Heart Valve Delivery Device

Abstract

The cardiac prosthesis delivery system includes a tubular loading member having a notch extending through its wall at a distal edge, and a prosthesis retention member disposed within the tubular loading member. The prosthesis retention member has multiple prosthesis retention areas configured to engage with prosthesis engagement portions of the cardiac prosthesis. The tubular loading member and the prosthesis retention member are longitudinally and rotationally movable relative to one another. The notch has multiple rotational positions to fully expose one of the prosthesis retention areas while covering the remaining areas. This delivery system enables accurate positioning and secure retention of the cardiac prosthesis during implantation.

Description

[Background technology]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 385,185, entitled "Valve Delivery System," filed November 28, 2022, the entire contents of which are incorporated herein by reference.

[0002] Valve heart disease is a common condition affecting millions of people worldwide. The heart has four valves that regulate blood flow by opening and closing during each heartbeat. When these valves become damaged or diseased, they may not function properly, causing a variety of symptoms, including shortness of breath, fatigue, and chest pain. In severe cases, valve heart disease can lead to heart failure and death.

[0003] Traditional treatment for valvular heart disease involves surgically replacing the diseased valve with a prosthetic valve. While this procedure is effective, it is invasive and requires a significant recovery period. Additionally, some patients cannot undergo surgery due to other health conditions.

[0004] In recent years, there has been growing interest in minimally invasive techniques for heart valve replacement, such as transcatheter aortic valve replacement (TAVR). This technique involves inserting a collapsible valve into the heart, usually via a catheter inserted into the femoral artery. The valve is then deployed into the damaged valve, replacing it and restoring normal blood flow.

[0005] More recently, there has been growing interest in using this technology for mitral and tricuspid valve replacement, known as transcatheter mitral valve replacement (TMVR) and transcatheter tricuspid valve replacement (TTVR). These valves are more complex than the aortic valve, making them difficult to replace using traditional surgical procedures. TMVR and TTVR offer a less invasive option for patients with mitral or tricuspid valve disease who are not suitable candidates for traditional surgical valve replacement.

[0006] TMVR and TTVR require specialized devices designed for the unique geometries of the mitral and tricuspid valves. These devices are typically constructed from biocompatible materials and are designed to be deployed via a catheter, similar to the TAVR procedure.

[0007] Overall, TMVR and TTVR offer promising new options for patients with mitral or tricuspid valve disease who may not be suitable for traditional surgical valve replacement. As with any new medical technology, many challenges remain to be addressed, including device design, patient selection, and long-term outcomes. However, the potential benefits of these technologies make them an attractive area of ​​research and development in the field of cardiology. Summary of the Invention

[0008] In some aspects, the technology described herein relates to a delivery system for a cardiac prosthesis, comprising: a tubular loading member having a notch, the notch extending completely through a wall of the tubular loading member and disposed at a distal edge of the tubular loading member; and a prosthesis retaining member disposed within the tubular loading member, the prosthesis retaining member comprising a plurality of prosthesis retaining areas configured to engage prosthesis engagement portions of the cardiac prosthesis, the tubular loading member and the prosthesis retaining member being longitudinally and rotationally movable relative to one another, the notch having a plurality of rotational positions that completely radially expose one of the plurality of prosthesis retaining areas while covering the remainder of the plurality of prosthesis retaining areas.

[0009] In some aspects, the technology described herein relates to a delivery system, wherein the plurality of prosthesis retaining regions are circumferentially arranged around a body of the prosthesis retaining element.

[0010] In some aspects, the technology described herein relates to a delivery system, wherein the notch is approximately the same size as or larger than each of the plurality of prosthesis-retaining areas.

[0011] In some aspects, the technology described herein relates to a delivery system, wherein the notch has a width and shape that allows the prosthesis engagement portion to pass through the notch.

[0012] In some aspects, the technology described herein relates to a delivery system, wherein the tubular loading member comprises a prosthetic loading device having a tubular structure, and wherein the tubular loading member is removable from the delivery system.

[0013] In some aspects, the technology described herein relates to a delivery system, wherein the tubular loading member includes a distal region that is reduced in diameter relative to a proximal region.

[0014] In some aspects, the technology described herein relates to a delivery system further comprising a funnel member removably connected to said tubular loading member.

[0015] In some aspects, the technology described herein relates to a delivery system further comprising a notch cover member removably positioned over the notch in the tubular loading member and around at least a portion of the tubular loading member.

[0016] In some aspects, the technology described herein relates to a delivery system, wherein the notch cover member includes a protrusion disposed on an inner surface of the notch cover member and sized to fit into the notch of the prosthesis loading device.

[0017] In some aspects, the technology described herein relates to a delivery system, wherein the cutout cover member has an open tubular shape.

[0018] In some aspects, the technology described herein relates to a delivery system, wherein the prosthesis engagement portion is an enlarged region disposed on a proximal portion of the cardiac prosthesis.

[0019] In some aspects, the technology described herein relates to a delivery system, wherein the enlarged region is an engagement hole.

[0020] In some aspects, the technology described herein relates to a delivery system, wherein the plurality of prosthesis-retaining areas comprise recesses having rectangular shapes adjacent to each other in a circular fashion.

[0021] In some aspects, the technology described herein relates to a delivery system, wherein the plurality of prosthesis-retaining areas comprise depressions, grooves, posts, walls, or combinations thereof.

[0022] In some aspects, the technology described herein relates to a delivery system, wherein the tubular loading member has a first tubular member, the notch is located at a distal edge of the first tubular member, and the first tubular member is non-removably secured to the delivery system.

[0023] In some aspects, the technology described herein relates to a delivery system comprising a first tubular member longitudinally movable relative to the prosthesis retention member.

[0024] In some aspects, the technology described herein relates to a delivery system, further comprising a second tubular member disposed within the lumen of the first tubular member and connected to the prosthesis retention member.

[0025] In some aspects, the technology described herein relates to a delivery system comprising a shaft disposed within a lumen of the second tubular member, the distal region of the shaft having a nosecone.

[0026] In some aspects, the technology described herein relates to a delivery system further comprising a third tubular member disposed around the first tubular member, the third tubular member forming an outer tube portion of the delivery system.

[0027] In some aspects, the technology described herein relates to a delivery system, further comprising a handle assembly, the handle assembly comprising a movement mechanism connected to the first tubular member that moves the first tubular member distally and proximally relative to the handle assembly.

[0028] In some aspects, the technology described herein relates to a delivery system, wherein the movement mechanism includes an outer tubular portion that rotates relative to an outer handle housing, the inner surface of the outer tubular portion engaging a nut via a threaded surface that moves the nut longitudinally as the outer tubular portion is rotated, and the nut is connected to the first tubular member.

[0029] In some aspects, the technology described herein relates to a delivery system, wherein the first outer tube portion comprises a distal tubular portion made of a rigid material and a proximal tubular portion made of a flexible material.

[0030] In some aspects, the technology described herein relates to a delivery system, wherein the cardiac prosthesis is a heart valve comprising an atrial flange portion, a valve engaging portion, and a body portion.

[0031] In some aspects, the technology described herein relates to a delivery system, wherein the valve engagement portion comprises a plurality of engagement struts disposed proximally of the body portion when the heart valve is in a radially compressed configuration and disposed along the body portion when the heart valve is in a radially expanded configuration.

[0032] In some aspects, the technology described herein relates to a method of loading a cardiac prosthesis into a delivery system, comprising: positioning a proximal end of the cardiac prosthesis adjacent a prosthesis retaining member of a delivery device; rotating a tubular loading member at a distal region of the delivery device to align a notch at the distal end of the tubular loading member with a first prosthesis retaining region of a plurality of prosthesis retaining regions; inserting a first prosthesis engaging portion of the cardiac prosthesis through the notch and into the first prosthesis retaining region of the plurality of prosthesis retaining regions; and rotating the tubular loading member to align the first prosthesis engaging portion of the cardiac prosthesis with the first prosthesis retaining region of the plurality of prosthesis retaining regions. aligning the notch with a second prosthesis holding area of ​​the plurality of prosthesis holding areas; inserting a second enlarged holding portion of the cardiac prosthesis through the notch and into the second prosthesis holding area of ​​the plurality of prosthesis holding areas; further rotating the tubular loading member to align the notch with a further holding area of ​​the plurality of prosthesis holding areas and positioning the further enlarged holding portion of the cardiac prosthesis in the corresponding holding area of ​​the plurality of prosthesis holding areas; and covering the notch to prevent radial expansion of the cardiac prosthesis.

[0033] In some aspects, the technology described herein relates to a method, wherein the tubular loading member is a prosthetic loading tool that is removable from the delivery device or a first tubular member that is not removable from the delivery device.

[0034] In some aspects, the technology described herein relates to a method, wherein covering the cardiac prosthesis comprises placing a notch-covering member 134 in the notch.

[0035] In some aspects, the technology described herein relates to a method, wherein placing a spacer in the notch comprises inserting a ridge on an inner surface of the spacer into the notch.

[0036] In some aspects, the technology described herein relates to a method, wherein covering the cardiac prosthesis comprises retracting the prosthesis retention member and the cardiac prosthesis back into the first tubular member of the delivery device.

[0037] In some aspects, the techniques described herein relate to a method, further comprising removing the prosthetic loading tool and the notch covering member.

[0038] In some aspects, the technology described herein relates to a method, comprising passing the proximal end of the cardiac prosthesis through a funnel member disposed at a distal end of the prosthesis loading tool.

[0039] In some aspects, the technology described herein relates to a method, wherein retracting the prosthesis retaining member and the cardiac prosthesis back into the first tubular member of the delivery device further includes rotating a first portion of a handle connected to a proximal end of the first tubular member. [Brief explanation of the drawings]

[0040] The following figures are included to illustrate certain exemplary aspects of the present disclosure and should not be considered exclusive or limiting. The subject matter of the present disclosure is capable of significant modification, alteration, combination, or equivalent in form and function to those skilled in the art based on the contents of the present disclosure. The present disclosure refers to the following drawings:

[0041] [Figure 1] FIG. 1 is a side view of a prosthesis delivery device.

[0042] [Figure 2] FIG. 2 is a side view of the prosthesis delivery device of claim 1.

[0043] [Figure 3] FIG. 3 is an enlarged view of area 3 in FIG.

[0044] [Figure 4] FIG. 4 is an enlarged view showing area 4 of FIG.

[0045] [Figure 5]FIG. 5 is an enlarged view of area 5 of FIG.

[0046] [Figure 6] FIG. 6 is an enlarged view of area 6 of FIG.

[0047] [Figure 7A] FIG. 7A is a diagram showing a prosthesis retention element. [Figure 7B] FIG. 7B shows a prosthesis retention element.

[0048] [Figure 8A] FIG. 8A is a diagram showing a funnel member. [Figure 8B] FIG. 8B is a diagram showing a funnel member.

[0049] [Figure 9A] FIG. 9A is a view showing a notch cover member. [Figure 9B] FIG. 9B is a view showing a notch cover member.

[0050] [Figure 10A] FIG. 10A shows a prosthetic loading tool. [Figure 10B] FIG. 10B shows a prosthetic loading tool.

[0051] [Figure 11] FIG. 11 is a diagram illustrating the distal end of the delivery device of FIG.

[0052] [Figure 12] FIG. 12 is a diagram illustrating the distal end of the delivery device of FIG.

[0053] [Figure 13] FIG. 13 is a diagram illustrating the distal end of the delivery device of FIG.

[0054] [Figure 14] FIG. 14 is a diagram illustrating the distal end of the delivery device of FIG.

[0055] [Figure 15] FIG. 15 is a diagram illustrating the distal end of the delivery device of FIG.

[0056] [Figure 16] FIG. 16 is a diagram illustrating the distal end of the delivery device of FIG.

[0057] [Figure 17] FIG. 17 is a diagram illustrating the distal end of the delivery device of FIG.

[0058] [Figure 18] FIG. 18 illustrates the distal end of the prosthesis delivery device.

[0059] [Figure 19] FIG. 19 is a perspective view of a prosthetic heart valve.

[0060] [Figure 20] FIG. 20 is a diagram showing the prosthetic heart valve of FIG.

[0061] [Figure 21] FIG. 21 is a side view of the prosthetic heart valve of FIG.

[0062] [Figure 22] 22 is a bottom view of the prosthetic heart valve of FIG. 19. FIG.

[0063] [Figure 23] FIG. 23 is a top view of the prosthetic heart valve of FIG.

[0064] [Figure 24] FIG. 24 is a cross-sectional view showing the prosthetic heart valve of FIG.

[0065] [Figure 25] FIG. 25 is a cross-sectional view showing the prosthetic heart valve of FIG.

[0066] [Figure 26] FIG. 26 is an enlarged view of the prosthetic heart valve of FIG.

[0067] [Figure 27] FIG. 27 is an enlarged view of the prosthetic heart valve of FIG.

[0068] [Figure 28] FIG. 28 is an enlarged view of the prosthetic heart valve of FIG.

[0069] [Figure 29] FIG. 29 is an enlarged view of the prosthetic heart valve of FIG.

[0070] [Figure 30] 30 is a perspective view showing the framework of the prosthetic heart valve of FIG. 19. FIG.

[0071] [Figure 31] 31 is a side view showing the framework of the prosthetic heart valve of FIG. 19. FIG.

[0072] [Figure 32] 32 is a side view showing the framework of the prosthetic heart valve of FIG. 19. FIG.

[0073] [Figure 33] 33 is a top view of the framework of the prosthetic heart valve of FIG. 19. FIG.

[0074] [Figure 34] 34 is a bottom view of the framework of the prosthetic heart valve of FIG. 19. FIG.

[0075] [Figure 35] FIG. 35 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0076] [Figure 36]FIG. 36 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0077] [Figure 37] FIG. 37 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0078] [Figure 38] FIG. 38 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0079] [Figure 39] FIG. 39 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0080] [Figure 40] 40 is a cross-sectional view showing the framework of the prosthetic heart valve of FIG. 19. FIG.

[0081] [Figure 41] FIG. 41 is a simplified diagram illustrating some components of the prosthetic heart valve of FIG.

[0082] [Figure 42] FIG. 42 shows the prosthetic heart valve of FIG. 19 with valve leaflets.

[0083] [Figure 43] FIG. 43 is a side view of the prosthetic heart valve of FIG. 19 placed within a native heart valve.

[0084] [Figure 44] FIG. 44 is a side view of the prosthetic heart valve of FIG. 19 placed within a native heart valve.

[0085] [Figure 45] FIG. 45 is a side view of the prosthetic heart valve of FIG. 19 placed within a native heart valve. Detailed Description

[0086] Those skilled in the art will recognize that the present disclosure is not limited to what has been particularly shown and described herein. Various modifications and variations are possible in light of the teachings herein without departing from the scope, spirit, or intent thereof.

[0087] Although different embodiments may be described herein, it is specifically contemplated that any features from these different embodiments can be used and used together in any combination. In other words, features from different embodiments can be mixed and matched with each other. Thus, while not all combinations of features from different embodiments are explicitly set forth, the intent of this disclosure is to encompass such combinations, particularly as would be understood by one of ordinary skill in the art.

[0088] The terms used in this disclosure should be interpreted broadly and are not intended to be interpreted in a limiting sense. The same elements are numbered the same in the figures. Unless otherwise specified, all accompanying drawings are not to scale. Unless otherwise specified, the term "about" is defined to mean plus or minus 5% of the stated value.

[0089] The terms distal or distally generally refer to the direction of the tip of the device within the patient (e.g., away from the physician / clinician), while the terms proximal or proximal refer to the direction of the end of the device that remains outside the patient (e.g., toward or near the physician / clinician or the handle / hub of the device).

[0090] The present disclosure generally relates to a delivery device for a cardiac prosthesis. For example, the cardiac prosthesis may include a prosthetic heart valve, a heart valve reconstruction device such as an annuloplasty ring, or similar device delivered into a heart valve. In the example of a prosthetic heart valve, these may be used to replace a human's native heart valve (e.g., aortic, mitral, pulmonary, or tricuspid valve), but may be particularly useful for replacing the mitral or tricuspid valve. Furthermore, the delivery device of the present disclosure may be used for devices intended for use in locations other than the heart, such as vascular stents.

[0091] Generally, the prosthetic heart valves described in this disclosure include a support structure that supports the prosthetic valve leaflets or similar mechanisms that allow blood to flow in only one direction through the prosthetic heart valve. It should be understood that the use of leaflets or similar structures in combination with a support structure is specifically contemplated. In other words, while portions of this disclosure describe aspects of a prosthetic valve support structure, the entire prosthetic valve is specifically included as part of this embodiment.

[0092] When referring to prosthetic valves and support structures herein, the terms "superior end," "inflow end," and similar expressions may be used interchangeably to refer to the end of a device from which blood normally enters the valve or device. For example, with respect to a tricuspid valve, the end of the device is located in or near the right atrium. The terms "inferior end," "outflow end," and similar expressions may be used interchangeably to refer to the end of a device from which blood normally exits the valve or device. For example, with respect to a tricuspid valve, the end of the device is located in or near the right ventricle. Additionally, prosthetic valves and support structures herein may be referred to as having a proximal end / portion and a distal end / portion in the context of a delivery device / catheter. Generally, the term "proximal" refers to the portion or direction along the delivery device that is closer to the physician, and "distal" refers to the portion or direction along the delivery device that is further away from the physician. In some examples described herein, the upper or inflow end of the support structure may be the proximal end, and the lower or outflow end of the support structure may be the distal end.

[0093] Similarly, when referring to a delivery system or device, the terms distal or distally generally refer to the direction of the tip of the device within the patient (e.g., away from the physician / clinician), and the terms proximal or proximal refer to the direction of the end of the device that remains outside the patient (e.g., toward or near the physician / clinician or the handle / hub of the device).

[0094] The present disclosure generally relates to a delivery system for a cardiac prosthesis, such as a prosthetic heart valve. The disclosure also generally relates to a method for loading a cardiac prosthesis into a delivery system and a method for delivering a cardiac prosthesis. The delivery system may allow for easier loading of the cardiac prosthesis into the delivery system prior to a procedure and for better positioning and deployment of the cardiac prosthesis within a patient's heart.

[0095] The delivery system may include a first tubular portion and a prosthesis retention element located within the lumen of the first tubular portion and proximate a distal region of the first tubular portion. The prosthesis retention element may include a retainer having multiple prosthesis retention areas within which or on which portions of the cardiac prosthesis may be positioned. The prosthesis retention element may be movable relative to the first tubular portion and configured to prevent release of the cardiac prosthesis (e.g., by radial expansion) when the prosthesis retention element is located within the first tubular portion.

[0096] The prosthesis retention element may have a solid shape, a solid shape with a through-passage, or a tubular shape. The multiple prosthesis retention regions may be arranged around a diameter perpendicular to the longitudinal axis of the delivery device. The multiple prosthesis retention regions may include depressions or recesses, raised surfaces such as walls, struts, protrusions, longitudinally-oriented grooves, or any combination thereof, or similar structures. The multiple prosthesis retention regions may be equally or unevenly spaced from one another. In one specific example, the multiple prosthesis retention regions are recesses having a mating shape corresponding to the distal engagement members of the cardiac prosthesis. In another specific example, the prosthesis retention regions are recesses having struts that fit into engagement holes in the engagement members of the cardiac prosthesis. The engagement members of the cardiac prosthesis may include regions of increased width, increased height, regions with openings such as engagement holes, curved / bent regions such as hooks or waves, or any combination of these features.

[0097] The cardiac prosthesis may be loaded onto the delivery device via a rotationally positionable notch over one of the prosthesis-retaining areas of the prosthesis-retaining member, leaving the remaining prosthesis-retaining areas covered (Note: the notch may include a groove, opening, passageway, or similar structure). This may be accomplished using a removable prosthesis loading tool or via structure built into the delivery device itself.

[0098] In one embodiment, the prosthesis loading tool may have a generally tubular shape with a notch at the distal edge of the tubular shape. The notch may extend completely through the wall of the tubular shape or may form an opening or passageway from a radially outer location into the lumen of the tubular shape. The notch may be wide enough to allow the engagement members of the cardiac prosthesis to pass through. The notch may have a generally uniform width, may increase or decrease in width between its proximal and distal ends, or may form various shapes (e.g., a distally expanding shape, a distally narrowing shape, a distally expanding and then narrowing shape, a distally narrowing and then expanding shape, a circular shape, a triangular shape, a rectangular shape, a square shape, a combination of a rectangular shape and a circular shape, or any combination of these and similar shapes). The prosthesis loading tool may be rotatable around the prosthesis retention member so that each engagement member of the cardiac prosthesis can be engaged with the prosthesis retention region.

[0099] In another embodiment, the first tube of the delivery device may include a notch as described above. The first tube may move longitudinally relative to the prosthesis retention member and rotate relative to the prosthesis retention member (or the distal portion of the first tube may rotate relative to the proximal portion of the first tube). In this respect, the first tube of the delivery device may function similarly to a prosthesis loader, but may otherwise be integrally incorporated into the delivery device itself. In one embodiment, the outer tube is movable proximally and distally relative to the prosthesis retention member, either via longitudinal manual movement or via a movement mechanism in the proximal handle of the delivery device. Alternatively, the prosthesis retention member may be movable relative to the first tube, either via longitudinal manual movement or via a movement mechanism in the proximal handle of the delivery device.

[0100] The prosthesis loading device or the first tube portion having the notch may further include a removable engagement member that can be positioned over the notch after the cardiac prosthesis is fully positioned on the prosthesis retention member, thereby preventing the engagement member of the cardiac prosthesis from disengaging and radially expanding from the prosthesis retention region of the prosthesis retention member. The removable engagement member may have a tube portion or C-clip sized to be positionable over the notch, and the removable engagement member may have a ridge or raised surface on its inner surface that mates with the notch.

[0101] The prosthesis loading device or the first tubular portion having the notch may further include a funnel member that may be positioned at the distal portion of the prosthesis loading device or the first tubular portion having the notch, and this funnel member may assist in allowing the cardiac prosthesis to be pulled proximally back into the delivery device after the engagement members of the cardiac prosthesis engage with the multiple prosthesis retaining members.

[0102] The delivery device may include a nosecone that is longitudinally movable proximally and distally relative to the prosthesis retention member and the first tubular member. In the loading configuration, the nosecone may be spaced distally from the first tubular member and the prosthesis retention member. After the cardiac prosthesis is retained by the prosthesis retention member and covered by the first tubular member, the nosecone may transition to a delivery configuration in which the nosecone abuts or is directly adjacent to the distal end of the first tubular member and the distal end of the cardiac prosthesis. The nosecone is connected and movable via an elongate shaft or tubular member that extends to the proximal end of the delivery device.

[0103] The delivery device may further comprise a second tube forming an outer tube of the delivery device and disposed around at least a majority of the first tube. In one embodiment, the second tube is connected to the proximal handle and fixed for longitudinal movement relative to the handle, the first tube is connected to the proximal handle and longitudinally movable by a movement mechanism of the handle, and a shaft connected to the nosecone is connected to the handle and longitudinally movable relative to the handle.

[0104] 1-18 illustrate various embodiments of an exemplary delivery system 100 and delivery device 100′ for a cardiac prosthesis. In these figures, the cardiac prosthesis is depicted and described as a prosthetic heart valve 150. However, other types of cardiac prostheses are possible, such as an annuloplasty ring, a stent, or similar devices. As discussed in more detail below, the prosthetic heart valve 150 engages with a prosthesis retention element 116, which can be loaded using a prosthesis loading tool 136 having a notch 162A or a distal tubular portion 108A having a notch 108C that accommodates an engagement element (such as an engagement hole 162A) on the prosthetic heart valve 150. Generally, the prosthesis loading device 136 having the distal region 136A or the distal tubular portion 108A having the notch 108C are also generally referred to as tubular loading members, since both have a generally tubular shape and can be used to load the prosthetic heart valve 150.

[0105] 1-17, Figure 1 shows a side view of a delivery device 100. Generally, the delivery device 100 has an elongate body assembly 102 having a length sufficient to reach a target site within the human body, such as a human heart valve. As described further below, a prosthetic heart valve 150 may be loaded into the elongate body assembly 102 and deployed.

[0106] Delivery device 100 may include a handle assembly 104 that controls longitudinal movement of one or more components of elongate body assembly 102 and is connected to the proximal end of the handle assembly.

[0107] 2 shows a side view of the delivery device 100 during the procedure of loading the prosthetic heart valve 150 into the elongate body assembly 102. In this example, the prosthesis loading tool 136, the notch cover member 134, and the funnel member 132 are removably positioned at or near the distal or end of the elongate body assembly 102 and are used to load the prosthetic heart valve 150 as described below.

[0108] 3 shows a cross-sectional view of the distal portion (area 3 in FIG. 1 ) of the elongate body assembly 102. The distal portion may include a prosthesis retention member 116 to which a prosthetic heart valve 150 is engaged along with the first tubular member 108. In this embodiment, the first tubular member 108 is longitudinally movable while the prosthesis retention member 116 remains in position relative to the handle assembly 104. However, the prosthesis retention member 116 may also be configured to be longitudinally movable while the first tubular member 108 remains in position relative to the handle assembly 104.

[0109] In this embodiment, the first tubular member 108 may be comprised of a distal tubular portion 108A connected to the distal end of a proximal tubular portion 108B. The distal tubular portion 108A may be comprised of a more rigid material, such as a biocompatible metal (e.g., stainless steel, nitinol, a rigid polymer, etc.), and may have a length that completely or at least partially covers the prosthetic heart valve 150 when it is retracted into the distal tubular portion 108A. The proximal tubular portion 108B may be comprised of a relatively flexible polymer (e.g., solid or braided polyurethane), and may have a length that is flexible enough to allow it to pass through tortuous pathways in the body, such as the human heart. Thus, the first tubular member 108 may have both rigidity characteristics to maintain the prosthetic heart valve 150 in a compressed state and flexibility characteristics that allow the elongate body assembly 102 to easily pass through the patient's vasculature.

[0110] Alternatively, instead of two separate attached sections, the first tubular member 108 may be a single, integral tubular structure. The integral tubular structure may be uniform and consistent throughout its length, or may have varying structures along its length to achieve different flexibility. In one embodiment, the first tubular member 108 may be constructed from a polymeric tube (e.g., polyurethane) and may incorporate reinforcement at one or more locations. For example, along the distal region of the first tubular member, the polymeric tube may have braided wire, coiled wire, or similar structures attached or embedded therein to partially or completely cover the prosthetic heart valve 150 when the prosthetic heart valve 150 is fully retracted into the first tubular member 108.

[0111] The prosthesis retention member 116 may be connected to the handle assembly 104 via a tube or shaft. In this example, a second tubular member 114 is connected to the prosthesis retention member 116 and the handle assembly 104. The second tubular member 114 may include an inner tubular layer 114A connected to the distal end of the prosthesis retention member 116 and an outer tubular layer 114B connected to the proximal end of the prosthesis retention member 116 (or vice versa), although the second tubular member 114 may be a single tubular layer connected to either the distal or proximal end of the prosthesis retention member 116.

[0112] The delivery device 100 may include a nosecone 112 that may be positioned distal to the prosthesis retention member 116 and the first tubular member 108, for example, via a shaft 110. The shaft 110 is longitudinally movable from the proximal end of the delivery device 100, allowing the nosecone 112 to be moved distally or proximally. The nosecone 112 may contribute to a gradual or tapered distal end of the delivery device 100 and may also contribute to retaining the prosthetic heart valve 150 within the first tubular member 108. The nosecone 112 may be constructed of various materials, such as braided polyimide or other polymers. The nosecone 112 may have a shape that increases in diameter from its distal end. The nosecone 112 may narrow only along its proximal portion and have a generally bulbous shape, as shown in FIG. 3.

[0113] The elongate body assembly 102 may further include a third tubular member 106 that forms an outer tube or layer on the elongate body assembly 102, and the first tubular member 108, the second tubular member 114, and the shaft 110 may be at least partially disposed within the third tubular member 106. In this example, the third tubular member 106 is connected to the handle assembly 104 and extends to a position proximal to the distal tubular portion 108A when the first tubular member 108 extends over the prosthesis retention member 116. This arrangement allows the first tubular member 108 to be retracted proximally to expose and deploy the prosthetic heart valve 150 during use.

[0114] FIG. 5 is a cross-sectional view of area 5 of FIG. 2, showing an intermediate region of the elongate body assembly 102 including a third tubular member 106 forming an outer tubular layer, a proximal tubular portion 108B forming an inner tubular layer, a second tubular member 114 forming the inner tubular layer within the proximal tubular portion 108B, and a shaft 110 disposed within the second tubular member 114.

[0115] Figure 6 shows a cross-sectional view of the handle assembly 104 at area 6 in Figure 2. The handle assembly 104 may include an outer handle housing 120 that at least partially encloses the third tubular member 106, the proximal tubular portion 108B, the second tubular member 114, and the shaft 110.

[0116] As previously described, the first tubular member 108 may be moved longitudinally proximally and distally relative to the elongate body assembly 102 to load the prosthetic heart valve 150 and release the prosthetic heart valve 150 upon delivery to the target site (e.g., a heart valve). The first tubular member 108 may be moved via a movement mechanism within the elongate body assembly 102. In one embodiment, the movement mechanism includes an outer tubular portion 122 (e.g., a tubular knob, a tubular dial, or a tubular thumbwheel), which may have an internally threaded surface. The first nut member 126 is located within the lumen of the outer tubular portion 122 and has an externally threaded surface that mates with the internally threaded surface of the outer tubular portion 122. The nut member 126 is also secured to the first tubular member 108. In this regard, when the outer tube 122 is rotated by the user, the first nut member 126 moves proximally or distally within the handle assembly 104, thereby moving the first tubular member 108 relative to the handle assembly 104 and other components of the delivery device 100. In another embodiment, the first nut member 126 may also be connected to the second tubular member 114 and may cause the prosthesis retaining member 116 to move longitudinally relative to the first tubular member 108.

[0117] A third tubular member 106 may be secured to the outer handle housing 120, forming an outer layer of the elongate body assembly 102. For example, the third tubular member 106 may be connected to a second nut member 124 that is maintained in a predetermined position relative to the outer handle housing 120, thereby maintaining the third tubular member 106 in the same position relative to the outer handle housing 120. In another example, the third tubular member 106 may be directly connected to the outer handle housing 120 (e.g., by adhesive).

[0118] The second tubular member 114 may be connected to the prosthesis retaining member 116 and secured to the outer handle housing 120. For example, the second tubular member 114 may be connected to a third nut 128 that is maintained in position relative to the outer handle housing 120, thereby maintaining the second tubular member 114 in the same position relative to the third tubular member 106. In another example, the second tubular member 114 may be directly connected to the outer handle housing 120 (e.g., by adhesive).

[0119] A shaft 110, which is connected to a nosecone 112, may also be supported by the handle assembly 104. In one embodiment, the shaft 110 extends through an outer handle housing 120 and a clamp valve 118 (e.g., a Touhy-Borst valve having a nut that clamps or blocks a passageway when the nut is tightened). In this manner, the clamp valve 118 can be tightened or loosened to prevent or allow movement of the shaft 110, respectively.

[0120] The handle assembly 104 may further include one or more (e.g., one, two, three, four) luer fittings 130 that provide fluid communication to various tubing portions of the handle assembly 104 and / or elongated body assembly 102.

[0121] 7A and 7B show enlarged views of the prosthesis retention element 116 connected to the distal portion of the second tubular member 114. The prosthesis retention element 116 may include an at least partially cylindrical body member. The cylindrical shape may have a plurality of prosthesis retention areas 116A disposed around the outer surface of the cylindrical portion. The plurality of prosthesis retention areas 116A may have shapes that engage with the prosthesis engagement portions 162A of the prosthetic heart valve 150. For example, the plurality of prosthesis retention areas 116A may have recesses, grooves, openings, channels, walls, ridges, struts, shafts, or similar shapes that, when engaged, prevent the prosthesis engagement portions 162A from disengaging longitudinally from the prosthesis retention element 116 while allowing radial expansion of the prosthesis 150 to disengage the prosthesis engagement portions 162A from the plurality of prosthesis retention areas 116A.

[0122] The prosthesis retention member 116 may also have a proximal conical surface 116B and a passageway 116C extending axially through the prosthesis retention member 116 through which the second tubular member 114 and shaft 110 pass.

[0123] In this embodiment, the prosthesis engagement portion 162A may be a region near the proximal end of the prosthetic heart valve 150 that expands to form a generally circular shape. This generally circular shape may include an opening or engagement hole. The multiple prosthesis retention regions 116A may have a similar mating shape, with a narrower region distally and a wider, more rounded region proximally. In this regard, one of the prosthesis engagement portions 162A may be radially compressed toward one of the prosthesis retention regions 116A, and the engaged prosthesis engagement portion 162A is prevented from radially expanding, thereby preventing longitudinal movement relative to the prosthesis retention element 116.

[0124] As previously mentioned, there are several possible mechanisms and / or techniques for loading the prosthetic heart valve 150 into the prosthesis retention member 116. First, there is the use of a prosthesis loading tool 136, best shown in Figures 2, 10A, and 10B. The prosthesis loading tool 136 may have a tubular structure with a distal region 136A that includes a notch 136B. The notch 136B may extend completely through the wall of the tubular structure, or a radially outer region of the tubular structure may be connected and communicate with the lumen of the tubular structure. Although the term notch 136B is used, this feature may also be a groove, opening, or aperture.

[0125] The notch 136B may have a shape that allows the prosthesis engagement portion 162A to pass radially from the outside of the tubular structure to the inside of the tubular structure and be positioned in multiple prosthesis retention areas 116A. For example, the notch 136B may be generally rectangular or U-shaped with a width greater than the maximum width of the prosthesis engagement portion 162A. In another embodiment, the notch 136B may have a shape similar to the rectangular shape of the prosthesis retention area 116A and the shape of the prosthesis engagement portion 162A, with a larger, more rounded proximal shape, resulting in an overall wider width that allows the prosthesis engagement portion 162A to pass through the notch 136B. The notch 136B may also extend from the distal edge of the tubular structure. In one embodiment, the prosthesis loader 136 may have only one notch 136B. In another embodiment, the prosthesis loading device 136 may include multiple notches 136B, such as two, three, four, five, six, seven, eight, or more notches 136B. Alternatively, the prosthesis loading device 136 may have an open tubular structure, such as a C-shaped cross-section, with an open groove extending along its entire length. In such an embodiment, the open groove may take the place of the notch 136B.

[0126] The prosthesis loading tool 136 may optionally have a reduced diameter region to aid in connecting the funnel member 132 and the notch cover member 134. The funnel member 132, best shown in FIGS. 2, 8A, and 8B, has a funnel portion 132A that increases in diameter distally and a flange portion 132B located proximal to the funnel portion 132A. The funnel member 132 may be located at the distal region 136A of the prosthesis loading tool 136 and may be used to assist in loading or guiding the prosthetic heart valve 150 into the delivery device 100, as described below. In another embodiment, the funnel member 132 may be an integral part of the prosthesis loading tool 136. In another embodiment, the funnel member 132 may not be used during the procedure.

[0127] The notch cover member 134, best shown in FIGS. 2, 9A, and 9B, may have a body portion 134A and a ridge portion 134B. The body portion 134A may have a C-shape or a tubular shape that sandwiches the distal region 136A of the prosthesis loading device 136. The ridge portion 134B may be shaped to protrude from the inner surface of the body portion 134A and sized to fit into the notch 136B of the prosthesis loading device 136. In this regard, the notch cover member 134 may be positioned over the distal region 136A after the prosthesis engaging portions 162A have engaged with the plurality of prosthesis retaining regions 116A, such that the ridge portion 134B can block the notch 136B and prevent any of the prosthesis engaging portions 162A from moving radially out of the notch 136B.

[0128] 11 illustrates an initial step in the process of loading a prosthetic heart valve 150 into the delivery device 100. First, the prosthesis loading tool 136 may be positioned over or around the nosecone 112 and shaft 110 and moved proximally to cover the distal tubular portion 108A and abut the third tubular member 106 (although the prosthesis loading tool 136 may be positioned at other proximal or distal locations). If a funnel member 132 is used, the funnel member 132 may be positioned at a distal region 136A of the prosthesis loading tool 136. The distal edge of the distal region 136A of the prosthesis loading tool 136 may be positioned adjacent to the prosthesis retention member 116 so that the notch 136B aligns with any one of the multiple prosthesis retention areas 116A.

[0129] The prosthetic heart valve 150 is then placed over or around the nosecone 112 and shaft 110 and moved proximally so that its prosthesis engagement portion 162A is positioned adjacent the notch 136B and the prosthesis retention member 116. Note that for clarity, only the support structure of the prosthetic heart valve 150 is shown, although other components of the prosthetic heart valve 150 may be included as described later in this specification.

[0130] 12 and 13 show enlarged views of the notch 136B. The notch 136B is first rotatably positioned over one of the plurality of prosthesis holding areas 116A, and one of the prosthesis engaging portions 162A is radially pressed through the notch 136B into the prosthesis holding area 116A. Next, the prosthesis loader 136 is rotated so that the distal region 136A is positioned over an adjacent, empty plurality of prosthesis holding areas 116A, and another prosthesis engaging portion 162A is radially pressed through the notch 136B into the plurality of prosthesis holding areas 116A. This process is continued until all of the prosthesis engaging portions 162A are positioned in the plurality of prosthesis holding areas 116A, maintaining the prosthetic heart valve 150 in a radially compressed shape as shown in FIG. 14.

[0131] As shown in Figures 15 and 16, the funnel member 132 may be moved distally and the notch cover member 134 may be positioned in the distal region 136A of the prosthesis loading device 136 so that the protrusion portion 134B shields or fills the notch 136B, thereby preventing the prosthesis engagement portion 162A from disengaging from the notch 136B.

[0132] The first tubular member 108 may then be advanced distally, such as by rotating the outer tubular portion 122 of the handle assembly 104, until the first tubular member 108 (e.g., distal tubular portion 108A) completely covers the prosthetic heart valve 150. The first tubular member 108 may be moved further distally until it reaches the nosecone 112, or the shaft 110 and nosecone 112 may be moved proximally until they abut the first tubular member 108 (e.g., 108A), as shown in FIG. 17. At this point, the prosthetic heart valve 150 may be considered loaded into the delivery device 100 and ready for use within a patient.

[0133] Although the present embodiment uses the funnel member 132 and the notch cover member 134, the prosthetic heart valve 150 may be loaded without using these components. For example, after using the prosthesis loading tool 136 to load the prosthesis engaging portion 162A into the plurality of prosthesis holding areas 116A, the notch 136B is rotated to a position between two of the plurality of prosthesis holding areas 116A to prevent the prosthesis engaging portion 162A from being released from the prosthesis loading tool 136. Next, the first tubular member 108 (e.g., the distal tubular portion 108A) may be advanced distally to cover the prosthetic heart valve 150 as described above.

[0134] In this embodiment, the prosthesis loading tool 136 is illustrated with a single notch 136B. However, two or more notches 136B may be included. For example, two notches 136B may be located at opposite positions in the distal region 136A. Alternatively, multiple notches 136B may be included. In one embodiment, the distal region 136A may include notches 136B corresponding to all of the multiple prosthesis holding regions 116A, allowing a user to simultaneously load all of the prosthesis engagement portions 162A. Similarly, the notch cover member 134 may have a ridge 134B for each of the multiple notches 136B.

[0135] The delivery device may be loaded in a similar manner without the use of the prosthesis loading tool 136. For example, FIG. 18 shows a delivery device 100′ that is the same as the delivery device 100 described above, except that the distal tubular portion 108A itself may have a notch 108C similar to the notch 136B described above. Furthermore, the distal tubular portion 108A may be rotated relative to the proximal tubular portion 108B. Thus, a user may rotate the distal tubular portion 108A to position the prosthesis engagement portion 162A within the prosthesis holding region 116A. The notch 108C may then be rotated to a position between two of the multiple prosthesis holding regions 116A and locked against rotation in that position (e.g., by a locking pin, longitudinal locking position, or similar locking mechanism). Again, a single notch 108C may be included, or multiple notches 108C may be included.

[0136] 19-29 illustrate various aspects of an exemplary prosthetic heart valve 150 that may be used with the delivery device 100 or delivery device 100' described above. Note that in some figures herein, only the underlying support structure of the prosthetic heart valve 150 is shown, and in some cases the prosthetic heart valve 150 may be referred to as the support structure. As best shown in FIG. 19, the prosthetic heart valve 150 generally includes a body portion 160, an atrial flange portion 156, and a valve engagement portion 158.

[0137] In this embodiment, the body portion 160 is generally cylindrical in shape, although other shapes are possible, such as an hourglass shape, a cone shape, a concave shape, or a convex shape.

[0138] In this embodiment, the atrial flange portion 156 extends radially outward from the upper or inflow end of the body portion 160. The atrial flange portion 156 may extend beyond the body portion 160 to form a complete circular or annular shape, or may alternatively have other shapes, such as an oval shape, and may extend only partially around the circumference of the body portion 160 (e.g., opposing flange regions). As best shown in FIG. 19 , the atrial flange portion 156 generally forms a multiple-petal, pointed, or outwardly tapering shape, with the width of each of these regions decreasing with increasing distance from the body portion 160.

[0139] In this embodiment, the atrial flange 156 may have at least two regions with different angles relative to one another, as best seen in the cross-sectional view of FIG. 19 . The first region initially extends radially outward away from the inflow end of the body portion 160. With respect to an axis through the internal passageway of the support structure, the first region may have an angle in the range of about 70 degrees to 140 degrees (e.g., about 120 degrees). The second region extends radially from the first region and may have an angle in the range of about 150 degrees to 220 degrees (e.g., about 200 degrees). Generally, these two regions of the atrial flange portion 156 may contribute to conforming to the native annulus superior / inflow surface as well as the atrial wall, other atrial regions, or the valve leaflets / annulus.

[0140] In this embodiment, the leaflet engagement portion 158 may include a plurality of engagement struts 164 connected to the outflow end of the body portion 160 and extending in the inflow or upward direction. As described in further detail below, the engagement struts 164 curve generally parallel to the body portion 160 and then curve away from the body portion 160, terminating in an enlarged portion 164A ( FIG. 20 ). The initial curve toward the body portion 160 may contribute to engaging or capturing the body portion 160 with the native valve leaflets. The enlarged portion 164A may be generally rounded to prevent damage to the patient's valve tissue and may further include one or more openings that can be used, if desired, to temporarily engage the prosthetic heart valve 150 with the delivery catheter 50.

[0141] In this embodiment, the engagement struts 164 are evenly spaced around the circumference of the body portion 160. Again, the struts 164 may be unevenly spaced, such as only on both sides of the body portion 160, or in locations that may help avoid chordae tendineae within the ventricle.

[0142] The prosthetic heart valve 150 of this embodiment includes a rigid framework 152 and a material covering 154 disposed on a portion of the framework 152. The material covering 154 is disposed on all or most of the inside and outside of a body portion 160 of the framework 152 (as best shown in FIGS. 28 and 29 ), and is also disposed on the outside of an atrial flange portion 156 of the framework 152. The engagement struts 164 remain generally uncovered by the material covering 154. As previously mentioned, other variations are possible, such as disposing the material covering 154 only on the inside, only on the outside, and / or on any combination of the portions 156, 158, and 160.

[0143] 28 and 29, the material covering 154 at the outflow end of the body portion 160 may form a petal-shaped, pointed, or triangular region 154A that generally matches the shape of the underlying framework 152 of the body portion 160. Alternatively, the outflow end of the body portion 160 may have a uniform circular edge.

[0144] Similarly, the edge of the material covering 154 at the inflow end of the body portion 160 may include one or more pointed or triangular-shaped, inset gaps, spaces, or recesses 154B. While the triangular regions 154A are shown immediately adjacent to each other, the recesses 154B may be less frequently spaced between relatively uniform edge regions. However, the inflow or outflow edges may take any combination of any of the disclosed patterns, or may have completely uniform, square edges. As also shown in FIG. 20, the material covering 154C may conform to the triangular or pointed petal shape of the atrial flange portion 156.

[0145] In this embodiment, material covering 154 may be attached by adhesive, sutures, combinations thereof, and similar mechanisms. Material covering 154 may be comprised of fabric material, EPTFE sheet, PET sheet, and similar materials described elsewhere herein. In addition to material covering 154, an additional material may be included on the underside of atrial flange portion 156, such as a hydrogel, to help form a better seal with the native annulus.

[0146] 30-41 show various aspects of the framework 152 in this embodiment. The main body 160 of the framework 152 is composed of a plurality of elongated vertical body supports 166B and a plurality of horizontal body supports 166A (best seen in the cross section of FIG. 41). The vertical body supports 166B extend generally parallel to an axis through the passage of the support structure (i.e., the axis from the inlet end to the outlet end), and the horizontal body supports 166A are arranged in a circle around this axis.

[0147] The vertical body columns 166B may be arranged to alternate between different heights or axial positions, such that a first vertical body column 166B has a first axial position and two adjacent vertical body columns 166B are arranged further in the inflow direction and closer to the inflow end than the other two adjacent columns. Thus, the vertical body columns 166B may form an alternating pattern.

[0148] The horizontal body struts 166A may form a V-shape or a relatively sharp angle toward the outflow direction, but may also be shaped to face the opposite direction. Each end of the horizontal body struts 166A is connected to a vertical body strut 166B, which passes directly through the center of the V-shape. The V-shape of the horizontal body struts 166A provides a bending point at the apex of the V, and the angle may increase or decrease depending on whether the prosthetic heart valve 150 is in a compressed or expanded configuration. In other words, the V-shape facilitates this radial compression and expansion. Alternatively, the horizontal body structure 166A may have other shapes that include multiple angles, such as a W-shape with two or more angles. In this embodiment, there are two rows of horizontal body struts 166A, but more rows may be present.

[0149] In one embodiment, body portion 160 of framework 152 has a length in the range of about 14 mm to about 18 mm and a radius in the range of about 27 mm to about 30 mm.

[0150] The atrial flange portion 156 of the framework 152 includes multiple flange struts 162. The shape of these flange struts 162 is best seen in FIGS. 33-41. The atrial flange portion 156 is arranged with alternating upper and lower radial struts 162C and 162D. Both struts 162C and 162D extend from a vertical body strut 166B. While both struts 162C and 162D may have similar shapes, sizes, and curvatures, the upper radial strut 162C is generally higher (i.e., closer to the inflow direction) than the lower radial strut 162D due to the elevation of the vertical body strut 166B (e.g., the V-shape or placement of the horizontal body strut 166A). In this example, the aperture 166C is positioned adjacent to the vertical body strut 166A and the upper radial strut 162D. This aperture 166C may be included as needed for use with delivery catheter 50.

[0151] 30 , each upper radial flange strut 162C forms a first angle 162E of approximately 90 degrees or more and 130 degrees or less, a relatively straight portion 162F having a length of approximately 3 mm or more and approximately 10 mm or less, a second angle 162G of approximately 20 degrees or more and approximately 150 degrees or less, and a prosthesis-engaging portion 162A (again, relative to the inflow / outflow axis of the prosthetic heart valve 150) having a length of approximately 1 mm or more and approximately 7 mm or less. Generally, the specific angles and sizes may vary slightly depending on the size of the patient's heart and valve. The prosthesis-engaging portion 162A may include an opening that can be used by the delivery catheter 50 to releasably retain the prosthetic heart valve 150 during deployment.

[0152] 35 and 36 , each lower radial flange strut 162D forms a first angle 162H of approximately 90 degrees or more and 150 degrees or less, a relatively straight portion 162I having a length of approximately 0 mm or more and approximately 5 mm or less, a second angle 162J of approximately 0 degrees or more and approximately 60 degrees or less, and a terminal portion 162K (again, relative to the inflow / outflow axis of the prosthetic heart valve 150) having a length of approximately 1 mm or more and approximately 7 mm or less. Generally, the specific angles and sizes may vary slightly depending on the size of the patient's heart and valve. The terminal portion 162K may include an opening that can be used by the delivery catheter 50 to releasably retain the prosthetic heart valve 150 during deployment.

[0153] The radially outer ends of each of the upper and lower radial struts 162C, 162D are connected to one another via one of the multiple outer radial struts 162B. Because the upper and lower radial struts 162C, 162D are positioned at different heights and distances from one another, the outer radial struts 162B tend to form a relatively triangular or petal shape that terminates at the prosthesis engagement portion 162A. Thus, the outer radial struts 162B may curve in multiple directions to accommodate differences in the positions of the upper and lower radial struts 162C, 162D.

[0154] The valve engagement portion 158 of the framework 152 includes a plurality of engagement struts 164, the shape of which is best shown in FIG. 35. Generally, the engagement struts 164 have straight portions 164B that are parallel to an axis through the passageway of the support structure (i.e., the axis from the inflow end to the outflow end). In other words, the engagement struts 164 are not angled toward the body portion 160 as in the conventional support structure 100, although such a configuration is possible. The engagement struts 164 are connected to the outflow ends of the vertical body struts 166B. From the vertical body strut 166B, the engagement strut 164 forms a first curved portion 164C that curves approximately 180 degrees (e.g., in a range of approximately 150 degrees to approximately 230 degrees), a first straight portion 164B having a length of approximately 3 mm to approximately 10 mm, a second curved portion 164D that curves approximately 90 degrees to approximately 150 degrees in the opposite direction from the first curved portion 164C, and an arc portion 164A having a length of approximately 2 mm to approximately 10 mm. While these curved portions are all generally formed in the same plane, additional curved portions (i.e., curves in multiple directions) that move portions of the engagement strut 164 out of a single plane are also possible. The arc portion 164A may include openings that can be used by the delivery catheter 50 to assist in releasably retaining the prosthetic heart valve 150 during deployment.

[0155] As mentioned above, the engagement posts 164 are not covered by the material cover 154 in this embodiment, but may be. Additionally, the engagement posts 164 may be coated or wrapped with a relatively soft material (e.g., a nonwoven fabric or an EPTFE layer). Additionally, the arcuate portions 164A of the engagement posts 164 may include a coating composed of similar materials described herein or other materials.

[0156] One notable aspect of the prosthetic heart valve 150 and framework 152 is the positional relationship of the atrial flange 156 to the engagement struts 164, which is most clearly shown in the simplified diagram of FIG. 41 and in FIG. 35. In the expanded configuration, the ends of the engagement struts 164 (i.e., part of the valve-engaging portion) are located more proximal, or further in the inflow direction, than the radially adjacent lower radial struts 162D of the atrial flange portion 156. In other words, the lower radial struts 162D on either side of each engagement strut 164 are curved axially distal, or further in the outflow direction, than the ends of the engagement struts 164. In one embodiment, the adjacent axial overlap is in the range of about 0.1 mm or more and about 10 mm or less.

[0157] This arrangement can be particularly useful in several respects. First, it forces the native valve leaflets and annulus to rest on the engagement struts 164 and then under the lower radial struts 162D, causing the leaflets / annulus to deform in an alternating or wavy pattern. Thus, the valve engagement portion 158 (i.e., engagement struts 164) and the atrial flange portion 156 (i.e., lower radial struts 162D) tend to pinch the leaflets / annulus, creating a paperclip effect. This design reduces regurgitation compared to conventional, defective native valves and may allow for better ventricular remodeling (e.g., reduction of dilated segments) as the body adapts. While some other replacement prosthetic valves may be relatively large, plug-like structures that rely on radial forces for anchoring and sealing, the superior sealing at the annulus of the present invention may allow the ventricle to recover better over time and potentially reduce in diameter without interference from the replacement valve.

[0158] Second, this configuration holds the material covering on the underside of the atrial flange portion taut around the top of the valve engaging portion, potentially providing good contact between the material covering and the valve leaflets and annulus, promoting sealing, healing, and even tissue infiltration.

[0159] Third, some of the lower radial struts 162D (e.g., 162H near the outflow end of the framework 152) may be positioned within the annulus of the native valve. Some of the lower radial struts 162D may be curved radially outward, which may further enhance the seal between the framework 152 and the native annulus and further restrict blood flow around the framework / valve.

[0160] The framework 152 of this example may be constructed as a single, unitary structure by laser cutting it from a shape-memory tube (e.g., nitinol tubing). Alternatively, one or more struts of the framework may be welded or otherwise joined to one another. Alternatively, some components may be separate from one another and connected only by other materials, such as a material cover 154 or other connecting mechanism. For example, the body portion 160, leaflet engagement portion 158, and / or atrial flange portion 156 may not be directly connected to one another in any combination. If a shape-memory material is used for the framework 152, the framework may be cut to the desired pattern and then heat-treated to impart the desired shape in the expanded configuration.

[0161] The prosthetic heart valve 150 may be deployed from the delivery device 100 or delivery device 100′. In this regard, the engagement struts 164 may start in a compressed shape within the delivery device 100 or delivery device 100′, with their ends (rounded, enlarged portions 164A) positioned distally from the body portion 160. As the prosthetic heart valve 150 is pushed out of the first tubular member 108 or the first tubular member 108 is pulled back from above the prosthetic heart valve 150, the engagement struts 164 extend radially outward from the delivery device 100 or delivery device 100′, and then, as the prosthetic heart valve 150 is further advanced or exposed, the engagement struts 164 bend back so that their rounded, enlarged ends 164A are positioned toward the inflow end of the body portion 160. In other words, as deployment progresses, the engagement struts 164 bend or invert radially rearward, allowing the body portion 160 to capture the native leaflets 14B and press them against the annulus 14A, as shown in FIG.

[0162] It should be noted that in the compressed configuration within the delivery device 100 or delivery device 100′, the prosthesis engagement portion 162A having the apertures is located at the proximal end of the compressed prosthetic heart valve 150, while the engagement struts 164 are constrained distally, with the arcuate portions 164A located at the most distal position of the delivery device 100 or delivery device 100′. In this regard, apertures are located at both the proximal and distal ends of the compressed configuration prosthetic heart valve 150. Additionally, the apertured portion 166C also includes apertures located midway through the length of the compressed configuration. These apertures may engage with structures on the delivery device 100 or delivery device 100′, such as struts, hooks, tethers, or similar structures to retain portions of the support structure until 150 is fully deployed.

[0163] As previously mentioned, while this specification primarily describes a prosthetic heart valve 150, it is specifically contemplated that a valve mechanism 170, such as a prosthetic or biological valve leaflet, may be mounted within the valve support mechanism, as shown in Figures 42 and 43.

[0164] 44 illustrates one approach to delivering the support structure 100 into the tricuspid valve 14 of the heart 10 by advancing a delivery catheter through the inferior vena cava 16 into the right atrium 18. In this manner, the support structure is delivered to the tricuspid valve 14 from the inflow end, i.e., the atrial side.

[0165] 45 illustrates another approach to delivering the support structure 100 to the mitral valve 12 by performing a transseptal procedure to allow the delivery catheter to pass through the septum between the right atrium 18 and the left atrium 20. This allows the support structure to be delivered to the mitral valve 12 from the inflow end, i.e., the atrial side.

Claims

1. 1. A delivery system for a cardiac prosthesis, comprising: a tubular loading member having a notch, the notch extending completely through the wall of the tubular loading member and located at a distal edge of the tubular loading member; a prosthesis retaining member disposed within the tubular loading member, the prosthesis retaining member having a plurality of prosthesis retaining regions configured to engage with a prosthesis engaging portion of a cardiac prosthesis; A delivery system wherein the tubular loading member and the prosthesis retaining member are longitudinally and rotationally movable relative to one another, and the cutout has a plurality of rotational positions that completely radially expose one of a plurality of prosthesis retaining areas while covering the remainder of the plurality of prosthesis retaining areas.

2. The delivery system of claim 1 , wherein the plurality of prosthesis retaining regions are circumferentially arranged around a body of the prosthesis retaining element.

3. The delivery system of claim 2 , wherein the notch is approximately the same size as or larger than each of the plurality of prosthesis-retaining areas.

4. The delivery system of claim 3 , wherein the notch has a width and shape that allows the prosthesis engagement portion to pass through the notch.

5. The delivery system of claim 1 , wherein the tubular loading member comprises a prosthetic loading device having a tubular structure, the tubular loading member being removable from the delivery system.

6. The delivery system of claim 5 , wherein the tubular loading member comprises a distal region that decreases in diameter relative to a proximal region.

7. The delivery system of claim 5 further comprising a funnel member removably connected to the tubular loading member.

8. The delivery system of claim 5 , further comprising a notch cover member removably disposed over the notch in the tubular loading member and at least partially around the tubular loading member.

9. 9. The delivery system of claim 8, wherein the notch cover member comprises a ridge disposed on an interior surface of the notch cover member and sized to fit within the notch of the prosthesis loading tool.

10. 10. The delivery system of claim 9, wherein the cutout cover member has an open tubular shape.

11. The delivery system of claim 5 , wherein the prosthesis engagement portion is an enlarged region on a proximal portion of the cardiac prosthesis.

12. 12. The delivery system of claim 11, wherein the enlarged area is an engagement hole.

13. The delivery system of claim 2 , wherein the plurality of prosthesis-retaining areas comprise recesses having rectangular shapes adjacent to each other in a circular fashion.

14. The delivery system of claim 2 , wherein the plurality of prosthesis-retaining areas comprise depressions, grooves, posts, walls, or combinations thereof.

15. 2. The delivery system of claim 1, wherein the tubular loading member has a first tubular member, the notch is located at a distal edge of the first tubular member, and the first tubular member is permanently secured to the delivery system.

16. The delivery system of claim 1 , comprising a first tubular member longitudinally movable relative to the prosthesis retention member.

17. 17. The delivery system of claim 16, further comprising a second tubular member disposed within the lumen of the first tubular member and connected to the prosthesis retention member.

18. 20. The delivery system of claim 17, comprising a shaft disposed within the lumen of the second tubular member, a distal region of the shaft having a nosecone.

19. 20. The delivery system of claim 18, further comprising a third tubular member disposed about the first tubular member, the third tubular member forming an outer tube of the delivery system.

20. 20. The delivery system of claim 19, further comprising a handle assembly comprising a movement mechanism connected to the first tubular member that moves the first tubular member distally and proximally relative to the handle assembly.

21. 21. The delivery system of claim 20, wherein the movement mechanism comprises an outer tubular portion that rotates relative to an outer handle housing, an inner surface of the outer tubular portion engaging a nut via a threaded surface that moves the nut longitudinally as the outer tubular portion is rotated, the nut being connected to the first tubular member.

22. 22. The delivery system of claim 21, wherein the first outer tube portion comprises a distal tubular portion made of a stiff material and a proximal tubular portion made of a soft material.

23. 23. The delivery system of claim 22, wherein the cardiac prosthesis is a heart valve comprising an atrial flange portion, a valve engaging portion, and a body portion.

24. 24. The delivery system of claim 23, wherein the valve engaging portion comprises a plurality of engagement struts disposed proximally of the body portion when the heart valve is in a radially compressed configuration and disposed along the body portion when the heart valve is in a radially expanded configuration.

25. 1. A method of loading a cardiac prosthesis into a delivery system, comprising: positioning a proximal end of the cardiac prosthesis adjacent a prosthesis retention member of a delivery device; rotating a tubular loading member at a distal region of the delivery device to align a notch at a distal end of the tubular loading member with a first prosthesis retaining region of a plurality of prosthesis retaining regions; inserting a first prosthesis engagement portion of a cardiac prosthesis through the notch into the first prosthesis holding area of ​​the plurality of prosthesis holding areas; rotating the tubular loading member so that the notch is aligned with a second prosthesis retaining area of ​​the plurality of prosthesis retaining areas; inserting a second enlarged support portion of the cardiac prosthesis through the notch into the second prosthesis support region of the plurality of prosthesis support regions; further rotating the tubular loading member to align the notch with an additional holding area of ​​the plurality of prosthesis holding areas and position an additional enlarged holding portion of the cardiac prosthesis at the corresponding holding area of ​​the plurality of prosthesis holding areas; and covering the notch to prevent radial expansion of the cardiac prosthesis.

26. 26. The method of claim 25, wherein the tubular loading member is a prosthetic loading tool that is removable from the delivery device or a first tubular member that is not removable from the delivery device.

27. 27. The method of claim 26, wherein covering the cardiac prosthesis comprises placing a notch cover member 134 in the notch.

28. 28. The method of claim 27, wherein placing a spacer in the notch comprises inserting a ridge on an inner surface of the spacer into the notch.

29. 30. The method of claim 28, wherein covering the cardiac prosthesis comprises retracting the prosthesis retention member and the cardiac prosthesis back into the first tubular member of the delivery device.

30. 30. The method of claim 29, further comprising removing the prosthesis loading tool and the notch cover member.

31. 31. The method of claim 30, comprising threading the proximal end of the cardiac prosthesis through a funnel member disposed at a distal end of the prosthesis loading tool.

32. 32. The method of claim 31 , wherein retracting the prosthesis retention member and the cardiac prosthesis back into the first tubular member of the delivery device further comprises rotating a first portion of a handle connected to a proximal end of the first tubular member.

Images