Anchor instrumentation and methods

• US 8,920,380 B2
• Filed: 02/27/2012
• Issued: 12/30/2014
• 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): Lucchesi, Nicholas
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US13/405,501
• Publication Number:
  US 20120157926A1
• Time in Patent Office: 1,037 Days
• Field of Search: 604/177, 604/178, 604/174, 604/175, 604/192, 604/164.01, 604/176, 604/104, 604/106, 604/544, 604/500, 604/506, 604/507, 604/508, 604/164.1, 604/164.11, 604/158, 604/264, 606/185
• US Class Current: 604/174
• 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 though 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 method of delivering a catheter device to an internal body site, comprising:

advancing flexible anchors of a catheter anchor device through a percutaneous opening in a skin layer so that the flexible anchors and a subcutaneous cuff device of the catheter anchor device are disposed in a subcutaneous region along an underside of the skin layer, the subcutaneous cuff device comprising a biocompatible material that is configure to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer;

moving a catheter through the percutaneous opening in the skin layer toward a targeted body site such that a distal tip of the catheter is moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer, wherein a distal length of the catheter extending distally from a distal end of the catheter anchor device is greater than a maximum length of the catheter anchor device, wherein the distance from the subcutaneous cuff device to the distal catheter tip defines a cuff-to-tip distance, wherein said moving causes adjustment of the cuff-to-tip distance while the subcutaneous cuff device is disposed in the subcutaneous region along the underside of the skin layer; and

releasably securing the catheter to the catheter anchor device after the adjustment of the cuff-to-tip distance.

2. The method of claim 1, wherein the distal end of the catheter anchor device resides 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.

3. The method of claim 1, wherein the 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 method of claim 1, wherein the catheter anchor device comprises a sleeve body.

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

7. The method of claim 1, wherein the catheter defines at least two lumens that extend to the distal tip of the catheter, and wherein a total axial length of the catheter is greater than a total axial length of the catheter anchor device.

8. The method of claim 1, wherein at least a proximal portion of the catheter anchor device resides external to the percutaneous opening in the skin layer while the flexible anchors and the subcutaneous cuff device are disposed in the subcutaneous region along the underside of the skin layer.

9. The method 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.

10. The method of claim 9, wherein the subcutaneous cuff device receives 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.

6. A method of delivering a catheter device to an internal body site, comprising:

advancing flexible anchors of a catheter anchor device through a percutaneous opening in a skin layer so that the flexible anchors and a subcutaneous cuff device of the catheter anchor device are disposed in a subcutaneous region along an underside of the skin layer, the subcutaneous cuff device comprising a biocompatible material that is configure to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer;

moving a catheter through the percutaneous opening in the skin layer toward a targeted body site such that a distal tip of the catheter is moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer, wherein the catheter anchor device comprises a gripper portion that is adjustable to frictionally engage at least a portion of an outer circumferential surface of the catheter, wherein the distance from the subcutaneous cuff device to the distal catheter tip defines a cuff-to-tip distance, wherein said moving causes adjustment the cuff-to-tip distance while the subcutaneous cuff device is disposed in the subcutaneous region along the underside of the skin layer; and

releasably securing the catheter to the catheter anchor device by adjusting the gripper portion of to releasably compress against said portion of the outer circumferential surface of the catheter, wherein at least a portion of the catheter anchor device is configured to adjust from a first position to a second position so as to simultaneously shift the flexible anchors to a deployed orientation and to shift the gripper portion to compress the outer surface of the catheter device.

12. The method of claim 6, wherein at least a proximal portion of the catheter anchor device resides external to the percutaneous opening in the skin layer while the flexible anchors and the subcutaneous cuff device are disposed in the subcutaneous region along the underside of the skin layer, and wherein the subcutaneous cuff device receives 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.

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 catheter engagement body having a gripper portion that is adjustable to frictionally engage at least a portion of an outer circumferential surface of a catheter when a catheter is inserted into a percutaneous opening in a skin layer;

a subcutaneous anchor mechanism coupled to the catheter engagement body, the subcutaneous anchor mechanism having first and second flexible anchors that are adjustable from a first position to a second position in which a free end of the first flexible anchor extends generally oppositely away from a free end of the second flexible anchor, wherein the first and second flexible anchors are configured to abut tissue in a subcutaneous region along an underside of the skin layer;

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 relative to the gripper portion of the catheter engagement body such that, 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

wherein the catheter engagement body is configured to releasably secure to the catheter by shifting the gripper portion of 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, 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 to shift the gripper portion to compress the outer surface of the catheter device.

13. The device of claim 11, 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, and 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.