Systems and methods for anchoring medical devices

• US 9,550,043 B2
• Filed: 12/13/2012
• Issued: 01/24/2017
• Est. Priority Date: 12/13/2012
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Christianson, Mark R.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Legette, Tiffany
• Application Number:
  US13/713,239
• Publication Number:
  US 20140171899A1
• Time in Patent Office: 1,503 Days
• Field of Search: 604/180, 604/500, 604/174
• US Class Current: 1/1
• 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. An anchor device for securing the position of a medical instrument, the anchor device comprising:

a retainer body comprising a first body portion that is hingedly coupled to a second body portion about a longitudinal folding region;

one or more flexible adhesive strips mounted to the retainer body and being configured to adhesively attach with one or more corresponding exterior surfaces of the medical instrument; and

first and second anchors that extend distally from a 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, the first anchor being coupled to the first body portion and the second anchor being coupled to the second body portion, wherein the first body portion of the retainer body is hingedly movable relative to the second body portion about the longitudinal folding region while the first and second body portions are hingedly coupled so that 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;

wherein the longitudinal folding region comprises a flexible web portion positioned generally centrally between the first and second body portions and extending longitudinally from the distal end of the retainer body to a proximal face of the retainer body, wherein the flexible web portion is configured to define a longitudinal fold axis along the longitudinal folding region, and the first body portion is hingedly movable relative to the second body portion about the longitudinal fold axis to adjust the first and second anchors between the first and second configurations; and

wherein the one more flexible adhesive strips comprise a first adhesive strip configured to define an adhesive strip fold axis that is substantially parallel to and offset from the longitudinal fold axis of the flexible web portion, the first adhesive strip foldable upon itself about the adhesive strip fold axis.

2. The anchor device of claim 1, wherein the one or more flexible adhesive strips each have a lateral width extending generally perpendicular to the longitudinal fold axis and a longitudinal length extending generally parallel to the longitudinal fold axis, wherein the lateral width of each respective flexible adhesive strip is substantially greater than the longitudinal length of the respective flexible adhesive strip.

4. The anchor device of claim 1, wherein the one or more flexible adhesive strips each comprise a flexible substrate carrying an adhesive layer along a major surface thereof and a releasable liner over the adhesive layer.

5. The anchor device of claim 4, wherein the flexible substrate comprises at least one of a fabric mesh material, a polymer mesh material, and a polymer sheet material.

6. The anchor device of claim 5, wherein the releasable liner comprises at least one of a polymer sheet material and wax paper material.

7. The anchor device of claim 1, wherein the retainer body further comprises a sloped nose region that has a generally planar upper surface that is oriented at a decline angle extending distally from the first and second body portions.

3. A system for securing the position of a medical instrument, the system comprising:

a medical instrument comprising a distal portion configured to extend through a skin penetration point and into a body, and an external portion configured to reside outside the body when the distal portion extends through the skin penetration point; and

an anchor device comprising;

a retainer body comprising a first body portion that is pivotably coupled to a second body portion;

one or more flexible adhesive strips mounted to the retainer body and being configured to adhesively attach with one or more surfaces of the external portion of the medical instrument; and

first and second anchors that extend distally from a distal end of the retainer body, each anchor comprising a flexible tine that is deployable through the skin penetration point occupied by the medical instrument and into a subcutaneous region to secure the retainer body relative to the skin penetration point, the first anchor being coupled to the first body portion and the second anchor being coupled to the second body portion, wherein the first body portion of the retainer body is pivotable relative to the second body portion while the first and second body portions are pivotably coupled so that the first and second anchors are adjustable from one another from a first configuration to a second configuration, in which the flexible tines extend generally in the same direction;

wherein the retainer body comprises a flexible web portion positioned generally centrally between the first and second body portions and extending longitudinally from the distal end of the retainer body to a proximal face of the retainer body, wherein the flexible web portion is configured to define a longitudinal fold axis, and the first body portion is pivotable relative to the second body portion about the longitudinal fold axis to adjust the first and second anchors between the first and second configurations; and

wherein the one or more flexible adhesive strips comprises a single flexible adhesive strip extending proximally from a proximal end of the retainer body and extending away from the first and second anchors; and

wherein the one more flexible adhesive strips comprise a first adhesive strip configured to define an adhesive strip fold axis that is substantially parallel to and offset from the longitudinal fold axis of the flexible web portion, the first adhesive strip foldable upon itself about the adhesive strip fold axis.

8. The system of claim 3, wherein the medical instrument comprises a catheter, and wherein the one or more flexible adhesive strips comprises an adhesive layer configured to bond with the one or more surfaces of the external portion of the catheter.

9. The system of claim 3, wherein the one or more flexible adhesive strips each comprise a flexible substrate carrying an adhesive layer along a major surface thereof and a releasable liner over the adhesive layer.

10. The system of claim 9, wherein the flexible substrate comprises at least one of a fabric mesh material, a polymer mesh material, and a polymer sheet material.

11. The system of claim 10, wherein the releasable liner comprises at least one of a polymer sheet material and wax paper material.

12. The system of claim 8, wherein the retainer body further comprises a sloped nose region that has a generally planar upper surface that is oriented at a decline angle extending distally from the first and second body portions.

13. The system of claim 8, wherein the one or more flexible adhesive strips each have a lateral width extending generally perpendicular to the longitudinal fold axis and a longitudinal length extending generally parallel to the longitudinal fold axis, wherein the lateral width of each width of each respective flexible adhesive strip is substantially greater than the longitudinal length of the respective flexible adhesive strip.

14. The system of claim 13, wherein at least one of the one or more flexible strips comprises a tear strip that extends generally parallel to the longitudinal fold axis of the retainer body configured to separate the flexible strip into multiple portions.

15. The system of claim 14, wherein the tear strip is substantially aligned with the catheter when the adhesive layer is bonded to the catheter.

16. A system for securing the position of a medical instrument, the system comprising:

a medical instrument comprising a distal portion configured to extend through a skin penetration point and into a body, and an external portion configured to reside outside the body when the distal portion extends through the skin penetration point; and

a retainer body comprising a first body portion that is hingedly coupled to a second body portion about a longitudinal folding region;

one or more flexible adhesive strips mounted to the retainer body and being configured to adhesively attach with one or more corresponding exterior surfaces of the medical instrument; and

first and second anchors that extend distally from a 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 the skin penetration point, the first anchor being coupled to the first body portion and the second anchor being coupled to the second body portion, wherein the first body portion of the retainer body is hingedly movable relative to the second body portion about the longitudinal folding region while the first and second body portions are hingedly coupled so that 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; and

wherein the one or more flexible adhesive strips comprise a first adhesive strip configured to define an adhesive strip fold axis that is substantially parallel to and offset from the longitudinal folding region of the flexible web portion, the first adhesive strip foldable over the medical instrument about the adhesive strip fold axis.

17. The system of claim 16, wherein the one or more flexible adhesive strips each have a lateral width extending generally perpendicular to the longitudinal folding region and a longitudinal length extending generally parallel to the longitudinal folding region, wherein the lateral width of each width of each respective flexible adhesive strip is substantially greater than the longitudinal length of the respective flexible adhesive strip.

18. The system of claim 17, wherein the retainer body further comprises sloped nose region that has 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.

19. The system of claim 18, wherein the one or more flexible adhesive strips comprises a single flexible adhesive strip extending proximally from a proximal end of the retainer body and extending away from the first and second anchors.