Anchor systems and methods

• US 10,335,576 B2
• Filed: 03/23/2018
• Issued: 07/02/2019
• Est. Priority Date: 07/16/2008
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Christianson, Mark R., Taylor, Kyle P., Forsberg, Andrew T., Killion, Jeffrey D.
• Primary Examiner(s): Hayman, Imani N
• Application Number:
  US15/933,964
• Publication Number:
  US 20180207405A1
• Time in Patent Office: 466 Days
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/0246 fixed on the skin having a cover for covering the holding means
• 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 medical instrument (such as a catheter or the like) and secures the instrument in place relative to a skin penetration point. In some circumstances, the anchor device may allow the anchor device to be used after medical instrument is already in place without the need for a second penetration point for the anchor device.

Claims

1. A method for securing a catheter relative to a skin penetration point, comprising:

inserting a catheter through a skin penetration point;

adjusting a first anchor and a second anchor of an anchor instrument from a first configuration to a deployed configuration, the first and second anchors being coupled to an external retainer device of the anchor instrument and being configured to extend distally away from a distal end of the external retainer device, wherein a first subcutaneous flexible tine of the first anchor and a second subcutaneous flexible tine of the second anchor are deployed in a subcutaneous region adjacent to an underside of a skin layer to secure the external retainer device relative to the skin penetration point;

inserting the first and second anchors of an anchor instrument through the skin penetration point while the catheter is occupying the skin penetration point;

connecting a removable cap member to the external retainer device; and

releasably engaging the external retainer device to an external portion of the catheter while the catheter is occupying the skin penetration point and while the first and second anchors extend distally away from the distal end of the external retainer device.

2. The method of claim 1, wherein connecting the removable cap member of the external retainer device comprises connecting the removable cap member with extension elements of the external retainer device.

3. The method of claim 2, wherein connecting the removable cap member of the external retainer device comprises frictionally engaging the removable cap member with a portion of an outer surface of the catheter.

4. The method of claim 2, wherein the removable cap member defines apertures that releasably receive first and second extension elements of the external retainer device when the external retainer device releasably couples to the catheter.

5. The method of claim 1, wherein the removable cap member is configured to prevent adjustment of the first and second anchors between the first configuration and the deployed configuration.

6. The method of claim 1, wherein the first subcutaneous flexible tine and the second subcutaneous flexible tine are positioned distal to the distal end of the external retainer device while deployed in the subcutaneous region adjacent to the underside of the skin layer and while the external retainer device resides fully external to the skin penetration point.

7. The method of claim 1, wherein the first anchor includes a first external longitudinal shaft portion extending in a longitudinal direction distally away from the distal end of the external retainer device toward the first subcutaneous flexible tine when the first anchor is in the deployed configuration, and wherein the second anchor includes a second external longitudinal shaft portion extending in the longitudinal direction distally away from the distal end of the external retainer device toward the second subcutaneous flexible tine when the second anchor is in the deployed configuration;

and wherein the first external longitudinal shaft portion of the first anchor and the second external longitudinal shaft portion of the second anchor extend generally parallel to another and generally side-by-side to one another.

8. The method of claim 1, wherein in the deployed configuration, the first subcutaneous flexible tine and the second subcutaneous flexible tine extend outwardly away from one another.

9. The method of claim 8, wherein the first subcutaneous flexible tine and the second subcutaneous flexible tine are curved tines having a convexly curved portion that extends longitudinally toward a non-sharp free end.

10. The method of claim 1, wherein the external retainer device comprises a channel that frictionally engages with at least a portion of an outer surface of the catheter.

11. The method of claim 10, wherein the channel of the external retainer device comprises a flexible gripping material that is compressed against the external portion of the catheter when the external retainer device releasably couples to the catheter.

12. The method of claim 11, wherein the removable cap member is more rigid than that the flexible gripping material of the external retainer device.

13. The method of claim 1, comprising an actuator mechanism to adjust the first and second anchors from the first configuration to the deployed configuration.

14. The method of claim 1, further comprising adjusting positions of the first and second anchors relative to one another during removal of the first and second anchors from the subcutaneous region.

15. A method for securing a catheter relative to a skin penetration point, comprising:

inserting a catheter through a skin penetration point;

adjusting a first anchor and a second anchor of an anchor instrument from a first configuration to a deployed configuration, the first and second anchors being coupled to an external retainer device of the anchor instrument and being configured to extend distally away from a distal end of the external retainer device, wherein the first anchor includes a first external longitudinal shaft portion extending in a longitudinal direction distally away from the distal end of the external retainer device and wherein the second anchor includes a second external longitudinal shaft portion extending in the longitudinal direction distally away from the distal end of the external retainer device, and wherein the first external longitudinal shaft portion of the first anchor and the second external longitudinal shaft portion of the second anchor extend generally parallel to another and generally side-by-side to one another in both the first configuration and the deployed configuration;

inserting the first and second anchors of an anchor instrument through the skin penetration point into a subcutaneous region while the catheter is occupying the skin penetration point;

connecting a removable cap member to the external retainer device; and

releasably engaging the external retainer device to an external portion of the catheter while the catheter is occupying the skin penetration point and while the first and second anchors extend distally away from the distal end of the external retainer device.

16. The method of claim 15, wherein the removable cap member defines apertures that releasably receive first and second extension elements of the external retainer device when the external retainer device releasably couples to the catheter.

17. The method of claim 16, wherein the removable cap member is more rigid than a flexible gripping material of the external retainer device, the flexible gripping material configured to frictionally engage the catheter.

18. The method of claim 15, comprising an actuator mechanism to adjust the first and second anchors from the first configuration to the deployed configuration.

19. The method of claim 15, further comprising adjusting positions of the first and second anchors relative to one another during removal of the first and second anchors from the subcutaneous region.

20. The method of claim 19, wherein the first anchor includes a first subcutaneous flexible tine and the second anchor includes a second subcutaneous flexible tine, and in the deployed configuration the first and second subcutaneous flexible tines extend outwardly away from one another.