Insertion device for an insertion set and method of using the same

• US 7,056,302 B2
• Filed: 02/26/2003
• Issued: 06/06/2006
• Est. Priority Date: 02/26/2002
• Status: Active Grant

• Current Assignee: Ypsomed AG (Ypsomed Holding AG)
• Original Assignee: Sterling Medivations, Inc. (Guided Therapeutics, Inc.)
• Inventors: Douglas, Joel S.
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US10/505,514
• Publication Number:
  US 20050131346A1
• Time in Patent Office: 1,196 Days
• Field of Search: 604/131, 604/136, 604/133, 604/137, 604/134, 604/138, 604/135, 604/200, 604/203, 604/204, 604/212, 604/244, 604/117
• US Class Current: 604/136
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

A system for inserting at least a portion of an insertion set through the surface of a tissue, having: an inserter with a moveable plunger disposed within a cavity therein; an insertion set holder received into the distal end of the cavity; and an insertion set received into the insertion set holder, wherein the insertion set is moveable within the insertion set holder such that when the plunger is advanced into contact with the insertion set, the insertion set advances through the insertion set holder to a position at which at least a portion of the insertion set extends out of the distal end of the cavity.

Claims

1. A transcutaneous infusion inserter for inserting at least a portion of an transcutaneous insertion set onto the surface of the tissue surface inserting an insertion needle through the surface of a tissue, comprising:

a housing having a cavity therein, wherein the distal end of the cavity is adapted to receive a removable holder for an insertion set therein, the holder being adapted for slidable motion of the insertion set therein; and

a moveable plunger disposed within the cavity for advancing the insertion set within the holder, wherein the plunger is moveable from a proximal position away from the insertion set to a distal position in contact with the insertion set, said insertion set being releasable and separable from said inserter once said plunger has applied the insertion set to the surface of the tissue.

2. The inserter of claim 1, wherein the holder is slideably removable from the distal end of the cavity.

3. The inserter of claim 1, wherein the distal end of the cavity is adapted to receive the holder in a fixed position thereat.

4. A system for applying an insertion set to the surface of a tissue and for inserting at least a portion of an insertion set through the surface of a tissue, comprising:

an inserter with a moveable plunger disposed within a cavity therein; and

an insertion set holder slideably and removeably received into the distal end of the cavity; and

an insertion set received into the insertion set holder, wherein the insertion set is moveable within the insertion set holder such that when the plunger is advanced into contact with the insertion set, the insertion set advances through the insertion set holder to a position at which at least a portion of the insertion set extends out of the distal end of the cavity, and wherein said insertion set is separable from said inserter after application from the tissue.

5. The device of claim 4, wherein the insertion set includes a contact surface for contacting the tissue and said surface includes means for adhering to the surface.

6. The system of claim 4, wherein the insertion set includes a contact surface for contacting the tissue and said surface includes an adherent for attaching to said surface and drawing said set out of said inserter.

7. The device of claim 4, wherein the insertion set is releaseably held at a fixed position in the distal end of the cavity.

8. The system of claim 4, wherein the insertion set is includes a holder which substantially surrounds said set and is sized to be slideably received within said inserter and wherein said infusion set is slideable within said holder, that when said plunger engages said infusion set, it is slide within said holder into contact with the tissue and then said holder is slideably removable from the inserter.

9. An insertion set for simultaneously contact and piercing living tissue, comprising:

a housing;

a piercing member extending from the housing; and

a holder, wherein the housing is slideably moveable within the holder from a first position at which a portion of the housing extends out of the holder and the piercing member does not extend out of the holder to a second position at which the piercing member extends out of the holder and wherein said housing is removable from said holder to allow said housing to remain in contact with said tissue after separation from said holder.

10. The system of claim 9, wherein the insertion set further comprises:

infusion tubing extending from the housing for infusing or extraction of tissue fluids.

11. The insertion set of claim 9, wherein the housing holds the insertion set such that the piercing member of the insertion set is at an angle of between 10 and 90 degrees to the skin.

12. An inserter system for inserting at least a portion of a combination insertion and sensor set capable of infusing fluid into tissue and sensing tissue fluids, onto the surface of the tissue surface by inserting at least one insertion needle through the surface of a tissue, comprising:

an inserter having a housing and a cavity therein, wherein the distal end of the cavity is adapted to receive an insertion and sensor set therein, the holder being adapted for slidable motion of the insertion set therein; and

a moveable plunger disposed within the cavity for advancing the insertion and sensor set, wherein the plunger is moveable from a proximal position away from the insertion and sensor set to a distal position in contact with the insertion and sensor set, said set being releasable and separable from said inserter once said plunger has applied the set to the surface of the tissue.

13. The system of claim 12 wherein said insertion and sensor set includes at least one piercing member associated for infusing of fluids and at least one piercing member associated with the sensor sensing of bodily fluids.

14. The system of claim 13 wherein said at least one piercing member of the set are space apart from each other, so that fluid infused is not immediately sensed by said piercing member associated with said sensor set.

15. The system of claim 12 wherein said insertion and sensor set comprises a substrate including a plurality of needles.

16. The system of claim 15 wherein said needles are micro-needles.

17. The system of claim 12 wherein said piercing members of a biodegradable material.

18. The system of claim 12 wherein said piercing members are constructed to soften after insertion into tissue.