Subcutaneous inserter device

• US 10,076,607 B2
• Filed: 03/30/2012
• Issued: 09/18/2018
• Est. Priority Date: 03/30/2011
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Gyrn, Steffen
• Primary Examiner(s): Patel, Shefali
• Application Number:
  US14/008,483
• Publication Number:
  US 20160243302A1
• Time in Patent Office: 2,363 Days
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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

The invention relates to an inserter device for subcutaneously inserting a medical device, the inserter device comprising an outer part comprising one or more locking elements including a first locking element and one or more release elements including a first release element; a housing; and a functional part accommodated in the housing; wherein the housing comprises a sidewall with an inner surface forming a cavity, the housing extending from a first end to a second end along a first axis and comprising one or more housing guide members including a first housing guide member for engagement with one or more guide members of the functional part, and where the housing is at least partly covered by the outer part;

wherein the functional part comprises a first part with a first body extending from a first end to a second end along the first axis, the first part comprising one or more first locking members; a second part releasably connected to the first part and comprising a second body extending from a first end to a second end along the first axis, the second part comprising a second guide member and one or more second locking members; an insertion needle attached to the second part; an insertion spring adapted for moving the first part from a first position to a second position in an insertion direction along the first axis in relation to the housing; and a retraction spring adapted for moving the second part from the second position to a third position in an extraction direction along the first axis in relation to the housing.

Claims

1. An inserter device for subcutaneously inserting a medical device, the inserter device comprising:

an outer part (300) comprising one or more locking elements including a first locking element (312) and one or more release elements including a first release element (308);

a housing (200); and

a functional part accommodated in the housing;

wherein the housing comprises a sidewall (203) with an inner surface forming a cavity, the housing extending from a first end to a second end along a first axis and comprising one or more housing guide members including a first housing guide member (206) for engagement with one or more guide members of the functional part, and where the housing is at least partly covered by the outer part;

wherein the functional part comprises;

a first part (400) with a first body extending from a first end to a second end along the first axis, the first part comprising one or more first locking members (410);

a second part (500) releasably connected to the first part and comprising a second body extending from a first end to a second end along the first axis, the second part comprising a second guide member (510) and one or more second locking members (508, 508′

);

an insertion needle (102) attached to the second part;

an insertion spring (402) adapted for moving the first part from a first position to a second position in an insertion direction along the first axis in relation to the housing; and

a retraction spring (502) adapted for moving the second part from the second position to a third position in an extraction direction along the first axis in relation to the housing;

wherein the first housing guide member and the second guide member are configured for rotating the second part about the first axis when the first part is moved from the first position to the second position, whereby the second part is moved from a locked position to an unlocked position relative to the first part.

2. The inserter device according to claim 1, wherein the first locking element is two protrusions positioned on an annular engaging device extending inwards.

3. The inserter device according to claim 2, wherein the first release element is two surfaces positioned on the annular engaging device.

4. The inserter device according to claim 2, wherein the one or more first locking members (410) are protrusions on an outer surface of the first part.

5. The inserter device according to claim 1, wherein the first housing guide member is a wall extending from the sidewall into the cavity of the housing.

6. The inserter device according to claim 1, wherein the second guide member (510) is an inclining sidewall extending outwardly from an outer surface of the second part.

7. The inserter device according to claim 1, wherein the one or more second locking members (508, 508′

) are protrusions extending outwardly from an outer surface of the second part.

8. The inserter device according to claim 1, wherein the outer part comprises an annular collar on an inside of the outer part, where the insertion spring at a first end encircles the annular collar.

9. The inserter device according to claim 1, wherein the insertion spring at a second end encircles an outer part of the first part.

10. The inserter device according to claim 1, wherein the first part comprises an annular recess on an inside of the first part for supporting the retraction spring at a first end.

11. The inserter device according to claim 1, wherein the retraction spring at a second end encircles an outer part of the second part.

12. The inserter device according to claim 1, wherein the medical device comprises a port site and a subcutaneous part for engaging inside an opening in the port site upon subcutaneous insertion of the medical device.

13. The inserter device according to claim 12, wherein the first part when in the second position exercises a pressure on the subcutaneous part thereby locking the subcutaneous part inside the opening of the port site.

14. The inserter device according to claim 13, wherein the first part when the second part is in the third position exercises a pressure on the subcutaneous part thereby preventing the subcutaneous part from departing from the port site upon extraction of the insertion needle.

15. The inserter device according to claim 12, wherein the first part when the second part is in the third position exercises a pressure on the subcutaneous part thereby preventing the subcutaneous part from departing from the port site upon extraction of the insertion needle.