Stomach treatment apparatus and method

• US 6,427,089 B1
• Filed: 02/18/2000
• Issued: 07/30/2002
• Est. Priority Date: 02/19/1999
• Status: Expired due to Fees

• Current Assignee: Edward W. Knowlton
• Original Assignee: Edward W. Knowlton
• Inventors: Knowlton, Edward W.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/507,597
• Time in Patent Office: 893 Days
• Field of Search: 606/27-29, 607/98-102, 607/105, 607/113, 607/116, 607/133, 607/138, 607/154, 607/156
• US Class Current: 607/101
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves

Abstract

An apparatus to modify a stomach wall comprises an elongated member including at least one lumen. A deployable member is coupled to the elongated member. The deployable member is configured to be advanceable and removable from the stomach in a non-deployed state and sized to be positioned in the stomach in a deployed state to engage at least portions of the stomach wall. The deployable member is further configured to house a fluidic media and at least portions of the deployable member wall is configured to be cooled by the fluidic media. The deployable member has a contour in the deployed state approximating at least a portion of a stomach. A microwave antenna is movably positioned in the deployable member so as to control a microwave field strength vector in relation to the antenna. The microwave antenna is configured to be coupled to a microwave energy source and deliver microwave energy to a selectable tissue site in the stomach wall while minimizing thermal injury to one of a mucosal or a submucosal layer. A cable member is coupled to the microwave antenna and is configured to be advanceable within the elongated member.

Claims

1. An apparatus to modify a stomach wall comprising:

an elongated member including at least one lumen;

a deployable member coupled to the elongated member, the deployable member configured to be advanceable and removable from the stomach in a non-deployed state and sized to be positioned in the stomach in a deployed state to engage at least portions of the stomach wall, the deployable member further configured to contain a fluidic media, at least a portion of a deployable member wall configured to be cooled by the fluidic media, at least a portion of the deployable member having a contour in the deployed state approximating at least a portion of a stomach interior, wherein at least a portion of the deployable member include one of a microwave absorbable material or a microwave absorbable material with a variable microwave absorption;

a microwave antenna movably positioned in the deployable member so as to control a microwave field strength vector in relation to the antenna, the microwave antenna being configured to be coupled to a microwave energy source and deliver microwave energy to a selectable tissue site in the stomach wall while minimizing thermal injury to one of a mucosal or a submucosal layer; and

a cable member coupled to the microwave antenna, the cable member configured to be advancecable within the elongated member.

2. The apparatus of claim 1, wherein the contour includes a first radius of curvature and a second radius of curvature, the second radius of curvature being greater than the first radius of curvature and at least a portion of the first curvature being substantially parallel to at least a portion of the second curvature.

3. The apparatus of claim 2, wherein the first radius of curvature approximates a stomach lesser curvature and the second radius of curvature approximates a stomach greater curvature.

4. The apparatus of claim 1, wherein the expansion device deployed has a contour approximating at least one of a fundus, an antrum, a stomach corpus or a pyloric region.

5. The apparatus of claim 1, wherein at least portion of the elongated member is formed of one of a microwave absorbable material or a microwave absorbable material with a variable microwave absorption.

6. The apparatus of claim 5, wherein the microwave absorption varies with respect to at least one of a temperature or an emitted microwave power.

7. The apparatus of claim 1, wherein the at least one expansion member or the elongated member includes at least one aperture.

8. The apparatus of claim 7, wherein the at least one aperture is fluidically coupled with the at least one lumen.

9. The apparatus of claim 1, wherein the fluidic medium contains at least one of a cooling fluid, a cooled fluid, a microwave absorbing solution, a microwave absorbing particle or a microwave absorbing solution with a variable microwave absorption.

10. The apparatus of claim 9, wherein the microwave absorbing solution has a microwave absorption that varies with one of a solution temperature or an emitted microwave power.

11. The apparatus of claim 1, wherein the antenna further comprises a plurality of radiating elements.

12. The apparatus of claim 11, wherein the plurality of radiating elements comprise an array of radiating elements or an array of radiating elements distributed along a beam axis of symmetry.

13. The apparatus of claim 1, further comprising:

a microwave absorbable sheath member slidably positioned over the microwave antenna.

14. The apparatus of claim 13, wherein the sheath member is configured to control one of a radiating length of the microwave antenna, an emitted microwave radiation power level, or a microwave field strength.

15. The apparatus of claim 1, wherein the antenna has a directionally selectable microwave beam.

16. The apparatus of claim 15, wherein the antenna has a selectable beam arc in the range from 1 to 360°

.

17. The apparatus of claim 1, wherein the position of the microwave absorbable material is configured to produce a directional microwave beam.

18. The apparatus of claim 17, wherein the beam has a beam arc in the range from 1 to 360°

.

19. The apparatus of claim 1, wherein the antenna is configured to radiate microwave energy at a frequency range selected from the group consisting of about 915 MHz to about 2.45 GHz and about 1250 MHz to about 1350 MHz.

20. The apparatus of claim 1, wherein the antenna comprises:

a first and a second dipole element.

21. The apparatus of claim 20, wherein one of the first dipole element has a cylindrical shape and the second dipole element has one of a cylindrical shape or a cylindrical ball-tipped shape.

22. The apparatus of claim 20 wherein one of a first dipole element length or a second dipole element length is substantially nonequivalent to one quarter of a selected microwave wavelength.

23. The apparatus of claim 22 wherein the microwave antenna has a slow wave structure.

24. The apparatus of claim 1, wherein an expansion member parameter is configured to yield an expansion member compliance less than the stomach wall.

25. The apparatus of claim 24, wherein the expansion member parameter includes at least one of an expansion member wall thickness, an expansion member shape, an expansion member size or an expansion member material.

26. The apparatus of claim 24, wherein the expansion member is configured to conform to at least a portion of the stomach wall when the expansion member is in the deployed state.

27. The apparatus of claim 24, wherein the expansion member is configured to uniformly contact the stomach wall including a stomach wall crevice.

28. The apparatus of claim 1, further comprising:

an inner elongated member disposed within the elongated member, the inner member including a lumen.

29. The apparatus of claim 28, wherein the inner member is advanceable within the elongated member.

30. The apparatus of claim 28, wherein at least portions of the inner member include a fluid lumen, a reinforcing braid, a radiopaque marker or an echogenic marker.

31. The apparatus of claim 28, wherein at least a portion of the inner member include one of a microwave absorbable material or a microwave absorbable material with a variable microwave absorption.

32. The apparatus of claim 28, wherein the inner member is slidably advanceable over at least portions of the antenna.

33. The apparatus of claim 28, wherein at least one of the elongated member or the inner member is deflectable.

34. The apparatus of claim 33, wherein at least one of the elongated member or the inner member has an articulated portion.

35. The apparatus of claim 33, wherein at least one of the elongated member or the inner member is coupled to a deflection mechanism.

36. The apparatus of claim 1, further comprising:

a sensor coupled to one of the expansion member or the elongated member.

37. The apparatus of claim 36, wherein the sensor is one of a microwave sensor, a thermal sensor, an ultrasound transducer, an optical sensor, a pressure sensor, a force sensor or a contact sensor.

38. The apparatus of claim 36, wherein the sensor is a contact sensor configured to facilitate positioning the deployable member adjacent a selectable portion of the stomach wall.

39. The apparatus of claim 36, wherein the sensor comprises a first sensor coupled to the deployable member and second sensor coupled to the microwave antenna.

40. The apparatus of claim 36, wherein the first and second sensors are configured to monitor one of a microwave antenna position, a microwave beam direction or a microwave field strength.

41. The apparatus of claim 36, further comprising feedback control resources coupled to at least one of the sensor, the antenna, microwave power source coupled to the antenna or a fluid delivery device coupled to the elongated member.

42. The apparatus of claim 41, wherein the feedback control resources are configured to reduce one of an expansion member surface temperature or an expansion member tissue interface temperature.

43. The apparatus of claim 41, wherein the feedback control resources are configured to minimize thermal injury to one of a mucosa or submucosa in proximity to the expansion member.

44. The apparatus of claim 41, wherein one of the feedback control resources, the antenna or an antenna beam is configured to cause collagen contraction of a selectable depth of the stomach wall.

45. The apparatus of claim 41, wherein one of the feedback control resources, the antenna or an antenna beam is configured to initiate a wound healing response of a selectable portion of the stomach.

46. The apparatus of claim 45, wherein the wound healing response is of a selectable circumferential portion of the stomach.

47. The apparatus of claim 45, wherein the wound healing response is of a selectable portion of the stomach w all.

48. The apparatus of claim 41, wherein the feedback control resources are configured to monitor and reduce a distensibility of at least a portion of the stomach.

49. The apparatus of claim 41, wherein the feedback control resources are configured to reduce a volume of at least a portion of the stomach.

50. The apparatus of claim 41, wherein the feedback control resources are configured to control one of an input microwave power to the antenna, an antenna emitted microwave power, an antenna microwave field strength, or a fluid media flow to the expansion member.

62. The apparatus of claim 1, wherein the microwave absorption varies with respect to at least one of a temperature or an emitted microwave power.

51. An apparatus to modify a stomach wall comprising:

an elongated member with at least one lumen that includes a fluid lumen and a cable member lumen, wherein the fluid lumen is positioned in a substantially surrounding relationship to the cable lumen;

a deployable member coupled to the elongated member, the deployable member configured to be advanceable and removable from the stomach in a non-deployed state and sized to be positioned in the stomach in a deployed state to engage at least portions of the stomach wall, the deployable member further configured to contain a fluidic media, at least a portion of a deployable member wall configured to be cooled by the fluidic media, the deployable member having a contour in the deployed state approximating at least a portion of a stomach interior;

a microwave antenna movably positioned in the deployable member so as to control a microwave field strength vector in relation to the antenna, the microwave antenna being configured to be coupled to a microwave energy source and deliver microwave energy to a selectable tissue site in the stomach wall while minimizing thermal injury to one of a mucosal or a submucosal layer; and

a cable member coupled to the microwave antenna, the cable member configured to be advanceable within the elongated member.

52. The apparatus of claim 51, wherein the fluid lumen includes a first fluid lumen and second fluid lumen.

53. The apparatus of claim 51, wherein the fluid lumen is positioned relative to the cable lumen to increase heat exchange between a cooling fluid disposed in the fluid lumen and the cable lumen.

54. The apparatus of claim 51, wherein the fluid lumen is positioned relative to the cable lumen to increase absorption of microwaves radiating from the cable lumen by a microwave absorbing media disposed in the fluid lumen.

55. The apparatus of claim 51, wherein the fluid lumen has one of a semi-circular shape, a kidney shape or a crescent shape.

56. The apparatus of claim 51, wherein the fluid lumen and the cable lumen have a substantially common locus.

57. An apparatus to modify a stomach wall comprising:

an elongated member with at least one lumen;

a deployable member coupled to the elongated member, the deployable member configured to be advanceable and removable from the stomach in a non-deployed state and sized to be positioned in the stomach in a deployed state to engage at least portions of the stomach wall, the deployable member further configured to contain a fluidic media, at least a portion of a deployable member wall configured to be cooled by the fluidic media, at least a portion of the deployable member having a contour in the deployed state approximating at least a portion of a stomach interior;

a microwave antenna movably positioned in the deployable member so as to control a microwave field strength vector in relation to the antenna, the microwave antenna being configured to be coupled to a microwave energy source and deliver microwave energy to a selectable tissue site in the stomach wall while minimizing thermal injury to one of a mucosal or a submucosal layer, wherein the antenna is constructed from a portion of a coaxial cable; and

a cable member coupled to the microwave antenna, the cable member configured to be advanceable within the elongated member.

58. The apparatus of claim 57, wherein the antenna comprises a slotted radiating portion of the coaxial cable.

59. The apparatus of claim 57, wherein the antenna further comprises:

an inner conductor;

an inner insulation layer substantially surrounding the inner conductor;

an outer conductor substantially surrounding the inner insulation; and

an outer insulation layer substantially surrounding the outer conductor.

60. The apparatus of claim 59, wherein the inner insulation layer comprises a plurality of insulation segments longitudinally distributed over the inner conductor with a gap between each insulation segment.

61. An apparatus to modify a stomach wall comprising:

an elongated member including at least one lumen;

a deployable member coupled to the elongated member, the deployable member configured to be advanceable and removable from the stomach in a non-deployed state and sized to be positioned in the stomach in a deployed state to engage at least portions of the stomach wall, the deployable member further configured to contain a fluidic media, at least a portion of a deployable member wall configured to be cooled by the fluidic media, at least a portion of the deployable member having a contour in the deployed state approximating at least a portion of a stomach interior;

a microwave antenna movably positioned in the deployable member so as to control a microwave field strength vector in relation to the antenna, the microwave antenna being configured to be coupled to a microwave energy source and deliver microwave energy to a selectable tissue site in the stomach wall while minimizing thermal injury to one of a mucosal or a submucosal layer; and

a cable member coupled to the microwave antenna, the cable member configured to be advancecable within the elongated member, wherein the antenna is configured to produce one of an omnidirectional beam, a pencil-beam, a flat-top flared beam or an asymmetrically flared beam.

63. An apparatus to modify a stomach wall comprising:

an elongated member including at least one lumen;

an inflatable balloon coupled to the elongated member, the inflatable balloon configured to be advanceable and removable from the stomach in a non-deployed state and sized to be positioned in the stomach in a deployed state to engage at least portions of the stomach wall, the inflatable balloon further configured to contain a fluidic media, at least a portion of a inflatable balloon wall configured to be cooled by the fluidic media, at least a portion of the inflatable balloon having a contour in the deployed state approximating at least a portion of a stomach interior, wherein the inflatable balloon is sized to produce a selected post treatment stomach volume;

a microwave antenna movably positioned in the inflatable balloon so as to control a microwave field strength vector in relation to the antenna, the microwave antenna being configured to be coupled to a microwave energy source and deliver microwave energy to a selectable tissue site in the stomach wall while minimizing thermal injury to one of a mucosal or a submucosal layer; and

a cable member coupled to the microwave antenna, the cable member configured to be advancecable within the elongated member.

64. The apparatus of claim 63, wherein the expansion member is sized to produce a selected post treatment stomach volume.

65. The apparatus of claim 63, wherein the inflatable balloon is shaped to produce a selected post treatment stomach shape.

66. An apparatus to modify a stomach wall comprising:

an elongated member including at least one lumen;

a deployable member coupled to the elongated member, the deployable member configured to be advanceable and removable from the stomach in a non-deployed state and sized to be positioned in the stomach in a deployed state to engage at least portions of the stomach wall, the deployable member further configured to contain a fluidic media, at least a portion of a deployable member wall configured to be cooled by the fluidic media, at least a portion of the deployable member having a contour in the deployed state approximating at least a portion of a stomach interior, wherein the deployable member is sized to produce a selected post treatment stomach volume;

a microwave antenna movably positioned in the deployable member so as to control a microwave field strength vector in relation to the antenna, the microwave antenna being configured to be coupled to a microwave energy source and deliver microwave energy to a selectable tissue site in the stomach wall while minimizing thermal injury to one of a mucosal or a submucosal layer; and

a cable member coupled to the microwave antenna, the cable member configured to be advancecable within the elongated member.

67. The apparatus of claim 66, wherein the deployable member parameter includes at least one of an expansion member wall thickness, an expansion member shape or an expansion member material.

68. The apparatus of claim 66, wherein the expansion member is configured to at least partial stretch at least a portion of the stomach wall when the expansion member is in the deployed state.