embodiments, the reduced strut width shown in FIG. 64 can be implemented at the outflow end portion 1332 of the strut 1328. The reduced strut width may be implemented in any of the struts of the inner frame. Further details regarding the prosthetic heart valve 1300 can be found in U.S. Patent Application Publication No. 2019 / 0262129, which is incorporated herein by reference.

[0155] Explanation of Terms For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being limited in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatuses, and systems are not limited to their particular aspects, features, or combinations, and the disclosed embodiments do not require the presence of one or more particular advantages or the solving of problems.

[0156] Some operations of the disclosed embodiments are described in a particular sequential order for convenient presentation, but it should be understood that this description of the technique includes rearrangements when the particular order is not required by express language stated later. For example, operations described sequentially may, in some cases, be rearranged or performed in parallel. Further, for simplicity, the attached figures may not show the various ways in which the disclosed method can be used in combination with other methods. Also, this description may use terms such as "provide" or "achieve" to describe the disclosed method. These terms are a high-level abstraction of the actual operations performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily recognizable by those skilled in the art.

[0157] As used in this application and the claims, the singular forms "a" and "the" include the plural unless the context clearly dictates otherwise. Also, the term "comprising" means "including." Further, the terms "coupled" and "associated" generally mean being coupled or connected electrically, electromagnetically, and / or physically (e.g., mechanically or chemically), and in the absence of specific contrary language, do not exclude the presence of intermediate elements between the coupled or associated items.

[0158] In the context of the present application, the terms "downward" and "upward" are interchangeably used with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end of a valve is its inflow end and the upper end of the valve is its outflow end.

[0159] As used herein, the term "proximal" refers to a position, direction, or part of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a position, direction, or part of a device that is farther from the user and closer to the implantation site. Thus, for example, movement of a device in the proximal direction is movement of the device toward the user, and movement of a device in the distal direction is movement of the device away from the user. The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless otherwise explicitly defined.

[0160] Additional description of embodiments of the example of interest In view of the above in relation to the subject matter, the present application discloses the following list of examples, where two or more features of the combined examples, which can be one feature of a separate example or, optionally, a combination of one or more features of one or more additional examples, are also further examples within the scope of the disclosure of the present application.

[0161] Example 1. A prosthetic implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, wherein the struts are interconnected at joints, and at least a portion of the plurality of struts has a reduced strut width at at least one joint.

[0162] Example 2. The prosthetic implant of any example herein, specifically the prosthetic implant of Example 1, wherein at least a portion of the plurality of struts has a reduced strut width at both joints.

[0163] Example 3. At least some of the plurality of struts of any example herein, specifically the patch implant of Example 1, have a reduced strut width at their inflow-side junctions.

[0164] Example 4. At least some of the plurality of struts of any example herein, specifically the patch implant of Example 1, have a reduced strut width at their outflow-side junctions.

[0165] Example 5. The struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame, for any example of a patch implant herein, specifically for any preceding example of a patch implant.

[0166] Example 6. At least the struts of the first row of struts have a reduced strut width at their inflow-side junctions, for any example of a patch implant herein, specifically the patch implant of Example 5.

[0167] Example 7. At least the struts of the first row of struts have a reduced strut width at their outflow-side junctions, for any example of a patch implant herein, specifically the patch implant of Example 5 or Example 6.

[0168] Example 8. At least the struts of the second row of struts have a reduced strut width at their outflow-side junctions, for any example of a patch implant herein, specifically any of the patch implants of Examples 5 to 7.

[0169] Example 9. At least the struts of the second row of struts have a reduced strut width at their inflow-side junctions, for any example of a patch implant herein, specifically any of the patch implants of Examples 5 to 8.

[0170] Example 10. The support pillar includes an inflow end portion, an outflow end portion, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the support pillars in the first row of support pillars has a first support pillar width, the outflow end portion of the support pillars in the first row of support pillars has a second support pillar width, and the intermediate portion of the support pillars in the first row of support pillars has a third support pillar width that is greater than the first support pillar width. The patch implant of any example in this specification, specifically, the patch implant of Example 5.

[0171] Example 11. The third support pillar width is greater than the first support pillar width and greater than the second support pillar width. The patch implant of any example in this specification, specifically, the patch implant of Example 10.

[0172] Example 12. The first support pillar width and the second support pillar width are substantially equal. The patch implant of any example in this specification, specifically, the patch implant of Example 10 or Example 11.

[0173] Example 13. The ratio of the first support pillar width to the third support pillar width is 0.95 or less, or is 0.7 to 0.95. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 10 to 12.

[0174] Example 14. The ratio of the second support pillar width to the third support pillar width is 0.95 or less, or is 0.7 to 0.95. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 10 to 13.

[0175] Example 15. The thickness of the support pillar is greater than the third support pillar width. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 10 to 14.

[0176] Example 16. The ratio of the third support pillar width to the support pillar thickness is 0.65 or more, or is 0.65 to 0.85. The patch implant of any example in this specification, specifically, the patch implant of Example 15.

[0177] Example 17. The joint has a joint width, and the joint width is greater than the third strut width. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 10 to 16.

[0178] Example 18. The ratio of the third strut width to the joint width is 0.3 to 0.5. The patch implant of any example in this specification, specifically, the patch implant of Example 17.

[0179] Example 19. The strut has a strut thickness, and the joint width is greater than the strut thickness. The patch implant of any example in this specification, specifically, the patch implant of Example 17 or Example 18.

[0180] Example 20. The ratio of the joint width to the strut thickness is 2.1 or less, or 1.5 to 2.1. The patch implant of any example in this specification, specifically, the patch implant of Example 19.

[0181] Example 21. When 80% of the total length of the patch implant is deployed from the delivery cylinder of the delivery device, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less, or 5.0 to 6.0. The patch implant of any example in this specification, specifically, the patch implant of any preceding example.

[0182] Example 22. The inflow end portion of the struts in the second row of struts has a first strut width, the outflow end portion of the struts in the second row of struts has a second strut width, and the middle portion of the struts in the second row of struts has a third strut width. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 10 to 21.

[0183] Example 23. Each joint has a curved inflow surface, the curved inflow surface defines a radius, and the ratio of the second strut width at the outflow end of the strut to the radius of the curved inflow surface is 4.0 to 7.5. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 10 to 22.

[0184] Example 24. All struts of the frame comprise a first strut width, a second strut width, and a third strut width, and are a patch implant of any example herein, specifically, a patch implant of any one of Examples 10 to 23.

[0185] Example 25. The patch implant is a patch heart valve comprising a plurality of valve leaflets coupled to the frame and configured to regulate blood flow through the frame, and is a patch implant of any example herein, specifically, a patch implant of any one of Examples 1 to 24.

[0186] Example 26. The patch implant is a docking station configured to be implanted into the valve annulus of a native heart valve and configured to receive a patch heart valve, and is a patch implant of any example herein, specifically, a patch implant of any one of Examples 1 to 24.

[0187] Example 27. A method comprising advancing, from a delivery cylinder of a delivery device in which a patch implant of any preceding example is held in a radially compressed state, the patch implant such that the inflow end of the patch implant at least partially expands, and retracting the patch implant back into the delivery cylinder such that the patch implant returns to a radially compressed state.

[0188] Example 28. A catheter comprising a handle portion at a proximal end portion and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder having an inner diameter at a distal end portion of the shaft, and a self-expanding patch implant according to any example herein, specifically, a self-expanding patch implant of any one of Examples 1 to 26 held in a radially compressed state in the delivery cylinder, a patch implant delivery device.

[0189] Example 29. The patch implant has a specific design diameter of at least 29 mm, and when the patch implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the patch implant is withdrawn, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less. The patch implant delivery device of any example herein, specifically, the patch implant delivery device of Example 28.

[0190] Example 30. A patch implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, wherein the struts are interconnected at joints, the struts define a first row of struts at the inflow end of the frame, the struts define a second row of struts at the outflow end of the frame, and at least one row of struts is defined between the inflow end and the outflow end of the frame. The struts comprise an inflow end portion, an outflow end portion, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the struts in the first row of struts has a first strut width, the outflow end portion of the struts in the first row of struts has a second strut width, and the intermediate portion of the struts in the first row of struts has a third strut width that is greater than the first strut width and greater than the second strut width.

[0191] Example 31. The first strut width and the second strut width are substantially equal. The patch implant of any example herein, specifically, the patch implant of Example 30.

[0192] Example 32. The ratio of the first strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95. The patch implant of any example herein, specifically, the patch implant of Example 30 or Example 31.

[0193] Example 33. The ratio of the second strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95. The patch implant of any example herein, specifically, the patch implant of any one of Examples 30 to 32.

[0194] Example 34. The thickness of the strut is greater than the third strut width. The patch implant of any example herein, specifically, the patch implant of any one of Examples 30 to 33.

[0195] Example 35. The ratio of the third strut width to the strut thickness is 0.65 or more, or is 0.65 to 0.85, for any example of the patch implant in this specification, specifically, the patch implant of Example 34.

[0196] Example 36. The joint has a joint width, and the joint width is greater than the third strut width, for any example of the patch implant in this specification, specifically, the patch implant of any one of Examples 30 to 35.

[0197] Example 37. The ratio of the third strut width to the joint width is 0.3 to 0.5, for any example of the patch implant in this specification, specifically, the patch implant of Example 36.

[0198] Example 38. The strut has a strut thickness, and the joint width is greater than the strut thickness, for any example of the patch implant in this specification, specifically, the patch implant of Example 36 or Example 37.

[0199] Example 39. The ratio of the joint width to the strut thickness is 2.1 or less, or is 1.5 to 2.1, for any example of the patch implant in this specification, specifically, the patch implant of Example 38.

[0200] Example 40. When 80% of the total length of the patch implant is deployed from the delivery cylinder of the delivery device, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less, or is 5.0 to 6.0, for any example of the patch implant in this specification, specifically, the patch implant of any one of Examples 30 to 39.

[0201] Example 41. The inflow end portion of the struts in the second row of struts has a first strut width, the outflow end portion of the struts in the second row of struts has a second strut width, and the middle portion of the struts in the second row of struts has a third strut width, for any example of the patch implant in this specification, specifically, the patch implant of any one of Examples 30 to 40.

[0202] Example 42. A patch implant of any example herein, specifically a patch implant of any one of Examples 30 to 41, wherein each joint has a curved inflow surface, the curved inflow surface defines a radius, and the ratio of the second strut width of the outflow end of the strut to the radius of the curved inflow surface is 4.0 to 7.5.

[0203] Example 43. A patch implant of any example herein, specifically a patch implant of any one of Examples 30 to 42, wherein all struts of the frame have a first strut width, a second strut width, and a third strut width.

[0204] Example 44. A patch implant of any example herein, specifically a patch implant of any one of Examples 30 to 43, which is a patch heart valve having a plurality of valve tips coupled to the frame and configured to regulate blood flow through the frame.

[0205] Example 45. A patch implant of any example herein, specifically a patch implant of any one of Examples 30 to 43, which is a docking station configured to be implanted in the valve annulus of a native heart valve and to receive a patch heart valve.

[0206] Example 46. A method comprising advancing, from a delivery cylinder of a delivery device in which a patch implant of any example herein, specifically a patch implant of any one of Examples 30 to 45, is held in a radially compressed state, the inflow end of the patch implant such that it at least partially expands; and retracting the patch implant back into the delivery cylinder such that the patch implant returns to a radially compressed state.

[0207] Example 47. A catheter having a handle portion at the proximal end portion and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder having an inner diameter at the distal end portion of the shaft; and a self-expanding patch implant according to any example herein, specifically a self-expanding patch implant of any one of Examples 30 to 45, held in a radially compressed state in the delivery cylinder, the patch implant delivery device.

[0208] Example 48. The prosthesis implant has a specific design diameter of at least 29 mm, and when the prosthesis implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the prosthesis implant is withdrawn, the ratio of the diameter of the inflow end of the prosthesis implant to the inner diameter of the delivery cylinder is 6.0 or less. The prosthesis implant delivery device of any example herein, specifically, the prosthesis implant delivery device of Example 47.

[0209] Example 49. A prosthesis implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, wherein the struts are interconnected at joints, and each strut comprises an inflow end portion coupled to each joint, an outflow end portion coupled to each joint, and an intermediate portion between the inflow end portion and the outflow end portion. The strut width of the intermediate portion of the strut is different from the strut width of the inflow end portion of the strut and different from the strut width of the outflow end portion of the strut. The strut has a strut thickness, and the ratio of the strut width of the intermediate portion of the strut to the strut thickness is 0.65 or more.

[0210] Example 50. The ratio of the strut width of the intermediate portion of the strut to the strut thickness is 0.65 to 0.85. The prosthesis implant of any example herein, specifically, the prosthesis implant of Example 49.

[0211] Example 51. The struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame. The inflow end portion of the struts in the first row of struts has a first strut width, the outflow end portion of the struts in the first row of struts has a second strut width, and the strut width of the intermediate portion of the struts in the first row of struts is a third strut width that is greater than the first strut width and greater than the second strut width. The prosthesis implant of any example herein, specifically, the prosthesis implant of Example 49 or Example 50.

[0212] Example 52. All the struts of the frame have a first strut width, a second strut width, and a third strut width. The prosthesis implant of any example herein, specifically, the prosthesis implant of Example 51.

[0213] Example 53. The first strut width and the second strut width are substantially equal, the patch implant of any example in this specification, specifically, the patch implant of Example 51 or Example 52.

[0214] Example 54. The ratio of the first strut width to the third strut width is 0.95 or less, or 0.7 to 0.95, the patch implant of any example in this specification, specifically, the patch implant of any one of Examples 51 to 53.

[0215] Example 55. The ratio of the second strut width to the third strut width is 0.95 or less, or 0.7 to 0.95, the patch implant of any example in this specification, specifically, the patch implant of any one of Examples 51 to 54.

[0216] Example 56. The thickness of the strut is greater than the third strut width, the patch implant of any example in this specification, specifically, the patch implant of any one of Examples 51 to 55.

[0217] Example 57. The joint has a joint width, and the joint width is greater than the strut width at the middle part of the strut, the patch implant of any example in this specification, specifically, the patch implant of any one of Examples 49 to 56.

[0218] Example 58. The ratio of the joint width to the strut width at the middle part of the strut is 0.3 to 0.5, the patch implant of any example in this specification, specifically, the patch implant of Example 57.

[0219] Example 59. The strut has a strut thickness, and the joint width is greater than the strut thickness, the patch implant of any example in this specification, specifically, the patch implant of Example 57 or Example 58.

[0220] Example 60. The ratio of the joint width to the strut thickness is 2.1 or less, or 1.5 to 2.1, the patch implant of any example in this specification, specifically, the patch implant of Example 59.

[0221] Example 61. When 80% of the total length of the patch implant is deployed from the delivery cylinder of the delivery device, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is less than 6.0, or is 5.0 to 6.0, for any example of a patch implant in this specification, specifically, any of the patch implants of Examples 49 to 60.

[0222] Example 62. The outflow end portion of the struts in the second row of struts has a first strut width, the outflow end portion of the struts in the second row of struts has a second strut width, and the middle portion of the struts in the second row of struts has a third strut width, for any example of a patch implant in this specification, specifically, the patch implant of Example 51.

[0223] Example 63. Each joint portion has a curved inflow surface, the curved inflow surface defines a radius, and the ratio of the strut width of the outflow end of the strut to the radius of the curved inflow surface is 4.0 to 7.5, for any example of a patch implant in this specification, specifically, any of the patch implants of Examples 49 to 62.

[0224] Example 64. The patch implant is a prosthetic heart valve comprising a plurality of valve leaflets coupled to a frame and configured to regulate blood flow through the frame, for any example of a patch implant in this specification, specifically, any of the patch implants of Examples 49 to 63.

[0225] Example 65. The patch implant is a docking station configured to be implanted in the valve annulus of a native heart valve and configured to receive a prosthetic heart valve, for any example of a patch implant in this specification, specifically, any of the patch implants of Examples 49 to 63.

[0226] Example 66. A method comprising advancing, from a delivery cylinder of a delivery device in which a patch implant of any example in this specification, specifically, any of the patch implants of Examples 49 to 65, is held in a radially compressed state, such that the inflow end of the patch implant expands at least partially; and retracting the patch implant back into the delivery cylinder such that the patch implant returns to a radially compressed state.

[0227] Example 67. A catheter comprising a handle portion at a proximal end portion and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder having an inner diameter at a distal end portion of the shaft, and a self-expanding prosthesis delivery device comprising a self-expanding prosthesis according to any example herein, specifically, a self-expanding prosthesis according to any one of Examples 49 to 65 held in a radially compressed state in the delivery cylinder.

[0228] Example 68. The prosthesis has a specific design diameter of at least 29 mm, and when the prosthesis is partially deployed from the delivery cylinder such that at least 80% of the total length of the prosthesis is withdrawn, the ratio of the diameter of the inflow end of the prosthesis to the inner diameter of the delivery cylinder is 6.0 or less. A prosthesis delivery device according to any example herein, specifically, the prosthesis delivery device of Example 67.

[0229] Example 69. A prosthesis comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, wherein the struts are interconnected at joints, the joints have a joint width, and the struts each comprise an inflow end portion coupled to each joint, an outflow end portion coupled to each joint, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the strut has a first strut width, the outflow end portion of the strut has a second strut width, the intermediate portion of the strut has a third strut width greater than the first strut width and greater than the second strut width, and the joint width is greater than the third strut width of the intermediate portion of the strut.

[0230] Example 70. The ratio of the third strut width to the joint width is from 0.3 to 0.5. A prosthesis according to any example herein, specifically, the prosthesis of Example 69.

[0231] Example 71. The first strut width and the second strut width are substantially equal. A prosthesis according to any example herein, specifically, the prosthesis of Example 69 or Example 70.

[0232] Example 72. The ratio of the first strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95, and is a patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 71.

[0233] Example 73. The ratio of the second strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95, and is a patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 72.

[0234] Example 74. The thickness of the strut is greater than the third strut width, and is a patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 73.

[0235] Example 75. The ratio of the third strut width to the strut thickness is 0.65 or more, or is 0.65 to 0.85, and is a patch implant of any example in this specification, specifically, the patch implant of Example 74.

[0236] Example 76. The joint width is greater than the strut thickness, and is a patch implant of any example in this specification, specifically, the patch implant of Example 74 or Example 75.

[0237] Example 77. The ratio of the joint width to the strut thickness is 2.1 or less, or is 1.5 to 2.1, and is a patch implant of any example in this specification, specifically, the patch implant of Example 76.

[0238] Example 78. When 80% of the total length of the patch implant is deployed from the delivery cylinder of the delivery device, the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is less than 6.0, or is 5.0 to 6.0, and is a patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 77.

[0239] Example 79. The struts define a first row of struts at the inlet end of the frame, define a second row of struts at the outlet end of the frame, define at least one row of struts between the inlet end and the outlet end of the frame, the inlet end portion of the struts in the first row of struts has a first strut width, the outlet end portion of the struts in the first row of struts has a second strut width, and the middle portion of the struts in the first row of struts has a third strut width that is greater than the first strut width and greater than the second strut width. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 78.

[0240] Example 80. The inlet end portion of the struts in the second row of struts has a first strut width, the outlet end portion of the struts in the second row of struts has a second strut width, and the middle portion of the struts in the second row of struts has a third strut width. The patch implant of any example in this specification, specifically, the patch implant of Example 79.

[0241] Example 81. Each joint has a curved inlet surface that defines a radius, and the ratio of the second strut width at the outlet end of the strut to the radius of the curved inlet surface is 4.0 to 7.5. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 80.

[0242] Example 82. All the struts of the frame have a first strut width, a second strut width, and a third strut width. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 81.

[0243] Example 83. The patch implant is a prosthetic heart valve that includes a plurality of valve tips coupled to the frame and is configured to regulate blood flow through the frame. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 82.

[0244] Example 84. The patch implant is a docking station configured to be implanted in the valve annulus of a native heart valve and to receive a prosthetic heart valve. The patch implant of any example in this specification, specifically, the patch implant of any one of Examples 69 to 82.

[0245] Example 85. A method comprising the steps of advancing any example of the patch implants herein, specifically any of the patch implants of Examples 69 to 84, from a delivery cylinder of a delivery device in which the patch implant is held in a radially compressed state such that the inflow end of the patch implant expands at least partially; and retracting the patch implant back into the delivery cylinder such that the patch implant returns to a radially compressed state.

[0246] Example 86. A catheter comprising a handle portion at a proximal end portion and an elongate shaft extending from the handle portion, the catheter further comprising a delivery cylinder having an inner diameter at a distal end portion of the shaft; and a self-expanding patch implant according to any example herein, specifically any of the self-expanding patch implants of Examples 69 to 84, held in a radially compressed state within the delivery cylinder.

[0247] Example 87. A patch implant delivery device according to any example herein, specifically the patch implant delivery device of Example 86, wherein the patch implant has a specific design diameter of at least 29 mm and the ratio of the diameter of the inflow end of the patch implant to the inner diameter of the delivery cylinder is 6.0 or less when the patch implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the patch implant is withdrawn.

[0248] Example 88. A catheter comprising a handle portion at a proximal end portion and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder having an inner diameter at a distal end portion of the shaft, and a self-expanding prosthesis implant retained in a radially compressed state in the delivery cylinder, the prosthesis implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at joints, the prosthesis implant having a specific design diameter of at least 29 mm, and when the prosthesis implant is partially deployed from the delivery cylinder such that at least 80% of the total length of the prosthesis implant is withdrawn, the ratio of the diameter of the inflow end of the prosthesis implant to the inner diameter of the delivery cylinder is 6.0 or less. Prosthesis implant delivery device.

[0249] Example 89. The ratio of the diameter of the inflow end of the prosthesis implant to the inner diameter of the delivery cylinder is from 5.0 to 6.0. The prosthesis implant delivery device of any example herein, specifically, the prosthesis implant delivery device of Example 88.

[0250] Example 90. At least a portion of the plurality of struts of the prosthesis implant has a reduced strut width at at least one joint. The prosthesis implant delivery device of any example herein, specifically, the prosthesis implant delivery device of Example 88 or Example 89.

[0251] Example 91. At least a portion of the plurality of struts have a reduced strut width at both joints. The prosthesis implant delivery device of any example herein, specifically, the prosthesis implant delivery device of Example 90.

[0252] Example 92. At least a portion of the plurality of struts have a reduced strut width at their inflow-side joints. The prosthesis implant delivery device of any example herein, specifically, the prosthesis implant delivery device of Example 90.

[0253] Example 93. At least a portion of the struts among the plurality of struts have a reduced strut width at their outflow-side joints, for any example of the patch implant delivery device herein, specifically, any of the patch implant delivery devices of Examples 90 to 92.

[0254] Example 94. The struts of the patch implant define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame, for any example of the patch implant delivery device herein, specifically, any of the patch implant delivery devices of Examples 88 to 93.

[0255] Example 95. At least the struts of the first row of struts have a reduced strut width at their inflow-side joints, for any example of the patch implant delivery device herein, specifically, the patch implant delivery device of Example 94.

[0256] Example 96. At least the struts of the first row of struts have a reduced strut width at their outflow-side joints, for any example of the patch implant delivery device herein, specifically, the patch implant delivery device of Example 94 or Example 95.

[0257] Example 97. At least the struts of the second row of struts have a reduced strut width at their outflow-side joints, for any example of the patch implant delivery device herein, specifically, any of the patch implant delivery devices of Examples 94 to 96.

[0258] Example 98. At least the struts of the second row of struts have a reduced strut width at their inflow-side joints, for any example of the patch implant delivery device herein, specifically, the patch implant delivery device of Example 97.

[0259] Example 99. The strut includes an inflow end portion, an outflow end portion, and an intermediate portion between the inflow end portion and the outflow end portion. The inflow end portion of the struts in the first row of struts has a first strut width, the outflow end portion of the struts in the first row of struts has a second strut width, and the intermediate portion of the struts in the first row of struts has a third strut width that is greater than the first strut width. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of Example 94.

[0260] Example 100. The third strut width is greater than the first strut width and greater than the second strut width. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of Example 99.

[0261] Example 101. The first strut width and the second strut width are substantially equal. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of Example 99 or Example 100.

[0262] Example 102. The ratio of the first strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of any one of Examples 99 to 106.

[0263] Example 103. The ratio of the second strut width to the third strut width is 0.95 or less, or is 0.7 to 0.95. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of any one of Examples 99 to 102.

[0264] Example 104. The thickness of the strut is greater than the third strut width. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of any one of Examples 99 to 103.

[0265] Example 105. The ratio of the third strut width to the strut thickness is 0.65 or more, or is 0.65 to 0.85. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of Example 104.

[0266] Example 106. The joint has a joint width, and the joint width is greater than the third strut width. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of any one of Examples 99 to 105.

[0267] Example 107. The ratio of the third strut width to the joint width is 0.3 to 0.5. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of Example 106.

[0268] Example 108. The strut has a strut thickness, and the joint width is greater than the strut thickness. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of Example 106 or Example 107.

[0269] Example 109. The ratio of the joint width to the strut thickness is 2.1 or less, or 1.5 to 2.1. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of Example 108.

[0270] Example 110. The inflow end portion of the struts in the second row of struts has a first strut width, the outflow end portion of the struts in the second row of struts has a second strut width, and the middle portion of the struts in the second row of struts has a third strut width. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of any one of Examples 99 to 109.

[0271] Example 111. Each joint has a curved inflow surface, the curved inflow surface defines a radius, and the ratio of the radius of the curved inflow surface to the second strut width at the outflow end of the strut is 4.0 to 7.5. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of any one of Examples 99 to 110.

[0272] Example 112. All the struts of the frame have a first strut width, a second strut width, and a third strut width. The patch implant delivery device of any example in this specification, specifically, the patch implant delivery device of any one of Examples 99 to 111.

[0273] Example 113. The prosthetic implant is a prosthetic heart valve comprising a plurality of valve leaflets coupled to a frame and configured to regulate blood flow through the frame, and is a prosthetic implant delivery device of any example herein, specifically, the prosthetic implant delivery device of any one of Examples 88 to 112.

[0274] Example 114. The prosthetic implant is a docking station configured to be implanted into the annulus of a native heart valve and configured to receive a prosthetic heart valve, and is a prosthetic implant delivery device of any example herein, specifically, the prosthetic implant delivery device of any one of Examples 88 to 113.

[0275] Considering the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of the present disclosure. Rather, the scope of the present invention is at least as broad as the following claims. Therefore, we claim all that falls within the scope and spirit of these claims.

Explanation of Reference Numerals

[0276] 10 Prosthetic aortic heart valve 12 Frame member, stent 14 Flexible leaflet region, leaflet assembly 16 Frame member, strut 18 Knot point 20 Upper portion, outflow end portion 22 Intermediate region 24 Inflow end portion, lower region 26 Inflow end, flared lower end 27 Outflow end 28 Aortic valve annulus 30 Retaining arm, post 32 Opening 34a, 34b, 34c Valve leaflets 36 Reinforcement region 38 Upper edge portion 42 Annular reinforcement skirt 44 Suture line 46 Inner reinforcement strip 48 and 50 suture threads 56 aortic sinus 58 congenital valve tip 60 inflow end portion 62 outflow end portion 100 delivery device 102 main catheter, outer catheter 104 outer shaft, main shaft 106 delivery sheath 108 intermediate catheter, torque shaft catheter 110 torque shaft 112 screw 114 valve holding mechanism 118 nose cone catheter 120 nose catheter shaft 122 nose piece, nose cone 126 and 126' distal segment 128 ring, tethering disc 130 outer fork, outer trident, release trident 132 inner fork, inner trident, locking trident 134 protrusion 138 base portion 140 opening 150 threaded nut, sheath retaining ring 152 female thread 154 leg 160 circular band, ring 162 pull wire 164 location, tab portion 166 proximal segment 168 deflection control mechanism 170 coupling member 172 opening 174 proximal end portion 176 intermediate region 178 groove, concave portion 180 proximal end 182 proximal face 186 housing, handle portion 188 slide nut 190 rail 192 rail, bar 202 Handle 204 Catheter assembly 212 Groove 214 Holding mechanism, anti-disengagement mechanism 216 Engagement part 218 Button 220 Spring 222 Driven nut 224 Driving cylinder 226 Electric motor 228, 230 Gears 231 Motor 232 Battery compartment 233 Shaft 234 Operator button 236 Distal end portion 238 Connector 240 Proximal end portion 242 Side panel 244 Main housing 246 O-ring 300 Stent 302 Top 304 Opening 306 Joining post 308 Small hole 400 Patch valve frame 402 Delivery cylinder 404 Inflow end 406 Support pillar 408, 408A Inflow side top 410 Guide wire 500 Frame 502 Inflow end 504 Outflow end 506, 506A, 506B, 506C, 506D Support pillars 510 Longitudinal axis 512 Upper part, outflow end part 514 Middle part, abdominal part 516 Lower part, constricted part, inflow end part 518 Inflow end part 520 Outflow end part 522 Middle part 524 Inflow side surface 526 Outflow side surface Outside of 528 530, 530A, 530B, 530′, 530″ Nodal points, junctions 532 Inflow side curved surface 534 Outflow side curved surface 536 Top 538 Top 544 Delivery cylinder, delivery sheath 546, 548 Latitudes 602, 604 Curves 700 Radial expansion force measuring device 702 Main body 704 Throttle assembly 706 Wedge member, mandrel 708 Opening, lumen 710 Calibration yoke 712 Screw 714 Hammer 800 Frame 802 Docking station, docking system 804 Inflow end, proximal inflow region 806 Outflow end, distal outflow region 808 Narrower part, constriction 810 Seating part, valve seat 812 Metal strut 814 Cell 816 Holding part 818 End 820 Sealing part 822 Patch valve 824 Inner surface of the circulatory system 826 Impermeable material, blood-impermeable fabric, covering 828 Lower rounded radially outwardly extending part 830 Permeable part 832 Impermeable part 834, 838 Regions 900 Docking system, docking station 902 Frame 903 Strut member 904 Holding part 906 Annular outer part, wall 908 Toroidal end face, end 910 feet, members 912 valve seat 914 sealing material, coating 1000 frame 1002 strut 1004 joint 1006 inlet end 1008 outlet end 1010 longitudinal axis 1012 first part, inlet end part 1014 second part, outlet end part 1016 third part, middle part 1100 frame 1102 strut member 1104 inlet end 1106 outlet end 1200 frame 1204 inlet end part 1206 outlet end part 1208 strut member 1210 strut 1212 longitudinal axis 1220 joint 1228 valve receiving part, valve seat 1300 patch heart valve 1302 inner frame 1303 inlet end 1304 outer frame 1305 outlet end 1306 upper region 1308 middle region 1310 lower region 1312 upper region 1314 middle region 1316 lower region 1318 mooring member 1322 cell 1326, 1328 struts 1330 inlet end part 1332 outlet end part 1334 top, joint A thickness dimension B joint width D1 diameter of the middle region 22 Minimum diameter of the D2 inflow end portion 24 Diameter of the D3 inflow end 26 Diameter of the D4 outflow end portion 20 D SPEC Specific design diameter Inner diameter of the D5 delivery cylinder 544 Diameter of the D6 inflow end 502 Total length of the L stent, strut length Q angle Radius of the r curved surface S1, S2 strut width T wall thickness, radial thickness, strut thickness W, W1, W2, W3 strut width Total length of the Y frame Angle of the α holding portion 816 Rows of the I, II, III, IV, V strut members 506, rows of the struts 1210

Claims

Claim 1 A prosthesis implant delivery device (100), A catheter (102), the catheter (102) comprising a handle portion (186) disposed at a proximal end portion of the catheter (102) and a rod-shaped shaft (104) extending from the handle portion (186), the catheter (102) comprising a delivery cylinder (402) disposed at a distal end portion of the shaft, the delivery cylinder (402) having a predetermined inner diameter, the catheter (102); A self-expandable prosthesis implant held in the delivery cylinder (402) in a radially compressed state, the prosthesis implant comprising a self-expandable frame (400; 500), the frame (400; 500) having an inflow end (404; 502), an outflow end (504), and a plurality of struts (406; 506), the struts (406; 506) being interconnected at a junction (530), the prosthesis implant; In the prosthesis implant delivery device (100) comprising the above, The prosthesis implant has a specific diameter of at least 29 mm, When the prosthesis implant is partially deployed from the delivery cylinder (402) such that at least 80% of the total length of the prosthesis implant is withdrawn, the diameter (D ５ of the inflow end (404; 502) of the prosthesis implant relative to the inner diameter (D ６ ) of the delivery cylinder (402) is 6.0 or less. A prosthesis implant delivery device (100) characterized by this. Claim 2 The diameter (D ５ of the inflow end (404; 502) of the patch implant relative to the inner diameter (D ６ ) of the delivery cylinder (402) is 5.0 to 6.0, and the patch implant delivery device (100) according to claim 1 is characterized by this. Claim 3 The prosthesis implant delivery device (100) according to claim 1 or 2, wherein at least some of the plurality of struts (406; 506) of the prosthesis implant have a reduced strut width (W) at at least one of the junctions. Claim 4 The prosthesis implant delivery device (100) according to claim 3, wherein at least some of the plurality of struts (406; 506) have a reduced strut width (W) at both of the junctions (530). Claim 5 The prosthesis implant delivery device (100) according to claim 3, wherein at least some of the plurality of struts (406; 506) have a reduced strut width (W) at the junction (530) on the inflow side of the strut (406; 506). Claim 6 The prosthesis implant delivery device (100) according to any one of claims 3 to 5, wherein at least some of the plurality of struts (406; 506) have a reduced strut width (W) at the junction (530) on the outflow side of the strut (406; 506). Claim 7 The support columns (406; 506) of the prosthesis implant define a first column (I) of the support columns (406; 506) formed at the inlet end (404; 502) of the frame (400, 500), a second column (II) of support columns formed at the outlet end (504) of the frame (400; 500), and at least one column of the support columns (406; 506) formed between the inlet end (404; 502) and the outlet end (504) of the frame (400; 500). The prosthesis implant delivery device (100) according to any one of claims 1 to 6 is characterized by this.

8. The prosthesis implant delivery device (100) according to claim 7 is characterized in that at least the support columns (406; 506) of the first column (I) have a reduced column width (W) at the joint (530) on the inlet side of the support columns (406; 506).

9. The prosthesis implant delivery device (100) according to claim 7 or 8 is characterized in that at least the support columns (406; 506) of the first column (I) have a reduced column width (W) at the joint (530) on the outlet side of the support columns (406; 506).

10. The prosthesis implant delivery device (100) according to any one of claims 7 to 9 is characterized in that at least the support columns (406; 506) of the second column (II) have a reduced column width (W) at the joint (530) on the outlet side of the support columns (406; 506).

11. The prosthesis implant delivery device (100) according to claim 10 is characterized in that at least the support columns (406; 506) of the second column (II) have a reduced column width (W) at the joint (530) on the inlet side of the support columns (406; 506).

12. The support columns (406; 506) are provided with an inlet end portion and an outlet end portion, and an intermediate portion is provided between the inlet end portion and the outlet end portion. The inlet end portion of the support columns (406; 506) of the first column (I) has a first column width (W), the outlet end portion of the support columns (406; 506) of the first column (I) has a second column width (W), and the intermediate portion of the support columns (406; 506) of the first column (I) has a third column width (W) that is larger than the first column width (W). The prosthesis implant delivery device (100) according to claim 7 is characterized by this.

13. The suturing implant delivery device (100) according to claim 12, characterized in that the third strut width (W) is larger than the first strut width (W) and larger than the second strut width (W).

14. The suturing implant delivery device (100) according to claim 12 or 13, characterized in that the first strut width (W) and the second strut width (W) are substantially the same.

15. The suturing implant delivery device (100) according to any one of claims 12 to 14, characterized in that the ratio of the first strut width (W) to the third strut width (W) is 0.95 or less, or 0.7 to 0.95.

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