Systems and methods for anchoring medical devices

• US 10,342,954 B2
• Filed: 03/05/2018
• Issued: 07/09/2019
• Est. Priority Date: 10/11/2012
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Christianson, Mark R.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Swanson, Leah J
• Application Number:
  US15/911,280
• Publication Number:
  US 20180193604A1
• Time in Patent Office: 491 Days
• 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
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors.

Claims

1. A method of securing a medical instrument, comprising:

securing an anchor device relative to a penetration point, the anchor device comprising a retainer body comprising a first body portion that is pivotably coupled to a second body portion about a longitudinal fold axis, the first body portion and the second body portion including first and second tabs, respectively, and first and second anchors that extend distally from a distal end of the retainer body, each anchor comprising a flexible tine, wherein securing the retainer body comprises;

deploying the first and second anchors in a subcutaneous region of the penetration point while in a folded configuration, wherein in the folded configuration the first anchor and the second anchor extend generally in a same direction; and

pivoting the first body portion relative to the second body portion, wherein pivoting the first body portion relative to the second body portion adjusts the first anchor and the second anchor from the folded configuration to a non-folded configuration, wherein in the non-folded configuration the first anchor and the second anchor extend outwardly away from one another, and the first and second tabs define a cutout region therebetween in the non-folded configuration to provide visualization and access of a surface under the retainer body.

2. The method of claim 1, comprising securing a hub of a catheter to the retainer body.

3. The method of claim 2, wherein securing the hub of the catheter to the retainer body comprises extending an anchor engagement portion of the retainer body through an aperture defined by the hub of the catheter.

4. The method of claim 3, wherein securing the hub of the catheter further comprises adjusting a location of the anchor engagement portion on the retainer body.

5. The method of claim 3, further comprising removing the hub of the catheter from the retainer body by:

grasping the hub of the catheter; and

separating the hub of the catheter from the anchor engagement portion.

6. The method of claim 5, wherein removing the hub of the catheter from the retainer body comprises sliding a finger along a relief portion of the anchor engagement portion.

7. The method of claim 5, wherein adjusting the first anchor and the second anchor from the folded configuration to the non-folded configuration comprises rotating each of the first and second anchors about 90 degrees.

8. The method of claim 1, wherein adjusting the first anchor and the second anchor from the folded configuration to the non-folded configuration comprises rotating each of the first and second anchors about 75 to about 105 degrees.

9. The method of claim 1, further comprising:

pivoting the first body portion relative to the second body portion, wherein pivoting the first body portion relative to the second body portion adjusts the first anchor and the second anchor from the non-folded configuration to the folded configuration; and

removing the first anchor and the second anchor from the subcutaneous region of the penetration point while in a folded configuration.

10. A method of securing a medical instrument, comprising:

securing an anchor device relative to a penetration point, the anchor device comprising a retainer body comprising a first body portion that is pivotably coupled to a second body portion about a longitudinal fold axis, the first body portion and the second body portion include first and second tabs, respectively, and first and second anchors that extend distally from a distal end of the retainer body, each anchor comprising a flexible tine, wherein securing the retainer body comprises;

deploying the first and second anchors in a subcutaneous region of the penetration point while in a folded configuration, wherein in the folded configuration the first anchor and the second anchor extend generally in a same direction; and

pivoting the first body portion relative to the second body portion, wherein pivoting the first body portion relative to the second body portion adjusts the first anchor and the second anchor from the folded configuration to a non-folded configuration, wherein in the non-folded configuration the first anchor and the second anchor extend outwardly away from one another, and the first and second tabs define a cutout region therebetween in the non-folded configuration that provides visualization and access of a surface under the retainer body; and

coupling an adapter to the retainer body.

11. The method of claim 10, wherein coupling the adapter to the retainer body comprises extending an anchor engagement portion of the retainer body through an aperture defined by an engagement member of the adapter.

12. The method of claim 11, wherein securing the retainer body further comprises adjusting a location of the anchor engagement portion on the retainer body.

13. The method of claim 10, further comprising engaging a catheter with the adapter.

14. The method of claim 13, wherein engaging a catheter with the adapter comprises inserting a portion of the catheter into a hub of the adapter.

15. The method of claim 14, wherein inserting a portion of the catheter into a hub of the adapter comprising inserting the portion of the catheter into the hub of the adapter via a longitudinal slit of the hub that is configured to open and receive the portion of the catheter.

16. A method of securing a medical instrument, comprising:

advancing an anchor device at least partially through a skin penetration point, the anchor device comprising a retainer body comprising a first body portion that is pivotably coupled to a second body portion about a longitudinal fold axis, and first and second anchors that extend distally from a distal end of the retainer body, each anchor comprising a flexible tine, the first anchor being coupled to the first body portion and the second anchor being coupled to the second body portion;

deploying the first and second anchors in a subcutaneous region of the penetration point while in a folded configuration, wherein in the folded configuration the first anchor and the second anchor extend generally in a same direction; and

pivoting the first body portion relative to the second body portion, wherein pivoting the first body portion relative to the second body portion adjusts the first anchor and the second anchor from the folded configuration to a non-folded configuration in which the flexible tines extend outwardly away from one another, wherein the first body portion and the second body portions define a cutout region therebetween at a proximal end opposite from the first and second anchors to provide visualization and access to a surface under the retainer body when in the non-folded configuration.

17. The method of claim 16, further comprising securing a hub of a catheter to the retainer body.

18. The method of claim 17, wherein securing the hub of the catheter to the retainer body comprises extending an anchor engagement portion of the retainer body through an aperture defined by the hub of the catheter.

19. The method of claim 18, wherein securing the hub of the retainer body further comprises adjusting a location of the anchor engagement portion on the retainer body.

20. The method of claim 16, wherein adjusting the first anchor and the second anchor from the folded configuration to the non-folded configuration comprises rotating each of the first and second anchors about 75 to about 105 degrees.