Devices and methods for pyloric anchoring

• US 20050055039A1
• Filed: 08/09/2004
• Published: 03/10/2005
• Est. Priority Date: 07/28/2003
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: Polymorfix Inc.
• Inventors: Burnett, Daniel R., Hall, Gregory W., Bajor, Jordan T., Campbell-White, Annette
• Granted Patent: US 9,498,366 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12086 magnetically detachable
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

A device for performing one or more functions in a gastrointestinal tract of a patient includes an anchoring member and at least one actuator, sensor, or combination of both coupled with the anchoring device. The anchoring device is adapted to maintain at least part of the device within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue. Actuators perform any suitable function, such as transmitting energy to tissue, acting as a sleeve to reduce nutrient absorption, occupying space in the stomach, eluting a drug and/or the like. Sensors may be adapted to sense any suitable patient characteristic within the patient'"'"'s gastrointestinal tract, such as pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and/or hemoglobin.

Claims

1. A device for performing one or more functions in a gastrointestinal tract of a patient, the device comprising:

an anchoring member adapted to maintain at least part of the device within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue; and

at least one actuator coupled with the anchoring member for performing a function in the patient'"'"'s gastrointestinal tract.

2. A device as in claim 1, wherein the anchoring member comprises a stomach retention portion having sufficient size and rigidity to prevent passage of the stomach retention portion through a pyloric valve out of the stomach.

3. A device as in claim 2, wherein at least one actuator is coupled with the stomach retention portion.

4. A device as in claim 2, wherein the stomach retention portion is expandable from a first configuration for delivery through an esophagus of the patient to a second configuration for preventing passage of the stomach retention portion through the pyloric valve.

5. A device as in claim 2, wherein the device is adapted to be placed into the stomach via an incision in a wall of the stomach.

6. A device as in claim 2, wherein the anchoring member further includes a tissue engagement portion adapted to intermittently engage pyloric stomach tissue without causing significant damage to the tissue.

7. A device as in claim 6, wherein at least one actuator is coupled with the tissue engagement portion.

8. A device as in claim 6, wherein the tissue engagement portion comprises at least one compliant material.

9. A device as in claim 2, wherein the anchoring member further comprises a pyloric valve spanning member extending from the stomach retaining portion at least partially through a pyloric valve of the patient.

10. A device as in claim 9, wherein at least one actuator is coupled with the pyloric valve spanning member.

11. A device as in claim 9, wherein the anchoring member further comprises a distal anchor member coupled with the pyloric valve spanning member and adapted to reside in a duodenum of the patient.

12. A device as in claim 11, wherein at least one actuator is coupled with at least one of the pyloric spanning member and the distal anchor member.

13. A device as in claim 12, wherein at least one actuator is coupled with the distal anchor member and is adapted to extend into a small intestine of the patient.

14. A device as in claim 11, wherein the distal anchor member is sufficiently small to pass through the pyloric valve through natural peristalsis but sufficiently large to resist passing back into the stomach.

15. A device as in claim 11, wherein the distal anchor member is sufficiently large so as to require placement into the duodenum beyond the pyloric valve.

16. A device as in claim 11, wherein at least one of the stomach retaining portion, the pyloric valve spanning member and the distal anchor member are adapted to change configurations while residing in the gastrointestinal tract.

17. A device as in claim 16, wherein the pyloric valve spanning member is adapted to change its length.

18. A device as in claim 16, wherein the pyloric valve spanning member is adapted to change its diameter.

19. A device as in claim 16, wherein the configuration changes occur upon receipt and processing of one or more signals by a receiver and processor of the device.

20. A device as in claim 19, wherein the one or more signals are transmitted by one or more external or internally implanted devices adapted to transmit signals selected from the group consisting of radiofrequecy, electromagnetic, microwave and ultrasound signals.

21. A device as in claim 16, wherein the configuration changes occur upon sensing by at least one sensor of the device at least one of pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and hemoglobin in the gastrointestinal tract.

22. A device as in claim 1, further comprising attachment means for attaching to a catheter device extended into the stomach to adjust or modify the device.

23. A device as in claim 22, wherein the attachment means comprises a magnet.

24. A device as in claim 1, wherein the anchoring member is adapted to intermittently obstruct a pyloric valve of the stomach.

25. A device as in claim 24, wherein the at least one actuator comprises a sleeve extending within at least a portion of the small intestine to reduce absorption of nutrients by the small intestine.

26. A device as in claim 25, further comprising at least one tether for coupling the sleeve with the anchoring member.

27. A device as in claim 25, wherein the sleeve includes at least one proximal opening for allowing partially digested food to enter the sleeve.

28. A device as in claim 25, wherein the sleeve comprises an impermeable or semi-permeable membrane to reduce the absorption of nutrients.

29. A device as in claim 1, wherein the anchoring member includes at least one passage for allowing substances to pass through the device and thus through a pyloric valve of the stomach.

30. A device as in claim 29, wherein the actuator comprises a sleeve in fluid communication with the at least one passage for extending into a duodenum of the patient such that substances pass through the device and through the sleeve to reduce absorption of nutrients by the duodenum.

31. A device as in claim 30, wherein the sleeve extends beyond the duodenum, thus further reducing absorption of nutrients.

32. A device as in claim 30, wherein the sleeve comprises an impermeable or semi-permeable membrane to reduce the absorption of nutrients.

33. A device as in claim 1, wherein the at least one actuator comprises at least one energy transmission member for applying energy to tissue of the gastrointestinal tract.

34. A device as in claim 33, wherein the at least one energy transmission member transmits energy selected from the group consisting of radiofrequency, ultrasound, microwave, cryogenic, laser, light, electrical, mechanical and thermal energy.

35. A device as in claim 33, wherein the at least one energy transmission member comprises a plurality of radiofrequency electrodes adapted to apply radiofrequency energy to at least one of the stomach, a pyloric valve and a small intestine of the patient.

36. A device as in claim 1, wherein the at least one actuator comprises one or more substances releasably coupled with the anchoring device.

37. A device as in claim 36, wherein the one or more substances are selected from the group consisting of lipids, drugs, enzymes, diagnostic agents, lipids, vitamins, and minerals.

38. A device as in claim 36, wherein the at least one substance is releasably coupled with at least one outer surface of the anchoring device such that the substance automatically releases from the surface(s) over time.

39. A device as in claim 38, further comprising a substrate coupled with the outer surface(s) for releasably coupling the substance(s) with the device.

40. A device as in claim 36, wherein the at least one substance is housed within at least one reservoir on the anchoring device.

41. A device as in claim 40, wherein the at least one substance is automatically released from the at least one reservoir over time.

42. A device as in claim 40, wherein the at least one substance is released from the at least one reservoir when the device receives a signal from a transmitter outside the patient.

43. A device as in claim 40, wherein the at least one reservoir is adapted to be refilled while the device resides in the gastrointestinal tract.

44. A device as in claim 43, wherein the reservoir(s) are adapted to be refilled via a catheter device passed into the stomach via the esophagus of the patient.

45. A device as in claim 1, wherein the at least one actuator comprises at least one space-occupying member for occupying space in the stomach to enhance the patient'"'"'s feeling of satiety.

46. A device as in claim 45, wherein the space-occupying member comprises an expanded portion of the anchoring member.

47. A device as in claim 45, wherein the space-occupying member is coupled to the anchoring member via a tether.

48. A device as in claim 1, wherein the at least one actuator comprises one or more triggers adapted to elicit a biological response.

49. A device as in claim 48, wherein the trigger comprises a surface coating adapted to induce a satiety response.

50. A device as in claim 49, wherein the surface coating is adapted to interact with biological lipid or fat sensors in the duodenum.

51. A device as in claim 49, wherein the wherein the surface coating is adapted to elute from the device over time to induce the satiety response.

52. A device as in claim 51, wherein the surface coating comprises at least one of fat, lipid, carbohydrate and protein derivatives.

53. A device as in claim 48, wherein the trigger comprises a mechanical stimulant adapted to induce a satiety response.

54. A device as in claim 1, wherein the at least one actuator comprises at least one imaging device.

55. A device as in claim 54, wherein the imaging device is selected from the group consisting of a fiber optic device, an ultrasound device, a laser imaging device, an endoscopic device, a camera and a radiographic imaging device.

56. A device as in claim 1, wherein the at least one actuator comprises a signal transmitter for transmitting a location signal for use in a global positioning system.

57. A device as in claim 1, wherein the at least one actuator comprises a data storage device.

58. A device as in claim 57, wherein the data storage device is adapted to store medical records of the patient.

59. A device as in claim 1, further comprising at least one sensor coupled with the anchoring member for sensing one or more characteristics in the gastrointestinal tract.

60. A device as in claim 59, wherein the at least one sensor is adapted to sense at least one of pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and hemoglobin.

61. A device as in claim 59, further including a processor adapted to process data related to the sensed signals and provide the processed data to the at least one actuator.

62. A device as in claim 1, further comprising at least one receiver for receiving signals from one or more transmitters located outside the patient or implanted in the patient.

63. A device as in claim 62, further including a processor adapted to process the received signals and provide the processed data to the at least one actuator.

64. A device as in claim 1, further comprising a rechargeable power source adapted to be recharged via an external charging device located outside the patient.

65. A device for performing one or more functions in a gastrointestinal tract of a patient, the device comprising:

an anchoring member adapted to maintain at least part of the device within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue; and

at least one sensor coupled with the anchoring member for sensing one or more characteristics in the patient'"'"'s gastrointestinal tract.

66. A device as in claim 65, wherein the at least one sensor is adapted to sense at least one of pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and hemoglobin.

67. A device as in claim 65, further comprising at least one actuator for performing a function in the gastrointestinal tract.

68. A device as in claim 67, wherein the at least one actuator is selected from the group consisting of an energy transmission member, a substance releasably coupled with the anchoring member, an absorption-reducing intestinal sleeve, a triggering device, a space-occupying device, an imaging device, a data transmitter and a data storage device.

69. A device as in claim 67, further including a processor adapted to process data related to the sensed signals and provide the processed data to the at least one actuator.

70. A device as in claim 67, further comprising at least one receiver for receiving signals from one or more transmitters located outside the patient or implanted in the patient.

71. A device as in claim 70, further including a processor adapted to process the received signals and provide the processed data to the at least one actuator.

72. A system for performing a function in a gastrointestinal tract of a patient, the system comprising:

a gastrointestinal device comprising;

an anchoring member adapted to maintain at least part of the device within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue; and

at least one actuator coupled with the anchoring member for performing a function in the patient'"'"'s gastrointestinal tract; and

at least one transmitter for activating and/or modulating activity of the actuator.

73. A system as in claim 72, further comprising at least one sensor coupled with the anchoring member for sensing one or more characteristics in the gastrointestinal tract.

74. A system as in claim 73, wherein the at least one sensor is adapted to sense at least one of pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and hemoglobin.

75. A system as in claim 73, further including a processor adapted to process data related to the sensed signals and provide the processed data to the at least one actuator.

76. A system as in claim 72, further comprising at least one receiver for receiving signals from the transmitter(s).

77. A system as in claim 76, further comprising a processor adapted to process the received signals and provide the processed data to the at least one actuator.

78. A system as in claim 72, further comprising a rechargeable power source adapted to be recharged via an external charging device located outside the patient.

79. A system as in claim 72, wherein the at least one actuator is selected from the group consisting of an energy transmission member, a substance releasably coupled with the anchoring member, an absorption-reducing intestinal sleeve, a triggering device, a space-occupying device, an imaging device, a data transmitter and a data storage device.

80. A system as in claim 72, wherein the at least one transmitter is adapted to be positioned outside the patient.

81. A system as in claim 72, wherein the at least one transmitter is adapted to be implanted within the patient.

82. A system as in claim 72, further comprising an elongate catheter device for delivering the gastrointestinal device through an esophagus of the patient.

83. A system as in claim 72, further comprising an elongate catheter device for coupling with the gastrointestinal device through an esophagus of the patient and recharging the actuator.

84. A system as in claim 83, wherein a magnetic end of the elongate catheter device is adapted to couple with an oppositely charged magnet on the gastrointestinal device.

85. A system as in claim 83, wherein the elongate catheter device is adapted to recharge one or more drug reservoirs on the gastrointestinal device.

86. A system as in claim 83, wherein the elongate catheter device is adapted to recharge a power supply of the gastrointestinal device.

87. A method for performing a function in a gastrointestinal tract of a patient, the method comprising:

delivering an anchoring device into the stomach, the anchoring device adapted to maintain at least part of the device within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue; and

performing a function in the gastrointestinal tract using at least one actuator coupled with the anchoring device.

88. A method as in claim 87, wherein delivering the anchoring device comprises:

advancing the anchoring device through an esophagus of the patient in a first, constrained configuration; and

releasing the anchoring device to allow at least a portion of the device to expand from the first configuration to a larger second configuration, wherein the portion in the expanded second configuration is adapted to prevent passage of the anchoring device through a pyloric valve of the patient.

89. A method as in claim 87, wherein delivering the anchoring device comprises passing the device through an incision in a wall of the patient'"'"'s stomach.

90. A method as in claim 87, wherein performing the at least one function comprises performing at least one of transmitting energy, releasing a substance, reducing absorption of a small intestine, stimulating gastrointestinal tissue to evoke a response, occupying space within the stomach, taking one or more images, transmitting data and storing data.

91. A method as in claim 87, further comprising sensing at least one patient characteristic using at least one sensing device coupled with the anchoring device.

92. A method as in claim 91, wherein sensing the at least one sensed characteristic comprises sensing at least one of pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and hemoglobin.

93. A method as in claim 87, further comprising:

transmitting data to the anchoring device via at least one transmitter; and

receiving the transmitted data via a receiver coupled with the anchoring device.

94. A method as in claim 93, wherein transmitting is performed via one or more transmitters located outside the patient.

95. A method as in claim 93, wherein transmitting is performed via one or more transmitters implanted in the patient.

96. A method as in claim 93, further comprising processing the transmitted data via a processor coupled with the anchoring member.

97. A method as in claim 87, further comprising recharging the actuator while the gastrointestinal device remains within the patient.

98. A method as in claim 97, wherein recharging the actuator is performed via an external charging device located outside the patient.

99. A method as in claim 97, wherein recharging the actuator is performed via a catheter device passed into the patient'"'"'s stomach via the patient'"'"'s esophagus.

100. A method as in claim 97, wherein recharging comprises refilling at least one drug reservoir of the gastrointestinal device.

101. A method as in claim 97, further comprising recharging a power source coupled with the anchoring member.

102. A method as in claim 87, wherein the anchoring member is adapted to intermittently obstruct a pyloric valve of the patient'"'"'s gastrointestinal tract, thus slowing passage of food through the valve.

103. A method as in claim 87, wherein the anchoring member extends across a pyloric valve of the patient'"'"'s gastrointestinal tract, and wherein the anchoring member is adapted to allow passage of food therethrough, thus reducing absorption of nutrients in at least part of the patient'"'"'s duodenum.

104. A method for sensing one or more patient characteristic in a gastrointestinal tract of a patient, the method comprising:

delivering an anchoring device into the stomach, the anchoring device adapted to maintain at least part of the device within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue; and

sensing one or more patient characteristic(s) in the gastrointestinal tract using at least one sensing device coupled with the anchoring device.

105. A method as in claim 104, wherein delivering the anchoring device comprises:

advancing the anchoring device through an esophagus of the patient in a first, constrained configuration; and

releasing the anchoring device to allow at least a portion of the device to expand from the first configuration to a larger second configuration, wherein the portion in the expanded second configuration is adapted to prevent passage of the anchoring device through a pyloric valve of the patient.

106. A method as in claim 104, wherein delivering the anchoring device comprises passing the device through an incision in a wall of the patient'"'"'s stomach.

107. A method as in claim 104, wherein sensing the at least one sensed characteristic comprises sensing at least one of pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and hemoglobin.

108. A method as in claim 104, further comprising performing at least one function in the gastrointestinal tract using at least one actuator coupled with the anchoring device.

109. A method as in claim 108, wherein performing the at least one function comprises performing at least one of transmitting energy, releasing a substance, reducing absorption of a small intestine, stimulating gastrointestinal tissue to evoke a response, occupying space within the stomach, taking one or more images, transmitting data and storing data.

110. A method as in claim 104, further comprising:

transmitting data to the anchoring device via at least one transmitter; and

receiving the transmitted data via a receiver coupled with the anchoring device.

111. A method as in claim 110, wherein transmitting is performed via one or more transmitters located outside the patient.

112. A method as in claim 110, wherein transmitting is performed via one or more transmitters implanted in the patient.

113. A method as in claim 110, further comprising processing the transmitted data via a processor coupled with the anchoring member.

114. A method as in claim 104, further comprising recharging the actuator while the gastrointestinal device remains within the patient.

115. A method as in claim 114, wherein recharging the actuator is performed via an external charging device located outside the patient.

116. A method as in claim 114, wherein recharging the actuator is performed via a catheter device passed into the patient'"'"'s stomach via the patient'"'"'s esophagus.

117. A method as in claim 114, wherein recharging comprises refilling at least one drug reservoir of the gastrointestinal device.

118. A method as in claim 114, further comprising recharging a power source coupled with the anchoring member.

119. A method as in claim 104, wherein the anchoring member is adapted to intermittently obstruct a pyloric valve of the patient'"'"'s gastrointestinal tract, thus slowing passage of food through the valve.

120. A method as in claim 104, wherein the anchoring member extends across a pyloric valve of the patient'"'"'s gastrointestinal tract, and wherein the anchoring member is adapted to allow passage of food therethrough, thus reducing absorption of nutrients in at least part of the patient'"'"'s duodenum.