Prosthetic valve and sensor system

Abstract

Devices, systems, and methods for a prosthetic valve having a sensor system are disclosed. Examples of prosthetic valves include replacement heart valves for replacing the function of native heart valves, such as mitral or tricuspid valves. In various embodiments, a replacement heart valve is provided with sensors or indicia for facilitating proper placement and / or fixation within the body. A replacement heart valve may include an anchor for securing the replacement heart valve to a native leaflet, with sensors and / or indicia providing feedback to a physician for confirming proper placement of the anchor during an implant procedure. Sensors may also be used to assess the functionality of the prosthetic valve after deployment. Sensors may also be used to monitor blood pressure, temperature, oxygen, insulin, cholesterol, and / or glucose in order to assess the patient's overall health.

Description

[0001] Cross-reference to related applications This application claims the benefit of U.S. Provisional Application No. 63 / 432,830, filed December 15, 2022, which is hereby incorporated by reference in its entirety. Technical Field

[0002] Certain features of the present disclosure relate to implants comprising a prosthetic valve for deployment. Certain features of the present disclosure relate to sensor systems for facilitating implantation and / or assessing functionality of an implant. Background Art

[0003] The human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, function as one-way valves that operate in sync with the heart's ability to pump blood. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit damage, such as valve narrowing or regurgitation, which inhibits the valve's ability to control blood flow. Such damage reduces the heart's efficiency in pumping blood and can lead to debilitating and life-threatening conditions. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilatation. Consequently, significant effort has been devoted to developing methods and devices for repairing or replacing damaged heart valves.

[0004] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged native heart valves. Recently, considerable effort has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, that can be delivered with less trauma to the patient than through open-heart surgery. Replacement valves are designed to be delivered through minimally invasive and even percutaneous procedures.

[0005] These replacement valves are desirably deployed to the implantation site in a desired configuration. For example, considerations such as anchoring the replacement valve, sealing the replacement valve with the native valve, and proper operation of the prosthetic valve leaflets may be problematic when deployed to the implantation site. Additionally, it may be desirable to sense one or more conditions within the patient's body while or after implantation of the replacement valve. Summary of the Invention

[0006] Examples of prosthetic valves and sensor systems disclosed herein relate to improvements in prosthetic valves and sensor systems. Examples of prosthetic valves include replacement heart valves. Features disclosed herein can be used to improve identification of proper anchoring, positioning, and other conditions during implantation surgery. Features disclosed herein can also aid in assessing proper implant function after implantation. Implantable sensor systems disclosed herein can also be used to monitor blood conditions, such as pressure, temperature, oxygen, insulin, platelets, cholesterol, and / or glucose, to assess patient health. Various other improvements are also disclosed.

[0007] In various aspects, a prosthetic valve for implantation within a native valve is provided. The prosthetic valve may include a valve body, one or more prosthetic valve leaflets coupled to the valve body, and one or more anchoring mechanisms adapted to secure the valve body to surrounding tissue. In a preferred embodiment, the anchoring mechanism is configured to capture one or more native valve leaflets between the anchoring mechanism and the valve body. The prosthetic valve preferably also includes one or more indicators (e.g., sensors) for providing feedback to a physician regarding the capture of the native valve leaflets and / or the proper placement of the one or more anchors relative to the native valve. The feedback is preferably provided to the physician via visualization using medical imaging techniques such as ultrasound or fluoroscopy, preferably in real time.

[0008] In various aspects, a method can include deploying a prosthetic valve to a native valve. The prosthetic valve can include a valve body, one or more prosthetic valve leaflets coupled to the valve body, one or more anchors adapted to anchor the valve body to the native valve by capturing the native valve leaflets, and an indicator adapted to indicate capture of the native valve leaflets.

[0009] In various aspects, the sensor system can include a prosthetic heart valve for deployment to a native valve of a patient's heart. One or more sensors are coupled to the prosthetic heart valve for detecting conditions within the patient's body.

[0010] In various aspects, a method can include deploying a sensor system to a native valve. The sensor system can include a prosthetic heart valve for deployment to the native valve of a patient's heart, and one or more sensors adapted to couple to the prosthetic heart valve and to detect a condition within the patient's body.

[0011] In various aspects, a delivery system for delivering an implant to a native heart valve is provided. The delivery system may include a delivery device for delivering the implant to the native heart valve; and one or more sensors coupled to the delivery device and adapted to sense a spatial relationship between the delivery device and at least a portion of the native heart valve.

[0012] In various aspects, a method may include delivering an implant to a native heart valve using a delivery system. The delivery system may include a delivery device for delivering the implant to the native heart valve, and one or more sensors coupled to the delivery device and adapted to sense a spatial relationship between the delivery device and at least a portion of the native heart valve.

[0013] In various aspects, a delivery system for delivering an implant to a native heart valve is provided. The delivery system may include a delivery device for delivering the implant to the native heart valve. An imaging device may be coupled to the delivery device for imaging an area external to the delivery device (e.g., surrounding tissue).

[0014] In various aspects, a method can include delivering an implant to a native heart valve using a delivery system. The delivery system can include a delivery device for delivering the implant to the native heart valve, and an imaging device coupled to the delivery device and adapted to image an area external to the delivery device.

[0015] In various aspects, a sensor system can include a sensor, and one or more anchors coupled to the sensor and adapted to engage an inner wall of a heart chamber.

[0016] In various aspects, a method can include deploying a sensor system to a native valve.The sensor system can include a sensor, and one or more anchors coupled to the sensor and adapted to engage an inner wall of a heart chamber to anchor the sensor to the inner wall.

[0017] In various aspects, a system may include a prosthetic heart valve for deployment to a native valve of a patient's heart, at least a portion of the prosthetic heart valve including a pacemaker electrical conduit adapted to conduct electrical signals for pacing the heart.

[0018] In various aspects, a method may include deploying a prosthetic heart valve to a native valve of a patient's heart, at least a portion of the prosthetic heart valve including a pacemaker electrical conduit adapted to conduct electrical signals for pacing the heart.

[0019] In various aspects, a system may include a prosthetic heart valve for deployment to a native valve of a patient's heart, the prosthetic heart valve including one or more anchors adapted to hook around one or more native valve leaflets to anchor the prosthetic heart valve to the native valve. The system may include a delivery catheter for delivering the prosthetic heart valve to the native valve. The system may include a retainer mechanism adapted to retain the one or more native valve leaflets in a contracted state when the one or more anchors are at least partially hooked around the one or more native valve leaflets.

[0020] In various aspects, a method may include deploying a prosthetic heart valve to a native valve of a patient's heart using a delivery catheter, the prosthetic heart valve including one or more anchors adapted to hook around one or more native valve leaflets to anchor the prosthetic heart valve to the native valve. The method may include retaining the one or more native valve leaflets in a contracted state using a retainer mechanism while the one or more anchors are at least partially hooked around the one or more native valve leaflets.

[0021] In various aspects, a prosthetic heart valve for deployment to a native valve is provided. The prosthetic valve may include one or more prosthetic valve leaflets (e.g., made from pericardium) for providing a one-way valve function. The prosthetic valve may include an inner frame that supports the one or more prosthetic valve leaflets and has an inflow end portion and an outflow end portion. The prosthetic valve may include a sealing body positioned radially outward of the inner frame and including a plurality of elongated prongs and a skirt, the plurality of elongated prongs each having a first end portion that is coupled to the inflow end portion of the inner frame and protrudes radially outward from the inner frame to a second end portion, the skirt being suspended between the second end portions of the plurality of prongs and the outflow end portion of the prosthetic valve, the skirt defining a pocket positioned between the skirt and the inner frame. The prosthetic valve may include one or more anchors adapted to anchor the prosthetic valve to the native valve by capturing the native valve leaflets.

[0022] In various aspects, a method can include deploying a prosthetic heart valve to a native heart valve. The prosthetic heart valve can include: one or more prosthetic valve leaflets; an inner frame supporting the one or more prosthetic valve leaflets and having an inflow end portion and an outflow end portion; a sealing body positioned radially outward of the inner frame and comprising a plurality of elongated prongs and a skirt, the plurality of elongated prongs each having a first end portion coupled to the inflow end portion of the inner frame and projecting radially outward from the inner frame to a second end portion, the skirt suspended between the second end portions of the plurality of prongs and the outflow end portion of the prosthetic valve, the skirt defining a pocket positioned between the skirt and the inner frame; and one or more anchors adapted to anchor the prosthetic heart valve to the native heart valve by capturing the native valve leaflets.

[0023] In various aspects, a prosthetic heart valve for deployment to a native valve is provided. The prosthetic valve may include one or more prosthetic valve leaflets. The prosthetic valve may include a support structure for supporting the one or more prosthetic valve leaflets and including at least one ring coupled to a skirt, the skirt or the at least one ring being adapted to form a seal with at least a portion of the native valve.

[0024] In various aspects, a method can include deploying a prosthetic heart valve to a native heart valve. The prosthetic heart valve can include one or more prosthetic valve leaflets. The prosthetic heart valve can include a support structure for supporting the one or more prosthetic valve leaflets and including at least one ring coupled to a skirt, the skirt or the at least one ring being adapted to form a seal with at least a portion of the native valve.

[0025] In various aspects, a sensor system can be incorporated into a prosthetic cardiac implant. The sensor system can include a sensor body comprising: a substrate; a sensor positioned on the substrate and adapted to detect a condition of the prosthetic cardiac implant; and an electrical detection trace positioned on the substrate and adapted to detect a force applied to the substrate.

[0026] In various aspects, a method may include deploying a prosthetic cardiac implant to a native heart valve; and detecting a condition of the prosthetic cardiac implant using a sensor body connected to the prosthetic cardiac implant, the sensor body comprising: a substrate; a sensor positioned on the substrate and adapted to detect the condition of the prosthetic cardiac implant; and an electrical detection trace positioned on the substrate and adapted to detect a force applied to the substrate.

[0027] Any feature of aspect or example disclosed herein is applicable to all other aspects and examples identified herein. In addition, any feature of aspect or example in each aspect or example can be independently combined in part or in its entirety with other aspects or examples described herein in any way, for example, one, two or three or more aspects or examples can be combined in its entirety or in part. In addition, any feature of aspect or example can be optional concerning other aspects or examples. Any aspect or example of method can be performed by the system or equipment of another aspect or example, and any aspect or example of system or equipment can be constructed to perform the method for another aspect or example. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The features and advantages of the systems, apparatus, and methods as disclosed herein will also become better understood with reference to the specification, claims, and drawings, in which: Figure 1A An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0029] Figure 1B Show Figure 1A Bottom perspective view of the prosthetic valve shown in .

[0030] Figure 2 Show Figure 1A Schematic side cross-section of the prosthetic valve shown in .

[0031] Figure 3Schematic diagram showing the delivery device approaching the implantation site.

[0032] Figure 4A Show Figure 1A Schematic side cross-sectional view of a prosthetic valve positioned within a delivery device and proximal to an implantation site is shown in FIG.

[0033] Figure 4B Show Figure 1A Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0034] Figure 4C Show Figure 1A Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0035] Figure 5 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0036] Figure 6 Show Figure 5 Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0037] Figure 7 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0038] Figure 8A Show Figure 7 Schematic side cross-sectional view of a prosthetic valve positioned within a delivery device and proximal to an implantation site is shown in FIG.

[0039] Figure 8B Show Figure 7 Schematic side cross-sectional view of a prosthetic valve shown partially deployed from a delivery device and proximate to an implantation site.

[0040] Figure 8C Show Figure 7 Schematic side cross-sectional view of a prosthetic valve shown partially deployed from a delivery device and proximate to an implantation site.

[0041] Figure 8D Show Figure 7 Schematic side cross-sectional view of a prosthetic valve shown partially deployed from a delivery device and proximate to an implantation site.

[0042] Figure 8E Show Figure 7 Schematic side cross-section of a prosthetic valve partially deployed from a delivery device is shown in .

[0043] Figure 8F Show Figure 7 Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0044] Figure 9 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0045] Figure 10 Show Figure 9 Schematic side cross-section of the prosthetic valve shown in .

[0046] Figure 11 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0047] Figure 12 Show Figure 11 Schematic diagram of a top cross-section of a prosthetic valve deployed to native heart valve leaflets is shown in FIG.

[0048] Figure 13 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0049] Figure 14 Show Figure 13 Schematic side cross-section of the prosthetic valve shown in .

[0050] Figure 15 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0051] Figure 16 Show Figure 15 Schematic side cross-section of the prosthetic valve shown in .

[0052] Figure 17 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0053] Figure 18 Show Figure 17 Schematic side cross-section of the prosthetic valve shown in .

[0054] Figure 19 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0055] Figure 20 Show Figure 19 Schematic side cross-section of the prosthetic valve shown in .

[0056] Figure 21 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0057] Figure 22 Showing an example according to the present disclosure Figure 21 Side perspective view of the indicator of the prosthetic valve shown in .

[0058] Figure 23A Show Figure 22A schematic side cross-sectional view of the indicator shown in FIG.

[0059] Figure 23B Shown from Figure 23A The position shown in the deflection Figure 23A A schematic side cross-sectional view of the indicator shown in FIG.

[0060] Figure 24 A schematic side cross-sectional view of a prosthetic valve according to an example of the present disclosure is shown.

[0061] Figure 25 A schematic side cross-sectional view of a prosthetic valve according to an example of the present disclosure is shown.

[0062] Figure 26 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0063] Figure 27 Showing an example according to the present disclosure Figure 26 Schematic side cross-section of a prosthetic valve deployed to an implantation site is shown in .

[0064] Figure 28 A perspective view is shown of a delivery device according to an example of the present disclosure.

[0065] Figure 29 Showing an example according to the present disclosure Figure 26 Schematic side cross-section of a prosthetic valve deployed to an implantation site is shown in .

[0066] Figure 30 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0067] Figure 31 Showing an example according to the present disclosure Figure 30 Schematic side cross-section of a prosthetic valve deployed to an implantation site is shown in .

[0068] Figure 32A Showing an example according to the present disclosure Figure 30 Schematic side cross-section of a prosthetic valve deployed to an implantation site is shown in .

[0069] Figure 32B A schematic side cross-sectional view of a prosthetic valve according to an example of the present disclosure is shown.

[0070] Figure 33 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0071] Figure 34 Showing an example according to the present disclosure Figure 33 Schematic side cross-section of a prosthetic valve deployed to an implantation site is shown in .

[0072] Figure 35 A schematic side cross-sectional view of a prosthetic valve according to an example of the present disclosure is shown.

[0073] Figure 36 A side perspective view of a sensor system according to an example of the present disclosure is shown.

[0074] Figure 37 A side perspective view of a sensor system according to an example of the present disclosure is shown.

[0075] Figure 38 A schematic side cross-sectional view of a prosthetic valve according to an example of the present disclosure is shown.

[0076] Figure 39 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0077] Figure 40 A schematic side cross-sectional view of a prosthetic valve according to an example of the present disclosure is shown.

[0078] Figure 41 An upper perspective view illustrating multiple sensors according to examples of the present disclosure is shown.

[0079] Figure 42A A top view of a sensor according to an example of the present disclosure is shown.

[0080] Figure 42B Showing an example according to the present disclosure Figure 42A Schematic side cross-section of the sensor shown in .

[0081] Figure 42C Showing an example according to the present disclosure Figure 42A Schematic side cross-section of the sensor shown in .

[0082] Figure 43 Show the use Figure 41 Schematic side cross-section of a prosthetic valve with the sensor shown in FIG.

[0083] Figure 44 A top view of a sensor for a prosthetic valve is shown according to an example of the present disclosure.

[0084] Figure 45 A schematic side cross-sectional view of a prosthetic valve according to an example of the present disclosure is shown.

[0085] Figure 46 Shown is a side view of a delivery device according to an example of the present disclosure.

[0086] Figure 47 Show Figure 46 Side view of the delivery device shown in FIG.

[0087] Figure 48 Show Figure 46 Side view of the delivery device shown in , with the implant partially deployed.

[0088] Figure 49 Shown is a side view of a delivery device according to an example of the present disclosure.

[0089] Figure 50A A side view of an imaging device is shown extending from a delivery system.

[0090] Figure 50B A side view of an imaging device is shown extending from a delivery system.

[0091] Figure 51 Shown is a side perspective view of an implant with an imaging window.

[0092] Figure 52 A side perspective view of a sensor for coupling to an inner wall is shown.

[0093] Figure 53 Schematic diagram showing the ventricles and atria.

[0094] Figure 54 A side view showing the sensor being anchored to the inner wall.

[0095] Figure 55 A side view showing the sensor being anchored to the inner wall.

[0096] Figure 56 An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0097] Figure 57 Show Figure 56 Schematic side cross-section of the prosthetic valve shown in .

[0098] Figure 58 Show Figure 56 Schematic side cross-section of a prosthetic valve deployed to a prosthetic heart valve is shown in .

[0099] Figure 59 A schematic side cross-sectional view of a pacemaker shown coupled to electrical terminals of a prosthetic heart valve.

[0100] Figure 60 A side perspective view of a pacemaker electrical conduit is shown according to an example of the present disclosure.

[0101] Figure 61 A side perspective view of a pacemaker electrical conduit is shown according to an example of the present disclosure.

[0102] Figure 62A Side partial cross-sectional view showing approach of the retainer mechanism to the implantation site.

[0103] Figure 62B Show Figure 62A A side partial cross-sectional view of the retainer mechanism shown in , wherein the retainer mechanism has been deployed.

[0104] Figure 62C Show Figure 62A A side partial cross-sectional view of the retainer mechanism shown in , wherein the retainer mechanism has been deployed.

[0105] Figure 62D Show Figure 62A Side partial cross-sectional view of the retainer mechanism shown in , with the retainer mechanism retracted.

[0106] Figure 62E Show Figure 62A A perspective view of the retainer mechanism shown in , wherein the retainer mechanism is unfolded.

[0107] Figure 62F Show Figure 62A A top cross-sectional view of the retainer mechanism shown in FIG, wherein the retainer mechanism is unfolded.

[0108] Figure 63A Side view showing approach of the retainer mechanism to the implantation site.

[0109] Figure 63B Show expanded Figure 63A Side partial cross-sectional view of the retainer mechanism shown in .

[0110] Figure 63C Shown retracted Figure 63A Side partial cross-sectional view of the retainer mechanism shown in .

[0111] Figure 64 A side partial cross-sectional view showing the deployed retainer mechanism.

[0112] Figure 65A A side partial cross-sectional view showing the deployed retainer mechanism.

[0113] Figure 65B Show expanded Figure 65A Side partial cross-sectional view of the retainer mechanism shown in .

[0114] Figure 65C Shown retracted Figure 65A Side partial cross-sectional view of the retainer mechanism shown in .

[0115] Figure 66A Side partial cross-sectional view showing the retainer mechanism retracted.

[0116] Figure 66B Show expanded Figure 66A Side partial cross-sectional view of the retainer mechanism shown in .

[0117] Figure 66C Shown retracted Figure 66A Side partial cross-sectional view of the retainer mechanism shown in .

[0118] Figure 66D Show Figure 66A A perspective view of the retainer mechanism shown in FIG.

[0119] Figure 67 Shown is a side partial cross-sectional view of the retainer mechanism.

[0120] Figure 68A Shown is a side partial cross-sectional view of the retainer mechanism.

[0121] Figure 68B Show expanded Figure 68A Side partial cross-sectional view of the retainer mechanism shown in .

[0122] Figure 68C Show expanded Figure 68B A perspective view of the coil shown in FIG.

[0123] Figure 69A A perspective view showing the frame of a prosthetic valve.

[0124] Figure 69B Show Figure 69A A top view of the frame shown in .

[0125] Figure 69C Show the use Figure 69A A perspective view of a prosthetic valve with a frame shown in FIG.

[0126] Figure 69D A perspective view showing the internal frame.

[0127] Figure 69E A plan view of an elongated support column is shown.

[0128] Figure 69F Show Figure 69C Side cross-sectional view of the prosthetic valve shown in .

[0129] Figure 69G Shows deployed Figure 69C Side cross-sectional view of the prosthetic valve shown in .

[0130] Figure 70A A perspective view showing a prosthetic valve.

[0131] Figure 70B The prosthetic valve is shown along Figure 70A A side cross-sectional view of a portion shown along line II.

[0132] Figure 70CA top view of the ring is shown.

[0133] Figure 70D Shows deployed Figure 70A Side cross-sectional view of the prosthetic valve shown in .

[0134] Figure 70E A top view of the ring is shown.

[0135] Figure 70F A partial perspective view showing the ring positioned within the channel.

[0136] Figure 71A A perspective view showing a prosthetic valve.

[0137] Figure 71B Show Figure 71A Side cross-sectional view of the prosthetic valve shown in .

[0138] Figure 71C Show Figure 71A Side cross-sectional view of the prosthetic valve shown in .

[0139] Figure 72A A perspective view showing a prosthetic valve.

[0140] Figure 72B Shows deployed Figure 72A Side cross-sectional view of the prosthetic valve shown in .

[0141] Figure 73A A perspective view showing a prosthetic valve.

[0142] Figure 73B Shows deployed Figure 73A Side cross-sectional view of the prosthetic valve shown in .

[0143] Figure 74 Shown is a side view of the delivery system.

[0144] Figure 75 Shown is a side view of the clip.

[0145] Figure 76 Showing implantation Figure 75 A partial cross-sectional view of the clip shown in .

[0146] Figure 77 Showing implantation Figure 75 A partial cross-sectional view of the clip shown in .

[0147] Figure 78 Shown implanted Figure 75 A partial cross-sectional view of the clip shown in .

[0148] Figure 79 A cross-sectional view showing the clip being implanted.

[0149] Figure 80 A cross-sectional view showing the clip being implanted.

[0150] Figure 81 A perspective view of the sensor body is shown.

[0151] Figure 82 A partial schematic diagram showing components of a sensor system.

[0152] Figure 83 Show Figure 81 A top view of a partially torn-away portion of the sensor body is shown in FIG.

[0153] Figure 84 Shown is a top view of the sensor body.

[0154] Figure 85 Shown is a top view of the sensor body.

[0155] Figure 86 Schematic diagram showing the delivery system approaching the implantation site.

[0156] Figure 87 A perspective view of a prosthetic heart valve incorporating a sensor body is shown.

[0157] Figure 88 Shows a top view of the compressed sensor body.

[0158] Figure 89 Showing expansion Figure 88 A top view of the sensor body is shown in FIG.

[0159] Figure 90 Showing expansion Figure 88 A perspective view of the sensor body is shown in FIG.

[0160] Figure 91 Shows compressed Figure 88 A perspective view of the sensor body is shown in FIG.

[0161] Figure 92 A perspective view of a prosthetic heart valve incorporating a sensor body is shown. DETAILED DESCRIPTION

[0162] Figure 1A A perspective view of an implant in the form of a prosthetic valve 10 is shown. The prosthetic valve 10 may comprise a prosthetic heart valve for deployment into a patient's body in the form of a native heart valve. In examples, other forms of implants and prosthetic valves may be utilized as desired.

[0163] The prosthetic valve 10 is adapted to be deployed within the annulus of a native valve, such as a native mitral valve or a native tricuspid valve. In examples, other implantation locations may be utilized, such as within the aortic valve or pulmonary valve, or other valves or locations within the patient's body as desired.

[0164] The prosthetic valve 10 includes a proximal end 12 or inlet end portion and a distal end 14 or outlet end portion (at Figure 2 ), and the length therebetween. The prosthetic valve 10 also includes a valve portion, which is preferably formed of a plurality of prosthetic valve leaflets 16. The valve portion is positioned in a flow channel or passageway for controlling flow through the prosthetic valve 10. The flow channel or passageway is formed by the support structure or valve body 15 of the valve 10. The valve body 15 or support structure has a proximal end portion or inlet end portion and a distal end portion or outlet end portion. The prosthetic valve leaflets 16 move between an open state and a closed state to mimic and replace the operation of the leaflets of a native valve. The valve portion is positioned within the passageway of the valve body 15 to allow blood to flow through the passageway in one direction, thereby replacing the function of a native heart valve. If desired, the prosthetic valve leaflets 16 can be made of pericardium (e.g., bovine pericardium or porcine pericardium) or another material. In alternative arrangements, the leaflets are formed of a synthetic (e.g., polymer) material, or the valve portion is a mechanical one-way valve.

[0165] The valve body 15 or support structure surrounds and supports the valve portion and one or more prosthetic valve leaflets 16. The valve body 15 includes a stent or frame or support frame (e.g., a valve frame or an internal support stent or internal frame 18 ... Figure 1B ) and an outer support bracket or outer frame 20 (as shown in Figure 1A and 2 ), as well as other forms of frames. An outer support bracket or outer frame 20 is part of the sealing body 11 and is spaced apart from the inner frame 18. The outer frame 20 surrounds the inner frame 18.

[0166] Figure 2 A schematic cross-sectional view of a prosthetic valve 10 is shown. An inner frame 18 includes a proximal portion including a proximal end 19 and a distal portion including a distal end 21. Inner frame 18 has a spherical shape, or another configuration as desired in the example, including a curved body that curves radially outward between proximal end 19 and distal end 21. In the example, inner frame 18 has a circular shape. Inner frame 18 supports a plurality of prosthetic valve leaflets 16.

[0167] refer to Figure 1B, the internal frame 18 includes a plurality of struts 23 separated by spaces 25 from each other. This configuration allows the internal frame 18 to move between an undeployed, unexpanded, or linearized configuration and a deployed or expanded configuration. For example, the internal frame 18 expands radially outward to move to the deployed or expanded configuration, and as the diameter of the internal frame 18 increases, the length of the internal frame 18 decreases. Other configurations of the internal frame 18 may be utilized as desired.

[0168] The valve body 15 includes a sealing body 11. The sealing body 11 is positioned radially outward from the prosthetic valve leaflets 16 and is adapted to seal against a portion of the native valve. The sealing body 11 includes an outer surface of the prosthetic valve 10. The sealing body 11 defines the outer diameter of the prosthetic valve 10 and constitutes the outer periphery of the prosthetic valve 10. The sealing body 11 includes a proximal portion having a proximal end 31 and a distal portion having a distal end 33 (at Figure 2 (marked in the middle).

[0169] refer to Figure 2 As shown in a cross-sectional view, the sealing body 11 includes a frame 20 and a sealing skirt 24, or may include only the frame or only the sealing skirt in an example as desired. The frame 20 includes an outer frame positioned radially outward from the inner frame 18. The sealing skirt 24 is coupled to the outer frame 20 and includes a Figure 1A The outer portion of the sealing body 11 is shown in FIG.

[0170] The outer frame 20 includes at least a portion of the sealing body 11 that is adapted to apply a seal to a portion of the heart. The outer frame 20 has a proximal portion 35 that is coupled to the proximal end 19 of the inner frame 18. The proximal portion 35 extends radially outward from the proximal end 19 of the inner frame 18 and from the prosthetic valve leaflets 16. A distal portion 37 of the outer frame 20 is separated from the prosthetic valve leaflets 16 and the inner frame 18 by a gap 39. The gap 39 is positioned between the outer frame 20 of the sealing body 11 and the distal portion of the inner frame 18. Thus, the inner frame 18 includes an inner frame, and the frame 20 of the sealing body 11 includes an outer frame that is positioned radially outward of the inner valve frame 18 and surrounds the inner frame 18 and the prosthetic valve leaflets 16.

[0171] The length of the outer frame 20 extends distally to a lesser distance than the distal end of the inner frame 18. Thus, the outer frame 20 can be shorter than the inner frame 18. The outer frame 20 has a curved configuration that curves outward from the inner frame 18, with the largest diameter of the outer frame 20 being located at the distal portion of the outer frame 20.

[0172] The outer frame 20 of the sealing body 11 includes a plurality of struts 49 (eg, Figure 1A), with spaces 51 between the struts. This configuration utilized with the frame 20 allows the frame 20 to move between an undeployed, unexpanded, or linearized configuration and a deployed or expanded configuration, as shown. Figure 1A , where the outer frame 20 and the sealing body 11 have a curved spherical shape. As with the valve frame 18, during deployment, as the diameter of the outer frame 20 of the sealing body 11 increases, the length of the outer frame 20 of the sealing body 11 decreases. In examples, the diameter of the outer frame 20 of the sealing body 11 can be expanded radially outward from the inner valve frame 18 simultaneously or at a different expansion time or rate than the inner valve frame 18.

[0173] The sealing body 11 includes a sealing skirt 24 (such as Figure 1A ), the sealing skirt extends around the inner valve frame 18 and the prosthetic valve leaflets 16. In examples, the skirt 24 can be coupled to the frame 20 of the sealing body, or can be free of the frame 20.

[0174] The sealing skirt 24 has a proximal portion 41 (at Figure 2 ), the proximal portion is coupled to the proximal portion of the frame 20 of the sealing body 11 and can be coupled to the proximal portion of the inner frame 18. The skirt 24 has a distal portion 43 (at Figure 2 ), the distal portion can be coupled to the distal end of the frame 20 and, in an example, can be coupled to the inner valve frame 18 or one or more anchors 17.

[0175] The sealing skirt 24 is made of a material that resists the flow of fluid therethrough, such as a cloth, a woven material, or other material, such as a polymer or other material that resists the flow of fluid therethrough. The material may comprise a fabric. A variety of materials may be used for the skirt 24 as desired.

[0176] The sealing body 11 is adapted to abut a portion of the patient's heart to reduce fluid flow. The skirt 24 is adapted to seal a portion of the annulus of the native valve. For example, the sealing body 11 abuts the surface of the patient's native valve leaflets to reduce fluid flow between the sealing body 11 and the native valve leaflets. The sealing body 11 can be adapted to abut other portions of the patient's heart to reduce fluid flow as needed.

[0177] In an example, the sealing body 11 is flexible to allow movement and conformation to the native valve annulus.

[0178] refer to Figure 1A and 2, the prosthetic valve 10 includes one or more anchors 17. The anchors 17 can each be adapted to anchor the prosthetic valve leaflets 16 to a portion of the patient's heart that includes the native valve. The anchors 17 can be particularly adapted to anchor to the native valve leaflets of the patient's heart. The anchors 17 can extend around the native valve leaflets to anchor to (i.e., capture) the native valve leaflets. The anchors 17 include distal anchors that are positioned at the distal end 14 of the valve 10, or in examples can be positioned in another location as desired.

[0179] Each anchor 17 is configured as a protruding arm that is adapted to extend distally and then bend in the proximal direction to the tip of a corresponding one of the anchors 17. This configuration allows the anchors 17 to extend around the native valve leaflets and around the distal tips of the leaflets to hook onto the distal tips of the native valve leaflets and to be positioned radially outward of the outward-facing surfaces of the leaflets of the native valve. The anchors 17 are adapted to be in a hook-shaped configuration, for example, as Figure 1A-2 As shown. If desired, the anchor 17 is adapted to clamp one or more native valve leaflets to the sealing body 11. When implanted within the native mitral valve or native tricuspid valve, the anchor 17 can thus resist forces applied to the valve 10 in the atrial or proximal direction and anchor the valve 10 within the native valve annulus. Other configurations of the anchor 17 may be utilized in embodiments as desired.

[0180] Anchor 17 anchors valve body 15 to native valve by capturing native valve leaflets. Capture has various forms, including extending above the distal tip of the native valve leaflets. In the example, anchor 17 hooks around the leaflets. In the example, other forms of capture can be utilized.

[0181] Anchor 17 Figure 1A-2 The anchor 17 is shown in a deployed or expanded configuration, wherein the tip of the anchor 17 extends proximally. The anchor 17 is adapted to be in an undeployed, unexpanded, or linearized configuration, wherein the tip of the anchor 17 extends distally. This configuration is Figure 4A The anchor 17 is adapted to be flexible. Once deployed, the anchor 17 can be configured to move radially outward from the undeployed configuration to the deployed configuration, with the tip flipped toward the proximal direction. This operation allows the anchor 17 to flip the native valve leaflets to anchor to the native valve leaflets during deployment. For example, this configuration Figure 4C Other methods of deploying the anchor 17 may be utilized in an embodiment as desired.

[0182] refer to Figure 2, a proximal portion of the inner frame 18 is coupled to proximal portions of a plurality of prosthetic valve leaflets 16. The inner frame 18 supports the prosthetic valve leaflets 16. The prosthetic valve leaflets 16 may be coupled to the inner frame 18 and may extend radially inward from the inner frame 18. The prosthetic valve leaflets 16 are coupled to the inner frame 18 via an intermediate body 28, which supports the prosthetic valve leaflets 16 and couples the leaflets 16 to the inner frame 18 via sutures or another method, as desired.

[0183] The prosthetic valve leaflets 16 surround the flow channel 27, as shown in FIG. Figure 2 and can be moved between an open state and a closed state to control the flow through the flow channel 27. Figure 2 , the proximal end of the prosthetic valve 10 comprises the inflow end of the valve 10, and the distal end of the prosthetic valve 10 comprises the outflow end, but other configurations may be utilized as desired. The prosthetic valve leaflets 16 are positioned about the central axis 61 of the prosthetic valve 10. The inner frame 18 and the outer frame 20 each surround the central axis 61 of the prosthetic valve 10.

[0184] The anchors 17 can each extend radially outward from the flow channel 27 and radially outward from the prosthetic valve leaflets 16 of the valve 10. The anchors 17 can be adapted to extend radially outward from the inner valve frame 18 and through the gap 39 to the tip of the respective anchor 17. The anchors 17 are coupled to a distal portion of the inner frame 18. The anchors 17 can each include a proximal portion 29 and a distal portion 45, wherein the proximal portion 29 is coupled to the inner frame 18 and the distal portion 45 includes the tip of the respective anchor 17. When the valve 10 is deployed, the anchors 17 extend vertically from the proximal portion 29 to a tip at the distal portion 45.

[0185] Indicators may be provided for indicating capture of the native valve leaflets and / or proper placement of one or more anchors 17. The indicators may take various forms while remaining within the scope of the present invention.

[0186] For example, reference Figure 1A , providing a conformal indicator 62 for indicating the capture of the native valve leaflets under imaging. The appearance of the indicator 62 can change in shape or brightness under imaging to confirm the proper placement of the anchor. The indicator 62 can take Figure 1A 6. In the form of exemplary indicators 62a, 62b marked for identification purposes.

[0187] The indicator 62 changes appearance under ultrasound imaging, depending on the position of the indicator and / or the forces acting on it. For example, the visibility of the indicator 62 under ultrasound imaging is reduced to indicate proper placement of the anchor and capture of the native valve leaflets. The indicator includes an echogenic marker that changes appearance under ultrasound imaging when the indicator contacts the native tissue. For example, when the anchor is properly positioned radially outward from the native valve leaflets (e.g., positioned on the ventricular side of the native valve leaflets), the appearance of the indicator on the anchor changes. When properly positioned, the indicator contacts the native tissue, such as the leaflets and / or the annulus, which confirms that the anchor is properly positioned.

[0188] The indicator 62 can be positioned in a variety of locations, depending on the desired information needed to confirm proper placement. Figure 1A , the indicator 62 is positioned on one or more anchors 17. Figure 1A As shown in FIG, each anchor 17 includes an indicator 62, but other configurations may be utilized as desired (e.g., only one anchor 17 includes an indicator 62, or at least one anchor 17 includes an indicator 62). Indicators 62a, 62b are located at Figure 1A , are marked on the exemplary anchors 17a, 17b. In the example, the indicator 62 is positioned on the distal portion 45 or tip of the corresponding anchor 17. Thus, when the native valve leaflets are captured between the anchor and the sealing body 11, the indicator 62 is positioned radially outward of the native valve leaflets. When the anchor is properly positioned, the indicator abuts the native tissue (e.g., the ventricular side of the native valve annulus) and is thereby deformed. If the anchor 17 fails to capture or misses capturing the native valve leaflets, the indicator 62 will be positioned radially inward of the native valve leaflets, where the indicator is not compressed against the native tissue (e.g., not contacting the annulus). Thus, the indicator 62 provides visual feedback information about the placement of the anchor, which can be seen using the visualization techniques described herein. When properly placed, the indicator on the anchor changes shape due to contact with the native tissue. In contrast, when the anchor is not properly positioned and the leaflets are not captured, indicator 62 has a substantially unchanged appearance, alerting the physician to the potential problem.

[0189] refer to Figure 3 , prosthetic valve 10 is deployed to the implantation site via delivery system 70 . Figure 3 The delivery system 70 is shown being advanced for deploying the prosthetic valve 10 to an implantation site. The delivery system 70 comprises an elongated 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. The delivery system 70 is advanced through the patient's vasculature, which may include Figure 3 Other access methods may be utilized in examples, including transapical, or via surgical approaches such as thoracotomy or open heart surgery.

[0190] The prosthetic valve 10 is positioned within the implant retention region of the delivery system 70. For example, the prosthetic valve 10 can be covered by a capsule or can be otherwise retained prior to deployment. The prosthetic valve 10 can be deployed as a self-expanding prosthetic valve or can be a balloon-expandable prosthetic valve (e.g., positioned on an expandable balloon upon entry into the patient's body, or slid onto an expandable balloon within the patient's body). The prosthetic valve can also be mechanically expanded, including other forms of deployment.

[0191] The delivery system 70 can be advanced to one atrium of the heart and can be delivered transseptally to the other atrium (e.g., from the right atrium to the left atrium) to reach the implantation site. For example, this delivery route can be used for mitral native valve access. In an example, the delivery system 70 is extended to the right atrium for tricuspid valve access, or other delivery routes to other implantation sites can be used as needed in an example.

[0192] Figure 4A A side cross-sectional view of the prosthetic valve 10 is shown in a compressed configuration and slightly protruding from the capsule 79 of the delivery system 70. The anchors 17a, 17b are shown extending longitudinally in the elongated configuration. The prosthetic valve 10 is positioned for deployment to the native valve 80.

[0193] refer to Figure 3 As the prosthetic valve 10 is deployed from the delivery system, the implant site can be imaged. Imaging can take various forms. Figure 3 As shown in , the imaging may include ultrasound imaging that may be produced by an echocardiographic device 81. The echocardiographic device 81 may include a transducer or other form of echocardiographic device 81 that produces images via ultrasound waves. In an example, the echocardiographic device 81 is positioned external to the patient's body. However, in an example, the echocardiographic device is adapted to be positioned within the patient's vasculature for imaging. Other forms of imaging, such as fluoroscopy or other forms, may be utilized as desired. Combinations of imaging forms, such as ultrasound and fluoroscopy, may be utilized. Combinations of other forms of imaging may also be utilized.

[0194] Imaging allows a user (eg, a surgeon or other form of medical technician) to observe the implant site during the implant procedure.

[0195] Imaging the implant site advantageously allows the user to determine the desired placement of the prosthetic valve 10 and the desired anchoring of the one or more anchors 17. For example, the capture of the native valve leaflets by the one or more anchors 17 can be advantageously imaged. The user can advantageously determine whether the anchors are properly placed and whether capture of the native valve leaflets has occurred, which indicates whether proper implantation of the prosthetic valve 10 has occurred.

[0196] refer to Figure 4A and 4B , the indicators 62a, 62b are adapted to indicate capture of the native valve leaflets 82a, 82b by one or more anchors 17a, 17b. Figure 4A , the anchors 17a, 17b include indicators 62a, 62b located on the tips of the respective anchors 17a, 17b. The indicators 62a, 62b have an appearance under imaging, and in particular under ultrasound imaging. For example, Figure 4A As shown in FIG, when the anchors 17a, 17b are partially deployed from the capsule 79, the indicators 62a, 62b have brightness under ultrasound imaging.

[0197] When the anchors 17a, 17b are fully deployed, Figure 4B As shown in FIG, anchor 17a misses capturing leaflet 82a, as shown in FIG. Figure 4B Thus, the indicator 62a remains uncovered by the leaflet 82a and has a visible Figure 4A For example, the brightness of the indicator 62a of the anchor 17a that missed capturing the leaflet 82a has the same Figure 4A The brightness of the positions shown in the figure is the same brightness.

[0198] However, the anchor 17b of the leaflet 82b is captured (at Figure 4B The indicator 62b has the same Figure 4A 82a. The appearance of indicator 62b of anchor 17b that captured leaflet 82b is different from the appearance of indicator 62a of anchor 17a that missed capturing leaflet 82a. For example, indicator 62b of anchor 17b that captured leaflet 82b appears darker under imaging than indicator 62a of anchor 17a that missed capturing leaflet 82a. Based on the appearance of indicators 62a, 62b, a user can determine whether missed capturing of leaflet 82a has occurred.

[0199] In an example, the indicators 62a, 62b can be imaged from the atrium so that the tissue of the native valve leaflets 82b covers the indicator 62b to reduce the brightness of the indicator 62b. In contrast to no tissue covering the indicator 62a, the leaflet tissue layer covering the indicator 62b can produce a darker appearance of the indicator 62b and an indication that the leaflets 82b have been captured. The brighter appearance of the indicator 62a indicates that the leaflets 82a have not been captured. Other differences in the appearance of the indicators 62a, 62b may result.

[0200] In an example, the user can redeploy anchor 17a or attempt to recapture leaflets 82a for proper deployment of prosthetic valve 10. The user can perform a redeployment or recapture procedure to capture leaflets 82a. The user visualizes indicator 62a to determine whether capture of leaflets 82a has occurred.

[0201] For example, Figure 4C A view of a prosthetic valve 10 is shown in which both leaflets 82a, 82b are captured. Indicators 62a, 62b have a similar appearance to each other, with reduced visibility to indicate capture of the respective leaflets 82a, 82b. A user can determine that both leaflets 82a, 82b have been captured based on the appearance of indicators 62a, 62b. Imaging can be performed from the atrium or from another location as desired.

[0202] The features of Figures 1 through 4C may be utilized alone or in combination with any of the examples disclosed herein.

[0203] In an example, the configuration of one or more indicators can be varied as desired. For example, Figure 5 An indicator 84 adapted to move to indicate capture of the native valve leaflets is shown. The indicator 84 is adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 84 under imaging may change to indicate capture of the native valve leaflets. The indicator 84 includes a marker for identification purposes. Figure 5 Exemplary indicators 84a, 84b are labeled in FIG.

[0204] In the example, each indicator 84 comprises an elongated body. A plurality of elongated bodies are provided. Each elongated body is positioned on a corresponding one of the anchors 17. The elongated body is positioned, for example, on the distal portion 45 or distal tip of the corresponding anchor 17. The elongated body protrudes proximally from the distal portion 45 or distal tip of the corresponding anchor 17, as shown in FIG. Figure 5 Indicators 84a, 84b are positioned on respective anchors 17a, 17b.

[0205] In an example, each elongated body is configured as a spring. The spring comprises a coil spring having a Figure 5The coil shape shown in FIG. Thus, the spring is configured to be in an extended position, and the spring can be compressed to a compressed position when distal pressure is applied to the spring. When the pressure is released, the spring is biased to extend back to the extended position. In an embodiment, the configuration of the elongated body can be varied as desired.

[0206] The difference in appearance of the elongated body between the extended position and the compressed position can be observed under imaging. For example, when the elongated body is in the extended position, the spacing 86 between adjacent wraps 88a, 88b of the elongated body (in Figure 5 In the case where the elongated body is compressed, the reduced spacing 86 between the wraps 88a, 88b may further be visible under imaging.

[0207] The user can observe the appearance of the indicator 84 to determine whether a force has been applied to the indicator 84, thereby determining whether capture of the native valve leaflets has occurred.

[0208] For example, reference Figure 6 , deployment of the prosthetic valve 85 has occurred. Anchor 17a (at Figure 6 ) has missed capturing leaflet 82a. Thus, indicator 84a on such anchor 17a remains in an extended position, which may be visible via imaging. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user determines that failed or missed capture of leaflet 82a has occurred by observing the extended position of indicator 84a.

[0209] Anchor 17b (at Figure 6 82b has been captured. Consequently, the indicator 84b on such anchor 17b moves to a compressed position, which may be visible via imaging. Thus, the user determines that capture of the leaflet 82b has occurred by observing the compressed position of the indicator 84b.

[0210] In an example, the user determines whether capture of the leaflet has occurred by observing the position difference between the indicators 84a, 84b. Figure 6 The height of the indicator 84a shown on the right side of the page is greater than that in Figure 6 If the height of indicator 84b shown on the left side of the page in FIG. 8 is greater, the user can determine that a missed capture has occurred.

[0211] Figure 5 and 6 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0212] In an example, the configuration of one or more indicators can be varied as desired. For example, Figure 7 An indicator 90 adapted to move to indicate capture of the native valve leaflets is shown. The indicator 90 may be adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 90 under imaging may change to indicate capture of the native valve leaflets. The indicator 90 may include a marker positioned on the left side of the valve body for identification purposes. Figure 7 Exemplary indicators 90a, 90b are marked in FIG.

[0213] The indicator 90 includes an elongated body. In an example, a plurality of elongated bodies may be utilized. Each elongated body is positioned on a corresponding one of the anchors 17. The elongated body is positioned, for example, on the distal portion 45 or distal tip of the corresponding anchor 17. The elongated body protrudes proximally from the distal portion 45 or distal tip of the corresponding anchor 17, as shown in FIG. Figure 7 Indicators 90a, 90b are positioned on respective anchors 17a, 17b.

[0214] In an example, each elongated body is configured as a spring. The spring includes an elongated lever arm adapted to deflect laterally. The spring includes a wave-like shape to increase the flexibility of the spring. In an example, the spring is in a straightened or extended position, such as Figure 7 In an example, a portion of the spring, such as the tip portion 92, is adapted to deflect laterally to move to a deflected position. This deflection may be visible under imaging to allow a user to determine the position of the anchor 17 and whether capture of the leaflet has occurred.

[0215] The user observes the appearance of indicator 90 to determine whether force has been applied to indicator 90, thereby determining the position of anchor 17 and whether capture of the leaflets has occurred.

[0216] For example, reference Figure 8A , partial deployment of the anchors 17a, 17b has occurred. Indicators 90a, 90b extend from the capsule 79 and extend laterally outward from the capsule 79. The indicators 90a, 90b may extend perpendicularly relative to the capsule 79, or may extend at another angle as desired.

[0217] The indicators 90a, 90b extend outward from the capsule 79 at a length that allows the indicators 90a, 90b, when extended, to contact the leaflets 82a, 82b of the native valve 80 or another portion (e.g., the annulus) of the native valve 80. The indicators 90a, 90b project radially outward from the capsule 79 and are circumferentially spaced apart from each other such that the indicators 90a, 90b contact a portion of the native valve 80 at a plurality of circumferential locations.

[0218] The user observes the position of the indicators 90a, 90b via imaging. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user visualizes the position of the indicators 90a, 90b. For example, referring to Figure 8A , the user visualizes the indicators 90a, 90b straightening and extending laterally from the capsule 79. In this way, the user determines that the indicators 90a, 90b have not yet contacted the leaflets 82a, 82b and are therefore positioned axially offset from the annulus of the native valve 80. One or more of the indicators 90a, 90b can be deflected to indicate a change in the position of the indicators 90a, 90b and the prosthetic valve 94.

[0219] As part of the deployment procedure, the indicators 90a, 90b are advanced distally. Figure 8B , the indicators 90a, 90b can be advanced distally, which can occur in conjunction with the distal movement of the capsule 79. The indicators 90a, 90b can be deflected proximally and can be deflected radially inwardly toward the capsule 79. The deflected position of the indicators 90a, 90b is Figure 8B The user can image the position of the indicators 90a, 90b to determine the position of the indicators 90a, 90b and therefore the prosthetic valve 94 (in Figure 7 The indicator 90a, 90b is now positioned between the leaflets 82a, 82b. The user can further determine that the indicator 90a, 90b has not been advanced to the distal side of the leaflets 82a, 82b because the indicator 90a, 90b is in a deflected position.

[0220] The user observes the change in the deflection of the indicators 90a, 90b to determine the position of the prosthetic valve 94 and the anchors 17a, 17b. Figure 8C , the user visualizes that the indicators 90a, 90b have been advanced further distally by observing the increased deflection of the indicators 90a, 90b radially inward. The user determines that the indicators 90a, 90b have not yet been advanced distally of the leaflets 82a, 82b because the indicators 90a, 90b are in a deflected position.

[0221] refer to Figure 8D, the indicators 90a, 90b can be further advanced distally to extend laterally outward from the capsule 79 in a straightened or extended position. The straightened configuration of the indicators 90a, 90b indicates that the indicators 90a, 90b are properly threaded through the chordae tendineae 96 of the heart so as to hook around the leaflets 82a, 82b. Thus, the user determines that the anchors 17a, 17b are in a position to hook around the leaflets 82a, 82b. If one indicator 90a is in a straightened position and the other indicator 90b is visualized as being in a deflected position, the user determines that the indicator 90b is not in a position to hook around the leaflets and attempts to reposition the indicator 90b and the associated anchor 17b.

[0222] With the indicators 90a, 90b indicating that the chordae tendineae 96 are properly threaded through the heart to hook around the leaflets 82a, 82b, the anchors 17a, 17b continue to deploy to hook around the leaflets 82a, 82b, e.g. Figure 8E As shown in .

[0223] The indicators 90a, 90b are of sufficient length so that the tip portion 92 moves to the deflected position when the prosthetic valve 94 is fully deployed. The tip portion 92, for example, contacts a portion of the native valve 80 (including the annulus) or another portion of the native valve 80 (e.g., the leaflets 82a, 82b) to indicate that capture of the native valve leaflets 82a, 82b has occurred. For example, Figure 8F In instances where capture has not occurred, tip portion 92 will not deflect. The user determines whether failed or missed capture of leaflets 82a, 82b has occurred due to tip portion 92 remaining in a straightened position relative to the rest of indicators 90a, 90b.

[0224] The deployment order can be as follows: Figures 8A-8F The order shown in is different.

[0225] Figure 7-8F The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0226] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 9 The indicator 100 is adapted to move to indicate capture of the native valve leaflets. The indicator 100 is adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 100 under imaging changes to indicate capture of the native valve leaflets. The indicator 100 includes a marker for identification purposes. Figure 9 2 and 3. Exemplary indicators 100a, 100b are shown in FIG.

[0227] The indicator 100 includes an elongated body. In an example, a plurality of elongated bodies may be provided. Each elongated body is positioned on a corresponding one of the anchors 17. The elongated body may be positioned, for example, on the distal portion 45 or distal tip of the corresponding anchor 17. The elongated body protrudes distally from the distal portion 45 or distal tip of the corresponding anchor 17, as shown in FIG. Figure 9 The indicators 100a, 100b are positioned on the respective anchors 17a, 17b.

[0228] In an example, each elongated body is adapted as a spring. The spring includes an elongated lever arm adapted to deflect radially outward toward the anchor 17. The spring is configured as a leaf spring or a cantilever spring, wherein a fixed end of the spring is coupled to the anchor 17 and a free end extends radially inward toward the valve body 15. The deflection of the spring toward the deflected position is visible under imaging to allow the user to determine whether capture of the leaflets has occurred.

[0229] The user observes the appearance of the indicator 100 to determine whether a force has been applied to the indicator 100, thereby determining whether capture of the native valve leaflets has occurred.

[0230] For example, reference Figure 10 , deployment of the prosthetic valve 102 has occurred. Anchor 17a (at Figure 10 82a has been missed. Thus, the indicator 100a on such anchor 17a remains in an undeflected position or extends radially inward, which may be visible via imaging. The imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, a user can determine that a failed or missed capture of the leaflet 82a has occurred by observing the undeflected position of the indicator 100a.

[0231] Anchor 17b (at Figure 10 ) has captured leaflet 82b. Thus, indicator 100b on such anchor 17b can be moved to a deflected position, which may be visible via imaging. Thus, a user can determine that capture of leaflet 82b has occurred by observing the deflected position of indicator 100b.

[0232] In an example, the user determines whether capture of the leaflet has occurred by observing the position difference between the indicators 100a, 100b. Figure 10 The deflection ratio of the indicator 100a shown on the right side of the page is Figure 10 If the deflection of the indicator 100b shown on the left side of the page in FIG. 1 is smaller, the user can determine that a missed capture has occurred.

[0233] Figure 9-10 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0234] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 11 Shown is an indicator 110 adapted to move to indicate capture of the native valve leaflets. The indicator 110 is adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 110 under imaging changes to indicate capture of the native valve leaflets.

[0235] The indicator 110 comprises an elongated body. The elongated body is positioned on the valve body 15 and includes a ring extending circumferentially around the valve body 15. The ring may be a full ring (continuous around the entire valve body 15) or a partial ring (extending partially around the valve body 15). The ring is positioned radially inward of the anchor 17. The ring is positioned on the valve body 15 at an axial height that positions the ring opposite the position of the anchor 17. Thus, when the anchor 17 captures the leaflet, the native heart valve leaflet will be positioned between the ring and the corresponding anchor 17. In an example, the indicator 110 comprises a radiopaque ring.

[0236] The indicator 110 is positioned on the outer frame 20 of the valve body 15 or the sealing body 11. In an example, the indicator 110 is positioned on the sealing skirt 24 of the sealing body 11. For example, the indicator 110 can be sewn into the sealing skirt 24 or otherwise coupled to the sealing skirt 24. In an example, the indicator 110 is positioned on the sealing skirt 24 distal to the outer frame 20 to allow the indicator 110 to be more easily deflected inwardly when capturing the native valve leaflets.

[0237] Indicator 110 comprises a flexible material adapted to deflect. The flexible material is adapted to deflect radially inward when an inward force is applied to the flexible material. For example, when a native heart valve leaflet is captured between anchor 17 and indicator 110, indicator 110 deflects inward due to the force applied by the native heart valve leaflet. In an example, the inward deflection of indicator 110 can be localized. Indicator 110 can be adapted to deflect radially inward at portion 112 of indicator 110, which can be positioned opposite a corresponding anchor 17.

[0238] The user observes the appearance of the indicator 110 to determine whether a force has been applied to the indicator 110, thereby determining whether capture of the native valve leaflets has occurred.

[0239] For example, reference Figure 12 , deployment of prosthetic valve 114 has occurred. A top or axial view of prosthetic valve 114 is provided. Some anchors (e.g., anchor 17a) have captured leaflets 82a (and leaflets 82c). Other anchors (e.g., anchor 17b) have failed to capture or have missed capturing leaflet 82b.

[0240] The indicator 110 is imaged to determine whether capture of the leaflets 82a-c has occurred. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Imaging occurs in the axial dimension of the prosthetic valve 114, such as Figure 12 Indicated in .

[0241] The user determines whether deflection of indicator 110 has occurred, thereby determining whether capture of leaflets 82a-c has occurred. Portion 112a of indicator 110 is positioned opposite anchor 17a. Portion 112b of indicator 110 is positioned opposite anchor 17b. For example, the user determines that inward deflection of indicator 110 at portion 112a has occurred, thereby determining that leaflet 82a has been captured and, therefore, has pressed indicator 110 radially inward. The user determines that no deflection or minimal deflection of portion 112b of indicator 110 has occurred, thereby determining that failed capture or missed capture of leaflet 82b has occurred.

[0242] In this example, the user determines whether capture of the leaflets has occurred by observing the positional difference between portions 112a, 112b of indicator 110. For example, if portion 112b of indicator 110 deflects less than portion 112a, the user determines that missed capture has occurred at portion 112b. If indicator 110 deflects at each of the anchoring locations, the user determines that each leaflet has been captured by anchor 17.

[0243] Figure 11 and 12 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0244] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 13 Shown is an indicator 120 adapted to move to indicate capture of the native valve leaflets. The indicator 120 may be adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 120 under imaging changes to indicate capture of the native valve leaflets.

[0245] The indicator 120 includes an elongated body that is positioned on the valve body 15 and extends axially along the valve body 15. The elongated body includes a wire that extends axially along the valve body 15.

[0246] The wire is positioned radially inward of one or more anchors 17. The wire is positioned at a circumferential position on the valve body 15 that positions the wire opposite a respective one of the anchors 17. Thus, when the anchors 17 capture the leaflets, the native heart valve leaflets will be positioned between the wire and the respective anchor 17.

[0247] In an example, the indicator 120 is positioned on the outer frame 20 of the valve body 15 or the seal body 11. In an example, the indicator 120 is positioned on the sealing skirt 24 of the seal body 11. For example, the indicator 120 can be sewn into the sealing skirt 24 or otherwise coupled to the sealing skirt 24.

[0248] Indicator 120 comprises a flexible material adapted to deflect. The flexible material is adapted to deflect radially inward when an inward force is applied to the flexible material. For example, when native heart valve leaflets are captured between anchor 17 and indicator 120, indicator 120 deflects inward due to the force applied by the native heart valve leaflets.

[0249] The user observes the appearance of the indicator 120 to determine whether a force has been applied to the indicator 120, thereby determining whether capture of the native valve leaflets has occurred. In an example, a plurality of indicators 120 are utilized. The plurality of indicators 120 are circumferentially spaced apart from one another, each located at the location of a corresponding one of the anchors 17. Each indicator 120 extends axially along the valve body 15.

[0250] For example, see Figure 14 , deployment of prosthetic valve 122 has occurred. A side or transverse view of prosthetic valve 122 is provided. Some anchors (e.g., anchor 17a) have failed to capture or missed capturing leaflets 82a. Other anchors (e.g., anchor 17b) have captured leaflets 82b.

[0251] The indicator 120 is imaged to determine whether capture of the leaflets 82a, 82b has occurred. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Imaging occurs in the lateral dimension of the prosthetic valve 122, such as Figure 14 Indicated in .

[0252] The indicator 120 includes a Figure 14 2 and 3. Exemplary indicators 120a, 120b are labeled in FIG.

[0253] The user determines whether deflection of indicators 120a, 120b has occurred, thereby determining whether capture of leaflets 82a, 82b has occurred. For example, the user determines that inward deflection of indicator 120b has occurred, thereby determining that leaflet 82b has been captured and, therefore, has pressed indicator 120b radially inward. The user determines that no deflection or minimal deflection of indicator 120a has occurred, thereby determining that failed capture or missed capture of leaflet 82a has occurred.

[0254] In an example, the user determines whether leaflet capture has occurred by observing the positional difference between indicators 120a, 120b. For example, if the deflection of indicator 120a is less than the deflection of indicator 120b, the user determines that missed capture has occurred at indicator 120a. If indicators 120a, 120b are each deflected at each of the anchoring positions, the user determines that leaflets 82a, 82b have been captured by anchors 17a, 17b, respectively.

[0255] Figure 13 and 14 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0256] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 15 Shown is an indicator 130 adapted to move to indicate capture of the native valve leaflets. The indicator 130 is adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 130 under imaging changes to indicate capture of the native valve leaflets.

[0257] The indicator 130 includes an elongated body. In the example, multiple elongated bodies are used. Each elongated body is positioned on the valve body 15. The elongated body is positioned on the outer frame 20 of the valve body 15 or the sealing body 11. In the example, the indicator 130 is positioned on the sealing skirt 24 of the sealing body 11. The elongated body protrudes distally from the valve body 15, as shown in FIG. Figure 15 As shown in .

[0258] In an example, each elongated body is configured as a spring. The spring includes an elongated lever arm adapted to deflect radially inwardly toward the valve body 15. The spring is configured as a leaf spring or a cantilever spring, wherein a fixed end of the spring is coupled to the valve body and a free end extends radially outwardly toward a corresponding one of the anchors 17. The deflection of the spring toward the deflected position may be visible under imaging to allow a user to determine whether capture of the leaflets has occurred.

[0259] The indicator 130 includes a Figure 15 1 and 2. Exemplary indicators 130a, 130b are labeled in FIG.

[0260] The user observes the appearance of the indicator 130 to determine whether a force has been applied to the indicator 130, thereby determining whether capture of the native valve leaflets has occurred.

[0261] For example, see Figure 16 , deployment of the prosthetic valve 132 has occurred. Anchor 17a (at Figure 1615). Thus, an indicator 130a positioned adjacent such anchor 17a remains in an undeflected position or extends radially outward from the valve body 15, which is visible via imaging. The imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, a user determines that a failed or missed capture of the leaflet 82a has occurred by observing the undeflected position of the indicator 130a.

[0262] Anchor 17b (at Figure 16 82b has been captured. Consequently, an indicator 130b located near such anchor 17b moves to a deflected position that is visible via imaging. Thus, the user determines that capture of the leaflet 82b has occurred by observing the deflected position of the indicator 130b.

[0263] In an example, each indicator 130 includes one or more markings that improve the ease of imaging the indicator 130. For example, one or more marking beads 134 are provided for each indicator 130. Each marking bead 134 is spaced apart from another marking bead 134 on the indicator 130 and indicates the location of a portion of the indicator 130. In an example, the marking beads 134 are configured to be visible under imaging, such as fluoroscopy.

[0264] In an example, the user determines whether capture of the leaflet has occurred by observing the positional differences between the indicators 130. For example, if Figure 16 The deflection ratio of the indicator 130a shown on the right side of the page is Figure 16 If the deflection of the indicator 130b shown on the left side of the page in FIG. 1 is smaller, the user determines that a missed capture has occurred.

[0265] In the examples, the configuration of the indicator varies as needed. For example, Figure 17 Shown with Figure 15 and 16 Indicator 130 is constructed in a similar manner to that shown in FIG, but is formed as an annulus 140. In the example, each end of the annulus is coupled to the valve body 15. Therefore, since each end of the annulus is coupled to the valve body 15, the likelihood of the indicator 140 piercing a portion of the native heart valve is reduced.

[0266] Indicator 140 includes a Figure 17 140a, 140b are shown as example indicators.

[0267] The indicator 140 may include one or more markings that may be associated with the Figure 15 and 16 The construction of the discussed markers is similar.

[0268] Users can contact Figure 15 and 16 Indicator 140 is imaged in a similar manner as discussed for indicator 130 shown in FIG.

[0269] For example, reference Figure 18 , deployment of the prosthetic valve 142 has occurred. Anchor 17a (at Figure 18 17a) has missed capturing leaflet 82a. Thus, indicator 140a positioned adjacent such anchor 17a remains in an undeflected position or extends radially outward from valve body 15, which is visible via imaging. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, a user determines that failed or missed capture of leaflet 82a has occurred by observing the undeflected position of indicator 140a.

[0270] Anchor 17b (at Figure 18 82b has been captured. Consequently, an indicator 140b located near such anchor 17b moves to a deflected position that is visible via imaging. Thus, the user can determine that capture of the leaflet 82b has occurred by observing the deflected position of the indicator 140b.

[0271] In an example, the user determines whether capture of the leaflet has occurred by observing the position difference between the indicators 140a, 140b. Figure 18 The deflection ratio of the indicator 140a shown on the right side of the page is Figure 18 If the deflection of the indicator 140b shown on the left side of the page in FIG. 1 is smaller, the user determines that a missed capture has occurred.

[0272] Figure 15-18 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0273] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 19 Shown is an indicator 150 adapted to move to indicate capture of the native valve leaflets. The indicator 150 is adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 150 under imaging changes to indicate capture of the native valve leaflets.

[0274] Indicator 150 includes an elongated body. In an example, multiple elongated bodies are utilized. Each elongated body extends from valve body 15 to at least one of one or more anchors 17. For example, a first end of the elongated body is coupled to valve body 15, and a second end of the elongated body is coupled to a corresponding one of anchors 17. The elongated body spans a gap positioned between valve body 15 and a corresponding one of anchors 17. In an example, each elongated body is configured as a wire.

[0275] Each elongate body is positioned so that it extends from a point of connection with the valve body 15 to a respective anchor 17 that is circumferentially aligned with a point of connection on the valve body 15. Each elongate body extends radially outward from the valve body 15 to a respective anchor 17.

[0276] Each elongated body is configured to deflect in the distal direction when the corresponding anchor captures the leaflet. Each elongated body is bent upward in the proximal direction, for example, as shown in FIG. Figure 19 Each elongated body is adapted to deflect downwardly or distally to a deflected position upon capturing a corresponding native valve leaflet. In an example, each elongated body is flexible and adapted to deflect downwardly or distally upon capturing a leaflet. Deflection of the elongated body toward the deflected position is visible under imaging to allow a user to determine whether capture of the leaflet has occurred.

[0277] Indicator 150 includes a Figure 19 2 and 3. Exemplary indicators 150a, 150b are shown in FIG.

[0278] The user observes the appearance of the indicator 150 to determine whether a force has been applied to the indicator 150, thereby determining whether capture of the native valve leaflets has occurred.

[0279] For example, reference Figure 20 , deployment of the prosthetic valve 152 has occurred. Anchor 17a (at Figure 20 82a has been missed. Thus, an indicator 150a positioned adjacent such anchor 17a remains in an undeflected position or extends upwardly or proximally from the valve body 15, which is visible via imaging. The imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user determines that a failed or missed capture of the leaflet 82a has occurred by observing the undeflected position of the indicator 150a.

[0280] Anchor 17b (at Figure 2082b has been captured. Consequently, an indicator 150b located near such anchor 17b moves to a deflected position, which may be visible via imaging. Thus, the user determines that capture of the leaflet 82b has occurred by observing the deflected position of the indicator 150b. Upon capture of the leaflet 82b, the indicator 150b deflects downwardly or distally.

[0281] In an example, each indicator 150 includes one or more markings 154 that improve the ease of imaging the indicator 150. The markings may be associated with Figure 15 and 16 The discussed markers are constructed in a similar manner.

[0282] In an example, a user can determine whether capture of the leaflet has occurred by observing the position difference between the indicators 150a, 150b. Figure 20 The deflection ratio of the indicator 150a shown on the right side of the page is Figure 20 If the deflection of indicator 150b shown on the left side of the page in FIG. 5 is smaller, the user can determine that a missed capture has occurred.

[0283] Figure 19 and 20 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0284] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 21 Shown is an indicator 160 adapted to move to indicate capture of the native valve leaflets. The indicator 160 is adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 160 under imaging changes to indicate capture of the native valve leaflets.

[0285] The indicator 160 comprises a button adapted to be depressed to indicate capture of the native valve leaflets. The indicator 160 is positioned on the valve body 162 of the prosthetic valve 164, which may additionally be associated with a valve body 162 of the prosthetic valve 164. Figure 1A-2 The valve body 15 discussed is constructed in a similar manner. In the example, the indicator 160 protrudes from the outer surface of the valve body 15.

[0286] The indicators 160 are positioned so that contact of the native heart valve leaflets against the indicators 160 presses the indicators 160 inwardly. The indicators 160 are positioned between adjacent anchors 17 so that the native heart valve leaflets press against the indicators 160 when captured.

[0287] The indicator 160 includes a movable protrusion 166 adapted to move radially inward when the indicator 160 is depressed. For example, Figure 22A side perspective view of an indicator 160 is shown, illustrating a movable protrusion 166 extending outward from a portion of a frame 168 of a prosthetic valve 164. The movable protrusion 166 includes one or more arms that can be angled to deflect outward from the frame 168. The one or more arms have a first end portion 170 coupled to the frame 168. The first end portion 170 can be coupled to the frame 168 via sutures or another form of coupling. The first end portion 170 can include a pivot about which the movable protrusion 166 can pivot. The second end portion 172 of the one or more arms includes a marking 174 that improves the ease of imaging the indicator 160. In an example, the marking 174 is adapted to be visible under imaging, such as fluoroscopy. The second end portion 172 of the one or more arms and the marking 174 are adapted to rotate about the pivot when the movable protrusion 166 is depressed.

[0288] For example, reference Figure 23A As shown, the indicator 160 is visible in a cross-sectional view relative to the frame 168 of the prosthetic valve 164. The movable protrusion 166 is shown extending from the frame 168. This configuration shows that no native valve leaflets or other parts of the native heart valve are pressed against the indicator 160.

[0289] Figure 23B A cross-sectional view of the movable protrusion 166 is shown having been pressed radially inward by the captured leaflet 82b. The leaflet 82b presses against the movable protrusion 166 and moves the movable protrusion 166 radially inward. The second end portion 172 of the one or more arms pivots radially inward about the first end portion 170.

[0290] The user observes the appearance of the indicator 160 to determine whether a force has been applied to the indicator 160, thereby determining whether capture of the native valve leaflets has occurred. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user determines that a failed capture or missed capture of the leaflets 82 has occurred by observing whether the indicator 160 remains in the undeflected position. The user is able to image the deflection of one or more arms or markers 174.

[0291] Figure 21-23B The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0292] about Figure 1A-23B The disclosed indicators and / or markers may include radiopaque materials for enhanced visualization. Heavy metals such as gold, platinum, iridium, or tantalum, or other forms of radiopaque materials may be utilized. In examples, materials such as nitinol or stainless steel may be utilized, which can be visualized under fluoroscopy or ultrasound. Other forms of materials may be utilized as desired.

[0293] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 24 Shown is an indicator 171 adapted to move to indicate capture of the native valve leaflets. The indicator 171 is adapted to indicate capture of the native valve leaflets under imaging. The appearance of the indicator 171 under imaging changes to indicate capture of the native valve leaflets.

[0294] Indicator 171 includes a bladder 173 and a contrast agent 175 filling the bladder 173. The bladder 173 is adapted to be filled with the contrast agent 175. In an example, the bladder 173 includes one or more openings 176 adapted to release the contrast agent 175 to indicate capture of the native valve leaflets. The bladder 173 is made of, for example, a flexible material adapted to deform to release the contrast agent 175 from the bladder 173 through the openings 176.

[0295] The sac 173 is positioned so that when the native valve leaflets are captured, the native valve leaflets are pressed against the sac 173. The sac 173 is positioned, for example, between the anchors of the prosthetic valve 178 (exemplary anchors indicated by anchors 17a, 17b) and the valve body 180 and is adapted to be pressed by the native valve leaflets when the native valve leaflets are captured. In examples, the sac 173 has other locations, such as between adjacent anchors 17 or otherwise in a position to receive pressure from the native valve leaflets.

[0296] The opening 176 includes a valve that allows for release of the contrast agent 175 when a certain amount of pressure is applied to the bladder 173. For example, the opening 176 includes a check valve or other form of valve for allowing for release of the contrast agent 175 when pressure is applied.

[0297] The openings 176 are positioned at locations circumferentially spaced apart from one another. This circumferential spacing allows for determining whether anchoring has occurred at various circumferential locations. For example, openings 176 are placed at circumferential locations on each anchor 17, or at other intervals as desired. In an example, a plurality of bladders are arranged circumferentially spaced apart from one another. Each bladder has an opening for releasing contrast agent, indicating that the native valve leaflets have been captured at the location of the corresponding bladder.

[0298] When the prosthetic valve 178 is deployed to the implantation site, the bladder 173 is filled with contrast agent 175. In this configuration, the openings 176 retain the contrast agent 175 within the bladder 173. Figure 24 On the right side, anchor 17a fails to capture or misses capturing leaflet 82a. Therefore, sac 173 does not have the pressure exerted on it by leaflet 82a, and contrast agent 175 is not expelled at that portion of sac 173.

[0299] refer to Figure 24 On the left side of the anterior chamber 82, anchor 17b has captured leaflet 82b. As a result, capsule 173 releases contrast agent 182 from opening 176. The release of contrast agent 182 can be imaged so that the user can determine that capture of leaflet 82b has occurred.

[0300] The user observes the appearance of indicator 171 to determine whether force has been applied to indicator 171, thereby determining whether capture of the native valve leaflets has occurred. Imaging can include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user determines that failed capture or missed capture of leaflets 82a has occurred by observing whether indicator 171 fails to release contrast agent 175.

[0301] Figure 24 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0302] In an embodiment, the configuration of the indicator can be varied as desired. For example, Figure 25 Shown is an indicator 190 adapted to indicate capture of native valve leaflets under imaging.

[0303] Indicator 190 includes a channel 192 adapted to allow contrast agent to pass therethrough. Channel 192 extends from the interior of prosthetic valve 194 to the exterior surface of prosthetic valve 194, allowing contrast agent to pass from the interior to the exterior surface of prosthetic valve 194. Channel 192 passes, for example, from the interior of valve frame or inner frame 18 to outer frame or sealing body 11. An opening 196 of channel 192 is positioned, for example, on the surface of outer frame or sealing body 11.

[0304] The channel 192 is positioned so that the native valve leaflets press against the opening 196 of the channel 192 to cover the opening 196. Thus, the flow of contrast agent through the channel 192 may be unimpeded, and a user visualizing the flow of contrast agent can determine that capture of the leaflets 82a has not occurred. In instances where the opening 196 of the channel is covered by the leaflets 82a, material flow may be impeded, and a user can determine that capture of the leaflets 82a has occurred.

[0305] In an example, the prosthetic valve 194 includes a plurality of channels and openings positioned at locations circumferentially spaced apart from one another. This circumferential spacing allows for determination of whether anchoring has occurred at various circumferential locations. The openings of the channels are positioned at locations where the native valve leaflets will be anchored.

[0306] When the prosthetic valve 194 is deployed to the implantation site, contrast agent 198 can flow through the interior of the prosthetic valve 194. The contrast agent flows into the channel 192 and into another channel 200. Figure 25On the right side of the prosthetic valve 194, anchor 17a failed to capture or missed capturing leaflet 82a. As a result, opening 196 remains uncovered and does not obstruct the flow of contrast agent therethrough. Consequently, contrast agent 202, visible on the exterior of prosthetic valve 194, is released. The presence of this contrast agent 202 after deployment of prosthetic valve 194 indicates that anchor 17a failed to capture or missed capturing leaflet 82a.

[0307] refer to Figure 25 82b. As shown in FIG. 2 , the anchor 17b has captured the leaflet 82b on the left side of the prosthetic valve 194. As a result, the opening 204 of the passageway 200 is covered by the leaflet 82b, thereby obstructing the flow of contrast medium therethrough. The absence of contrast medium visible on the exterior of the prosthetic valve 194 at the opening 204 indicates that the anchor 17b has captured the leaflet 82b.

[0308] The user observes the appearance of indicator 190 to determine whether capture of the native valve leaflets has occurred. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user can determine that failed capture or missed capture of the leaflets 82a has occurred by observing whether contrast agent 202 is released. In this example, Figure 24 and 25 Contrast agents utilized in examples of may include radiopaque materials or fluids. Iodine or other forms of radioactive contrast agents may be utilized.

[0309] Figure 25 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0310] In an example, one or more sensors adapted to sense a condition within the patient's body can be utilized. The condition can include a condition of the prosthetic valve, such as whether the prosthetic valve has been deployed as desired or has certain characteristics. For example, the condition can include whether capture of the native valve leaflets has occurred. In an example, the condition can include whether the prosthetic valve is operating as desired within the patient's body. In an example, the condition can include environmental conditions within the patient's body (e.g., pressure within the patient's body or flow through the valve of the patient's body). Various other conditions can be sensed. One or more sensors can be adapted to be coupled to a prosthetic heart valve that can be deployed to a native valve of the patient's heart.

[0311] refer to Figure 26 In an example, one or more sensors are provided that detect whether capture of the native valve leaflets has occurred. The one or more sensors may include an indicator adapted to indicate capture of the native valve leaflets by the one or more anchors via a signal provided by the one or more sensors. The one or more sensors are adapted to sense whether at least one anchor has captured the native valve leaflets.

[0312] In an example, the sensor 210 comprises a contact sensor adapted to sense contact between the sensor 210 and a surface of the native valve (e.g., a surface of a native heart valve leaflet). The sensor 210 can be positioned in a variety of locations, including on the anchor 17. The sensor 210 can be positioned on the distal portion 45 of the anchor 17, including on the distal tip of the anchor 17. The sensor 210 is adapted to be positioned on the inwardly facing surface of the anchor 17 so that the sensor 210 can contact the surface of the native valve leaflet when the anchor 17 is anchored to the native valve leaflet. The sensor 210 can be positioned in other locations as desired, such as on the valve body.

[0313] The sensor 210 may include various forms of sensors. The sensors 210 utilized may include one or more piezoelectric sensors, strain gauges, pressure transducers, and / or capacitive sensors. Such forms of sensors may include contact sensors and / or force sensors. Other forms of sensors for detecting contact or force may be utilized. In an example, the sensor 210 may include electrodes, wherein a reference electrode is positioned on the patient's body. Contact between the electrode and tissue within the patient's body (e.g., a heart valve leaflet) provides an electrical signal between the electrode and the reference electrode, which may indicate contact between the electrode and the heart valve leaflet. Other forms of sensors disclosed herein may be utilized. The sensor may be utilized in conjunction with any other example disclosed herein.

[0314] In an example, a plurality of sensors 210 are provided, each sensor being located on a respective anchor 17. Each sensor 210 is adapted to sense whether or not anchoring to the native valve leaflet has occurred via the respective anchor 17. The sensors 210 comprise a plurality of sensors 210 located on a respective anchor 17 for identification purposes. Figure 26 Exemplary sensors 210a, 210b are labeled in FIG.

[0315] In an example, each sensor 210 includes a wired connection to a terminal of the corresponding sensor. For example, an electrical conduit 212 extends from the sensor 210 to the electrical terminal 214. The electrical conduit 212 extends along the valve body 15 and connects the sensor 210 to the electrical terminal 214. The electrical terminal 214 is positioned at various locations as needed. For example, Figure 26 As shown in FIG, electrical terminals 214 are positioned at a proximal portion 218 of a prosthetic valve 216. In an example, electrical terminals 214 are positioned at a coupling portion of the prosthetic valve 216 that is adapted to couple to a delivery device for the prosthetic valve 216. A connector 220 or end tab on the prosthetic valve 216 that couples to the delivery device can each include an electrical terminal 214. Such a connector 220 couples to a connector 222 on the delivery device ( Figure 29), the connector can be connected to the connector 220 for the prosthetic valve 216.

[0316] For example, the delivery device may include one or more electrical terminals 224 (at the Figure 29 ). Electrical terminals 224 can be coupled to electrical conduits 226 that extend along the delivery device. Electrical conduits 226 transmit the signals provided by sensor 210 to an output for use.

[0317] For example, Figure 28 An exemplary delivery system 230 that can be utilized in the examples herein is shown. The delivery system 230 is Figure 3 2 is constructed in a similar manner to the delivery system 70 shown in FIG, but is adapted to receive a signal output from the sensor 210. The delivery system 230 includes a delivery device having an elongated shaft 232. The elongated shaft 232 includes a distal portion 234 that includes an implant retention region 236 (e.g., Figure 27 The implant retention area 236 includes the connector 222 on the delivery device (in the Figure 29 Connector 222 can have various forms and can include a receiving slot adapted to receive connector 220 in the form of a tab, or can have another configuration (eg, a suture or another form of connector) as desired.

[0318] The proximal portion 239 of the elongated shaft 232 is coupled to a housing 240, which may be in the form of a handle of a delivery device. In examples, the housing 240 has other forms.

[0319] The electrical conduit 226 extends along the elongated shaft 232 to provide the signal from the sensor 210 to an indicator device adapted to generate an indication of the signal provided by the sensor 210. The indicator device can take various forms. For example, referring to Figure 28 Indicator devices include visual indicators, tactile indicators 242, or audible indicators 244, as well as other forms of indicator devices. Audible indicator 244 includes a speaker or other device adapted to produce an audible indication. Tactile indicator 242 includes a motor or other device adapted to produce a tactile indication. Visual indicators have various forms. Visual indicators include one or more lights 246, or one or more display screens 248, 250, or another device adapted to produce a visual indication. In an example, a combination of indicator devices may be utilized.

[0320] In some examples, the indicator device is located on the delivery device or remotely from the delivery device. For example, the indicator device is located on the housing 240 or handle of the delivery device (as shown by indicator devices 242, 244, 246, and 248). The indicator device can be located remotely (e.g., indicator device or display screen 250).

[0321] The indicator devices may be adapted to provide an indication of a condition sensed by the sensor 210. For example, when a leaflet is captured, one or more indicator devices indicate that capture has occurred. The light 246 flashes, or one or more of the display screens 248, 250 may provide, for example, Figure 28 ” sign or another form of indication as shown in . In an example, the indicator device is adapted to provide an indication of failed capture or missed capture of the leaflet. For example, the light 246 may flash in a particular manner to indicate failed capture (e.g., the color of the light may change, or the light may lack illumination corresponding to the point of missed capture), or the display screens 248, 250 may indicate failed capture or missed capture. For example, the display screens 248, 250 display a symbol, such as a “-” sign, to indicate failed capture or missed capture.

[0322] In an example, the signal from the sensor 210 is provided directly to the indicator device. In an example, the signal is received by a processor 252 that processes the signal provided by the sensor 210. The processor 252 can be configured to operate based on programming provided in the memory 254. The processor 252 receives the signal and can determine an output to provide to one or more indicator devices based on the signal.

[0323] The processor 252 has various forms, including a microprocessor, a controller, or multiple processors utilized in combination, as well as other forms of processors. The memory 254 includes a hard disk (e.g., mechanical or solid-state), or may include flash memory, RAM, ROM, or other forms of memory. The memory stores non-transitory data or instructions for use by the processor 252. In some embodiments, a distributed processing unit or a remote processing unit may be utilized. For example, a cloud computing environment or remote processing utilizing the Internet or a wireless network may be utilized.

[0324] In an example, processor 252 and memory 254 are located on handle or housing 240. A power source 256 is provided that powers processor 252 and memory 254, as well as other components of delivery system 230 (e.g., indicator devices 242, 244, 246, and 248). Power source 256 includes a battery or other form of power source (e.g., a wired or wireless connection to an external power source) for powering the components of delivery system 230. In an example, processor 252, memory 254, or other components of delivery system 230 can be located remotely from handle or housing 240.

[0325] The elongated shaft 232 is Figure 3 The elongated shaft 232 is adapted to be deflected via operation of a control mechanism in a similar manner to the elongated shaft shown in FIG. The elongated shaft 232 can be navigated to a desired implantation site.

[0326] Figure 27 An exemplary embodiment of a sensor 210 sensing a condition within a patient's body, such as whether anchors 17a, 17b have captured corresponding native valve leaflets 82a, 82b, is shown. As shown, a prosthetic valve 216 is deployed such that electrical terminals 214 of the prosthetic valve 216 remain electrically connected to terminals 224 of a delivery system 230. For example, connector 220 of the prosthetic valve 216 remains coupled to connector 222 of the delivery system 230. In this configuration, a signal from the sensor 210 is provided through electrical conduit 212 and transmitted to electrical terminals 224 and electrical conduit 226 to provide an output of the sensor 210 signal.

[0327] refer to Figure 27 On the right side, anchor 17a fails to capture or misses capturing leaflet 82a. Consequently, sensor 210a is unable to contact leaflet 82a. Consequently, sensor 210a indicates that leaflet 82a is not captured. Sensor 210a provides a signal indicating a lack of capture, or provides a lack of a signal corresponding to a lack of capture of leaflet 82a.

[0328] refer to Figure 27 On the left side, anchor 17b has captured leaflet 82b. Thus, sensor 210b contacts leaflet 82b. Thus, sensor 210b indicates capture of leaflet 82b. Sensor 210b provides a signal indicating capture of leaflet 82b.

[0329] The signal is transmitted to one or more of indicator devices 242, 244, 246, 248, and 250. The indicator device indicates whether capture has occurred. The indicator device indicates missed capture of leaflet 82a or captured leaflet 82b, or a combination of missed capture and captured. In instances where anchors 17a, 17b each properly deploy and capture the respective leaflet, the indicator device indicates respective capture of the leaflet. In instances where anchors 17a, 17b each fail to capture leaflet 82a, 82b, the indicator device indicates failure to capture leaflet 82a, 82b.

[0330] The prosthetic valve 216 can be redeployed to allow the anchor 17a to anchor to the heart valve leaflets 82a. For example, Figure 29 This configuration is shown.

[0331] In an example, the delivery system can be withdrawn from the prosthetic valve 216 after deployment. For example, Figure 29The delivery system 230 is shown withdrawn. The connector 220 of the prosthetic valve 216 is disconnected from the connector 222 of the delivery system 230. Similarly, the electrical terminals 214 of the prosthetic valve 216 are disconnected from the electrical terminals 224. Thus, the prosthetic valve 216 remains implanted in the patient's body with the delivery system 230 withdrawn.

[0332] In an example, other forms of transmission of signals from sensor 210 may be utilized. In an example, wireless transmission from sensor 210 may be utilized.

[0333] refer to Figure 30 In an example, prosthetic valve 260 is adapted to wirelessly transmit a signal from sensor 210. The signal may be of a condition sensed within the patient's body.

[0334] Wireless transmitter 262 is used to transmit signals from prosthetic valve 260. Wireless transmitter 262 can be coupled to prosthetic valve 260 and positioned, for example, on valve body 15. Wireless transmitter 262 can be positioned at other locations as desired.

[0335] In an example, a power source 264 is provided for wireless transmitter 262. Power source 264 comprises a battery or other form of power source that powers wireless transmitter 262. In an example, power source 264 comprises a rechargeable power source that can be recharged via wireless charging (e.g., induction) or via kinetic movement of the patient. In an example, power source 264 powers other components of prosthetic valve 260 (e.g., sensors).

[0336] In the example, a processor 266 is utilized that receives signals from the sensor 210. The processor 266 processes the signals based on programming stored in the memory 268 to provide data to the wireless transmitter 262 for transmission. The sensor 210 provides electrical signals to the processor 266 via an electrical conduit 270. In the example, a separate processor 266 is not used, and the signals are provided directly to the wireless transmitter 262 for transmission.

[0337] refer to Figure 31 , showing an exemplary transmission of wireless transmitter 262. Figure 31 On the right side, anchor 17a fails to capture or misses capturing leaflet 82a. Consequently, sensor 210a is unable to contact leaflet 82a. Consequently, sensor 210a indicates that leaflet 82a is not captured. Sensor 210a provides a signal indicating a lack of capture, or provides a lack of a signal corresponding to a lack of capture of leaflet 82a. The signal can be wirelessly transmitted from wireless transmitter 262 to receiver 269.

[0338] Receiver 269 is positioned outside the patient's body, or in an example, inside the patient's body. Receiver 269 comprises a wireless receiver adapted to receive wireless signals from wireless transmitter 262. Receiver 269 is adapted to process the signals from wireless transmitter 262 and cause one or more indicator devices (e.g., indicator device 250 or another form of indicator device) to provide an indication that anchor 17a has missed capturing the native valve leaflet.

[0339] refer to Figure 31 On the left side, anchor 17b has captured leaflet 82b. Thus, sensor 210b contacts leaflet 82b. Sensor 210b provides a signal indicating capture of leaflet 82b. The signal indicating capture is wirelessly transmitted from wireless transmitter 262 to receiver 269.

[0340] Receiver 269 causes one or more indicator devices (eg, indicator device 250 or another form of indicator device) to provide an indication of capture of the native leaflet by the anchor 17b.

[0341] The prosthetic valve 260 can be redeployed to allow the anchor 17a to anchor to the heart valve leaflets 82a. For example, Figure 32A This configuration is shown.The wireless transmitter 262 provides a wireless signal indicating that capture of the leaflets 82a, 82b has occurred.

[0342] In an example, each sensor 210 may include a wireless sensor. Each sensor 210 may include a wireless transmitter that is integrated as part of the sensor 210 and adapted to transmit wireless signals to a receiver in a manner similar to wireless transmitter 262.

[0343] In examples, other forms of sensors are used to determine whether capture of a heart valve leaflet has occurred. For example, one or more of a proximity sensor, a force sensor, an optical sensor, or a chemical sensor may be used to determine whether capture has occurred.

[0344] For example, the proximity sensor includes a sensor that senses the proximity of the leaflets using detection of changes in electromagnetic waves or magnetic fields. Such a sensor may include an electrical impedance sensor. Proximity sensors such as infrared, electromagnetic, capacitive, or ultrasonic proximity sensors may be used.

[0345] The force sensor senses the contact force on the force sensor.

[0346] The optical sensor can determine the capture of the leaflets using light, such as infrared light or other forms of light, which can be blocked by the native valve leaflets. In an example, the optical sensor can include a transmitter and a receiver. For example, referring to Figure 32B, transmitter 271a can be positioned on anchor 17a of prosthetic valve 273. Transmitter 271a can include an optical transmitter adapted to emit light (e.g., infrared light or other forms of light) for receipt by optical receiver 275a. For example, optical receiver 275a can be positioned on valve body 15 or at another location as desired.

[0347] refer to Figure 32B , optical receiver 275a receives light from transmitter 271a indicating that anchor 17a has failed to capture or missed capturing leaflet 82a. Thus, optical receiver 275a provides a signal for transmission by wireless transmitter 262 indicating failed capture or missed capture of leaflet 82a.

[0348] A transmitter 271b may be provided that may be configured in a manner similar to transmitter 271a. Transmitter 271b may transmit light for receipt by optical receiver 275b. Thus, upon capture of leaflet 82b, light from transmitter 271b may be blocked by leaflet 82b and not received by optical receiver 275b. Optical receiver 275b provides a signal for transmission by wireless transmitter 262 indicating capture of leaflet 82b.

[0349] In an example, the positions of the emitters 271a, 271b and the receivers 275a, 275b can be reversed as desired. Other positions of the emitters and receivers can be utilized in an example. Other forms of optical sensors can be utilized.

[0350] Chemical sensors may include biosensors that sense contact with tissue of the native valve leaflets.

[0351] In an example, the location of the sensors can be varied as desired. For example, one or more sensors can be positioned on the valve body 15 or another portion of the prosthetic valve to sense whether capture of the leaflets has occurred. One or more sensors can be positioned on a combination of the anchor and the valve body as desired.

[0352] Figure 26-32B The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0353] In an example, other conditions within the patient's body may be sensed by one or more sensors. Figure 33 , sensing pressure within a patient's body. Pressure includes pressure within at least one chamber of the heart. Pressure can be sensed for a variety of reasons, including determining whether a prosthetic valve is operating properly, determining the health of the patient's heart, or determining whether proper remodeling has occurred following treatment (e.g., remodeling of a ventricle (e.g., the right ventricle) for tricuspid valve deployment). Pressure can also be used to determine whether a patient is recovering from surgery or may require another procedure.

[0354] A sensor in the form of pressure sensor 267 can be used to sense pressure in one or more chambers of the heart. Pressure sensor 267 is positioned on prosthetic valve 272. Pressure sensor 267 is positioned to determine pressure within the proximal or atrial chambers of the heart and can directly sense fluid pressure on the proximal or atrial side of the heart.

[0355] refer to Figure 34 In an example, pressure sensor 267 can be positioned on valve body 15. In an example, other locations can be utilized (e.g., on anchor 17 or at another location as desired). Pressure sensor 267 can be positioned between the outer frame or sealing body 11 and the inner body or inner frame 18 of prosthetic valve 272. Pressure sensor 267 protrudes from the surface of valve body 15 and is positioned within the proximal or atrial side of the heart.

[0356] In an example, pressure sensor 267 is positioned to sense pressure in a distal chamber or ventricular chamber of the heart. The position of pressure sensor 267 is varied to achieve pressure sensing in the distal chamber or ventricular chamber. Pressure sensor 267 is in direct contact with the fluid in the distal chamber or ventricular chamber.

[0357] In an example, one or more pressure sensors may be adapted to sense pressure in both the proximal or atrial chamber and the distal or ventricular chamber. For example, the pressure sensor is adapted to sense two pressures and provide a signal indicative of the two pressures. In an example, a pressure differential may be determined. Figure 35 In an example, the first pressure sensor 267 is adapted to sense pressure within the proximal or atrial chamber, and the second pressure sensor 274 is adapted to sense pressure within the distal or ventricular chamber. In an example, a greater number of pressure sensors may be utilized as desired.

[0358] One or more pressure sensors are used to transmit a wireless signal indicative of the sensed pressure. Figure 30 and 31 The described configuration is used to allow wireless transmission of signals from one or more pressure sensors. In an example, a wired connection between the pressure sensors is used to transmit signals from the one or more pressure sensors.

[0359] The one or more pressure sensors are configured to transmit a signal of the sensed pressure to a receiver. The one or more pressure sensors can transmit a signal for a user to determine a condition within the patient's body. For example, a user can determine whether proper implantation of the prosthetic valve 272 has occurred, or whether there is a problem with the patient's other health condition (e.g., undesirable pressure within the patient's body). The signal can be sent at the time the prosthetic valve 272 is implanted or after implantation. For example, the signal is sent after the implantation procedure to allow monitoring of the patient during a recovery period or after use and implantation of the prosthetic valve 272. In an example, the signal is provided to a user regarding Figure 28 One or more of the discussed indicator devices 242, 244, 246, 248, 250, or another form of indicator device.

[0360] In an example, one or more pressure sensors are integral to the prosthetic valve 272. In an example, one or more pressure sensors can be attached to the prosthetic valve 272.

[0361] For example, Figure 36 A pressure sensor 276 is shown attached to a prosthetic valve. A coupler 278 is attached to the pressure sensor 276 and is adapted to attach the pressure sensor 276 to the prosthetic valve. The coupler 278 includes a clip that is adapted to clamp onto a portion of the prosthetic valve. Thus, the sensor is adapted to clamp to the prosthetic valve. The clip includes a pivotable arm 280 that is adapted to pivot open to allow a portion of the prosthetic valve to fit into the recess 282. In examples, other forms of couplers may be used. For example, Figure 37 A coupler 285 is shown in the form of a clip having slidable arms 284 adapted to slide open to allow a portion of a prosthetic valve to fit into a recess 286. The respective arms 280, 284 can be biased (e.g., spring-biased) toward a closed state to close the respective recesses 282, 286 and retain the portion of the prosthetic valve therein.

[0362] refer to Figure 38 , a prosthetic valve 290 can have one or more pressure sensors 276 attached to the prosthetic valve 290. For example, a first pressure sensor 276a is coupled to a proximal portion of the prosthetic valve 290. A second pressure sensor 276b, constructed in a similar manner as the first pressure sensor 276a, can be coupled to a distal portion of the prosthetic valve 290. The respective pressure sensors 276a, 276b are adapted to measure respective pressures on the proximal or atrial side of the prosthetic valve 290 and the distal or ventricular side of the prosthetic valve 290.

[0363] Pressure sensors 276a, 276b can be adapted to be attached to prosthetic valve 290 by being clamped to the frame of prosthetic valve 290. Coupler 278 can be attached to a strut of the frame of prosthetic valve 290. Pressure sensors 276a, 276b can be placed in a variety of locations as desired. Pressure sensors 276a, 276b can be provided during surgery after implantation of prosthetic valve 290, or before or during the implantation procedure via a delivery device as desired.

[0364] The pressure sensors 276a, 276b may be adapted to provide wireless signals (e.g., as described with respect to Figure 30 and 31 as described), or in an example a wired signal may be provided.

[0365] Figures 33-38 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0366] In an example, other conditions within the patient's body may be sensed by one or more sensors. Figure 39 , a temperature within the patient's body can be sensed. The temperature can include a temperature within at least one chamber of the heart.

[0367] The temperature sensor 300 can be coupled to the prosthetic valve 302. The temperature sensor 300 can be adapted to sense the temperature on the proximal or atrial side of the prosthetic valve 302. The temperature sensor 300 can be adapted to sense the temperature on the proximal or atrial side of the prosthetic valve 302. Figures 33-38 The pressure sensor discussed similarly provides a signal indicative of the sensed temperature.

[0368] In an example, the temperature sensor 300 or another temperature sensor is used to sense the temperature on the distal or ventricular portion of the prosthetic valve. For example, the temperature sensor 300 has a portion configured to sense the temperature on the distal or ventricular portion of the prosthetic valve. The temperature sensor 300 is adapted to Figures 33-38 The pressure sensor discussed similarly provides a signal indicative of the sensed temperature.

[0369] In an example, the temperature sensor 300 is adapted to sense temperature on the proximal or atrial side of the prosthetic valve and the distal or ventricular side of the prosthetic valve. The temperature sensor 300 is adapted to provide a signal indicative of a temperature difference between the proximal and distal sides of the prosthetic valve.

[0370] If desired, flow is determined using signals from one or more temperature sensors 300. For example, a Swan-Ganz catheter method can be used to determine valve function and blood flow based on sensed temperature.

[0371] The temperature sensor 300 can be positioned as needed. For example, Figure 40, the temperature sensor 300 is positioned between the valve frame or inner frame 18 of the prosthetic valve and the outer frame or sealing body 11 of the prosthetic valve 302 .

[0372] In an example, other conditions within the patient's body may be sensed by one or more sensors. Figure 41 , flow within a patient's body can be sensed. The flow can include fluid flow within at least one chamber of the heart. For example, the fluid flow can be through a prosthetic valve.

[0373] One or more flow sensors 310 are arranged to sense flow through the flow channel 312. The flow sensors 310 are positioned circumferentially around the flow channel 312 and are adapted to sense flow through the channel 312. The flow sensors 310 determine, for example, the flow rate through the channel 312. The flow channel 312 includes a plurality of flow sensors 310 and a plurality of flow sensors 310. Figure 2 Flow channels similar to flow channels labeled 27 in FIG, through which one or more prosthetic valve leaflets control flow.

[0374] The flow sensor 310 has various forms. In an example, the flow sensor 310 includes a piezoelectric sensor. For example, referring to Figure 42A Flow sensor 310 includes a deflection surface 313 and a plurality of piezoelectric transducers 314. Piezoelectric transducers 314 are adapted to sense the deflection of deflection surface 313 and provide electrical signals indicative of the deflection of deflection surface 313. Deflection surface 313 deflects in response to pressure or flow generated through flow channel 312. The amount of deflection changes the resistance or voltage generated by piezoelectric transducers 314, as well as other characteristics.

[0375] For example, Figure 42B The deflection surface 313 is shown undeflected. Figure 42C The deflection surface 313 is shown deflected. The transducer 314 senses the movement of the deflection surface 313 and provides an electrical signal corresponding to the amount of deflection of the deflection surface 313.

[0376] refer to Figure 43 , flow sensor 310 is positioned around the flow passage 27 including the flow passage of the prosthetic valve 316. Flow sensor 310 is adapted to sense flow through the prosthetic valve 316 to determine flow conditions through the prosthetic valve 316. Flow sensor 310 may be used to indicate potential valve thickening or poor performance as desired.

[0377] The flow sensor 310 is adapted to Figures 33-38 The pressure sensors discussed provide signals indicative of the sensed flow in a similar manner. For example, wireless or wired signals may be provided.

[0378] Figures 41-43The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0379] In an example, other conditions within the patient's body may be sensed by one or more sensors. Figure 44 , a force applied to at least a portion of the heart by a portion of prosthetic valve 320 can be sensed via force sensor 322 .

[0380] like Figure 44 The force sensor 322 shown in FIG is adapted to sense the force applied by the prosthetic valve 320 to the native heart valve. The force is applied by the outer frame or sealing body 11 of the prosthetic valve 320. For example, referring to Figure 45 The force sensor 322 is positioned to sense the force applied by the sealing body 11 to the annulus of the native heart valve. Thus, a measure of strain on the annulus can be determined. In an example, the force sensor 322 comprises a strain gauge. Annular remodeling sensing and overload detection can be provided as desired.

[0381] Additionally, in an example, a force sensor 324 is positioned on the anchor 17. The force sensor 324 detects whether the anchor 17 applies excessive force to the native heart valve, which could disrupt electrical conduction of the native heart valve or cause other undesirable consequences.

[0382] The force sensor is adapted to Figures 33-38 The pressure sensors discussed provide signals indicative of the sensed flow in a similar manner. For example, wireless or wired signals may be provided.

[0383] Figure 44 and 45 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0384] In an example, a combination of sensors may be utilized as desired.

[0385] Figure 26-45 The features of the prosthetic valve shown in FIG may include other prosthetic valves disclosed herein (e.g., as described with respect to FIG). Figure 1A-3 Other forms of prosthetic valves may be used in the examples as needed.

[0386] In an example, the delivery device has one or more sensors 330 adapted to sense a spatial relationship between the delivery device and at least a portion of the native heart valve.

[0387] For example, reference Figure 46 , delivering equipment to Figure 3 Discussed or concerning Figure 28The delivery device discussed herein is constructed in a similar manner. A delivery system including the delivery device, for example, comprises an elongated shaft. The elongated shaft comprises a distal portion 332 containing an implant retention region in the form of a capsule 334. Capsule 334 is adapted to retract to release the implant. The proximal portion of the elongated shaft 232 is coupled to a housing that can be constructed in a similar manner to the housings disclosed herein. The delivery device is adapted to deliver the implant to a native heart valve.

[0388] Sensor 330 is positioned on the elongated shaft. For example, sensor 330 is positioned on capsule 334 and is adapted to sense the spatial relationship between capsule 334 and a portion of the native heart valve. Sensor 330 may include a proximity sensor or a contact sensor adapted to sense the spatial relationship. A contact sensor is considered to sense contact between the delivery device and a portion of the native heart valve, which may include one or more native leaflets of the native heart valve. Sensor 330 may include various types of sensors. Utilized sensors 330 may include one or more piezoelectric sensors, strain gauges, pressure transducers, and / or capacitive sensors. Other types of sensors for detecting contact or force may also be utilized. In one example, sensor 330 may include electrodes, with a reference electrode positioned on the patient's body. Contact between the electrodes and tissue within the patient's body (e.g., heart valve leaflets) provides an electrical signal between the electrodes and the reference electrode, which may indicate contact between the electrodes and the heart valve leaflets. Such sensors may include contact sensors and / or force sensors. Proximity sensors such as infrared, electromagnetic, capacitive, or ultrasonic proximity sensors may be utilized. Other forms of sensors disclosed herein may be utilized. The sensors may be utilized with any other examples disclosed herein.

[0389] refer to Figure 46 In an example, the sensors 330 are spaced apart from one another circumferentially around the capsule 334. The spacing of the sensors 330 allows the sensors 330 to determine whether one or more native valve leaflets are in proximity to the one or more sensors 330. For example, if one leaflet is in contact with or in close proximity to the sensor 330, the user can determine that the sensor is in proximity to the native heart valve and in position for implant deployment.

[0390] For example, Figure 47 Capsule 334 is shown proximate the implant site with the native valve leaflets 82a, 82b in contact with sensor 330. Thus, signals from sensor 330 indicate that capsule 334 is in position for deployment of the implant contained therein. The axial position of the elongated shaft and capsule 334 is determined by signals from one or more sensors 330.

[0391] Sensor 330 can also be used to determine whether capture of the leaflet has occurred. Figure 48 , the anchors 17a, 17b of the prosthetic valve are deployed from the capsule 334. The anchor 17a may fail to capture or miss capturing the leaflet 82a. As a result, the one or more sensors 330 generate a signal indicating no contact or proximity with the leaflet 82a. Thus, the user determines that a failure to capture the leaflet 82a has occurred. The one or more sensors 330 indicate that capture of the leaflet 82b has occurred. For example, the one or more sensors 330 provide a signal that contact or close proximity with the leaflet 82b has occurred. The user determines that redeployment of the prosthetic valve will occur for capturing the leaflet 82a.

[0392] A first sensor of sensors 330 provides a signal indicative of contact with a portion of the heart valve, and a second sensor of sensors 330 indicates a lack of contact with the portion of the heart valve at the same time as the first sensor of sensors 330 provides the signal.

[0393] One or more sensors 330 determine that capture of leaflet 82b has occurred, and one or more sensors 330 therefore determine that capture of leaflet 82a has occurred. Different groups of sensors 330 generate different signals based on whether the corresponding leaflets 82a and 82b have been captured. For example, a first group of sensors 330 near leaflet 82b generates a signal that capture has occurred. A second group of sensors 330 near leaflet 82a generates a signal that capture has not occurred. Different sensors at different locations generate different signals.

[0394] In some embodiments, the configuration of one or more sensors 330 may vary. For example, referring to Figure 49 , one or more sensors 336 are positioned in axial alignment on the capsule 334 of the delivery device. The one or more sensors 336 include a plurality of sensors 336 spaced apart from one another along the length of the capsule 334. The one or more sensors 336 are aligned with one another along the length of the capsule 334. The one or more sensors 336 are adapted to determine the axial position of the capsule 334 from signals generated by the one or more sensors 336. For example, a greater depth of the capsule 334 causes different sensors 336 spaced axially along the capsule 334 to provide signals (e.g., a signal generated by a sensor 336 positioned more proximally may indicate a greater depth of the capsule 334 relative to the native valve).

[0395] The output from any sensor can be provided to the user in a variety of ways. It can be provided using wired signals or wireless signals. In an example, it can be provided using Figure 28, 244, 246, 248, 250. For example, a signal may be provided that produces an indication on one or more indicator devices 242, 244, 246, 248, 250. For example, different lights 246 may produce different indications based on the depth of the capsule 334 or based on the location of capture or missed capture of the leaflets. One or more of the indicator devices 242, 244, 246, 248, 250 produces an indication of the spatial relationship between the delivery device and at least a portion of the native heart valve sensed by one or more sensors. One or more of the indicator devices 242, 244, 246, 248, 250 produces an indication of the depth of the delivery device relative to the native heart valve. Other forms of output may be provided to the user as desired.

[0396] In the example, using Figure 28 252. Memory similar to memory 254 may also be utilized. The processor is adapted to receive one or more signals from the sensor. The processor is adapted to determine capture or missed capture of the native valve leaflet based on the one or more signals. The processor is adapted to determine a depth of the delivery device relative to the native heart valve based on the one or more signals. Other determinations by the processor may be provided based on the one or more signals.

[0397] Figures 46-49 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0398] In examples, other forms of indicators can be utilized with the delivery device. For example, any other form of indicator disclosed herein can be utilized with the delivery device. The indicator can be positioned on the capsule or other portion of the delivery device. For example, the indicator can include a protrusion extending radially outward from the delivery device. The indicator can extend radially outward from the capsule of the delivery device. Figure 15 and 16 indicator 130 shown in, or Figure 17 and 18 The indicator 140 shown in , or other forms of indicators. The movement or appearance change of the indicator can be used to determine the proximity to the implant site or the capture or missed capture of the native valve leaflets. In the example, other forms of indicators are used as needed.

[0399] In an example, an imaging device is coupled to a delivery device and can be adapted to image an area external to the delivery device. Figure 50A , imaging device 340 is adapted to extend along delivery device 342. Imaging device 340 can have various forms and can include an ultrasound imaging device or a fluoroscopic imaging device, or a combination of these imaging devices. In examples, other forms of imaging devices can be utilized.

[0400] Delivery device 342 can be used with Figure 3 Discussed or concerning Figure 28 The delivery device 342 is constructed in a similar manner to the delivery devices discussed herein. A delivery system including the delivery device, for example, comprises an elongated shaft. The elongated shaft comprises a distal portion 339 that includes an implant retention region in the form of a capsule 349. The proximal portion of the elongated shaft can be coupled to a housing that can be constructed in a similar manner to the housings disclosed herein. The delivery device 342 is adapted to deliver an implant to a native heart valve.

[0401] In an example, the imaging device 340 comprises an IVUS (Intravascular Ultrasound) imaging device or catheter. In an example, the imaging device 340 comprises an OCT (Optical Coherence Tomography) imaging device or catheter.

[0402] Imaging device 340 can be positioned in a variety of locations. For example, imaging device 340 extends within an elongated sheath of delivery device 342. The elongated sheath comprises an outer sheath of delivery device 342 and extends coaxially with delivery device 342. In an example, imaging device 340 extends external to delivery device 342. Imaging device 340 protrudes distally from a capsule, distal end, or other portion of delivery device 342 during imaging. Capsule 349, for example, contains distal end 347 of the elongated sheath. Other locations for imaging device 340 may be utilized.

[0403] In an example, imaging device 340 is positioned within prosthetic valve 344 when the prosthetic valve is deployed. Imaging device 340 extends distally, for example, to be positioned within prosthetic valve 344 and to image the area surrounding prosthetic valve 344. Imaging device 340 is positioned within the flow channel of prosthetic valve 344.

[0404] The imaging device 340 is adapted to image at least a portion of the native heart valve. The imaging device 340 images one or more leaflets of the native heart valve. The imaging device 340 is adapted to image the capture of one or more leaflets by one or more anchors. For example, anchor 17a fails to capture leaflet 82a. The imaging device 340 can image such an area to provide an image that a failed capture or missed capture has occurred. Anchor 17b has captured leaflet 82b. The imaging device 340 can image such an area to provide an image that a capture has occurred. The user can attempt to recapture leaflet 82a with anchor 17a, and such recapture can be imaged by the imaging device 340.

[0405] The imaging device may be used to image other conditions in the area external to the delivery device.

[0406] In an example, the prosthetic valve comprises one or more windows that allow imaging through the prosthetic valve. Figure 51 , the valve body 346 includes one or more imaging windows 348 that can allow imaging therethrough (e.g., ultrasound transmission or x-ray transmission, etc.). In an example, the windows 348 are positioned at the locations of the anchors to allow imaging of the anchors' capture of the native valve leaflets. The imaging windows 348 are circumferentially spaced apart from one another and positioned at the ends of the anchors 17. In an example, other locations for the windows can be utilized as desired. The windows 348 comprise openings in the metal frame of the prosthetic valve to allow imaging therethrough.

[0407] In an example, imaging device 341 is adapted to be positioned outside of valve body 343 of prosthetic valve 345 during deployment of prosthetic valve 345. Imaging device 341 can be positioned between valve body 343 and one or more anchors 17. Thus, imaging device 341 can image the implantation site without imaging through valve body 343. Thus, imaging device 341 images whether capture of one or more leaflets 82a, 82b occurs.

[0408] The signal from the imaging device is provided for viewing by the user during the implantation procedure or at another time as desired.

[0409] Figures 50A-51 The features of can be utilized alone or in combination with any of the examples disclosed herein. The prosthetic valve utilized can include other prosthetic valves disclosed herein (e.g., as described with respect to Figure 1A-3 Other forms of prosthetic valves may be used in embodiments as desired.

[0410] In an example, a sensor may be provided and one or more anchors may be coupled to the sensor. The one or more anchors may be adapted to engage the inner wall of a heart chamber to anchor the sensor to the inner wall. For example, referring to Figure 52 , an anchor 352 is coupled to the sensor 350. The anchor 352 is adapted to engage the inner wall of the heart chamber to anchor the sensor 350 to the inner wall.

[0411] Sensor 350 may have various forms. Sensor 350 may be adapted to sense a condition within a patient's body. Sensor 350 may be adapted to sense a condition within a heart chamber. Sensor 350 may be adapted to sense a property of a fluid within a heart chamber.

[0412] In an example, sensor 350 includes a pressure sensor. The pressure sensor is adapted to sense pressure within a heart chamber. In an example, the sensor includes a temperature sensor or a flow sensor adapted to sense the corresponding temperature or flow within the heart chamber. In an example, other types of sensors may be utilized. In an example, a combination of different sensors may be provided.

[0413] In an example, the sensor 350 is positioned within a support body 351. For example, the support body 351 can include a housing for the sensor 350, or can have another configuration as desired.

[0414] The anchor 352 is positioned at the end portion 354 of the sensor 350, or may have another location as desired. For example, the anchor 352 may be positioned at the middle or center portion of the sensor 350, or at the end portion of the sensor 350. Figure 52 At the opposite end portion shown in .

[0415] The anchor 352 has various forms as required. Figure 52 As shown in FIG, the anchor 352 may include a clip 356 including a plurality of arms 358a, 358b. The arms 358a, 358b may be adapted to compress tissue (e.g., tissue of the inner wall) between the arms 358a, 358b to anchor the anchor to the tissue. The proximal end portions of the arms 358a, 358b may be coupled together at a pivot 360. The arms 358a, 358b are adapted to rotate about the pivot 360 to move the respective distal end portions 362a, 362b of the arms toward and away from each other. The arms 358a, 358b are adapted to pivot relative to the support body 351. The arms 358a, 358b include one or more penetrating bodies 364 for penetrating the inner wall. The penetrating bodies 364 are adapted to enhance anchoring to the tissue (e.g., tissue of the inner wall).

[0416] The anchor 352 is adapted to penetrate the inner wall. In an example, the anchor 352 includes a threaded body 366 adapted to penetrate the inner wall. The threaded body 366 can be adapted to be screwed into the tissue of the inner wall to anchor to the inner wall.

[0417] In an example, a shaft 368 is provided that is adapted to slide into a threaded body 366. As the shaft 368 slides distally into the threaded body 366, the pivot link 370 moves proximally relative to the distal end portions 362a, 362b of the arms to allow the distal end portions 362a, 362b to be pulled toward each other. Upon such movement, the distal end portions 362a, 362b of the arms 358a, 358b may be proximal to the distal tip 372 of the threaded body 366. In an example, other anchor configurations may be provided as desired.

[0418] refer to Figure 53 , the sensor 350 can be deployed in various locations. In an example, the sensor 350 can be deployed to the inner wall 380 of the left ventricle 382. The sensor 350 can be positioned at the apex, on the interventricular septum 383, or at another location as desired. In an example, the sensor 350 can be deployed to the inner wall 384 of the left atrium 386. In an example, other inner walls (e.g., of the right ventricle or right atrium) can be utilized.

[0419] The sensor 350 is inserted into the patient's heart, and the anchor 352 can engage the tissue of the inner wall 380. For example, referring to Figure 54 , a portion of the anchor, such as the threaded body 366, can be inserted into the inner wall. The threaded body 366 can be inserted to a desired distance.

[0420] The tissue of the inner wall 380 can be retracted proximally. When retracted, the arms 358a, 358b of the clip 356 can be closed, such as Figure 55 The sensor 350 may be anchored to the inner wall 380 .

[0421] refer to Figure 55 , sensor 350 is positioned within a chamber of the heart. Sensor 350 is positioned to protrude from inner wall 380 into the chamber, with one or more anchors 352 attached to inner wall 380. Thus, sensor 350 is positioned to sense conditions within the chamber. In an example, sensor 350 includes a sensing portion 385 at an end portion or other location of sensor 350 for sensing conditions within the chamber. Sensor 350 is adapted to be positioned at a plurality of locations along inner wall 380.

[0422] The sensor 350 is adapted to communicate with Figures 33-38 The pressure sensors discussed above provide signals indicating the sensed condition in a similar manner. For example, the signals may be provided wirelessly or wired. A wireless transmitter as disclosed herein may be used to transmit the signals from sensor 350. For example, the wireless transmitter may be disposed within support body 351. A power source or other components (e.g., a processor, memory) may be positioned within support body 351 as desired.

[0423] In examples, the configuration of the sensor 350 and anchor 352 can vary.

[0424] Figures 52-55 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0425] In an example, at least a portion of a prosthetic heart valve can include a pacemaker electrical conduit adapted to conduct electrical signals for pacing the heart. Figure 56, a prosthetic heart valve 390 can include a pacemaker electrical conduit 392. Various portions of a prosthetic heart valve can include a pacemaker electrical conduit.

[0426] like Figure 56 As shown in , the anchoring member of the prosthetic heart valve 390 includes a pacemaker electrical conduit 392. The prosthetic heart valve 390 includes one or more anchoring members 17 adapted to anchor the prosthetic heart valve 390 to the native heart valve, and the pacemaker electrical conduit 392 includes at least a portion of the one or more anchoring members. The pacemaker electrical conduit 392 is adapted to anchor the prosthetic heart valve 390 in place. The pacemaker electrical conduit 392 is adapted to anchor to the prosthetic heart valve leaflets in a manner similar to the other anchoring members 17 of the prosthetic heart valve 390. For example, the pacemaker electrical conduit 392 is adapted to extend over the distal tips of the native valve leaflets for anchoring to the leaflets. The anchoring member may extend radially outward from the valve body 15. The pacemaker electrical conduit 392 may be adapted to resist proximal forces applied to the prosthetic heart valve 390.

[0427] In the example, refer to Figure 57 The prosthetic valve 390 includes a proximal end portion 391 and a distal end portion 393. A pacemaker electrical conduit 392 extends along the valve body 15 to the proximal end portion 391 of the prosthetic valve 390. The pacemaker electrical conduit 392 extends to an electrical terminal 394 positioned at the proximal end portion 391 of the prosthetic valve 390. The electrical terminal 394 is adapted to electrically connect the pacemaker electrical conduit 392 to another electrical terminal 396 (e.g., a pacemaker 398) of the pacemaker 398. Figure 59 In an example, electrical terminals 394 are coupled to the frame of prosthetic valve 390 .

[0428] The pacemaker electrical conduit 392 includes a portion 395 that extends along the valve body 15 and a portion 400 that extends radially outward from the valve body 15. The portion 400 includes a tip portion that includes the tip of the pacemaker electrical conduit 392. In the example, the portion 395 extends along the frame of the valve body 15.

[0429] In an example, other portions of the prosthetic valve include pacemaker electrical conduits. For example, a frame portion including an outer frame or an inner frame includes pacemaker electrical terminals. The pacemaker electrical terminals are adapted to contact a portion of the native heart valve to enable cardiac pacing.

[0430] like Figure 58As shown in , when the prosthetic valve 390 is deployed, the pacemaker electrical conduit 392 contacts a portion of the patient's heart. For example, the pacemaker electrical conduit 392 captures the leaflets of the native heart valve. The pacemaker electrical conduit 392 hooks around the leaflets 82a to anchor to the leaflets 82a. The tip portion 400 of the pacemaker electrical conduit 392 contacts the surface of the heart to conduct electrical signals to the heart. For example, the tip portion 400 contacts an area near the annulus of the heart valve. In an example, the tip portion 400 contacts the annulus radially outside the leaflets of the native valve. In the event of missed capture or other configurations of the pacemaker electrical conduit 392, the tip portion 400 may be positioned inside the leaflets of the native valve.

[0431] A prosthetic valve 390 may be implanted, and a pacemaker 398 (in Figure 59 398) can be coupled to an electrical terminal 394 of a pacemaker electrical conduit 392. Coupling occurs as part of the implantation procedure of the prosthetic valve 390, or can occur in a separate procedure. For example, it can be determined that a pacemaker 398 should be provided to the patient. The pacemaker 398 can be provided after the prosthetic valve 390 is implanted, wherein the pacemaker electrical conduit 392 can be used to electrically connect to the pacemaker 398. In an example, the pacemaker 398 can be integral or pre-connected to the pacemaker electrical conduit 392 and can be provided to the patient at the time the prosthetic valve 390 is implanted.

[0432] refer to Figure 59 During surgery, the patient is provided with a pacemaker 398, wherein the electrical terminal 402 of the pacemaker electrical conduit 404 is connected to the electrical terminal 394. Thus, the pacemaker 398 provides an electrical signal to the pacemaker electrical conduit 392 for pacing the heart.

[0433] In examples, other forms of connection to the pacemaker electrical conduit 392 may be made.

[0434] In an example, the configuration of the pacemaker electrical conduit 392 can vary. The pacemaker electrical conduit 392 may include one or more coils. For example, Figure 60 An example of an available pacemaker electrical conduit is shown comprising coils 406a, 406b wound alternately and adjacent to each other. The coils 406a, 406b may have the same diameter, and insulation prevents electrical shorting of the coils 406a, 406b. Figure 61 A configuration is shown in which a first coil 408a is wound over a second coil 408b, with an insulating layer 410 positioned between the coils 408a, 408b. If desired, an insulating layer 412 is wound around the outer coil 408a. Coils 406a, 406b, 408a, 408b include corresponding cathode and anode coils as needed.

[0435] Using a prosthetic valve with pacemaker leads offers various benefits. For example, if a patient requires a pacemaker, the pacemaker leads are provided along with the prosthetic valve for use with the pacemaker. This configuration can reduce the need to insert the pacemaker leads into the flow path through the prosthetic valve, which could hinder operation of the prosthetic valve leaflets. Additionally, because the prosthetic valve provides a desired location for the pacemaker leads when the prosthetic valve is implanted, positioning the pacemaker leads can be easier. This can lead to other benefits.

[0436] Figures 56-59 The features of the prosthetic valve shown in FIG may include other prosthetic valves disclosed herein (e.g., as described with respect to FIG). Figure 1A-3 Other forms of prosthetic valves may be used in embodiments as desired.

[0437] Figures 56-61 The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0438] Figures 62A-68C An embodiment is shown for retaining one or more native valve leaflets in a contracted state using a retainer mechanism when one or more anchors of a prosthetic heart valve are at least partially hooked around one or more native valve leaflets.

[0439] refer to Figure 62A , for example, a distal end portion of a delivery device, such as a delivery catheter 420, is shown proximal to an implantation site. The delivery device is constructed in a manner similar to other forms of delivery devices disclosed herein and includes an implant retention region in the form of a capsule 422 for retaining a prosthetic heart valve. The delivery catheter 420 is adapted to deliver a prosthetic heart valve to a native valve. The prosthetic heart valve may be constructed in a manner similar to other forms of prosthetic heart valve disclosed herein. For example, the anchor 17 of the prosthetic heart valve (in conjunction with the Figure 1A -1C and anchor 17 shown in 4A) is shown in a linearized configuration and extends from the distal end of capsule 422.

[0440] The retainer mechanism 424 comprises one or more arms 426a, 426b adapted to hook around the native valve leaflets 82a, 82b. Figure 62A 426a, 426b extend parallel to the length of the capsule 422 and the delivery catheter 420. In an example, the delivery catheter 420 includes one or more channels 428a, 428b that receive the arms 426a, 426b and within which the arms 426a, 426b can slide. Figure 62AThe retracted, unexpanded, compressed or linearized configuration shown in FIG. Figure 62B , 426a, 426b. The proximal portions 430a, 430b of the retainer mechanism 424 are controllable or adjustable at the proximal portion of the delivery device to allow control of one or more arms 426a, 426b. The proximal portions 430a, 430b can be advanced to advance the arms 426a, 426b and retracted to retract the arms 426a, 426b. The proximal portions 430a, 430b can be independently controllable to independently control each arm 426a, 426b, or can be controlled in combination as a group.

[0441] in Figure 62A The arms 426a, 426b are shown in a retracted, unexpanded, compressed, or linearized configuration in a configuration for advancement to an implantation site and extending along the capsule 422 and delivery catheter 420. The arms 426a, 426b can be advanced to move to an advanced, expanded, deployed, or unfolded configuration, as shown in FIG. Figure 62B As shown in .

[0442] refer to Figure 62B , arms 426a, 426b are shown in a propulsion, expansion, deployment or open configuration. Arms 426a, 426b protrude radially outward from delivery catheter 420 and capsule 422. Arms 426a, 426b form a hook shape with corresponding bent portions or curved portions 432a, 432b and tips 434a, 434b. Corresponding elongated portions 436a, 436b extend between curved portions 432a, 432b and tips 434a, 434b. Arms 426a, 426b are adapted to hook around native valve leaflets 82a, 82b, wherein tips 434a, 434b and elongated portions 436a, 436b are positioned radially outward of corresponding leaflets 82a, 82b. The tips of corresponding leaflets 82a, 82b can be positioned within curved portions 432a, 432b.

[0443] The plurality of arms 426a, 426b may be circumferentially spaced apart from one another, with each arm projecting radially outward from the capsule 422 and the delivery catheter 420. For example, Figure 62E An arrangement is shown in which arms 426 project radially outward from the delivery catheter 420. Figure 62F A top cross-sectional view is shown. A greater or fewer number of arms 426 may be used as desired.

[0444] Arm 426 may include a flexible body shaped into a hook-shaped configuration. Arm 426 may be made of a shape-memory material (e.g., nitinol) or another type of material, as desired. In an example, arm 426 may be more flexible than the material forming anchor 17 of a prosthetic heart valve. Arm 426 may be thinner than anchor 17. In an example, this feature may facilitate deployment or threading between chordae tendineae of a native heart valve.

[0445] In operation, the retainer mechanism 424 is used to retain the native valve leaflets 82a, 82b in a contracted state when the anchor 17 is at least partially hooked around the native valve leaflets 82a, 82b. The arms 426a, 426b, for example, extend radially outward to retain the native valve leaflets 82a, 82b in a closed or partially closed configuration (e.g., the contracted configuration of the mitral or tricuspid valve). In an example, the arms 426a, 426b retain the native valve leaflets 82a, 82b in place or against the outer surface of the delivery catheter 420 or capsule 422. This feature can facilitate capture of the native valve leaflets 82a, 82b by the anchor 17.

[0446] refer to Figure 62A For example, the arms 426a, 426b are in a retracted, unexpanded, compressed, or linearized configuration and then advanced to an advanced, expanded, deployed, or open configuration to provide a desired effect during the contraction and relaxation motion of the leaflets 82a, 82b (in Figure 62A During the contraction movement, the arms 426a, 426b hook around the leaflets 82a, 82b and capture the leaflets. Figure 62B The construction shown in .

[0447] In such Figure 62B In the configuration shown in FIG, arms 426a, 426b have captured leaflets 82a, 82b. The reduced motion or static position of leaflets 82a, 82b makes it easier for anchor 17 to capture. For example, Figure 62C Anchor 17 is shown deployed to anchor to leaflets 82a, 82b in a manner similar to that disclosed herein.

[0448] At a desired time, arms 426a, 426b are retracted radially inwardly, as shown. Figure 62D The anchor 17 remains in place and the prosthetic heart valve can be deployed from the capsule 422 as disclosed herein. The use of a retainer mechanism improves the deployment of the prosthetic heart valve.

[0449] In an example, the arms 426a, 426b can be deployed from other locations on the delivery device or delivery catheter. Figures 63A-63C Shown with Figures 62A-62F4. The embodiment of the invention is shown in FIG. 4 , wherein arms 440a, 440b, configured in a manner similar to arms 426a, 426b, project radially outward from a nose body 442 of a delivery catheter 444. The nose body 442 comprises a nose cone for the delivery catheter 444. In an example, a guidewire lumen 446 couples the nose body 442 to the remainder of the delivery catheter 444. The guidewire lumen 446 passes a guidewire therethrough, which in this example passes through the nose body 442.

[0450] refer to Figure 63B , the nose body 442 includes respective passages 448a, 448b through which the arms 440a, 440b can pass. In an example, the passages 448a, 448b are curved to deflect the arms 440a, 440b toward the annulus radially positioned outside the leaflets 82a, 82b. The delivery catheter 444 includes passages 450a, 450b along a guidewire lumen 446 through which the arms 440a, 440b can pass. The nose body 442 includes openings 451a, 451b through which the arms 440a, 440b can protrude.

[0451] Arms 440a, 440b operate in a similar manner to arms 426a, 426b. Figure 63C , arms 440a, 440b can be retracted into nose body 442 when anchor 17 is deployed, as disclosed herein.

[0452] Figure 64 A variation is shown in which the guidewire lumen 446 includes respective openings 453a, 453b through which the arms 440a, 440b pass. The arms 440a, 440b are adapted to project radially outwardly from the guidewire lumen 446.

[0453] Other forms of retainer mechanisms may be utilized in examples. Figures 65A-65C An embodiment is shown in which the retainer mechanism 455 includes one or more barbs 452a, 452b for engaging the native valve leaflets 82a, 82b. The barbs 452a, 452b are positioned at the ends of respective arms 454a, 454b, which can be pivotally coupled to a portion of a delivery device or delivery catheter 456 (e.g., a sheath 458 extending over a capsule 460 of the delivery catheter 456). The arms 454a, 454b are adapted to project radially outward from the delivery catheter 456. The arms 454a, 454b are circumferentially spaced apart from one another, with the corresponding barbs 452a, 452b spaced apart from one another.

[0454] Retention members 462, such as sheaths, extend over arms 454a, 454b to retain arms 454a, 454b in a retracted, unexpanded, compressed, or linearized configuration. Retention members 462 can be retracted to allow arms 454a, 454b to pivot radially outward to engage leaflets 82a, 82b (e.g., Figure 65A). Arms 454a, 454b can operate in a similar manner to other forms of retainer mechanisms disclosed herein and retain leaflets 82a, 82b in a contracted state when anchor 17 is at least partially hooked around leaflets 82a, 82b.

[0455] For example, Figure 65B The barbs 452a, 452b are shown engaging the leaflets 82a, 82b with the radially outwardly pivoted arms 454a, 454b. As the anchor 17 is deployed, the retaining member 462 can be advanced to retract the arms 454a, 454b, as shown. Figure 65C Indicated in .

[0456] Other configurations of retainer mechanisms may be utilized in examples. Figures 66A-66D An example is shown in which a plurality of barbs 470 are coupled to a sheath 472 and are circumferentially spaced apart from one another. The sheath 472 and barbs 470 may be formed by an outer sheath 474 (e.g., Figure 66A ) covering (representative barbs 470a, 470b in Figure 66A (marked in the middle).

[0457] The outer sheath 474 can be retracted relative to the sheath 472 to expose the barbs 470 and allow the barbs 470a, 470b to engage the leaflets 82a, 82b, as shown. Figure 66B The barbs 470a, 470b can hold the leaflets 82a, 82b in the contracted state when the anchor 17 is at least partially hooked around the leaflets 82a, 82b.

[0458] The outer sheath 474 can be advanced relative to the barbs 470a, 470b to cover the barbs 470a, 470b, thereby releasing or disengaging the barbs 470a, 470b from the leaflets 82a, 82b, as shown. Figure 66C Indicated in .

[0459] Other configurations of retainer mechanisms may be utilized in examples. Figure 67 An example is shown in which the retainer mechanism 480 includes one or more suction ports 482 for applying a suction force to the native valve leaflets 82a, 82b to maintain the leaflets 82a, 82b in a contracted state. The suction ports 482 are positioned on an outer surface of a delivery device or delivery catheter 484. The suction ports 482 are circumferentially spaced from one another, or may have another configuration in an example. One or more suction lumens 486 extend along the delivery device or delivery catheter 484 to transmit the suction force to the ports 482. A suction device 488 (e.g., a pump or syringe) is provided to generate the suction force along the suction lumens 486. The suction ports 482 can be used to maintain the leaflets 82a, 82b in a contracted state when the anchor 17 is at least partially hooked around the leaflets 82a, 82b, as disclosed herein.

[0460] Other configurations of retainer mechanisms may be utilized in examples. Figures 68A-68C An embodiment is shown in which the retainer mechanism 490 includes a coil 492 for extending around the radially outwardly facing surfaces of the leaflets 82a, 82b. For example, the coil 492 can be adapted to be deployed from a delivery catheter 494 and, in an example, can protrude from a channel 496 of the delivery catheter 494. Other configurations can be utilized in examples.

[0461] The coil 492 may be shape-set (eg, using a shape memory material such as Nitinol) into a coil shape, or may be controlled (eg, using a guidewire or other mechanism) into a coil shape. Figure 68A The coil 492 is shown in a retracted, unexpanded, compressed or linearized configuration. Figure 68B The coil 492 is shown having been advanced (to an advanced, expanded, deployed, or coiled configuration). The coil 492 is wrapped around the radially outwardly facing surfaces of the leaflets 82a, 82b one or more times as desired. Figure 68C The coil 492 is shown in an advanced, expanded, deployed, or coiled configuration. The coil 492 can have a flat coil shape, or can have a helical or spiral shape, among other shapes.

[0462] refer to Figure 68B , the coil 492 is used to hold the leaflets 82a, 82b in a contracted state when the anchor 17 is at least partially hooked around the leaflets 82a, 82b, as disclosed herein. The coil 492 is retracted when the anchor 17 is deployed.

[0463] In embodiments, other configurations of retainer mechanisms may be utilized. For example, Figure 7-8F The indicator 90 shown in Figure 1 comprises a retainer mechanism that maintains implantation of the prosthetic heart valve when deployed. The indicator 90 comprises flexible arms that retain the native valve leaflets in a contracted state when the anchors 17a, 17b are at least partially hooked around the leaflets 82a, 82b.

[0464] Figures 62A-68C The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0465] Figures 69A-69G A prosthetic heart valve 500 is shown ( Figure 69C 、 69F and 69G). The frame 502 of the prosthetic heart valve 500 is Figure 69A Frame 502 includes an inner frame 504 (in Figure 69A ). A perspective view of the inner frame 504 is shown in Figure 69D506. The inner frame 504 can be constructed in a manner similar to other forms of internal frames disclosed herein. The inner frame 504 includes an inflow end portion 508 and an outflow end portion 510. The inner frame 504 can be adapted to move between an expanded configuration and a compressed configuration in the manner discussed with respect to other forms of internal frames disclosed herein.

[0466] In an example, the proximal or inflow end portion 508 of the inner frame 504 includes a coupler 512 or eyelet. The distal or outflow end portion 510 is coupled to an anchor 514 that can be constructed in a similar manner to the anchor 17 disclosed herein.

[0467] The inner frame 504 supports one or more prosthetic valve leaflets 16 (e.g., as shown in FIG. 5A ) positioned within the flow channel 516 of the prosthetic heart valve 500. Figure 69F (marked in ).

[0468] The prosthetic heart valve 500 includes a sealing body 520 positioned radially outwardly of an inner frame 504 (at Figure 69C The sealing body 520 includes a plurality of elongated prongs 522 and a skirt 524.

[0469] refer to Figure 69A , each of the plurality of elongated prongs 522 has a first end portion 526 coupled to the inflow end portion 508 of the inner frame 504. Each of the elongated prongs 522 projects radially outward from the inner frame 504 to a second end portion 528 of the elongated prongs 522. The elongated prongs 522 include elongated arms that project radially outward along radial lines extending outward from the central axis of the prosthetic heart valve 500. The first end portion 526 of the elongated prongs 522 includes a coupler for coupling with the coupler 512 of the inner frame 504. For example, Figure 69E A plan view of one elongated prong 522 is shown showing a first end portion 526 including a coupler in the form of an eyelet for suturing connection to an eyelet of the inner frame 504. In some examples, other forms of couplers may be used.

[0470] The elongated prongs 522 project radially outward from the first end portion 526 to form a platform portion 530 or planar portion of the seal body 520. The platform portion 530 has a generally planar shape that extends outward from the inner frame 504 as a disc.

[0471] The elongated prongs 522 are circumferentially spaced apart from one another around the inflow end portion 508 of the inner frame 504. The elongated prongs 522 extend outwardly to the second end portion 528 such that the second end portion 528 forms the outermost portion of the platform portion 530. The elongated prongs 522 extend to be circumferentially positioned between adjacent anchors 514 (e.g., Figure 69B ), or in an example may be radially aligned with an adjacent anchor 514.

[0472] The elongated tip 522 is deflectable in the axial dimension of the prosthetic heart valve 500. For example, an axial force on the second end portion 528 of the elongated tip 522 causes the second end portion 528 to deflect about the first end portion 526.

[0473] Skirt 524 (at Figure 69C (marked in the middle) is suspended between the second end portion 528 of the elongated tip 522 and the outflow end portion 532 of the prosthetic heart valve 500 (at Figure 69F ). The outflow end portion 532 of the prosthetic heart valve 500 includes the outflow end portion 510 of the inner frame 504. Figure 69F 504. In a cross-sectional view of FIG. 504, for example, the skirt 524 includes a first portion 534 positioned at the second end portion 528 of the elongated prong 522, and includes a second portion 536 coupled to the inner frame 504. An intermediate portion 537 is suspended between the first portion 534 and the second portion 536. The skirt 524 defines a pocket 538 positioned between the skirt 524 and the inner frame 504. The pocket 538 has a loop or ring shape surrounding the inner frame 504. An inner portion 540 of the skirt 524 is positioned inside the intermediate portion 537.

[0474] Skirt 524 extends along elongated tip 522 from first end portion 526 to second end portion 528 of tip 522 and then extends to couple to the distal or outflow end portion of inner frame 504. Inner portion 540 of skirt 524 covers a surface of inner frame 504.

[0475] refer to Figure 69F , the inner portion 540 of the skirt 524 includes a plurality of orifices 550 that allow blood to enter the bag 538. The blood flows through the inner frame 504 and the orifices 550 to enter the bag 538. In an example, the blood forms a clot within the bag 538 to improve the seal with the native annulus.

[0476] The anchor 514 is constructed in a similar manner to other forms of anchors disclosed herein. The anchor 514 can anchor the prosthetic valve to the native valve by capturing the native valve leaflets. The anchor 514 is coupled to the outflow end portion 510 of the inner frame 504 and projects radially outward from the outflow end portion 510. The anchor 514 is adapted to hook around the native valve leaflets to anchor the prosthetic heart valve 500 to the native valve. For example, Figure 69G Prosthetic heart valve 500 is shown in a deployed configuration.

[0477] refer to Figure 69GSkirt 524 contacts and forms a seal with tissue of the native valve (e.g., leaflets or annulus). Skirt 524 comprises a conformable body that is contoured to the shape of the local annulus. Elongated tip 522 comprises an atrial anchor that blocks ventricular movement of prosthetic heart valve 500. Anchor 514 comprises a ventricular anchor that blocks atrial movement of prosthetic heart valve 500. Pocket 538 is filled with blood and clot to stabilize prosthetic heart valve 500 within the native annulus.

[0478] In an example, during deployment, the elongated prongs 522 can be deflected using one or more tethers 560. The tethers 560 can be individually actuated to allow independent retraction of any of the elongated prongs 522. Retraction allows the elongated prongs 522 to be repositioned or relocated during deployment. The tethers 560 comprise part of a delivery device, such as a delivery catheter 562, and can be removed after implantation.

[0479] The configuration of the sealing body 520 allows for conformability to the shape of the native annulus and improves sealing. Additionally, as opposed to configurations of sealing bodies with rigid outer frames, reduced radial forces may be applied.

[0480] Figures 69A-69G The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0481] Figures 70A-73B An embodiment of a prosthetic heart valve is shown that includes one or more prosthetic valve leaflets and a support structure for supporting the one or more prosthetic valve leaflets and including at least one ring connected to the skirt, wherein the skirt or at least one ring is adapted to form a seal with at least a portion of the native heart valve.

[0482] For example, reference Figure 70A , shows an embodiment of a prosthetic heart valve 600 comprising a first ring 602, a second ring 604, and a third ring 606. A skirt 608 is coupled to the rings 602, 604, 606 and extends between the first ring 602 and the second ring 604. The skirt 608 forms a sheath between the first ring 602 and the second ring 604.

[0483] The third ring 606 includes a support body for supporting the prosthetic valve leaflets 610. The third ring 606 or support body is coupled to the prosthetic valve leaflets 610 and, along with the skirt 608, to the first ring 602 and the second ring 604. The third ring 606 is shaped to support the prosthetic valve leaflets 610 and may include commissure supports 612 for supporting the commissures of the prosthetic valve leaflets 610. The commissure supports 612 include upright bodies sewn to the prosthetic valve leaflets 610, or may have another configuration in examples.

[0484] The first ring 602 is positioned at the inflow end portion of the prosthetic heart valve 600. The second ring 604 is positioned at the outflow end portion of the prosthetic heart valve 600. Each ring can be compliant and flexible to allow the ring to be compressed to a compressed state for deployment. Each ring can be adapted to change shape. Each ring can be biased to expand radially outward so as to expand during deployment. For example, each ring can be made of a shape memory material (e.g., nitinol or another form of shape memory material).

[0485] The skirt 608 is coupled to the first and second rings 602, 604 by overlapping a portion of the first and / or second rings 602, 604. Figure 70B Cross-sectional view (along Figure 70A ), an end portion 614 of skirt 608 overlaps ring 602 to couple to ring 602. A channel 616 is formed by end portion 614 of skirt 608 for receiving ring 602. Skirt 608 can be coupled to itself via sutures 618 or, in an example, another form of coupling to form channel 616. Figure 70C The ring 602 is shown isolated from the skirt 608 .

[0486] Figure 70D A prosthetic heart valve 600 is shown deployed. A first ring 602 is positioned on the atrial side of the valve annulus, and a second ring 604 is positioned on the ventricular side of the valve annulus. A third ring 606 is supported between the first and second rings 602, 604 by a skirt 608. The rings 602, 604, 606, and skirt 608 form a seal with a portion of the native valve. The rings 602, 604, 606, and skirt 608 form a compliant body that contours to the shape of the native valve for an improved seal.

[0487] Variations in the features of the prosthetic heart valve 600 may be provided. For example, Figure 70E A variation of the rings in either the first ring 602 or the second ring 604 is shown, wherein the ring 620 includes a first end 622 and a second end 624, and the first end 622 is adapted to slide relative to the second end 624 to change the diameter of the ring 620. The ring 620 may have improved expansion and contraction capabilities to expand and compress the ring as needed, wherein the ends 622, 624 slide freely relative to each other.

[0488] Figure 70F A variation of the rings in either the first ring 602 or the second ring 604 is shown, wherein the ring 630 passes in vivo through a passage 632 of a skirt 634 to in vivo control the diameter of the ring 630. By controlling the length of material comprising the ring within the passage 632, either ring 602, 604 can have an adjustable in vivo diameter.

[0489] Figures 71A-71CA variation is shown in which one or more tethers 640 are used to compress together the first ring 602 and the second ring 604. The tethers 640 extend along a channel 642 that extends axially along the skirt 608. An end of the tether 640 is coupled to the first ring 602. An opposite end portion 644 of the tether 640 is pulled or retracted to pull the rings 602, 604 axially toward each other.

[0490] For example, Figure 71B The opposite end portion 644 of the tether 640 leads to a sheath 646 and can be retracted through the sheath 646. Figure 71C As shown in . Tether 640 can be locked and / or cut in place to ensure axial compression at the implant site. Axial compression can be preferred over radial expansion to reduce the possibility of conduction disturbances or other adverse effects on the valve annulus.

[0491] Figure 72A and 72B A configuration is shown in which a support structure 650 of a prosthetic heart valve 652 includes an inner frame 654 and an outer frame 656 positioned radially outward of the inner frame 654. The prosthetic heart valve 652 may be provided with Figure 1A-2 , but may include a skirt 658 that forms a disc extending radially outward from an outer frame 656. The skirt 658 is supported at the outer periphery of the disc by a ring 660 that may be constructed in a manner similar to other examples of rings disclosed herein. The skirt 658 projects radially outward from a distal end portion 662 or outflow end portion of the outer frame 656 and provides a seal with the native valve when deployed, as shown in FIG. Figure 72B The ring 660 and / or skirt 658 can be pressed against the native valve (eg, leaflets or annulus) to provide an enhanced seal when deployed.

[0492] Figure 73A Shown is a diagram in which the skirt 670 is formed from Figure 69A The inner frame 504 is shown in FIG. 6 , which is a variation of a disc extending radially outwardly from the inner frame 504. The skirt 670 is supported at the outer periphery by a ring 672. The skirt 670 projects radially outwardly from the proximal end portion 674 or inflow end portion of the inner frame 504. The skirt 670 is adapted to be positioned on the inflow side of a native valve, for example Figure 73B The ring 672 and / or skirt 670 form a seal with the annulus or native valve leaflets on the atrial side of the native valve.

[0493] Figures 70A-73B The features of may be utilized alone or in combination with any of the examples disclosed herein.

[0494] Figures 74-83An embodiment of a sensor system according to examples herein is shown. The sensor system can be used with various other systems, devices, or methods disclosed herein. Figures 74-83 An embodiment is shown in which the sensor system comprises a prosthetic heart implant in the form of a clip 700, but other forms of prosthetic heart implants (eg, prosthetic heart valves) may utilize features of the sensor system.

[0495] Figure 74 A side view of a delivery system 702 that can be used with a clip 700 is shown. The delivery system 702 can include multiple catheters, including a guide catheter 704, a steering catheter 706, and / or an implant deployment catheter 708. The implant deployment catheter 708 can be passed through the steering catheter 706. The steering catheter 706 can be passed through the guide catheter 704. The steering catheter 706 can be used to steer the clip 700 to a desired position. The implant deployment catheter 708 can be used to position the clip 700 and release the clip 700 at a desired time. Variations in the configuration of the delivery system can be utilized in examples.

[0496] Figure 75 A side view of a clip 700 is shown. Clip 700 includes a plurality of arms or paddles 710 pivotally coupled to one another. A pivot link 712 may be provided that allows the arms or paddles 710 to be opened or closed in a manner similar to pivot link 370. Clip 700 includes one or more engagement arms, including a first or upper set of engagement arms 714 and a second, lower set of engagement arms 715. Respective sets of engagement arms 714, 715 include barbs 717 or other engagement features for grasping leaflet tissue therebetween. Features of the available clips and / or delivery systems are disclosed in WIPO Publication No. WO / 2023 / 003755, entitled “Sensing Heart Valve Repair Devices,” published on January 26, 2023, and a publication of International Application No. PCT / US2022 / 037176; WIPO Publication No. WO / 2023 / 004098, entitled “Heart Valve Repair Devices,” published on January 26, 2023, and a publication of International Application No. PCT / US2022 / 037983; and International Application No. PCT / US2023 / 028329, filed on July 21, 2023; the entire contents of each of the foregoing are incorporated herein by reference for all purposes.

[0497] The set of coaptation arms 714, 715 and paddle 710 are controllable to control the coaptation of the heart valve leaflets. Figures 76-78 An exemplary deployment sequence is shown. For example, Figure 76The clip 700 is shown positioned between two heart valve leaflets 82a, 82b with the engagement arms 714, 715 and paddle 710 in an open configuration. Portions of the heart valve leaflets 82a, 82b fit between the engagement arms 714, 715. The clip 700 is coupled to an implant deployment catheter 708. At least one of the upper set of engagement arms 714 can be closed to clamp a portion of a heart valve leaflet with one of the lower set of engagement arms 715. For example, Figure 77 This configuration is shown. At a desired time, the other engaging arms 714, 715 close to clamp a portion of another heart valve leaflet therebetween. Paddle 710 can be closed.

[0498] With the clip 700 in place, the implant deployment catheter 708 is removed, as shown. Figure 78 As shown in FIG. 7 , the clip 700 has clamped the heart valve leaflets together. The heart valve leaflets are clamped together to reduce valvular regurgitation or other diseases.

[0499] In an example, one or more sensor bodies 720 (in Figure 80 into the system. Figure 81 A perspective view of the sensor body 720 is shown in FIG. Figure 81 , the sensor body 720 includes a substrate 722 and a sensor 724 positioned on the substrate 722 .

[0500] The sensor 724 is adapted to detect a condition of a prosthetic heart implant (e.g., clip 700). The sensor 724 is adapted to detect contact between a portion of the clip 700 and a heart valve leaflet. For example, the sensor 724 includes electrodes, wherein a second reference electrode 726 (at Figure 82 724 is coupled to a portion of the patient's body. When contact is made between sensor 724 and tissue (e.g., heart valve leaflets), an electrical signal between sensor 724 and reference electrode 726 indicates contact between clip 700 and the heart valve leaflets. The signal from sensor 724 is transmitted along electrical trace 728 to electrical terminal 730. Electrical terminal 730 is coupled to controller 732 (at Figure 82 ), the controller determines whether contact occurs due to a signal from the sensor 724. The controller 732 includes a processor as disclosed herein, or includes other forms of controllers for detecting signals from the sensor 724. Figure 82 As shown in , the reference electrode 726 can be electrically coupled to the controller 732.

[0501] The sensor body 720 and sensor 724 are positioned to detect contact between the clip 700 and the heart valve leaflets. Figure 79 and 80, sensor body 720 and sensor 724 are positioned in one or more of engagement arms 714, 715 or paddle 710 for detecting contact between the corresponding engagement arms 714, 715 or paddle 710 and heart valve leaflet tissue. Sensor 724 is positioned to contact heart valve tissue for detecting contact.

[0502] In an example, the sensor body 720 is adapted to be withdrawn from a portion of the clip 700 after implantation. Figure 80 , the sensor body 720 is shown removed from the clip 700 during implantation, so that the sensor body 720 does not remain within the patient's body with the clip 700 implanted. Tension is applied to the sensor body 720 using a tether 734, or tension can be applied directly to the sensor body 720 for withdrawal (e.g., at the proximal end portion of the delivery system). The sensor body 720 can be retracted into the catheter of the delivery system at a desired time.

[0503] refer to Figure 81 Substrate 722 comprises a circuit board. The circuit board is a flexible circuit board on which sensors 724 and electrical traces 728 are printed. The flexible circuit board is a laminated structure comprising multiple layers of material, including the conductive layers of sensor 724 and electrical traces 728. Sensor body 720 is constructed as a strip of material and has relatively narrow dimensions (e.g., a width 736 of less than 1 mm or less than 0.5 mm, and a thickness 738 of less than 0.5 mm or less than 0.2 mm). Sensor body 720 is relatively long (with a length 740 of greater than 100 cm or greater than 150 cm), which allows the proximal end of sensor body 720 to be pulled through the delivery system after implantation.

[0504] A concern during extraction of the sensor body 720 is the potential for excessive forces to be generated on the sensor body 720 during the extraction process. Tension on the sensor body 720 can generate forces that can damage (e.g., partially or completely tear) the sensor body 720. This can be undesirable because fragments of the sensor body 720 can become dislodged within the patient's body or cause other damage to the sensor body 720 if other forces are generated.

[0505] Therefore, it is desirable to be able to detect the force applied to the sensor body 720 and substrate 722. The force may indicate a complete or partial tearing of the substrate 722, or other undesirable forces on the substrate 722 (e.g., excessive extraction forces on the substrate 722).

[0506] refer to Figure 81, an electrical detection trace 741 is positioned on the substrate 722. The electrical detection trace 741 is adapted to detect a force applied to the substrate 722. The electrical detection trace 741 comprises a conductive trace on the substrate 722 extending along the periphery of the substrate 722. A ring shape is formed having a first end 742 and a second end 744. A first electrical terminal 746 is located at the first end 742, and a second electrical terminal 748 is located at the second end 744. The electrical terminals are adapted to be electrically coupled to the controller 732, as shown. Figure 82 Controller 732 generates a current along electrical detection trace 741 and monitors the current or resistance maintained along electrical detection trace 741 during withdrawal.

[0507] For example, Figure 83 A partial tear 749 in the substrate 722 is shown during the extraction procedure. The tear interrupts the electrical detection trace 741, thereby increasing the resistance of the electrical detection trace 741 and / or reducing the current applied along the electrical detection trace 741. The controller 732 detects this change. The controller 732 generates an indication using any form of indicator device disclosed herein. The technician is aware of the damage to the substrate 722 and can modify the procedure by stopping the extraction of the sensor body 720 and completely removing the clip 700 and delivery system.

[0508] The electrical detection trace 741 is adapted to detect partial or complete tearing of the substrate 722 when the sensor body 720 is withdrawn from the clip 700 in vivo.

[0509] Other forms of electrical detection traces may be utilized in examples. For example, Figure 84 A variation is shown in which the electrical detection trace 750 is electrically conducted through the sensor 724. Figure 83 , the electrical detection trace 750 electrically passes through the sensor 724 to reduce the size of the electrical detection trace 750. The controller 732 can be modified to take into account that the electrical detection trace 750 and the sensor 724 share the same electrical trace.

[0510] Figure 85 A variation is shown in which the electrical detection trace 752 includes a strain gauge 754 on the substrate 722. The strain gauge 754 generates an electrical signal indicative of the amount of force applied to the substrate 722. The signal is received by the controller 732. The controller 732 is adapted to generate an output on an indicator device 759 (e.g., a display screen on one of the catheters of the delivery system), such as Figure 86 Thus, the technician knows the force applied to the base plate 722 and the amount of force to determine if corrective action is needed during the procedure.

[0511] The sensor bodies disclosed herein may be implemented with other forms of prosthetic heart implants. Figure 87 Shown with Figures 82-84An embodiment of a sensor body 760 constructed in a manner similar to any of the sensor bodies shown in , but coupled to a prosthetic heart valve 762 and including a plurality of sensors 761. The prosthetic heart valve 762 is configured in a manner similar to any of the sensor bodies shown in . Figure 1A-2 . A sensor body 760 extends circumferentially around a prosthetic heart valve 762. Sensor 761 is constructed in a similar manner to sensor 724 and is adapted to detect contact between sensor 761 and cardiac tissue. Sensor 761 is connected via a single electrical conduit or trace, or multiple electrical conduits or traces may be utilized.

[0512] refer to Figure 88 and 89 , the sensor body 760 has a wavy shape that is adapted to expand radially outward as the prosthetic heart valve 762 expands. Figure 88 is shown in a compressed configuration and in Figure 89 The base plate 766 has a corrugated shape that is adapted to expand radially outward with the prosthetic heart valve 762.

[0513] Figure 90 The sensor body 760 is shown isolated from a prosthetic heart valve 762 and extending circumferentially in an expanded configuration. Figure 91 The sensor body 760 is shown isolated from a prosthetic heart valve 762 and in a compressed configuration.

[0514] refer to Figure 87 , the sensor 761 is positioned to detect heart valve tissue between the anchor and the valve body 764. Thus, the sensor 761 detects whether capture of the leaflet by the anchor 768 has occurred, which can be constructed in a manner similar to other forms of anchors disclosed herein. Sensing tissue between the anchor 768 and the valve body 764 indicates capture. The electrical signal can be transmitted along the electrical conduit 770 of the delivery system, which can be constructed in a manner similar to other forms of electrical conduits disclosed herein. In an example, the disconnected portion 772 of the sensor body 760 or the electrical conduit 770 (at Figure 90 ) allows the electrical conduit 770 to be disconnected. The disconnect portion 772 allows the connection to be torn apart due to the applied force, but other disconnection methods (e.g., separation of the terminals, magnetic release, etc.) can be utilized in examples.

[0515] Other locations for sensor 761 may be utilized. Figure 92 A variation is shown in which the sensor 761 is circumferentially offset from the position of the anchors 768 (circumferentially offset between the anchors 768). This position may provide an indication that a seal is being formed with the native annulus.

[0516] Examples of prosthetic valves may be used in a mitral valve as disclosed herein, or may be used in other deployment locations such as a native tricuspid valve or other deployment locations, such as deployment to the aortic or pulmonary valve, or other implantation sites.

[0517] Various modifications of the examples disclosed herein may be provided. Features of an example may be modified, substituted, excluded, or combined as desired between examples. Combinations of features between examples may be provided as desired. Combinations of features between examples may be provided, and other features of such examples may be excluded as desired.

[0518] The various examples of sealing skirts disclosed herein can have various forms, including cloth skirts, foam skirts, or woven skirts as desired. Various materials can be used as desired.

[0519] The implants disclosed herein may include prosthetic heart valves or other forms of implants, such as stents or filters, or diagnostic devices, etc. The implant may be an expandable implant adapted to move from a compressed or undeployed state to an expanded or deployed state. The implant may be a compressible implant adapted to compress inwardly to have a reduced outer profile and move the implant to a compressed or undeployed state.

[0520] Various forms of delivery devices can be used in the examples disclosed herein. Delivery devices as disclosed herein can also be used for replacement and repair of the aorta, mitral valve, tricuspid valve, and pulmonary artery. Delivery devices can include delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, etc.

[0521] The implants and systems disclosed herein can be used for transcatheter mitral or tricuspid valve implantation, as well as transaortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein can be used for transarterial access (including transfemoral access) to a patient's heart. The delivery devices and systems can be used for transcatheter percutaneous procedures, including transarterial procedures, which can be transfemoral. In addition, transapical procedures can also be used. Other procedures can be used as desired.

[0522] Furthermore, the methods herein are not limited to the specifically described methods and may include methods using the systems and devices disclosed herein. Steps of the methods may be modified, eliminated, or added to the systems, devices, and methods disclosed herein. In an example, the examples disclosed herein may include a system for implantation in a human body.

[0523] For the purposes of this description, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. On the contrary, the present 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, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems. Features, elements, or combinations of one example may be combined into other examples herein.

[0524] Example 1: A prosthetic valve for deployment in a native valve, the prosthetic valve comprising: a valve body; one or more prosthetic valve leaflets connected to the valve body; one or more anchors adapted to anchor the valve body to the native valve by capturing the native valve leaflets; and an indicator adapted to indicate capture of the native valve leaflets by the one or more anchors.

[0525] Example 2: The prosthetic valve according to any example herein, in particular the prosthetic valve according to example 1, wherein the indicator is visible under imaging.

[0526] Example 3: The prosthetic valve according to any example herein, in particular the prosthetic valve according to example 1 or example 2, wherein the appearance of the indicator changes to indicate capture of the native valve leaflets.

[0527] Example 4: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 3, wherein the visibility of the indicator is reduced under ultrasound imaging to indicate capture of the native valve leaflets.

[0528] Example 5: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 4, wherein the indicator moves to indicate capture of the native valve leaflets.

[0529] Example 6: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 5, wherein the indicator is positioned on the one or more anchors.

[0530] Example 7: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 6, wherein the indicator comprises one or more elongated bodies.

[0531] Example 8: The prosthetic valve of any example herein, particularly the prosthetic valve of Example 7, wherein the one or more elongated bodies are positioned on the one or more anchors.

[0532] Example 9: The prosthetic valve of any example herein, particularly example 7 or example 8, wherein each of the one or more elongated bodies comprises an axially compressible structure, such as a spring.

[0533] Example 10: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 7 to 9, wherein the one or more elongated bodies are positioned on the valve body.

[0534] Example 11: The prosthetic valve of any example herein, in particular the prosthetic valve of examples 1 to 10, wherein the indicator comprises a ring extending circumferentially around the valve body.

[0535] Example 12: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 11, wherein the indicator extends axially along the valve body.

[0536] Example 13: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 12, wherein the indicator comprises a ring.

[0537] Example 14: The prosthetic valve of any example herein, particularly examples 1 to 13, wherein the indicator extends from the valve body to at least one of the one or more anchors.

[0538] Example 15: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 14, wherein the indicator comprises a button adapted to be depressed to indicate capture of the native valve leaflets.

[0539] Example 16: The prosthetic valve according to any example herein, in particular according to examples 1 to 15, wherein the indicator comprises a balloon adapted to be filled with a contrast agent.

[0540] Example 17: The prosthetic valve of any example herein, in particular the prosthetic valve of Example 16, wherein the sac comprises an opening adapted to release the contrast agent to indicate capture of the native valve leaflets.

[0541] Example 18: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 17, wherein the indicator comprises a channel adapted to allow a contrast agent to pass therethrough.

[0542] Example 19: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 18, wherein the indicator comprises a sensor.

[0543] Example 20: The prosthetic valve according to any example herein, in particular the prosthetic valve according to examples 1 to 19, wherein the prosthetic valve is adapted to be deployed to the mitral valve or the tricuspid valve.

[0544] Example 21: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: a valve body, one or more prosthetic valve leaflets connected to the valve body, one or more anchors adapted to anchor the valve body to the native valve by capturing the native valve leaflets, and an indicator adapted to indicate capture of the native valve leaflets by the one or more anchors.

[0545] Example 22: The method according to any example herein, in particular the method according to Example 21, wherein the indicator is adapted to indicate capture of the native valve leaflets under imaging.

[0546] Example 23: The method according to any example herein, in particular the method according to example 21 or example 22, wherein the appearance of the marker under imaging changes to indicate capture of the native valve leaflets.

[0547] Example 24: The method according to any example herein, in particular according to examples 21 to 23, wherein the indicator is adapted to move to indicate capture of the native valve leaflets.

[0548] Example 25: The method according to any example herein, in particular according to examples 21 to 24, wherein the indicator is positioned on the one or more anchors.

[0549] Example 26: The method according to any example herein, in particular the method according to examples 21 to 25, wherein the indicator comprises one or more elongated bodies.

[0550] Example 27: The method according to any example herein, in particular the method according to Example 26, wherein the one or more elongated bodies are positioned on the valve body.

[0551] Example 28: The method according to any example herein, in particular according to examples 21 to 27, wherein the indicator comprises a capsule adapted to be filled with a contrast agent.

[0552] Example 29: The method according to any example herein, in particular the method according to examples 21 to 28, wherein the indicator comprises a sensor.

[0553] Example 30: The method according to any example herein, in particular according to examples 21 to 29, wherein the native valve is a mitral valve or a tricuspid valve.

[0554] Example 31: A sensor system comprises: a prosthetic heart valve for deployment to a native valve of a patient's heart; and one or more sensors adapted to couple to the prosthetic heart valve and adapted to detect a condition within the patient's body.

[0555] Example 32: A sensor system according to any example described herein, in particular the sensor system according to Example 31, wherein the prosthetic heart valve comprises a valve body and a plurality of anchors, wherein the plurality of anchors are adapted to capture native valve leaflets in the space between the anchors and the valve body for fixing the prosthetic heart valve in the heart.

[0556] Example 33: The sensor system according to any example herein, in particular the sensor system according to Example 32, wherein at least one of the sensors is positioned on the one or more anchors.

[0557] Example 34: The sensor system according to any example herein, in particular the sensor system according to Example 33, wherein at least one of the sensors is positioned on a tip of the one or more anchors.

[0558] Example 35: The sensor system according to any example herein, in particular the sensor system according to examples 32 to 34, wherein at least one of the sensors is positioned on the valve body.

[0559] Example 36: A sensor system according to any example herein, in particular a sensor system according to examples 31 to 35, wherein the one or more sensors include one or more of a proximity sensor, a contact sensor, a force sensor, an optical sensor, or a chemical sensor.

[0560] Example 37: The sensor system according to any example herein, in particular the sensor system according to examples 31 to 36, wherein the condition comprises a pressure within at least one chamber of the heart.

[0561] Example 38: The sensor system according to any example herein, in particular the sensor system according to examples 31 to 37, wherein the condition comprises a pressure differential across the prosthetic heart valve.

[0562] Example 39: The sensor system according to any example herein, in particular the sensor system according to examples 31 to 38, wherein the condition comprises a temperature within at least one chamber of the heart.

[0563] Example 40: The sensor system according to any example herein, in particular the sensor system according to examples 31 to 39, wherein the condition comprises fluid flow within at least one chamber of the heart.

[0564] Example 41 The sensor system of any example herein, in particular examples 31 to 40, wherein the condition comprises a force applied by the prosthetic heart valve to at least a portion of the heart.

[0565] Example 42: The sensor system according to any example herein, in particular the sensor system according to examples 31 to 41, further comprises a wireless transmitter for transmitting signals from the one or more sensors to a receiver.

[0566] Example 43: The sensor system according to any example herein, in particular the sensor system according to examples 31 to 42, further comprises a power supply for powering the one or more sensors.

[0567] Example 44: The sensor system according to any example herein, in particular the sensor system according to Examples 31 to 43, wherein the one or more sensors are adapted to be clipped to the prosthetic heart valve.

[0568] Example 45: The sensor system according to any example herein, in particular the sensor system according to Example 44, wherein the prosthetic heart valve comprises a frame, and the one or more sensors are adapted to be clipped to the frame.

[0569] Example 46: A sensor system according to any example described herein, in particular a sensor system according to Examples 31 to 45, wherein the one or more sensors include a first sensor and a second sensor, the first sensor being adapted to detect a condition within the atria of the patient's heart and the second sensor being adapted to detect a condition within the ventricles of the patient's heart.

[0570] Example 47: The sensor system according to any example described herein, in particular the sensor system according to Examples 31 to 46, further includes a first electrical terminal for electrically connecting the sensor to a second electrical terminal on a delivery device for the prosthetic heart valve.

[0571] Example 48: A sensor system according to any example described herein, in particular the sensor system according to Example 47, wherein the prosthetic heart valve includes a valve body supporting one or more prosthetic valve leaflets, and the prosthetic heart valve also includes an electrical conduit extending along the valve body and connecting the sensor to the first electrical terminal.

[0572] Example 49: A sensor system according to any example described herein, in particular the sensor system according to Examples 31 to 48, wherein the prosthetic heart valve includes an inner body and a sealing body, the sealing body being positioned radially outside the inner body and adapted to allow fluid flow to form a seal with the native valve, and the one or more sensors being positioned between the inner body and the sealing body.

[0573] Example 50: The sensor system according to any example herein, in particular the sensor system according to examples 31 to 49, wherein the prosthetic heart valve is adapted to be deployed to the mitral valve or the tricuspid valve.

[0574] Example 51: The sensor system according to any example described herein, in particular the sensor system according to Examples 31 to 50, further includes a substrate, and wherein the one or more sensors are positioned on the substrate, and the sensor system further includes an electrical detection trace, which is positioned on the substrate and is adapted to detect a force applied to the substrate.

[0575] Example 52: A sensor system according to any example herein, in particular the sensor system according to Example 51, wherein the prosthetic heart valve is adapted to expand radially from a compressed structure to an expanded structure, and wherein the substrate is adapted to expand radially outward together with the prosthetic heart valve.

[0576] Example 53: The sensor system according to any example herein, in particular the sensor system according to Example 52, wherein the substrate has a corrugated shape adapted to expand radially outwardly together with the prosthetic heart valve.

[0577] Example 54: A sensor system according to any example herein, in particular the sensor system according to examples 51 to 53, wherein the one or more sensors include a plurality of the sensors positioned on the substrate and electrically connected to electrical conduits positioned on the substrate.

[0578] Example 55: The sensor system according to any example herein, in particular the sensor system according to examples 51 to 54, wherein the electrical detection trace comprises a disconnect portion adapted to be disconnected from an electrical conduit of a delivery device.

[0579] Example 56: A method comprising: deploying a sensor system to a native valve, the sensor system comprising: a prosthetic heart valve for deployment to the native valve of a patient's heart; and one or more sensors adapted to be connected to the prosthetic heart valve and adapted to detect a condition within the patient's body.

[0580] Example 57: A method according to any example described herein, in particular the method according to Example 56, wherein the prosthetic heart valve comprises a valve body and one or more anchors, wherein the one or more anchors are adapted to anchor the valve body to the native valve by capturing the native valve leaflets, and the condition includes whether at least one of the anchors has captured the native valve leaflets.

[0581] Example 58: The method according to any example herein, in particular the method according to Example 57, wherein at least one of the sensors is positioned on the one or more anchors.

[0582] Example 59: A method according to any example herein, in particular according to examples 56 to 58, wherein the one or more sensors include one or more of a proximity sensor, a contact sensor, a force sensor, an optical sensor, or a chemical sensor.

[0583] Example 60: The method according to any example herein, in particular according to examples 56 to 59, wherein the condition comprises pressure within at least one chamber of the heart.

[0584] Example 61: The method according to any example herein, in particular according to examples 56 to 60, wherein the condition comprises a temperature within at least one chamber of the heart.

[0585] Example 62: The method according to any example herein, in particular according to examples 56 to 61, wherein the condition comprises fluid flow within at least one chamber of the heart.

[0586] Example 63: The method according to any example herein, in particular according to examples 56 to 62, wherein the condition comprises a force applied by the prosthetic heart valve to at least a portion of the heart.

[0587] Example 64: The method according to any example herein, in particular the method according to examples 56 to 63, wherein a wireless transmitter is used to transmit the signal from the one or more sensors to the receiver.

[0588] Example 65: The method according to any example herein, in particular the method according to Examples 56 to 64, wherein the prosthetic heart valve is for deployment to the mitral valve or the tricuspid valve.

[0589] Example 66: A delivery system for delivering an implant to a native heart valve, the delivery system comprising: a delivery device for delivering the implant to the native heart valve; and one or more sensors connected to the delivery device and adapted to sense a spatial relationship between the delivery device and at least a portion of the native heart valve.

[0590] Example 67: The delivery system of any example herein, in particular the delivery system of Example 66, wherein the delivery device comprises a capsule adapted to be retracted for releasing the implant, and wherein the one or more sensors are coupled to the capsule.

[0591] Example 68: The delivery system of any example herein, in particular the delivery system of Example 67, wherein the one or more sensors comprises a plurality of the sensors spaced circumferentially from one another around the capsule.

[0592] Example 69: The delivery system of any example herein, particularly Example 67, wherein the capsule has a length, and the one or more sensors comprise a plurality of the sensors spaced apart from one another along the length.

[0593] Example 70: The delivery system according to any example herein, in particular the delivery system according to Example 69, wherein the plurality of sensors are aligned with each other along the length of the capsule.

[0594] Example 71: The delivery system of any example herein, in particular examples 66 to 70, wherein the one or more sensors are adapted to sense contact between the delivery device and the portion of the native heart valve.

[0595] Example 72: A delivery system according to any example herein, in particular according to examples 66 to 71, wherein the one or more sensors are adapted to sense contact between the delivery device and one or more native leaflets of the native heart valve.

[0596] Example 73: A delivery system according to any of the examples herein, in particular the delivery systems according to Examples 66 to 72, wherein the one or more sensors include a plurality of the sensors, and a first sensor of the plurality of sensors is adapted to provide a signal indicating contact with the portion of the native heart valve, and a second sensor of the plurality of sensors is adapted to indicate a lack of contact with the portion of the native heart valve at the same time as the first sensor provides the signal.

[0597] Example 74: The delivery system according to any example described herein, in particular the delivery system according to Examples 66 to 73, further includes an indicator device adapted to generate an indication of the spatial relationship between the delivery device and at least a portion of the native heart valve sensed by the one or more sensors.

[0598] Example 75: The delivery system according to any example herein, in particular the delivery system according to Example 74, wherein the indicator device comprises one or more of a visual indicator, a tactile indicator, or an audible indicator.

[0599] Example 76: The delivery system of any example herein, in particular example 74 or example 75, wherein the indicator means is adapted to indicate the depth of the delivery device relative to the native heart valve.

[0600] Example 77: The delivery system of any example herein, in particular examples 74 to 76, wherein the indicator device is adapted to indicate missed capture of the native leaflets by the implant.

[0601] Example 78: The delivery system according to any example described herein, in particular the delivery system according to Examples 66 to 77, further includes a processor for receiving one or more signals from the one or more sensors, and the processor is used to determine the depth of the delivery device relative to the native heart valve based on the one or more signals.

[0602] Example 79: The delivery system described in any example herein, in particular the delivery system described in Examples 66 to 78, further includes a processor for receiving one or more signals from the one or more sensors, wherein the processor is used to determine the missed capture of the native leaflet by the implant based on the one or more signals.

[0603] Example 80: The delivery system of any example herein, in particular the delivery system of Examples 66 to 79, further comprising an implant, wherein the implant comprises a prosthetic heart valve.

[0604] Example 81: A method comprising: delivering an implant to a native heart valve using a delivery system, wherein the delivery system includes: a delivery device for delivering the implant to the native heart valve; and one or more sensors connected to the delivery device for sensing a spatial relationship between the delivery device and at least a portion of the native heart valve.

[0605] Example 82: The method according to any example herein, in particular according to Example 81, wherein the delivery device comprises a capsule adapted to be retracted for releasing the implant, and wherein the one or more sensors are coupled to the capsule.

[0606] Example 83: The method according to any example herein, in particular the method according to Example 82, wherein the one or more sensors include a plurality of the sensors spaced circumferentially from one another around the capsule.

[0607] Example 84: The method according to any example herein, in particular the method according to Example 82, wherein the capsule has a length, and the one or more sensors include a plurality of the sensors spaced apart from one another along the length.

[0608] Example 85: The method according to any example herein, in particular according to examples 81 to 84, wherein the one or more sensors are adapted to sense contact between the delivery device and the portion of the native heart valve.

[0609] Example 86: The method according to any example herein, in particular the method according to Examples 81 to 85, wherein the one or more sensors are adapted to sense contact between the delivery device and one or more native leaflets of the native heart valve.

[0610] Example 87: A method according to any example herein, in particular according to examples 81 to 86, wherein the indicator device is adapted to generate an indication of the spatial relationship between the delivery device and at least a portion of the native heart valve sensed by the one or more sensors.

[0611] Example 88: The method according to any example herein, in particular the method according to Example 87, wherein the indicator device comprises one or more of a visual indicator, a tactile indicator or an audible indicator.

[0612] Example 89: A method according to any example described herein, in particular the method according to Examples 81 to 88, wherein a processor is used to receive one or more signals from the one or more sensors, and the processor is used to determine the depth of the delivery device relative to the native heart valve based on the one or more signals.

[0613] Example 90: A delivery system method according to any of the examples described herein, in particular the methods described in Examples 81 to 89, wherein a processor is used to receive one or more signals from the one or more sensors, and the processor is used to determine the missed capture of the native leaflet by the implant based on the one or more signals.

[0614] Example 91: A delivery system for delivering an implant to a native heart valve, the delivery system comprising: a delivery device for delivering the implant to the native heart valve; and an imaging device connected to the delivery device and adapted to image an area external to the delivery device.

[0615] Example 92: The delivery system of any example herein, in particular the delivery system of Example 91, wherein the imaging device comprises an ultrasound imaging device.

[0616] Example 93: The delivery system according to any example herein, in particular the delivery system according to example 91 or example 92, wherein the imaging device comprises an optical coherence tomography imaging device.

[0617] Example 94: The delivery system of any example herein, in particular examples 91 to 93, wherein the imaging device is adapted to image at least a portion of the native heart valve.

[0618] Example 95: The delivery system of any example herein, in particular examples 91 to 94, wherein the imaging device is adapted to image one or more leaflets of the native heart valve.

[0619] Example 96: The delivery system of any example herein, in particular examples 91 to 95, wherein the delivery device comprises an elongated sheath, and the imaging device is adapted to extend within the elongated sheath.

[0620] Example 97: The delivery system of any example herein, particularly Example 96, wherein the elongated sheath comprises a distal end, and the imaging device is adapted to protrude from the distal end of the elongated sheath.

[0621] Example 98: The delivery system of any example herein, in particular the delivery system of Example 97, wherein the elongated sheath comprises a capsule for surrounding the implant, and the capsule comprises the distal end of the elongated sheath.

[0622] Example 99: The delivery system of any example herein, in particular the delivery system of examples 91 to 98, wherein the imaging device comprises a catheter.

[0623] Example 100: A delivery system according to any example herein, in particular according to examples 91 to 99, wherein the implant comprises a prosthetic heart valve having a flow channel, and the imaging device is adapted to be positioned within the flow channel of the prosthetic heart valve.

[0624] Example 101: The delivery system according to any example described herein, in particular the delivery system according to Examples 91 to 100, further includes an implant, wherein the implant includes a prosthetic heart valve having a valve body and one or more anchors extending above the distal tip of the native valve leaflets.

[0625] Example 102: The delivery system of any example herein, particularly Example 101, wherein the imaging device is adapted to perform imaging through the valve body of the prosthetic heart valve.

[0626] Example 103: The delivery system according to any example herein, in particular the delivery system according to Example 101 or Example 102, wherein the valve body comprises one or more imaging windows, and the imaging device performs imaging through the one or more imaging windows.

[0627] Example 104: A delivery system according to any example described herein, in particular the delivery system according to Example 103, wherein the one or more anchors comprise a plurality of the anchors circumferentially spaced apart from each other, and the one or more imaging windows comprise a plurality of the imaging windows circumferentially spaced apart from each other and each positioned at one of the anchors.

[0628] Example 105: The delivery system of any example herein, in particular the delivery system of Examples 91 to 104, wherein the delivery device is adapted to deliver the implant to the mitral valve or the tricuspid valve.

[0629] Example 106: A method comprising: delivering an implant to a native heart valve using a delivery system, the delivery system comprising: a delivery device for delivering the implant to the native heart valve; and an imaging device connected to the delivery device and adapted to image an area external to the delivery device.

[0630] Example 107: The method according to any example herein, in particular the method according to Example 106, wherein the imaging device comprises an ultrasound imaging device.

[0631] Example 108: The method according to any example herein, in particular the method according to example 106 or example 107, wherein the imaging device comprises an optical coherence tomography imaging device.

[0632] Example 109: The method according to any example herein, in particular according to examples 106 to 108, wherein the imaging device is adapted to image at least a portion of the native heart valve.

[0633] Example 110: The method according to any example herein, in particular according to Examples 106 to 109, wherein the imaging device is adapted to image one or more leaflets of the native heart valve.

[0634] Example 111: The method according to any example herein, in particular according to examples 106 to 110, wherein the delivery device comprises an elongated sheath, and the imaging device is adapted to extend within the elongated sheath.

[0635] Example 112: The method according to any example herein, in particular the method according to Example 111, wherein the elongated sheath comprises a distal end, and the imaging device is adapted to protrude from the distal end of the elongated sheath.

[0636] Example 113: The method according to any example herein, in particular the method according to Example 112, wherein the elongated sheath comprises a capsule for surrounding the implant, and the capsule comprises the distal end of the elongated sheath.

[0637] Example 114: The method according to any example herein, in particular the method according to examples 106 to 113, wherein the imaging device comprises a catheter.

[0638] Example 115: The method of any example herein, in particular examples 106 to 114, wherein the implant comprises a prosthetic heart valve having a flow channel, and the imaging device is adapted to be positioned within the flow channel of the prosthetic heart valve.

[0639] Example 116: A sensor system comprises: a sensor, and one or more anchors coupled to the sensor and adapted to engage an inner wall of a heart chamber to anchor the sensor to the inner wall.

[0640] Example 117: The sensor system according to any example herein, in particular the sensor system according to Example 116, wherein the one or more anchors comprise a clip.

[0641] Example 118: A sensor system according to any example herein, in particular the sensor system according to Example 117, wherein the clip comprises a first arm and a second arm, the first arm and the second arm being adapted to compress the tissue of the inner wall between the first arm and the second arm.

[0642] Example 119: The sensor system according to any example herein, in particular the sensor system according to Example 118, further includes a support body, wherein the first arm and the second arm are each adapted to pivot relative to the support body.

[0643] Example 120: The sensor system according to any example herein, in particular the sensor system according to Example 119, wherein the support body comprises a housing of the sensor.

[0644] Example 121: The sensor system according to any example herein, in particular the sensor system according to Examples 118 to 120, wherein the first arm or the second arm comprises one or more penetrating bodies for penetrating the inner wall.

[0645] Example 122: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 121, wherein the one or more anchors are adapted to penetrate the inner wall.

[0646] Example 123: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 122, wherein the one or more anchors comprise a threaded body adapted to penetrate the inner wall.

[0647] Example 124: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 123, wherein the sensor is adapted to sense conditions within the heart chamber.

[0648] Example 125: The sensor system according to any example herein, in particular according to Examples 116 to 124, wherein the sensor is adapted to sense a property of a fluid within the heart chamber.

[0649] Example 126: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 125, wherein the sensor comprises a pressure sensor.

[0650] Example 127: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 126, wherein the sensor is adapted to protrude into the heart chamber, wherein the one or more anchors are engaged to the inner wall.

[0651] Example 128: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 127, further comprises a wireless transmitter for transmitting the signal from the sensor to a receiver.

[0652] Example 129: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 128, further comprises a power supply for powering the sensor.

[0653] Example 130: The sensor system according to any example herein, in particular the sensor system according to Examples 116 to 129, wherein the sensor is adapted to be positioned in a plurality of locations along the inner wall.

[0654] Example 131: A method comprising: deploying a sensor system to a native valve, the sensor system comprising: a sensor; and one or more anchors coupled to the sensor and adapted to engage an inner wall of a heart chamber to anchor the sensor to the inner wall.

[0655] Example 132: The method according to any example herein, in particular the method according to Example 131, wherein the one or more anchors comprise a clip.

[0656] Example 133: A method according to any example herein, in particular according to Example 132, wherein the clip comprises a first arm and a second arm adapted to compress tissue of the inner wall therebetween.

[0657] Example 134: The method according to any example described herein, in particular the method according to Example 133, wherein the first arm or the second arm comprises one or more penetrating bodies for penetrating the inner wall.

[0658] Example 135: The method according to any example herein, in particular according to examples 131 to 134, wherein the one or more anchors are adapted to penetrate the inner wall.

[0659] Example 136: The method according to any example herein, in particular according to examples 131 to 135, wherein the one or more anchors comprise a threaded body adapted to penetrate the inner wall.

[0660] Example 137: The method according to any example herein, in particular according to examples 131 to 136, wherein the sensor is adapted to sense a condition within the heart chamber.

[0661] Example 138: The method according to any example herein, in particular according to examples 131 to 137, wherein the sensor is adapted to sense a property of a fluid within the heart chamber.

[0662] Example 139: The method according to any example herein, in particular the method according to examples 131 to 138, wherein the sensor comprises a pressure sensor.

[0663] Example 140: The method according to any example herein, in particular according to Examples 131 to 139, wherein the sensor is adapted to protrude into the heart chamber, wherein the one or more anchors are engaged to the inner wall.

[0664] Example 141: A system comprising: a prosthetic heart valve for deployment to a native valve of a patient's heart, at least a portion of the prosthetic heart valve comprising a pacemaker electrical conduit adapted to conduct electrical signals for pacing the heart.

[0665] Example 142: A system according to any example described herein, in particular according to Example 141, wherein the prosthetic heart valve includes one or more anchors adapted to anchor the prosthetic heart valve to the native valve, and the pacemaker electrical conduit includes at least a portion of the one or more anchors.

[0666] Example 143: The system of any example herein, particularly Example 142, wherein the prosthetic heart valve comprises a valve body supporting one or more prosthetic valve leaflets, and wherein the one or more anchors extend radially outward from the valve body.

[0667] Example 144: The system of any example herein, particularly Example 142 or Example 143, wherein the one or more anchors are adapted to extend over distal tips of the native valve leaflets.

[0668] Example 145: The system according to any example herein, in particular the system according to Examples 141 to 144, further comprises a first electrical terminal for electrically connecting the pacemaker electrical conduit to a second electrical terminal of the pacemaker.

[0669] Example 146: The system of any example herein, in particular Example 145, wherein the prosthetic heart valve comprises a proximal end portion and a distal end portion, and the first electrical terminal is positioned at the proximal end portion of the prosthetic heart valve.

[0670] Example 147: The system of any example herein, particularly Example 145 or Example 146, wherein the prosthetic heart valve comprises a frame, and the first electrical terminal is coupled to the frame.

[0671] Example 148: A system according to any example described herein, in particular the system according to Examples 141 to 147, wherein the prosthetic heart valve includes a valve body supporting one or more prosthetic valve leaflets, and the pacemaker electrical conduit includes a first portion extending along the valve body and a second portion extending radially outward from the valve body.

[0672] Example 149: The system according to any example herein, in particular the system according to Example 148, wherein the second portion comprises a tip of the pacemaker electrical conduit.

[0673] Example 150: The system of any example herein, particularly Example 148 or Example 149, wherein the valve body comprises a frame and the first portion of the pacemaker electrical conduit extends along the frame.

[0674] Example 151: The system according to any example herein, in particular according to Examples 148 to 150, wherein the second portion is adapted to contact a surface of the heart.

[0675] Example 152: The system of any example herein, in particular examples 148 to 151, wherein the second portion comprises a coil.

[0676] Example 153: A system according to any example described herein, in particular according to examples 141 to 152, wherein the prosthetic heart valve includes one or more prosthetic valve leaflets adapted to allow flow in a distal direction, and the pacemaker electrical conduit is adapted to resist proximal forces applied to the prosthetic heart valve.

[0677] Example 154: A system according to any example described herein, in particular according to examples 141 to 153, wherein the prosthetic heart valve comprises an inner body and a sealing body, the sealing body being positioned radially outward from the inner body and adapted to seal fluid flow with the native valve.

[0678] Example 155: The system of any example herein, in particular examples 141 to 154, wherein the prosthetic heart valve is adapted to be deployed to the mitral valve or the tricuspid valve.

[0679] Example 156: A method comprising: deploying a prosthetic heart valve to a native valve of a patient's heart, at least a portion of the prosthetic heart valve comprising a pacemaker electrical conduit adapted to conduct electrical signals for pacing the heart.

[0680] Example 157: A method according to any example described herein, in particular the method according to Example 156, wherein the prosthetic heart valve includes one or more anchors adapted to anchor the prosthetic heart valve to the native valve, and the pacemaker electrical conduit includes at least a portion of the one or more anchors.

[0681] Example 158: The method of any example herein, particularly Example 157, wherein the prosthetic heart valve comprises a valve body supporting one or more prosthetic valve leaflets, and wherein the one or more anchors extend radially outward from the valve body.

[0682] Example 159: The method according to any example herein, in particular the method according to Example 157 or Example 158, wherein the one or more anchors are adapted to extend over the distal tips of the native valve leaflets.

[0683] Example 160: The method according to any example herein, in particular the method according to examples 156 to 159, wherein the first electrical terminal is used to electrically connect the pacemaker electrical conduit to a second electrical terminal of the pacemaker.

[0684] Example 161: The method according to any example herein, in particular the method according to Example 160, wherein the prosthetic heart valve includes a proximal end portion and a distal end portion, and the first electrical terminal is positioned at the proximal end portion of the prosthetic heart valve.

[0685] Example 162: The method according to any example herein, in particular the method according to Example 160 or Example 161, wherein the prosthetic heart valve includes a frame and the first electrical terminal is coupled to the frame.

[0686] Example 163: A method according to any example described herein, in particular the method according to Examples 156 to 162, wherein the prosthetic heart valve includes a valve body supporting one or more prosthetic valve leaflets, and the pacemaker electrical conduit includes a first portion extending along the valve body and a second portion extending radially outward from the valve body.

[0687] Example 164: The method according to any example herein, in particular the method according to Example 163, wherein the second portion comprises a tip of the pacemaker electrical conduit.

[0688] Example 165: The method according to any example herein, in particular the method according to Example 163 or Example 164, wherein the valve body comprises a frame and the first portion of the pacemaker electrical conduit extends along the frame.

[0689] Example 166: A system comprising: a prosthetic heart valve for deployment to a native valve of a patient's heart, the prosthetic heart valve comprising one or more anchors adapted to hook around one or more native valve leaflets to anchor the prosthetic heart valve to the native valve; a delivery catheter for delivering the prosthetic heart valve to the native valve; and a retainer mechanism adapted to retain the one or more native valve leaflets in a contracted state when the one or more anchors are at least partially hooked around the one or more native valve leaflets.

[0690] Example 167: A system according to any example described herein, in particular the system according to Example 166, wherein the retainer mechanism includes one or more suction ports, and the one or more suction ports are used to apply a suction force to the one or more native valve leaflets to maintain the one or more native valve leaflets in the contracted state.

[0691] Example 168: The system of any example herein, in particular the system of Example 167, wherein the one or more aspiration ports are positioned on the delivery catheter.

[0692] Example 169: The system of any example herein, in particular examples 166 to 168, wherein the retainer mechanism comprises a coil extending around a radially outward-facing surface of the one or more native valve leaflets.

[0693] Example 170: The system of any example herein, in particular the system of Example 169, wherein the coil is adapted to be deployed from the delivery catheter.

[0694] Example 171: The system of any example herein, in particular examples 166 to 170, wherein the retainer mechanism comprises one or more barbs for engaging the one or more native valve leaflets.

[0695] Example 172: A system according to any example herein, in particular according to Example 171, wherein the one or more barbs are coupled to one or more arms.

[0696] Example 173: The system of any example herein, particularly Example 172, wherein the one or more arms are adapted to project radially outward from the delivery catheter.

[0697] Example 174: The system of any example herein, in particular examples 171 to 173, wherein the one or more barbs comprise a plurality of barbs spaced circumferentially apart from one another.

[0698] Example 175: The system of any example herein, in particular examples 171 to 174, wherein the one or more barbs are coupled to a sheath.

[0699] Example 176: The system of any example herein, in particular examples 166 to 175, wherein the retainer mechanism comprises one or more arms adapted to hook around the one or more native valve leaflets.

[0700] Example 177: The system of any example herein, in particular the system of Example 176, wherein the one or more arms are adapted to retract radially inward.

[0701] Example 178: The system of any example herein, particularly Example 176 or Example 177, wherein the delivery catheter comprises a guidewire lumen and the one or more arms are adapted to project radially outward from the guidewire lumen.

[0702] Example 179: The system of any example herein, particularly Examples 176 to 178, wherein the delivery catheter comprises a nasal body and the one or more arms are adapted to project radially outward from the nasal body.

[0703] Example 180: The system of any example herein, in particular examples 166 to 179, wherein the prosthetic heart valve comprises a prosthetic mitral heart valve or a prosthetic tricuspid heart valve.

[0704] Example 181: A method comprising: deploying a prosthetic heart valve to a native valve of a patient's heart using a delivery catheter, the prosthetic heart valve comprising one or more anchors adapted to hook around one or more native valve leaflets to anchor the prosthetic heart valve to the native valve; and maintaining the one or more native valve leaflets in a contracted state using a retainer mechanism when the one or more anchors are at least partially hooked around the one or more native valve leaflets.

[0705] Example 182: A method according to any example described herein, in particular the method according to Example 181, wherein the retainer mechanism includes one or more suction ports, and the one or more suction ports are used to apply a suction force to the one or more native valve leaflets to maintain the one or more native valve leaflets in the contracted state.

[0706] Example 183: The method of any example herein, in particular example 181 or example 182, wherein the retainer mechanism comprises a coil for extending around a radially outwardly facing surface of the one or more native valve leaflets.

[0707] Example 184: The method according to any example herein, in particular the method according to Examples 181 to 183, wherein the retainer mechanism comprises one or more barbs for engaging the one or more native valve leaflets.

[0708] Example 185: The method according to any example herein, in particular the method according to Examples 181 to 184, wherein the retainer mechanism comprises one or more arms adapted to hook around the one or more native valve leaflets.

[0709] Example 186: A prosthetic valve for deployment to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; an internal frame supporting the one or more prosthetic valve leaflets and having an inflow end portion and an outflow end portion; a sealing body positioned radially outward of the internal frame and comprising a plurality of elongated prongs and a skirt, the plurality of elongated prongs each having a first end portion connected to the inflow end portion of the internal frame and protruding radially outward from the internal frame to a second end portion, the skirt suspended between the second end portions of the plurality of prongs and the outflow end portion of the prosthetic valve, the skirt defining a pocket positioned between the skirt and the internal frame; and one or more anchors adapted to anchor the prosthetic valve to the native valve by capturing the native valve leaflets.

[0710] Example 187: The prosthetic valve of any example herein, particularly the prosthetic valve of Example 186, wherein the one or more anchors are coupled to the outflow end portion of the inner frame and project radially outward from the outflow end portion of the inner frame.

[0711] Example 188: The prosthetic valve of any example herein, in particular the prosthetic valve of Example 186 or Example 187, wherein the one or more anchors are adapted to hook around one or more native valve leaflets to anchor the prosthetic valve to the native valve.

[0712] Example 189 The prosthetic valve of any example herein, particularly Examples 186 to 188, wherein the elongated prongs are spaced circumferentially around the inflow end portion of the inner frame.

[0713] Example 190 The prosthetic valve of any example herein, particularly Examples 186 to 189, wherein the plurality of elongated prongs form a platform portion of the sealing body.

[0714] Example 191 The prosthetic valve of any example herein, particularly the prosthetic valve of Example 190, wherein the second end portion of the plurality of elongated prongs forms an outermost portion of the platform portion.

[0715] Example 192: The prosthetic valve of any example herein, particularly Examples 186 to 191, wherein each of the plurality of elongated prongs is deflectable in an axial dimension of the prosthetic valve.

[0716] Example 193: The prosthetic valve of any example herein, particularly examples 186 to 192, wherein the skirt extends along the elongated prongs from the second end portion of the elongated prongs to the first end portion of the elongated prongs.

[0717] Example 194: The prosthetic valve of any example herein, particularly Examples 186 to 193, wherein a portion of the skirt extends along the inner frame and includes a plurality of apertures to allow blood to enter the pocket.

[0718] Example 195: The prosthetic valve of any example herein, particularly the prosthetic valve of Examples 186 to 194, wherein the prosthetic valve comprises a prosthetic mitral heart valve or a prosthetic tricuspid heart valve.

[0719] Example 196: A method comprising: deploying a prosthetic heart valve to a native heart valve, the prosthetic heart valve comprising: one or more prosthetic valve leaflets; an internal frame supporting the one or more prosthetic valve leaflets and having an inflow end portion and an outflow end portion; a sealing body positioned radially outside the internal frame and comprising a plurality of elongated prongs and a skirt, the plurality of elongated prongs each having a first end portion connected to the inflow end portion of the internal frame and projecting radially outward from the internal frame to a second end portion, the skirt suspended between the second end portions of the plurality of prongs and the outflow end portion of the prosthetic valve, the skirt defining a pocket positioned between the skirt and the internal frame; and one or more anchors adapted to anchor the prosthetic heart valve to the native heart valve by capturing the native valve leaflets.

[0720] Example 197: The method of any example herein, particularly Example 196, wherein the one or more anchors are coupled to the outflow end portion of the inner frame and project radially outward from the outflow end portion of the inner frame.

[0721] Example 198: The method of any example described herein, in particular Example 196 or Example 197, wherein the one or more anchors are adapted to hook around one or more native valve leaflets to anchor the prosthetic heart valve to the native heart valve.

[0722] Example 199: The method according to any example herein, in particular according to examples 196 to 198, wherein the plurality of elongated prongs are circumferentially spaced apart from one another around the inflow end portion of the inner frame.

[0723] Example 200: The method of any example herein, particularly examples 196 to 199, wherein the plurality of elongated prongs form a platform portion of the sealing body.

[0724] Example 201: A prosthetic valve for deployment to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and a support structure for supporting the one or more prosthetic valve leaflets and including at least one ring connected to a skirt, the skirt or the at least one ring being adapted to form a seal with at least a portion of the native valve.

[0725] Example 202: The prosthetic valve of any example herein, in particular the prosthetic valve of Example 201, wherein the at least one ring is compliant.

[0726] Example 203: A prosthetic valve according to any example herein, in particular the prosthetic valve according to Example 201 or Example 202, wherein the at least one ring comprises a first ring adapted to be positioned on the inflow side of the native valve and a second ring adapted to be positioned on the outflow side of the native valve.

[0727] Example 204: The prosthetic valve of any example herein, in particular the prosthetic valve of Example 203, wherein the skirt extends between the first ring and the second ring and forms a sheath.

[0728] Example 205: The prosthetic valve according to any example described herein, in particular the prosthetic valve according to Example 203 or Example 204, further includes a support body that is connected to the one or more prosthetic valve leaflets and is connected to the first ring and the second ring using the skirt.

[0729] Example 206: The prosthetic valve of any example herein, particularly the prosthetic valve of Example 205, wherein the support body comprises a third ring.

[0730] Example 207: The prosthetic valve of any example herein, particularly the prosthetic valve of Examples 203 to 206, further comprising one or more tethers for axially compressing the first and second rings together.

[0731] Example 208: A prosthetic valve according to any example herein, in particular a prosthetic valve according to Examples 201 to 207, wherein the support structure includes an internal frame and the skirt forms a disc that extends radially outward from the internal frame and is supported at the outer periphery of the disc by the at least one ring.

[0732] Example 209: The prosthetic valve of any example herein, in particular the prosthetic valve of Example 208, wherein the disc is adapted to be positioned on the inflow side of the native valve.

[0733] Example 210: A prosthetic valve according to any of the examples herein, in particular the prosthetic valves of Examples 201 to 209, wherein the support structure comprises an inner frame and an outer frame positioned radially outward of the inner frame, and the skirt forms a disc that extends radially outward from the outer frame and is supported at the outer periphery of the disc by the at least one ring.

[0734] Example 211: The prosthetic valve of any example herein, in particular the prosthetic valve of Examples 208 to 210, further comprises one or more anchors adapted to anchor the prosthetic valve to the native valve by capturing the native valve leaflets.

[0735] Example 212: The prosthetic valve of any example herein, particularly examples 201 to 211, wherein the at least one ring is biased radially outward.

[0736] Example 213: The prosthetic valve of any example herein, particularly examples 201 to 212, wherein the at least one ring is adapted to change shape.

[0737] Example 214: The prosthetic valve of any example herein, in particular the prosthetic valve of Examples 201 to 213, wherein the at least one ring comprises a first end and a second end, and the first end is adapted to slide relative to the second end to change the diameter of the at least one ring.

[0738] Example 215: The prosthetic valve of any example herein, in particular the prosthetic valve of Examples 201 to 214, wherein the prosthetic valve comprises a prosthetic mitral heart valve or a prosthetic tricuspid heart valve.

[0739] Example 216: A method comprising: deploying a prosthetic heart valve to a native heart valve, the prosthetic heart valve comprising: one or more prosthetic valve leaflets; and a support structure for supporting the one or more prosthetic valve leaflets and comprising at least one ring connected to a skirt, the skirt or the at least one ring being adapted to form a seal with at least a portion of the native valve.

[0740] Example 217: The method according to any example herein, in particular the method according to Example 216, wherein at least one of the rings is compliant.

[0741] Example 218: A method according to any example described herein, in particular the method according to Example 216 or Example 217, wherein the at least one ring includes a first ring adapted to be positioned on the inflow side of the native heart valve and a second ring adapted to be positioned on the outflow side of the native heart valve.

[0742] Example 219: The method of any example herein, in particular the method of Example 218, wherein the skirt extends between the first ring and the second ring and forms a sheath.

[0743] Example 220: A method according to any of the examples herein, in particular the method according to Examples 216 to 219, wherein the support structure includes an internal frame and the skirt forms a disk that extends radially outward from the internal frame and is supported at the outer periphery of the disk by the at least one ring.

[0744] Example 221: A sensor system comprising: a prosthetic cardiac implant; and a sensor body comprising: a substrate; a sensor positioned on the substrate and adapted to detect a condition of the prosthetic cardiac implant; and an electrical detection trace positioned on the substrate and adapted to detect a force applied to the substrate.

[0745] Example 222: The sensor system of any example herein, in particular the sensor system of Example 221, wherein the electrical detection trace is adapted to detect a partial or complete tear of the substrate.

[0746] Example 223: The sensor system of any example herein, in particular example 221 or example 222, wherein the electrical detection trace is adapted to provide an electrical signal indicative of an amount of force applied to the substrate.

[0747] Example 224: The sensor system according to any example herein, in particular the sensor system according to Examples 221 to 223, wherein the substrate comprises a flexible circuit board.

[0748] Example 225: The sensor system according to any example herein, in particular the sensor system according to examples 221 to 224, wherein the sensor comprises an electrode.

[0749] Example 226: The sensor system according to any example herein, in particular the sensor system according to Examples 221 to 225, wherein the prosthetic heart implant comprises a clip adapted to clamp heart valve leaflets together.

[0750] Example 227: The sensor system of any example herein, in particular the sensor system of Example 226, wherein the sensor is adapted to detect contact between the clip and the heart valve leaflet.

[0751] Example 228: The sensor system according to any example herein, in particular the sensor system according to Example 226 or Example 227, wherein the sensor body comprises a strip adapted to be withdrawn from a portion of the clip.

[0752] Example 229: A sensor system according to any example herein, in particular the sensor system according to Example 228, wherein the electrical detection trace is adapted to detect partial or complete tearing of the substrate when the sensor body is withdrawn from the portion of the clamp in vivo.

[0753] Example 230: A sensor system according to any example herein, in particular according to examples 227 to 229, wherein the clip comprises one or more arms and the sensor body is positioned on at least one of the one or more arms.

[0754] Example 231: A sensor system according to any example described herein, in particular the sensor system according to Examples 221 to 230, wherein the prosthetic heart implant includes a prosthetic heart valve having one or more anchors adapted to anchor the prosthetic heart implant to a native heart valve, and the sensor is adapted to detect whether at least one of the anchors has captured the native valve leaflets.

[0755] Example 232: A sensor system according to any example herein, in particular the sensor system according to Example 231, wherein the prosthetic heart valve is adapted to expand radially from a compressed structure to an expanded structure, and wherein the substrate is adapted to expand radially outward together with the prosthetic heart valve.

[0756] Example 233: A sensor system according to any example described herein, in particular the sensor system according to Examples 221 to 232, wherein the electrical detection trace comprises a ring shape having a first end and a second end, and comprises a first electrical terminal at the first end and a second electrical terminal at the second end.

[0757] Example 234: The sensor system according to any example herein, in particular the sensor system according to Examples 221 to 233, wherein the electrical detection trace electrically conducts through the sensor.

[0758] Example 235: The sensor system of any example herein, in particular the sensor system of Examples 221 to 234, wherein the electrical detection trace comprises a strain gauge on the substrate.

[0759] Example 236: A method comprising: deploying a prosthetic cardiac implant to a native heart valve; and detecting a condition of the prosthetic cardiac implant using a sensor body connected to the prosthetic cardiac implant, the sensor body comprising: a substrate; a sensor positioned on the substrate and adapted to detect the condition of the prosthetic cardiac implant; and an electrical detection trace positioned on the substrate and adapted to detect a force applied to the substrate.

[0760] Example 237: The method according to any example herein, in particular the method according to Example 236, wherein the electrical detection trace is adapted to detect partial or complete tearing of the substrate.

[0761] Example 238: The method according to any example herein, in particular the method according to Example 236 or Example 237, wherein the electrical detection trace is adapted to provide an electrical signal indicative of an amount of force applied to the substrate.

[0762] Example 239: The method according to any example herein, in particular the method according to Examples 236 to 238, wherein the substrate comprises a flexible circuit board.

[0763] Example 240: The method according to any example herein, in particular the method according to examples 236 to 239, wherein the sensor comprises an electrode.

[0764] Any feature of any example, including but not limited to any one of the first to 240 examples mentioned above, may be applicable to all other aspects and examples identified herein, including but not limited to any one of the first to 240 examples mentioned above. In addition, any one of the features of any example of each example, including but not limited to any one of the first to 240 examples mentioned above, may be independently combined with other examples described herein in part or completely in any way, for example, one, two, or three or more examples may be combined in whole or in part. In addition, any feature of any example of each example, including but not limited to any one of the first to 240 examples mentioned above, may make the other examples optional. Any example of a method may be performed by a system or device of another example, and any aspect or example of a system or device may be configured to perform another aspect or example, including but not limited to the method of any example of any one of the first to 240 examples mentioned above.

[0765] Finally, it should be understood that although various aspects of this specification have been highlighted with reference to specific examples, it will be readily understood by those skilled in the art 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, protocols, and / or reagents described herein. Therefore, without departing from the spirit of this specification, various modifications or changes or alternative configurations may be made to the disclosed subject matter according to the teachings herein. Finally, the terms used herein are only used for the purpose of describing specific examples and are not intended to limit the scope of the systems, devices, and methods disclosed herein, which scope is limited only by the claims. Therefore, the systems, devices, and methods are not limited to the precise content shown and described.

[0766] Certain examples of systems, devices, and methods are described herein, including the best modes known to the inventors for performing these examples. Of course, after reading the foregoing description, variations to these described examples will become apparent to those of ordinary skill in the art. The inventors expect that skilled artisans will appropriately adopt such variations, and the inventors intend to practice systems, devices, and methods with systems, devices, and methods other than those specifically described herein. Therefore, the systems, devices, and methods include all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. In addition, unless otherwise indicated herein or clearly contradicted by the context, the systems, devices, and methods encompass any combination of the above-described examples in all their possible variations.

[0767] The grouping of alternative embodiments, elements, or steps of the systems, apparatus, and methods should not be construed as limiting. Each group member may be referenced and claimed individually or in any combination with other group members disclosed herein. For purposes of convenience and / or patentability, it is contemplated that one or more members of a group may be included in or deleted from the group. When any such inclusion or deletion is made, the specification is deemed to contain the modified group, thereby satisfying the written description of all Markush groups used in the appended claims.

[0768] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, properties, terms and the like used in the specification and claims are to be understood as being modified in all instances by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so defined encompasses approximate values that may vary but are capable of performing the desired operation or process discussed herein.

[0769] Unless otherwise indicated herein or clearly contradicted by context, the terms "a," "an," "the," and similar referents used in the context of describing systems, apparatus, and methods (especially in the context of the following claims) should be construed to cover both the singular and the plural. Unless otherwise indicated herein or otherwise clearly contradicted by context, all methods described herein can be performed in any suitable order. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to better illustrate the systems, apparatus, and methods and does not limit the scope of the claimed systems, apparatus, and methods. No language in this specification should be construed as indicating any non-claimed element as essential to the practice of the systems, apparatus, and methods.

[0770] All patents, patent publications, and other publications cited 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, such as those 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 the right to precede such disclosure by virtue of prior invention or for any other reason. All statements regarding the dates or contents of these documents are based on information available to the applicant and do not constitute any admission as to the correctness of the dates or contents of these documents.

Claims

1. A prosthetic valve for deployment in a native valve, the prosthetic valve comprising: valve body; one or more prosthetic valve leaflets coupled to the valve body for allowing blood flow through the valve body in only one direction; one or more anchors adapted to anchor the valve body to the native valve by capturing native valve leaflets; as well as An indicator is adapted to indicate capture of the native valve leaflets by the one or more anchors.

2. The prosthetic valve of claim 1, wherein the indicator is visible under imaging.

3. A prosthetic valve according to claim 1 or claim 2, wherein the appearance of the indicator changes to indicate capture of the native valve leaflets.

4. The prosthetic valve of any one of claims 1 to 3, wherein the visibility of the indicator is reduced under ultrasound imaging to indicate capture of the native valve leaflets.

5. The prosthetic valve of any one of claims 1 to 4, wherein the indicator moves to indicate capture of the native valve leaflets.

6. The prosthetic valve of any one of claims 1 to 5, wherein the indicator is disposed on the one or more anchors.

7. The prosthetic valve of any one of claims 1 to 6, wherein the indicator comprises one or more elongated bodies.

8. The prosthetic valve of claim 7, wherein the one or more elongated bodies are positioned on the one or more anchors.

9. A prosthetic valve according to claim 7 or claim 8, wherein each of the one or more elongate bodies comprises an axially compressible structure, such as a spring.

10. The prosthetic valve of any one of claims 7 to 9, wherein the one or more elongate bodies are disposed along the valve body.

11. The prosthetic valve of any one of claims 1 to 10, wherein the indicator comprises a ring extending circumferentially around the valve body.

12. The prosthetic valve of any one of claims 1 to 11, wherein the indicator extends axially along the valve body.

13. The prosthetic valve of any one of claims 1 to 12, wherein the indicator comprises a balloon adapted to be filled with a contrast agent.

14. The prosthetic valve of any one of claims 1 to 13, wherein the indicator comprises a sensor.

15. The prosthetic valve of any one of claims 1 to 14, wherein the prosthetic valve is adapted to be deployed to the mitral valve or the tricuspid valve.

16. A sensor system comprising: prosthetic heart valves, which are native valves for deployment into a patient's heart; as well as One or more sensors adapted to be coupled to the prosthetic heart valve and adapted to detect a condition within the patient's body.

17. A sensor system according to claim 16, wherein the prosthetic heart valve comprises a valve body and a plurality of anchors, wherein the plurality of anchors are adapted to capture native valve leaflets in a space between the anchors and the valve body for fixing the prosthetic heart valve in the heart.

18. The sensor system of claim 17, wherein at least one of the sensors is positioned on the one or more anchors.

19. The sensor system of claim 18, wherein at least one of the sensors is positioned on a tip of the one or more anchors.

20. The sensor system of any one of claims 17 to 19, wherein at least one of the sensors is positioned on the valve body.

21. The sensor system of any one of claims 16 to 20, wherein the one or more sensors comprise one or more of a proximity sensor, a contact sensor, a force sensor, an optical sensor, or a chemical sensor.

22. The sensor system of any one of claims 16 to 21, wherein the condition comprises pressure within at least one chamber of the heart.

23. The sensor system of any one of claims 16 to 22, wherein the condition comprises a pressure differential across the prosthetic heart valve.

24. The sensor system of any one of claims 16 to 23, wherein the condition comprises a temperature within at least one chamber of the heart.

25. The sensor system of any one of claims 16 to 24, wherein the condition comprises fluid flow within at least one chamber of the heart.

26. The sensor system of any one of claims 16 to 25, wherein the condition comprises a force applied by the prosthetic heart valve to at least a portion of the heart.

27. The sensor system of any one of claims 16 to 26, further comprising a wireless transmitter for transmitting signals from the one or more sensors to a receiver.

28. The sensor system of any one of claims 16 to 27, further comprising a power supply for powering the one or more sensors.

29. The sensor system of any one of claims 16 to 28, further comprising a first electrical terminal for electrically connecting the sensor to a second electrical terminal on a delivery device for the prosthetic heart valve.

30. The sensor system of any one of claims 16 to 29, further comprising a substrate, and wherein the one or more sensors are positioned on the substrate, and wherein the sensor system further comprises an electrical detection trace positioned on the substrate and adapted to detect a force applied to the substrate.

31. The sensor system of any one of claims 16 to 30, wherein the one or more sensors comprise piezoelectric sensors.

32. The sensor system of any one of claims 16 to 31 , wherein the one or more sensors comprise strain gauges.

33. The sensor system of any one of claims 16 to 32, wherein the one or more sensors comprise electrodes.

34. The sensor system of any one of claims 16 to 33, wherein the one or more sensors comprise a pressure transducer.

35. The sensor system of any one of claims 16 to 34, wherein the one or more sensors comprise capacitive sensors.

36. A prosthetic valve for deployment to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; an inner frame supporting the one or more prosthetic valve leaflets and having an inflow end portion and an outflow end portion; a sealing body positioned radially outward of the inner frame and comprising a plurality of elongated prongs, the plurality of elongated prongs each having a first end portion coupled to the inflow end portion of the inner frame and projecting radially outward from the inner frame to a second end portion, the skirt suspended between the second end portions of the plurality of prongs and the outflow end portion of the prosthetic valve, the skirt defining a pocket positioned between the skirt and the inner frame; as well as One or more anchors adapted to anchor the prosthetic valve to the native valve by capturing the native valve leaflets.

37. The prosthetic valve of claim 36, wherein the one or more anchors are coupled to the outflow end portion of the inner frame and project radially outward from the outflow end portion of the inner frame.

38. A prosthetic valve according to claim 36 or claim 37, wherein the one or more anchors are adapted to hook around one or more native valve leaflets to anchor the prosthetic valve to the native valve.

39. The prosthetic valve of any one of claims 36 to 38, wherein the elongated prongs are spaced circumferentially around the inflow end portion of the inner frame.

40. The prosthetic valve of any one of claims 36 to 39, wherein the plurality of elongated prongs form a platform portion of the sealing body.

41. A sensor system comprising: prosthetic heart implants; as well as A sensor body comprising: substrate, a sensor positioned on the substrate and adapted to detect a condition of the prosthetic heart implant, and An electrical detection trace is positioned on the substrate and adapted to detect a force applied to the substrate.

42. The sensor system of claim 41, wherein the electrical detection trace is adapted to detect a partial or complete tear of the substrate.

43. A sensor system according to claim 41 or claim 42, wherein the sensor comprises an electrode.

44. The sensor system of any one of claims 41 to 43, wherein the prosthetic heart implant comprises a clip adapted to clamp heart valve leaflets together.

45. The sensor system of claim 44, wherein the electrical detection trace is adapted to detect partial or complete tearing of the substrate upon in vivo withdrawal of the sensor body from a portion of the clip.

46. A prosthetic valve for replacing the function of a native heart valve, the prosthetic valve comprising: a self-expanding valve body formed of nitinol, the valve body being compressible for advancement in a compressed state through the vasculature of a patient via a catheterization technique; three prosthetic valve leaflets formed from pericardium, the prosthetic valve leaflets coupled to the valve body for allowing blood flow through the valve body in only one direction; one or more anchors adapted to secure the valve body to surrounding native tissue within the heart; as well as An indicator is adapted to confirm fixation of the valve body to the surrounding tissue.

47. The prosthetic valve of claim 46, wherein the indicator has a shape that changes during fixation of the valve body to surrounding tissue.

48. The prosthetic valve of claim 47, wherein the indicator comprises a radiopaque material for enhanced visualization.

49. The prosthetic valve of claim 46, wherein the indicator is a sensor.

50. The prosthetic valve of claim 49, wherein the sensor is a piezoelectric sensor.

51. The prosthetic valve of claim 49, wherein the sensor is a strain gauge.

52. The prosthetic valve of claim 49, wherein the sensor is an electrode.

53. The prosthetic valve of claim 49, wherein the sensor is a pressure transducer.

54. The prosthetic valve of claim 49, wherein the sensor is a capacitive sensor.

55. A prosthetic valve according to any one of claims 46 to 54, wherein the prosthetic valve further comprises a plurality of anchors adapted to capture native valve leaflets in the space between the anchors and the valve body for securing the prosthetic valve in the heart.

56. The prosthetic valve of claim 55, wherein an indicator is positioned on the plurality of anchors.

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