Systems and methods for anchoring medical devices

• US 9,415,190 B2
• Filed: 02/13/2013
• Issued: 08/16/2016
• Est. Priority Date: 02/13/2013
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Christianson, Mark R.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US13/766,102
• Publication Number:
  US 20140228810A1
• Time in Patent Office: 1,280 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/0206 where the catheter is secured by using devices worn by the patient, e.g. belts or harnesses
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• 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, a tether, and an adapter for securing a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors.

Claims

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

a first external body comprising a proximal end and a distal end;

one or more anchors that extend distally from the distal end of the first external body, each anchor comprising a flexible tine that is deployable in a subcutaneous region to secure the first external body relative to a penetration point;

a tether member that extends proximally from the first external body, the tether member being directly connected to the first external body so that a distal end of the tether member is permanently maintained in a fixed positioned relative to the one or more anchors that extend distally from the distal end of the first external body; and

a second external body that is attachable to the tether member at a position proximally spaced away from the proximal end of the first external body, wherein the second external body is configured to directly contact and mate with an exterior of a medical instrument at a releasable mating location proximally spaced away from the proximal end of the first external body.

2. The anchor device of claim 1, wherein the first external body is configured to releasably couple to the medical instrument while the second external body is releasably coupled to the medical instrument.

3. The anchor device of claim 2, wherein the first external body is configured to releasably couple with an outer surface of the medical instrument using a friction grip.

4. The anchor device of claim 1, wherein the tether member is connected to and extends proximally away from the proximal end of the first external body.

5. The anchor device of claim 1, wherein the second external body comprises one or more engagement portions that are configured to releasably mate with one or more corresponding elements of the medical instrument.

6. The anchor device of claim 5, wherein the one or more engagement portions each comprise a retention post that extends from the second external body.

11. The anchor device of claim 1, wherein the second external body is attachable to the tether member at a plurality of positions proximally spaced away from the first external body.

12. The anchor device of claim 1, wherein the tether member is integrally formed with the first external body.

18. The anchor device of claim 3, wherein the first external body comprises a first body portion that is pivotably coupled to a second body portion about a longitudinal fold axis that extends parallel to a receiving channel of the first external body that is configured to accommodate a portion of the medical instrument and releasably couple with the outer surface of the medical instrument using the friction grip.

19. The anchor device of claim 18, wherein the first external body comprises a sloped nose region having a generally planar upper surface that is oriented at a decline angle extending distally from generally planar surfaces of the first and second body portions.

20. The anchor device of claim 18, wherein a first anchor of the one or more anchors is coupled to and extends distally from the first body portion, and wherein a second anchor of the one or more anchors is coupled to and extends distally from the second body portion, and wherein when the first body portion pivots in relation to the second body portion, the first and second anchors are adjustable from a first configuration in which the flexible tines extend outwardly away from one another to a second configuration in which the flexible tines extend generally in the same direction.

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

a first external body comprising a proximal end and a distal end, wherein the first external body comprises a first body portion that is pivotably coupled to a second body portion about a longitudinal fold axis;

one or more anchors that extend distally from the distal end of the first external body, each anchor comprising a flexible tine that is deployable in a subcutaneous region to secure the first external body relative to a penetration point;

a tether member that extends proximally from the first external body; and

a second external body that is attachable to the tether member at a position proximally spaced away from the proximal end of the first external body, wherein the second external body is configured to releasably couple to a medical instrument.

8. The anchor device of claim 7, wherein the first external body comprises a sloped nose region having a generally planar upper surface that is oriented at a decline angle extending distally from generally planar surfaces of the first and second body portions.

9. The anchor device of claim 7, wherein a first anchor of the one or more anchors is coupled to and extends distally from the first body portion, and wherein a second anchor of the one or more anchors is coupled to and extends distally from the second body portion.

10. The anchor device of claim 9, wherein when the first body portion pivots in relation to the second body portion, the first and second anchors are adjustable from a first configuration in which the flexible tines extend outwardly away from one another to a second configuration in which the flexible tines extend generally in the same direction.

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

a retainer body comprising a proximal end and a distal end, wherein the retainer body is configured to releasably couple to a first external portion of a medical instrument;

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

a tether member configured to extend proximally from the proximal end of the retainer body; and

an adapter that is attachable to the tether at a user-selectable position proximally spaced a distance away from the retainer body, wherein the adapter is configured to releasably couple to a second external portion of the medical instrument, and wherein the tether member defines a plurality of mating locations spaced apart at different longitudinal positions relative to the proximal end of the retainer body, and the adapter being releasably and directly matable to the tether member at any of the plurality of mating locations so as to secure the adapter at the user-selectable position proximally spaced away from the proximal end of the retainer body.

16. The anchor device of claim 13, wherein the distance is about 2 cm to about 10 cm.

17. The anchor device of claim 13, wherein the adapter comprises one or more protrusions extending from the adapter for releasably coupling to the medical instrument.

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

a retainer body comprising a proximal end and a distal end, wherein the retainer body is configured to releasably couple to a first external portion of a medical instrument, wherein the retainer body comprises a first body portion and a second body portion, wherein the first body portion is pivotably coupled to the second body portion at a longitudinal fold axis that extends between the proximal and distal ends of the retainer body;

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

a tether member configured to extend proximally from the proximal end of the retainer body; and

an adapter that is attachable to the tether at a position proximally spaced a distance away from the retainer body, wherein the adapter is configured to releasably couple to a second external portion of the medical instrument.

15. The anchor device of claim 14, wherein the first anchor is coupled to and extends distally from the first body portion, wherein the second anchor is coupled to and extends distally from the second body portion, and wherein when the first body portion pivots in relation to the second body portion, the first and second anchors are adjustable from a first configuration in which the flexible tines extend outwardly away from one another to a second configuration in which the flexible tines extend generally in the same direction.