Anchor device and method

• US 9,381,323 B2
• Filed: 06/02/2014
• Issued: 07/05/2016
• 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): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US14/293,125
• Publication Number:
  US 20140276438A1
• Time in Patent Office: 764 Days
• Field of Search: 604/174
• US Class Current: 1/1
• 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 for using a tubular catheter at a skin penetration point, comprising:

inserting a distal tip of a tubular catheter through a skin penetration point such that a proximal end portion of a tubular catheter resides external to the skin penetration point, the tubular catheter comprising;

a longitudinal axis, an inner lumen, and an outer tubular wall extending for a longitudinal length from the proximal end portion to the distal tip;

after the distal tip of the tubular catheter is inserted through the skin penetration point, securing a plurality of subcutaneous anchors of the tubular catheter in a subcutaneous layer along an underside of a skin layer proximate to the skin penetration point while the plurality of subcutaneous anchors are fixed to and extend outwardly from the outer tubular wall of the tubular catheter at a position that is located proximally from the distal tip of the tubular catheter and that is located distally of the proximal end portion of the tubular catheter, wherein the plurality of subcutaneous anchors are non-retractable and are positioned outwardly from the outer tubular wall of the tubular catheter during insertion of the plurality of subcutaneous anchors through the skin penetration point; and

withdrawing the tubular catheter and the plurality of subcutaneous anchors from the skin penetration point while the plurality of subcutaneous anchors are positioned outwardly from the outer tubular wall of the tubular catheter.

2. The method of claim 1, wherein the plurality of subcutaneous anchors flexibly adjust to an insertion orientation during insertion of the plurality of subcutaneous anchors through the skin penetration point, and wherein the plurality of subcutaneous anchors flexibly adjust to a removal orientation that is different from the insertion orientation during withdrawal of the plurality of subcutaneous anchors through the skin penetration point.

3. The method of claim 2, wherein the plurality of subcutaneous anchors comprise a bio-compatible polymer material that is configured to elastically flex during insertion of the plurality of subcutaneous anchors through the skin penetration point and configured to elastically flex or plastically deform during withdrawal of the plurality of subcutaneous anchors through the skin penetration point.

4. The method of claim 1, wherein the plurality of subcutaneous anchors are permanently coupled to the outer tubular wall of the tubular catheter at the position that is located proximally from the distal tip of the tubular catheter and that is located distally of the proximal end portion of the tubular catheter.

5. The method of claim 2, wherein the plurality of subcutaneous anchors are self-actuated to deploy in the subcutaneous layer without the need for a separate actuation device to extend or retract the subcutaneous anchors.

6. The method of claim 1, wherein each of the subcutaneous anchors extends outwardly in a convexly curved shape when the subcutaneous anchors are deployed in the subcutaneous layer along the underside of the skin layer.

7. The method of claim 1, wherein while the plurality of subcutaneous anchors secure the tubular catheter in the subcutaneous layer along the underside of the skin layer, the plurality of subcutaneous anchors provide a holding force of about 1 lb. to about 50 lbs.

8. The method of claim 7, wherein while the plurality of subcutaneous anchors secure the tubular catheter in the subcutaneous layer along the underside of the skin layer, the plurality of subcutaneous anchors provide a holding force of about 2 lbs. to about 3 lbs.

9. The method of claim 1, wherein the plurality of subcutaneous anchors comprise at least two anchor barbs that extend outwardly away from one another, the free end of each of the anchor barbs being biased to extend outwardly away from the outer wall of the tubular catheter.

10. The method of claim 9, wherein the anchor barbs are integrally formed with one another and with a tubular structure such that the subcutaneous anchor barbs are unitary with the tubular structure.

11. The method of claim 1, wherein said insertion of the plurality of subcutaneous anchors through the skin penetration point is provided by applying a pushing force to the proximal end portion of the tubular catheter so that the plurality of subcutaneous anchors along the tubular catheter advance through the skin penetration point.

12. The method of claim 11, wherein said withdrawing the plurality of subcutaneous anchors through the skin penetration point is provided by applying a pulling force to the proximal end portion of the tubular catheter so that the plurality of subcutaneous anchors along the tubular catheter are removed through the skin penetration point.

13. The method of claim 1, wherein at least two of the subcutaneous anchors are fixed to and extend outwardly from the outer tubular wall of the tubular catheter such that the two of the subcutaneous anchors are both spaced a same longitudinal distance from the distal tip of the tubular catheter.

14. The method of claim 1, wherein the plurality of subcutaneous anchors of the tubular catheter are secured in a subcutaneous layer along the underside of the skin layer adjacent to the skin penetration point after the distal tip of the tubular catheter is inserted through the skin penetration point and into a vasculature system.