MANUAL PRESSURE ACTIVATED APPLICATION MECHANISM

• US 20150105691A1
• Filed: 04/08/2013
• Published: 04/16/2015
• Est. Priority Date: 04/11/2012
• Status: Active Grant

• Current Assignee: PharmaSens AG
• Original Assignee: PharmaSens AG
• Inventors: Hadvary, Paul, Tschirky, Hansjrg
• Granted Patent: US 10,080,582 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• 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

A skin insertion mechanism of a needle fixedly positioned in a needle holder with connective means to an injection or analysis system has a skin attachment plate coated with an adhesive layer and a spacer mechanism keeping in the ready-to-use position the skin attachment plate spaced away from the needle support covering the needle. Subcutaneous insertion of the needle is effected by attachment with the adhesive layer to the skin and releasing the spacer mechanism by applying a pre-set trigger point pressure against the skin.

Claims

1. A skin insertion mechanism of a needle fixedly positioned in a needle holder and having connecting means to an injection or analysis system, which comprises:

a) a skin attachment plate coated with an adhesive layer for attachment to the skin and having a hole allowing the passage of the needle;

b) a spacer mechanism connected to the needle holder and, via movable withholding means, to the skin attachment plate, positioning the needle holder and the skin attachment plate in parallel planes and guiding their axial movement relative to each-other, being configured such that in the ready-to-use position the skin attachment plate is fixedly spaced away from the needle holder and covers the tip of the needle; and

c) a release element movably linked to the spacer mechanism and releasing the withholding means from the ready-to-use position, characterized by requiring a pre-set trigger point pressure against the skin attachment plate for releasing the withholding means and allowing an axial movement of the needle holder towards the skin attachment plate with sufficient velocity for piercing the skin by the needle tip and inserting the needle into the skin.

2. The skin insertion mechanism according to claim 1, further comprising means for firmly attaching the outer rim of the adhesive layer to the skin;

3. The skin insertion mechanism according to claim 2, wherein the means for firmly attaching the outer rim of the adhesive layer to the skin is a functional package with a rim pressing the adhesive layer towards the skin and protecting the release element against unintended activation.

4. The skin insertion mechanism according to claim 2, wherein the means for firmly attaching the outer rim of the adhesive layer to the skin is the bottom of the skin attachment plate to which the adhesive surface for attachment to the skin is fixed by a reduced surface in comparison to the adhesive surface attached to the skin.

5. The skin insertion mechanism according to claim 1, further comprising means for coupling skin attachment plate with needle holder and decoupling from spacer mechanism and release element, characterized by performing these functions automatically upon stacking-up of needle holder and skin attachment plate and allowing removal of spacer mechanism together with release element.

6. The skin insertion mechanism according to claim 5, wherein the means for coupling skin attachment plate with needle holder and decoupling from spacer mechanism and release element are hook-type elements actuated by the axial movement of the needle holder towards the skin attachment plate.

7. The skin insertion mechanism according to claim 1, wherein the needle is a cannula for subcutaneous delivery of injection fluid.

8. The skin insertion mechanism according to claim 1, characterized in that wherein the needle is a plastic tube with a removable inner mandrin for insertion into the skin, the mandarin being removed together with the spacer mechanism and release element.

9. The skin insertion mechanism according to claim 1, wherein the needle holder with the fixedly positioned needle and the connecting means to an injection system are separated in the ready-to-use position and get functionally connected only following needle insertion into the skin by consecutive stacking-up, first of skin attachment plate with needle holder, followed by stacking-up of the needle holder with the connecting means.

10. The skin insertion mechanism according to claim 9, further comprising means for coupling needle holder, connecting means to an injection system, and release element together, characterized by performing these functions automatically upon stacking-up of skin attachment plate, needle holder and connecting means with the release element and allowing removal from the skin by pulling away from the skin as a unit, with the skin attachment plate being pulled by the adhesive layer attached to the skin and becoming fixed in the pulled-out position as needle protection.

11. The skin insertion mechanism according to claim 1, wherein the needle is a diagnostic probe.

12. The skin insertion mechanism according to claim 1, wherein the needle is a removable guide needle for insertion of a flexible cannula or diagnostic probe into the skin, the guide needle being removed together with the spacer mechanism and release element.

13. A method for injection of a fluid into the skin or determining analyte concentrations in the subcutaneous tissue by a) attaching a needle insertion mechanism according to claim 1 to the prepared skin of a subject, b) pressing the skin insertion mechanism against the skin by pressing on the release element with the pre-set trigger-point pressure, c) removing the spacer mechanism together with the release element, and d) connecting the needle to an injection or analysis system.

14. A method for injection of a fluid into the skin by a) attaching a skin insertion mechanism according to claim 1 to the prepared skin of a subject, b) pressing the skin insertion mechanism against the skin by pressing on the release element with the preset trigger-point pressure, c) introducing the fluid into the skin with a syringe-type fluid delivery system, and d) removing the skin insertion mechanism by pulling away from the attached skin.