Systems and methods for improving prosthetic valve deployment

Abstract

The present disclosure provides apparatus, systems, and methods for various devices such as prosthetic valves. Some examples relate to improvements in anchoring at a native heart valve, which may reduce trauma that may be caused to a treatment or implantation site. Compliance and flexibility anchoring features and methods are disclosed to reduce the forces withstood by a treatment or implantation site around the mitral or tricuspid leaflet, including heart tissue. Improved device deployment mechanisms, including power-on methods, are also disclosed.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 542,259, filed October 3, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Features of this disclosure relate to implants, including prosthetic valves for replacing the function of autologous heart valves. Background Technology

[0004] The human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, function essentially like one-way valves that work in sync with the pumping heart. Valves allow blood to flow downstream but prevent it from flowing upstream. Diseased heart valves exhibit damage, such as narrowing or backflow, which inhibits the valve's ability to control blood flow. Such damage reduces the heart's pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valvular insufficiency can cause conditions such as cardiac hypertrophy and ventricular dilation. Therefore, considerable effort has been devoted to developing methods and devices to repair or replace damaged heart valves.

[0005] Recently, significant efforts have been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which cause less trauma to patients during delivery than open-heart surgery. The expectation is that replacement valves will achieve proper deployment and sealing at the implantation site. Summary of the Invention

[0006] This summary is intended to provide examples and is not intended to limit the scope of this disclosure in any way. For example, any features included in the examples of this summary are not claimed by the claims unless those features are expressly stated in the claims. Furthermore, features, components, steps, concepts, etc., described in some embodiments of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described in other parts of this disclosure may include those in the examples summarized herein.

[0007] In some embodiments described herein, implantable prostheses or implantable devices, such as replacement heart valves and / or valve repair devices, are provided. In some embodiments, the prostheses or devices described herein include a compliance anchoring mechanism for the prosthetic heart valve (also referred to as a replacement heart valve). In some embodiments, improved delivery systems are provided for better control of the rotation and / or axial movement of the prosthesis or device (e.g., a prosthetic heart valve, repair device, etc.). In some embodiments, improved imaging systems are provided for enhanced visualization during the implantation procedure. These and other concepts may be used alone or in combination with other concepts described herein to facilitate the implantation of prosthetic heart valves.

[0008] In some embodiments, prostheses or devices with improved anchoring (e.g., heart valves, repair devices, replacement devices, etc.) are disclosed. In some embodiments, the prosthesis or device can be configured for use and / or implantation at a treatment site (e.g., implantation site, repair site, etc.). In some embodiments, the treatment site may be an autologous mitral valve or an autologous tricuspid valve (but other valves for implantation, such as aortic valves, pulmonary valves, vena cava valves, etc., are also considered).

[0009] In some implementations, the improved anchoring features and / or methods are configured to enhance stability while reducing trauma at or around the treatment or implantation site. For example, the systems, devices, methods, etc., described herein are configured to reduce the likelihood of impact, compression, and / or potential contusions (e.g., pseudoaneurysms, myocardial punctures, or electrical conduction disorders).

[0010] In some embodiments, the improved anchoring system disclosed herein includes a compliant anchoring structure. In some embodiments, the anchor is a compliant or flexible anchor and is configured to reduce trauma to surrounding tissues at the treatment or implantation site.

[0011] In some embodiments, mechanisms and / or methods for operating the delivery system are also disclosed herein. In some embodiments, said mechanisms / methods are provided to improve the operation and deployment of devices or implants from elongated delivery catheters, enabling treatment (e.g., repair, implantation, etc.) via percutaneous non-invasive procedures. Various other improvements are disclosed.

[0012] In some embodiments, a prosthesis or device (e.g., a prosthetic heart valve repair device, replacement device, implant, therapeutic device, etc.) is provided for and / or deployed to an autologous heart valve. In some embodiments, the device (e.g., a prosthetic heart valve, etc.) includes a support structure having an inlet portion. In some embodiments, the support structure includes an outlet portion. The prosthesis or device may include any of the features of other prostheses or devices described herein and may be used with any of the delivery systems described herein.

[0013] In some implementations, the support structure includes a pathway extending through it.

[0014] In some embodiments, the support structure may include an inner frame having an inlet end portion and an outlet end portion. In some embodiments, the support structure may include an outer frame including an inlet end portion.

[0015] In some implementations, the entrance portion of the outer frame is connected to the entrance portion of the inner frame.

[0016] In some embodiments, the outer frame has a platform portion or flange that extends radially outward from the inlet end portion of the outer frame to form a shoulder. In some embodiments, an axially extending portion extends axially from the shoulder toward the outlet end portion.

[0017] In some embodiments, the shoulder tilts the platform portion relative to the axially extending portion. In some embodiments, the platform portion includes a flexible feature that allows the platform portion to deflect, causing the inner frame to translate axially relative to the shoulder.

[0018] In some embodiments, the valve portion is positioned within the passageway of the support structure. In some embodiments, the valve portion includes a plurality of prosthetic valve leaflets configured to allow blood to flow through the passageway in one direction and to prevent blood from flowing in the opposite direction.

[0019] In some embodiments, the device (e.g., a prosthetic heart valve, a treatment device, etc.) includes a support structure having an inlet portion and an outlet portion. In some embodiments, the support structure includes a passageway.

[0020] In some embodiments, the valve portion is positioned within the pathway of the supporting structure. In some embodiments, the valve portion includes multiple prosthetic valve leaflets. In some embodiments, the valve portion allows blood to flow through the pathway in one direction, replacing the function of an autologous heart valve.

[0021] In some implementations, one or more anchors extend radially outward from the support structure.

[0022] In some embodiments, each of the one or more anchors has a hook shape.

[0023] In some embodiments, each of the one or more anchors includes an anchor arm that splits or branches along its end.

[0024] In some embodiments, each of the one or more anchors includes a tip portion having an undulating or serpentine configuration to increase compliance and flexibility along the tip portion, which can help reduce trauma to surrounding tissues.

[0025] In some embodiments, the one or more anchors include a tip portion having a compliant weave.

[0026] In some embodiments, the one or more anchors include a tip portion that forms a loop.

[0027] In some implementations, the one or more anchors include more than one or more of the features described above.

[0028] In some implementations, the device includes a sealing body.

[0029] In some implementations, the device includes one or more flexible features.

[0030] In some embodiments, a delivery system is provided for advancing a device (e.g., a prosthetic heart valve, a repair device, a replacement device, a therapeutic device, etc.) through the patient's vascular system. In some embodiments, the delivery system is operable and / or configured to use, operate, and / or implant the device at, near, or within an autologous heart valve. The delivery system can be used with any of the devices, prostheses, systems, etc., described above or elsewhere herein.

[0031] In some embodiments, the delivery system includes a catheter shaft for advancing the device to the treatment site and / or implantation site. In some embodiments, the catheter shaft includes a proximal portion and a distal portion.

[0032] In some embodiments, at least a portion of the catheter shaft includes a receiving area for a device. In some embodiments, the receiving area may be in the form of a sheath or sac, sized to hold the device (e.g., a prosthetic heart valve, etc.) in a compressed state.

[0033] In some implementations, the delivery system may include an actuation mechanism for rotating a device (e.g., a prosthetic heart valve, a treatment device, etc.) about or relative to the axis of the catheter shaft (e.g., the axis of the distal portion or distal end of the catheter shaft, etc.).

[0034] In some implementations, the mechanism for rotating the device allows clinicians to orient the device (e.g., a prosthetic valve, treatment device, etc.) within the autologous valve in a more desired manner (e.g., the optimal way for a specific treatment, a better way to avoid damage to sensitive tissues, etc.). This can be particularly advantageous when using non-cylindrical or asymmetrical devices, such as those designed to conform to the shape of the autologous valve.

[0035] In some embodiments, the delivery system includes a catheter shaft for advancing a device (e.g., a prosthetic heart valve, a treatment device, etc.) to a treatment site (e.g., an implantation site, a repair site, a replacement site, etc.). In some embodiments, the catheter shaft extends along an axis (or may extend along an axis). In some embodiments, the catheter shaft includes a proximal portion and a distal portion.

[0036] In some implementations, at least a portion of the catheter shaft includes a receiving area for a device (e.g., for a prosthetic heart valve).

[0037] In some embodiments, the delivery system includes a motor for controlling axial movement of the device along or relative to at least a portion of the conduit shaft. In some embodiments, the motor may be positioned along a distal portion of the delivery system.

[0038] In some implementations, the delivery system (e.g., any delivery system described anywhere herein) includes an imaging system.

[0039] In some embodiments, the catheter shaft includes a nasal body. In some embodiments, another part of the catheter shaft or delivery system includes a sheath having a distal portion that attaches to the nasal body.

[0040] In some embodiments, the sheath includes an internal lumen for the passage of a guidewire. In some embodiments, a portion of the catheter shaft includes a receiving area for a device (e.g., a prosthetic heart valve).

[0041] In some embodiments, the delivery system includes an imaging system coupled to one or more of the nasal body or sheath. In some embodiments, the imaging system is used to image internal portions of a subject's body from within the subject's body. In some embodiments, the imaging system is used to image the vascular system of a subject's body from within the subject's vascular system. The subject of any of the devices, systems, or methods described herein can be a living organism or a simulant.

[0042] In some embodiments, the guidewire system (which can be used with any of the delivery systems and / or devices described herein) includes a guidewire body having a proximal portion and a distal portion. In some embodiments, an imaging system is coupled to the guidewire body. In some embodiments, the imaging system is used to image internal portions of a subject's body from within the subject's body. In some embodiments, the imaging system is used to image the vascular system of a subject's body from within the subject's vascular system. Integrating an imaging system into the guidewire has many advantages and is suitable for many procedures besides prosthetic heart valve implantation.

[0043] The delivery system may also include any of the features of the delivery system described below.

[0044] Any method used in this document to refer to systems, components, devices, apparatuses, etc., may be performed on a living organism (e.g., a human or other animal) or a simulated object (e.g., a corpse, a corpse heart, a virtual human, a simulated body, etc.). Through simulation, body parts may optionally be referred to as “simulated” (e.g., a simulated heart, simulated tissue, etc.) and may optionally include computerized and / or physical representations.

[0045] Any of the aforementioned systems, components, devices, equipment, parts, etc., may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use in patients, and the methods described herein may include (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) sterilizing one or more of the systems, devices, equipment, parts, etc. described herein (or additional methods may include or consist of said sterilization). Attached Figure Description

[0046] Referring to the specification, claims, and drawings, the features and advantages of the systems, apparatus, and methods disclosed herein will be better understood, wherein:

[0047] Figure 1 This shows a perspective view of the prosthetic valve as seen from the inflow side.

[0048] Figure 2 Showing Figure 1 A perspective view of the frame of the prosthetic valve shown.

[0049] Figure 3 Showing Figure 2 The perspective view of the inner frame shown.

[0050] Figure 4 Showing Figure 2 The perspective view of the outer frame shown.

[0051] Figure 5 Showing Figure 1The diagram shows a cross-sectional view of the prosthetic valve.

[0052] Figure 6 A schematic diagram of a delivery system located near the treatment or implantation site is shown.

[0053] Figure 7 A schematic cross-sectional view of the prosthetic valve within the delivery system is shown.

[0054] Figure 8 Demonstrates deployment to treatment or implantation sites. Figure 7 A schematic diagram of the cross-section of a prosthetic valve.

[0055] Figure 9 The side view shows a representation of the frame deployed to the treatment or implantation site.

[0056] Figure 10 A perspective view of the outer frame is shown.

[0057] Figure 11 Showing Figure 10 A close-up perspective view of a portion of the outer frame shown.

[0058] Figure 12 Showing Figure 10 A plan view of a portion of the outer frame shown.

[0059] Figure 13 The side view shows a representation of the frame deployed to the treatment or implantation site.

[0060] Figure 14 A perspective view of the anchoring element is shown.

[0061] Figure 15 A top view of the frame, including multiple anchors with forks, is shown.

[0062] Figure 16 A schematic diagram of an anchor with forks is shown.

[0063] Figure 17 A side view of the frame, including anchors with forks, is shown.

[0064] Figure 18 A perspective view of the anchoring element is shown.

[0065] Figure 19 A top view of the frame, including anchors with forks, is shown.

[0066] Figure 20 A plan view of the anchor, including the flexible tip portion, is shown.

[0067] Figure 21 Showing Figure 20A perspective view of the flexible tip portion shown.

[0068] Figure 22 A side cross-sectional view of the anchor is shown.

[0069] Figure 23 A perspective view of the anchoring element is shown.

[0070] Figure 24 A schematic diagram of an anchor component with compliant woven fabric is shown.

[0071] Figure 25 A side cross-sectional view of an anchor with compliant braided fabric is shown.

[0072] Figure 26 A side view of an anchor with compliant braided fabric is shown.

[0073] Figure 27 A side view of an anchor with compliant braided fabric is shown.

[0074] Figure 28 A side cross-sectional view of an anchor with compliant braided fabric is shown.

[0075] Figure 29 A side view of an anchor with compliant braided fabric is shown.

[0076] Figure 30 Showing Figure 29 The rear view of the anchor with compliant braid shown.

[0077] Figure 31 Showing Figure 29 The side view of the anchor shown.

[0078] Figure 32 A perspective view of an anchor with a ring is shown.

[0079] Figure 33A Showed along Figure 32 The cross-sectional view of line II in the diagram.

[0080] Figure 33B A side view of the woven fabric on the core is shown.

[0081] Figure 34 Showing Figure 32 The image shows a side cross-sectional view of the arm of the ring.

[0082] Figure 35 Showing included Figure 32 A perspective view of the ring-shaped prosthetic heart valve shown.

[0083] Figure 36 Showing Figure 32The side view showing the deflection of the ring.

[0084] Figure 37 Showing Figure 32 The top view showing the deflection of the ring.

[0085] Figure 38 A perspective view of the anchor with a ring and an indicator is shown.

[0086] Figure 39A and 39B Showing Figure 38 The side view of the anchor shown.

[0087] Figure 40 A perspective view of the anchor with a ring and an indicator is shown.

[0088] Figure 41A and 41B Showing Figure 40 The side view of the anchor shown.

[0089] Figure 42 A cross-sectional view of the ring's arm is shown.

[0090] Figure 43 A perspective view of an anchor with multiple rings is shown.

[0091] Figure 44 Showing Figure 43 Side view of the multiple rings shown.

[0092] Figure 45 A perspective view of an anchor with a ring is shown.

[0093] Figure 46 A perspective view of the anchor with a ring and an indicator is shown.

[0094] Figure 47 and 48 Showing Figure 46 The side view of the anchor shown.

[0095] Figure 49 A perspective view of the delivery system is shown.

[0096] Figure 50 A side view of the distal portion of the catheter shaft is shown.

[0097] Figure 51 A detailed cross-sectional diagram of the tip of the conduit shaft is shown.

[0098] Figure 52 A side view cross-sectional diagram of the guidewire sheath is shown.

[0099] Figure 53 A side-view cross-sectional diagram of the bladder sheath is shown.

[0100] Figure 54 A side view schematic diagram of a delivery system close to the treatment or implantation site is shown.

[0101] Figure 55 A side view schematic diagram of a delivery system for deploying implants to treatment or implantation sites is shown.

[0102] Figure 56 A side view of the guidewire is shown.

[0103] Figure 57 Showing Figure 56 A perspective cross-sectional view of a portion of the guidewire shown.

[0104] Figure 58 A side view schematic diagram of a delivery system for deploying implants to treatment or implantation sites is shown.

[0105] Figure 59 A perspective view of the actuation mechanism of the delivery system is shown.

[0106] Figure 60 A perspective view of the actuation mechanism of the delivery system is shown.

[0107] Figure 61 A perspective view of the actuation mechanism of the delivery system is shown.

[0108] Figure 62 A perspective view of the actuation mechanism of the delivery system is shown.

[0109] Figure 63 This diagram shows a top view of the implant's anchoring element relative to the leaflets of an autologous heart valve.

[0110] Figure 64 This diagram shows a top view of the implant's anchoring element relative to the leaflets of an autologous heart valve.

[0111] Figure 65 A side cross-sectional schematic diagram of the actuation mechanism of the delivery system is shown.

[0112] Figure 66 A side cross-sectional schematic diagram of the actuation mechanism of the delivery system is shown.

[0113] Figure 67 A side cross-sectional schematic diagram of the actuation mechanism of the delivery system is shown.

[0114] Figure 68 A side cross-sectional schematic diagram of the actuation mechanism of the delivery system is shown.

[0115] Figure 69 A side-view cross-sectional schematic diagram of a delivery system that alters the depth of an implant is shown.

[0116] Figure 70 A side view of the delivery system, including the guidewire, is shown.

[0117] Figure 71 A side view cross-sectional diagram of the guidewire inside the lumen of the delivery system is shown.

[0118] Figure 72 A side view cross-sectional diagram of the guidewire inside the lumen of the delivery system is shown.

[0119] Figure 73 A side view cross-sectional diagram of the guidewire inside the lumen of the delivery system is shown.

[0120] Figure 74 A side view cross-sectional diagram of the guidewire inside the lumen of the delivery system is shown. Detailed Implementation

[0121] Figure 1 A perspective view of the prosthesis or device configured as a replacement device or prosthetic valve 10 is shown. While many examples in this paper use replacement devices or prosthetic valves for illustration, it should be understood that the same concepts can be applied to other types of devices, such as therapeutic devices, repair devices, various implantable devices, etc.

[0122] In some embodiments, the devices described herein, such as the prosthetic valve 10, are configured for use and / or deployment within the body of a subject. For example, the prosthetic valve 10 may be deployed to the annulus of an autologous valve, which may include an autologous mitral valve or an autologous tricuspid valve. In some embodiments, other implantation sites may be used, such as within the aortic or pulmonary valve, or other valves or sites within the body of the subject as needed.

[0123] In some embodiments, the device or prosthetic valve 10 includes a proximal portion 12 or an inlet portion and a distal portion 14 or an outlet portion (in... Figure 5 The device or prosthetic valve 10 further includes a valve portion, preferably formed by a plurality of prosthetic valve leaflets 16.

[0124] In some embodiments, the valve portion is positioned within a flow channel or pathway to control flow through the device or prosthetic valve 10. In some embodiments, the flow channel or pathway is formed by a support structure 15 of the device / valve 10. In some embodiments, the support structure 15 has a proximal portion or inlet portion 5 and a distal portion or outlet portion 7 (in... Figure 5 (marked in the middle).

[0125] In some embodiments, the prosthetic valve leaflet 16 moves between open and closed states to mimic and replace the operation of the autologous valve leaflet. In some embodiments, the valve portion is positioned within the passage of the support structure 15 to allow blood to flow through the passage in one direction, thereby replacing the function of the autologous heart valve.

[0126] In some embodiments, the prosthetic valve leaflet 16 is made of pericardium, such as bovine or porcine pericardium, or, if desired, of another material. In some embodiments, the leaflet is formed of a synthetic (e.g., polymer) material, or the valve portion may be a mechanically unidirectional valve.

[0127] In some embodiments, the support structure 15 or valve body surrounds and supports the prosthetic valve leaflet 16. In some embodiments, the support structure 15 includes a stent or frame or support frame (e.g., a valve frame or internal support stent or internal frame 18). Figure 3 (shown separately) and external support bracket or outer frame 20 (in Figure 4 (shown separately), and other forms of frames. In some embodiments, the outer support bracket or outer frame 20 is part of the sealing body 11 and spaced apart from the inner frame 18. In some embodiments, the outer frame 20 surrounds the inner frame 18.

[0128] In some embodiments, the device or prosthetic valve 10 includes one or more anchors 17 for stabilizing the device or prosthetic valve in the body after implantation. The one or more anchors can be used with various types of devices, not limited to prosthetic valves.

[0129] In some embodiments, the anchor 17 may be specifically anchored to the leaflet of a patient's own heart valve. In some embodiments, the anchor 17 extends around the leaflet of the patient's own heart to anchor to it. In some embodiments, the anchor 17 includes a distal anchor positioned at the distal end 14 or outlet portion of the valve 10, or in some embodiments positioned at another location as needed.

[0130] In some embodiments, the anchor 17 extends radially outward from the support structure 15, or may extend in this manner. In some embodiments, when the device or prosthetic valve is used, deployed, or implanted, the autologous leaflet is captured between the anchor 17 and the outer frame 20.

[0131] In some embodiments, each anchor 17 is configured as a protruding anchor arm that extends distally and then bends proximally to the tip of a corresponding anchor 17. This configuration allows the anchor 17 to extend around the autologous leaflet and around the distal tip of the leaflet to hook onto the distal tip of the autologous valve leaflet and to be positioned radially outward of the outward-facing surface of the autologous valve leaflet.

[0132] In some embodiments, the anchor 17 is configured in a hook shape, for example as... Figure 1-3 As shown in Figure 5. In some embodiments, one or more, some or all of the anchors 17 have a hook shape. Thus, the anchors 17 can resist forces applied to the valve 10 in the atrium or proximal direction and anchor the valve 10 within the natural valve annulus.

[0133] In some implementations, anchor 17 is attached to the distal portion 67 or the outlet portion of the inner frame 18. Other attachment locations are possible.

[0134] In some embodiments, each anchor 17 includes a strut arm 21 (in Figure 2 , 3 (as marked in 5), the strut arm may be covered with a covering material. In some embodiments, the covering material may include one or more layers of padding or cushioning material covering the strut arm 21. For example, refer to Figure 5 In a cross-sectional view, the strut arm 21 may include a tip 23, which may be covered by a pad 25. In some embodiments, a sleeve 27 may extend along the length of the strut arm 21 and may cover the tip 23 and the pad 25. The sleeve 27 and the pad 25 serve to provide cushioning for the anchor 17. For example, the strut arm 21 may be relatively rigid compared to a pad or cushioning material.

[0135] In some implementations, other configurations of the anchor 17 may be used as needed.

[0136] In some implementations, the prosthetic valve leaflet 16 is positioned within the access or flow channel 29, such as... Figure 1 and 5 The marker is moved between open and closed states to control the flow through the passage or flow channel 29. For example... Figure 5 As shown, the proximal end 12 of the prosthetic valve 10 includes the inflow end of the prosthetic valve 10, and the distal end 14 of the prosthetic valve 10 includes the outflow end, but other configurations may be used as needed.

[0137] In some embodiments, the prosthetic valve leaflet 16 may be positioned around the central axis 31 of the prosthetic valve 10. In some embodiments, the inner frame 18 and the outer frame 20 each surround the central axis 31 of the prosthetic valve 10.

[0138] like Figure 5 As shown, when the prosthetic valve leaflet 16 is in the closed position, the passage is blocked, and blood cannot flow backward through the passage (i.e., blood cannot flow from the outflow end back to the inflow end).

[0139] Refer again Figure 1 In some embodiments, the device (e.g., prosthetic valve 10, etc.) may include a sealing body 11. In some embodiments, the sealing body 11 is positioned radially outside a support structure (e.g., an inner frame and / or an outer frame). In some embodiments, the sealing body 11 is positioned centrally. In some embodiments, the sealing body seals a portion of the autologous valve.

[0140] In some embodiments, the scaling element is positioned radially lateral to the prosthetic valve leaflet 16. In some embodiments, the sealing element seals a portion of the autologous valve.

[0141] In some embodiments, the sealing body 11 may include the outer surface of the valve 10. In some embodiments, the sealing body 11 may define the outer diameter of the device and may include the outer periphery of the device (e.g., valve 10, etc.). In some embodiments, the sealing body 11 includes a proximal portion or inlet portion having a proximal end 33 and a distal portion or outlet portion having a distal end 35.

[0142] In some embodiments, the sealing body 11 includes a frame or outer support bracket or outer frame 20 and a sealing skirt 24, or in some embodiments it may include only a frame or only a sealing skirt as needed.

[0143] In some embodiments, the outer frame 20 is positioned radially outward of the inner support bracket or inner frame 18. In some embodiments, the sealing skirt 24 is coupled to the outer frame 20 and includes the outer portion of the sealing body 11.

[0144] In some embodiments, the sealing skirt 24 is made of a material that prevents fluid from flowing through it, such as fabric, woven material, or other materials, such as polymers, or other materials that prevent fluid from flowing through it. The material may include fabric. Various materials can be used for the skirt 24 as needed.

[0145] In some embodiments, the sealing body 11 is adjacent to a portion of the recipient's heart to reduce fluid flow. In some embodiments, the skirt 24 seals a portion of the natural valve annulus. For example, the sealing body 11 is adjacent to the surface of the recipient's own valve leaflet to reduce fluid flow between the sealing body 11 and the own valve leaflet. In some embodiments, the sealing body 11 is adjacent to other portions of the recipient's heart as needed to reduce fluid flow.

[0146] In some implementations, the sealing body 11 is flexible so that it can move and conform to the natural valve annulus.

[0147] In some embodiments, the outer frame 20 is positioned radially outward of the inner frame 18. In some embodiments, the outer frame 20 is made of a plurality of struts 37, which are shaped into a desired shape or profile of the outer frame 20. In some embodiments, the plurality of struts 37 form a grid structure, wherein corresponding openings 39 are provided between the struts 37 (in... Figure 2 (marked in the middle).

[0148] In some embodiments, the strut 37 forms a unit that encloses the opening 39. In some embodiments, the unit (e.g., Figure 2 The marked unit 41 includes Figure 2 The closed unit shown includes an opening that is completely enclosed by a strut, or in some embodiments, an open unit is included, in which the opening is not completely enclosed by a strut.

[0149] In some embodiments, the grid structure of the outer frame 20 allows the outer frame 20 to move radially outward from a collapsed, compressed, or rolled configuration to an expanded or unfolded configuration. In some embodiments, the grid structure is elongated in the collapsed, compressed, or rolled configuration, but its length may be shortened and it expands radially outward in the expanded or unfolded configuration.

[0150] Figure 4 An example outer frame 20 is shown separately. In some embodiments, the outer frame 20 includes a proximal portion 43 or an inlet portion. In some embodiments, the proximal portion 43 or the inlet portion is coupled to the proximal portion 45 or the inlet portion of the inner frame 18 (in...). Figure 3 (Note: This is a Chinese character indicating a missing element). In some embodiments, the proximal portion 43 includes a connector for attachment to the proximal portion 45 of the inner frame. In some embodiments, the connector includes eyelets for attachment to sutures of the inner frame 18, or has another configuration. Other forms of connectors are used in some embodiments.

[0151] In some embodiments, the outer frame 20 includes a platform portion 47 that extends radially outward from a proximal portion 43 or an inlet portion of the outer frame 20. The platform portion 47 may be flat or curved. In some embodiments, the platform portion 47 extends radially outward to a shoulder 49. In some embodiments, the shoulder 49 tilts the platform portion 47 relative to the axial extension portion 51 of the outer frame 20.

[0152] refer to Figure 5In a cross-sectional view, shoulder 49 includes an outwardly radially curved portion of outer frame 20 with a convex curvature. The distal portion 53 of shoulder 49 extends inwardly radially such that the apex 55 of shoulder 49 projects outwardly radially. In some embodiments, an axially extending portion 51 extends axially from the distal portion 53 of shoulder 49 to the distal end portion 59 or outlet portion of outer frame 20.

[0153] In some embodiments, the shoulder 49 prevents the prosthetic valve 10 from moving distally or toward the ventricle after implantation. In some embodiments, for example, the shoulder 49 is adjacent to the atrial side of the heart valve annulus to prevent distal or ventricular movement. In some embodiments, the axially extending portion 51 extends along the autologous valve leaflet and surrounds its inwardly facing surface.

[0154] In some implementations, the outer frame can use other configurations.

[0155] refer to Figure 3 The inner frame 18 is shown separately. In some embodiments, the inner frame 18 includes a plurality of struts 61 that form a grid structure in a manner similar to the outer frame 20. In some embodiments, for example, the struts 61 enclose an opening 63. In some embodiments, the struts 61 form closed units 65 around the opening 63, or in some embodiments, they form open units. In some embodiments, the grid structure allows the inner frame 18 to move radially outward from a collapsed, compressed, or curled configuration to an expanded or unfolded configuration in a manner similar to the outer frame 20. In some embodiments, the grid structure is elongated in the collapsed, compressed, or curled configuration, but shortens in length and expands radially outward in the expanded or unfolded configuration.

[0156] In some embodiments, the inner frame 18 includes a proximal portion 45 or an inlet portion of the inner frame 18 and extends axially to a distal portion 67 or an outlet portion of the inner frame 18. In some embodiments, the strut arm 21 is integral with the strut of the inner frame 18 at the distal portion 67 and extends radially outward from the distal portion 67 of the inner frame 18.

[0157] In some implementation schemes, skirt 69 (in) Figure 1 and 5 The prosthetic valve leaflet 16 (marked in center) extends along the inner surface of the inner frame 18 and attaches to the prosthetic valve leaflet 16. The prosthetic valve leaflet 16 is attached to the skirt 69 using sutures or other forms of connectors. In some embodiments, other configurations of the prosthetic valve are used.

[0158] Figure 6One method of advancing a delivery system 70 or delivery catheter toward a treatment or implantation site is illustrated. In some embodiments, the delivery system 70 includes an elongated shaft or catheter shaft 72 having a proximal portion and a distal portion, wherein the proximal portion is coupled to a housing in the form of a handle 74. In some embodiments, the delivery system 70 can advance through the subject's vascular system, which may include the femoral vein, such as... Figure 6 As shown. In some implementations, other approaches may be used, including transapical approach, transatrial approach, transjugular approach, transradial approach, or surgical methods such as open-chest surgery or open-heart surgery.

[0159] In some embodiments, the device or prosthetic valve 10 may be positioned within the receiving area of ​​the delivery system 70 and may be covered by the capsule 75 or otherwise retained prior to deployment. In some embodiments, the device or prosthetic valve 10 may be self-expanding (e.g., including a self-expanding portion or feature) such that the device expands after being released from the receiving area.

[0160] In some embodiments, the device or prosthetic valve may include and / or be formed of a shape memory material. In some embodiments, the shape memory material may include nitinol, or in some embodiments may have other forms (such as those disclosed herein). In some embodiments, for example, the struts of frames 18, 20 may be made of a shape memory material and may be self-expanding to a deployable configuration.

[0161] In some implementations, the device or prosthetic valve may also take the form of a balloon-expandable prosthesis (e.g., positioned on an inflatable body or balloon after entering the patient's body, or slid into an inflatable body or balloon within the patient's body), or be mechanically expanded, as well as other deployment methods.

[0162] Refer again Figure 6 The delivery system 70 can be advanced into the atria of the heart and can pass through the septum into another atrium (e.g., from the right atrium to the left atrium) to reach the treatment or implantation site. For example, this delivery route can be used for an autologous mitral valve access. In some embodiments, the delivery system 70 can extend into the right atrium to achieve tricuspid valve access, or in some embodiments, other delivery methods can be used at other implantation sites as needed.

[0163] Figure 7 A device or prosthetic valve 10 is shown held in a compressed configuration within a capsule 75 of a delivery system 70. The capsule 75 typically has a tubular shape and a hollow interior. When held within the capsule, the prosthetic valve 10 is elongated, with the anchor 17 held in either a straightened or elongated configuration. Figure 7In this structure, both the sealing body 11 (including the outer frame 20) and the inner frame 18 have reduced diameters and are elongated. The anchor 17 is advanced and deployed radially outward from the bladder.

[0164] Figure 8 A device or prosthetic valve 10 deployed to an autologous valve 80 (e.g., an autologous mitral valve) is shown. A sealing body 11 extends radially outward to contact the inward-facing surface of the autologous valve leaflet 82. An anchor 17 hooks onto the autologous valve leaflet 82 such that the tip of the anchor 17 is positioned radially outward of the autologous valve leaflet 82.

[0165] Figure 9 A side view representation of the frame of the device or prosthetic valve 10 after deployment to the treatment site (e.g., implantation site, etc.) is shown. For clarity, autologous valve leaflets have been excluded from the view.

[0166] In some implementations, after deployment, the shoulder 49 of the outer frame 20 is positioned proximal to or atrially to the annulus 84 of the autologous heart valve.

[0167] In some deployment configurations, the tip of the anchor or the tip 23 of the strut arm 21 may be close to or in contact with the cardiac tissue 86 on the ventricular side of the heart valve. This cardiac tissue 86 extends radially outward from the autologous valve leaflet 82 (e.g., Figure 8 The annulus 82 is marked (and forms a ring around the valve leaflet 82). Such proximity or contact could cause impact, compression, or potential contusion to the cardiac tissue 86 (e.g., pseudoaneurysm, myocardial puncture, or conduction disturbance), and is therefore potentially undesirable. Furthermore, the positioning of the anchors could create tension in the chordae tendineae attached to the leaflet, which may also be undesirable. The outer frame 20 may be positioned too high above the valve annulus.

[0168] Figure 10 Examples of outer frames 90 that can be used in some implementations described herein are shown.

[0169] In some implementations, the device (e.g., outer frame 90, inner frame, one or more anchors, etc.) includes flexible features 92.

[0170] In some embodiments, the flexible feature allows the outer frame 90 to deflect. In some embodiments, the flexible feature 92 allows the outer frame 90 to deflect, and thus allows the inner frame 18 to move axially.

[0171] In some embodiments, the flexible feature 92 has various configurations and includes portions of the outer frame 90 that are more flexible than adjacent or other portions of the outer frame 90. In some embodiments, for example, the flexible feature 92 includes a pattern of struts cut into the outer frame 90, including a wavy pattern, a serpentine pattern, or other desired form of pattern. In some embodiments, the flexible feature 92 includes a strain relief feature.

[0172] In some implementations, the flexible feature 92 includes undulations in the struts of the outer frame 90. For example, Figure 11 A close-up perspective view shows the flexible feature 92, which is part of the strut 93 of the outer frame 90. Figure 12 A flat pattern of a strut including a portion of an outer frame 90 with a flexible feature 92 is shown. In some embodiments, the portion of the strut including the flexible feature 92 is more flexible than the adjacent portion of the strut.

[0173] refer to Figure 10 The flexible feature 92 can be positioned at the platform portion 94 of the outer frame 90, between the entrance portion 96 and the shoulder 98. The position of the flexible feature 92 at the platform portion 94 allows the platform portion 94 to deflect, enabling the inner frame 18 to translate axially relative to the shoulder 98.

[0174] In some embodiments, the flexible feature 92 allows axial movement of the inlet portion 96 relative to the shoulder 98, thus allowing axial movement of the inner frame 18 in the distal direction. Therefore, the axial translation of the inner frame 18 allows the anchor 17 to translate axially relative to the shoulder 98. Although one arrangement is shown, it should be understood that other structures are contemplated that allow axial movement of the inner frame within the outer frame to reduce stress, reduce pressure on surrounding tissue, and / or provide more natural valve movement during heartbeat.

[0175] Figure 13 An example flexible feature 92 during operation is shown according to some embodiments. Upon deployment, the flexible feature 92 allows the outer frame 90 to be more compliant in the axial direction, allowing the inner frame 18 to move further axially to a more distal or ventricular position. The outer frame 90 is axially compliant. In some embodiments, the corresponding movement of the inner frame 18 results in a larger gap 100 or reduced pressure between the tip of the anchor (e.g., the tip 23 of the strut arm 21) and the cardiac tissue 86. Therefore, the increased gap reduces the likelihood of adverse pressure or impact on the cardiac tissue 86 (or reduces the tension on the chordae tendineae attached to the leaflets).

[0176] about Figure 10-13 The disclosed features may be used alone or in combination with any of the examples disclosed herein.

[0177] Figure 14Another improvement to the prosthetic heart valve is shown, wherein the anchor arm 110 splits or bifurcates to form multiple forks 112a, 112b that circumferentially diverge from each other.

[0178] In some embodiments, the anchor arm 110 includes a strut arm that includes a rod portion 114 directly connected to the inner frame 18 (e.g., the distal or outflow portion of the inner frame 18 or the support structure 15).

[0179] In some embodiments, the rod portion 114 extends radially outward to a split portion 116 that branches the anchor arm 110. In some embodiments, the split portion 116 separates the plurality of forks 112a, 112b. In some embodiments, the forks 112a, 112b diverge from each other in opposite circumferential directions and from the split portion 116. In some embodiments, the rod portion 114 is positioned radially inward of the split portion 116.

[0180] In some embodiments, the anchor arm includes a bend that includes a drooping ring 118 or a downwardly projecting ring. In some embodiments, for example, the anchor arm 110 including forks 112a, 112b follows a hook-shaped profile of the anchor arm, such as... Figure 13 As shown, and includes a dangling ring 118 in a similar manner. However, in some embodiments, the dangling ring 118 may be present on the forks 112a, 112b to follow... Figure 13 The hook-shaped profile of the anchor arm is shown.

[0181] In some embodiments, the split portion 116 can therefore be positioned inward along the anchor arm 110 relative to the sag ring 118. In some embodiments, the split portion 116 may appear at approximately half the length of the anchor arm 110, but other positions may be used as needed. In some embodiments, for example, the split portion may be positioned outward along the anchor arm relative to the sag ring, such as... Figure 18 As shown in the image.

[0182] In some embodiments, forks 112a, 112b extend from the separating portion 116 to corresponding, spaced-apart, and separated tips 120a, 120b of the forks 112a, 112b. A gap 122 or space extends circumferentially between the tips 120a, 120b.

[0183] In some implementations, the forks 112a and 112b are circumferentially divergent from each other, covering a larger circumferential area than a single-arm configuration, for example... Figure 3 As shown. For example. Figure 15 The separation of fork-shaped elements 112a and 112b is shown, thus covering a circumferential area greater than that covered by a single arm 123 (in...). Figure 15(Indicated by dashed lines) Large. In some embodiments, the forks 112a, 112b of the plurality of anchors collectively extend across a circumferential region of at least 80 degrees across the periphery of the prosthetic valve, or in some embodiments, across at least 90 degrees, at least 100 degrees, or at least 120 degrees. In some embodiments, for example, 360-degree coverage is provided, such as... Figure 19 As shown (for example, where fork 113b overlaps with fork 113c of the adjacent anchor, and forks 113a, 113d radiate from the respective forks 113b, 113d).

[0184] refer to Figure 16 The circumferential width 124 of each of the forks 112a and 112b is approximately half the circumferential width 126 of the rod portion 114. Therefore, the circumferential width 126 of the rod portion 114 is equal to the combination of the circumferential widths 124 of each of the forks 112a and 112b. In some embodiments, the circumferential width of the rod portion 114 is greater than the combined circumferential width of the forks 112a and 112b. Other widths are used in some embodiments.

[0185] Figure 17 A side perspective view of the inner frame is shown, in which the forks 112a and 112b radiate outwards from each other circumferentially.

[0186] In some embodiments, the total number of anchoring elements required is reduced by using forks, while circumferential anchoring and stability are increased after deployment. Therefore, the risk of leaflet capture failure during deployment is reduced. In some embodiments, forks 112a, 112b may be thinner than the rod portion 114 (e.g., smaller circumferential width), which can increase the flexibility and compliance of both forks 112a, 112b. For example, the likelihood of adverse compression or impact (e.g., pseudoaneurysm or conduction disturbance) is reduced. Radial stiffness is reduced while maintaining or enhancing atrial migration resistance. Forks 112a, 112b also distribute the anchoring load over a larger surface area compared to a single anchor arm.

[0187] The ease of coiling and loading implants, including forks, is increased. For example, delivery systems have lower loading capacity compared to systems using more anchor arms.

[0188] Figure 18 An embodiment is shown in which the separated portion 128 is positioned outside the drooping ring 130. Therefore, the lengths of the forks 132a and 132b are compared to... Figure 14 The length represented in the middle decreases.

[0189] In some implementations, the tips of the forks overlap, causing the space between the forks of adjacent anchors to close. For example, Figure 19The tips of the overlapping adjacent anchor forks 113b, 113c are shown, the overlap providing 360-degree circumferential coverage for the forks.

[0190] In some implementations, the fork follows the contour of a single anchor arm (e.g., Figure 13 The hook-shaped profile of the anchor arm shown can also have a greater lateral extension range as needed.

[0191] about Figure 14-19 The disclosed features may be used alone or in combination with any other examples disclosed herein.

[0192] Figure 20 An example of an anchor arm 140 including a tip portion 142 is shown, the tip portion having an undulation portion 144 to increase the flexibility of the tip portion 142. The undulation portion 144 includes a repeating undulation pattern that extends sequentially along the tip portion 142.

[0193] In some embodiments, the undulations extend in the circumferential direction or in the circumferential width of the tip portion 142, such that the flat surface 146 rests on the radially inward-facing surface 147 of the tip portion 142 and on the radially outward-facing surface 148 of the tip portion 142 (in... Figure 22 (marked in the middle).

[0194] In some embodiments, the circumferential width of the tip portion 142 is greater than the radial thickness of the tip portion 142. The tip portion 142 includes a portion of the strut arm 141 and includes an end or distal end of the strut arm 141.

[0195] In some embodiments, if the flexible tip portion 142 contacts the heart tissue, then the flexible tip portion 142 reduces pressure and impact on the heart tissue. In some embodiments, the undulation portion 144 increases the flexibility of the tip portion 142 in the radially inward direction. The tip portion 142 bends in the radially inward direction. (Reference) Figure 21 For example, the flexible tip portion 142 deflects radially inward, reducing the force on the cardiac tissue 150. In some embodiments, the stiffness of the flexible tip portion 142 may gradually decrease towards the end of the anchor strut. In some embodiments, uniform flexibility may be provided.

[0196] refer to Figure 22 The strut arm 141 and the flexible tip portion 142 are covered with padding or cushioning material, for example, regarding Figure 5 The pad 25 and sleeve 27 are discussed. In some embodiments, the strut arm 141 may not be covered, with the tip portion 142 in direct contact with the tissue.

[0197] This creates a stress-relieved anchor tip. The tip is partially deflected to distribute the contact force over a larger contact area proportional to the anchoring force. This results in a smaller force per unit contact area. This allows for the absorption of more contact energy and reduces the loading force entering the delivery system.

[0198] about Figure 20-22 The disclosed features may be used alone or in conjunction with any of the examples disclosed herein.

[0199] Figure 23 An example is shown of the tip portion 152 of the anchor 154, which has a compliant braid 156. In some embodiments, the compliant braid 156 is positioned on the end surface 158 of the strut arm 155 (in... Figure 25 The compliant braid 156 extends or protrudes from the axial end surface 158 at the marked location. The compliant braid 156 includes woven ribbons or other forms of braid and may be compressible. The yarn may include bare yarn, or in some embodiments, it may be coated.

[0200] Figure 24 and 25 An example method or manner of positioning the compliant braid 156 at the axial end surface 158 of the strut arm 155 is shown. (Reference) Figure 24 The sleeve 160 of the compliant braid 156 includes an internal cavity 162 for receiving the axial end surface 158 of the strut arm 155. The sleeve 160 includes an outer end 163 and an inner end 164, wherein the inner end 164 surrounds the strut arm 155.

[0201] In some embodiments, the outer end 163 is inverted and folded outwards to reposition itself toward the inner end 164 of the sleeve 160. The resulting configuration is... Figure 25 As shown in the diagram. One or more seams 166 hold the compliant fabric 156 in this configuration, or the compliant fabric 156 can be heat-set to... Figure 25 The configuration shown.

[0202] In some embodiments, the inversion of the outer end 163 forms an annular space 168 enclosed by an inverted sleeve 160. In some embodiments, the use of the annular space 168 allows the compliant fabric 156 to move further or have greater flexibility, thereby increasing the compliance of the compliant fabric 156. In some embodiments, a cushioning material 170, such as foam, is positioned within the annular space 168. Figure 28 (Marked in the middle). For example, a ring of cushioning material 170 is positioned within the annular space 168.

[0203] In some embodiments, the inversion of the outer end 163 causes the compliant braid 156 to form a bulb shape. Other shapes are available as needed. The distal portion 172 of the compliant braid 156 has a woven fabric with a lower density than the proximal portion 174 of the compliant braid 156.

[0204] Figure 26 The resulting configuration of the compliant fabric 156 is shown. The compliant fabric 156 acts as a buffer against stress on the strut arm 155, such as... Figure 27 The compliant fabric 156 deforms and spreads out upon contact with a portion of the heart, with the degree of spread being proportional to the force. The greater the force, the larger the contact area, and therefore the lower the pressure per unit contact area. In some embodiments, the compliant fabric further conforms to calcified tissue at the treatment or implantation site (e.g., mitral annular calcification (MAC)).

[0205] refer to Figure 29 In some embodiments, a compliant braid 176 is provided that extends along the outward-facing surface 180 of the strut arm 181 of the anchor. The compliant braid 176 is offset from the longitudinal axis 184 of the strut arm 181 such that the compliant braid 176 extends further from the radially outward-facing surface 180 of the strut arm 181 than from the radially inward-facing surface 182 of the strut arm 181. This configuration allows the compliant braid 176 to be stitched 186 at the inward-facing surface 182 of the strut arm 181 (e.g., ...). Figure 30 (The material is marked in the middle) or otherwise attached to the strut arm 181. The compliant fabric 176 provides cushioning to the outward-facing surface 180 of the strut arm 181, for example, as shown in the image. Figure 31 The compliant fabric 176 also provides cushioning for the axial end surface and the inward-facing surface 182 of the strut arm 181. The compliant fabric 176 covers the radially outward-facing surface 180, the radially inward-facing surface 182, and the axial end surface of the strut arm.

[0206] In some implementations, the compliant weave 176 has a rectangular shape, or may have another shape as needed.

[0207] The compliant fabrics disclosed herein can be configured and / or used to provide cushioning for a portion of the heart to reduce the likelihood of punctures, electrical interference, or contusions (e.g., pseudoaneurysms).

[0208] In some implementations, the attachment to the strut arm can use other forms (e.g., welding).

[0209] about Figure 23-31 The disclosed features may be used alone or in conjunction with any of the examples disclosed herein.

[0210] Figure 32 An example is shown in which the tip portion 192 of the anchor 194 includes a ring 196. The ring 196 includes a closed loop that encloses an internal space 198 or opening. In some embodiments, the ring 196 includes a compliant ring 196, increasing the flexibility of the anchor at the tip portion 192.

[0211] The 196-view anomaly requires various components. For example, Figure 33A Showed along Figure 32 A cross-sectional view of line II in the diagram. Ring 196 includes a core 200, which comprises one or more filaments extending along the central axis of ring 196. Core 200 may include multiple filaments (e.g., Figure 33A (Two filaments are shown). In some implementations, different numbers of filaments are used. For example, Figure 42 A single filament or cable, for example, is used as core 202. Core 200 includes one or more nitinol wires, or another form of material as required (e.g., shape memory material or another form of material).

[0212] In some implementations, the core cover 204 extends over the core 200. The core cover 204 provides a cushioning pad for the core 200. The core cover 204 provides structural support for the core 200 and reduces fatigue wear on the core 200.

[0213] In some embodiments, the core cover 204 comprises a woven material or other form of material for providing cushioning on the core 200. In some embodiments, the woven material comprises woven stitches, such as... Figure 33B The core cover 204 includes spacers or filler material between the core 200 and the outer cover 206 of the ring 196.

[0214] In some embodiments, the outer cover 206 extends over the core cover 204 and includes a sleeve extending over the core cover 204. In some embodiments, the outer cover 206 includes a lubricating coating. In some embodiments, for example, the outer cover 206 includes polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE), or another form of lubricating coating, on the core cover 204. The lubricating coating helps reduce abrasion with the autologous anatomical structure and allows for deflection. Figure 33A The cross-section shown in the figure comprises a continuously extending material that forms a ring that encloses the internal space 198.

[0215] In some embodiments, the ring 196 is attached to the anchor 194 by a core 200 extending along the side of the anchor 194 and a stitch 208 for attaching the ring 196 to the anchor 194. For example, Figure 34A side cross-sectional view of the arm of ring 196 is shown.

[0216] In some implementations, for example, ring 196 includes the distal tip of each anchor of the prosthetic valve, such as Figure 35 The text indicates that in some implementations, ring 196 can be deflected in a radially inward direction (e.g., ...). Figure 36 (as indicated in the text), and can be compressed in the direction along the axis of the corresponding anchor (e.g. Figure 37 (as shown in the image). The ring shape provides resilience to the tip of the anchor, allowing it to return to, for example... Figure 32 The ring configuration is shown. In some embodiments, the strut arm remains relatively rigid, while the ring is more flexible. Therefore, the strut arm provides support for the ring, where the ring provides a compliant cushioning pad for use. The size of the ring (e.g.) Figure 37 (As shown in the diagram) changes to increase the contact surface area and reduce the force per unit contact area.

[0217] Furthermore, the use of compliant rings allows for ventricular remodeling as needed. The ring construction further includes echo and / or fluoroscopic indicators that can indicate whether proper anchoring has been achieved (e.g., whether the leaflets have been captured).

[0218] Variations can be used. For example, Figure 38 An example is shown in which the capture indicator 210 is positioned at the tip of the ring. The capture indicator 210 is in the form of an indicator arm attached to the ring 196.

[0219] In some implementations, the indicator 210 protrudes radially inward from the ring 196 (e.g.) Figure 39A (as indicated in the diagram). In some embodiments, the indicator 210 presses the autologous valve leaflet 212 radially inward against the ring 196 to indicate capture of the leaflet 212 by the corresponding anchor (e.g., ...). Figure 39B (as indicated in the diagram). In some embodiments, the immobile indicator leaflet 212 of indicator 210 fails to capture the signal. In some embodiments, the indicator includes an echo or fluorescent transillumination indicator, as well as other forms of indicators.

[0220] Other forms of indicators can be used. Figure 40 The configuration of indicator 220 is shown, wherein a gap 222 is created after capture leaflet 212 (in Figure 41B The indicator 220 includes a protrusion 224 (in the center of the marker) to indicate the capture of the leaflet 212. Figure 41B (as shown in the image), it protrudes radially inward and is pressed by the leaflet 212 after being captured by the leaflet 212 (as shown in the image). Figure 41B (as indicated in the image). Gap 222 is formed between portion 226 of indicator 220 and portion 228 of ring. Portions 226 and 228 may include corresponding echo or fluorescent transparent markings, as well as other forms of markings.

[0221] Figure 42 The variation using a single main core 202 is shown. Core 202 may include a single filament or cable as needed. Figure 43 This illustrates a variation in which ring 196 has another ring 230 laterally passing through the space 198 or opening of ring 196. Rings 196 and 230 form an elliptical spherical configuration, as shown... Figure 43 and 44 As shown in the image.

[0222] In some embodiments, a filler 240 is disposed within the space 198 of the ring 196. The filler 240 comprises a sheet of material spanning the space 198. In some embodiments, the filler 240 is provided for inward tissue growth, or in some embodiments it has another configuration.

[0223] Figure 46 An example is shown where material sheet 242 is used in combination with indicator 243. Material sheet 242 extends over indicator 243 and is used for tissue ingrown growth or, if needed, for another purpose. Indicator 243 operates in a manner similar to indicator 210, such as... Figure 47 and 48 The Chinese side indicated that...

[0224] about Figure 32-48 The disclosed features may be used alone or in conjunction with any of the examples disclosed herein.

[0225] Various improvements to the delivery system will now be disclosed. In the first example, Figure 49 A delivery system 250 is shown having an elongated shaft or catheter shaft 252 having a distal portion 254 and a proximal portion 256. The proximal portion 256 is coupled to a housing in the form of a handle 258 of the catheter shaft 252. The distal portion 254 includes an implant receiving area for holding an implant (e.g., a prosthetic heart valve) onto the catheter shaft 252.

[0226] In some implementations, the catheter shaft 252 is flexible to allow it to advance through the patient's vascular system, approaching the treatment or implantation site, in a manner similar to that described above. Figure 6 The delivery method can be open or different (e.g., transapical or direct to the right atrium for tricuspid valve deployment). The catheter shaft 252 is used to advance the prosthetic heart valve to the treatment or implantation site, such as an autologous mitral or tricuspid valve, or another autologous valve (e.g., an aortic or pulmonary valve). The catheter shaft can be steered to advance through the vascular system. Steering capability can be achieved by incorporating one or more drawstrings, which can be actuated by a knob on the handle 258.

[0227] In some embodiments, the catheter shaft 252 includes multiple shafts or sheaths that may overlap each other. In some embodiments, the multiple shafts or sheaths provide various functions, including a capsular sheath extending over a compressed or coiled implant to hold the implant within an implant receiving area, and / or shafts or sheaths holding the implant in place for deployment to a treatment or implantation site.

[0228] Now for reference Figure 50 The image shows a side view of the distal portion 254 of the catheter shaft 252. In some embodiments, the shaft or sheath includes a guidewire sheath 260 and a balloon sheath 262. In some embodiments, the guidewire sheath 260 includes an internal lumen 264 (in... Figure 52 The guidewire is marked (in the center) to allow the guidewire to pass through. In some embodiments, the distal portion of the guidewire sheath 260 is attached to the nasal body 266, which forms the tip of the catheter shaft 252.

[0229] In some embodiments, the sheath 262 includes a portion of the catheter shaft 252 that covers a receiving area of ​​the prosthetic heart valve. In some embodiments, the sheath 262 is used for advancement or retraction over an implant (not shown), wherein retraction of the sheath 262 allows the implant to expand radially outward and be deployed at the treatment or implantation site.

[0230] In some embodiments, the catheter shaft 252 features an implant retainer 268 coupled to the shaft or sheath of the catheter shaft 252. The implant retainer 268 retains a portion of the implant. For example, the implant retainer 268 retains a proximal portion of the implant and includes a groove for engaging an end tab portion of the implant, or may have another configuration as needed. For example, the implant retainer may include one or more sutures for releasable coupling to the implant. Other configurations of the implant retainer may be used.

[0231] In some implementations, a retention sheath 270 is used that extends over a portion of the implant to secure the implant to the catheter shaft 252. For example, the retention sheath 270 extends over the proximal portion of the implant to hold the implant to the implant retainer 268. Other forms of the retention sheath 270 may be used.

[0232] The catheter shaft 252 is used for extension within the patient's vascular system. The catheter shaft 252 can be passively deflected within the vascular system, or it can be actively deflected laterally as needed using a mechanism. Active deflection allows for control of advancement within the patient's vascular system.

[0233] In some embodiments, one or more components of the delivery system 250 include an imaging system. In some embodiments, the imaging system is used to image the vascular system of a subject's body from within the subject's vascular system. In some embodiments, the imaging may be performed as the delivery system 250 passes through the vascular system of the subject's body or during this period.

[0234] In some embodiments, the imaging system includes optical coherence tomography (OCT) or ultrasound imaging (e.g., intravascular ultrasound (IVUS)). The sensors of the imaging system are disposed on the delivery system 250, specifically on the elongated axis or catheter axis 252 of the delivery system 250. For example, see reference... Figure 49 The signal conduit 272 extends along the conduit axis 252 for transmitting signals from the sensor in order to receive and / or process signals.

[0235] In some embodiments, the sensors of the imaging system are positioned on the nasal body 266. For example, see reference... Figure 51 The nasal body 266 includes sensors 274 and 276, which can be used for imaging. In some embodiments, the nasal body 266 includes a distal surface 278, which is angled to face distally and may include sensor 274. The nasal body 266 further includes a proximal surface 280, which is angled to face proximally and includes sensor 276.

[0236] In some embodiments, sensor 274 allows imaging in a distal direction, and sensor 276 allows imaging in a proximal direction. In some embodiments, a signal conduit 282 extends from sensors 276, 274 to transmit signals from sensors 276, 274. The signal conduit 282 extends along the guidewire sheath 260 toward the shank of the conduit shaft.

[0237] In some implementations, the sensor can be used in other locations. For example, Figure 52 A view showing a portion of the guidewire sheath 260 is presented, showing the outer surface 284 of the guidewire sheath 260 and the inner surface 286 facing the inner lumen 264 of the guidewire. A sensor 288 provides radial imaging outward from the outer surface 284 of the guidewire sheath 260. A signal conduit 290 extends from the sensor 288 to transmit signals from the sensor 288. The signal conduit 290 extends proximally along the shank of the guidewire sheath 260 toward the conduit shaft.

[0238] In some implementations, the sensor can be used in other locations. For example, Figure 53A view showing a portion of the balloon sheath 262 is provided, illustrating the outer surface 292 of the balloon sheath 262 and the inner surface 294 of the lumen 296 facing the balloon sheath 262. A sensor 298 images radially outward from the outer surface 292 of the balloon sheath 262. A signal conduit 300 extends from the sensor 298 to transmit signals from the sensor 298. The signal conduit 300 extends proximally along the stem of the balloon sheath 262 toward the conduit shaft.

[0239] During operation, the imaging system can be used to image the implantation site and deploy the implant there. The imaging system can also be used to image the anchoring, including the connection between the implant's anchor and the leaflet of the autologous valve. Figure 54 and 55 Example methods or procedures are shown.

[0240] Figure 54 The advancement of the distal portion of the catheter shaft toward the implantation site is demonstrated. One or more sensors (e.g., sensor 274 and / or sensor 298) can be used to image the implantation site. Sensor 274, facing distally, can be used after approaching the implantation site.

[0241] exist Figure 55 In the middle, the capsule sheath 262 retracts, allowing the implant anchors 304a, 304b to expand radially outward. A sensor 276 on the nasal body 266, facing proximally, is used for imaging the deployment due to its proximal perspective. A sensor 288 on the guidewire sheath 260 may also be used. The implant can be positioned so as not to obstruct observation of leaflet capture in such a configuration. In some embodiments, a portion of the implant includes an opening or orifice to enable imaging of leaflet capture.

[0242] In some implementations, the position of the guidewire sheath 260 is axially adjusted as needed to alter the view provided by imaging. The guidewire sheath 260 is axially translated relative to the rest of the catheter axis. This change in the position of the guidewire sheath 260 alters the position of the nasal body 266 and the imaging provided by the nasal body 266. Therefore, the nasal body 266 is axially translated relative to the rest of the catheter axis. Figure 55 The image demonstrates anchor 304a capturing the leaflet and anchor 304b failing to capture the leaflet. The imaging system is used to image these captures and failed captures. The imaging plane is positioned at the plane where the leaflet was captured or failed to be captured. Other planes (proximal or distal) can be positioned if needed. If required, the implant can be redeployed so that anchor 304b captures the leaflet.

[0243] In some embodiments, signals from the imaging system are delivered via a wired connection to a processor for signal processing. In some embodiments, the signals are processed and displayed on a display 305, such as... Figure 49 The text indicates that, in some embodiments, ultrasound and / or OCT signals (e.g., optical signals) are processed to provide an image on a display. In some embodiments, two-dimensional images are processed and configured to form a three-dimensional image on display 305. Other forms of output may be used.

[0244] In some implementations, wireless signals from the imaging system are provided. For example, the sensor communicates wirelessly with a processing unit for processing signals from the sensor.

[0245] exist Figure 55 In the configuration shown, the sensor can be moved flexibly and advantageously, thereby altering the view of the deployment procedure. Advantageously, the sensor's position can improve the visualization of leaflet capture status or capture failure, as well as the visualization of the location of other features of the deployment procedure.

[0246] For illustrative purposes, various sensor types, locations, and combinations are described herein. However, it should be understood that the sensor concepts described above can be used alone or in combination with other concepts. The scope of this disclosure considers various other configurations of imaging systems.

[0247] For example, Figure 56 An example in which the guidewire 310 includes an imaging system is shown. The guidewire 310 includes a flexible guidewire body 312 with one or more sensors 314 located thereon.

[0248] In some implementations, the sensor is used for optical coherence tomography (OCT) or ultrasound imaging (e.g., intravascular ultrasound (IVUS)), as well as other forms of imaging.

[0249] The guidewire body 312 includes a non-invasive tip 313 at its distal portion and extends proximally to the proximal end of the guidewire.

[0250] Figure 57 A close-up perspective view of the guidewire body 312 is shown. A sensor conduit 316 extends spirally around a helical groove 318 in the guidewire body 312 and also has other configurations. The sensor conduit 316 transmits signals from the imaging system to the processor in a manner similar to that disclosed with respect to other imaging system sensors herein.

[0251] Figure 58 An example method or use of guidewire 310 is illustrated. Guidewire 310 extends within the lumen of guidewire sheath 260. An imaging system for the guidewire is used to image through guidewire sheath 260 via slots or openings 317 in guidewire sheath 260. In some embodiments, a portion of guidewire sheath 260 may be substantially transparent to the imaging form used by the imaging sensor.

[0252] exist Figure 58 In the example shown, the guidewire 310 may advance or retract relative to the guidewire sheath 260 as needed to change the imaging position (e.g., imaging plane) provided by the sensor 314. The position of the imaging system on the guidewire 310 facilitates better adjustment of the imaging plane position. Signals from the imaging system are processed in a manner similar to other imaging systems disclosed herein.

[0253] Figures 49-58 The features can be used alone or in combination with any other examples disclosed herein.

[0254] Additional improvements will now be described, wherein the delivery system is provided with additional degrees of freedom to facilitate the use, operation, and / or implantation of devices (e.g., prosthetic heart valves, therapeutic devices, etc.) that can be used with any of the various delivery systems described anywhere in this document.

[0255] In the first example, Figure 59 An actuation mechanism 320 is shown that is advantageously used to rotate an implant about the axis of catheter shaft 252. The actuation mechanism 320 rotates the implant about the axis relative to at least a portion of catheter shaft 252. For example, the actuation mechanism 320 rotates an implant retainer 268 to correspondingly rotate the implant. The implant retainer 268 is coupled to the implant during rotation. The implant retainer 268 rotates about the axis of catheter shaft 252 to correspondingly rotate the implant about the axis.

[0256] The actuating mechanism 320 can take various forms. For example, refer to... Figure 59 The actuation mechanism 320 includes a transmission assembly 321. The transmission assembly 321 converts a longitudinal force along the length of the catheter shaft 252 into a rotational force about the axis of the catheter shaft 252. The transmission assembly 321 converts linear or longitudinal movement of the actuator 322 into rotational movement of the implant retainer 268. For example, the implant retainer 268 is coupled to a gear body 324 or a threaded body at an angle such that the gear body 324 or threaded body rotates as a corresponding gear body 326 or threaded body slides along the axial direction of the gear body 324. Therefore, linear movement of the actuator 322 causes rotation of the implant retainer 268 via the transmission assembly 321.

[0257] In some embodiments, actuator 322 includes a shaft or sheath extending along the catheter shaft and operating at the proximal end of the delivery system. In some embodiments, actuator 322 moves linearly or longitudinally at the proximal end of the delivery system to rotate implant retainer 268.

[0258] Figure 60The illustration shows a configuration in which the actuator 330 includes a sheath having a pin 332 that engages with an inclined or cam surface of the body 334. The pin 332 moves linearly or longitudinally to rotate the body 334. An implant retainer 268 is coupled to the body 334. Thus, the linear or longitudinal movement of the actuator 330 causes the implant retainer 268 to rotate. Other types of actuators can be used for longitudinal or linear movement (e.g., sutures, wires, spools, cables, etc.). Other types of transmission mechanisms can be used as needed to convert longitudinal movement into rotational movement (e.g., gears, cams, screws, etc.). The longitudinal or linear movement of the actuator reduces the torque transmitted along the length of the catheter axis.

[0259] In some implementations, the actuator's movement is achieved through manual actuation by the user. For example, the user may manually operate the actuator at the proximal portion of the catheter shaft as needed. Various forms of manual actuation (e.g., knobs, levers, etc.) may be used as needed.

[0260] In some implementations, a motor is used to actuate the actuator. For example, see reference... Figure 61 The motor 340 moves the actuator longitudinally, thereby rotating the implant retainer 342. The implant retainer 342... Figure 61 The image shows a suture retainer (with suture 343 extending to connect with the implant), but in some embodiments, the retainer may use other forms.

[0261] In some embodiments, motor 340 may be operated by controller 344, which may receive signals from input device 346. Controller 344 may include a processor and memory to generate instructions to motor 340 based on input from input device 346. In some embodiments, direct user control of motor 340 may be implemented.

[0262] In some embodiments, the motor 340 is positioned at the proximal portion of the catheter shaft (e.g., at or near the handle). Reference Figure 62 In some implementations, the motor 350 is positioned within the catheter shaft and / or at the distal portion of the catheter shaft. Figure 62A motor 350 is shown positioned at the distal portion of the catheter shaft. In some embodiments, the motor drive shaft 352 extends to a transmission assembly in the form of one or more gears 354 for rotating the retainer sheath 360 to retain the implant onto the implant retainer 268 (not shown) and / or directly rotating the implant retainer 268. In some embodiments, the motor 350 is operated based on control signals provided by the catheter 362 extending to a controller 364, or otherwise by a user. In some embodiments, a power source (e.g., a battery) is positioned with the motor 350 to power the motor. In some embodiments, the power source is positioned at the proximal portion of the catheter shaft, where power is provided via the catheter 362. In some embodiments herein, various types of motors (e.g., stepper motors, micromotors, etc.) are used as needed.

[0263] In some implementations, the controller operates based on feedback signals provided from sensors during the deployment procedure. For example, if the feedback signal indicates that the implant needs to be rotated, the controller operates to automatically operate the motor to cause the implant to perform such rotation.

[0264] In some implementations, rotation of other sheaths of the catheter shaft or other components of the delivery system may be used.

[0265] During the procedure, rotation of the implant can position it in the desired location. For example, refer to... Figure 63 The diagram shows a top view of the implant anchors 380a to 380e relative to the leaflets 382a and 382b. Figure 63 As shown, anchors 380e and 380c are not in the desired position to hook (i.e., capture) the autologous leaflets 382a and 382b. More specifically, anchors 380e and 380c are positioned at the gap or suture between the autologous leaflets. Therefore, slight rotation of the implant is expected to position the anchors in a more desired location. Figure 64 As shown, rotation can adjust the position of anchors 380c and 380e relative to leaflets 382a and 382b. Figure 64 The anchors 380c and 380e shown are now positioned adjacent to the autologous leaflets 382a and 382b, and are therefore able to be anchored to them more securely.

[0266] In some implementations, the rotation of the implant can be relative to Figure 50 The implant is rotated along with the marked capsular sheath 262. In some embodiments, rotation of the implant can be performed simultaneously with rotation of the capsular sheath 262.

[0267] Other forms of actuation mechanisms may be used. For example, in some embodiments, an actuation mechanism with a rotating actuator may be used to rotate the implant accordingly.

[0268] In some implementations, other configurations may be used.

[0269] In other examples, the actuation mechanism on the delivery system can be used to change the depth of the implant, which advantageously provides another degree of freedom during use. For example, see reference... Figure 65 The actuation mechanism 390 includes a transmission assembly 392 for linearly or longitudinally advancing the implant retainer based on rotation of the actuator 394. The transmission assembly 392 is positioned at the distal portion of the catheter shaft. The actuator 394 is operable at the proximal portion of the catheter shaft for rotation by the user, thereby causing linear or longitudinal movement of the implant retainer 268. The actuator 394 includes a sheath or shaft or another means for generating a corresponding rotation at the distal portion of the catheter shaft.

[0270] In some embodiments, the transmission assembly 392 includes a gear system for transmitting forces to change the depth of the implant. The gear system includes one or more gears (e.g., worm gears) for changing the depth of the implant and causing a corresponding longitudinal or linear movement of the implant retainer 268, such as... Figure 65 As shown in the image.

[0271] Actuator 394 can be rotated manually. In some embodiments, motor 400 is used to rotate actuator 394. For example, see reference... Figure 66 A motor 400 is disposed at the proximal portion of the catheter shaft and is used to rotate the actuator 394 to cause linear or longitudinal movement of the implant retainer 268. The motor 400 operates in a similar manner to that disclosed herein in response to a controller. The motor is capable of changing the depth of the implant along the axis of the catheter shaft.

[0272] refer to Figure 67 In some embodiments, the motor 410 is positioned on the catheter shaft and / or at the distal portion of the catheter shaft. (See reference...) Figure 67 Motor 410 is coupled to control catheter 412, which extends along the catheter axis to controller 417. Motor 410 provides rotational force, which causes linear or longitudinal movement of implant retainer 268 via transmission assembly 392. In some embodiments, a motor for generating longitudinal movement (e.g., a linear motor) is used. Other forms of motors disclosed herein may be used.

[0273] In some implementations, the form of the implant retainer and the gear system can be varied. For example, Figure 68 An implant retainer 421 comprising one or more sutures and a transmission assembly 420 comprising multiple worm gears are shown.

[0274] Examples of this system are used in Figure 69Presented herein. The drive assembly 420 operates in response to the motor 410 to change the depth of the implant as needed. In some embodiments, the drive assembly 420 changes the depth of the implant relative to the capsular sheath 262. Changing the depth of the implant is used to position the implant at a desired location, which may be the implantation site. For example, changing the depth of the implant is used to capture a leaflet during deployment or otherwise position the implant at a desired location. Using the methods disclosed herein, feedback from sensors can be used to operate the motor 410 and control the depth as needed.

[0275] In some implementations, a combination of mechanisms for altering the depth and rotation of the implant can be provided.

[0276] Figures 59 to 69 The features can be used alone or in combination with any other examples disclosed herein.

[0277] In some implementations, a guide wire is used to transmit the actuation of the actuation mechanism. For example, see reference... Figure 70 The guidewire 430 extends along the catheter axis 432. The proximal portion 434 of the guidewire 430 engages with the motor 436, or may be otherwise manipulated by the user (e.g., manually). The guidewire 430 includes a keyed portion or engagement portion 438 for engagement with components coupled to the implant retainer 440.

[0278] In some embodiments, the engagement portion 438 may slide longitudinally within the catheter shaft until it engages with the engagement member 442 coupled to the implant retainer 440. For example, see reference... Figure 71 The engagement member 442 includes a pin biased toward the guide wire 430. In some embodiments, the guide wire body 444 includes a smooth surface or is not readily engaged with the engagement member 442. At a desired time, the engagement portion 438 slides to engage with the engagement member 442, for example as... Figure 72 As shown in the image.

[0279] refer to Figure 72 The engagement member 442 engages with the engagement portion 438, and rotation of the guidewire causes a corresponding rotation of the implant retainer 440. The guidewire slides longitudinally to disengage from the engagement member 442 at a desired time.

[0280] In some implementations, the rotation of the guidewire is generated by motor 436. In some implementations, the guidewire can be manually operated.

[0281] In some implementations, a coupling mechanism is used. For example, see reference... Figure 73Actuator 452 is used to selectively engage clamping body 450, which slides proximally or distally to selectively engage guidewire 454. Pressing clamping body 450 forward causes it to engage the outer surface of guidewire 454, as... Figure 74 As shown in the diagram. The implant retainer 456 rotates with the guidewire 454 as needed. In some embodiments, other forms of engagement may be used.

[0282] Figures 70-74 The features can be used alone or in combination with any other examples disclosed herein.

[0283] Variations of the systems and methods disclosed herein are possible and are taken into account.

[0284] Examples of prosthetic valves can be used in the mitral valve disclosed herein, or in other deployment sites, such as autologous tricuspid valves or other deployment sites, unless otherwise stated. They can also be used in aortic or pulmonary valve deployments, or other implantation sites.

[0285] The features in the examples can be used alone or in combination with other features disclosed herein.

[0286] Various modifications to the examples disclosed herein can be provided. Features of the examples can be modified, replaced, excluded, or combined as needed. Combinations of features between examples can be provided as needed. Combinations of features between examples can be provided, and other features of such examples can be excluded as needed.

[0287] The devices disclosed herein may include therapeutic devices, repair devices, replacement devices, prosthetic heart valves and / or other forms of implants, such as stents or filters, or diagnostic devices, etc. The device may be an expandable implant capable of moving from a compressed or undeployed state to an expanded or deployed state. The device may be a compressible implant for inward compression to have a reduced outer contour and for moving the implant to a compressed or undeployed state.

[0288] The examples disclosed herein can utilize various forms of delivery systems and / or devices. The delivery systems / devices disclosed herein can also be used for replacement and repair of the aorta, mitral valve, tricuspid valve, and pulmonary artery. Delivery systems / devices may include delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, etc.

[0289] The devices and systems disclosed herein can be used for transcatheter mitral or tricuspid valve implantation, as well as aortic valve implantation (TAVI) or replacement of other autologous heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein can be used for transarterial access to the patient's heart, including transfemoral access. The delivery devices and systems can be used for percutaneous catheter procedures, including transarterial procedures, which may be transfemoral. Alternatively, transapical procedures can be used. Transjugular procedures can be utilized. Other procedures can be used as needed.

[0290] Furthermore, the methods described herein are not limited to those specifically described, and may include methods using the systems and apparatus disclosed herein. The steps of the methods may be modified, excluded, or added using the systems, apparatus, and methods disclosed herein. In some embodiments, the examples disclosed herein may include systems for implantation in the human body.

[0291] For the purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, together and in various combinations and sub-combinations of each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed examples do not require the existence of any one or more specific advantages or problems solved. Features, elements, or combinations of one example may be incorporated into other examples herein.

[0292] Example 1: A prosthetic heart valve for deployment to an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passageway, the support structure comprising: an inner frame having an inlet portion and an outlet portion, and / or an outer frame including an inlet portion of the inlet portion coupled to the inner frame, the outer frame including a platform portion extending radially outward from the inlet portion of the outer frame to a shoulder of the outer frame, and / or the outer frame including an axial extension portion extending axially from the shoulder to the outlet portion of the outer frame, the shoulder tilting the platform portion relative to the axial extension portion, and / or the platform portion including a flexible feature allowing the platform portion to deflect to cause the inner frame to translate axially relative to the shoulder; and / or a valve portion positioned within the passageway of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow through the passageway in one direction to replace the function of the autologous heart valve.

[0293] Example 2: According to any example in this document, particularly Example 1, the prosthetic heart valve, wherein the flexible feature includes a portion of the strut of the outer frame that is more flexible than the adjacent portion of the strut.

[0294] Example 3: A prosthetic heart valve according to any example in this document, particularly any example 1 or example 2, wherein the flexible feature includes the undulating portion of the struts of the outer frame.

[0295] Example 4: A prosthetic heart valve according to any example in this document, particularly any of Examples 1 to 3, further includes one or more anchors coupled to the outlet portion of the inner frame, each of the one or more anchors having a hook shape.

[0296] Example 5: According to any example in this document, particularly Example 4, the prosthetic heart valve wherein the flexible feature allows the platform to partially deflect so that the one or more anchors are axially translated relative to the shoulder.

[0297] Example 6: According to any example in this document, particularly Example 5, each of the one or more anchors has a tip, and / or axial translation of the one or more anchors relative to the shoulder causes the tip of the respective anchor to move relative to the shoulder.

[0298] Example 7: A prosthetic heart valve according to any example in this document, particularly any of Examples 1 to 6, wherein the flexible feature allows the platform portion to deflect so that the inlet end portion of the inner frame is axially translated relative to the shoulder.

[0299] Example 8: A prosthetic heart valve according to any of the examples in this article, particularly any of Examples 1 to 7, wherein the outer frame is self-expanding.

[0300] Example 9: The prosthetic heart valve according to any of the examples in this document, particularly any of Examples 1 to 8, further includes a sealing skirt attached to the outer frame.

[0301] Example 10: A prosthetic heart valve according to any example in this document, particularly any of Examples 1 to 9, wherein the prosthetic heart valve is a replacement mitral heart valve or a replacement tricuspid heart valve.

[0302] Example 11: A method comprising: deploying a prosthetic heart valve onto an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passageway, the support structure comprising: an inner frame having an inlet portion and an outlet portion, and / or an outer frame including an inlet portion of the inlet portion coupled to the inner frame, the outer frame including a platform portion extending radially outwardly from the inlet portion of the outer frame to a shoulder of the outer frame, and / or the outer frame including an axially extending portion extending axially from the shoulder to an outlet portion of the outer frame, the shoulder tilting the platform portion relative to the axially extending portion, and / or the platform portion including a flexible feature allowing the platform portion to deflect to cause the inner frame to translate axially relative to the shoulder; and / or a valve portion positioned within the passageway of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow through the passageway in one direction to replace the function of the autologous heart valve.

[0303] Example 12: According to any example in this document, particularly Example 11, the method wherein the flexible feature includes a portion of the strut of the outer frame that is more flexible than the adjacent portion of the strut.

[0304] Example 13: The method according to any example in this document, particularly any example 11 or 12, wherein the flexible feature includes the undulating portion of the struts of the outer frame.

[0305] Example 14: The method according to any example in this document, particularly any of Examples 11 to 13, wherein one or more anchors are coupled to the outlet end portion of the inner frame, each of the one or more anchors having a hook shape.

[0306] Example 15: According to any example in this document, particularly Example 14, the method wherein the flexible feature allows the platform to partially deflect so that the one or more anchors translate axially relative to the shoulder.

[0307] Example 16: According to any example in this document, particularly Example 15, each of the one or more anchors has a tip, and / or axial translation of the one or more anchors relative to the shoulder causes the tip of the respective anchor to move relative to the shoulder.

[0308] Example 17: The method according to any example in this document, particularly any of Examples 11 to 16, wherein the flexible feature allows the platform portion to deflect so that the entrance end portion of the inner frame translates axially relative to the shoulder.

[0309] Example 18: The method described according to any of the examples in this document, particularly any of Examples 11 to 17, wherein the outer frame is self-expanding.

[0310] Example 19: The method according to any of the examples in this document, particularly any of Examples 11 to 18, wherein the sealing skirt is coupled to the outer frame.

[0311] Example 20: The method according to any of the examples in this document, particularly any of Examples 11 to 19, wherein the autologous heart valve is a mitral heart valve or a tricuspid heart valve.

[0312] Example 21: A prosthetic heart valve for deployment to an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow through the passage in one direction to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including an anchor arm that branches to form a plurality of forks that circumferentially diverge from each other.

[0313] Example 22: A prosthetic heart valve according to any example herein, particularly Example 21, wherein the anchor arm includes a split portion that bifurcates the anchor arm, and / or a rod portion positioned radially inward of the split portion, the rod portion being coupled to the outlet end portion of the support structure.

[0314] Example 23: A prosthetic heart valve according to any example in this document, particularly Example 22, wherein the rod portion has a circumferential width equal to or greater than the combination of the circumferential widths of each of the plurality of forks.

[0315] Example 24: A prosthetic heart valve according to any example in this document, particularly any example 22 or 23, wherein the one or more anchors include a plurality of said anchors, and / or the plurality of forks of said plurality of said anchors extend across the perimeter of said prosthetic heart valve by at least about 120 degrees.

[0316] Example 25: A prosthetic heart valve according to any example in this document, particularly any of Examples 21 to 24, wherein the one or more anchors include a plurality of said anchors, wherein one of said plurality of forks overlaps with one of the plurality of forks of a neighboring one of said plurality of anchors.

[0317] Example 26: A prosthetic heart valve according to any example in this document, particularly any of Examples 21 to 25, wherein the anchor arm includes a drooping ring and / or a split portion that bifurcates the anchor arm, the split portion being located outside the drooping ring.

[0318] Example 27: A prosthetic heart valve according to any example in this document, particularly any of Examples 21 to 26, wherein the support structure includes an inner frame having an inlet end portion and / or an outlet end portion, and / or an outer frame including an inlet end portion connected to the inner frame.

[0319] Example 28: A prosthetic heart valve according to any example in this document, particularly Example 27, wherein one or more anchors are coupled to the outlet portion of the inner frame.

[0320] Example 29: A prosthetic heart valve according to any of the examples in this document, particularly any of Examples 27 or 28, wherein the outer frame is self-expanding.

[0321] Example 30: A prosthetic heart valve according to any example in this document, particularly any of Examples 21 to 29, wherein the prosthetic heart valve is a replacement mitral heart valve or a replacement tricuspid heart valve.

[0322] Example 31: A method comprising: deploying a prosthetic heart valve onto an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow in one direction through the passage to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including an anchor arm that branches to form a plurality of forks that circumferentially diverge from each other.

[0323] Example 32: According to any example in this document, particularly Example 31, the method wherein the anchor arm includes a split portion that bifurcates the anchor arm, and / or a rod portion located radially inward of the split portion, the rod portion being coupled to the outlet end portion of the support structure.

[0324] Example 33: According to any example in this document, particularly Example 32, the method wherein the rod portion has a circumferential width equal to or greater than the combination of the circumferential widths of each of the plurality of forks.

[0325] Example 34: The method according to any example in this document, particularly any example 32 or 33, wherein the one or more anchors include a plurality of said anchors, and / or the plurality of forks of said plurality of said anchors extend across the perimeter of the prosthetic heart valve by at least about 120 degrees.

[0326] Example 35: The method according to any example in this document, particularly any of Examples 31 to 34, wherein the one or more anchors include a plurality of anchors, wherein one of the plurality of forks overlaps with one of the plurality of forks of a neighboring anchor.

[0327] Example 36: The method according to any example in this document, particularly any of Examples 31 to 35, wherein the anchor arm includes a sag ring and / or a split portion that bifurcates the anchor arm, the split portion being located outside the sag ring.

[0328] Example 37: The method according to any example in this document, particularly any of Examples 31 to 36, wherein the support structure includes an inner frame having an inlet end portion and / or an outlet end portion, and / or an outer frame including an inlet end portion connected to the inner frame.

[0329] Example 38: According to any example in this document, particularly Example 37, the method wherein one or more anchors are coupled to the outlet end portion of the inner frame.

[0330] Example 39: The method described according to any of the examples in this document, particularly any of the examples 37 or 38, wherein the outer frame is self-expanding.

[0331] Example 40: The method according to any of the examples in this document, particularly any of Examples 31 to 39, wherein the autologous heart valve is a mitral heart valve or a tricuspid heart valve.

[0332] Example 41: A prosthetic heart valve for deployment to an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow through the passage in one direction to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including a tip portion, the tip portion having undulations for increasing the flexibility of the tip portion.

[0333] Example 42: A prosthetic heart valve according to any example herein, particularly Example 41, wherein each of the anchors includes a strut arm having the tip portion having a circumferential width greater than the radial thickness of the tip portion of the strut arm.

[0334] Example 43: A prosthetic heart valve according to any example in this document, particularly any example 41 or 42, wherein the undulation extends in the circumferential direction on the tip portion.

[0335] Example 44: A prosthetic heart valve according to any example in this document, particularly any of Examples 41 to 43, wherein the undulation increases the flexibility of the tip portion in the radially inward direction.

[0336] Example 45: A prosthetic heart valve according to any example in this document, particularly any of Examples 41 to 44, wherein the undulation allows the tip portion to bend in a radially inward direction.

[0337] Example 46: A prosthetic heart valve according to any example in this document, particularly any of Examples 41 to 45, wherein the stiffness of the tip portion gradually decreases toward the end of the corresponding anchor.

[0338] Example 47: A prosthetic heart valve according to any example in this document, particularly any of Examples 41 to 46, wherein the support structure includes an inner frame having an inlet end portion and an outlet end portion, and / or an outer frame including an inlet end portion connected to the inner frame.

[0339] Example 48: A prosthetic heart valve according to any example herein, particularly Example 47, wherein one or more anchors are coupled to the outlet portion of the inner frame.

[0340] Example 49: A prosthetic heart valve according to any of the examples in this document, particularly any of Examples 47 or 48, wherein the outer frame is self-expanding.

[0341] Example 50: A prosthetic heart valve according to any example in this document, particularly any of Examples 41 to 49, wherein the prosthetic heart valve is a replacement mitral heart valve or a replacement tricuspid heart valve.

[0342] Example 51: A method comprising deploying a prosthetic heart valve onto an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow in one direction through the passage to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including a tip portion having undulations for increasing the flexibility of the tip portion.

[0343] Example 52: According to any example in this document, particularly Example 51, each of the anchors includes a strut arm having the tip portion having a circumferential width greater than the radial thickness of the tip portion of the strut arm.

[0344] Example 53: The method according to any of the examples in this document, particularly any of the examples 51 or 52, wherein the undulation extends in the circumferential direction on the tip portion.

[0345] Example 54: The method according to any of the examples in this document, particularly any of Examples 51 to 53, wherein the undulation increases the flexibility of the tip portion in the radially inward direction.

[0346] Example 55: The method according to any of the examples in this document, particularly any of Examples 51 to 54, wherein the undulation allows the tip portion to bend in a radially inward direction.

[0347] Example 56: The method described in any of the examples in this document, particularly any of Examples 51 to 55, wherein the stiffness of the tip portion gradually decreases toward the end of the corresponding anchor.

[0348] Example 57: The method according to any example in this document, particularly any of Examples 51 to 56, wherein the support structure includes an inner frame having an inlet end portion and an outlet end portion, and / or an outer frame including an inlet end portion connected to the inner frame.

[0349] Example 58: According to any example in this document, particularly Example 57, the method wherein one or more anchors are coupled to the outlet end portion of the inner frame.

[0350] Example 59: The method described according to any of the examples in this document, particularly any of the examples 57 or 58, wherein the outer frame is self-expanding.

[0351] Example 60: The method according to any of the examples in this document, particularly any of Examples 51 to 59, wherein the autologous heart valve is a mitral heart valve or a tricuspid heart valve.

[0352] Example 61: A prosthetic heart valve for deployment to an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow through the passage in one direction to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including a tip portion having a compliant weave.

[0353] Example 62: A prosthetic heart valve according to any example in this document, particularly Example 61, wherein the compliant braid comprises a braided ribbon.

[0354] Example 63: A prosthetic heart valve according to any example in this document, particularly any example 61 or 62, wherein each of the one or more anchors includes a strut arm, and / or the compliant braid extends from the axial end surface of the strut arm.

[0355] Example 64: A prosthetic heart valve according to any example in this document, particularly any of Examples 61 to 63, wherein each of the one or more anchors includes a strut arm, and / or the compliant fabric covers the radially outward-facing surface of the strut arm.

[0356] Example 65: A prosthetic heart valve according to any example in this document, particularly Example 64, wherein the compliant weave is offset to extend further from the strut arm in the radially outward direction than in the radially inward direction.

[0357] Example 66: A prosthetic heart valve according to any of the examples in this document, particularly any of Examples 61 to 65, wherein the compliant fabric has a bulb shape.

[0358] Example 67: A prosthetic heart valve according to any example in this document, particularly any of Examples 61 to 66, wherein the support structure includes an inner frame having an inlet end portion and an outlet end portion, and / or an outer frame including an inlet end portion connected to the inner frame.

[0359] Example 68: A prosthetic heart valve according to any example herein, particularly Example 67, wherein one or more anchors are coupled to the outlet portion of the inner frame.

[0360] Example 69: A prosthetic heart valve according to any of the examples in this document, particularly any of Examples 67 or 68, wherein the outer frame is self-expanding.

[0361] Example 70: A prosthetic heart valve according to any of the examples in this document, particularly any of Examples 61 to 69, wherein the prosthetic heart valve is a replacement mitral heart valve or a replacement tricuspid heart valve.

[0362] Example 71: A method comprising deploying a prosthetic heart valve onto an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow in one direction through the passage to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including a tip portion having a compliant weave.

[0363] Example 72: The method described in any of the examples herein, particularly Example 71, wherein the compliant weave comprises a woven ribbon.

[0364] Example 73: The method according to any example in this document, particularly any example 71 or 72, wherein each of the one or more anchors includes a strut arm, and / or the compliant fabric extends from the axial end surface of the strut arm.

[0365] Example 74: The method according to any example in this document, particularly any of Examples 71 to 73, wherein each of the one or more anchors includes a strut arm, and / or the compliant fabric covers the radially outward-facing surface of the strut arm.

[0366] Example 75: According to any example in this document, particularly Example 74, the compliant weave is offset to extend further from the strut arm in the radially outward direction than in the radially inward direction.

[0367] Example 76: The method according to any of the examples in this document, particularly any of Examples 71 to 75, wherein the compliant fabric has a bulb shape.

[0368] Example 77: The method according to any example in this document, particularly any of Examples 71 to 76, wherein the support structure includes an inner frame having an inlet end portion and an outlet end portion, and an outer frame including an inlet end portion connected to the inner frame.

[0369] Example 78: The method described in any of the examples herein, particularly Example 77, wherein one or more anchors are coupled to the outlet end portion of the inner frame.

[0370] Example 79: The method described according to any of the examples in this document, particularly any of the examples 77 or 78, wherein the outer frame is self-expanding.

[0371] Example 80: The method according to any of the examples in this document, particularly any of Examples 71 to 79, wherein the autologous heart valve is a mitral heart valve or a tricuspid heart valve.

[0372] Example 81: A prosthetic heart valve for deployment to an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow through the passage in one direction to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including a tip portion having a ring.

[0373] Example 82: A prosthetic heart valve according to any example in this document, particularly Example 81, wherein the ring increases the flexibility of the tip portion.

[0374] Example 83: A prosthetic heart valve according to any example in this document, particularly any example 81 or 82, wherein each of the one or more anchors includes an anchor arm, and / or the ring includes a continuous extension of material enclosing an internal space.

[0375] Example 84: A prosthetic heart valve according to any of the examples herein, particularly any of Examples 81 to 83, wherein the ring comprises a core, a core cover extending over the core, and / or a lubricating coating extending over the core cover.

[0376] Example 85: According to any example in this document, particularly any of Examples 81 to 84, the prosthetic heart valve further includes a capture indicator at the tip portion of the ring, the capture indicator being used to indicate capture of the leaflet of the autologous heart valve by the corresponding of the one or more anchors.

[0377] Example 86: A prosthetic heart valve according to any of the examples in this article, particularly any of Examples 81 to 85, wherein the ring is capable of deflecting in a radially inward direction.

[0378] Example 87: A prosthetic heart valve according to any example herein, particularly any of Examples 81 to 86, wherein the support structure includes an inner frame having an inlet end portion and an outlet end portion, and / or an outer frame including an inlet end portion connected to the inner frame.

[0379] Example 88: A prosthetic heart valve according to any example herein, particularly Example 87, wherein one or more anchors are coupled to the outlet portion of the inner frame.

[0380] Example 89: A prosthetic heart valve according to any of the examples in this document, particularly any of Examples 87 or 88, wherein the outer frame is self-expanding.

[0381] Example 90: A prosthetic heart valve according to any example in this document, particularly any of Examples 81 to 89, wherein the prosthetic heart valve is a replacement mitral heart valve or a replacement tricuspid heart valve.

[0382] Example 91: A method comprising deploying a prosthetic heart valve onto an autologous heart valve, the prosthetic heart valve comprising: a support structure having an inlet portion and an outlet portion and a passage; a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of prosthetic valve leaflets, wherein the valve portion allows blood to flow in one direction through the passage to replace the function of the autologous heart valve; and / or one or more anchors extending radially outward from the support structure, each of the one or more anchors having a hook shape and / or including a tip portion having a ring.

[0383] Example 92: The method according to any example in this document, particularly Example 91, wherein the ring increases the flexibility of the tip portion.

[0384] Example 93: The method according to any example in this document, particularly any example 91 or 92, wherein each of the one or more anchors includes an anchor arm, and / or the ring includes a continuous extension of material enclosing an interior space.

[0385] Example 94: The method according to any of the examples in this document, particularly any of Examples 91 to 93, wherein the ring includes a core, a core cover extending over the core, and / or a lubricating coating extending over the core cover.

[0386] Example 95: The method according to any of the examples herein, particularly any of Examples 91 to 94, further includes a capture indicator at the tip portion of the ring, the capture indicator being used to indicate capture of the leaflet of the autologous heart valve by the corresponding of the one or more anchors.

[0387] Example 96: The method according to any of the examples in this document, particularly any of Examples 91 to 95, wherein the ring is capable of deflecting in a radially inward direction.

[0388] Example 97: The method according to any example in this document, particularly any of Examples 91 to 96, wherein the support structure includes an inner frame having an inlet end portion and an outlet end portion, and / or an outer frame including an inlet end portion connected to the inner frame.

[0389] Example 98: The method described in any of the examples herein, particularly Example 97, wherein one or more anchors are coupled to the outlet end portion of the inner frame.

[0390] Example 99: The method described according to any of the examples in this document, particularly any of the examples 97 or 98, wherein the outer frame is self-expanding.

[0391] Example 100: The method according to any example in this document, particularly any of Examples 91 to 99, wherein the autologous heart valve is a mitral heart valve or a tricuspid heart valve.

[0392] Example 101: A delivery system for a prosthetic heart valve, the delivery system comprising: a catheter shaft for advancing the prosthetic heart valve to a treatment or implantation site and extending along an axis, the catheter shaft including a proximal portion and a distal portion, at least a portion of the catheter shaft including a receiving region for the prosthetic heart valve; and / or an actuation mechanism for rotating the prosthetic heart valve about the axis of the catheter shaft.

[0393] Example 102: A delivery system according to any example herein, particularly Example 101, wherein the actuation mechanism is used to rotate the prosthetic heart valve about the axis of the catheter shaft relative to at least a portion of the catheter shaft.

[0394] Example 103: A delivery system according to any example in this document, particularly any example 101 or 102, wherein the catheter shaft includes a sac extending over the receiving area, and / or the actuation mechanism is used to rotate the prosthetic heart valve relative to the sac.

[0395] Example 104: A delivery system according to any of the examples herein, particularly any of Examples 101 to 103, wherein the actuation mechanism includes a motor for rotating the prosthetic heart valve about the axis of the catheter shaft.

[0396] Example 105: A delivery system according to any example herein, particularly Example 104, wherein the motor is located at the distal portion of the conduit shaft.

[0397] Example 106: A delivery system according to any of the examples herein, particularly any of Examples 101 to 105, wherein the actuation mechanism is used to rotate the retainer to retain the prosthetic heart valve onto the catheter shaft.

[0398] Example 107: A delivery system according to any example herein, particularly Example 106, wherein the actuation mechanism is used to rotate the retainer and / or the prosthetic heart valve, wherein the prosthetic heart valve is held onto the retainer.

[0399] Example 108: A delivery system according to any example in this document, particularly any of Examples 101 to 107, wherein the actuation mechanism is used to convert a longitudinal force along the length of the catheter axis into a rotational force about the axis, thereby causing the prosthetic heart valve to rotate about the axis of the catheter axis.

[0400] Example 109: A delivery system according to any example herein, particularly any of Examples 101 to 108, further includes the prosthetic heart valve, wherein the prosthetic heart valve includes anchors, each anchor having a hook shape to capture the leaflets of the autologous heart valve, and / or wherein rotation of the prosthetic heart valve by the actuation mechanism causes the anchors to rotate relative to the leaflets of the autologous heart valve.

[0401] Example 110: A delivery system according to any example in this document, particularly any of Examples 101 to 109, wherein the delivery system includes a mitral valve replacement heart valve delivery system or a tricuspid valve replacement heart valve delivery system.

[0402] Example 111: A method comprising deploying a prosthetic heart valve onto an autologous heart valve using a delivery system, the delivery system comprising: a catheter shaft for advancing the prosthetic heart valve onto the autologous heart valve and extending along an axis, the catheter shaft including a proximal portion and a distal portion, at least a portion of the catheter shaft including a receiving region for the prosthetic heart valve, and / or an actuation mechanism for rotating the prosthetic heart valve about the axis of the catheter shaft.

[0403] Example 112: The method according to any example herein, particularly Example 111, wherein the actuation mechanism is used to rotate the prosthetic heart valve about the axis of the catheter shaft relative to at least a portion of the catheter shaft.

[0404] Example 113: The method according to any of the examples in this document, particularly any of the examples 111 or 112, wherein the catheter shaft includes a sac extending over the receiving area, and / or the actuation mechanism is used to rotate the prosthetic heart valve relative to the sac.

[0405] Example 114: The method according to any of the examples herein, particularly any of Examples 111 to 113, wherein the actuation mechanism includes a motor for rotating the prosthetic heart valve about the axis of the catheter shaft.

[0406] Example 115: The method according to any example in this document, particularly Example 114, wherein the motor is positioned at the distal portion of the conduit shaft.

[0407] Example 116: The method according to any of the examples herein, particularly any of Examples 111 to 115, wherein the actuation mechanism is used to convert a longitudinal force along the length of the catheter axis into a rotational force about the axis, thereby causing the prosthetic heart valve to rotate about the axis of the catheter axis.

[0408] Example 117: The method according to any of the examples in this document, particularly any of Examples 111 to 116, wherein the actuation mechanism is used to rotate the retainer to retain the prosthetic heart valve onto the catheter shaft.

[0409] Example 118: The method according to any example herein, particularly Example 117, wherein the actuation mechanism is used to rotate the retainer and / or the prosthetic heart valve, wherein the prosthetic heart valve is held onto the retainer.

[0410] Example 119: The method according to any example herein, particularly any of Examples 111 to 118, further includes the prosthetic heart valve, wherein the prosthetic heart valve includes anchors, each anchor having a hook shape to capture the leaflets of the autologous heart valve, and / or wherein rotation of the prosthetic heart valve by the actuation mechanism causes the anchors to rotate relative to the leaflets of the autologous heart valve.

[0411] Example 120: The method according to any of the examples in this document, particularly any of Examples 111 to 119, wherein the autologous heart valve is a mitral heart valve or a tricuspid heart valve.

[0412] Example 121: A delivery system for a prosthetic heart valve, the delivery system comprising: a catheter shaft for advancing the prosthetic heart valve to a treatment or implantation site and extending along an axis, the catheter shaft including a proximal portion and a distal portion, at least a portion of the catheter shaft including a receiving area for the prosthetic heart valve; and / or a motor positioned at the distal portion of the catheter shaft and / or for changing the depth of the prosthetic heart valve along the axis relative to at least a portion of the catheter shaft.

[0413] Example 122: The delivery system according to any example herein, particularly Example 121, further includes a transmission assembly for transmitting the force provided by the motor to change the depth of the prosthetic heart valve along the axis.

[0414] Example 123: A delivery system according to any example herein, particularly Example 122, wherein the transmission assembly includes one or more gears that transmit the force provided by the motor to change the depth of the prosthetic heart valve along the axis.

[0415] Example 124: A delivery system according to any of the examples herein, particularly Example 123, wherein the one or more gears include one or more worm gears.

[0416] Example 125: A delivery system according to any example herein, particularly any of Examples 121 to 124, wherein the catheter shaft includes a sac for extending over the prosthetic heart valve, and / or the motor is used to change the depth of the prosthetic heart valve relative to the sac.

[0417] Example 126: The delivery system according to any of the examples herein, particularly any of Examples 121 to 125, further includes a controller for operating the motor.

[0418] Example 127: The delivery system according to any example herein, particularly Example 126, further includes one or more control conduits that extend along the conduit axis and / or connect the controller to the motor.

[0419] Example 128: A delivery system according to any of the examples in this document, particularly any of Examples 121 to 127, wherein the motor is used to generate rotational force to cause the prosthetic heart valve to move linearly.

[0420] Example 129: A delivery system according to any example herein, particularly any of Examples 121 to 128, further includes the prosthetic heart valve, wherein the prosthetic heart valve includes anchors, each anchor having a hook shape to capture the leaflets of the autologous heart valve, and / or wherein rotation of the prosthetic heart valve by the actuation mechanism causes the anchors to rotate relative to the leaflets of the autologous heart valve.

[0421] Example 130: A delivery system according to any example in this document, particularly any of Examples 121 to 129, wherein the delivery system includes a mitral valve replacement heart valve delivery system or a tricuspid valve replacement heart valve delivery system.

[0422] Example 131: A method comprising deploying a prosthetic heart valve onto an autologous heart valve using a delivery system, the delivery system comprising: a catheter shaft for advancing the prosthetic heart valve onto the autologous heart valve and extending along an axis, the catheter shaft including a proximal portion and a distal portion, at least a portion of the catheter shaft including a receiving region for the prosthetic heart valve; and / or a motor positioned at the distal portion of the catheter shaft and / or for changing the depth of the prosthetic heart valve along the axis relative to at least a portion of the catheter shaft.

[0423] Example 132: The method according to any example in this document, particularly Example 131, wherein the transmission assembly transmits the force provided by the motor to change the depth of the prosthetic heart valve along the axis.

[0424] Example 133: According to any example in this document, particularly Example 132, the method wherein the transmission assembly includes one or more gears that transmit the force provided by the motor to change the depth of the prosthetic heart valve along the axis.

[0425] Example 134: The method according to any example in this document, particularly Example 133, wherein the one or more gears include one or more worm gears.

[0426] Example 135: The method according to any example in this document, particularly any of Examples 131 to 134, wherein the catheter shaft includes a sac for extending over the prosthetic heart valve, and / or the motor is used to change the depth of the prosthetic heart valve relative to the sac.

[0427] Example 136: The method according to any of the examples in this document, particularly any of Examples 131 to 135, further includes operating the motor using a controller.

[0428] Example 137: The method according to any example in this document, particularly Example 136, wherein one or more control conduits extend along the conduit axis and / or connect the controller to the motor.

[0429] Example 138: The method according to any of the examples in this document, particularly any of Examples 131 to 137, wherein the motor is used to generate rotational force to cause the prosthetic heart valve to move linearly.

[0430] Example 139: The method according to any example herein, particularly any of Examples 131 to 138, wherein the prosthetic heart valve includes anchors, each anchor having a hook shape to capture the leaflets of the autologous heart valve, and / or wherein rotation of the prosthetic heart valve by the actuation mechanism causes the anchors to rotate relative to the leaflets of the autologous heart valve.

[0431] Example 140: The method according to any example in this document, particularly any of Examples 131 to 139, wherein the autologous heart valve is a mitral heart valve or a tricuspid heart valve.

[0432] Example 141: A delivery system for a prosthetic heart valve, the delivery system comprising: a catheter shaft for advancing the prosthetic heart valve to a treatment or implantation site, the catheter shaft including a proximal portion and a distal portion, the catheter shaft including a nasal body and a sheath having a distal portion attached to the nasal body, the sheath including an internal lumen for a guidewire to pass through, and a portion of the catheter shaft including a receiving area for the prosthetic heart valve; and / or an imaging system coupled to one or more of the nasal body or the sheath, the imaging system being used to image the vascular system of a subject's body from within the subject's vascular system.

[0433] Example 142: A delivery system according to any example herein, particularly Example 141, wherein the imaging system includes an optical coherence tomography imaging system.

[0434] Example 143: A delivery system according to any example herein, particularly any example 141 or 142, wherein the imaging system includes an ultrasound imaging system.

[0435] Example 144: A delivery system according to any of the examples in this document, particularly any of Examples 141 to 143, wherein the nasal body is used for axial translation relative to another portion of the catheter axis.

[0436] Example 145: A delivery system according to any of the examples in this document, particularly any of Examples 141 to 144, wherein the sheath is used for axial translation relative to another portion of the catheter axis.

[0437] Example 146: A delivery system according to any of the examples herein, particularly any of Examples 141 to 145, further includes one or more signal conduits extending along the conduit axis and for transmitting signals from the imaging system.

[0438] Example 147: A delivery system according to any of the examples herein, particularly any of Examples 141 to 146, wherein the catheter shaft includes a balloon sheath for extending over the receiving area.

[0439] Example 148: A delivery system according to any of the examples herein, particularly any of Examples 141 to 147, further includes a handle positioned at the proximal portion of the catheter shaft.

[0440] Example 149: A delivery system according to any of the examples herein, particularly any of Examples 141 to 148, further includes the prosthetic heart valve, wherein the prosthetic heart valve includes anchors, each anchor having a hook shape to capture the leaflets of an autologous heart valve.

[0441] Example 150: A delivery system according to any example in this document, particularly any of Examples 141 to 149, wherein the delivery system includes a mitral valve replacement heart valve delivery system or a tricuspid valve replacement heart valve delivery system.

[0442] Example 151: A method comprising imaging a subject's vascular system from within the subject's vascular system using an imaging system coupled to one or more of a nasal body or sheath of a catheter shaft for advancing a prosthetic heart valve to a treatment or implantation site, the catheter shaft including a proximal portion and a distal portion, the catheter shaft including the nasal body and the sheath, the sheath having a distal portion attached to the nasal body and having an internal lumen for a guidewire to pass through therethrough, and / or a portion of the catheter shaft including a receiving area for the prosthetic heart valve.

[0443] Example 152: The method according to any example herein, particularly Example 151, wherein the imaging system includes an optical coherence tomography imaging system.

[0444] Example 153: The method according to any example in this document, particularly any example 151 or 152, wherein the imaging system includes an ultrasound imaging system.

[0445] Example 154: The method according to any of the examples in this document, particularly any of Examples 151 to 153, wherein the nasal body is used for axial translation relative to another portion of the duct axis.

[0446] Example 155: The method according to any of the examples in this document, particularly any of Examples 151 to 154, wherein the sheath is used for axial translation relative to another portion of the catheter axis.

[0447] Example 156: The method according to any example in this document, particularly any of Examples 151 to 155, wherein one or more signal conduits extend along the conduit axis and are used to transmit signals from the imaging system.

[0448] Example 157: The method according to any of the examples in this document, particularly any of Examples 151 to 156, wherein the catheter shaft includes a balloon sheath for extending over the receiving area.

[0449] Example 158: The method according to any of the examples in this document, particularly any of Examples 151 to 157, wherein the handle is positioned at the proximal portion of the catheter shaft.

[0450] Example 159: The method according to any of the examples in this document, particularly any of Examples 151 to 158, wherein the prosthetic heart valve includes anchors, each anchor having a hook shape to capture the leaflets of the autologous heart valve.

[0451] Example 160: The method according to any example in this document, particularly any of Examples 151 to 159, wherein the catheter shaft has a mitral valve replacement heart valve delivery system or a tricuspid valve replacement heart valve delivery system.

[0452] Example 161: A guidewire system for a prosthetic heart valve delivery system, the guidewire system comprising: a guidewire body having a proximal portion and a distal portion; and an imaging system coupled to the guidewire body, the imaging system being used to image the vascular system of the subject's body from within the subject's vascular system.

[0453] Example 162: A guidewire system according to any example herein, particularly Example 161, wherein the imaging system includes an optical coherence tomography imaging system.

[0454] Example 163: A guidewire system according to any example in this document, particularly any example 161 or 162, wherein the imaging system includes an ultrasound imaging system.

[0455] Example 164: A guidewire system according to any example in this document, particularly any of Examples 161 to 163, wherein the distal portion of the guidewire body includes a tip that does not cause trauma.

[0456] Example 165: A guidewire system according to any of the examples herein, particularly any of Examples 161 to 164, further includes one or more catheters extending along the guidewire body and / or for transmitting signals from the imaging system to a processor.

[0457] Example 166: A method comprising imaging the vascular system of a subject's body from within the subject's vascular system using an imaging system coupled to a guidewire body.

[0458] Example 167: The method according to any example herein, particularly Example 166, wherein the imaging system includes an optical coherence tomography imaging system.

[0459] Example 168: The method according to any of the examples herein, particularly any of Example 166 or Example 167, wherein the imaging system includes an ultrasound imaging system.

[0460] Example 169: The method according to any of the examples in this document, particularly any of Examples 166 to 168, wherein the distal portion of the guidewire body includes a tip that does not cause trauma.

[0461] Example 170: The method according to any of the examples in this document, particularly any of Examples 166 to 169, wherein one or more catheters extend along the guidewire body to transmit signals from the imaging system to the processor.

[0462] Example 171: A device for use at or deployed to an autologous heart valve, the device comprising: (1) a support structure including a proximal portion and a distal portion; and (2) one or more anchors extending radially outward from or capable of extending radially outward from the support structure, wherein the one or more anchors comprises one or more of the following: (a) a hook shape, (b) an anchor arm that branches into a plurality of forks that diverge circumferentially from each other, (c) a tip portion having undulations to increase its own flexibility, (d) a tip portion having a braid, and / or (e) a tip portion having a ring.

[0463] Example 172: The apparatus according to Example 171, wherein the proximal portion is an inlet portion, the distal portion is an outlet portion, and / or a passage extends between the inlet portion and the outlet portion.

[0464] Example 173: The apparatus according to any one of Examples 171 to 172, wherein the support structure includes an inner frame having a proximal portion and a distal portion.

[0465] Example 174: The apparatus according to Example 173, wherein the support structure further includes an outer frame, the outer frame including a proximal portion.

[0466] Example 175: The apparatus according to Example 174, wherein the proximal portion of the outer frame is coupled to the proximal portion of the inner frame.

[0467] Example 176: The apparatus according to any one of claims 171 to 175, wherein the support structure includes a platform portion extending radially outward from the proximal portion of the support structure to a shoulder of the support structure.

[0468] Example 177: The apparatus according to Example 176, wherein the support structure includes an axially extending portion that extends axially from the shoulder to the distal portion of the support structure, the shoulder causing the platform portion to tilt relative to the axially extending portion.

[0469] Example 178: An apparatus according to any one of Examples 171 to 177, wherein the platform portion includes a flexible feature that allows the platform portion to deflect to cause the inner frame to translate axially relative to the shoulder.

[0470] Example 179: The apparatus according to Example 178, wherein the flexible feature includes a portion of the strut of the support structure that is more flexible than the adjacent portion of the strut.

[0471] Example 180: The apparatus according to any one of Examples 178 to 179, wherein the flexible feature includes the undulating portion of the struts of the outer frame.

[0472] Example 181: The device according to any one of Examples 171 to 180, wherein the device is a prosthetic heart valve capable of being deployed at an autologous heart valve.

[0473] Example 182: The device according to any one of Examples 171 to 181 further includes a valve portion positioned within a passage of the support structure, wherein the valve portion allows blood to flow through the passage in one direction but prevents blood from flowing in the opposite direction.

[0474] Example 183: The device according to Example 182, wherein the valve portion includes a plurality of prosthetic valve leaflets.

[0475] Example 184: The apparatus according to any one of Examples 171 to 183 further includes one or more anchors connected to the distal portion of the support structure.

[0476] Example 185: The apparatus according to Example 184, wherein each of the one or more anchors has a hook shape.

[0477] Example 186: The apparatus according to any one of Examples 184 to 185, wherein each of the one or more anchoring elements includes an anchor arm that branches to form a plurality of forks that diverge from each other.

[0478] Example 187: The apparatus according to Example 186, wherein the anchor arm includes a split portion that bifurcates the anchor arm, and / or a rod portion positioned radially inward of the split portion.

[0479] Example 188: The apparatus according to Example 187, wherein the rod portion has a circumferential width equal to or greater than the combination of the circumferential widths of each of the plurality of forks.

[0480] Example 189: The device according to any one of Examples 187 or 188, wherein the one or more anchors include a plurality of said anchors, and / or the plurality of forks of said plurality of said anchors extend across the perimeter of the device by at least about 120 degrees.

[0481] Example 190: The apparatus according to any one of Examples 184 to 189, wherein each of the one or more anchors includes a tip portion having undulations for increasing the flexibility of the tip portion.

[0482] Example 191: The device according to Example 190, wherein the undulation extends in the circumferential direction on the tip portion.

[0483] Example 192: The apparatus according to any one of Examples 190 to 191, wherein each of the one or more anchoring members includes a strut arm having the tip portion, the tip portion of the strut arm having a circumferential width greater than the radial thickness of the tip portion of the strut arm.

[0484] Example 193: The device according to any one of Examples 190 to 192, wherein the undulation increases the flexibility of the tip portion in the radially inward direction.

[0485] Example 194: The device according to any one of Examples 184 to 193, wherein each of the one or more anchors includes a tip portion having a braid.

[0486] Example 195: The apparatus according to Example 194, wherein the knitted fabric is a compliant knitted fabric.

[0487] Example 196: The apparatus according to Example 195, wherein the compliant weave is a woven ribbon.

[0488] Example 197: The apparatus according to any one of Examples 194 to 196, wherein each of the one or more anchors includes a strut arm, and / or the fabric covers the radially outward-facing surface of the strut arm.

[0489] Example 198: The apparatus according to Example 197, wherein the braid is offset to extend further from the strut arm in the radially outward direction than in the radially inward direction.

[0490] Example 199: The device according to any one of Examples 184 to 198, wherein each of the one or more anchors includes a tip portion having a ring.

[0491] Example 200: The device according to Example 199, wherein the ring increases the flexibility of the tip portion.

[0492] Example 201: The apparatus according to any one of Examples 199 or 200, wherein each of the one or more anchors comprises an anchor arm, and / or the ring comprises a continuous extension of material enclosing an interior space.

[0493] Example 202: The apparatus according to any one of Examples 199 to 201, wherein the ring includes a core, a core cover extending over the core, and / or a lubricating coating extending over the core cover.

[0494] Example 203: A delivery system for a device, the delivery system including a catheter shaft for advancing the device into a treatment site within a subject (e.g., within a live animal or a simulator) and extending along an axis, the catheter shaft including a proximal portion and a distal portion, at least a portion of the catheter shaft including a receiving area for the device.

[0495] Example 204: The delivery system according to Example 203 further includes an actuation mechanism for rotating the device about the axis of the conduit shaft.

[0496] Example 205: A delivery system according to Example 204, wherein the actuation mechanism is used to rotate the device about the axis of the catheter shaft relative to at least a portion of the catheter shaft.

[0497] Example 206: A delivery system according to any one of Examples 203 to 205, wherein the catheter shaft includes a pouch extending over the receiving area, and / or the actuation mechanism is used to rotate the device relative to the pouch.

[0498] Example 207: A delivery system according to any one of Examples 203 to 206, wherein the actuation mechanism includes a motor for rotating the device about the axis of the conduit shaft.

[0499] Example 208: A delivery system according to any one of Examples 203 to 207, further comprising a motor positioned at the distal portion of the catheter shaft and for rotating the device and / or changing the depth of the device along the axis relative to at least a portion of the catheter shaft.

[0500] Example 209: The delivery system according to any one of Examples 203 to 208 further includes an imaging system directly or indirectly coupled to the conduit shaft, the imaging system being used to image the interior of the subject's body from within the subject's body.

[0501] Example 210: The delivery system according to any one of Examples 203 to 209 further includes a guidewire system comprising: (a) a guidewire body having a proximal portion and a distal portion; and (b) an imaging system coupled to the guidewire body, the imaging system being used to image the interior of the subject's body from within the subject's body.

[0502] Any feature of any example, including but not limited to any feature of any of the first to 170 examples above, applies to all other aspects and examples identified herein, including but not limited to any example of any of the first to 170 examples above. Furthermore, any feature of one example among the various examples, including but not limited to any example of any of the first to 170 examples above, may be independently combined, in any way, partially or completely combined with other examples described herein; for example, one, two, or three or more examples may be combined completely or partially. Furthermore, any feature of the various examples, including but not limited to any example of any of the first to 170 examples above, may be optional for other examples. Any example of a method may be executed by a system or device of another example, and any aspect or example of a system or device may be configured to execute a method of another aspect or example, including but not limited to any example of any of the first to 170 examples above.

[0503] Finally, it should be understood that although various aspects of this specification have been highlighted with reference to specific examples, those skilled in the art will readily recognize that these disclosed examples are merely illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is by no means limited to the specific methods, schemes, and / or reagents described herein. Consequently, various modifications, alterations, or alternative configurations can be made to the disclosed subject matter based on the teachings herein without departing from the spirit of this specification. Finally, the terminology used herein is for the purpose of describing particular examples only and is not intended to limit the scope of the systems, apparatuses, and methods disclosed herein, the scope of which is defined only by the claims. Therefore, the systems, apparatuses, and methods are not limited to the precise contents shown and described.

[0504] This document describes several embodiments of systems, apparatuses, and methods, including the best modes known to the inventors for implementing these embodiments. Of course, variations of these described examples will become apparent to those skilled in the art after reading the foregoing description. The inventors expect those skilled in the art to appropriately employ such variations, and the inventors intend to practice the systems, apparatuses, and methods differently from those specifically described herein. Therefore, the systems, apparatuses, and methods include all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. Furthermore, unless otherwise stated herein or clearly contradicted by the context, the systems, apparatuses, and methods encompass any combination of the foregoing examples in all their possible variations.

[0505] The techniques, methods, processes, operations, procedures, etc., described or suggested herein or in the references incorporated herein, as well as any methods using the systems, components, devices, apparatuses, etc., described herein, may be performed on a living organism (e.g., a human, other animals, etc.) or on a simulated object (e.g., a cadaver, a cadaver's heart, a simulated body, a virtual human, etc.). When performed on a simulated object, it may be assumed that body parts (e.g., a heart, tissue, valves, etc.) are simulated, or said body parts may be optionally referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valves, etc.) and may optionally include computerized and / or physical representations of body parts, tissues, etc. The term "simulated" covers use on cadavers, computer simulators, virtual humans (e.g., if they are merely aerial demonstrations on a virtual heart), etc.

[0506] Any of the various systems, components, devices, parts, equipment, etc. disclosed herein can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use in patients, and the methods described herein may include (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) sterilizing the relevant systems, devices, parts, equipment, etc. (or other methods may include or consist of said sterilization).

[0507] Alternative examples, elements, or groupings of the systems, devices, and methods described herein should not be construed as limiting. Each member of a group may be referenced and claimed individually or in any combination with other members of the groups disclosed herein. For convenience and / or patentability purposes, it is contemplated that one or more members of a group may be included in or removed from the group. When any such inclusion or removal is made, the specification shall be deemed to contain the modified group, thereby satisfying the written description of all Markush groups used in the appended claims.

[0508] Unless otherwise stated, all figures used in this specification and claims to represent features, items, quantities, parameters, properties, terms, etc., shall be understood to be modified by the term "about" in all cases. As used herein, the term "about" means that the features, items, quantities, parameters, properties, or terms so defined cover approximate values ​​that may vary but are capable of performing the desired operation or process discussed herein.

[0509] Unless otherwise stated herein or clearly contradicted by the context, the terms “a,” “an,” “the,” and similar designations used in the context of describing systems, devices, and methods (particularly in the context of the following claims) shall be construed as encompassing both the singular and plural. Unless otherwise stated herein or otherwise clearly contradicted by the context, all methods described herein may be performed in any suitable order. The use of any and all examples or exemplary language (e.g., “such”) provided herein is intended only to better illustrate the systems, devices, and methods and does not constitute a limitation on the scope of the claimed systems, devices, and methods. No language in this specification should be construed as indicating any unclaimed element essential to the practice of the systems, devices, and methods.

[0510] All patents, patent publications, and other publications referenced and identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing compositions and methods that may be used in conjunction with systems, devices, and methods, as described in such publications. These publications are provided solely for their disclosure prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventor has a right to use prior art or for any other reason prior to such disclosure. All statements regarding the dates or contents of these documents are based on information available to the applicant and do not constitute any admission of the accuracy of the dates or contents of these documents.

Claims

1. A device for use at or deployed to an autologous heart valve, the device comprising: The supporting structure includes a proximal portion and a distal portion; as well as One or more anchoring elements that extend radially outward from or are capable of extending radially outward from the support structure, wherein the one or more anchoring elements include one or more of the following: (a) hook-shaped, (b) anchor arms that branch into a plurality of forks that diverge circumferentially from each other, (c) a tip portion having undulations to increase its own flexibility, (d) a tip portion having a braid, and / or (e) a tip portion having a ring.

2. The apparatus of claim 1, wherein the proximal portion is an inlet portion, the distal portion is an outlet portion, and a passage extends between the inlet portion and the outlet portion.

3. The device according to any one of claims 1 to 2, wherein the support structure comprises an inner frame having a proximal portion and a distal portion.

4. The apparatus of claim 3, wherein the support structure further comprises an outer frame, the outer frame including a proximal portion.

5. The apparatus of claim 4, wherein the proximal portion of the outer frame is coupled to the proximal portion of the inner frame.

6. The apparatus according to any one of claims 1 to 5, wherein the support structure includes a platform portion extending radially outward from the proximal portion of the support structure to a shoulder of the support structure.

7. The apparatus of claim 6, wherein the support structure includes an axially extending portion extending axially from the shoulder to the distal portion of the support structure, the shoulder causing the platform portion to tilt relative to the axially extending portion.

8. The apparatus according to any one of claims 6 to 7, wherein the platform portion includes a flexible feature that allows the platform portion to deflect to cause the inner frame to translate axially relative to the shoulder.

9. The apparatus of claim 8, wherein the flexible feature includes a portion of the strut of the support structure that is more flexible than the adjacent portion of the strut.

10. The apparatus according to any one of claims 8 to 9, wherein the flexible feature includes the undulating portion of the struts of the outer frame.

11. The device according to any one of claims 1 to 10, wherein the device is a prosthetic heart valve capable of being deployed at an autologous heart valve.

12. The device according to any one of claims 1 to 11, further comprising a valve portion positioned within a passage of the support structure, wherein the valve portion allows blood to flow through the passage in one direction but prevents blood from flowing in the opposite direction.

13. The device of claim 12, wherein the valve portion comprises a plurality of prosthetic valve leaflets.

14. The apparatus according to any one of claims 1 to 13, further comprising one or more anchors connected to the distal portion of the support structure.

15. The apparatus of claim 14, wherein each of the one or more anchoring elements has a hook shape.

16. The apparatus according to any one of claims 14 to 15, wherein each of the one or more anchoring elements comprises an anchor arm that branches to form a plurality of forks that diverge from each other.

17. The apparatus of claim 16, wherein the anchor arm includes a split portion that bifurcates the anchor arm and a rod portion positioned radially inward of the split portion.

18. The device of claim 17, wherein the rod portion has a circumferential width equal to or greater than the combination of the circumferential widths of each of the plurality of forks.

19. The device of claim 17 or claim 18, wherein the one or more anchors comprise a plurality of said anchors, and the plurality of forks of said plurality of anchors extend across the perimeter of the device by at least about 120 degrees.

20. The apparatus according to any one of claims 14 to 19, wherein each of the one or more anchoring members includes a tip portion having an undulating portion for increasing the flexibility of the tip portion.

21. The device of claim 20, wherein the undulation extends in the circumferential direction on the tip portion.

22. The apparatus according to any one of claims 20 to 21, wherein each of the one or more anchoring members comprises a strut arm having the tip portion, the tip portion of the strut arm having a circumferential width greater than the radial thickness of the tip portion of the strut arm.

23. The device according to any one of claims 20 to 22, wherein the undulation increases the flexibility of the tip portion in the radially inward direction.

24. The device according to any one of claims 14 to 23, wherein each of the one or more anchors includes a tip portion having a braid.

25. The apparatus of claim 24, wherein the knitted fabric is a compliant knitted fabric.

26. The apparatus of claim 25, wherein the compliant weave is a woven ribbon.

27. The apparatus according to any one of claims 24 to 26, wherein each of the one or more anchors comprises a strut arm, and the fabric covers the radially outward-facing surface of the strut arm.

28. The apparatus of claim 27, wherein the braid is offset to extend further from the strut arm in the radially outward direction than in the radially inward direction.

29. The device according to any one of claims 14 to 28, wherein each of the one or more anchors comprises a tip portion having a ring.

30. The device of claim 29, wherein the ring increases the flexibility of the tip portion.

31. The apparatus of claim 29 or claim 30, wherein each of the one or more anchors comprises an anchor arm, and the ring comprises a continuous extending material enclosing an internal space.

32. The apparatus according to any one of claims 29 to 31, wherein the ring comprises a core, a core cover extending over the core, and a lubricating coating extending over the core cover.

33. A delivery system for an apparatus, the delivery system comprising: A catheter shaft for advancing the device into a treatment site within a subject and extending along an axis, the catheter shaft including a proximal portion and a distal portion, at least a portion of the catheter shaft including a receiving area for the device; as well as An actuation mechanism for rotating the device about the axis of the conduit shaft.

34. The delivery system of claim 33, wherein the actuation mechanism is used to rotate the device about the axis of the catheter shaft relative to at least a portion of the catheter shaft.

35. The delivery system of claim 33 or claim 34, wherein the catheter shaft includes a pouch extending over the receiving region, and the actuation mechanism is used to rotate the device relative to the pouch.

36. The delivery system according to any one of claims 33 to 35, wherein the actuation mechanism comprises a motor for rotating the device about the axis of the conduit shaft.

37. The delivery system according to any one of claims 33 to 36, further comprising a motor positioned at the distal portion of the catheter shaft and for rotating the device and / or changing the depth of the device along the axis relative to at least a portion of the catheter shaft.

38. The delivery system according to any one of claims 33 to 37, further comprising an imaging system directly or indirectly coupled to the conduit shaft, the imaging system being used to image the interior of the subject's body from within the subject's body.

39. The delivery system according to any one of claims 33 to 38, further comprising a guidewire system, the guidewire system comprising: The guidewire body has a proximal portion and a distal portion; as well as An imaging system, which is connected to the guidewire body, is used to image the inside of the subject's body from within.

40. A delivery system for an apparatus, the delivery system comprising: A catheter shaft for advancing the device to a treatment site and extending along an axis, the catheter shaft including a proximal portion and a distal portion, at least a portion of the catheter shaft including a receiving area for the device; as well as A motor, positioned at the distal portion of the catheter shaft and used to change the depth of the device along the axis relative to at least a portion of the catheter shaft.

41. The delivery system of claim 40, further comprising a transmission assembly for transmitting the force provided by the motor to change the depth or axial position of the device along the axis.

42. A delivery system for an apparatus, the delivery system comprising: A catheter shaft for advancing the device to a treatment or implantation site, the catheter shaft including a proximal portion and a distal portion, the catheter shaft including a nasal body and a sheath having a distal portion attached to the nasal body, the sheath including an internal lumen for a guidewire to pass through therethrough, and a portion of the catheter shaft including a receiving area for the device; as well as An imaging system, connected to one or more of the nasal body or the sheath, for imaging the interior of the subject's body from within, for example, from within the vascular system of the subject's body.

43. The delivery system of claim 42, wherein the imaging system comprises one or more of the following: (a) an optical coherence tomography imaging system, (b) an ultrasound imaging system, and (c) an intravenous ultrasound imaging system.

44. The delivery system according to any one of claims 42 to 43, wherein the nasal body is used for axial translation relative to another portion of the catheter axis.

45. A guidewire system for a prosthetic heart valve delivery system, the guidewire system comprising: The guidewire body has a proximal portion and a distal portion; as well as An imaging system, connected to the guidewire body, is used to image the vascular system of the subject's body from within the subject's vascular system.

46. ​​The guidewire system of claim 45, wherein the imaging system comprises one or more of the following: (a) an optical coherence tomography imaging system, (b) an ultrasound imaging system, and (c) an intravenous ultrasound imaging system.

Images