Anchor device and method

• US 8,016,794 B2
• Filed: 03/09/2006
• Issued: 09/13/2011
• Est. Priority Date: 03/09/2006
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Claude, Timothy J.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Price; Nathan R
• Application Number:
  US11/372,283
• Publication Number:
  US 20070225651A1
• Time in Patent Office: 2,014 Days
• Field of Search: 604104-109, 604174-175, 604177-178, 606/60, 606213-221, 606246-279
• US Class Current: 604/175
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Some embodiments of an anchor device may include bendable anchor mechanism that is deployable in a subcutaneous layer to releasably secure the anchor device to a patient'"'"'s body. Certain embodiments of the anchor mechanism may include one or more barbs that flexibly bend in response to an insertion or removal force. As such, the anchor mechanism may be inserted into a subcutaneous layer, and removed from the subcutaneous layer, without the need for a separate actuation device to extend or retract the barbs.

Claims

1. An anchor device, comprising:

an elongate body having a body wall that at least partially defines a lumen extending to a distal tip to slideably receive a catheter therein; and

a subcutaneous anchor mechanism coupled to the elongate body at a location proximal from the distal tip of the elongate body, the subcutaneous anchor mechanism having a plurality of non-retractable barbs that extend away from the body wall to abut a dermis layer when in a deployed orientation in a subcutaneous layer, each of the non-retractable barbs having a free end that is biased to extend outwardly away from the body wall, wherein the plurality of non-retractable barbs are integrally formed with one another as a unitary structure,

wherein the non-retractable barbs are flexibly bendable to a removal orientation that is different from an insertion orientation when the anchor mechanism is withdrawn from the subcutaneous layer and out through the dermis layer, and

wherein the body wall defines a reduced-diameter portion that extends distally of at least one barb to receive the free end of said at least one barb when said at least one barb is flexed distally toward the body wall so as to maintain an outer dimension of the body wall during withdrawal through the dermis layer.

2. The anchor device of claim 1, wherein the non-retractable barbs extend from the body wall in an arcuate manner when in the deployed orientation.

3. The anchor device of claim 2, wherein at least a portion of the non-retractable barbs extend proximally away from the body wall in an arcuate manner when in the deployed orientation.

4. The anchor device of claim 2, wherein each of the non-retractable barbs has a free end that is biased to extend outwardly away from the body wall.

5. The anchor device of claim 1, wherein at least a portion of each non-retractable barb comprises nitinol, the nitinol being processed to exhibit superelasticity at about 37°

C.

6. The anchor device of claim 1, wherein the elongate body is a catheter body and the body wall is a catheter wall.

7. The anchor device of claim 1, wherein the elongate body is a sleeve body and the body wall is a sleeve wall to slidably receive a catheter or medical instrument.

8. The anchor device of claim 1, wherein at least a portion of the anchor mechanism extends into the body wall to secure the anchor mechanism to the elongate body.

9. The anchor device of claim 1, wherein the reduced-diameter portion is at least partially defined by a shoulder formed in an exterior of the body.

10. The anchor device of claim 1, wherein at least a portion of the anchor mechanism comprises at least one polymer material selected from the group consisting of a PEEK material, a polyurethane material, a polyethylene material, a polyimide material.

11. The anchor device of claim 1, wherein the plurality of non-retractable barbs extend away from the body wall with a curvature so that tips of the barbs extend away from contact with an underside of the dermis layer.

12. A subcutaneous anchor mechanism, comprising:

a base attachable to a medical device; and

at least one non-retractable barb coupled to the base at a location proximal from a distal tip of the base, the non-retractable barb having a free end that is biased to extend outwardly from the base such that, when the base is attached to the medical device, the non-retractable barb extends away from the medical device to abut a dermis layer when in a deployed orientation in a subcutaneous layer,

wherein the non-retractable barb is flexibly bendable toward the base to a removal orientation such that the free end extends distally and is adjacent to the base when the non-retractable barb is withdrawn from the subcutaneous layer and out through the dermis layer, and

wherein the base defines a reduced-diameter portion that extends distally of at the non-retractable barb to receive the free end of the non-retractable barb when the non-retractable barb is flexed distally toward the base so as to maintain an outer dimension of the base during withdrawal through the dermis layer.

13. The subcutaneous anchor mechanism of claim 12, wherein at least a portion of the non-retractable barb extends away from the base in an arcuate manner when in the deployed orientation.

14. The subcutaneous anchor mechanism of claim 13, wherein the at least one non-retractable barb comprises a pair of opposing non-retractable barbs, each of the pair of barbs has a free end that is biased to extend away from the base.

15. The subcutaneous anchor mechanism of claim 12, wherein at least a portion of the non-retractable barb comprises nitinol, the nitinol exhibiting superelasticity below or at a normal human body temperature.

16. The subcutaneous anchor mechanism of claim 12, wherein at least a portion of the non-retractable barb comprises at least one polymer material selected from the group consisting of a PEEK material, a polyurethane material, a polyimide material.

17. The subcutaneous anchor mechanism of claim 12, wherein the reduced-diameter portion is at least partially defined by a shoulder formed in an exterior of the base.

18. The subcutaneous anchor mechanism of claim 12, wherein when in the deployed orientation, the non-retractable barb extends away from the medical device with a curvature so that a tip of the barb extends away from contact with an underside of the dermis layer.

19. The subcutaneous anchor mechanism of claim 12, wherein the barb is integrally formed with the base as a unitary structure.