Anchor instrumentation and methods

• US 10,046,142 B2
• Filed: 11/20/2014
• Issued: 08/14/2018
• Est. Priority Date: 06/15/2007
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Lee, Weng
• Application Number:
  US14/548,766
• Publication Number:
  US 20150080804A1
• Time in Patent Office: 1,363 Days
• Field of Search: None
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Some embodiments of a medical device anchor system includes an anchor sleeve and a catheter (or other medical instrument) to advance through a working channel of the anchor sleeve. The anchor sleeve may have a subcutaneous cuff device arranged along an outer surface. In such circumstances, the embedded cuff device can inhibit the migration of infection from outside the skin and into the blood stream.

Claims

1. A catheter anchor device for securing a position of a catheter relative to a percutaneous opening in a skin layer occupied by the catheter, comprising:

a proximal end, a distal end, and a length extending therebetween;

a catheter engagement body configured to releasably secure with a catheter when the catheter is inserted into a percutaneous opening in a skin layer and extends distally away from the distal end;

a subcutaneous anchor mechanism coupled to the catheter engagement body, the subcutaneous anchor mechanism having first and second flexible anchors that are adjustable to a deployed position in which the first and second flexible anchors are configured to abut an underside of the skin layer in a subcutaneous region; and

a subcutaneous cuff device coupled to the catheter engagement body, the subcutaneous cuff device comprising a biocompatible material to receive ingrowth of bodily tissue when disposed in the subcutaneous region, wherein the subcutaneous cuff device is positioned closer to the distal end of the catheter anchor device than to the proximal end of the catheter anchor device, and wherein when the catheter is moved through the percutaneous opening in the skin layer, a cuff-to-tip distance between the subcutaneous cuff device and a distal tip of the catheter is manually selectable; and

an actuator adjustable relative to the subcutaneous cuff device between a first position and a second position to simultaneously shift i) the catheter engagement body to secure the catheter in a fixed position relative to the subcutaneous cuff and ii) the flexible anchors to the deployed configuration.

2. The device of claim 1, wherein the subcutaneous cuff device is coupled to the catheter engagement body at a position such that the subcutaneous cuff device is configured to reside in the subcutaneous region along the underside of the skin layer while at least a proximal portion of the catheter engagement body resides external to the skin layer.

3. The device of claim 1, wherein the first and second flexible anchors are adjustable from a non-deployed orientation to a deployed orientation in the subcutaneous region along the underside of the skin layer.

4. The device of claim 1, wherein the catheter engagement body comprises a sleeve body.

5. The device of claim 4, wherein the sleeve body comprises a lumen configured to receive the catheter.

6. The device of claim 1, wherein at least a portion of the catheter engagement body is configured to adjust from a first position to a second position so as to simultaneously shift the flexible anchors to the second position and a gripper portion of the catheter engagement body to compress the outer surface of the catheter.

7. The device of claim 1, wherein the subcutaneous cuff device inhibits migration of infection when the cuff device is embedded in the subcutaneous region along the underside of the skin layer.

8. The device of claim 7, wherein the subcutaneous cuff device is configured to receive the ingrowth of bodily tissue over a period of time so as to inhibit the migration of infection from outside the skin and into the blood stream.

9. The device of claim 1, wherein the catheter engagement body includes a gripper portion that is adjustable to frictionally engage at least a portion of an outer circumferential surface of the catheter.

10. The device of claim 9, wherein the catheter engagement body is configured to releasably secure to the catheter by shifting the gripper portion to releasably compress against said portion of the outer circumferential surface of the catheter after each of the catheter and the flexible anchors is inserted through the percutaneous opening in the skin layer.

11. A catheter anchor device for securing a position of a catheter relative to a percutaneous opening in a skin layer occupied by the catheter, comprising:

a subcutaneous cuff device;

means for subcutaneously anchoring the catheter anchor device at a percutaneous opening in a skin layer so that the subcutaneous anchor means and the subcutaneous cuff device of the catheter anchor device are disposed in a subcutaneous region along an underside of the skin layer;

means for receiving a catheter such that a distal tip of the catheter is movable relative to the subcutaneous cuff device to provide a distal length of the catheter extending distally from a distal end of the catheter anchor device that is greater than a maximum length of the catheter anchor, wherein the distance from the subcutaneous cuff device to the distal catheter tip defines a cuff-to-tip distance that is adjustable when the subcutaneous cuff device is disposed in the subcutaneous region along the underside of the skin layer; and

means for simultaneously i) releasably securing the catheter to the catheter anchor device after the adjustment of the cuff-to-tip distance and ii) shifting the means for subcutaneously anchoring the catheter anchor device to a deployed configuration.

12. The device of claim 11, wherein the distal end of the catheter anchor device is configured to reside external to a venous entry point of a blood vessel that is occupied by the catheter after the distal tip of the catheter is advanced to the targeted body site.

13. The device of claim 11, wherein the subcutaneous cuff device comprises a biocompatible material that is configure to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer.

14. The device of claim 11, wherein the means for subcutaneously anchoring comprises one or more flexible anchors configured to deploy in the subcutaneous region.

15. The device of claim 14, wherein the one or more flexible anchors are adjustable from a non-deployed orientation to a deployed orientation in the subcutaneous region along the underside of the skin layer.

16. The device of claim 11, wherein the means for receiving the catheter comprises at least a lumen of a sleeve body.

17. The device of claim 16, wherein the subcutaneous cuff device is positioned closer to the distal end of the sleeve body than to the proximal end of the sleeve body.

18. The device of claim 11, wherein the subcutaneous cuff device is configured to inhibit migration of infection when the cuff device is embedded in the subcutaneous region along the underside of the skin layer.

19. The device of claim 18, wherein the subcutaneous cuff device is configured to receive the ingrowth of bodily tissue over a period of time so as to inhibit the migration of infection from outside the skin and into the blood stream.