Disposable assembly containing a skin piercing element

• US 20090030442A1
• Filed: 02/07/2006
• Published: 01/29/2009
• Est. Priority Date: 02/07/2005
• Status: Active Grant

• Current Assignee: Avaxzipen Limited
• Original Assignee: Glide Pharmaceutical Technologies Limited
• Inventors: Potter, David Stuart, Paterson, Graeme, Potter, Charles David Ogilvy
• Granted Patent: US 9,072,472 B2
• Time in Patent Office: Days
• US Class Current: 606/182
• 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 for use with an actuator device comprising:

a housing configured to allow operative connection to the actuator device;

the housing having a channel adapted to receive a skin piercing element such that on actuation of the actuator device the skin piercing element is, at least in part, displaced from an end of the housing to penetrate the skin; and

an indicating and disabling mechanism;

the indicating mechanism signaling when the assembly has been used and the disabling mechanism rendering the assembly disabled, after actuation of the actuator device.

2. An assembly as claimed in claim 1, wherein the channel contains a skin piercing element.

3. An assembly as claimed in claim 1, wherein the housing comprises a stem for engaging the actuator device.

4. An assembly as claimed in claim 1, wherein the stem defines at least a portion of the channel.

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

6. An assembly as claimed in claim 5, wherein the skin contacting component has a primary skin tensioning surface.

7. An assembly as claimed in claim 6, 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.

8. An assembly as claimed in claim 1, wherein the assembly includes a drive pin located within the housing, the drive pin communicating force generated by the actuator device to the skin piercing element.

9. An assembly as claimed in claim 1, wherein the skin piercing element is temporarily displaced from the end of the housing.

10. An assembly as claimed in claim 8, 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 actuator device.

11. An assembly as claimed in claim 1, wherein the skin piercing element is a needle, or a plurality of needles.

12. An assembly as claimed in claim 11, wherein the needle is a capillary needle, or a lancet, or a solid needle, or a tine needle.

13. An assembly as claimed in claim 1, wherein the skin piercing element is a pioneer projectile.

14. An assembly as claimed in claim 1, wherein the indicating and disabling mechanism comprises at least one actuatable member.

15. An assembly as claimed in claim 14, wherein the actuatable member or members extend in a lateral direction across the channel after actuation of the actuator device preventing a second actuation of the actuator device.

16. An assembly as claimed in claim 15, wherein the actuatable member or members extend outwardly of the stem wall to restrict the actuator device sliding along a length of the stem.

17. An assembly as claimed in claim 15, wherein the actuatable member or members extend inwardly of the stem wall to restrict movement of the skin piercing element or drive pin.

18. An assembly as claimed in claim 14, wherein the actuatable member or members 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.

19. An assembly as claimed in claim 8, 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.

20. An assembly as claimed in claim 1, wherein the indicating and disabling mechanism comprises a plurality of actuatable members.

21. An assembly as claimed in claim 20, comprising a first actuatable member which is acted on by actuation of the device and a second actuatable member which acts after actuation of the actuator device.

22. An assembly as claimed in claim 21, wherein the second actuatable member comprises integral resilient arms.

23. An assembly as claimed in claim 21, wherein the first actuatable member is a release plunger and the second actuatable member is a slide detent.

24. An assembly as claimed in claim 20, wherein actuation of the second actuatable member causes all or a part of the stem to expand radially outwards from the channel.

25. An assembly as claimed in claim 14, wherein the at least one actuatable member is hinged or sprung.

26. An assembly as claimed in claim 1, wherein the 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.

27. An assembly as claimed in claim 26, wherein the disabling mechanism locks the skin piercing element within the channel.

28. An assembly as claimed in claim 3, comprising first and second actuatable members which form part of the stem and which are biased to move towards the channel.

29. An assembly as claimed in claim 28, further comprising first and second channel bridging members which, prior to actuation of the actuator device, counter the first and second actuatable members.

30. An assembly as claimed in claim 29, wherein the first and second channel bridging members are respectively a drive pin head and a ring member.

31. An assembly as claimed in claim 1, wherein the assembly is disposable.

32. A reusable actuator device fitted with a disposable assembly as claimed in claim 31.

33. A single use actuator device comprising a disposable assembly as claimed in claim 31.

34. (canceled)