Inserter for a multiplicity of subcutaneous parts

• US 9,440,051 B2
• Filed: 10/23/2012
• Issued: 09/13/2016
• Est. Priority Date: 10/27/2011
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Gyrn, Steffen
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US13/658,125
• Publication Number:
  US 20130110047A1
• Time in Patent Office: 1,421 Days
• Field of Search: 604/136, 604/173, 604/174, 604/164.01
• US Class Current: 1/1
• 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 subcutaneous units under sterile conditions, the holding device comprising:

a casing providing at least two closed cavities each comprising walls where the walls encompass a 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 penetrable in order to transfer an impact from outside the layer to the held subcutaneous unit, the casing comprising a needle upon which the subcutaneous unit is releasably attached and a spring unit providing retraction of the needle after insertion of the subcutaneous unit, the needle extending from a needle hub retained in each cavity;

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

2. The holding device according to claim 1, wherein the holding device comprises an attachment hub 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.

3. The holding device according to claim 1, wherein the spring unit comprises 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.

4. The holding device according to claim 1, wherein the subcutaneous unit is configured to be attached to an infusion site at a point during insertion of the subcutaneous unit where the subcutaneous unit has reached a final subcutaneous position, wherein the infusion site before insertion comprises at least a part of or the complete first side of the holding device and the infusion site is provided with a mounting pad to permanently attach the infusion site to the patient'"'"'s skin surface.

5. The holding device according to claim 4, wherein a proximal side of the subcutaneous unit is configured to be attached to the infusion site at a point during insertion of the subcutaneous unit where the subcutaneous unit has reached a final subcutaneous position.

6. The holding device according to claim 4, wherein the casing comprises guiding parts corresponding to receiving or guiding parts of the infusion site, where joining of the corresponding guiding parts ensures correct positioning of the casing before insertion relative to the infusion site.

7. 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 a longish 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.