CUTANEOUS STABILIZATION BY VACUUM FOR DELIVERY OF MICRO-NEEDLE ARRAY

• US 20060264926A1
• Filed: 06/30/2006
• Published: 11/23/2006
• Est. Priority Date: 11/08/2002
• Status: Abandoned Application

• Current Assignee: Medical Microdevices Incorporated
• Original Assignee: Medical Microdevices Incorporated
• Inventors: Kochamba, Gary S.
• Application Number:
  US11/428,303
• Publication Number:
  US 20060264926A1
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2230/00 Measuring parameters of the user
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/42 having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced

Abstract

A device permits effective engagement of micro-needles with a cutaneous layer thereby to permit for a substance to pass effectively to the cutaneous layer. A flexible or non-flexible material supports an array of micro-needles for receiving the surface of the cutaneous layer so that the proximal ends of the micro-needles pierce to effect a passage of a substance with the micro-needles to the cutaneous layer. A passageway or bladder acts on the substrate to cause the proximal ends of the micro-needles to pass to the cutaneous layer for passage of a substance associated with the micro-needles to the cutaneous layer. The bladder includes apertures located about and spaced from the micro-needles such that suction transmitted though the apertures. The micro-needles are mounted with a movable first substrate. In one form, the first substrate includes a surface with concavities and the micro-needles are mounted in the concavities, and the apertures are located in the concavities. In another form the surface is substantially flat. There can be a third layer spaced relative to the second substrate layer at least partly forming a chamber between the second layer and third layer. There can be a biasing device for urging the first substrate from the cutaneous layer.

Claims

13. A device for permitting effective engagement of needles with internal body tissue with a living body thereby to permit for a energy to pass effectively to the tissue comprising:

a) a first substrate of material having a transverse area and a peripheral edge;

b) an array of needles arranged about the area for effectively engaging the tissue;

c) a passageway for transmitting suction pressure on the tissue, to cause proximal ends of the needles to pass to the tissue for passage of a energy associated with the needles to the tissue;

d) the area transversely within peripheral edge of the material and with which the needles being for receiving the surface of the tissue with which the proximal ends of the needles are to pierce to effect a passage of a energy with the micro needles to the cutaneous layer; and

e) a connector for a suction generator for creating a suction force thereby to urge the tissue towards the area within the peripheral edge of the material;

the arrangement being such that suction causes the needles and tissue to move relatively closer to each other and thereby permit the proximal ends of the needles to pierce the surface of the tissue and permit the passage of energy from the needles to the tissue.

14. A device as claimed in claim 13 including apertures located about the needles such that suction is transmitted though the apertures thereby to draw the tissue into engagement with a side of the substrate directed in the same direction as the needles.

15. A device as claimed in claim 13 wherein the passageway communicates with spaces between the needle array, and wherein there are apertures between the needles for transmitting suction.

16. A device as claimed in claim 13 wherein the passageway permits for suction to be drawn in the area around the array of needles thereby causing the needles and tissue to be drawn together in relatively closer contact.

17. A device as claimed in claim 13 including a second substrate of material formed with the first material and having a space between the materials thereby to form the passageway.

18. A device as claimed in claim 13 including a port in the layer for connection to a suction generator, the port being connected to a suction array about the needle array.

19. A device as claimed in claim 13 including a mounting for supporting needles, and wherein a differential pressure in the bladder effectively causes the needles to move transversely between a position of repose withdrawn relative to the tissue towards a position relatively closer to the tissue.

20. A device as claimed in claim 13 wherein the passage is formed in part of elastomeric material, and wherein there is an array of needles and array of ports arranged about the first substrate, the array of needles and array of ports being separated from each other.

21. A device as claimed in claim 13 including a surface on the transverse area, the surface being for receiving the tissue under action of the suction force, and thereby stabilizing the tissue prior to and during piercing of the tissue by the proximal end of the micro needles.

22. A device as claimed in claim 13 wherein there are multiple needles in relative adjacency with each other thereby to permit multiple piercings of the tissue.

23. A device as claimed in claim 13 wherein the first substrate includes a surface with concavities and wherein the needles are mounted in the concavities, and the apertures being located in the concavities.

24. A device as claimed in claim 13 wherein the needles are hollow and energy passes through the needles to the cutaneous layer.

25. A device as claimed in claim 13 wherein the needles are solid and energy passes from surface of the needles to the cutaneous layer.

36. A device as claimed in claim 13 wherein the needle array are micro needles measuring about 25 to about 300 microns in height, are selectively biodegradable, and selectively made of silicon, and are formed with a density of about several hundred micro needles in an area of about one square centimeter.

64. A device as claimed in claim 13 including an energy source for applying the energy at a level for ablating endocardial or myocardial tissue.

26. A device for penetrating internal tissue into a living body to permit for energy to pass through the tissue comprising:

a) a first substrate of material having an area and a peripheral edge;

b) an array of needles arranged about the area for piercing the tissue, the micro needles having a proximal end and a distal end;

c) a bladder or drug cartridge for containing fluid for passing across the tissue for injection below the tissue;

d) an area transversely within peripheral edge of the material and through which the needles are directed, and the area being for receiving the surface of the tissue about which the needles are to pierce to effect a passage of energy; and

e) a connector for a suction generator for creating a suction force at the area thereby to urge the tissue towards the area within the peripheral edge of the material and thereby provide a stabilizing force to the tissue;

the arrangement being such that the needles and tissue are caused to move relatively closer to each other and thereby permit the proximal ends of the needles to pierce the surface of the tissue; and

permitting the passage of energy into the distal end of the needle and thereby permit the expulsion of energy into the tissue.

27. A device as claimed in claim 26 wherein the bladder communicates with the needles such that energy is transmitted through an outlet in the needles, and the bladder delivers the energy by piezo actuator.

28. A device as claimed in claim 26 wherein, in use, a cavity is formed between the first substrate and a tissue, and whereby suction is drawn into the cavity around the array of needles thereby causing the needles and tissue to be drawn together in relatively closer contact.

29. A device as claimed in claim 26 including a material layer at least partly parallel to and spaced relative to the first substrate layer thereby forming the bladder at least partly between the spaced layers.

30. A device as claimed in claim 29 including a third layer spaced relative to the second substrate layer at least partly forming a chamber between the second layer and third layer.

31. A device as claimed in claim 29 including a biasing device for urging the first substrate from the tissue.

32. A device as claimed in claim 26 including a mounting for supporting needles with the first layer, and wherein a differential force causes the needles to move transversely between a position of repose relatively withdrawn towards the tissue.

33. A device as claimed in claim 26 wherein there are multiple needles in relative adjacency with each other thereby to permit multiple piercings of the tissue.

37. A device as claimed in claim 26 wherein the needle array are micro needles measuring about 25 to about 300 microns in height, are selectively biodegradable, and selectively made of silicon, and are formed with a density of about several hundred micro needles in an area of about one square centimeter.

65. A device as claimed in claim 26 including an energy source for applying the energy at a level for ablating endocardial or myocardial tissue.

34. A device for penetrating internal tissue inside a living body to permit for energy to pass through the tissue comprising:

a) a first substrate of material having an area and a peripheral edge;

b) an array of needles arranged about the area for piercing the tissue, the needles having a proximal end and a distal end;

c) selectively a spring or electromagnetic system for causing the needles to move relatively with the tissue;

d) an area transversely within peripheral edge of the material and through which the needles are directed, and the area being for receiving the surface of the tissue about which the micro needles are to pierce to effect an injection of fluid; and

e) thereby to urge the tissue towards the area within the peripheral edge of the material and thereby provide a stabilizing force to the tissue;

the arrangement being such that the needles and tissue are caused to move relatively closer to each other and thereby permit the proximal ends of the needles to pierce the surface of the tissue; and

permitting the passage of energy into the distal end of the needle and thereby permit the expulsion of fluid into the tissue.

38. A device as claimed in claim 34 wherein the needle array are micro needles measuring about 25 to about 300 microns in height, are selectively biodegradable, and selectively made of silicon, and are formed with a density of about several hundred micro needles in an area of about one square centimeter.

66. A device as claimed in claim 34 including an energy source for applying the energy at a level for ablating endocardial or myocardial tissue.

39. A device for permitting effective engagement of needles with internal tissue inside a living body thereby to permit for energy to pass effectively to the tissue comprising:

a) a first substrate of flexible material having a transverse area and a peripheral edge;

b) an array of needles arranged about the area for effectively engaging the tissue;

c) a bladder related to the substrate for acting on the substrate for causing proximal ends of the needles to pass to the tissue for passage of energy associated with the needles to the tissue;

d) the area transversely within peripheral edge of the material and with which the needles are connected being for receiving the surface of the tissue with which the proximal ends of the needles are to engage to effect a passage of energy with the needles to the tissue; and

e) a connector for a suction generator for creating a suction force in the bladder thereby to urge the tissue towards the area within the peripheral edge of the material;

the arrangement being such that suction causes the needles and tissue to move relatively closer to each other and thereby permit the proximal ends of the needles to engage the surface of the tissue, and permit the passage of energy from the needles to the cutaneous layer.

40. A device as claimed in claim 39 wherein the bladder includes apertures located about and spaced from the needles such that suction transmitted though the apertures thereby draws the tissue into engagement with a face of the substrate directed in the same direction as the proximate ends of the needles.

41. A device as claimed in claim 39 wherein the bladder communicates with spaces between the needle array, and wherein there are apertures between the needles for transmitting suction, and including a second substrate substantially parallel to the first substrate and the bladder being formed between the substrates and the peripheral edge.

42. A device as claimed in claim 39 wherein the bladder permits for suction to be drawn in the area around the array of micro needles thereby causing the needles and tissue to be drawn together in relatively closer contact.

43. A device as claimed in claim 39 wherein the bladder is at least partly formed by a space between a first substrate and a closure structure above the tissue.

44. A device as claimed in claim 39 wherein the bladder is at least partly formed by two spaced layers, and including a port in one of the layers for connection to a suction generator, the port being connected to a suction array about the needle array.

45. A device as claimed in claim 39 including a mounting for supporting needles, and wherein a differential pressure in the bladder effectively causes the micro needles to move transversely between a position of repose withdrawn relative to the cutaneous layer towards a position relatively closer to the tissue.

46. A device as claimed in claim 39 wherein the bladder is formed in part of elastomeric material, and wherein there is an array of needles and array of ports arranged about the first substrate, the array of needles and the array of ports being separated from each other.

47. A device as claimed in claim 39 including a surface on the transverse area, the surface being for receiving the tissue under action of the suction force, and thereby stabilizing the tissue prior to and during engagements of the tissue by the proximal end of the needles.

48. A device as claimed in claim 39 wherein there are multiple needles in relative adjacency with each other thereby to permit multiple engagements of the tissue.

50. A device as claimed in claim 39 including a source of energy, the energy being selectively one of cryoenergy, ultrasound energy, RF energy, or other electromagnetic energy.

51. A device as claimed in claim 39 including having different micro needles with different electrical polarities.

52. A device as claimed in claim 39 including an energy source for applying energy to attain ablation of cutaneous or subcutaneous material or cells of organs, and selectively having an irrigation supply for applying irrigation through the needle hole.

53. A device as claimed in claim 39 including an energy source for applying energy to attain ablation of cutaneous or subcutaneous material or cells of organs, and selectively having an irrigation supply for applying irrigation through the needle hole.

54. A device as claimed in claim 39 including having the micro needles interact with the tissue to enhance the porosity or permeability of the layer thereby permitting the enhanced absorption of substances.

49. A device for penetrating internal tissue in a living body to permit for interaction with the cutaneous layer comprising:

a) a first substrate of material having an area and a peripheral edge;

b) an array of needles arranged about the area for interacting with the tissue, the needles having a proximal end and a distal end;

c) selectively a spring or electromagnetic system for causing the needles to move relatively with the tissue;

d) an area transversely within peripheral edge of the material and through which the needles are directed, and the area being for receiving the surface of the tissue about which the micro needles are to interact; and

e) thereby to urge the cutaneous layer towards the area within the peripheral edge of the material and thereby provide a stabilizing force to the tissue;

the arrangement being such that the needles and tissue are caused to move relatively closer to each other and thereby permit the proximal ends of the needles to interact with the surface of the tissue; and

permitting the interaction of the distal end of the needle with the tissue.

1. A device for permitting effective engagement of needles within a living body with internal body tissue thereby to permit for energy to pass effectively to the tissue comprising:

a) a first substrate of flexible material having a transverse area and a peripheral edge;

b) an array of needles arranged about the area for effectively engaging the cutaneous layer;

c) a bladder related to the substrate for acting on the substrate for causing proximal ends of the needles to pass to the cutaneous layer for passage of energy associated with the needles to the tissue;

d) the area transversely within peripheral edge of the material and with which the needles are connected being for receiving the surface of the tissue with which the proximal ends of the needles are to pierce to effect a passage of a energy with the needles to the tissue; and

e) a connector for a suction generator for creating a suction force in the bladder thereby to urge the tissue towards the area within the peripheral edge of the material;

the arrangement being such that suction causes the needles and cutaneous layer to move relatively closer to each other and thereby permit the proximal ends of the needles to pierce the surface of the tissue, and permit the passage of a energy from the needles to the tissue.

2. A device as claimed in claim 1 wherein the bladder includes apertures located about and spaced from the needles such that a suction transmitted though the apertures thereby draws the tissue into engagement with a face of the substrate directed in the same direction as the proximate ends of the needles.

3. A device as claimed in claim 1 wherein the bladder communicates with spaces between the needle array, and wherein there are apertures between the needles for transmitting the suction, and including a second substrate substantially parallel to the first substrate and the bladder being formed between the substrates and the peripheral edge.

4. A device as claimed in claim 1 wherein the bladder permits for suction to be drawn in the area around the array of micro needles thereby causing the needles and tissue to be drawn together in relatively closer contact.

5. A device as claimed in claim 1 wherein the bladder is at least partly formed by a space between a first substrate and a closure structure above the tissue.

6. A device as claimed in claim 1 wherein the bladder is at least partly formed by two spaced layers, and including a port in one of the layers for connection to a suction generator, the port being connected to a suction array about the needle array.

7. A device as claimed in claim 1 including a mounting for supporting needles, and wherein a differential pressure in the bladder effectively causes the micro needles to move transversely between a position of repose withdrawn relative to the tissue towards a position relatively closer to the tissue.

8. A device as claimed in claim 1 wherein the bladder is formed in part of elastomeric material, and wherein there is an array of needles and array of ports arranged about the first substrate, the array of needles and the array of ports being separated from each other.

9. A device as claimed in claim 1 including a surface on the transverse area, the surface being for receiving the tissue under action of the suction force, and thereby stabilizing the tissue prior to and during piercing of the cutaneous layer by the proximal end of the needles.

10. A device as claimed in claim 1 wherein there are multiple needles in relative adjacency with each other thereby to permit multiple piercings of the tissue.

11. A device as claimed in claim 1 wherein the needles are mounted with a movable first substrate.

12. A device as claimed in claim 1 wherein the first substrate includes a surface with concavities and wherein the needles are mounted in the concavities, and the apertures being located in the concavities.

35. A device as claimed in claim 1 wherein the needle array are micro needles measuring about 25 to about 300 microns in height, are selectively biodegradable, and selectively made of silicon, and are formed with a density of about several hundred micro needles in an area of about one square centimeter.

55. A device as claimed in claim 1 including effecting delivery of a substance to attain increased porosity of the tissue permits for the inflammation of the cutaneous layer.

56. A device as claimed in claim 1 to effect an ablation of cutaneous or subcutaneous material or cells of organs.

57. A device as claimed in claim 1 including having the micro needles interact with the tissue to enhance the porosity or permeability of the tissue thereby permitting the enhanced absorption of energy.

58. A device as claimed in claim 49 including a source of energy, the energy being selectively one of cryoenergy, ultrasound energy, RF energy, or other electromagnetic energy.

59. A device as claimed in claim 49 including having different micro needles with different electrical polarities or selectively sensors or needles to effect removal of biologic substance.

60. A device as claimed in claim 49 including applying energy to attain increased porosity of the cutaneous layer permits for the inflammation of the cutaneous layer.

61. A device as claimed in claim 49 including an energy source for applying energy to attain ablation of subcutaneous material or cells of organs.

62. A device as claimed in claim 49 including having the micro needles interact with the tissue to enhance the porosity or permeability of the layer thereby permitting the enhanced absorption of energy.

63. A device as claimed in claim 1 including an energy source for applying the energy at a level for ablating endocardial or myocardial tissue.

67. A device as claimed in claim 39 including an energy source for applying the energy at a level for ablating endocardial or myocardial tissue.

68. A device as claimed in claim 1 including increasing the conductivity of the tissue through the needles, the conductivity being increased selectively by the irrigation fluid dispersed to the tissue.

67-1. A device as claimed in claim 49 including an energy source for applying the energy at a level for ablating endocardial or myocardial tissue.