Mechanical heartburn and reflux treatment

• US 6,470,892 B1
• Filed: 02/10/2000
• Issued: 10/29/2002
• 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:
  US09/502,074
• Time in Patent Office: 992 Days
• Field of Search: 128/897, 128/898, 128/899, 600/29-32, 600/37, 606/139-141, 606/157-158, 623/23.65, 623/23.67
• US Class Current: 128/899
• CPC Class Codes: A61B 17/1322 comprising a flexible encircling member A61B17/135 takes precedence
• CPC Class Codes: A61B 17/1327 Tensioning clamps
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 5/0059 with wireless means

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 cross-sectional area of the food passageway in the stomach or esophagus, and a post-operation non-invasive adjustment device for mechanically adjusting the restriction device to change the cross-sectional area of the passageway. By using a wireless remote control the patient can control the adjustment device, whereby the restriction device works like an artificial sphincter.

Claims

1. A heartburn and reflux disease treatment comprising:

an adjustable non-inflatable 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 cross-sectional area of the 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

a post-operation adjustment device for mechanically non-invasively adjusting said restriction device to change the size of the cross-sectional area 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 restriction device comprises an elongated restriction member and forming means adapted to form 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.

3. The apparatus according to claim 2, wherein said adjustment device adjusts the longitudinal extension of said elongated restriction member.

4. The apparatus according to claim 3, wherein said restriction member comprises a main portion and two elongated end portions, and said adjustment device establishes a longitudinal relative displacement between said end portions of said restriction member, such that the size of said restriction opening is adjusted.

5. The apparatus according to claim 4, wherein said adjustment device comprises a movement transferring member in engagement with at least one of said end portions of said restriction member and operable to displace said one end portion relative to said other end portion of said restriction member.

6. The apparatus according to claim 5, further comprising a motor, which is fixed relative to said main portion of said restriction member and has a rotating drive shaft operatively connected to said movement transferring member.

7. The apparatus according to claim 6, wherein said motor is positioned relative to said elongated restriction member such that said drive shaft extends in parallel with a chord in said loop of the restriction member.

8. The apparatus according to claim 3, wherein said elongated restriction member is longitudinally resilient and said adjustment device comprises a contraction device, which longitudinally contracts said resilient restriction member.

9. The apparatus according to claim 8, wherein said elongated restriction member comprises a substantially nonresilient main portion and an end portion forming an elongated helical spring, which is contractable by said contraction device.

10. The apparatus according to claim 9, wherein said contraction device comprises an elongated flexible pulling member connected to said main portion of said restriction member and extending through said helical spring to contract said helical spring against an arresting member, which is fixed relative to said main portion of said restriction member.

11. The apparatus according to claim 3, wherein said restriction member comprises an elongated helical spring having a free end, and a body to which said spring is nonrotatably secured at its opposite end, said adjustment means device rotates said helical spring in one direction to enlarge the coils of said helical spring to longitudinally contract said elongated helical spring and to rotate said helical spring in the opposite direction to reduce the size of the coils of said helical spring to longitudinally extend said helical spring.

12. The apparatus according to claim 11, wherein said restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to said body at its opposite end, and said adjustment device comprises a drive shaft having two opposite end portions connected to said helical springs, respectively, at their free ends, said helical coils forming left and right hand helices, respectively.

13. The apparatus according to claim 12, wherein said restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to said body at its opposite end, and said adjustment device comprises a gearing having an input shaft and two opposite aligned output shafts connected to said helical springs, respectively, at their free ends, said input shaft being connected to said output shafts such that said output shafts rotate in opposite directions upon rotation of said input shaft, said helical coils forming the same helices.

14. The apparatus according to claim 3, further comprising a motor operatively connected to said adjustment device.

15. The apparatus according to claim 14, wherein said motor is fixed to said restriction member.

16. The apparatus according to claim 15, wherein said motor is remote from said restriction member and is connected to said adjustment device by a power transmission conduit.

17. The apparatus according to claim 2, wherein said restriction member forms a radially innermost at least partly circumferential confinement surface of said restriction member, and said adjustment device mechanically adjusts said restriction member such that at least a portion of said confinement surface is substantially radially displaced in said loop.

18. The apparatus according to claim 17, wherein said adjustment device comprises an elongated voltage responsive element forming part of said confinement surface and capable of bending into a bow in response to a voltage applied across said element, the radius of curvature of said bow being adjustable by changing the level of said voltage.

19. The apparatus according to claim 17, wherein said restriction member comprises an elastic annular element forming said confinement surface, and said adjustment device changes the diameter of said elastic annular element.

20. The apparatus according to claim 17, wherein said forming means comprises a substantially rigid outer annular element, and said restriction member comprises an elongated helical spring extending internally along said outer annular element and contacting the latter, said helical spring forming part of said circumferential confinement surface and having a free end, and a body to which said helical spring is nonrotatably secured at its opposite end, said adjustment device rotates said helical spring in one direction to enlarge the coils of said helical spring to contract said circumferential confinement surface and to rotate said helical spring in the opposite direction to reduce the size of the coils of said helical spring to expand said circumferential confinement surface.

21. The apparatus according to claim 17, wherein said forming means comprises a substantially rigid outer annular element, and said restriction member comprises a first and a second elongated helical spring extending internally along said outer annular element and contacting the latter, said helical springs forming part of said circumferential confinement surface, said first and said second spring, respectively, having a free end, and a body to which said first and said second spring, respectively, is nonrotatably secured at its opposite end, said adjustment device rotating said first and said second spring, respectively, in one direction to enlarge the coils of said spring to contract said circumferential confinement surface and to rotate said first and said second spring, respectively, in the opposite direction to reduce the size of the coils of said spring to expand said circumferential confinement surface.

22. The apparatus according to claim 17, further comprising a motor operatively connected to said adjustment device.

23. The apparatus according to claim 22, comprising a reversing device adapted to be implanted in the patient for reversing said motor.

24. The apparatus according to claim 2, wherein said forming means form said restriction member into a loop having a predetermined size.

25. The apparatus according to claim 2, 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 decrease the cross-sectional area in the esophagus or stomach 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 increase the cross-sectional area.

26. The apparatus according to claim 2, wherein said restriction member comprises at least two separate elements, at least one of which is pivoted such that it may turn in a plane in which said loop of said restriction member extends, and said adjustment device turns said pivoted element to change the size of said restriction opening.

27. The apparatus according to claim 2, wherein said restriction member comprises at least two frame elements, which are foldable towards each other by said adjustment device.

28. The apparatus according to claim 27, wherein said foldable frame elements comprise two substantially or partly semi-circular frame elements, which are hinged together such that said semi-circular elements are swingable relative to each other from a fully open state in which they substantially or partly form a circle to a fully folded state in which they substantially form a semi-circle.

29. The apparatus according to claim 2, wherein said elongated restriction member is elastic and varies in thickness as seen in a cross-section therethrough, and said adjustment device turns said restriction member around the longitudinal extension thereof.

30. The apparatus according to claim 2, further comprising a hydraulic device which operates said adjustment device.

31. The apparatus according to claim 30, further comprising a reservoir containing a predetermined amount of fluid for supplying said hydraulic device with fluid.

32. The apparatus according to claim 31, wherein said reservoir defines a chamber for said predetermined amount of fluid and said hydraulic device changes the volume of said chamber.

33. The apparatus according to claim 31, wherein said hydraulic device comprises an activatable pump for pumping fluid between said reservoir and said adjustment device.

34. The apparatus according to claim 31, wherein said hydraulic device comprises a servo means.

35. The apparatus according to claim 34, wherein said hydraulic 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.

36. The apparatus according to claim 2, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is changed.

37. The apparatus according to claim 2, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of the restriction member is unchanged.

38. The apparatus according to claim 2, wherein said forming means comprises a spring material forming said elongated restriction member into said loop, such that said restriction opening has a predetermined size, and said adjustment device adjusts said restriction member against the spring action of said spring material.

39. The apparatus according to claim 38, wherein said spring material is integrated in said restriction member.

40. The apparatus according to claim 1, further comprising a wireless remote control for non-invasively controlling said adjustment device.

41. The apparatus according to claim 40, wherein said remote control comprises a separate signal transmitter and/or receiver and a signal receiver and/or transmitter adapted to be implanted in the patient.

42. The apparatus according to claim 41, wherein said signal transmitter and signal receiver transmit and receive signals in the form of digital pulses.

43. The apparatus according to claim 42, wherein said digital pulses comprise an electric or magnetic field.

44. The apparatus according to claim 41, wherein said signal receiver comprises a control unit for controlling said adjustment device in response to signals received from said signal transmitter.

45. The apparatus according to claim 44, further comprising an energizer unit adapted to be implanted in the patient for providing energy to energy consuming components of said restriction device.

46. The apparatus according to claim 45, further comprising a motor adapted to be implanted in the patient for operating said adjustment device.

47. The apparatus according to claim 46, wherein said control unit powers said motor with energy provided by said energizer unit in response to signals received from said signal transmitter.

48. The apparatus according to claim 45, wherein said energizer unit transfers energy from said signals, as they are transmitted to said signal receiver, into electric energy.

49. The apparatus according to claim 48, further comprising an electric motor implanted in the patient for operating said adjustment device, said energizer unit comprising a rechargeable electric power supply for storing said electric energy and said control unit powers said electric motor with energy from said rechargeable electric power supply in response to signals received from said signal transmitter.

50. The apparatus according to claim 45, wherein said energizer unit comprises a battery, an electrically operable switch for connecting said battery to said signal receiver in an “

on”

mode when said switch is powered and to keep said battery disconnected from said signal receiver means in a “

standby”

mode when said switch is unpowered, and a rechargeable electric power supply for powering said switch.

51. The apparatus according to claim 50, wherein said control unit powers said electric motor with energy from said battery in response to signals received from said signal transmitter, when said switch is in its “

on”

mode.

52. The apparatus according to claim 45, further comprising an external energy transmitter for transmitting wireless energy, wherein said energizer unit comprises a battery and an operable switch for connecting said battery to said signal receiver in an “

on”

mode when said switch is powered and to keep said battery disconnected from said signal receiver in a “

standby”

mode when said switch is unpowered, said external energy transmitter for powering said switch.

53. The apparatus according to claim 52, wherein said energy transmitter directly powers said switch with said wireless energy to switch into said “

on”

mode.

54. The apparatus according to claim 45, wherein said energizer unit transfers said energy from said signals into direct or alternating current.

55. The apparatus according to claim 44, wherein said motor comprises an electric motor.

56. The apparatus according to claim 41, wherein said signal transmitter and signal receiver transmit and receive wave signals.

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

58. The apparatus according to claim 40, wherein said remote control comprises means for wireless transfer of energy from outside the patient'"'"'s body to energy consuming components of said restriction device.

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

60. The apparatus according to claim 58, wherein said means for wireless transfer of energy directly powers said energy consuming components of said restriction device.

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

62. The apparatus according to claim 40, wherein said remote control is capable of obtaining information on the size of the cross-sectional area of the food passageway when said restriction device is implanted in the patient and of commanding said adjustment device to adjust said restriction device in response to obtained information.

63. The apparatus according to claim 58, wherein said energy transferred by said means for transfer of energy comprises an electric or magnetic field.

64. The apparatus according to claim 40, wherein said remote control is capable of obtaining information from implantable parts of the apparatus and of commanding said adjustment device to adjust said restriction device in response to obtained information.

65. 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 squeeze the esophagus or stomach between said elements to decrease the cross-sectional area in the esophagus or stomach and moves said elements away from each other to release the esophagus or stomach from said elements to increase the cross-sectional area.

66. The apparatus according to claim 1, wherein said restriction device comprises at least two articulated clamping elements adapted to be positioned on opposite or different sides of the esophagus or stomach, and said adjustment device turns said clamping elements toward each other to clamp the esophagus or stomach between said clamping elements to decrease the cross-sectional area in the esophagus or stomach, and turns said clamping elements away from each other to release the esophagus or stomach from said elements to increase the cross-sectional area in the esophagus or stomach.

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

68. The apparatus according to claim 67, 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 reduce the cross-sectional area in the esophagus or stomach, and moves said bending members away from each other to release the esophagus or stomach from said bending members to increase the cross-sectional area.

69. The apparatus according to claim 68, wherein said bending members comprise rollers.

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

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

72. The apparatus according to claim 71, wherein said restriction device is operable to open and close the food passageway.

73. The apparatus according to claim 71, wherein said restriction device is adapted to steplessly control the cross-sectional area of the food passageway.

74. The apparatus according to claim 1, further comprising a pressure sensor for directly or indirectly sensing the pressure against the restriction device.

75. The apparatus according to claim 74, wherein said restriction device is controlled in response to signals from said pressure sensor.

76. The apparatus according to claim 1, further comprising an energy transfer device adapted to be implanted in the patient for transferring wireless energy directly or indirectly into kinetic energy for operation of said restriction device.

77. The apparatus according to claim 1, wherein said restriction device comprises a holding device adapted to prevent the region of the cardia from passing through the esophagal hiatus diaphragmatica, when said restriction device is implanted.

78. The apparatus according to claim 77, wherein said holding device comprises a support member.

79. The apparatus according to claim 1, wherein said post-operation adjustment device is adapted to non-invasively adjust said restriction device to change the size of the cross-sectional area.

80. The apparatus according to claim 1, further comprising a reversing device adapted be implanted in the patient, wherein said restriction device is capable of performing a reversible function and said reversing device reverses said reversible function.

81. The apparatus according to claim 1, further comprising an energy transmission device for transmitting wireless energy from outside the patient'"'"'s body for energizing said adjustment device or other implantable components of the apparatus.

82. The apparatus according to claim 1, further comprising an accumulator or battery adapted to be implanted in the patient and adapted to be controlled from outside the patient'"'"'s body to supply energy to said adjustment device or other implantable energy consuming components of the apparatus.

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

84. The apparatus according to claim 1, further comprising means for wireless transfer of energy from outside the patient'"'"'s body to energy consuming implantable components of the apparatus including said operation device.

85. The apparatus according to claim 84, wherein said means for wireless transfer of energy directly powers said energy consuming implantable components of the apparatus including said operation device.

86. The apparatus according to claim 84, wherein said energy transferred by said means for transfer of energy comprises a wave signal.

87. The apparatus according to claim 84, wherein said energy transferred by said means for transfer of energy comprises an electric or magnetic field.

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

89. A method for treating heartburn and reflux disease, comprising:

(a) surgically implanting in the abdomen of a patient suffering from heartburn and reflux disease an adjustable non-inflatable restriction device which forms a food passageway having a restricted cross-sectional area in the esophagus or in the stomach close to the cardia, and

(b) in a non-invasive procedure, mechanically adjusting the restriction device to change the size of the cross-sectional area of the food passageway.

90. A surgical method for laparoscopically implanting an adjustable restriction device of a heartburn and reflux disease treatment apparatus for forming a food passageway having a restricted cross-sectional area in the esophagus or stomach immediately close to the cardia, the method comprising:

(a) insufflating the abdomen of the patient to form a pneumoperitoneum;

(b) introducing at least one laparoscopic trocar into the abdomen;

(c) using a dissecting tool inserted through the laparoscopic trocar, dissecting the region of the esophagus or stomach adjacent or above the bursa omentalis;

(d) introducing the restriction device into the abdomen and applying the restriction device on the esophagus or stomach; and

(e) post-operatively adjusting the restriction device in a non-invasive procedure to change the cross-sectional area of the food passageway.

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

an adjustable non-inflatable 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 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.

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

an adjustable non-inflatable 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, and

non-invasively activatable adjustment device to be implanted in the patient for mechanically adjusting 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.

93. The apparatus according to claim 92, wherein said adjustment device steplessly adjusts said restriction device.