Prosthetic valve and sensor system

Abstract

Disclosed are devices, systems, and methods for prosthetic valves with sensor systems. Examples of prosthetic valves include replacement heart valves for replacing the function of native heart valves, such as the mitral valve or tricuspid valve. In various embodiments, the replacement heart valve is provided with sensors or markers to assist in proper placement and / or fixation within the body. The replacement heart valve may include anchors for securing the replacement heart valve to the native valve leaflets, and the sensors and / or markers provide feedback to the physician to confirm proper placement of the anchors during the implantation procedure. Sensors may also be used to assess the function of the prosthetic valve after deployment. Sensors may also be used to monitor blood pressure, temperature, oxygen, insulin, cholesterol, and / or glucose to assess overall patient health.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 432,830, filed December 15, 2022, which is incorporated herein by reference in its entirety.

[0002] Certain features of the present disclosure relate to implants, including prosthetic valves, for deployment. Certain features of the present disclosure relate to sensor systems for facilitating implantation and / or assessing the function of the implant. [Background technology]

[0003] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, function as one-way valves that operate in synchronization with the beating heart. The valves allow blood to flow downstream but prevent blood from flowing upstream. Affected heart valves exhibit defects such as valve stenosis or regurgitation, which inhibit the valve's ability to control blood flow. Such defects reduce the heart's blood-pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valve dysfunction can lead to symptoms such as cardiac hypertrophy and ventricular dilation. Therefore, considerable efforts have been made to develop methods and devices for repairing or replacing dysfunctional heart valves.

[0004] Prosthetic valves exist to correct problems associated with dysfunctional heart valves. For example, mechanical tissue-based prosthetic heart valves can be used to replace dysfunctional native heart valves. Recently, significant efforts have been made to develop replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient compared to open-heart surgery. Replacement valves are designed to be delivered by minimally invasive, and even percutaneous, techniques.

[0005] It is desirable for these replacement valves to be deployed at the implantation site in a desired configuration. For example, considerations such as fixation of the replacement valve, sealing of the replacement valve with the native valve, and proper movement of the prosthetic valve leaflets may be at issue during deployment at the implantation site. Additionally, sensing one or more conditions within the patient's body may be desirable during or after implantation of the replacement valve. Summary of the Invention [Means for solving the problem]

[0006] The embodiments of the prosthetic valve and sensor system disclosed herein are directed to improvements in prosthetic valves and sensor systems. Examples of prosthetic valves include replacement heart valves. The features disclosed herein may be utilized for proper anchoring, positioning, and improved identification of other conditions during the implantation procedure. The features disclosed herein may also assist in assessing proper implant function after implantation. The implantable sensor systems disclosed herein may be used to monitor blood conditions, such as pressure, temperature, oxygen, insulin, platelets, cholesterol, and / or glucose, to assess a patient's health. Various other improvements have also been disclosed.

[0007] In an aspect, a prosthetic valve is provided for implantation within a native valve. 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 shaped to capture one or more native valve leaflets between the anchoring mechanism and the valve body. The prosthetic valve preferably includes one or more indicators (e.g., sensors) for providing feedback to a physician regarding the capture of the native valve leaflets and / or proper placement of the one or more anchors relative to the native valve. Feedback is preferably provided to the physician via visualization, preferably in real time, using medical imaging techniques such as ultrasound or fluoroscopy.

[0008] In aspects, a method may include deploying a prosthetic valve to a native valve. The prosthetic valve may 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 the capture of the native valve leaflets.

[0009] In aspects, the sensor system may include a prosthetic heart valve for deployment over a native valve of a patient's heart, with one or more sensors coupled to the prosthetic heart valve for detecting conditions within the patient's body.

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

[0011] In aspects, a delivery system is provided for delivering an implant to a native heart valve. 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 aspects, the method may include delivering the implant to the native heart valve utilizing 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 aspects, a delivery system is provided for delivering the implant to the native heart valve. 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 for imaging an area external to the delivery device (e.g., surrounding tissue).

[0014] In aspects, the method may include delivering the implant to the native heart valve utilizing a delivery system. The delivery system may 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 an embodiment, a sensor system may include a sensor and one or more anchors coupled to the sensor and adapted to engage an interior heart wall of a heart chamber.

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

[0017] In an aspect, the system may include a prosthetic heart valve for deployment over a native valve of a patient's heart, at least a portion of the prosthetic heart valve including a pacemaker electrical conduit adapted to carry an electrical signal for pacing the heart.

[0018] In an aspect, the method may include deploying a prosthetic heart valve over a native valve of the patient's heart, at least a portion of the prosthetic heart valve including a pacemaker electrical conduit adapted to carry an electrical signal for pacing the heart.

[0019] In aspects, a system may include a prosthetic heart valve for deployment into 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 retention mechanism adapted to hold the one or more native valve leaflets in a contracted state when the one or more anchors at least partially hook around the one or more native valve leaflets.

[0020] In aspects, the method may include deploying a prosthetic heart valve into a native valve of the 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 utilizing a retention mechanism to retain the one or more native valve leaflets in a contracted state when the one or more anchors at least partially hook around the one or more native valve leaflets.

[0021] In an aspect, 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 one-way valve function. The prosthetic valve may include an inner frame supporting the one or more prosthetic valve leaflets and having 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, wherein the plurality of elongated prongs are each coupled to the inflow end portion of the inner frame and have a first end portion that projects radially outward from the inner frame to a second end portion, the skirt is suspended between the second end portions of the plurality of prongs and the outflow end portion of the prosthetic valve, and the skirt bounds 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 leaflets of the native valve.

[0022] In aspects, the method may include deploying a prosthetic heart valve to a native heart valve, the prosthetic heart valve including one or more prosthetic leaflets, an inner frame supporting the one or more prosthetic leaflets and having an inflow end portion and an outflow end portion, a sealing body positioned radially outward of the inner frame and including a plurality of elongated prongs and a skirt, wherein the plurality of elongated prongs are each coupled to the inflow end portion of the inner frame and have a first end portion that projects radially outward from the inner frame to a second end portion, the skirt is suspended between the second end portions of the plurality of prongs and the outflow end portion of the prosthetic valve, the skirt bounding 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 leaflets of the native valve.

[0023] In an aspect, a prosthetic heart valve for deployment into 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, wherein the skirt or the at least one ring is adapted to seal with at least a portion of the native valve.

[0024] In some embodiments, the method may include deploying a prosthetic heart valve over the native heart valve. The prosthetic heart valve may include one or more prosthetic valve leaflets. The prosthetic heart 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, wherein the skirt or the at least one ring is adapted to seal with at least a portion of the native heart valve.

[0025] In aspects, a sensor system may be incorporated into an artificial cardiac implant. The sensor system may include a sensor body including a substrate, a sensor positioned on the substrate and adapted to detect a state of the artificial cardiac implant, and electrical detection traces positioned on the substrate and adapted to detect a force applied to the substrate.

[0026] In an aspect, a method may include deploying a prosthetic cardiac implant to a native heart valve and detecting a condition of the prosthetic cardiac implant utilizing a sensor body coupled to the prosthetic cardiac implant, the sensor body including a substrate, a sensor positioned on the substrate and adapted to detect a condition of the prosthetic cardiac implant, and electrical detection traces positioned on the substrate and adapted to detect a force applied to the substrate.

[0027] Any feature of an aspect or embodiment disclosed herein is applicable to all other aspects and embodiments identified herein. Furthermore, any feature of an aspect or embodiment of various aspects or embodiments may be independently combined in any way, in whole or in part, with other aspects or embodiments described herein. For example, one, two, or three or more aspects or embodiments may be combined in whole or in part. Furthermore, any feature of an aspect or embodiment may be optional with respect to other aspects or embodiments. Any aspect or embodiment of a method may be performed by a system or device of another aspect or embodiment. Also, any aspect or embodiment of a system or device may be configured to perform a method of another aspect or embodiment.

[0028] The features and advantages of the systems, apparatus, and methods disclosed herein will become apparent as they become more clearly understood with reference to the specification, claims, and accompanying drawings. [Brief explanation of the drawings]

[0029] [Figure 1A] FIG. 1A shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 1B] FIG. 1B shows a bottom perspective view of the prosthetic valve shown in FIG. 1A. [Figure 2] FIG. 2 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 1A. [Figure 3]FIG. 3 shows a schematic diagram of the delivery device approaching the implantation site. [Figure 4A] FIG. 4A shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 1A positioned within a delivery device and approaching an implantation site. [Figure 4B] FIG. 4B shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 1A deployed in a native heart valve. [Figure 4C] FIG. 4C shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 1A deployed in a native heart valve. [Figure 5] FIG. 5 shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 6] FIG. 6 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 5 deployed in a native heart valve. [Figure 7] FIG. 7 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 8A] FIG. 8A shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 7 positioned within a delivery device and approaching an implantation site. [Figure 8B] FIG. 8B shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 7 partially deployed from the delivery device and approaching the implantation site. [Figure 8C] FIG. 8C shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 7 partially deployed from the delivery device and approaching the implantation site. [Figure 8D] FIG. 8D shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 7 partially deployed from the delivery device and approaching the implantation site. [Figure 8E] FIG. 8E shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 7 partially deployed from the delivery device. [Figure 8F] FIG. 8F shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 7 deployed in a native heart valve. [Figure 9] FIG. 9 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 10] FIG. 10 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. [Figure 11]FIG. 11 shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 12] FIG. 12 shows a schematic diagram of a cross-sectional top view of the prosthetic valve shown in FIG. 11 deployed over the leaflets of a native heart valve. [Figure 13] FIG. 13 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 14] FIG. 14 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. [Figure 15] FIG. 15 shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 16] FIG. 16 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. [Figure 17] FIG. 17 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 18] FIG. 18 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. [Figure 19] FIG. 19 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 20] FIG. 20 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. [Figure 21] FIG. 21 shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 22] FIG. 22 illustrates a side perspective view of an indicator of the prosthetic valve shown in FIG. 21 according to an embodiment of the present disclosure. [Figure 23A] FIG. 23A shows a schematic cross-sectional side view of the indicator shown in FIG. [Figure 23B] FIG. 23B shows a schematic cross-sectional side view of the indicator shown in FIG. 23A deflected from the position shown in FIG. 23A. [Figure 24] FIG. 24 shows a schematic side cross-sectional view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 25] FIG. 25 shows a schematic cross-sectional side view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 26] FIG. 26 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 27]FIG. 27 shows a side cross-sectional schematic view of the prosthetic valve shown in FIG. 26 deployed at an implantation site according to an embodiment of the present disclosure. [Figure 28] FIG. 28 illustrates a perspective view of a delivery device according to an embodiment of the present disclosure. [Figure 29] FIG. 29 shows a side cross-sectional schematic view of the prosthetic valve shown in FIG. 26 deployed at an implantation site according to an embodiment of the present disclosure. [Figure 30] FIG. 30 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 31] FIG. 31 shows a side cross-sectional schematic view of the prosthetic valve shown in FIG. 30 deployed at an implantation site according to an embodiment of the present disclosure. [Figure 32A] FIG. 32A shows a side cross-sectional schematic view of the prosthetic valve shown in FIG. 30 deployed at an implantation site according to an embodiment of the present disclosure. [Figure 32B] FIG. 32B shows a schematic cross-sectional side view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 33] FIG. 33 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 34] FIG. 34 shows a side cross-sectional schematic view of the prosthetic valve shown in FIG. 33 deployed at an implantation site according to an embodiment of the present disclosure. [Figure 35] FIG. 35 shows a schematic side cross-sectional view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 36] FIG. 36 illustrates a side perspective view of a sensor system according to an embodiment of the present disclosure. [Figure 37] FIG. 37 illustrates a side perspective view of a sensor system according to an embodiment of the present disclosure. [Figure 38] FIG. 38 shows a schematic side cross-sectional view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 39] FIG. 39 illustrates a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 40] FIG. 40 shows a schematic cross-sectional side view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 41] FIG. 41 illustrates a top perspective view of multiple sensors according to an embodiment of the present disclosure. [Figure 42A] FIG. 42A shows a top view of a sensor according to an embodiment of the present disclosure. [Figure 42B] FIG. 42B shows a schematic cross-sectional side view of the sensor shown in FIG. 42A, according to an embodiment of the present disclosure. [Figure 42C] FIG. 42C shows a schematic cross-sectional side view of the sensor shown in FIG. 42A, according to an embodiment of the present disclosure. [Figure 43] FIG. 43 shows a schematic diagram of a side cross section of an artificial valve utilizing the sensor shown in FIG. [Figure 44] FIG. 44 illustrates a top view of a sensor for a prosthetic valve, according to an embodiment of the present disclosure. [Figure 45] FIG. 45 shows a schematic cross-sectional side view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 46] FIG. 46 illustrates a side view of a delivery device according to an embodiment of the present disclosure. [Figure 47] FIG. 47 shows a side view of the delivery device shown in FIG. 46 moved distally. [Figure 48] FIG. 48 shows a side view of the delivery device shown in FIG. 46 with the implant partially deployed. [Figure 49] FIG. 49 illustrates a side view of a delivery device according to an embodiment of the present disclosure. [Figure 50A] FIG. 50A shows a side view of the imaging device extending from the delivery system. [Figure 50B] FIG. 50B shows a side view of the imaging device extending from the delivery system. [Figure 51] FIG. 51 shows a side perspective view of an implant with an imaging window. [Figure 52] FIG. 52 shows a side perspective view of a sensor for coupling to the internal heart wall. [Figure 53] Figure 53 shows a schematic diagram of the ventricles and atria. [Figure 54] FIG. 54 shows a side view of the sensor anchored to the internal heart wall. [Figure 55] FIG. 55 shows a side view of the sensor anchored to the internal heart wall. [Figure 56]FIG. 56 shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 57] FIG. 57 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. [Figure 58] FIG. 58 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 56 deployed into a prosthetic heart valve. [Figure 59] FIG. 59 shows a schematic side cross-sectional view of a pacemaker coupled to the electrical terminals of a prosthetic heart valve. [Figure 60] FIG. 60 shows a side perspective view of a pacemaker electrical conduit according to an embodiment of the present disclosure. [Figure 61] FIG. 61 shows a side perspective view of a pacemaker electrical conduit according to an embodiment of the present disclosure. [Figure 62A] FIG. 62A shows a side partial cross-sectional view of the approach of the retention mechanism to the implantation site. [Figure 62B] FIG. 62B shows a side partial cross-sectional view of the retention mechanism shown in FIG. 62A in an expanded state. [Figure 62C] FIG. 62C shows a side partial cross-sectional view of the retention mechanism shown in FIG. 62A in an expanded state. [Figure 62D] FIG. 62D shows a side partial cross-sectional view of the retention mechanism shown in FIG. 62A with the retention mechanism in a retracted position. [Figure 62E] FIG. 62E shows a perspective view of the retention mechanism shown in FIG. 62A with the retention mechanism deployed. [Figure 62F] FIG. 62F shows a top cross-sectional view of the retention mechanism shown in FIG. 62A in an expanded state. [Figure 63A] FIG. 63A shows a side view of the approach of the retention mechanism to the implantation site. [Figure 63B] FIG. 63B shows a side partial cross-sectional view of the retention mechanism shown in FIG. 63A unfolded. [Figure 63C] FIG. 63C shows a side partial cross-sectional view of the retention mechanism shown in FIG. 63A retracted. [Figure 64] FIG. 64 shows a side partial cross-sectional view of the retention mechanism deployed. [Figure 65A] FIG. 65A shows a side partial cross-sectional view of the retention mechanism deployed. [Figure 65B] FIG. 65B shows a side partial cross-sectional view of the retention mechanism shown in FIG. 65A unfolded. [Figure 65C] FIG. 65C shows a side partial cross-sectional view of the retention mechanism shown in FIG. 65A retracted. [Figure 66A] FIG. 66A shows a side partial cross-sectional view of the retention mechanism retracted. [Figure 66B] FIG. 66B shows a side partial cross-sectional view of the retention mechanism shown in FIG. 66A unfolded. [Figure 66C] FIG. 66C shows a side partial cross-sectional view of the retention mechanism shown in FIG. 66A retracted. [Figure 66D] FIG. 66D shows a perspective view of the retention mechanism shown in FIG. 66A. [Figure 67] FIG. 67 shows a side partial cross-sectional view of the retention mechanism. [Figure 68A] FIG. 68A shows a side partial cross-sectional view of the retention mechanism. [Figure 68B] FIG. 68B shows a side partial cross-sectional view of the retention mechanism shown in FIG. 68A with the coil deployed. [Figure 68C] FIG. 68C shows a perspective view of the coil shown in FIG. 68B unfolded. [Figure 69A] FIG. 69A shows a perspective view of the frame of the prosthetic valve. [Figure 69B] FIG. 69B shows a top view of the frame shown in FIG. 69A. [Figure 69C] FIG. 69C shows a perspective view of an artificial valve employing the frame shown in FIG. 69A. [Figure 69D] FIG. 69D shows a perspective view of the inner frame. [Figure 69E] FIG. 69E shows a top view of the elongated struts. [Figure 69F] FIG. 69F shows a side cross-sectional view of the prosthetic valve shown in FIG. 69C. [Figure 69G] FIG. 69G shows a side cross-sectional view of the prosthetic valve shown in FIG. 69C deployed. [Figure 70A]FIG. 70A shows a perspective view of the prosthetic valve. [Figure 70B] FIG. 70B shows a side cross-sectional view of a portion of the prosthetic valve along line II in FIG. 70A. [Figure 70C] FIG. 70C shows a top view of the ring. [Figure 70D] FIG. 70D shows a side cross-sectional view of the prosthetic valve shown in FIG. 70A deployed. [Figure 70E] FIG. 70E shows a top view of the ring. [Figure 70F] FIG. 70F shows a partial perspective view of the ring positioned within the channel. [Figure 71A] FIG. 71A shows a perspective view of the prosthetic valve. [Figure 71B] FIG. 71B shows a side cross-sectional view of the prosthetic valve shown in FIG. 71A. [Figure 71C] FIG. 71C shows a side cross-sectional view of the prosthetic valve shown in FIG. 71A. [Figure 72A] FIG. 72A shows a perspective view of the prosthetic valve. [Figure 72B] FIG. 72B shows a side cross-sectional view of the prosthetic valve shown in FIG. 72A deployed. [Figure 73A] FIG. 73A shows a perspective view of the prosthetic valve. [Figure 73B] FIG. 73B shows a side cross-sectional view of the prosthetic valve shown in FIG. 73A deployed. [Figure 74] FIG. 74 shows a side view of the delivery system. [Figure 75] FIG. 75 shows a side view of the clip. [Figure 76] FIG. 76 shows a partial cross-sectional view of the clip shown in FIG. 75 being implanted. [Figure 77] FIG. 77 shows a partial cross-sectional view of the clip shown in FIG. 75 being implanted. [Figure 78] FIG. 78 shows a cutaway view of the clip shown in FIG. 75 being implanted. [Figure 79] FIG. 79 shows a cross-sectional view of the clip being implanted. [Figure 80] FIG. 80 shows a cross-sectional view of the clip being implanted. [Figure 81] FIG. 81 shows a perspective view of the sensor body. [Figure 82] FIG. 82 shows a partial schematic diagram of the components of the sensor system. [Figure 83] FIG. 83 shows a top view of the partial cutaway of the sensor body shown in FIG. [Figure 84] Figure 84 shows a top view of the sensor body. [Figure 85] Figure 85 shows a top view of the sensor body. [Figure 86] Figure 86 shows a schematic diagram of the delivery system approaching the implantation site. [Figure 87] FIG. 87 shows a perspective view of a prosthetic heart valve including a sensor body. [Figure 88] FIG. 88 shows a top view of the compressed sensor body. [Figure 89] FIG. 89 shows a top view of the sensor body shown in FIG. 88 expanded. [Figure 90] FIG. 90 shows a perspective view of the sensor body shown in FIG. 88 expanded. [Figure 91] FIG. 91 shows a perspective view of the sensor body shown in FIG. 88 in compression. [Figure 92] FIG. 92 shows a perspective view of a prosthetic heart valve including a sensor body. DETAILED DESCRIPTION OF THE INVENTION

[0030] 1A illustrates a perspective view of an implant in the form of a prosthetic valve 10. Prosthetic valve 10 may include a prosthetic heart valve for deployment over a native heart valve in a patient's body. In embodiments, other types of implants and prosthetic valves may be used as desired.

[0031] The prosthetic valve 10 is adapted to be deployed within the annulus of a native valve (e.g., the native mitral valve or the native tricuspid valve). In embodiments, other implantation locations may be utilized, such as within the aortic or pulmonary valve, or within other valves or other locations within the patient's body, as desired.

[0032] The prosthetic valve 10 may include a proximal end 12 or inlet end portion, a distal end 14 or outlet end portion (shown in FIG. 2 ), and a length therebetween. The prosthetic valve 10 further includes a valve portion preferably formed by a plurality of prosthetic valve leaflets 16. The valve portion is positioned within a flow channel or passageway for controlling flow through the prosthetic valve 10. The flow channel or passageway is formed by a support structure or valve body 15 of the valve 10. The valve body 15 or support structure has a proximal or inlet end portion and a distal or outlet end portion. The prosthetic valve leaflets 16 move between open and closed states to mimic and replace the behavior of the leaflets of a native valve. The valve portion is positioned within the passageway of the valve body 15 and allows blood to flow unidirectionally through the passageway, thereby replacing the function of a native heart valve. The prosthetic valve leaflets 16 are fabricated from pericardium, such as bovine or porcine pericardium, or other suitable material. In alternative arrangements, the leaflets are formed of synthetic (eg, polymeric) materials, or the valve portion is a mechanical one-way valve.

[0033] 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 inner support stent or inner frame 18 (as shown in FIG. 1B) and an outer support stent or outer frame 20 (as shown in FIGS. 1A and 2), including other frame configurations). The outer support stent or outer frame 20 forms part of the seal 11 and is spaced apart from the inner frame 18. The outer frame 20 surrounds the inner frame 18.

[0034] 2 shows a schematic cross-sectional view of the prosthetic valve 10. The inner frame 18 includes a proximal portion including a proximal end 19 and a distal portion including a distal end 21. The inner frame 18 may have a spherical shape, including a curved body that bends radially outward between the proximal end 19 and the distal end 21, or may have other configurations as desired. In one embodiment, the inner frame 18 has a circular shape. The inner frame 18 supports a plurality of prosthetic valve leaflets 16.

[0035] 1B, the inner frame 18 includes a plurality of struts 23 spaced apart by spaces 25. Such a configuration may allow the inner frame 18 to move between a non-deployed or unextended or straight configuration and a deployed or expanded configuration. For example, the inner frame 18 may move to the deployed or expanded configuration by expanding radially outward, increasing the diameter of the inner frame 18 and thereby decreasing the length of the inner frame 18. Other configurations of the inner frame 18 may be utilized as desired.

[0036] 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 comprises the outer surface of the prosthetic valve 10. The sealing body 11 defines the outer diameter of the prosthetic valve 10 and comprises the 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 (shown in FIG. 2 ).

[0037] 2, closure 11 includes a frame 20 and a sealing skirt 24, or in some embodiments, may include only a frame or only a sealing skirt, as desired. Frame 20 may include an outer frame positioned radially outward from inner frame 18. Sealing skirt 24 may be coupled to outer frame 20 and may comprise an outer portion of closure 11, as shown in FIG. 1A.

[0038] The outer frame 20 includes at least a portion of the sealer 11 configured to apply a seal to a portion of the heart. The outer frame 20 can have a proximal portion 35 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 leaflets 16 of the prosthetic valve. A distal portion 37 of the outer frame 20 is spaced apart from the leaflets 16 of the prosthetic valve and from the inner frame 18 by a gap 39. The gap 39 is positioned between the outer frame 20 of the sealer 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 sealer 11 includes an outer frame positioned radially outward from the inner frame 18 and surrounding the inner frame 18 and the leaflets 16 of the prosthetic valve.

[0039] The outer frame 20 has a length that extends distally over a shorter distance compared to the distal end of the inner frame 18. As such, the outer frame 20 is shorter than the inner frame 18. The outer frame 20 further has a curved configuration that curves outward from the inner frame 18, with the largest diameter of the outer frame 20 being at the distal portion of the outer frame 20.

[0040] The outer frame 20 of the seal 11 includes a plurality of struts 49 (shown in FIG. 1 ) that form the frame 20, with spaces 51 between the struts. This configuration utilized with the frame 20 allows the frame 20 to move between a non-deployed or unexpanded or straight configuration and a deployed or expanded configuration, as shown in FIG. 1A , in which the outer frame 20 and seal 11 have a curved, bulbous shape. As with the valve frame 18, the length of the outer frame 20 of the seal 11 decreases as the diameter of the outer frame 20 of the seal 11 increases upon deployment. The diameter of the outer frame 20 of the seal 11 may expand radially outward simultaneously with the inner valve frame 18, or, in some embodiments, may expand radially outward at a different time or rate than the inner valve frame 18.

[0041] The seal 11 includes a sealing skirt 24 (as shown in FIG. 1 ) that extends around the inner valve frame 18 and around the prosthetic valve leaflets 16. The skirt 24 can be coupled to the seal frame 20 or can be separate from the frame 20, in some embodiments.

[0042] The sealing skirt 24 has a proximal portion 41 (shown in FIG. 2) that is coupled to a proximal portion of the frame 20 of the seal 11 and may be coupled to a proximal portion of the inner frame 18. The skirt 24 is provided with a distal portion 43 (shown in FIG. 2) that is coupleable to the distal end of the frame 20 and, in some embodiments, to the inner valve frame 18 or one or more anchors 17.

[0043] The sealing skirt 24 is made of a material that can withstand fluid flow therethrough, such as a cloth material, a woven material, or other material such as a polymer, or other material that can withstand fluid flow therethrough. The material can include a fabric. A variety of materials can be utilized for the skirt 24, as desired.

[0044] The sealing body 11 is adapted to contact a portion of the patient's heart to reduce fluid flow. The skirt 24 is adapted to seal against a portion of the annulus of the native valve. For example, the sealing body 11 abuts against the surface of the leaflets of the patient's native valve to reduce fluid flow between the sealing body 11 and the native valve leaflets. The sealing body 11 can be adapted to contact other portions of the patient's heart to reduce fluid flow as needed.

[0045] In an embodiment, the seal 11 is flexible to allow movement and conformance to the annulus of the native valve.

[0046] 1A and 2, prosthetic valve 10 includes one or more anchors 17. Each anchor 17 is adaptable to secure a leaflet 16 of the prosthetic valve to a portion of the patient's heart, including a native valve. Anchors 17 may be specifically adapted to anchor to the leaflets of a native valve in the patient's heart. Anchors 17 may extend around and anchor (i.e., capture) the leaflets of the native valve. Anchors 17 include distal anchors positioned at a distal end 14 of valve 10, or, in embodiments, may be positioned at another location, as desired.

[0047] Each anchor 17 is configured as a protruding arm adapted to extend distally and then bend proximally to one tip of the anchor 17. With this configuration, the anchor 17 extends around and around the distal tip of the native valve leaflet, hooks onto the distal tip of the native valve leaflet, and is positioned radially outward of the outward-facing surface of the native valve leaflet. The anchor 17 is adapted to have a hook configuration, as shown in FIGS. 1A-2 , for example. If desired, the anchor 17 is adapted to clamp one or more native valve leaflets against the seal 11. When implanted within a native mitral or tricuspid valve, the anchor 17 resists forces applied to the valve 10 from the atrial or proximal direction, anchoring the valve 10 within the native valve annulus. Other configurations of the anchor 17 may be utilized in embodiments as desired.

[0048] The anchors 17 anchor the valve body 15 to the native valve by capturing the leaflets of the native valve. The capture can have a variety of forms, including extending over the distal tips of the leaflets of the native valve. In some embodiments, the anchors 17 hook around the leaflets. Other forms of capture can be utilized in some embodiments.

[0049] Anchor 17 is shown in FIGS. 1A-2 in a deployed or expanded configuration with a tip of anchor 17 extending proximally. Anchor 17 is adapted to have a tip that extends distally in the undeployed, unexpanded, or straight configuration. Such a configuration is shown in FIG. 4A. Anchor 17 is adapted to be flexible. Upon deployment, anchor 17 may be configured to move radially outward from the undeployed configuration to the deployed configuration, with the tip everting proximally. This movement allows anchor 17 to evert the leaflets of the native valve during deployment to anchor to the leaflets of the native valve. Such a configuration is shown, for example, in FIG. 4. Other deployment techniques for anchor 17 may be utilized in embodiments, as desired.

[0050] 2 , a proximal portion of the inner frame 18 is coupled to the 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 technique, as desired.

[0051] The leaflets 16 of the prosthetic valve surround a flow channel 27 and can move between open and closed states to control flow through the flow channel 27, as shown in FIG. 2. As shown in FIG. 2, the proximal end of the prosthetic valve 10 includes the inflow end of the valve 10 and the distal end of the prosthetic valve 10 includes the outflow end, although other configurations can be utilized as desired. The leaflets 16 of the prosthetic valve can be positioned about a central axis 61 of the prosthetic valve 10. An inner frame 18 and an outer frame 20 each surround the central axis 61 of the prosthetic valve 10.

[0052] The anchors 17 may each extend radially outward from the flow channel 27 and from the prosthetic valve leaflets 16 of the valve 10. The anchors 17 extend radially outward from the inner valve frame 18 and are adaptable to span the gap 39 to the tip of each anchor 17. The anchors 17 are coupled to a distal portion of the inner frame 18. Each of the anchors 17 may include a proximal portion 29 and a distal portion 45, where the proximal portion 29 is coupled to the inner frame 18 and the distal portion 45 comprises the tip of the respective anchor 17. The anchors 17 extend perpendicularly from the proximal portion 29 to the tip of the distal portion 45 when the valve 10 is deployed.

[0053] Indicators may be provided to indicate capture of the native valve leaflets and / or proper placement of one or more of the anchors 17. The indicators may take a variety of forms while remaining within the scope of the present invention.

[0054] For example, referring to FIG. 1A, a conforming indicator 62 is provided to indicate capture of the native valve leaflets during imaging. The appearance of the indicator 62 may change shape or brightness under imaging to confirm proper placement of the anchor. For identification purposes, the indicator 62 takes the form of exemplary indicators 62a, 62b shown in FIG. 1A.

[0055] The indicator 62 changes appearance under ultrasound imaging depending on the location of the indicator and / or the force acting on it. For example, the indicator 62 has reduced visibility under ultrasound imaging 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 native tissue. For example, the indicator on the anchor changes appearance when the anchor is properly positioned radially outward of the native valve leaflets (e.g., on the ventricular side). When properly positioned, the indicator contacts native tissue, such as the leaflets and / or annulus, confirming that the anchor is properly positioned.

[0056] The indicators 62 may be positioned in various locations depending on the desired information needed to confirm proper placement. For example, referring to FIG. 1A , the indicators 62 are positioned on one or more of the anchors 17. As shown in FIG. 1A , each anchor 17 includes one indicator 62, although other configurations may be utilized as desired (e.g., only one of the anchors 17 includes an indicator 62, or at least one of the anchors 17 includes an indicator 62). Indicators 62a, 62b are shown on exemplary anchors 17a, b in FIG. 1A . In an embodiment, the indicators 62 are positioned on the distal portion 45 or tip of each anchor 17. In this manner, the indicators 62 are positioned radially outward of the native valve leaflets when the native valve leaflets are captured between the anchors and the seal 11. When the anchors are properly seated, the indicators abut against native tissue (e.g., the ventricular side of the native valve annulus) and are therefore deformed. If the anchor 17 fails to capture or incorrectly captures a leaflet of the native valve, the indicator 62 will be positioned radially inward of the leaflet of the native valve, and the indicator will not be compressed against the native tissue (e.g., not contacting the annulus). Thus, the indicator 62 provides visual feedback regarding anchor placement that can be viewed using the visualization techniques described herein. When properly placed, the indicator on the anchor will change shape due to contact with the native tissue. In contrast, if the anchor is not properly placed and the leaflet is not captured, the indicator 62 will have a substantially unchanged appearance, alerting the physician to a potential problem.

[0057] Referring to Figure 3, the prosthetic valve 10 is deployed to the implantation site via a delivery system 70. Figure 3 shows the advancement of the delivery system 70 to deploy the prosthetic valve 10 at the implantation site. The delivery system 70 includes an elongate shaft 72 having a proximal portion and a distal portion, the proximal portion being 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 the femoral vein as shown in Figure 3. In embodiments, other introduction techniques may be utilized, including transapical, and including via a surgical technique such as open-chest or open-heart surgery.

[0058] The prosthetic valve 10 is positioned within an implant-retaining region of the delivery system 70. The prosthetic valve 10 may be, for example, encapsulated or otherwise retained prior to deployment. The prosthetic valve 10 can be deployable as a self-expanding prosthetic valve or a balloon-expandable prosthetic valve (e.g., positioned on an inflatable balloon upon insertion into the patient's body, or slid onto an expandable balloon within the patient's body). The prosthetic valve can be mechanically expanded, among other forms of deployment.

[0059] Delivery system 70 may be advanced through an atrium of the heart and passed transseptally to another atrium (e.g., from the right atrium to the left atrium) to reach the implantation site. Such a delivery approach may be utilized, for example, for access to the native mitral valve. In some embodiments, delivery system 70 extends to the right atrium for tricuspid valve access, or other delivery approaches to other implantation sites may be utilized in some embodiments, as desired.

[0060] 4A shows a side cross-sectional view of the prosthetic valve 10 in a compressed configuration, protruding slightly from the capsule 79 of the delivery system 70. The anchors 17a,b are shown in an elongated configuration and extending longitudinally. The prosthetic valve 10 is positioned to be deployed into the native valve 80.

[0061] Referring to FIG. 3 , once the prosthetic valve 10 is deployed from the delivery system, the implantation site can be imaged. The imaging can take a variety of forms. As shown in FIG. 3 , the imaging can include ultrasound imaging, which can be generated by an echocardiogram device 81. The echocardiogram device 81 can include a transducer or other form of echocardiogram device that generates images via ultrasonic waves. In embodiments, the echocardiogram device 81 is positioned external to the patient's body. However, in embodiments, the echocardiogram device is adapted to be positioned within the patient's vasculature for imaging. Other forms of imaging, such as fluoroscopy or other forms, can be utilized as desired. Combinations of forms of imaging, such as a combination of ultrasound and fluoroscopy, can be utilized. Combinations of other forms of imaging can be utilized.

[0062] Imaging allows a user (eg, a surgeon or other form of medical technician) to view the implantation site during the implantation procedure.

[0063] Imaging the implantation site beneficially allows a user to determine the desired placement of prosthetic valve 10 and the desired anchor fixation of one or more of anchors 17. For example, capture of the native valve leaflets by one or more of anchors 17 may be beneficially imaged. The user can beneficially determine whether the anchors are properly placed and capture of the native valve leaflets has occurred, identifying whether proper implantation of prosthetic valve 10 has occurred.

[0064] 4A and 4B, the indicators 62a, b are adapted to indicate capture of native valve leaflets 82a, b by one or more anchors 17a, b. For example, referring to FIG. 4A, the anchors 17a, b include indicators 62a, b positioned on the tips of the respective anchors 17a, b. The indicators 62a, b have an appearance under imaging, particularly ultrasound imaging. For example, as shown in FIG. 4A, the indicators 62a, b exhibit brightness under ultrasound imaging when the anchors 17a, b are partially deployed from the capsule 79.

[0065] As shown in Figure 4B, when anchors 17a, b are fully deployed, anchor 17a fails to capture leaflet 82a, as shown on the right side of Figure 4B. Therefore, indicator 62a is not covered by leaflet 82a and, when imaged, appears identical to its appearance in the position shown in Figure 4A. For example, the brightness of indicator 62a, indicating anchor 17a has failed to capture leaflet 82a, is identical to its brightness in the position shown in Figure 4A.

[0066] However, indicator 62b for anchor 17b that has captured leaflet 82b (shown on the left side of FIG. 4B) has a different appearance than its appearance in the position shown in FIG. 4A. The appearance of indicator 62b for anchor 17b that has captured leaflet 82b is different from the appearance of indicator 62a for anchor 17a that failed to capture leaflet 82a. For example, indicator 62b for anchor 17b that has captured leaflet 82b has a darker appearance under imaging than indicator 62a for anchor 17a that failed to capture leaflet 82a. Based on the appearance of indicators 62a,b, a user can determine whether failure to capture leaflet 82a has occurred.

[0067] In an embodiment, indicators 62a, b may be imaged from the atrium such that tissue from the native valve leaflets 82b covers indicator 62b, reducing the brightness of such indicator 62b. A layer of leaflet tissue covering indicator 62b, as opposed to a lack of tissue covering indicator 62a, may produce a darker appearance of indicator 62b and an indication that leaflet 82b is captured. A lighter appearance of indicator 62a indicates that leaflet 82a is not captured. Other differences in the appearance of indicators 62a, b may result.

[0068] In some embodiments, the user may attempt to redeploy anchor 17a or recapture leaflet 82a for proper deployment of prosthetic valve 10. The user may perform a redeployment or recapture procedure to capture leaflet 82a. The user may visualize indicator 62a to determine whether capture of leaflet 82a has occurred.

[0069] 4C, for example, shows a view of the prosthetic valve 10 in which both leaflets 82a, b have been captured. The indicators 62a, b have a similar appearance to one another and are reduced in visibility to indicate capture of the respective leaflets 82a, b. A user can determine that both leaflets 82a, b are captured based on the appearance of the indicators 62a, b. Imaging can occur from the atrium or from another location as desired.

[0070] The features of Figures 1 through 4C may be utilized alone or in combination with any of the embodiments disclosed herein.

[0071] In embodiments, the configuration of one or more of the indicators may be varied as desired. For example, FIG. 5 illustrates an indicator 84 adapted to move to indicate capture of a native valve leaflet. The indicator 84 is adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 84 under imaging may change to indicate capture of a native valve leaflet. The indicator 84 includes exemplary indicators 84a, b, shown in FIG. 5 for identification purposes.

[0072] Each indicator 84 includes an elongate body in one embodiment. A plurality of elongate bodies are provided. Each elongate body is positioned on a respective one of the anchors 17. The elongate body is positioned, for example, on the distal portion 45 or distal tip of each anchor 17. The elongate body protrudes proximally from the distal portion 45 or distal tip of each anchor 17, as shown in FIG. 5. Indicators 84a, b are positioned on each anchor 17a, b.

[0073] Each elongate body is configured as a spring in some embodiments. The springs include helical springs having a coiled configuration as shown in FIG. 5. As such, the springs are configured in an extended position where they can be compressed to a compressed position when distal pressure is applied to the springs. Upon release of the pressure, the springs are biased back to the extended position. In some embodiments, the configuration of the elongate bodies can be varied as desired.

[0074] The difference in appearance of the elongate body between the expanded and compressed positions may be visible under imaging. For example, spacing 86 (shown in FIG. 5) between adjacent wraps 88 a, 88 b of the elongate body may be visible under imaging with the elongate body in the expanded position. The reduced spacing 86 between wraps 88 a, 88 b may be even more visible under imaging with the elongate body in a compressed position.

[0075] A user can determine by visual appearance of indicator 84 whether a force has been applied to indicator 84 and, therefore, whether capture of the native valve leaflets has occurred.

[0076] For example, referring to FIG. 6, deployment of a prosthetic valve 85 has occurred. Anchor 17a (shown on the right side of the page in FIG. 6) has failed to capture a valve leaflet 82a. Accordingly, indicator 84a on such anchor 17a remains in an expanded position that is visible via imaging, including fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, a user determines that a failure to capture or missed capture of a valve leaflet 82a has occurred by viewing the expanded position of indicator 84a.

[0077] Anchor 17b (shown on the left side of the page in FIG. 6) captures leaflet 82b. Accordingly, indicator 84b on such anchor 17b moves to a compressed position visible via imaging. Thus, a user determines that capture of leaflet 82b has occurred by viewing the compressed position of indicator 84b.

[0078] In an embodiment, a user determines whether capture of a leaflet has occurred by looking at the difference in position between indicators 84a, b. For example, if indicator 84a, shown on the right side of the page in Figure 6, has a greater height than indicator 84b, shown on the left side of the page in Figure 6, the user can determine that capture failure has occurred.

[0079] Each feature in FIGS. 5 and 6 may be utilized alone or in combination with any of the embodiments disclosed herein.

[0080] In embodiments, the configuration of one or more indicators can be varied as desired. For example, FIG. 7 illustrates an indicator 90 adapted to move to indicate capture of a native valve leaflet. The indicator 90 can be adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 90 during imaging can change to indicate capture of a native valve leaflet. The indicator 90 includes exemplary indicators 90a, b shown in FIG. 7 for identification purposes.

[0081] Indicator 90 includes an elongate body. Multiple elongate bodies may be utilized in some embodiments. Each elongate body is positioned on a respective one of anchors 17. The elongate bodies may be positioned, for example, on the distal portion 45 or distal tip of each anchor 17. The elongate bodies protrude proximally from the distal portion 45 or distal tip of each anchor 17, as shown in FIG. 7. Indicators 90a,b are positioned on each anchor 17a,b.

[0082] Each elongate body is configured as a spring in an embodiment. The spring includes an elongate lever arm adapted to be laterally deflected. The spring includes a contoured shape to increase the spring's flexibility. In an embodiment, the spring is in a straightened or extended state, as shown in FIG. 7 . In an embodiment, a portion of the spring, such as tip portion 92, is adapted to deflect laterally to a deflected position. This deflection is visible under imaging and can enable a user to determine the position of anchor 17 and determine whether leaflet capture has occurred.

[0083] The user looks at the appearance of indicator 90 to determine if a force has been applied to indicator 90, to determine the position of anchor 17, and to determine if leaflet capture has occurred.

[0084] For example, see Figure 8A, where partial deployment of anchors 17a,b has occurred. Indicators 90a,b extend from capsule 79 and extend laterally outward from capsule 79. Indicators 90a,b may extend perpendicular to capsule 79 or at another angle as desired.

[0085] The indicators 90a, b extend outward from the capsule 79 a length that allows the indicators 90a, b to contact the leaflets 82a, b of the native valve 80 or another portion of the native valve 80 (e.g., the annulus) upon extension of the indicators 90a, b. The indicators 90a, b project radially outward from the capsule 79 and are circumferentially spaced from one another such that the indicators 90a, b contact portions of the native valve 80 at multiple circumferential locations.

[0086] The user views the position of the indicators 90a, b via imaging, which may include fluoroscopy or ultrasound, a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user visualizes the position of the indicators 90a, b. For example, referring to FIG. 8A , the user visualizes that the indicators 90a, b are straight and extend laterally from the capsule 79. Thus, the user determines that the indicators 90a, b are not yet in contact with the valve leaflets 82a, b and are therefore positioned axially offset from the annulus of the native valve 80. One or more of the indicators 90a, b may be deflected to indicate a change in the position of the indicators 90a, b and the prosthetic valve 94.

[0087] The indicators 90a, b advance distally as part of the deployment procedure. For example, in FIG. 8B, the indicators 90a, b can advance distally, which may occur with distal movement of the capsule 79. The indicators 90a, b can deflect proximally and deflect radially inward toward the capsule 79. The deflected positions of the indicators 90a, b are shown in FIG. 8B. The user can image the positions of the indicators 90a, b and determine that the indicators 90a, b, and accordingly the prosthetic valve 94 (shown in FIG. 7) are now positioned between the valve leaflets 82a, b. Because the indicators 90a, b are in the deflected position, the user can further determine that the indicators 90a, b have not advanced distally of the valve leaflets 82a, b.

[0088] The user views the change in the amount of deflection of the indicators 90a,b to determine the position of the prosthetic valve 94 and anchors 17a,b. For example, in FIG. 8C, the user visualizes that the indicators 90a,b have advanced further distally by viewing the increased radial inward deflection of the indicators 90a,b. Because the indicators 90a,b are in a deflected position, the user determines that the indicators 90a,b have not advanced distally of the valve leaflets 82a,b.

[0089] 8D, the indicators 90a, b can be advanced further distally to extend laterally outward from the capsule 79 in a straight or elongated position. The straight configuration of the indicators 90a, b indicates that the indicators 90a, b are properly threaded into the chordae tendineae 96 of the heart to hook around the valve leaflets 82a, b. Thus, the user determines that the anchors 17a, b are in position to hook around the valve leaflets 82a, b. If one of the indicators 90a is visualized in the straight position and another indicator 90b is visualized in the deflected position, the user determines that the indicator 90b is not in position to hook around the valve leaflets and attempts to reposition the indicator 90b and its associated anchor 17b.

[0090] With indicators 90a,b indicating proper threading through the chordae tendineae 96 of the heart to hook around leaflets 82a,b, anchors 17a,b continue to be deployed to hook around leaflets 82a,b, as shown, for example, in FIG. 8E.

[0091] The indicators 90a,b have a length sufficient to allow the tip portion 92 to move to a deflected position upon full deployment of the prosthetic valve 94. The tip portion 92 may contact a portion of the native valve 80, including, for example, the annulus, or another portion of the native valve 80 (e.g., leaflets 82a,b), to indicate that capture of the native valve leaflets 82a,b has occurred. FIG. 8 illustrates, for example, such a configuration. In embodiments where capture has not occurred, the tip portion 92 is not deflected. The user determines whether a missed capture or capture of a leaflet 82a,b has occurred due to the tip portion 92 remaining in a straight position relative to the rest of the indicators 90a,b.

[0092] The deployment sequence can be varied as desired from the sequence shown in Figures 8A-8F.

[0093] Each of the features in Figures 7-8F may be utilized alone or in combination with any of the embodiments disclosed herein.

[0094] In some examples, the configuration of the indicator can be varied as desired. For example, FIG. 9 illustrates an indicator 100 adapted to move to indicate capture of a native valve leaflet. The indicator 100 is adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 100 during imaging changes to indicate capture of a native valve leaflet. The indicator 100 includes exemplary indicators 100a, b, shown in FIG. 9 for identification purposes.

[0095] Indicator 100 includes an elongate body. In some embodiments, multiple elongate bodies can be provided, with each elongate body positioned on a respective one of the anchors 17. The elongate bodies can be positioned, for example, on the distal portion 45 or distal tip of each anchor 17. The elongate bodies protrude distally from the distal portion 45 or distal tip of each anchor 17, as shown in FIG. 9. Indicators 100a, b are positioned on each anchor 17a, b.

[0096] Each elongate body is configured as a spring in this embodiment. The spring includes an elongate lever arm adapted to be biased radially outward toward anchor 17. The spring may be configured as a flat spring or a cantilever spring, with a fixed end of the spring coupled to anchor 17 and a free end extending radially inward toward valve body 15. The deflection of the spring to the biased position is visible under imaging so that a user can determine whether leaflet capture has occurred.

[0097] The user determines by visual appearance of indicator 100 whether a force has been applied to indicator 100 and therefore whether capture of the native valve leaflets has occurred.

[0098] For example, referring to FIG. 10 , deployment of a prosthetic valve 102 has occurred. Anchor 17a (shown on the right side of the page in FIG. 10 ) has failed to capture a valve leaflet 82a. Accordingly, indicator 100a on such anchor 17a either 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 failure to capture or missed capture of a valve leaflet 82a has occurred by viewing the undeflected position of indicator 100a.

[0099] Anchor 17b (shown on the left side of the page in FIG. 10) captures leaflet 82b. Accordingly, indicator 100b on such anchor 17b can move to a deflected position visible via imaging. Thus, a user determines that capture of leaflet 82b has occurred by viewing the deflected position of indicator 100b.

[0100] In an embodiment, a user determines whether capture of a leaflet has occurred by looking at the difference in position between indicators 100 a, b. For example, if indicator 100 a shown on the right side of the page in FIG. 10 has less deflection than indicator 100 b shown on the left side of the page in FIG. 10, the user can determine that capture failure has occurred.

[0101] Each of the features in FIGS. 9-10 may be used alone or in combination with any of the embodiments disclosed herein.

[0102] In some examples, the configuration of the indicator can be varied. For example, Figure 11 shows an indicator 110 adapted to move to indicate capture of a native valve leaflet. The indicator 110 is adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 110 under imaging changes to indicate capture of a native valve leaflet.

[0103] Indicator 110 includes an elongate body. The elongate body is positioned on valve body 15 and includes a ring extending circumferentially around valve body 15. The ring may be a complete ring (a continuous body around valve body 15) or a partial ring (extending partially around valve body 15). The ring is positioned radially inward of anchors 17. The ring is positioned at an axial height on valve body 15 that positions the ring opposite the location of anchors 17. In this manner, the leaflets of the native heart valve are positioned between the ring and each anchor 17 upon capture of the leaflets by anchors 17. Indicator 110, in one embodiment, includes a radiopaque ring.

[0104] Indicator 110 is positioned on outer frame 20 or seal 11 of valve body 15. In an embodiment, indicator 110 is positioned on sealing skirt 24 of seal 11. For example, indicator 110 may be sewn into or otherwise coupled to sealing skirt 24. In an embodiment, indicator 110 is positioned on sealing skirt 24 distal to outer frame 20, allowing indicator 110 to more easily deflect inward upon capture of the leaflets of the native valve.

[0105] The indicator 110 includes 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, upon capturing a leaflet of a native heart valve between the anchor 17 and the indicator 110, the indicator 110 deflects inward due to the force applied by the leaflet of the native heart valve. The inward deflection of the indicator 110 may be localized in some embodiments. The indicator 110 may be adapted to deflect radially inward at a portion 112 of the indicator 110 that may be positioned opposite the respective anchor 17.

[0106] The user determines by visual appearance of indicator 110 whether a force has been applied to indicator 110 and therefore whether capture of the native valve leaflets has occurred.

[0107] 12, deployment of prosthetic valve 114 is occurring. A top or axial view of prosthetic valve 114 is provided. Certain anchors (e.g., anchor 17a) capture leaflet 82a (and leaflet 82c). Other anchors (e.g., anchor 17b) fail to capture or miss capture leaflet 82b.

[0108] The indicator 110 is imaged to determine if capture of the valve leaflets 82a-c has occurred. The imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. The imaging is performed in the axial dimension of the prosthetic valve 114, as shown in FIG. 12.

[0109] The user determines whether deflection of indicator 110 has occurred to determine whether capture of leaflet 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 to determine that leaflet 82a has been captured, correspondingly pushing indicator 110 radially inward. The user determines that a lack of deflection or lesser deflection of portion 112b of indicator 110 has occurred to determine that a failure to capture or missed capture of leaflet 82b has occurred.

[0110] In an embodiment, a user determines whether leaflet capture has occurred by looking at the difference in position between portions 112a, 112b of indicator 110. For example, if portion 112b of indicator 110 has less deflection than portion 112a, the user determines that failed capture has occurred at portion 112b. If indicator 110 is deflected at each of the anchor positions, the user determines that a leaflet has been captured by each anchor 17.

[0111] Each of the features in Figures 11 and 12 may be utilized alone or in combination with any of the embodiments disclosed herein.

[0112] In some examples, the configuration of the indicator can be varied. For example, Figure 13 shows an indicator 120 adapted to move to indicate capture of a native valve leaflet. The indicator 120 can be adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 120 under imaging changes to indicate capture of a native valve leaflet.

[0113] Indicator 120 includes an elongated body that is positioned on and extends axially along valve body 15. The elongated body includes a wire that extends axially along valve body 15.

[0114] The wires are positioned radially inward of one or more anchors 17. The wires are positioned at circumferential locations on the valve body 15 that position the wires opposite each one of the anchors 17. Thus, upon capture of the leaflets by the anchors 17, the leaflets of the native heart valve are positioned between the wires and their respective anchors 17.

[0115] In an embodiment, indicator 120 is positioned on outer frame 20 of valve body 15 or on closure 11. In an embodiment, indicator 120 is positioned on sealing skirt 24 of closure 11. For example, indicator 120 may be sewn into or otherwise coupled to sealing skirt 24.

[0116] Indicator 120 includes 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, upon capture of a native heart valve leaflet between anchor 17 and indicator 120, indicator 120 deflects inward due to the force applied by the native heart valve leaflet.

[0117] A user can visually determine whether a force has been applied to the indicator 120 and, therefore, whether capture of the native valve leaflets has occurred by visually inspecting the indicator 120. In one embodiment, multiple indicators 120 are utilized. Each indicator 120 is circumferentially spaced apart from one another at a respective location on the anchor 17. Each indicator 120 extends axially along the valve body 15.

[0118] For example, referring to Figure 14, deployment of prosthetic valve 122 is occurring. A side or lateral view of prosthetic valve 122 is provided. Certain anchors (e.g., anchor 17a) fail to capture or miss capture of leaflet 82a. Other anchors (e.g., anchor 17b) capture leaflet 82b.

[0119] The indicator 120 is imaged to determine if capture of the valve leaflets 82 a, b has occurred. The imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. The imaging occurs in the transverse dimension of the prosthetic valve 122, as shown in FIG. 14.

[0120] The indicators 120 include exemplary indicators 120a, b shown in FIG. 14 for identification purposes.

[0121] The user determines whether deflection of indicators 120a,b has occurred to determine whether capture of leaflet 82a,b has occurred. For example, the user determines that inward deflection of indicator 120b has occurred to determine that leaflet 82b has been captured, correspondingly pushing indicator 120b radially inward. The user determines that a lack of deflection or lesser deflection of indicator 120a has occurred to determine that a failure to capture or missed capture of leaflet 82a has occurred.

[0122] In an embodiment, a user determines whether leaflet capture has occurred by looking at the difference in position between indicators 120a, b. For example, if indicator 120a has less deflection than indicator 120b, the user determines that failed capture has occurred at indicator 120a. If indicators 120a, b are each deflected at each of the anchor positions, the user determines that leaflets 82a, b have been captured by anchors 17a, b, respectively.

[0123] The features of Figures 13 and 14 may be used alone or in combination with any of the embodiments disclosed herein.

[0124] In some examples, the configuration of the indicator can be varied. For example, Figure 15 shows an indicator 130 adapted to move to indicate capture of a native valve leaflet. The indicator 130 is adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 130 under imaging changes to indicate capture of a native valve leaflet.

[0125] Indicator 130 includes an elongated body. Multiple elongated bodies are utilized in some embodiments. Each elongated body is positioned on valve body 15. The elongated bodies are positioned on the outer frame 20 of valve body 15 or on the seal 11. In some embodiments, indicator 130 is positioned on the sealing skirt 24 of seal 11. As shown in FIG. 15 , the elongated bodies protrude distally from valve body 15.

[0126] Each elongate body is configured as a spring in one embodiment. The spring includes an elongate lever arm adapted to be biased radially inward toward the valve body 15. The springs are configured as flat or cantilever springs with a fixed end coupled to the valve body and a free end extending radially outward toward a respective one of the anchors 17. The deflection of the springs to their biased positions can be visible under imaging to allow a user to determine whether leaflet capture has occurred.

[0127] The indicators 130 include exemplary indicators 130a, b shown in FIG. 15 for identification purposes.

[0128] The user determines whether a force has been applied to the indicator 130 by looking at the indicator 130 and, therefore, whether capture of the native valve leaflets has occurred.

[0129] For example, referring to FIG. 16 , deployment of a prosthetic valve 132 has occurred. Anchor 17a (shown on the right side of the page in FIG. 16 ) has failed to capture a valve leaflet 82a. Accordingly, indicator 130a, positioned proximate such anchor 17a, remains in an undeflected position or extends radially outward from valve body 15 where it 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 failure to capture or missed capture of a valve leaflet 82a has occurred by viewing the undeflected position of indicator 130a.

[0130] Anchor 17b (shown on the left side of the page in FIG. 16) captures leaflet 82b. Accordingly, indicator 130b, which is proximate to such anchor 17b, moves to a deflected position that is visible via imaging. Thus, a user determines that capture of leaflet 82b has occurred by viewing the deflected position of indicator 130b.

[0131] In an embodiment, each indicator 130 includes one or more markers that improve the ease of imaging of the indicator 130. For example, one or more marker beads 134 are provided for each indicator 130. Each marker bead 134 is spaced apart from other marker beads 134 on the indicator 130 to indicate the location of a portion of the indicator 130. In an embodiment, the marker beads 134 are configured to be visible under imaging, such as fluoroscopy.

[0132] In an embodiment, a user determines whether capture of a leaflet has occurred by looking at the difference in position between indicators 130. For example, if indicator 130a shown on the right side of the page in FIG. 16 has less deflection than indicator 130b shown on the left side of the page in FIG. 16, the user determines that failure to capture has occurred.

[0133] In some embodiments, the configuration of the indicator may vary as desired. Figure 17, for example, illustrates an indicator 140 configured similarly to indicator 130 shown in Figures 15 and 16, but formed into a loop. Each end of the loop, in some embodiments, is coupled to valve body 15. In this manner, because each end of the loop is coupled to valve body 15, there is a reduced likelihood of puncturing a portion of the native heart valve with indicator 140.

[0134] The indicators 140 include exemplary indicators 140a, b shown in FIG. 17 for identification purposes.

[0135] Indicator 140 may include one or more markers, which may be similar in configuration to the markers discussed with respect to FIGS.

[0136] The indicator 140 may be imaged by a user in a manner similar to that discussed with respect to the indicator 130 shown in FIGS.

[0137] For example, referring to FIG. 18 , deployment of a prosthetic valve 142 has occurred. Anchor 17a (shown on the right side of the page in FIG. 18 ) has failed to capture a valve leaflet 82a. Accordingly, indicator 140a positioned near such anchor 17a remains in an undeflected position or extends radially outward from valve body 15 where it 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 a failure to capture or missed capture of a valve leaflet 82a has occurred by viewing the undeflected position of indicator 140a.

[0138] Anchor 17b (shown on the left side of the page in FIG. 18) captures leaflet 82b. Accordingly, indicator 140b, which is proximate to such anchor 17b, moves to a deflected position that is visible via imaging. Thus, a user determines that capture of leaflet 82b has occurred by viewing the deflected position of indicator 140b.

[0139] In an embodiment, a user determines whether capture of a leaflet has occurred by looking at the difference in position between indicators 140a, b. For example, if indicator 140a, shown on the right side of the page in FIG. 18, has less deflection than indicator 140b, shown on the left side of the page in FIG. 18, the user determines that capture failure has occurred.

[0140] Each of the features in Figures 15-18 may be used alone or in combination with any of the embodiments disclosed herein.

[0141] In some examples, the indicator settings can be changed as desired. For example, Figure 19 shows an indicator 150 adapted to move to indicate capture of a native valve leaflet. The indicator 150 is adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 150 under imaging changes to indicate capture of a native valve leaflet.

[0142] Indicator 150 includes an elongate body. Multiple elongate bodies are utilized in some embodiments. Each elongate body extends from valve body 15 to at least one of one or more anchors 17. For example, a first end of the elongate body is coupled to valve body 15 and a second end of the elongate body is coupled to a respective one of anchors 17. The elongate body spans a gap located between valve body 15 and a respective one of anchors 17. Each elongate body is configured as a wire in some embodiments.

[0143] Each elongate body is positioned such that the elongate body extends from the attachment point onto the valve body 15 to a respective anchor 17 that is circumferentially aligned with the attachment point on the valve body 15. Each elongate body extends radially outward from the valve body 15 to a respective anchor 17.

[0144] Each elongate body is configured to be deflected distally upon capture of a valve leaflet by its respective anchor. Each elongate body may be bent upward or bent proximally, for example, as shown in FIG. 19 . Each elongate body is adapted to be deflected downward or distally to a deflected position upon capture of a respective native valve leaflet. Each elongate body, in embodiments, is flexible and adapted to deflect downward or distally upon capture of a valve leaflet. The deflection of the elongate body to the deflected position is visible under imaging to enable a user to determine whether leaflet capture has occurred.

[0145] The indicators 150 include exemplary indicators 150a, b shown in FIG. 19 for identification purposes.

[0146] The user determines by visual appearance of indicator 150 whether a force has been applied to indicator 150 and therefore whether capture of the native valve leaflets has occurred.

[0147] For example, referring to FIG. 20 , deployment of a prosthetic valve 152 has occurred. Anchor 17a (shown on the right side of the page in FIG. 20 ) has failed to capture a valve leaflet 82a. Accordingly, indicator 150a, positioned proximal to such anchor 17a, remains in an undeflected position or extends upward or proximally from valve body 15, where it 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 failure to capture or missed capture of a valve leaflet 82a has occurred by viewing the undeflected position of indicator 150a.

[0148] Anchor 17b (shown on the left side of the page in FIG. 20) captures leaflet 82b. Accordingly, indicator 150b, which is proximate such anchor 17b, moves to a deflected position visible via imaging. Thus, a user determines that capture of leaflet 82b has occurred by viewing the deflected position of indicator 150b. Indicator 150b deflects downward or distally upon capture of leaflet 82b.

[0149] In an embodiment, each indicator 150 includes one or more markers 154 that improve the ease of imaging of indicator 150. The markers may be configured similarly to the markers discussed with respect to Figures 15 and 16.

[0150] In an embodiment, a user can determine whether capture of a leaflet has occurred by looking at the difference in position between indicators 150 a, b. For example, if indicator 150 a shown on the right side of the page in FIG. 20 has less deflection than indicator 150 b shown on the left side of the page in FIG. 20, a user can determine that failure to capture has occurred.

[0151] Each feature in Figures 19 and 20 may be utilized alone or in combination with any of the embodiments disclosed herein.

[0152] In some examples, the configuration of the indicator can be varied. For example, Figure 21 shows an indicator 160 adapted to move to indicate capture of a native valve leaflet. The indicator 160 is adapted to indicate capture of a native valve leaflet under imaging. The appearance of the indicator 160 under imaging changes to indicate capture of a native valve leaflet.

[0153] Indicator 160 includes a button adapted to be depressed to indicate capture of a native valve leaflet. Indicator 160 is positioned on a valve body 162 of a prosthetic valve 164 and may be otherwise configured similar to valve body 15 discussed with respect to FIGS. 1A-2. Indicator 160, in some embodiments, protrudes from an outer surface of valve body 15.

[0154] The indicator 160 is positioned so that contact from the leaflets of the native heart valve against the indicator 160 pushes the indicator 160 inward. The indicator 160 is positioned between adjacent anchors 17 so that the leaflets of the native heart valve are pushed against the indicator 160 when they are captured.

[0155] Indicator 160 includes a movable protrusion 166 adapted to move radially inward as indicator 160 is depressed. FIG. 22, for example, shows a side perspective view of indicator 160 showing movable protrusion 166 extending outward from a portion of frame 168 of prosthetic valve 164. Movable protrusion 166 includes one or more arms that can be angled to flex outward from frame 168. One or more arms have a first end portion 170 that couples to frame 168. First end portion 170 can be coupled to frame 168 via sutures or another form of coupling. First end portion 170 can include a pivot about which movable protrusion 166 can pivot. Second end portions 172 of one or more arms include markers 174 that improve ease of imaging of indicator 160. In embodiments, markers 174 are adapted to be visible under imaging, such as fluoroscopy. The second end portion 172 of the arm or arms and the marker 174 are adapted to rotate about a pivot as the movable protrusion 166 is depressed.

[0156] For example, referring to Figure 23A, a cross-sectional view of indicator 160 relative to frame 168 of prosthetic valve 164 is visible. The extension of movable protrusion 166 from frame 168 is shown. Such a configuration represents a lack of pressure from the native valve leaflets or other portions of the native heart valve against indicator 160.

[0157] 23B shows a cross-sectional view of the movable protrusion 166 being pushed radially inward by the captured leaflet 82b. The leaflet 82b presses against the movable protrusion 166, causing it to move radially inward. The second end portion 172 of the arm or arms pivots radially inward about the first end portion 170.

[0158] The user determines whether a force has been applied to the indicator 160 by looking at the appearance of the indicator 160, and thus whether capture of the native valve leaflet has occurred. 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 failure to capture or missed capture of the leaflet 82 has occurred by looking at whether the indicator 160 remains in an undeflected position. The user may image the deflection of one or more of the arms or markers 174.

[0159] Each of the features in Figures 21-23B may be used alone or in combination with any of the embodiments disclosed herein.

[0160] The indicators and / or markers disclosed with respect to Figures 1A-23B can include radiopaque materials for enhanced visualization. Heavy metals such as gold, platinum, iridium, or tantalum, or other forms of radiopaque materials, can be utilized. In embodiments, materials such as nitinol or stainless steel can be utilized, which can be visualized under fluoroscopy or ultrasound. Other types of materials can be utilized as needed.

[0161] In some examples, the configuration of the indicator can be varied. For example, Figure 24 shows indicator 171 adapted to move to indicate capture of a native valve leaflet. Indicator 171 is adapted to indicate capture of a native valve leaflet under imaging. The appearance of indicator 171 under imaging changes to indicate capture of a native valve leaflet.

[0162] Indicator 171 includes a bladder 173 and a contrast agent 175 filling bladder 173. Bladder 173 is adapted to be filled with contrast agent 175. In an embodiment, bladder 173 includes one or more openings 176 adapted to release contrast agent 175 to indicate capture of a native valve leaflet. Bladder 173 is made, for example, of a flexible material adapted to deform to release contrast agent 175 from bladder 173 through openings 176.

[0163] Bladder 173 is positioned such that, upon capture of the native valve leaflets, the native valve leaflets are pressed against bladder 173. Bladder 173 is positioned, for example, between anchors of prosthetic valve 178 (exemplary anchors shown by anchors 17a, b) and valve body 180 and is adapted to be pressed by the native valve leaflets upon capture of the native valve leaflets. In embodiments, bladder 173 is in other positions, such as between adjacent anchors 17a, b, or otherwise in a position to receive pressure from the native valve leaflets.

[0164] Opening 176 includes a valve that allows the release of contrast agent 175 when a certain amount of pressure is applied to bladder 173. For example, opening 176 includes a check valve or other form of valve to allow the release of contrast agent 175 upon application of pressure.

[0165] The openings 176 are positioned at circumferentially spaced locations from one another. Such circumferential spacing allows for determination of whether anchoring has occurred at various circumferential locations. For example, openings 176 may be located at the circumferential location of each anchor 17, or at other intervals as desired. In an embodiment, multiple bladders are provided circumferentially spaced from one another. Each bladder has an opening for releasing a contrast agent that indicates capture of a native valve leaflet at its respective bladder location.

[0166] Bladder 173 is filled with contrast agent 175 upon deployment of prosthetic valve 178 at the implantation site. Openings 176 retain contrast agent 175 within bladder 173 in this configuration. Referring to the right side of Figure 24, anchor 17a fails to capture or misses leaflet 82a. Thus, bladder 173 does not have pressure applied to it by leaflet 82a and does not emit contrast agent 175 in that portion of bladder 173.

[0167] 24, anchor 17b captures leaflet 82b, and bladder 173 therefore releases contrast agent 182 from opening 176. The release of contrast agent 182 can be imaged by a user to determine that capture of leaflet 82b has occurred.

[0168] The user determines whether capture of a native valve leaflet 82 a has occurred by observing the appearance of indicator 171 to determine whether a force has been applied to indicator 171. Imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user determines that a failure to capture or missed capture of a valve leaflet 82 a has occurred by observing whether indicator 171 fails to release contrast agent 175.

[0169] Each feature in FIG. 24 may be utilized alone or in combination with any of the embodiments disclosed herein.

[0170] In some examples, the settings of the indicator can be changed arbitrarily. Figure 25, for example, shows an indicator 190 adapted to indicate capture of a leaflet of a native valve under imaging.

[0171] The indicator 190 includes a channel 192 adapted to pass a contrast agent therethrough. The channel 192 extends from the interior of the prosthetic valve 194 to the exterior surface of the prosthetic valve 194 such that the contrast agent passes from the interior of the prosthetic valve 194 to the exterior surface. The channel 192 passes from the interior of, for example, the valve frame or inner frame 18 to the outer frame or seal 11. An opening 196 of the channel 192 is positioned on the surface of, for example, the outer frame or seal 11.

[0172] The channel 192 is positioned such that the leaflets of the native valve press against and cover the opening 196 of the channel 192. Thus, the flow of contrast agent through the channel 192 may not be obstructed, and a user visualizing the flow of contrast agent can determine that capture of the leaflet 82 a has not occurred. In embodiments where the channel opening 196 is covered by the leaflet 82 a, the flow of material therethrough is obstructed, and a user can determine that capture of the leaflet 82 a has occurred.

[0173] In some embodiments, the prosthetic valve 194 includes multiple channels and openings positioned at circumferentially spaced locations. Such 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 leaflets of the native valve are anchored.

[0174] When the prosthetic valve 194 is deployed at the implantation site, contrast agent 198 can flow through the interior of the prosthetic valve 194. The contrast agent flows into channel 192 and into another channel 200. Referring to the right side of FIG. 25 , anchor 17a fails to capture or misses valve leaflet 82a. Thus, opening 196 is uncovered and does not impede the flow of contrast agent therethrough. In this manner, contrast agent 202 is released, visible on the outside of prosthetic valve 194. The presence of such contrast agent 202 after deployment of prosthetic valve 194 indicates that anchor 17a failed to capture or missed valve leaflet 82a.

[0175] 25, anchor 17b has captured leaflet 82b. Thus, opening 204 of channel 200 is covered by leaflet 82b, thereby preventing contrast from flowing therethrough. The lack of contrast visible outside prosthetic valve 194 at opening 204 indicates that anchor 17b has captured leaflet 82b.

[0176] The user determines whether capture of a native valve leaflet 82a has occurred by observing the appearance of the indicator 190. The imaging may include fluoroscopy or ultrasound, or a combination of fluoroscopy and ultrasound, or other forms of imaging. Thus, the user can determine whether a failure to capture or missed capture of a valve leaflet 82a has occurred by observing whether the contrast agent 202 has been released. The contrast agent utilized in the embodiments of FIGS. 24 and 25 may include a radiopaque material or fluid in some embodiments. Iodine or other forms of radioactive contrast agents may be utilized.

[0177] Each feature in FIG. 25 may be utilized alone or in combination with any of the embodiments disclosed herein.

[0178] In some embodiments, one or more sensors adapted to sense a condition within a patient's body may be utilized. The condition may include, for example, the condition of the prosthetic valve, whether the prosthetic valve has been deployed in a desired manner or has certain characteristics. For example, the condition may include whether capture of a native valve leaflet has occurred. In some embodiments, the condition may include whether the prosthetic valve is operating in a desired manner within the patient's body. In some embodiments, the condition may include an environmental condition within the patient's body (e.g., pressure within the patient's body or flow through the valve in the patient's body). Various other conditions may be sensed. One or more sensors may be adapted to be coupled to a prosthetic heart valve that may be deployed over a native valve in the patient's heart.

[0179] 26 , in an embodiment, one or more sensors are provided to 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 of the anchors has captured a native valve leaflet.

[0180] In embodiments, sensor 210 includes a contact sensor adapted to sense contact between sensor 210 and a surface of a native valve (e.g., a surface of a leaflet of a native heart valve). Sensor 210 may be positioned in various locations, including on anchor 17. Sensor 210 may be positioned on a distal portion 45 of anchor 17, including the distal tip of anchor 17. Sensor 210 is adapted to be positioned on an inward-facing surface of anchor 17 such that sensor 210 can contact the surface of the leaflet of the native valve when anchor 17 is secured to the leaflet. Sensor 210 may be provided in other locations as desired, such as on the valve body.

[0181] The sensor 210 may include various forms of sensors. The sensor 210 utilized may include one or more piezoelectric sensors, strain gauges, pressure transducers, and / or capacitance sensors. These 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 embodiment, the sensor 210 may include an electrode having a reference electrode positioned on the patient's body. Contact between the electrode and tissue within the patient's body (e.g., a leaflet of a heart valve) provides an electrical signal between the electrode and the reference electrode that may indicate contact between the electrode and the leaflet of the heart valve. Other forms of sensors disclosed herein may be utilized. The sensor may be utilized in any other embodiment disclosed herein.

[0182] In an embodiment, multiple sensors 210 are provided, each provided on a respective anchor 17. Each sensor 210 is adapted to sense whether anchoring to the native valve leaflets has occurred by a respective anchor 17. The sensors 210 include exemplary sensors 210a, b shown in FIG. 26 for identification purposes.

[0183] In some embodiments, each of the sensors 210 includes a wired connection to a respective sensor terminal. For example, an electrical conduit 212 extends from the sensor 210 to an 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 can be positioned in various locations as desired. As shown in FIG. 26 , for example, the electrical terminal 214 can be positioned on a proximal portion 218 of the prosthetic valve 216. In some embodiments, the electrical terminal 214 can be positioned on a mating portion of the prosthetic valve 216 that is adapted to couple to a delivery device of the prosthetic valve 216. Each connector 220 or end tab on the prosthetic valve 216 that couples to the delivery device can include an electrical terminal 214. Such connectors 220 couple to a connector 222 on the delivery device (as shown in FIG. 29 ), which can couple to the connector 220 of the prosthetic valve 216.

[0184] The delivery device may include, for example, one or more electrical terminals 224 (shown in FIG. 29) adapted to contact the electrical terminals 214 of the prosthetic valve 216. The electrical terminals 224 may be coupled to an electrical conduit 226 extending along the delivery device. The electrical conduit 226 transmits the signal provided by the sensor 210 to an output for utilization.

[0185] FIG. 28, for example, illustrates an exemplary delivery system 230 for use herein. Delivery system 230 is configured similarly to delivery system 70 shown in FIG. 3, but is adapted to receive a signal output from sensor 210. Delivery system 230 includes a delivery device having an elongate shaft 232. Elongate shaft 232 includes a distal portion 234 that includes an implant holding area 236 (e.g., capsule 238 shown in FIG. 27 or another form of implant holding area). Implant holding area 236 includes a connector 222 on the delivery device (shown in FIG. 29). Connector 222 can have a variety of forms and can include a receiving slot adapted to receive connector 220 in the form of a tab, or can have another configuration (e.g., a suture, or another form of connector) as desired.

[0186] A proximal portion 239 of elongate shaft 232 is coupled to a housing 240, which may be in the form of a handle for a delivery device. In embodiments, housing 240 has other configurations.

[0187] An electrical conduit 226 extends along the elongate shaft 232 to provide a 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 may have a variety of forms. For example, with reference to FIG. 28 , the indicator device may include a visual indicator, a tactile indicator 242, or an audible indicator 244, among other forms of indicator devices. The audible indicator 244 may include a speaker or other device adapted to generate an audible indication. The tactile indicator 242 may include a motor or other device adapted to generate a tactile indication. The visual indicator may have a variety of forms. The visual indicator may include one or more lights 246, or one or more display screens 248, 250, or another device adapted to generate a visual indication. A combination of indicator devices may be utilized in an embodiment.

[0188] In embodiments, an indicator device is provided on the delivery device or is provided remotely from the delivery device. For example, an indicator device is located on the housing 240 or handle of the delivery device (as shown by indicator devices 242, 244, 246, and 248). An indicator device may also be located remotely (such as on indicator device or display screen 250).

[0189] Indicator devices may be adapted to provide an indication of the condition sensed by sensor 210. For example, upon capture of a valve leaflet, one or more of the indicator devices indicates that capture has occurred. Light 246 may flash, or one or more of display screens 248, 250 may provide a symbol, such as a "+" or another form of indication, as shown in FIG. 28 . In some embodiments, indicator devices are adapted to provide an indication of a failure to capture a valve leaflet or a missed capture. For example, light 246 may flash in a particular manner to indicate a failure to capture (e.g., the color of the light may change, or the light may lack illumination corresponding to a missed capture), or display screens 248, 250 may indicate a failure to capture or a missed capture. For example, display screens 248, 250 may display a symbol, such as a "-" symbol, to indicate a failure to capture or a missed capture.

[0190] In an embodiment, the signal from sensor 210 is provided directly to the indicator devices. In an embodiment, the signal is received by processor 252, which processes the signal provided by sensor 210. Processor 252 may be configured to operate based on programming provided in memory 254. Processor 252 may receive the signal and, based on the signal, determine an output to provide to one or more of the indicator devices.

[0191] The processor 252 may take various forms and may include a microprocessor, a controller, or multiple processors used in combination, among other forms of processors. The memory 254 may consist of a hard disk (e.g., mechanical or solid state) or other memory types, including flash memory, RAM, and ROM. The memory may be non-transitory and store data or instructions for use by the processor 252. In embodiments, a distributed processing unit or a remote processing unit may be used. For example, a cloud computing environment or remote processing using the Internet or a wireless network may be used.

[0192] In an embodiment, processor 252 and memory 254 are located on handle or housing 240. A power source 256 is provided to power processor 252 and memory 254 and 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 embodiment, processor 252, memory 254, or other components of delivery system 230 may be provided remotely from handle or housing 240.

[0193] The elongate shaft 232 is adapted to bend by manipulation of a control mechanism, performing operations similar to the elongate shaft shown in Figure 3. The elongate shaft 232 can be moved to a desired implantation site.

[0194] 27 shows an exemplary implementation of a sensor 210 for sensing a condition within a patient's body, such as, for example, whether anchors 17 a,b have captured respective native valve leaflets 82 a,b. As shown, a prosthetic valve 216 is deployed with electrical terminals 214 of the prosthetic valve 216 remaining in electrical communication with terminals 224 of a delivery system 230. A connector 220 of the prosthetic valve 216 remains coupled to, for example, connector 222 of the delivery system 230. In such a 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.

[0195] 27, anchor 17a fails to capture or misses leaflet 82a. As such, sensor 210a does not contact leaflet 82a. Accordingly, sensor 210a indicates a lack of capture of leaflet 82a. Sensor 210a provides a signal indicating a lack of capture, or a lack of signal corresponding to a lack of capture of leaflet 82a.

[0196] 27, anchor 17b captures leaflet 82b. As such, sensor 210b contacts leaflet 82b. Thus, sensor 210b indicates the capture of leaflet 82b. Sensor 210b provides a signal indicative of the capture of leaflet 82b.

[0197] 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 failure to capture leaflet 82a, or capture of leaflet 82b, or a combination of failure to capture and capture. In embodiments where anchors 17a, b are each properly deployed and capture a respective leaflet, the indicator device indicates the capture of each of the leaflets. In embodiments where anchors 17a, b fail to capture leaflets 82a, b, respectively, the indicator device indicates the lack of capture of leaflets 82a, b.

[0198] The prosthetic valve 216 can be redeployed to allow the anchors 17a to be anchored to the cusps 82a of the heart valve. Figure 29, for example, shows such a configuration.

[0199] In some embodiments, the delivery system can be retracted from the prosthetic valve 216 after deployment. Figure 29, for example, illustrates delivery system 230 being retracted. Connector 220 of prosthetic valve 216 disengages from connector 222 of delivery system 230. Similarly, electrical terminal 214 of prosthetic valve 216 disengages from electrical terminal 224. Thus, prosthetic valve 216 remains implanted within the patient with delivery system 230 retracted.

[0200] In embodiments, other forms of transmission of signals from the sensor 210 may be used. In embodiments, wireless transmission from the sensor 210 may be used.

[0201] 30, in an embodiment, the prosthetic valve 260 is adapted to wirelessly transmit a signal from the sensor 210. The signal may be a condition sensed within the patient's body.

[0202] A wireless transmitter 262 is utilized to transmit signals from the prosthetic valve 260. The wireless transmitter 262 may be coupled to the prosthetic valve 260, for example, positioned on the valve body 15. The wireless transmitter 262 may be positioned elsewhere as desired.

[0203] In some embodiments, a power source 264 is provided for wireless transmitter 262. Power source 264 includes a battery or other form of power source that provides energy to wireless transmitter 262. In some embodiments, power source 264 includes a rechargeable power source that can be recharged via wireless charging (e.g., induction) or via the patient's exercise activity. Power source 264 provides power to other components of prosthetic valve 260, in some embodiments (e.g., sensors).

[0204] In an embodiment, a processor 266 is utilized that receives signals from the sensor 210. The processor 266 processes the signals based on programming stored in memory 268 and provides the data to the wireless transmitter 262 for transmission. The sensor 210 provides electrical signals to the processor 266 via electrical conduits 270. In an embodiment, the use of a separate processor 266 is eliminated and the signals are provided directly to the wireless transmitter 262 for transmission.

[0205] Referring to FIG. 31 , an exemplary transmission by the wireless transmitter 262 is shown. On the right side of FIG. 31 , the anchor 17a fails to capture or misses capture of the valve leaflet 82a. As such, the sensor 210a does not contact the valve leaflet 82a. Thus, the sensor 210a indicates the lack of capture of the valve leaflet 82a. The sensor 210a provides a signal indicating the lack of capture, or a lack of signal corresponding to the lack of capture of the valve leaflet 82a. The signal may be transmitted wirelessly from the wireless transmitter 262 to the receiver 269.

[0206] Receiver 269 is positioned external to the patient's body or, in embodiments, internal to the patient's body. Receiver 269 includes 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 provide an indication to one or more indicator devices (such as indicator device 250 or another form of indicator device) of failure of capture of the native valve leaflets by anchor 17 a.

[0207] 31, anchor 17b captures leaflet 82b. As such, sensor 210b contacts leaflet 82b. Sensor 210b provides a signal indicative of the capture of leaflet 82b. The signal is transmitted wirelessly from wireless transmitter 262 to receiver 269 indicating the capture.

[0208] Receiver 269 causes one or more indicator devices (such as indicator device 250 or another form of indicator device) to provide an indication of capture of the native valve leaflets by anchor 17b.

[0209] The prosthetic valve 260 can be redeployed to allow the anchors 17a to be anchored to the leaflets 82a of the heart valve. Figure 32A shows, for example, such a configuration. The wireless transmitter 262 provides a wireless signal indicating that capture of the leaflets 82a, 82b has occurred.

[0210] In an embodiment, each sensor 210 may include a wireless sensor. Each sensor 210 may include a wireless transmitter integrated as part of sensor 210 and adapted to transmit a wireless signal to a receiver in a manner similar to wireless transmitter 262.

[0211] In embodiments, 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.

[0212] Proximity sensors include sensors that sense leaflet proximity, for example, using detection of electromagnetic waves or magnetic field fluctuations. Such sensors may include electrical impedance sensors. Proximity sensors such as infrared, electromagnetic, capacitive, or ultrasonic proximity sensors may be utilized.

[0213] A force sensor senses the force of the contact on the force sensor.

[0214] An optical sensor can determine leaflet capture using light, such as infrared light, or other forms of light that may be blocked by the native valve leaflets. The optical sensor, in some embodiments, can include an emitter and a receiver. For example, referring to FIG. 32B, an emitter 271a can be positioned on the anchor 17a of the prosthetic valve 273. The emitter 271a can include an optical emitter adapted to emit light (such as infrared or other forms of light) that is received by the optical receiver 275a. The optical receiver 275a can be positioned, for example, on the valve body 15 or elsewhere as desired.

[0215] 32B, optical receiver 275a receives light from emitter 271a indicating a failure or missed capture of leaflet 82a by anchor 17a. Optical receiver 275a thus provides a signal for transmission by wireless transmitter 262 indicating a failure or missed capture of leaflet 82a.

[0216] An emitter 271b may be provided, which may be configured similarly to emitter 271a. Emitter 271b may emit light that is received by optical receiver 275b. In this manner, upon capture of leaflet 82b, light from emitter 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.

[0217] In embodiments, the positions of emitters 271 a,b and receivers 275 a,b can be reversed as desired. Other positions of the emitters and receivers can be used in embodiments. Other forms of optical sensors can be used.

[0218] The chemical sensor may include a biosensor that senses contact with tissue of the native valve leaflets.

[0219] In examples, the location of the sensors can be optionally adjusted. For example, one or more sensors can be positioned on the valve body 15 or another portion of the prosthetic valve to sense whether leaflet capture has occurred. One or more sensors can be positioned on the anchor and valve body combination, as desired.

[0220] Each of the features in Figures 26-32A may be used alone or in combination with any of the embodiments disclosed herein.

[0221] In embodiments, other conditions within the patient's body may be sensed by one or more sensors. For example, referring to FIG. 33 , pressure within the patient's body is sensed. The pressure includes pressure within at least one chamber of the heart. Pressure may be sensed for a variety of reasons, including determining proper operation of a prosthetic valve, determining the health of the patient's heart, or determining that appropriate remodeling is occurring after treatment (e.g., remodeling of a ventricle, such as the right ventricle, for tricuspid valve deployment). Pressure may be utilized to determine whether the patient is recovering from a procedure or may require another procedure.

[0222] A sensor in the form of a pressure sensor 267 may be utilized to sense pressure within one or more chambers of the heart. Pressure sensor 267 is positioned on prosthetic valve 272. Pressure sensor 267 may be positioned to determine pressure within a proximal or atrial chamber of the heart and may be exposed to fluid pressure on the proximal or atrial side of the heart.

[0223] 34 , in an embodiment, pressure sensor 267 may be positioned on valve body 15. In an embodiment, other locations may be utilized (e.g., on anchor 17, or elsewhere as desired). Pressure sensor 267 may be positioned between outer frame or seal 11 and 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.

[0224] In an embodiment, pressure sensor 267 is positioned to sense pressure in a distal or ventricular chamber of the heart. The location of pressure sensor 267 is varied to allow for pressure sensing in the distal or ventricular chamber. Pressure sensor 267 is exposed to fluid in the distal or ventricular chamber.

[0225] In embodiments, 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, a pressure sensor may be adapted to sense both pressures and provide a signal indicative of both pressures. A pressure differential may be determined in embodiments. Referring to FIG. 35 , in embodiments, a first pressure sensor 267 is adapted to sense pressure in the proximal or atrial chamber, and a second pressure sensor 274 is adapted to sense pressure in the distal or ventricular chamber. In embodiments, a greater number of pressure sensors may be utilized, as desired.

[0226] One or more pressure sensors may be utilized to transmit wireless signals indicative of the sensed pressure. For example, the configurations described in connection with Figures 30 and 31 may be utilized to enable wireless transmission of signals from one or more pressure sensors. In an embodiment, a wired connection between the pressure sensors is utilized to transmit signals from one or more pressure sensors.

[0227] 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 may transmit a signal to a user to determine a condition within the patient's body. For example, the user may determine whether proper implantation of the prosthetic valve 272 has occurred or whether another health condition of the patient (e.g., undesirable pressure within the patient's body) is at issue. The signal may be transmitted at the time of or after implantation of the prosthetic valve 272. For example, the signal may be transmitted after the implantation procedure to allow monitoring of the patient for a recovery period, or generally after use and implantation of the prosthetic valve 272. In an embodiment, the signal is provided to one or more of the indicator devices 242, 244, 246, 248, 250 discussed with respect to FIG. 28 or another form of indicator device.

[0228] In some embodiments, one or more pressure sensors are integral with prosthetic valve 272. In some embodiments, one or more of the pressure sensors may be mounted on prosthetic valve 272.

[0229] FIG. 36 , for example, shows a pressure sensor 276 attached to a prosthetic valve. A coupler 278 is attached to the pressure sensor 276 and adapted to attach the pressure sensor 276 to the prosthetic valve. The coupler 278 includes a clip adapted to clip onto a portion of the prosthetic valve. Thus, the sensor is adapted to be clipped onto the prosthetic valve. The clip includes a pivotable arm 280 adapted to pivot open to allow a portion of the prosthetic valve to fit within a recess 282. Other types of couplers can be used in embodiments. For example, FIG. 37 shows a coupler 285 in the form of a clip having a slidable arm 284 adapted to slide open to allow a portion of the prosthetic valve to fit within a recess 286. Each arm 280, 284 can be biased (e.g., spring-biased) toward a closed position to close the respective recess 282, 286 and retain a portion of the prosthetic valve therein.

[0230] 38 , the prosthetic valve 290 may have one or more pressure sensors 276 attached thereto. A first pressure sensor 276 a, for example, is coupled to a proximal portion of the prosthetic valve 290. A second pressure sensor 276 b, configured similarly to the first pressure sensor 276 a, may be coupled to a distal portion of the prosthetic valve 290. Each pressure sensor 276 a, b is adapted to measure pressure on the proximal or atrial side of the prosthetic valve 290 and the distal or ventricular side of the prosthetic valve 290, respectively.

[0231] The pressure sensors 276 a,b may be adapted to be attached to the prosthetic valve 290 by clipping onto the frame of the prosthetic valve 290. The couplers 278 may be attached to the struts of the frame of the prosthetic valve 290. The pressure sensors 276 a,b may be positioned in various locations as desired. The pressure sensors 276 a,b may be provided via a delivery device after implantation of the prosthetic valve 290, or before or during the implantation procedure, as needed.

[0232] The pressure sensors 276a,b may be adapted to provide a wireless signal (eg, as described in connection with Figures 30 and 31) or may provide a wired signal in some embodiments.

[0233] Each of the features in Figures 33-38 may be used alone or in combination with any of the embodiments disclosed herein.

[0234] In some embodiments, other conditions within the patient's body may be sensed by one or more sensors. For example, with reference to FIG. 39, the temperature within the patient's body may be sensed. The temperature may include the temperature within at least one chamber of the heart.

[0235] The temperature sensor 300 may be coupled to the prosthetic valve 302. The temperature sensor 300 may be adapted to sense the temperature on the proximal or atrial side of the prosthetic valve 302. The temperature sensor 300 may be adapted to provide a signal indicative of the sensed temperature in a manner similar to the pressure sensor discussed with respect to FIGS.

[0236] In an embodiment, temperature sensor 300 or another temperature sensor is utilized to sense the temperature on the distal or ventricular portion of the prosthetic valve. For example, temperature sensor 300 has a portion configured to sense the temperature on the distal or ventricular portion of the prosthetic valve. Temperature sensor 300 is adapted to provide a signal indicative of the sensed temperature in a manner similar to the pressure sensor discussed with respect to FIGS. 33-38 .

[0237] In an embodiment, temperature sensor 300 is adapted to sense the temperature on the proximal or atrial side of the prosthetic valve and the distal or ventricular side of the prosthetic valve, and is adapted to provide a signal indicative of the temperature difference between the proximal and distal sides of the prosthetic valve.

[0238] The signals from one or more temperature sensors 300 may be used to determine flow, if desired. For example, Swan-Ganz catheterization may be used to determine valve function and blood flow based on sensed temperatures.

[0239] The temperature sensor 300 may be positioned as desired. For example, referring to 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 seal 11 of the prosthetic valve 302.

[0240] In embodiments, other conditions within the patient's body may be sensed by one or more sensors. For example, referring to FIG. 41 , a flow within the patient's body may be sensed. The flow may include a fluid flow within at least one chamber of the heart. The fluid flow may be, for example, through an artificial valve.

[0241] One or more flow sensors 310 are disposed to sense flow through flow channel 312. Flow sensors 310 are positioned circumferentially around flow channel 312 and adapted to sense flow through channel 312. Flow sensor 310 determines, for example, the flow rate through channel 312. Flow channel 312 is the flow channel through which one or more prosthetic valve leaflets control flow and has a structure similar to flow channel 27 shown in FIG. 2.

[0242] The flow sensor 310 has a variety of forms. In an embodiment, the flow sensor 310 comprises a piezoelectric sensor. For example, referring to FIG. 42A, the flow sensor 310 comprises a deflecting surface 313 and a plurality of piezoelectric transducers 314. The piezoelectric transducers 314 are adapted to sense deflection of the deflecting surface 313 and provide an electrical signal indicative of the deflection of the deflecting surface 313. The deflecting surface 313 deflects in response to pressure or flow generated through the flow channel 312. The amount of deflection changes the resistance or voltage generated by the piezoelectric transducers 314, among other characteristics.

[0243] Figure 42B, for example, illustrates an undeflected deflection surface 313. Figure 42C illustrates a deflected deflection surface 313. Transducer 314 senses movement of deflection surface 313 and provides an electrical signal corresponding to the amount of deflection of deflection surface 313.

[0244] 43, flow sensors 310 are positioned about the flow channels, including flow channel 27, of prosthetic valve 316. Flow sensors 310 are adapted to sense flow through prosthetic valve 316 to determine flow conditions through prosthetic valve 316. Flow sensors 310 may be utilized to indicate potential valve thickening or poor performance, as desired.

[0245] The flow sensor 310 is adapted to provide a signal indicative of the sensed flow in a manner similar to the pressure sensor discussed with respect to Figures 33-38. For example, a wireless or wired signal may be provided.

[0246] Each of the features in Figures 41-43 may be used alone or in combination with any of the embodiments disclosed herein.

[0247] In embodiments, other conditions within the patient's body may be sensed by one or more sensors. For example, with reference to FIG. 44 , a force exerted by a portion of prosthetic valve 320 on at least a portion of the heart may be sensed via force sensor 322.

[0248] The force sensor 322 shown in FIG. 44 is adapted to sense the force exerted by the prosthetic valve 320 on the native heart valve. The force is applied by the outer frame or seal 11 of the prosthetic valve 320. For example, referring to FIG. 45, the force sensor 322 is positioned to sense the force exerted by the seal 11 against the annulus of the native heart valve. In this manner, a measure of strain on the annulus can be determined. In an embodiment, the force sensor 322 includes a strain gauge. Sensing of annular remodeling and overload detection can be provided, if desired.

[0249] Additionally, a force sensor 324 is positioned on the anchor 17 in this embodiment. The force sensor 324 detects whether the anchor 17 is providing excessive force against the native heart valve, which may result in impaired electrical conduction or other undesirable consequences to the native heart valve.

[0250] The force sensor is adapted to provide a signal indicative of the sensed flow in a manner similar to the pressure sensor discussed with respect to Figures 33-38. For example, a wireless or wired signal may be provided.

[0251] Each feature in Figures 44 and 45 may be utilized alone or in combination with any of the embodiments disclosed herein.

[0252] In some instances, a combination of sensors may be utilized as desired.

[0253] 26-45 may include features of other prosthetic valves disclosed herein (e.g., the prosthetic valves disclosed with respect to FIGS. 1A-3, or other forms of prosthetic valves). Other types of prosthetic valves are illustrated where appropriate.

[0254] In an embodiment, the delivery device comprises 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.

[0255] For example, with reference to FIG. 46 , a delivery device has a configuration similar to the delivery devices described with respect to FIG. 3 or FIG. 28 . A delivery system including the delivery device includes, for example, an elongate shaft. The elongate shaft includes a distal portion 332 that includes an implant retention region in the form of a capsule 334. The capsule 334 is adapted to be retracted for release of the implant. A proximal portion of the elongate shaft 232 is coupled to a housing, which may be configured similarly to the housings disclosed herein. The delivery device is adapted to deliver the implant to the native heart valve.

[0256] The sensor 330 is positioned on the elongate shaft. For example, the sensor 330 is positioned on the capsule 334 and adapted to sense the spatial relationship between the capsule 334 and a portion of the native heart valve. The sensor 330 can 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. The sensor 330 can include various forms of sensors. Utilized sensors 330 can include one or more piezoelectric sensors, strain gauges, pressure transducers, and / or capacitance sensors. Other forms of sensors for detecting contact or force can be utilized. In an embodiment, the sensor 330 can include an electrode having a reference electrode positioned on the patient's body. Contact between the electrode and tissue within the patient's body (e.g., a leaflet of the heart valve) provides an electrical signal between the electrode and the reference electrode that can indicate contact between the electrode and the leaflet of the heart valve. Such forms of sensors can include contact sensors and / or force sensors. Proximity sensors such as infrared, electromagnetic, capacitive, or ultrasonic proximity sensors may be used. Other forms of sensors disclosed herein may be used. Sensors may be used in any other embodiment disclosed herein.

[0257] 46 , in an embodiment, the sensors 330 are spaced from one another circumferentially around the capsule 334. The spacing of the sensors 330 allows the sensors 330 to determine whether one or more of the leaflets of the native valve are in proximity to one or more of the sensors 330. For example, if one of the leaflets touches or is in proximity to the sensor 330, the user can determine that the sensor is in proximity to the native heart valve and in position for deployment of the implant.

[0258] 47, for example, shows a capsule 334 with native valve leaflets 82 a, b approaching the implantation site and in contact with a sensor 330. A signal from the sensor 330 indicates that the capsule 334 is in position for deployment of the implant contained therein. The axial position of the elongate shaft and capsule 334 is determined by the signal from the one or more sensors 330.

[0259] The sensors 330 may further be utilized to determine whether leaflet capture has occurred. For example, referring to FIG. 48 , prosthetic valve anchors 17a, b are deployed from a capsule 334. Anchor 17a may fail to capture or miss capture of leaflet 82a. As such, one or more sensors 330 generate a signal indicative of lack of contact or proximity with leaflet 82a. Accordingly, the user determines that lack of capture of leaflet 82a has occurred. The one or more sensors 330 indicate that capture of leaflet 82b has occurred. For example, one or more sensors 330 provide a signal that they are in contact with or proximity to leaflet 82b. The user determines that prosthetic valve redeployment will occur due to the capture of leaflet 82a.

[0260] A first one of sensors 330 provides a signal indicative of contact with a portion of the heart valve, and a second one of sensors 330 provides a signal indicative of lack of contact with a portion of the heart valve simultaneously with the first one of sensors 330 providing a signal.

[0261] One or more sensors 330 determine that capture of leaflet 82b has occurred, and one or more sensors 330 correspondingly determine that lack of capture of leaflet 82a has occurred. Different groups of sensors 330 generate different signals based on whether the respective leaflet 82a,b has been captured. For example, a first group 330 of sensors proximate leaflet 82b generates a signal that capture has occurred. A second group 330 of sensors proximate leaflet 82a generates a signal that capture has not occurred. Different sensors in different locations generate different signals.

[0262] In embodiments, the configuration of the one or more sensors 330 varies. For example, with reference to FIG. 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 multiple 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 via signals generated by the one or more sensors 336. For example, a greater depth of the capsule 334 will cause different sensors 336 spaced axially along the capsule 334 to provide signals (e.g., a more proximally positioned sensor 336 generating a signal may indicate a greater depth of the capsule 334 relative to the native valve).

[0263] Output from any of the sensors may be provided to the user in a variety of ways. Wired or wireless signals may be utilized. In an embodiment, the output depicted in FIG. 28 may be utilized. For example, a signal may be provided that generates an indication on one or more indicator devices 242, 244, 246, 248, 250. For example, different lights 246 may generate different indications based on the depth of the capsule 334 or based on the location of capture or missed capture of the valve leaflets. One or more of the indicator devices 242, 244, 246, 248, 250 generate 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 generate 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.

[0264] In an example, a processor similar to processor 252 shown in FIG. 28 is used. A memory similar to memory 254 can also be utilized. The processor is adapted to receive one or more signals from the sensor. The processor is adapted to determine capture or failure to capture of the native valve leaflets based on the one or more signals. The processor is adapted to determine the depth of the delivery device relative to the native heart valve based on the one or more signals. Other determinations by the processor can be made based on the one or more signals.

[0265] Each of the features in Figures 46-49 may be used alone or in combination with any of the embodiments disclosed herein.

[0266] In embodiments, other forms of indicators may be utilized with the delivery device. For example, any other form of indicator disclosed herein may be utilized with the delivery device. The indicator may be positioned on the capsule or other portion of the delivery device. The indicator may, for example, include a protrusion extending radially outward from the delivery device. The indicator extends radially outward from the capsule of the delivery device. Indicator 130 shown in FIGS. 15 and 16, or indicator 140 shown in FIGS. 17 and 18, or other forms of indicators may be utilized as desired. Movement or change in the appearance of the indicator may be utilized to determine proximity to the implantation site or to determine capture or failure to capture the native valve leaflets. In embodiments, other forms of indicators are utilized as desired.

[0267] In embodiments, an imaging device is coupled to the delivery device that may be adapted to image an area external to the delivery device. For example, referring to FIG. 50A , imaging device 340 is adapted to extend along delivery device 342. Imaging device 340 may have a variety of forms and may include an ultrasound imaging device or a fluoroscopic imaging device, or a combination of such imaging devices. In embodiments, other forms of imaging devices may be utilized.

[0268] The delivery device 342 can be configured similarly to the delivery devices described in FIG. 3 or 28. A delivery system including the delivery device includes, for example, an elongate shaft. The elongate shaft includes a distal portion 339 that includes an implant retention region in the form of a capsule 349. A proximal portion of the elongate shaft can be coupled to a housing that can be configured similarly to the housings disclosed herein. The delivery device 342 is adapted to deliver an implant to a native heart valve.

[0269] Imaging device 340 may, in some embodiments, include an IVUS (intravascular ultrasound) imaging device or catheter. Imaging device 340 may, in some embodiments, include an OCT (optical coherence tomography) imaging device or catheter.

[0270] The imaging device 340 may be provided in a variety of locations. For example, the imaging device 340 extends within an elongate sheath of the delivery device 342. The elongate sheath includes the outer sheath of the delivery device 342 and extends coaxially with the delivery device 342. In embodiments, the imaging device 340 extends externally of the delivery device 342. The imaging device 340 protrudes distally from the capsule, distal end, or other portion of the delivery device 342 during imaging. The capsule 349 includes, for example, the distal end 347 of the elongate sheath. Other locations for the imaging device 340 may be utilized.

[0271] In an embodiment, imaging device 340 is positioned inside prosthetic valve 344 as the prosthetic valve is deployed. Imaging device 340 extends distally to be positioned within prosthetic valve 344, for example, to image the area surrounding prosthetic valve 344. Imaging device 340 is positioned within a flow channel of prosthetic valve 344.

[0272] 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 capture of one or more leaflets by one or more of the anchors. For example, anchor 17a is unable to capture leaflet 82a. The imaging device 340 can image such areas to provide images where failed or missed capture occurs. Anchor 17b has captured leaflet 82b. The imaging device 340 can image such areas to provide images where capture occurs. The user can attempt to capture leaflet 82a with anchor 17a, and such recapture can be imaged by the imaging device 340.

[0273] Other conditions in the area external to the delivery device can be imaged with the imaging device.

[0274] In some embodiments, the prosthetic valve includes one or more windows that can enable imaging through the prosthetic valve. For example, referring to FIG. 51 , a valve body 346 includes one or more imaging windows 348 that can enable imaging (e.g., transmission of ultrasound waves or x-rays, among others) therethrough. The windows 348 are positioned at the anchor locations in some examples to enable imaging of the capture of the native valve leaflets by the anchors. The imaging windows 348 are circumferentially spaced apart from one another and positioned at the ends of the anchors 17. In some embodiments, other window locations can be utilized as desired. The windows 348 comprise openings in the metal frame of the prosthetic valve to enable imaging through the windows 348.

[0275] In an embodiment, the imaging device 341 is adapted to be positioned outwardly of the valve body 343 of the prosthetic valve 345 during deployment of the prosthetic valve 345. The imaging device 341 may be positioned between the valve body 343 and one or more anchors 17. In this manner, the imaging device 341 images the implantation site without imaging through the valve body 343. Thus, the imaging device 341 images whether capture of one or more of the valve leaflets 82 a, b occurs.

[0276] Signals from the imaging device are provided for viewing by the user during the implantation procedure, or at other times as desired.

[0277] 50A-51 may be used alone or in combination with any of the embodiments disclosed herein. The prosthetic valve utilized may include features of other prosthetic valves disclosed herein (e.g., the prosthetic valves disclosed with respect to FIGS. 1A-3, or other forms of prosthetic valves). Other forms of prosthetic valves may be used in embodiments as desired.

[0278] In embodiments, a sensor can be provided and one or more anchors can be coupled to the sensor. The one or more anchors can be adapted to engage with an interior heart wall of a heart chamber to anchor the sensor to the interior heart wall. With reference to FIG. 52 , for example, anchor 352 is coupled to sensor 350. Anchor 352 is adapted to engage with an interior heart wall of a heart chamber to anchor sensor 350 to the interior heart wall.

[0279] The sensor 350 may have a variety of forms. The sensor 350 may be adapted to sense a condition within the patient's body. The sensor 350 may be adapted to sense a condition within a heart chamber. The sensor 350 may be adapted to sense a property of a fluid within a heart chamber.

[0280] In an embodiment, the sensor 350 includes a pressure sensor. The pressure sensor is adapted to sense the pressure within the heart chamber. In an embodiment, the sensor includes a temperature sensor or a flow sensor adapted to sense the temperature or flow, respectively, within the heart chamber. Other types of sensors may be utilized in embodiments. In an embodiment, a combination of different sensors may be provided.

[0281] In an embodiment, sensor 350 is positioned within support 351. For example, support 351 may include a housing for sensor 350 or may have another configuration as desired.

[0282] The anchors 352 may be positioned at the end portions 354 of the sensor 350 or may have another location as desired. For example, the anchors 352 may be positioned at the mid- or central portion of the sensor 350 or at the opposite end portions of the sensor 350 shown in FIG. 52.

[0283] The anchor 352 can have various configurations as desired. As shown in FIG. 52 , the anchor 352 can include a clip 356 including multiple arms 358 a, b. The arms 358 a, b can be adapted to compress tissue (e.g., tissue of the interior heart wall) between the arms 358 a, b to anchor them to the tissue. The proximal end portions of the arms 358 a, b can be coupled together at a pivot 360. The arms 358 a, b are adapted to rotate about the pivot 360 to move the distal end portions 362 a, b of the arms toward and away from each other. The arms 358 a, b are adapted to pivot relative to the support 351. The arms 358 a, b include one or more penetrators 364 for penetrating the interior heart wall. The penetrators 364 are adapted to enhance fixation to the tissue (e.g., tissue of the interior heart wall).

[0284] Anchor 352 is adapted to penetrate the interior heart wall. In an embodiment, anchor 352 includes a threaded body 366 adapted to penetrate the interior heart wall. Threaded body 366 can be adapted to be threaded into tissue of the interior heart wall to anchor it thereto.

[0285] In an embodiment, a shaft 368 is provided that is adapted to slide within the threaded body 366. As the shaft 368 slides distally within the threaded body 366, a pivot linkage 370 moves proximally relative to the distal end portions 362 a,b of the arms, allowing the distal end portions 362 a,b to be drawn toward each other. With this movement, the distal end portions 362 a,b of the arms 358 a,b may be proximal to a distal tip 372 of the threaded body 366. In examples, other configurations of anchors may be provided as desired.

[0286] 53 , sensor 350 may be deployed in a variety of locations. In some embodiments, sensor 350 may be deployed in an interior heart wall 380 of the left ventricle 382. Sensor 350 may be positioned at the apex, or in the interventricular septum 383, or elsewhere as desired. In some embodiments, sensor 350 may be deployed in an interior heart wall 384 of the left atrium 386. Other interior heart walls (e.g., the right ventricle or right atrium) may be utilized in some embodiments.

[0287] The sensor 350 is inserted into the patient's heart and the anchor 352 can engage tissue of the interior heart wall 380. For example, with reference to FIG. 54 , a portion of the anchor, such as a threaded body 366, can be inserted into the interior heart wall. The threaded body 366 can be inserted a desired distance.

[0288] The tissue of the interior heart wall 380 can be retracted proximally. The arms 358a,b of the clip 356 can close upon retraction, as shown in Figure 55. The sensor 350 can be anchored to the interior heart wall 380.

[0289] 55 , a sensor 350 is positioned within a chamber of the heart. The sensor 350 is positioned to protrude into the chamber from an interior heart wall 380, with one or more anchors 352 engaging the interior heart wall 380. The sensor 350 is accordingly positioned to sense a condition within the chamber. In an embodiment, the sensor 350 includes a sensing portion 385 at an end portion or other location of the sensor 350 for sensing a condition within the chamber. The sensor 350 is adapted to be positioned at multiple locations along the interior heart wall 380.

[0290] Sensor 350 is adapted to provide a signal indicative of the sensed condition in a manner similar to the pressure sensor discussed with respect to FIGS. 33-38. For example, a wireless or wired signal may be provided. A wireless transmitter as disclosed herein may be utilized to transmit the signal from sensor 350. The wireless transmitter may be provided, for example, within support 351. A power source or other components (e.g., processor, memory) may be located within support 351 as desired.

[0291] The placement of the sensor 350 and anchor 352 may vary in different embodiments.

[0292] Each feature in Figures 52-55 may be used alone or in combination with any of the embodiments disclosed herein.

[0293] In embodiments, at least a portion of the prosthetic heart valve may include a pacemaker electrical conduit adapted to conduct electrical signals for pacing the heart. Referring to Figure 56, a prosthetic heart valve 390 may include a pacemaker electrical conduit 392. Various portions of the prosthetic heart valve may include a pacemaker electrical conduit.

[0294] As shown in FIG. 56 , the anchors of the prosthetic heart valve 390 include a pacemaker electrical conduit 392. The prosthetic heart valve 390 includes one or more anchors 17 adapted to anchor the prosthetic heart valve 390 to the native heart valve, and the pacemaker electrical conduit 392 comprises at least a portion of the one or more anchors. 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 leaflets of the prosthetic heart valve in a manner similar to the other anchors 17 of the prosthetic heart valve 390. For example, the pacemaker electrical conduit 392 is adapted to extend over the distal tips of the leaflets of the native valve for anchoring to the leaflets. The anchors may extend radially outward from the valve body 15. The pacemaker electrical conduit 392 can be adapted to resist proximal forces applied to the prosthetic heart valve 390.

[0295] In an embodiment, referring to FIG. 57 , a 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 a pacemaker 398 (as shown in FIG. 59 ) having another electrical terminal 396. The electrical terminal 394, in an embodiment, is coupled to a frame of the prosthetic valve 390.

[0296] 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 distal portion that includes the distal end of the pacemaker electrical conduit 392. The portion 395 extends along the frame of the valve body 15 in this embodiment.

[0297] In some embodiments, other portions of the prosthetic valve include pacemaker electrical conduits, such as portions of the frame including the outer frame or inner frame, that include pacemaker electrical terminals adapted to contact portions of the native heart valve to pace the heart.

[0298] As shown in FIG. 58 , upon deployment of the prosthetic valve 390, the pacemaker electrical conduit 392 contacts a portion of the patient's heart. For example, the pacemaker electrical conduit 392 captures a leaflet of the native heart valve. The pacemaker electrical conduit 392 hooks around and anchors to the valve leaflet 82 a. A distal portion 400 of the pacemaker electrical conduit 392 contacts a surface of the heart to conduct an electrical signal to the heart. For example, the distal portion 400 contacts the annulus of the heart valve proximate to the annulus. In some embodiments, the distal portion 400 contacts the annulus radially outward of the native valve leaflets. If the pacemaker electrical conduit 392 loses capture or other configuration, the distal portion 400 can be positioned inside the leaflet of the native valve.

[0299] A prosthetic valve 390 can be implanted, and a pacemaker 398 (shown in FIG. 59 ) can be coupled to electrical terminals 394 of pacemaker electrical conduit 392. The coupling can occur as part of the prosthetic valve 390 implantation procedure or can occur in a separate procedure. For example, a determination can be made that a pacemaker 398 should be provided for the patient. After implantation of prosthetic valve 390, pacemaker 398 can be provided, and pacemaker electrical conduit 392 is available for electrical connection to pacemaker 398. In an embodiment, pacemaker 398 can be provided to the patient, either integrally or pre-connected to pacemaker electrical conduit 392, at the time prosthetic valve 390 is implanted.

[0300] 59, in a procedure, a pacemaker 398 is provided for the patient with electrical terminals 402 of electrical pacemaker conduits 404 connected to electrical terminals 394. Thus, the pacemaker 398 provides electrical signals to the pacemaker electrical conduits 392 for pacing the heart.

[0301] In some embodiments, other forms of connection to the pacemaker electrical conduit 392 may be made.

[0302] In some embodiments, the configuration of the pacemaker electrical conduit 392 can vary. The pacemaker electrical conduit 392 includes one or more coils. For example, FIG. 60 illustrates an embodiment in which a pacemaker electrical conduit may be utilized including coils 406a, b wound alternately and adjacent to one another. The coils 406a, b may have the same diameter, and insulation prevents electrical shorting of the coils 406a, b. FIG. 61 illustrates a configuration in which a first coil 408a is wound over a second coil 408b, with an insulating layer 410 positioned between the coils 408a, b. An insulating layer 412 is optionally wound over the outer coil 408a. The coils 406a, b, 408a, b may include respective cathode and anode coils, as desired.

[0303] The use of a prosthetic valve with a pacemaker electrical lead provides various advantages. For example, if a pacemaker is desired for the patient, a pacemaker electrical lead may be provided with the prosthetic valve for use with the pacemaker. Such a configuration may reduce the need to insert the pacemaker electrical lead through the flow channels of the prosthetic valve, which may interfere with the movement of the prosthetic valve leaflets. Furthermore, increased ease of positioning of the pacemaker electrical lead may result, as the prosthetic valve provides a desired location for the pacemaker electrical lead upon implantation of the prosthetic valve. Other benefits may arise.

[0304] The features of the prosthetic valves shown in Figures 56-59 may include other prosthetic valves disclosed herein (e.g., the prosthetic valves disclosed in Figures 1A-3, or other forms of prosthetic valves). Other forms of prosthetic valves may be used in embodiments as desired.

[0305] Each feature in Figures 56-61 may be used alone or in combination with any of the embodiments disclosed herein.

[0306] 62A-68C illustrate implementations that utilize a retention mechanism to hold one or more native valve leaflets in a contracted state when one or more anchors of a prosthetic heart valve at least partially hook around the one or more native valve leaflets.

[0307] Referring to FIG. 62A, a distal end portion of a delivery device, such as a delivery catheter 420, is shown approaching an implantation site. The delivery device is configured similarly 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 the prosthetic heart valve to the native valve. The prosthetic heart valve can be configured similarly to other forms of prosthetic heart valves disclosed herein. For example, anchor 17 of the prosthetic heart valve (similar to anchor 17 shown in FIGS. 1A-1C and 4A) is shown in a straight configuration and extends from the distal end of capsule 422.

[0308] The retention mechanism 424 includes one or more arms 426 a, b adapted to hook around the leaflets 82 a, b of the native valve. The arms 426 a, b are shown in a retracted, unexpanded, compressed, or straight configuration in FIG. 62A , where the arms 426 a, b extend parallel to the length of the capsule 422 and the delivery catheter 420. In an embodiment, the delivery catheter 420 includes one or more channels 428 a, b that receive the arms 426 a, b and within which the arms 426 a, b may slide. The arms 426 a, b are slidable between the retracted, unexpanded, compressed, or straight configuration shown in FIG. 62A and the advanced, expanded, deployed, or flared configuration shown in FIG. 62B. In embodiments, the retention mechanism 424 or proximal portions 430a,b of the arms 426a,b are controllable or adjustable at the proximal portion of the delivery device, allowing control of one or more of the arms 426a,b. The proximal portions 430a,b can be advanced to advance the arms 426a,b and can be retracted to retract the arms 426a,b. The proximal portions 430a,b can be independently controllable to independently control each arm 426a,b, or can be controlled in combination as a group.

[0309] Arms 426a, b in a retracted, unextended, compressed, or straightened configuration shown in FIG. 62A are in a configuration for advancement to an implantation site and extend along capsule 422 and delivery catheter 420. Arms 426a, b can be advanced to move to an advanced, expanded, deployed, or flared configuration as shown in FIG. 62B.

[0310] Referring to FIG. 62B , the arms 426 a, b are shown in an advanced, extended, deployed, or flared configuration. The arms 426 a, b project radially outward from the delivery catheter 420 and capsule 422. The arms 426 a, b form a hook shape with respective bends or curved portions 432 a, b and tips 434 a, b. Respective elongated portions 436 a, b extend between the curved portions 432 a, b and the tips 434 a, b. The arms 426 a, b are adapted to hook around the leaflets 82 a, b of a native valve, with the tips 434 a, b and elongated portions 436 a, b positioned radially outward of the respective leaflets 82 a, b. The tips of the respective leaflets 82 a, b can be positioned within the curved portions 432 a, b.

[0311] Multiple arms 426a,b can be circumferentially spaced apart from one another and each project radially outward from capsule 422 and delivery catheter 420. Figure 62E, for example, illustrates an arrangement of arms 426 projecting radially outward from delivery catheter 420. Figure 62F shows a top cross-sectional view. The number of arms 426 can be increased or decreased as desired.

[0312] The arms 426 may include a flexible body that is shaped into a hook configuration. The arms 426 may be made of a shape-memory material (e.g., nitinol) or another desired form of material. The arms 426, in some embodiments, may be more flexible than the material that forms the anchors 17 of the prosthetic heart valve. The arms 426 may also be thinner than the anchors 17. Such a feature, in some embodiments, may provide improved ease of deployment or threading between the chordae of the native heart valve.

[0313] In operation, the retention mechanism 424 is utilized to retain the native valve leaflets 82 a, b in a contracted state when the anchor 17 at least partially hooks around the native valve leaflets 82 a, b. The arms 426 a, b, for example, extend radially outward to retain the native valve leaflets 82 a, b in a closed or partially closed configuration (e.g., a contracted configuration for a mitral or tricuspid valve). In some embodiments, the arms 426 a, b hold the native valve leaflets 82 a, b in place or against the outer surface of the delivery catheter 420 or capsule 422. Such features can allow for increased ease of capture of the native valve leaflets 82 a, b by the anchor 17.

[0314] 62A, arms 426a,b are in a retracted, unexpanded, compressed, or straightened configuration, and then advance to an advanced, expanded, deployed, or flared configuration to capture leaflets 82a,b during contraction and expansion (shown by solid and dashed lines in FIG. 62A). During contraction, arms 426a,b hook around and capture leaflets 82a,b, resulting in the configuration shown in FIG. 62B.

[0315] In the configuration shown in Figure 62B, arms 426a,b capture leaflets 82a,b. The reduced movement or static position of leaflets 82a,b allows for ease of capture by anchor 17. Figure 62C shows anchor 17 deployed and anchored to leaflets 82a,b, for example, in a manner similar to that disclosed herein.

[0316] At a predetermined time, arms 426a,b retract radially inward, as shown in Figure 62D. Anchor 17 remains in place and the prosthetic heart valve can be deployed from capsule 422 as disclosed herein. The use of a retention mechanism provides for improved deployment of the prosthetic heart valve.

[0317] Arms 426a,b can, in some embodiments, be deployed from elsewhere on the delivery device or delivery catheter. Figures 63A-63C show arms 440a,b configured similarly to arms 426a,b as shown in Figures 62A-62F, projecting radially outward from a nose body 442 of a delivery catheter 444. Nose body 442 comprises a nosecone for delivery catheter 444. In some embodiments, a guidewire lumen 446 couples nose body 442 to the remainder of delivery catheter 444. Guidewire lumen 446 passes a guidewire, which in some embodiments passes through nose body 442.

[0318] 63B, nose body 442 includes respective channels 448a,b through which arms 440a,b can pass. In some embodiments, channels 448a,b are curved to deflect arms 440a,b toward the annulus, which is positioned radially outward of valve leaflets 82a,b. Delivery catheter 444 includes channels 450a,b along guidewire lumen 446 through which arms 440a,b can pass. Nose body 442 includes openings 451a,b through which arms 440a,b can protrude.

[0319] Arms 440a,b operate similarly to arms 426a,b. Referring to Figure 63C, arms 440a,b can be retracted into nose body 442 upon deployment of anchor 17 as disclosed herein.

[0320] 64 shows a variation in which guidewire lumen 446 includes respective openings 453a,b for passage of arms 440a,b, which are adapted to project radially outward from guidewire lumen 446.

[0321] Other types of retention mechanisms may be utilized in embodiments. Figures 65A-65C show an implementation in which a retention mechanism 455 includes one or more barbs 452 a, b for engaging the native valve leaflets 82 a, b. The barbs 452 a, b are positioned at the end of respective arms 454 a, b, which may be pivotally coupled to a portion of a delivery device or delivery catheter 456 (such as a sheath 458 extending over a capsule 460 of the delivery catheter 456). The arms 454 a, b are adapted to protrude radially outward from the delivery catheter 456. The arms 454 a, b are circumferentially spaced apart from one another, and the corresponding barbs 452 a, b are spaced apart from one another.

[0322] A retention member 462, such as a sheath, extends over the arms 454a,b to hold the arms 454a,b in a retracted, unexpanded, compressed, or straightened configuration. The retention member 462 can be retracted to allow the arms 454a,b to pivot radially outward and engage the leaflets 82a,b (as shown in FIG. 65A). The arms 454a,b operate in a manner similar to other forms of retention mechanisms disclosed herein and can hold the leaflets 82a,b in a contracted state when the anchors 17 at least partially hook around the leaflets 82a,b.

[0323] Figure 65B, for example, illustrates barbs 452a,b engaging arms 454a,b that pivot radially outwardly around leaflets 82a,b. Once anchor 17 is deployed, retainer 462 can be advanced to retract arms 454a,b as shown in Figure 65C.

[0324] Other configurations of retention mechanisms may be utilized in embodiments. Figures 66A-66D illustrate an embodiment in which multiple barbs 470 are coupled to a sheath 472 and circumferentially spaced apart from one another. The sheath 472 and barbs 470 may be covered by an outer sheath 474 (as shown in Figure 66A) (representative barbs 470a, b are shown in Figure 66A).

[0325] The outer sheath 474 can be retracted relative to the sheath 472, exposing the barbs 470 and allowing the barbs 470a,b to engage the leaflets 82a,b as shown in FIG. 66B. The barbs 470a,b can hold the leaflets 82a,b in a contracted state when the anchors 17 at least partially hook around the leaflets 82a,b.

[0326] The outer sheath 474 can be advanced relative to the barbs 470a,b to cover the barbs 470a,b and thereby release or disengage the barbs 470a,b from the valve leaflets 82a,b, as shown in FIG. 66C.

[0327] Other configurations of retention mechanisms may be utilized in embodiments. FIG. 67 illustrates an embodiment in which a retention mechanism 480 includes one or more suction ports 482 for applying suction to the native valve leaflets 82 a, b to retain the leaflets 82 a, b 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 may be circumferentially spaced apart from one another or may have another configuration in embodiments. One or more suction lumens 486 extend along the delivery device or delivery catheter 484 to transmit suction to the ports 482. A suction device 488 (e.g., a pump or syringe) is provided for generating suction along the suction lumens 486. The suction ports 482 may operate to retain the leaflets 82 a, b in a contracted state when the anchors 17 are at least partially hooked around the leaflets 82 a, b, as disclosed herein.

[0328] Other configurations of the retention mechanism may be utilized in embodiments. Figures 68A-68C illustrate an implementation in which the retention mechanism 490 includes a coil 492 for extending around the radially outward-facing surfaces of the valve leaflets 82a,b. The coil 492 may be adapted to be deployed from a delivery catheter 494, for example, and may protrude from a channel 496 in the delivery catheter 494 in embodiments. Other configurations may be utilized in embodiments.

[0329] The coil 492 can be shape-set into a coil shape (e.g., with a shape memory material such as Nitinol) or controlled into a coil shape (e.g., with a guidewire or other mechanism). FIG. 68A illustrates the coil 492 in a retracted, unexpanded, compressed, or straight configuration. FIG. 68B shows the coil 492 advanced (to an advanced, expanded, deployed, or coil configuration). The coil 492 is wrapped around the radial outside of the valve leaflets 82a,b for one or more wraps as desired. FIG. 68C illustrates the coil 492 in an advanced, expanded, deployed, or coil configuration. The coil 492 can have a flat coil shape, or can have a spiral or helical shape, among other shapes.

[0330] 68B, coil 492 operates as disclosed herein to hold leaflets 82 a, b in a contracted state when anchor 17 at least partially hooks around leaflets 82 a, b. Coil 492 retracts upon deployment of anchor 17.

[0331] Other configurations of retention mechanisms may be utilized in embodiments. For example, the indicator 90 depicted in Figures 7-8F includes a retention mechanism that remains implanted upon deployment of the prosthetic heart valve. The indicator 90 includes flexible arms that hold the native valve leaflets in a contracted state on the anchors 17a,b, and hook at least partially around the leaflets 82a,b.

[0332] Each feature in Figures 62A-68C may be utilized alone or in combination with any of the embodiments disclosed herein.

[0333] Figures 69A-69G illustrate implementations of a prosthetic heart valve 500 (shown in Figures 69C, 69F, and 69G). Figure 69A shows a frame 502 of the prosthetic heart valve 500. The frame 502 includes an inner frame 504 (shown in a schematic diagram in Figure 69A). A perspective view of the inner frame 504 is shown in Figure 69D and includes a plurality of struts 506. The inner frame 504 can be configured similarly to other forms of inner 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 inner frames disclosed herein.

[0334] The proximal or inflow end portion 508 of the inner frame 504 includes, in some embodiments, a connector 512 or eyelet. The distal or outflow end portion 510 connects to an anchor 514, which may be configured similarly to the anchor 17 disclosed herein.

[0335] The inner frame 504 supports one or more prosthetic valve leaflets 16 positioned within the flow channel 516 of the prosthetic heart valve 500, as shown in Figure 69F.

[0336] The prosthetic heart valve 500 has a seal 520 (shown in FIG. 69C) positioned radially outward of the inner frame 504. The seal 520 includes a plurality of elongated prongs 522 and a skirt 524.

[0337] Referring to FIG. 69A , each of the plurality of elongated prongs 522 has a first end portion 526 that is 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 prong 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 portions 526 of the elongated prongs 522 include a connector for coupling with the connector 512 of the inner frame 504. FIG. 69E shows a top view of one of the elongated prongs 522, showing the first end portion 526 including a connector in the form of, for example, an eyelet for suture connection with the eyelet of the inner frame 504. Other types of connectors may be used in embodiments.

[0338] The elongated prongs 522 project radially outward from the first end portion 526 to form a plateau portion 530 or planar portion of the closure 520. The plateau portion 530 has a generally planar shape that extends outward from the inner frame 504 as a disk.

[0339] 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 outward from the second end portion 528 such that the second end portion 528 forms the outermost portion of the plateau portion 530. The elongated prongs 522 extend to be positioned circumferentially between adjacent anchors 514 (as shown in the top view in FIG. 69B ) or can be radially aligned with adjacent anchors 514 in some embodiments.

[0340] The elongated prongs 522 are deflectable in the axial dimension of the prosthetic heart valve 500. For example, an axial force applied to the second end portion 528 of the elongated prongs 522 causes the second end portion 528 to deflect about the first end portion 526.

[0341] A skirt 524 (shown in FIG. 69C) is suspended between a second end portion 528 of the elongated prongs 522 and an outflow end portion 532 of the prosthetic heart valve 500 (shown in FIG. 69F). The outflow end portion 532 of the prosthetic heart valve 500 includes the outflow end portion 510 of the inner frame 504. In FIG. 69F, the skirt 524 includes a first portion 534 positioned at the second end portion 528 of the elongated prongs 522 and 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 bounds a pocket 538 positioned between the skirt 524 and the inner frame 504. The pocket 538 has an annular or ring shape around the inner frame 504. An inner portion 540 of the skirt 524 is positioned inside the intermediate portion 537.

[0342] The skirt 524 extends along the elongated prongs 522 from a first end portion 526 to a second end portion 528 of the prongs 522, and then extends to join the distal or outflow end portion of the inner frame 504. An inner portion 540 of the skirt 524 covers the surface of the inner frame 504.

[0343] 69F, inner portion 540 of skirt 524 includes a plurality of openings 550 that allow blood to enter pocket 538. Blood flows through inner frame 504 and openings 550 and enters pocket 538. In an embodiment, the blood forms a clot in pocket 538, providing an improved seal with the native annulus.

[0344] The anchors 514 have a configuration similar to other forms of anchors disclosed herein. The anchors 514 can secure the prosthetic valve to the native valve by capturing the leaflets of the native valve. The anchors 514 are coupled to the outflow end portion 510 of the inner frame 504 and protrude radially outward from the outflow end portion 510. The anchors 514 are adapted to hook around the leaflets of the native valve to anchor the prosthetic heart valve 500 to the native valve. Figure 69G, for example, shows the prosthetic heart valve 500 in a deployed configuration.

[0345] Referring to Figure 69G, the skirt 524 contacts and seals against the tissue of the native valve (e.g., the valve leaflets or annulus). The skirt 524 includes a conforming body that contours to the shape of the local annulus. The elongated prongs 522 include an atrial anchor that prevents ventricular migration of the prosthetic heart valve 500. The anchors 514 are comprised of ventricular anchors that prevent atrium migration of the prosthetic heart valve 500. The pockets 538 fill with blood and clots, stabilizing the prosthetic heart valve 500 within the native annulus.

[0346] In embodiments, during deployment, elongate prongs 522 are deflectable using one or more tethers 560. Tethers 560 may be individually actuatable to allow independent retraction of any of elongate prongs 522. Retraction allows for redeployment or reseating of elongate prongs 522 during deployment. Tethers 560 may comprise a portion of a delivery device, such as a delivery catheter 562, and may be removed after implantation.

[0347] The seal 520 configuration allows for compliance and improved sealing with the shape of the native annulus, and also allows for the application of reduced radial forces as opposed to seal configurations with a rigid outer frame.

[0348] Each feature in Figures 69A-69G may be utilized alone or in combination with any of the embodiments disclosed herein.

[0349] 70A-73B illustrate implementations of a prosthetic heart valve including one or more prosthetic valve leaflets and a support structure including at least one ring supporting the one or more prosthetic valve leaflets and coupled to a skirt, wherein the skirt or the at least one ring is adapted to seal with at least a portion of the native heart valve.

[0350] 70A, for example, an implementation of a prosthetic heart valve 600 is illustrated, including 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.

[0351] The third ring 606 includes a support for supporting the prosthetic valve leaflets 610. The third ring 606 or support is coupled to the prosthetic valve leaflets 610 and is coupled to the first ring 602 and the second ring 604 with a skirt 608. The third ring 606 is shaped to support the prosthetic valve leaflets 610 and may include a commissure support 612 for supporting the commissures of the prosthetic valve leaflets 610. The commissure support 612 may include a vertical body sutured to the prosthetic valve leaflets 610 or may have another configuration in some embodiments.

[0352] 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 of the rings may be pliable and flexible to allow the rings to be compressed into a compressed state for deployment. Each ring may be adapted to change shape. Each ring may be biased to expand radially outward upon deployment. For example, each ring may be made from a shape memory material (e.g., nitinol or other shape memory material).

[0353] The skirt 608 is coupled to the first ring 602 and the second ring 604 by overlapping a portion of the first ring 602 and / or the second ring 604. For example, referring to the cross-sectional view of FIG. 70B (along line II in FIG. 70A ), an end portion 614 of the skirt 608 overlaps and couples to the ring 602. A channel 616 is formed by the end portion 614 of the skirt 608 for receiving the ring 602. The skirt 608 can be coupled to itself via sutures 618 or another form of coupling in some embodiments to form the channel 616. FIG. 70C illustrates the ring 602 separated from the skirt 608.

[0354] Figure 70D illustrates the prosthetic heart valve 600 during deployment. The first ring 602 is positioned on the atrial side of the annulus, and the second ring 604 is positioned on the ventricular side of the annulus. The third ring 606 is supported by a skirt 608 between the first ring 602 and the second ring 604. The rings 602, 604, 606, and skirt 608 seal with a portion of the native valve. The rings 602, 604, 606, and skirt 608 form a flexible body that conforms to the shape of the native valve for improved sealing.

[0355] Variations in the features of the prosthetic heart valve 600 may be provided. Figure 70E illustrates, for example, a variation of the ring of the first ring 602 or the second ring 604, where the ring 620 includes a first end 622 and a second end 624, where 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 ability to expand and contract for expansion and compression of the ring as needed, with the ends 622, 624 sliding freely relative to one another.

[0356] 70F shows a variation of the ring of first ring 602 or second ring 604, where ring 630 passes through a channel 632 in skirt 634 in vivo to control the diameter of ring 630 in vivo. Either ring 602, 604 can have an adjustable diameter in vivo by controlling the length of material comprising the ring within channel 632.

[0357] 71A-71C illustrate a variation in which one or more tethers 640 are utilized to compress the first ring 602 and the second ring 604 together. The tether 640 extends 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 draw the rings 602, 604 axially toward one another.

[0358] Figure 71B, for example, shows the deployed configuration. The opposite end portion 644 of the tether 640 passes through and may be retracted through the sheath 646. As shown in Figure 71C, axial compression results. The tether 640 may be locked in place and / or cut to ensure axial compression at the implantation site. Axial compression may be preferable to radial expansion to reduce the possibility of conduction obstruction or other adverse effects to the valve annulus.

[0359] 72A and 72B illustrate a configuration 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 configured similarly to the prosthetic heart valve 10 shown in FIGS. 1A-2, but may further include a skirt 658 forming a disc extending radially outward from the outer frame 656. The skirt 658 is supported on the outer periphery of the disc by a ring 660, which may be configured similarly to other embodiments of the rings disclosed herein. The skirt 658 projects radially outward from a distal end portion 662 or outflow end portion of the outer frame 656, as shown in FIG. 72B, and forms a seal with the native valve upon deployment. The ring 660 and / or skirt 658 may compress against the native valve (e.g., the valve leaflets or annulus) to provide an enhanced seal upon deployment.

[0360] FIG. 73A shows a variation of a skirt 670 forming a disk that extends radially outward from the inner frame 504, as shown in FIG. 69A. The skirt 670 is supported at its periphery by a ring 672. The skirt 670 projects radially outward from a 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 the native valve, as shown, for example, in FIG. 73B. The ring 672 and / or skirt 670 seal against the atrial annulus of the native valve or the leaflets of the native valve.

[0361] Each feature in Figures 70A-73B may be used alone or in combination with any of the embodiments disclosed herein.

[0362] 74-83 illustrate implementations of a sensor system according to embodiments of the present disclosure. The sensor system may be utilized with various other systems, devices, or methods disclosed herein. Figures 74-83 illustrate implementations in which the sensor system includes a prosthetic cardiac implant in the form of a clip 700, and in which other forms of prosthetic cardiac implants (e.g., prosthetic heart valves) may utilize the features of the sensor system.

[0363] 74 shows a side view of a delivery system 702 that may be utilized with clip 700. Delivery system 702 may include multiple catheters, including a guide catheter 704, a steering catheter 706, and / or an implant deployment catheter 708. The implant deployment catheter 708 may pass through the steering catheter 706. The steering catheter 706 may pass through the guide catheter 704. The steering catheter 706 may be utilized to direct the clip 700 to a desired location. The implant deployment catheter 708 may be utilized to position the clip 700 and release the clip 700 at a desired time. Variations in the configuration of the delivery system may be utilized in embodiments.

[0364] 75 shows a side view of clip 700. Clip 700 includes multiple arms or paddles 710 that may be pivotally coupled to one another. A pivot linkage 712 may be provided that allows arms or paddles 710 to open and close in a manner similar to pivot linkage 370. Clip 700 includes one or more engagement arms including a first or upper set of engagement arms 714 and a second or lower set of engagement arms 715. Each set of engagement arms 714, 715 includes barbs 717 or other engagement features for grasping tissue of the valve leaflets therebetween. Features of clips and / or delivery systems that may be utilized are disclosed in WIPO Publication No. WO / 2023 / 003755, entitled "Sensing Heart Valve Repair Devices," which is a publication of International Patent Application No. PCT / US2022 / 037176, published on January 26, 2023; WIPO Publication No. WO / 2023 / 004098, entitled "Heart Valve Repair Devices," which is a publication of International Patent Application No. PCT / US2022 / 037983, published on January 26, 2023; and International Application No. PCT / US2023 / 028329, filed on July 21, 2023, the entire contents of each of the foregoing being incorporated herein by reference for all purposes.

[0365] The set of engagement arms 714, 715 and paddles 710 are controllable to control engagement of the heart valve leaflets. Figures 76-78 show an exemplary deployment sequence. Figure 76, for example, illustrates a clip 700 positioned between two heart valve leaflets 82a, b with the engagement arms 714, 715 and paddles 710 in an open configuration. Portions of the heart valve leaflets 82a, b 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 grasp a portion of the heart valve leaflet with one of the lower set of engagement arms 715. Figure 77 illustrates this configuration. At a desired time, the other engagement arms 714, 715 can be closed to grasp a portion of the other heart valve leaflet therebetween. The paddles 710 can be closed.

[0366] After the clip 700 is deployed in place, the implant deployment catheter 708 is removed, as shown in Figure 78. The clip 700 clips the leaflets of the heart valve together to reduce valvular regurgitation or other disorders.

[0367] In an embodiment, one or more sensor bodies 720 (shown in FIG. 80) are incorporated into the system. A perspective view of the sensor body 720 is shown in FIG. 81. Referring to FIG. 81, the sensor body 720 includes a substrate 722 and a sensor 724 positioned on the substrate 722.

[0368] The sensor 724 is adapted to detect the condition of the artificial cardiac implant (e.g., clip 700). The sensor 724 is adapted to detect contact between a portion of the clip 700 and a cardiac valve leaflet. For example, the sensor 724 includes an electrode having a second reference electrode 726 (shown in FIG. 82) coupled to a portion of the patient's body. Upon contact between the sensor 724 and tissue (e.g., a cardiac valve leaflet), an electrical signal between the sensor 724 and the reference electrode 726 indicates contact between the clip 700 and the cardiac valve leaflet. The signal from the sensor 724 passes along electrical traces 728 to electrical terminals 730. The electrical terminals 730 are coupled to a controller 732 (shown in FIG. 82) that determines whether contact has occurred due to the signal from the sensor 724. The controller 732 may include a processor as disclosed herein or other form of controller for detecting the signal from the sensor 724. As shown in FIG. 82, the reference electrode 726 may be electrically coupled to the controller 732.

[0369] The sensor body 720 and sensor 724 are positioned to detect contact between the clip 700 and the heart valve leaflets. For example, with reference to Figures 79 and 80, the sensor body 720 and sensor 724 are positioned on one or more of the engagement arms 714, 715 or paddles 710 to detect contact between the respective engagement arms 714, 715 or paddles 710 and heart valve leaflet tissue. The sensor 724 is positioned to contact the heart valve tissue for contact detection.

[0370] In an embodiment, sensor body 720 is adapted to be extracted from a portion of clip 700 after implantation. Referring to FIG. 80 , sensor body 720 is shown to be detached from clip 700 upon implantation such that sensor body 720 does not remain implanted within the patient's body with clip 700 implanted. Tension can be applied to sensor body 720 using tether 734, or tension can be applied directly to sensor body 720 (e.g., at the proximal end portion of the delivery system) for extraction. Sensor body 720 can be retracted into the catheter of the delivery system at a desired time.

[0371] Referring to FIG. 81 , the substrate 722 includes a circuit board. The circuit board is a flexible circuit board on which the sensor 724 and electrical traces 728 are printed. The flexible circuit board is a laminated structure including multiple layers of material, including the conductive layers of the sensor 724 and the electrical traces 728. The sensor body 720 is configured as a strip of material and has relatively narrow dimensions (e.g., a width 736 of less than 1 millimeter or less than 0.5 millimeters, and a thickness 738 of less than 0.5 millimeters or less than 0.2 millimeters). The sensor body 720 is relatively long (a length 740 of more than 100 centimeters, or more than 150 centimeters), which allows the proximal end of the sensor body 720 to be pulled through a delivery system after implantation.

[0372] A concern with extracting the sensor body 720 is excessive force that may be generated during the extraction process on the sensor body 720. Tension on the sensor body 720 can create forces that may result in damage (e.g., partial or complete rupture) to the sensor body 720. Such an outcome is undesirable because pieces of the sensor body 720 may be loose within the patient's body or damage may occur to the sensor body 720 as a result of other forms of force.

[0373] Therefore, it is desirable to be able to detect forces applied to the sensor body 720 and the substrate 722. The forces may indicate a complete or partial fracture of the substrate 722 or other undesirable forces on the substrate 722 (e.g., excessive extraction forces on the substrate 722).

[0374] Referring to FIG. 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 includes a conductive trace on the substrate 722 that extends along the periphery of the substrate 722. A loop shape is formed with a first end 742 and a second end 744. A first electrical terminal 746 is at the first end 742 and a second electrical terminal 748 is at the second end 744. The electrical terminals are adapted to be electrically connected to a controller 732, as shown in FIG. 82 . The controller 732 generates a current along the electrical detection trace 741 and monitors the current or resistance maintained along the electrical detection trace 741 during extraction.

[0375] 83, for example, shows a partial tear 749 in the substrate 722 during an extraction procedure. The tear breaks the electrical detection trace 741, thus increasing the resistance of the electrical detection trace 741 and / or decreasing 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. A technician can recognize the damage to the substrate 722 and correct the procedure by halting removal of the sensor body 720 and completely removing the clip 700 and delivery system.

[0376] Electrical detection traces 741 are adapted to detect partial or complete rupture of substrate 722 upon in vivo removal of sensor body 720 from clip 700 .

[0377] Other forms of electrical detection traces may be utilized in embodiments. For example, FIG. 84 illustrates a variation in which electrical detection traces 750 are electrically conducted through sensors 724. Thus, electrical detection traces 750 electrically pass through sensors 724, thereby reducing the size of electrical detection traces 750 compared to the configuration shown in FIG. 83. Controller 732 may be modified to account for electrical detection traces 750 and sensors 724 sharing the same electrical trace lines.

[0378] FIG. 85 shows a variation in which the electrical sensing traces 752 include strain gauges 754 on the substrate 722. The strain gauges 754 generate electrical signals indicative of the amount of force applied to the substrate 722. The signals are received by the controller 732. The controller 732 is adapted to generate an output to an indicator device 759 (such as a display screen on one of the catheters of the delivery system), as shown in FIG. 86. Thus, a technician knows the force, and amount of force, applied to the substrate 722 to determine if corrective action is needed during the procedure.

[0379] The sensor bodies disclosed herein may be implemented in other forms of prosthetic cardiac implants. FIG. 87 illustrates an implementation of a sensor body 760 configured similarly to any of the sensor bodies shown in FIGS. 82-84, but coupled to a prosthetic heart valve 762 and including multiple sensors 761. The prosthetic heart valve 762 is configured similarly to the prosthetic heart valve 10 shown in FIGS. 1A-2. The sensor body 760 extends circumferentially around the prosthetic heart valve 762. The sensors 761 are configured similarly to the sensors 724 and are adapted to detect contact between the sensors 761 and cardiac tissue. The sensors 761 may be coupled by a single electrical conduit or trace, or multiple electrical conduits or traces may be utilized.

[0380] 88 and 89, the sensor body 760 has an undulating shape adapted to expand radially outward with the expansion of the prosthetic heart valve 762. In Fig. 88, the undulating shape is shown in a compressed configuration, and in Fig. 89, it is shown in an expanded or elongated position. The substrate 766 has an undulating shape adapted to expand radially outward with the prosthetic heart valve 762.

[0381] Figure 90 shows the sensor body 760 separated from the prosthetic heart valve 762 and extending circumferentially in an expanded configuration. Figure 91 shows the sensor body 760 separated from the prosthetic heart valve 762 and in a compressed configuration.

[0382] Referring to FIG. 87 , a sensor 761 is positioned to detect heart valve tissue between the anchor and the valve body 764. The sensor 761 accordingly detects whether capture of the valve leaflet has occurred by the anchor 768, which may be configured similarly to other forms of anchors disclosed herein. Sensing tissue between the anchor 768 and the valve body 764 indicates capture. An electrical signal can pass along an electrical conduit 770 of the delivery system, which may be configured similarly to other forms of electrical conduits disclosed herein. In embodiments, a cutting portion 772 (shown in FIG. 90 ) of the sensor body 760 or electrical conduit 770 allows for severing of the electrical conduit 770. The cutting portion 772 allows for severing of the connection by an applied force, although other cutting modes may be utilized in embodiments (e.g., contact separation, magnetic release, among others).

[0383] Other locations for the sensor 761 may be utilized. Figure 92 shows a variation in which the sensor 761 is circumferentially offset from the location of the anchors 768 (circumferentially between the anchors 768). The location can produce an indication of a seal with the native annulus.

[0384] Examples of prosthetic valves, as disclosed herein, may be utilized in the mitral valve, or in other deployment locations, such as the native tricuspid valve, aortic valve, or pulmonary valve deployment, or other implantation sites.

[0385] Various variations of the embodiments disclosed herein may be provided. Features of the embodiments may be modified, substituted, omitted, or combined between embodiments as desired. Combinations of features across embodiments may be made as desired. Combinations of features may be provided across examples to the exclusion of other features of such examples as desired.

[0386] The various examples of sealing skirts disclosed herein can have a variety of configurations, including fabric skirts, foam skirts, or braided skirts, as desired. A variety of materials can be utilized, as desired.

[0387] The implants disclosed herein may include prosthetic heart valves or other forms of implants such as stents or filters, among other things, diagnostic devices. The implant may be an expandable implant configured to move from a compressed or undeployed state to an expanded or deployed state. The implant may be a compressible implant configured to be compressed inward to have a reduced profile, moving the implant to the compressed or undeployed state.

[0388] Various forms of delivery devices may be utilized in the embodiments disclosed herein. The delivery devices disclosed herein may also be utilized in aortic, mitral, tricuspid, and pulmonary replacement and repair. Delivery devices may include, among other things, delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, among other things.

[0389] The implants and systems disclosed herein can be used in transcatheter mitral or tricuspid valve implantation, and in transaortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein can be utilized for transarterial access, including transfemoral access, to a patient's heart. The delivery devices and systems can be utilized in transcatheter percutaneous procedures, including transarterial procedures, which can be transfemoral. Transapical procedures, among others, can also be utilized. Other procedures can be utilized as desired.

[0390] Additionally, the methods described herein are not limited to the specifically described methods, but may include methods utilizing the systems and devices disclosed herein. Steps in the methods may be modified, omitted, or added depending on the systems, devices, and methods disclosed herein. The embodiments disclosed herein may, in some embodiments, include systems for implantation within the human body.

[0391] For purposes of this specification, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any respect. Instead, the present disclosure covers all novel and non-obvious features and aspects of the various disclosed embodiments in various combinations and subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, nor do they require that any one or more particular advantages or problems be present or solved. Features, elements, or combinations of any embodiment may be combined in other embodiments herein. [Example]

[0392] Example 1: 1. A prosthetic valve for deployment on a native valve, the prosthetic valve comprising: 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 leaflets of the native valve; and an indicator adapted to indicate the capture of the leaflets of the native valve by the one or more anchors.

[0393] Example 2: The prosthetic valve of any embodiment herein, particularly embodiment 1, wherein the indicator is visible under imaging.

[0394] Example 3: The prosthetic valve of any example herein, particularly example 1 or example 2, wherein the indicator changes appearance to indicate capture of the native valve leaflets.

[0395] Example 4: The prosthetic valve of any example herein, particularly Examples 1-3, wherein the visibility of the indicator is reduced under ultrasound imaging to indicate capture of the native valve leaflets.

[0396] Example 5: The prosthetic valve of any embodiment herein, particularly embodiments 1-4, wherein the indicator moves to indicate capture of the native valve leaflets.

[0397] Example 6: The prosthetic valve of any embodiment herein, particularly embodiments 1-5, wherein the indicator is located on one or more anchors.

[0398] Example 7: The prosthetic valve of any embodiment herein, particularly embodiments 1-6, wherein the indicator comprises one or more elongate bodies.

[0399] Example 8: The prosthetic valve of any embodiment herein, particularly embodiment 7, wherein the one or more elongate bodies are positioned on one or more anchors.

[0400] Example 9: The prosthetic valve of any example herein, particularly example 7 or example 8, wherein each of the one or more elongate bodies comprises an axially compressible structure, such as a spring.

[0401] Example 10: The prosthetic valve of any embodiment herein, particularly embodiments 7-9, wherein one or more elongate bodies are positioned on the valve body.

[0402] Example 11: The prosthetic valve of any embodiment herein, particularly embodiments 1-10, wherein the indicator comprises a ring extending circumferentially around the valve body.

[0403] Example 12: The prosthetic valve of any embodiment herein, particularly embodiments 1-11, wherein the indicator extends axially along the valve body.

[0404] Example 13: The prosthetic valve of any embodiment herein, particularly embodiments 1-12, wherein the indicator comprises a loop.

[0405] Example 14: The prosthetic valve of any embodiment herein, particularly embodiments 1-13, wherein the indicator extends from the valve body to at least one of the one or more anchors.

[0406] Example 15: The prosthetic valve of any embodiment herein, particularly embodiments 1-14, wherein the indicator comprises a button adapted to be depressed to indicate capture of the native valve leaflets.

[0407] Example 16: The prosthetic valve of any embodiment herein, particularly embodiments 1-15, wherein the indicator comprises a bladder adapted to be filled with a contrast agent.

[0408] Example 17: The prosthetic valve of any embodiment herein, particularly embodiment 16, wherein the bladder comprises an opening adapted to release a contrast agent to indicate capture of the native valve leaflets.

[0409] Example 18: The prosthetic valve of any embodiment herein, particularly embodiments 1-17, wherein the indicator comprises a channel adapted to pass a contrast agent therethrough.

[0410] Example 19: The prosthetic valve of any embodiment herein, particularly embodiments 1-18, wherein the indicator comprises a sensor.

[0411] Example 20: The prosthetic valve of any embodiment herein, particularly embodiments 1-19, wherein the prosthetic valve is adapted to be deployed in a mitral valve or a tricuspid valve.

[0412] Example 21: 1. A method comprising: deploying a prosthetic valve to a native valve, wherein the prosthetic valve includes 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 the capture of the native valve leaflets by the one or more anchors.

[0413] Example 22: The method of any embodiment herein, particularly embodiment 21, wherein the indicator is adapted to indicate capture of a leaflet of a native valve under imaging.

[0414] Example 23: The method of any example herein, particularly example 21 or example 22, wherein the appearance of the indicator during imaging changes to indicate capture of a leaflet of the native valve.

[0415] Example 24: The method of any embodiment herein, particularly embodiments 21-23, wherein the indicator is adapted to move to indicate capture of a leaflet of the native valve.

[0416] Example 25: The method of any embodiment herein, particularly embodiments 21-24, wherein the indicator is located on one or more anchors.

[0417] Example 26: The method of any embodiment herein, particularly embodiments 21-25, wherein the indicator comprises one or more elongate bodies.

[0418] Example 27: The method of any embodiment herein, particularly embodiment 26, wherein one or more elongate bodies are positioned on the valve body.

[0419] Example 28: The method of any embodiment herein, particularly embodiments 21-27, wherein the indicator comprises a bladder adapted to be filled with a contrast agent.

[0420] Example 29: The method of any embodiment herein, particularly embodiments 21-28, wherein the indicator comprises a sensor.

[0421] Example 30: The method of any embodiment herein, particularly embodiments 21-29, wherein the native valve is a mitral valve or a tricuspid valve.

[0422] Example 31: A sensor system comprising: a prosthetic heart valve for deployment over a native valve of a patient's heart; and one or more sensors adapted to be coupled to the prosthetic heart valve and adapted to detect a condition within the patient's body.

[0423] Example 32: The sensor system described in any embodiment herein, particularly embodiment 31, wherein the prosthetic heart valve includes a valve body and a plurality of anchors adapted to capture the leaflets of the native valve in the space between the anchors for fixing the prosthetic heart valve in the heart and the valve body.

[0424] Example 33: The sensor system of any embodiment herein, particularly embodiment 32, wherein at least one of the sensors is positioned on one or more anchors.

[0425] Example 34: The sensor system of any embodiment herein, particularly embodiment 33, wherein at least one of the sensors is positioned on a tip of one or more anchors.

[0426] Example 35: The sensor system of any embodiment herein, particularly embodiments 32-34, wherein at least one of the sensors is positioned on the valve body.

[0427] Example 36: The sensor system of any embodiment herein, particularly embodiments 31-35, 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.

[0428] Example 37: The sensor system of any embodiment herein, particularly embodiments 31-36, wherein the condition comprises pressure in at least one chamber of the heart.

[0429] Example 38: The sensor system of any embodiment herein, particularly embodiments 31-37, wherein the condition comprises a pressure differential across the prosthetic heart valve.

[0430] Example 39: The sensor system of any embodiment herein, particularly embodiments 31-38, wherein the condition comprises temperature within at least one chamber of the heart.

[0431] Example 40: The sensor system of any embodiment herein, particularly embodiments 31-39, wherein the condition comprises fluid flow in at least one chamber of the heart.

[0432] Example 41: The sensor system of any embodiment herein, particularly embodiments 31-40, wherein the condition comprises a force exerted on at least a portion of the heart by the prosthetic heart valve.

[0433] Example 42: The sensor system of any embodiment herein, particularly embodiments 31-41, further comprising a wireless transmitter for transmitting signals from one or more sensors to a receiver.

[0434] Example 43: The sensor system of any embodiment herein, particularly embodiments 31-42, further comprising a power source for powering the one or more sensors.

[0435] Example 44: The sensor system described in any embodiment herein, particularly embodiments 31-43, wherein the one or more sensors are adapted to be clipped onto a prosthetic heart valve.

[0436] Example 45: The sensor system described in any embodiment herein, particularly embodiment 44, wherein the prosthetic heart valve includes a frame and the one or more sensors are adapted to be clipped to the frame.

[0437] Example 46: The sensor system of any of the embodiments herein, particularly embodiments 31-45, wherein the one or more sensors include a first sensor and a second sensor, the first sensor adapted to detect conditions within an atrium of the patient's heart, and the second sensor adapted to detect conditions within a ventricle of the patient's heart.

[0438] Example 47: The sensor system of any example herein, particularly examples 31-46, 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.

[0439] Example 48: A sensor system as described in any embodiment herein, particularly embodiment 47, wherein the prosthetic heart valve includes a valve body supporting one or more prosthetic valve leaflets, and the prosthetic heart valve further includes an electrical conduit extending along the valve body and connecting the sensor to the first electrical terminal.

[0440] Example 49: A sensor system described in any embodiment herein, particularly embodiments 31 to 48, wherein the prosthetic heart valve comprises an inner body and a sealing body positioned radially outside the inner body and adapted to seal fluid flow with the native valve, and one or more sensors are positioned between the inner body and the sealing body.

[0441] Example 50: The sensor system of any embodiment herein, particularly embodiments 31-49, wherein the prosthetic heart valve is adapted to be deployed in a mitral valve or a tricuspid valve.

[0442] Example 51: The sensor system of any embodiment herein, particularly embodiments 31-50, further comprising a substrate, wherein the one or more sensors are positioned on the substrate, and wherein the sensor system further comprises electrical detection traces positioned on the substrate and adapted to detect a force applied to the substrate.

[0443] Example 52: A sensor system described in any embodiment herein, particularly embodiment 51, wherein the prosthetic heart valve is adapted to expand radially from a compressed configuration to an expanded configuration and the substrate is adapted to expand radially outward with the prosthetic heart valve.

[0444] Example 53: The sensor system of any embodiment herein, particularly embodiment 52, wherein the substrate has an undulating shape adapted to expand radially outward in the prosthetic heart valve.

[0445] Example 54: The sensor system described in any example herein, particularly examples 51-53, wherein one or more sensors are positioned on a substrate and the plurality of sensors are electrically coupled to electrical conduits positioned on the substrate.

[0446] Example 55: The sensor system of any embodiment herein, particularly embodiments 51-54, wherein the electrical detection trace comprises a disconnection portion adapted to disconnect an electrical conduit of the delivery device.

[0447] Example 56: 1. A method comprising: deploying a sensor system on a native valve, the sensor system including: a prosthetic heart valve for deployment on the native valve of a patient's heart; and one or more sensors adapted to be coupled to the prosthetic heart valve and adapted to detect a condition within the patient's body.

[0448] Example 57: The method of any embodiment herein, particularly embodiment 56, wherein the prosthetic heart valve includes a valve body and one or more anchors adapted to anchor the valve body to the native valve by capturing the leaflets of the native valve, and the condition includes whether at least one of the anchors has captured a leaflet of the native valve.

[0449] Example 58: The method of any embodiment herein, particularly embodiment 57, wherein at least one sensor is positioned on one or more anchors.

[0450] Example 59: The method of any embodiment herein, particularly embodiments 56-58, 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.

[0451] Example 60: The method of any embodiment herein, particularly embodiments 56-59, wherein the condition comprises pressure in at least one chamber of the heart.

[0452] Example 61: The method of any embodiment herein, particularly embodiments 56-60, wherein the condition comprises the temperature in at least one chamber of the heart.

[0453] Example 62: The method of any embodiment herein, particularly embodiments 56-61, wherein the condition comprises fluid flow in at least one chamber of the heart.

[0454] Example 63: The method of any embodiment herein, particularly embodiments 56-62, wherein the condition comprises a force exerted by the prosthetic heart valve on at least a portion of the heart.

[0455] Example 64: The method of any embodiment herein, particularly embodiments 56-63, wherein the wireless transmitter is for transmitting signals from one or more sensors to a receiver.

[0456] Example 65: The method of any of the embodiments herein, particularly embodiments 56-64, wherein the prosthetic heart valve is for deployment in a mitral valve or a tricuspid valve.

[0457] Example 66: A delivery system for delivering an implant to a native heart valve, comprising: 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.

[0458] Example 67: A delivery system described in any embodiment herein, particularly embodiment 66, wherein the delivery device includes a capsule adapted to be retracted to release the implant, and one or more sensors are coupled to the capsule.

[0459] Example 68: The delivery system of any example herein, particularly example 67, wherein the one or more sensors comprise a plurality of sensors spaced apart circumferentially around the capsule.

[0460] 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 sensors spaced apart along the length.

[0461] Example 70: The delivery system of any embodiment herein, particularly embodiment 69, wherein the multiple sensors are aligned with one another along the length of the capsule.

[0462] Example 71: The delivery system of any embodiment herein, particularly embodiments 66-70, wherein one or more sensors are adapted to sense contact between the delivery device and a portion of the native heart valve.

[0463] Example 72: A delivery system described in any embodiment herein, particularly embodiments 66-71, wherein one or more sensors are adapted to sense contact between the delivery device and one or more native leaflets of the native heart valve.

[0464] Example 73: The delivery system of any embodiment herein, particularly embodiments 66-72, wherein the one or more sensors comprises a plurality of sensors, a first sensor of the plurality of sensors adapted to provide a signal indicative of contact with a portion of the native heart valve, and a second sensor of the plurality of sensors adapted to indicate lack of contact with the portion of the native heart valve simultaneously with the first sensor providing a signal.

[0465] Example 74: The delivery system described in any embodiment herein, particularly embodiments 66-73, further comprising 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.

[0466] Example 75: The delivery system of any embodiment herein, particularly embodiment 74, wherein the indicator device comprises one or more of a visual indicator, a tactile indicator, or an audible indicator.

[0467] Example 76: The delivery system described in any example herein, particularly example 74 or example 75, wherein the indicator device is adapted to indicate the depth of the delivery device relative to the native heart valve.

[0468] Example 77: The delivery system of any embodiment herein, particularly embodiments 74-76, wherein the indicator device is adapted to indicate failure of the implant to capture the native valve leaflets.

[0469] Example 78: The delivery system described in any embodiment herein, particularly embodiments 66-77, further comprising a processor for receiving one or more signals from the one or more sensors, wherein the processor determines the depth of the delivery device relative to the native heart valve based on the one or more signals.

[0470] Example 79: The delivery system of any embodiment herein, particularly embodiments 66-78, further comprising a processor for receiving one or more signals from the one or more sensors, wherein the processor is for determining failure of the implant to capture the native valve leaflets based on the one or more signals.

[0471] Example 80: The delivery system of any example herein, particularly examples 66-79, further comprising an implant, wherein the implant comprises a prosthetic heart valve.

[0472] Example 81: 1. A method comprising: delivering an implant to a native heart valve utilizing a delivery system, the delivery system including a delivery device for delivering the implant to the native heart valve and one or more sensors coupled to the delivery device for sensing a spatial relationship between the delivery device and at least a portion of the native heart valve.

[0473] Example 82: The method of any embodiment herein, particularly embodiment 81, wherein the delivery device includes a capsule adapted to be retracted to release the implant, and wherein one or more sensors are coupled to the capsule.

[0474] Example 83: The method of any embodiment herein, particularly embodiment 82, wherein the one or more sensors comprise a plurality of sensors spaced apart circumferentially around the capsule.

[0475] Example 84: The method of any example herein, particularly example 82, wherein the capsule has a length and the one or more sensors include a plurality of sensors spaced apart along the length.

[0476] Example 85: The method of any embodiment herein, particularly embodiments 81-84, wherein one or more sensors are adapted to sense contact between the delivery device and a portion of the native heart valve.

[0477] Example 86: The method described in any embodiment herein, particularly embodiments 81-85, wherein one or more sensors are adapted to sense contact between the delivery device and one or more native leaflets of the native heart valve.

[0478] Example 87: The method of any embodiment herein, particularly embodiments 81-86, 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.

[0479] Example 88: The method of any embodiment herein, particularly embodiment 87, wherein the indicator device comprises one or more of a visual indicator, a tactile indicator, or an audible indicator.

[0480] Example 89: The method of any embodiment herein, particularly embodiments 81-88, wherein the processor is for receiving one or more signals from one or more sensors, and the processor determines the depth of the delivery device relative to the native heart valve based on the one or more signals.

[0481] Example 90: The method of any embodiment herein, particularly embodiments 81-89, wherein the processor is for receiving one or more signals from the one or more sensors, and the processor is for determining failure of the implant to capture the native valve leaflets based on the one or more signals.

[0482] Example 91: A delivery system for delivering an implant to a native heart valve, comprising: 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.

[0483] Example 92: The delivery system described in any embodiment herein, particularly embodiment 91, wherein the imaging device comprises an ultrasound imaging device.

[0484] Example 93: The delivery system described in any example herein, particularly example 91 or example 92, wherein the imaging device comprises an optical coherence tomography imaging device.

[0485] Example 94: The delivery system of any embodiment herein, particularly embodiments 91-93, wherein the imaging device is adapted to image at least a portion of a native heart valve.

[0486] Example 95: The delivery system of any embodiment herein, particularly embodiments 91-94, wherein the imaging device is adapted to image one or more leaflets of a native heart valve.

[0487] Example 96: The delivery system of any embodiment herein, particularly embodiments 91-95, wherein the delivery device includes an elongate sheath and the imaging device is adapted to extend within the elongate sheath.

[0488] Example 97: The delivery system described in any embodiment herein, particularly embodiment 96, wherein the elongate sheath includes a distal end and the imaging device is adapted to protrude from the distal end of the elongate sheath.

[0489] Example 98: The delivery system of any embodiment herein, particularly embodiment 97, wherein the elongate sheath comprises a capsule for surrounding the implant, the capsule comprising a distal end of the elongate sheath.

[0490] Example 99: The delivery system of any embodiment herein, particularly embodiments 91-98, wherein the imaging device comprises a catheter.

[0491] Example 100: A delivery system described in any embodiment herein, particularly embodiments 91-99, wherein the implant includes 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.

[0492] Example 101: The delivery system of any embodiment herein, particularly embodiments 91-100, further comprising an implant, the implant comprising a prosthetic heart valve having a valve body and one or more anchors for extending over the distal tips of the leaflets of a native valve.

[0493] Example 102: The delivery system described in any embodiment herein, particularly embodiment 101, wherein the imaging device is adapted to image through the valve body of the prosthetic heart valve.

[0494] Example 103: The delivery system described in any embodiment herein, particularly embodiment 101 or embodiment 102, wherein the valve body includes one or more imaging windows for imaging by the imaging device.

[0495] Example 104: A delivery system described in any embodiment herein, particularly embodiment 103, wherein the one or more anchors include multiple anchors circumferentially spaced apart from each other, and the one or more imaging windows include multiple imaging windows circumferentially spaced apart from each other, each positioned in one of the anchors.

[0496] Example 105: The delivery system of any embodiment herein, particularly embodiments 91-104, wherein the delivery device is adapted to deliver the implant to the mitral valve or tricuspid valve.

[0497] Example 106: 1. A method comprising: delivering an implant to a native heart valve utilizing a delivery system, the delivery system including 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.

[0498] Example 107: The method described in any embodiment herein, particularly embodiment 106, wherein the imaging device includes an ultrasound imaging device.

[0499] Example 108: The method described in any embodiment herein, particularly embodiment 106 or embodiment 107, wherein the imaging device comprises an optical coherence tomography imaging device.

[0500] Example 109: The method according to any embodiment herein, particularly embodiments 106-108, wherein the imaging device is adapted to image at least a portion of a native heart valve.

[0501] Example 110: The method according to any embodiment herein, particularly embodiments 106-109, wherein the imaging device is adapted to image one or more leaflets of a native heart valve.

[0502] Example 111: The method of any of the embodiments herein, particularly embodiments 106-110, wherein the delivery device includes an elongate sheath and the imaging device is adapted to extend within the elongate sheath.

[0503] Example 112: The method described in any embodiment herein, particularly embodiment 111, wherein the elongate sheath includes a distal end and the imaging device is adapted to protrude from the distal end of the elongate sheath.

[0504] Example 113: The method of any embodiment herein, particularly embodiment 112, wherein the elongate sheath comprises a capsule for surrounding the implant, the capsule comprising a distal end of the elongate sheath.

[0505] Example 114: The method of any embodiment herein, particularly embodiments 106-113, wherein the imaging device comprises a catheter.

[0506] Example 115: The method described in any of the embodiments herein, particularly embodiments 106 to 114, wherein the implant includes 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.

[0507] Example 116: A sensor system including a sensor and one or more anchors coupled to the sensor and adapted to engage an interior heart wall of a heart chamber to anchor the sensor to the interior heart wall.

[0508] Example 117: A sensor system described in any embodiment herein, particularly embodiment 116, wherein one or more anchors include a clip.

[0509] Example 118: A sensor system described in any embodiment herein, particularly embodiment 117, wherein the clip includes a first arm and a second arm, the first arm and the second arm adapted to compress tissue of the internal heart wall between the first arm and the second arm.

[0510] Example 119: The sensor system of any embodiment herein, particularly embodiment 118, further comprising a support, wherein the first arm and the second arm are each adapted to pivot relative to the support.

[0511] Example 120: The sensor system of any embodiment herein, particularly embodiment 119, wherein the support comprises a housing for the sensor.

[0512] Example 121: The sensor system described in any embodiment herein, particularly embodiments 118-120, wherein the first arm or the second arm includes one or more penetrators for penetrating the internal heart wall.

[0513] Example 122: The sensor system described in any embodiment herein, particularly embodiments 116-121, wherein one or more anchors are adapted to penetrate the internal heart wall.

[0514] Example 123: A sensor system described in any embodiment herein, particularly embodiments 116-122, wherein one or more anchors include a threaded body adapted to penetrate the internal heart wall.

[0515] Example 124: The sensor system of any embodiment herein, particularly embodiments 116-123, wherein the sensor is adapted to sense a condition within a chamber of the heart.

[0516] Example 125: The sensor system of any embodiment herein, particularly embodiments 116-124, wherein the sensor is adapted to sense a property of a fluid within a chamber of the heart.

[0517] Example 126: The sensor system of any embodiment herein, particularly embodiments 116-125, wherein the sensor comprises a pressure sensor.

[0518] Example 127: A sensor system described in any embodiment herein, particularly embodiments 116-126, wherein the sensor is adapted to protrude into a chamber of the heart with one or more anchors engaged with the internal heart wall.

[0519] Example 128: The sensor system of any embodiment herein, particularly embodiments 116-127, further comprising a wireless transmitter for transmitting a signal from the sensor to the receiver.

[0520] Example 129: The sensor system of any embodiment herein, particularly embodiments 116-128, further comprising a power source for powering the sensor.

[0521] Example 130: The sensor system described in any embodiment herein, particularly embodiments 116-129, wherein the sensor is adapted to be positioned at multiple locations along the internal heart wall.

[0522] Example 131: 1. A method comprising: deploying a sensor system in a native valve, the sensor system including a sensor and one or more anchors coupled to the sensor and adapted to engage an interior heart wall of a heart chamber to anchor the sensor to the interior heart wall.

[0523] Example 132: The method of any embodiment herein, particularly embodiment 131, wherein one or more anchors comprise a clip.

[0524] Example 133: The method of any example herein, particularly example 132, wherein the clip comprises a first arm and a second arm, the first arm and the second arm adapted to compress tissue of the interior heart wall between the first arm and the second arm.

[0525] Example 134: The method of any example herein, particularly example 133, wherein the first arm or the second arm comprises one or more penetrators for penetrating the interior heart wall.

[0526] Example 135: The method of any embodiment herein, particularly embodiments 131-134, wherein the one or more anchors are adapted to penetrate the interior heart wall.

[0527] Example 136: The method of any of the embodiments herein, particularly embodiments 131-135, wherein one or more anchors comprise a threaded body adapted to penetrate the interior heart wall.

[0528] Example 137: The method of any embodiment herein, particularly embodiments 131-136, wherein the sensor is adapted to sense a condition within a chamber of the heart.

[0529] Example 138: The method of any embodiment herein, particularly embodiments 131-137, wherein the sensor is adapted to sense a property of a fluid within a chamber of the heart.

[0530] Example 139: The method of any embodiment herein, particularly embodiments 131-138, wherein the sensor comprises a pressure sensor.

[0531] Example 140: The method of any embodiment herein, particularly embodiments 131-139, wherein the sensor is adapted to protrude into a chamber of the heart with one or more anchors engaging the interior heart wall.

[0532] Example 141: A system including a prosthetic heart valve for deployment over a native valve of a patient's heart, at least a portion of the prosthetic heart valve including a pacemaker electrical conduit adapted to carry an electrical signal for pacing the heart.

[0533] Example 142: A system described in any embodiment herein, particularly embodiment 141, wherein the prosthetic heart valve includes one or more anchors adapted to secure the prosthetic heart valve to the native valve, and the pacemaker electrical conduit includes at least a portion of the one or more anchors.

[0534] Example 143: A system described in any embodiment herein, particularly embodiment 142, wherein the artificial heart valve includes a valve body supporting one or more artificial valve leaflets, and one or more anchors extending radially outward from the valve body.

[0535] Example 144: A system described in any embodiment herein, particularly embodiment 142 or embodiment 143, wherein one or more anchors are adapted to extend beyond the distal tips of the leaflets of the native valve.

[0536] Example 145: The system described in any embodiment herein, particularly embodiments 141-144, further comprising a first electrical terminal for electrically connecting the pacemaker electrical conduit to a second electrical terminal of the pacemaker.

[0537] Example 146: A system described in any embodiment herein, particularly embodiment 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.

[0538] Example 147: A system described in any embodiment herein, particularly embodiment 145 or embodiment 146, wherein the prosthetic heart valve includes a frame and the first electrical terminal is coupled to the frame.

[0539] Example 148: A system described in any embodiment herein, particularly embodiments 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.

[0540] Example 149: A system described in any embodiment herein, particularly embodiment 148, wherein the second portion includes the tip of a pacemaker electrical conduit.

[0541] Example 150: A system described in any embodiment herein, particularly embodiment 148 or embodiment 149, wherein the valve body includes a frame and the first portion of the pacemaker electrical conduit extends along the frame.

[0542] Example 151: The system described in any embodiment herein, particularly embodiments 148-150, wherein the second portion is adapted to contact the surface of the heart.

[0543] Example 152: The system of any embodiment herein, particularly embodiments 148-151, wherein the second portion comprises a coil.

[0544] Example 153: A system described in any embodiment herein, particularly embodiments 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.

[0545] Example 154: A system described in any embodiment herein, particularly embodiments 141 to 153, wherein the prosthetic heart valve comprises an inner body and a sealing body positioned radially outward from the inner body and adapted to seal fluid flow between the inner body and the native valve.

[0546] Example 155: The system described in any embodiment herein, particularly embodiments 141 to 154, wherein the prosthetic heart valve is adapted to be deployed in a mitral valve or tricuspid valve.

[0547] Example 156: 1. A method comprising: deploying a prosthetic heart valve over a native valve of a patient's heart, at least a portion of the prosthetic heart valve including a pacemaker electrical conduit adapted to carry an electrical signal for pacing the heart.

[0548] Example 157: The method described in any embodiment herein, particularly embodiment 156, wherein the prosthetic heart valve includes one or more anchors adapted to secure the prosthetic heart valve to the native valve, and the pacemaker electrical conduit includes at least a portion of the one or more anchors.

[0549] Example 158: A method as described in any embodiment herein, particularly embodiment 157, wherein the prosthetic heart valve includes a valve body supporting one or more prosthetic valve leaflets, and one or more anchors extending radially outward from the valve body.

[0550] Example 159: The method described in any embodiment herein, particularly embodiment 157 or embodiment 158, wherein one or more anchors are adapted to extend beyond the distal tips of the leaflets of the native valve.

[0551] Example 160: The method of any embodiment herein, particularly embodiments 156-159, wherein the first electrical terminal is for electrically connecting a pacemaker electrical conduit to the second electrical terminal of the pacemaker.

[0552] Example 161: The method of any embodiment herein, particularly embodiment 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.

[0553] Example 162: The method of any embodiment herein, particularly embodiment 160 or embodiment 161, wherein the prosthetic heart valve comprises a frame and the first electrical terminal is coupled to the frame.

[0554] Example 163: The method described in any embodiment herein, particularly embodiments 156-162, 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.

[0555] Example 164: The method of any embodiment herein, particularly embodiment 163, wherein the second portion comprises a tip of a pacemaker electrical conduit.

[0556] Example 165: The method of any embodiment herein, particularly embodiment 163 or embodiment 164, wherein the valve body includes a frame and the first portion of the pacemaker electrical conduit extends along the frame.

[0557] Example 166: 1. A system comprising: a prosthetic heart valve for deployment into a native valve of a patient's heart, the prosthetic heart valve including one or more anchors adapted to hook around the leaflets of the one or more native valves 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 retention mechanism adapted to hold the leaflets of the one or more native valves in a contracted state when the one or more anchors at least partially hook around the leaflets of the one or more native valves.

[0558] Example 167: A system described in any embodiment herein, particularly embodiment 166, wherein the retention mechanism includes one or more suction ports for applying suction force to one or more native valve leaflets to retain the one or more native valve leaflets in a contracted state.

[0559] Example 168: A system described in any embodiment herein, particularly embodiment 167, wherein one or more suction ports are positioned on the delivery catheter.

[0560] Example 169: A system described in any embodiment herein, particularly embodiments 166 to 168, wherein the retention mechanism includes a coil for extending around the radially outward-facing surfaces of one or more native valve leaflets.

[0561] Example 170: A system described in any embodiment herein, particularly embodiment 169, wherein the coil is adapted to be deployed from a delivery catheter.

[0562] Example 171: A system described in any embodiment herein, particularly embodiments 166-170, wherein the retention mechanism includes one or more barbs for engaging with the leaflets of one or more native valves.

[0563] Example 172: A system described in any embodiment herein, particularly embodiment 171, wherein one or more barbs are coupled to one or more arms.

[0564] Example 173: A system described in any embodiment herein, particularly embodiment 172, wherein one or more arms are adapted to protrude radially outward from the delivery catheter.

[0565] Example 174: The system described in any embodiment herein, particularly embodiments 171-173, wherein the one or more barbs include a plurality of barbs circumferentially spaced apart from one another.

[0566] Example 175: The system described in any embodiment herein, particularly embodiments 171-174, wherein one or more barbs are coupled to the sheath.

[0567] Example 176: A system described in any embodiment herein, particularly embodiments 166 to 175, wherein the retention mechanism includes one or more arms adapted to hook around the leaflets of one or more native valves.

[0568] Example 177: A system described in any embodiment herein, particularly embodiment 176, wherein one or more arms are adapted to retract radially inward.

[0569] Example 178: A system described in any embodiment herein, particularly embodiment 176 or embodiment 177, wherein the delivery catheter includes a guidewire lumen and one or more arms are adapted to protrude radially outward from the guidewire lumen.

[0570] Example 179: A system described in any embodiment herein, particularly embodiments 176 to 178, wherein the delivery catheter includes a nose body and one or more arms are adapted to protrude radially outward from the nose body.

[0571] Example 180: The system of any embodiment herein, particularly embodiments 166-179, wherein the prosthetic heart valve comprises a prosthetic mitral heart valve or a prosthetic tricuspid heart valve.

[0572] Example 181: 1. A method comprising: deploying, using a delivery catheter, a prosthetic heart valve into a native valve of a patient's heart, wherein the prosthetic heart valve includes one or more anchors adapted to hook around leaflets of the one or more native valves to anchor the prosthetic heart valve to the native valve; and using a retention mechanism to hold the leaflets of the one or more native valves in a contracted state when the one or more anchors at least partially hook around the leaflets of the one or more native valves.

[0573] Example 182: The method described in any embodiment herein, particularly embodiment 181, wherein the retention mechanism includes one or more suction ports for applying suction force to the leaflets of one or more native valves to retain the leaflets of the one or more native valves in a contracted state.

[0574] Example 183: The method described in any embodiment herein, particularly embodiment 181 or embodiment 182, wherein the retention mechanism includes a coil for extending around the radially outward-facing surface of one or more native valve leaflets.

[0575] Example 184: The method of any embodiment herein, particularly embodiments 181-183, wherein the retention mechanism includes one or more barbs for engaging the leaflets of one or more native valves.

[0576] Example 185: The method described in any embodiment herein, particularly embodiments 181 to 184, wherein the retention mechanism includes one or more arms adapted to hook around the leaflets of one or more native valves.

[0577] Example 186: 1. 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 including a plurality of elongated prongs and a skirt, wherein each of the plurality of elongated prongs is coupled to the inflow end portion of the inner frame and has a first end portion that 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; and one or more anchors adapted to anchor the prosthetic valve to the native valve by capturing the leaflets of the native valve.

[0578] Example 187: An artificial valve as described in any embodiment herein, particularly embodiment 186, wherein one or more anchors are coupled to the outflow end portion of the inner frame and protrude radially outward from the outflow end portion of the inner frame.

[0579] Example 188: An artificial valve as described in any embodiment herein, particularly embodiment 186 or embodiment 187, wherein one or more anchors are adapted to hook around one or more leaflets of the native valve and anchor the artificial valve to the native valve.

[0580] Example 189: The prosthetic valve of any embodiment herein, particularly embodiments 186-188, wherein the elongated prongs are circumferentially spaced about the inflow end portion of the inner frame.

[0581] Example 190: The prosthetic valve of any embodiment herein, particularly embodiments 186-189, wherein the plurality of elongated prongs form a plateau portion of the seal.

[0582] Example 191: The prosthetic valve described in any embodiment herein, particularly embodiment 190, wherein the second end portions of the plurality of elongated prongs form the outermost portion of the plateau portion.

[0583] Example 192: The prosthetic valve of any embodiment herein, particularly embodiments 186-191, wherein each of the plurality of elongated prongs is deflectable in the axial dimension of the prosthetic valve.

[0584] Example 193: An artificial valve as described in any embodiment herein, particularly embodiments 186 to 192, wherein the skirt extends along the plurality of elongated prongs from the second end portions of the plurality of elongated prongs to the first end portions of the plurality of elongated prongs.

[0585] Example 194: A prosthetic valve as described in any embodiment herein, particularly embodiments 186-193, wherein a portion of the skirt extends along the inner frame and includes a plurality of openings that allow blood to enter the pocket.

[0586] Example 195: The prosthetic valve of any embodiment herein, particularly embodiments 186-194, wherein the prosthetic valve comprises a prosthetic mitral heart valve or a prosthetic tricuspid heart valve.

[0587] Example 196: 1. A method of deploying a prosthetic heart valve to a native heart valve, the method comprising: deploying a prosthetic heart valve to include one or more prosthetic leaflets; an inner frame supporting the one or more prosthetic leaflets and having an inflow end portion and an outflow end portion; a sealing body positioned radially outward of the inner frame and including a plurality of elongated prongs and a skirt, wherein each of the plurality of elongated prongs is coupled to the inflow end portion of the inner frame and has a first end portion that projects 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; and one or more anchors adapted to anchor the prosthetic heart valve to the native heart valve by capturing the leaflets of the native valve.

[0588] Example 197: The method described in any embodiment herein, particularly embodiment 196, wherein one or more anchors are coupled to the outflow end portion of the inner frame and protrude radially outward from the outflow end portion of the inner frame.

[0589] Example 198: The method described in any embodiment herein, particularly embodiment 196 or embodiment 197, wherein 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.

[0590] Example 199: The method of any embodiment herein, particularly embodiments 196-198, wherein the plurality of elongated prongs are circumferentially spaced apart from one another around the inflow end portion of the inner frame.

[0591] Example 200: The method of any embodiment herein, particularly embodiments 196-199, wherein a plurality of elongated prongs form a plateau portion of the encapsulant.

[0592] Example 201: 1. A prosthetic valve for deployment in a native valve, comprising: one or more prosthetic valve leaflets; and a support structure supporting the one or more prosthetic valve leaflets and including at least one ring coupled to a skirt, wherein the skirt or the at least one ring is adapted to seal with at least a portion of the native valve.

[0593] Example 202: The prosthetic valve of any embodiment herein, particularly embodiment 201, wherein at least one ring is flexible.

[0594] Example 203: An artificial valve as described in any embodiment herein, particularly embodiment 201 or embodiment 202, wherein 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.

[0595] Example 204: The prosthetic valve of any embodiment herein, particularly embodiment 203, wherein the skirt extends between the first ring and the second ring to form a sheath.

[0596] Example 205: The prosthetic valve described in any embodiment herein, particularly embodiment 203 or embodiment 204, further comprising a support coupled to one or more prosthetic valve leaflets and coupled to the first ring and the second ring using a skirt.

[0597] Example 206: The prosthetic valve of any embodiment herein, particularly embodiment 205, wherein the support comprises a third ring.

[0598] Example 207: The prosthetic valve of any embodiment herein, particularly embodiments 203-206, further comprising one or more tethers for axially compressing the first ring and the second ring together.

[0599] Example 208: The prosthetic valve of any embodiment herein, particularly embodiments 201-207, wherein the support structure includes an inner frame and a skirt extending radially outward from the inner frame to form a disc supported on the outer periphery of the disc by at least one ring.

[0600] Example 209: The prosthetic valve of any embodiment herein, particularly embodiment 208, wherein the disc is adapted to be positioned on the inflow side of the native valve.

[0601] Example 210: An artificial valve as described in any embodiment herein, particularly embodiments 201-209, wherein the support structure includes an inner frame and an outer frame positioned radially outward of the inner frame, and a skirt extending radially outward from the outer frame to form a disc supported on the outer periphery of the disc by at least one ring.

[0602] Example 211: The prosthetic valve of any embodiment herein, particularly embodiments 208-210, further comprising one or more anchors adapted to secure the prosthetic valve to the native valve by capturing the leaflets of the native valve.

[0603] Example 212: The prosthetic valve of any embodiment herein, particularly embodiments 201-211, wherein at least one ring is biased radially outward.

[0604] Example 213: The prosthetic valve of any embodiment herein, particularly embodiments 201-212, wherein at least one ring is adapted to change shape.

[0605] Example 214: The prosthetic valve of any of the embodiments herein, particularly embodiments 201-213, wherein at least one ring comprises a first end and a second end, the first end adapted to slide relative to the second end to change the diameter of the at least one ring.

[0606] Example 215: The prosthetic valve of any embodiment herein, particularly embodiments 201-214, wherein the prosthetic valve comprises a prosthetic mitral heart valve or a prosthetic tricuspid heart valve.

[0607] Example 216: 1. A method for deploying a prosthetic heart valve over a native heart valve, the prosthetic heart valve including one or more prosthetic leaflets and a support structure including at least one ring for supporting the one or more prosthetic leaflets and coupled to a skirt, wherein the method is performed such that the skirt or the at least one ring is adapted to seal with at least a portion of the native valve.

[0608] Example 217: The method of any embodiment herein, particularly embodiment 216, wherein at least one ring is pliable.

[0609] Example 218: The method described in any embodiment herein, particularly embodiment 216 or embodiment 217, wherein at least one ring comprises 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.

[0610] Example 219: The method of any embodiment herein, particularly embodiment 218, wherein a skirt extends between the first ring and the second ring to form a sheath.

[0611] Example 220: The method of any embodiment herein, particularly embodiments 216-219, wherein the support structure includes an inner frame, a skirt extending radially outward from the inner frame to form a disk supported on the outer periphery of the disk by at least one ring.

[0612] Example 221: A sensor system including an artificial cardiac implant, a substrate, a sensor positioned on the substrate and adapted to detect a state of the artificial cardiac implant, and a sensor body including electrical detection traces positioned on the substrate and adapted to detect a force applied to the substrate.

[0613] Example 222: The sensor system of any embodiment herein, particularly embodiment 221, wherein the electrical detection traces are adapted to detect partial or complete fractures in the substrate.

[0614] Example 223: The sensor system of any embodiment herein, particularly embodiment 221 or embodiment 222, wherein the electrical detection trace is adapted to provide an electrical signal indicative of an amount of force applied to the substrate.

[0615] Example 224: The sensor system of any embodiment herein, particularly embodiments 221-223, wherein the substrate comprises a flexible circuit board.

[0616] Example 225: The sensor system of any embodiment herein, particularly embodiments 221-224, wherein the sensor comprises an electrode.

[0617] Example 226: The sensor system of any embodiment herein, particularly embodiments 221-225, wherein the artificial cardiac implant comprises a clip adapted to clip the cardiac valve leaflets together.

[0618] Example 227: A sensor system described in any embodiment herein, particularly embodiment 226, wherein the sensor is adapted to detect contact between the clip and the cardiac valve leaflets.

[0619] Example 228: The sensor system described herein in any example, particularly example 226 or example 227, wherein the sensor body comprises a strip adapted to be pulled from a portion of the clip.

[0620] Example 229: A sensor system described in any embodiment herein, particularly embodiment 228, wherein the electrical detection traces are adapted to detect partial or complete rupture of the substrate upon in vivo removal of the sensor body from a portion of the clip.

[0621] Example 230: The sensor system described in any embodiment herein, particularly embodiments 227-229, wherein the clip includes one or more arms and the sensor body is positioned on at least one of the one or more arms.

[0622] Example 231: The sensor system described in any embodiment herein, particularly embodiments 221-230, wherein the artificial cardiac implant includes a prosthetic heart valve having one or more anchors adapted to anchor the artificial cardiac implant to a native heart valve, and the sensor is adapted to detect whether at least one of the anchors has captured a leaflet of the native valve.

[0623] Example 232: A sensor system as described in any embodiment herein, particularly embodiment 231, wherein the prosthetic heart valve is adapted to expand radially from a compressed configuration to an expanded configuration and the substrate is adapted to expand radially outward with the prosthetic heart valve.

[0624] Example 233: The sensor system of any embodiment herein, particularly embodiments 221-232, wherein the electrical detection trace has a loop shape having a first end and a second end, and includes a first electrical terminal at the first end and a second electrical terminal at the second end.

[0625] Example 234: The sensor system of any embodiment herein, particularly embodiments 221-233, wherein the electrical sensing traces conduct electricity through the sensor.

[0626] Example 235: The sensor system of any embodiment herein, particularly embodiments 221-234, wherein the electrical sensing traces include strain gauges on the substrate.

[0627] Example 236: 1. A method comprising: deploying an artificial cardiac implant in a native heart valve; and detecting a condition of the artificial cardiac implant utilizing a sensor body coupled to the artificial cardiac implant, the sensor body including a substrate, a sensor positioned on the substrate and adapted to detect a condition of the artificial cardiac implant, and an electrical detection trace positioned on the substrate and adapted to detect a force applied to the substrate.

[0628] Example 237: The method of any embodiment herein, especially embodiment 236, wherein the electrical detection traces are adapted to detect partial or complete fractures in the substrate.

[0629] Example 238: The method of any embodiment herein, particularly embodiment 236 or embodiment 237, wherein the electrical detection traces are adapted to provide an electrical signal indicative of the amount of force applied to the substrate.

[0630] Example 239: The method of any embodiment herein, particularly embodiments 236-238, wherein the substrate comprises a flexible circuit board.

[0631] Example 240: The method of any embodiment herein, particularly embodiments 236-239, wherein the sensor comprises an electrode.

[0632] Any of the features of any of the embodiments, including but not limited to any of the above-mentioned 1-240 embodiments, are applicable to all other aspects and embodiments identified herein, including but not limited to any of the above-mentioned 1-240 embodiments. Moreover, any feature of various embodiments, including but not limited to any of the above-mentioned 1-240 embodiments, can be independently combined, partially or in whole, in any manner, with other embodiments described herein; for example, one, two, three, or more embodiments can be combined, in whole or in part. Furthermore, any feature of various embodiments, including but not limited to any of the above-mentioned 1-240 embodiments, can be optional with other embodiments. Any embodiment of a method can be performed by a system or device of another embodiment, and any aspect or embodiment of a system or device can be configured to perform a method of another embodiment or embodiment, including but not limited to any of the above-mentioned 1-240 embodiments.

[0633] In summary, while aspects of the present specification are emphasized by reference to particular examples, it will be understood that those skilled in the art will readily recognize that these disclosed examples are merely illustrative of the principles of the subject matter disclosed herein. Accordingly, it will be understood that the disclosed subject matter is not limited in any way to the particular methodology, protocols, and / or reagents, etc., described herein. Therefore, various modifications or variations of the disclosed subject matter, or alternative configurations, can be made in accordance with the teachings herein without departing from the spirit of the specification. Finally, the terminology used herein is for the purpose of describing particular examples only and is not intended to limit the scope of the systems, devices, and methods as disclosed herein, which are defined solely by the claims. Thus, the systems, devices, and methods are not limited to those precisely as shown and described.

[0634] Particular embodiments of the systems, devices, and methods are described herein, including the best modes known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors anticipate that skilled artisans will adopt such variations as appropriate, and the inventors intend for the systems, devices, and methods to be practiced otherwise than as specifically described herein. Accordingly, the systems, devices, and methods include all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. Moreover, unless otherwise indicated herein or clearly contradicted by context, combinations of the above-described examples in all possible variations thereof are encompassed by the systems, devices, and methods.

[0635] Groupings of alternative embodiments, elements, or steps of systems, devices, and methods are not to be construed as limitations. Members of each group may be referenced and claimed individually or in any combination with members of other groups disclosed herein. It is contemplated that one or more members of a group may be included within, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion is made, the specification is deemed to include the modified group, and thus fulfills the recitation of all Markush groups used in the appended claims.

[0636] 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 in all instances as being modified by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so qualified encompasses approximations that may vary but may still perform the desired operation or process described herein.

[0637] The terms "a," "an," "the," and similar reference words, as used in the context of describing systems, devices, and methods (particularly in the context of the claims below), should be construed to cover both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. All methods described herein may be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all example or exemplary language (e.g., "etc.") as provided herein is merely to more clearly illustrate the systems, devices, and methods and does not pose a limitation on the scope of the otherwise claimed systems, devices, and methods. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0638] All patents, patent publications, and other publications referenced or identified herein are individually and explicitly incorporated by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described therein that may be used in connection with the systems, apparatus, and methods. These publications are provided only as they are disclosed prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to retroactively rely on such disclosure by virtue of prior invention or for any other reason. All statements as to the date or contents of these documents are based on the 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. 1. A prosthetic valve for deployment within a native valve, comprising: A valve body; one or more prosthetic valve leaflets coupled to the valve body to allow blood to flow in only one direction through the valve body; one or more anchors adapted to anchor the valve body to the native valve by capturing the leaflets of the native valve; and an indicator adapted to indicate capture of a leaflet of the native valve by the one or more anchors.

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

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

4. 4. The prosthetic valve of claim 1, 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 a leaflet of the native valve.

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 elongate bodies.

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

9. 9. The prosthetic valve of 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 arranged 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 bladder adapted to be filled with a contrast agent.

14. The artificial 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 in a mitral valve or a tricuspid valve.

16. 1. A sensor system comprising: a prosthetic heart valve for deployment over a native valve in a patient's heart; 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. 17. The sensor system of claim 16, wherein the prosthetic heart valve comprises a valve body and a plurality of anchors adapted to capture leaflets of a native valve in a space between the anchors and the valve body to secure the prosthetic heart valve within 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 include 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 in 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 in 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 exerted by the prosthetic heart valve on 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. 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. 30. The sensor system of any one of claims 16 to 29, further comprising a substrate, the one or more sensors being positioned on the substrate, the sensor system further comprising electrical detection traces positioned on the substrate and adapted to detect forces applied to the substrate.

31. The sensor system of any one of claims 16 to 30, wherein the one or more sensors include a piezoelectric sensor.

32. The sensor system of any one of claims 16 to 31, wherein the one or more sensors include strain gauges.

33. The sensor system of any one of claims 16 to 32, wherein the one or more sensors comprise an electrode.

34. The sensor system of any one of claims 16 to 33, wherein the one or more sensors include a pressure transducer.

35. The sensor system of any one of claims 16 to 34, wherein the one or more sensors include a capacitance sensor.

36. 1. A prosthetic valve for deployment to a native 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 seal positioned radially outward from the inner frame, the seal including 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 an outflow end portion of the prosthetic valve, the skirt bounding a pocket positioned between the skirt and the inner frame; and one or more anchors adapted to anchor the prosthetic valve to the native valve by capturing leaflets of the native valve.

37. 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. 38. The prosthetic valve of 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 circumferentially spaced about 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 plateau portion of the seal.

41. 1. A sensor system comprising: Artificial heart implants, A sensor body, A substrate; a sensor positioned on the substrate and adapted to detect a condition of the artificial heart implant; a sensor body including electrical detection traces positioned on the substrate and adapted to detect a force applied to the substrate.

42. 42. The sensor system of claim 41, wherein the electrical detection traces are adapted to detect partial or complete fractures in the substrate.

43. 43. The sensor system of claim 41 or claim 42, wherein the sensor comprises an electrode.

44. 44. The sensor system of any one of claims 41 to 43, wherein the artificial cardiac implant comprises a clip adapted to clip the cardiac valve leaflets together.

45. 45. The sensor system of claim 44, wherein the electrical detection traces are adapted to detect partial or complete rupture of the substrate upon in vivo removal of the sensor body from a portion of the clip.

46. A prosthetic valve for replacing the function of a natural heart valve, a self-expanding valve body formed from nitinol, said valve body being compressible for advancement through a patient's vasculature in a compressed state via a catheterization technique; three prosthetic valve leaflets formed from pericardium and coupled to the valve body to permit 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; and an indicator adapted to confirm fixation of the valve body to the surrounding tissue.

47. 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. 48. The prosthetic valve of claim 47, wherein the indicator comprises a radiopaque material for enhanced visualization.

49. 47. The prosthetic valve of claim 46, wherein the indicator is a sensor.

50. 50. The prosthetic valve of claim 49, wherein the sensor is a piezoelectric sensor.

51. 50. The prosthetic valve of claim 49, wherein the sensor is a strain gauge.

52. 50. The prosthetic valve of claim 49, wherein the sensor is an electrode.

53. 50. The prosthetic valve of claim 49, wherein the sensor is a pressure transducer.

54. 50. The prosthetic valve of claim 49, wherein the sensor is a capacitance sensor.

55. 55. The prosthetic valve of any one of claims 46 to 54, wherein the prosthetic valve further comprises a plurality of anchors adapted to capture leaflets of a native valve in spaces between the anchors and the valve body to secure the prosthetic valve within the heart.

56. 56. The prosthetic valve of claim 55, wherein indicators are positioned on the plurality of anchors.

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