Inserter

• US 7,867,199 B2
• Filed: 12/09/2005
• Issued: 01/11/2011
• Est. Priority Date: 12/10/2004
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Göransson, Magnus Walter, Mogensen, Lasse Wesseltoft
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/298,259
• Publication Number:
  US 20060161108A1
• Time in Patent Office: 1,859 Days
• Field of Search: 604/164.04, 604/164.08, 604/164.12, 604/165.01, 604/288.01, 604/288.04, 604/181
• US Class Current: 604/164.04
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• 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 an inserter for an infusion set for intermittent or continuous administration of a therapeutical substance such as e.g. insulin. The inserter comprises a needle unit comprising a needle hub and a carrier body, and a cannula housing. The cannula housing and the needle hub are releasably connected and when they are connected, the insertion needle is placed inside the cannula. The carrier body guides the movement relative to the set housing between a retracted and an advanced position. When released the needle unit and the cannula housing are forced by a spring unit to an advanced position where the needle and cannula are placed subcutaneously. One object of the invention is to provide a disposable inserter for an infusion set which inserter is easy and safe for the user to handle during use and to dispose of after use.

Claims

1. An inserter for an angled infusion set;

the inserter comprising;

a set housing provided with first guiding means on an internal surface for guiding the movement of a carrier body, the carrier body is provided with second guiding means on an external surface for guiding the movement relative to the set housing between a retracted and an advanced position;

a cannula housing comprising a soft cannula to be placed subcutaneously,

a needle hub comprising an insertion needle for piercing of the skin, the cannula housing and the needle hub are releasably connected to each other, and when they are connected, the insertion needle is adjoined to the cannula, the needle hub and the carrier body are provided with unreleasable interacting locking means;

a spring unit connected to release means and when the release means are activated, the cannula housing, the needle hub and the carrier body are forced by the spring unit to an advanced position where the needle and cannula can be placed subcutaneously; and

a projecting portion extending from a lower base of the set housing, the projecting portion forming an angle in relation to an axis extending in a longitudinal direction of the insertion needle indicating the correct insertion angle for the user during insertion, the projecting portion extending across the axis in front of an end of the cannula when the needle hub is in the retracted position such that the projecting portion lifts up at least a portion of a mounting pad relative to the lower base to a position for contacting the skin during insertion.

2. An inserter according to claim 1, wherein the insertion needle is placed inside the cannula.

3. An inserter according to claim 1, wherein the needle hub and the carrier body are created as a single unit.

4. An inserter according to claim 1, wherein the needle hub comprises openings in a part of the needle hub which openings are covered by material of the set housing, and the carrier body is provided with projections corresponding to the openings in the needle hub.

5. An inserter according to claim 1, wherein the needle unit comprising the needle hub and the carrier body can be placed in a retracted position after insertion.

6. An inserter according to claim 1, wherein the inserter further comprises a stopper.

7. An inserter according to claim 6, wherein the stopper comprises at least one end of a track for a flange.

8. The inserter as claimed in claim 1, wherein the set housing forms at least a part of the delivering packing for the inserter.

9. The inserter as claimed in claim 1, wherein the set housing is provided with a hard top.

10. The inserter as claimed in claim 1, wherein the spring unit is fastened to the set housing in a first position and to the carrier body or the needle hub in a second position, and the first position is situated closer to the front end of the set housing than the second position when the spring unit is unbiased.

11. The inserter as claimed in claim 1, wherein the spring unit is an elastic O-ring.

12. The inserter as claimed in claim 1, wherein the spring unit is fastened to the set housing in a first position and fixed to the carrier body or the needle hub in a second position, and the first position is situated closer to the back end of the set housing than the second position when the spring unit is unbiased.

13. The inserter as claimed in claim 1, wherein the spring unit is a flat spring placed between the back end of the set housing and the needle unit.

14. An inserter for an angled infusion set;

the inserter comprising;

a set housing made of a single piece of material and provided with first guiding means on an internal surface for guiding the movement of a carrier body, the carrier body is provided with second guiding means on an external surface for guiding the movement relative to the set housing between a retracted and an advanced position;

a cannula housing comprising a soft cannula to be placed subcutaneously,

a needle hub comprising an insertion needle for piercing of the skin, the cannula housing and the needle hub are releasably connected to each other, and when they are connected, the insertion needle is adjoined to the cannula,

a spring unit connected to release means and when the release means are activated, the cannula housing, the needle hub and the carrier body are forced by the spring unit to an advanced position where the needle and cannula can be placed subcutaneously; and

a projecting portion extending from a lower base of the set housing, the projecting portion forming an angle in relation to an axis extending in a longitudinal direction of the insertion needle indicating the correct insertion angle for the user during insertion, the projecting portion extending in front of an end of the cannula when the needle hub is in the retracted position such that the projecting portion lifts up at least a portion of a mounting pad relative to the lower base to a position for contacting the skin during insertion.

15. An inserter according to claim 14, wherein the insertion needle is placed inside the cannula.

16. The inserter as claimed in claim 14, wherein the set housing is U-shaped.

17. The inserter as claimed in claim 16, wherein the lower leg of the U-shape comprises a projecting part forming an angle with a base line below and parallel to the needle.

18. The inserter as claimed in claim 14, wherein the set housing is formed as a piece of pipe with a rounded or poly-sided profile.

19. Inserter as claimed in claim 14, wherein the set housing forms at least a part of the delivering packing for the inserter.

20. The inserter as claimed in claim 14, wherein the set housing is provided with a hard top.

21. The inserter as claimed in claim 14, wherein the spring unit is fastened to the set housing in a first position and to the carrier body or the needle hub in a second position, and the first position is situated closer to the front end of the set housing than the second position when the spring unit is unbiased.

22. The inserter as claimed in claim 14, wherein the spring unit is an elastic O-ring.

23. The inserter as claimed in claim 14, wherein the spring unit is fastened to the set housing in a first position and fixed to the carrier body or the needle hub in a second position, and the first position is situated closer to the back end of the set housing than the second position when the spring unit is unbiased.

24. The inserter as claimed in claim 14, wherein the spring unit is a flat spring placed between the back end of the set housing and the needle unit.

25. The inserter as claimed in claim 24, wherein the spring unit has the form of two convex curves placed on each side of the needle unit, and that each curve is fixed to the needle unit at one end and to the set housing behind the fixation to the needle unit at the other end in the unbiased state.