Injection devices and methods for testing implants

• US 20030233126A1
• Filed: 06/12/2003
• Published: 12/18/2003
• Est. Priority Date: 06/12/2002
• Status: Abandoned Application

• Current Assignee: HC Starck GmbH (OPUS Investment SARL)
• Original Assignee: Alfred E MANN Institute For Biomedical Engineering At The University of Southern California, University of Southern California
• Inventors: Loeb, Gerald E., Kaplan, Hilton M.
• Application Number:
  US10/461,560
• Publication Number:
  US 20030233126A1
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

The invention relates to devices and methods for positioning an implant at a target location in the body. The methods include testing an implant while within an injection device at a target location to determine whether the implant is functioning effectively. The methods also include testing from or delivery of materials to the target location during implantation, and loading the injection device for use. The device may be configured to permit the longitudinal and/or axial position of the implant to be maintained relative to an injection device during implantation. The device may also be configured to permit testing of the implant. The invention also may include implants configured for use in the injection devices.

Claims

1. A method for positioning an implant in a body at a target location at which the implant will function effectively comprising:

a) inserting a distal tip of a cannula having the implant retained within a cannula lumen into the body until the implant reaches a testing position;

b) testing the implant while within the cannula lumen at the testing position to determine whether the implant is functioning effectively;

c) discharging the implant from the lumen of the cannula at the testing location if the testing reveals that the implant is functioning effectively at the test location.

2. The method of claim 1, further including moving the implant within the cannula lumen to a new position if testing shows the implant is not located at effective position and re-testing the implant while within the cannula lumen at the testing position to determine whether the implant is functioning effectively.

3. The method of claim 2 wherein the movement of the implant includes longitudinal movement relative to the target location.

4. The method of claim 2 wherein the movement of the implant includes axial rotation relative to the target location.

5. The method of claim 1, wherein the implant is a microstimulator.

6. The implant of claim 1, wherein the implant includes a dissolvable capsule.

7. The method of claim 1 wherein the implant is a microstimulator, and wherein testing includes the delivery of a signal to the microstimulator.

8. The method of claim 1, wherein the implant is a microstimulator, and wherein testing includes the receipt and analysis of a signal from the microstimulator.

9. The method of claim 1, wherein the implant is a microstimulator, and wherein testing includes determining whether the microstimulator is stimulating the target location.

10. The method of claim 1, wherein the implant is a microstimulator having at least one external electrode, and wherein the external electrode is exposed to interstitial fluid of the target location during testing.

11. The method of claim 1, wherein the implant is maintained at the testing location during the discharge of the implant from the lumen.

12. The method of claim 11, wherein the implant is maintained in that same axial orientation relative to the testing location.

13. The method of claim 11, wherein the implant is maintained in that same longitudinal orientation relative to the testing location.

14. A method for positioning an implant in a body at a target location at which the implant will function effectively, comprising:

a) inserting a distal tip of a cannula having the implant retained within a cannula lumen into the body until the tip reaches a testing position;

b) withdrawing material from the testing position through a lumen extending from a cannula distal end proximate to the testing position to a cannula proximal end;

c) testing the material withdrawn from the testing position;

d) discharging the implant from the cannula lumen at the testing position if the testing shows that the implant will operate effectively at the test location.

15. The method of claim 14, further including moving the implant within the cannula lumen to a new position if testing shows the implant is not located at effective position and withdrawing material from the testing position through a lumen extending from a cannula distal end proximate to the testing position to a cannula proximal end;

and testing the material withdrawn from the new testing position.

16. The method of claim 14, wherein the implant is a microstimulator.

17. The implant of claim 14, wherein the implant includes a dissolvable capsule.

18. The method of claim 14, wherein the testing of the material from the testing position is to determine the presence or absence of blood.

19. A method for injecting material at the site of an implant in a body, comprising:

a) inserting a distal tip of a cannula having an implant retained within a cannula lumen to a site within the body;

b) delivering material to the area of the site through a lumen extending from a cannula proximal end to a cannula distal end; and

c) discharging the implant from the cannula lumen at the site.

20. The method of claim 19, wherein the material is a selected from the group comprising steroids, anti-inflammatory agents, antibiotics, analgesics.

21. The method of claim 19, testing the implant while within the cannula lumen at the testing position to determine whether the implant is functioning effectively prior to delivering material to the area.

22. The method of claim 19, wherein the implant is a microstimulator.

23. The implant of claim 19 wherein the implant includes a dissolvable capsule.

24. A method for injecting material at the site of an implant in a body, comprising:

a) inserting a distal tip of a cannula having an implant retained within a cannula lumen to a site within the body;

b) discharging the implant from the cannula lumen at the site;

c) delivering material to the area of the site through a lumen extending from a cannula proximal end to a cannula distal end.

25. The method of claim 24, testing the implant while within the cannula lumen at the testing position to determine whether the implant is functioning effectively prior to discharging the implant from the cannula site.

26. The method of claim 24, wherein the material is a selected from the group comprising steroids, anti-inflammatory agents, antibiotics, or analgesics.

27. The method of claim 24, wherein the implant is a microstimulator.

28. The implant of claim 24, wherein the implant includes a dissolvable capsule.

29. A method of loading an implant having an end into an injection device used to inject the loaded implant into a body, the injection device including a cannula with a cannula lumen and a probe sized to fit within the lumen having a distal end, the method comprising:

a) inserting the probe distal end within the cannula lumen;

b) abutting the implant end of the implant against the probe distal end;

and

c) moving the cannula relative to the probe until the cannula substantially covers the implant without allowing the implant end to separate from the probe distal end.

30. The method of claim 29, further including rotating the probe relative to cannula.

31. The method of claim 29, wherein the implant is a microstimulator.

32. The implant of claim 29, wherein the implant includes a dissolvable capsule.

33. An injection device for positioning an implant in a body at a target location at which the implant will function effectively comprising:

a) a cannula having a cannula lumen;

b) an implant positioned within the cannula lumen;

c) a surface at the end of the implant configured to releasably engage a surface within the cannula lumen.

34. The injection device of claim 33, wherein the cannula lumen includes a cannula detent and the implant includes an annular ring having a notch therein, wherein the notch is configured to move slidable along the detent, when the detent and notch are axially aligned in the cannula lumen.

35. The injection device of claim 33, wherein the cannula lumen includes a cannula detent and the implant includes an retaining member comprising a post and an annular ring, wherein the length of the post is configured to permit the detent to rest within a detent space formed between the implant end surface and the annular ring, and wherein the annular ring includes a notch is configured to move slidable along the detent, when the detent and notch are axially aligned in the cannula lumen.

36. The injection device of claim 33, wherein the injection device further includes a probe positioned substantially within the lumen and having a probe distal end;

and a surface at the end of the implant abutting a surface at the probe distal end of, wherein both the implant end surface and probe distal end surface are configured to prevent the implant from rotating with respect to the probe while the surfaces abut.

37. The injection device of claim 33, wherein the injection device wherein the implant includes at least one implant external electrode positioned within the cannula lumen;

and the injection device includes at least one fluid communication channel within the cannula wall substantially aligned with the implant external electrode.

38. The injection device of claim 33, wherein the cannula includes a distal end formed into a trochar.

39. The injection device of claim 33, wherein the cannula is comprised of a material that will not shield/interfere with electromagnetic signals.

40. The injection device of claim 33, wherein the cannula is comprised of electrically insulating material.

41. The injection device of claim 33, wherein the implant is a microstimulator.

42. The injection device of claim 33, wherein the implant includes a dissolvable capsule.

43. An injection device for positioning an implant in a body at a target location at which the implant will function effectively comprising:

a) a cannula having a cannula lumen;

b) a probe positioned substantially within the cannula lumen and having a probe distal end;

c) an implant positioned within the cannula lumen;

d) a surface at the end of the implant abutting a surface at the distal end of the probe, the implant end surface and the probe end surface being configured to prevent the implant from rotating with respect to the probe while the implant end surface and probe end surface abut.

44. The injection device of claim 43, wherein the implant end surface and probe end surface are further configured to permit the implant to separate longitudinally from the probe.

45. The injection device of claim 43, wherein the implant end surface includes a slot and the probe end surface includes tab.

46. The injection device of claim 43, wherein the implant end surface includes a tab and probe end surface includes a slot.

47. The injection device of claim 43, wherein the cannula further includes a cannula handle at a cannula proximal end, and wherein the probe further includes a probe handle at a probe proximal end, wherein the probe handle is configured to move longitudinally within a lumen in the cannula handle and wherein the cannula handle and probe handle are configured to permit defined longitudinal movement of the cannula relative to the probe.

48. The injection device of claim 43, wherein the cannula further includes a cannula handle at a cannula proximal end, and wherein the probe further includes a probe handle at a probe proximal end, wherein the probe handle is configured to move longitudinally within a lumen in the cannula handle and wherein the cannula handle and probe handle are configured to permit defined axial movement of the cannula relative to the probe.

49. The injection device of claim 43, wherein the implant end surface is further configured to releasably engage a surface within the lumen.

50. The injection device of claim 43, wherein the implant includes at least one implant external electrode positioned within the cannula lumen;

and the injection device includes at least one fluid communication channel within the cannula wall substantially aligned with the implant external electrode.

51. The injection device of claim 43, wherein the cannula includes a distal end formed into a trochar.

52. The injection device of claim 43, wherein the cannula is comprised of a material that will not shield/interfere with electromagnetic signals.

53. The injection device of claim 43, wherein the cannula is comprised of electrically insulating material.

54. The injection device of claim 43, wherein the implant is a microstimulator.

55. The injection device of claim 43, wherein the implant includes a dissolvable capsule.

56. An injection device for injecting an implant in a body at a target location at which the implant will function effectively comprising:

a) a cannula having a cannula wall forming a cannula lumen, and a cannula distal end formed into a trochar;

b) an implant releasably engaged within the cannula.

57. The injection device of claim 56, further including an apparatus for assisting in the release of an implant into the body at the target location.

58. The injection device of claim 56, wherein the cannula has a slit formed the cannula wall to form a cannula upper casing and a cannula lower casing, wherein the slit extends from the cannula distal end for a distance greater than a length of the implant.

59. The injection device of claim 56, wherein the implant includes an implant end surface is configured to releasably engage a surface within the cannula lumen.

60. The injection device of claim 56, wherein the injection device further includes:

a) a probe positioned substantially within the cannula lumen and having a probe distal end;

b) a surface at the end of the implant abutting a surface at the probe distal end, wherein the implant end surface and the probe end surface are configured to prevent the implant from rotating with respect to the probe while the implant end surface and probe end surface abut.

61. The injection device of claim 56, wherein the implant includes at least one implant external electrode positioned within the cannula lumen;

and the injection device includes at least one fluid communication channel within the cannula wall substantially aligned with the implant external electrode.

62. The injection device of claim 56, wherein the cannula is comprised of a material that will not shield/interfere with electromagnetic signals.

63. The injection device of claim 56, wherein the cannula is comprised of electrically insulating material.

64. The injection device of claim 56, wherein the implant includes a dissolvable capsule.

65. The injection device of claim 56, wherein the implant is a microstimulator.

66. An implant configured to be injected by an injection device into body tissue or a body cavity and configured with at least one surface that releasably interlocks with a surface in the injection device.

67. The implant of claim 66, wherein the implant interlocking surface is configured to maintain longitudinal alignment between the implant and the injection device while the capsule is contained within the injection device.

68. The implant of claim 66, wherein the implant interlocking surface is configured to maintain axial alignment between the implant and the injection device while the capsule is contained within the injection device.

69. The implant of claim 68 wherein the implant interlocking surface is configured to allow the implant to be separated longitudinally from the injection device after during implantation.

70. The injection device of claim 66, wherein the implant is a microstimulator.

71. The implant of claim 66, wherein the implant includes a dissolvable capsule.

72. The implant of claim 66 wherein the capsule comprises polyglactic acid or polydioxanone or a combination of polyglactic acid or polydioxanone.

73. An injection device comprising:

a) a cannula having a cannula wall forming a cannula lumen, wherein the cannula lumen includes a detent, and wherein the cannula wall includes at least one channel therein;

b) a probe configured to move slidably within the cannula lumen, and wherein the probe includes a tab at the probe distal end;

c) an implant including a retaining member, wherein the retaining member includes a notch configured to move slidably along the detent when the implant is rotated axially with respect to the cannula lumen; and

d) the implant further including a surface configured to be releasable connected to the probe tab such that rotational, but not longitudinal movement between the probe and implant is prevented while the implant surface and tab are connected.

74. The injection device of claim 73, wherein the implant is a microstimulator.

75. The injection device of claim 73, wherein the implant includes a dissolvable capsule.