System for anchoring medical devices

• US 10,709,874 B2
• Filed: 12/08/2017
• Issued: 07/14/2020
• Est. Priority Date: 09/15/2011
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Christianson, Mark R., Forsberg, Andrew T., Beeson, Andrew R., Bormann, Ryan J., Augustine, Michael W.
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US15/836,313
• Publication Number:
  US 20180099122A1
• Time in Patent Office: 949 Days
• Field of Search: 604174, 604175
• CPC Class Codes: A61M 2025/028 having a mainly rigid support 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

Abstract

Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

Claims

1. An anchor device for securing the position of a medical device, comprising:

an external retainer assembly comprising a base, a cap configured to releasably couple with the base, and a gripping channel configured to engage an exterior surface of a medical device; and

first and second anchors that extend distally from a distal end of the external retainer assembly, each anchor comprising a flexible tine that is deployable in a subcutaneous region to secure the external retainer assembly relative to a skin penetration point;

wherein the external retainer assembly defines a longitudinal axis extending from a proximal end to a distal end, and the gripping channel has a non-circular cross-sectional shape in a plane generally perpendicular to the longitudinal axis, the non-circular cross-sectional shape defined in part by flat channel walls of the base and in part by flat channel walls of the cap and the cap has an outer peripheral shape that is non-symmetrical about the longitudinal axis.

2. The anchor device of claim 1, wherein the base and the cap each include a compliant gripper member that frictionally engages the medical device in the channel when the retainer body releasably couples to the medical device.

3. The anchor device of claim 1, wherein the channel is at least partially defined by a wall comprising a thermoplastic elastomer material to press against the medical device when the base releasably couples to the medical device.

4. The anchor device of claim 1, wherein the base further comprises one or more locating tabs to align the medical device adjacent to the base prior to engagement of the base with a cap.

5. The anchor device of claim 1, wherein the base comprises non-symmetrical engagement features shaped to releasably mate with corresponding non-symmetrical engagement features of the cap such that the cap is configured to attach to the base in only one orientation.

6. The anchor device of claim 1, wherein at least a portion of the external retainer assembly is foldable about a fold axis generally parallel to the longitudinal axis.

7. The anchor device of claim 6, wherein the flexible tines of the first and second anchors are arranged in a generally side-by-side position when the external retainer member is in a folded condition, and wherein the flexible tines of the first and second anchors extend generally away from one another when said portion of the external retainer member is in a non-folded condition.

8. The anchor device of claim 1, wherein the first and second anchors extend distally from the distal end of the external retainer assembly toward a portion of the medical device that passes through the skin penetration point when the external retainer assembly releasably couples to the medical device.

9. The anchor device of claim 8, wherein the first and second anchors extend distally from the distal end of the external retainer assembly to deploy into the skin penetration point occupied by the medical device when the external retainer assembly releasably couples to the medical device.

10. The anchor device of claim 1, wherein the channel defines a proximal opening and a distal opening, the gripping channel being enclosed and tapered such that the proximal opening of the channel is larger than the distal opening of the channel.

11. The anchor device of claim 1, wherein the non-circular cross-sectional shape of the gripping channel comprises a diamond cross-sectional shape.

12. The anchor device of claim 1, wherein at least a portion of the gripping channel is tapered to provide a larger size at a proximal region of the gripping channel.

13. The anchor device of claim 1, wherein the first and second anchors are fixedly mounted to the external retainer assembly.

14. An anchor device for securing the position of a medical device, comprising:

an external retainer assembly comprising a base, a cap configured to releasably couple with the base, and a gripping channel configured to engage an exterior surface of a medical device, wherein the base comprises one or more means for aligning the medical device adjacent to the base prior to engagement of the base with the cap; and

first and second anchors that extend distally from a distal end of the external retainer assembly, each anchor comprising a flexible tine that is deployable in a subcutaneous region to secure the external retainer assembly relative to a skin penetration point;

wherein the external retainer assembly defines a longitudinal axis extending from a proximal end to a distal end, and the gripping channel has a non-circular cross-sectional shape in a plane generally perpendicular to the longitudinal axis, the non-circular cross-sectional shape defined in part by the base and in part by the cap.

15. The anchor device of claim 14, wherein the base comprises non-symmetrical engagement features that are non-symmetrical about the longitudinal axis and that are shaped to releasably mate with corresponding non-symmetrical engagement features of the cap such that the cap is configured to attach to the base in only one orientation.

16. The anchor device of claim 15, wherein the gripping channel is enclosed and continuously tapered along an entire length of the gripping channel to provide a larger size at a proximal opening of the gripping channel.

17. An anchor system for securing a catheter relative to a skin penetration point, comprising:

a catheter having an exterior cylindrical surface;

an external retainer assembly comprising a base, a cap configured to releasably couple with the base, and a gripping channel having flat, inwardly facing walls to compress upon opposing sides of the exterior cylindrical surface of the catheter such that the gripping channel defines a cross-sectional channel shape that is different from a cross-sectional catheter shape at the exterior cylindrical surface of the catheter; and

first and second anchors that extend distally from a distal end of the external retainer assembly, each anchor comprising a flexible tine that is deployable in a subcutaneous region to secure the external retainer assembly relative to a skin penetration point;

wherein the gripping channel is defined in part by the base and in part by the cap.

18. The anchor device of claim 17, wherein the external retainer assembly defines a longitudinal axis extending from a proximal end to a distal end, and the gripping channel has a non-circular cross-sectional shape in a plane generally perpendicular to the longitudinal axis, the non-circular cross-sectional shape is defined in part by the base and in part by the cap.

19. The anchor device of claim 18, wherein at least a portion of the external retainer assembly is foldable about a fold axis generally parallel to the longitudinal axis, wherein the flexible tines of the first and second anchors are arranged in a generally side-by-side position when the external retainer member is in a folded condition, and wherein the flexible tines of the first and second anchors extend generally away from one another when said portion of the external retainer member is in a non-folded condition.

20. The anchor device of claim 19, wherein the non-circular cross-sectional shape of the gripping channel comprises a diamond cross-sectional shape.

21. The anchor device of claim 20, wherein at least a portion of the gripping channel is tapered to provide a larger size at a proximal region of the gripping channel.

22. The anchor device of claim 21, wherein the first and second anchors are fixedly mounted to the external retainer assembly.