Apparatus and method for reversibly reshaping a body part

• US 5,979,456 A
• Filed: 04/22/1996
• Issued: 11/09/1999
• Est. Priority Date: 04/22/1996
• Status: Expired due to Term

• Current Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Original Assignee: George J. Magovern
• Inventors: Magovern, George J.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/636,135
• Time in Patent Office: 1,296 Days
• Field of Search: 128/899, 128/716-719, 602/6-8, 623/1, 623/11, 623/16, 600/3, 600/30, 600/31, 600/37, 600/529-531, 607/42-48
• US Class Current: 128/899
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00

Abstract

An apparatus and method for reversibly modifying the shape of a selected portion of the body such as the pharynx, to produce a desired result, for example, to overcome obstructive sleep apnea by urging open the pharynx. The apparatus includes a preconfigured structure having a shape-memory with an activated shape and a quiescent shape. The preconfigured structure is shaped to conform to the selected portion of the body. The shape-memory is responsive to activation energy and urges the preconfigured structure from the quiescent shape to the activated shape. Furthermore, the activated shape of the preconfigured structure exerts a force on the selected portion, thereby modifying the shape of the selected portion. The preconfigured structure can be attached to an exterior surface of, or can be implanted within the body proximate to, the selected portion of the body. The apparatus can include an energy source coupled to the preconfigured structure for providing the activation energy, responsive to a predetermined stimulus and can be attached external to, or implanted within, the body. The invention also provides a method for reversibly modifying the shape of a selected portion of a body. The method includes attaching a preconfigured shape-memory structure to the selected portion of the body; and applying the activation energy to the preconfigured structure with an energy source, thereby the preconfigured shape-memory structure from the quiescent shape to the activated shape.

Claims

1. An apparatus for reversibly modifying the shape of a selected portion of a body, comprising:

a. a preconfigured structure having a shape-memory, the preconfigured structure having an activated shape and a quiescent shape;

b. the preconfigured structure being shaped to conform to the selected portion of the body, the preconfigured structure being connectable to the selected portion, the shape-memory being responsive to an activation energy and urging the preconfigured structure from the quiescent shape to the activated shape;

c. the activated shape of the preconfigured structure adapted to exert a force on the selected portion, thereby tending to modify the shape of the selected portion; and

d. wherein the shape memory responds to removal of the activation energy by urging the preconfigured structure from the activated shape to the quiescent shape and at least partially removing the force on the selected portion of the body thus tending to restore the shape of the selected portion of the body.

2. The apparatus of claim 1 wherein the preconfigured structure is adapted to be attached to an exterior surface of the selected portion of the body.

3. The apparatus of claim 2 wherein the activation energy is applied gradatim.

4. The apparatus of claim 2 wherein the activation energy is intermittently applied.

5. The apparatus of claim 1 wherein the preconfigured structure is adapted to be implanted within the body proximate to the selected portion.

6. The apparatus of claim 1 further comprising an energy source for providing the activation energy, the energy source being coupled with the preconfigured structure, the energy source being responsive to a predetermined stimulus.

7. The apparatus of claim 6 wherein the energy source is selected from the group consisting of an electrical energy source, a mechanical energy source, a thermal energy source and an electromagnetic energy source.

8. The apparatus of claim 7, wherein the predetermined stimulus is selected from the group consisting of a mechanical stimulus an electrical stimulus, an electromagnetic stimulus, an acoustic stimulus and an optical stimulus.

9. The apparatus of claim 8, wherein the energy source is external to the surface of the body.

10. The apparatus of claim 9, wherein the activation energy is applied gradatim so that the modifying and restoring of the shape of the selected portion is substantially unobtrusive.

11. The apparatus of claim 9, wherein the activation energy is intermittently applied to accommodate a function of the body.

12. The apparatus of claim 8, wherein the energy source is adapted to be implanted within the body.

13. The apparatus of claim 8, wherein exerting the force is performed gradatim so that modifying the shape of the selected portion is substantially unobtrusive.

14. The apparatus of claim 8, wherein the shape-memory responds to removal of the activation energy, and urges the preconfigured structure from the activated shape to the quiescent shape, thereby at least partially removing the force on the selected portion, thereby tending to restore the shape of the selected portion.

15. The apparatus of claim 6, wherein the activation energy is applied gradatim so that the modifying and restoring of the shape of the selected portion is substantially unobtrusive.

16. The apparatus of claim 1 wherein the force is exerted gradatim.

17. The apparatus of claim 16, wherein the activation energy is applied gradatim.

18. The apparatus of claim 1 wherein the preconfigured structure is selected from the group consisting of a first linear form and a first planar form.

19. The apparatus of claim 18, wherein the planar form includes a plurality selected from the group consisting of a second linear form, a second planar form, ones of each plurality of forms being selectively activatable.

20. The apparatus of claim 1 wherein the selected portion of the body is a pharyngeal wall and the activated shape of the structure is adapted to exert onward force on the wall, thereby tending to urge open the pharynx.

21. The apparatus of claim 20, further comprising an energy source for providing the activation energy, the energy source being coupled with the preconfigured structure and being responsive to a predetermined stimulus.

22. The apparatus of claim 21, wherein the energy source is selected from the group consisting of an electrical energy source, a mechanical energy source, a thermal energy source and an electromagnetic energy source.

23. The apparatus of claim 22, wherein the predetermined stimulus is selected from the group consisting of a mechanical stimulus, electromagnetic stimulus, electrical stimulus, acoustic stimulus and optical stimulus.

24. The apparatus of claim 23, wherein the energy source is external to the surface of the body.

25. The apparatus of claim 23, wherein the energy source is adapted to be implanted within the body.

26. The apparatus of claim 23, wherein:

a. the preconfigured structure is selected from the group consisting of a linear form, a planar form, and a composite form, and the preconfigured structure is adapted to be affixed to the tissues proximate to the pharyngeal wall;

b. the linear form is selected from the group consisting of a single-stranded thread, a multistranded braid, and a strip;

c. the planar form is selected from the group consisting of a mesh and a plate;

d. the composite form is a plurality selected from the group consisting of one of the linear form and the planar form;

e. the shape-memory responds to removal of the activation energy, and urges the preconfigured structure from the activated shape to the quiescent shape, thereby tending to restore the shape of the pharyngeal wall; and

f. the activation energy is selectively applied so that the modifying and restoring is substantially unobtrusive.

27. The apparatus of claim 26, wherein the activation energy applied with is selected from the group consisting of intermittently, gradatim and synchronously with a body function so that the modifying and restoring is substantially unobtrusive and the body function is accommodated.

28. The apparatus of claim 20, wherein the preconfigured structure is adapted to be attached to an exterior surface of the neck proximate to the pharyngeal wall.

29. The apparatus of claim 28, wherein the preconfigured structure is selected from the group consisting of a linear form and a planar form.

30. The apparatus of claim 29, further comprising an adhesive form adaptable to be at least partially interposed between the preconfigured structure and the exterior surface of the neck, the adhesive form adapted for removably attaching the preconfigured structure to the exterior surface of the neck.

31. The apparatus of claim 29, further comprising a collar and at least one adhesive pad, the collar having the preconfigured structure therein, the at least one adhesive pad adapted for removably attaching the preconfigured structure to the exterior surface of the neck.

32. The apparatus of claim 29, further comprising an energy source for providing the activation energy, the energy source being coupled with the preconfigured structure and being responsive to a predetermined stimulus.

33. The apparatus of claim 32, wherein:

a. the energy source is selected from the group consisting of an electrical energy source, a mechanical energy source, a thermal energy source and an electromagnetic energy source; and

b. the predetermined stimulus is selected from the group consisting of a mechanical stimulus, an electrical stimulus, an electromagnetic stimulus, an acoustical stimulus and an optical stimulus.

34. The apparatus of claim 33, wherein:

a. the preconfigured structure is selected from the group consisting of a linear form, a planar form, and a composite form, and the preconfigured structure is adapted to be affixed to the tissues proximate to the pharyngeal wall;

b. the linear form is selected from the group consisting of a single-stranded thread, a multistranded braid, and a strip;

c. the planar form is selected from the group consisting of a mesh and a plate;

d. the composite form is a plurality of at least one selected from the group consisting of linear form and the planar form;

e. the shape-memory responds to removal of the activation energy, and urges the preconfigured structure from the activated shape to the quiescent shape, thereby tending to restore the shape of the pharyngeal wall; and

f. the activation energy is selectively applied so that the modifying and restoring is substantially unobtrusive.

35. The apparatus of claim 34, wherein the activation energy applied is selected from the group consisting of intermittently, gradatim and synchronously with a body function so that the modifying and restoring is substantially unobtrusive and the body function is accommodated.

36. The apparatus of claim 20, wherein the preconfigured structure is adapted to be implanted within a tissue proximate to the pharyngeal wall.

37. The apparatus of claim 36, wherein the preconfigured structure is selected from the group consisting of a linear form and a planar form.

38. The apparatus of claim 37, further comprising an energy source for providing the activation energy, the energy source being coupled with the preconfigured structure and being responsive to a predetermined stimulus.

39. The apparatus of claim 38, wherein:

a. the energy source is selected from the group consisting of an electrical energy source, a mechanical energy source, a thermal energy source and an electromagnetic energy source; and

b. the predetermined stimulus is selected from the group consisting of a mechanical stimulus, an electrical stimulus, an electromagnetic stimulus, an acoustical stimulus and an optical stimulus.

40. The apparatus of claim 37, wherein:

a. the preconfigured structure is the linear form, which linear form is selected from the group consisting of a single-stranded thread, a multi-stranded braid, and a strip; and

b. the linear form is adapted to be affixed to tissues proximate to the pharyngeal wall.

41. The apparatus of claim 37 wherein:

a. the preconfigured structure is the planar form, which planar form is selected from the group consisting of a mesh and a plate; and

b. the planar form is adapted to be affixed to tissues proximate to the pharyngeal wall.

42. The apparatus of claim 20, wherein the preconfigured structure is selected from the group consisting of a first linear form and a first planar form.

43. The apparatus of claim 42, wherein the planar form includes a plurality selected from the group consisting of a second linear form, a second planar form, ones of the plurality of forms being selectively activatable.

44. the apparatus of claim 1 wherein the selected portion of the body is selected from the group consisting of the chest and the abdomen, and the activated shape of the structure exerts a force upon the selected portion, thereby tending to assist respiratory function.

45. The apparatus of claim 44, further comprising an energy source for providing the activation energy, the energy source being coupled with the preconfigured shape-memory structure and being responsive to a predetermined stimulus.

46. The apparatus of claim 45, wherein the energy source is selected from the group consisting of a mechanical energy source, a thermal energy source and an electromagnetic energy source.

47. The apparatus of claim 46, wherein the predetermined stimulus is selected from the group consisting of a mechanical stimulus, an electromagnetic stimulus, an electrical stimulus, and acoustic stimulus and an optical stimulus.

48. The apparatus of claim 44, wherein the preconfigured structure is selected from the group consisting of a linear form and a planar form.

49. A method for reversibly modifying the shape of a selected portion of a body comprising the steps of:

a. attaching a preconfigured shape-memory structure to the selected portion, the structure having a shape-memory being shaped to generally conform to the selected portion, the structure having an activated shape and a quiescent shape, the shape-memory being responsive to an activation energy; and

b. applying the activation energy to the preconfigured structure, thereby transforming the preconfigured shape-memory structure from the quiescent shape to the activated shape, the activated shape exerting a force upon selected portion, thereby tending to modify the shape of the selected portion.

50. The method of claim 49, wherein applying the activation energy includes the steps of:

a. sensing a predetermined condition;

b. generating a stimulus responsive to the predetermined condition; and

c. generating the activation energy responsive to the stimulus.

51. The method of claim 49, wherein the step of attaching includes interposing an adhesive pad between the selected portion and the preconfigured shape-memory structure, the structure being at least partially embedded in the adhesive pad, the adhesive pad being removably attached to an exterior surface of the body proximate to the selected portion, the adhesive pad transmitting the force to the external surface from the activated shape, responsive to the activation energy.

52. The method of claim 51, wherein the shape-memory structure is connected to an energy source and further comprising the steps of:

a. sensing a predetermined condition;

b. generating a stimulus responsive to the predetermined condition; and

c. generating the activation energy responsive to the stimulus.

53. The method of claim 50 wherein the step of attaching includes implanting the preconfigured shape-memory structure in the body proximate to the selected portion.

54. The method of claim 53 wherein the shape-memory structure is connected to an energy source, and further comprising the steps of:

a. sensing a predetermined condition;

b. generating a stimulus responsive to the predetermined condition; and

c. generating the activation energy responsive to the stimulus.

55. The method of claim 49, wherein the step of attaching includes removably attaching a collar, belt, or band to the selected portion, the collar, belt, or band having the preconfigured shape-memory structure therein.

56. The method of claim 49, wherein the shape-memory structure is connected of an energy source, and further comprising the steps of:

a. sensing a predetermined condition;

b. generating a stimulus responsive to the predetermined condition;

c. selectively generating the activation energy responsive to the stimulus, the selectively generating including those selected from the group consisting of intermittent generating, gradatim generating, and synchronously generating so that the reversibly modifying is substantially unobtrusive is substantially unobtrusive.