Inserter for a Multiplicity of Subcutaneous Parts

• US 20130110047A1
• Filed: 10/23/2012
• Published: 05/02/2013
• Est. Priority Date: 10/27/2011
• Status: Active Grant

• Current Assignee: Unomedical AS (ConvaTec Group Plc)
• Original Assignee: Unomedical AS (ConvaTec Group Plc)
• Inventors: GYRN, Steffen
• Granted Patent: US 9,440,051 B2
• Time in Patent Office: Days
• US Class Current: 604/164.08
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61M 2005/004 Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• 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 holding device and an inserter are provided. The holding device includes a casing providing a cavity including walls, the was encompass a subcutaneous unit. The cavity includes a first side having an outlet opening, the outlet opening before use is covered with a penetrable or removable cover, and a second side comprising a layer having an outer surface and being penetrable, removable or flexible to transfer an impact from outside the layer to the subcutaneous unit. The casing includes a releasable attachment member corresponding to a member on the subcutaneous unit and a needle secured to the casing. An impact towards the outer surface of the layer pushes the subcutaneous unit at least partly out of the casing into a subcutaneous position, when the unit is in the subcutaneous position the releasable attachment member of the casing is released allowing detachment of the unit from the casing.

Claims

1. A holding device holding a subcutaneous unit under sterile conditions, the holding device comprising:

a casing providing a cavity comprising walls where the walls encompass a subcutaneous unit, the cavity having a first side comprising an outlet opening, the outlet opening before use is covered with a penetrable or removable cover, and a second side comprising a layer having an outer surface and being either penetrable or removable or flexible in order to transfer an impact from outside the layer to the held subcutaneous unit, the casing comprising a releasable attachment member corresponding to a member on the subcutaneous unit; and

a needle unreleasably secured to a part of the casing;

wherein an impact towards the outer surface of the layer of the second side pushes the subcutaneous unit at least partly out of the casing and into a subcutaneous position, when the subcutaneous unit is in the subcutaneous position the releasable attachment member of the casing is released allowing detachment of the subcutaneous unit from the casing.

2. The holding device according to claim 1, wherein the subcutaneous unit comprises a body part, the body part after detachment from the holding device is positioned above the patient'"'"'s skin surface and an extension part which after detachment from the holding device is positioned below the patient'"'"'s skin surface in a depth below the skin surface between about 1-15 mm.

3. The holding device according to claim 1, wherein the casing of the holding device comprises at least two cavities, each cavity encompassing one subcutaneous unit.

4. The holding device according to claim 1, wherein the holding device comprises attachment members attaching the holding device to and interacting with an inserter able to provide an impact toward the outer surface of the layer of the second side of the casing.

5. The holding device according to claim 1, wherein the casing comprises a spring unit providing retraction of the needle after insertion of the subcutaneous unit.

6. The holding device according to claim 5, wherein the spring unit either comprises:

an elastic unit attached close to or at the second side and to the distal end of the needle, such that the elastic unit pulls the needle into a retracted position when biased;

or

an elastic unit positioned between the distal end of the needle or of a proximal surface of a needle hub to which the needle is attached and the first side such that the elastic unit pushes the needle into a retracted position after detachment of the subcutaneous unit.

7. The holding device according to claim 1, wherein the subcutaneous unit comprises attachment members attaching the subcutaneous unit to an injection site at a point during insertion of the subcutaneous unit where the subcutaneous unit has reached a final subcutaneous position.

8. The holding device according to claim 7, wherein the injection site before insertion comprises at least a part of or the complete second side and the injection site is provided with members to permanently attach the injection site to the patient'"'"'s skin surface.

9. The holding device according to claim 7, wherein the attachment members are positioned on a proximal side of subcutaneous unit.

10. The holding device according to claim 1, wherein the casing comprises guiding parts corresponding to receiving or guiding parts of an infusion site, where joining of the corresponding guiding parts ensures correct positioning of the casing before insertion relative to the infusion site.

11. A system comprising a holding device according to claim 1 and an inserter comprising a plunger, the plunger upon activation penetrates or pushes away the layer of the second side and provides an impact to the subcutaneous unit.

12. The system according to claim 11, wherein the inserter comprises a lancet and an actuator for the lancet, the lancet upon actuation will be inserted between about 0.5-5.5 mm below a skin surface when pressed against the skin surface.

13. An inserter comprising a position and attachment member in which position a holding device holding a subcutaneous unit under sterile conditions can be attached with said attachment member,

the holding device comprising a casing comprising at least two cavities, each cavity comprising was where the walls encompass one subcutaneous unit, each cavity having a first side comprising an outlet opening, the outlet opening before use is covered with a penetrable or removable cover, and a second side comprising a layer having an outer surface and being either penetrable or removable or flexible in order to transfer an impact from outside the layer to the subcutaneous unit and a needle,

the inserter comprising at least two plungers corresponding to the cavities of the holding device or member for repositioning a single plunger relative to each cavity, each plunger upon activation penetrates or pushes away the layer of the second side and provides an impact to the subcutaneous unit where an impact by each plunger towards the outer surface of the layer of the second side pushes the subcutaneous unit at least partly out of the casing.

14. The inserter according to claim 13, wherein each subcutaneous unit comprises a body part which after detachment from the holding device is positioned above the patient'"'"'s skin surface and an extension part which after detachment from the holding device is positioned below the patients skin surface.

15. The inserter according to claim 13, wherein the holding device comprises an attachment member attaching the holding device to and interacting with the inserter able to provide an impact toward the outer surface of the layer of the second side of the casing.

16. The inserter according to claim 13, wherein the needle is part of the casing.

17. The inserter according to claim 13, wherein the casing comprises a spring unit providing retraction of the needle after insertion of the subcutaneous unit.

18. The inserter according to claim 17, wherein the spring unit either comprises

an elastic unit attached close to or at the second side and to the distal end of the needle such that the elastic unit pulls the needle into a retracted position when biased or

an elastic unit positioned between the distal end of the needle or a proximal surface of a needle hub to which the needle is attached and the first side such that the elastic unit pushes the needle into a retracted position after detachment of the subcutaneous unit.

19. The inserter according to claim 13, wherein each subcutaneous unit comprises an attachment member attaching the subcutaneous unit to an infusion site at a point during insertion of the subcutaneous unit.

20. The inserter according to claim 19, wherein the attachment member is positioned on the proximal side of the subcutaneous unit.

21. The inserter according to claim 13, wherein the casing comprises guiding parts corresponding to receiving or guiding parts of an infusion site, where joining of the corresponding guiding parts ensures correct positioning of the casing relative to the infusion site.

22. The inserter according to claim 21, wherein the inserter comprises a lancet and an actuator for the lancet, the lancet upon actuation will be inserted between about 0.5-5.5 mm below a skin surface when pressed against the skin surface.