Inserter Assembly

• US 20110040263A1
• Filed: 02/06/2009
• Published: 02/17/2011
• Est. Priority Date: 02/08/2008
• Status: Abandoned Application

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Hasted, Søren Bo, Hørdum, Elo Lau, Morton, Richard Morgan, Jeppesen, Henrik, Morton, Alistair Daive, Gyrn, Steffen
• Application Number:
  US12/866,337
• Publication Number:
  US 20110040263A1
• Time in Patent Office: Days
• US Class Current: 604/272
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• 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 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 assembly according to the invention comprises an inserter device (10), a penetrating member (7) and a base part (100), where: the base part comprises a surface adapted to be attached to a skin surface, a position adapted to receive and/or attach to the penetrating member, and means (14) adapted to secure the base part to the inserter device, the penetrating member comprises a part to be placed subcutaneously or intramuscularly, a body (24) which is in contact with the inserter device during insertion and with the base part during use, and the inserter device comprises a cavity for receiving the penetrating member, means (45) for accelerating the penetrating member and bringing the penetrating member to the receiving position in the base part and means for penetrating the skin of the patient. The length of the joined assembly (1 total) before use is larger than the length of the base part (12) alone.

Claims

1. An assembly comprising:

a base part

comprising a surface adapted to be attached to a skin surface and an opening,

a penetrating member comprising a part adapted to be received through the opening and to be placed subcutaneously or intramuscularly, a body contacting the base part during use, and

an inserter device removably secured to the base part and contacting the body during insertion, the inserter device comprising a cavity for receiving the penetrating member, an accelerating portion adapted for accelerating the penetrating member and bringing the penetrating member to the opening in the base part and an insertion member for penetrating the skin of the patient,

wherein a length of the joined assembly (I_total) in a dimension horizontal to the patient'"'"'s skin when attached to the patient'"'"'s skin before use is larger than a length of the base part (I₂) alone.

2. An assembly according to claim 1, wherein a height of the joined assembly (h_total) before use is smaller than the sum of individual heights of the inserter device (h₁) and the base part (h₂).

3. An assembly according to claim 1, wherein the insertion device comprises

a moving part comprising a guide members that restricts the movement of the penetrating member and guides the penetrating member from a first to a second position in a first direction, and

a stationary housing comprising a guide members that restricts the movement of the moving part, and

the penetrating member comprises a portion corresponding to the guide member of the moving part.

4. An assembly according to claim 2, wherein the guide member of the stationary housing guide the moving part in a second direction which is linear and different from the first direction.

5. An assembly according to claim 1, wherein the base part and the penetrating member comprises corresponding attachment members adapted to attach the penetrating member to the base part during use and after insertion.

6. An assembly according to claim 1, wherein the inserter comprises an inserter attachment member releasably locking the inserter to the base part before and during insertion of the penetrating member the inserter attachment member unlockable to remove the inserter from the base part after insertion of the penetrating member, the inserter attachment member comprising at least one protruding part or at least one corresponding opening.

7. An assembly according to claim 6, wherein either the at least one protruding part or the at least one corresponding opening part is positioned on a surface of the base part and a corresponding part either comprising a protruding part or an opening is positioned on a surface of the inserter.

8. An assembly according to claim 1, wherein the inserter is released from the base part by applying a force to the inserter or a part of the inserter in a direction different from a direction of insertion of the penetrating member.

9. An assembly according to claim 1, wherein the release of the inserter from the base part is at least partly provided by the release of a force in a direction towards the base part.

10. An assembly according to claim 9, wherein the released force is provided by a spring unit exercising a force directed to a proximal surface of the inserter housing and a distal surface of the base part.

11. An assembly according to claim 10, wherein the spring is a leaf spring fastened unreleasably at one end to a part of the inserter and at the other end touches the upper surface of the base part before the inserter is released from the base part.

12. An assembly according to claim 1, wherein the base part comprises an internal fluid path and constitutes an infusion part provided with a cannula part during use, and

the body comprises a hard material having an inner through going opening in fluid contact with a cannula providing fluid contact with the patient, the body of the cannula part has an opening corresponding to an opening of the internal fluid path resulting in fluid contact between the internal fluid path and the cannula part and these two corresponding openings allow unrestricted flow when the two corresponding openings are positioned opposite each other;

and

a seal is positioned between the cannula part and the opening of the fluid path when the cannula part is in position for use

13. An assembly according to claim 12, wherein the seal surrounds the opening of the internal fluid path or a distance d₁ between a centre line c of the cannula part and a point on an outer surface of the cannula part positioned at or above an upper edge of the sealing is larger than a distance d₂ between the centre line c of the cannula part and a point on the outer surface of the cannula part positioned at or below a lower edge of the seal.

14. An assembly according to claim 12, wherein the body of the cannula part is provided with the seal before use or the opening of the fluid path is provided with the seal before use.

15. An assembly according to claim 12, wherein the body of the cannula part has at least a second opening to the inner through going opening.

16. An assembly according to claim 15, wherein the second opening to the inner through going opening is covered by a self closing membrane, the membrane can be penetrated by a blunt or pointed needle.

17. An assembly according to claim 12, wherein a membrane completely covers an opening giving access to a space in the assembly the membrane is made of an elastic material penetrable by a needle, the membrane is fastened around the opening and the membrane protrudes from the opening and forms an air filled volume in front of the opening the air filled volume can be reduced in size when a pressure is put on the membrane from the outside, the inner surfaces of the membrane define a passage at the first closed end of the membrane through which a needle can pass and the second end of the membrane is adapted to attach the membrane to a holding part.

18. An assembly according to claim 17, wherein walls of the membrane have a thickness and shape to maintain the protruding shape in a use position without outer surfaces of the membrane being supported with walls of rigid material.

19. An assembly according to claim 1, where the assembly comprises a fluid connection having at least a first and a second opening, where the first opening forms a fluid connection to a medication supply and the second opening forms a fluid connection to an opening in the body of a separate cannula part and an at least partly sub- or transcutaneous positioned cannula.

20. An assembly according to claim 19, wherein the fluid connection is attached to a surface plate the fluid connection comprising a tube made of a rigid material.

21. An assembly according to claim 20, wherein a pointed end of the tube forms a connector needle connecting a connector part and a reservoir.

22. An assembly according to claim 19, wherein the tube consists of a single piece.

23. An assembly according to claim 22, wherein the tube bent in an angle>

0 degrees in at least one position or the tube is bent in an angle>

0 degrees in at least two positions.

24-31. -31. (canceled)