Anchor device and method

• US 8,016,813 B2
• Filed: 09/03/2009
• 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:
  US12/553,555
• Publication Number:
  US 20090326470A1
• Time in Patent Office: 740 Days
• Field of Search: 604104-109, 604/174, 604/175, 604/177, 604/178, 604/506, 606/60, 606213-221, 606246-279
• US Class Current: 604/506
• 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. A method of anchoring a medical device to skin of a patient, the method comprising:

inserting at least a portion of an elongate body through a dermis layer so that a subcutaneous anchor mechanism flexibly adjusts from an outwardly extending orientation to a first bent orientation in which free ends of the subcutaneous anchor mechanism extend toward a proximal end of the elongate body, wherein the elongate body comprises a body wall that at least partially defines a lumen to slideably receive a catheter and the subcutaneous anchor mechanism is coupled to the elongate body at a location proximal from a distal tip of the elongate body; and

removing the elongate body from the dermis layer so that the subcutaneous anchor mechanism flexibly adjusts from a deployed orientation in a subcutaneous layer beneath the dermis layer to a second bent orientation in which the free ends of the subcutaneous anchor mechanism non-retractably extend toward the distal tip of the elongate body when the anchor mechanism exits through the dermis layer,

wherein removing the elongate body so that the subcutaneous anchor mechanism flexibly adjusts comprises receiving at least one of the free ends of the anchor mechanism in at least one reduced-diameter portion formed in the body wall that extends distally of said at least one of the free ends to accommodate said at least one of the free ends when said at least one of the free ends is flexed distally toward the body wall of the elongate body.

2. The method of claim 1, further comprising anchoring the elongate body to the subcutaneous layer so that the subcutaneous anchor mechanism flexibly adjusts from the first bent orientation to the deployed orientation.

3. The method of claim 1, wherein inserting the at least a portion of the elongate body so that the subcutaneous anchor mechanism flexibly adjusts comprises applying an insertion force to the elongate body that flexes the anchor mechanism against the dermis layer in a motion toward the first bent orientation.

4. The method of claim 1, wherein removing the elongate body so that the subcutaneous anchor mechanism flexibly adjusts comprises applying a removal force to the elongate body that flexes the anchor mechanism against the dermis layer in a generally sweeping motion toward the second bent orientation.

5. The method of claim 1, wherein inserting the at least a portion of the elongate body so that the subcutaneous anchor mechanism flexibly adjusts comprises receiving the free ends of the anchor mechanism in at least one reduced-diameter portion formed in the body wall of the elongate body.

6. The method of claim 1, wherein the anchor mechanism comprises a base integrally formed as a unitary structure with flexible barbs having the one or more free ends.

7. The method of claim 1, wherein the one or more free ends of the anchor mechanism are arranged on one or more non-retractable barbs that extend away from a body wall of the elongate body when deployed in the subcutaneous layer.

8. The method of claim 7, wherein at least a portion of the one or more non-retractable barbs comprises a metallic material exhibiting superelasticity below or at a normal human body temperature.

9. The method of claim 7, wherein at least a portion of the one or more non-retractable barbs comprises at least one polymer material selected from the group consisting of a PEEK material, a polyurethane material, a polyethylene material, a polyimide material.

10. The method of claim 1, further comprising slideably receiving the catheter in the lumen of the elongate body.

11. The method of claim 10, further comprising adhering the catheter within the elongate body after the catheter is slideably received.

12. The method of claim 1, further comprising advancing the elongate body through the dermis layer so that the free ends of the subcutaneous anchor mechanism flexibly adjust to the deployed orientation from the first bent orientation to anchor the subcutaneous anchor mechanism within the subcutaneous layer.

13. The method of claim 12, wherein convexly curved portions of the subcutaneous anchor mechanism abut an underside of the dermis layer when the free ends reside in the subcutaneous layer in the deployed orientation.

14. The method of claim 13, wherein inserting the elongate body comprises applying an insertion force to the elongate body in a direction toward the dermis layer to non-retractably flex the free ends of the subcutaneous anchor mechanism in a motion toward the first bent orientation.

15. The method of claim 14, wherein removing the elongate body comprises applying a removal force to the elongate body in a direction away from the dermis layer to non-retractably flex the free ends of the subcutaneous anchor mechanism in a generally sweeping motion toward the second bent orientation.

16. The method of claim 15, wherein removing the elongate body comprises receiving the free ends of the anchor mechanism in said at least one surface reduced-diameter portion formed in the body wall of the elongate body when the free ends are flexed into the second bent orientation.

17. The method of claim 16, further comprising:

slideably receiving the catheter in the lumen of the elongate body; and

retaining the catheter within the lumen of the elongate body with an adhesive portion of the elongate body.

18. A method of anchoring a medical device to skin of a patient, the method comprising:

inserting at least a portion of an elongate body through a dermis layer so that a subcutaneous anchor mechanism flexibly adjusts from an outwardly extending orientation to a first bent orientation in which free ends of the subcutaneous anchor mechanism extend toward a proximal end of the elongate body, wherein the elongate body comprises a body wall that at least partially defines a lumen to slideably receive a catheter and the subcutaneous anchor mechanism is coupled to the elongate body at a location proximal from a distal tip of the elongate body;

advancing the elongate body through the dermis layer so that the free ends of the subcutaneous anchor mechanism flexibly adjust to a deployed orientation from the first bent orientation to anchor the subcutaneous anchor mechanism within a subcutaneous layer, wherein a portion of the free ends of the subcutaneous anchor mechanism abut an underside of the dermis layer when the free ends are in the deployed orientation; and

removing the elongate body from the dermis layer so that the subcutaneous anchor mechanism flexibly adjusts from the deployed orientation in the subcutaneous layer beneath the dermis layer to a second bent orientation in which the free ends of the subcutaneous anchor mechanism non-retractably extend toward the distal tip of the elongate body when the anchor mechanism exits through the dermis layer, wherein removing the elongate body comprises receiving the free ends of the anchor mechanism in at least one surface reduced-diameter portion formed in the body wall of the elongate body when the free ends are flexed into the second bent orientation.

19. The method of claim 18, wherein inserting the elongate body comprises applying an insertion force to the elongate body in a direction toward the dermis layer to non-retractably flex the free ends of the subcutaneous anchor mechanism in a motion toward the first bent orientation.

20. The method of claim 19, wherein removing the elongate body comprises applying a removal force to the elongate body in a direction away from the dermis layer to non-retractably flex the free ends of the subcutaneous anchor mechanism in a generally sweeping motion toward the second bent orientation.

21. The method of claim 20, wherein removing the elongate body comprises receiving the free ends of the anchor mechanism in at least one surface reduced diameter portion formed in the body wall of the elongate body when the free ends are flexed into the second bent orientation.

22. The method of claim 21, further comprising:

slideably receiving the catheter in the lumen of the elongate body; and

retaining the catheter within the lumen of the elongate body with an adhesive portion of the elongate body.