Patch-like infusion device

• US 20050065472A1
• Filed: 08/12/2004
• Published: 03/24/2005
• Est. Priority Date: 07/22/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Cindrich, Chris N., Vedrine, Lionel, Harding, Weston F., Sonderegger, Ralph L., Lastovich, Alexander G., Howell, Glade
• Granted Patent: US 8,512,287 B2
• Time in Patent Office: Days
• US Class Current: 604/134
• CPC Class Codes: A61M 2005/14256 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16804 Flow controllers

Abstract

A system and method for a patch-like, self-contained substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir assembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. The device can be attached to a skin surface via an adhesive contact surface and a push button activation assembly can then be used to remove an interlock, allowing a disk, or Belleville spring assembly to apply an essentially even and constant pressure to the contents of a fluid reservoir assembly. The push button activation assembly further allows the release of one or more spring-loaded patient needles into the skin surface, and establishes a fluid communication path between the patient needles and the pressurized fluid reservoir contents thereby delivering an infusion into the skin. The push button activation assembly further allows the release of one or more improved safety mechanisms after use.

Claims

1. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, and a top surface;

an injection needle adapted for penetration of tissue, said needle having a lumen;

a reservoir disposed within said housing forming a chamber for containing said medicament, said reservoir defining a body opening having a longitudinal axis, a reservoir end and a body end, and a reservoir port wherein said body opening is in fluid communication to said chamber via a reservoir port, and said body opening is in fluid communication to the lumen of the injection needle via a needle port disposed between said reservoir end and said body end of the body opening;

a pressurizing system for pressurizing said chamber when the device is activated; and

a valve disposed in said body opening having a reservoir seal for sealing said reservoir port and a body seal for sealing said body end of said body opening, and movable along said longitudinal axis, between a first and a second position within said body opening;

wherein when said valve is in said second position, fluid communication between said reservoir port and said needle port is established, thereby allowing medicament to flow from the chamber, which is pressurized by said pressurizing system, through the reservoir port, through the body opening, through the needle port, and through the lumen of the needle into the patient.

2. A device as claimed in claim 1, wherein the body seal and the reservoir seal are comprised of an elastomeric material.

3. A device as claimed in claim 2, wherein the body seal further comprises a plurality of body sealing rings adapted for an interference fit with the interior of the body opening, and the reservoir seal further comprises a plurality of reservoir sealing rings adapted for an interference fit with the interior of the body opening.

9. A device as claimed in claim 1, wherein said reservoir port is disposed at said reservoir end.

10. A device as claimed in claim 1, further comprising a fluid path as defined by the chamber, the reservoir port, the body opening, the needle port and valve means for maintaining sterility of the fluid path.

4. A device as claimed in 1, wherein the valve is comprised of a plunger portion and a stopper portion, said stopper portion on the exterior of said plunger portion, forming both the reservoir seal and the body seal, and said stopper portion being formed from a material which is more flexible than said plunger portion.

5. A device as claimed in 1, wherein the body opening has a taper, said taper extending from the reservoir end to the body end and the body end has a greater relative diameter than said reservoir end.

6. A device as claimed in 1, wherein the body opening a first section and a second section therebetween said reservoir end and said body end, said first section having a first diameter and said second section having a second diameter, wherein said first diameter is smaller than said second diameter.

7. A device as claimed in 6, wherein the transition between said first and second sections is tapered.

8. A device as claimed in 3, wherein the reservoir sealing rings have a first diameter and the body sealing rings have a second diameter, wherein said first diameter is less than said second diameter.

11. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface, and a top surface;

an injection needle adapted for penetration of tissue, said needle having a lumen;

a reservoir disposed within said housing for containing said medicament, said reservoir having a body opening;

a pressurizing means for pressurizing said reservoir when the device is activated; and

a valve means movable between a first and a second position within said body opening;

the valve means including a movable stopper, which maintains its integrity, whilst in either first or second positions;

wherein when said valve means is in said second position, fluid communication between the reservoir and the needle is established, thereby allowing medicament to flow from the reservoir, which is pressurized by said pressurizing means and through the needle into the patient.

12. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, and a top surface;

an injection needle adapted for penetration of tissue;

a reservoir disposed within said housing adapted for containing said medicament, said reservoir having a body opening having a longitudinal axis, and said body opening is in selective fluid communication to the injection needle;

a pressurizing system adapted for pressurizing said reservoir; and

a valve disposed in said body opening adapted for sealing the reservoir defining a first position, and movable along said longitudinal axis, to a second position within said body opening;

wherein when said valve is moved to said second position, fluid communication between said reservoir and said needle is established, thereby allowing medicament to flow from the reservoir, which is pressurized by said pressurizing system, and through the needle into the patient.

13. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface, and a top surface;

an injection needle adapted for penetration of tissue;

a reservoir disposed within said housing adapted for containing said medicament, said reservoir having a first flow path, in fluid communication to the reservoir;

a pressurizing system adapted for pressurizing said reservoir;

a fluid path as defined by the first flow path and a second flow path, wherein the second flow path is in fluid communication to the injection needle; and

a valve disposed in said fluid path having a reservoir seal and a fluid path seal, said reservoir seal and fluid path seal connected by a valve body therebetween, the fluid path seal having an internal side, which contacts the fluid path, and an external side which does not contact the fluid path, the reservoir seal disposed entirely within the fluid path and movable between a first and a second position within said fluid path;

wherein, when the reservoir seal is in the first position, fluid communication between the first flow path and the second flow path is not allowed and when the reservoir seal is in the second position fluid communication between the first flow path and the second flow path is allowed.

14. A device as claimed in claim 13, wherein when the reservoir seal is in the first position, in the second position, or therebetween, the integrity of the reservoir seal is maintained.

15. A device as claimed in claim 13, wherein when the reservoir seal is in the first position, in the second position, or therebetween, the external side of the fluid path seal does not contact the fluid path.

16. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, and a top surface;

an injection needle adapted for penetration of tissue, said needle having a lumen;

a reservoir, disposed within said housing, comprised of a substantially rigid plate and a substantially flexible membrane bonded thereto, forming a chamber for containing said medicament, said reservoir having a body opening having a longitudinal axis and a reservoir end and a body end, and a reservoir port wherein said body opening in fluid communication to said chamber via the reservoir port, and said body opening is in fluid communication to the lumen of the injection needle via a needle port disposed between said reservoir end and said body end of the body opening;

a pressurizing system for pressurizing said chamber by compressing said membrane; and

a valve disposed in said body opening having a reservoir seal for sealing said reservoir port and a body seal for sealing said body end of said body opening, and movable along said longitudinal axis, between a first and a second position within said body opening;

wherein when said valve is moved from said first position to said second position, fluid communication between said reservoir port and said needle port is established, thereby allowing medicament to flow from the chamber which is pressurized by said pressurizing system, through the reservoir port, through the body opening, through the needle port, and through the lumen of the needle into the patient.

17. A device as claimed in claim 16, further comprising a needle conduit having a manifold end and a needle port end, wherein the needle port end is in fluid communication with the needle port and the manifold end is in fluid communication with the lumen of the needle, and the manifold end is adapted to hold the needle.

18. A device as claimed in claim 16, wherein said reservoir is substantially planar and substantially circular.

19. A device as claimed in claim 18, wherein said needle conduit is in an arcuate path around a periphery of said reservoir.

20. A device as claimed in claim 16, wherein said needle conduit is integrally formed in said rigid plate.

21. A device as claimed in claim 16, wherein said needle conduit is formed from a different material than the rigid plate.

22. A device as claimed in claim 17, wherein the manifold end of the needle conduit is movable between a first position and a second position, said first position corresponding to the needle being within the housing, and said second position corresponding to the needle being outside of the housing.

23. A device as claimed in claim 17, further comprising a needle hub wherein the needle hub is adapted to hold the needle and the needle hub is rigidly attached to manifold end of said needle conduit, such that the lumen of the needle is in fluid communication with the needle conduit.

24. A device as claimed in claim 22, wherein the needle conduit is cantilevered such that the needle conduit is deflected when the manifold end is in the first position, and the needle conduit is substantially non-deflected when the manifold end is in the second position, and the manifold end of the needle conduit moves in an arcuate path from the first position to the second position.

25. A device as claimed in claim 19, further comprising a needle stabilizer projecting from said body opening, the needle stabilizer having a manifold end attached to the manifold end of the needle conduit, wherein the needle stabilizer is in an arcuate path around a periphery of said reservoir, opposing the needle conduit.

26. A device as claimed in claim 16, wherein the pressurizing system is a disk spring, adapted to compress said membrane.

27. A device as claimed in claim 16, wherein the pressurizing system is a Belleville spring, adapted to compress said membrane.

28. A device as claimed in claim 22, wherein the needle conduit is cantilevered such that the needle conduit is deflected when the manifold end is in the first position, and the needle conduit is less deflected than in the first position when the manifold end is in the second position, and the manifold end of the needle conduit moves in a substantially arcuate path from the first position to the second position.

29. A device as claimed in claim 22, wherein the needle conduit is cantilevered such that the needle conduit has a first potential energy when the manifold end is in the first position, and the needle conduit has a second potential energy when the manifold end is in the second position, and first potential energy is greater than the second potential energy.

30. A device as claimed in claim 22, further comprising a needle actuation spring, coupled to the needle conduit, wherein the needle actuation spring has a first potential energy when the manifold end is in the first position, and the needle actuation spring has a second potential energy when the manifold end is in the second position, and first potential energy is greater than the second potential energy.

31. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface, and a top surface, and a longitudinal axis;

an injection needle adapted for penetration of tissue;

a reservoir, disposed within said housing, forming a chamber for containing said medicament, said reservoir in selective fluid communication to the injection needle;

a disk spring, having a central aperture and selectively, operably engaged to the reservoir; and

an activation member, disposed within said housing, with a first end and a second end and a longitudinal axis, the second end having a pin adapted for insertion and removal from the central aperture of the disk spring, the activation member having a first position wherein the pin is disposed in the central aperture of the disc spring, and a second position wherein the pin is removed from the central aperture of the disk spring;

wherein when said activation member is moved into said second position by application of a removal force.

32. A device as claimed in claim 31, wherein when the activation member is in the second position, said disk spring is allowed to pressurize said reservoir, thereby discharging the medicament to the needle and into the patient.

33. A device as claimed in claim 31, wherein the reservoir is comprised of a substantially rigid plate and a substantially flexible membrane bonded thereto.

34. A device as claimed in claim 31, wherein the pin is held within the central aperture of the disk spring, at least in part, by friction.

35. A device as claimed in claim 31, further comprising a detent disposed on the pin which engages the disk spring.

36. A device as claimed in claim 35, wherein the pin and detent is segmented, thereby reducing the removal force of the pin from the central aperture of the disk spring.

37. A device as claimed in claim 34, wherein the pin is segmented, thereby reducing the removal force of the pin from the central aperture of the disk spring.

38. A device as claimed in claim 31, further comprising a fulcrum disposed between said first end and said second end of the activation member, thereby forming the activation member into a lever, wherein a first force applied on the first end of the activation member is transmitted through the activation member to produce the removal force of the pin from the disk spring.

39. A device as claimed in claim 38, further comprising a button, movable in a path substantially parallel to the longitudinal axis of the activation member, the button having a ramp, which engages the first end of the activation member, thereby the ramp forms an inclined plane upon which the first end of the activation member is engaged, and movement of the ramp towards the activation member applies a reaction force on the first end of the activation member which is transmitted through the activation member to produce the removal force of the pin from the disk spring.

40. A device as claimed in claim 38, wherein the fulcrum is disposed on the activation member.

41. A device as claimed in claim 40, wherein the fulcrum is disposed on the activation member and is engaged to said disk spring.

42. A device as claimed in claim 40, wherein the fulcrum is disposed along an arcuate path.

43. A device as claimed in claim 42, wherein the fulcrum is disposed at least 20 degrees along radial portion of the disk spring.

44. A device as claimed in claim 40, wherein the fulcrum is disposed between the second end of the activation member and the midpoint between the first end and second end of the activation member.

45. A device as claimed in claim 42, wherein the disk spring has a plurality of radial voids extending from the central aperture of the disk spring, and fulcrum is disposed radially so that it spans at least one void.

46. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, and a top surface viewable by the patient during use of the device, and a longitudinal axis;

an injection needle adapted for penetration of tissue;

a reservoir, disposed within said housing, forming a chamber for containing said medicament, said reservoir in fluid communication to the injection needle;

a disk spring, having first side and second side, a central portion and at least one radial void extending from the central portion of the disk spring, wherein the disk spring has a start position, and an end position; and

a spring covering which extends radially from the central portion and substantially covers the at least one void in the disk spring on at least the first side of the disk spring.

47. A device as claimed in claim 46, wherein the reservoir is comprised of a substantially rigid plate and a substantially flexible membrane bonded thereto and the spring covering contacts the flexible membrane.

48. A device as claimed in claim 47, wherein the spring cover is composed of an elastomeric material.

49. A device as claimed in claim 47, wherein the spring covering is adapted to match a geometry of the rigid plate, thereby eliminating dead space in the reservoir when the disk spring is in the second position.

50. A device as claimed in claim 47, wherein the rigid plate is composed of a substantially clear material.

51. A device as claimed in claim 50, wherein the spring cover is composed of an elastomeric material.

52. A device as claimed in claim 51, further comprising at least one indicating protrusion disposed on the spring covering wherein when the disk spring is in the start position, the indicating protrusion contacts the flexible membrane and forms an impression in the flexible membrane, which is visible through the rigid plate, and when the disk spring is in the end position, the impression formed by the indicating protrusion is compressed by the rigid plate and is not visible through the rigid plate.

53. A device as claimed in claim 52, wherein the at least one indicating protrusion is a plurality of protrusions.

54. A device as claimed in claim 53, wherein the plurality of protrusions forms indicia, thereby indicating the state of the device.

55. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, and a top surface having a view window;

an injection needle adapted for penetration of tissue;

a reservoir, disposed within said housing, comprised of a top membrane, composed of a substantially clear material, and a substantially flexible membrane bonded thereto, forming a chamber for containing said medicament, said reservoir in fluid communication to the injection needle;

a pressure generating system, having a reservoir contacting surface, wherein the pressure generating system has a start position, and an end position, the reservoir contacting surface having a resilient portion; and

at least one indicating protrusion disposed on the resilient portion wherein when the pressure generating system is in the start position, the indicating protrusion contacts the flexible membrane and forms an impression in the flexible membrane, which is visible through the top membrane and through the view window, and when the pressure generating member is in the end position the impression is not visible.

56. A device as claimed in claim 55 wherein the impression formed by the indicating protrusion is compressed by the top membrane and is not visible through the top membrane, thereby indicating the pressure generating system is at the second position.

57. A device as claimed in claim 55, wherein the at least one indicating protrusion is a plurality of protrusions.

58. A device as claimed in claim 57, wherein the plurality of protrusions forms indicia, thereby indicating the state of the device.