Heartburn and reflux disease treatment apparatus with wireless energy supply

• US 6,454,700 B1
• Filed: 02/09/2000
• Issued: 09/24/2002
• Est. Priority Date: 02/09/2000
• Status: Expired due to Term

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Cadugan, Joseph A.
• Application Number:
  US09/501,266
• Time in Patent Office: 958 Days
• Field of Search: 128/897-898, 600/29-32, 600/37, 600/593, 604/27-28, 606/139-141, 606/151, 606/157, 606/201-203, 606/213, 606/218, 607/41, 623/23.65, 623/23.67
• US Class Current: 600/37
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• 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
• CPC Class Codes: A61F 5/0059 with wireless means

Abstract

A heartburn and reflux disease treatment apparatus and method employ 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. An energy transmission device for wireless transmission of energy of a first form from outside the patient'"'"'s body is provided. An implanted energy transfer device transfers the first form energy transmitted by the energy transmission device into energy of a second form, which is used in connection with the operation of the restriction device to minimize the adverse affects of, or cure, chronic heartburn and reflux disease.

Claims

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

an energy transmission device for wireless transmission of energy of a first form from outside a patient'"'"'s body;

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 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 and operable in response to a second energy form different than the first form energy to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus; and

an energy transfer device implantable in the patient for transferring energy of the first form transmitted by said energy transmission device into energy of the second form, to operate said restriction device.

2. The apparatus according to claim 1, wherein said restriction device is electrically operated, and the second form energy comprises electric energy.

3. The apparatus according to claim 2, further comprising electric conductors connected to said energy transfer device, whereby said energy transfer device supplies an electric current via said conductors.

4. The apparatus according to claim 3, wherein said energy transfer device supplies a direct current, a pulsating direct current or a combination of a direct current and pulsating direct current via said conductors.

5. The apparatus according to claim 3, wherein said energy transfer device supplies an alternating current or a combination of a direct and alternating current via said conductors.

6. The apparatus according to claim 2, wherein said energy transfer device is capable of generating a current exceeding 1 μ

A when transferring the first form energy transmitted by said energy transmission device.

7. The apparatus according to claim 1, wherein said energy transfer device supplies a frequency, amplitude or frequency and amplitude modulated signal.

8. The apparatus according to claim 1, wherein said energy transfer device supplies an analog, digital or a combination of an analog and digital signal.

9. 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 energy transfer device powers said operation device with the second form energy.

10. The apparatus according to claim 9, wherein said operation device comprises a motor.

11. The apparatus according to claim 10, further comprising a control device, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

12. The apparatus according to claim 10, wherein said motor comprises a linear motor.

13. The apparatus according to claim 10, further comprising a control device, wherein said motor comprises a hydraulic or pneumatic fluid motor, and said control device controls the said fluid motor.

14. The apparatus according to claim 10, wherein said motor comprises an electric motor having electrically conductive parts made of plastics.

15. The apparatus according to claim 9, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

16. The apparatus according to claim 15, wherein said operation device comprises a motor for driving said pump.

17. The apparatus according to claim 15, 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.

18. The apparatus according to claim 17, wherein said hydraulic means, pump and conduit is devoid of any non-return valve.

19. The apparatus according to claim 18, 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.

20. The apparatus according to claim 9, further comprising a control device for controlling said operation device.

21. The apparatus according to claim 20, wherein said control device shifts polarity of the second form energy to reverse said operation device.

22. The apparatus according to claim 21, wherein said operation device comprises an electric motor and the second form energy comprises electric energy.

23. The apparatus according to claim 19, wherein said restriction device is operable to preform a reversible function.

24. The apparatus according to claim 23, further comprising a reversing device adapted to be implanted in the patient for reversing said function performed by said restriction device.

25. The apparatus according to claim 24, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

26. The apparatus according to claim 24, wherein said reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid flow in said hydraulic means.

27. The apparatus according to claim 24, wherein said reversing device comprises a mechanical reversing device.

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

29. The apparatus according to claim 24, wherein said reversing device comprises a switch.

30. The apparatus according to claim 29, wherein said switch is operable by said second form energy.

31. The apparatus according to claim 30, wherein said control device controls the operation of said switch by shifting polarity of said second form energy.

32. The apparatus according to claim 30, wherein said switch comprises an electric switch and said second form energy comprises electric energy.

33. The apparatus according to claim 9, wherein said operation device comprises hydraulic means and at least one valve for controlling a fluid flow in said hydraulic means.

34. The apparatus according to claim 33, further comprising a wireless remote control for controlling said valve.

35. The apparatus according to claim 1, wherein said energy transfer device forms a flat and thin sheet, and has a volume of less than 2000 cm³.

36. The apparatus according to claim 1, wherein said energy transfer device comprises at least one semiconductor.

37. The apparatus according to claim 1, further comprising an energy storage device adapted to be implanted in the patient for storing the second form energy and for supplying energy for operation of said restriction device.

38. The apparatus according to claim 37, wherein said energy storage device comprises an accumulator.

39. The apparatus according to claim 38, wherein the second form energy comprises electric energy and said energy storage device comprises an electric accumulator.

40. The apparatus according to claim 39, wherein said electric accumulator comprises at least one capacitor or at least one rechargeable battery.

41. The apparatus according to claim 37, further comprising a switch adapted to be implanted in the patient for directly or indirectly switching the operation of said restriction device.

42. The apparatus according to claim 41, further comprising a source of energy adapted to be implanted in the patient, wherein said switch is operated by the second form energy supplied by said energy storage device to switch from an off mode, in which said source of energy is not in use, to an on mode, in which said source of energy supplies energy for the operation of said restriction device.

43. The apparatus according to claim 41, further comprising a source of energy adapted to be implanted in the patient, and a remote control for controlling the supply of energy of said implantable source of energy, wherein said switch is operated by the second form energy supplied by said energy storage device to switch from an off mode, in which said remote control is prevented from controlling said source of energy and said source of energy is not in use, to a standby mode, in which said remote control is permitted to control said source of energy to supply energy for the operation of said restriction device.

44. The apparatus according to claim 1, further comprising a switch adapted to be implanted in the patient for switching the operation of said restriction device.

45. The apparatus according to claim 44, further comprising a source of energy adapted to be implanted in the patient for supplying energy for the operation of said restriction device, wherein said switch is operated by the energy of the second form supplied by said energy transfer device to switch from an off mode, in which said source of energy is not in use, to an on mode, in which said source of energy supplies energy for the operation of said restriction device.

46. The apparatus according to claim 44, further comprising a source of energy adapted to be implanted in the patient for supplying energy for the operation of said restriction device, and a remote control for controlling the supply of energy of said implanted source of energy, wherein said switch is operated by the second form energy supplied by said energy transfer device to switch from an off mode, in which said remote control is prevented from controlling said source of energy and said source of energy is not in use, to a standby mode, in which said remote control is permitted to control said source of energy to supply energy for the operation of said restriction device.

47. The apparatus according to claim 1, wherein said energy transmission device transmits the energy of the first form by at least one wireless signal.

48. The apparatus according to claim 47, wherein said signal comprises a wave signal.

49. The apparatus according to claim 48, wherein said wave signal comprises an electromagnetic wave signal including one of an infrared light signal, a visible light signal, an ultra violet light signal,a laser signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.

50. The apparatus according to claim 48, wherein said wave signal comprises a sound wave signal.

51. The apparatus according to claim 47, wherein said signal contains radiant energy.

52. The apparatus according to claim 47, wherein said signal comprises a digital or analog signal, or a combination of a digital and analog signal.

53. The apparatus according to claim 1, wherein the first form energy transmitted by said energy transmission device comprises an electric field.

54. The apparatus according to claim 53, wherein said electric field is transmitted in pulses or digital pulses, or a combination of pulses and digital pulses by said energy transmission device.

55. The apparatus according to claim 1, wherein the first form energy transmitted by said energy transmission device comprises a magnetic field.

56. The apparatus according to claim 55, wherein said magnetic field is transmitted in pulses or digital pulses, or a combination of pulses and digital pulses by said energy transmission device.

57. The apparatus according to claim 1, wherein said energy transfer device transfers the first form energy into a direct current or pulsating direct current, or a combination of a direct current and a pulsating direct current.

58. The apparatus according to claim 1, wherein said energy transfer device transfers the first form energy into an alternating current or a combination of a direct and alternating current.

59. The apparatus according to claim 1, wherein the second form energy comprises a frequency or amplitude modulated signal, or a combination of a frequency and amplitude modulated signal.

60. The apparatus according to claim 1, wherein the second form energy comprises an analog or a digital signal, or a combination of an analog and digital signal.

61. The apparatus according to claim 1, further comprising a pulse generator adapted to be implanted in the patient for generating electrical pulses from the second form energy rendered by said energy field.

62. 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.

63. The apparatus according to claim 62, wherein said sensor comprises a pressure sensor for directly or indirectly sensing the pressure in the passageway.

64. The apparatus according to claim 62, further comprising a control device for controlling said restriction device in response to signals from said sensor.

65. The apparatus according to claim 64, wherein said control device comprises an internal control unit adapted to be implanted in the patient for controlling said restriction device in response to signals from said sensor.

66. The apparatus according to claim 64, wherein said intern control unit directly controls said restriction device in response to signals from said sensor.

67. The apparatus according to claim 64, wherein said control device comprises an external control unit outside the patient'"'"'s body for controlling said restriction device in response to signals from said sensor.

68. The apparatus according to claim 67, 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.

69. The apparatus according to claim 62, further comprising at least one sender adapted to be implanted in the patient for sending information on said physical parameter sensed by said sensor.

70. The apparatus according to claim 1, further comprising a wireless remote control transmitting at least one wireless control signal for controlling said restriction device.

71. The apparatus according to claim 70, wherein said remote control is capable of obtaining information on the condition of said restriction device and to control said restriction device in response to said information.

72. The apparatus according to claim 70, wherein said remote control comprises a control unit adapted to be implanted in the patient for controlling said restriction device.

73. The apparatus according to claim 72, wherein said control unit comprises a microprocessor.

74. The apparatus according to claim 70, wherein said wireless remote control comprises at least one external signal transmitter or transceiver and at least one implantable internal signal receiver or transceiver.

75. The apparatus according to claim 70, wherein said wireless remote control comprises at least one external signal receiver or transceiver and at least one implantable internal signal transmitter or transceiver.

76. The apparatus according to claim 70, wherein said remote control is capable of sending information related to said restriction device from inside a patient'"'"'s body to the outside thereof.

77. The apparatus according to claim 76, wherein said remote control controls said restriction device in response to said information.

78. The apparatus according to claim 70, wherein said remote control comprises a control signal transmitter for transmitting said control signal, and said energy transmission device comprises said control signal transmitter, whereby the energy of the first form is transmitted by said signal.

79. The apparatus according to claim 70, wherein said energy transmission device transmits the energy of the first form by at least one signal separate from said control signal.

80. The apparatus according to claim 70, wherein said remote control transmits a carrier signal for carrying said control signal.

81. The apparatus according to claim 70, wherein said energy transmission device transmits the energy of the first form by at least one signal, which is used as a carrier signal for said control signal transmitted by said remote control.

82. The apparatus according to claim 81, wherein said carrier signal is frequency, amplitude or frequency and amplitude modulated.

83. The apparatus according to claim 81, wherein said carrier signal comprises digital, analog or a combination of digital and analog waves.

84. The apparatus according to claim 81, wherein said control signal used with said carrier signal is frequency, amplitude or frequency and amplitude modulated.

85. The apparatus according to claim 81, wherein said control signal used with said carrier signal is digital, analog or combined digital and analog.

86. The apparatus according to claim 70, 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.

87. The apparatus according to claim 70, wherein said control signal comprises an electric or magnetic field, or a combined electric and magnetic field.

88. The apparatus according to claim 70, wherein said control signal comprises a digital, analog or combined digital and analog control signal.

89. The apparatus according to claim 88, wherein said remote control transmits an electromagnetic carrier wave signal for carrying said digital or analog control signal.

90. The apparatus according to claim 1, wherein the energy of the second form used for operating said restriction device is wirelessly transmitted by said energy transfer device.

91. The apparatus according to claim 1, further comprising a control unit adapted to be implanted in the patient for controlling said restriction device.

92. The apparatus according to claim 91, wherein said control unit is programmable for controlling said restriction device in accordance with a program.

93. The apparatus according to claim 92, wherein said control unit controls said restriction device over time in accordance with an activity schedule program.

94. The apparatus according to claim 92, further comprising an external wireless remote control for programming said control unit.

95. The apparatus according to claim 1, further comprising an external data communicator and a data communicator adapted to be implanted in the patient communicating with said external communicator, wherein said implantable communicator feeds data related to said restriction device back to said external communicator or said external communicator feeds data to said implantable data communicator.

96. The apparatus according to claim 95, wherein said implantable data communicator feeds data related to at least one physical signal of the patient.

97. The apparatus according to claim 1, wherein said restriction device controls the cross-sectional area of the restricted passageway.

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

99. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises magnetic energy.

100. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises kinetic energy.

101. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises sound energy.

102. The apparatus according to claim 1, wherein the second form energy comprises chemical energy.

103. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises radiant energy.

104. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises electromagnetic energy.

105. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises photo energy.

106. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises nuclear energy.

107. The apparatus according to claim 1, wherein one of the first form energy and the second form energy comprises thermal energy.

108. The apparatus according to claim 1, wherein one of the first form energy and the second form energy is non-magnetic.

109. The apparatus according to claim 1, wherein one of the first form energy and the second form energy is non-kinetic.

110. The apparatus according to claim 1, wherein one of the first form energy and the second form energy is non-chemical.

111. The apparatus according to claim 1, wherein one of the first form energy and the second form energy is non-sonic.

112. The apparatus according to claim 1, wherein one of the first form energy and the second form energy one of the first form energy and the second form energy is non-nuclear.

113. The apparatus according to claim 1, wherein one of the first form energy and the second form energy is non-thermal.

114. The apparatus according to claim 1, further comprising a stabilizer implanted in the patient for stabilizing the second form energy.

115. The apparatus according to claim 114, wherein said second form energy comprises electric current and said stabilizer comprises a capacitor.

116. The apparatus according to claim 1, wherein said energy transmission device functions differently from said energy transfer device.

117. The apparatus according to claim 1, wherein said energy transmission device functions similar to said energy transfer device.

118. The apparatus according to claim 1, wherein said restriction device is directly operated with the second form energy, as said energy transmission device transmits the first form energy.

119. The apparatus according to claim 118, wherein said energy transfer device directly operates said restriction device with the second form energy in a non-magnetic manner.

120. The apparatus according to claim 118, wherein said energy transfer device directly operates said restriction device with the second form energy in a non-mechanical manner.

121. The apparatus according to claim 1, wherein said energy transfer device is adapted to be implanted subcutaneously or in the abdomen of the patient.

122. The apparatus according to claim 1, wherein said energy transfer device is adapted to be implanted in the thorax or in the cephalic region of the patient.

123. The apparatus according to claim 1, wherein said energy transfer device is adapted to be implanted in an orifice of the patient'"'"'s body and under the mucosa or intraluminar outside the mucosa of the orifice.

124. An implanting method, comprising the steps of:

providing a heartburn and reflux disease treatment apparatus according to claim 1,

cutting an opening in a patient'"'"'s mucosa in an orifice of the patient'"'"'s body, and

implanting the energy transfer device in the patient'"'"'s body through the opening.

125. An implanting method, comprising the steps of:

providing a heartburn and reflux disease treatment apparatus according to claim 1,

cutting an opening in a patient'"'"'s skin, and

implanting the energy transfer device in the patient'"'"'s body through the opening.

126. A laparascopical implanting method, comprising the steps of:

providing a heartburn and reflux disease treatment apparatus according to claim 1,

placing at least two laparascopic cannula within a patient'"'"'s body, and

implanting the energy transfer device in the patient'"'"'s body by using the at least two laparascopic cannula.

127. A laparoscopic surgical method of implanting a heartburn and reflux disease treatment apparatus, comprising the steps of:

a) laparoscopically placing an operable restriction device of the apparatus through the abdomen or thorax of a patient,

b) placing at least two laparoscopic cannula within the patient'"'"'s body,

c) using a dissecting tool inserted through the laparoscopic trocar, dissecting the region of the esophagus or stomach,

d) introducing the restriction device through the trocar,

e) placing the restriction device in engagement with the esophagus or the stomach close to the cardia without forming an upper pouch of the stomach that substantially accumulates food to create a restricted stoma, and

f) postoperatively adjusting the restricted stoma in a non-invasive procedure at least several times daily so as (i) to open the restricted stoma to allow food to readily pass therethrough into the patient'"'"'s stomach, or to allow the patient to regurgitate, or (ii) to close the stoma sufficiently so as to substantially prevent stomach acids and food from being regurgitated into the esophagus.