Prosthetic aortic valve pacing system

Abstract

A valve prosthesis system is provided, including a prosthetic aortic valve and a non-implantable unit. The prosthetic aortic valve includes a plurality of prosthetic leaflets; a frame; a cathode and an anode; and a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode. The non-implantable unit includes an energy transmission coil; and a non-implantable control circuit configured to drive the cathode and the anode to apply a pacing signal by inductively coupling energy from the energy transmission coil to the prosthetic valve coil wirelessly, and to set parameters of the pacing signal; to start each pulse of the pacing signal by starting the wireless transfer of energy from the energy transmission coil to the prosthetic valve coil; and to end each pulse of the pacing signal by stopping the wireless transfer of energy from the energy transmission coil to the prosthetic valve coil. Other embodiments are also described.

Description

Prosthetic aortic valve pacing system

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Application No. 16 / 734,798 (now U.S. Patent No. 10,835,750), filed January 6, 2020, which is assigned to the assignee of this application and is incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to surgical implants and systems, and more specifically to prosthetic aortic valves and systems. Background Technology

[0004] Aortic valve replacement may be necessary to treat valvular regurgitation or calcified leaflet stenosis. In the percutaneous transluminal delivery technique, a prosthetic aortic valve is compressed for delivery in a catheter and advanced through the descending aorta to the heart, where it is deployed within the aortic annulus. New-onset cardiac conduction disturbances are common after transcatheter aortic valve implantation (TAVI). The most common complication is left bundle branch block (LBBB).

[0005] U.S. Patent No. 7,914,569 to Nguyen et al. (incorporated herein by reference) describes a heart valve prosthesis with a self-opening multi-level frame supporting a valve body comprising a skirt and multiple intercalating leaflets. The frame transitions between a contractile delivery configuration (or configuration) that enables percutaneous transluminal delivery, and an open deployment configuration having an asymmetrical hourglass shape. The valve body skirt and leaflets are configured such that the intercalation center can be selected to reduce the horizontal forces applied to the valve intercalation and to effectively distribute and transmit forces along the leaflets to the frame. Alternatively, the valve body can be used as a surgically implantable replacement valve prosthesis. Summary of the Invention

[0006] Some embodiments of this disclosure provide a prosthetic aortic valve comprising a plurality of prosthetic leaflets, a frame, and one or more electrodes coupled to the frame. The frame is shaped to define an upstream inflow portion; a downstream outflow portion; and a constriction portion axially located between the upstream inflow and downstream outflow portions. The prosthetic leaflets are coupled to the constriction portion. When the prosthetic aortic valve is in its fully deployed, open configuration: the free edges of the prosthetic leaflets face the downstream outflow portion, and the annular longitudinal boundary between the downstream outflow and constriction portions is defined by the lowest point of the frame to which the prosthetic leaflets are coupled. The prosthetic aortic valve also includes a prosthetic valve coil, which is non-wirelessly electrically connected to one or more electrodes and coupled to the frame, for example, axially along the downstream outflow portion no more than 1 mm upstream of the annular longitudinal boundary.

[0007] In some embodiments of this disclosure, a valve prosthesis system is provided, comprising a prosthetic aortic valve and a non-implantable unit. The prosthetic aortic valve includes a plurality of prosthetic leaflets; a frame; a cathode and an anode mechanically coupled to the frame; and a prosthetic valve coil non-wirelessly electrically connected to the cathode and anode. The non-implantable unit includes an energy delivery coil; and non-implantable control circuitry configured to wirelessly transfer energy from the energy delivery coil to the prosthetic valve coil via inductive coupling to drive the cathode and anode to apply a pacing signal and set parameters of the pacing signal.

[0008] Therefore, according to the inventive concept 1 of this disclosure, a valve prosthesis system is provided, comprising:

[0009] (i) A prosthetic aortic valve comprising:

[0010] (a) Multiple prosthetic lobules;

[0011] (b) Framework;

[0012] (c) The cathode and anode are mechanically coupled to the frame; and

[0013] (d) A pseudovalve coil, which is electrically connected to the cathode and anode non-wirelessly; and

[0014] (ii) Non-implantable units, including:

[0015] (a) an energy transfer coil; and

[0016] (b) A non-implantable control circuit configured to wirelessly transmit energy from the energy transfer coil to the prosthetic valve coil via inductive coupling to drive the cathode and anode to apply a pacing signal and set the parameters of the pacing signal.

[0017] Inventive Concept 2. According to the valve prosthesis system of Inventive Concept 1, the prosthetic aortic valve includes one or more elongated insulated electrical conductors that directly couple the prosthetic valve coil to the cathode and anode in a non-radio-communication manner.

[0018] Inventive Concept 3. According to the valve prosthesis system of Inventive Concept 1, the corresponding ends of the prosthesis valve coil are electrically connected to the cathode and anode in a non-wireless manner.

[0019] Inventive Concept 4. According to Inventive Concept 1, a valve prosthesis system is provided, wherein corresponding non-electrically insulated ends of the prosthesis valve coil define a cathode and an anode.

[0020] Inventive Concept 5. According to the valve prosthesis system of Inventive Concept 1, the non-implantable control circuit is configured to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil.

[0021] Inventive Concept 6. According to the valve prosthesis system of Inventive Concept 1, the pacing signal comprises pulses, and wherein a non-implantable control circuit is configured to drive the cathode and anode to: (a) initiate the application of each pulse of the pacing signal by starting to wirelessly transmit energy from the energy transfer coil to the prosthetic valve coil; and (b) terminate the application of each pulse of the pacing signal by stopping the wireless transmission of energy from the energy transfer coil to the prosthetic valve.

[0022] Inventive Concept 7. According to the valve prosthesis system of Inventive Concept 1,

[0023] The frame is defined as follows: (1) an upstream inflow portion, (2) a downstream outflow portion, and (3) a contraction portion, the contraction portion being axially located between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the contraction portion, and

[0024] The cathode is mechanically coupled to the upstream inflow portion of the frame.

[0025] Inventive Concept 8. A valve prosthesis system according to Inventive Concept 7, wherein the prosthesis valve coil is axially disposed along the downstream outflow portion of the frame.

[0026] Inventive Concept 9. According to the valve prosthesis system of Inventive Concept 1, the cathode and anode are disposed on the frame such that when the prosthetic aortic valve is in the fully deployed open configuration, there is at least 15 mm between the cathode and the anode, the 15 mm being measured along the central longitudinal axis of the frame when the prosthetic aortic valve is in the fully deployed open configuration.

[0027] Inventive Concept 10. A valve prosthesis system according to any one of inventive concepts 1 to 9, wherein the non-implantable unit is an external unit configured to be disposed outside the body of an object in which a prosthetic aortic valve is disposed.

[0028] Inventive Concept 11. A valve prosthesis system according to any one of inventive concepts 1 to 9,

[0029] The non-implantable unit is the delivery system, which further includes a delivery tube and one or more wires passing along the delivery tube.

[0030] Among them, the energy transfer coil is the delivery system coil.

[0031] Among them, the non-implantable control circuit is the delivery system control circuit, which is electrically connected to the delivery system coil via one or more wires, and

[0032] The delivery system coil is coupled to the delivery tube at the far end of the delivery tube.

[0033] Inventive Concept 12. According to the valve prosthesis system of Inventive Concept 11, the delivery system control circuit is configured to wirelessly transmit energy from the energy transfer coil to the prosthetic valve coil via inductive coupling to drive the cathode and anode to apply rapid ventricular pacing.

[0034] Inventive Concept 13. According to the valve prosthesis system of Inventive Concept 11,

[0035] Wherein, the prosthetic aortic valve (i) is removably disposable and located in the delivery cannula in a compressed delivery configuration, and (ii) is configured to present:

[0036] (A) A partially open, partially deployed configuration upon partial release from the distal end of the delivery tube, such that: (1) at least the cathode is located outside the delivery tube; and (2) the prosthetic valve coil is compressed within the delivery tube; and

[0037] (B) The fully deployed configuration when completely released from the distal end of the delivery tube, and

[0038] The delivery system control circuit is configured to drive the cathode and anode to apply a pacing signal and set the parameters of the pacing signal by wirelessly transmitting energy from the energy transfer coil to the prosthetic valve coil at least when the prosthetic aortic valve is in a partially deployed configuration.

[0039] Inventive Concept 14. The valve prosthesis system according to Inventive Concept 13 further includes an external unit configured to be disposed outside the body of the object in which the prosthetic aortic valve is disposed, and the external unit includes:

[0040] External unit coil; and

[0041] The external unit control circuit is configured to drive the external unit coil to wirelessly transmit energy to the prosthetic valve coil via inductive coupling when the prosthetic aortic valve is in the fully deployed open configuration, thereby driving the cathode and anode to apply a pacing signal and setting the parameters of the pacing signal.

[0042] According to the inventive concept 15 of this disclosure, a method is also provided, comprising:

[0043] The prosthetic aortic valve of the valve prosthesis system is deployed in the aortic annulus via the patient's vascular system. The prosthetic aortic valve includes: (a) multiple prosthetic leaflets; (b) a frame; (c) a cathode and an anode mechanically coupled to the frame; and (d) a prosthetic valve coil non-wirelessly electrically connected to the cathode and anode; and

[0044] The non-implantable control circuit of the non-implantable unit of the valve prosthesis system is activated to wirelessly transmit energy from the energy transfer coil of the non-implantable unit to the prosthesis valve coil via inductive coupling to drive the cathode and anode to apply a pacing signal and set the parameters of the pacing signal.

[0045] Inventive Concept 15. According to the method of Inventive Concept 15,

[0046] The non-implantable unit is the delivery system of the valve prosthesis system, and the energy transfer coil is the delivery system coil coupled to the delivery tube at the distal end of the delivery tube.

[0047] The non-implantable control circuit is the delivery system control circuit, which is electrically connected to the delivery system coil via one or more wires passing through the delivery tube.

[0048] The deployment of a prosthetic aortic valve includes:

[0049] The delivery cannula is advanced through the vascular system until its distal end is positioned in the patient's ascending aorta, while the prosthetic aortic valve is removably housed within the delivery cannula in a compressed delivery configuration; and

[0050] The prosthetic aortic valve is partially released from the distal end of the delivery cannula, such that the prosthetic aortic valve is in a partially open, partially deployed configuration, wherein (a) at least the cathode is located outside the delivery cannula, and (b) the prosthetic valve coil is compressed within the delivery cannula.

[0051] The activation of the non-implantable control circuitry includes, after partially releasing the prosthetic aortic valve from the distal end of the delivery cannula, activating the delivery system control circuitry to drive the cathode and anode to apply pacing signals and set the parameters of the pacing signals. This is achieved by wirelessly transferring energy from the delivery system coil to the prosthetic valve coil via inductive coupling, at least while the prosthetic aortic valve is in a partially deployed configuration.

[0052] The deployment of the prosthetic aortic valve also includes, after activating the delivery system control circuit, fully releasing the prosthetic aortic valve from the distal end of the delivery cannula, so that the prosthetic aortic valve is in a fully deployed configuration.

[0053] Inventive Concept 16. The method according to Inventive Concept 15, wherein activating the delivery system control circuit includes activating the delivery system control circuit to drive the cathode and anode to apply rapid ventricular pacing, which is achieved by wirelessly transferring energy from the energy transfer coil to the prosthetic valve coil via inductive coupling, at least when the prosthetic aortic valve is in a partially deployed configuration.

[0054] Inventive Concept 17. The method according to Inventive Concept 15 further includes: after the prosthetic aortic valve is fully released from the distal end of the delivery tube, activating the external unit control circuit of the external unit to drive the external unit coil of the external unit, thereby driving the cathode and anode to apply pacing signals and set the parameters of the pacing signals, which is achieved by inductively coupling wirelessly transferring energy to the prosthetic valve coil when the prosthetic aortic valve is in the fully deployed configuration, the prosthetic valve coil being disposed outside the body of the object in which the prosthetic aortic valve is arranged.

[0055] Inventive Concept 18. According to the method of Inventive Concept 15, the delivery system control circuit is configured to stop driving the delivery system coil to drive the cathode and anode when the prosthetic aortic valve is in a fully deployed configuration when it is fully released from the distal end of the delivery cannula.

[0056] Inventive Concept 19. According to the method of Inventive Concept 15, wherein partially releasing the prosthetic aortic valve from the distal end of the delivery tube includes positioning the cathode adjacent to cardiac tissue near the His bundle.

[0057] Inventive Concept 20. According to the method of Inventive Concept 19, positioning the cathode adjacent to cardiac tissue near the His bundle includes: if necessary, rotating the prosthetic aortic valve during opening such that the cathode is positioned against cardiac tissue near the His bundle.

[0058] This disclosure will be more fully understood through the following detailed description of embodiments of this disclosure in conjunction with the accompanying drawings, in which: Attached Figure Description

[0059] Figures 1A and 1B are schematic diagrams of prosthetic aortic valves according to the application of this disclosure;

[0060] Figure 2 is a schematic diagram of the components of the prosthetic aortic valve of Figures 1A and 1B before completion of assembly according to the application of this disclosure;

[0061] Figure 3 is a schematic diagram of another prosthetic aortic valve according to the application of this disclosure;

[0062] Figures 4A to 4C are schematic diagrams of valve prosthesis systems for corresponding applications according to this disclosure and methods of using such systems; and

[0063] Figure 5 is a schematic diagram of an electronic implant according to the application of this disclosure. Detailed Implementation

[0064] Figures 1A and 1B are schematic diagrams of a prosthetic aortic valve 20 according to the application of this disclosure. Figures 1A and 1B show the prosthetic aortic valve 20 in an open configuration, similar to the fully deployed configuration described below with reference to Figure 4C, except that in Figures 1A and 1B, the opening of the prosthetic aortic valve 20 is not limited by the patient's anatomy. Figure 1B is a view of the prosthetic aortic valve 20 as seen from the downstream outflow end 52, as described below.

[0065] The prosthetic aortic valve 20 includes:

[0066] • Frame 30;

[0067] • Multiple prosthetic leaflets 32 are coupled to the frame 30;

[0068] One or more electrodes 34 are coupled to the frame 30; and

[0069] • The prosthetic valve coil 36 is coupled to the frame 30 and is in non-wireless electrical communication (electrical connection) with one or more electrodes 34, optionally via one or more elongated insulated electrical conductors 38 (e.g.,

[0070] The wire is electrically connected to one or more electrodes 34 in a non-wireless manner.

[0071] The frame 30 typically includes a support or other structure, which is typically self-opening and can be formed by laser cutting or etching of a metal alloy tube comprising, for example, stainless steel or a shape memory material such as nitinol. For some applications, one or more electrodes 34 are coupled to the frame 30 using the techniques described in U.S. Patent No. 9,526,637 to Dagan et al. and / or U.S. Patent No. US2016 / 0278951 to Dagan et al., both of which are incorporated herein by reference. For some applications, the prosthetic valve coil 36 includes gold wire to provide low resistance.

[0072] For some applications, the prosthetic aortic valve 20 also includes a prosthetic aortic valve control circuit 40, which is coupled to the frame 30 and is in non-radio-ground electrical communication with one or more electrodes 34. In these applications, the prosthetic valve coil 36 is in non-radio-ground electrical communication with the prosthetic aortic valve control circuit 40, such that the prosthetic valve coil 36 is in non-radio-ground electrical communication with one or more electrodes 34 via the prosthetic aortic valve control circuit 40. One or more of the electrodes 34 may be directly attached to the prosthetic aortic valve control circuit 40 in a non-radio-communication manner, and / or may be attached to the prosthetic aortic valve control circuit 40 in a non-radio-communication manner via one or more elongated insulated electrical conductors 38. Typically, the prosthetic aortic valve control circuit 40 is flexible and has a thin linear package, and can implement the techniques described below with reference to FIG5. The thinness of the control circuit 40 allows it to be compressed in the delivery cannula during the deployment of the prosthetic aortic valve 20 without increasing the diameter of the delivery cannula. Furthermore, the flexibility of the control circuit 40 prevents damage to the control circuit when it is coiled up while being compressed into the delivery tube.

[0073] For some applications, frame 30 is shaped to define an upstream inflow portion 42, a downstream outflow portion 44, and a constriction portion 46 axially located between the upstream inflow portion 42 and the downstream outflow portion 44. Prosthetic leaflet 32 ​​is coupled to the constriction portion 46 such that when the prosthetic aortic valve 20 is in its fully deployed configuration as described below with reference to FIG4C, the free edge 48 of prosthetic leaflet 32 ​​faces the downstream outflow portion 44. Prosthetic leaflet 32 ​​is not coupled to the downstream outflow portion 44; therefore, the annular longitudinal boundary 58 between the downstream outflow portion 44 and the constriction portion 46 is defined by the most downstream point of frame 30 to which prosthetic leaflet 32 ​​is coupled (e.g., as described immediately below, prosthetic leaflet 32 ​​may be coupled to the most downstream point of frame 30 at the junction (or suture) 60). (The annular longitudinal boundary 58 is located at the same longitudinal position surrounding the frame 30.) Typically, the prosthetic aortic valve 20 also includes a skirt 49 coupled to the upstream inflow portion 42 of the frame 30, and the prosthetic leaflet 32 ​​is attached to the skirt 49 along its base, for example, using sutures or a suitable biocompatible adhesive. Adjacent pairs of leaflets connect with each other at their lateral ends to form a junction 60, and the free edges 48 of the prosthetic leaflets form converging junction edges. The skirt 49 and the prosthetic leaflet 32 ​​typically comprise a piece of animal pericardial tissue, such as porcine pericardial tissue, or a synthetic or polymeric material.

[0074] For some applications, the prosthetic valve coil 36 is typically positioned axially along the downstream outflow portion 44, no more than 1 mm upstream of the annular longitudinal boundary 58 between the downstream outflow portion 44 and the constriction portion 46. This arrangement allows the prosthetic aortic valve 20 to be coiled (compressed) into the delivery cannula during deployment without requiring a larger diameter delivery cannula to accommodate the prosthetic valve coil 36. This is possible because the downstream outflow portion 44 does not include material of the prosthetic leaflet 32, thus allowing the prosthetic valve coil 36 to be accommodated without giving the downstream outflow portion 44 a larger compression diameter than other axial portions of the prosthetic aortic valve 20. Typically, the prosthetic valve coil 36 is not positioned axially along the constriction portion 46, nor along the upstream inflow portion 42. Furthermore, since the downstream outflow portion 44 typically has a larger diameter than each of the constriction portion 46 and the upstream inflow portion 42, the axial arrangement of the prosthetic valve coil 36 along the downstream outflow portion 44 improves delivery efficiency. Furthermore, the contraction portion 46 typically has a smaller diameter than each of the upstream inflow portion 42 and the downstream outflow portion 44.

[0075] Typically, at least one of one or more electrodes 34 is coupled to the upstream inflow portion 42 of the frame 30, such as precisely one electrode of one or more electrodes 34 coupled to the upstream inflow portion 42 of the frame 30. For some applications, one or more electrodes 34 include a cathode 54 coupled to the upstream inflow portion 42 of the frame 30, and the prosthetic aortic valve control circuitry 40 is configured to drive the cathode 54 to apply a cathode current. For some applications, the cathode 54 has a lateral dimension α (alpha) measured angularly around the frame 30 relative to the central longitudinal axis 55 of the frame 30, which is between 10 and 40 degrees, for example between 20 and 40 degrees, such as 30 degrees, to accommodate rotational misalignment of the frame 30 relative to the His bundle. Typically, imaging such as fluoroscopy is used to deploy the prosthetic aortic valve 20, and if necessary, the prosthetic aortic valve 20 is rotated during deployment such that the cathode 54 is positioned against annular tissue located near the His bundle. For some applications, the prosthetic aortic valve 20 includes a plurality of cathodes 54 (e.g., two or three, or more) positioned at corresponding angular locations (e.g., spaced 10-15 degrees apart) around the frame 30. After implantation of the prosthetic aortic valve 20, the cathode 54 with the most precise angular position is activated by the prosthetic aortic valve control circuit 40 or external control circuitry (such as external unit control circuitry 104) to apply a pacing signal and / or sense, as described below with reference to FIG4C. Optionally or additionally, for some applications, the cathode 54 has an axial length of at least 10 mm to accommodate axial misalignment of the frame 30 relative to the natural aortic valve annulus, and thus relative to the His bundle. As included in the claims and used herein, “axial length” is the length of the structure measured along the central longitudinal axis 55.

[0076] For some applications, the cathode 54 has a thickness between 75 micrometers and 125 micrometers, for example, about 100 micrometers, and / or at least 2.5 mm. 2 The surface area is adjusted to provide sufficient stimulation. For some applications, the cathode 54 comprises titanium nitride (TiN). For some applications, the skirt 49 is coupled to the outer surface of the upstream inflow portion 42 of the frame 30, and the cathode 54 is disposed on the outer surface of the skirt 49. As included in the claims and used herein, the “central longitudinal axis” 55 of the frame 30 is the set of all centroids of the frame 30 along its cross-section. Thus, the cross-section is locally perpendicular to the central longitudinal axis extending along the frame 30. (For applications where the cross-section of the frame 30 is circular, the centroid corresponds to the center of the circular cross-section.)

[0077] For some applications, when the prosthetic aortic valve 20 is in the fully deployed configuration described below with reference to FIG4C:

[0078] The frame 30 has an inflow end 50 at the upstream inflow portion 42 and a downstream outflow end 52 at the downstream outflow portion 44, and an axial length measured between the inflow end 50 and the downstream outflow end 52.

[0079] • At least one of the one or more electrodes 34 (e.g., specifically, one of the one or more electrodes 34, such as cathode 54) is coupled to the upstream inflow portion 42 at a distance from the inflow end 50, which is equal to 10% of the axial length of the frame 30 (when in the fully deployed configuration, (a) this distance is measured along the central longitudinal axis 55 of the frame 30, and (b) this distance is measured between the inflow end 50 and the upstream point of at least one electrode).

[0080] Typically, the prosthetic aortic valve control circuit 40 is coupled to the frame 30 such that the upstream point 56 of the prosthetic aortic valve control circuit 40 is axially positioned along the constriction portion 46 and / or the downstream outflow portion 44 of the frame 30.

[0081] Typically, the prosthetic aortic valve control circuit 40 is coupled to the frame 30 within the frame 30. This prevents friction between the prosthetic aortic valve control circuit 40 and the delivery tube 72 during the deployment of the prosthetic aortic valve 20, as will be described below with reference to Figures 4A to 4C. Note that for applications where the upstream point 56 is located no more than 1 mm upstream of the annular longitudinal boundary 58, as described above, there is generally sufficient space within the frame 30 to accommodate the prosthetic aortic valve control circuit 40.

[0082] For some applications, the prosthetic leaflet 32 ​​is coupled to the frame 30 at at least a first suture 60A and a second suture 60B of the prosthetic aortic valve 20, the first suture 60A and the second suture 60B being located at corresponding first angular positions 62A and 62B around the frame 30. When the prosthetic aortic valve 20 is in the fully deployed configuration described below with reference to FIG4C, the first angular positions 62A and 62B are separated by a first angular offset β (beta) around the frame 30. When the prosthetic aortic valve 20 is in the fully deployed configuration described below with reference to FIG4C, the prosthetic aortic valve control circuitry 40 is coupled to the frame 30 at a third angular position 62C, the third angular position 62C being separated from the first angular position 62A by a second angular offset δ (delta), the second angular offset δ (delta) being equal to between 40% and 60% (e.g., 50%) of the first angular offset β (beta). At the triangular position 62C surrounding frame 30, the frame is more flexible than at the more rigid joint. As included in the claims and used herein, "angular position" is a location on frame 30 at a specific point around the central longitudinal axis 55, i.e., at a specific "o'clock" position relative to the central longitudinal axis 55. (Note that in FIG. 1A, the third joint 60C is shown on the far side of the frame, i.e., at 180 degrees to circuit 40.)

[0083] Referring now to Figure 2, which is a schematic diagram of the components of a prosthetic aortic valve 20 prior to full assembly according to the application of this disclosure. These components include valve components 64 and electronic components 66. Valve components 64 typically consist of a heart valve prosthesis known in the art, which includes at least a frame 30 and a prosthetic leaflet 32. For example, known heart valve prostheses may include the CoreValve™ Evolut™ R prosthesis (Medtronic, Minneapolis, Minnesota, USA), the CoreValve™ Evolut™ PRO prosthesis (Medtronic), the LOTUS Edge™ aortic valve (Boston Scientific, Marlborough, Massachusetts, USA), or the ACURATE neo™ aortic valve (Boston Scientific). Electronic components 66 include at least one or more electrodes 34 and a prosthetic valve coil 36, as well as optional prosthetic aortic valve control circuitry 40.

[0084] During the assembly of the prosthetic aortic valve 20, electronic components 66 are inserted into the valve component 64. For some applications, a first portion of the electronic components 66 (such as the prosthetic valve coil 36, the prosthetic aortic valve control circuit 40, and one of one or more electrodes 34) is coupled to the inner surface of the frame 30, while a second portion of the electronic components 66 (such as the cathode 54) is coupled to the outer surface of the frame 30. For example, one of one or more elongated insulated conductors 38, an elongated insulated conductor 38A, can electrically couple the cathode 54 to the prosthetic aortic valve control circuit 40, and conductor 38A can pass from inside the frame 30 to the outside, typically through the skirt 49. (Coupling one of the one or more electrodes 34 to the inner surface of the frame 30 can expose the electrode to the subject's blood during implantation of the assembled prosthetic aortic valve 20. Attaching the cathode 54 to the outer surface of the frame 30 can, during implantation of the assembled prosthetic aortic valve 20, position the cathode against tissue (such as annular tissue near the His bundle), as described herein.) Optionally, components of the electronic component 66 can be sutured to the frame 30 and / or the skirt 49.

[0085] For some applications, whether the prosthetic valve coil 36 is coupled to the inner or outer surface of the frame 30, the prosthetic valve coil 36 is electrically isolated from the frame 30, such as by means of an insulating material (e.g., a sheet of material or a coating) disposed between the prosthetic valve coil 36 and the frame 30. For example, the insulating material may include a non-conductive polymer.

[0086] The assembly of the aforementioned prosthetic aortic valve 20 is typically performed in a manufacturing facility, after which the assembled prosthetic aortic valve 20 is packaged and transported to a healthcare facility for implantation. Therefore, the method of assembling the prosthetic aortic valve 20 is non-surgical.

[0087] Figure 3 is a schematic diagram of a prosthetic aortic valve 120 according to the application of this disclosure. The prosthetic aortic valve 120 shown in Figure 3 is in an open configuration, similar to the fully deployed open configuration of the prosthetic aortic valve 20 described below with reference to Figure 4C, except that in Figure 3, the opening of the prosthetic aortic valve 120 is not limited by the patient's anatomy. Except as described below, the prosthetic aortic valve 120 is identical to the prosthetic aortic valve 20 described herein with reference to Figures 1A, 1B, and 2, and the same reference numerals denote the same components. The prosthetic aortic valve 120 can be assembled as described above with reference to Figure 2 for the prosthetic aortic valve 20, with necessary modifications in detail.

[0088] As described below with reference to Figure 4B regarding the prosthetic aortic valve 20, for some applications, the delivery system control circuitry 80 is configured to drive one or more electrodes 34 to apply rapid ventricular pacing. In this configuration, the prosthetic aortic valve control circuitry 40, even if provided, is typically passive; that is, the delivery system control circuitry 80 sets the parameters of the pacing signal. The prosthetic aortic valve 120 shown in Figure 3 is one embodiment of this configuration. Unlike the construction of the prosthetic aortic valve 20 shown in Figures 1A and 1B, the prosthetic aortic valve 120 does not include the prosthetic aortic valve control circuitry 40.

[0089] A valve prosthesis system is provided, comprising (a) a prosthetic aortic valve 120 and (b) a non-implantable unit, such as a delivery system 70 described below with reference to Figures 4A through 4C, or an external unit 100 described below with reference to Figure 4C. Energy is wirelessly transmitted from an energy delivery coil (such as, depending on the case, delivery system coil 74 or external unit coil 102 described below with reference to Figure 4C) to the prosthetic valve coil 36 via inductive coupling. Non-implantable control circuitry (such as, depending on the case, delivery system control circuitry 80 or external unit control circuitry 104 of external unit 100) is configured to drive a cathode 54 and an anode 57 to apply a pacing signal and set parameters of the pacing signal (e.g., a standard, chronic pacing signal, or a rapid ventricular pacing signal). The applied pacing is typically bipolar.

[0090] Optionally, the valve prosthesis system includes two non-implantable units: (1) a delivery system 70, described below with reference to Figures 4A to 4C, and (2) an external unit 100, described below with reference to Figure 4C, which include corresponding control circuitry and energy delivery coils. When the prosthetic aortic valve 120 is in a partially deployed configuration, the delivery system control circuitry 80 is configured to drive the delivery system coil 74 to wirelessly transfer energy to the prosthetic valve coil 36 via inductive coupling to drive the cathode 54 and anode 57 to apply a pacing signal, and to set the parameters of the pacing signal as described below with reference to Figure 4B. When the prosthetic aortic valve 120 is in an open, fully deployed configuration, as described below with reference to Figure 4C, the external unit control circuitry 104 is configured to drive the external unit coil 102 to wirelessly transfer energy to the prosthetic valve coil 36 via inductive coupling to drive the cathode 54 and anode 57 to apply a pacing signal, and to set the parameters of the pacing signal.

[0091] Typically, each end of the prosthetic valve coil 36 is electrically connected to the cathode 54 and anode 57 via non-wireless ground.

[0092] For some applications, the respective non-electrically insulated ends of the prosthetic valve coil 36 define a cathode 54 and an anode 57. In these applications, the prosthetic aortic valve 120 typically does not include an elongated insulating conductor 38. Instead, the respective insulated ends of the prosthetic valve coil 36 are bent away from the prosthetic valve coil 36 along the path of the elongated insulating conductor 38 shown in FIG. 3, such that the respective non-electrically insulated ends of the prosthetic valve coil 36 are located at the positions of the cathode 54 and anode 57 shown in FIG. 3.

[0093] As described above, the non-implantable control circuit is configured to drive the cathode 54 and anode 57 to set the parameters of the pacing signal. For example, the non-implantable control circuit can be configured to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transfer coil to the prosthetic valve coil 36. Optionally or additionally, for example, the non-implantable control circuit can be configured to drive the cathode 54 and anode 57 to (a) begin each pulse of the pacing signal by starting to wirelessly transmit energy from the energy transfer coil to the prosthetic valve coil 36, and (b) end each pulse of the pacing signal by stopping to wirelessly transmit energy from the energy transfer coil to the prosthetic valve coil 36.

[0094] Referring to Figures 1A, 1B, 2, and 3, and additionally to Figures 4A through 4C, these are schematic diagrams of a valve prosthesis system 68 according to a corresponding application of the present disclosure and a method of using the system. Although the technique described with reference to Figures 4A through 4C is generally described with respect to a prosthetic aortic valve 120, the same technique can be applied to a prosthetic aortic valve 20, with necessary modifications in detail. The rotational orientation of the prosthetic aortic valve is schematically shown in Figures 4A through 4C to illustrate the components of the prosthetic aortic valve; as described below, in actual use, the prosthetic aortic valve is typically rotationally oriented such that the cathode 54 is positioned adjacent to cardiac tissue near the His bundle.

[0095] The valve prosthesis system 68 includes a prosthetic aortic valve 20 or a prosthetic aortic valve 120 and a delivery system 70.

[0096] Delivery system 70 includes:

[0097] • Delivery tube 72;

[0098] • Delivery system coil 74, which is coupled to delivery tube 72 at the distal end 76 of delivery tube 72; for example, the distal end 77 of delivery system coil 74 may be located within 10 mm of the distal end 82 of delivery tube 72.

[0099] • One or more wires 78 that pass along the delivery tube 72, for example, attached to the outside of the delivery tube 72.

[0100] Surface or inner surface, or embedded in the wall of delivery tube 72; and

[0101] • Delivery system control circuit 80, which is electrically connected to delivery system coil 74 via one or more wires 78.

[0102] The delivery system control circuit 80 is configured to drive the delivery system coil 74 so as to wirelessly transfer energy to the prosthetic valve coil 36 via inductive coupling, at least when the prosthetic aortic valve 120 is in the partially deployed configuration described below with reference to FIG4B.

[0103] As shown in Figure 4A, in the compressed delivery configuration, the prosthetic aortic valve 120 is detachably disposed within the delivery cannula 72. During implantation, the delivery cannula 72 travels through the patient's vascular system until its distal end 82 is positioned in the patient's ascending aorta 84, while the prosthetic aortic valve 120 is detachably disposed within the delivery cannula 72 in the compressed delivery configuration.

[0104] As shown in Figure 4B, the prosthetic aortic valve 120 is also configured to present a partially open, partially deployed configuration upon partial release from the distal end 82 of the delivery tube 72, such that: (a) at least one of the one or more electrodes 34 (such as cathode 54) is located outside the delivery tube 72 and near (e.g., in contact with) the target tissue (such as the natural aortic valve annulus); and (b) the prosthetic valve coil 36 is compressed within the delivery tube 72. Typically, the delivery system coil 74 surrounds the compressed prosthetic valve coil 36, providing high transmission efficiency even though the prosthetic valve coil 36 remains compressed. After the prosthetic aortic valve 120 presents the partially open, partially deployed configuration, the delivery system control circuitry 80 is activated to drive the delivery system coil 74 to wirelessly transfer energy to the prosthetic valve coil 36 via inductive coupling. Conversely, power transfer from the external coil to the compressed prosthetic valve coil 36 would be considerably less efficient due to the large distance between the transmitting and receiving coils and the compressed prosthetic valve coil 36.

[0105] For some applications of the valve prosthesis system 68, which includes a prosthetic aortic valve 20, as described above with reference to Figures 1A, 1B, and 2, the prosthetic aortic valve control circuit 40 is configured to drive one or more electrodes 34 to apply rapid ventricular pacing. This pacing can temporarily reduce left ventricular output to allow for more accurate placement of the prosthetic aortic valve 20. Alternatively, as described above with reference to Figure 3, the delivery system control circuit 80 is configured to drive one or more electrodes 34 to apply rapid ventricular pacing; in this configuration, the prosthetic aortic valve control circuit 40, even if provided (as in the prosthetic aortic valve 20), is typically passive, or the prosthetic aortic valve control circuit 40 is not provided (as in the prosthetic aortic valve 120), i.e., the delivery system control circuit 80 sets the parameters of the pacing signal. Alternatively, the prosthetic aortic valve 20 or 120 may not be used to apply rapid ventricular pacing, but may be used to apply post-implantation pacing as described below, and / or for post-implantation sensing as described below.

[0106] As described above with reference to Figures 1A and 1B, for some applications, one or more electrodes 34 include a cathode 54 coupled to the upstream inflow portion 42 of the frame 30. When the prosthetic aortic valve 120 is in the partially open, partially deployed configuration shown in Figure 4B, the cathode 54 is positioned adjacent to cardiac tissue near the His bundle to pace the heart by stimulating the cardiac tissue with a cathode current. For some applications, one or more electrodes also include an anode 57, which can be used for bipolar sensing and / or pacing, as known in the art. Typically, the cathode 54 and anode 57 are positioned on the frame 30 such that when the prosthetic aortic valve 120 is in the fully deployed, open configuration described below with reference to Figure 4C, there is at least 15 mm between the cathode and anode (15 mm is measured along the central longitudinal axis 55 of the frame 30 when in the fully deployed, open configuration).

[0107] As shown in Figure 4C, the prosthetic aortic valve 120 is also configured to present an open, fully deployed configuration when fully released from the distal end 82 of the delivery cannula 72. For some applications, the delivery system control circuit 80 is configured to stop driving the delivery system coil 74 to wirelessly deliver energy when the prosthetic aortic valve 120 is in an open, fully deployed configuration after being fully released from the distal end 82 of the delivery cannula 72.

[0108] For some applications, as shown in Figure 4C, the valve prosthesis system 68 also includes an external unit 100, which includes (a) an external unit coil 102 and (b) an external unit control circuit 104 configured to drive the external unit coil 102 to wirelessly transfer energy to the prosthesis valve coil 36 via inductive coupling when the prosthesis aortic valve 120 is in its fully deployed, open configuration. In these applications, after the prosthesis aortic valve 120 has been fully released from the distal end 82 of the delivery tube 72, the external unit control circuit 104 is activated to drive the external unit coil 102, thereby wirelessly transferring energy to the prosthesis valve coil 36 via inductive coupling when the prosthesis aortic valve 120 is in its fully deployed, open configuration.

[0109] For some applications, the external unit coil 102 is incorporated into a loop configured to be worn around the patient's neck or placed on the patient's chest (as described in PCT disclosure WO2016 / 157183 by Dagan et al., which is incorporated herein by reference), and / or into a strap configured to be worn around the patient's chest or a necklace configured to be worn around the patient's neck. This positioning of the external unit coil 102 provides high transmission efficiency because the respective axes of the external unit coil 102 and the prosthetic valve coil 36 are substantially aligned.

[0110] Alternatively or additionally, for some applications, the external unit 100 is incorporated into a band or strip configured to be worn around the patient's chest.

[0111] For some applications in which the valve prosthesis system 68 includes a prosthetic aortic valve 20, as described above with reference to Figures 1A, 1B, and 2, the prosthetic aortic valve control circuit 40 is configured to use the received energy to drive one or more electrodes 34 to perform, for example, post-implantation pacing several months later. This pacing can employ any standard pacing protocol. For some applications, pacing is VVI pacing, which is applied only when no QRS complex is detected in the ventricle. Alternatively, for some applications in which the valve prosthesis system 68 includes a prosthetic aortic valve 120, as described above with reference to Figure 3, the external unit control circuit 104 is configured to drive one or more electrodes 34 to apply a pacing signal; in this configuration, the prosthetic aortic valve control circuit 40 is not provided (or, if provided, is typically passive), i.e., the external unit control circuit 104 sets the parameters of the pacing signal.

[0112] Optionally, for some applications in which the valve prosthesis system 68 includes a prosthetic aortic valve 20, as described above with reference to Figures 1A, 1B, and 2, the prosthetic aortic valve control circuitry 40 is configured to: (a) use one or more electrodes 34 to sense cardiac signals; and (b) drive the prosthetic valve coil 36 to transmit a wireless signal indicative of the sensed cardiac signals. For some applications, cardiac sensing is performed using the technique described in U.S. Patent No. 9,005,106 to Gross et al., which is incorporated herein by reference. In these applications, one or more electrodes 34 are typically not used to apply pacing, and therefore no electrodes need to be configured as cathodes and anodes. This sensing allows patients to be discharged from the hospital as early as possible after the prosthetic aortic valve 20 is implanted, before left bundle branch block (LBBB) may occur. If LBBB develops (as occurs in approximately 20-30% of patients), an alarm is generated by sensing the LBBB, and the LBBB can be treated appropriately.

[0113] Referring now to Figure 5, which is a schematic diagram of an electronic implant 200 according to the application of this disclosure, the features of the electronic implant 200 can be realized by the prosthetic aortic valve control circuit 40 described above with reference to Figures 1A to 2.

[0114] The electronic implant 200 includes circuitry 210, which includes electronic components 212, typically mounted on a long and flexible printed circuit board (PCB) 214. The electronic implant 200 also includes a multilayer protective coating comprising layers in the following order:

[0115] • For example, a first internal aluminum oxide (AlOx) is deposited on circuit 210 using atomic layer deposition (ALD).

[0116] 220 film layers;

[0117] • A second poly(p-phenylene dimethyl) layer 222 is deposited (typically vapor-deposited in a vacuum) on the first internal AlOx film 220; the second poly(p-phenylene dimethyl) layer 222 provides chemical support for the circuit 210.

[0118] Protect;

[0119] Optionally, a third layer 224 is disposed (typically cast thereon) on the second poly(p-phenylene dimethyl) layer 222. The third layer comprises, for example, a polymer selected from the group consisting of silicone and PTFE. The third layer 224 typically has a thickness between 100 and 200 micrometers.

[0120] Configured to provide mechanical protection for circuit 210; and

[0121] Optionally, a fourth external poly(p-phenylene dimethyl) layer 226 is deposited on the third layer 224 (typically vapor-deposited in a vacuum); the fourth external poly(p-phenylene dimethyl) layer 226 provides chemical protection for the circuit 210 and the third layer 224.

[0122] The electron-injected material 200 and the layer are drawn schematically in Figure 5 and are not drawn to scale; in particular, the layer is actually much thinner than shown and has a different relative thickness.

[0123] Typically, circuit 210 is not encapsulated in a housing, but rather coated only with a layer, as described above. A “housing” is a shell, typically comprising glass and / or metal, which has a structure prior to the placement of the circuitry therein; in contrast, a coating takes the shape of the coated circuitry. In contrast, housing-type encapsulation is standard in the field of implantable circuitry. This lack of a housing allows the electronic implant 200 to be thin and flexible, at the cost of a shorter lifespan. For the prosthetic aortic valve control circuit 40, a shorter lifespan is generally not a problem, as the prosthetic aortic valve control circuit 40 is typically used for only a few months.

[0124] For applications where the prosthetic aortic valve control circuit 40 implements the features of the electronic implant 200, one or more electrodes 34 are masked during coating application. Thus, the prosthetic aortic valve control circuit 40, one or more elongated insulated electrical conductors 38 (e.g., wires), and the prosthetic valve coil 36 are all coated in the same coating process.

[0125] The technique described herein for the prosthetic aortic valve 20 can be alternatively (with necessary modifications to the details) used for non-aortic prosthetic valves, such as prosthetic mitral or tricuspid valves.

[0126] In embodiments, the technologies and apparatus described in one or more of the following patents and / or applications (which are assigned to the assignee of this application and are incorporated herein by reference) are combined with the technologies and apparatus described herein:

[0127] • Gross's U.S. Patent No. 10,543,083;

[0128] Gross's European patent application, EP3508113A1, has been published.

[0129] Gross's U.S. Patent No. 10,835,750;

[0130] Gross's U.S. patent application number 2020 / 0261224 has been published;

[0131] On the same day, Gross also filed an international patent application entitled "Prosthetic Aortic Valve Pacing System".

[0132] It will be understood by those skilled in the art that this disclosure is not limited to what has been specifically shown and described above. Rather, the scope of this disclosure includes combinations and sub-combinations of the various features described above that are not in the prior art, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the foregoing description.

Claims

1. A valve prosthesis system, the valve prosthesis system comprising: (i) a prosthetic aortic valve, the prosthetic aortic valve comprising: (a) a plurality of prosthetic leaflets; (b) a frame; (c) a cathode and an anode mechanically coupled to the frame; and (d) a prosthetic valve coil non-wirelessly electrically connected to the cathode and the anode; and (ii) a non-implantable unit, the non-implantable unit comprising: (a) a power delivery coil; and (b) a non-implantable control circuit configured to start and stop each pacing pulse only by starting and stopping wireless power delivery, and driving The cathode and the anode are configured to: apply a pacing signal comprising pulses by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil via inductive coupling, and set parameters of the pacing signal; begin applying each pulse of the pacing signal only by starting to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil; and end applying each pulse of the pacing signal only by stopping to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil; wherein the valve prosthesis system does not include implantation control circuitry.

2. The valve prosthesis system according to claim 1, wherein, The prosthetic aortic valve includes one or more elongated insulated electrical conductors that directly couple the prosthetic valve coil to the cathode and the anode in a non-radio-communication manner.

3. The valve prosthesis system according to claim 1, wherein, The corresponding ends of the prosthetic valve coil are electrically connected to the cathode and the anode in a non-wireless manner.

4. The valve prosthesis system according to claim 1, wherein, The respective non-electrically insulated ends of the prosthetic valve coil define the cathode and the anode.

5. The valve prosthesis system according to claim 1, wherein, The non-implantable control circuit is configured to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil.

6. The valve prosthesis system according to claim 1, wherein, The frame is shaped to define: (1) an upstream inflow portion, (2) a downstream outflow portion and (3) a contraction portion, the contraction portion being axially located between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the contraction portion, and wherein the cathode is mechanically coupled to the upstream inflow portion of the frame.

7. The valve prosthesis system according to claim 6, wherein, The prosthetic valve coil is axially positioned along the downstream outflow portion of the frame.

8. The valve prosthesis system according to claim 1, wherein, The cathode and the anode are disposed on the frame such that when the prosthetic aortic valve is in its fully deployed open configuration, there is a distance of at least 15 mm between the cathode and the anode, the 15 mm being measured along the central longitudinal axis of the frame when the prosthetic aortic valve is in its fully deployed open configuration.

9. The valve prosthesis system according to any one of claims 1 to 8, wherein, The non-implantable unit is an external unit configured to be disposed outside the body of the object in which the prosthetic aortic valve is arranged.

10. The valve prosthesis system according to any one of claims 1 to 8, wherein, The non-implantable unit is a delivery system, which further includes a delivery tube and one or more wires passing through the delivery tube, wherein the energy transfer coil is a delivery system coil, wherein the non-implantable control circuit is a delivery system control circuit, which is electrically connected to the delivery system coil via the one or more wires, and wherein the delivery system coil is coupled to the delivery tube at a distal end of the delivery tube.

11. The valve prosthesis system according to claim 10, wherein, The delivery system control circuit is configured to wirelessly transmit energy from the energy transfer coil to the prosthetic valve coil via inductive coupling to drive the cathode and the anode to apply rapid ventricular pacing.

12. The valve prosthesis system according to claim 10, wherein, The prosthetic aortic valve (i) is removably disposable and located in the delivery tube in a compressed delivery configuration, and (ii) is configured to present: (A) a partially open, partially unfolded configuration when partially released from the distal end of the delivery tube, such that: (1) at least the cathode is located outside the delivery tube; (2) The prosthetic valve coil is compressed within the delivery cannula; and (B) a fully deployed configuration when fully released from the distal end of the delivery cannula, wherein the delivery system control circuit is configured to drive the cathode and the anode to apply the pacing signal and set the parameters of the pacing signal by wirelessly transmitting energy from the energy transfer coil to the prosthetic valve coil at least when the prosthetic aortic valve is in the partially deployed configuration.

13. The valve prosthesis system of claim 12, further comprising an external unit configured to be disposed outside the body of an object in which the prosthetic aortic valve is disposed, and the external unit comprising: External unit coil; And an external unit control circuit configured to drive an external unit coil to wirelessly transmit energy to the prosthetic valve coil via inductive coupling to drive the cathode and the anode to apply the pacing signal when the prosthetic aortic valve is in the fully deployed open configuration, and to set the parameters of the pacing signal.

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