Inserter having bistable equilibrium states

• US 8,430,850 B2
• Filed: 07/02/2008
• Issued: 04/30/2013
• Est. Priority Date: 07/03/2007
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Gyrn, Steffen, Hagedorn, Brian Boyum, Hasted, Sren Bo
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US12/665,274
• Publication Number:
  US 20100286615A1
• Time in Patent Office: 1,763 Days
• Field of Search: 604/164.04, 604/136, 604/156, 604/157
• US Class Current: 604/156
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

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 means for insertion and retraction of an introducer needle. With an inserter device according to the invention it is possible to introduce an insertion needle when placing a medical device sub- or transcutaneously. The Inserter device comprises a housing (1, 2, 12) which hides the insertion needle (7, 17) before insertion and can hide the insertion needle (7, 17) after insertion and placing of the medical device. The insertion needle (7, 17) moves relative to the housing (1, 2, 12) toward the patients skin surface during insertion and the inserter device comprises a bi-stable elastic element (1, 11) having two equilibrium states.

Claims

1. Inserter device used to introduce an insertion needle into a sub- or transcutaneous layer, the inserter comprising:

an insertion needle;

an elastic element attached to the insertion needle, the elastic element providing a driving force instigating insertion of the insertion needle, the elastic element is a bi-stable elastic element having two equilibrium states, a first state and a second state where in each of the first and second states, the elastic element is in equilibrium and has no incitement to move, where the elastic element moves from the first state toward the second state to drive the insertion of the insertion needle; and

a housing configured to conceal the insertion needle before insertion and optionally configured to conceal the insertion needle after insertion and placing of a medical device, and

wherein the insertion needle moves relative to the housing toward the patient'"'"'s skin surface during insertion.

2. The inserter device according to claim 1, wherein one equilibrium state is in a retracted position where the insertion needle or a cannula is protected from the surroundings and the second equilibrium state is in a forward position where the insertion needle, the cannula, or both the needle and the cannula extend from the housing.

3. The inserter device according to claim 1, wherein the insertion needle is secured to the elastic element.

4. The inserter device according to claim 1, wherein the elastic element is a part of an outer surface of the housing of the inserter device.

5. The inserter device according to claim 1, wherein the elastic element comprises a flexible piece of material having two opposite ends, the ends are held stationary relative to the housing at a distance shorter than a length of the elastic element in a stretched or unloaded state.

6. The inserter device according to claim 1, wherein the inserter device further comprises activating means configured to move the elastic element from one position to the other position.

7. The inserter device according to claim 1, wherein the inserter device is disposable.

8. The inserter device according to claim 1, wherein the inserter device is configured to insert a medical device comprising an infusion part comprising a through going opening and a cannula.

9. The inserter device according to claim 1, wherein the inserter device is configured to insert a medical device comprising a sensor part comprising a sensor for sub- or transcutaneous positioning.

10. The inserter device according to claim 1, wherein the inserter device includes a penetrating insertion needle and a medical device configured to be inserted by the inserter device includes a soft cannula.

11. The inserter device according to claim 1, wherein the elastic element comprises a spring.

12. The inserter device according to claim 1, further comprising a medical device removably secured to the inserter, the medical device being configured to be sub- or transcutaneously placed by the inserter.

13. The inserter device according to claim 12, wherein the medical device is removably secured to the insertion needle.

14. The inserter device according to claim 11, wherein the medical device comprises an adhesive proximal surface for fastening of the medical device to the skin of the patient.

15. The inserter device according to claim 11, wherein the medical device includes a hard self-penetrating cannula.