Systems and methods for anchoring medical devices

• US 9,789,288 B2
• Filed: 12/20/2016
• Issued: 10/17/2017
• 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): Sirmons, Kevin C
• Assistant Examiner(s): Legette-Thompson, Tiffany
• Application Number:
  US15/384,910
• Publication Number:
  US 20170100567A1
• Time in Patent Office: 301 Days
• Field of Search: 604174, 604180, 604500
• 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 using a medical anchor system, the method comprising:

advancing an anchor device toward a skin penetration point while the anchor device is in a folded condition so that a plurality of subcutaneous tines of the anchor device are generally adjacent to each other and oriented to extend in substantially the same direction;

inserting the subcutaneous tines through the skin penetration point and into a subcutaneous region adjacent to an underside of a skin layer while the anchor device is in the folded condition, wherein each of the subcutaneous tines has a shape which terminates at a tip of a free end during insertion through the skin penetration point;

adjusting the anchor device to a non-folded condition after the subcutaneous tines are inserted into the subcutaneous region so that the subcutaneous tines are in an anchored position in which the free ends of the subcutaneous tines extend generally away from one another; and

adhesively securing a medical instrument to the anchor device after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region, wherein the adhesively securing comprises coupling one or more flexible adhesive members of the anchor device with one or more exterior surfaces of the medical instrument by folding at least one of the one or more flexible adhesive members onto itself about an adhesive member fold axis and around an exterior surface of the medical instrument.

2. The method of claim 1, wherein adjusting the anchor device to the non-folded condition comprises adjusting the anchor device along a longitudinal folding region positioned generally centrally between a first body portion of the anchor device and a second body portion of the anchor device.

3. The method of claim 2, wherein a longitudinal fold axis is defined along the longitudinal folding region, the first body portion movable relative to the second body portion about the longitudinal fold axis to adjust the anchor device to the non-folded condition.

4. The method of claim 2, wherein the longitudinal folding region comprises a flexible web portion.

5. The method of claim 3, wherein the one or more flexible adhesive members comprises a flexible adhesive strip.

6. The method of claim 5, wherein the flexible adhesive strip has 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 the flexible adhesive strip is substantially greater than the longitudinal length of the flexible adhesive strip.

7. The method of claim 5, wherein the flexible adhesive strip extends proximally away from proximal ends of the first and second body portions and extend away from the first and second subcutaneous tines.

8. The method of claim 5, further comprising tearing the flexible adhesive strip along a tear strip that extends generally parallel to the longitudinal fold axis.

9. The method of claim 5, wherein the flexible adhesive strip comprises a flexible substrate carrying an adhesive layer along a major surface thereof and a releasable liner over the adhesive layer.

10. The method 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 method of claim 1, wherein the medical instrument comprises a catheter, and wherein the flexible adhesive strip comprises an adhesive layer configured to bond with the one or more exterior surfaces of the medical instrument.

12. The method of claim 1, wherein the at least one flexible adhesive member comprises a flexible adhesive strip that has a lateral width extending generally perpendicular to the adhesive member fold axis and a longitudinal length extending generally parallel to the adhesive member fold axis, wherein the lateral width of the flexible adhesive strip is substantially greater than the longitudinal length of the flexible adhesive strip, and the flexible adhesive strength is attached to a body portion of the anchor device along less than the entire longitudinal length.

13. The method of claim 1, wherein at least one of the one or more flexible adhesive members is positioned between the medical instrument and a body portion of the anchor device when the medical instrument is adhesively secured to the anchor device.

14. A method of using a medical anchor system, the method comprising:

advancing an anchor device toward a skin penetration point while the anchor device is in a folded condition so that a plurality of subcutaneous tines of the anchor device are generally adjacent to each other and oriented to extend in substantially the same direction, the anchor device comprising a retainer body having a first body portion that is coupled to a second body portion about a longitudinal fold region having a longitudinal fold axis;

inserting the subcutaneous tines through the skin penetration point and into a subcutaneous region adjacent to an underside of a skin layer while the anchor device is in the folded condition, wherein each of the subcutaneous tines has a shape which terminates at a tip of a free end during insertion through the skin penetration point;

adjusting the anchor device along the longitudinal fold axis of the longitudinal fold region to a non-folded condition after the subcutaneous tines are inserted into the subcutaneous region so that the subcutaneous tines are in an anchored position in which the free ends of the subcutaneous tines extend generally away from one another; and

adhesively securing a medical instrument to the anchor device after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region by coupling a flexible adhesive strip of the anchor device with one or more exterior surfaces of the medical instrument;

wherein coupling the flexible adhesive strip of the anchor device with one or more exterior surfaces of the medical instrument comprises folding the flexible adhesive strip about an adhesive strip fold axis that is substantially parallel to and offset from the longitudinal fold axis of the longitudinal fold region.

15. The method of claim 14, wherein the flexible adhesive strip has 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 the flexible adhesive strip is substantially greater than the longitudinal length of the flexible adhesive strip.

16. The method of claim 15, wherein the anchor device comprises first and second anchors that extend distally from a distal end of the retainer body, the first and second anchors each comprising one of the plurality of subcutaneous tines.

17. The method of claim 16, wherein the flexible adhesive strip extends proximally away from a proximal end of the retainer body and extends away from the first and second anchors.

18. The method of claim 14, further comprising tearing the flexible adhesive strip along a tear strip that extends generally parallel to the longitudinal fold axis of the retainer body.

19. The method of claim 18, wherein the flexible adhesive strip comprises a flexible substrate carrying an adhesive layer along a major surface thereof and a releasable liner over the adhesive layer.

20. A method of using a medical anchor system, the method comprising:

advancing an anchor device toward a skin penetration point while the anchor device is in a folded condition so that a plurality of subcutaneous tines of the anchor device are generally adjacent to each other and oriented to extend in substantially the same direction;

inserting the subcutaneous tines through the skin penetration point and into a subcutaneous region adjacent to an underside of a skin layer while the anchor device is in the folded condition, wherein each of the subcutaneous tines has a shape which terminates at a tip of a free end during insertion through the skin penetration point;

adjusting the anchor device to a non-folded condition after the subcutaneous tines are inserted into the subcutaneous region so that the subcutaneous tines are in an anchored position in which the free ends of the subcutaneous tines extend generally away from one another; and

adhesively securing a medical instrument to the anchor device after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region, wherein the adhesively securing comprises coupling one or more flexible adhesive members of the anchor device with one or more exterior surfaces of the medical instrument;

wherein adjusting the anchor device to a non- folded condition comprises adjusting the anchor device along a longitudinal folding region positioned generally centrally between a first body portion of the anchor device and a second body portion of the anchor device;

wherein a longitudinal fold axis is defined along the longitudinal folding region, the first body portion movable relative to the second body portion about the longitudinal fold axis to adjust the anchor device to the non-folded condition;

wherein the one or more flexible adhesive members comprises a flexible adhesive strip; and

wherein coupling the one or more flexible adhesive members of the anchor device with one or more exterior surfaces of the medical instrument comprises folding the flexible adhesive strip about an adhesive strip fold axis that is substantially parallel to and offset from the longitudinal fold axis.

21. The method of claim 20, wherein the longitudinal folding region comprises a flexible web portion.

22. The method of claim 20, wherein the flexible adhesive strip has 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 the flexible adhesive strip is substantially greater than the longitudinal length of the flexible adhesive strip.

23. The method of claim 20, wherein the flexible adhesive strip extends proximally away from proximal ends of the first and second body portions and extend away from the first and second subcutaneous tines.

24. The method of claim 20, comprising folding the first adhesive strip upon itself about the adhesive strip fold axis.

25. The method of claim 20, further comprising tearing the flexible adhesive strip along a tear strip that extends generally parallel to the longitudinal fold axis.

26. The method of claim 20, wherein the flexible adhesive strip comprises a flexible substrate carrying an adhesive layer along a major surface thereof and a releasable liner over the adhesive layer.