Inserter for transcutaneous sensor

• US 8,439,838 B2
• Filed: 06/07/2007
• Issued: 05/14/2013
• Est. Priority Date: 06/07/2006
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Mogensen, Lasse W., Gransson, Magnus W.
• Primary Examiner(s): Krass, Frederick
• Assistant Examiner(s): Parad, Dennis J
• Application Number:
  US12/303,494
• Publication Number:
  US 20100022863A1
• Time in Patent Office: 2,168 Days
• Field of Search: None
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15061 by material engagement, e.g. welding, bonding
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• 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 for a transcutaneous sensor comprising a sensor part e.g. for registration of the bloods content of glucose. The inserter comprises a needle unit comprising a needle hub and a carrier body, and a sensor housing. The sensor housing and the needle hub are releasably connected and when they are connected, the insertion needle is placed along the sensor e.g. surrounding the sensor wholly or partly. The carrier body guides the movement relative to the housing between a retracted and an advanced position. When released the needle unit and the sensor housing are forced by a spring unit to an advanced position where the needle and sensor are placed subcutaneously. The object of the invention is to provide a disposable inserter for a transcutaneous sensor which inserter is easy and safe for the user to handle during use and to dispose of after use.

Claims

1. An inserter for a transcutaneous sensor comprising:

a housing, the housing comprising housing guiding members on an internal surface of the housing;

a carrier body, the carrier body comprising carrier body guiding members on an external surface of the carrier body, wherein the carrier body guiding members and the housing guiding members guide movement of the carrier body relative to the housing between a retracted and an advanced position;

a needle hub comprising an insertion needle for piercing of the skin and an unreleasable locking member for interacting with a corresponding locking member on the carrier body;

a sensor housing comprising a sensor part configured for subcutaneous placement, the sensor housing and the needle hub being releasably connected to each other, wherein the insertion needle is adjoined to the sensor part when the sensor housing and the needle hub are connected, wherein the insertion needle has a proximal and distal end along a longitudinal axis, wherein the sensor part has a proximal and distal end along the longitudinal axis therebetween, and wherein the needle at least partly surrounds the sensor part along the longitudinal axis; and

a spring unit connected to a release member, the release member being activatable so that the spring unit moves the sensor housing, the needle hub and the carrier body to an advanced position for subcutaneous placement of the needle and sensor part.

2. The inserter according to claim 1, wherein the needle hub and the carrier body are created as a single unit.

3. The inserter according to claim 1, wherein the needle hub comprises openings and the carrier body is provided with projections corresponding to the openings in the needle hub.

4. The inserter according to claim 1, wherein a needle unit comprising the needle hub and the carrier body after insertion can be placed in a retracted position.

5. The inserter according to claim 1, wherein a lower base of the housing is formed with a projecting part.

6. The inserter according to claim 5, wherein the projecting part forms an angle with the longitudinal direction of the insertion needle.

7. The inserter according to claim 1, wherein the inserter further comprises a stopper.

8. The inserter according to claim 7, wherein the stopper comprises at least one end of a track for a flange.

9. The inserter as claimed in claim 1, wherein the housing forms at least a part of the delivery packing for the inserter.

10. The inserter as claimed in claim 1, wherein the housing is provided with a substantially rigid cover.

11. The inserter as claimed in claim 1, wherein the spring unit is fastened to the housing in a first position and to the carrier body or the needle hub in a second position, and the first position is situated closer to a front end of the housing than the second position when the spring unit is unbiased.

12. The inserter as claimed in claim 1, wherein the spring unit is an elastic O-ring.

13. The inserter as claimed in claim 1, wherein the spring unit is fastened to the housing in a first position and fixed to the carrier body or the needle hub in a second position, and the first position is situated closer to a back end of the housing than the second position when the spring unit is unbiased.

14. The inserter as claimed in claim 1, wherein the spring unit is a flat spring placed between a back end of the housing and a needle unit.

15. The inserter as claimed in claim 14, wherein the spring unit comprises two convex curves placed on each side of the needle unit, and that each curve is fixed to the needle unit at one end and to the housing behind the fixation to the needle unit at another end in the unbiased state.

18. A method of inserting a sensor for detecting glucose in the blood of a patient, the method comprising:

providing an inserter of claim 1;

releasing the release member to activate the spring unit;

inserting the sensor part into the skin of the patient; and

removing the inserter from the sensor part while maintaining subcutaneous placement of the sensor part.

16. An inserter for a transcutaneous sensor comprising:

a set housing, the housing comprising housing guiding members on an internal surface of the housing;

a carrier body, the carrier body comprising carrier body guiding members on an external surface of the carrier body, wherein the carrier body guiding members and the housing guiding members guide movement of the carrier body relative to the housing between a retracted and an advanced position;

a needle hub comprising an insertion needle for piercing of the skin and an unreleasable locking member for interacting with a corresponding locking member on the carrier body;

a sensor housing comprising a sensor part configured for subcutaneous placement, the sensor housing and the needle hub being releasably connected to each other, wherein the insertion needle is adjoined to the sensor part when the sensor housing and the needle hub are connected, wherein the insertion needle has a proximal and distal end along a longitudinal axis, wherein the sensor part has a proximal and distal end along the longitudinal axis therebetween, and wherein the needle at least partly surrounds the sensor part along the longitudinal axis; and

a spring unit connected to a release member, the release member being activatable so that the spring unit moves the sensor housing, the needle hub and the carrier body to an advanced position for subcutaneous placement of the needle and sensor part;

and a lower base of the housing comprising a projecting part, the projecting part forming an angle with a longitudinal direction of the insertion needle indicating a correct insertion angle for the user during insertion.

17. The inserter as claimed in claim 16 wherein a part of the projecting part is positioned above the line along which the insertion needle can move and a part of the projecting part is positioned beyond said line.