Subcutaneous needle insertion mechanism

• US 10,076,356 B2
• Filed: 04/08/2013
• Issued: 09/18/2018
• Est. Priority Date: 04/11/2012
• Status: Active Grant

• Current Assignee: PharmaSens AG
• Original Assignee: PharmaSens AG
• Inventors: Hadvary, Paul, Tschirky, Hansjorg
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/391,402
• Publication Number:
  US 20150141776A1
• Time in Patent Office: 1,989 Days
• 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 2017/00951 adhesive
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• 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 subcutaneous access device has a skin attachment plate coated with an adhesive layer. The skin attachment plate is moveably linked by a retraction mechanism to a needle support with fixedly positioned needles. In the ready-to-use position the skin attachment plate is spaced away from the needle support and covers the fixedly positioned needles. Subcutaneous insertion of the needles is effected by attachment of the skin attachment plate with the adhesive layer to the skin and releasing the retraction mechanism, thus triggering the pulling of the attached skin with high velocity against the tip of the needles.

Claims

1. A device for subcutaneous access adapted to insert a needle into an individual'"'"'s skin by effecting a relative movement between a surface of the skin and the needle, the device comprising:

a device body, including a needle support, and the needle is fixedly held by the needle support in the device body;

a skin attachment plate, including an adhesive surface adapted for attachment to the skin, the skin attachment plate being placed between the device body and the skin, and the device body and the skin attachment plate being movable relative to one another by linear guideways, with one end of the linear guideways being fixedly connected to the skin attachment plate and another end of the linear guideways being movably connected to the device body; and

the linear guideways, the linear guideways including inner tubes connected to the skin attachment plate, the inner tubes being telescopically slidable in outer tubes that are connected to the device body, and the linear guideways being provided with retraction mechanisms, the retraction mechanisms being spring-type mechanisms arranged between the skin attachment plate and the movable end of the linear guideways and configured such that in a ready-to-use position, with the skin attachment plate spaced from the device body, the spring-type mechanisms are held pre-stressed by a withholding mechanism and, actuated by a release element, shoot into a relaxed state so that the device body with the fixedly held needle and the skin attachment plate move towards one another.

2. The subcutaneous access device according to claim 1, wherein in the ready-to-use position the skin attachment plate is pushed away from the needle support and shields a tip of the needle, and upon actuation of the retraction mechanism, effects subcutaneous insertion of the needle by the tip of the fixedly held needle and the skin, which is attached by the adhesive surface, moving towards one another.

3. The subcutaneous access device according to claim 1, wherein the release element comprises a sliding bolt mechanism actuated by pressing a handle or knob.

4. The subcutaneous access device according to claim 1, wherein the skin attachment plate is attached to the needle support by a sliding mechanism, keeping the skin attachment plate and the needle support parallel in the ready-to-use position and throughout movement relative to each-other.

5. The subcutaneous access device according to claim 1, wherein the skin attachment plate is attached to the needle support by an axially sliding mechanism.

6. The subcutaneous access device according to claim 1, wherein the skin attachment plate is attached to the needle support by a linearly sliding mechanism at an angle different from axial.

7. The subcutaneous access device according to claim 1, wherein the skin attachment plate is fixed at one locus of its periphery to the needle support by a hinge-type mechanism, an opposite part of the periphery being pushed away from the needle support against pull-back of a spring-type mechanism thereby shielding a tip of the fixedly held needle.

8. The subcutaneous access device according to claim 1, wherein multiple needles are held in the needle support for simultaneous insertion into the skin.

9. The subcutaneous access device according to claim 1, wherein the skin attachment plate includes a rigid layer and a flexible layer coated with the adhesive surface.

10. The subcutaneous access device according to claim 9, wherein the retraction mechanism is configured such that in the ready-to-use position, both the rigid and the flexible layers of the skin attachment plate are pushed away from the needle support and together shield a tip of the needle, and upon actuation of the retraction mechanism, the rigid and the flexible layers of the skin attachment plate shoot consecutively towards the needle support.

11. The subcutaneous access device according to claim 1, wherein the adhesive surface adapted for attachment to the skin is fixed on the skin attachment plate by a reduced surface in comparison to the adhesive surface attached to the skin.

12. The subcutaneous access device according to claim 1, wherein the retraction mechanisms are partially removable after skin insertion of the needle.

13. The subcutaneous access device according to claim 1, further comprising a single pump and a mechanism to consecutively open and close multiple needles, wherein for subcutaneous delivery of an injection fluid into a patient, the multiple needles are connected to the single pump for sequential actuation and the mechanism to consecutively open and close the needles.

14. The subcutaneous access device according to claim 1, further comprising a sensor to determine subcutaneous analyte levels.

15. The subcutaneous access device according to claim 14, wherein the sensor to determine subcutaneous analyte levels includes analyte determining systems comprising needles formed as diagnostic probes to contact the subcutaneous tissue.

16. The subcutaneous access device according to claim 15, wherein the sensor to determine subcutaneous analyte levels includes a calibration system to periodically calibrate the analyte determining systems.

17. The subcutaneous access device according to claim 16, wherein the calibration system comprises a delivery system with a cannula inserted into the skin together with the diagnostic probes to deliver calibration fluid to a vicinity of an active surface of the diagnostic probes in situ.

18. The subcutaneous access device according to claim 1, further comprising at least one delivery system for different functions that comprises circular syringe pumps.

19. The subcutaneous access device according to claim 1, wherein an insertion mechanism actuates piercing of a protecting septum covering a tip of the needle before insertion into the skin.

20. The subcutaneous access device according to claim 1, wherein the device is comprised in a functional package including a rim to press an outer rim of the adhesive layer towards the skin and protecting the release and actuation elements of the device against unintended activation.