Hydraulic heartburn and reflux treatment

• US 6,475,136 B1
• Filed: 02/14/2000
• Issued: 11/05/2002
• Est. Priority Date: 02/14/2000
• 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:
  US09/504,047
• Time in Patent Office: 995 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, 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 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 includes an adjustable restriction device implanted in a patient and engaging the stomach close to the cardia or engaging the esophagus to form a restricted food passageway in the stomach or esophagus. An adjustment device is implanted in the patient for adjusting the restriction device to restrict and enlarge the passageway and a hydraulic operation device is implanted in the patient for operating the adjustment device. By using a wireless remote control the patient can control the hydraulic operation device, whereby the restriction device works like an artificial sphincter.

Claims

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

an adjustable 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,

an adjustment device adapted to be implanted in the patient for adjusting said restriction device to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus, and

a hydraulic operation device adapted to be implanted in the patient for operating said adjustment device.

2. The apparatus according to claim 1, further comprising a reservoir adapted to be implanted in the patient and containing a predetermined amount of hydraulic fluid, wherein said hydraulic operation device operates said adjustment device by using said hydraulic fluid of said reservoir.

3. The apparatus according to claim 2, wherein said adjustment device comprises an expandable cavity in said restriction device, and said hydraulic operation device distributes hydraulic fluid from said reservoir to expand said cavity, and distributes hydraulic fluid from said cavity to said reservoir to contract said cavity, to thereby control the restriction of the food passageway, whereby the food passageway is restricted upon expansion of said cavity and enlarged upon contraction of said cavity when said restriction device is implanted.

4. The apparatus according to claim 3, wherein said reservoir defines a chamber for said predetermined amount of fluid and said hydraulic operation device changes the volume of said chamber.

5. The apparatus according to claim 4, wherein said hydraulic operation device comprises an injection port adapted to be implanted subcutaneously in the patient and in fluid communication with said chamber.

6. The apparatus according to claim 5, wherein said injection port is integrated in said reservoir.

7. The apparatus according to claim 4, wherein said hydraulic operation device comprises first and second wall portions of said reservoir, which are displaceable relative to each other to change the volume of said chamber of said reservoir.

8. The apparatus according to claim 7, wherein said first and second wall portions of said reservoir are displaceable relative to each other by manual manipulation thereof.

9. The apparatus according to claim 7, wherein said first and second wall portions of said reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means.

10. The apparatus according to claim 7, wherein said hydraulic operation device distributes fluid from said reservoir to said cavity in response to a predetermined first displacement of said first wall portion of said reservoir relative to said second wall portion of said reservoir and distributes fluid from said cavity to said reservoir in response to a predetermined second displacement of said first wall portion relative to said second wall portion.

11. The apparatus according to claim 3, wherein said hydraulic operation device comprise an activatable pump for pumping fluid between said reservoir and said cavity.

12. The apparatus according to claim 11, wherein said pump comprises a first activation member for activating said pump to pump fluid from said reservoir to said cavity and a second activation member for activating said pump to pump fluid from said cavity to said reservoir.

13. The apparatus according to claim 12, wherein said first and second activation members are operable by manual manipulation thereof.

14. The apparatus according to claim 12, wherein at least one of said activation members operates when subjected to a predetermined pressure external to the patient'"'"'s body.

15. The apparatus according to claim 12, wherein at least one of said first and second activating members are operable by magnetic means, hydraulic means, or electric control means.

16. The apparatus according to claim 4, wherein said hydraulic operation device comprises a servo means.

17. The apparatus according to claim 16, wherein said hydraulic operation device comprises first and second wall portions of said reservoir, and said servo means provides relative displacement between said first and second wall portions of said reservoir to change the volume of said chamber of said reservoir.

18. The apparatus according to claim 17, wherein said servo means comprises magnetic means, or electric means.

19. The apparatus according to claim 17, wherein said servo means comprises hydraulic means.

20. The apparatus according to claim 19, wherein said servo means comprises a servo reservoir defining a chamber containing servo fluid, and said hydraulic operation device comprises first and second wall portions of said servo reservoir, which are displaceable relative to each other to change the volume of said chamber of said servo reservoir.

21. The apparatus according to claim 20, wherein said first and second wall portions of said servo reservoir are displaceable relative to each other by manual manipulation.

22. The apparatus according to claim 20, wherein said first and second wall portions of said servo reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means.

23. The apparatus according to claim 16, wherein said servo means comprises a servo reservoir and a fluid supply reservoir connected in a closed system and containing a further predetermined amount of fluid.

24. The apparatus according to claim 23, wherein said fluid supply reservoir defines a chamber for the further predetermined amount of fluid and said hydraulic operation device changes the volume of said chamber and thereby control the amount of fluid in said servo reservoir.

25. The apparatus according to claim 24, wherein said fluid supply reservoir comprises first and second wall portions, which are displaceable relative to each other to change the volume of said chamber of said fluid supply reservoir.

26. The apparatus according to claim 25, wherein said fluid supply reservoir increases the amount of fluid in said servo reservoir in response to a predetermined first displacement of said first wall portion of said fluid supply reservoir relative to said second wall portion of said fluid supply reservoir and desreases the amount of fluid in said servo reservoir in response to a predetermined second displacement of said first wall portion of said fluid supply reservoir relative to said second wall portion of said fluid supply reservoir.

27. The apparatus according to claim 3, further comprising a conduit providing fluid connection between said reservoir and said cavity, wherein said conduit and hydraulic operation device are devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in said conduit.

28. The apparatus according to claim 27, wherein said reservoir forms a fluid chamber with a variable volume, and said hydraulic operation device distributes fluid from said chamber to said cavity by reduction of the volume of said chamber and withdraws fluid from said cavity by expansion of the volume of said chamber.

29. The apparatus according to claim 28, wherein said hydraulic operation device comprises a pump and a motor for driving said pump.

30. The apparatus according to claim 29, wherein said pump comprises a movable wall of said reservoir for changing the volume of said chamber.

31. The apparatus according to claim 29, wherein said motor is an electric motor.

32. The apparatus according to claim 1, wherein said restriction device comprises an elongated restriction member and forming means for forming said restriction member into at least a substantially closed loop around the esophagus or stomach, said loop defining a restriction opening, whereby said adjustment device adjusts said restriction member in said loop to change the size of said restriction opening.

33. The apparatus according to claim 32, wherein said forming means forms said restriction member into a loop having a predetermined size.

34. The apparatus according to claim 32, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is changed.

35. The apparatus according to claim 32, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is unchanged.

36. The apparatus according to claim 32, wherein said restriction member is non-inflatable, and said adjustment device mechanically adjusts said restriction member in said loop.

37. The apparatus according to claim 36, wherein said elongated restriction member is flexible, and said adjustment device pulls a first portion of said flexible restriction member from a second portion of said flexible restriction member opposite said first portion in said loop to squeeze the esophagus or stomach between two opposite lengths of said elongated flexible restriction member to restrict the passageway and moves said first portion toward said second portion of said restriction member to release the esophagus or stomach from said flexible restriction member to enlarge the passageway.

38. The apparatus according to claim 1, wherein said adjustment device mechanically adjusts said restriction device.

39. The apparatus according to claim 38, wherein said restriction device comprises two articulated clamping elements adapted to be positioned on opposite sides of the esophagus or stomach, and said adjustment device moves said clamping elements toward each other to clamp the esophagus or stomach between said clamping elements to restrict the passageway, and moves said clamping elements away from each other to release the esophagus or stomach from said elements to enlarge the passageway.

40. The apparatus according to claim 38, wherein said restriction device is adapted to bend a portion of the esophagus or stomach.

41. The apparatus according to claim 38, wherein said restriction device comprises at least two bending members adapted to be positioned on opposite sides of the esophagus or stomach displaced relative to each other along the food passageway in the esophagus or stomach, and said adjustment device moves said bending members toward each other to bend the esophagus or stomach between said bending members to restrict the passageway, and away from each other to release the esophagus or stomach from said bending members to enlarge the passageway.

42. The apparatus according to claim 41, wherein said bending members comprise rollers.

43. The apparatus according to claim 1, wherein said restriction device comprises at least two elements adapted to be positioned on different sides of the esophagus or stomach, and said adjustment device moves said elements toward each other to restrict the esophagus or stomach between said elements to restrict the passageway and moves said elements away from each other to release the esophagus or stomach from said elements to enlarge the passageway.

44. The apparatus according to claim 1, wherein said restriction device is adapted to bend a portion of the esophagus or stomach.

45. The apparatus according to claim 1, further comprising a wireless remote control for controlling said hydraulic operation device.

46. The apparatus according to claim 45, wherein said remote control comprises an external signal transmitter, receiver or transceiver and a signal receiver, transmitter or transceiver adapted to be implanted in the patient.

47. The apparatus according to claim 46, wherein said signal receiver comprises a control unit for controlling said hydraulic operation device in response to signals received from said signal transmitter.

48. The apparatus according to claim 47, further comprising an energizer unit adapted to be implanted in the patient for providing energy to energy consuming components of the apparatus adapted to be implanted in the patient.

49. The apparatus according to claim 48, further comprising a motor adapted to be implanted in the patient for operating said hydraulic operation device.

50. The apparatus according to claim 49, wherein said control unit powers said motor with energy provided by said energizer unit in response to signals received from said signal transmitter.

51. The apparatus according to claim 48, wherein said energizer unit transfers energy from said signals, as they are transmitted to said signal receiver, into electric energy.

52. The apparatus according to claim 47, wherein said energizer unit transfers the energy from said signals into direct or alternating current or a combination thereof.

53. The apparatus according to claim 46, wherein said signal transmitter and signal receiver transmit and receive signals in the form of digital pulses.

54. The apparatus according to claim 53, wherein said digital pulses comprise a magnetic field or an electric field.

55. The apparatus according to claim 46, wherein said signal transmitter and signal receiver transmit and receive wave signals.

56. The apparatus according to claim 55, wherein said wave signals comprise electromagnetic waves, sound waves or carrier waves for remote control signals or a combination thereof.

57. The apparatus according to claim 45, wherein said remote control comprises means for wireless transfer of energy from outside the patient'"'"'s body to energy consuming implanted components of the apparatus adapted to be implanted in the patient.

58. The apparatus according to claim 57, further comprising a motor adapted to be implanted in the patient for operating said hydraulic operation device, wherein said means for wireless transfer of energy directly powers said motor with transferred energy.

59. The apparatus according to claim 58, wherein the energy transferred by said means for transfer of energy comprises wave signals.

60. The apparatus according to claim 58, wherein the energy transferred by said means for transfer of energy comprises an electric field or a magnetic field or a combination thereof.

61. The apparatus according to claim 45, wherein said remote control is capable of obtaining information correlated to implanted components of the apparatus adapted to be implanted in the patient and of commanding said adjustment device to adjust said restriction device in response to obtained information.

62. The apparatus according to claim 45, wherein said remote control is capable of obtaining information related to the food passageway in the stomach or esophagus and of commanding said adjustment device to adjust said restriction device in response to obtained information.

63. The apparatus according to claim 1, further comprising a control device for controlling said restriction device.

64. The apparatus according to claim 63, wherein said control device comprises an internal control unit implantable in the patient for controlling said restriction device.

65. The apparatus according to claim 64, wherein said internal control unit is programmable.

66. The apparatus according to claim 65, 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.

67. The apparatus according to claim 63, wherein said control device comprises an external control unit outside the patient'"'"'s body for wirelessly controlling said restriction device.

68. The apparatus according to claim 67, wherein said external control unit is programmable.

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

70. The apparatus according to claim 69, wherein said sensor directly or indirectly senses as said physical parameter the horizontal position of the patient.

71. The apparatus according to claim 69, wherein said sensor directly or indirectly senses as said physical parameter the pressure against said restriction device.

72. The apparatus according to claim 71, wherein said adjustment device is adapted to adjust said restriction device to enlarge the food passageway in response to said sensor sensing a predetermined pressure.

73. The apparatus according to claim 69, further comprising a control device for controlling said restriction device in response to signals from said sensor.

74. The apparatus according to claim 73, wherein said control device comprises an internal control unit implantable in the patient for directly controlling said restriction device in response to signals from said sensor.

75. The apparatus according to claim 73, 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.

76. The apparatus according to claim 1, wherein said hydraulic operation device non-invasively operates said adjustment device.

77. The apparatus according to claim 1, wherein said adjustment device comprises an expandable cavity in said restriction device, and said hydraulic operation device comprises an injection port implantable subcutaneously in the patient for transcutaneous supply of fluid to and withdrawal of fluid from said cavity, whereby the food passageway is restricted upon expansion of said cavity and enlarged upon contraction of said cavity when said restriction device is implanted.

78. The apparatus according to claim 1, further comprising a holding device adapted to be implanted in the patient to hold the esophagus or stomach in a position where the left and right crus muscles are located, to prevent the region of the cardia from moving through the diaphragm muscle.

79. The apparatus according to claim 1, wherein said operation device operates said adjustment device to adjust said restriction device to open and close the food passageway, when said restriction device engages the patient'"'"'s stomach or esophagus.

80. The apparatus according to claim 79, wherein said operation device operates said adjustment device to steplessly adjust said restriction device.

81. The apparatus according to claim 1, wherein said operation device uses hydraulic fluid, the viscosity of which changes when said hydraulic fluid is exposed to energy different from thermal energy.

82. The apparatus according to claim 81, wherein the viscosity of said hydraulic fluid changes when said fluid is exposed to electric energy.

83. The apparatus according to claim 1, wherein said operation device and/or other energy consuming components of the apparatus are adapted to be energised with wirelessly transmitted energy from outside the patient'"'"'s body.

84. The apparatus according to claim 1, further comprising an implantable battery or accumulator for energizing said operation device and/or other energy consuming components of the apparatus, wherein the energy from said battery or accumulator is releasable from outside the patient'"'"'s body.

85. The apparatus according to claim 1, wherein said adjustment device adjusts said restriction device in a non-thermal manner.

86. The apparatus according to claim 1, wherein said adjustment device adjusts said restriction device in a non-manual manner.

87. The apparatus according to claim 1, wherein said adjustment device adjusts said restriction device in a non-magnetic manner.

88. The apparatus according to claim 1, wherein said hydraulic operation device is powered.

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

an adjustable 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,

an adjustment device adapted to be implanted in the patient for adjusting said restriction device to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus,

wherein said adjustment device comprises servo means.

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

an adjustable 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,

an adjustment device adapted to be implanted in the patient for adjusting said restriction device to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus, and

an electrically powered operation device for operating said adjustment device.

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

(a) surgically implanting in the abdomen of the human or animal an adjustable restriction device which restricts a food passageway in the esophagus or the stomach close to the cardia without forming an upper pouch of the stomach that substantially accumulates food, and

(b) from time to time, adjusting the restriction device so as (i) to enlarge the restricted 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 passageway sufficiently so as to substantially prevent regurgitation of stomach acids and foods into the esophagus.

92. A method as recited in claim 91, wherein the restriction device comprises a cavity which is expandable and contractable by the supply of hydraulic fluid thereto;

and wherein (a) is practiced in part by implanting in the human or animal a reservoir containing a predetermined amount of hydraulic fluid and connecting the reservoir to the cavity and a hydraulic operation device for distributing fluid from the reservoir to the cavity; and

wherein (b) is practiced by controlling the hydraulic operation device from a point outside the human'"'"'s or animal'"'"'s body without physically penetrating the human'"'"'s or animal'"'"'s body.

93. A method as recited in claim 91, wherein the restriction device comprises a cavity which is expandable and contractable by the supply of hydraulic fluid thereto;

and wherein (a) is practiced in part by subcutaneously implanting in the human or animal an injection port connected to the cavity of the restriction device; and

wherein (b) is practiced by injecting fluid through the injection port to expand the cavity to restrict the passageway and by withdrawing fluid from the injection port to contract the cavity to enlarge the passageway.

94. A method as recited in claim 91, wherein the restriction device is acted upon by an adjustment device which mechanically adjusts the restriction of the food passageway;

and wherein (a) is practiced in part by implanting in the human or animal the adjustment device, implanting a reservoir containing a predetermined amount of hydraulic fluid and connecting the reservoir to the cavity, and implanting a hydraulic operation device for distributing fluid from the reservoir to the cavity; and

wherein (b) is practiced by controlling the hydraulic operation device from a point outside the human or animal'"'"'s body without physically penetrating the human'"'"'s or animal'"'"'s body to control the adjustment device so that the restriction of the food passageway is changed.

95. A method as recited in claim 91, wherein (a) is practiced by:

(i) inflating the human'"'"'s or animal'"'"'s abdomen with gas by penetration of the human'"'"'s or animal'"'"'s skin, (ii) introducing at least two laparascopic trocars into the abdomen to introduce the restriction device and one or more medical instruments, and then (iii) applying the restriction device on the esophagus or stomach.

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

a) placing at least two laparoscopic trocars within the human'"'"'s or animal'"'"'s body,

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

c) introducing a restriction device of the apparatus through the trocars,

d) 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

(e) from time to time, adjusting the restriction device so as (i) to enlarge the restricted stoma 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 stoma sufficiently so as to substantially prevent regurgitation of stomach acids and foods into the esophagus.

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

an adjustable 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,

an adjustment device implantable in the patient for adjusting said restriction device to restrict the passageway sufficiently so as to substantially prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus, and

a holding device adapted to be implanted in the patient to hold the esophagus or stomach in a position where the left and right crus muscles are located, to prevent the region of the cardia from moving through the diaphragm muscle.

98. The apparatus according to claim 97, further comprising a wireless remote control for controlling said operation device.

99. The apparatus according to claim 97, further comprising a motor implantable in the patient for operating said operation device.

100. The apparatus according to claim 97, wherein said operation device non-invasively operates said adjustment device.

101. The apparatus according to claim 97, further comprising an implantable battery or accumulator for energizing said adjustment device or other energy consuming components of the apparatus, wherein the energy from said battery or accumulator is released from outside the patient'"'"'s body.

102. The apparatus according to claim 101, wherein said adjustment device adjusts said restriction device in a non-thermal manner.

103. The apparatus according to claim 101, wherein said adjustment device adjusts said restriction device in a non-magnetic manner.

104. The apparatus according to claim 101, wherein said operation device is powered.

105. The apparatus according to claim 104, wherein said operation device is electrically powered.

106. The apparatus according to claim 97, further comprising an internal control unit implantable in the patient for controlling said restriction device.

107. The apparatus according to claim 97, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient.

108. The apparatus according to claim 97, wherein said restriction device comprises an elongated restriction member adapted to be formed into a loop having a predetermined size.

109. The apparatus according to claim 97, wherein said operation device and/or other energy consuming components of the apparatus are adapted to be energised with wirelessly transmitted energy from outside the patient'"'"'s body.

110. The apparatus according to claim 97, further comprising an implantable battery or accumulator for energizing said operation device and/or other energy consuming components of the apparatus, wherein the energy from said battery or accumulator is releasable from outside the patient'"'"'s body.

111. The apparatus according to claim 110, further comprising an energy transmission device for transmitting wireless energy and an implantable energy transfer device adapted to transfer said wireless energy into an energy form suited for charging said battery or accumulator.

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

an adjustable 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 restrictable food passageway in the stomach or esophagus,

an adjustment device implantable in the patient for adjusting said restriction device, and

an operation device implantable in the patient for operating said adjustment device to adjust said restriction device to open the passageway to allow food to readily pass through the passageway and close the passageway to prevent regurgitation of stomach acids or foods into the patient'"'"'s esophagus, when said restriction device engages the patient'"'"'s stomach or esophagus.

113. The apparatus according to claim 112, wherein said operation device operates said adjustment device to steplessly adjust said restriction device.