Heartburn and reflux disease treatment with controlled wireless energy supply

• US 6,450,173 B1
• Filed: 02/10/2000
• Issued: 09/17/2002
• Est. Priority Date: 08/12/1999
• 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:
  US09/501,235
• Time in Patent Office: 950 Days
• Field of Search: 128/897-899, 600/29-32, 600/37, 600/593, 604/27-28, 606/139-141, 606/157, 606/201-203, 606/213, 606/228, 606/151, 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 2/004 inflatable
• 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: A61N 1/3787 from an external energy source

Abstract

A heartburn and reflux disease treatment apparatus and method includes and uses 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 external to the patient'"'"'s body and a control device for releasing wireless energy from the source of energy from outside the patient'"'"'s body are provided, so that the released wireless energy is used in connection with the operation of the restriction device to enlarge or contract the 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 and operable to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus,

a source of energy external to the patient'"'"'s body, and

a control device operable from outside the patient'"'"'s body for releasing wireless energy from said source of energy, said released wireless energy being used to prevent said restriction device, including to enlarge or contract the restricted passageway.

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 1, wherein said wireless energy released from said external source of energy is directly used for operation of said restriction device.

17. The apparatus according to claim 16, wherein said wireless energy is directly used for operation of said restriction device in a non-magnetic manner.

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

19. The apparatus according to claim 16, wherein said wireless energy is directly used for operation of said restriction device in a non-mechanical manner.

20. The apparatus according to claim 16, further comprising an operation device for operating said restriction device, wherein said wireless energy directly or indirectly powers said operation device.

21. The apparatus according to claim 20, wherein said control device controls said operation device.

22. The apparatus according to claim 21, wherein said operation device comprises a motor.

23. The apparatus according to claim 22, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

24. The apparatus according to claim 22, wherein said motor comprises a linear motor.

25. The apparatus according to claim 22, wherein said motor comprises an electric motor having electrically conductive parts made of plastics.

26. The apparatus according to claim 21, wherein said control device releases polarized energy from said source of energy.

27. The apparatus according to claim 26, wherein said operation device comprises an electric motor and said released energy comprises electric energy.

28. The apparatus according to claim 21, wherein said control device shifts polarity of said released energy to reverse said operation device.

29. The apparatus according to claim 21, wherein said restriction device is operable to perform a reversible function.

30. The apparatus according to claim 29, further comprising a reversing device implanted in the patient for reversing said function performed by said restriction device.

31. The apparatus according to claim 30, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

32. The apparatus according to claim 30, wherein said reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in said hydraulic means.

33. The apparatus according to claim 30, wherein said reversing device comprises a mechanical reversing device.

34. The apparatus according to claim 33, wherein said mechanical reversing device comprises a switch.

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

36. The apparatus according to claim 30, wherein said reversing device comprises a switch.

37. The apparatus according to claim 36, wherein said switch is operated by said released energy.

38. The apparatus according to claim 37, wherein said control device controls the operation of said switch by shifting polarity of said released energy operating said switch.

39. The apparatus according to claim 37, wherein said switch comprises an electric switch and said source of energy supplies electric energy for the operation of said switch.

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

41. The apparatus according to claim 20, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

42. The apparatus according to claim 41, wherein said operation device comprises a motor for driving said pump.

43. The apparatus according to claim 42, 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.

44. The apparatus according to claim 43, wherein said hydraulic means, pump and conduit is devoid of any non-return valve.

45. The apparatus according to claim 44, 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.

46. The apparatus according to claim 16, further comprising a stabilizer adapted to be implanted in the patient for stabilizing the energy released by said control device.

47. The apparatus according to claim 46, wherein the energy released by said control device comprises electric energy and said stabilizer comprises at least one capacitor.

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

49. The apparatus according to claim 48, further comprising an internal source of energy adapted to be implanted in the patient for supplying energy for the operation of said restriction device, wherein said switch directly or indirectly affects the supply of energy from said internal source of energy.

50. The apparatus according to claim 49, further comprising an energy transfer device adapted to be implanted in the patient for transferring said wireless energy into storable energy, wherein said internal source of energy is capable of storing said storable energy.

51. The apparatus according to claim 50, wherein said switch switches from an “

off”

mode, in which said internal 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.

52. The apparatus according to claim 51, wherein said control device controls said switch to switch between said “

on” and

“

off”

modes.

53. The apparatus according to claim 52, wherein said control device comprises a wireless remote control.

54. The apparatus according to claim 49, wherein said switch switches between an “

off”

mode, in which said internal source of energy is not in use, and an “

on”

mode, in which said internal source of energy supplies energy for the operation of said restriction device.

55. The apparatus according to claim 54, wherein said switch is operable by said wireless energy released from said external source of energy.

56. The apparatus according to claim 55, wherein said control device controls said external source of energy to release said wireless energy.

57. The apparatus according to claim 56, wherein said control device comprises a wireless remote control.

58. The apparatus according to claim 54, wherein said internal source of energy comprises an electric source of energy.

59. The apparatus according to claim 58, wherein said electric 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.

60. The apparatus according to claim 58, wherein said electric source of energy comprises an accumulator or a battery having a life-time of at least 10 years.

61. The apparatus according to claim 54, wherein said internal source of energy comprises a nuclear source of energy.

62. The apparatus according to claim 54, wherein said internal source of energy comprises a chemical source of energy.

63. The apparatus according to claim 49, wherein said control device comprises a wireless remote control for controlling said internal source of energy.

64. The apparatus according to claim 63, wherein said switch is operable by said wireless energy from said external source of energy to switch between an “

off”

mode, in which said internal source of energy and remote control are not in use, and a “

standby”

mode, in which said remote control is permitted to control said internal source of energy to supply energy for the operation of said restriction device.

65. The apparatus according to claim 49, further comprising an energy transfer device adapted to be implanted in the patient for transferring said wireless energy into storable energy and an energy storage device implanted in the patient for storing said storable energy.

66. The apparatus according to claim 65, wherein said switch is operable by energy from said implanted energy storage device to switch between an “

off”

mode, in which said internal source of energy is not in use, and an “

on”

mode, in which said internal source of energy supplies energy for the operation of said restriction device.

67. The apparatus according to claim 66, wherein said control device controls said energy storage device to operate said switch.

68. The apparatus according to claim 67, wherein said control device comprises a wireless remote control.

69. The apparatus according to claim 48, further comprising a powered operation device adapted to be implanted in the patient for operating said restriction device.

70. The apparatus according to claim 69, wherein said control device controls said operation device.

71. The apparatus according to claim 70, wherein said operation device comprises a motor.

72. The apparatus according to claim 71, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

73. The apparatus according to claim 71, wherein said motor comprises a linear motor.

74. The apparatus according to claim 71, wherein said motor comprises a hydraulic or pneumatic fluid motor, and said control device controls said fluid motor.

75. The apparatus according to claim 71, wherein said motor comprises an electric motor having electrically conductive parts made of plastics.

76. The apparatus according to claim 71, wherein said operation device comprises an electric motor and said released energy comprises electric energy.

77. The apparatus according to claim 70, wherein said control device releases polarized energy from said external source of energy for powering said operation device.

78. The apparatus according to claim 70, wherein said control device shifts polarity of said released energy to reverse said operation device.

79. The apparatus according to claim 70, wherein said restriction device is operable to perform a reversible function.

80. The apparatus according to claim 79, further comprising a reversing device adapted to be implanted in the patient for reversing said function performed by said restriction device.

81. The apparatus according to claim 80, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

82. The apparatus according to claim 80, wherein said reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in said hydraulic means.

83. The apparatus according to claim 80, wherein said reversing device comprises a mechanical reversing device.

84. The apparatus according to claim 83, wherein said mechanical reversing device comprises a gear box.

85. The apparatus according to claim 80, wherein said reversing device comprises a switch.

86. The apparatus according to claim 85, wherein said switch is operable by said released energy.

87. The apparatus according to claim 86, wherein said control device controls the operation of said switch by shifting polarity of said released energy.

88. The apparatus according to claim 86, wherein said switch comprises an electric switch and said control device releases electric energy from said external source of energy for the operation of said switch.

89. The apparatus according to claim 80, wherein said operation device comprises a motor, and said reversing device reverses said motor.

90. The apparatus according to claim 70, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

91. The apparatus according to claim 90, wherein said operation device comprises a motor for driving said pump.

92. The apparatus according to claim 91, 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.

93. The apparatus according to claim 92, wherein said hydraulic means, pump and conduit is devoid of any non-return valve.

94. The apparatus according to claim 93, 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.

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

96. The apparatus according to claim 95, wherein said sensor comprises a pressure sensor for directly or indirectly sensing the pressure in said passageway.

97. The apparatus according to claim 95, wherein said control device controls said restriction device in response to signals from said sensor.

98. The apparatus according to claim 97, wherein said control device comprises an internal control unit adapted to be implanted in the patient, said internal control unit controlling said restriction device in response to signals from said sensor.

99. The apparatus according to claim 97, 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.

100. The apparatus according to claim 97, 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.

101. The apparatus according to claim 95, further comprising at least one sender adapted to be implanted in the patient for sending information on said physical parameter sensed by said sensor.

102. 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 communicator, wherein said internal communicator feeds data related to the patient back to said external communicator or said external communicator feeds data to said internal communicator.

103. The apparatus according to claim 102, wherein said internal communicator feeds data related to said restriction device.

104. The apparatus according to claim 102, wherein said internal communicator feeds data related to at least one physical signal of the patient.

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

106. The apparatus according to claim 105, wherein said restriction device is operable to open and close said passageway.

107. The apparatus according to claim 105 wherein said restriction device steplessly controls the cross-sectional area of said passageway.

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

109. The apparatus according to claim 108, wherein said restriction device is directly operated with said kinetic energy, as said energy transfer device transfers said electric energy into said kinetic energy.

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

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

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

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

114. 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.

115. The apparatus according to claim 114, 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.

116. The apparatus according to claim 114, 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.

117. The apparatus according to claim 114, 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.

118. The apparatus according to claim 114, wherein said remote control is capable of sending information related to said restriction device from inside the patient'"'"'s body to the outside thereof.

119. The apparatus according to claim 118, wherein said remote control controls said restriction device in response to said information.

120. The apparatus according to claim 114, wherein said remote control transmits a carrier signal for carrying said control signal.

121. The apparatus according to claim 120, wherein said carrier signal is frequency, amplitude or frequency and amplitude modulated.

122. The apparatus according to claim 120, wherein said carrier signal is digital, analog or digital and analog.

123. The apparatus according to claim 120, wherein said control signal used with said carrier signal is frequency, amplitude or frequency and amplitude modulated.

124. The apparatus according to claim 114, 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.

125. The apparatus according to claim 114, wherein said control signal comprises an electric, magnetic or electric and magnetic field.

126. The apparatus according to claim 114, wherein said control signal is digital, analog or digital and analog.

127. The apparatus according to claim 126, wherein said remote control transmits an electromagnetic carrier wave signal for carrying said digital or analog control signal.

128. The apparatus according to claim 114, wherein said control signal is transmitted in pulses by said wireless remote control.

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

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

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

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

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

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

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

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

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

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

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

140. A method of treating a human or animal having heartburn and reflux disease, comprising:

(a) surgically implanting in the human or animal an operable restriction device engaging the human'"'"'s or animal'"'"'s esophagus or 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,

(b) providing a source of energy external to the human'"'"'s or animal'"'"'s body, and

(c) controlling the external source of energy from outside the human'"'"'s or animal'"'"'s body to release wireless energy,

(d) implanting in the human or animal an operation device, which can adjust the restricted food passageway in response to supplied energy, and

(e) using the released wireless 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 human'"'"'s or animal'"'"'s stomach, or to allow the human or animal 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.

141. A method according to claim 140 wherein step (e) is practiced at least once a day.

142. A method of treating a human or animal having heartburn and reflux disease, comprising the steps of:

placing at least two laparascopical trocars in the human'"'"'s or animal'"'"'s body,

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

placing an operable restriction device in the dissected area, so that the restriction device engages 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,

providing a source of energy outside the human'"'"'s or animal'"'"'s body,

controlling the external source of energy from outside the human'"'"'s or animal'"'"'s body to release wireless energy, and

using the released wireless energy to operate the restriction device so as (i) to enlarge the restricted food passageway to allow food to readily pass therethrough into the human'"'"'s or animal'"'"'s stomach, or to allow the human or animal 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.

143. A method of treating a human or animal having heartburn and reflux disease, comprising the steps of:

placing at least two laparascopical trocars in the human'"'"'s or animal'"'"'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 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,

implanting an energy transfer device,

providing an external source of energy,

controlling the external source of energy to release wireless energy,

transferring the wireless energy by the energy transfer device into energy different than the wireless, and

using the transferred energy to operate the restriction device so as (i) to enlarge the restricted food passageway to allow food to readily pass therethrough into the human'"'"'s or animal'"'"'s stomach, or to allow the human or animal 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.

144. A method according to claim 143, further comprising implanting a stabilizer in the human or animal for stabilizing the energy transferred by the energy transfer device.