Anchor device and method

• US 10,293,140 B2
• Filed: 06/02/2016
• Issued: 05/21/2019
• 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): Hall, Deanna K
• Application Number:
  US15/171,540
• Publication Number:
  US 20160279389A1
• Time in Patent Office: 1,083 Days
• 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 system for anchoring a medical device to skin of a patient, comprising:

a tubular catheter configured to advance through a skin penetration point, the tubular catheter comprising a proximal end portion configured to reside external to the skin penetration point, a longitudinal axis, an inner lumen, and an outer tubular wall extending for a longitudinal length from the proximal end portion to a distal tip; and

a plurality of subcutaneous anchors fixed to and extending 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, the plurality of anchors being non-retractable and positioned outwardly from the outer tubular wall of the tubular catheter during insertion of the plurality of subcutaneous anchors through the skin penetration point, each of the plurality of anchors including a free end;

wherein the anchors are positionable between an insertion orientation when the tubular catheter is inserted into a subcutaneous layer and a removal orientation when the tubular catheter is withdrawn from the subcutaneous layer that is different from an insertion orientation, and wherein in the insertion orientation the plurality of subcutaneous anchors are positioned outwardly from the outer tubular wall of the tubular catheter and the free ends of the anchors extend towards a proximal direction, and in the removal orientation the plurality of subcutaneous anchors are positioned outwardly from the outer tubular wall of the tubular catheter and the free ends of the anchors extend towards a distal direction.

2. The system of claim 1, wherein the plurality of subcutaneous anchors are flexibly adjustable between the insertion orientation and the removal orientation.

3. The system 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 system 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 system 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.

6. The system of claim 1, 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.

7. The system of claim 6, wherein the subcutaneous anchors are configured to be inserted through the skin penetration point by a pushing force to the proximal end portion of the tubular catheter such that the plurality of subcutaneous anchors advance through the skin penetration point.

8. The system of claim 7, wherein the subcutaneous anchors are configured to be withdrawn through the skin penetration point by a pulling force to the proximal end portion of the tubular catheter such that the plurality of subcutaneous anchors are removed through the skin penetration point.

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

10. A system for anchoring a medical device to skin of a patient, comprising:

a tubular catheter configured to advance through a skin penetration point, the tubular catheter comprising a proximal end portion configured to reside external to the skin penetration point, a longitudinal axis, an inner lumen, and an outer tubular wall extending for a longitudinal length from the proximal end portion to a distal tip; and

a plurality of subcutaneous anchors fixed to and extending 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, the plurality of anchors being non-retractable and positioned outwardly from the outer tubular wall of the tubular catheter during insertion of the plurality of subcutaneous anchors through the skin penetration point;

wherein the anchors are positionable between an insertion orientation when the tubular catheter is inserted into a subcutaneous layer and a removal orientation when the tubular catheter is withdrawn from the subcutaneous layer that is different from an insertion orientation, and wherein in the insertion orientation and in the removal orientation the plurality of subcutaneous anchors are positioned outwardly from the outer tubular wall of the tubular catheter;

wherein each of the subcutaneous anchors extend outwardly in a convexly curved shape when the subcutaneous anchors are deployed in the subcutaneous layer along an underside of the skin layer; and

wherein each of the plurality of anchors include a free end, and wherein in the insertion orientation the free ends of the anchors extend towards a proximal direction, and in the removal orientation the free ends of the anchors extend towards a distal direction.

11. The system of claim 10, 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.

12. The system of claim 11, wherein in the removal orientation the plurality of subcutaneous anchors are positioned outwardly from the outer tubular wall of the tubular catheter.

13. The system of claim 12, wherein the subcutaneous anchors are configured to be inserted through the skin penetration point by a pushing force to the proximal end portion of the tubular catheter such that the plurality of subcutaneous anchors advance through the skin penetration point.

14. The system of claim 13, wherein the subcutaneous anchors are configured to be withdrawn through the skin penetration point by a pulling force to the proximal end portion of the tubular catheter such that the plurality of subcutaneous anchors are removed through the skin penetration point.

15. The system of claim 14, wherein the plurality of subcutaneous anchors are configured to provide a holding force of about 2 lbs. to about 3 lbs. when the plurality of subcutaneous anchors secure the tubular catheter in the subcutaneous layer.

16. A system for anchoring a medical device to skin of a patient, comprising:

a tubular catheter configured to advance through a skin penetration point, the tubular catheter comprising a proximal end portion configured to reside external to the skin penetration point, a longitudinal axis, an inner lumen, and an outer tubular wall extending for a longitudinal length from the proximal end portion to a distal tip; and

a plurality of subcutaneous anchors fixed to and extending 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, the plurality of anchors being non-retractable and positioned outwardly from the outer tubular wall of the tubular catheter during insertion of the plurality of subcutaneous anchors through the skin penetration point;

wherein the anchors are positionable between an insertion orientation when the tubular catheter is inserted into a subcutaneous layer and a removal orientation when the tubular catheter is withdrawn from the subcutaneous layer that is different from an insertion orientation, and wherein in the insertion orientation and in the removal orientation the plurality of subcutaneous anchors are positioned outwardly from the outer tubular wall of the tubular catheter;

wherein the plurality of subcutaneous anchors are configured to provide a holding force of about 2 lbs. to about 3 lbs. when the plurality of subcutaneous anchors secure the tubular catheter in the subcutaneous layer; and

wherein each of the plurality of anchors include a free end, and wherein in the insertion orientation the free ends of the anchors extend towards a proximal direction, and in the removal orientation the free ends of the anchors extend towards a distal direction.