Heart valve prosthesis with integrated medical device

Abstract

A heart valve prosthesis include a frame configured to transition from a radially compressed configuration for delivery within a vasculature to a radially expanded configuration for placement within a heart valve of a patient, a prosthetic valve component disposed within and coupled to the frame, a plurality of electrodes disposed on an outer surface of the frame, the plurality of electrodes being configured to sense electrical signals of a heart of the patient, and an implantable medical device disposed within the frame with the frame in the radially expanded configuration. The implantable medical device includes a housing, a power source, and control circuitry configured to detect arrhythmia based on the sensed electrical signals and to apply a pacing signal or shock to the heart via at least one of the plurality of electrodes.

Description

HEART VALVE PROSTHESIS WITH INTEGRATED MEDICAL DEVICECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 625,629, filed January 26, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present technology is generally related to heart valve prostheses, and in particular is directed to heart valve prostheses including an implantable medical device configured to detect, monitor, and treat cardiac arrhythmias.BACKGROUND

[0003] The human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs into systemic circulation. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atrium and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The valve leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

[0004] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots whichcan increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0005] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses may be delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position. Furthermore, the heart valve prosthesis may be implanted and secured within the annulus through an open surgical process.

[0006] The advent of heart valve prostheses has increased the frequency of new onset conduction disturbance that may require pacing. Patients who receive heart valve prostheses, either traditional open surgical valves or transcatheter valves, may require temporary or permanent pacing and monitoring of the heart after implant.

[0007] An implantable medical device (“IMD”), such as an implantable cardiac monitor (“ICM”), implantable artificial pacemaker, or an implantable cardioverter defibrillator (“ICD”), may be used for sensing, pacing, and shocking functions. The ICD or the implantable artificial pacemaker may provide cardiac pacing therapy to the heart when the natural pacemaker and / or conduction system of the heart fails to provide synchronized atrial and ventricular contractions at rates and intervals sufficient to sustain healthy function. Such antibradycardia pacing may provide relief from symptoms, or even life support, for a patient. Cardiac pacing may also provide electrical overdrive stimulation to suppress or convert tachyarrhythmias, again supplying relief from symptoms and preventing or terminating arrhythmias that could lead to sudden cardiac death. Cardiac pacing by conventional pacemakers and / or ICDs is usually provided by a pulse generator implanted subcutaneously or sub-muscularly in or near a pectoral region of a patient.

[0008] ICDs and pacemakers typically use endocardial leads which extend from the ICD housing through the venous system to the heart. Electrodes positioned in or adjacent to the heart are used by the leads for Cardioversion and defibrillation shocks (e.g., antitachyarrhythmia shocks) and pacing functions. The ICD typically connects to the proximal end of one or more implanted leads, the distal end of which contains one or more electrodes for positioning adjacent to the inside or outside wall of a cardiac chamber. Each of the leads may be secured near or against the cardiac tissue to provide adequate transmission of electricalenergy to the cardiac tissue. The electrodes deliver the electrical impulses to the heart and they also sense the heart’s electrical activity and relay this information back to the ICD or pacemaker.

[0009] ICDs may also be used to deliver high energy cardioversion or defibrillation shocks to a patient’s heart when atrial or ventricular fibrillation is detected. Cardioversion shocks are typically delivered when fibrillation detection criteria are met.SUMMARY

[0010] In some examples, the present disclosure combines a heart valve prosthesis with an implantable medical device configured to detect, monitor, and treat cardiac arrhythmias. The heart valve prosthesis may have a radially expanded configuration and a radially compressed configuration. In some examples, the implantable medical device may be disposed outside the heart valve prosthesis in the radially compressed configuration, and the implantable medical device may be disposed inside a frame of the heart valve prosthesis in the radially compressed configuration. Thus, the positioning and deployment of the implantable medical device facilitates deliverability and transcatheter deployability of the prosthetic valve device.

[0011] In an example of the present application, a heart valve prosthesis comprises: a frame configured to transition from a radially compressed configuration for delivery within a vasculature to a radially expanded configuration for placement within a heart valve of a patient; a prosthetic valve component disposed within and coupled to the frame; a plurality of electrodes disposed on an outer surface of the frame, the plurality of electrodes being configured to sense electrical signals of a heart of the patient; and an implantable medical device disposed within the frame with the frame in the radially expanded configuration, the implantable medical device comprising a housing, a power source, and control circuitry configured to detect arrhythmia based on the sensed electrical signals and to apply a pacing signal or shock to the heart via at least one of the plurality of electrodes.

[0012] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the implantable medical device is disposed at a first position longitudinally outside of the frame when the frame is in the radially compressed configuration and is disposed at a second position at least partially longitudinally inside the frame in the radially expanded configuration.

[0013] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the heart valve prosthesis is configured such that radial expansion fromthe radially compressed configuration to the radially expanded configuration causes the implantable medical device to move from the first position to the second position.

[0014] In another example of the present application, a heart valve prosthesis comprises: a frame comprising an inner frame and an outer frame circumferentially surrounding at least a portion of the inner frame, wherein the frame has a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for placement within a heart valve of a patient; a prosthetic valve component disposed within and attached to the inner frame; an implantable medical device coupled to the frame, wherein the implantable medical device is disposed longitudinally outside of the outer frame with the frame in the radially compressed configuration and is disposed at least partially longitudinally inside the outer frame with the frame in the radially expanded configuration; and a plurality of electrodes coupled to an outer surface of the outer frame and electrically coupled to the implantable medical device, wherein the implantable device comprises a housing, a power source, and control circuitry to detect arrhythmia and to apply a pacing signal or shock to a heart of the patient via at least one of the plurality of electrodes.

[0015] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the implantable medical device is movably coupled to the frame.

[0016] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, radial expansion of the frame from the radially compressed configuration to the radially expanded configuration causes the implantable medical device to move from longitudinally outside of the outer frame to at least partially longitudinally inside the frame.

[0017] In another example hereof, the heart valve prosthesis of any of the preceding or following examples further comprises a first cord having a first end coupled to the implantable device and a second end fixedly attached to the inner frame, wherein the first cord is slidingly coupled to the outer frame.

[0018] In another example hereof, the heart valve prosthesis of any of the preceding or following examples further comprises a C-shaped restraint extending from the inner surface of the outer frame, wherein the cord extends through the C-shaped restraint to be slidingly coupled to the outer frame.

[0019] In another example hereof, the heart valve prosthesis of any of the preceding or following examples further comprises a first cord having a first end coupled to the implantable medical device and a second end fixedly coupled to the inner frame.

[0020] In another example hereof, the heart valve prosthesis of any of the preceding or following examples further comprises a second cord having a first end coupled to the implantable medical device and a second end fixedly coupled to the outer frame.

[0021] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the first cord is coupled to a proximal end of the implantable medical device and the second cord is coupled to a distal end of the implantable medical device, and wherein radially expansion of the frame causes the implantable medical device to flip from longitudinally outside of the outer frame in the radially compressed configuration to at least partially longitudinally inside of the outer frame in the radially expanded configuration.

[0022] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the implantable medical device is configured to sense electrical signals of a heart of the patient and to apply a pacing signal to the heart.

[0023] In another example of the present application, a method comprises: delivering a heart valve prosthesis to the site of a native heart valve in a radially compressed configuration, the heart valve prosthesis including a frame, a prosthetic valve component disposed within and coupled to the frame, and an implantable medical device coupled to the frame and disposed longitudinally outside the frame with the heart valve prosthesis in the radially compressed configuration; and deploying the heart valve prosthesis at the site of the native heart valve by radially expanding the heart valve prosthesis to a radially expanded configuration, wherein radially expanding the heart valve prosthesis causes the implantable medical device to move from longitudinally outside of the frame to at least partially longitudinally inside of the frame.

[0024] In another example hereof, in the method of any of the preceding or following examples, the heart valve prosthesis further includes a plurality of electrodes coupled to an outer surface of the frame and wherein the implantable medical device comprises a housing, a power source, and control circuitry to detect arrhythmia and to apply a pacing signal or shock to a heart of the patient via at least one of the plurality of electrodes.

[0025] In another example hereof, in the method of any of the preceding or following examples, the frame comprises an inner frame and an outer frame at least partially surrounding the inner frame, the prosthetic valve component is disposed within and coupled to the inner frame, the implantable medical device is fixedly coupled to the inner frame and slidingly coupled to the outer frame, and radially expanding the frame causes the outer frame to radially expand more than the inner frame, thereby moving the implantable medical device from longitudinally outside of the outer frame to at least partially longitudinally inside the outer frame.

[0026] In another example hereof, in the method of any of the preceding or following examples, the implantable medical device longitudinally translates from longitudinally outside of the outer frame to at least partially longitudinally inside the outer frame.

[0027] In another example hereof, in the method of any of the preceding or following examples, the implantable medical device flips from longitudinally outside of the outer frame to at least partially longitudinally inside the outer frame.

[0028] In another example hereof, the method of any of the preceding or following examples further comprises: sampling electrical signals received from each of the plurality of electrodes for P- and R- wave amplitudes; determining, based on the sampling, the need for at least two of the plurality of electrodes to apply a pacing signal or shock to the heart; and determining, based on the sampling, at least two of the plurality of electrodes to sense electrical signals of the heart.

[0029] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0030] The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments thereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale.

[0031] FIG. 1 is a diagram illustrating an example of a heart valve prosthesis including an implantable medical device in accordance with an aspect of the disclosure.

[0032] FIG. 2 is a diagram illustrating an example of the heart valve prosthesis of FIG. 1 in a radially compressed configuration in accordance with an aspect of the disclosure.

[0033] FIG. 3 is a diagram illustrating an example of the heart valve prosthesis of FIG. in a radially expanded configuration in accordance with an aspect of the disclosure.

[0034] FIG. 4 is a diagram illustrating an example of a valve support of the heart valve prosthesis of FIG. 3 in accordance with an aspect of the disclosure.

[0035] FIG. 5 is a diagram illustrating an example of an anchoring member of the heart valve prosthesis of FIG. 3 in accordance with an aspect of the disclosure.

[0036] FIG. 6 is a diagram illustrating an example of an atrial end view of the heart valve prosthesis shown in FIG. 1 in accordance with an aspect of the disclosure.

[0037] FIG. 7 is a diagram illustrating an example of a ventricular end view of the heart valve prosthesis shown in FIG. 1 in accordance with an aspect of the disclosure.

[0038] FIG. 8 is a diagram illustrating an example of the implantable medical device of FIG. 1 in accordance with an aspect of the disclosure.

[0039] FIG. 9 is a functional block diagram illustrating an example of the implantable medical device of FIG. 1 in accordance with an aspect of the disclosure.

[0040] FIG. 10A is a diagram illustrating an example of electrodes disposed on the outer surface of the frame of the heart valve prosthesis in accordance with an aspect of the disclosure.

[0041] FIG. 10B is a diagram illustrating an example of cleats disposed on the outer surface of the frame of the heart valve prosthesis in accordance with an aspect of the disclosure.

[0042] FIG. 10C is a diagram illustrating an example of hooks emerging from a brim of the frame of the heart valve prosthesis in accordance with an aspect of the disclosure.

[0043] FIGS. 10D-10F are diagrams illustrating embodiments of connectivity between electrodes and the implantable medical device in accordance with aspects of the disclosure.

[0044] FIGS. 11A and 11B are diagrams illustrating examples of the implantable medical device disposed outside the heart valve prosthesis of FIG. 1 when the heart valve prosthesis is in a crimped state in accordance with an aspect of the disclosure.

[0045] FIGS. 11C and I ID are diagrams illustrating examples of the implantable medical device disposed on the inside of a frame of the heart valve prosthesis of FIG. 1 when the heart valve prosthesis is in an expanded state in accordance with an aspect of the disclosure.

[0046] FIGS. 12A and 12B are diagrams illustrating examples of the implantable medical device disposed outside the heart valve prosthesis of FIG. 1 when the heart valve prosthesis is in a crimped state in accordance with an aspect of the disclosure.

[0047] FIGS. 12C and 12D are diagrams illustrating examples of the implantable medical device disposed on the inside of the frame of the heart valve prosthesis of FIG. 1 when the heart valve prosthesis is in the expanded state in accordance with an aspect of the disclosure.

[0048] FIG. 13 is a diagram illustrating an example of a method of detecting signals sensed by electrodes disposed on an outer surface of the frame of the heart valve prosthesis and for applying pacing signals to the heart in accordance with an aspect of the disclosure.

[0049] Throughout the drawings and the detailed description, unless otherwise described or provided, the same drawing reference numerals will be understood to refer to the same elements, features, and structures. The drawings may not be to scale, and the relative size,proportions, and depiction of elements in the drawings may be exaggerated for clarity, illustration, and convenience.DETAILED DESCRIPTION

[0050] Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal”, when used in the following description to refer to a valve, or a device to be implanted into a native vessel or native valve, such as a heart valve prosthesis and implantable medical device, are with reference to the direction of blood flow. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow and the terms “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow.

[0051] Many patients require invasive postoperative pacing after receiving heart valve prostheses, either through traditional open surgical valves or transcatheter valves. Accordingly, the present disclosure. As illustrated in FIG. 1, a heart valve prosthesis 100 according to embodiment herein includes an implantable medical device 140.

[0052] In some examples, the heart valve prosthesis 100 includes a dual frame support structure (frame 102) comprising an inner frame (valve support 104) and an outer frame (anchor element 106) circumferentially surrounding at least a portion of the inner frame, wherein the dual frame support structure has a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for placement within a heart valve of a patient. In some examples, the heart valve prosthesis 100 disclosed herein may include electrodes 130 for sensing heart rhythm and for pacing. Since the frame of the heart valve prosthesis 100 is in close contact with excitable tissue, especially near the interventricular septum, deploying electrodes 130 on the valve frame may facilitate pacing and sensing. In some examples, the electrodes 130 may be distributed around the valve frame in a way that maintains blood flow through the heart valve prosthesis 100, once the heart valve prosthesis 100 is deployed. In some examples, some of the electrodes 130 contact the interventricular septum and the atrial endocardium — both frequent pacing locations. In some examples, the electrodes 130 that are positioned around the frame may be selectable and programmable. In some examples, programming may be accomplished through wireless communication, such as low energy Bluetooth, and the electrodes 130 may be independently selectable for optimized patientspecific pacing and sensing.

[0053] The heart valve prosthesis 100 with the implantable medical device 140 disclosed herein provides a pacing / ICD system that is packaged together with the electrodes 130, eliminating the need for a separate temporary pacing / defibrillation leads and systems or postoperative intervention. The embodiments disclosed herein may integrate battery, telemetry, electronic circuitry with a small computer, firmware, sensing / pacing electrodes, and other components for the implantable medical device 140 on to the frame 102 of the heart valve prosthesis 100 to implement a standalone defibrillation, pacing, and sensing system.

[0054] In some examples, the heart valve prosthesis 100 with the implantable medical device 140 and the electrodes 130 may be used to deliver high energy cardioversion or defibrillation shocks to a patient’s heart when atrial or ventricular fibrillation is detected.

[0055] FIGS. 1-7 illustrate a heart valve prosthesis 100 that includes an implantable medical device 140 according to embodiments herein. The heart valve prosthesis 100 and the implantable medical device 140 are illustrated herein in order to facilitate description of the present invention. The following description of the heart valve prosthesis 100 and the implantable medical device 140 is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. It is understood that any number of alternate heart valve prostheses can be used with the implantable medical device described herein. Other non-limiting examples of transcatheter heart valve prostheses that can be used with the implantable medical device described herein are described in U.S. Patent No. 11, 318,013 to McVeigh etal., U.S. Patent No. 9,034,032 to McUean etal. and International Patent Application No. PCT / US2014 / 029549 to McUean et al, each of which is incorporated by reference herein in its entirety. Although the heart valve prosthesis 100 is a heart valve prosthesis configured for placement within a mitral heart valve, embodiments of the current disclosure may be utilized with any valve prosthesis. For example, embodiments of the heart valve prosthesis including an implantable medical device described herein may be utilized with a transcatheter heart valve configured for placement within a pulmonary, aortic, mitral, or tricuspid valve, or may be utilized with a transcatheter valve prosthesis configured for placement within a venous valve or within other body passageways where it is deemed useful. There is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. In addition, embodiments of heart valve prosthesis 100 that includes an implantable medical device described herein may be utilized with any stent or frame interacting with a medical device or where interaction between a prosthesis and a medical device is desirable, and it is not required that the stent or frame include a prosthetic valve component disposed therein.

[0056] As shown in FIGS. 1-7, the heart valve prosthesis 100 is configured to be radially compressed into a reduced-diameter, or compressed configuration as shown in FIG. 2 for delivery within the vasculature and to return to a radially expanded, deployed configuration, which is shown in FIG. 1 and 3. Stated another way, the heart valve prosthesis 100 has a radially crimped configuration for delivery within the vasculature and a radially expanded configuration for deployment within a native heart valve. In accordance with embodiments hereof, when in the radially compressed or reduced-diameter configuration, the heart valve prosthesis 100 has a low profile suitable for delivery to and deployment within a native heart valve via a suitable delivery system that may be tracked to the deployment site of the native heart valve of a heart via any one of a transatrial, antegrade, or transapical approach. The heart valve prosthesis 100 includes a stent or frame 102, valve component 108 including at least one valve leaflet 109 disposed within and secured to the frame 102, an implantable medical device 140, and electrodes 130. The valve component 108 of the heart valve prosthesis 100 is capable of regulating flow via the valve leaflets 109 to thereby form a replacement valve.

[0057] Any portion of the frame 102 described herein as an element of the heart valve prosthesis 100 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as Nitinol™, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials. A suitable biocompatible material would be selected to provide the heart valve prosthesis 100 to be configured to be compressed into a reduced-diameter crimped configuration for transcatheter delivery to a native valve, whereby release from a delivery catheter returns the prosthesis to an expanded, deployed configuration. Alternatively, the heart valve prosthesis 100 may be balloon expandable as would be understood by one of ordinary skill in the art.

[0058] In the example heart valve prosthesis 100, the frame 102 of the heart valve prosthesis 100 includes an inner stent or valve support 104 at least partially surrounded by and attached to an outer stent or anchoring member 106. The valve support 104 is configured to support the valve component 108 therein. The valve support 104 may be a tubular stent-like or frame structure that defines a central lumen 110 from a first or inflow end 101 of the valve support 104 to a second or outflow end 103 of the valve support 104. At the second end 103, the valve support 104 is attached to the anchoring member 106 via a plurality of connectors (not shown). In an embodiment, the plurality of connectors are rivets. In addition, at the second end 103, thevalve support 104 may include a plurality of attachment bars extending therefrom that function to releasably couple the heart valve prosthesis 100 to a delivery system.

[0059] The anchoring member 106 is a stent-like or frame structure that functions as an anchor for the heart valve prosthesis 100 to secure its deployed position within a native annulus. The anchoring member 106 is a substantially cylindrically shaped structure that is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve. In the radially expanded configuration, at the first end 101 of the valve support 104, the anchoring member 106 is radially spaced a distance S from the valve support 104 to mechanically isolate the first end 101 of the valve support 104 from the anchoring member 106. The anchoring member 106 may include one or more fixation elements 114 that extend outward from an exterior side thereof to engage heart tissue. The fixation elements 114 project radially outward and are inclined toward an upstream or proximal direction. The fixation elements 114, for example, can be prongs, cleats, barbs, hooks, or other elements that are inclined only in the upstream direction (e.g., a direction extending away from the downstream portion of the heart valve prosthesis 100).

[0060] The anchoring member 106 may include a plurality of crowns 126 and a plurality of struts 124 with each crown 126 being formed between a pair of opposing struts 124. Each crown 126 is a curved segment or bend extending between opposing struts 124. The anchoring member 106 may be generally tubular, with a plurality of side openings 129 being defined by edges of the plurality of crowns 126 and the plurality of struts 124. In an embodiment, the plurality of side openings 129 may be substantially diamond-shaped. The anchoring member 106 may include a plurality of nodes 128. A node 128 is defined as a region where two crowns of the plurality of crowns 126 within the anchoring member 106 meet or connect. When attached to the valve support 104 via the plurality of connectors, the anchoring member 106 forms an outer frame portion of the frame 102 and the valve support 104 forms an inner frame portion of the frame 102 with the anchoring member 106 circumferentially surrounding the valve support 104 disposed therein.

[0061] Each of the valve support 104 and the anchoring member 106 may include a skirt or graft material 112, 125, respectively, secured thereto. More particularly, the graft material 112 may be coupled to an inner or an outer surface of the valve support 104 to line a portion thereof. The graft material 125 may be coupled to an inner surface of the anchoring member 106 to line a portion thereof. The graft material 112, 125 may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa. Alternatively, thegraft material 112, 125 may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent.

[0062] The valve component 108 of the heart valve prosthesis 100 is capable of regulating flow via valve leaflets 109 that may form a replacement valve. FIGS. 1-7 illustrate an exemplary valve component 108 having three leaflets 109, although a bicuspid leaflet configuration may alternatively be used in embodiments hereof. The valve leaflets 109 may be attached to the graft material 112 to form the valve component 108. The valve leaflets 109 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0063] Although described herein as including an inner frame (valve support 104) and an outer frame (anchoring member 106), this is not meant to be limiting. In other embodiments, the heart valve prosthesis may include a single frame with a valve component coupled thereto, as known to those skill in the art. The dual-frame embodiment described herein assists in the movement of the implantable medical device 140 from longitudinally outside of the frame when in the radially compressed configuration to longitudinally within the frame in the radially expanded configuration, as described in more detail below.

[0064] For delivery, the heart valve prosthesis 100 is radially compressed, as illustrated in FIG. 2, into a reduced-diameter crimped configuration for placement onto a delivery system for delivery within a vasculature. As illustrated in FIG. 2, in the crimped configuration, the implantable medical device 140 may be movably disposed longitudinally outside of the heart valve prosthesis 100. As illustrated in FIGS. 1 and 3, the implantable medical device 140 may be disposed at a second position at least partially longitudinally inside the frame 102 of the heart valve prosthesis 100 when the heart valve prosthesis 100 is in the radially expanded configuration. The movement of the implantable medical device 140 from longitudinally outside the heart valve prosthesis 100 to at least partially longitudinally inside the frame 102 and details regarding the attachment of the implantable medical device 140 to the heart valve prosthesis 100 will be described in more detail below with respect to FIGS. 11A-1 ID and 12A-

[0065] As illustrated in FIG. 1, the heart valve prosthesis 100 disclosed herein may include a plurality of electrodes 130 for sensing heart rhythm and for pacing. Since the frame 102 of the heart valve prosthesis 100 is in close contact with excitable native tissue, especially near the septum, deploying electrodes 130 on the frame 102 may facilitate pacing and sensing. As illustrated in FIG. 1, the electrodes 130 may be disposed on an outer surface 107a of the anchoring member 106 of the frame 102 of the heart valve prosthesis 100. In some examples, as shown in FIG. 1, the electrodes 130 may be disposed evenly in one or more rows along the outer surface 107a of the anchoring member 106 of the frame 102. In some examples, a total of nine (9) electrodes 130 may be disposed on one row around a circumference of the anchor element 106 of the frame 102. The quantity and arrangement of the electrodes 130 may be varied without deviating from the spirit or scope of the illustrated examples described. For example, although the embodiments of FIG. 1 depict the electrodes 130 having a generally linear or straight configuration along the circumference of the frame 102, the electrodes 130 may be disposed in a wavy, sinusoidal, or zig-zag configuration along the outer surface 107a of the anchoring member 106 of the frame 102. Different arrangements and distribution of the electrodes 130 along the outer surface 107a of the anchoring member 106 of the frame 102 will be described in more detail below.

[0066] FIG. 8 illustrates an example of the implantable medical device 140 of FIG. 1. As shown in FIG. 8, the implantable medical device 140 includes a case 141, a cap 142, a flange 146, and an opening 147. Together, the case 141 and the cap 142 may be considered the housing of the implantable medical device 140. The case 141 may enclose substantially all the electrical components of the implantable medical device 140 and a power source 148, and the cap 142 may seal the case 141 to create a hermetically sealed housing for the components of the implantable medical device 140. In this manner, the case 141 and the cap 142 may enclose and protect the various electrical components within the implantable medical device 140.

[0067] The flange 146 may be provided at a first end of the case 141 to enable tethering of the implantable medical device 140 to the frame 102 of the heart valve prosthesis 100. For example, a first cord 170 or other device may be inserted around the flange 146 and / or through the opening 147 to tether the implantable medical device 140 to the frame 102 of the heart valve prosthesis 100, as described below. In some examples, the flange 146 and / or the opening 147 may also be used to extract the implantable medical device 140, if the implantable medical device 140 needs to be explanted (or removed) from a heart of a patient. In some examples, a second flange (not shown) and a second opening (not shown) may be provided on the cap 149 of the implantable medical device 140.

[0068] FIG. 9 is a functional block diagram illustrating an example of the implantable medical device 140 of FIG. 1 in accordance with an aspect ofthe disclosure. In the illustrated example, the implantable medical device 140 includes a processor 155, memory 157, a signal generator 152, a sensing module 151, a shock detector 153, an activity sensor 154, a telemetry module 156, and a power source 148. Memory 157 includes computer-readable instructions that, when executed by the processor 155, cause the implantable medical device 140 and the processor 155 to perform various functions attributed to the implantable medical device 140 and the processor 155 herein (e.g., detecting arrhythmias, communicating with another device, and delivering anti -tachycardia pacing (“ATP”) and post-shock pacing). Memory 157 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random-access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically- erasable programmable ROM (EEPROM), flash memory, or any other digital or analog media.

[0069] The processor 155 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field- programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, the processor 155 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry.

[0070] The processor 155 controls the signal generator 152 to deliver stimulation therapy to the heart according to therapy parameters, which may be stored in memory 157. For example, the processor 155 may control the signal generator 152 to deliver electrical pulses with the amplitudes, pulse widths, frequency, or electrode polarities specified by the therapy parameters. In this manner, the signal generator 152 may deliver pacing pulses (e.g., antitachycardia pacing (ATP) pulses or post-shock pacing pulses) to the heart via one or more of the electrodes 130.

[0071] The signal generator 152 is electrically coupled to the electrodes 130 disposed on the outer surface 107a of the anchoring member 106 of the frame 102 of the heart valve prosthesis 100. In the illustrated example, the signal generator 152 is configured to generate and deliver electrical stimulation therapy to the heart. For example, the signal generator 152 may deliver ATP to a portion of cardiac muscle within the heart via the electrodes 130. In some examples, the signal generator 152 may deliver pacing stimulation in the form of electrical pulses, i.e., applying a pacing signal to the heart. In other examples, the signal generator may deliver one or more of these types of stimulation in the form of other signals, such as sine waves, square waves, or other substantially continuous time signals. Although the implantable medical device140 is generally described delivering pacing pulses, implantable medical device 140 may deliver cardioversion or defibrillation pulses in other examples.

[0072] ATP may be delivered to a patient as defined by a set of parameters. These parameters may include pulse intervals, pulse width, current and / or voltage amplitudes, and durations for each pacing mode. For example, the pulse interval may be between approximately 150 milliseconds (ms) and 500 (ms) (e.g., between approximately 2.0 Hz and 7.0 Hz), and the pulse width may be between approximately 1.0 ms and 2.0 ms. The amplitude of each pacing pulse may be between approximately 2.0 Volts (V) and 10.0 V, such as approximately 6.0 V. In some examples, the pulse amplitude may be approximately 6.0 V and the pulse width may be approximately 1.5 ms; another example may include pulse amplitudes of approximately 5.0 V and pulse widths of approximately 1.0 ms. Each train of pulses during ATP may last for a duration of between approximately 0.5 seconds to approximately 15 seconds. Each pulse, or burst of pulses, may include a ramp up in amplitude. In addition, trains of pulses in successive ATP periods may in delivered at increasing pulse rate in an attempt to capture the heart and terminate the tachycardia. Example ATP parameters and other criteria involving the delivery of ATP are described in U.S. Pat. No. 6,892,094 to Ousdigian et al., entitled, “COMBINED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR TREATING VENTRICULAR ARRHYTHMIAS,” and issued on May 10, 2005, the entire content of which is incorporated herein by reference.

[0073] The signal generator 152 may also include circuitry for measuring the capture threshold of the electrodes 130. The capture threshold may indicate the voltage necessary to induce depolarization of the surrounding cardiac muscle. For example, signal generator 152 may measure the voltage of pacing signals needed to induce ventricular contractions. In examples in which implantable medical device 140 includes more than two electrodes, signal generator 152 may include a switch module and processor 155 may use the switch module to select, e.g., via a data / address bus, which of the available electrodes are used to deliver pacing pulses. The switch module may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple stimulation energy to selected electrodes. In the instance that the capture threshold exceeds usable limits, processor 155 may withhold delivery of ATP or post-shock pacing. In addition, processor 155 may transmit communication to an external computer or another device if pacing cannot be delivered.

[0074] The sensing module 151 monitors signals from at least one of the electrodes 130 in order to monitor electrical activity of the heart, impedance, or other electrical phenomenon. Sensing may be done to determine heart rates or heart rate variability, or to detect arrhythmias(e.g., tachyarrhythmias) or other electrical signals. The sensing module 151 may also include a switch module to select which of the available electrodes (or electrode polarity) are used to sense the heart activity, depending upon which electrode combination, or electrode vector, is used in the current sensing configuration. In examples with several electrodes, such as the electrodes 130, the processor 155 may select the electrodes that function as sense electrodes, i. e. , select the sensing configuration, via the switch module within the sensing module 151. The sensing module 151 may include one or more detection channels, each of which may be coupled to a selected electrode configuration for detection of cardiac signals via that electrode configuration. Some detection channels may be configured to detect cardiac events, such as P- or R-waves, and provide indications of the occurrences of such events to the processor 155, e.g., as described in U.S. Pat. No. 5,117,824 to Keimel et al., which issued on Jun. 2, 19147 and is entitled, “APPARATUS FOR MONITORING EUECTRICAU PHYSIOLOGIC SIGNALS,” and is incorporated herein by reference in its entirety. The processor 155 may control the functionality of the sensing module 151 by providing signals via a data / address bus.

[0075] The processor 155 may include a timing and control module, which may be embodied as hardware, firmware, software, or any combination thereof. The timing and control module may comprise a dedicated hardware circuit, such as an ASIC, separate from other processor components, such as a microprocessor, or a software module executed by a component of the processor 155, which may be a microprocessor or ASIC. The timing and control module may implement programmable counters. If implantable medical device 140 is configured to generate and deliver pacing pulses to the heart, such counters may control the basic time intervals associated with DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes of pacing. Example leadless pacemaker devices (“LPDs”) that may deliver pacing using such modes are described in U.S. Patent No. 8,923,963 to Bonner et al., or in U.S. Patent No. 9,808,633 to Bonner et al., both of which are both incorporated herein by reference in their entirety. Intervals defined by the timing and control module within the processor 155 may include atrial and ventricular pacing escape intervals, refractory periods during which sensed P-waves and R-waves are ineffective to restart timing of the escape intervals, and the pulse widths of the pacing pulses. As another example, the timing and control module may withhold sensing from one or more channels of the sensing module 151 for a time interval during and after delivery of electrical stimulation to the heart. The durations of these intervals may be determined by the processor 155 in response to stored data in memory 157. The timing and control module of the processor 155 may also determine the amplitude of the cardiac pacing pulses.

[0076] Interval counters implemented by the timing and control module of the processor 155 may be reset upon sensing of R-waves and P-waves with detection channels of the sensing module 151. In examples in which the implantable medical device 140 provides pacing, the signal generator 152 may include pacer output circuits that are coupled to at least one of the electrodes 130, for example, appropriate for delivery of a bipolar or unipolar pacing pulse to one of the chambers of the heart. In such examples, the processor 155 may reset the interval counters upon the generation of pacing pulses by the signal generator 152, and thereby control the basic timing of cardiac pacing functions, including ATP or post-shock pacing.

[0077] The value of the count present in the interval counters when reset by sensed R-waves and P-waves may be used by the processor 155 to measure the durations of R-R intervals, P-P intervals, P-R intervals and R-P intervals, which are measurements that may be stored in memory 157. The processor 155 may use the count in the interval counters to detect a tachyarrhythmia event, such as atrial fibrillation (AF), atrial tachycardia (AT), ventricular fibrillation (VF), or ventricular tachycardia (VT). These intervals may also be used to detect the overall heart rate, ventricular contraction rate, and heart rate variability. A portion of memory 157 may be configured as a plurality of recirculating buffers, capable of holding series of measured intervals, which may be analyzed by processor 155 in response to the occurrence of a pace or sense interrupt to determine whether the patient's heart is presently exhibiting atrial or ventricular tachyarrhythmia.

[0078] In some examples, an arrhythmia detection method may include any suitable tachyarrhythmia detection algorithms. In one example, processor 155 may utilize all or a subset of the rule-based detection methods described in U.S. Pat. No. 5,545,186 to Olson et al., or in U.S. Pat. No. 5,755,736 to Gillberg et al., both of which are incorporated herein by reference in their entirety. However, other arrhythmia detection methodologies, such as those methodologies that utilize timing and morphology of the electrocardiogram, may also be employed by the processor 155 in other examples.

[0079] In some examples, the processor 155 may determine that tachyarrhythmia has occurred by identification of shortened R-R (or P-P) interval lengths. Generally, processor 155 detects tachycardia when the interval length falls below 220 milliseconds (ms) and fibrillation when the interval length falls below 180 ms. In other examples, processor 70 may detect ventricular tachycardia when the interval length falls between 330 ms and ventricular fibrillation when the interval length falls between 240 ms. These interval lengths are merely examples, and a user may define the interval lengths as desired, which may then be stored within memory 157. This interval length may need to be detected for a certain number of consecutive cycles, for a certainpercentage of cycles within a running window, or a running average for a certain number of cardiac cycles, as examples. In other examples, additional physiological parameters may be used to detect an arrhythmia. For example, the processor 155 may analyze one or more morphology measurements, impedances, or any other physiological measurements to determine that the patient is experiencing a tachyarrhythmia.

[0080] In the event that the processor 155 detects an atrial or ventricular tachyarrhythmia based on signals from the sensing module 151, and an ATP regimen is desired, timing intervals for controlling the generation of ATP therapies by the signal generator 152 may be loaded by the processor 155 into the timing and control module to control the operation of the escape interval counters therein and to define refractory periods during which detection of R-waves and P- waves is ineffective to restart the escape interval counters for the ATP.

[0081] In addition to detecting and identifying specific types of cardiac rhythms (types of cardiac events), the sensing module 151 may also sample the detected intrinsic signals to generate an electrogram or other time-based indication of cardiac events.

[0082] The shock detector 153 may be used to detect anti -tachyarrhythmia shocks delivered by another device. For example, the processor 155 may enable the shock detector 153 in response to detecting a tachyarrhythmia or receiving a communication indicating that an arrhythmia has been detected or a shock is imminent. The processor 155 may also disable the shock detector 153 after a predetermined time period has elapsed or a shock is otherwise not anticipated. When the shock detector 153 is enabled, the shock detector 153 may identify with an electric signal received by the sensing module 151 is representative of an artificial cardioversion or defibrillation shock pulse.

[0083] In response to detecting a shock via shock detector 153, processor 155 may begin postshock pacing when such functionality has been enabled for therapy. Processor 155 may also re-start post-shock pacing in response to detecting additional shocks via shock detector 153. In some examples, processor 155 may terminate ATP upon detection of a shock.

[0084] Memory 157 may be configured to store a variety of operational parameters, therapy parameters, sensed and detected data, and any other information related to the therapy and treatment of patient 14. In some examples, memory 157 may store sensed ECGs, detected arrhythmias, communications from another device, and therapy parameters that define ATP and / or post-shock pacing regimens. In other examples, memory 157 may act as a temporary buffer for storing data until it can be uploaded to another device or another implanted device.

[0085] The activity sensor 154 may be contained within the housing of the implantable medical device 140 and include one or more accelerometers or other devices capable of detectingmotion and / or position of the implantable medical device 140. For example, the activity sensor 154 may include a 3-axis accelerometer that is configured to detect accelerations in any direction in space. Specifically, the 3-axis accelerator may be used to detect the implantable medical device 140 motion that may be indicative of cardiac events and / or noise. For example, the processor 155 may monitor the accelerations from the activity sensor 154 to confirm or detect arrhythmias. Since the implantable medical device 140 may move with a chamber wall of the heart, the detected changes in acceleration may also be indicative of contractions. Therefore, the implantable medical device 140 may be configured to identify heart rates and confirm arrhythmias, such as a tachycardia, sensed via the sensing module 151.

[0086] The telemetry module 156 includes any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as an external computer or medical device. Under the control of the processor 155, the telemetry module 156 may receive downlink telemetry from and send uplink telemetry to another device with the aid of an antenna, which may be internal and / or external. The processor 155 may provide the data to be uplinked to another device and the control signals for the telemetry circuit within the telemetry module 156, e.g., via an address / data bus. In some examples, the telemetry module 156 may provide data that it receives to the processor 155 via a multiplexer.

[0087] In some examples, the implantable medical device 140 may signal another device to further communicate with and pass an alert through a network such as the Medtronic CareLink® Network developed by Medtronic, Inc., of Minneapolis, Minn., or some other network linking patient to a clinician. The implantable medical device 140 may spontaneously transmit information to the network or in response to an interrogation request from a user or authorized care provider.

[0088] The power source 148 may be any type of device that is configured to hold a charge to operate the circuitry of the implantable medical device 140. The power source 148 may be provided as a rechargeable or non-rechargeable battery. Examples of non-rechargeable power sources include batteries having a lithium-ion chemistry, such as lithium (Li) in combination with one or more of iodide (12), silver vanadium oxide (SVO), or carbon monofluoride (CFx). Examples of rechargeable power sources include batteries having a lithium-ion chemistry, such as lithium in combination with one or more oxides of nickel (Ni), manganese (Mn), or cobalt (Co). In other examples, the power source 148 may also incorporate an energy scavenging system that stores electrical energy from movement of the implantable medical device 140 within the heart of the patient.

[0089] FIGS. 10A-10C are diagrams illustrating examples of the electrodes disposed on the frame 102 of the heart valve prosthesis 100 in accordance with aspects of the disclosure. Since the frame 102 of the heart valve prosthesis 100 is in close contact with excitable native tissue, especially near the septum, the triangle of Koch, the atrial floor, and the superior right ventricle, deploying the electrodes 130 on the valve frame may facilitate pacing and sensing as the electrodes 130 come in intimate contact with the myocardium.

[0090] In the embodiment of FIG. 10A, the electrodes 130 may be distributed throughout the anchoring member 106 of the frame 102. In the embodiment shown, the electrodes 130 are disposed at nodes 128 and crowns 126 of the anchoring member 106. In some examples, the electrodes 130 may be disposed on wires that are looped around the nodes 128 or otherwise bound to the struts 124. In other embodiments, however, the electrodes 130 may be disposed within the side openings 129. The number of rows of electrodes 130 and the number of electrodes 130 on each row may be varied without deviating from the spirit or scope of the illustrated examples described. In addition, the arrangement of the electrodes 130 may be varied without deviating from the spirit or scope of the illustrated examples described. For example, although the embodiments of FIG. 10A depict the electrodes 130 having a generally linear or straight arrangement along the circumference of the frame 102, the electrodes 130 may be disposed in a wavy, sinusoidal, or zig-zag configuration along the outer surface 107a of the anchoring member 106 of the frame 102. In other examples, the electrodes 130 may be configured as “T” or “X” on one or more locations of the of the anchoring member 106 of the frame 102. Distributing the electrodes 130 throughout the anchoring member 106 enables physicians to use a semiautomatic algorithm to detect R- and P-waves from the resulting EGM signals, as described below. The electrodes 130 that do not provide sufficient amplitude of either sensing wave are eliminated as options for pacing and sensing. Physicians can then observe cardiac EGM signals for the handful of useful pacing and sensing sites to determine which locations they prefer to pace and sense from. In other embodiments, the electrodes 130 may be disposed along only portions of the anchoring member 106.

[0091] In the embodiment of FIG. 10B, the electrodes 130 are in the form of cleats 133 (radial spikes) for sensing heart rhythm and for pacing may be disposed on the outer surface 107a of the anchoring member 106 of the frame 102 of the heart valve prosthesis 100. The cleats 133 may replace some of the fixation elements 114 described above such that the cleats 133 serve as electrodes and as fixation elements. In the embodiment shown, there are six cleats 133 (three are shown) and a circumferentially aligned (i.e., they are an equivalent longitudinal distance from an end of the frame 102). However, this is not meant to be limiting, and there may bemore or fewer cleats 133 in different arrangements. After implant, the physician again may use a semiautomatic algorithm to sample each of the cleats / electrodes 133 for P- and R- wave amplitudes to determine where to best pace and sense, as described below. Opposing cleats may contain radiographically unique markers allowing the physician to visualize the location of each cleat and estimate which contact points are likely to be touching the septum.

[0092] FIG. 10C is a diagram illustrating an example of hooks 135 emerging from the brim 116 of the heart valve prosthesis 100 in accordance with an aspect of the disclosure. In the embodiment illustrated in FIG. 10C, flexible active wires emerging from the brim 116 of the heart valve prosthesis 100 may form the hooks 135. In some examples, these flexible wires (hooks 135) may pierce the myocardium as the device is deployed into native tissue. As illustrated in FIG. 10C, the hooks 135 may be distributed evenly along the circumference of the brim 116 of the anchoring member 106 of the frame 102. In some examples, twelve (12) hooks 135 may be disposed in a row around the circumference of the brim 116. The number of hooks 135 and the spacing between any two hooks may be varied without deviating from the spirit or scope of the illustrated examples described. After implant, the physician may use a semiautomatic algorithm to sample each of the hooks 135 for P- and R- wave amplitudes to determine where to best pace and sense, as described below. Further, opposing hooks 135 may contain radiographically unique markers allowing the physician to visualize the location of each cleat and estimate which contact points are likely to be touching the septum.

[0093] FIGS. 10D-10F are enlarged views of the anchoring member 106 of the frame 102 illustrating embodiments of connectivity between the electrodes 130 and the implantable medical device 140 according to aspects of the disclosure. As described earlier, the anchoring member 106 may include a plurality of crowns 126, a plurality of struts 124, and a plurality of nodes 128 forming a plurality of side openings 129.

[0094] In some examples, as illustrated in FIG. 10D, holes 127 may be provided in one or more of the nodes 128 of the anchoring member 106. Holes 127 may be formed for example by laser-cutting, precision-cutting, etching, drilling, and / or formed when forming the anchoring member 106 without deviating from the spirit or scope of the illustrated examples described. Electrically conductive wire 123 may be looped through each hole 127 and a first end of the wire 123 may be connected to the implantable medical device 140 and a second end of the wire 123 may be connected to one or more of the electrodes 130. In some examples, instead of the electrically conductive wire 123 being looped through the holes 127, the electrically conductive wire 123 may be soldered to the laser-cut holes 127. In some examples, the electrically conductive wire 123 may have an insulation coating on the outside. In another example, a rivetor similar connector may be disposed in the holes 127, and the electrically conducting wire 123 may be coupled to the rivet. Thus, the electrically conductive wire 123 may provide electrical connectivity between the implantable medical device 140 and the electrodes 130.

[0095] In some examples, as illustrated in FIG. 10E, the electrically conductive wire 123 may connect the strut nodes 128 with each other. The electrically conductive wire 123 may be woven or looped around the strut nodes 128 to be disposed along the circumference of the anchoring member 106. In some examples, the strut nodes 128, around which the electrically conductive wire 123 is woven, may be coated with a conducting coating 121 to improve conductivity. The conductive coating may be, for example and not by way of limitation, a gold coating. The electrically conductive wires 123 may connect one or more of the electrodes 130 to the implantable medical device 140. Thus, the electrically conductive wire 123 may provide electrical connectivity between the implantable medical device 140 and the electrodes 130.

[0096] In some examples, as illustrated in FIG. 10F, the electrically conductive wire 123 may connect the nodes 128 with each other by extending the conducting wire along the struts 124. The electrically conductive wire 123 may be disposed along the struts 124 to connect the strut nodes 128 to each other. In some examples, the strut nodes 128 may be coated with a conductive coating 121, such as gold, to improve conductivity. In some embodiments, the conductive wire 123 may be wrapped around the struts 124. In other embodiments, the electrically conductive wire 123 may be coupled to the struts 124, such as by using crimp fit connectors at various locations along the struts 124. The electrically conductive wires 123 may connect one or more of the electrodes 130 to the implantable medical device 140. Thus, the electrically conductive wire 123 may provide electrical connectivity between the implantable medical device 140 and the electrodes 130.

[0097] In another example, electrically conductive coatings may be disposed on an inner surface or an outer surface of the anchoring member 106 of the frame 102. The electrically conductive coatings may connect one or more of the electrodes 130 to the implantable medical device 140. Thus, the electrically conductive coatings may provide electrical connectivity between the implantable medical device 140 and the electrodes 130.

[0098] FIGS 11A-11D are diagrams illustrating an embodiment of a mechanism for moving the implantable medical device 140 from longitudinally outside the heart valve prosthesis 100 to at least being partially longitudinally disposed inside the frame 102 as the heart valve prosthesis 100 moves from the radially compressed configuration to the radially expanded configuration. FIGS. 11A and 11B are diagrams illustrating the heart valve prosthesis 100 in the radially compressed configuration with the implantable medical device 140 disposedlongitudinally outside the frame 102. FIGS. 11C and 1 ID are diagrams illustrating the heart valve prosthesis 100 in the radially expanded configuration with the implantable medical device 140 disposed longitudinally within the frame 102.

[0099] The implantable medical device 140 may have a first or proximal surface 149a and a second or distal surface 149b. In the embodiment of FIGS. 11A-1 ID a first cord or tether 170 is attached to the distal surface 149b of the implantable medical device 140 and extends to the frame 102 of the heart valve prosthesis 100. In some examples, the first cord 170 may be an electrically conductive or passive inextensible wire with a length L. A first end of the first cord 170 is coupled to the implantable medical device 140 and a second end of the first cord 170 is coupled to the valve support 104 via a pinned (i.e., fixed) connection 160. A sliding connection 150 may be provided on an inner surface of the anchoring member 106 to guide the first cord 170 and the implantable medical device 140. The first cord 170 extends through the sliding connection 150 and is slidable relative thereto.

[0100] As shown in FIGS. 11A and 11B, with the heart valve prosthesis 100 in the radially compressed configuration, the anchoring member 106 is disposed close to the valve support 104. For example, and not by way of limitation, pinned connection 160 on the valve support 104 may be spaced a first distance DI from sliding connection 150 on the anchoring member 106. Further, the fixed connection 160 is spaced a longitudinal distance D2 from the first end of the anchoring member 106. Thus, due to the length L of the first cord 170 being longer than the combined distance DI and D2 with the heart valve prosthesis 100 in the radially compressed configuration, the implantable medical device 140 is disposed longitudinally outside of the frame 102 (in the present example, upstream of the frame 102). In an example, the distance DI may be less than 2 mm, the distance D2 may be in the range of about 20 mm to about 25 mm, and the length L of the first cord 170 may be about 20 mm.

[0101] When the heart valve prosthesis 100 radially expands from the radially compressed configuration to the radially expanded configuration shown in FIGS. 11C and 11D, the anchoring member 106 expands more than the valve support 104. For example, in some embodiments, the anchoring member 106 radially expands to a diameter of up to about 48 mm while the valve support 104 radially expands to a diameter of about27 mm. Therefore, as shown in FIGS. 11C-1 ID, a third distance D3 from the pinned connection 160 to the sliding connection 150 is greater than the first distance DI. Further, the combined third distance D3 and a fourth distance D4 from the sliding connection 150 to the first end of the anchoring member 106 is greater than the length L of the first cord 170. Accordingly, at least a portion of the implantable medical device 140 will be disposed in a trough 190 defined between an innersurface 107b of the anchoring member 106 and an outer surface 105a of the valve support 104 of the heart valve prosthesis 100. If the combined distance D2 and D3 is greater than the length L of the first cord 170 and a length of the implantable medical device 140, then all of the implantable medical device 140 will be disposed within the trough 190. In an example, the third distance D3 may be in the range of about 10 mm to about 11 mm and the fourth distance D4 may be in the range of about 11 mm to about 13 mm.

[0102] In some examples, as illustrated in FIGS 11C and 1 ID, the implantable medical device 140 is shown as conforming to an outer wall of the trough 190 formed in the heart valve prosthesis 100, i.e., the inner surface 107b of the anchor element 106 of the of the heart valve prosthesis 100. The orientation of the implantable medical device 140 is irrelevant to long term performance because the trough 190 will be filled with pannus over time. The inextensible first cord 170, which automatically pulls the implantable medical device 140 into the trough 190 of the heart valve prosthesis 100 does not need the intervention of the implanting physician, obviating the need for additional guidewires and hence reduces complexity in design.

[0103] FIGS 12A-12D are diagrams illustrating an embodiment of a mechanism for moving the implantable medical device 140 from longitudinally outside the heart valve prosthesis 100 to at least being partially disposed longitudinally inside the frame 102 as the heart valve prosthesis 100 radially expands from the radially compressed configuration to the radially expanded configuration. The functionality of the embodiment of FIGS. 12A-12D is similar to the embodiment of FIGS . 11 A- 11 D in that the expansion of the heart valve prosthesis 100, and in particular the relative expansion of the anchoring member 106 as compared to the valve support 104, causes the implantable medical device 140 to move from longitudinally outside of the frame 102 in the radially compressed configuration to longitudinally within the frame in the radially expanded configuration.

[0104] In the embodiment of FIGS. 12A-12D, the implantable medical device 140 is flipped into the trough 190 of the heart valve prosthesis 100 when the frame 102 radially expands. In particular, in the embodiment of FIGS. 12A-12D, the first cord 170 is attached to the valve support 104 at the first pinned connection 160 and extends through the sliding connection 150 on the anchoring member 106 as described above. However, the first cord 170 is coupled to the implantable medical device 140 at the proximal end 149a of the implantable medical device 140. A second cord 180 is coupled at a first end to the distal end 149b of the implant medical device 140 and at a second end is fixedly coupled to the anchoring member 106 at a second pinned connection 165, as shown in FIGS. 12A-12B. The second cord 180 is shorter than thefirst cord 170 and the second pinned connection 165 is adjacent the first end of the anchoring member 106, e.g., at the brim 116.

[0105] As described above, when the heart valve prosthesis 100 is deployed such that the frame radially expands, the distance between the first pinned connection 160 and the sliding connection increases, thereby pulling the first cord 170 and the proximal end 147a of the implantable medical device 140 towards the trough 190. Because the second cord 180 is fixed at its second end to the second pinned connection 165, and the second cord 180 is shorter than the first cord 170, the distal end 147b of the implantable medical device 140 cannot translate as far as the proximal end 147a coupled to the first cord 170. Therefore, when the limit of the second cord 180 length is reached, the implantable medical device 140 flips, as shown by the arrows in FIGS. 12B and 12C. In other words, the downwards movement of the implantable medical device 140 is checked by the second cord 180. When the limit of the downward movement is reached, the implantable medical device 140 may flip, that is, rotate 180 degrees, into the trough 190 of the heart valve prosthesis 100. FIGS. 12C and 12D show the implantable medical device 140 flipped and disposed within the trough 190 between the anchoring member 106 and the valve support 104.

[0106] FIG. 13 is a diagram illustrating an example of a method of detecting signals sensed by electrodes disposed on an outer surface of the frame of the heart valve prosthesis and for applying pacing signals to the heart in accordance with an aspect of the disclosure. The operations in FIG. 13 may be performed in the sequence and manner as shown, although the order of some operations may be changed or some of the operations omitted without departing from the spirit and scope of the illustrative examples described. Many of the operations shown in FIG. 13 may be performed in parallel or concurrently. One or more blocks of FIG. 13, and combinations of the blocks, can be implemented by special purpose hardware-based computer, such as a processor, that perform the specified functions, or combinations of special purpose hardware and computer instructions. For example, operations of the method may be performed by an implantable medical device (e.g., implantable medical device 140 of FIGS. 8 and 9).

[0107] In operation 1310, signals detected by the electrodes 130 disposed on the outer surface 107a of the anchoring member 106 of the frame 102 of the heart valve prosthesis 100 are received at the implantable medical device 140. In some examples, the sensing module 151 monitors signals from at least one of the electrodes 130 in order to monitor electrical activity of the heart, impedance, or other electrical phenomenon. Sensing may be done to determine heart rates or heart rate variability, or to detect arrhythmias (e.g., tachyarrhythmias) or other electrical signals. In some examples, the processor 155 may provide data related to theelectrical activity of the heart to be uplinked to another device to the telemetry module 156, which may send uplink telemetry to the device.

[0108] In operation 1320, the sensing module 151 of the implantable medical device 140 may include one or more detection channels, each of which may be coupled to a selected electrode configuration (from among the electrodes 130) for detection of cardiac signals via that electrode configuration. Some detection channels may be configured to detect cardiac events, such as P- or R-waves, and provide indications of the occurrences of such events to processor 155 of the implantable medical device 140. The processor 155 executing an automatic or a semiautomatic algorithm may analyze the sensing data to detect electrodes that do not provide sufficient amplitude of sensing wave. Such electrodes may be eliminated as options for pacing and / or sensing.

[0109] In operation 1330, the processor 155 may select the electrodes from among electrodes 130 for sensing in operation 1337 and for pacing in operation 1333.

[0110] The sensing module 151 may include one or more detection channels, each of which may be coupled to a selected electrode configuration for detection of cardiac signals via that electrode configuration. Some detection channels may be configured to detect cardiac events, such as P- or R-waves, and provide indications of the occurrences of such events to processor 155. In operation 1337, the processor 155 may select the sensing electrodes, i.e., select the sensing configuration, via the switch module within sensing module 151. The switch module may select which of the available electrodes (or electrode polarity) are used to sense the heart activity, depending upon which electrode combination, or electrode vector, is used in the current sensing configuration and the result of the analyzing in operation 1320.[oni] In operation 1333, based on the result of the analyzing in operation 1320, the processor 155 may control the switch module that is coupled to at least one of the electrodes 130, to use the appropriate electrodes to deliver pacing pulses.

[0112] In operation 1340, the processor 155 may determine the need for a pacing signal.

[0113] In operation 1350, the processor 155 controls the signal generator 152 to deliver stimulation therapy to the heart according to therapy parameters, which may be stored in the memory 157. For example, the processor 155 may control signal generator 152 to deliver electrical pulses with the amplitudes, pulse widths, frequency, or electrode polarities specified by the therapy parameters. In this manner, signal generator 152 may deliver pacing pulses (e.g., ATP pulses or post-shock pacing pulses) to the heart via one or more of the selected electrodes 130.

[0114] Throughout the specification, when a component is described as being “connected to,” or “coupled to” another component, it may be directly “connected to,” or “coupled to” the other component, or there may be one or more other components intervening therebetween. In contrast, when an element is described as being “directly connected to,” or “directly coupled to” another element, there can be no other elements intervening therebetween.

[0115] Although terms such as “first,” “second,” and “third,” A, B, C, (a), (b), (c), or the like may be used herein to describe various members, components, regions, layers, or sections, these members, components, regions, layers, or sections are not to be limited by these terms. Rather, these terms are only used to distinguish one member, component, region, layer, or section from another member, component, region, layer, or section. Thus, a first member, component, region, layer, or section referred to in the examples described herein may also be referred to as a second member, component, region, layer, or section without departing from the teachings of the examples.

[0116] Spatially relative terms, such as “lower,” “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0117] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0118] The following examples are illustrative of the techniques described herein.

[0119] Example 1. A heart valve prosthesis, comprising: a frame configured to transition from a radially compressed configuration for delivery within a vasculature to a radially expanded configuration for placement within a heart valve of a patient; a prosthetic valve component disposed within and coupled to the frame; a plurality of electrodes disposed on an outer surface of the frame, the plurality of electrodes being configured to sense electrical signals of a heart of the patient; and an implantable medical device disposed within the frame with the frame in the radially expanded configuration, the implantable medical device comprising a housing, a power source, and control circuitry configured to detect arrhythmia based on the sensed electrical signals and to apply a pacing signal or shock to the heart via at least one of the plurality of electrodes.

[0120] Example 2. The heart valve prosthesis of Example 1, wherein the implantable medical device is disposed at a first position longitudinally outside of the frame when the frame is in the radially compressed configuration and is disposed at a second position at least partially longitudinally inside the frame in the radially expanded configuration.

[0121] Example 3. The heart valve prosthesis of Example 2, wherein the heart valve prosthesis is configured such that radial expansion from the radially compressed configuration to the radially expanded configuration causes the implantable medical device to move from the first position to the second position.

[0122] Example 4. A heart valve prosthesis, comprising: a frame comprising an inner frame and an outer frame circumferentially surrounding at least a portion of the inner frame, wherein the frame has a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for placement within a heart valve of a patient; a prosthetic valve component disposed within and attached to the inner frame; an implantable medical device coupled to the frame, wherein the implantable medical device is disposed longitudinally outside of the outer frame with the frame in the radially compressed configuration and is disposed at least partially longitudinally inside the outer frame with the frame in the radially expanded configuration; and a plurality of electrodes coupled to an outer surface of the outer frame and electrically coupled to the implantable medical device, wherein the implantable device comprises a housing, a power source, and control circuitry to detect arrhythmia and to apply a pacing signal or shock to a heart of the patient via at least one of the plurality of electrodes.

[0123] Example 5. The heart valve prosthesis of Example 4, wherein the implantable medical device is movably coupled to the frame.

[0124] Example 6. The heart valve prosthesis of Example 4 or Example 5, wherein radial expansion of the frame from the radially compressed configuration to the radially expanded configuration causes the implantable medical device to move from longitudinally outside of the outer frame to at least partially longitudinally inside the frame.

[0125] Example 7. The heart valve prosthesis of any one of Examples 4 to 6, further comprising a first cord having a first end coupled to the implantable device and a second end fixedly attached to the inner frame, wherein the first cord is slidingly coupled to the outer frame.

[0126] Example 8. The heart valve prosthesis of Example 7, further comprising a C-shaped restraint extending from the inner surface of the outer frame, wherein the cord extends through the C-shaped restraint to be slidingly coupled to the outer frame.

[0127] Example 9. The heart valve prosthesis of any one of Examples 4 to 6, further comprising: a first cord having a first end coupled to the implantable medical device and a second end fixedly coupled to the inner frame.

[0128] Example 10. The heart valve prosthesis of Example 8 or Example 9, further comprising a second cord having a first end coupled to the implantable medical device and a second end fixedly coupled to the outer frame.

[0129] Example 11. The heart valve prosthesis of Example 10, wherein the first cord is coupled to a proximal end of the implantable medical device and the second cord is coupled to a distal end of the implantable medical device, and wherein radially expansion of the frame causes the implantable medical device to flip from longitudinally outside of the outer frame in the radially compressed configuration to at least partially longitudinally inside of the outer frame in the radially expanded configuration.

[0130] Example 12. The heart valve prosthesis of any one of Examples 4 to 11, wherein the implantable medical device is configured to sense electrical signals of a heart of the patient and to apply a pacing signal to the heart.

[0131] Example 13. A method comprising: delivering a heart valve prosthesis to the site of a native heart valve in a radially compressed configuration, the heart valve prosthesis including a frame, a prosthetic valve component disposed within and coupled to the frame, and an implantable medical device coupled to the frame and disposed longitudinally outside the frame with the heart valve prosthesis in the radially compressed configuration; and deploying the heart valve prosthesis at the site of the native heart valve by radially expanding the heart valve prosthesis to a radially expanded configuration, wherein radially expanding the heart valve prosthesis causes the implantable medical device to move from longitudinally outside of the frame to at least partially longitudinally inside of the frame.

[0132] Example 14. The method of Example 13, wherein the heart valve prosthesis further includes a plurality of electrodes coupled to an outer surface of the frame and wherein the implantable medical device comprises a housing, a power source, and control circuitry to detect arrhythmia and to apply a pacing signal or shock to a heart of the patient via at least one of the plurality of electrodes.

[0133] Example 15. The method of Example 13 or Example 14, wherein: the frame comprises an inner frame and an outer frame at least partially surrounding the inner frame; the prosthetic valve component is disposed within and coupled to the inner frame; the implantable medical device is fixedly coupled to the inner frame and slidingly coupled to the outer frame; and radially expanding the frame causes the outer frame to radially expand more than the inner frame, thereby moving the implantable medical device from longitudinally outside of the outer frame to at least partially longitudinally inside the outer frame.

[0134] Example 16. The method of Example 15, wherein the implantable medical device longitudinally translates from longitudinally outside of the outer frame to at least partially longitudinally inside the outer frame.

[0135] Example 17. The method of Example 15, wherein the implantable medical device flips from longitudinally outside of the outer frame to at least partially longitudinally inside the outer frame.

[0136] Example 18 The method of Example of any one of Examples 13 to 17, further comprising: sampling electrical signals received from each of the plurality of electrodes for P- and R- wave amplitudes, determining, based on the sampling, the need for at least two of the plurality of electrodes to apply a pacing signal or shock to the heart; and determining, based on the sampling, at least two of the plurality of electrodes to sense electrical signals of the heart.

Claims

CLAIMSWhat is claimed is:

1. A heart valve prosthesis ( 100), comprising: a frame (102) configured to transition from a radially compressed configuration for delivery within a vasculature to a radially expanded configuration for placement within a heart valve of a patient; a prosthetic valve component (108) disposed within and coupled to the frame; a plurality of electrodes (130) coupled to the frame, the plurality of electrodes being configured to sense electrical signals of a heart of the patient; and an implantable medical device (140) disposed within the frame with the frame in the radially expanded configuration, the implantable medical device comprising a housing, a power source, and control circuitry configured to detect arrhythmia based on the sensed electrical signals and to apply a pacing signal or shock to the heart via at least one of the plurality of electrodes.

2. The heart valve prosthesis (100) of claim 1, wherein the implantable medical device (140) is disposed at a first position longitudinally outside of the frame (102) when the frame is in the radially compressed configuration and is disposed at a second position at least partially longitudinally inside the frame in the radially expanded configuration.

3. The heart valve prosthesis (100) of claim 2, wherein the heart valve prosthesis is configured such that radial expansion from the radially compressed configuration to the radially expanded configuration causes the implantable medical device (140) to move from the first position to the second position.

4. The heart valve prosthesis (100) of any one of claims 1 to 3, wherein the frame (102) comprises an inner frame (104) and an outer frame (106) circumferentially surrounding at least a portion of the inner frame, wherein the prosthetic valve component (108) is disposed within and attached to the inner frame (104).

5. The heart valve prosthesis (100) of claim 4, wherein the implantable medical device (140) is disposed longitudinally outside of the outer frame (106) with the frame (102) in the radially compressed configuration and is disposed at least partially longitudinally inside the outer frame (106) with the frame (102) in the radially expanded configuration.

6. The heart valve prosthesis (100) of claim 4 or claim 5, wherein the implantable medical device is movably coupled to the frame.

7. The heart valve prosthesis (100) of any one of claims 4 to 6, wherein radial expansion of the frame (102) from the radially compressed configuration to the radially expanded configuration causes the implantable medical device (140) to move from longitudinally outside of the outer frame (106) to at least partially longitudinally inside the outer frame (106).

8. The heart valve prosthesis (100) of any one of claims 4 to 7, further comprising a first cord (170) having a first end coupled to the implantable device (140) and a second end fixedly attached to the inner frame (104), wherein the first cord is slidingly coupled to the outer frame (106).

9. The heart valve prosthesis of claim 8, further comprising a C-shaped restraint (150) extending from an inner surface of the outer frame (106), wherein the first cord (170) extends through the C-shaped restraint to be slidingly coupled to the outer frame (106).

10. The heart valve prosthesis (100) of any one of claims 4 to 7, further comprising: a first cord (170) having a first end coupled to the implantable medical device (140) and a second end fixedly coupled to the inner frame (104).

11. The heart valve prosthesis (100) of claim 10, further comprising a second cord (180) having a first end coupled to the implantable medical device (140) and a second end fixedly coupled to the outer frame (106).

12. The heart valve prosthesis of claim 11, wherein the first cord (170) is coupled to a proximal end of the implantable medical device (140) and the second cord (180) is coupled to a distal end of the implantable medical device (140), and wherein radially expansion of the frame (102) causes the implantable medical device (140) to flip from longitudinally outside of the outer frame (106) in the radially compressed configuration to at least partially longitudinally inside of the outer frame (106) in the radially expanded configuration.

13. The heart valve prosthesis (100) of any one of claims 1 to 11, wherein the implantable medical device (140) is configured to sense electrical signals of a heart of the patient and to apply a pacing signal to the heart.

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