CN117062584A - Prosthetic aortic valve pacing system - Google Patents
Prosthetic aortic valve pacing system Download PDFInfo
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- CN117062584A CN117062584A CN202280019121.3A CN202280019121A CN117062584A CN 117062584 A CN117062584 A CN 117062584A CN 202280019121 A CN202280019121 A CN 202280019121A CN 117062584 A CN117062584 A CN 117062584A
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Abstract
A prosthetic aortic valve (820) is provided that is configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath. The prosthetic aortic valve (820) comprises: a frame (30) comprising interconnecting stent struts (831) arranged so as to define an interconnecting stent unit (833); a plurality of prosthetic leaflets (32) coupled to the frame (30); a cathode (54) and an anode (57) mechanically coupled to the frame (30); and a prosthetic valve coil (836) in non-wireless electrical communication with the cathode (54) and the anode (57) and coupled to a plurality of stent struts (831) in extending fashion along the stent struts (831) so as to encircle a plurality of ones of the stent units (833) when the prosthetic aortic valve (820) is in an expanded fully deployed configuration after release from the delivery sheath. Other embodiments are also described.
Description
Cross Reference to Related Applications
The present application is a continuing application of U.S. application Ser. No. 17/328,588, filed 5/24/2021, which:
(i) Is a part continuation of U.S. application 16/868,121, now U.S. patent 11,013,597, filed 5/6/2020, which is a part continuation of U.S. application 16/734,798, now U.S. patent 10,835,750, which (a) is a part continuation of U.S. application 15/864,661, now U.S. patent 10,543,083, filed 8/2018, and (b) claims foreign priority to european application 19150581.7, filed 7/2019, which is published as EP 3 508,113 A1;
(ii) Is part of the continuation-in-part application of International application PCT/IL2021/050017 filed on 1/6/2021;
(iii) Is part of the continuation-in-part application of International application PCT/IL2021/050016 filed on 1/6/2021; and is also provided with
(iv) Is part of the continuation-in-part application of U.S. application Ser. No. 17/142,729, now U.S. patent No. 11,065,451, filed on 1/6 at 2021.
All of the above-referenced applications are assigned to the assignee of the present application and are incorporated herein by reference.
(European application 19150581.7 claims priority to foreign countries of U.S. application 17/142,729.)
The present application claims priority from U.S. application Ser. No. 17/328,588 filed on month 5 and 24 of 2021 and U.S. application Ser. No. 17/142,729 filed on month 1 and 6 of 2021.
Technical Field
The present application relates generally to surgical implants and systems, and in particular to prosthetic aortic valves and systems.
Background
Treatment of valve regurgitation or stenotic calcification of the leaflets may require aortic heart valve replacement. In percutaneous transluminal delivery techniques, the prosthetic aortic valve is compressed for delivery in a catheter and advanced through the descending aorta to the heart where the prosthetic valve is deployed in the aortic valve annulus. New heart conduction disorders are common after Transcatheter Aortic Valve Implantation (TAVI). The most common complication is Left Bundle Branch Block (LBBB).
U.S. Pat. No. 7,914,569 to Nguyen et al, which is incorporated herein by reference, describes a heart valve prosthesis having a self-expanding multi-stage frame that supports a valve body comprising a skirt and a plurality of engaging leaflets. The frame transitions between a contracted delivery configuration allowing percutaneous transluminal delivery and an expanded deployment configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are configured such that the center of the commissures can be selected to reduce the horizontal force applied to the valve commissures and effectively force along the valve She Fenbu and transfer the force to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.
Disclosure of Invention
Some embodiments of the present invention provide a valve prosthesis system comprising a prosthetic aortic valve configured to be implanted in a native aortic valve of a patient, and the prosthetic aortic valve comprising a plurality of prosthetic leaflets, a frame, and one or more electrodes mechanically coupled to the frame, the one or more electrodes comprising a cathode and an anode. The prosthetic aortic valve further includes a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode. Typically, the prosthetic aortic valve does not include any active electronic components.
In some applications, the valve prosthesis system further comprises a non-implantable unit comprising: an energy transmission coil; at least two sensing skin ECG electrodes; and a non-implantable control circuit. The non-implantable control circuit is configured to:
the cathodes and anodes are driven to apply pacing signals to the patient's heart,
detecting at least one cardiac parameter using at least two sensing skin ECG electrodes, and
in response, at least in part, to the detected at least one cardiac parameter, a parameter of the pacing signal is set by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
For some applications, the frame is shaped so as to define: an upstream inflow portion; a downstream outflow portion; and a constriction axially between the upstream inflow portion and the downstream outflow portion. The prosthetic leaflet is coupled to the narrowed portion.
For some applications, when the prosthetic aortic valve is in the expanded fully deployed configuration: the free edge of the prosthetic leaflet faces the downstream outflow portion, and the annular longitudinal boundary between the downstream outflow portion and the narrowed portion is defined by the downstream-most point of the frame to which the prosthetic leaflet is coupled. The prosthetic aortic valve further includes a prosthetic valve coil in non-wireless electrical communication with the one or more electrodes and axially coupled to the frame no more than 1mm upstream of the annular longitudinal boundary, such as along the downstream outflow portion.
In some embodiments of the present invention, a valve prosthesis system is provided that includes a prosthetic aortic valve and a non-implantable unit. The prosthetic aortic valve comprises: a plurality of prosthetic leaflets; a frame; a cathode and an anode mechanically coupled to the frame; and a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode. The non-implantable unit comprises: an energy transmission coil; and a non-implantable control circuit configured to drive the cathode and anode to apply a pacing signal and set parameters of the pacing signal by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
Some embodiments of the present invention provide a prosthetic aortic valve configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath. The prosthetic aortic valve comprises: a frame; a plurality of prosthetic leaflets coupled to the frame; a cathode and an anode mechanically coupled to the frame; and a prosthetic valve coil coupled to the frame and in non-wireless electrical communication with the cathode and the anode. When the prosthetic aortic valve is in the expanded fully deployed configuration after release from the delivery sheath, (a) a line defined between an upstream-most point and a downstream-most point of the mechanical coupling between the prosthetic valve coil and the frame, and (b) a central longitudinal axis defined by the frame form an angle between 20 degrees and 70 degrees, such as between 30 degrees and 60 degrees, for example between 40 degrees and 50 degrees, such as 45 degrees.
For some applications, a valve prosthesis system is provided that includes a prosthetic aortic valve and an external unit. The external unit is configured to be disposed outside the body of the patient and includes (a) an energy transmission coil and (b) an external unit control circuit configured to drive the energy transmission coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling when the prosthetic aortic valve is in an expanded fully deployed configuration.
For some of these applications, the energy transmission coil is configured to be positioned against the chest of the patient, typically over the sternum. This positioning of the energy transmission coil provides high transmission efficiency because the respective axes of the energy transmission coil and the prosthetic valve coil are generally aligned due to the angle formed between the prosthetic valve coil and the central longitudinal axis of the frame as described above. Such high transmission efficiency may allow the prosthetic valve coil and/or the energy transmission coil to include fewer turns of the coil and/or to have a smaller diameter. Alternatively or in addition, such high transmission efficiency may allow the external unit to use less power to induce the same amount of current in the prosthetic valve coil.
For other applications, the energy transfer coil is configured to be positioned around the neck of the patient. This positioning of the energy transmission coil provides high transmission efficiency because the respective axes of the energy transmission coil and the prosthetic valve coil are generally aligned due to the angle formed between the prosthetic valve coil and the central longitudinal axis of the frame as described above.
For some applications, when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) the most downstream point of mechanical coupling between the prosthetic valve coil and the frame and (b) the center of mass of the cathode are rotationally aligned with each other or rotationally offset from each other by less than 50 degrees, such as less than 30 degrees, about the central longitudinal axis of the frame. As a result of this rotational alignment, aligning the cathode adjacent to the heart tissue in the vicinity of the his bundle (generally posteriorly facing) automatically aligns the prosthetic valve coil generally in an opposite direction, facing generally anteriorly and superior toward the sternum. This orientation provides a good wireless coupling with the energy transfer coil.
In some applications of the invention, the frame of the prosthetic aortic valve comprises interconnecting stent struts arranged so as to define interconnecting stent units. The prosthetic valve coil is coupled to the plurality of stent struts in a manner extending along the stent struts so as to encircle a plurality of the stent units when the prosthetic aortic valve is in an expanded fully deployed configuration after release from the delivery sheath. The stent struts are shaped to allow for effective crimping (compression) of the frame when the frame is in a constrained delivery configuration within the delivery sheath. The coupling of the prosthetic valve coil to the stent struts in a manner that extends along the stent struts effectively curls the prosthetic valve coil together with the frame.
Thus, according to inventive concept 1 of the present invention, there is provided a method of assembling an electronic prosthetic aortic valve, the method comprising:
inserting an electronic component into the valve component, the electronic component comprising one or more electrodes and a prosthetic valve coil, and the valve component comprising a frame and a prosthetic leaflet coupled to the frame; and
the electronic component is coupled to the valve component.
Inventive concept 2. The method of inventive concept 1, wherein coupling the electronic component to the valve component comprises:
coupling a first portion of the electronic component to an inner surface of the frame; and
a second portion of the electronic component is coupled to an outer surface of the frame.
Inventive concept 3. According to the method of inventive concept 2,
wherein the first portion of the electronic component comprises a prosthetic valve coil and one of the one or more electrodes, an
Wherein the second portion of the electronic component comprises a cathode of the one or more electrodes.
Inventive concept 4. The method of inventive concept 3, wherein the electronic component further comprises a prosthetic aortic valve control circuit, and wherein the first portion of the electronic component comprises a prosthetic aortic valve control circuit.
Inventive concept 5. According to the method of inventive concept 4,
Wherein the electronic component further comprises an elongated insulated electrical conductor electrically coupling the cathode to the prosthetic aortic valve control circuit, and
wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component such that the conductors pass from the interior of the frame to the exterior.
Inventive concept 6. The method of inventive concept 5, wherein the valve component further comprises a skirt, and wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component such that the conductors pass from the interior of the frame to the exterior through the skirt.
Inventive concept 7. The method of any of inventive concepts 1-6, wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component.
Inventive concept 8. The method of inventive concept 7, wherein the valve component further comprises a skirt, and wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the skirt.
Inventive concept 9. The method according to any one of the inventive concepts 1 to 8,
wherein the frame is shaped so as to define: (1) an upstream inflow portion, (2) a downstream outflow portion, and (3) a constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein the prosthetic aortic valve is configured such that when in the expanded configuration: (A) The free edge of the prosthetic leaflet faces the downstream outflow portion, and (B) the annular longitudinal boundary between the downstream outflow portion and the narrowed portion is defined by the downstream-most point of the frame to which the prosthetic leaflet is coupled,
Wherein the prosthetic valve coil is in non-wireless electrical communication with the one or more electrodes, and wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component,
such that the prosthetic valve coil is coupled to the frame no more than 1mm upstream of the annular longitudinal boundary.
Inventive concept 10. The method of inventive concept 9, wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component such that the prosthetic valve coil is disposed axially along the downstream outflow portion.
Inventive concept 11. The method of inventive concept 9, wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component such that at least one of the one or more electrodes is coupled to the upstream inflow portion of the frame.
Inventive concept 12. According to the method of inventive concept 11,
wherein the prosthetic aortic valve is configured such that when the prosthetic aortic valve is in the expanded configuration, the frame has an inflow end at the upstream inflow portion and a downstream outflow end at the downstream outflow portion, and an axial length measured between the inflow end and the downstream outflow end, and
wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component 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 that is equal to 10% of the axial length of the frame.
There is also provided, in accordance with the inventive concept 13 of the present invention, a device including a prosthetic aortic valve, the device including:
(a) A plurality of prosthetic leaflets;
(b) A frame shaped so as to define:
(1) An upstream inflow portion of the housing,
(2) Downstream outflow portion, and
(3) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein when the prosthetic aortic valve is in the expanded fully deployed configuration: (A) The free edge of the prosthetic leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the narrowed portion is defined by a downstream-most point of the frame to which the prosthetic leaflet is coupled;
(c) One or more electrodes coupled to the frame; and
(d) A prosthetic valve coil in non-wireless electrical communication with the one or more electrodes and coupled to the frame no more than 1mm upstream of the annular longitudinal boundary.
Inventive concept 14. The device of inventive concept 13, wherein the prosthetic valve coil is disposed axially along the downstream outflow portion.
Inventive concept 15. The apparatus of inventive concept 13, wherein at least one of the one or more electrodes is coupled to an upstream inflow portion of the frame.
Inventive concept 16. The device according to inventive concept 15, wherein when the prosthetic aortic valve is in an expanded fully deployed configuration:
the frame has an inflow end at the upstream inflow portion and a downstream outflow end at the downstream outflow portion, and an axial length measured between the inflow end and the downstream outflow end, and
at least one of the one or more electrodes is coupled to the upstream inflow portion within a distance from the inflow end that is equal to 10% of the axial length of the frame.
Inventive concept 17. A valve prosthesis system comprising a prosthetic aortic valve according to inventive concept 13, the valve prosthesis system further comprising an external unit comprising:
an external unit coil; and
an external unit control circuit configured to drive the external unit coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling when the prosthetic aortic valve is in an expanded fully deployed configuration.
Inventive concept 18. The valve prosthesis system of inventive concept 17, wherein the external unit control circuit is configured to drive the one or more electrodes to apply the pacing signal.
Inventive concept 19. The valve prosthesis system of inventive concept 17, wherein the external unit comprises a collar configured to be worn around the neck of the patient, and the external unit coil is incorporated into the collar.
Inventive concept 20. A valve prosthesis system according to inventive concept 13,
wherein the prosthetic aortic valve further comprises a prosthetic aortic valve control circuit coupled to the frame and in non-wireless electrical communication with the one or more electrodes, and
wherein the prosthetic valve coil is in non-wireless electrical communication with the prosthetic aortic valve control circuit such that the prosthetic valve coil is in non-wireless electrical communication with the one or more electrodes via the prosthetic aortic valve control circuit.
Inventive concept 21. The valve prosthesis system of inventive concept 20, wherein the prosthetic aortic valve control circuit is configured to apply pacing.
Inventive concept 22. A valve prosthesis system according to the inventive concept 20,
wherein one or more of the electrodes comprises a cathode coupled to the upstream inflow portion of the frame, an
Wherein the prosthetic aortic valve control circuit is configured to drive the cathode to apply a cathodic current.
Inventive concept 23. The valve prosthesis system according to inventive concept 22, wherein the prosthetic aortic valve further comprises a skirt coupled to an outer surface of the upstream inflow portion of the frame, and wherein the cathode is disposed on the outer surface of the skirt.
Inventive concept 24. A valve prosthesis system according to the inventive concept 20,
wherein the prosthetic leaflet is coupled to the frame at least first and second commissures that are located at respective first and second angular positions about the frame that are separated about the frame by a first angular offset when the prosthetic aortic valve is in the expanded fully deployed configuration, and
wherein the prosthetic aortic valve control circuit is coupled to the frame at a third angular position about the frame that is separated from the first angular position by a second angular offset equal to between 40% and 60% of the first angular offset when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 25. The valve prosthesis system of inventive concept 20, wherein the prosthetic aortic valve control circuit is coupled to the frame inside the frame.
Inventive concept 26. The valve prosthesis system of inventive concept 20, wherein the prosthetic aortic valve control circuit is coupled to the frame.
Inventive concept 27. The valve prosthesis system of inventive concept 20, wherein the prosthetic aortic valve further comprises a skirt coupled to an outer surface of the upstream inflow portion of the frame, and wherein the prosthetic aortic valve control circuit is coupled to the skirt.
Inventive concept 28. The valve prosthesis system of inventive concept 20, wherein the prosthetic aortic valve control circuit is configured to (a) sense cardiac signals using one or more electrodes, and (b) drive the prosthetic valve coil to transmit wireless signals indicative of the sensed cardiac signals.
Inventive concept 29. The valve prosthesis system according to inventive concept 20, wherein the prosthetic aortic valve comprises an electronic implant comprising:
a prosthetic aortic valve control circuit; and
a multilayer protective coating comprising, in order, the following layers:
a first internal aluminum oxide (AlOx) film layer deposited over the circuit; and
a second parylene layer deposited on the first inner AlOx film layer,
wherein the prosthetic aortic valve control circuit is not enclosed in the housing.
There is also provided, in accordance with the inventive concept 30 of the present invention, an apparatus including an electronic implant, the apparatus including:
a circuit; and
a multilayer protective coating comprising, in order, the following layers:
a first internal aluminum oxide (AlOx) film layer deposited over the circuit; and
a second parylene layer deposited on the first inner AlOx film layer,
wherein the circuit is not enclosed in the housing.
Inventive concept 31. The apparatus of inventive concept 30, wherein the multi-layer protective coating further comprises a third layer disposed on the second parylene layer, the third layer having a thickness between 100 microns and 200 microns and configured to provide mechanical protection to the circuit.
Inventive concept 32. The device of inventive concept 31, wherein the third layer comprises a material selected from the group consisting of silicone and PTFE.
Inventive concept 33. The apparatus of inventive concept 31, wherein the third layer is cast onto the second parylene layer.
Inventive concept 34. The device of inventive concept 31, wherein the multi-layer protective coating further comprises a fourth outer parylene layer deposited on the third layer.
Inventive concept 35 the device of inventive concept 30, further comprising a prosthetic aortic valve comprising:
A frame;
a plurality of prosthetic leaflets coupled to the frame;
one or more electrodes coupled to the frame; and
a prosthetic valve coil coupled to the frame,
wherein the electronic implant is coupled to the frame and in non-wireless electrical communication with the one or more electrodes, and
wherein the prosthetic valve coil is in non-wireless electrical communication with the electrical circuit such that the prosthetic valve coil is in non-wireless electrical communication with the one or more electrodes via the electrical circuit.
There is also provided, in accordance with the inventive concept 36, a method of manufacturing an electronic implant, the method comprising:
depositing a first internal aluminum oxide (AlOx) film layer over the circuitry of the electronic implant; and depositing a second parylene layer over the first inner AlOx film layer to form a multi-layer protective coating with the first inner AlOx film layer,
wherein manufacturing the electronic implant does not include encapsulating the electrical circuit in a housing.
Inventive concept 37. The method according to inventive concept 36, further comprising: a third layer is disposed on the second parylene layer, the third layer having a thickness between 100 microns and 200 microns and configured to provide mechanical protection to the circuit.
Inventive concept 38. The method of inventive concept 37, wherein the third layer comprises a material selected from the group consisting of silicone and PTFE.
Inventive concept 39. The method of inventive concept 37, wherein disposing the third layer comprises: the third layer is cast onto the second parylene layer.
Inventive concept 40. The method according to inventive concept 37, further comprising: a fourth outer parylene layer is deposited over the third layer.
There is additionally provided, in accordance with the inventive concept 41 of the present invention, a device including a prosthetic aortic valve, the device including:
(a) A plurality of prosthetic leaflets;
(b) A frame shaped so as to define:
(1) An upstream inflow portion of the housing,
(2) Downstream outflow portion, and
(3) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein when the prosthetic aortic valve is in the expanded fully deployed configuration: (A) The free edge of the prosthetic leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the narrowed portion is defined by a downstream-most point of the frame to which the prosthetic leaflet is coupled;
(c) One or more electrodes coupled to the upstream inflow portion of the frame;
and
(d) A prosthetic valve coil in non-wireless electrical communication with the one or more electrodes.
Inventive concept 42. The device according to inventive concept 41, wherein when the prosthetic aortic valve is in an expanded fully deployed configuration:
the frame has an inflow end at the upstream inflow portion and a downstream outflow end at the downstream outflow portion, and an axial length measured between the inflow end and the downstream outflow end, and
at least one of the one or more electrodes is coupled to the upstream inflow portion within a distance from the inflow end that is equal to 10% of the axial length of the frame.
Inventive concept 43. According to the arrangement of inventive concept 41,
wherein the prosthetic aortic valve further comprises a prosthetic aortic valve control circuit coupled to the frame and in non-wireless electrical communication with the one or more electrodes, and
wherein the prosthetic valve coil is in non-wireless electrical communication with the prosthetic aortic valve control circuit such that the prosthetic valve coil is in non-wireless electrical communication with the one or more electrodes via the prosthetic aortic valve control circuit.
Inventive concept 44. The device according to inventive concept 43, wherein the prosthetic aortic valve control circuit is configured to apply pacing.
Inventive concept 45. According to the arrangement of inventive concept 43,
wherein one or more of the electrodes comprises a cathode coupled to the upstream inflow portion of the frame, an
Wherein the prosthetic aortic valve control circuit is configured to drive the cathode to apply a cathodic current.
Inventive concept 46. The device of inventive concept 45, wherein the prosthetic aortic valve further comprises a skirt coupled to an outer surface of the upstream inflow portion of the frame, and wherein the cathode is disposed on the outer surface of the skirt.
There is also provided, in accordance with the inventive concept 47 of the present invention, a method of assembling an electronic prosthetic aortic valve, the method comprising:
inserting an electronic component into the valve component, the electronic component comprising one or more electrodes and a prosthetic valve coil, and the valve component comprising a frame and a prosthetic leaflet coupled to the frame; to be used for
A kind of electronic device with high-pressure air-conditioning system
The electronic component is coupled to the valve component.
Inventive concept 48. The method according to inventive concept 47, wherein coupling the electronic component to the valve component comprises:
coupling a first portion of the electronic component to an inner surface of the frame; and
A second portion of the electronic component is coupled to an outer surface of the frame.
Inventive concept 49. According to the method of inventive concept 48,
wherein the first portion of the electronic component comprises a prosthetic valve coil and one of the one or more electrodes, an
Wherein the second portion of the electronic component comprises a cathode of the one or more electrodes.
Inventive concept 50. The method of inventive concept 49, wherein the electronic component further comprises a prosthetic aortic valve control circuit, and wherein the first portion of the electronic component comprises a prosthetic aortic valve control circuit.
Inventive concept 51. According to the method of inventive concept 50,
wherein the electronic component further comprises an elongated insulated electrical conductor electrically coupling the cathode to the prosthetic aortic valve control circuit, and
wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component,
so that the conductors pass from the inside of the frame to the outside.
Inventive concept 52. The method of inventive concept 51, wherein the valve component further comprises a skirt, and wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component such that the conductors pass from the interior of the frame to the exterior through the skirt.
Inventive concept 53. The method of inventive concept 47, wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the valve component.
Inventive concept 54. The method of inventive concept 47, wherein the valve component further comprises a skirt, and wherein coupling the electronic component to the valve component comprises: the electronic component is coupled to the skirt.
There is also provided, in accordance with the inventive concept 55 of the present invention, an apparatus including a valve prosthesis system, the apparatus including:
(a) A delivery system, the delivery system comprising:
a delivery tube;
a delivery system coil coupled to the delivery tube at a distal site of the delivery tube;
one or more wires, the one or more wires being passed along the delivery tube; and
a delivery system control circuit in electrical communication with the delivery system coil via one or more wires; and
(b) A prosthetic aortic valve, the prosthetic aortic valve comprising:
a frame;
a plurality of prosthetic leaflets coupled to the frame;
one or more electrodes coupled to the frame; and
a prosthetic valve coil coupled to the frame and in non-wireless electrical communication with the one or more electrodes,
Wherein the prosthetic aortic valve is (i) removably disposable in the delivery tube in a compressed delivery configuration, and (ii) configured to:
(A) Assuming a partially expanded, partially deployed configuration after being partially released from the distal end of the delivery tube such that (1) at least one of the one or more electrodes is positioned outside the delivery tube and (2) the prosthetic valve coil is compressed inside the delivery tube and
(B) Assumes an expanded fully deployed configuration upon full release from the distal end of the delivery tube, and
wherein the delivery system control circuit is configured to drive the delivery system coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling at least when the prosthetic aortic valve is in the partially deployed configuration.
Inventive concept 56. The device of inventive concept 55, the valve prosthesis system further comprises an external unit comprising:
an external unit coil; and
an external unit control circuit configured to drive the external unit coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling when the prosthetic aortic valve is in an expanded fully deployed configuration.
Inventive concept 57. The device according to inventive concept 56, wherein the external unit control circuit is configured to start driving the external unit coil to wirelessly transmit energy only after the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 58. The device of inventive concept 55, wherein the delivery system control circuit is configured to stop driving the delivery system coil to wirelessly transmit energy when the prosthetic aortic valve assumes an expanded fully deployed configuration after being fully released from the distal end of the delivery tube.
Inventive concept 59. According to the arrangement of inventive concept 55,
wherein the frame is shaped so as to define:
an upstream inflow portion of the housing,
downstream outflow portion, and
a constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction such that a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration, an
Wherein the prosthetic valve coil is disposed axially along the downstream outflow portion.
Inventive concept 60. The device of inventive concept 59, wherein the prosthetic valve coil is not disposed axially along the narrowed portion and is not disposed axially along the upstream inflow portion.
Inventive concept 61. The apparatus of inventive concept 59, wherein at least one electrode of the one or more electrodes is coupled to an upstream inflow portion of the frame.
Inventive concept 62. The device according to inventive concept 61, wherein when the prosthetic aortic valve is in an expanded fully deployed configuration:
the frame has an inflow end at the upstream inflow portion and a downstream outflow end at the downstream outflow portion, and an axial length measured between the inflow end and the downstream outflow end, and at least one of the one or more electrodes is coupled to the upstream inflow portion within a distance from the inflow end equal to 10% of the axial length of the frame.
Inventive concept 63. According to the arrangement of inventive concept 55,
wherein the prosthetic aortic valve further comprises a prosthetic aortic valve control circuit coupled to the frame and in non-wireless electrical communication with the one or more electrodes, and
wherein the prosthetic valve coil is in non-wireless electrical communication with the prosthetic aortic valve control circuit such that the prosthetic valve coil is in non-wireless electrical communication with the one or more electrodes via the prosthetic aortic valve control circuit.
Inventive concept 64. The device according to inventive concept 63,
wherein the frame is shaped so as to define:
an upstream inflow portion of the housing,
downstream outflow portion, and
A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction such that a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration,
wherein one or more of the electrodes comprises a cathode coupled to the upstream inflow portion of the frame, an
Wherein the prosthetic aortic valve control circuit is configured to drive the cathode to apply a cathodic current.
Inventive concept 65. The device of inventive concept 64, wherein the prosthetic aortic valve further comprises a skirt coupled to an outer surface of the upstream inflow portion of the frame, and wherein the cathode is disposed on the outer surface of the skirt.
Inventive concept 66. The device according to inventive concept 63,
wherein the prosthetic leaflet is coupled to the frame at least first and second commissures that are located at respective first and second angular positions about the frame that are separated about the frame by a first angular offset when the prosthetic aortic valve is in the expanded fully deployed configuration, and
Wherein the prosthetic aortic valve control circuit is coupled to the frame at a third angular position about the frame that is separated from the first angular position by a second angular offset equal to between 40% and 60% of the first angular offset when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 67. The device of inventive concept 63, wherein the prosthetic aortic valve control circuit is coupled to the frame inside the frame.
Inventive concept 68 the apparatus of inventive concept 63, wherein the prosthetic aortic valve control circuit is configured to (a) sense cardiac signals using one or more electrodes, and (b) drive the prosthetic valve coil to transmit wireless signals indicative of the sensed cardiac signals.
Inventive concept 69. The device of inventive concept 63, wherein the prosthetic aortic valve control circuit is configured to drive the one or more electrodes to apply rapid ventricular pacing.
Inventive concept 70. The apparatus of inventive concept 55, wherein the delivery system control circuit is configured to drive the one or more electrodes via the delivery system coil and the prosthetic valve coil to apply rapid ventricular pacing.
There is also provided, in accordance with the inventive concept 71 of the present invention, a method including:
advancing a delivery tube of a delivery system of a valve prosthesis system through a vasculature of a patient until a distal end of the delivery tube is disposed in an ascending aorta of the patient, while a prosthetic aortic valve of the valve prosthesis system is removably disposed in the delivery tube in a compressed delivery configuration, wherein the prosthetic aortic valve comprises: (a) a frame, (b) a plurality of prosthetic leaflets coupled to the frame, (c) one or more electrodes coupled to the frame, and (d) a prosthetic valve coil coupled to the frame and in non-wireless electrical communication with the one or more electrodes;
partially releasing the prosthetic aortic valve from the distal end of the delivery tube such that the prosthetic aortic valve assumes a partially expanded, partially deployed configuration in which (a) at least one of the one or more electrodes is positioned outside of the delivery tube, and (b) the prosthetic valve coil is compressed within the delivery tube;
then, activating the delivery system control circuit to drive the delivery system coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling at least when the prosthetic aortic valve is in the partially deployed configuration, wherein the delivery system coil is coupled to the delivery tube at a distal site of the delivery tube, and wherein the delivery system control circuit is in electrical communication with the delivery system coil via one or more wires passing along the delivery tube; and
The prosthetic aortic valve is then fully released from the distal end of the delivery tube such that the prosthetic aortic valve assumes an expanded fully deployed configuration.
Inventive concept 72. The method of inventive concept 71, further comprising: after the prosthetic aortic valve is fully released from the distal end of the delivery tube, an external unit control circuit of the external unit is activated to drive the external unit coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 73. The method according to inventive concept 71, wherein the delivery system control circuit is configured to stop driving the delivery system coil to wirelessly transmit energy when the prosthetic aortic valve assumes an expanded fully deployed configuration after being fully released from the distal end of the delivery tube.
Inventive concept 74. According to the method of inventive concept 71,
wherein the frame is shaped so as to define:
an upstream inflow portion of the housing,
downstream outflow portion, and
a constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction such that a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration, an
Wherein the prosthetic valve coil is disposed axially along the downstream outflow portion.
Inventive concept 75. The method according to inventive concept 74, wherein the prosthetic valve coil is not axially disposed along the constriction or upstream inflow portion.
Inventive concept 76. The method of inventive concept 74, wherein at least one electrode of the one or more electrodes is coupled to an upstream inflow portion of the frame.
Inventive concept 77. The method according to inventive concept 76, wherein when the prosthetic aortic valve is in an expanded fully deployed configuration:
the frame has an inflow end at the upstream inflow portion and a downstream outflow end at the downstream outflow portion, and an axial length measured between the inflow end and the downstream outflow end, and
at least one of the one or more electrodes is coupled to the upstream inflow portion within a distance from the inflow end that is equal to 10% of the axial length of the frame.
Inventive concept 78. According to the method of inventive concept 71,
wherein the prosthetic aortic valve further comprises a prosthetic aortic valve control circuit coupled to the frame and in non-wireless electrical communication with the one or more electrodes, and
Wherein the prosthetic valve coil is in non-wireless electrical communication with the prosthetic aortic valve control circuit such that the prosthetic valve coil is in non-wireless electrical communication with the one or more electrodes via the prosthetic aortic valve control circuit.
Inventive concept 79. According to the method of inventive concept 78,
wherein the frame is shaped so as to define:
an upstream inflow portion of the housing,
downstream outflow portion, and
a constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction such that a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration,
wherein one or more of the electrodes comprises a cathode coupled to the upstream inflow portion of the frame, an
Wherein the prosthetic aortic valve control circuit is configured to drive the cathode to apply a cathodic current. Inventive concept 80. According to the method of inventive concept 78,
wherein the prosthetic leaflet is coupled to the frame at least first and second commissures that are located at respective first and second angular positions about the frame that are separated about the frame by a first angular offset when the prosthetic aortic valve is in the expanded fully deployed configuration, and
Wherein the prosthetic aortic valve control circuit is coupled to the frame at a third angular position about the frame that is separated from the first angular position by a second angular offset equal to between 40% and 60% of the first angular offset when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 81. The method according to inventive concept 78, wherein the prosthetic aortic valve control circuit is coupled to the frame inside the frame.
Inventive concept 82. The method according to inventive concept 78, wherein the prosthetic aortic valve control circuit is configured to (a) sense cardiac signals using one or more electrodes, and (b) drive the prosthetic valve coil to transmit wireless signals indicative of the sensed cardiac signals.
Inventive concept 83. The method of inventive concept 78, wherein the prosthetic aortic valve control circuit is configured to drive one or more electrodes to apply rapid ventricular pacing.
Inventive concept 84. The method according to inventive concept 71, wherein activating the delivery system control circuit comprises: the delivery system control circuit is activated to drive one or more electrodes via the delivery system coil and the prosthetic valve coil to apply rapid ventricular pacing.
There is also provided, in accordance with the inventive concept 85 of the present invention, a valve prosthesis system comprising:
(i) A prosthetic aortic valve, the prosthetic aortic valve comprising:
(a) A plurality of prosthetic leaflets;
(b) A frame;
(c) A cathode and an anode mechanically coupled to the frame; and
(d) A prosthetic valve coil in non-wireless electrical communication with the cathode and the anode; and
(ii) A non-implantable unit, the non-implantable unit comprising:
(a) An energy transmission coil; and
(b) An implantable control circuit configured to drive the cathode and anode to apply a pacing signal and set parameters of the pacing signal by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
Inventive concept 86. The valve prosthesis system according to inventive concept 85, wherein the prosthetic aortic valve comprises one or more elongated insulated electrical conductors that directly couple the prosthetic valve coil in non-wireless electrical communication with the cathode and the anode.
Inventive concept 87. The valve prosthesis system according to inventive concept 85, wherein respective ends of the prosthetic valve coil are in non-wireless electrical communication with the cathode and the anode.
Inventive concept 88. The valve prosthesis system according to inventive concept 85, wherein the respective non-electrically insulated ends of the prosthetic valve coil define a cathode and an anode.
Inventive concept 89. The valve prosthesis system according to inventive concept 85, wherein the non-implantable control circuit is configured to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil.
The inventive concept 90. The valve prosthesis system according to the inventive concept 85, wherein the pacing signal comprises pulses, and wherein the non-implanted control circuitry is configured to drive the cathode and the anode to (a) start applying each pulse of the pacing signal by starting to transmit energy wirelessly from the energy transmission coil to the prosthetic valve coil, and (b) end applying each pulse of the pacing signal by stopping to transmit energy wirelessly from the energy transmission coil to the prosthetic valve coil.
Inventive concept 91. A valve prosthesis system according to inventive concept 85,
wherein the frame is shaped so as to define: (1) an upstream inflow portion, (2) a downstream outflow portion, and (3) a constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and
Wherein the cathode is mechanically coupled to the upstream inflow portion of the frame.
Inventive concept 92. The valve prosthesis system according to inventive concept 91, wherein the prosthetic valve coil is axially disposed along the downstream outflow portion of the frame.
Inventive concept 93. The valve prosthesis system according to inventive concept 85, wherein the cathode and the anode are arranged on the frame such that when the prosthetic aortic valve is in the expanded fully deployed configuration, there is at least 15mm between the cathode and the anode, the 15mm being measured along a central longitudinal axis of the frame when in the expanded fully deployed configuration.
Inventive concept 94. The valve prosthesis system according to inventive concept 85, wherein the non-implantable unit is an external unit configured to be disposed outside the body of the subject in which the prosthetic aortic valve is disposed.
Inventive concept 95. A valve prosthesis system according to inventive concept 85,
wherein the non-implantable unit is a delivery system further comprising a delivery tube and one or more wires passing along the delivery tube,
wherein the energy transfer coil is a delivery system coil,
wherein the non-implantable control circuit is a delivery system control circuit that is in electrical communication with the delivery system coil via one or more wires and
Wherein the delivery system coil is coupled to the delivery tube at a distal site of the delivery tube.
Inventive concept 96. The valve prosthesis system according to inventive concept 95, wherein the delivery system control circuit is configured to drive the cathode and the anode to apply rapid ventricular pacing by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
Inventive concept 97. A valve prosthesis system according to inventive concept 95,
wherein the prosthetic aortic valve is (i) removably disposable in the delivery tube in a compressed delivery configuration, and (ii) configured to:
(A) A partially expanded, partially deployed configuration after being partially released from the distal end of the delivery tube such that (1) at least the cathode is positioned outside the delivery tube and (2) the prosthetic valve coil is compressed inside the delivery tube and
(B) Assumes an expanded fully deployed configuration upon full release from the distal end of the delivery tube, and
wherein the delivery system control circuit is configured to drive the cathode and anode to apply a pacing signal and set parameters of the pacing signal by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil at least when the prosthetic aortic valve is in a partially deployed configuration.
Inventive concept 98. The valve prosthesis system of inventive concept 97, further comprising an external unit configured to be disposed outside the body of the subject in which the prosthetic aortic valve is disposed, and comprising:
an external unit coil; and
an external unit control circuit configured to drive the external unit coil to drive the cathode and anode to apply a pacing signal and set parameters of the pacing signal by wirelessly transmitting energy to the prosthetic valve coil by means of inductive coupling when the prosthetic aortic valve is in an expanded fully deployed configuration.
There is also provided, in accordance with inventive concept 99 of the present invention, a method including:
deploying a prosthetic aortic valve of a valve prosthesis system in an aortic valve annulus via a vasculature of a patient, the prosthetic aortic valve comprising: (a) a plurality of prosthetic leaflets, (b) a frame, (c) a cathode and an anode mechanically coupled to the frame, and (d) a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode; and
the non-implantable control circuit of the non-implantable unit of the valve prosthesis system is activated to drive the cathode and anode to apply the pacing signal and set parameters of the pacing signal by wirelessly transmitting energy from the energy transmission coil of the non-implantable unit to the prosthetic valve coil by means of inductive coupling.
Inventive concept 100. The method according to inventive concept 99, wherein the prosthetic aortic valve comprises one or more elongated insulated electrical conductors that directly couple the prosthetic valve coil in non-wireless electrical communication with the cathode and the anode.
Inventive concept 101. The method according to inventive concept 99, wherein respective ends of the prosthetic valve coil are in non-wireless electrical communication with the cathode and the anode.
Inventive concept 102. The method according to inventive concept 99, wherein the respective non-electrically insulated ends of the prosthetic valve coil define a cathode and an anode.
Inventive concept 103. The method of inventive concept 99, wherein activating the non-implantable control circuit to drive the cathode and anode to apply the pacing signal comprises: the non-implantable control circuit is activated to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil.
Inventive concept 104. The method of inventive concept 99, wherein the pacing signal comprises pulses, and wherein activating the non-implanted control circuit to drive the cathode and anode to apply the pacing signal comprises: activating the non-implantable control circuit to drive the cathode and anode (a) to begin applying each pulse of the pacing signal by beginning to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil, and (b) to end applying each pulse of the pacing signal by ceasing to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil.
Inventive concept 105. According to the method of inventive concept 99,
wherein the frame is shaped so as to define: (1) an upstream inflow portion, (2) a downstream outflow portion, and (3) a constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and
wherein the cathode is mechanically coupled to the upstream inflow portion of the frame.
Inventive concept 106. The method according to inventive concept 105, wherein the prosthetic valve coil is axially disposed along the downstream outflow portion of the frame.
Inventive concept 107. The method according to inventive concept 99, wherein the cathode and the anode are arranged on the frame such that when the prosthetic aortic valve is in the expanded fully deployed configuration, there is at least 15mm between the cathode and the anode, the 15mm being measured along a central longitudinal axis of the frame when in the expanded fully deployed configuration.
Inventive concept 108. The method according to inventive concept 99, wherein the non-implantable unit is an external unit, which is arranged outside the body of the subject in which the prosthetic aortic valve is arranged.
Inventive concept 109. According to the method of inventive concept 99,
wherein the non-implantable unit is a delivery system of the valve prosthesis system and the energy transmission coil is a delivery system coil coupled to a delivery tube of the delivery system at a distal site of the delivery tube,
Wherein the non-implantable control circuit is a delivery system control circuit in electrical communication with the delivery system coil via one or more wires routed along the delivery tube,
wherein deploying the prosthetic aortic valve comprises:
advancing the delivery tube through the vasculature until the distal end of the delivery tube is disposed in the ascending aorta of the patient, while the prosthetic aortic valve is removably disposed in the delivery tube in a compressed delivery configuration; and
partially releasing the prosthetic aortic valve from the distal end of the delivery tube such that the prosthetic aortic valve assumes a partially expanded, partially deployed configuration in which (a) at least the cathode is positioned outside of the delivery tube, and (b) the prosthetic valve coil is compressed within the delivery tube;
wherein activating the non-implantable control circuit comprises: after partial release of the prosthetic aortic valve from the distal end of the delivery tube, the delivery system control circuit is activated to drive the cathode and anode to apply and set parameters of the pacing signal by wirelessly transmitting energy from the delivery system coil to the prosthetic valve coil by means of inductive coupling at least when the prosthetic aortic valve is in the partially deployed configuration, and
Wherein deploying the prosthetic aortic valve further comprises: after activating the delivery system control circuit, the prosthetic aortic valve is fully released from the distal end of the delivery tube such that the prosthetic aortic valve assumes an expanded fully deployed configuration.
Inventive concept 110. The method of inventive concept 109, wherein activating the delivery system control circuit comprises: the delivery system control circuit is activated to drive the cathode and anode to apply rapid ventricular pacing by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling at least when the prosthetic aortic valve is in a partially deployed configuration.
Inventive concept 111 the method of inventive concept 109, further comprising: after the prosthetic aortic valve is fully released from the distal end of the delivery tube, an external unit control circuit of the external unit is activated to drive an external unit coil of the external unit to drive the cathode and anode to apply a pacing signal by wirelessly transmitting energy to the prosthetic valve coil by means of inductive coupling and to set parameters of the pacing signal when the prosthetic aortic valve is in the expanded fully deployed configuration, wherein the external unit is disposed outside the body of the subject in which the prosthetic aortic valve is disposed.
Inventive concept 112. The method of inventive concept 109, wherein the delivery system control circuit is configured to stop driving the delivery system coil to drive the cathode and anode when the prosthetic aortic valve assumes an expanded fully deployed configuration after being fully released from the distal end of the delivery tube.
Inventive concept 113. The method according to inventive concept 109, wherein partially releasing the prosthetic aortic valve from the distal end of the delivery tube comprises: the cathode is positioned adjacent to heart tissue in the vicinity of the his bundle.
Inventive concept 114. The method of inventive concept 113, wherein positioning the cathode adjacent to cardiac tissue in the vicinity of the his bundle comprises: the prosthetic aortic valve is rotated during deployment if necessary so that the cathode is placed against the heart tissue in the vicinity of the bundle of his.
There is additionally provided, in accordance with the inventive concept 115 of the present invention, a valve prosthesis system comprising:
(i) A prosthetic aortic valve configured to be implanted in a native aortic valve of a patient, and comprising:
(a) A plurality of prosthetic leaflets;
(b) A frame;
(c) A cathode and an anode mechanically coupled to the frame; and
(d) A prosthetic valve coil in non-wireless electrical communication with the cathode and the anode, wherein the prosthetic aortic valve does not include any active electronic components; and
(ii) A non-implantable unit, the non-implantable unit comprising:
(a) An energy transmission coil;
(b) At least two sensing skin ECG electrodes; and
(c) A non-implantable control circuit configured to:
the cathodes and anodes are driven to apply pacing signals to the patient's heart,
detecting at least one cardiac parameter using at least two sensing skin ECG electrodes, and
parameters of the pacing signal are set by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling at least partially in response to the detected at least one cardiac parameter.
There is also provided, in accordance with the inventive concept 116 of the present invention, a valve prosthesis system, comprising:
(i) A prosthetic aortic valve configured to be implanted in a native aortic valve of a patient, and comprising:
(a) A plurality of prosthetic leaflets;
(b) A frame;
(c) A cathode and an anode mechanically coupled to the frame; and
(d) A prosthetic valve coil in non-wireless electrical communication with the cathode and the anode, wherein the prosthetic aortic valve does not include any active electronic components; and
(ii) A non-implantable unit, the non-implantable unit comprising:
(a) An energy transmission coil;
(b) A heart sensor; and
(c) A non-implantable control circuit configured to:
the cathodes and anodes are driven to apply pacing signals to the patient's heart,
at least one cardiac parameter is detected using a cardiac sensor, and a parameter of the pacing signal is set by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling at least partially in response to the detected at least one cardiac parameter.
The valve prosthesis system of any one of the inventive concepts 115 and 116, wherein the non-implantable control circuit is configured to:
analyzing the detected at least one cardiac parameter to assess a level of response of the heart to the pacing signal, and
upon determining that the level of response is unsatisfactory, the intensity of the pacing signal is increased in response to the detected at least one cardiac parameter.
Inventive concept 118. The valve prosthesis system according to any one of the inventive concepts 115 and 116,
Wherein the at least one cardiac parameter comprises at least one timing characteristic,
wherein the parameter of the pacing signal comprises at least one timing parameter, an
Wherein 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 characteristic of the detected at least one cardiac parameter.
Inventive concept 119. The valve prosthesis system of any one of inventive concepts 115 and 116, wherein the prosthetic aortic valve comprises one or more elongated insulated electrical conductors that directly couple the prosthetic valve coil in non-wireless electrical communication with the cathode and the anode.
Inventive concept 120 the valve prosthesis system of any one of the inventive concepts 115 and 116, wherein the respective non-electrically insulated ends of the prosthetic valve coil define a cathode and an anode.
Inventive concept 121. The valve prosthesis system of any one of inventive concepts 115 and 116, wherein the non-implantable control circuit is configured to set the amplitude of the pacing signal by modulating the amplitude of energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil.
The valve prosthesis system of any one of the inventive concepts 115 and 116, wherein the pacing signal comprises pulses, and wherein the non-implantable control circuit is configured to drive the cathode and the anode to (a) begin applying each pulse of the pacing signal by beginning to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil, and (b) end applying each pulse of the pacing signal by ceasing to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil.
The valve prosthesis system of any one of the inventive concepts 115-122, wherein the non-implantable unit is an external unit configured to be disposed outside of a body of the patient.
Inventive concept 124. The valve prosthesis system of any one of inventive concepts 115-122, wherein the non-implantable unit is a delivery system, the delivery system further comprising a delivery tube and one or more wires passing along the delivery tube,
wherein the energy transfer coil is a delivery system coil,
wherein the non-implantable control circuit is a delivery system control circuit that is in electrical communication with the delivery system coil via one or more wires and
wherein the delivery system coil is coupled to the delivery tube at a distal site of the delivery tube.
Inventive concept 125. The valve prosthesis system of inventive concept 124, wherein the delivery system control circuit is configured to drive the cathode and the anode to apply rapid ventricular pacing by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
The valve prosthesis system of any one of the inventive concepts 126-122, wherein the non-implantable control circuit is configured to wirelessly transmit energy by generating a plurality of AC pulses, each AC pulse comprising an AC burst, and
Wherein the prosthetic aortic valve comprises a passive diode coupled in electrical communication with the prosthetic valve coil and configured to rectify current in the prosthetic valve coil.
Inventive concept 127. The valve prosthesis system of inventive concept 126, wherein the non-implanted control circuitry is configured to generate AC bursts at a frequency between 3kHz and 130kHz, such as between 3kHz and 100kHz or between 100kHz and 130 kHz.
Inventive concept 128 the valve prosthesis system of inventive concept 126, wherein the non-implantable control circuit is configured to include 20 to 100 AC bursts in each of the AC pulses.
There is also provided, in accordance with the inventive concept 129 of the present invention, a method including:
implanting a prosthetic aortic valve of a valve prosthesis system in an aortic valve annulus via a vasculature of a patient in a native aortic valve of the patient, the prosthetic aortic valve comprising: (a) a plurality of prosthetic leaflets, (b) a frame, (c) a cathode and an anode mechanically coupled to the frame, and (d) a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode, wherein the prosthetic aortic valve does not include any active electronic components; and
Activating a non-implantable control circuit of a non-implantable unit of the valve prosthesis system to drive the cathode and anode to apply pacing signals to the heart of the patient; detecting at least one cardiac parameter using a cardiac sensor; and setting a parameter of the pacing signal by wirelessly transmitting energy from the energy transmission coil of the non-implantable unit to the prosthetic valve coil by means of inductive coupling at least partially in response to the detected at least one cardiac parameter.
Inventive concept 130. The method of inventive concept 129, wherein activating the non-implantable control circuit comprises: activating the non-implantable control circuit to:
analyzing the detected at least one cardiac parameter to assess a level of response of the heart to the pacing signal, and
upon determining that the level of response is unsatisfactory, the intensity of the pacing signal is increased in response to the detected at least one cardiac parameter.
Inventive concept 131. According to the method of inventive concept 129,
wherein the at least one cardiac parameter comprises at least one timing characteristic,
wherein the parameter of the pacing signal comprises at least one timing parameter, an
Wherein activating the non-implantable control circuit comprises: the non-implantable control circuit is activated to set at least one timing parameter of the pacing signal in response to at least one timing characteristic of the detected at least one cardiac parameter.
Inventive concept 132. The method of inventive concept 129, wherein activating the non-implantable control circuit to drive the cathode and anode to apply the pacing signal comprises: the non-implantable control circuit is activated to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil.
Inventive concept 133. The method of inventive concept 129, wherein the pacing signal comprises pulses, and wherein activating the non-implanted control circuit to drive the cathode and anode to apply the pacing signal comprises: activating the non-implantable control circuit to drive the cathode and anode (a) to begin applying each pulse of the pacing signal by beginning to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil, and (b) to end applying each pulse of the pacing signal by ceasing to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil.
Inventive concept 134. The method according to inventive concept 129, wherein the non-implantable unit is an external unit, the external unit being arranged outside the body of the patient.
Inventive concept 135. According to the method of inventive concept 129,
wherein activating the non-implantable control circuit comprises: activating the non-implantable control circuit to wirelessly transmit energy by generating a plurality of AC pulses, each AC pulse comprising an AC burst, and
Wherein the prosthetic aortic valve comprises a passive diode coupled in electrical communication with the prosthetic valve coil and configured to rectify current in the prosthetic valve coil.
Inventive concept 136. The method according to inventive concept 135, wherein activating the non-implantable control circuit comprises: activating the non-implantable control circuit generates AC bursts at a frequency between 3kHz and 130kHz, such as between 3kHz and 100kHz or between 100kHz and 130 kHz.
Inventive concept 137. The method according to inventive concept 135, wherein activating the non-implantable control circuit comprises: the non-implanted control circuit is activated to include 20 to 100 AC bursts in each of the AC pulses.
There is also provided in accordance with the inventive concept 138 of the present invention, a valve prosthesis system comprising:
(i) A prosthetic aortic valve, the prosthetic aortic valve comprising:
(a) A plurality of prosthetic leaflets;
(b) A frame;
(c) A cathode and an anode mechanically coupled to the frame; and
(d) A prosthetic valve coil in non-wireless electrical communication with the cathode and the anode; and
(ii) A non-implantable unit, the non-implantable unit comprising:
(a) An energy transmission coil; and
(b) A non-implantable control circuit configured to drive the cathode and the anode to:
by applying a pacing signal comprising pulses and setting parameters of the pacing signal by wirelessly transmitting energy from an energy transmission coil to a prosthetic valve coil by means of inductive coupling,
each pulse of the pacing signal is initiated by initiating wireless transmission of energy from the energy transmission coil to the prosthetic valve coil and each pulse of the pacing signal is terminated by ceasing wireless transmission of energy from the energy transmission coil to the prosthetic valve coil.
Inventive concept 139. The valve prosthesis system of inventive concept 138, wherein the prosthetic aortic valve comprises one or more elongated insulated electrical conductors that directly couple the prosthetic valve coil in non-wireless electrical communication with the cathode and the anode.
Inventive concept 140. The valve prosthesis system according to inventive concept 138, wherein the respective ends of the prosthetic valve coil are in non-wireless electrical communication with the cathode and the anode.
Inventive concept 141. The valve prosthesis system according to inventive concept 138, wherein the respective non-electrically insulated ends of the prosthetic valve coil define a cathode and an anode.
Inventive concept 142. The valve prosthesis system of inventive concept 138, wherein the non-implantable control circuit is configured to set the amplitude of the pacing signal by modulating the amplitude of energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil.
Inventive concept 143 the valve prosthesis system according to inventive concept 138,
wherein the frame is shaped so as to define: (1) an upstream inflow portion, (2) a downstream outflow portion, and (3) a constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and
wherein the cathode is mechanically coupled to the upstream inflow portion of the frame.
Inventive concept 144. The valve prosthesis system according to inventive concept 143, wherein the prosthetic valve coil is axially disposed along the downstream outflow portion of the frame.
Inventive concept 145. The valve prosthesis system according to inventive concept 138, wherein the cathode and the anode are arranged on the frame such that when the prosthetic aortic valve is in the expanded fully deployed configuration, there is at least 15mm between the cathode and the anode, the 15mm being measured along a central longitudinal axis of the frame when in the expanded fully deployed configuration.
Inventive concept 146. The valve prosthesis system of any one of the inventive concepts 138-145, wherein the non-implantable unit is an external unit configured to be disposed outside a body of a subject in which the prosthetic aortic valve is disposed.
Inventive concept 147. The valve prosthesis system according to any of the inventive concepts 138 to 145,
wherein the non-implantable unit is a delivery system further comprising a delivery tube and one or more wires passing along the delivery tube,
wherein the energy transfer coil is a delivery system coil,
wherein the non-implantable control circuit is a delivery system control circuit that is in electrical communication with the delivery system coil via one or more wires and
wherein the delivery system coil is coupled to the delivery tube at a distal site of the delivery tube.
Inventive concept 148. The valve prosthesis system of inventive concept 147, wherein the delivery system control circuit is configured to drive the cathode and the anode to apply rapid ventricular pacing by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
Inventive concept 149. A valve prosthesis system according to inventive concept 147,
Wherein the prosthetic aortic valve is (i) removably disposable in the delivery tube in a compressed delivery configuration, and (ii) configured to:
(A) A partially expanded, partially deployed configuration after being partially released from the distal end of the delivery tube such that (1) at least the cathode is positioned outside the delivery tube and (2) the prosthetic valve coil is compressed inside the delivery tube and
(B) Assumes an expanded fully deployed configuration upon full release from the distal end of the delivery tube, and
wherein the delivery system control circuit is configured to drive the cathode and anode to apply a pacing signal and set parameters of the pacing signal by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil at least when the prosthetic aortic valve is in a partially deployed configuration.
The valve prosthesis system of claim 149, further comprising an external unit configured to be disposed outside a body of a subject in which the prosthetic aortic valve is disposed, and the external unit comprising:
an external unit coil; and
an external unit control circuit configured to drive the external unit coil to drive the cathode and anode to apply a pacing signal and set parameters of the pacing signal by wirelessly transmitting energy to the prosthetic valve coil by means of inductive coupling when the prosthetic aortic valve is in an expanded fully deployed configuration.
There is also provided in accordance with inventive concept 151 of the present invention, a prosthetic aortic valve configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath, and comprising:
a frame;
a plurality of prosthetic leaflets coupled to the frame;
a cathode and an anode mechanically coupled to the frame; and
a prosthetic valve coil coupled to the frame and in non-wireless electrical communication with the cathode and the anode,
wherein when the prosthetic aortic valve is in the expanded fully deployed configuration after release from the delivery sheath, (a) a line defined between an upstream-most point and a downstream-most point of the mechanical coupling between the prosthetic valve coil and the frame and (b) a central longitudinal axis defined by the frame form an angle of between 20 degrees and 70 degrees.
Inventive concept 152 the prosthetic aortic valve according to inventive concept 151, wherein the angle is between 30 degrees and 60 degrees.
Inventive concept 153. The prosthetic aortic valve according to inventive concept 151, wherein respective non-electrically insulated ends of the prosthetic valve coil define a cathode and an anode.
Inventive concept 154 the prosthetic aortic valve according to inventive concept 151, wherein the prosthetic aortic valve does not comprise any active electronic components.
Inventive concept 155. The prosthetic aortic valve according to inventive concept 151, wherein the central longitudinal axis passes through a space surrounded by a prosthetic valve coil when the prosthetic aortic valve is in an expanded fully deployed configuration.
Inventive concept 156. The prosthetic aortic valve according to inventive concept 151, wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a downstream-most point of mechanical coupling between the prosthetic valve coil and the frame and (b) a centroid of the cathode are rotationally aligned with each other or rotationally offset from each other by less than 50 degrees about the central longitudinal axis.
Inventive concept 157 the prosthetic aortic valve according to inventive concept 151, wherein the cathode is located upstream of the anode along the frame.
Inventive concept 158 the prosthetic aortic valve according to any one of inventive concepts 151-157, wherein the frame is shaped when the prosthetic aortic valve is in an expanded fully deployed configuration
To define:
(a) An upstream inflow portion of the housing,
(b) Downstream outflow portion, and
(c) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration, and
Wherein the cathode is coupled to the upstream inflow portion of the frame.
Inventive concept 159 the prosthetic aortic valve according to any one of inventive concepts 151-157, wherein the frame is shaped when the prosthetic aortic valve is in an expanded fully deployed configuration
To define:
(a) An upstream inflow portion of the housing,
(b) Downstream outflow portion, and
(c) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a free edge of the prosthetic leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the constriction is defined by a downstream-most point of a frame to which the prosthetic leaflet is coupled, and
wherein a downstream-most point of the mechanical coupling between the prosthetic valve coil and the frame is located on the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 160. The prosthetic aortic valve according to inventive concept 159, wherein an upstream-most point of the mechanical coupling between the prosthetic valve coil and the frame is located on the constriction when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 161. A valve prosthesis system comprising a prosthetic aortic valve according to any one of the inventive concepts 151 to 157, the valve prosthesis system further comprising an external unit configured to be disposed outside a body of a patient, and the external unit comprising:
an energy transmission coil; and
an external unit control circuit configured to drive the energy transmission coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling.
Inventive concept 162. The valve prosthesis system according to inventive concept 161, wherein the external unit control circuit is configured to drive the cathode and the anode to apply a pacing signal to the heart of the patient by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
Inventive concept 163. A valve prosthesis system according to inventive concept 162,
wherein the external unit further comprises a heart sensor, and
wherein the external unit control circuit is configured to:
detecting at least one cardiac parameter using a cardiac sensor, and
parameters of the pacing signal are set by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling at least partially in response to the detected at least one cardiac parameter.
Inventive concept 164. The valve prosthesis system of inventive concept 163, wherein the cardiac sensor comprises at least two sensing skin ECG electrodes.
Inventive concept 165. A valve prosthesis system according to inventive concept 161,
wherein the external unit control circuit is configured to wirelessly transmit energy by generating a plurality of AC pulses, each AC pulse comprising an AC burst, and
wherein the prosthetic aortic valve comprises a passive diode coupled in electrical communication with the prosthetic valve coil and configured to rectify current in the prosthetic valve coil.
Inventive concept 166. The valve prosthesis system of inventive concept 165, wherein the external unit control circuit is configured to generate the AC bursts at a frequency between 3kHz and 130 kHz.
Inventive concept 167. The valve prosthesis system of inventive concept 165, wherein the external unit control circuit is configured to include 20 to 100 AC bursts in each of the AC pulses.
There is also provided, in accordance with the inventive concept 168 of the present invention, a method including:
delivering a prosthetic aortic valve to a native aortic valve of a patient while in a constrained delivery configuration within a delivery sheath via a vasculature of the patient, the prosthetic aortic valve comprising: (a) a frame, (b) a plurality of prosthetic leaflets coupled to the frame, (c) a cathode and an anode mechanically coupled to the frame, and (d) a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode; and
Releasing the prosthetic aortic valve from the delivery sheath such that the prosthetic aortic valve transitions to an expanded fully deployed configuration in which (a) a line defined between an upstream-most point and a downstream-most point of the mechanical coupling between the prosthetic valve coil and the frame and (b) a central longitudinal axis defined by the frame form an angle of between 20 degrees and 70 degrees.
Inventive concept 169. The method according to inventive concept 168, wherein the angle is between 30 degrees and 60 degrees.
Inventive concept 170. The method according to inventive concept 168, wherein the prosthetic aortic valve does not comprise any active electronic components.
Inventive concept 172. The method according to inventive concept 168, wherein releasing the prosthetic aortic valve from the delivery sheath comprises: releasing the prosthetic aortic valve from the delivery sheath, such that the prosthetic aortic valve transitions to an expanded fully deployed configuration in which the central longitudinal axis passes through the space surrounded by the prosthetic valve coil.
Inventive concept 172. The method of inventive concept 168, further comprising: the prosthetic aortic valve is rotationally oriented such that the prosthetic valve coil faces generally anteriorly and superior toward the sternum of the patient.
Inventive concept 173. According to the method of inventive concept 172,
wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a downstream-most point of mechanical coupling between the prosthetic valve coil and the frame and (b) a centroid of the cathode are rotationally aligned with each other or rotationally offset from each other by less than 50 degrees about the central longitudinal axis, and
wherein rotationally orienting the prosthetic aortic valve comprises: the cathode is aligned adjacent to heart tissue adjacent to the patient's his bundle so as to automatically align the prosthetic valve coil generally anteriorly superior facing toward the patient's sternum.
Inventive concept 174. The method according to inventive concept 168, wherein releasing the prosthetic aortic valve from the delivery sheath comprises: the prosthetic aortic valve is released from the delivery sheath such that the prosthetic aortic valve transitions to an expanded fully deployed configuration with the cathode positioned upstream of the anode along the frame.
Inventive concept 175. According to the method of inventive concept 168,
wherein releasing the prosthetic aortic valve from the delivery sheath comprises: releasing the prosthetic aortic valve from the delivery sheath such that the prosthetic aortic valve transitions to an expanded fully deployed configuration where
In the fully expanded configuration of the sheet, the frame is shaped so as to define:
(a) An upstream inflow portion of the housing,
(b) Downstream outflow portion, and
(c) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration, and
wherein the cathode is coupled to the upstream inflow portion of the frame.
Inventive concept 176. According to the method of inventive concept 168,
wherein releasing the prosthetic aortic valve from the delivery sheath comprises: releasing the prosthetic aortic valve from the delivery sheath such that the prosthetic aortic valve transitions to an expanded fully deployed configuration where
In the fully expanded configuration of the sheet, the frame is shaped so as to define:
(a) An upstream inflow portion of the housing,
(b) Downstream outflow portion, and
(c) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a free edge of the prosthetic leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the constriction is defined by a downstream-most point of a frame to which the prosthetic leaflet is coupled, and
Wherein a downstream-most point of the mechanical coupling between the prosthetic valve coil and the frame is located on the downstream outflow portion.
Inventive concept 177. The method according to inventive concept 176, wherein an uppermost stream point of the mechanical coupling between the prosthetic valve coil and the frame is located on the constriction.
Inventive concept 178 the method of inventive concept 168, further comprising: an external unit control circuit of an external unit disposed outside the body of the patient is activated to drive an energy transmission coil of the external unit to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling.
The method according to inventive concept 179, further comprising: an energy transmission coil is positioned against the chest of the patient over the sternum of the patient.
Inventive concept 180. The method of inventive concept 178 further comprises: an energy transmission coil is positioned around the patient's neck.
Inventive concept 181. The method of inventive concept 178, wherein activating the external unit control circuit comprises: an external unit control circuit is activated to drive the cathode and anode to apply a pacing signal to the patient's heart by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
Inventive concept 182. The method according to inventive concept 181, wherein activating the external unit control circuit comprises: activating the external unit control circuit to:
detecting at least one cardiac parameter using a cardiac sensor, and
parameters of the pacing signal are set by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling at least partially in response to the detected at least one cardiac parameter.
Inventive concept 183. The method according to inventive concept 182, wherein the heart sensor comprises at least two sensing skin ECG electrodes placed on the skin of the patient.
Inventive concept 184. According to the method of inventive concept 178,
wherein activating the external unit control circuit comprises: activating an external unit control circuit to wirelessly transmit energy by generating a plurality of AC pulses, each AC pulse comprising an AC burst, and
wherein the prosthetic aortic valve comprises a passive diode coupled in electrical communication with the prosthetic valve coil and configured to rectify current in the prosthetic valve coil.
Inventive concept 185. The method according to inventive concept 184, wherein activating the external unit control circuit comprises: the external unit control circuit is activated to generate AC bursts at a frequency between 3kHz and 130 kHz.
Inventive concept 186. The method according to inventive concept 184, wherein activating the external unit control circuit comprises: the external unit control circuit is activated to include 20 to 100 AC bursts in each of the AC pulses.
There is also provided in accordance with the inventive concept 187 of the present invention, a prosthetic aortic valve configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath, and comprising:
a frame comprising interconnecting stent struts arranged so as to define interconnecting stent units;
a plurality of prosthetic leaflets coupled to the frame;
a cathode and an anode mechanically coupled to the frame; and
a prosthetic valve coil in non-wireless electrical communication with the cathode and anode and coupled to the plurality of stent struts in extending fashion along the stent struts so as to encircle a plurality of the stent units when the prosthetic aortic valve is in an expanded fully deployed configuration upon release from the delivery sheath.
Inventive concept 188. The prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil is shaped substantially as a diamond when the prosthetic aortic valve is in an expanded fully deployed configuration.
Inventive concept 189. The prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil is shaped such that there is no single line passing more than twice through the projection of the prosthetic valve coil onto the best fit plane when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 190. The prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil is not shaped so as to define any zigzags when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 191 the prosthetic aortic valve according to inventive concept 187, wherein a plurality of stent units of the stent units surrounded by the prosthetic valve coil comprises at least 4 stent units.
Inventive concept 192. The prosthetic aortic valve according to inventive concept 191, wherein a plurality of stent units of the stent units surrounded by the prosthetic valve coil comprises at least 9 stent units.
Inventive concept 193. The prosthetic aortic valve according to inventive concept 192, wherein a plurality of stent units of the stent units surrounded by the prosthetic valve coil comprises at least 16 stent units.
Inventive concept 194. The prosthetic aortic valve according to inventive concept 187, wherein a plurality of stent units of the stent units surrounded by the prosthetic valve coil comprises no more than 32 stent units.
Inventive concept 195. The prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil has a circumference of between 4cm and 8cm when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 196 the prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil is shaped so as to define 1 to 4 turns.
The prosthetic aortic valve according to inventive concept 197, wherein the prosthetic valve coil has a first dimension between 2cm and 4cm measured parallel to a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 198 the prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil has a second dimension between 1cm and 3cm measured about a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
The prosthetic aortic valve according to inventive concept 199, wherein the prosthetic valve coil has a first dimension between 2cm and 4cm and a second dimension between 1cm and 3cm when the prosthetic aortic valve is in the expanded fully deployed configuration, the first dimension measured parallel to a central longitudinal axis defined by the frame, and the second dimension measured about the central longitudinal axis.
Inventive concept 200. The prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil has a second dimension between 30 degrees and 180 degrees measured in degrees around the frame relative to a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 201 the prosthetic aortic valve according to inventive concept 200, wherein the second dimension is between 30 degrees and 150 degrees.
Inventive concept 202 the prosthetic aortic valve according to inventive concept 200, wherein the second dimension is between 90 degrees and 180 degrees.
Inventive concept 203 the prosthetic aortic valve according to inventive concept 202, wherein the second dimension is between 90 degrees and 150 degrees.
Inventive concept 204 the prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil encircles an area between 1cm2 and 4cm2 when the prosthetic aortic valve is in an expanded fully deployed configuration.
The prosthetic aortic valve according to inventive concept 187, wherein the prosthetic valve coil has a second dimension between 1cm and 3cm measured about a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 206 the prosthetic aortic valve according to inventive concept 187, wherein the stent struts comprise a shape memory alloy.
Inventive concept 207 the prosthetic aortic valve according to inventive concept 187, wherein the prosthetic aortic valve does not comprise any commissure posts.
Inventive concept 208. The prosthetic aortic valve according to inventive concept 187, wherein respective non-electrically insulated ends of the prosthetic valve coil define a cathode and an anode.
Inventive concept 209 the prosthetic aortic valve according to inventive concept 187, wherein the cathode is located upstream of the anode along the frame.
Inventive concept 210. A prosthetic aortic valve according to inventive concept 187,
wherein the frame is shaped to when the prosthetic aortic valve is in the expanded fully deployed configuration
So as to define:
(a) An upstream inflow portion of the housing,
(b) Downstream outflow portion, and
(c) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration, and
wherein the cathode is coupled to the upstream inflow portion of the frame.
Inventive concept 211 the prosthetic aortic valve according to any one of the inventive concepts 187-210, wherein the prosthetic aortic valve comprises only one prosthetic valve coil.
The prosthetic aortic valve according to any one of inventive concepts 187-210, wherein the prosthetic valve coil is a first prosthetic valve coil, the plurality of stent struts is a first plurality of stent struts, and the plurality of stent units in the stent unit is a first plurality of stent units in the stent unit,
wherein the prosthetic aortic valve further comprises a second prosthetic valve coil in non-wireless electrical communication with the cathode and the anode and coupled to the second plurality of stent struts in extending along the stent struts so as to encircle a second plurality of the stent units when the prosthetic aortic valve is in the expanded fully deployed configuration, an
Wherein the first plurality of rack units and the second plurality of rack units do not include any common rack unit.
Inventive concept 213 the prosthetic aortic valve according to inventive concept 212, wherein the first prosthetic valve coil and the second prosthetic valve coil comprise a single wire shaped so as to define both the first prosthetic valve coil and the second prosthetic valve coil.
The prosthetic aortic valve according to inventive concept 214, wherein respective centroids of the first prosthetic valve coil and the second prosthetic valve coil are offset from each other by at least 90 degrees about a central longitudinal axis defined by the frame when the prosthetic aortic valve is in an expanded fully deployed configuration.
Inventive concept 215 the prosthetic aortic valve according to inventive concept 214, wherein the respective centroids are offset from each other by 180 degrees about the central longitudinal axis when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 216 the prosthetic aortic valve according to any one of the inventive concepts 187-210, wherein the prosthetic aortic valve does not comprise any active electronic components.
The prosthetic aortic valve of any one of claims 187-210, wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a centroid of the prosthetic valve coil and the frame and (b) a centroid of the cathode are rotationally offset from each other by an angle of at least 150 degrees about a central longitudinal axis when the prosthetic aortic valve is in the expanded fully deployed configuration, the central longitudinal axis being defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
Inventive concept 218 the prosthetic aortic valve according to inventive concept 217, wherein the angle is at least 160 degrees.
Inventive concept 219. A valve prosthesis system comprising a prosthetic aortic valve according to any one of the inventive concepts 187 to 210, the valve prosthesis system further comprising an external unit configured to be disposed outside the body of the patient, and the external unit comprising:
an energy transmission coil; and
an external unit control circuit configured to drive the energy transmission coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling.
Inventive concept 220. The valve prosthesis system according to inventive concept 219, wherein the external unit control circuit is configured to drive the cathode and the anode to apply a pacing signal to the heart of the patient by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
Inventive concept 221. A valve prosthesis system according to inventive concept 220,
wherein the external unit further comprises a heart sensor, and
wherein the external unit control circuit is configured to:
detecting at least one cardiac parameter using a cardiac sensor, and
Parameters of the pacing signal are set by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling at least partially in response to the detected at least one cardiac parameter.
Inventive concept 222. The valve prosthesis system according to inventive concept 221, wherein the heart sensor comprises at least two sensing skin ECG electrodes.
Inventive concept 223. A valve prosthesis system according to inventive concept 219,
wherein the external unit control circuit is configured to wirelessly transmit energy by generating a plurality of AC pulses, each AC pulse comprising an AC burst, and
wherein the prosthetic aortic valve comprises a passive diode coupled in electrical communication with the prosthetic valve coil and configured to rectify current in the prosthetic valve coil.
Inventive concept 224. The valve prosthesis system according to inventive concept 223, wherein the external unit control circuit is configured to generate the AC burst at a frequency between 12MHz and 20 MHz.
Inventive concept 225 the valve prosthesis system according to inventive concept 223, wherein the external unit control circuit is configured to include 20 to 100 AC bursts in each of the AC pulses.
There is also provided, in accordance with the inventive concept 226 of the present invention, a method including:
delivering a prosthetic aortic valve to a native aortic valve of a patient while in a constrained delivery configuration within a delivery sheath via a vasculature of the patient, the prosthetic aortic valve comprising: (a) A frame comprising interconnecting stent struts arranged so as to define interconnecting stent units; (b) A plurality of prosthetic leaflets coupled to the frame; (c) A cathode and an anode mechanically coupled to the frame; and (d) a prosthetic valve coil in non-wireless electrical communication with the cathode and anode and coupled to the plurality of stent struts in a manner extending along the stent struts; and
releasing the prosthetic aortic valve from the delivery sheath such that the prosthetic aortic valve transitions to an expanded fully deployed configuration in which the prosthetic valve coil encircles a plurality of the stent units.
Inventive concept 227 the method of inventive concept 226, further comprising: the prosthetic aortic valve is rotationally oriented such that the prosthetic valve coil faces generally anteriorly and superior toward the sternum of the patient.
Inventive concept 228. According to the method of inventive concept 227,
when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a centroid of the prosthetic valve coil and (b) a centroid of the cathode are rotationally offset from each other by an angle of at least 150 degrees about a central longitudinal axis when the prosthetic aortic valve is in the expanded fully deployed configuration, the central longitudinal axis being defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration, and
wherein rotationally orienting the prosthetic aortic valve comprises: the cathode is aligned adjacent to heart tissue adjacent to the patient's his bundle so as to automatically align the prosthetic valve coil generally anteriorly superior facing toward the patient's sternum.
Inventive concept 229. The method of inventive concept 226 further comprises: an external unit control circuit of an external unit disposed outside the body of the patient is activated to drive an energy transmission coil of the external unit to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling.
Inventive concept 230. The method according to inventive concept 229, further comprising: an energy transmission coil is positioned against the chest of the patient over the sternum of the patient.
Inventive concept 231. The method according to inventive concept 229, further comprises: an energy transmission coil is positioned around the patient's neck.
Inventive concept 232. The method according to inventive concept 229, wherein activating the external unit control circuit comprises: an external unit control circuit is activated to drive the cathode and anode to apply a pacing signal to the patient's heart by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
The invention will be more fully understood from the following detailed description of embodiments of the invention, taken in conjunction with the accompanying drawings, in which:
drawings
FIGS. 1A and 1B are schematic illustrations of a prosthetic aortic valve in accordance with the application of the present invention;
FIG. 2 is a schematic illustration of the components of the prosthetic aortic valve of FIGS. 1A-1B prior to complete assembly in accordance with the application of the present invention;
FIG. 3A is a schematic illustration of another prosthetic aortic valve in accordance with the application of the present invention;
FIG. 3B is a schematic diagram of the passive electronic components and cardiac tissue of the prosthetic aortic valve of FIG. 3A in accordance with the application of the present invention;
fig. 4A-4C are schematic illustrations of a valve prosthesis system and a method of use of the system according to a corresponding application of the present invention;
FIG. 5 is a schematic view of an electronic implant according to an application of the present invention;
FIG. 6 is a schematic view of a prosthetic aortic valve in accordance with the application of the present invention;
FIG. 7 is a schematic view of the prosthetic aortic valve of FIG. 6 as viewed from the downstream outflow end of the prosthetic aortic valve in accordance with the application of the present invention;
FIG. 8 is a schematic illustration of the components of the prosthetic aortic valve of FIG. 6 prior to complete assembly in accordance with the application of the present invention;
FIG. 9 is a schematic view of another prosthetic aortic valve in accordance with the application of the present invention;
FIGS. 10A-10D are schematic illustrations of a valve prosthesis system and methods of use of the system according to respective applications of the present invention;
fig. 11 is a schematic diagram of an external control unit according to an application of the invention;
FIG. 12 is a schematic view of a patient showing exemplary locations of skin electrodes according to an application of the present invention;
13A-13B are schematic views of a shirt with integrated components according to the application of the invention;
FIG. 13C is a schematic illustration of a necklace in accordance with the application of the invention;
fig. 14A-14C are schematic illustrations of respective configurations of another prosthetic aortic valve according to respective applications of the present invention; and is also provided with
Fig. 15 is a schematic view of another valve prosthesis system upon deployment of the prosthetic aortic valve of fig. 14A-14B, in accordance with an application of the present invention.
Detailed Description
Fig. 1A and 1B are schematic illustrations of a prosthetic aortic valve 20 according to the application of the present invention. The prosthetic aortic valve 20 is shown in fig. 1A-1B in an expanded configuration similar to the expanded fully deployed configuration described below with reference to fig. 4C, except that the expansion of the prosthetic aortic valve 20 in fig. 1A-1B is not limited by the anatomy of the patient. Fig. 1B is a view of the prosthetic aortic valve 20 from the downstream outflow end 52, as described below.
The prosthetic aortic valve 20 comprises:
a frame 30;
a plurality of prosthetic leaflets 32 coupled to the frame 30;
one or more electrodes 34 coupled to the frame 30; and
a prosthetic valve coil 36, such as a lead, coupled to the frame 30 and optionally in non-wireless electrical communication with the one or more electrodes 34 through one or more elongated insulated electrical conductors 38.
The frame 30 typically includes a stent or other structure that is typically self-expanding and may be formed by laser cutting or etching a metal alloy tube containing, for example, stainless steel or a shape memory material such as nitinol. For some applications, one or more of the electrodes 34 are coupled to the frame 30 using techniques described in U.S. patent 9,526,637 to Dagan et al and/or U.S. patent 2016/0278951 to Dagan et al, both of which are incorporated herein by reference. For some applications, the prosthetic valve coil 36 includes gold wire to provide low resistance.
For some applications, the prosthetic aortic valve 20 further includes a prosthetic aortic valve control circuit 40 coupled to the frame 30 and in non-wireless electrical communication with the one or more electrodes 34. In these applications, the prosthetic valve coil 36 is in non-wireless electrical communication with the prosthetic aortic valve control circuit 40 such that the prosthetic valve coil 36 is in non-wireless electrical communication with the one or more electrodes 34 via the prosthetic aortic valve control circuit 40. One or more of the one or more electrodes 34 may be directly attached to the prosthetic aortic valve control circuit 40 in non-radio communication and/or may be attached to the prosthetic aortic valve control circuit 40 in non-radio communication by one or more elongated insulated electrical conductors 38. In general, the prosthetic aortic valve control circuit 40 is flexible and has a thin linear package and may implement the techniques described below with reference to fig. 5. The thinness of the control circuit 40 allows the control circuit to be compressed in the delivery tube during deployment of the prosthetic aortic valve 20 without the need to increase the diameter of the delivery tube. In addition, the flexibility of the control circuit 40 prevents damage to the control circuit in the event that the control circuit curls as it is compressed into the delivery tube.
For some applications, the frame 30 is shaped so as to define an upstream inflow portion 42, a downstream outflow portion 44, and a narrowed portion 46 axially between the upstream inflow portion 42 and the downstream outflow portion 44. The prosthetic leaflet 32 is coupled to the narrowed portion 46 such that a free edge 48 of the prosthetic leaflet 32 faces the downstream outflow portion 44 when the prosthetic aortic valve 20 is in the expanded fully deployed configuration described below with reference to fig. 4C. The prosthetic leaflet 32 is not coupled to the downstream outflow portion 44; thus, an annular longitudinal boundary 58 between the downstream outflow portion 44 and the narrowed portion 46 is defined by a downstream-most point of the frame 30 to which the prosthetic leaflet 32 is coupled (e.g., the prosthetic leaflet 32 may be coupled to the downstream-most point of the frame 30 at a commissure 60, as will be described below). Typically, the prosthetic aortic valve 20 further includes a skirt 49 coupled to the upstream inflow portion 42 of the frame 30 (the annular longitudinal boundary 58 is located at the same longitudinal position around the frame 30), and the prosthetic leaflets 32 are attached to the skirt 49 along their bases, for example, using sutures or a suitable biocompatible adhesive. The leaflets of the adjoining pair attach to each other at their lateral ends to form a commissure 60 such that the free edges 48 of the prosthetic leaflets form joined edges that meet each other. The skirt 49 and prosthetic leaflet 32 typically comprise a sheet of animal pericardial tissue, such as porcine pericardial tissue, or a sheet of synthetic or polymeric material.
For some applications, the prosthetic valve coil 36 is generally disposed axially along the downstream outflow portion 44 no more than 1mm upstream of the annular longitudinal boundary 58 between the downstream outflow portion 44 and the constriction 46. This placement allows the prosthetic aortic valve 20 to be crimped (compressed) into the delivery tube during deployment of the prosthetic aortic valve 20 without 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 include the material of the prosthetic leaflet 32 and thus can accommodate the prosthetic valve coil 36 without causing the downstream outflow portion 44 to have a larger compressed diameter than other axial portions of the prosthetic aortic valve 20. Typically, the prosthetic valve coil 36 is not disposed axially along the narrowed portion 46 nor along the upstream inflow portion 42. In addition, axially positioning the prosthetic valve coil 36 along the downstream outflow portion 44 increases the delivery efficiency because the downstream outflow portion 44 generally has a diameter that is greater than the diameter of each of the constriction 46 and the upstream inflow portion 42. In addition, narrowed portion 46 generally has a diameter that is smaller than the diameter of each of upstream inflow portion 42 and downstream outflow portion 44.
Typically, at least one of the one or more electrodes 34, such as only one of the one or more electrodes 34, is coupled to the upstream inflow portion 42 of the frame 30. 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 prosthetic aortic valve control circuit 40 is configured to drive the cathode 54 to apply a cathodic current. For some applications, the cathode 54 has a lateral dimension α (alpha) measured in degrees about the frame 30 between 10 degrees and 40 degrees (e.g., between 20 degrees and 40 degrees, such as 30 degrees) relative to the central longitudinal axis 55 of the frame 30 in order to accommodate rotational misalignment of the frame 30 relative to the his bundle. Typically, the prosthetic aortic valve 20 is deployed using imaging such as fluoroscopy, and is rotated during deployment if necessary so that the cathode 54 is disposed against the annulus tissue in the vicinity of the bundle of his. For some applications, the prosthetic aortic valve 20 includes a plurality of cathodes 54 (e.g., two or three or more) disposed at respective plurality of angular positions (e.g., 10 degrees to 15 degrees apart) about the frame 30. After implantation of the prosthetic aortic valve 20, the cathode 54 with the most accurate angular position is activated by the prosthetic aortic valve control circuit 40 or an external control circuit such as the external unit control circuit 104 described below with reference to fig. 4C to apply pacing signals and/or sensing. Alternatively or in addition, for some applications, the cathode 54 has an axial length of at least 10mm in order to accommodate axial misalignment of the frame 30 relative to the annulus of the native aortic valve and thus relative to the bundle of his. As used in the present application (including in the claims), an "axial length" is the length of the structure measured along the central longitudinal axis 55.
For some applications, the cathode 54 has a thickness of between 75 and 125 microns, for example about 100 microns, and/or a surface area of at least 2.5mm2, in order to provide adequate stimulation. For some applications, 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 the outer surface of the skirt 49. As used in the present application (including in the claims), the "central longitudinal axis" 55 of the frame 30 is the collection of cross-sectional profiles of the frame 30 along all centroids of the frame 30. Thus, the cross-sectional profile is locally perpendicular to a central longitudinal axis extending along the frame 30. (for applications where the cross-section of the frame 30 is circular, the centroid corresponds to the center of the circular cross-section profile.)
For some applications, when the prosthetic aortic valve 20 is in the expanded fully deployed configuration described below with reference to fig. 4C:
the frame 30 has an inflow end 50 at the upstream inflow portion 42 and a downstream outflow end 52 at the downstream outflow portion 44, and an axial length measured between the inflow end 50 and the downstream outflow end 52, and
at least one electrode (e.g., only one electrode, such as cathode 54) of the one or more electrodes 34 is coupled to the upstream inflow portion 42 within a distance from the inflow end 50 equal to 10% of the axial length of the frame 30 (the distance being measured (a) along the central longitudinal axis 55 of the frame 30 when the frame 30 is in the expanded fully deployed configuration, and (b) between the inflow end 50 and the most upstream point of the at least one electrode).
Typically, the prosthetic aortic valve control circuit 40 is coupled to the frame 30 such that an upstream-most point 56 of the prosthetic aortic valve control circuit 40 is axially disposed along the narrowed portion 46 and/or downstream outflow portion 44 of the frame 30.
Typically, the prosthetic aortic valve control circuit 40 is coupled to the frame 30 inside the frame 30, which may prevent friction between the prosthetic aortic valve control circuit 40 and the delivery tube 72 during deployment of the prosthetic aortic valve 20, as described below with reference to fig. 4A-4C. It is noted that for applications in which the most upstream point 56 is not more than 1mm upstream of the annular longitudinal boundary 58, such as described above, there is typically sufficient space within the frame 30 to accommodate the prosthetic aortic valve control circuit 40.
For some applications, the prosthetic leaflet 32 is coupled to the frame 30 at least a first commissure 60A and a second commissure 60B of the prosthetic aortic valve 20 that are located at respective first and second angular positions 62A, 62B about the frame 30. When the prosthetic aortic valve 20 is in the expanded fully deployed configuration described below with reference to fig. 4C, the first and second angular positions 62A, 62B are separated about the frame 30 by a first angular offset β (beta). When the prosthetic aortic valve 20 is in the expanded fully deployed configuration described below with reference to fig. 4C, the prosthetic aortic valve control circuit 40 is coupled to the frame 30 at a third angular position 62C about the frame 30 that is separated from the first angular position 62A by a second angular offset δ (delta) that is equal to between 40% and 60% (e.g., 50%) of the first angular offset β (beta). The frame 30 is more flexible at a third angular position 62C around the frame than at a more rigid commissure. As used in the present disclosure (including in the claims), an "angular position" is a position on the frame 30 at a particular location about the central longitudinal axis 55, i.e., at a particular "o' clock" with respect to the central longitudinal axis 55. (note that the third commissure 60C is shown in fig. 1A on the distal side of the frame, i.e., 180 degrees from the circuit 40).
Referring now to fig. 2, fig. 2 is a schematic illustration of the components of the prosthetic aortic valve 20 prior to complete assembly in accordance with the application of the present invention. These components include a valve component 64 and an electronic component 66. Valve component 64 is typically comprised of a heart valve prosthesis known in the art that includes at least frame 30 and prosthetic leaflets 32. For example, known heart valve prostheses may include CoreValve TM Evolut TM R prothesis(Medtronic,Inc.,Minneapolis,MN,USA)、CoreValve TM Evolut TM PRO prosthesis(Medtronic,Inc.)、LOTUS Edge TM Aortic Valve (Boston Scientific Corporation, marlborough, mass., USA) or ACURATE neo TM Aortic Valve (Boston Scientific Corporation). The electronics 66 include at least one or more electrodes 34 and prosthetic valve coil 36, and optionally the prosthetic aortic valve control circuit 40.
During assembly of the prosthetic aortic valve 20, the electronic component 66 is inserted into the valve component 64. For some applications, a first portion of the electronic component 66, such as one of the prosthetic valve coil 36, the prosthetic aortic valve control circuit 40, and the one or more electrodes 34, is coupled to an inner surface of the frame 30, and a second portion of the electronic component 66, such as the cathode 54, is coupled to an outer surface of the frame 30. For example, one elongate insulated electrical conductor 38A of the one or more elongate insulated electrical conductors 38 may electrically couple the cathode 54 to the prosthetic aortic valve control circuit 40, and the conductor 38A may pass from the interior to the exterior of the frame 30, typically through the skirt 49. Alternatively, components of the electronic component 66 may be coupled to the frame 30 and/or the skirt 49.
For some applications, whether the prosthetic valve coil 36 is coupled to the inner surface or the outer surface of the frame 30, the prosthetic valve coil 36 is electrically isolated from the frame 30, such as by an isolating material (e.g., a sheet of material or a coating) disposed between the prosthetic valve coil 36 and the frame 30. For example, the isolating material may comprise a non-conductive polymer.
The above-described assembly of the prosthetic aortic valve 20 is typically performed in a manufacturing facility, after which the assembled prosthetic aortic valve 20 is packaged and transported to a medical facility for implantation. Thus, the method of assembling the prosthetic aortic valve 20 is non-surgical.
Fig. 3A is a schematic illustration of a prosthetic aortic valve 120 in accordance with the application of the present invention. The prosthetic aortic valve 120 is shown in fig. 3A in an expanded configuration similar to the expanded fully deployed configuration of the prosthetic aortic valve 20 described below with reference to fig. 4C, except that the expansion of the prosthetic aortic valve 120 in fig. 3A is not limited by the anatomy of the patient. The prosthetic aortic valve 120 is identical to the prosthetic aortic valve 20 described herein with reference to fig. 1A-1B and 2, except as described below, and like reference numerals refer to like components. The prosthetic aortic valve 120 can be assembled as described above with respect to the prosthetic aortic valve 20 with the necessary modifications, as described above with reference to fig. 2.
Referring also to fig. 3B, fig. 3B is a schematic diagram of passive electronic components of a prosthetic aortic valve 120 and tissue 122 in accordance with an application of the present invention. Tissue 122 includes cardiac tissue and blood. Cathode 54 is configured to contact heart tissue and anode 57 is configured to contact blood. As is known in the art, cardiac tissue acts as a resistor.
For some applications, the prosthetic aortic valve 120 includes a passive diode 124 (shown highly schematically in the upper exploded view of fig. 3A and in fig. 3B) coupled in electrical communication with the prosthetic valve coil 36 and rectifying current in the prosthetic valve coil. For example, the diode 124 may be positioned at one end of the coil, or positioned adjacent to the cathode 54 or anode 57, or (as shown in fig. 3A) at some point along the prosthetic valve coil 36. The non-implantable control circuit, such as the delivery system control circuit 80 (fig. 4B) or the external unit control circuit 104 (fig. 4C), typically transmits energy wirelessly to the prosthetic valve coil 36 by generating a plurality of AC pulses, each AC pulse comprising a burst of AC. The AC bursts may be generated, for example, at a frequency between 3kHz and 130kHz (e.g., between 3kHz and 100kHz, or between 100kHz and 130 kHz) or between 12MHz and 20MHz (such as between 13MHz and 20MHz, e.g., 13.56 MHz) to increase efficiency. For some applications, there are 20 to 100 AC bursts in each of the AC pulses. Other frequencies and numbers of bursts are within the scope of the invention. For some applications, the non-implantable control circuit, such as the delivery system control circuit 80 (fig. 4B) or the external unit control circuit 104 (fig. 4C), is configured to wirelessly transmit between 5V and 10V of energy generated in the prosthetic valve coil 36 to the prosthetic valve coil 36.
For some applications, the prosthetic aortic valve 120 includes only one passive diode 124 that provides half-wave rectification of the AC pulse. For other applications, the prosthetic aortic valve 120 includes a plurality of passive diodes 124 that provide full wave rectification of the AC pulses; for example, the prosthetic aortic valve 120 may include four passive diodes 124 arranged in a bridge configuration, as is known in the electronics arts.
For some applications, the prosthetic aortic valve 120 includes a capacitor 126 (shown in exploded view on the right side of fig. 3A and highly schematically in fig. 3B) in electrical communication with the cathode 54 and anode 57 (parallel to the heart tissue 122 in the circuit formed when the electrodes are implanted). The capacitor 126 generally improves the efficiency of the circuit by delivering a greater proportion of the received energy into the tissue 122. (as is known in the electronics arts, capacitors are passive electronic components.)
Optionally, the prosthetic aortic valve 120 includes additional passive electronic components, such as one or more resistors.
As described below with respect to the prosthetic aortic valve 20 with reference to fig. 4B, 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, the prosthetic aortic valve control circuit 40 (if actually provided) is typically passive, i.e., the delivery system control circuit 80 sets the parameters of the pacing signal. The prosthetic aortic valve 120 shown in fig. 3A is one implementation of this configuration; unlike the configuration of the prosthetic aortic valve 20 shown in fig. 1A-1B and 2, the prosthetic aortic valve 120 does not include the prosthetic aortic valve control circuit 40 or any other active electronic components.
A valve prosthesis system is provided that includes (a) a prosthetic aortic valve 120 and (b) a non-implantable unit, such as the delivery system 70 described below with reference to fig. 4A-4C, or the external unit 100 described below with reference to fig. 4C. The non-implanted control circuitry (such as delivery system control circuitry 80 or external unit control circuitry 104 of external unit 100, as the case may be) is configured to drive cathode 54 and anode 57 to apply the pacing signal and set parameters of the pacing signal (e.g., set to a standard chronic pacing signal or a rapid ventricular pacing signal) by wirelessly transmitting energy from an energy transmission coil (such as delivery system coil 74 or external unit coil 102, as the case may be, as described below with reference to fig. 4C) to prosthetic valve coil 36 by means of inductive coupling. The pacing applied is typically bipolar.
For some applications, the wireless transmission of energy by means of inductive coupling described herein utilizes resonant inductive wireless energy transmission as is known in the art.
Optionally, the valve prosthesis system comprises the following two non-implantable units: (1) The delivery system 70 described below with reference to fig. 4A-4C and (2) the external unit 100 described below with reference to fig. 4C, the delivery system and the external unit including corresponding control circuitry and energy transmission coils. The delivery system control circuit 80 is configured to drive the delivery system coil 74 to drive the cathode 54 and anode 57 to apply a pacing signal and set parameters of the pacing signal by wirelessly transmitting energy to the prosthetic valve coil 36 by means of inductive coupling when the prosthetic aortic valve 120 is in a partially deployed configuration, such as described below with reference to fig. 4B. The external unit control circuit 104 is configured to drive the external unit coil 102, described below with reference to fig. 4C, to drive the cathode 54 and anode 57 to apply a pacing signal by wirelessly transmitting energy to the prosthetic valve coil 36 by means of inductive coupling and to set parameters of the pacing signal when the prosthetic aortic valve 120 is in an expanded fully deployed configuration, such as described below with reference to fig. 4C.
Typically, the respective ends of the prosthetic valve coil 36 are in non-wireless electrical communication with the cathode 54 and the anode 57.
For some applications, the respective non-electrically-insulating end portions of the prosthetic valve coil 36 define a cathode 54 and an anode 57. In these applications, the prosthetic aortic valve 120 typically does not include the elongate insulated electrical conductor 38. Instead, the respective insulated end portions of the prosthetic valve coil 36 are bent away from the prosthetic valve coil 36 along the path of the elongate insulated electrical conductor 38 shown in fig. 3A such that the respective non-electrically insulated end portions of the prosthetic valve coil 36 are located at the locations of the cathode 54 and anode 57, respectively, shown in fig. 3A.
As described above, the non-implanted control circuitry is configured to drive cathode 54 and anode 57 to set parameters of the pacing signal. For example, the non-implantable control circuit may be configured to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil 36. Alternatively or in addition, for example, the non-implantable control circuit may be configured to drive the cathode 54 and anode 57 to (a) begin applying each pulse of the pacing signal by beginning to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil 36, and (b) end applying each pulse of the pacing signal by ceasing to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil 36.
The inventors have determined that in some configurations, it is difficult to evaluate suitable pacing parameters, for example, due to patient size or patient weight distribution, or for example, due to technical issues such as variable impedance between the heart tissue and the cathode 54 and anode 57, or variable relative orientations of the external unit coil 102 and the prosthetic valve coil 36. Thus, for some applications, the non-implantable unit includes an energy transfer coil (e.g., external unit coil 102, as shown in fig. 4C) and at least two sensing skin ECG electrodes 106 placed on the patient's skin 108 (e.g., on the chest, as shown in fig. 4C). A non-implantable control circuit (e.g., external unit control circuit 104) drives cathode 54 and anode 57 to apply pacing signals to the patient's heart and to detect at least one cardiac parameter using sensing skin ECG electrodes 106. In response, at least in part, to the detected cardiac parameter, the non-implantable control circuit sets a parameter of the pacing signal by wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil 36 via inductive coupling. Because the prosthetic aortic valve 120 generally does not include any active electronic components, wireless transmission of energy from the energy transmission coil to the prosthetic valve coil 36 by means of inductive coupling itself inductively drives pacing current through the prosthetic valve coil 36.
Alternatively, the non-implantable unit includes another type of cardiac sensor, rather than sensing the skin ECG electrodes 106. For example, the heart 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 Si1172 or Si1173 biometric module manufactured by Silicon Laboratories inc., austin, TX, USA).
The non-implanted control circuitry typically analyzes the detected cardiac parameter to assess the level of response of the heart to the pacing signal. Upon determining that the level of response is not satisfactory, the non-implantable control circuit increases the strength of the pacing signal in response to the detected cardiac parameter (e.g., by increasing the amplitude or duration of the pacing signal). For example, the pulse width of the pulses of the pacing signal (typically 0.1ms to 1ms, e.g., 0.25ms to 0.8 ms) or the current amplitude in the energy transfer coil may be iteratively increased until it is determined that the heart is properly responsive to the pacing pulse applied to the tissue. At this point, optionally, the intensity of the pacing signal is further increased, for example by 50% to 150%, for example by 100%.
For some applications, the detected cardiac parameter is a timing characteristic of cardiac activity (e.g., the heart rate, or the timing of a particular characteristic of the cardiac cycle). In this case, the parameter of the pacing signal may include a timing parameter of the pacing signal, and the non-implanted control circuitry sets the timing parameter of the pacing signal in response to a timing characteristic of the detected cardiac parameter.
It is noted that, as appropriate for a given patient, pacing of the heart may be applied in synchrony with the patient's cardiac cycle (based on signals received by the sensing skin ECG electrodes 106), or pacing may not be synchronized with the patient's cardiac cycle.
The sensing skin ECG electrodes 106 are typically either adsorbed ECG electrodes or are configured to be electrically coupled to the skin by an adhesive. Generally, conventional ECG electrodes are suitable for sensing skin ECG electrodes 106. It is noted that although conventional ECG electrodes may be used, a complete ECG analysis as known in the art of electrocardiography is typically not performed in order to achieve the functionality of the non-implantable control circuit described above.
With reference to fig. 1A-1B, 2 and 3A, and with additional reference to fig. 4A-4C, fig. 4A-4C are schematic illustrations of a valve prosthesis system 68 and methods of use of the system according to respective applications of the present invention. Although the techniques described with reference to fig. 4A-4C are generally described with respect to the prosthetic aortic valve 120, these techniques are equally applicable to the prosthetic aortic valve 20, mutatis mutandis. The rotational orientation of the prosthetic aortic valve is schematically illustrated in fig. 4A-4C to illustrate the components of the prosthetic aortic valve; as described below, in actual use, the prosthetic aortic valve is generally rotationally oriented such that the cathode 54 is positioned adjacent to heart tissue adjacent to the bundle of his.
The valve prosthesis system 68 includes the prosthetic aortic valve 20 or prosthetic aortic valve 120 and the delivery system 70.
The delivery system 70 includes:
delivery tube 72;
a delivery system coil 74 coupled to the delivery tube 72 at a distal site 76 of the delivery tube 72; for example, the distal-most portion 77 of the delivery system coil 74 may be disposed within 10mm of the distal end 82 of the delivery tube 72;
one or more wires 78 that pass along the delivery tube 72, for example attached to an outer or inner surface of the delivery tube 72, or embedded in a wall of the delivery tube 72; and
delivery system control circuitry 80 in electrical communication with the delivery system coil 74 via one or more wires 78.
The delivery system control circuit 80 is configured to drive the delivery system coil 74 to wirelessly transmit energy to the prosthetic valve coil 36 by means of inductive coupling at least when the prosthetic aortic valve 120 is in a partially deployed configuration as described below with reference to fig. 4B.
As shown in fig. 4A, the prosthetic aortic valve 120 can be removably disposed in the delivery tube 72 in a compressed delivery configuration. During the implantation procedure, the delivery tube 72 is advanced through the vasculature of the patient until the distal end 82 of the delivery tube 72 is disposed in the ascending aorta 84 of the patient, while the prosthetic aortic valve 120 is removably disposed in the delivery tube 72 in a compressed delivery configuration.
As shown in fig. 4B, the prosthetic aortic valve 120 is further configured to assume a partially expanded, partially deployed configuration after being partially released from the distal end 82 of the delivery tube 72 such that (a) at least one electrode of the one or more electrodes 34, such as the cathode 54, is positioned outside the delivery tube 72, adjacent to (e.g., in contact with) a target tissue, such as a native aortic valve annulus, and (B) the prosthetic valve coil 36 is compressed within the delivery tube 72. In general, the delivery system coil 74 surrounds the compressed prosthetic valve coil 36, which provides high transmission efficiency even though the prosthetic valve coil 36 is still compressed. After the prosthetic aortic valve 120 has assumed the partially expanded, partially deployed configuration, the delivery system control circuit 80 is activated to drive the delivery system coil 74 to wirelessly transmit energy to the prosthetic valve coil 36 by means of inductive coupling. In contrast, the transfer of power from the external coil to the compressed prosthetic valve coil 36 would be very inefficient due to the large distance between the transmit coil and the receive coil and the compression of the prosthetic valve coil 36.
For some applications in which the valve prosthesis system 68 includes the prosthetic aortic valve 20 described above with reference to fig. 1A-1B and 2, the prosthetic aortic valve control circuit 40 is configured to drive the one or more electrodes 34 to apply rapid ventricular pacing. Such pacing may temporarily reduce left ventricular output to enable more accurate placement of the prosthetic aortic valve 20. Alternatively, such as described above with reference to fig. 3A, delivery system control circuitry 80 is configured to drive one or more electrodes 34 to apply rapid ventricular pacing; in this configuration, the prosthetic aortic valve control circuit 40 (if actually provided (as in the prosthetic aortic valve 20)) is typically passive or no prosthetic aortic valve control circuit 40 (as in the prosthetic aortic valve 120) is provided, i.e., the delivery system control circuit 80 sets the parameters of the pacing signal. Alternatively, the prosthetic aortic valve 20 or 120 is not used to administer rapid ventricular pacing, but may be used to apply post-implant pacing, such as described below, and/or for post-implant sensing, such as described below.
As described above with reference to fig. 1A-1B, for some applications, one or more electrodes 34 include a cathode 54 coupled to the upstream inflow portion 42 of the frame 30. When the prosthetic aortic valve 120 is in the partially expanded, partially deployed configuration shown in fig. 4B, the cathode 54 is positioned adjacent to the heart tissue near the bundle of his so as to pace the heart by stimulating the heart tissue with a cathodic current. For some applications, one or more of the electrodes also include an anode 57, which may be used for bipolar sensing and/or pacing, as is known in the art. Typically, the cathode 54 and the anode 57 are disposed on the frame 30 such that there is at least 15mm between the cathode and the anode when the prosthetic aortic valve 120 is in the expanded fully deployed configuration described below with reference to fig. 4C (the 15mm being measured along the central longitudinal axis 55 of the frame 30 when in the expanded fully deployed configuration).
As shown in fig. 4C, the prosthetic aortic valve 120 is also configured to assume an expanded fully deployed configuration upon full release from the distal end 82 of the delivery tube 72. For some applications, the delivery system control circuit 80 is configured to stop driving the delivery system coil 74 wirelessly to transmit energy when the prosthetic aortic valve 120 assumes an expanded fully deployed configuration after being fully released from the distal end 82 of the delivery tube 72.
For some applications, as shown in fig. 4C, the valve prosthesis system 68 further comprises an external unit 100 comprising (a) an external unit coil 102 and (b) an external unit control circuit 104 configured to drive the external unit coil 102 to wirelessly transmit energy to the prosthetic valve coil 36 by means of inductive coupling when the prosthetic aortic valve 120 is in the expanded fully deployed configuration. In these applications, after the prosthetic aortic valve 120 is fully released from the distal end 82 of the delivery tube 72, the external unit control circuit 104 is activated to drive the external unit coil 102 to wirelessly transmit energy to the prosthetic valve coil 36 by means of inductive coupling when the prosthetic aortic valve 120 is in the expanded fully deployed configuration.
For some applications, the external unit coil 102 is incorporated into a collar configured to be worn around the neck of a patient or placed on the chest of a patient, such as described in PCT publication WO 2016/157183 to Dagan et al, which disclosure is incorporated herein by reference, and/or into a strap configured to be worn around the chest of a patient or a necklace configured to be worn around the neck of a patient. This positioning of the outer unit coil 102 provides high transmission efficiency because the respective axes of the outer unit coil 102 and the prosthetic valve coil 36 are generally aligned.
Alternatively or in addition, for some applications, the external unit 100 is incorporated into a belt or strap configured to be worn around the chest of the patient.
For some applications in which the valve prosthesis system 68 includes the prosthetic aortic valve 20 described above with reference to fig. 1A-1B and 2, the prosthetic aortic valve control circuit 40 is configured to drive the one or more electrodes 34 with the received energy to perform post-implantation pacing, for example, for several months. Such pacing may employ any standard pacing protocol. For some applications, pacing is VVI pacing applied only when no QRS complex is sensed in the ventricle. Alternatively, for some applications in which the valve prosthesis system 68 includes the prosthetic aortic valve 120 described above with reference to fig. 3A, the external unit control circuit 104 is configured to drive the one or more electrodes 34 to apply pacing signals; in this configuration, the prosthetic aortic valve control circuit 40 is not provided (or is typically passive if provided), i.e., the external unit control circuit 104 sets the parameters of the pacing signal.
Alternatively, for some applications in which the valve prosthesis system 68 includes the prosthetic aortic valve 20 described above with reference to fig. 1A-1B and 2, the prosthetic aortic valve control circuit 40 is configured to (a) sense cardiac signals using the one or more electrodes 34, and (B) drive the prosthetic valve coil 36 to transmit wireless signals indicative of the sensed cardiac signals. For some applications, cardiac sensing is performed using techniques described in U.S. patent 9,005,106 to Gross et al, which is incorporated herein by reference. In these applications, one or more electrodes 34 are not typically used to apply pacing and, therefore, need not be configured as a cathode and anode. Such sensing may enable the patient to discharge early after implantation of the prosthetic aortic valve 20, before Left Bundle Branch Block (LBBB) may develop. If LBBB is developed, as in about 20% to 30% of patients, an alarm is generated by sensing that LBBB is detected, and LBBB can be appropriately treated.
Referring now to fig. 5, fig. 5 is a schematic illustration of an electronic implant 200 according to an application of the present invention. The prosthetic aortic valve control circuit 40 described above with reference to fig. 1A-2 may implement features of the electronic implant 200.
The electronic implant 200 includes a circuit 210 that includes electronic components 212 typically mounted on a long and flexible Printed Circuit Board (PCB) 214. The electronic implant 200 further comprises a multilayer protective coating comprising, in order, the following layers:
a first internal aluminum oxide (AlOx) film layer 220 deposited on the circuit 210, for example using Atomic Layer Deposition (ALD);
a second parylene layer 222 deposited (typically, vapor deposited in a vacuum) on the first interior AlOx film layer 220; the second parylene layer 222 provides chemical protection for the circuit 210;
optionally, a third layer 224 disposed on (typically cast onto) the second parylene layer 222, the third layer comprising, for example, a polymer such as a polymer selected from the group consisting of silicone and PTFE; the third layer 224 typically has a thickness between 100 microns and 200 microns and is configured to provide mechanical protection to the circuit 210; and
Optionally, a fourth outer parylene layer 226 deposited (typically, vapor deposited in vacuum) on the third layer 224; the fourth outer parylene layer 226 provides chemical protection for the circuit 210 and the third layer 224.
The electronic implant 200 and the layers are highly schematically drawn in fig. 5 and are not drawn to scale; in particular, these layers are actually much thinner than shown, and the relative thicknesses are different from those shown.
Typically, the circuit 210 is not enclosed in a housing, but is only coated with a layer, as described above. A "housing" is a casing, typically comprising glass and/or metal, having structure prior to the circuit being disposed therein; in contrast, the coating takes the shape of the circuit to which the coating is applied. In contrast, encapsulation in a housing is standard in the field of implantable circuits. This lack of housing allows the electronic implant 200 to be thin and flexible at the cost of a shorter life cycle. For the prosthetic aortic valve control circuit 40, a shorter life cycle is generally not a problem, as the prosthetic aortic valve control circuit 40 is typically only used for a few months.
For applications in which the prosthetic aortic valve control circuit 40 implements the features of the electronic implant 200, one or more of the electrodes 34 are masked during application of the coating. Thus, the prosthetic aortic valve control circuit 40, the one or more elongated insulated electrical conductors 38 (e.g., wires), and the prosthetic valve coil 36 are all coated in the same coating process.
Referring now to fig. 6, fig. 6 is a schematic illustration of a prosthetic aortic valve 320 in accordance with the application of the present invention. The prosthetic aortic valve 320 is substantially similar to the prosthetic aortic valve 120 described above with reference to fig. 3A-3B, except as described below, and any of its features may be implemented, mutatis mutandis.
Referring also to fig. 7, fig. 7 is a schematic view of the prosthetic aortic valve 320 as seen from the downstream outflow end 52 of the prosthetic aortic valve 320 in accordance with the application of the present invention, as described below.
The prosthetic aortic valve 320 is shown in fig. 6 and 7 in an expanded configuration similar to the expanded fully deployed configuration described below with reference to fig. 10C-10D, except that the expansion of the prosthetic aortic valve 320 in fig. 6 and 7 is not limited by the patient anatomy.
The prosthetic aortic valve 320 comprises:
a frame 30;
a plurality of prosthetic leaflets 32 coupled to the frame 30;
electrodes 34, comprising a cathode 54 and an anode 57, and mechanically coupled to the frame 30; and
a prosthetic valve coil 336 coupled to the frame 30 in non-wireless electrical communication with the cathode 54 and the anode 57.
The frame 30 typically includes a stent or other structure that is typically self-expanding and may be formed by laser cutting or etching a metal alloy tube containing, for example, stainless steel or a shape memory material such as nitinol. For some applications, one or more of the electrodes 34 are coupled to the frame 30 using techniques described in U.S. patent 9,526,637 to Dagan et al and/or U.S. patent 2016/0278951 to Dagan et al, both of which are incorporated herein by reference. For some applications, the prosthetic valve coil 336 includes gold wire to provide low resistance.
The prosthetic valve coil 336 may be coupled to the frame 30 inside or outside the frame, or partially inside and partially outside the frame.
The prosthetic aortic valve 320 is configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath 372, such as described below with reference to fig. 10A-10B.
For some applications, when the prosthetic aortic valve 320 is in an expanded fully deployed configuration after release from the delivery sheath 372, such as shown in fig. 6, 7, and 10C-10D, (a) a line 322 defined between an upstream-most point 324A and a downstream-most point 324B of the mechanical coupling between the prosthetic valve coil 336 and the frame 30, and (B) a central longitudinal axis 326 defined by the frame 30 form an angle γ (gamma) that is between 20 degrees and 70 degrees, such as between 30 degrees and 60 degrees, for example between 40 degrees and 50 degrees, such as 45 degrees. This angle provides a good coupling between the prosthetic valve coil 336 and the energy transmission coil, such as described below with reference to fig. 10D.
For some applications, when the prosthetic aortic valve 320 is in the expanded fully deployed configuration, such as shown in fig. 6, 7, and 10C-10D, the central longitudinal axis 326 passes through a space surrounded by a prosthetic valve coil 336, such as shown in the figures.
Alternatively or in addition, for some applications, the prosthetic valve coil 336 is shaped so as to define a best fit plane forming an angle γ (gamma) with the central longitudinal axis 326 of the frame 30.
As used in the present application (including in the claims and inventive concepts), the "central longitudinal axis" 326 of the frame 30 is the collection of cross-sectional profiles of the frame 30 along all centroids of the frame 30. Thus, the cross-sectional profile is locally perpendicular to a central longitudinal axis extending along the frame 30. (for applications where the cross-section of the frame 30 is circular, the centroid corresponds to the center of the circular cross-section profile.) as used in the present application (including in the claims and inventive concepts), the "best fit plane" is the plane that most closely matches the shape of the prosthetic valve coil 336, i.e., the plane that results in the least sum of squares of the distances between the plane and the prosthetic valve coil 336. As used in the present application (including in the claims and the inventive concept), the angle between two lines or between a line and a plane is the smaller of the two complementary angles between the two lines or between a line and a plane, or is equal to 90 degrees in the case where the two lines or lines and the plane are perpendicular.
Such an angle of the prosthetic valve coil 336 relative to the central longitudinal axis 326 of the frame 30 allows for more compact crimping (compression) of the prosthetic valve coil 336 into the delivery sheath 372 than in alternative configurations in which the prosthetic valve coil 336 is perpendicular to the central longitudinal axis 326 of the frame 30, such as described below with reference to fig. 10A-10B, because the metal of the prosthetic valve coil 336 is more easily distributed axially along the frame 30.
For other applications, the prosthetic valve coil 336 is at a different angle relative to the central longitudinal axis 326 of the frame 30. For example, the prosthetic valve coil 336 may be perpendicular to the central longitudinal axis 326 of the frame 30, such as shown in fig. 1A.
For some applications, when the prosthetic aortic valve 320 is in an expanded fully deployed configuration, such as shown in fig. 6, 7, and 10C-10D, (a) the downstream-most point 324B of the mechanical coupling between the prosthetic valve coil 336 and the frame 30, and (B) the centroid 328 of the cathode 54 are rotationally aligned with each other or rotationally offset from each other by less than 50 degrees, such as less than 30 degrees, about the central longitudinal axis 326. The reason for this rotational alignment is provided below with reference to fig. 10B and 10D.
For some applications, cathode 54 is located along frame 30 upstream of anode 57.
For some applications, cathode 54 and anode 57 are used for bipolar sensing and/or pacing, as is known in the art.
For some applications, the cathode 54 and anode 57 are disposed on the frame 30 such that there is at least 15mm between the cathode and anode when the prosthetic aortic valve 320 is in the expanded fully deployed configuration described below with reference to fig. 10C-10D (the 15mm being measured along the central longitudinal axis 326 of the frame 30 when in the expanded fully deployed configuration).
For some applications, respective non-electrically-insulating end portions of prosthetic valve coil 336 define cathode 54 and anode 57. In these applications, the prosthetic aortic valve 320 generally does not include an elongated insulated electrical conductor, as described below with reference to fig. 8. Instead, the respective insulated end portions of the prosthetic valve coil 336 are bent away from the prosthetic valve coil 336 along the path of an elongate insulated electrical conductor 438 described below with reference to fig. 9 such that the respective non-electrically insulated end portions 336 of the prosthetic valve coil are located at the positions of the cathode 54 and anode 57, respectively, shown in fig. 6.
For other applications, the prosthetic aortic valve 320 also includes one or more elongated insulated electrical conductors 438, such as wires, coupling the prosthetic valve coil 336 in non-wireless electrical communication with the cathode 54 and anode 57, mutatis mutandis, such as described below with reference to fig. 9.
For some applications, the prosthetic aortic valve 320 does not include any active electronic components.
For some applications, when the prosthetic aortic valve 320 is in the expanded fully deployed configuration, the frame 30 is shaped so as to define an upstream inflow portion 42, a downstream outflow portion 44, and a constriction 46 axially between the upstream inflow portion 42 and the downstream outflow portion 44. The prosthetic valve leaflet 32 is coupled to the narrowed portion 46 such that the free edge 48 of the prosthetic valve leaflet 32 faces the downstream outflow portion 44 when the prosthetic aortic valve 320 is in the expanded fully deployed configuration described below with reference to fig. 10C-10D. The prosthetic leaflet 32 is not coupled to the downstream outflow portion 44; thus, an annular longitudinal boundary 58 between the downstream outflow portion 44 and the narrowed portion 46 is defined by a downstream-most point of the frame 30 to which the prosthetic leaflet 32 is coupled (e.g., the prosthetic leaflet 32 may be coupled to the downstream-most point of the frame 30 at a commissure 60, as will be described below). Typically, the prosthetic aortic valve 320 further includes a skirt 49 coupled to the upstream inflow portion 42 of the frame 30 (the annular longitudinal boundary 58 is located at the same longitudinal position around the frame 30), and the prosthetic leaflets 32 are attached to the skirt 49 along their bases, for example, using sutures or a suitable biocompatible adhesive. The leaflets of the adjoining pair attach to each other at their lateral ends to form a commissure 60 such that the free edges 48 of the prosthetic leaflets form joined edges that meet each other. The skirt 49 and prosthetic leaflet 32 typically comprise a sheet of animal pericardial tissue, such as porcine pericardial tissue, or a sheet of synthetic or polymeric material.
For some applications, the cathode 54 is coupled to the upstream inflow portion 42 of the frame 30.
For some applications, the cathode 54 has a lateral dimension α (alpha) measured in degrees about the frame 30 between 10 degrees and 40 degrees (e.g., between 20 degrees and 40 degrees, such as 30 degrees) relative to the central longitudinal axis 326 of the frame 30 in order to accommodate rotational misalignment of the frame 30 relative to the his bundle. Typically, the prosthetic aortic valve 320 is deployed using imaging such as fluoroscopy, and is rotated during deployment if necessary so that the cathode 54 is disposed against the annulus tissue in the vicinity of the bundle of his. For some applications, the prosthetic aortic valve 320 includes a plurality of cathodes 54 (e.g., two or three or more) disposed at respective plurality of angular positions (e.g., 10 degrees to 15 degrees apart) about the frame 30. After implantation of the prosthetic aortic valve 320, the cathode 54 with the most accurate angular position is activated to apply pacing signals and/or sensing by (a) an external control circuit, such as external unit control circuit 104, as described below with reference to fig. 10D, or (b) a prosthetic aortic valve control circuit 440 (if provided), such as described below with reference to fig. 9. Alternatively or in addition, for some applications, the cathode 54 has an axial length of at least 10mm in order to accommodate axial misalignment of the frame 30 relative to the annulus of the native aortic valve and thus relative to the bundle of his. As used in the present application (including in the claims and inventive concepts), an "axial length" is the length of a structure measured along the central longitudinal axis 326.
For some applications, the cathode 54 has a thickness of between 75 and 125 microns, for example about 100 microns, and/or a surface area of at least 2.5mm2, in order to provide adequate stimulation. For some applications, 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 the outer surface of the skirt 49.
For some applications, when the prosthetic aortic valve 320 is in the expanded fully deployed configuration described below with reference to fig. 10C-10D:
the frame 30 has an inflow end 50 at the upstream inflow portion 42 and a downstream outflow end 52 at the downstream outflow portion 44, and an axial length measured between the inflow end 50 and the downstream outflow end 52, and
at least one electrode (e.g., only one electrode, such as cathode 54) of the one or more electrodes 34 is coupled to the upstream inflow portion 42 within a distance from the inflow end 50 equal to 10% of the axial length of the frame 30 (the distance being measured (a) along the central longitudinal axis 326 of the frame 30 when the frame 30 is in the expanded fully deployed configuration, and (b) between the inflow end 50 and the most upstream point of the at least one electrode).
For some applications, the downstream-most point 324B of mechanical coupling between the prosthetic valve coil 336 and the frame 30 is located on the downstream outflow portion 44 when the prosthetic aortic valve 320 is in the expanded fully deployed configuration.
For some applications, the most upstream point 324A of the mechanical coupling between the prosthetic valve coil 336 and the frame 30 is located on the constriction 46 when the prosthetic aortic valve 320 is in the expanded, fully deployed configuration.
For some applications, the prosthetic leaflet 32 is coupled to the frame 30 at least a first commissure 60A and a second commissure 60B of the prosthetic aortic valve 320 that are located at respective first and second angular positions 62A, 62B about the frame 30. When the prosthetic aortic valve 320 is in the expanded fully deployed configuration described below with reference to fig. 10C-10D, the first and second angular positions 62A, 62B are separated about the frame 30 by a first angular offset epsilon (labeled in fig. 7). The cathode 54 is coupled to the frame 30 at a third angular position 62C about the frame 30 that is separated from the first angular position 62A by a second angular offset δ (delta) that is equal to between 40% and 60% (e.g., 50%) of the first angular offset epsilon (epsilon) when the prosthetic aortic valve 320 is in the expanded fully deployed configuration described below with reference to fig. 10C-10D. The frame 30 is more flexible at a third angular position 62C around the frame than at a more rigid commissure. As used in the present application (including in the claims and inventive concepts), an "angular position" is a position on the frame 30 at a particular location about the central longitudinal axis 326, i.e., at a particular "o' clock" with respect to the central longitudinal axis 326. (note that the third commissure 60C is shown in fig. 1A on the distal side of the frame, i.e., 180 degrees from the cathode 54).
Referring again to fig. 6, and additionally referring again to fig. 3B, as described above, fig. 3B is a schematic view of the passive electronic components of the prosthetic aortic valve 120 and tissue 122 described above with reference to fig. 3A-3B, in accordance with an application of the present invention. For some applications, the prosthetic aortic valve 320 implements the technique of the prosthetic aortic valve 120 described with reference to fig. 3B. The external unit control circuitry 104 (shown in fig. 10D) transmits energy wirelessly to the prosthetic valve coil 336, typically by generating a plurality of AC pulses, each AC pulse comprising an AC burst. The AC bursts may be generated, for example, at a frequency between 3kHz and 130kHz (e.g., between 3kHz and 100kHz, or between 100kHz and 130 kHz) or between 12MHz and 20MHz (such as between 13MHz and 20MHz, e.g., 13.56 MHz) to increase efficiency. For some applications, there are 20 to 100 AC bursts in each of the AC pulses. Other frequencies and numbers of bursts are within the scope of the invention. For some applications, the external unit control circuit 104 is configured to wirelessly transmit between 5V and 10V of energy generated in the prosthetic valve coil 336 to the prosthetic valve coil 336.
For some applications, the prosthetic aortic valve 320 includes only one passive diode 124 that provides half-wave rectification of the AC pulse. For other applications, the prosthetic aortic valve 320 includes a plurality of passive diodes 124 that provide full wave rectification of the AC pulses; for example, the prosthetic aortic valve 320 may include four passive diodes 124 arranged in a bridge configuration, as is known in the electronics arts.
For some applications, the prosthetic aortic valve 320 includes a capacitor 126 (shown in exploded view on the right side of fig. 6 and highly schematically in fig. 3B) in electrical communication with the cathode 54 and anode 57 (parallel to the tissue 122 in the circuit formed when the electrodes are implanted). The capacitor 126 generally improves the efficiency of the circuit by delivering a greater proportion of the received energy into the tissue 122. (as is known in the electronics arts, capacitors are passive electronic components.)
Optionally, the prosthetic aortic valve 320 includes additional passive electronic components, such as one or more resistors.
Referring now to fig. 8, fig. 8 is a schematic illustration of the components of the prosthetic aortic valve 320 prior to complete assembly in accordance with the application of the present invention. These components include valve component 64 and electronic component 366. Valve component 64 is typically comprised of a heart valve prosthesis known in the art that includes at least frame 30 and prosthetic leaflets 32. For example, known heart valve prostheses may include CoreValve TM Evolut TM R prothesis(Medtronic,Inc.,Minneapolis,MN,USA)、CoreValve TM Evolut TM PRO prosthesis(Medtronic,Inc.)、LOTUS Edge TM Aortic Valve (Boston Scientific Corporation, marlborough, mass., USA) or ACURATE neo TM Aortic Valve (Boston Scientific Corporation). The electronic component 366 includes at least one or more electrodes 34 and the prosthetic valve coil 336, and optionally, the prosthetic aortic valve control circuit 440 in a configuration described below with reference to fig. 9.
During assembly of the prosthetic aortic valve 320, the electronic component 366 is inserted into the valve component 64. For some applications, a first portion of the electronic component 366, such as the prosthetic valve coil 336 and one of the one or more electrodes 34, is coupled to an inner surface of the frame 30, and a second portion of the electronic component 366, such as the cathode 54, is coupled to an outer surface of the frame 30. For example, one of the non-electrically insulated end portions of the prosthetic valve coil 336 may (a) electrically couple the prosthetic valve coil 336 to the cathode 54, and (b) pass from the interior to the exterior of the frame 30, typically through the skirt 49. Alternatively, components of the electronic component 366 may be coupled to the frame 30 and/or the skirt 49.
For some applications, whether the prosthetic valve coil 336 is coupled to an inner surface or an outer surface of the frame 30, the prosthetic valve coil 336 is electrically isolated from the frame 30, such as by an isolating material (e.g., a sheet of material or a coating) disposed between the prosthetic valve coil 336 and the frame 30. For example, the isolating material may comprise a non-conductive polymer.
The above-described assembly of the prosthetic aortic valve 320 is typically performed in a manufacturing facility, after which the assembled prosthetic aortic valve 320 is packaged and transported to a medical facility for implantation. Thus, the method of assembling the prosthetic aortic valve 320 is non-surgical.
Referring now to fig. 9, fig. 9 is a schematic illustration of a prosthetic aortic valve 420 in accordance with the application of the present invention. The prosthetic aortic valve 420 is shown in fig. 9 in an expanded configuration similar to the expanded fully expanded configuration of the prosthetic aortic valve 320 described below with reference to fig. 10C-10D, except that the expansion of the prosthetic aortic valve 420 is not limited by the anatomy of the patient in fig. 9. The prosthetic aortic valve 420 is identical to the prosthetic aortic valve 320 described herein with reference to fig. 6-8, except as described below, and like reference numerals refer to like components. The prosthetic aortic valve 420 can be assembled as described above with respect to the prosthetic aortic valve 320 with the necessary modifications, as described above with reference to fig. 8.
The prosthetic aortic valve 420 also includes a prosthetic aortic valve control circuit 440 coupled to the frame 30 and in non-wireless electrical communication with the one or more electrodes 34. In these applications, the prosthetic valve coil 336 is in non-wireless electrical communication with the prosthetic aortic valve control circuit 440 such that the prosthetic valve coil 336 is in non-wireless electrical communication with the one or more electrodes 34 via the prosthetic aortic valve control circuit 440. One or more of the one or more electrodes 34 may be directly attached to the prosthetic aortic valve control circuit 440 in non-radio communication and/or may be attached to the prosthetic aortic valve control circuit 440 in non-radio communication by one or more elongated insulated electrical conductors 438. Typically, the prosthetic aortic valve control circuit 440 is flexible and has a thin linear package, and the techniques described with reference to fig. 5 can be implemented, mutatis mutandis. The thinness of the control circuit 440 allows the control circuit to be compressed in the delivery sheath 372 during deployment of the prosthetic aortic valve 420 without the need to increase the diameter of the delivery sheath. In addition, the flexibility of the control circuit 440 prevents damage to the control circuit in the event that the control circuit curls as it is compressed into the delivery sheath.
Typically, the prosthetic aortic valve control circuit 440 is coupled to the frame 30 such that the most upstream point 56 of the prosthetic aortic valve control circuit 440 is axially disposed along the narrowed portion 46 and/or downstream outflow portion 44 of the frame 30.
With the necessary modifications, typically, the prosthetic aortic valve control circuit 440 is coupled to the frame 30 inside the frame 30, which may prevent friction between the prosthetic aortic valve control circuit 440 and the delivery sheath 372 during deployment of the prosthetic aortic valve 320, as described below with respect to the prosthetic aortic valve 320 with reference to fig. 10A-10D.
For some applications, the prosthetic aortic valve control circuit 440 is coupled to the frame 30 at a third angular position 62C about the frame 30, as described above with reference to fig. 7.
Referring now to fig. 10A-10D, fig. 10A-10D are schematic illustrations of a valve prosthesis system 368 and methods of use of the system according to respective applications of the present invention. Although the techniques described with reference to fig. 10A-10D are generally described with respect to the prosthetic aortic valve 320, these techniques are equally applicable to the prosthetic aortic valves 20, 120, 420, and 820, mutatis mutandis. The rotational orientation of the prosthetic aortic valve is schematically illustrated in fig. 10A-10C to illustrate the components of the prosthetic aortic valve; as described below, in actual use, the prosthetic aortic valve is generally rotationally oriented such that the cathode 54 is positioned adjacent to heart tissue adjacent to the bundle of his, such as shown in fig. 10D.
Valve prosthesis system 368 includes (a) a prosthetic aortic valve 320 or a prosthetic aortic valve 420 and (b) a delivery system 370.
The delivery system 370 includes:
delivery sheath 372;
one or more wires 78 that pass along delivery sheath 372, e.g., attached to an outer or inner surface of delivery sheath 372, or embedded in a wall of delivery sheath 372; and
optionally, a delivery system control circuit 80 in electrical communication with the delivery system coil 74 via one or more wires 78.
As shown in fig. 10A, the prosthetic aortic valve 320 can be removably disposed in a delivery sheath 372 in a compressed delivery configuration. During the implantation procedure, the delivery sheath 372 is advanced through the vasculature of the patient until the distal end 82 of the delivery sheath 372 is disposed in the ascending aorta 84 of the patient, while the prosthetic aortic valve 320 is removably disposed in the delivery sheath 372 in a compressed delivery configuration.
As described above with reference to fig. 6-7, for some applications, one or more of the electrodes 34 includes a cathode 54 coupled to the upstream inflow portion 42 of the frame 30. Prior to deployment, the prosthetic aortic valve is rotated (such as under guidance using imaging such as a marker on delivery sheath 372, e.g., fluoroscopy) such that cathode 54 is positioned adjacent to the heart tissue near the bundle of his (non-coronary cusps 112 (labeled in fig. 10D) near the native aortic valve) in order to pace the heart by stimulating the heart tissue with cathodic current.
Due to the rotational alignment of the angled prosthetic valve coil 336 relative to the cathode 54 described above with reference to fig. 6-7, the alignment of the cathode 54 adjacent to the heart tissue near the bundle of his (generally posteriorly facing) automatically aligns the prosthetic valve coil 336 to face generally in an opposite direction, generally anteriorly and superior, such as shown in fig. 10D. This orientation provides good wireless coupling with the energy transfer coil 102, such as described below with reference to fig. 10D.
For some applications, the delivery system 370 includes a cathode 430 separate from the prosthetic aortic valve 320 or the prosthetic aortic valve 420. For some applications, a separate cathode is provided on a guidewire 432 used to introduce the prosthetic aortic valve 320 or the prosthetic aortic valve 420 into the native aortic valve. For example, the cathode 430 may be positioned on a lead 434 of the guidewire 432. To this end, the lead 434 may optionally include an inner conductive wire coated with a non-conductive insulator, and the cathode 430 may be defined by a non-insulated portion of the lead 434. The delivery system 370 is configured to use this guidewire cathode 430 to apply rapid ventricular pacing (instead of the cathode 54 of the prosthetic aortic valve 320 or the prosthetic aortic valve 420). In this case, the prosthetic aortic valve 320 or the cathode 54 of the prosthetic aortic valve 420 is still generally used to apply post-implantation chronic pacing using the external unit 100, such as described below.
For some applications, such as those in which the delivery system 370 includes a cathode 430 separate from the prosthetic aortic valve 320 or 420, the delivery system 370 includes an anode 436 separate from the prosthetic aortic valve 320 or 420, and is configured to use this separate anode 436 to apply rapid ventricular pacing (rather than the anode 57 of the prosthetic aortic valve 320 or 420). In this case, the prosthetic aortic valve 320 or the anode 57 of the prosthetic aortic valve 420 is still typically used to apply post-implantation chronic pacing using the external unit 100, such as described below.
For some applications, the separate anode 436 of the delivery system 370 includes:
a skin electrode 442 (shown in fig. 12 and 13B, described below), such as a patch electrode, configured to be placed on the skin of a patient; the patch electrode may have a relatively large surface area, for example a diameter of 6cm to 10cm (e.g. 8 cm), in order to provide good conduction; alternatively, patch electrodes are incorporated into the shirt 600, as described below with reference to fig. 13A-13B (such as embedded in the shirt, or attached to the inner surface of the shirt),
Sheath electrode 444, e.g., an electrically conductive coating, disposed along delivery sheath 372, such as along a proximal portion of the sheath configured to be disposed in an aorta, e.g., a descending aorta, when distal end 82 of delivery sheath 372 is disposed in ascending aorta 84 for deployment of a prosthetic aortic valve, or
A sheath-introducer electrode disposed on an introducer for introducing a sheath into the vasculature at a vascular access site (e.g., a femoral vascular access site); typically, a sheath-introducer electrode is disposed along the introducer.
For some applications, delivery system control circuit 80 is configured to drive cathode 430 to apply unipolar rapid ventricular pacing using anode 436 as a return electrode. Such pacing may temporarily reduce left ventricular output to enable more accurate placement of the prosthetic aortic valve. Delivery system control circuit 80 sets parameters of the pacing signal.
As shown in fig. 10C-10D, the prosthetic aortic valve 320 is further configured to assume an expanded fully deployed configuration upon full release from the distal end 82 of the delivery sheath 372.
For some applications, as shown in fig. 10D, the valve prosthesis system 368 also includes an external unit 100. The external unit 100 is configured to be disposed outside the patient's body and includes (a) an energy transmission coil 102 and (b) an external unit control circuit 104 configured to drive the energy transmission coil 102 to wirelessly transmit energy to the prosthetic valve coil 336 by means of inductive coupling when the prosthetic aortic valve 320 is in an expanded fully deployed configuration, as shown in fig. 10D. In these applications, after the prosthetic aortic valve 320 is fully released from the distal end 82 of the delivery sheath 372, the external unit control circuit 104 is activated to drive the energy transmission coil 102 to wirelessly transmit energy to the prosthetic valve coil 336 by means of inductive coupling when the prosthetic aortic valve 320 is in the expanded fully deployed configuration.
Alternatively, the valve prosthesis system 368 includes the external unit 100, but does not include the delivery system 370.
Further alternatively, in some applications, a single external unit may be provided that provides the functionality of both the delivery system 370 and the external unit 100. The single external unit may include control circuitry configured to provide the functionality of both the delivery system control circuitry 80 of the delivery system 370 and the external unit control circuitry 104 of the external unit 100. A single external unit may be configured to operate in a delivery mode and a post-delivery mode. The user control may be provided to switch between two modes of operation, or the control circuit may be configured to automatically switch between two modes of operation.
For some applications, the energy transmission coil 102 is configured to be positioned against the chest of the patient, generally above the sternum 110. This positioning of the energy transmission coil 102 provides high transmission efficiency because the respective axes of the energy transmission coil 102 and the prosthetic valve coil 336 are generally aligned due to the angle γ (gamma) formed between the prosthetic valve coil 336 and the central longitudinal axis 326 of the frame 30 as described above with reference to fig. 6-7. Such high transmission efficiency may allow the prosthetic valve coil 336 and/or the energy transmission coil 102 to include fewer turns of the coil and/or to have a smaller diameter. Alternatively or in addition, such high transmission efficiency may allow the external unit 100 to use less power to induce the same amount of current in the prosthetic valve coil 336.
For other applications, the energy transfer coil 102 is configured to be positioned around the neck of a patient, such as described below with reference to fig. 13C. This positioning of the energy transmission coil 102 provides high transmission efficiency (although perhaps not as high as when against the patient's chest) because the respective axes of the energy transmission coil 102 and the prosthetic valve coil 336 are generally aligned due to the angle γ (gamma) formed between the prosthetic valve coil 336 and the central longitudinal axis 326 of the frame 30 as described above with reference to fig. 6-7.
Further alternatively, for some applications, the energy transfer coil 102 is configured to be positioned on the back of the patient. In this configuration, the prosthetic valve coil 336 may be angled to face generally posteriorly and superior, rather than generally anteriorly and superior as shown. For example, (a) the most upstream point 324A of the mechanical coupling between the prosthetic valve coil 336 and the frame 30 and (b) the centroid 328 of the cathode 54 may be rotationally aligned with each other or rotationally offset from each other by less than 50 degrees, such as less than 30 degrees, about the central longitudinal axis 326. This positioning of the energy transmission coil 102 provides high transmission efficiency (although perhaps not as high as when against the patient's chest) because the respective axes of the energy transmission coil 102 and the prosthetic valve coil 336 are generally aligned due to the angle γ (gamma) formed between the prosthetic valve coil 336 and the central longitudinal axis 326 of the frame 30 as described above with reference to fig. 6-7.
Alternatively, the energy transfer coil 102 is shaped so as to define 4 to 10 turns.
Alternatively, the energy transfer coil 102 has a diameter of 15cm to 20 cm.
For some applications in which the valve prosthesis system 368 includes the prosthetic aortic valve 120 described above with reference to fig. 3A-3B or the prosthetic aortic valve 320 described above with reference to fig. 6-8, the external unit control circuit 104 is configured to drive the cathode 54 to apply a cathodic current. For some applications in which the valve prosthesis system 368 includes the prosthetic aortic valve 20 described above with reference to fig. 1A-2 or the prosthetic aortic valve 420 described above with reference to fig. 9, the prosthetic aortic valve control circuit 40 or 440 is configured to drive the cathode 54 to apply a cathodic current.
For some applications in which the valve prosthesis system 368 includes the prosthetic aortic valve 120 described above with reference to fig. 3A-3B or the prosthetic aortic valve 320 described above with reference to fig. 6-8, the external unit control circuit 104 is configured to drive the one or more electrodes 34 to perform post-implantation pacing by applying a pacing signal, such as a standard chronic pacing signal, for example, for several months. The external unit control circuit 104 sets parameters of the pacing signal. Such pacing may employ any standard pacing protocol. Such pacing is typically bipolar. For some applications, pacing is VVI pacing applied only when no QRS complex is sensed in the ventricle.
For some applications in which the valve prosthesis system 368 includes the prosthetic aortic valve 20 described above with reference to fig. 1A-2 or the prosthetic aortic valve 420 described above with reference to fig. 9, the prosthetic aortic valve control circuit 40 or 440 is configured to drive the one or more electrodes 34 using energy received from the external unit control circuit 104 to perform post-implantation pacing. Alternatively, for some applications in which the valve prosthesis system 368 includes the prosthetic aortic valve 20 described above with reference to fig. 1A-2 or the prosthetic aortic valve 420 described above with reference to fig. 9, the prosthetic aortic valve control circuit 40 or 440 is configured to (a) sense cardiac signals using the one or more electrodes 34, and (b) drive the prosthetic valve coil 336 to transmit wireless signals indicative of the sensed cardiac signals. For some applications, cardiac sensing is performed using techniques described in U.S. patent 9,005,106 to Gross et al, which is incorporated herein by reference. In these applications, one or more electrodes 34 are not typically used to apply pacing and, therefore, need not be configured as a cathode and anode. Such sensing may enable the patient to discharge early after implantation of the prosthetic aortic valve 320, before Left Bundle Branch Block (LBBB) may develop. If LBBB is developed, as in about 20% to 30% of patients, an alarm is generated by sensing that LBBB is detected, and LBBB can be appropriately treated.
For some applications in which valve prosthesis system 368 includes prosthetic aortic valve 120 described above with reference to fig. 3A-3B or prosthetic aortic valve 320 described above with reference to fig. 6-8, external unit control circuit 104 (fig. 10D) is configured to drive cathode 54 and anode 57 to set parameters of the pacing signal. For example, the non-external unit control circuitry 104 may be configured to set the amplitude of the pacing signal by modulating the amplitude of the energy wirelessly transmitted from the energy transmission coil to the prosthetic valve coil 336. Alternatively or in addition, for example, the external unit control circuit 104 may be configured to drive the cathode 54 and anode 57 to (a) begin applying each pulse of the pacing signal by beginning to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil 336, and (b) end applying each pulse of the pacing signal by ceasing to wirelessly transmit energy from the energy transmission coil to the prosthetic valve coil 336.
The inventors have determined that in some configurations, it is difficult to evaluate suitable pacing parameters, for example, due to patient size or patient weight distribution, or for example, due to technical issues such as variable impedance between the heart tissue and the cathode 54 and anode 57, or variable relative orientations of the energy transmission coil 102 and the prosthetic valve coil 336. Thus, for some applications, the external unit 100 further includes at least two sensing skin ECG electrodes 106 placed on the patient's skin 108 (e.g., on the chest, as shown in fig. 10D). The external unit control circuit 104 drives the cathode 54 and anode 57 to apply pacing signals to the patient's heart and detect at least one cardiac parameter using the sensed skin ECG electrodes 106. In response, at least in part, to the detected cardiac parameter, external unit control circuitry 104 sets a parameter of the pacing signal by wirelessly transmitting energy from the energy transmission coil to prosthetic valve coil 336 via inductive coupling. Because prosthetic aortic valves 120 and 320 generally do not include any active electronic components, the wireless transmission of energy from the energy transmission coil to either prosthetic valve coil 36 or prosthetic valve coil 336 by means of inductive coupling itself inductively drives pacing current through either prosthetic valve coil 36 or 336.
Alternatively, the external unit 100 includes another type of heart sensor, instead of sensing the skin ECG electrodes 106. For example, the heart 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 Si1172 or Si1173 biometric module manufactured by Silicon Laboratories inc., austin, TX, USA).
The external unit control circuitry 104 typically analyzes the detected cardiac parameter to assess the level of response of the heart to the pacing signal. Upon determining that the level of response is not satisfactory, the external unit control circuit 104 increases the strength of the pacing signal in response to the detected cardiac parameter (e.g., by increasing the amplitude or duration of the pacing signal). For example, the pulse width of the pulses of the pacing signal (typically 0.1ms to 1ms, e.g., 0.25ms to 0.8 ms) or the current amplitude in the energy transfer coil may be iteratively increased until it is determined that the heart is properly responsive to the pacing pulse applied to the tissue. At this point, optionally, the intensity of the pacing signal is further increased, for example by 50% to 150%, for example by 100%.
For some applications, the detected cardiac parameter is a timing characteristic of cardiac activity (e.g., the heart rate, or the timing of a particular characteristic of the cardiac cycle). In this case, the parameters of the pacing signal may include timing parameters of the pacing signal, and the external unit control circuit 104 sets the timing parameters of the pacing signal in response to the timing characteristics of the detected cardiac parameter.
It is noted that, as appropriate for a given patient, pacing of the heart may be applied in a synchronized manner with the patient's cardiac cycle (based on signals received by the sensed skin ECG electrodes 106 or other cardiac sensor), or pacing may not be synchronized with the patient's cardiac cycle.
The sensing skin ECG electrodes 106 are typically either adsorbed ECG electrodes or are configured to be electrically coupled to the skin by an adhesive. Generally, conventional ECG electrodes are suitable for sensing skin ECG electrodes 106. It is noted that although conventional ECG electrodes may be used, a complete ECG analysis as known in the art of electrocardiography is typically not performed in order to achieve the functionality of the external unit control circuit 104 described above.
For some applications, the energy transmission coil 102 and/or the ECG electrode 106 (or another heart sensor) are incorporated into a shirt 600 configured to be worn by a patient (such as embedded in a shirt, or attached to an inner surface of a shirt), such as described below with reference to fig. 13A-13B, and/or into a necklace 700 configured to be worn around a chest of a patient or configured to be worn around a neck of a patient, such as described below with reference to fig. 13C. Alternatively or in addition, for some applications, the external unit 100 is incorporated into a belt or strap configured to be worn around the chest of the patient.
Referring now to fig. 11, fig. 11 is a schematic diagram of an external control unit 500 according to an application of the present invention. For some applications, external control unit 500 may be configured to provide user-selectable dual-mode pacing, including rapid ventricular pacing applied during an implantation procedure, as described above with reference to fig. 10A-10B, as well as post-implantation chronic bipolar pacing, such as described above with reference to fig. 10D. The external control unit 500 generally includes the delivery system control circuit 80 and the external unit control circuit 104 described above with reference to fig. 10A-10B. In this way, the external control unit 500 serves the dual function of both the components of the delivery system 370 described above with reference to fig. 10A-10C and the external unit 100 described above with reference to fig. 10D.
The external control unit 500 typically includes several electrical connectors to which connections may be made, for example, using connector clips as known in the art:
an anode connector 502 for connection to the anode 436 of the delivery system 370;
a cathode connector 504 for connection to a cathode 430 of the delivery system 370;
an ECG connector 506 for connection to the sensing skin ECG electrode 106; and
Coil connector 508 for connection to the energy transfer coil 102.
Referring now to fig. 12, fig. 12 is a schematic view of a patient showing exemplary locations of skin electrodes according to an application of the present invention. Fig. 12 shows exemplary locations of the sensing skin ECG electrode 106 described above with reference to fig. 10D and the anodic skin electrode 442 described above with reference to fig. 10A-10B.
Referring now to fig. 13A-13B, fig. 13A-13B are schematic views of a shirt 600 with integrated components according to the application of the invention. These components may be attached to a surface of the shirt, such as an interior surface, or embedded in the shirt. These components may include:
transmission coil 102 described above with reference to fig. 10D;
sense skin ECG electrode 106 described above with reference to fig. 10D; and/or
Anode skin electrode 442 described above with reference to fig. 10A-10B.
Typically, shirt 600 also comprises a connector 602 for electrical connection to external control unit 500 described above with reference to fig. 11.
Referring now to fig. 13C, fig. 13C is a schematic illustration of a necklace 700 in accordance with the application of the invention. As described above with reference to fig. 10B, necklace 700 includes integrated energy transmission coil 102.
Alternatively, the energy transmission coil 102 may be integrated into the shirt around the collar for placement around the neck of the patient.
A temporary pacemaker 702 may also be provided.
Referring now to fig. 14A-14C, fig. 14A-14C are schematic illustrations of respective configurations of a prosthetic aortic valve 820 according to respective applications of the present invention. The prosthetic aortic valve 820 is substantially similar to the prosthetic aortic valve 320 described above with reference to fig. 6-7, except as described below, and any of its features may be implemented, mutatis mutandis. Alternatively, prosthetic aortic valve 820 may implement any of the features of prosthetic aortic valve 420 described above with reference to fig. 9, and/or any of the features of any of the other prosthetic aortic valves described herein, mutatis mutandis.
The prosthetic aortic valve 820 is shown in fig. 14A-14C in an expanded configuration similar to the expanded fully deployed configuration described below with reference to fig. 15, except that the expansion of the prosthetic aortic valve 820 in fig. 14A-14C is not limited by the anatomy of the patient.
The prosthetic aortic valve 820 includes:
a frame 30;
a plurality of prosthetic leaflets 32 coupled to the frame 30;
electrodes 34, comprising a cathode 54 and an anode 57, and mechanically coupled to the frame 30; and
a prosthetic valve coil 836 coupled to the frame 30 in non-wireless electrical communication with the cathode 54 and anode 57.
The frame 30 typically includes a stent or other structure that is typically self-expanding and may be formed by laser cutting or etching a metal alloy tube comprising, for example, stainless steel or a shape memory alloy such as nitinol. In this configuration, the frame 30 includes interconnecting stent struts 831 arranged so as to define interconnecting stent cells 833. For some applications, one or more of the electrodes 34 are coupled to the frame 30 using techniques described in U.S. patent 9,526,637 to Dagan et al and/or U.S. patent 2016/0278951 to Dagan et al, both of which are incorporated herein by reference. For some applications, the prosthetic valve coil 836 includes gold wire to provide low resistance.
For some applications, such as shown in the figures, the prosthetic aortic valve 820 does not include any commissure posts.
The prosthetic valve coil 836 is coupled to the plurality of stent struts 831 in a manner that extends along the stent struts 831 so as to encircle a plurality of stent units 835 in the stent unit 833 when the prosthetic aortic valve 820 is in an expanded fully deployed configuration after release from the delivery sheath. For example, at least 50% (e.g., at least 75%) of the circumference of the prosthetic valve coil 836 may extend along the stent struts 831, such as 100% of the circumference, as shown. The stent struts 831 are shaped to allow for effective crimping (compression) of the frame 30 when in a constrained delivery configuration within the delivery sheath. The coupling of the prosthetic valve coil 836 to the stent struts 81 in a manner that extends along the stent struts effectively curls the prosthetic valve coil 836 together with the frame.
Fig. 14A and 14B illustrate prosthetic valve coils 836A and 836B, respectively, as an exemplary configuration of prosthetic valve coil 836. It should be understood that many other configurations are possible within the scope of the invention.
For some applications, the prosthetic valve coil 836 is shaped generally as a diamond when the prosthetic aortic valve 820 is in an expanded, fully deployed configuration, as shown.
Typically, the plurality of stent units 835 in the stent unit 833 surrounded by the prosthetic valve coil 836 include at least 4 stent units 833 as shown in fig. 14A and 14B, for example at least 9 stent units 833 as shown in fig. 14A, or at least 16 stent units 833 (configuration not shown in fig. 14A or 14B). Optionally, the plurality of stent units 835 in the stent unit 833 surrounded by the prosthetic valve coil 836 include no more than 32 stent units 833.
For some applications, when the prosthetic aortic valve 820 is in the expanded fully deployed configuration, (a) the centroid 839 of the prosthetic valve coil 836 and (b) the centroid 328 of the cathode 54 are rotationally offset from each other by an angle of at least 150 degrees (e.g., at least 160 degrees, typically 180 degrees) about the central longitudinal axis 326 when the prosthetic aortic valve 820 is in the expanded fully deployed configuration.
For some applications, the prosthetic valve coil 836 has a circumference of at least 5cm, no more than 8cm, and/or between 4cm and 8cm when the prosthetic aortic valve 820 is in the expanded fully deployed configuration.
For some applications, the prosthetic valve coil 836 has, when in an expanded, fully deployed configuration:
a first dimension D1 of at least 2cm, no more than 4cm and/or between 2cm and 4cm, the first dimension D1 being measured parallel to a central longitudinal axis 326 defined by the frame 30 when the prosthetic aortic valve 820 is in the expanded fully deployed configuration, and/or
A second dimension D2 of at least 1cm, no more than 3cm and/or between 1cm and 3cm, the second dimension D2 measured about the central longitudinal axis 326 and/or between 30 degrees and 180 degrees, such as between 30 degrees and 150 degrees or between 90 degrees and 180 degrees (e.g., between 90 degrees and 150 degrees, such as between 90 degrees and 120 degrees), the second dimension D2 measured about the frame 30 in degrees relative to the central longitudinal axis 326.
For some applications, where the prosthetic aortic valve 820 is in an expanded fully deployed configuration, the prosthetic valve coil 836 surrounds at least 1cm2, no more than 4cm2, and/or an area between 1cm2 and 4cm 2.
For some applications, the prosthetic valve coil 836 is shaped so as to define 1-4 turns (3 turns shown in the figures as an example).
For some applications, the prosthetic valve coil 836 is shaped such that when the prosthetic aortic valve 820 is in the expanded fully deployed configuration, there is no single wire passing more than twice through the projection of the prosthetic valve coil 836 on the best fit plane (although in a configuration in which the coil is shaped so as to define more than one turn, a single wire will pass more than twice through the turns of the coil).
For some applications, the prosthetic valve coil 836 is not shaped so as to define any zigzags when the prosthetic aortic valve 820 is in the expanded fully deployed configuration.
Reference is made to fig. 14A to 14B and 14C. In the configuration shown in fig. 14A-14B, the prosthetic aortic valves 820A and 820B include only one prosthetic valve coil 836.
Fig. 14C shows a prosthetic aortic valve 820C. In this configuration, the prosthetic valve coil 836 is a first prosthetic valve coil 836C, the plurality of stent struts 831 is a first plurality of stent struts 831, and the plurality of stent units 835 in the stent unit 833 are a first plurality of stent units 835C in the stent unit 833. The prosthetic aortic valve 820 also includes a second prosthetic valve coil 836D in non-wireless electrical communication with the cathode 54 and anode 57 and coupled to the second plurality of stent struts 831 in extending along the stent struts 831 so as to encircle a second plurality 835D of the stent cells 833 when the prosthetic aortic valve 820 is in the expanded fully deployed configuration. Generally, the first plurality of rack units 835C and the second plurality of rack units 833D in the rack unit 833 do not include any common rack unit 833. Optionally, the first and second prosthetic valve coils 836C, 836D are not coupled to any common stent struts 831.
For some applications, the first and second prosthetic valve coils 836C and 836D include a single wire 837 shaped so as to define both the first and second prosthetic valve coils.
Typically, when the prosthetic aortic valve 820 is in the expanded fully deployed configuration, the respective centroids of the first and second prosthetic valve coils 836C, 836D are offset from one another by at least 90 degrees (e.g., at least 150 degrees, typically 180 degrees) about the central longitudinal axis 326.
Referring now to fig. 15, fig. 15 is a schematic view of a valve prosthesis system 868 upon deployment of a prosthetic aortic valve 820 in accordance with an application of the present invention. The valve prosthesis system 868 includes the prosthetic aortic valve 820 instead of the prosthetic aortic valve 320, but otherwise any of the features of the valve prosthesis system 368 described above with reference to fig. 10A-10D may be implemented with the necessary modifications and/or any of the features of the valve prosthesis system 68 described above with reference to fig. 4A-4C may be implemented with the necessary modifications.
The techniques described herein for prosthetic aortic valves 20, 120, 320, 420, and 820 may alternatively be used with non-aortic prosthetic valves, such as prosthetic mitral or tricuspid valves, mutatis mutandis.
In embodiments, the techniques and apparatus described in one or more of the following patents and/or applications, which are assigned to the assignee of the present application and are incorporated herein by reference, are combined with the techniques and apparatus described herein:
U.S. Pat. No. 10,543,083 to Gross
European patent application publication EP 3508113 A1 to Gross
U.S. Pat. No. 10,835,750 to Gross
U.S. patent application publication 2020/0261224 to Gross
International patent application PCT/IL2021/050016 filed on 1/6/2021
International patent application PCT/IL2021/050017 filed on 1/6/2021
U.S. patent application Ser. No. 17/142,729, now U.S. patent 11,065,451, filed on 1/6 of 2021
It will be appreciated by persons skilled in the art that the present application is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present application includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description.
Claims (41)
1. A prosthetic aortic valve configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath, and comprising:
A frame comprising interconnecting stent struts arranged so as to define interconnecting stent units;
a plurality of prosthetic leaflets coupled to the frame;
a cathode and an anode mechanically coupled to the frame; and
a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode and coupled to a plurality of the stent struts in extending fashion along the stent struts so as to encircle a plurality of the stent units when the prosthetic aortic valve is in an expanded fully deployed configuration after release from the delivery sheath.
2. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil is generally shaped as a diamond when the prosthetic aortic valve is in the expanded fully deployed configuration.
3. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil is shaped such that there is no single line passing more than twice through the projection of the prosthetic valve coil on a best fit plane when the prosthetic aortic valve is in the expanded fully deployed configuration.
4. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil is not shaped so as to define any zigzags when the prosthetic aortic valve is in the expanded fully deployed configuration.
5. The prosthetic aortic valve of claim 1, wherein the plurality of the stent units surrounded by the prosthetic valve coil comprises at least 4 stent units.
6. The prosthetic aortic valve of claim 5, wherein the plurality of the stent units surrounded by the prosthetic valve coil comprises at least 9 stent units.
7. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil has a circumference of between 4cm and 8cm when the prosthetic aortic valve is in the expanded fully deployed configuration.
8. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil is shaped so as to define 1 to 4 turns.
9. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil has a first dimension between 2cm and 4cm, the first dimension measured parallel to a central longitudinal axis defined by the frame, when the prosthetic aortic valve is in the expanded fully deployed configuration.
10. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil has a second dimension between 1cm and 3cm measured about a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
11. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil has a second dimension between 30 degrees and 180 degrees measured about the frame relative to a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
12. The prosthetic aortic valve according to claim 1, wherein the prosthetic valve coil surrounds an area between 1cm2 and 4cm2 when the prosthetic aortic valve is in the expanded fully deployed configuration.
13. The prosthetic aortic valve according to claim 1, wherein the stent struts comprise a shape memory alloy.
14. The prosthetic aortic valve according to claim 1, wherein the prosthetic aortic valve does not comprise any commissure posts.
15. The prosthetic aortic valve according to claim 1, wherein the prosthetic aortic valve comprises only one prosthetic valve coil.
16. The prosthetic aortic valve of claim 1,
wherein the prosthetic valve coil is a first prosthetic valve coil, the plurality of stent struts is a first plurality of stent struts, and the plurality of stent units in the stent unit is a first plurality of stent units in the stent unit,
wherein the prosthetic aortic valve further comprises a second prosthetic valve coil in non-wireless electrical communication with the cathode and the anode and coupled to a second plurality of the stent struts in extending along the stent struts so as to encircle a second plurality of the stent cells when the prosthetic aortic valve is in the expanded fully deployed configuration, an
Wherein the first plurality of rack units and the second plurality of rack units do not include any common rack unit.
17. The prosthetic aortic valve according to claim 16, wherein the first and second prosthetic valve coils comprise a single wire shaped so as to define both the first and second prosthetic valve coils.
18. The prosthetic aortic valve according to claim 16, wherein respective centroids of the first and second prosthetic valve loops are offset from each other by at least 90 degrees about a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
19. The prosthetic aortic valve according to claim 1, wherein the prosthetic aortic valve does not include any active electronic components.
20. The prosthetic aortic valve according to claim 1, wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a centroid of the prosthetic valve coil and the frame and (b) a centroid of the cathode are rotationally offset from each other by an angle of at least 150 degrees about a central longitudinal axis defined by the frame when the prosthetic aortic valve is in the expanded fully deployed configuration.
21. A valve prosthesis system comprising the prosthetic aortic valve of claim 1, the valve prosthesis system further comprising an external unit configured to be disposed outside the body of the patient, and the external unit comprising:
An energy transmission coil; and
an external unit control circuit configured to drive the energy transmission coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling.
22. The valve prosthesis system of claim 21, wherein the external unit control circuit is configured to drive the cathode and the anode to apply a pacing signal to the patient's heart by wirelessly transmitting the energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
23. The valve prosthesis system of claim 21,
wherein the external unit control circuit is configured to wirelessly transmit the energy by generating a plurality of AC pulses, each AC pulse comprising an AC burst, and
wherein the prosthetic aortic valve comprises a passive diode coupled in electrical communication with the prosthetic valve coil and configured to rectify current in the prosthetic valve coil.
24. The valve prosthesis system of claim 23, wherein the external unit control circuit is configured to generate the AC burst at a frequency between 12MHz and 20 MHz.
25. A prosthetic aortic valve configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath, and comprising:
a frame;
a plurality of prosthetic leaflets coupled to the frame;
a cathode and an anode mechanically coupled to the frame; and
a prosthetic valve coil coupled to the frame and in non-wireless electrical communication with the cathode and the anode,
wherein when the prosthetic aortic valve is in an expanded fully deployed configuration after release from the delivery sheath, (a) a line defined between an upstream-most point and a downstream-most point of a mechanical coupling between the prosthetic valve coil and the frame and (b) a central longitudinal axis defined by the frame form an angle of between 20 degrees and 70 degrees.
26. The prosthetic aortic valve according to claim 25, wherein the angle is between 30 degrees and 60 degrees.
27. The prosthetic aortic valve of claim 25, wherein respective non-electrically insulated end portions of the prosthetic valve coil define the cathode and the anode.
28. The prosthetic aortic valve according to claim 25, wherein the prosthetic aortic valve does not include any active electronic components.
29. The prosthetic aortic valve according to claim 25, wherein the central longitudinal axis passes through a space surrounded by the prosthetic valve coil when the prosthetic aortic valve is in the expanded fully deployed configuration.
30. The prosthetic aortic valve according to claim 25, wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a downstream-most point of mechanical coupling between the prosthetic valve coil and the frame and (b) a centroid of the cathode are rotationally aligned with each other or rotationally offset from each other by less than 50 degrees about the central longitudinal axis.
31. The prosthetic aortic valve of claim 25, wherein the cathode is located along the frame upstream of the anode.
32. The prosthetic aortic valve according to any one of claims 25 to 31,
wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, the frame is shaped so as to define:
(a) An upstream inflow portion of the housing,
(b) Downstream outflow portion, and
(c) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein a free edge of the prosthetic leaflet faces the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration, and
wherein the cathode is coupled to the upstream inflow portion of the frame.
33. The prosthetic aortic valve according to any one of claims 25 to 31,
wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, the frame is shaped so as to define:
(a) An upstream inflow portion of the housing,
(b) Downstream outflow portion, and
(c) A constriction axially between the upstream inflow portion and the downstream outflow portion, wherein the prosthetic leaflet is coupled to the constriction, and wherein when the prosthetic aortic valve is in the expanded fully deployed configuration, (a) a free edge of the prosthetic leaflet faces the downstream outflow portion, and (B) an annular longitudinal boundary between the downstream outflow portion and the constriction is defined by a downstream-most point of the frame to which the prosthetic leaflet is coupled, and
Wherein a downstream-most point of mechanical coupling between the prosthetic valve coil and the frame is located on the downstream outflow portion when the prosthetic aortic valve is in the expanded fully deployed configuration.
34. The prosthetic aortic valve according to claim 33, wherein an upstream-most point of mechanical coupling between the prosthetic valve coil and the frame is located on the narrowed portion when the prosthetic aortic valve is in the expanded fully deployed configuration.
35. A valve prosthesis system comprising the prosthetic aortic valve according to any one of claims 25 to 31, the valve prosthesis system further comprising an external unit configured to be disposed outside the body of the patient, and the external unit comprising:
an energy transmission coil; and
an external unit control circuit configured to drive the energy transmission coil to wirelessly transmit energy to the prosthetic valve coil by means of inductive coupling.
36. The valve prosthesis system of claim 35, wherein the external unit control circuit is configured to drive the cathode and the anode to apply a pacing signal to the patient's heart by wirelessly transmitting the energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling.
37. The valve prosthesis system of claim 36,
wherein the external unit further comprises a heart sensor, and
wherein the external unit control circuit is configured to:
detecting at least one cardiac parameter using the cardiac sensor, and
parameters of the pacing signal are set by wirelessly transmitting the energy from the energy transmission coil to the prosthetic valve coil by means of inductive coupling at least partially in response to the detected at least one cardiac parameter.
38. The valve prosthesis system of claim 37, wherein the heart sensor comprises at least two sensing skin ECG electrodes.
39. The valve prosthesis system of claim 35,
wherein the external unit control circuit is configured to wirelessly transmit the energy by generating a plurality of AC pulses, each AC pulse comprising an AC burst, and
wherein the prosthetic aortic valve comprises a passive diode coupled in electrical communication with the prosthetic valve coil and configured to rectify current in the prosthetic valve coil.
40. The valve prosthesis system of claim 39, wherein the external unit control circuit is configured to generate the AC bursts at a frequency between 3kHz and 130 kHz.
41. The valve prosthesis system of claim 39, wherein the external unit control circuit is configured to include 20 to 100 AC bursts in each of the AC pulses.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17/142,729 | 2021-01-06 | ||
| US17/328,588 US11291844B2 (en) | 2018-01-08 | 2021-05-24 | Prosthetic aortic valve pacing system |
| US17/328,588 | 2021-05-24 | ||
| PCT/IL2022/050019 WO2022149130A1 (en) | 2021-01-06 | 2022-01-05 | Prosthetic aortic valve pacing systems |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117062584A true CN117062584A (en) | 2023-11-14 |
Family
ID=88655872
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202280019121.3A Pending CN117062584A (en) | 2021-01-06 | 2022-01-05 | Prosthetic aortic valve pacing system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117062584A (en) |
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2022
- 2022-01-05 CN CN202280019121.3A patent/CN117062584A/en active Pending
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