Artificial valve for implantation and related methods

• US 8,147,543 B2
• Filed: 11/01/2006
• Issued: 04/03/2012
• Est. Priority Date: 11/02/2005
• Status: Active Grant

• Current Assignee: Thoraxica AG
• Original Assignee: Thoraxica AG
• Inventors: Forsell, Peter
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/591,290
• Publication Number:
  US 20070225802A1
• Time in Patent Office: 1,980 Days
• Field of Search: 623 315- 324, 623 22- 234, 623/2.1, 137/625.3, 137/625.31, 251/208
• US Class Current: 623/2.28
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

An artificial valve (100) and related methods are provided for implantation in a patient'"'"'s blood vessel (200), in particular an artificial heart valve, including a first (10) and a second (20) valve member each having a first smooth surface (11, 21) facing each other so as to form a sealing contact between the first and second valve members and further having at least one blood flow passage (13, 23a) extending from the first surface to a second surface (12, 22) located on an opposite side of the respective valve member, wherein at least one (10) of the valve members is arranged so as to be displaceable relative to the other (20) valve member in a slidable manner such that the passage (23a) of the second valve (20) member can be brought into at least partial alignment with the passage (13) of the first valve member (10) while maintaining the sealing contact between the first and second valve members, and a displacing mechanism (M; 50-56) for the relative displacement of the valve members (10, 20). The valve members can be made from ceramics. A valve system comprises the artificial valve (100) and additional components such as a motor (M), an energy source (E), a control unit (C), a pressure sensor (P), a feed back system and/or an alarm system.

Claims

1. An artificial valve for implantation in a patient'"'"'s blood vessel comprising:

a first valve member of the artificial valve,

a second valve member of the artificial valve,

each of the first and second valve members having a first smooth surface on a first side of the respective valve member and a second surface on a second side of the respective valve member, opposite the first side of the respective valve member,

the first smooth surface of the first valve member facing the first smooth surface of the second valve member so as to form a sealing contact between the first and second valve members,

each of the first and second valve members further having at least one blood flow passage extending from the first surface of the respective valve member, completely through the respective valve member to the second surface of the respective valve member,

at least one of the first and second valve members being arranged so as to be displaceable relative to the other valve member in a slidable manner, such that the blood flow passage of the second valve member can be brought into at least partial alignment with the blood flow passage of the first valve member while maintaining the sealing contact between the first and second valve members, and

a displacing mechanism of the artificial valve for the displacement of the first and second valve members relative to one another, the displaceable arrangement of the first and second valve members relative to one another being such that the at least one displaceably arranged valve members is continuously slidable in one direction.

2. The artificial valve of claim 1, further comprising a third valve member having a first smooth surface arranged to form a sealing contact with the second surface of the first valve member and further having at least one blood flow passage extending from the first surface to a second surface located on an opposite side of the third valve member, wherein the third valve member is arranged so as to be displaceable relative to the first valve member in a slidable manner such that the passage of the third valve member can be brought into at least partial alignment with the passages of the first and second valve members while maintaining the sealing contact between the first and third valve members.

3. The artificial valve of claim 2, further comprising at least one further valve member having a first smooth surface for sealingly contacting a second surface of one of the other valve members and further having a blood flow passage for at least partial alignment with the passages of the other valve members.

4. The artificial valve of claim 1, wherein the valve members are rotatably slidable so as to allow for the at least partial alignment of their blood flow passages.

5. The artificial valve of claim 4, wherein the passages of the valve members are identically arranged about a common axis.

6. The artificial valve of claim 4, wherein the passages of the valve members have an interrupted or uninterrupted angular extension of exactly or preferably somewhat less than 360.times.n/(n+1) degrees, where n is the number of the displaceably arranged valve members.

7. The artificial valve of claim 4, wherein the passages of at least one of the valve members are divided into angularly extending sections by means of radially extending bridges.

8. The artificial valve of claim 7, wherein the number of bridges is n−

1, where n is the number of the displaceably arranged valve members.

9. The artificial valve of claim 7, wherein the number of bridges is larger than n−

1, where n is the number of the displaceably arranged valve members.

10. The artificial valve of claim 9, wherein the bridges of each valve member each have a center line, wherein the center lines are arranged about the common axis at an equal angular distance and the bridges each have an angular extension equal to or preferably somewhat larger than the angular extension of each of the sections of the angularly extending passages.

11. The artificial valve of claim 1, wherein at least two of the surfaces together forming a sealing contact are parallel.

12. The artificial valve of claim 11, wherein the sealing contact is overall flat.

13. The artificial valve of claim 1, wherein at least two of the surfaces together forming a sealing contact have a concave and convex shape, respectively.

14. The artificial valve of claim 1, wherein the valve members are made of a material inert enough to maintain over time a low friction between the surfaces forming the sealing contact.

15. The artificial valve of claim 14, wherein the material comprises a ceramic material.

16. The artificial valve of claim 1, wherein the sealing contact formed by two of the surfaces withstands without leaking an internal positive blood pressure of at least 80 mmHg (1.05 N/cm2).

17. The artificial valve of claim 16, wherein the two surfaces together forming said sealing contact each have a maximum roughness good enough to substantially avoid leakage through said sealing contact.

18. The artificial valve of claim 16, wherein the two surfaces together forming said sealing contact each have a maximum unevenness over the entire contact area good enough to substantially avoid leakage through said sealing contact.

19. The artificial valve of claim 16, wherein with respect of the two surfaces together forming said sealing contact, the minimum contact length between one of the corresponding passages and an outer border of one of the two surfaces is large enough to substantially avoid leakage through said sealing contact.

20. The artificial valve of claim 1, comprising at least one pretensioning element by which the valve members are urged together.

21. The artificial valve of claim 1, wherein an exposed surface of the valve on the upstream or downstream side or upstream and downstream side of the valve is designed to provide for a laminar blood flow along the entire surface area under in vivo conditions.

22. The artificial valve of claim 1, wherein the displacing mechanism is a blood-pressure driven mechanism, which is mechanically driven by forces exerted by the blood pressure.

23. The artificial valve of claim 22, wherein the blood-pressure driven displacing mechanism comprises a pressure transforming member arranged for transforming, when the valve is implanted in a patient'"'"'s blood vessel, a blood pressure change into relative movement of the displaceably arranged valve members.

24. The artificial valve of claim 23, wherein the pressure transforming member comprises a pressure plate or diaphragm arranged to be moveable by changes of the blood pressure acting on the valve, and mechanically coupled to at least one of the displaceably arranged valve members.

25. The artificial valve of claim 24, wherein the pressure plate or diaphragm is positioned on an upstream side of the valve and coupled to the at least one of the valve members such that increased blood pressure acting on the valve on the upstream side of the valve causes the pressure plate or diaphragm to move in a downstream direction and thereby further causes at least partial alignment of the passages of the valve members.

26. The artificial valve of claim 24, wherein the pressure transforming member comprises a pressure plate or diaphragm positioned on a downstream side of the valve and coupled to the at least one of the valve members such that increased blood pressure acting on the valve on the downstream side of the valve causes disalignment of the passages of the valve members.

27. The artificial valve of claim 24, wherein the pressure plate or diaphragm is positioned on an upstream side of the valve and coupled to the at least one of the valve members such that increased blood pressure acting on the valve on the upstream side of the valve causes the pressure plate or diaphragm to move in a downstream direction and thereby further causes at least partial alignment of the passages of the valve members, and wherein the pressure transforming member comprises a pressure plate or diaphragm positioned on a downstream side of the valve and coupled to the at least one of the valve members such that increased blood pressure acting on the valve on the downstream side of the valve causes disalignment of the passages of the valve members, and wherein the pressure plate or diaphragm on the upstream side of the valve is rigidly connected to the pressure plate or diaphragm on the downstream side of the valve.

28. The artificial valve of claim 24, wherein resilient means are provided for urging the pressure plate or diaphragm positioned on the upstream side in an upstream direction.

29. The artificial valve of claim 1, wherein the displacing mechanism comprises a motor for bringing the blood flow passages of the valve members into and out of alignment.

30. The artificial valve of claim 29, wherein the motor is incorporated in the valve.

31. The artificial valve of claim 30, wherein the motor is contained within a valve housing formed and sealed against blood ingression by the valve members.

32. The artificial valve of claim 29, wherein the motor is arranged for being driven by an electromagnetic field.

33. The artificial valve of claim 29, wherein means are provided to urge the blood flow passages into at least partial alignment when the motor is not energized.

34. The artificial valve of claim 29, wherein the displacing mechanism is provided with an energy source for the motor, said energy source to be implanted in a blood vessel along with the valve.

35. The artificial valve of claim 34, wherein the energy source for the motor comprises a blood flow energy transforming device for transforming blood flow energy into electrical energy, when the energy source is implanted in a patient'"'"'s blood vessel.

36. The artificial valve of claim 35, wherein the blood flow energy transforming device comprises an impeller.

37. The artificial valve of claim 35, wherein the displacing mechanism further comprises an energy storage device for temporarily storing the transformed electrical energy.

38. The artificial valve of claim 37, wherein the energy source includes a capacitor.

39. The artificial valve of claim 34, wherein the energy source comprises a rechargeable battery.

40. The artificial valve according to claim 29 further comprising a control unit for controlling the motor of the valve so as to bring the blood flow passages into and out of alignment in conformity with a control signal.

41. The artificial valve of claim 40, wherein the control unit is adapted for controlling the motor from outside the patient'"'"'s body.

42. The artificial valve of claim 40, wherein the control unit is adapted for implantation inside the patient'"'"'s body outside the blood vessel.

43. The artificial valve of claim 40, wherein the control unit is adapted for implantation inside the blood vessel.

44. The artificial valve of claim 43, wherein the control unit is integrated in the artificial valve.

45. The artificial valve of claim 40, further comprising a control signal transmission device for wireless transmission of the control signal.

46. The artificial valve of claim 45, comprising a data transmission interface for wirelessly transmitting data from outside the patient'"'"'s body to the control unit inside the patient.

47. The artificial valve of claim 45, wherein the wireless control signal and/or data transmission comprises an electromagnetic wave signal, including at least one of an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma radiation signal.

48. The artificial valve of claim 45, wherein the wireless control signal comprises a sound or ultrasound wave signal.

49. The artificial valve of claim 45, wherein the wireless control signal comprises a digital or analog signal or a combination thereof.

50. The artificial valve of claim 40, adapted to transmit the control signal in the same manner as energy is transmitted to the motor.

51. The artificial valve of claim 50, adapted for transmitting the control signal by modulation of an energy signal.

52. The artificial valve of claim 40, adapted to provide the control signal as at least one of a frequency, phase and amplitude modulated signal.

53. The artificial valve of any of claims 50 to 52, wherein the control signal is influenced by external signals.

54. The artificial valve of claim 53, wherein the control signal relates to a blood pressure signal.

55. The artificial valve of claim 54, further comprising a blood pressure sensor, said blood pressure sensor providing the blood pressure signal, when the system is installed on a patient.

56. The artificial valve of claim 55, wherein the blood pressure sensor is arranged on an upstream side of the valve.

57. The artificial valve of claim 55, wherein the blood pressure sensor is fixed to the valve.

58. The artificial valve of claim 56, wherein the blood pressure sensor is provided for being located in a heart chamber.

59. The artificial valve of claim 53, wherein the control signal relates to a pacemaker signal.

60. The artificial valve of claim 40, further comprising a pacemaker, said pacemaker, when the system is installed on a patient, directly providing the control signal or influencing the control signal.

61. The artificial valve of claim 40, wherein the control unit is freely programmable so as to be flexibly adaptable to provide control signals for the motor according to changing demands.

62. The artificial valve of claim 61, wherein the control unit is programmable from outside the patient'"'"'s body.

63. The artificial valve of claim 61, comprising a programming unit adapted for programming the control unit.

64. The artificial valve of claim 62, wherein the control unit is adapted for implantation inside the patient'"'"'s body and is programmable by wireless remote control.

65. The artificial valve of claim 40, wherein the control unit is adapted to provide feedback information.

66. The artificial valve of claim 65, wherein the feedback information relates to physiological data of the person, such as blood pressure data.

67. The artificial valve of claim 65, wherein the feedback information relates to technical data of the valve system.

90. The valve system of claim 54, further comprising an alarm system.

91. The valve system according to claim 90, wherein the alarm system comprises a blood pressure sensor.

92. The valve system of claim 91, wherein the blood pressure sensor is arranged on an upstream side of the valve.

93. The valve system of claim 91, wherein the blood pressure sensor is fixed to the valve.

94. The valve system of claim 92, wherein the blood pressure sensor is provided for being located in a heart chamber, when the system is installed on a patient.

68. A valve system comprising an artificial valve for implantation in a patient'"'"'s blood vessel comprising:

a first valve member of the artificial valve,

a second valve member of the artificial valve,

each of the first and second valve members having a first smooth surface on a first side of the respective valve member and a second surface on a second side of the respective valve member, opposite the first side of the respective valve member,

the first smooth surfaces of the first and a second valve members facing each other so as to form a sealing contact between the first and second valve members,

the first and second valve members further having at least one blood flow passage extending completely through the respective valve member from the first surface of the respective valve member to the second surface of the respective valve member,

at least one of the valve members being arranged so as to be displaceable relative to the other valve member in a slidable manner such that the blood flow passage of the second valve member can be brought into at least partial alignment with the blood flow passage of the first valve member while maintaining the sealing contact between the first and second valve members, and

a displacing mechanism of the artificial valve for the relative displacement of the first and second valve members, the displacing mechanism comprising a motor for displacing the at least one displaceably arranged valve member continuously in one direction and thereby bringing the blood flow passages of the first and second valve members into and out of alignment, and

an energy source for providing the motor with energy from outside the blood vessel.

69. The valve system of claim 68, wherein the energy source is adapted to provide energy from outside the patient'"'"'s body to the motor for use by the motor at the time the energy is transferred.

70. The valve system of claim 69, further comprising an energy transmission device for wireless energy transfer from the energy source outside the patient'"'"'s body to the motor.

71. The valve system of claim 68, wherein the energy source comprises energy storage means.

72. The valve system of claim 71, further comprising an energy transmission device for wireless energy transfer from the energy storagemeans to the motor.

73. The valve system of claim 72, further comprising an energy transmission device for wireless energy transfer from outside the patient'"'"'s body to the energy storage means, said energy storage means being adapted to be implanted inside the patient'"'"'s body.

74. The valve system of claim 70 or 72, wherein the energy transmission device for wireless energy transfer is adapted to generate an electromagnetic field.

75. The valve system of claim 70 or 72, wherein the energy transmission device for wireless energy transfer is adapted to generate a magnetic field.

76. The valve system of claim 70 or 72, wherein the energy transmission device for wireless energy transfer is adapted to generate an electrical field.

77. The valve system of claim 70 or 72, wherein the energy transmission device for wireless energy transfer transmits energy by at least one wireless signal.

78. The valve system of claim 77, wherein the wireless energy signal comprises an electromagnetic wave signal, including at least one of an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a micro wave signal, a microwave signal, an X-ray radiation signal, and a gamma radiation signal.

79. The valve system of claim 77, wherein the wireless energy signal comprises a sound or ultrasound wave signal.

80. The valve system of claim 77, wherein the wireless energy signal comprises a digital or analog signal or a combination thereof.

81. The valve system of claim 71, wherein the energy storage means comprises at least one of a battery, a capacitor, a rechargeable battery and any other type of accumulator.

82. The valve system of claim 71, wherein the energy storage means is adapted to be implanted inside the patient'"'"'s body.

83. The valve system of claim 82, wherein the energy storage means is adapted to be implanted inside the blood vessel.

84. The valve system of claim 82, wherein the energy storage means is adapted to be implanted outside the blood vessel.

85. The valve system of claim 82, further comprising galvanic coupling elements adapted to connect the energy storage means, when implanted inside the patient'"'"'s body, to an extra corporal primary energy source for transmitting energy to the energy storage means in contacting fashion.

86. The valve system of claim 85, further comprising the extra corporal primary energy source.

87. The valve system of claim 68, wherein the motor is adapted to directly transform the wirelessly transferred energy into kinetic energy.

88. The valve system of claim 68, comprising a transforming device for transforming wirelessly transferred energy into electric energy.

89. The valve system of claim 68, further comprising galvanic coupling elements for coupling with the motor for transmitting energy to the motor in contacting fashion.