Disposable assembly containing a skin piercing element

• US 9,072,472 B2
• Filed: 02/07/2006
• Issued: 07/07/2015
• Est. Priority Date: 02/07/2005
• Status: Active Grant

• Current Assignee: Avaxzipen Limited
• Original Assignee: Glide Pharmaceutical Technologies Limited
• Inventors: Potter, David Stuart, Potter, Charles David Ogilvy, Paterson, Graeme
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US11/883,901
• Publication Number:
  US 20090030442A1
• Time in Patent Office: 3,437 Days
• Field of Search: 606/181, 606/182, 606/183, 600/573, 600/583, 604/110, 604/136, 604137-139
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150893 by indicating if used, tampered with, unsterile or defective
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

The invention relates to devices used in the fields of drag delivery or sampling. More particularly, it relates to a disposable assembly which is fitted to an actuator device which causes the skin piercing element to enter the skin to deliver a drug (or other substance) or take a sample. Preferably the assembly is “made safe” after actuation, such that the disposable assembly can'"'"'t be reused and more preferably still the skin piercing element is safely housed in the assembly such that it does not constitute a “sharps” risk.

Claims

1. An assembly in combination with a mechanical actuator device therefore, the assembly comprising:

a housing having a proximal end and a distal end, the housing further having an opening to allow operative connection to the mechanical actuator device, a stem for engaging the mechanical actuator device and a channel within the stem, said channel containing;

a skin piercing element that, prior to actuation of the mechanical actuator device, is positioned inside the housing such that it is unable to penetrate the skin and, upon actuation of the mechanical actuator device the skin piercing element is, at least in part, displaced from the distal end of the housing to penetrate the skin; and

a drive pin or needle shaft in communication with the mechanical actuator device and the skin piercing element; and

an indicating mechanism that signals when the assembly has been used;

the indicating mechanism being visible on the stem; and

wherein the opening is located at the proximal end of the housing; and

wherein the indicating mechanism is located on the drive pin or needle shaft and, wherein the mechanical actuator device comprises a driving means for displacing the skin piercing element from the distal end of the housing upon actuation of the mechanical actuator device.

2. The combination as claimed in claim 1, wherein the stem defines at least a portion of the channel.

3. The combination as claimed in claim 1, wherein the skin piercing element is temporarily displaced from the end of the housing.

4. The combination as claimed in claim 1, wherein the assembly includes a resilient member located in the channel for retracting the skin piercing element or drive pin back into the housing after actuation of the mechanical actuator device.

5. The combination as claimed in claim 1, wherein the skin piercing element is a needle, or a plurality of needles.

6. The combination as claimed in claim 5, wherein the needle is a capillary needle, or a lancet, or a solid needle, or a tine needle.

7. The combination as claimed in claim 1, wherein the skin piercing element is a pioneer projectile or a drug splinter.

8. The combination as claimed in claim 1, wherein the indicating mechanism is combined with a disabling mechanism and the disabling mechanism comprises at least one actuatable member.

9. The combination as claimed in claim 8, wherein the at least one actuatable member extend in a lateral direction across the channel after actuation of the actuator device preventing a second actuation of the actuator device.

10. The combination as claimed in claim 9, wherein the at least one actuatable member extend outwardly of the stem wall to restrict the actuator device sliding along a length of the stem.

11. The combination as claimed in claim 9, wherein the at least one actuatable member extend inwardly of the stem wall to restrict movement of the skin piercing element or drive pin.

12. The combination as claimed in claim 8, wherein the at least one actuatable member are located on a shaft of the skin piercing element or drive pin, which after actuation of the actuator device extends outwardly from the needle or drive pin to engage a stop member within the stem which prevents the needle or drive pin being withdrawn back into the assembly.

13. The combination as claimed in claim 8 wherein the disabling mechanism prevents the assembly from being re-used with the mechanical actuator device.

14. The combination as claimed in claim 1, wherein the indicating mechanism is a deformable member located along a length of the stem or across the channel, the deformable member engagable with the actuator device or drive pin on actuation of the actuator device.

15. The combination as claimed in claim 8, wherein the at least one actuatable member is hinged or sprung.

16. The combination as claimed in claim 1, wherein a disabling mechanism disables the assembly after first actuation of the actuator device such that despite further attempts of actuation of the actuator device, the skin piercing element is inactivated such that it cannot leave the end of the housing.

17. The combination as claimed in claim 16, wherein the disabling mechanism locks the skin piercing element within the channel.

18. The combination as claimed in claim 16, wherein the indicating and disabling mechanisms comprises a plurality of actuatable members.

19. The combination as claimed in claim 18, comprising a first actuatable member which is acted on by actuation of the mechanical actuator device and a second actuatable member which acts after actuation of the mechanical actuator device.

20. The combination as claimed in claim 19, wherein the second actuatable member comprises integral resilient arms.

21. The combination as claimed in claim 19, wherein the first actuatable member is a release plunger and the second actuatable member is a slide detent.

22. The combination as claimed in claim 18, wherein actuation of the second actuatable member causes all or a part of the stem to expand radially outwards from the channel.

23. The combination as claimed in claim 1, comprising a first and second actuatable members which form part of the stem and which are biased to move towards the channel.

24. The combination as claimed in claim 23, further comprising first and second channel bridging members which, prior to actuation of the actuator device, counter the first and second actuatable members.

25. The combination as claimed in claim 24, wherein the first and second channel bridging members are respectively a drive pin head and a ring member.

26. The combination as claimed in claim 1, wherein the assembly comprises a skin contacting component located at a leading end of the assembly remote from the mechanical actuator device.

27. The combination assembly as claimed in claim 26, wherein the skin contacting component has a primary skin tensioning surface.

28. The combination as claimed in claim 26, wherein the skin contacting component has a secondary skin tensioning surface located intermediate the primary skin tensioning surface and a trailing end of the assembly.

29. The combination as claimed in claim 1 wherein the indicator mechanism is visible through an aperture in the housing.

30. The combination as claimed in claim 1, wherein the assembly is disposable.

31. A combination as claimed in claim 30 wherein the mechanical actuator is reusable.

32. A single use combination device comprising a disposable assembly as claimed in claim 30.

33. An assembly for use with a mechanical actuator device, the assembly comprising:

a housing having an opening to allow operative connection to the mechanical actuator device, an aperture and a stem for engaging the mechanical actuator device and a channel within the stem, said channel containing;

a skin piercing element that, prior to actuation of the mechanical actuator device, is positioned inside the housing such that it is unable to penetrate the skin and, upon actuation of the mechanical actuator device the skin piercing element is, at least in part, displaced from an end of the housing to penetrate the skin; and

a drive pin or needle shaft in communication with the mechanical actuator device and the skin piercing element; and

an indicating mechanism located on the drive pin or needle shaft that signals when the assembly has been used;

the indicating mechanism being visible on the stem; and

wherein the indicating mechanism is combined with a disabling mechanism located on the needle shaft or drive pin, the disabling mechanism comprising at least one actuatable member that engages with the aperture to disable the assembly.