Controlled heartburn and reflux disease treatment

• US 6,463,935 B1
• Filed: 02/10/2000
• Issued: 10/15/2002
• Est. Priority Date: 02/10/2000
• Status: Expired due to Term

• Current Assignee: Obtech Medical AG
• Original Assignee: Obtech Medical AG
• Inventors: Forsell, Peter
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Cadugan, Joseph A.
• Application Number:
  US09/501,571
• Time in Patent Office: 978 Days
• Field of Search: 128/897-899, 600/29-32, 600/37, 600/593, 604/27-28, 606/139-141, 606/151, 606/157, 606/201-203, 606/213, 606/228, 607/41
• US Class Current: 128/899
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04

Abstract

A heartburn and reflux disease treatment apparatus and method include and utilize: an operable restriction device implanted in a patient and engaging the stomach close to the cardia or engaging the esophagus to form a restricted passageway in the stomach or esophagus, a source of energy for energizing the restriction device, and a control device for releasing energy from the source of energy from outside the patient'"'"'s body. The released energy is used in connection with the operation of the restriction device including to enlarge or contract the restricted passageway.

Claims

1. A heartburn and reflux disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient having heartburn and reflux disease to engage the esophagus or the stomach close to the cardia without forming an upper pouch of the stomach that substantially accumulates food to form a restricted food passageway in the stomach or esophagus, said restriction device being designed to work like an artificial sphincter to allow food to readily pass through the passageway,

a source of energy, and

a control device operable from outside the patient'"'"'s body for releasing energy from said source of energy for use in operating said restriction device to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus.

2. The apparatus according to claim 1, wherein said control device controls said restriction device.

3. The apparatus according to claim 2, wherein said control device comprises an internal control unit adapted to be implanted in the patient for controlling said operation device.

4. The apparatus according to claim 3, wherein said internal control unit is programmable.

5. The apparatus according to claim 4, wherein said control device comprises an external control unit outside the patient'"'"'s body, said internal control unit being programmable by said external control unit.

6. The apparatus according to claim 5, wherein said external control unit loads said internal control unit with data in accordance with a loading mode only authorized for a doctor.

7. The apparatus according to claim 5, wherein said external control unit controls said internal control unit in accordance with a doctor mode only authorized for a doctor.

8. The apparatus according to claim 5, wherein said external control unit controls said internal control unit in accordance with a patient mode permitted for the patient.

9. The apparatus according to claim 4, wherein said internal control unit is programmable for controlling said restriction device over time.

10. The apparatus according to claim 9, wherein said internal control unit controls said restriction device over time in accordance with an activity schedule program.

11. The apparatus according to claim 9, wherein said internal control unit comprises a microprocessor.

12. The apparatus according to claim 1, further comprising an operation device adapted to be implanted in the patient for operating said restriction device, wherein said control device controls said operation device to operate said restriction device.

13. The apparatus according to claim 12, wherein said operation device comprises hydraulic means and at least one valve for controlling a fluid flow in said hydraulic means.

14. The apparatus according to claim 13, wherein said control device comprises a wireless remote control for controlling said valve.

15. The apparatus according to claim 12, wherein said restriction device comprises hydraulic means and said operation device comprises a reservoir forming a fluid chamber with a variable volume connected to said hydraulic means, and said operation device distributes fluid from said chamber to said hydraulic means by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

16. The apparatus according to claim 12, wherein said source of energy is adapted to be external to the patient'"'"'s body and said control device releases wireless energy from said external source of energy.

17. The apparatus according to claim 16, wherein said operation device comprises a motor.

18. The apparatus according to claim 17, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

19. The apparatus according to claim 17, wherein said motor comprises a linear motor.

20. The apparatus according to claim 17, wherein said motor comprises a hydraulic or pneumatic fluid motor, and said control device controls said fluid motor.

21. The apparatus according to claim 17, wherein said motor comprises an electric motor having electrically conductive parts made of plastics.

22. The apparatus according to claim 16, wherein said control device releases polarized energy from said external source of energy.

23. The apparatus according to claim 16, wherein said control device shifts polarity of said released energy to reverse said operation device.

24. The apparatus according to claim 16, wherein said operation device comprises an electric motor and said released energy comprises electric energy.

25. The apparatus according to claim 16, wherein said restriction device is operable to perform a reversible function.

26. The apparatus according to claim 25, further comprising a reversing device adapted to be implanted in the patient for reversing said function performed by said restriction device.

27. The apparatus according to claim 26, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

28. The apparatus according to claim 27, wherein said reversing device comprises a switch.

29. The apparatus according to claim 28, wherein said switch is operable by said released energy.

30. The apparatus according to claim 29, wherein said control device controls the operation of said switch by shifting polarity of said released energy supplied to said switch.

31. The apparatus according to claim 26, wherein said reversing device comprises a mechanical reversing device.

32. The apparatus according to claim 31, wherein said mechanical reversing device comprises a switch.

33. The apparatus according to claim 31, wherein said reversing device comprises a gear box.

34. The apparatus according to claim 26, wherein said reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in said hydraulic means.

35. The apparatus according to claim 28, wherein said switch comprises an electric switch and said source of energy supplies electric energy for the operation of said switch.

36. The apparatus according to claim 28, wherein said operation device comprises a motor, and said reversing device reverses said motor.

37. The apparatus according to claim 16, further comprising a battery adapted to be implanted in the patient for supplying electric energy to implantable electric energy consuming components of the apparatus.

38. The apparatus according to claim 16, further comprising an energy storage device adapted to be implanted in the patient for storing said wireless energy released from said external source of energy.

39. The apparatus according to claim 38, wherein said energy storage device comprises an accumulator.

40. The apparatus according to claim 39, wherein said accumulator comprises an electric accumulator.

41. The apparatus according to claim 40, wherein said electric accumulator comprises at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

42. The apparatus according to claim 16, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

43. The apparatus according to claim 42, wherein said operation device comprises a motor for driving said pump.

44. The apparatus according to claim 43, wherein said operation device comprises a fluid conduit between said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

45. The apparatus according to claim 44, wherein said hydraulic means, pump and conduit is devoid of any non-return valve.

46. The apparatus according to claim 45, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

47. The apparatus according to claim 1, wherein said source of energy is adapted to be implanted in the patient.

48. The apparatus according to claim 47, wherein said implantable source of energy comprises at least one accumulator, at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

49. The apparatus according to claim 48, wherein said implantable source of energy comprises an electric source of energy.

50. The apparatus according to claim 49, wherein said electric source of energy comprises an accumulator, or a battery having a life-time of at least 10 years.

51. The apparatus according to claim 47, wherein said control device controls said restriction device.

52. The apparatus according to claim 51, further comprising an operation device adapted to be implanted in the patient for operating said restriction device, wherein said control device controls said operation device to operate said restriction device.

53. The apparatus according to claim 52, wherein said operation device comprises a motor.

54. The apparatus according to claim 53, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

55. The apparatus according to claim 53, wherein said motor comprises a hydraulic or pneumatic fluid motor, and said control device controls said fluid motor.

56. The apparatus according to claim 53, wherein said motor comprises a casing of electrically conductive plastics.

57. The apparatus according to claim 51, wherein said control device releases energy from said implantable source of energy.

58. The apparatus according to claim 51, wherein said control device shifts polarity of said released energy to reverse said operation device.

59. The apparatus according to claim 58, wherein said restriction device comprises hydraulic means, and said operation device comprises a pump for pumping a fluid in said hydraulic means and a motor for driving said pump.

60. The apparatus according to claim 51, wherein said operation device comprises an electric motor and said released energy comprises electric energy.

61. The apparatus according to claim 47, wherein said restriction device is operable to perform a reversible function.

62. The apparatus according to claim 61, further comprising a reversing device adapted to be implanted in the patient for reversing said function performed by said restriction device.

63. The apparatus according to claim 62, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

64. The apparatus according to claim 62, wherein said reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in said hydraulic means.

65. The apparatus according to claim 62, wherein said reversing device comprises a mechanical reversing device.

66. The apparatus according to claim 65, wherein said mechanical reversing device comprises a switch.

67. The apparatus according to claim 65, wherein said mechanical reversing device comprises a gear box.

68. The apparatus according to claim 62, wherein said reversing device comprises a switch.

69. The apparatus according to claim 68, wherein said switch is operable by energy released from said source of energy.

70. The apparatus according to claim 68, wherein said control device controls the operation of said switch by shifting polarity of said released energy supplied to said switch.

71. The apparatus according to claim 68, wherein said switch comprises an electric switch and said source of energy supplies electric energy for the operation of said switch.

72. The apparatus according to claim 62, wherein said operation device comprises a motor, and said reversing device reverses said motor.

73. The apparatus according to claim 52, wherein said restriction device comprises hydraulic means, and said operation device comprises a pump for pumping a fluid in said hydraulic means and a motor for driving said pump.

74. The apparatus according to claim 73, wherein said operation device comprises a fluid conduit between said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

75. The apparatus according to claim 74, wherein said hydraulic means, pump and conduit are devoid of any non-return valve.

76. The apparatus according to claim 74, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reducing the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expanding the volume of said chamber.

77. The apparatus according to claim 1, further comprising at least one sensor adapted to be implanted in the patient for sensing at least one physical parameter of the patient.

78. The apparatus according to claim 77, wherein said control device controls said restriction device in response to signals from said sensor.

79. The apparatus according to claim 78, wherein said control device comprises an internal control unit adapted to be implanted in the patient, said internal control unit directly controlling said restriction device in response to signals from said sensor.

80. The apparatus according to claim 78, wherein said control device comprises an external control unit outside the patient'"'"'s body, said external control unit controlling said restriction device in response to signals from said sensor.

81. The apparatus according to claim 80, wherein said external control unit directly controls said restriction device in response to signals from said sensor.

82. The apparatus according to claim 80, wherein said external control unit stores information on said physical parameter sensed by said sensor and is manually operated to control said restriction device based on said stored information.

83. The apparatus according to claim 77, further comprising at least one sender adapted to be implanted in the patient for sending information on said physical parameter sensed by said sensor.

84. The apparatus according to claim 1, further comprising an external data communicator outside the patient'"'"'s body and an internal data communicator adapted to be implanted in the patient for communicating with said external data communicator, wherein said internal data communicator feeds data related to the patient back to said external data communicator or said external data communicator feeds data to said internal data communicator.

85. The apparatus according to claim 84, wherein said internal data communicator feeds data related to said restriction device.

86. The apparatus according to claim 84, wherein said internal data communicator feeds data related to at least one physical signal of the patient.

87. The apparatus according to claim 1, further comprising a switch adapted to be implanted in the patient for directly or indirectly switching said energy released from said source of energy.

88. The apparatus according to claim 1, wherein said restriction device is adapted to control the cross-sectional area of the food passageway.

89. The apparatus according to claim 88, wherein said restriction device is operable to open and close the food passageway.

90. The apparatus according to claim 88, wherein said restriction device is adapted to steplessly control the cross-sectional area of the food passageway.

91. The apparatus according to claim 1, further comprising

a pressure sensor for directly or indirectly sensing the pressure in the food passageway.

92. The apparatus according to claim 91, wherein said control device controls said restriction device in response to sensing from said pressure sensor.

93. The apparatus according to claim 1, further comprising an energy transfer device adapted to be implanted in the patient, wherein said control device releases electric energy and said energy transfer device transfers said electric energy into kinetic energy for operation of said restriction device.

94. The apparatus according to claim 93, further comprising a capacitor adapted to be implanted in the patient for stabilizing said electric energy released by said control device.

95. The apparatus according to claim 93, wherein said restriction device is directly operated with said kinetic energy, as said energy transfer device transfers said electric energy into kinetic energy.

96. The apparatus according to claim 1, wherein said restriction device is non-inflatable.

97. The apparatus according to claim 1, wherein said control device releases energy for a determined time period.

98. The apparatus according to claim 1, wherein said control device releases energy in a determined number of energy pulses.

99. The apparatus according to claim 1, wherein said control device comprises a wireless remote control transmitting at least one wireless control signal for controlling said restriction device.

100. The apparatus according to claim 99, wherein said remote control is capable of obtaining information on the condition of said restriction device and of controlling said restriction device in response to said information.

101. The apparatus according to claim 99, wherein said wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver adapted to be implanted in the patient.

102. The apparatus according to claim 99, wherein said wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver adapted to be implanted in the patient.

103. The apparatus according to claim 99, wherein said remote control is capable of sending information related to said restriction device from inside the patient'"'"'s body to the outside thereof.

104. The apparatus according to claim 103, wherein said remote control controls said restriction device in response to said information.

105. The apparatus according to claim 99, wherein said remote control transmits a carrier signal for carrying said control signal.

106. The apparatus according to claim 105, wherein said carrier signal is frequency, amplitude or frequency and amplitude modulated.

107. The apparatus according to claim 105, wherein said carrier signal is digital, analog or digital and analog.

108. The apparatus according to claim 105, wherein said control signal used with said carrier signal is frequency, amplitude or frequency and amplitude modulated.

109. The apparatus according to claim 99, wherein said control signal comprises a wave signal comprising one of a sound wave signal including an ultrasound wave signal, an electromagnetic wave signal including an infrared light signal, a visible light signal, an ultra violet light signal and a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.

110. The apparatus according to claim 99, wherein said control signal comprises an electric, magnetic or electric and magnetic field.

111. The apparatus according to claim 99, wherein said control signal is digital, analog or digital and analog.

112. The apparatus according to claim 111, wherein said remote control transmits an electromagnetic carrier wave signal for carrying said digital or analog control signal.

113. The apparatus according to claim 99, wherein said control signal is transmitted in pulses by said wireless remote control.

114. The apparatus according to claim 1, wherein said control device releases energy from said source of energy in a non-invasive manner.

115. apparatus according to claim 1, wherein said control device releases magnetic energy.

116. The apparatus according to claim 1, wherein said control device releases electromagnetic energy.

117. The apparatus according to claim 1, wherein said control device releases kinetic energy.

118. The apparatus according to claim 1, wherein said control device releases thermal energy.

119. The apparatus according to claim 1, wherein said control device releases energy from said source of energy in a mechanical manner.

120. The apparatus according to claim 1, wherein said control device releases non-magnetic energy.

121. The apparatus according to claim 1, wherein said control device releases non-electromagnetic energy.

122. The apparatus according to claim 1, wherein said control device releases non-kinetic energy.

123. The apparatus according to claim 1, wherein said control device releases non-thermal energy.

124. The apparatus according to claim 1, wherein said control device releases energy from said source of energy in a non-mechanical manner.

125. A method of treating a patient having heartburn and reflux disease, comprising:

(a) implanting in the patient an operable restriction device, so that the restriction device engages the stomach close to the cardia or engages the esophagus without forming an upper pouch of the stomach that substantially accumulates food to form a restricted food passageway in the stomach or esophagus,

(b) implanting in the patient a source of energy,

(c) implanting in the patient an operation device for operating said restriction device,

(d) controlling the source of energy to release energy, and

(e) using the released energy to activate the implanted operation device so as (i) to enlarge the restricted food passageway to allow food to readily pass therethrough into the patient'"'"'s stomach, or to allow the patient to regurgitate, or (ii) to restrict the restricted food passageway sufficiently so as to substantially prevent regurgitation of stomach acids and foods into the esophagus.

126. A method of treating a patient having heartburn and reflux disease, comprising the steps of:

(a) placing at least two laparoscopical trocars in the patient'"'"'s body,

(b) inserting a dissecting tool through the trocars and dissecting an area of the stomach or esophagus,

(c) placing an operable restriction device in the dissected area, so that the restriction device engages the stomach close to the cardia or engages the esophagus without forming an upper pouch of the stomach that substantially accumulates food to form a restricted food passageway in the stomach or esophagus,

(d) implanting a source of energy in the patient,

(e) implanting in the patient an operation device for operating said restriction device,

(f) controlling the source of energy from outside the patient'"'"'s body to release energy, and

(g) using the released energy to activate the implanted operation device so as to (i) enlarge the restricted food passageway to allow food to readily pass therethrough into the patient'"'"'s stomach, or to allow the patient to regurgitate, or (ii) restrict the restricted food passageway sufficiently so as to substantially prevent regurgitation of stomach acids and foods into the esophagus.

127. A method of treating heartburn and reflux disease, comprising the steps of:

placing at least two laparascopical trocars in a patient'"'"'s body,

inserting a dissecting tool through the trocars and dissecting an area of the stomach or esophagus,

implanting an operable restriction device in the dissected area, so that the restriction device engages the stomach close to the cardia or engages the esophagus without forming an upper pouch of the stomach that substantially accumulates food to form a restricted food passageway in the stomach or esophagus,

implanting an internal source of energy in the patient,

providing an external source of energy,

controlling the external source of energy to release wireless energy,

transferring the wireless energy released from the external energy into storable energy,

charging the internal source of energy with the storable energy, and

using energy from the internal source of energy for operating the restriction device to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus.