Anchor instrumentation and methods

• US 7,753,889 B2
• Filed: 06/15/2007
• Issued: 07/13/2010
• 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 D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/763,576
• Publication Number:
  US 20080312599A1
• Time in Patent Office: 1,124 Days
• Field of Search: 604/174, 604/175, 604/192, 604/164.01, 604/176, 604/104, 604/106, 604/544, 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. An anchor sleeve device, comprising:

an elongate body that defines at least one working channel extending from a proximal portion to a distal tip portion;

a subcutaneous anchor mechanism coupled to the elongate body, the subcutaneous anchor mechanism having one or more flexible anchors that extend away from an outer wall of the elongate body when in a deployed orientation with the distal tip portion of the elongate body in a subcutaneous layer;

a subcutaneous cuff device arranged along an outer surface of the elongate body at a position distally of the one or more flexible anchors, the subcutaneous cuff device comprising a biocompatible material to receive ingrowth of bodily tissue when disposed in the subcutaneous layer, wherein the working channel of the elongate body is sized to receive a catheter having a catheter tip, wherein when the catheter is distally advanced through the working channel, a cuff-to-tip distance between the subcutaneous cuff device and the catheter tip is adjusted; and

a locking device that releasably affixes to the catheter when the catheter is received in the working channel, wherein the locking device is shiftable to compress at least a portion of an outer surface of the catheter when the catheter is received in the working channel, wherein the locking device affixes the catheter in response to the one or more flexible anchors being adjusted to the deployed orientation.

2. The anchor sleeve of claim 1, wherein the subcutaneous cuff device inhibits migration of infection when the cuff device is embedded in the subcutaneous layer.

3. The anchor sleeve of claim 2, 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.

4. The anchor sleeve of claim 1, wherein the subcutaneous cuff device comprises a Dacron mesh material to receive the ingrowth of the bodily tissue.

5. The anchor sleeve of claim 1, further comprising an actuator that is movable relative to the elongate body so as to adjust the flexible anchors from a non-deployed orientation to the deployed orientation.

6. The anchor sleeve of claim 5, the flexible anchors comprise a Nitinol material that exhibits superelasticity when used in a human body.

7. The anchor sleeve of claim 5, wherein the actuator is located at a proximal end of the elongate body and is coaxial with the working channel.

8. The anchor sleeve of claim 7, wherein the elongate body further defines an actuator channel extending from a proximal opening to a terminal end that is interior to the elongate body so that the actuator channel does not extend fully through the elongate body, and further comprising an actuator rod that joins to the actuator, extends through the actuator channel proximal opening, and joins with the flexible anchors within the actuator channel.

9. The anchor sleeve of claim 7, further comprising a means for inhibiting further longitudinal movement of the actuator after compression of the outer surface of the catheter.

10. An anchor system for placement of a catheter device, comprising:

an anchor sleeve having an elongate body that defines at least one working channel extending from a proximal portion to a distal tip portion of the anchor sleeve, and having a subcutaneous cuff device arranged along an outer surface of the elongate body, the subcutaneous cuff device comprising a biocompatible material to embed in bodily tissue when disposed in a subcutaneous layer; and

a catheter device to advance though the working channel of the anchor sleeve and into a targeted body site, the catheter device defining at least one lumen that extends to a catheter tip opening, the catheter device having a length greater than the anchor sleeve such that the subcutaneous cuff device and the distal tip portion of the anchor sleeve remain in the subcutaneous layer when the catheter device advances distally into the targeted body site,

wherein, when the catheter device is advanced through the working channel of the anchor sleeve, the distance from the subcutaneous cuff device to the catheter tip opening is adjustable,

wherein the anchor sleeve further comprises a subcutaneous anchor mechanism coupled to the elongate body, the subcutaneous anchor mechanism having one or more flexible anchors that extend away from an outer wall of the elongate body when in a deployed orientation in a subcutaneous layer,

wherein the anchor sleeve further comprises a locking device that releasably affixes to the catheter when the catheter is received in the working channel, and

wherein the anchor sleeve further comprises an actuator that is adjustable relative to the elongate body from a first position to a second position so as to simultaneously shift the flexible anchors to the deployed orientation and shift the locking device to compress at least a portion of an outer surface of the catheter when the catheter is received in the working channel.

11. The anchor system of claim 10, wherein the subcutaneous cuff device inhibits migration of infection when the cuff device is embedded in the subcutaneous layer.

12. The anchor system of claim 11, 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.

13. The anchor system of claim 10, wherein the actuator is movable relative to the elongate body so as to adjust the flexible anchors from a non-deployed orientation to the deployed orientation.

14. The anchor system of claim 10, wherein the subcutaneous cuff device inhibits migration of infection when the cuff device is embedded in the subcutaneous layer.

15. The anchor system of claim 10, wherein the actuator is located at a proximal end of the elongate body and is coaxial with the working channel.

16. The anchor system of claim 15, wherein the elongate body further defines an actuator channel extending from a proximal opening to a terminal end that is interior to the elongate body so that the actuator channel does not extend fully through the elongate body, and further comprising an actuator rod that joins to the actuator, extends through the actuator channel proximal opening, and joins with the flexible anchors within the actuator channel.

17. The anchor system of claim 15, further comprising a means for inhibiting further longitudinal movement of the actuator after compression of the outer surface of the catheter.

18. An anchor sleeve device, comprising:

an elongate body that defines at least one working channel extending from a proximal opening to a distal tip opening so as to receive a catheter;

a subcutaneous anchor mechanism coupled to the elongate body, the subcutaneous anchor mechanism having one or more flexible anchors that extend away from the body wall when in a deployed orientation in a subcutaneous layer;

a locking device that releasably affixes to the catheter when the catheter is received in the working channel; and

an actuator that is adjustable relative to the elongate body from a first position to a second position so as to simultaneously shift the flexible anchors to the deployed orientation and shift the locking device to compress at least a portion of an outer surface of the catheter when the catheter is received in the working channel.

19. The anchor sleeve of claim 18, further comprising a subcutaneous cuff device arranged along the elongate body.

20. The anchor sleeve of claim 19, wherein the subcutaneous cuff device comprising a biocompatible material that receives ingrowth of bodily tissue when disposed in the subcutaneous layer.

21. The anchor sleeve of claim 20, wherein when the catheter is distally advanced through the working channel, a cuff-to-tip distance between the subcutaneous cuff device and the catheter tip is adjusted.

22. The anchor sleeve of claim 18, wherein the flexible anchors comprise a Nitinol material that exhibits superelasticity when used in a human body.

23. The anchor sleeve device of claim 18, wherein the actuator is located at a proximal end of the elongate body and is coaxial with the working channel.

24. The anchor sleeve device of claim 23, wherein the elongate body further defines an actuator channel extending from a proximal opening to a terminal end that is interior to the elongate body so that the actuator channel does not extend fully through the elongate body, and further comprising an actuator rod that joins to the actuator, extends through the actuator channel proximal opening, and joins with the flexible anchors within the actuator channel.

25. The anchor sleeve device of claim 23, further comprising a means for inhibiting further longitudinal movement of the actuator after compression of the outer surface of the catheter.