Artificial valve

• US 9,452,045 B2
• Filed: 10/12/2009
• Issued: 09/27/2016
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Kirk Promotion Ltd.
• Inventors: Forsell, Peter
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/123,667
• Publication Number:
  US 20110202129A1
• Time in Patent Office: 2,542 Days
• Field of Search: 623/2.11, 623 22- 234, 623 31- 33, 600/16
• US Class Current: 1/1
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/205 Non-positive displacement blood pumps
• CPC Class Codes: A61M 60/405 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/873 specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves

Abstract

The invention discloses an artificial valve (10, 20) for implantation in a mammal aorta or heart as an auxiliary aortic valve in addition to an aortic valve. The artificial valve (10, 20) comprises at least a first (12,17) moving part adapted to be able to move to assume an open and a closed position for opening and closing, respectively, of the blood flow through a blood vessel. The artificial valve (10, 20) also comprises a casing (14, 24), and said at least one first (12,17) moving part is movably attached to said casing (14, 24). The artificial valve (10, 20) is adapted to let the at least one moving part initiate its movement to the open position at a level of blood pressure on a blood supplying side of the valve which is at least 5 mm Hg higher than the mammal'"'"'s diastolic aortic blood pressure on the other side of the valve.

Claims

1. An artificial valve for implantation in a mammal aorta, comprising an auxiliary artificial aortic valve adapted to together with an normal aortic heart valve to increase blood flow to the coronary arteries, when placed in the mammal aorta,

wherein the auxiliary artificial aortic valve is adapted to be placed in the aorta between the exit to the coronary arteries and the exit to the carotid arteries as an auxiliary aortic valve in addition to the aortic heart valve,

wherein the artificial auxiliary aortic valve comprising;

at least a first moving part, adapted to move to an open and a closed position, respectively, to open and close the blood flow through the aorta,

a casing, in which said at least one first moving part is movably attached to said casing, and

a control device, adapted to control the movement of the first moving part to control the opening and closing of the auxiliary artificial aortic valve, and

wherein the control device is constructed and configured to control the at least one first moving part to initiate the movement to the closed position at a point in the mammal'"'"'s cardiac cycle which is delayed compared to the closing of a normal aortic heart valve, when the auxiliary artificial aortic valve is implanted in the aorta between the exit to the coronary arteries and the exit to the carotid arteries,

a passive resistance mechanism arranged to create a barrier force corresponding to a level of blood pressure on a blood supplying side of the valve which is at least 5 mm Hg higher than the mammal'"'"'s diastolic aortic blood pressure on the other side of the valve, wherein the passive resistance mechanism is arranged to prevent the movement of the at least one moving part to an open position before said barrier force has been reached.

2. The artificial valve of claim 1, being adapted to let the at least one moving part initiate the movement being delayed, compared to the normal aortic heart valve, by at least ⅓

of the mammal'"'"'s heart'"'"'s diastolic phase.

3. The artificial valve of claim 1, wherein the at least one moving part is adapted to be opened by the blood flow at said level of blood pressure, and wherein the artificial valve is adapted to let said at least one first moving part move freely after said barrier force has been reached.

4. The artificial valve of claim 3, in which the passive resistance mechanism is arranged to offer resistance until said predetermined level of the barrier force is reached.

5. The artificial valve of claim 3, in which the passive resistance mechanism is arranged to only offer resistance in the opening movement of said at least one first moving part.

6. The artificial valve of claim 1, additionally comprising at least one of:

a second moving part, in which artificial valve the moving parts come together to form a cupola in the closed position of the artificial valve, and

two or more additional moving parts, at least a second and third moving part, in which artificial valve the moving parts come together to form a cupola in the closed position of the artificial valve.

7. The artificial valve of claim 1, wherein the at least one first moving part comprises two or more moving parts, in which each of said moving parts is movably hinged about respective first and second hinges in said casing, about which hinges each of said moving parts can move to assume a closed and an open position as well as positions in between said open and closed positions, said first and second hinges of at least one of the moving parts being positioned at or adjacent to a meeting point of two of said parts.

8. The artificial valve of claim 7, in which the first and second hinges of at least one of said moving parts are placed at substantially opposite distal ends of said moving part along the casing.

9. The artificial valve of claim 1, in which the first moving part comprises an elongated essentially flat plate which is adapted to, when the valve is arranged in or adjacent to an opening in said blood vessel, move in a direction essentially perpendicular to said blood vessel to limit or close the blood flow through said vessel, with at least a portion of said first moving part assuming a position external to said blood vessel in a non-closed position, in which a closing mechanism is housed in the casing, with the first moving part being adapted to protrude from the housing in its closing movements, the first moving part further comprising a biasing mechanism for biasing the flat plate to an open position.

10. The artificial valve of claim 1, wherein the artificial valve is adapted to be at least partly an active artificial valve, adapted to be powered, and comprising a receiving device, adapted to receive a signal by at least one of:

cabling and wirelessly,

the receiving device being adapted to perform an interpretation of the signal, to serve as the basis for opening or closing the artificial valve or to keep the artificial valve open or closed,

wherein the signal is received as the result of at least one of;

the blood pressure or blood flow at a defined point in the circulatory system of the user of the valve reaching a predetermined threshold,

a parameter related to the contraction of a muscle at a defined point in the user of the valve reaching a predetermined threshold,

a body or device generated parameter related to the contraction of a heart muscle reaching a predetermined threshold,

one or more predefined body generated parameters related to at least one of;

blood pressure, heart contractions, movement, bending, volume and heart electrical body generated signals, a device generated signal generated by a pacemaker, and

a sensor sensing the appropriate parameter and generating said signal to the receiving device of the valve, and

a sensor for sensing one or more parameters, such as a physical parameter of the mammal or a functional parameter of the receiving device.

11. The artificial valve of claim 10, further comprising an operating mechanism which is adapted to power the at least one moving part, so that at least a part of the function of the artificial valve is active, said powering being done at least in part by means of a power source external to said blood vessel.

12. The artificial valve of claim 11, wherein the operating mechanism comprises at least one of:

one or more magnets adapted to receive energy from the energy device as a first pulse, said one or more magnets further being adapted to receive one or more additional pulses with a time delay in relation to said first pulse to affect said kinetic movement of said at least one first moving part,

one or more coils which is/are adapted to be energized or energized stepwise so as to affect said movement of the at least one first moving part,

one or more magnets or one or more coils, which is/are adapted to interact with the at least one moving part to affect the closing, opening or closing and opening of said valve,

at least two magnets, wherein said closing mechanism being adapted to receive energy from the energy source as a first pulse, the at least two magnets further being adapted to receive one or more additional pulses with a time delay in relation to said first pulse to affect a different magnet or a different group of magnets than said first pulse to control the first moving part, and

magnets or coils arranged at intervals in the casing along an intended path of movement of the moving part.

13. The artificial valve according to claim 11, comprising a drive unit for at least partly powering the valve movements, adapted to be placed outside a blood stream, including being placed outside a blood vessel, the aorta and the heart, said drive unit being adapted to supply wireless or magnetic energy, said valve being adapted to receive said wireless or magnetic energy to control the movement of said artificial valve.

14. The artificial valve of claim 11, in which said operating mechanism comprises at least one of:

one or more magnets and one or more coils, which are adapted to interact with the movement of the at least one moving part of the artificial valve.

15. The artificial valve according to claim 11, comprising an electric wire adapted to connect the valve, including the operating mechanism or a drive unit, to an internal energy source, said wire being adapted to pass into the right atrium of the heart and further up into the venous blood vessel system, and being adapted to exit the blood vessel system in or closer to the subcutaneous area, and wherein said internal energy source is adapted to be connected to said wire in the subcutaneous area.

16. The artificial valve of claim 10, wherein the interpretation of the received signal, to serve as the basis for opening or closing the valve, or to keep the valve open or closed, being adapted to be achieved by means of comparing the received signal to one or more threshold levels to see if the valve should open or close, or remain open or closed.

17. The artificial valve of claim 10, wherein the receiving device comprises a control device adapted to control the operating mechanism in order to control the opening and closing of the valve and the movement of the moving parts, the control device being thus adapted to receive the input signal, and further adapted to process the signal and control the operation of the valve accordingly.

18. The artificial valve of claim 17, further comprising a sensor adapted to sense a physical parameter of the mammal or a functional parameter of the device, and in which the control device controls the operating mechanism using parameters sensed by the sensor.

19. The artificial valve according to claim 10, wherein an energy receiver or internal energy source is adapted to be placed in the abdomen, thorax or subcutaneously.

20. The artificial valve of claim 1, in which said at least one moving part comprises at least one of:

titanium material,

a structured surface, thereby allowing growth of mammal material upon them, and

mammal valve material to cover the moving parts.

21. The artificial valve according to claim 1, further adapted to be inserted into the mammal'"'"'s femoral artery and to be released inside of the aorta.

22. The artificial valve of claim 1, comprising a drive unit for at least partly powering the artificial valve, adapted to be placed inside the blood stream, including inside a blood vessel, the aorta and the heart, wherein said drive unit is adapted to supply wireless or magnetic energy, said valve being adapted to receive said wireless or magnetic energy to control movements of said valve.

23. The artificial valve of claim 1, adapted to close said at least one first moving part either by a non-powered movement, passively, by a return flow of blood in the relaxation phase of the heart, or by a powered movement, when a parameter in question has reached a certain value, and a sensor is used to sense when the parameter in question has reached the correct level for closing.

24. The artificial valve of claim 1, comprising an operating mechanism adapted to cause operation of the at least one moving part, the artificial valve comprising a control device adapted to control the operating mechanism in order to control the opening and closing of the valve and the movement of the moving parts, the control device being adapted to receive an input signal, process the signal, and control the operation of the valve in response to the received, processed signal.

25. The artificial valve of claim 24, wherein the control device comprises a processor and a memory for storing executable code and parameters which are relevant to the operation of the valve.

26. The artificial valve of claim 24, wherein the control device controls the operating mechanism, the control device being adapted to use input parameters received via a receiving device, sensed by an internal sensor, or received via a receiving device and sensed by an internal sensor, wherein the sensor being adapted to sense a physical parameter of the mammal or a functional parameter of a device, and the control device is adapted to control the operating mechanism using parameters sensed by the sensor, when implanted in the mammal body.

27. The artificial valve of claim 1, comprising a closing mechanism, wherein a powered movement is obtained by coils and cooperating magnets to obtain the closing mechanism.

28. The artificial valve of claim 1, comprising an internal control adapted to be programmable from outside the patient'"'"'s body and further adapted to regulate the apparatus according to input from any sensor sensing any possible physical parameter of the patient or any functional parameter of the system.

29. The artificial valve of claim 28, comprising a switch comprising at least one of:

a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any other electronic component or circuit that may switch the power on and off, the switch being controlled by or part of the implanted internal control unit.

30. The artificial valve of claim 1, comprising a feedback device, comprising a sensor or measuring device adapted to be implanted in the patient for sensing at least one of:

a physical parameter of the patient being at least one selected from the group consisting of pressure, volume, diameter, stretching, elongation, extension, movement, bending, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, heartbeats and breathing, and

a functional parameter selected from at least one in the group of parameters consisting of;

electricity, any electrical parameter, pressure, volume, diameter, stretch, elongation, extension, movement, bending, elasticity, temperature, flow and a parameter correlated to the transfer of energy for charging an implanted energy source, and

wherein the feedback may be sent to an internal control unit or out to an external control unit preferably via the internal control unit.

31. The artificial valve of claim 1, wherein the artificial valve is part of a system comprising an external data communicator and an implantable internal data communicator communicating with the external data communicator, the internal communicator feeding data related to the apparatus or the patient to the external data communicator and/or the external data communicator feeding data to the internal data communicator.

32. The artificial valve of claim 1, wherein the artificial valve is part of a system comprising an energy receiver comprising at least one of:

an energy source and an energy-transforming device, the energy receiver being adapted to receive wireless energy being transmitted from an external energy source located outside the patient and being received by the internal energy receiver located inside the patient.

33. The artificial valve of claim 32, further comprising a drive unit adapted to supply wireless or magnetic energy to said valve, thereby causing movement of said valve, and wherein the drive unit is adapted to be connected to the energy receiver or source of energy for powering said drive unit.

34. The artificial valve according to claim 1, comprising:

an internal control unit, and

a sensor sensing physiological electrical pulses or muscle contractions of the heart,

said internal control unit controlling said valve according to the sensed physiological electrical pulses or muscle contractions of the heart.

35. The artificial valve according to claim 1, in which an internal energy source is adapted to be controlled by an internal control unit adapted to transmit energy pulses to an electrode for achieving and controlling heart contractions, and wherein said internal control unit is adapted to coordinate the valve including an operating mechanism or a drive unit.

36. The artificial valve according to claim 1, wherein the artificial valve is adapted to be part of a system comprising an implantable internal energy source for powering implantable energy consuming components of the apparatus.

37. The artificial valve according to claim 36, wherein the artificial valve is adapted to be part of a system comprising an external energy source for transferring energy in a wireless mode, wherein the internal energy source is chargeable by the energy transferred in the wireless mode, and further comprising a sensor or measuring device sensing or measuring a functional parameter correlated to the transfer of energy for charging the internal energy source, and a feedback device for sending feedback information from inside the patient'"'"'s body to the outside thereof, the feedback information being related to the functional parameter sensed by the sensor or measured by the measuring device.