Heartburn and reflux disease treatment apparatus

• US 20020193842A1
• Filed: 06/29/2001
• Published: 12/19/2002
• Est. Priority Date: 05/23/2001
• Status: Active Grant

• Current Assignee: Surgical Development AG
• Original Assignee: Surgical Development AG
• Inventors: Forsell, Peter
• Granted Patent: US 6,678,561 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A heartburn and reflux disease treatment apparatus comprises an electric stimulation device (56) adapted to engage the cardia sphincter (58) of a patient, who suffers from heartburn and reflux disease, and electrically stimulate the cardia sphincter to increase the sphincter tonus, so that the cardia completely closes. A control device (62) is provided for controlling a source of energy (64), which may or may not be implanted, to release electric energy for use in connection with the power of the stimulation device.

Claims

1. A heartburn and reflux disease treatment apparatus, characterised by an implantable electric stimulation device adapted to engage with the cardia sphincter of a patient, who suffers from heartburn and reflux disease, and electrically stimulate the cardia sphincter to increase the sphincter tonus, so that the cardia completely closes.

2. An apparatus according to claim 1, further comprising a source of energy, and a control device controllable from outside the patient'"'"'s body for controlling the source of energy to release energy for use in connection with the power of the stimulation device, when the stimulation device is implanted.

3. An apparatus according to claim 2, wherein the source of energy comprises an electric source of energy and the control device is adapted to supply the stimulation device with electric energy from the electric source of energy.

4. An apparatus according to claim 3, wherein the electric source of energy is adapted to provide a current through the electric conductors, and the control device is adapted to control the electric source of energy to release electric energy such that the intensity of the current through the electric conductors amounts to a predetermined value.

5. An apparatus according to claim 4, wherein the control device is adapted to control the electric source of energy to release electric energy in the form of an alternating current.

6. An apparatus according to claim 3, wherein the control device controls the stimulation device.

7. An apparatus according to claim 6, wherein the control device is adapted to control the stimulation device to vary the intensity of the electric stimulation of the cardia sphincter over time.

8. An apparatus according to claim 7, wherein the control device is controllable from outside the patient'"'"'s body to control the stimulation device to change the intensity of the electric stimulation of the cardia sphincter so that the tonus of the cardia sphincter is changed.

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

10. An apparatus according to claim 9, wherein the sensor comprises a pressure sensor for directly or indirectly sensing as the physical parameter the pressure in the esophagus of the patient.

11. An apparatus according to claim 9, wherein the sensor senses as the physical parameter the contraction wave in the esophagus caused by the patient swallowing food.

12. An apparatus according to claim 11, wherein the electric stimulation device is adapted to cease the stimulation of the cardia sphincter in response to the sensor sensing the contraction wave in the patient'"'"'s esophagus.

13. An apparatus according to claim 9, further comprising a control device adapted to control the stimulation device in response to signals from the sensor.

14. An apparatus according to claim 13, wherein the control device comprises an internal control unit implantable in the patient, the internal control unit controlling the stimulation device in response to signals from the sensor.

15. An apparatus according to claim 14, wherein the control device comprises an external control unit outside the patient'"'"'s body, the external control unit controlling the stimulation device in response to signals from the sensor.

16. An apparatus according to claim 15, wherein the external control unit stores information on the physical parameter sensed by the sensor and is manually operated to control the stimulation device based on the stored information.

17. An apparatus according to claim 9, further comprising at least one implantable sender for sending information on the physical parameter sensed by the sensor.

18. An apparatus according to claim 6, wherein the control device comprises an internal control unit implantable in the patient for controlling the stimulation device.

19. An apparatus according to claim 18, wherein the internal control unit is programmable.

20. An apparatus according to claim 19, wherein the control device comprises an external control unit intended to be outside the patient'"'"'s body, the internal control unit being programmable by the external control unit.

21. An apparatus according to claim 19, wherein the internal control unit is programmable for controlling the stimulation device over time.

22. An apparatus according to claim 21, wherein the internal control unit controls the stimulation device over time in accordance with an activity schedule program.

23. An apparatus according to claim 21, wherein the internal control unit comprises a microprocessor.

24. An apparatus according to claim 20, wherein the external control unit loads the internal control unit with data in accordance with a loading mode only authorised for a doctor.

25. An apparatus according to claim 20, wherein the external control unit controls the internal control unit in accordance with a doctor mode only authorised for a doctor.

26. An apparatus according to claim 20, wherein the external control unit controls the internal control unit in accordance with a patient mode permitted for the patient.

27. An apparatus according to claim 2, wherein the source of energy is intended to be external to the patient'"'"'s body when the stimulation device is implanted therein, and the control device is adapted to control the external source of energy to release wireless energy for use in connection with the power of the stimulation device.

28. An apparatus according to claim 27, further comprising an energy storage device implantable in the patient for storing the wireless energy released from the external source of energy.

29. An apparatus according to claim 28, wherein the energy storage device comprises an accumulator.

30. An apparatus according to claim 29, wherein the accumulator comprises an electric accumulator.

31. An apparatus according to claim 30, wherein the electric accumulator comprises at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

32. An apparatus according to claim 27, wherein the control device is adapted to control the external source of energy to release wireless energy for direct use in connection with the power of the stimulation device.

33. An apparatus according to claim 32, further comprising an activatable source of energy implantable in the patient, wherein the implantable source of energy is activated by wireless energy released from the external source of energy, to supply energy which is used in connection with the power of the stimulation device.

34. An apparatus according to claim 32, wherein the control device is adapted to control the external source of energy to intermittently release wireless energy in the form of a train of energy pulses for direct use in connection with the power of the stimulation device.

35. An apparatus according to claim 34, wherein the control device is adapted to control the source of energy to release electric energy, and further comprising an implantable capacitor for producing the train of energy pulses from the released energy.

36. An apparatus according to claim 35, wherein the capacitor has a capacity less than 0,1 μ

F.

37. An apparatus according to claim 1, further comprising a battery implantable in the patient for supplying electric energy to implantable electric energy consuming components of the apparatus.

38. An apparatus according to claim 2, wherein the source of energy comprises an implantable internal source of energy.

39. An apparatus according to claim 38, wherein the internal source of energy comprises an electric source of energy.

40. An apparatus according to claim 39, wherein the internal 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.

41. An apparatus according to claim 1, further comprising a switch implantable in the patient for directly or indirectly switching the power of the stimulation device.

42. An apparatus according to claim 41, further comprising an internal electric source of energy implantable in the patient for supplying electric energy to the stimulation device, wherein the switch directly or indirectly affects the supply of electric energy from the internal electric source of energy.

43. An apparatus according to claim 42, wherein the switch switches between an “

off”

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

on”

mode, in which the internal electric source of energy supplies electric energy to the stimulation device.

44. An apparatus according to claim 27, wherein the switch is operable by the wireless energy released from the external source of energy.

45. An apparatus according to claim 44, wherein the control device controls the external source of energy to release the wireless energy.

46. An apparatus according to claim 2, wherein the control device comprises a wireless remote control.

47. An apparatus according to claim 42, wherein the control device comprises a wireless remote control for controlling the internal electric source of energy.

48. An apparatus according to claim 47, wherein the switch is operable by the wireless energy from the external source of energy to switch between an “

off”

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

standby”

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

49. An apparatus according to claim 42, further comprising an energy transforming device implantable in the patient for transforming the wireless energy into storable energy and an energy storage device implantable in the patient for storing the storable energy.

50. An apparatus according to claim 49, wherein the switch is operable by energy from the implantable energy storage device to switch between an “

off”

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

on”

mode, in which the internal electric source of energy supplies electric energy to the stimulation device.

51. An apparatus according to claim 50, wherein the control device controls the energy storage device to operate the switch.

52. An apparatus according to claim 51, wherein the control device comprises a wireless remote control.

53. An apparatus according to claim 42, further comprising an energy transforming device implantable in the patient for transforming the wireless energy into electric energy, which is stored by the internal electric source of energy.

54. An apparatus according to claim 53, wherein the switch switches from an “

off”

mode, in which the internal electric source of energy is not in use, to an “

on”

mode, in which the internal source of electric energy supplies energy to the stimulation device.

55. An apparatus according to claim 54, wherein the control device controls the switch to switch between the “

on” and

“

off”

modes.

56. An apparatus according to claim 55, wherein the control device comprises a wireless remote control.

57. An apparatus according to claim 1, further comprising an external data communicator intended to be outside the patient'"'"'s body and an internal data communicator implantable in the patient for communicating with the external communicator, wherein the internal data communicator feeds data related to the patient back to the external data communicator or the external data communicator feeds data to the internal data communicator.

58. An apparatus according to claim 57, wherein the internal data communicator feeds data related to the stimulation device.

59. An apparatus according to claim 57, wherein the internal data communicator feeds data related to at least one physical signal of the patient.

60. An apparatus according to claim 1, wherein the control device controls the source of energy to release energy for a determined time period.

61. An apparatus according to claim 1, wherein the control device controls the source of energy to release energy in a determined number of energy pulses.

62. An apparatus according to claim 1, wherein the control device is adapted to control the source of energy to release energy in a non-invasive manner.

63. An apparatus according to claim 2, wherein the control device comprises a wireless remote control for transmitting at least one wireless control signal for controlling the stimulation device.

64. An apparatus according to claim 63, wherein the remote control is capable of obtaining information on the condition of the stimulation device when the stimulation device is implanted and to control the stimulation device in response to the information.

65. An apparatus according to claim 63, wherein the wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient.

66. An apparatus according to claim 63, wherein the wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver implantable in the patient.

67. An apparatus according to claim 63, wherein the remote control transmits a carrier signal for carrying the control signal.

68. An apparatus according to claim 67, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

69. An apparatus according to claim 67, wherein the carrier signal is digital, analogue or digital and analogue.

70. An apparatus according to claim 67, wherein the control signal used with the carrier signal is frequency, amplitude or frequency and amplitude modulated.

71. An apparatus according to claim 63, wherein he 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.

72. An apparatus according to claim 63, wherein the control signal comprises an electric, magnetic or electric and magnetic field.

73. An apparatus according to claim 63, wherein the control signal is digital, analogue or digital and analogue.

74. An apparatus according to claim 78, wherein the remote control transmits an electromagnetic carrier wave signal for carrying the digital or analogue control signal.

75. An apparatus according to claim 63, wherein the control signal is transmitted in pulses by the wireless remote control.

76. An apparatus according to claim 27, further comprising an implantable stabiliser for stabilising the energy released by the control device.

77. An apparatus according to claim 76, wherein the energy released by the control device comprises electric energy and the stabiliser comprises at least one capacitor.

78. An apparatus according to claim 32, wherein the wireless energy comprises electromagnetic waves excluding radio waves.

79. An apparatus according to claim 27, wherein the wireless energy comprises a signal.

80. An apparatus according to claim 27, further comprising an implantable energy transforming device for transforming wireless energy directly or indirectly into electric energy for the power of the stimulation device.

81. An apparatus according to claim 80, wherein the energy transforming device transforms the wireless energy in the form of sound waves into electric energy for the power of the stimulation device.

82. An apparatus according to claim 81, wherein the energy transforming device transforms the wireless energy in the form of sound waves directly into electric energy.

83. An apparatus according to claim 81, wherein the energy transforming device comprises a capacitor.

84. An apparatus according to claim 83, wherein the capacitor is adapted to produce electric pulses from the transformed electric energy.

85. An apparatus according to claim 1, wherein the stimulation device is embedded in a soft or gel-like material.

86. An apparatus according to claim 1, wherein the stimulation device is embedded in a silicone material having hardness less than 20 Shore.

87. An apparatus according to claim 1, wherein the stimulation device comprises a band for application around the cardia, the band having electric conductors for engaging the cardia sphincter.

88. An apparatus according to claim 87, wherein the electric conductors comprise hooks to secure the conductors on the cardia.

89. An apparatus according to claim 88, wherein the hooks are inserted into the cardia.

90. An apparatus according to claim 9, wherein the sensor senses as the physical parameter when the patient is lying, and the electric stimulation device is adapted to maintain the stimulation of the cardia sphincter in response to the sensor sensing that the patient is lying.