Injector device for placing a subcutaneous infusion set

• US 8,162,892 B2
• Filed: 03/29/2004
• Issued: 04/24/2012
• Est. Priority Date: 09/27/2001
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Mogensen, Lasse Wesseltoft, Kornerup, Grete, Göransson, Magnus Walter
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US10/813,214
• Publication Number:
  US 20050043687A1
• Time in Patent Office: 2,948 Days
• Field of Search: 604/93.01, 604/164.01, 604/164.12, 604156-158, 604136-138, 604/164.08, 604192-198, 604/263
• US Class Current: 604/165.01
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• 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

An injector device assembly and a method for making an injector device assembly are provided. The injector assembly includes a sterile insertion set with a housing and a hollow cannula and a device housing. A plunger is slidably received within the device housing for movement between an advanced position and a retracted position wherein the cannula is transcutaneously placed upon movement of the plunger from the advanced position to the retracted position. The device housing has a forward end defining a surface of placement against the skin of a patient with the device housing in a predetermined orientation relative to the patient'"'"'s skin. The injector device assembly includes a spring for urging the plunger toward the advanced position and a releasable cover member covering the forward end. The cover member and the device housing assure sterile conditions of the insertion set within the device housing prior to removal of the cover member.

Claims

1. An injector device assembly comprising:

a sterile insertion set with a housing and a hollow cannula;

a device housing, said insertion set positioned removably from and within said device housing;

a plunger received within said device housing for movement between an advanced position and a retracted position, said cannula being transcutaneously placed upon movement of the plunger from the retracted position to the advanced position, said insertion set being separable from said plunger;

said device housing having a forward end defining a surface of placement against the skin of a patient; and

a cover member covering an opening defined in said forward end and removably connected to a portion of said device housing, said cover member and said device housing assuring sterile conditions of said insertion set within said device housing prior to removal of said cover member.

2. The injector device assembly of claim 1, said injector device including an insertion needle extending through said hollow cannula and being in frictional engagement with said hollow cannula.

3. The injector device assembly of claim 1, said insertion set being an infusion set, said insertion set housing including an adhesive layer for adhering said insertion set housing to the skin of a patient.

4. The injector device assembly of claim 1, said insertion set being a glucose sensor.

5. The injector device assembly of claim 2, said insertion needle being secured to said plunger by a stable connection preventing loss of the insertion needle during use of the device.

6. The injector device of claim 5, said insertion needle being secured to said plunger by press-fit.

7. The injector device assembly of claim 1, including a trigger for releasably retaining said plunger in the retracted position, the trigger being operable to release the plunger for movement with a controlled force and speed toward the advanced position.

8. The injector device assembly of claim 1, said plunger including a support structure for reception and support of said insertion set, said support structure being removable from said insertion set while maintaining a transcutaneous placement of said insertion needle.

9. The injector device assembly of claim 1, indicia relating to the shelf life of said assembly being on said cover member.

10. The injector device assembly of claim 1, said plunger being in said advanced position prior to first time removal of said cover member.

11. The injector device assembly of claim 2, wherein said removable cover is member includes a hollow for receiving a part of said insertion needle when said plunger is in said advanced position.

12. The injector device assembly of claim 1, said cover being repositionable subsequent to removal of said insertion set.

13. The injector device assembly of claim 7, said trigger releasing said plunger by manual deformation of said housing.

14. The injector device assembly of claim 7, said insertion set including tubing for delivery of medication to said hollow cannula, said housing including an annular space for accommodating said tubing.

15. The injector device assembly of claim 1, said device housing including a releasable cover at a rearward end of said device housing.

16. The injector device of claim 15, said releasable cover at said rearward end being a membrane.

17. The injector device of claim 16, said releasable cover allowing through-flow of a sterilizing agent into said device housing with said insertion set.

18. The injector device assembly of claim 2, wherein said cover includes an upstanding cylinder for surrounding at least a portion of said insertion needle.

22. The injector device assembly of claim 21, two strips extending in a common plane around a respective part of said periphery of said plunger, and two further strips extending in a second plane around a respective part of said periphery, in said advanced position of said plunger.

19. An injector device assembly comprising:

a sterile insertion set having a housing and a hollow cannula;

a device housing;

a plunger slidably received within said device housing for movement between an advanced position and a retracted position, said cannula being transcutaneously placed upon movement of the plunger from the retracted position to the advanced position;

a spring for urging said plunger toward the advanced position;

said device housing having a forward end defining a surface for placement against the skin of a patient; and

a releasable cover member covering said forward end, said cover member and said device housing assuring sterile conditions of said insertion set within said device housing prior to removal of said cover member;

wherein said spring comprises a number of individual, flexible plastics strips extending around a respective part of the periphery of the plunger, in a space between the plunger and the device housing, each strip being connected with the plunger and with the device housing.

20. The injector device assembly of claim 19, wherein said strips are integrally molded with said plunger and said device housing.

21. The injector device assembly of claim 19, each strip being essentially planar and non-deformed when the plunger is in the advanced position.

23. The injector device assembly of claim 19, wherein said strips and said plunger are molded as a unitary component, said unitary component being connected to said device housing.

24. An injector device assembly, comprising:

a sterile insertion set with a housing and a hollow cannula, a molded device housing, said insertion set positioned within said device housing for delivery of said sterile insertion set to a patient;

a molded plunger received within the device housing for movement between an advanced position and a retracted position;

a lock for releasably locking said plunger in said retracted position, said housing being manually deformable to effect release of said plunger;

a spring for urging the plunger from the retracted position towards the advanced position, said insertion set being separable from said plunger after placement of said cannula;

said cannula being transcutaneously placed upon movement of the plunger from the retracted position to the advanced position;

said housing having a forward end defining a surface for placement against the skin of a patient with the device housing in a predetermined orientation relative to the patient'"'"'s skin; and

a removable cover member covering an opening defined in said forward end and connected to a portion of said device housing;

said cover member and said device housing assuring sterile conditions of said separable insertion set within said device housing prior to removal of said cover member.

25. The injector device assembly of claim 24 wherein the spring comprises a plurality of flexible plastic strips connected with the plunger and the housing, each strip extending around a respective part of the periphery of the plunger.

26. The injector device assembly of claim 25, wherein each of said strips is connected with the plunger and with the device housing, said connections being at different peripheral locations around the plunger.

27. The injector device assembly of claim 25, wherein each strip is essentially planar and non-deformed when the plunger is in the advanced position.

28. The injector device assembly of claim 25, wherein said strips and said plunger are molded as a unitary component, said unitary component being connected to said housing.

29. The injector device assembly of claim 25, wherein each of said flexible strips extends in a space between the plunger and the device housing.

30. The injector device assembly of claim 24, wherein said insertion set is an infusion set.

31. The injector device assembly of claim 24, wherein said insertion set is a glucose sensor.

32. The injector device assembly according to claim 24, wherein said insertion set includes an insertion needle that is substantially non-detachably secured to said plunger.

33. The injector device assembly of claim 32, wherein said insertion needle is hollow and has a lateral opening near said plunger.

34. The injector device assembly of claim 24, including manual engagement areas for the manual deformation of said housing to effect said release of said plunger.

35. The injector device assembly of claim 34, said manual engagement areas being diametrically opposed on said housing and being peripherally offset with respect to said lock.

36. The injector device assembly of claim 35 wherein said manual engagement areas are offset about 90°

.

37. The injector device assembly of claim 35, said manual engagement areas being of fingertip size.

38. The injector device assembly of claim 24, said device housing including a releasable cover at a rearward end of said device housing.

39. The injector device of claim 38, said releasable cover at said rearward end being a membrane.

40. The injector device of claim 39, said releasable cover allowing through-flow of a sterilizing agent into said device housing with said insertion set.

41. A method for making an injector device assembly comprising the steps of:

providing an injector device housing, said injector device housing having a movable plunger and providing an insertion set, said insertion set having an insertion set housing and a hollow cannula;

placing said insertion set within said injector device housing;

connecting at least one releasable cover to at least a portion of said injector device housing to seal said insertion set within said injector device housing, said cover comprising a membrane; and

sterilizing said insertion set by flowing a sterilizing agent through said membrane into an interior of said injector device housing.

42. The method of claim 41, said device housing having a forward end defining a surface of placement against the skin of a patient with the device housing in a predetermined orientation relative to the patient'"'"'s skin, said releasable cover member covering said forward end.

43. The method of claim 41, said device housing including a releasable cover at a rearward end of said housing.

44. An injector device for transcutaneously placing at least a portion of a cannula of a removable medical device through the skin of a patient, said injector device comprising:

a generally cylindrically shaped housing having a cavity formed therein, said housing including a forward end, said forward end defining a generally planar surface for placement against the skin of the patient;

a carrier member adapted for at least partial reception in said cavity, said carrier member comprising at least one piercing member substantially non-detachably secured to said carrier member;

a drive for urging movement of said carrier member relative to said housing, said drive extending at least partially around at least a portion of said carrier member; and

a releasable cover member covering said forward end, said cover member comprising an upstanding portion defining a bore;

wherein said at least one piercing member is adapted to receive said removable medical device.

45. The injector device of claim 44, wherein said upstanding portion surrounds a portion of the at least one piercing member.

46. The injector device of claim 44, wherein said upstanding portion is cylindrically shaped.

47. The injector device of claim 44, wherein said cover member and said housing are configured to provide sterile conditions for the medical device prior to removal of said cover member.

48. An injector device assembly comprising:

a sterile insertion set comprising a housing and a hollow cannula;

a device housing having a cavity formed therein, said insertion set positioned removably from and within said device housing;

a plunger having a piercing member connected to the plunger and positioned at least partially within said cavity, said piercing member extending at least partially through said cannula of said insertion set and said plunger configured to move said insertion set toward the skin of a patient; and

a cover removably connected to a portion of said device housing, said cover accommodating a part of said piercing member, said cover and said device housing assuring sterile conditions of said insertion set within said device housing prior to removal of said cover.

49. The injector device assembly of claim 48, wherein said cover connects to and extends partially along a side wall at said forward portion of said device housing.

50. The injector device assembly of claim 48 wherein said cover is removably connected to said portion of said device housing by snap engagement.

51. A method for providing an injector device assembly having a sterile inertion set provided within an injector device housing, the method comprisiing:

proiding an injector device housing, said injector device housing having a movable plunger and a piercing member connected to the plunger;

providing an insertion set, said insertion set havig an insertion set housing and a hollow cannula;

placing said insertion set within said injector device housing so that said piercing member extends at least partially through said cannula;

connecting at least one removable cover to a portion of said injector device housing to cover an opening defined in said injector device housing and to seal said insertion set within said injector device housing, the cover accommodating a part of said piercing member; and

strerilizing said insertion set within said injector device housing.