System for anchoring medical devices

• US 10,471,236 B2
• Filed: 02/15/2018
• Issued: 11/12/2019
• Est. Priority Date: 06/27/2008
• 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.
• Primary Examiner(s): Patel, Shefali D
• Application Number:
  US15/897,908
• Publication Number:
  US 20180169387A1
• Time in Patent Office: 635 Days
• 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 2210/04 Skin
• 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
• CPC Class Codes: Y10S 128/26 Cannula supporters

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 penetration point without the use of sutures or skin tapes.

Claims

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

advancing the medical instrument through a skin penetration point of a patient'"'"'s body, the medical instrument comprising an external portion configured to reside external to the skin penetration point when the medical instrument is inserted into the skin penetration point;

engaging the external portion of the medical instrument with a retainer device by adjusting a flexible portion of the retainer device from a first configuration to a second configuration, the retainer device comprising;

a retainer body comprising the flexible portion;

a first anchor comprising a first external shaft portion, the first anchor extending distally from a distal end of the retainer body and toward the skin penetration point when the medical instrument is inserted into the skin penetration point and engaged with the retainer body; and

a second anchor comprising a second external shaft portion, the second anchor extending distally from the distal end of the retainer body and toward the skin penetration point when the medical instrument is inserted into the skin penetration point and engaged with the retainer body, the first and second external shaft portions positionable side-by-side during insertion and movable relative to one another during removal from a subcutaneous region; and

inserting the first and second anchors through the skin penetration point so that at least a portion of each of the first and second anchors is deployed in the subcutaneous region proximate the skin penetration point, wherein the first external shaft portion of the first anchor and the second external shaft portion of the second anchor are positioned side-by-side during insertion through the skin penetration point.

2. The method of claim 1, wherein the first and second anchors are inserted through the skin penetration point so that the at least a portion of each of the first and second anchors is deployed in the subcutaneous region while the entire retainer body is arranged externally of the skin penetration point.

3. The method of claim 1, wherein the first anchor comprises a first flexible tine coupled to the first external shaft portion and the second anchor comprises a second flexible tine coupled to the second external shaft portion, and the first flexible tine of the first anchor is configured to extend outwardly away from the second flexible tine of the second anchor when the flexible tines are deployed in the subcutaneous region.

4. The method of claim 3, comprising inserting the first and second flexible tines through the skin penetration point while the skin penetration point is occupied by the medical instrument.

5. The method of claim 1, comprising engaging the external portion of the medical instrument with the retainer device while the medical instrument is occupied within the skin penetration point.

6. The method of claim 5, wherein inserting the first and second anchors through the skin penetration point occurs before engaging the external portion of the medical instrument with the retainer device.

7. The method of claim 1, wherein the retainer body comprises a cap member and a lower body member, the cap member releasably engageable with the lower body member via an engagement structure of the cap member configured to mate with a corresponding engagement structure of the lower body member.

8. The method of claim 7, comprising adjusting the retainer body from the first configuration to the second configuration while the cap member is engaged with the lower body member.

9. The method of claim 1, wherein the retainer body comprises first and second body portions, and the flexible portion comprises a hinged connection between the first and second body portions.

10. The method of claim 9, comprising separating the first body portion from the second body portion during removal of the first and second anchors from the skin penetration point.

11. The method of claim 1, wherein the first configuration is an open position in which the medical instrument is movable independent from the retainer body and the second configuration is a closed position in which the medical instrument is engaged by the retainer body.

12. The method of claim 1, wherein the retainer body comprises a cap member comprising the flexible portion.

13. The method of claim 1, comprising removing the first anchor from the skin penetration point independent from the second anchor.

14. The method of claim 1, wherein the retainer body comprises a catheter receiving channel that extends along a longitudinal axis, and the first and second external shaft portions of the first and second anchors extend generally parallel to the longitudinal axis.

15. A method of anchoring a medical instrument, comprising:

advancing the medical instrument through a skin penetration point of a patient'"'"'s body, the medical instrument comprising an external portion configured to reside external to the skin penetration point when the medical instrument is inserted into the skin penetration point;

engaging the external portion of the medical instrument with a retainer device by adjusting a flexible portion of the retainer device from a first configuration to a second configuration, the retainer device comprising;

a retainer body comprising the flexible portion;

a first anchor comprising a first external shaft portion and a first flexible tine coupled to the first external shaft portion, the first anchor extending distally from a distal end of the retainer body and toward the skin penetration point when the medical instrument is inserted into the skin penetration point and engaged with the retainer body; and

a second anchor comprising a second external shaft portion and a second flexible tine coupled to the second external shaft portion, the second anchor extending distally from the distal end of the retainer body and toward the skin penetration point when the medical instrument is inserted into the skin penetration point and engaged with the retainer body, the first and second external shaft portions positionable side-by-side during insertion and movable relative to one another during removal from a subcutaneous region; and

inserting the first and second anchors through the skin penetration point so that at least the first and second flexible tines and at least portions of each of the first and second external shaft portions are deployed in the subcutaneous region proximate the skin penetration point, wherein the first external shaft portion of the first anchor and the second external shaft portion of the second anchor are positioned side-by-side during insertion through the skin penetration point.

16. The method of claim 15, comprising simultaneously inserting the first and second flexible tines through the skin penetration point while the skin penetration point is occupied by the medical instrument.

17. The method of claim 16, comprising engaging the external portion of the medical instrument with the retainer device after the first and second flexible;

tines are deployed in the subcutaneous region.

18. The method of claim 17, wherein the retainer body comprises first and second body portions, and the flexible portion comprises a hinged connection between the first and second body portions.

19. The method of claim 18, comprising separating the first body portion from the second body portion during removal of the first and second anchors from the skin penetration point.

20. The method of claim 19, wherein the first flexible tine is configured to extend outwardly away from the second flexible tine when the flexible tines are deployed in the subcutaneous region.