Patch-like infusion device

• US 8,512,287 B2
• Filed: 08/12/2004
• Issued: 08/20/2013
• Est. Priority Date: 07/22/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Cindrich, Chris N., Sonderegger, Ralph L., Howell, Glade, Harding, Weston F., Lastovich, Alexander G., Vedrine, Lionel
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US10/916,649
• Publication Number:
  US 20050065472A1
• Time in Patent Office: 3,295 Days
• Field of Search: 604/132, 604/134, 604/136, 604138-139, 604/148, 604/204, 604/206, 604236-238, 604/246, 604/249, 604/153, 604/156, 604/173, 604200-202, 604/255, 604/890.1, 604/891.1
• 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, wherein 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 the fluid reservoir, allow the release of the patient needles into the skin surface, and establish a fluid communication path between the patient needles and the pressurized fluid reservoir contents. The push button activation assembly further allows the release of one or more improved safety mechanisms after use.

Claims

1. A device capable of being user-activated to deliver 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 having a body opening comprising a longitudinal axis substantially parallel to said bottom surface of said housing, a reservoir end, a body end, a reservoir port at said reservoir end, and a needle port between said reservoir end and said body end, wherein said body opening is in fluid communication to said chamber via said reservoir port, and said body opening is in fluid communication to the lumen of the injection needle via said 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 of said reservoir end of said body opening and preventing fluid communication between said reservoir port and said needle port, thereby preventing medicament from flowing from the chamber, 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, 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 has a first section and a second section between 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.

10. A device capable of being user-activated to deliver 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 between said top and bottom surfaces, 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 member, disposed within said housing between said top and bottom surfaces, movable along an axis substantially parallel to said housing bottom surface between a first and a second position within said body opening, the valve member comprising a movable stopper having a distal end to seal a first end of said body opening, and a proximal end to seal a second end of said body opening, and which maintains its integrity while in either said first or second position;

wherein when said valve member is in said second position, fluid communication between the reservoir and the injection needle is established around an outer circumference of said distal end of said valve member, thereby allowing medicament to flow from the reservoir, which is pressurized by said pressurizing means, and through the injection needle into the patient.

11. A device capable of being user-activated to deliver 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 substantially parallel to said bottom surface of said housing, said body opening being in selective fluid communication to the injection needle;

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

a valve, disposed in said body opening and adapted for sealing the reservoir when in a first position, and movable along said longitudinal axis to a second position within said body opening, having a distal end to seal a first end of said body opening, and a proximal end to seal a second end of said body opening;

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

12. A device capable of being user-activated to deliver 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 between said top and bottom surfaces, adapted for containing said medicament, said reservoir having a first flow path in fluid communication with the reservoir;

a pressurizing system for pressurizing said reservoir when the device is activated;

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

a valve disposed within said housing between said top and bottom surfaces, and in said fluid path, and 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 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 established around an outer circumference of said reservoir seal of said valve.

13. A device as claimed in claim 12, wherein when the reservoir seal is in the first position, in the second position, or therebetween, the integrity of the reservoir seal is maintained.

14. A device as claimed in claim 12, 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.

15. A device capable of being user-activated to deliver 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 substantially planar and substantially circular 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 comprising a longitudinal axis substantially parallel to said bottom surface of said housing, a reservoir end, a body end, and a reservoir port at said reservoir end, wherein said body opening is in fluid communication with said chamber via the reservoir port, and said body opening is in fluid communication with the lumen of the injection needle via a needle port disposed between said reservoir end and said body end of the body opening;

a needle conduit in an arcuate path around a periphery of said reservoir;

a needle stabilizer projecting from said body opening, the needle stabilizer having a manifold end attached to a 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;

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

a valve disposed in said body opening having a reservoir seal for sealing said reservoir port of said reservoir end of said body opening and preventing fluid communication between said reservoir port and said needle port, thereby preventing medicament from flowing from the chamber, 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.

16. A device as claimed in claim 15, wherein said needle conduit comprises 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.

17. A device as claimed in claim 15, wherein said needle conduit is integrally formed in said rigid plate.

18. A device as claimed in claim 15, wherein said needle conduit is formed from a different material than the rigid plate.

19. A device as claimed in claim 16, 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.

20. A device as claimed in claim 16, further comprising a needle hub wherein the needle hub is adapted to hold the needle and the needle hub is rigidly attached to the manifold end of said needle conduit, such that the lumen of the needle is in fluid communication with the needle conduit.

21. A device as claimed in claim 19, 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.

22. A device as claimed in claim 15, wherein the pressurizing system comprises a disk spring, adapted to compress said membrane.

23. A device as claimed in claim 15, wherein the pressurizing system comprises a Belleville spring, adapted to compress said membrane.

24. A device as claimed in claim 19, 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 in the first position than 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.

25. A device as claimed in claim 19, 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 the first potential energy is greater than the second potential energy.

26. A device capable of being user-activated to deliver 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, 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 extending substantially perpendicular to said bottom surface of said housing, said pin having a length in the direction perpendicular to the bottom surface of the housing exceeding a length in the direction parallel to the bottom surface of the housing and 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 disk 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, said disk spring is allowed to pressurize said reservoir, thereby discharging the medicament to the needle and into the patient.

27. A device as claimed in claim 26, wherein the reservoir is comprised of a substantially rigid plate and a substantially flexible membrane bonded thereto.

28. A device as claimed in claim 26, wherein the pin is held within the central aperture of the disk spring, at least in part, by friction.

29. A device as claimed in claim 26, further comprising a detent disposed on the pin which engages the disk spring.

30. A device as claimed in claim 29, wherein the pin and detent is segmented, thereby reducing the removal force of the pin from the central aperture of the disk spring.

31. A device as claimed in claim 28, wherein the pin is segmented, thereby reducing the removal force of the pin from the central aperture of the disk spring.

32. A device as claimed in claim 26, 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.

33. A device as claimed in claim 32, 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.

34. A device as claimed in claim 32, wherein the fulcrum is disposed on the activation member.

35. A device as claimed in claim 34, wherein the fulcrum is disposed on the activation member and is engaged to said disk spring.

36. A device as claimed in claim 34, wherein the fulcrum is disposed along an arcuate path.

37. A device as claimed in claim 36, wherein the fulcrum is disposed across a width of the activation member to span a radial portion of the disk spring.

38. A device as claimed in claim 34, 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.

39. A device as claimed in claim 37, wherein the disk spring has a plurality of radial voids extending from the central aperture of the disk spring, and the fulcrum is disposed so that it spans at least one void.

40. A device capable of being user-activated to deliver 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 comprising a longitudinal axis substantially parallel to said bottom surface of said housing, a reservoir end, a body end, and a reservoir port at said reservoir end, wherein said body opening is in fluid communication with said chamber via the reservoir port, and said body opening is in fluid communication with the lumen of the injection needle via a needle port disposed between said reservoir end and said body end of the body opening;

a needle conduit in a path around a periphery of said reservoir;

a needle stabilizer projecting from said body opening, the needle stabilizer having a manifold end attached to a manifold end of the needle conduit, wherein the needle stabilizer is in a path around a periphery of said reservoir, opposing the needle conduit;

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

a valve disposed in said body opening having a reservoir seal for sealing said reservoir port of said reservoir end of said body opening and preventing fluid communication between said reservoir port and said needle port, thereby preventing medicament from flowing from the chamber, 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.

41. A device as claimed in claim 40, wherein said needle conduit comprises 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.

42. A device as claimed in claim 40, wherein said needle conduit is integrally formed in said rigid plate.

43. A device as claimed in claim 40, wherein said needle conduit is formed from a different material than the rigid plate.

44. A device as claimed in claim 41, 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.

45. A device capable of being user-activated to deliver 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, 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;

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 extending substantially perpendicular to said bottom surface of said housing, said pin having a length in the direction perpendicular to the bottom surface of the housing exceeding a length in the direction parallel to the bottom surface of the housing and 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 disk spring, and a second position wherein the pin is removed from the central aperture of the disk spring; and

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 a removal force of the pin from the disk spring,

wherein when said activation member is moved into said second position by application of the removal force, said disk spring is allowed to pressurize said reservoir, thereby discharging the medicament to the needle and into the patient.