Cutaneous injection delivery under suction

• US 6,896,666 B2
• Filed: 11/08/2002
• Issued: 05/24/2005
• Est. Priority Date: 11/08/2002
• Status: Expired due to Fees

• Current Assignee: Kochamba Family Trust
• Original Assignee: Kochamba Family Trust
• Inventors: Kochamba, Gary Steven
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/290,819
• Publication Number:
  US 20040092875A1
• Time in Patent Office: 928 Days
• Field of Search: 604/146, 604/506, 604/513, 604/115, 604/131, 604/132, 604/134, 604/136, 604/139, 604/141, 604/143, 604/144, 604/147, 604/148, 604/156, 604/157, 604/200, 604/201, 604/204, 604/212, 604/187, 604/194
• US Class Current: 604/141
• 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 2018/1425 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 2230/00 Measuring parameters of the user
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• 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
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

The delivery of a fluid cutaneously is effected by generating a suction force on a surface of a housing. A surface of a cutaneous layer is received under the suction force about which the proximal end of a needle thereby to pierce the cutaneous surface and to effect an injection of fluid. There is generated a suction force to operate the movement of a needle in the housing. The needle is moved under the suction force from the housing thereby to permit piercing a cutaneous layer. The bladder for containing fluid is emptied under the suction into the distal end of the needle and thereby permit the expulsion of fluid through the proximal end of the needle for injection below the cutaneous layer.

Claims

1. A device for delivery of a fluid cutaneously comprising:

a) a housing having a peripheral edge;

b) a needle in the housing for piercing a cutaneous layer;

c) a bladder for containing fluid for injection below the cutaneous layer;

d) an area transversely within the peripheral edge of the housing and through which the proximal end of the needle may be directed, and the area being for receiving the surface of the cutaneous layer about which the proximal end of the needle is to pierce to effect an injection of fluid; and

e) a suction generator for creating a suction force at the area thereby to urge the cutaneous layer towards the area within the peripheral edge of the housing and thereby provide a stabilizing force to the cutaneous layer;

f) the arrangement of the needle, bladder and suction generator being such that the needle is caused to move by the suction force through the transverse area and thereby pierce the surface of the cutaneous layer; and

permitting the expulsion of fluid from the bladder into the distal end of the needle and thereby permit the expulsion of fluid through the proximal end of the needle.

2. A device as claimed in claim 1 including a mounting for supporting a needle, and wherein a differential pressure causes the needle to move through the transverse area and provides a force to cause the movement of the needle mounting and thereby cause the needle to move between a position of repose relatively withdrawn from the transverse area and a position extending through the transverse area.

3. A device as claimed in claim 1 including permitting the bladder to move under a suction force towards the proximal end of the needle, and thereby permit the distal end to pierce the bladder and permit fluid from the bladder to enter the distal end of the needle and subsequently exit the proximal end of the needle.

4. A device as claimed in claim 1 wherein the bladder is formed in part of elastomeric material whereby the elastomeric material retains a force on the fluid in the bladder.

5. A device as claimed in claim 2 including applying a further suction to the needle mounting means and thereby permit movement of the plate a predetermined amount and thereby permit piercing of a sealed chamber in the housing, and thereby to cause venting of that suction force causing the needle to be urged from the position of repose.

6. A device as claimed in claim 1 including a biasing force for causing the needle to be normally urged from the transverse area.

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

8. A device as claimed in claim 7 wherein the surface includes multiple ports through which a suction can be applied to the surface.

9. 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 cutaneous layer.

10. A device as claimed in claim 1 including a suction generating chamber, an inlet from the suction generating chamber into the housing for transmitting the suction to the housing, at least one secondary needle for permitting a pressure connection between the inlet for the suction and a ventilation chamber after a predetermined amount of movement of the needle whereby the suction force is vented to the ventilation chamber.

11. A device as claimed in claim 10 wherein the venting of the suction force firstly permits the needle to be retracted from the exposed position, and thereafter permits the cutaneous layer to move from the transverse area.

12. A device as claimed in claim 1 wherein the housing is a cylindrical member with a circular outer edge, the transverse area being inwardly concavely shaped area within the peripheral outer edge to permit the cutaneous surface to be drawn under suction to form a convex shape against the concave surface, the concave surface having multiple outlets surrounding a location for permitting passage of the needle through the area.

13. A device as claimed in claim 1 including a ventilation chamber removed from the transverse area, there being a needle mounting means between the transverse area and the bladder being located between the needle mounting means and the ventilation chamber.

14. A device as claimed in claim 1 including signaling element for indicating the substantial completion of fluid expulsion from the needle, the signaling element selectively being an audible signal, the signal being caused by the suction.

15. A device as claimed in claim 1 wherein the needle is mounted with a movable plate, the plate having a biasing located between a block for holding the needle and the plate, the biasing acting to urge the block and needle from the plate, and the suction acting to urge the block towards the needle plate.

16. A device as claimed in claim 15 wherein the plate is mounted about its periphery with an internal wall of the housing, and wherein the mounting includes an elastic diaphragm thereby to permit movement of the plate under action of the biasing and the suction.

17. A device as claimed in claim 1 wherein the bladder is formed with a mounting plate for the needle, and wherein one wall of the bladder is the mounting plate, and wherein there is pierceable member of the mounting plate, such that, under suction, the plate is drawn towards the distal end of the needle, and the distal end of the needle is permitted to penetrate the pierceable member and enter the bladder.

18. A device as claimed in claim 1 wherein there is a normally sealed wall between the bladder and a ventilation chamber, and the suction beyond a predetermined level causes the breakage of the sealed wall and thereby the venting of the suction from the transverse area.

19. A device as claimed in claim 1 wherein the housing is an elongated structure, the needle being centrally located, and there being sequentially from a proximal end of the housing, firstly the transverse area including a surface through which the needle is adapted to move in an axial direction, a stabilizing block, one end of which forms the transverse surface, ports being directed through the block from a side removed from the transverse surface, a guide block for receiving a needle block so that the needle block is movable in the guide block, the guide block having ports to permit suction to pass to an axially movable needle mounting plate, and the suction inlet to the housing, the suction inlet being located between the guide block and the stabilizing block, a bladder connected with the needle mounting plate, and a ventilation chamber located on the opposite side of the bladder.

20. A device as claimed in claim 19 including a secondary needle to permit suction to pass from the suction inlet to the ventilation chamber when the needle plate is moved to a pre-selected position sufficiently close to the proximal end of the housing, and there being biasing for urging the needle plate to a position removed from the proximal end of the housing.

21. A device for delivery of a fluid cutaneously comprising:

a) a housing having a peripheral edge;

b) a needle in the housing for piercing a cutaneous layer;

c) a bladder for containing fluid for injection below the cutaneous layer;

d) an area transversely within peripheral edge of the housing and through which a proximal end of the needle may be directed, and the area being for receiving the surface of the cutaneous layer about which the proximal end of the needle is to pierce to effect an injection of fluid;

e) means for generating a suction force at the area thereby to urge the cutaneous layer towards the area within the peripheral edge of the housing and thereby provide a stabilizing force to the cutaneous layer, the suction force causing the needle to move through the transverse area and thereby pierce the surface of the cutaneous layer, the suction force permitting the expulsion of fluid from the bladder into a distal end of the needle and thereby permit the expulsion of fluid through a proximal end of the needle;

f) mounting means for supporting a needle, and wherein the suction force causes movement of the mounting means, thereby causing the needle to move between a position of repose relatively withdrawn from the transverse area and a position extending through the transverse area the suction force permitting the bladder to move towards the proximal end of the needle, and thereby permit the distal end to pierce the bladder and permit fluid from the bladder to enter the distal end of the needle and subsequently exit the proximal end of the needle; and

g) the bladder being formed in part of elastomeric material whereby the elastomeric material retains a force on the fluid in the bladder.

22. A device as claimed in claim 21 including means for applying a further suction to the needle mounting means and thereby permit movement of the plate a predetermined amount and thereby permit piercing of a sealed chamber in the housing, and thereby to cause venting of that suction force causing the needle to be urged from the position of repose.

23. A device as claimed in claim 21 including a biasing means for causing the needle to be normally urged from the transverse area.

24. A device as claimed in claim 21 including a surface on the transverse area, the surface being for receiving the cutaneous layer under action of the suction force, and thereby stabilizes the cutaneous layer prior to and during piercing of the cutaneous layer by the proximal end of the needle.

25. A device as claimed in claim 21 wherein there are multiple needles in relative adjacency with each other thereby to permit multiple piercings of the cutaneous layer.

26. A device as claimed in claim 21 including a suction generating chamber, an inlet from the suction generating chamber into the housing for transmitting the suction to the housing, at least one secondary needle for permitting a pressure connection between the inlet for the suction and a ventilation chamber after a predetermined amount of movement of the needle whereby the suction force is vented to the ventilation chamber.

27. A device as claimed in claim 21 wherein the housing is a cylindrical member with a circular outer edge, the transverse area being inwardly concavely shaped area within the peripheral outer edge to permit the cutaneous surface to be drawn under suction to form a convex shape against the concave surface, the concave surface having multiple outlets surrounding a location for permitting passage of the needle through the area.

28. A device as claimed in claim 21 including a ventilation chamber removed from the transverse area, wherein said mounting means is between the transverse area and the bladder, the bladder being located between the mounting means and the ventilation chamber.

29. A device as claimed in claim 21 including signaling means for indicating the substantial completion of fluid expulsion from the needle, the signaling means selectively being an audible signal, the signal being caused by the suction.

30. A device as claimed in claim 21 wherein the needle is mounted with a movable plate, the plate having a biasing means located between a block for holding the needle and the plate, the biasing means acting to urge the block and needle from the plate, and the suction acting to urge the block towards the needle plate.

31. A device as claimed in claim 21 wherein the bladder is formed with a mounting plate for the needle, and wherein one wall of the bladder is the mounting plate, and wherein there is pierceable member of the mounting plate, such that, under suction, the plate is drawn towards the distal end of the needle, and the distal end of the needle is permitted to penetrate the pierceable member and enter the bladder.

32. A device as claimed in claim 21 wherein there is a normally sealed wall between the bladder and a ventilation chamber, and the suction beyond a predetermined level causes the breakage of the sealed wall and thereby the venting of the suction from the transverse area.

33. A device as claimed in claim 21 wherein the housing is an elongated structure, the needle being centrally located, and there being sequentially from a proximal end of the housing, firstly the transverse area including a surface through which the needle is adapted to move in an axial direction, a stabilizing block, one end of which forms the transverse surface, ports being directed through the block from a side removed from the transverse surface, a guide block for receiving a needle block so that the needle block is movable in the guide block, the guide block having ports to permit suction to pass to an axially movable needle mounting plate, and the suction inlet to the housing, the suction inlet being located between the guide block and the stabilizing block, a bladder connected with the needle mounting plate, and a ventilation chamber located on the opposite side of the bladder.

51. A device as claimed in claim 21 including means for venting suction after a predetermined amount of movement of the needle.

34. A method for delivery of a fluid cutaneously comprising:

a) generating a suction force on a surface of a housing thereby to receive under the suction force a surface of a cutaneous layer about which the proximal end of a needle is to pierce to effect an injection of fluid;

b) generating a suction force to operate the movement of a needle in the housing;

c) moving a needle under the suction force from the housing thereby to permit piercing a cutaneous layer; and

d) emptying a bladder for containing fluid into the distal end of the needle and thereby permit the expulsion of fluid through the proximal end of the needle for injection below the cutaneous layer.

35. A method as claimed in claim 34 including causing the needle to move through the transverse area under a suction force to cause the movement of the needle to move between a position of repose relatively withdrawn from the transverse area and a position extending through the transverse area.

36. A method as claimed in claim 34 including permitting the bladder to move under a suction force towards the proximal end of the needle, and thereby permit the distal end to pierce the bladder and permit fluid from the bladder to enter the distal end of the needle and subsequently exit the proximal end of the needle.

37. A method as claimed in claim 34 including applying a further suction to the needle and thereby permit a predetermined amount of movement and thereby permit piercing of a sealed chamber in the housing, and thereby to cause venting of that suction force causing the needle to be urged from the position of repose.

38. A method as claimed in claim 34 including biasing the needle to be urged from the transverse area, the biasing effect being operable selectively after the needle has been urged into he cutaneous region for a predetermined distance, and further selectively after the bladder has been substantially emptied.

39. A method as claimed in claim 34 including applying the suction force at multiple points on the surface thereby to stabilize the cutaneous layer.

40. A method as claimed in claim 34 including effecting multiple piercings of the cutaneous layer by multiple needles in the housing.

41. A method as claimed in claim 34 including transmitting the suction in the housing through at least one secondary needle for permitting a pressure connection between an inlet for the suction to be ventilated after a predetermined amount of movement of the needle.

42. A method as claimed in claim 41 wherein the venting of the suction force firstly permits the needle to be retracted from the exposed position, and thereafter permits the cutaneous layer to move from the transverse area.

43. A method as claimed in claim 34 including signaling the substantial completion of fluid expulsion from the needle, the signaling selectively being an audible signal, the signal being caused by the suction.

44. A method as claimed in claim 34 including moving the needle through a mounting with a movable plate, the plate being biased to urge the needle from the plate, and the suction acting to urge the needle towards the proximal end of the housing.

45. A method as claimed in claim 34 including piercing the bladder when the plate is drawn towards the distal end of the needle, and the distal end of the needle is permitted to penetrate and enter the bladder.

46. A method as claimed in claim 34 wherein the suction beyond a predetermined level causes venting of the suction from the transverse area.

47. A method for delivery of a fluid cutaneously comprising:

a) generating a suction force on a surface of a housing thereby to receive under the suction force a surface of a cutaneous layer about which the proximal end of a needle is to pierce to effect an injection of fluid;

b) generating a suction force to operate the movement of a needle in the housing;

c) moving a needle under the suction force from the housing thereby to permit piercing a cutaneous layer;

d) emptying a bladder for containing fluid into the distal end of the needle and thereby permit the expulsion of fluid through the proximal end of the needle for injection below the cutaneous layer;

e) moving the needle to move through the transverse area under a suction force and thereby cause the needle to move between a position of repose relatively withdrawn from the transverse area and a position extending through the transverse area; and

f) moving the bladder to move under a suction force towards the proximal end of the needle, and thereby permit the distal end to pierce the bladder and permit fluid from the bladder to enter the distal end of the needle and subsequently exit the proximal end of the needle.

48. A method as claimed in claim 47 including applying a further suction to the needle and thereby permit movement a predetermined amount and thereby cause venting of that suction force causing the needle to be urged from the position of repose.

49. A method as claimed in claim 47 including biasing the needle to be urged from the transverse area, the biasing effect being operable selectively after the needle has been urged into he cutaneous region for a predetermined distance, and further selectively after the bladder has been substantially emptied.

50. A method as claimed in claim 47 including effecting multiple piercings of the cutaneous layer through multiple needles in the housing.

52. A device for delivery of a fluid cutaneously comprising:

a) a housing having a peripheral edge;

b) a needle in the housing for piercing a cutaneous layer;

c) a bladder for containing fluid for injection below the cutaneous layer;

d) an area transversely within the peripheral edge of the housing and through which the proximal end of the needle may be directed, and the area being for receiving the surface of the cutaneous layer about which the proximal end of the needle is to pierce to effect an injection of fluid; and

e) a generator for creating a pressure differential, selectively a higher pressure force, or a suction pressure, and means to transmit the pressure differential as a suction at the area thereby to urge the cutaneous layer towards the area within the peripheral edge of the housing and thereby provide a stabilizing force to the cutaneous layer;

f) the arrangement of the needle, bladder and generator being such that the needle is caused to move by the pressure differential, selectively higher pressure force or the suction pressure through the transverse area and thereby pierce the surface of the cutaneous layer; and

permitting the expulsion of fluid from the bladder into the distal end of the needle and thereby permit the expulsion of fluid through the proximal end of the needle.