Artificial aortic valve pacing system

Abstract

A valve prosthesis system includes a prosthetic aortic valve (120) and a non-implanted unit. The prosthetic aortic valve (120) includes a plurality of prosthetic leaflets (32), a frame (30), a cathode (54) and an anode (57) mechanically coupled to the frame (30), and a prosthetic valve coil (36) in non-radio communication with the cathode (54) and the anode (57). The prosthetic aortic valve (120) does not include any active electronic components. The non-implanted unit includes an energy transmission coil, a sensing skin ECG electrode (106), and a non-implanted control circuit that drives the cathode (54) and the anode (57) to apply a pacing signal to the heart, detects at least one heart parameter using the sensing skin ECG electrode (106), and at least partially in response to the detected heart parameter, wirelessly transfers energy from the energy transmission coil to the prosthetic valve coil (36) via inductive coupling to set a parameter of the pacing signal. Other embodiments are also described.

Description

[0001] Cross-referencing related applications

[0002] This application claims priority to U.S. Application No. 16 / 868,121, filed May 6, 2020, and is a partial continuation of U.S. Application No. 16 / 868,121; U.S. Application No. 16 / 868,121 is a partial continuation of U.S. Application No. 16 / 734,798 (now U.S. Patent No. 10,835,750), filed January 6, 2020; U.S. Patent No. 10,835,750 is a partial continuation of (a) U.S. Application No. 15 / 864,661 (now U.S. Patent No. 10,543,083), filed January 8, 2018, and (b) claims foreign priority to European Application No. 19150581.7, filed January 7, 2019, with publication number EP 3 508 113 A1. All of the applications cited above have been assigned to the assignee of this application and are incorporated herein by reference.

[0003] (The aforementioned European application No. 19150581.7 claims foreign priority to the aforementioned U.S. application No. 15 / 864,661.) Technical Field

[0004] This invention relates generally to surgical implants and systems, and more specifically to artificial aortic valves and systems. Background Technology

[0005] Aortic valve replacement may be necessary to treat valvular regurgitation or stenosis and calcification of the valve leaflets. In the percutaneous intraluminal delivery technique, the prosthetic aortic valve is compressed for delivery in a catheter and advanced through the descending aorta to the heart, where it is placed within the aortic annulus. New-onset cardiac conduction disorders are common after transcatheter aortic valve implantation (TAVI). The most common complication is left bundle branch block (LBBB).

[0006] U.S. Patent No. 7,914,569 to Ruan et al., incorporated herein by reference, describes a heart valve prosthesis having a self-expanding multilayered frame supporting a valve body, the valve body including a skirt and a plurality of engaging leaflets. The frame transitions between a contractile delivery configuration enabling percutaneous delivery and an expandable deployment configuration having an asymmetrical hourglass shape. The configuration of the valve body skirt and leaflets allows for selection of engagement centers to reduce horizontal forces applied to the valve engagement and to effectively distribute and transmit forces to the frame along the leaflets. Alternatively, the valve body can be used as a surgically implantable replacement valve prosthesis. Summary of the Invention

[0007] Some embodiments of the present invention provide a valve prosthesis system comprising an artificial aortic valve configured for implantation in a patient's natural aortic valve, the artificial aortic valve comprising a plurality of artificial leaflets, a frame, and one or more electrodes comprising a cathode and an anode, the cathode and the anode being mechanically coupled to the frame. The artificial aortic valve further comprises an artificial valve coil, the artificial valve coil being in non-radio communication with the cathode and the anode. Typically, the artificial aortic valve does not include any active electronic components.

[0008] In some applications, the valve prosthesis system further includes a non-implantable unit comprising an energy delivery coil, at least two skin-sensing ECG electrodes, and non-implantable control circuitry. The non-implantable control circuitry is configured to:

[0009] • Drive the cathode and the anode to apply a pacing signal to the patient's heart.

[0010] • Using the at least two sensory skin ECG electrodes to detect at least one cardiac parameter, and

[0011] • In at least a partial response to at least one detected cardiac parameter, energy is wirelessly transmitted from the energy transmission coil to the artificial valve coil via inductive coupling to set the parameters of the pacing signal.

[0012] For some applications, the frame is shaped to define an upstream inflow portion, a downstream outflow portion, and a constriction portion axially located between the upstream inflow portion and the downstream outflow portion. The artificial leaflet is coupled to the constriction portion.

[0013] For some applications, when the artificial aortic valve is in a fully expanded configuration: the free edge of the artificial leaflet faces the downstream outflow portion, and an annular longitudinal boundary between the downstream outflow portion and the constricted portion is defined by a downstreammost point of a frame coupled to the artificial leaflet. The artificial aortic valve further includes an artificial valve coil that is in non-radio communication with the one or more electrodes, and the artificial valve coil is coupled to the frame no more than 1 mm upstream of the annular longitudinal boundary, for example, axially along the downstream outflow portion.

[0014] In some embodiments of the present invention, a valve prosthesis system is provided, the valve prosthesis system including an artificial aortic valve and a non-implantable unit. The artificial aortic valve is configured to be implanted in a patient's natural aortic valve, and the artificial aortic valve includes a plurality of artificial leaflets, a frame, a cathode and an anode, and an artificial valve coil, the cathode and the anode being mechanically coupled to the frame; the artificial valve coil is in non-radio communication with the cathode and the anode. The non-implantable unit includes an energy transfer coil and a non-implantable control circuit configured to wirelessly transfer energy from the energy transfer coil to the artificial valve coil via inductive coupling, and to set parameters of the pacing signal.

[0015] Therefore, according to inventive concept 1 of the present invention, a method for assembling an electronic artificial aortic valve is provided, the method comprising the steps of:

[0016] An electronic component is inserted into a valve element, the electronic component including one or more electrodes and an artificial valve coil, the valve element including a frame and an artificial leaflet, the artificial leaflet being coupled to the frame; and

[0017] The electronic components are connected to the valve components.

[0018] Invention Concept 2: The method according to Invention Concept 1, wherein coupling the electronic element to the valve element includes the steps of:

[0019] A first portion of the electronic component is coupled to an inner surface of the frame; and

[0020] A second portion of the electronic component is coupled to an outer surface of the frame.

[0021] Inventive Concept 3: The method described according to Inventive Concept 2,

[0022] The first part of the electronic component includes the artificial valve coil and one of the one or more electrodes, and

[0023] The second part of the electronic component includes a cathode of one or more electrodes.

[0024] Invention Concept 4: According to the method of Invention Concept 3, the electronic component further includes an artificial aortic valve control circuit, and the first portion of the electronic component includes the artificial aortic valve control circuit.

[0025] Inventive Concept 5: The method described according to Inventive Concept 4.

[0026] The electronic component further includes an elongated insulated electrical conductor that electrically couples the cathode to the artificial aortic valve control circuit.

[0027] The coupling of the electronic component to the valve element includes coupling the electronic component to the valve element such that the conductor passes from the inside of the frame through the outside of the frame.

[0028] Invention Concept 6: According to the method of Invention Concept 5, wherein the valve element further includes a skirt, and wherein coupling the electronic element to the valve element includes coupling the electronic element to the valve element such that the conductor passes through the skirt from the inside of the frame to the outside of the frame.

[0029] Invention Concept 7: A method according to any one of Invention Concepts 1 to 6, wherein coupling the electronic element to the valve element comprises suturing the electronic element to the valve element.

[0030] Invention Concept 8: The method according to Invention Concept 7, wherein the valve element further includes a skirt, and wherein coupling the electronic element to the valve element includes sewing the electronic element to the skirt.

[0031] Inventive Concept 9: The method according to any one of Inventive Concepts 1 to 8,

[0032] The frame is shaped to define: (1) an upstream inflow portion, (2) a downstream outflow portion, and (3) a constriction portion, the constriction portion being axially located between the upstream inflow portion and the downstream outflow portion, the artificial valve leaflet being coupled to the constriction portion, and wherein the artificial aortic valve is configured such that, in an expanded configuration: (A) the free edge of the artificial valve leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the constriction portion is defined by a downstreammost point of the frame coupled to the artificial valve leaflet.

[0033] The artificial valve coil is in non-radio communication with the one or more electrodes, and

[0034] The coupling of the electronic component to the valve element includes coupling the electronic component to the valve element such that the artificial valve coil is coupled to the frame no more than 1 mm upstream of the annular longitudinal boundary.

[0035] Invention Concept 10: The method according to Invention Concept 9, wherein coupling the electronic element to the valve element includes coupling the electronic element to the valve element such that the artificial valve coil is axially disposed along the downstream outflow portion.

[0036] Invention Concept 11: The method according to Invention Concept 9, wherein coupling the electronic element to the valve element includes coupling the electronic element to the valve element such that at least one of the one or more electrodes is coupled to the upstream inflow portion of the frame.

[0037] Inventive Concept 12: The method described according to Inventive Concept 11,

[0038] The artificial aortic valve is configured such that, when the artificial aortic valve is in an expanded configuration, the frame has an inlet end, a downstream outlet end, and an axial length, the inlet end being located at the upstream inlet portion, the downstream outlet end being located at the downstream outlet portion, and the axial length being detected between the inlet end and the downstream outlet end; and

[0039] The coupling of the electronic component to the valve element includes coupling the electronic component to the valve element such that at least one of the one or more electrodes is coupled to the upstream inflow portion within a distance from the inflow end, the distance being equal to 10% of the axial length of the frame.

[0040] According to inventive concept 13 of the present invention, a device comprising an artificial aortic valve is further provided, comprising:

[0041] (a) Multiple artificial leaflets;

[0042] (b) A framework that can be shaped to define:

[0043] (1) The upstream inflow portion,

[0044] (2) The downstream outflow portion, and

[0045] (3) A constriction portion, the constriction portion being axially located between the upstream inflow portion and the downstream outflow portion, wherein the artificial valve leaflet is coupled to the constriction portion, and wherein when the artificial aortic valve is in a fully expanded configuration: (A) the free edge of the artificial valve leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the constriction portion is defined by a downstream point of the frame coupled to the artificial valve leaflet;

[0046] (c) one or more electrodes coupled to the frame; and

[0047] (d) An artificial valve coil that is in non-radio communication with the one or more electrodes, and the artificial valve coil is coupled to the frame no more than 1 mm upstream of the annular longitudinal boundary.

[0048] Invention Concept 14: The device according to Invention Concept 13, wherein the artificial valve coil is disposed axially along the downstream outflow portion.

[0049] Invention Concept 15: The device according to Invention Concept 13, wherein at least one of the one or more electrodes is coupled to the upstream inflow portion of the frame.

[0050] Inventive Concept 16: The device according to Inventive Concept 15, wherein when the artificial aortic valve is in its fully expanded, dilated configuration:

[0051] The frame has an inflow end, a downstream outflow end, and an axial length. The inflow end is located at the upstream inflow portion, the downstream outflow end is located at the downstream outflow portion, and the axial length is detected between the inflow end and the downstream outflow end.

[0052] At least one of the one or more electrodes is coupled to the upstream inflow portion at a distance from the inflow end, the distance being equal to 10% of the axial length of the frame.

[0053] Invention Concept 17: A valve prosthesis system includes the artificial aortic valve according to Invention Concept 13, the valve prosthesis system further including an external unit, the external unit comprising:

[0054] An external unit coil; and

[0055] An external unit control circuit is configured to drive the external unit coil when the artificial aortic valve is in its fully expanded, expanded configuration, and wirelessly transmit energy to the artificial valve coil via inductive coupling.

[0056] Invention Concept 18: The valve prosthesis system according to Invention Concept 17, wherein the external unit control circuit is configured to drive the one or more electrodes to apply a pacing signal.

[0057] Invention Concept 19: A valve prosthesis system according to Invention Concept 17, wherein the external unit includes a collar configured to be worn around the neck of a patient, and an external unit coil is incorporated into the collar.

[0058] Invention Concept 20: A valve prosthesis system according to Invention Concept 13,

[0059] The artificial aortic valve further includes an artificial aortic valve control circuit coupled to the frame, and the frame is in non-radio communication with the one or more electrodes.

[0060] The artificial valve coil is not radio-connected to the artificial aortic valve control circuit, such that the artificial valve coil is non-radio-connected to the one or more electrodes via the artificial aortic valve control circuit.

[0061] Invention Concept 21: The valve prosthesis system according to Invention Concept 20, wherein the artificial aortic valve control circuit is configured to apply pacing.

[0062] Inventive Concept 22: A valve prosthesis system according to Inventive Concept 20,

[0063] The one or more electrodes include a cathode coupled to an upstream inflow portion of the frame, and

[0064] The artificial aortic valve control circuit is configured to drive the cathode to apply a cathode current.

[0065] Invention Concept 23: The valve prosthesis system according to Invention Concept 22, wherein the artificial aortic valve further includes a skirt coupled to an outer surface of an upstream inflow portion of the frame, and wherein the cathode is disposed on an outer surface of the skirt.

[0066] Inventive Concept 24: A valve prosthesis system according to Inventive Concept 20,

[0067] When the artificial aortic valve is in its fully expanded, dilated configuration, the artificial leaflet is coupled to the frame at at least a first and a second junction, the first and second junctions being located at corresponding first and second angular positions around the frame, the first and second angular positions being separated by an offset around a first angle of the frame.

[0068] When the artificial aortic valve is in its fully expanded, expanded configuration, the artificial aortic valve control circuit is coupled to the frame at a third corner position around the frame, the third corner position being separated from the first corner position by a second corner offset, the second corner offset being between 40% and 60% of the first corner offset.

[0069] Invention Concept 25: A valve prosthesis system according to Invention Concept 20, wherein the artificial aortic valve control circuit is coupled to the frame within the frame.

[0070] Invention Concept 26: The valve prosthesis system according to Invention Concept 20, wherein the artificial aortic valve control circuit is sutured to the frame.

[0071] Invention Concept 27: The valve prosthesis system according to Invention Concept 20, wherein the artificial aortic valve further includes a skirt coupled to an outer surface of an upstream inflow portion of the frame, and wherein the artificial aortic valve control circuitry is sutured to the skirt.

[0072] Invention Concept 28: A valve prosthesis system according to Invention Concept 20, wherein the artificial aortic valve control circuit is configured to (a) use the one or more electrodes to sense a cardiac signal, and (b) drive the artificial valve coil to transmit a wireless signal indication of the sensed cardiac signal.

[0073] Invention Concept 29: The valve prosthesis system according to Invention Concept 20, wherein the artificial aortic valve includes an electronic implant, the electronic implant comprising:

[0074] The artificial aortic valve control circuit; and

[0075] A multilayer protective coating comprising the following layers arranged in the following order:

[0076] A first internal alumina (AlOx) film layer is deposited on the circuit; and

[0077] A second parylene layer is deposited on the first inner AlOx film layer.

[0078] The artificial aortic valve control circuit described therein is not encapsulated in a housing.

[0079] According to inventive concept 30 of the present invention, a device comprising an electronic implant is further provided, the electronic implant comprising:

[0080] Circuits; and

[0081] A multilayer protective coating comprising the following layers arranged in the following order:

[0082] A first internal alumina (AlOx) film layer is deposited on the circuit; and

[0083] A second parylene layer is deposited on the first inner AlOx film layer.

[0084] The circuit described therein is not encapsulated in a housing.

[0085] Invention Concept 31: The apparatus according to Invention Concept 30, wherein the multilayer protective coating further comprises a third layer disposed on the second parylene layer, the third layer having a thickness between 100 micrometers and 200 micrometers and configured to provide mechanical protection for the circuit.

[0086] Invention Concept 32: The device according to Invention Concept 31, wherein the third layer comprises a material selected from the group consisting of silicone resin and PTFE.

[0087] Invention Concept 33: The apparatus according to Invention Concept 31, wherein the third layer is cast onto the second parylene layer.

[0088] Invention Concept 34: The apparatus according to Invention Concept 31, wherein the multilayer protective coating further comprises a fourth external parylene layer, the fourth external parylene layer being deposited on the third layer.

[0089] Invention Concept 35: The device according to Invention Concept 30, the device further comprising an artificial aortic valve, the artificial aortic valve comprising:

[0090] A framework;

[0091] Multiple artificial leaflets coupled to the frame;

[0092] One or more electrodes coupled to the frame; and

[0093] An artificial valve coil, coupled to the frame,

[0094] The electronic implant is coupled to the frame and has non-radio communication with the one or more electrodes, and

[0095] The artificial valve coil is non-radio-connected to the circuit, such that the artificial valve coil is non-radio-connected to the one or more electrodes via the circuit.

[0096] According to inventive concept 36 of the present invention, a method for preparing an electronic implant is further provided, the method comprising the steps of:

[0097] A first internal alumina (AlOx) film is deposited on the circuitry of the electronic implant; and

[0098] A second parylene layer is deposited on the first inner AlOx film to form a multilayer protective coating with the first inner AlOx film.

[0099] The fabrication of the electronic implant does not include encapsulating the circuitry in a housing.

[0100] Invention Concept 37: The method according to Invention Concept 36 further includes the step of: disposing a third layer on the second parylene layer, the third layer having a thickness between 100 micrometers and 200 micrometers and being configured to provide mechanical protection for the circuit.

[0101] Invention Concept 38: The method according to Invention Concept 37, wherein the third layer comprises a material selected from the group consisting of silicone resin and PTFE.

[0102] Invention Concept 39: The method according to Invention Concept 37, wherein setting the third layer includes the step of: casting the third layer onto the second parylene layer.

[0103] Invention Concept 40: The method according to Invention Concept 37, the method further comprising the step of: depositing a fourth external parylene layer on the third layer.

[0104] According to inventive concept 41 of the present invention, a device comprising an artificial aortic valve is also provided, the artificial aortic valve comprising:

[0105] (a) Multiple artificial leaflets;

[0106] (b) A framework, which is shaped to define:

[0107] (1) The upstream inflow portion,

[0108] (2) The downstream outflow portion, and

[0109] (3) A constriction portion, the constriction portion being axially located between the upstream inflow portion and the downstream outflow portion, wherein the artificial valve leaflet is coupled to the constriction portion, and wherein when the artificial aortic valve is in a fully expanded configuration: (A) the free edge of the artificial valve leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the constriction portion is defined by a downstream point of the frame coupled to the artificial valve leaflet;

[0110] (c) One or more electrodes coupled to the upstream inflow portion of the frame; and

[0111] (d) An artificial valve coil that is in non-radio communication with the one or more electrodes.

[0112] Inventive Concept 42: The device according to Inventive Concept 41, wherein when the artificial aortic valve is in its fully expanded, dilated configuration:

[0113] The frame has an inflow end, a downstream outflow end, and an axial length. The inflow end is located at the upstream inflow portion, the downstream outflow end is located at the downstream outflow portion, and the axial length is detected between the inflow end and the downstream outflow end.

[0114] At least one of the one or more electrodes is coupled to the upstream inflow portion at a distance from the inflow end, the distance being equal to 10% of the axial length of the frame.

[0115] Inventive Concept 43: The apparatus according to Inventive Concept 41.

[0116] The artificial aortic valve further includes an artificial aortic valve control circuit, which is coupled to the frame and has non-radio communication with the one or more electrodes.

[0117] The artificial valve coil is not radio-connected to the artificial aortic valve control circuit, such that the artificial valve coil is non-radio-connected to the one or more electrodes via the artificial aortic valve control circuit.

[0118] Invention Concept 44: The device according to Invention Concept 43, wherein the artificial aortic valve control circuit is configured to apply pacing.

[0119] Inventive Concept 45: The apparatus according to Inventive Concept 43.

[0120] The one or more electrodes include a cathode coupled to an upstream inflow portion of the frame, and

[0121] The artificial aortic valve control circuit is configured to drive the cathode to apply a cathode current.

[0122] Invention Concept 46: The device according to Invention Concept 45, wherein the artificial aortic valve further includes a skirt coupled to an outer surface of an upstream inflow portion of the frame, and wherein the cathode is disposed on an outer surface of the skirt.

[0123] According to inventive concept 47 of the present invention, a method for assembling an electronic artificial aortic valve is also provided, the method comprising the steps of:

[0124] An electronic component is inserted into a valve element, the electronic component including one or more electrodes and an artificial valve coil, and the valve element including a frame and an artificial leaflet, the artificial leaflet being coupled to the frame; and

[0125] The electronic component is coupled to the valve element.

[0126] Inventive Concept 48: The method according to Inventive Concept 47, wherein coupling the electronic element to the valve element includes the steps of:

[0127] A first portion of the electronic component is coupled to an inner surface of the frame; and

[0128] A second portion of the electronic component is coupled to an outer surface of the frame.

[0129] Inventive Concept 49: The method described according to Inventive Concept 48

[0130] The first part of the electronic component includes the artificial valve coil and one of the one or more electrodes, and

[0131] The second part of the electronic component includes the cathode of the one or more electrodes.

[0132] Invention Concept 50: The method according to Invention Concept 49, wherein the electronic element further includes an artificial aortic valve control circuit, and wherein a first portion of the electronic element includes the artificial aortic valve control circuit.

[0133] Inventive Concept 51: The method according to Inventive Concept 50,

[0134] The electronic component further includes an elongated insulated electrical conductor that electrically couples the cathode to the artificial aortic valve control circuit.

[0135] The coupling of the electronic component to the valve element includes coupling the electronic component to the valve element such that the conductor passes from the inside of the frame through the outside of the frame.

[0136] Invention Concept 52: The method according to Invention Concept 51, wherein the valve element further includes a skirt, and wherein coupling the electronic element to the valve element includes coupling the electronic element to the valve element such that the conductor passes through the skirt from the inside of the frame to the outside of the frame.

[0137] Invention Concept 53: The method according to Invention Concept 47, wherein coupling the electronic element to the valve element includes suturing the electronic element to the valve element.

[0138] Invention Concept 54: The method according to Invention Concept 47, wherein the valve element further includes a skirt, and wherein coupling the electronic element to the valve element includes sewing the electronic element to the skirt.

[0139] According to inventive concept 55 of the present invention, an apparatus comprising a valve prosthesis system is further provided, the valve prosthesis system comprising:

[0140] (a) A delivery system comprising:

[0141] One delivery tube;

[0142] A delivery system coil is coupled to the delivery tube at a distal end of the delivery tube;

[0143] One or more wires passing through the delivery tube; and

[0144] A delivery system control circuit, electrically connected to the delivery system coil via one or more wires; and

[0145] (b) An artificial aortic valve, comprising:

[0146] A framework;

[0147] Multiple artificial leaflets coupled to the frame;

[0148] One or more electrodes coupled to the frame; and

[0149] An artificial valve coil, coupled to the frame,

[0150] The artificial aortic valve is (i) removably and disposablely disposed in the delivery cannula with a compression delivery configuration, and (ii) configured to present:

[0151] (A) Upon partial release from a distal end of the delivery tube, the partially expanded, partially deployed configuration such that (1) at least one of the one or more electrodes is located outside the delivery tube, and (2) the artificial valve coil is compressed within the delivery tube, and

[0152] (B) The fully extended configuration after complete release from the distal end of the delivery tube, and

[0153] The delivery system control circuit is configured to drive the delivery system coil to wirelessly transmit energy to the artificial valve coil via inductive coupling, at least when the artificial aortic valve is in a partially deployed configuration.

[0154] Invention Concept 56: According to the device of Invention Concept 55, the valve prosthesis system further includes an external unit, the external unit comprising:

[0155] An external unit coil; and

[0156] An external unit control circuit is configured to drive the external unit coil when the artificial aortic valve is in its fully expanded, expanded configuration, and wirelessly transmit energy to the artificial valve coil via inductive coupling.

[0157] Invention Concept 57: The device according to Invention Concept 56, wherein the external unit control circuit is configured to begin driving the external unit coil only after the artificial aortic valve is in its fully expanded, dilated configuration, to wirelessly transmit energy.

[0158] Invention Concept 58: The device according to Invention Concept 55, wherein when the artificial aortic valve is in a fully expanded configuration after being fully released from the distal end of the delivery cannula, the delivery system control circuit is configured to stop driving the delivery system coil to wirelessly transmit the energy.

[0159] Inventive Concept 59: The apparatus according to Inventive Concept 55.

[0160] The frame is shaped to define:

[0161] One upstream inflow portion,

[0162] The downstream outflow portion, and

[0163] A constricting portion, axially located between the upstream inflow portion and the downstream outflow portion, wherein the artificial valve leaflet is coupled to the constricting portion such that, when the artificial aortic valve is in its fully expanded, dilated configuration, the free edge of the artificial valve leaflet faces the downstream outflow portion.

[0164] The artificial valve coil is axially arranged along the downstream outflow portion.

[0165] Invention Concept 60: The device according to Invention Concept 59, wherein the artificial valve coil is not axially arranged along the constriction portion and is not axially arranged along the upstream inflow portion.

[0166] Invention Concept 61: The device according to Invention Concept 59, wherein at least one of the one or more electrodes is coupled to the upstream inflow portion of the frame.

[0167] Inventive Concept 62: The device according to Inventive Concept 61, wherein when the artificial aortic valve is in its fully expanded, dilated configuration:

[0168] The frame has an inflow end, a downstream outflow end, and an axial length. The inflow end is located at the upstream inflow portion, the downstream outflow end is located at the downstream outflow portion, and the axial length is detected between the inflow end and the downstream outflow end.

[0169] At least one of the one or more electrodes is coupled to the upstream inflow portion at a distance from the inflow end, the distance being equal to 10% of the axial length of the frame.

[0170] Inventive Concept 63: The apparatus according to Inventive Concept 55.

[0171] The artificial aortic valve further includes an artificial aortic valve control circuit, which is coupled to the frame and has non-radio communication with the one or more electrodes.

[0172] The artificial valve coil is not radio-connected to the artificial aortic valve control circuit, such that the artificial valve coil is non-radio-connected to the one or more electrodes via the artificial aortic valve control circuit.

[0173] Inventive Concept 64: The apparatus according to Inventive Concept 63.

[0174] The frame is shaped to define:

[0175] One upstream inflow portion,

[0176] The downstream outflow portion, and

[0177] A constricting portion, axially located between the upstream inflow portion and the downstream outflow portion, wherein the artificial valve leaflet is coupled to the constricting portion such that, when the artificial aortic valve is in its fully expanded, dilated configuration, the free edge of the artificial valve leaflet faces the downstream outflow portion.

[0178] The one or more electrodes include a cathode coupled to an upstream inflow portion of the frame, and

[0179] The artificial aortic valve control circuit is configured to drive the cathode to apply a cathode current.

[0180] Invention Concept 65: The device according to Invention Concept 64, wherein the artificial aortic valve further includes a skirt coupled to an outer surface of an upstream inflow portion of the frame, and wherein the cathode is disposed on an outer surface of the skirt.

[0181] Inventive Concept 66: The apparatus according to Inventive Concept 63

[0182] When the artificial aortic valve is in its fully expanded, dilated configuration, the artificial leaflet is coupled to the frame at at least a first and a second junction, the first and second junctions being located at corresponding first and second angular positions around the frame, the first and second angular positions being separated by an offset around a first angle of the frame.

[0183] When the artificial aortic valve is in its fully expanded, expanded configuration, the artificial aortic valve control circuit is coupled to the frame at a third corner position around the frame, the third corner position being separated from the first corner position by a second corner offset, the second corner offset being between 40% and 60% of the first corner offset.

[0184] Invention Concept 67: The device according to Invention Concept 63, wherein the artificial aortic valve control circuit is coupled to the frame within the frame.

[0185] Invention Concept 68: The device according to Invention Concept 63, wherein the artificial aortic valve control circuit is configured to (a) use the one or more electrodes to sense a cardiac signal, and (b) drive the artificial valve coil to transmit a wireless signal indication of the sensed cardiac signal.

[0186] Invention Concept 69: The device according to Invention Concept 63, wherein the artificial aortic valve control circuit is configured to drive the one or more electrodes to apply rapid ventricular pacing.

[0187] Invention Concept 70: The apparatus according to Invention Concept 55, wherein the delivery system control circuit is configured to drive the one or more electrodes via the delivery system coil and the artificial valve coil to apply rapid ventricular pacing.

[0188] According to inventive concept 71 of the present invention, a method is also provided, the method comprising the steps of:

[0189] Through a patient's vascular system, a delivery cannula of a delivery system for a valve prosthesis system is advanced, including until a distal end of the delivery cannula is positioned in the patient's ascending aorta, wherein an artificial aortic valve of the valve prosthesis system is removably disposed in the delivery cannula in a compressed delivery configuration, wherein the artificial aortic valve includes (a) a frame, (b) a plurality of artificial leaflets coupled to the frame, (c) one or more electrodes coupled to the frame, and (d) an artificial valve coil coupled to the frame and in non-radio communication with the one or more electrodes;

[0190] The artificial aortic valve is partially released from the distal end of the delivery cannula such that the artificial aortic valve presents a partially expanded, partially deployed configuration, wherein (a) at least one of one or more electrodes is located outside the delivery cannula, and (b) the artificial valve coil is compressed within the delivery cannula;

[0191] Subsequently, at least when the artificial aortic valve is in a partially deployed configuration, the delivery system control circuit is activated to drive a delivery system coil, wirelessly transmitting energy to the artificial valve coil via inductive coupling, wherein the delivery system coil is coupled to the delivery cannula distal to the delivery cannula, and wherein the delivery system control circuit is electrically connected to the delivery system coil via one or more wires passing through the delivery cannula; and

[0192] Subsequently, the artificial aortic valve is fully released from the distal end of the delivery tube, so that the artificial aortic valve presents an expanded, fully deployed configuration.

[0193] Invention Concept 72: The method according to Invention Concept 71 further includes, after the artificial aortic valve is fully released from the distal end of the delivery tube, when the artificial aortic valve is in a fully expanded configuration, activating an external unit control circuit of an external unit to drive an external unit coil to wirelessly transmit energy to the artificial valve coil via inductive coupling.

[0194] Invention Concept 73: The method according to Invention Concept 71, wherein when the artificial aortic valve presents a fully expanded configuration after being fully released from the distal end of the delivery cannula, the delivery system control circuit is configured to stop driving the delivery system coil to wirelessly transmit the energy.

[0195] Inventive Concept 74: The method described according to Inventive Concept 71,

[0196] The frame is shaped to define:

[0197] One upstream inflow portion,

[0198] The downstream outflow portion, and

[0199] A constricting portion, axially located between the upstream inflow portion and the downstream outflow portion, wherein the artificial valve leaflet is coupled to the constricting portion such that, when the artificial aortic valve is in its fully expanded, dilated configuration, the free edge of the artificial valve leaflet faces the downstream outflow portion.

[0200] The artificial valve coil is axially arranged along the downstream outflow portion.

[0201] Invention Concept 75: The method according to Invention Concept 74, wherein the artificial valve coil is not axially disposed along the constriction portion or the upstream inflow portion.

[0202] Inventive Concept 76: The method according to Inventive Concept 74, wherein at least one of the one or more electrodes is coupled to the upstream inflow portion of the frame.

[0203] Inventive Concept 77: The method according to Inventive Concept 76, wherein when the artificial aortic valve is in a fully expanded, dilated configuration:

[0204] The frame has an inflow end, a downstream outflow end, and an axial length. The inflow end is located at the upstream inflow portion, the downstream outflow end is located at the downstream outflow portion, and the axial length is detected between the inflow end and the downstream outflow end.

[0205] At least one of the one or more electrodes is coupled to the upstream inflow portion at a distance from the inflow end, the distance being equal to 10% of the axial length of the frame.

[0206] Inventive Concept 78: The method according to Inventive Concept 71,

[0207] The artificial aortic valve further includes an artificial aortic valve control circuit, which is coupled to the frame and has non-radio communication with the one or more electrodes.

[0208] The artificial valve coil is not radio-connected to the artificial aortic valve control circuit, such that the artificial valve coil is non-radio-connected to the one or more electrodes via the artificial aortic valve control circuit.

[0209] Inventive Concept 79: The method described according to Inventive Concept 78

[0210] The frame is shaped to define:

[0211] One upstream inflow portion,

[0212] The downstream outflow portion, and

[0213] A constricting portion, axially located between the upstream inflow portion and the downstream outflow portion, wherein the artificial valve leaflet is coupled to the constricting portion such that, when the artificial aortic valve is in its fully expanded, dilated configuration, the free edge of the artificial valve leaflet faces the downstream outflow portion.

[0214] The one or more electrodes include a cathode coupled to an upstream inflow portion of the frame, and

[0215] The artificial aortic valve control circuit is configured to drive the cathode to apply a cathode current.

[0216] Inventive Concept 80: The method described according to Inventive Concept 78,

[0217] When the artificial aortic valve is in its fully expanded, dilated configuration, the artificial leaflet is coupled to the frame at at least a first and a second junction, the first and second junctions being located at corresponding first and second angular positions around the frame, the first and second angular positions being separated by an offset around a first angle of the frame.

[0218] When the artificial aortic valve is in its fully expanded, expanded configuration, the artificial aortic valve control circuit is coupled to the frame at a third corner position around the frame, the third corner position being separated from the first corner position by a second corner offset, the second corner offset being between 40% and 60% of the first corner offset.

[0219] Invention Concept 81: The method according to Invention Concept 78, wherein the artificial aortic valve control circuit is coupled to the frame within the frame.

[0220] Invention Concept 82: The method according to Invention Concept 78, wherein the artificial aortic valve control circuit is configured to (a) use the one or more electrodes to sense a cardiac signal, and (b) drive the artificial valve coil to transmit a wireless signal indication of the sensed cardiac signal.

[0221] Invention Concept 83: The method according to Invention Concept 78, wherein the artificial aortic valve control circuit is configured to drive the one or more electrodes to apply rapid ventricular pacing.

[0222] Invention Concept 84: The method according to Invention Concept 71, wherein activating the delivery system control circuit includes the steps of: activating the delivery system control circuit to drive the one or more electrodes via the delivery system coil and the artificial valve coil to apply rapid ventricular pacing.

[0223] According to inventive concept 85 of the present invention, a valve prosthesis system is further provided, comprising:

[0224] (i) An artificial aortic valve, comprising:

[0225] (a) Multiple artificial leaflets;

[0226] (b) A framework;

[0227] (c) a cathode and an anode, mechanically coupled to the frame; and

[0228] (d) An artificial valve coil, which is in non-radio communication with the cathode and the anode, wherein the artificial aortic valve does not include any active electronic components; and

[0229] (ii) A non-implantable unit comprising:

[0230] (a) an energy transfer coil; and

[0231] (b) A non-implantable control circuit configured to drive the cathode and the anode to wirelessly transmit energy from the energy transmission coil to the artificial valve coil via inductive coupling to apply a pacing signal and set parameters of the pacing signal.

[0232] Inventive Concept 86: The valve prosthesis system according to Inventive Concept 85, wherein the artificial aortic valve includes one or more elongated insulated electrical conductors, the one or more elongated insulated electrical conductors directly coupling the artificial valve coil to the cathode and the anode in a non-radio-connected manner.

[0233] Inventive Concept 87: A valve prosthesis system according to Inventive Concept 85, wherein a corresponding end of the artificial valve coil is in non-radio communication with the cathode and the anode.

[0234] Inventive Concept 88: A valve prosthesis system according to Inventive Concept 85, wherein a corresponding non-electrically insulated end of the artificial valve coil defines the cathode and the anode.

[0235] Invention Concept 89: A valve prosthesis system according to Invention Concept 85, wherein the non-implantable control circuit is configured to set an amplitude of the pacing signal by modulating an amplitude of energy wirelessly transmitted from the energy transmission coil to the artificial valve coil.

[0236] Invention Concept 90: A valve prosthesis system according to Invention Concept 85, wherein the pacing signal comprises a plurality of pulses, and wherein the non-implantable control circuitry is configured to drive the cathode and the anode to (a) initiate the application of each pulse of the pacing signal by initiating the wireless transmission of energy from the energy transmission 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 transmission coil to the prosthetic valve coil.

[0237] Inventive Concept 91: A valve prosthesis system according to Inventive Concept 85,

[0238] The frame is shaped to define: (1) an upstream inflow portion, (2) a downstream outflow portion, and (3) a constriction portion, the constriction portion being axially located between the upstream inflow portion and the downstream outflow portion, wherein the artificial leaflet is coupled to the constriction portion.

[0239] The cathode is mechanically coupled to the upstream inflow portion of the frame.

[0240] Invention Concept 92: The valve prosthesis system according to Invention Concept 91, wherein the artificial valve coil is axially disposed along the downstream outflow portion of the frame.

[0241] Invention Concept 93: A valve prosthesis system according to Invention Concept 85, wherein the cathode and the anode are disposed on the frame such that when the artificial aortic valve is in a fully expanded configuration, there is a distance of at least 15 mm between the cathode and the anode, wherein the 15 mm is measured along a central longitudinal axis of the frame when in the fully expanded configuration.

[0242] Invention Concept 94: A valve prosthesis system according to Invention Concept 85, wherein the non-implantable unit is an external unit configured to be disposed outside a subject, wherein the subject is provided with the artificial aortic valve.

[0243] Inventive Concept 95: A valve prosthesis system according to Inventive Concept 85.

[0244] The non-implantable unit is a delivery system, which further includes a delivery tube and one or more wires passing through the delivery tube.

[0245] The energy transfer coil mentioned above is a delivery system coil.

[0246] The non-implantable control circuit is a delivery system control circuit, which is electrically connected to the delivery system coil via one or more wires.

[0247] The delivery system coil is coupled to the delivery tube at a distal location of the delivery tube.

[0248] Invention Concept 96: A valve prosthesis system according to Invention Concept 95, wherein the delivery system control circuit is configured to drive the cathode and the anode to wirelessly transmit energy from the energy transmission coil to the artificial valve coil via inductive coupling to apply rapid ventricular pacing.

[0249] Inventive Concept 97: Valve prosthesis system according to Inventive Concept 95.

[0250] The artificial aortic valve is (i) removably and disposablely disposed in the delivery cannula with a compression delivery configuration, and (ii) configured to present:

[0251] (A) Upon partial release from a distal end of the delivery tube, the partially expanded, partially deployed configuration such that (1) at least the cathode is located outside the delivery tube, and (2) the artificial valve coil is compressed within the delivery tube, and

[0252] (B) The fully extended configuration after complete release from the distal end of the delivery tube, and

[0253] The delivery system control circuit is configured to apply the pacing signal and set parameters of the pacing signal by wirelessly transmitting energy from the energy transmission coil to the artificial valve coil to drive the anode and the cathode, at least when the artificial aortic valve is in a partially deployed configuration.

[0254] Inventive Concept 98: The valve prosthesis system according to Inventive Concept 97 further includes an external unit configured to be disposed outside a subject, wherein the subject has the artificial aortic valve, and the external unit includes:

[0255] An external unit coil; and

[0256] An external unit control circuit is configured to drive the external unit coil and the anode and cathode to wirelessly transmit energy to the artificial valve coil via inductive coupling when the artificial aortic valve is in its fully expanded, dilated configuration, in order to apply the pacing signal and set the parameters of the pacing signal.

[0257] According to inventive concept 99 of the present invention, a method is further provided, comprising the steps of:

[0258] An artificial aortic valve of a valve prosthesis system is placed in an aortic valve annulus via a patient's vascular system. The artificial aortic valve includes (a) a plurality of artificial leaflets, (b) a frame, (c) a cathode and an anode mechanically coupled to the frame, and (d) an artificial valve coil non-radio-connected to the cathode and the anode; and

[0259] The non-implantable control circuit of a non-implantable unit of the valve prosthesis system is activated to drive the cathode and the anode, and through inductive coupling, wirelessly transmit energy from an energy transmission coil of the non-implantable unit to the artificial valve coil to apply a pacing signal and set the parameters of the pacing signal.

[0260] Inventive Concept 100: The method according to Inventive Concept 99, wherein the artificial aortic valve includes one or more elongated insulated electrical conductors, the one or more elongated insulated electrical conductors directly coupling the artificial valve coil to the cathode and the anode in a non-radio-connected manner.

[0261] Invention Concept 101: The method according to Invention Concept 99, wherein the respective ends of the artificial valve coil are in non-radio communication with the cathode and the anode.

[0262] Invention Concept 102: The method according to Invention Concept 99, wherein the respective non-electrically insulated ends of the artificial valve coil define the cathode and the anode.

[0263] Invention Concept 103: The method according to Invention Concept 99, wherein activating the non-implantable control circuit to drive the cathode and the anode to apply the pacing signal comprises: activating the non-implantable control circuit to set an amplitude of the pacing signal by modulating an amplitude of energy wirelessly transmitted from the energy transmission coil to the artificial valve coil.

[0264] Invention Concept 104: The method according to Invention Concept 99, wherein the pacing signal comprises a plurality of pulses, and wherein activating the non-implantable control circuit to drive the cathode and the anode to apply the pacing signal comprises: activating the non-implantable control circuit to drive the cathode and the anode to (a) begin applying each pulse of the pacing signal by initiating wireless transmission of energy from the energy transmission coil to the artificial valve coil, and (b) terminate applying each pulse of the pacing signal by stopping wireless transmission of energy from the energy transmission coil to the artificial valve coil.

[0265] Inventive Concept 105: The method according to Inventive Concept 99,

[0266] 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.

[0267] The cathode is mechanically connected to the upstream inflow portion of the frame.

[0268] Invention Concept 106: The method according to Invention Concept 105, wherein the artificial valve coil is axially disposed along the downstream outflow portion of the frame.

[0269] Invention Concept 107: The method according to Invention Concept 99, wherein the cathode and the anode are disposed on the frame such that when the artificial aortic valve is in a fully expanded configuration, there is a distance of at least 15 mm between the cathode and the anode, wherein the 15 mm is measured along a central longitudinal axis of the frame when in the fully expanded configuration.

[0270] Inventive Concept 108: The method according to Inventive Concept 99, wherein the non-implantable unit is an external unit disposed outside a subject, wherein the subject is provided with the artificial aortic valve.

[0271] Inventive Concept 109: The method according to Inventive Concept 99,

[0272] The non-implantable unit is a delivery system of the valve prosthesis system, and the energy transfer coil is a delivery system coil coupled to the delivery tube at a distal end of the delivery tube.

[0273] The steps involved in setting the artificial aortic valve are as follows:

[0274] Through the vascular system, the delivery tube is advanced until a distal end of the delivery tube is positioned in the patient's ascending aorta; and

[0275] The artificial aortic valve is released from the distal portion of the delivery tube such that the artificial aortic valve presents a partially expanded, partially deployed configuration, wherein (a) at least the cathode is located outside the delivery tube, and (b) the artificial valve coil is compressed within the delivery tube;

[0276] Activating the non-implantable control circuit includes the steps of: after releasing the artificial aortic valve from the distal portion of the delivery cannula, at least while the artificial aortic valve is in a partially deployed configuration, driving the anode and the cathode to wirelessly transmit energy from the delivery system coil to the artificial valve coil via inductive coupling to apply the pacing signal, and setting the parameters of the pacing signal, and

[0277] The provision of the artificial aortic valve further includes the step of: after activating the delivery system control circuit, completely releasing the artificial aortic valve from the distal end of the delivery tube, so that the artificial aortic valve presents an expanded, fully deployed structure.

[0278] Invention Concept 110: The method according to Invention Concept 109, wherein activating the delivery system control circuit includes the steps of: at least when the artificial aortic valve is in a partially deployed configuration, activating the delivery system control circuit to drive the anode and the cathode to wirelessly transmit energy from the energy transmission coil to the artificial valve coil via inductive coupling to apply rapid ventricular pacing.

[0279] Invention Concept 111: The method according to Invention Concept 109 further includes, after the artificial aortic valve is fully released from the distal end of the delivery tube, when the artificial aortic valve is in a fully expanded, extended configuration, activating an external unit control circuit of an external unit to drive an external unit coil of the external unit and drive the anode and the cathode to wirelessly transmit energy to the artificial valve coil via inductive coupling to apply the pacing signal and set the parameters of the pacing signal, wherein the external unit is disposed outside a subject, wherein the subject is provided with the artificial aortic valve.

[0280] Invention Concept 112: The method according to Invention Concept 109, wherein when the artificial aortic valve presents a fully expanded configuration after being fully released from the distal end of the delivery cannula, the delivery system control circuit is configured to stop driving the delivery system coil to drive the cathode and the anode.

[0281] Invention Concept 113: The method according to Invention Concept 109, wherein partially releasing the artificial aortic valve from the distal end of the delivery tube includes positioning the cathode adjacent to cardiac tissue near the His bundle.

[0282] Invention Concept 114: The method according to Invention Concept 113, wherein positioning the cathode adjacent to cardiac tissue near the His bundle includes, if necessary, rotating the artificial aortic valve during placement such that the cathode rests against the cardiac tissue near the His bundle.

[0283] According to inventive concept 115 of the present invention, a valve prosthesis system is also provided, comprising:

[0284] (i) an artificial aortic valve configured to be implanted in an aortic valve in a patient, wherein the artificial aortic valve comprises:

[0285] (a) Multiple artificial leaflets;

[0286] (b) A framework;

[0287] (c) a cathode and an anode, mechanically coupled to the frame; and

[0288] (d) An artificial valve coil, which is in non-radio communication with the cathode and the anode, wherein the artificial aortic valve does not include any active electronic components; and

[0289] (ii) A non-implantable unit, comprising:

[0290] (a) An energy transfer coil;

[0291] (b) at least two skin-sensing ECG electrodes; and

[0292] (c) A non-implantable control circuit, configured as follows:

[0293] The cathode and the anode are driven to apply a pacing signal to the patient's heart.

[0294] The at least two skin-sensing ECG electrodes are used to detect at least one cardiac parameter, and

[0295] In at least a partial response to the detected at least one cardiac parameter, energy is wirelessly transmitted from the energy transmission coil to the artificial valve coil via inductive coupling, setting the parameters of the pacing signal.

[0296] According to inventive concept 116 of the present invention, a valve prosthesis system is also provided, comprising:

[0297] (i) an artificial aortic valve configured to be implanted in a patient's natural aortic valve, wherein the artificial aortic valve comprises:

[0298] (a) Multiple artificial leaflets;

[0299] (b) A framework;

[0300] (c) a cathode and an anode, mechanically coupled to the frame; and

[0301] (d) An artificial valve coil, which is in non-radio communication with the cathode and the anode, wherein the artificial aortic valve does not include any active electronic components; and

[0302] (ii) A non-implantable unit, comprising:

[0303] (a) An energy transfer coil;

[0304] (b) A heart sensor; and

[0305] (c) A non-implantable control circuit, configured as follows:

[0306] The cathode and the anode are driven to apply a pacing signal to the patient's heart.

[0307] The cardiac sensor is used to detect at least one cardiac parameter, and

[0308] In at least a partial response to the detected at least one cardiac parameter, energy is wirelessly transmitted from the energy transmission coil to the artificial valve coil via inductive coupling, setting the parameters of the pacing signal.

[0309] Inventive Concept 117: A valve prosthesis system according to any one of Inventive Concepts 115 and 116, wherein the non-implantable control circuit is configured to:

[0310] Analyze at least one detected cardiac parameter to assess the level of cardiac response to the pacing signal, and

[0311] If the response level is determined to be unsatisfactory, the intensity of the pacing signal is increased in response to at least one of the detected cardiac parameters.

[0312] Inventive Concept 118: A valve prosthesis system according to any one of Inventive Concepts 115 and 116,

[0313] The at least one cardiac parameter includes at least one temporal feature.

[0314] The parameters of the pacing signal include at least one timing parameter, and

[0315] The non-implantable control circuit is configured to set at least one timing parameter of the pacing signal in response to at least one timing feature of the detected at least one cardiac parameter.

[0316] Invention Concept 119: A valve prosthesis system according to any one of Invention Concepts 115 and 116, wherein the artificial aortic valve includes one or more elongated insulated electrical conductors that directly couple the artificial valve coil to the cathode and the anode in a non-radio-connected manner.

[0317] Inventive Concept 120: A valve prosthesis system according to any one of Inventive Concepts 115 and 116, wherein a respective non-electrically insulated end of the artificial valve coil defines the cathode and the anode.

[0318] Invention Concept 121: A valve prosthesis system according to any one of Invention Concepts 115 and 116, wherein the non-implantable control circuit is configured to set an amplitude of the pacing signal by modulating an amplitude of energy wirelessly transmitted from the energy transmission coil to the artificial valve coil.

[0319] Invention Concept 122: A valve prosthesis system according to any one of Invention Concepts 115 and 116, wherein the pacing signal comprises a plurality of pulses, and wherein the non-implantable control circuitry is configured to drive the cathode and the anode to (a) initiate the application of each pulse of the pacing signal by initiating the wireless transmission of energy from the energy transmission 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 transmission coil to the prosthetic valve coil.

[0320] Invention Concept 123: A valve prosthesis system according to any one of Invention Concepts 115 to 122, wherein the non-implantable unit is an external unit configured to be disposed outside the patient's body.

[0321] Inventive Concept 124: A valve prosthesis system according to any one of Inventive Concepts 115 to 122,

[0322] The non-implantable unit is a delivery system, which further includes a delivery tube and one or more wires passing through the delivery tube;

[0323] The energy transfer coil mentioned above is a delivery system coil;

[0324] The non-implantable control circuit is a delivery system control circuit, which is electrically connected to the delivery system coil via one or more wires.

[0325] The delivery system coil is coupled to the delivery tube at a distal location of the delivery tube.

[0326] Invention Concept 125: A valve prosthesis system according to Invention Concept 124, wherein the delivery system control circuit is configured to drive the cathode and the anode to wirelessly transmit energy from the energy transmission coil to the artificial valve coil via inductive coupling to apply rapid ventricular pacing.

[0327] Inventive Concept 126: A valve prosthesis system according to any one of Inventive Concepts 115 to 122,

[0328] The non-implantable control circuitry is configured to wirelessly transmit the energy by generating multiple AC pulses, each AC pulse comprising a series of AC pulse trains, and

[0329] The artificial aortic valve includes a passive diode that is electrically coupled to the artificial valve coil and configured to rectify the current in the artificial valve coil.

[0330] Invention Concept 127: The valve prosthesis system according to Invention Concept 126, wherein the non-implantable control circuit is configured to generate the series of AC pulses at a frequency between 3 kHz and 130 kHz, for example between 3 kHz and 100 kHz or between 100 kHz and 130 kHz.

[0331] Invention Concept 128: A valve prosthesis system according to Invention Concept 126, wherein the non-implantable control circuit is configured such that each pulse in the plurality of AC pulses comprises a train of 20 to 100 AC pulses.

[0332] According to inventive concept 129 of the present invention, another method is also provided, comprising:

[0333] An artificial aortic valve, part of a valve prosthesis system in an aortic annulus, is implanted into a patient's natural aortic valve via the patient's vascular system. The artificial aortic valve includes (a) a plurality of artificial leaflets, (b) a frame, (c) a cathode and an anode mechanically coupled to the frame, and (d) an artificial valve coil non-radio-connected to the cathode and the anode. The artificial aortic valve does not include any active electronic components.

[0334] Activate the non-implantable control circuit of a non-implantable unit of the valve prosthesis system to drive the cathode and the anode to wirelessly transmit energy from an energy transmission coil of the non-implantable unit to the artificial valve coil via inductive coupling to apply a pacing signal to the patient's heart; use a cardiac sensor to detect at least one cardiac parameter; and set the parameters of the pacing signal in at least a portion of response to the detected at least one cardiac parameter.

[0335] Invention Concept 130: The method according to Invention Concept 129, wherein activating the non-implantable control circuitry includes activating the non-implantable control circuitry to:

[0336] Analyze at least one detected cardiac parameter to assess the level of cardiac response to the pacing signal, and

[0337] If the response level is determined to be unsatisfactory, the intensity of the pacing signal is increased in response to at least one detected cardiac parameter.

[0338] Inventive Concept 131: The method according to Inventive Concept 129,

[0339] The at least one cardiac parameter includes at least one temporal feature;

[0340] The parameters of the pacing signal include at least one timing parameter, and

[0341] Activating the non-implantable control circuit includes activating the non-implantable control circuit to set at least one timing parameter of the pacing signal in response to at least one timing feature of the detected at least one cardiac parameter.

[0342] Invention Concept 132: The method according to Invention Concept 129, wherein activating the non-implantable control circuit to drive the cathode and the anode to apply the pacing signal includes activating the non-implantable control circuit to set an amplitude of the pacing signal by modulating an amplitude of energy wirelessly transmitted from the energy transmission coil to the artificial valve coil.

[0343] Invention Concept 133: The method according to Invention Concept 129, wherein the pacing signal comprises a plurality of pulses, and wherein activating the non-implantable control circuit to drive the cathode and the anode to apply the pacing signal comprises activating the non-implantable control circuit to drive the cathode and the anode to (a) begin applying each pulse of the pacing signal by initiating wireless transmission of energy from the energy transmission coil to the artificial valve coil, and (b) terminate applying each pulse of the pacing signal by stopping wireless transmission of energy from the energy transmission coil to the artificial valve coil.

[0344] Invention Concept 134: The method according to Invention Concept 129, wherein the non-implantable unit is an external unit disposed outside the patient's body.

[0345] Inventive Concept 135: The method according to Inventive Concept 129,

[0346] Activating the non-implantable control circuit includes activating the non-implantable control circuit to wirelessly transmit the energy by generating multiple AC pulses, each AC pulse comprising a series of AC pulse trains, and

[0347] The artificial aortic valve includes a passive diode that is electrically coupled to the artificial valve coil and configured to rectify the current in the artificial valve coil.

[0348] Invention Concept 136: The method according to Invention Concept 135, wherein activating the non-implantable control circuitry includes activating the non-implantable control circuitry to generate the series of AC pulses at a frequency between 3 kHz and 130 kHz, for example, between 3 kHz and 100 kHz or between 100 kHz and 130 kHz.

[0349] Invention Concept 137: The method according to Invention Concept 135, wherein activating the non-implantable control circuitry includes activating the non-implantable control circuitry such that each pulse in the plurality of AC pulses comprises a train of 20 to 100 AC pulses.

[0350] The invention will be more fully understood from the following detailed description of its embodiments in conjunction with the accompanying drawings, in which: Attached Figure Description

[0351] Figure 1A and Figure 1B This is a schematic diagram of an artificial aortic valve according to the present invention;

[0352] Figure 2 This is an application according to the present invention. Figure 1A and Figure 1B A schematic diagram of the components of an artificial aortic valve before it is fully assembled;

[0353] Figure 3A This is a schematic diagram of another artificial aortic valve according to the present invention;

[0354] Figure 3B This is an application according to the present invention. Figure 3A A schematic diagram of the passive electronic components of an artificial aortic valve and cardiac tissue;

[0355] Figures 4A to 4C A schematic diagram of a valve prosthesis system and a method of using the system according to a corresponding application of the present invention; and

[0356] Figure 5 This is a schematic diagram of an electronic implant according to the present invention. Detailed Implementation

[0357] Figure 1A and Figure 1B This is a schematic diagram of an artificial aortic valve 20 according to the present invention. The artificial aortic valve 20 is shown in an expanding configuration. Figure 1A and Figure 1B In addition to Figure 1A and Figure 1B The expansion of the artificial aortic valve 20 is not limited by the patient's anatomy, and is similar to that described below. Figure 4C The described extended fully expanded construction. As described below, Figure 1B This is a view of the artificial aortic valve 20 shown from one downstream outflow end 52.

[0358] Artificial aortic valve 20 includes:

[0359] • One frame 30;

[0360] • Multiple artificial leaflets 32, coupled to the frame 30;

[0361] • One or more electrodes 34, coupled to the frame 30; and

[0362] • An artificial valve coil 36, coupled to the frame 30 and electrically connected in a non-wireless manner to the one or more electrodes 34, optionally via one or more elongated insulated electrical conductors 38, such as wires.

[0363] The frame 30 typically includes a support or other structure, which is generally self-expanding and can be shaped by laser cutting or etching a metal alloy tube, including, 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 Da Gan et al. and / or U.S. Patent Application No. 2016 / 0278951 to Da Gan et al., both of which are incorporated herein by reference. For some applications, the artificial valve coil 36 includes gold bonding wires to provide low resistance.

[0364] For some applications, the artificial aortic valve 20 further includes an artificial aortic valve control circuit 40 coupled to the frame 30 and in non-radio communication with the one or more electrodes 34. In these applications, the artificial valve coil 36 is in non-radio communication with the artificial aortic valve control circuit 40, such that the artificial valve coil 36 is in non-radio communication with the one or more electrodes 34 via the artificial aortic valve control circuit 40. One or more of the one or more electrodes 34 can be directly attached to the artificial aortic valve control circuit 40 in a non-radio communication manner, and / or can be attached to the artificial aortic valve control circuit 40 in a non-radio communication manner via one or more elongated insulated electrical conductors 38. Typically, the artificial aortic valve control circuit 40 is flexible and has a thin linear package, and can be implemented as described below. Figure 5The thickness of the control circuit 40 allows it to be compressed within the delivery tube during the deployment of the artificial aortic valve 20 without increasing the diameter of the delivery tube. Furthermore, the flexibility of the control circuit 40 prevents damage to the control circuit 40 during coiling when it is compressed into the delivery tube.

[0365] For some applications, the frame 30 is shaped to define an upstream inflow portion 42, a downstream outflow portion 44, and a constriction portion 46, which is axially located between the upstream inflow portion 42 and the downstream outflow portion 44. The artificial valve leaflet 32 ​​is coupled to the constriction portion 46 such that when the artificial aortic valve 20 is in position (see below) Figure 4C When fully expanded, the free edge 48 of the prosthetic leaflet 32 ​​faces the downstream outflow portion 44. The prosthetic leaflet 32 ​​is not coupled to the downstream outflow portion 44; therefore, an annular longitudinal boundary 58 between the downstream outflow portion 44 and the constriction portion 46 is defined by a downstream point of the frame 30 coupled to the prosthetic leaflet 32 ​​(e.g., as described below, the prosthetic leaflet 32 ​​may be coupled to the downstream point of the frame 30 at the commissure 60). (The annular longitudinal boundary 58 is located at the same longitudinal position around the frame 30). Typically, the artificial aortic valve 20 further 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 are attached to each other at their lateral ends to form the commissure 60, with the free edges 48 of the prosthetic leaflets forming intersecting engagement edges. The skirt 49 and the artificial leaflet 32 ​​typically include a piece of animal pericardial tissue, such as porcine pericardial tissue, or synthetic or polymeric material.

[0366] For some applications, the prosthetic valve coil 36 is positioned no more than 1 mm upstream of the annular longitudinal boundary 58 between the downstream outflow portion 44 and the constriction portion 46, typically along the downstream outflow portion 44. This placement allows the artificial aortic valve 20 to be coiled (compressed) into a delivery tube during deployment, eliminating the need for a larger diameter delivery tube to accommodate the prosthetic valve coil 36. This is possible because the downstream outflow portion 44 does not contain material of the prosthetic leaflet 32 ​​and can therefore accommodate the prosthetic valve coil 36 without resulting in a larger compression diameter in the downstream outflow portion 44 than in other axial portions of the artificial aortic valve 20. Typically, the prosthetic valve coil 36 is not axially positioned 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 either the constriction portion 46 or the upstream inflow portion 42, axial placement 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.

[0367] Typically, at least one of the one or more electrodes 34 is coupled to the upstream inflow portion 42 of the frame 30, for example, exactly one of the one or more electrodes 34. For some applications, the one or more electrodes 34 include a cathode 54 coupled to the upstream inflow portion 42 of the frame 30, and the artificial aortic valve control circuit 40 is configured to drive the cathode 54 to apply a cathode current. For some applications, the cathode 54 has a lateral dimension α, which is detected as a degree about the frame 30 relative to a central longitudinal axis 55, 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, the artificial aortic valve 20 is set using imaging such as fluoroscopy, and, if necessary, rotated during setup so that the cathode 54 is positioned against the valve annulus adjacent to the His bundle. For some applications, the artificial aortic valve 20 includes a plurality of cathodes 54 (e.g., two or three, or more) positioned at corresponding angular locations around the frame 30 (e.g., spaced 10 to 15 degrees apart). See below. Figure 4CAfter implantation of the artificial aortic valve 20, the cathode 54, with the most precise angular position, is activated to apply pacing signals and / or sense signals via the artificial aortic valve control circuit 40 or an external control circuit such as the external unit control circuit 104. Alternatively or additionally, for some applications, the cathode 54 has an axial length of at least 10 mm to accommodate the axial misalignment of the frame 30 relative to the annulus of the natural aortic valve, and therefore relative to the His bundle. As used in this application, including the claims, "axial length" is the length of the structure detected along the central longitudinal axis 55.

[0368] 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 an outer surface of the upstream inflow portion 42 of the frame 30, and the cathode 54 is disposed on an outer surface of the skirt 49. As used herein, including in the claims, the “central longitudinal axis” 55 of the frame 30 is the set of all centroids along the cross-section of the frame 30. 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 centroids correspond to the center of the circular cross-section.)

[0369] For some applications, when the artificial aortic valve 20 is in the following condition (see below) Figure 4C When the expansion is fully unfolded:

[0370] The frame 30 has an inlet end 50, a downstream outlet end 52, and an axial length, wherein the inlet end 50 is located at an upstream inlet portion 42, the downstream outlet end 52 is located at a downstream outlet portion 44, and the axial length is detected between the inlet end 50 and the downstream outlet end 52.

[0371] • At least one of the one or more electrodes 34 (e.g., exactly one, such as cathode 54) is coupled to the upstream inflow portion 42 at a distance from the inflow end 50, said distance being equal to 10% of the axial length of the frame (when in the fully expanded configuration, said distance is (a) measured along the central longitudinal axis 55 of the frame 30, and (b) measured between the inflow end 50 and the upstream point of the at least one electrode).

[0372] Typically, the artificial aortic valve control circuit 40 is coupled to the frame 30 such that the upstream point 56 of the artificial aortic valve control circuit 40 is axially positioned along the constriction portion 46 and / or the downstream outflow portion 44 of the frame 30.

[0373] Typically, see below. Figures 4A to 4C As described, the artificial aortic valve control circuit 40 is coupled within the frame 30 to prevent friction between the artificial aortic valve control circuit 40 and the delivery tube 72 during the placement of the artificial aortic valve 20. It should be noted that for applications where the upstream point 56 is located no more than 1 mm upstream of the annular longitudinal boundary 58, as mentioned above, the interior of the frame 30 typically has sufficient space to accommodate the artificial aortic valve control circuit 40.

[0374] For some applications, the artificial leaflet 32 ​​is coupled to the frame 30 at at least a first junction 60A and a second junction 60B of the artificial aortic valve 20, the first junction 60A and the second junction 60B being located at corresponding first corner positions 62A and second corner positions 62B around the frame 30. See below. Figure 4C As described, when the artificial aortic valve 20 is in its fully expanded, dilated configuration, the first angular position 62A and the second angular position 62B are separated by a first angular offset β (beta) around the frame 30. See below. Figure 4C When the artificial aortic valve 20 is in its fully expanded, dilated configuration, the artificial aortic valve control circuit 40 is coupled to the frame 30 at a third triangular position 62C surrounding the frame 30. This third triangular position 62C is separated from the first triangular position 62A by a second triangular offset δ (delta), the second triangular offset δ being between 40% and 60% (e.g., 50%) of the first triangular offset β. At the third triangular position 62C surrounding the frame 30, the frame is more flexible than at a more rigid joint. As used in this application, including the claims, a “triangular position” is a location on the frame 30 at a specific point around the central longitudinal axis 55, i.e., at a specific “o'clock” relative to the central longitudinal axis 55 (note that a third joint point 60C is at...). Figure 1A It is shown at the far end of the frame, i.e., at a 180-degree angle to circuit 40.

[0375] See now Figure 2This is a schematic diagram of an element of an artificial aortic valve 20 before final assembly, according to the present invention. The element includes a valve element 64 and an electronic element 66. The valve element 64 typically includes a known cardiac valve prosthesis, comprising at least a frame 30 and an artificial leaflet 32. For example, known cardiac valve prostheses may include the CoreValve™ Evolut™ R prosthesis (Medtronic, Inc., Minneapolis, MN, USA), the CoreValve™ Evolut™ PRO prosthesis (Medtronic, Inc.), the LOTUS Edge™ aortic valve (Boston Scientific, Marburg, Massachusetts, USA), or the ACURATE neo™ aortic valve (Boston Scientific). The electronic element 66 includes at least one or more electrodes 34 and an artificial valve coil 36, as well as optional artificial aortic valve control circuitry 40.

[0376] During the assembly of the artificial aortic valve 20, electronic components 66 are inserted into the valve element 64. For some applications, a first portion of electronic component 66, such as the artificial valve coil 36, the artificial aortic valve control circuit 40, and one or more electrodes 34, is coupled to the inner surface of the frame 30, and a second portion of electronic component 66, such as a cathode 54, is coupled to the outer surface of the frame 30. For example, one or more elongated insulated conductors 38, 38A, can electrically couple the cathode 54 to the artificial aortic valve control circuit 40, and conductor 38A can pass from the inside of the frame 30 to the outside, typically through the skirt 49. (Coupling one or more electrodes 34 to the inner surface of the frame 30 exposes the electrodes to the blood of the subject during implantation of the assembled artificial aortic valve 20. As described herein, coupling the cathode 54 to the outer surface of the frame 30 allows the cathode to be positioned against tissue, such as tissue near the valve annulus of the His bundle, during implantation of the assembled artificial aortic valve 20.) Optionally, the electronic component 66 may be sewn to the frame 30 and / or the skirt 49.

[0377] For some applications, regardless of whether the artificial valve coil 36 is coupled to an inner or outer surface of the frame 30, the artificial valve coil 36 and the frame 30 are electrically isolated, for example by means of an insulating material (e.g., a sheet or coating) disposed between the artificial valve coil 36 and the frame 30. For example, the insulating material may include a non-conductive polymer.

[0378] The assembly of the artificial aortic valve 20 is typically performed in a manufacturing facility, after which the assembled artificial aortic valve 20 is packaged and transported to a medical facility for implantation. Therefore, the method of assembling the artificial aortic valve 20 is non-surgical.

[0379] Figure 3A This is a schematic diagram of an artificial aortic valve 120 according to the present invention. The artificial aortic valve 120 is shown in an expanding configuration. Figure 3A In addition to Figure 3A The expansion of the artificial aortic valve 120 is not limited by a patient's anatomy, and is similar to that described below. Figure 4C The fully expanded structure of the artificial aortic valve 20. In addition to being described below, the artificial aortic valve 120 is similar to [see also...] Figures 1A to 1B and Figure 2 The artificial aortic valve 20 described herein is identical, and the same reference numerals refer to the same parts. The artificial aortic valve 120 can be compared to the one described above. Figure 2 The assembly process is then carried out.

[0380] See also Figure 3B This is a schematic diagram of the passive electronic components of the artificial aortic valve 120 and tissue 122 according to the present invention. Tissue 122 includes heart tissue and blood. Cathode 54 is configured to contact the heart tissue, and anode 57 is configured to contact the blood. As is known in the art, heart tissue acts as a resistor.

[0381] For some applications, the artificial aortic valve 120 includes a passive diode 124 (shown highly schematically). Figure 3A and Figure 3B (In the upper exploded view), it is electrically connected to the artificial valve coil 36 and rectifyes the current in the artificial valve coil. For example, diode 124 may be located at one end of the coil or adjacent to cathode 54 or anode 57, or (as in...) Figure 3A (As shown) at a point along the artificial valve coil 36. Non-implantable control circuitry (e.g., delivery system control circuitry 80) Figure 4B ) or external unit control circuit 104 ( Figure 4C Energy is typically transmitted wirelessly to the artificial valve coil 36 by generating multiple AC pulses, each comprising a series of AC pulse trains. To improve efficiency, AC pulse trains can be generated, for example, at frequencies between 3 kHz and 130 kHz (e.g., between 3 kHz and 100 kHz, or between 100 kHz and 130 kHz). For some applications, each AC pulse contains 20 to 100 AC pulse trains. Other frequencies and pulse numbers are also within the scope of this invention.

[0382] For some applications, the artificial aortic valve 120 includes exactly one passive diode 124 that provides half-wave rectification of the AC pulse. For other applications, the artificial aortic valve 120 includes multiple passive diodes 124 that provide full-wave rectification of the AC pulse; for example, the artificial aortic valve 120 may include four passive diodes 124, configured as a bridge structure as known in the field of electronics.

[0383] For some applications, the artificial aortic valve 120 includes a capacitor 126 (shown schematically). Figure 3A as well as Figure 3B (In the exploded view on the right), it is electrically connected to the cathode 54 and anode 57 (parallel to the heart tissue 122 in the circuit formed after the electrodes are implanted). The capacitor 126 typically improves the efficiency of the circuit by transferring a larger proportion of the received energy to the tissue 122 (as is known in the field of electronics, a capacitor is a passive electronic component).

[0384] Optionally, the artificial aortic valve 120 includes additional passive electronic components, such as one or more resistors.

[0385] See below Figure 4B Regarding the artificial aortic valve 20, for some applications, the delivery system control circuit 80 is configured to drive the one or more electrodes 34 to apply rapid ventricular pacing; in this configuration, even if the artificial aortic valve control circuit 40 is provided, it is usually passive, i.e., the delivery system control circuit 80 sets the parameters of the pacing signal. Figure 3A The artificial aortic valve 120 shown is one embodiment of this structure; different from the one in... Figures 1A to 1B and Figure 2 The artificial aortic valve 20 shown is constructed without artificial aortic valve control circuitry 40 or any other active electronic components.

[0386] A valve prosthesis system is provided, comprising (a) an artificial aortic valve 120 and (b) a non-implantable unit, as described below. Figures 4A to 4C The aforementioned, for example, delivery system 70, or see below. Figure 4C The external unit 100. A non-implantable control circuit (e.g., depending on the application, delivery system control circuit 80 or external unit control circuit 104 of external unit 100) is configured to drive the cathode 54 and anode 57, transferring energy via inductive coupling from an energy transfer coil (depending on the application, see below for example). Figure 4C The delivery system coil 74 or external unit coil 102 wirelessly transmits to the artificial valve coil 36 to apply a pacing signal and set parameters of the pacing signal (e.g., as a standard, chronic pacing signal or a rapid ventricular pacing signal). The applied pacing is typically bipolar.

[0387] Optionally, the valve prosthesis system comprises two non-implantable units: (1) see below Figures 4A to 4C The delivery system 70 described herein, and (2) see below. Figure 4C The described external unit 100 includes corresponding control circuitry and an energy transfer coil. See below for an example. Figure 4B As described, when the artificial aortic valve 120 is in a partially deployed configuration, the delivery system control circuit 80 is configured to drive the delivery system coil 74 to wirelessly transmit energy to the artificial valve coil 36 via inductive coupling, thereby driving the cathode 54 and anode 57 to apply the pacing signal and set the parameters of the pacing signal. See below for example. Figure 4C As described herein, when the artificial aortic valve 120 is in its fully expanded, dilated configuration, the external unit control circuit 104 is configured to drive the external unit coil 102 to wirelessly transmit energy to the artificial valve coil 36 via inductive coupling, as described below. Figure 4C The method described above is to drive the cathode 54 and anode 57, apply the pacing signal, and set the parameters of the pacing signal.

[0388] Typically, the corresponding ends of the artificial valve coil 36 are in non-radio communication with the cathode 54 and the anode 57.

[0389] For some applications, the respective non-electrically insulated ends of the artificial valve coil 36 define a cathode 54 and an anode 57. In these applications, the artificial aortic valve 120 typically does not include an elongated insulated conductor 38. Instead, the respective insulated ends of the artificial valve coil 36 are positioned along... Figure 3A The path of the elongated insulated conductor 38 shown bends away from the artificial valve coil 36, such that each non-electrically insulated end of the artificial valve coil 36 is located at... Figure 3A The positions of cathode 54 and anode 57 are shown in the diagram.

[0390] As described above, the non-implantable control circuit is configured to drive the cathode 54 and anode 57 to set parameters of the pacing signal. For example, the non-implantable control circuit may be configured to set an amplitude of the pacing signal by modulating an amplitude of the energy wirelessly transmitted from the energy transmission coil to the artificial valve coil 36. Alternatively, for example, the non-implantable control circuit may be configured to drive the cathode 54 and anode 57 to (a) begin applying individual pulses of the pacing signal by starting to wirelessly transmit energy from the energy transmission coil to the artificial valve coil 36, and (b) end applying individual pulses of the pacing signal by stopping to wirelessly transmit energy from the energy transmission coil to the artificial valve coil 36.

[0391] The inventors have determined that in some configurations, it is difficult to assess suitable pacing parameters, for example, due to patient body size or weight distribution, or due to technical issues, such as the variable impedance between cardiac tissue and cathode 54 and anode 57, or the variable relative orientation of the external unit coil 102 and the artificial valve coil 36. Therefore, for some applications, the non-implantable unit includes an energy delivery coil (e.g., as...). Figure 4C The external unit coil 102 and at least two skin-sensing ECG electrodes 106 shown are placed on the patient's skin 108, for example, as Figure 4C The chest is shown. The non-implantable control circuitry (e.g., external unit control circuitry 104) drives cathode 54 and anode 57 to apply a pacing signal to the patient's heart and uses a skin-sensing ECG electrode 106 to detect at least one cardiac parameter. The non-implantable control circuitry, at least partially responsive to the detected cardiac parameter, wirelessly transmits energy from the energy transfer coil to the artificial valve coil 36 via inductive coupling to set the parameters of the pacing signal. Since the artificial aortic valve 120 typically does not include any active electronics, the pacing current is driven by the artificial valve coil 36 itself via inductive coupling, wirelessly transmitting energy from the energy transfer coil to the artificial valve coil 36.

[0392] Alternatively, the non-implantable unit may include another type of cardiac sensor, rather than the skin-sensing ECG electrode 106. For example, the cardiac sensor may include a heart rate sensor, such as an optical heart rate sensor (e.g., using photoplethysmography), or an ECG sensor, such as an optical ECG sensor (e.g., a single-channel ECG sensor, such as a Si1172 or Si1173 biometric module manufactured by Silicon Laboratories Inc. in Austin, Texas).

[0393] The non-implantable control circuitry typically analyzes the detected cardiac parameters to assess the heart's response level to the pacing signal. If the response level is determined to be unsatisfactory, the non-implantable control circuitry, in response to the detected cardiac parameters, increases the intensity of the pacing signal (e.g., by increasing the amplitude or duration of the pacing signal). For example, the pulse width of multiple pulses of the pacing signal (typically 0.1 ms to 1 ms, e.g., 0.25 ms to 0.8 ms) or the current amplitude in the energy delivery coil may be iteratively increased until it is determined that the heart is appropriately responding to the pacing pulse applied to the tissue. Optionally, at this point, the intensity of the pacing signal may be further increased, e.g., by 50% to 150%, or for example, by 100%.

[0394] For some applications, the detected cardiac parameters are temporal characteristics of cardiac activity (e.g., heart rate, or the temporal sequence of specific characteristics of the cardiac cycle). In this case, the parameters of the pacing signal may include the temporal parameters of the pacing signal, and the non-implantable control circuitry sets the temporal parameters of the pacing signal in response to the temporal characteristics of the detected cardiac parameters.

[0395] It should be noted that, for a given patient, the pacing of the heart may be applied in a manner synchronized with the patient's cardiac cycle (based on signals received via the sensory skin ECG electrode 106), or the pacing may be asynchronous with the patient's cardiac cycle.

[0396] The skin-sensing ECG electrode 106 is typically an inhalation ECG electrode or configured to be electrically coupled to the skin via an adhesive. Generally, conventional ECG electrodes are suitable for use with the skin-sensing ECG electrode 106. It should be noted that although conventional ECG electrodes can be used, a full ECG analysis as known in the field of electrocardiography is not typically performed to achieve the functions of the non-implantable control circuit described above.

[0397] See Figures 1A to 1B , Figure 2 and Figure 3A , and see also Figures 4A to 4C This is a schematic diagram of a valve prosthesis system 68 and a method of using said system according to a corresponding application of the present invention. Although see Figures 4A to 4C The described technology is generally applicable to artificial aortic valve 120, but such technology is equally applicable to artificial aortic valve 20. The direction of rotation of the artificial aortic valve is schematically shown. Figures 4A to 4C The following describes the components of an artificial aortic valve; as described below, in actual use, the artificial aortic valve is typically rotationally oriented such that the cathode 54 is positioned in cardiac tissue near the His bundle.

[0398] The valve prosthesis system 68 includes an artificial aortic valve 20 or an artificial aortic valve 120 and a delivery system 70.

[0399] Delivery system 70 includes:

[0400] • One delivery tube 72;

[0401] • A delivery system coil 74 is coupled to the delivery tube 72 at a distal position 76; for example, a distal portion 77 of the delivery system coil 74 may be disposed within 10 mm of a distal end 82 of the delivery tube 72.

[0402] • One or more wires 78 that pass through the delivery tube 72, for example, attached to the outer or inner surface of the delivery tube 72, or embedded in the wall of the delivery tube 72; and

[0403] • Delivery system control circuit 80, which is electrically connected to delivery system coil 74 via one or more wires 78.

[0404] The delivery system control circuit 80 is configured to drive the delivery system coil 74, at least when the artificial aortic valve 120 is in the position described below. Figure 4B During the partial unfolding construction, energy is wirelessly transmitted to the artificial valve coil 36 via inductive coupling.

[0405] like Figure 4A As shown, the artificial aortic valve 120 is removable in a delivery cannula 72 in a compressed delivery configuration. During an implantation procedure, the delivery cannula 72 is advanced through a patient's vascular system until the distal end 82 of the delivery cannula 72 is placed in the patient's ascending aorta 84, while the artificial aortic valve 120 is removably disposed in the compressed delivery cannula 72 in a compressed delivery configuration.

[0406] like Figure 4B As shown, the artificial aortic valve 120 is also configured to present a partially expanded, 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 is located outside the delivery tube 72, for example, cathode 54, near (e.g., in contact with) target tissue such as the natural aortic valve annulus, and (b) the artificial valve coil 36 is compressed within the delivery tube 72. Typically, the delivery system coil 74 surrounds the compressed artificial valve coil 36, providing high transmission efficiency even while the artificial valve coil 36 remains compressed. After the artificial aortic valve 120 has presented its partially expanded, partially deployed configuration, the delivery system control circuit 80 is activated to drive the delivery system coil 74, wirelessly transmitting energy to the artificial valve coil 36 via inductive coupling. In contrast, power transmission from an external coil to the compressed artificial valve coil 36 would be highly inefficient due to the greater distance between the transmitting and receiving coils and the compression of the artificial valve coil 36.

[0407] For some applications, see Figures 1 to 14 above. Figure 1B and Figure 2 The valve prosthesis system 68 includes an artificial aortic valve 20, and an artificial 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 artificial aortic valve 20. Alternatively, see above, for example. Figure 3AThe delivery system control circuit 80 is configured to drive the one or more electrodes 34 to apply rapid ventricular pacing. In this configuration, even if an artificial aortic valve control circuit 40 is provided (as in artificial aortic valve 20), it is typically passive or not provided (as in artificial aortic valve 120), i.e., the delivery system control circuit 80 sets the parameters of the pacing signal. Alternatively, as described below, artificial aortic valve 20 or artificial aortic valve 120 may not be used to apply rapid ventricular pacing, but may be used to apply post-implantation pacing, and / or, as described below, may be used for post-implantation sensing.

[0408] See above. Figures 1A to 1B As described, for some applications, the one or more electrodes 34 include a cathode 54 coupled to the upstream inflow portion 42 of the frame 30. When the artificial aortic valve 120 is in such a position... Figure 4B In the partially expanded configuration shown, the cathode 54 is located near cardiac tissue adjacent to the His bundle to pace the heart by stimulating the cardiac tissue with a cathode current. For some applications, the one or more electrodes further include an anode 57, which, as known in the art, can be used for bipolar sensing and / or pacing. Typically, the cathode 54 and anode 57 are positioned on the frame 30 such that when the artificial aortic valve 120 is in the position described below... Figure 4C In the fully expanded configuration, there is a distance of at least 15 mm between the cathode and the anode (when in the fully expanded configuration, the 15 mm is measured along the central longitudinal axis 55 of the frame 30).

[0409] like Figure 4C As shown, the artificial aortic valve 120 is also configured to present an expanded, fully deployed configuration when fully released from the distal end 82 of the delivery cannula 72. For some applications, when the artificial aortic valve 120 presents an expanded, fully deployed configuration after being fully released from the distal end 82 of the delivery cannula 72, the delivery system control circuit 80 is configured to stop driving the delivery system coil 74.

[0410] For some applications, such as Figure 4CAs shown, the valve prosthesis system 68 further includes an external unit 100, which includes (a) an external unit coil 102 and (b) an external unit control circuit 104. When the artificial aortic valve 120 is in its fully deployed, expanded configuration, the external unit control circuit 104 is configured to drive the external unit coil 102 to wirelessly transmit energy to the artificial valve coil 36 via inductive coupling. In these applications, after the artificial aortic valve 120 has been fully released from the distal end 82 of the delivery tube 72, when the artificial aortic valve 120 is in its fully deployed, expanded configuration, the external unit control circuit 104 is activated to drive the external unit coil 102 to wirelessly transmit energy to the artificial valve coil 36 via inductive coupling.

[0411] For some applications, the external unit coil 102 is incorporated into a collar configured to be worn around the patient's neck or placed on the patient's chest, as described, for example, in PCT Publication No. WO 2016 / 157183 by Dai Gan et al., which is incorporated herein by reference, and / or the external unit coil 102 is incorporated into a strap or necklace configured to be worn around the patient's chest and the necklace configured to be worn around the patient's neck. Since the respective axes of the external unit coil 102 and the artificial valve coil 36 are generally aligned, this positioning of the external unit coil 102 provides high transmission efficiency.

[0412] Alternatively or additionally, for some applications, the external unit 100 is integrated with a belt or strap, which is configured to be worn around the patient's chest.

[0413] For some applications, where the valve prosthesis system 68 includes an artificial aortic valve 20, see above. Figures 1A to 1B and Figure 2 As described, the artificial aortic valve control circuit 40 is configured to use the received energy to drive one or more electrodes 34 to perform post-implantation pacing, for example, for several months. This pacing can employ any standard pacing procedure. For some applications, the pacing is VVI pacing, which is applied only when the ventricle does not sense a QRS complex. Alternatively, for some applications, the valve prosthesis system 68 includes an artificial aortic valve 120, as described above. Figure 3A As described, the external unit control circuit 104 is configured to drive one or more electrodes 34 to apply the pacing signal; in this device, an artificial aortic valve control circuit 40 is not provided (or if provided, it is typically passive), i.e., the external unit control circuit 104 sets the parameters of the pacing signal.

[0414] Alternatively, for some applications, where the valve prosthesis system 68 includes an artificial aortic valve 20, see above. Figures 1A to 1B and Figure 2 As described, the artificial aortic valve control circuit 40 is configured to (a) sense a cardiac signal using the one or more electrodes 34, and (b) drive the artificial valve coil 36 to deliver a wireless signal indication of the sensed cardiac signal. 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, the one or more electrodes 34 are typically not used to apply pacing and therefore do not need to be configured as a cathode and an anode. This sensing allows the patient to be discharged early after implantation of the artificial aortic valve 20, before left bundle branch block (LBBB) may develop. If LBBB develops (which occurs in approximately 20% to 30% of patients), an alarm is generated by sensing the LBBB, and the LBBB can be treated appropriately.

[0415] See now Figure 5 This is a schematic diagram of an electronic implant 200 according to the present invention. See above. Figure 1A and Figure 2 As described, the artificial aortic valve control circuit 40 enables the features of the electronic implant 200.

[0416] 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 further includes a multilayer protective coating comprising the following layers in sequence:

[0417] • A first internal alumina (AlOx) film 220 is deposited on the circuit 210, for example, using atomic layer deposition (ALD);

[0418] A second parylene layer 222 is deposited on the first inner AlOx film layer 220 (typically vapor-deposited in a vacuum); the second parylene layer 222 provides chemical protection for the circuit 210;

[0419] Optionally, a third layer 224 is disposed (typically cast onto) the second parylene layer 222. The third layer includes, for example, a polymer selected from the group consisting of silicone resin and PTFE. The third layer 224 typically has a thickness between 100 micrometers and 200 micrometers and is configured to provide mechanical protection for the circuit 210.

[0420] Optionally, a fourth external parylene layer 226 is deposited on the third layer 224 (typically, vapor-phase deposited in a vacuum); the fourth external parylene layer 226 provides chemical protection for the circuit 210 and the third layer 224.

[0421] The electronic implant 200 and the height of each layer are schematically drawn on [the map]. Figure 5 Furthermore, these layers are not drawn to scale; in particular, they are actually much thinner than they appear to be, and their relative thickness differs from what is shown.

[0422] Typically, as described above, circuit 210 is not encapsulated in a housing, but rather coated with multiple layers. A "housing" is a shell, typically comprising glass and / or metal, which has a structure prior to the circuit being placed therein; conversely, a coating takes the shape of the coating applied to the circuit. In contrast, encapsulation within a housing is standard practice in the field of implantable circuits. The absence of this housing allows the electronic implant 200 to be thin and flexible, but at the cost of a shorter lifespan. Since the artificial aortic valve control circuit 40 is typically used for only a few months, this shorter lifespan is generally not a problem for the artificial aortic valve control circuit 40.

[0423] For the application of the artificial aortic valve control circuit 40 to realize the features of the electronic implant 200, the one or more electrodes 34 are shielded during the application of the coating. Therefore, the artificial aortic valve control circuit 40, the one or more elongated insulated electrical conductors 38 (e.g., wires), and the artificial valve coil 36 are all coated in the same coating process.

[0424] The techniques described herein for the artificial aortic valve 20 can be used alternatively, with necessary modifications, for non-aortic artificial valves, such as artificial mitral or tricuspid valves.

[0425] In one embodiment, the technology and apparatus described herein are assigned to the assignee of this application and combined with the technology and apparatus described herein by reference to one or more of the following patents and / or applications incorporated herein:

[0426] • U.S. Patent No. 10,543,083 granted to Gross

[0427] • European patent application publication No. EP 3508113 A1 granted to Gross

[0428] • U.S. Patent No. 10,835,750 granted to Gross

[0429] • U.S. Patent Application Publication No. 2020 / 0261224 granted to Gross

[0430] • An international patent application entitled "Artificial Aortic Valve Pacing System" was filed on the same day as Gross's application.

[0431] Those skilled in the art will understand that this invention is not limited to the content specifically shown and described above. Rather, the scope of this invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof that are not part of the prior art, as will occur to those skilled in the art upon reading the foregoing description.

Claims

1. A valve prosthesis system, characterized in that: The valve prosthesis system includes: (i) An artificial aortic valve, configured to be implanted in a patient's natural aortic valve, wherein the artificial aortic valve comprises: (a) Multiple artificial leaflets; (b) A framework; (c) A cathode and an anode, mechanically coupled to the frame; and (d) An artificial valve coil, in non-radio communication with the cathode and the anode; and (ii) A non-implantable unit comprising: (a) An energy transfer coil; (b) At least two sensory skin electrocardiogram electrodes; and (c) A non-implantable control circuit, configured as follows: The cathode and the anode are driven to apply a pacing signal to the patient's heart. The at least two sensory skin electrocardiogram electrodes are used to detect at least one cardiac parameter, and In at least a partial response to at least one detected cardiac parameter, energy is wirelessly transmitted from the energy transmission coil to the artificial valve coil via inductive coupling, setting the parameters of the pacing signal. The non-implantable control circuitry is further configured to analyze the detected at least one cardiac parameter to assess the level of cardiac response to the pacing signal. The at least one cardiac parameter includes at least one timing feature; the parameters of the pacing signal include at least one timing parameter; and the non-implantable control circuitry is configured to set the at least one timing parameter of the pacing signal in response to the at least one timing feature of the detected at least one cardiac parameter. The artificial aortic valve described therein does not contain any active electronic components.

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

3. The valve prosthesis system according to claim 1, characterized in that: The corresponding non-electrically insulated ends of the artificial valve coil define the cathode and the anode.

4. The valve prosthesis system according to claim 1, characterized in that: 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 artificial valve coil.

5. The valve prosthesis system according to claim 1, characterized in that: The pacing signal includes multiple pulses, and the non-implantable control circuitry is configured to drive the cathode and the anode to begin applying each pulse of the pacing signal by starting to wirelessly transmit energy from the energy transmission coil to the artificial valve coil, and to end applying each pulse of the pacing signal by stopping the wireless transmission of energy from the energy transmission coil to the artificial valve coil.

6. The valve prosthesis system according to any one of claims 1 to 5, characterized in that: The non-implantable unit is an external unit configured to be placed outside the patient's body.

7. The valve prosthesis system according to any one of claims 1 to 5, characterized in that: The non-implantable unit is a delivery system, which further includes a delivery tube and one or more wires passing through the delivery tube; the energy transfer coil is a delivery system coil; 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 the delivery system coil is coupled to the delivery tube at a distal end of the delivery tube.

8. The valve prosthesis system according to claim 7, characterized in that: The delivery system control circuit is configured to drive the cathode and the anode to wirelessly transmit the energy from the energy transmission coil to the artificial valve coil via inductive coupling in order to apply rapid ventricular pacing.

9. The valve prosthesis system according to any one of claims 1 to 5, characterized in that: The non-implantable control circuit is configured to wirelessly transmit the energy by generating multiple AC pulses, each AC pulse comprising a series of AC pulse trains, and wherein the artificial aortic valve includes a passive diode electrically coupled to the artificial valve coil and configured to rectify the current in the artificial valve coil.

10. The valve prosthesis system according to claim 9, characterized in that: The non-implantable control circuit is configured to generate the series of AC pulses at a frequency between 3 kHz and 130 kHz.

11. The valve prosthesis system according to claim 9, characterized in that: The non-implantable control circuit is configured such that each of the plurality of AC pulses comprises a train of 20 to 100 AC pulses.

12. The valve prosthesis system according to claim 9, characterized in that: The artificial aortic valve includes a capacitor that is electrically connected to the cathode and anode.

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