Systems and methods for anchoring medical devices

• US 9,662,476 B2
• Filed: 06/07/2016
• Issued: 05/30/2017
• Est. Priority Date: 09/29/2010
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Taylor, Kyle P., Forsberg, Andrew T., Rosenberg, Michael S., Christianson, Mark R.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US15/175,735
• Publication Number:
  US 20160287841A1
• Time in Patent Office: 357 Days
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• 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: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

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. In some implementations, the anchor device can be installed using a technique in which the subcutaneous anchors undergo relatively little or no flexing when being inserted through the skin into the subcutaneous region between the skin and underlying muscle tissue which may be occupied by fatty tissue.

Claims

1. A method of using a medical anchor system, 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 curved 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 layer so that subcutaneous tines are in an anchored position in which the free ends of the subcutaneous tines extend generally away from one another; and

securing a medical instrument to the anchor device after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region.

2. The method of claim 1, wherein the subcutaneous tines have a generally non-stressed and non-flexed shape during insertion through the skin penetration point.

3. The method of claim 2, wherein the subcutaneous tines have the same generally non-stressed and non-flexed shape after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region.

4. The method of claim 3, wherein during the inserting step, the tips of the subcutaneous tines are immediately adjacent to one another so that the tips are the initial portion of the subcutaneous tines to initially advance through the skin penetration point and into the subcutaneous region.

5. The method of claim 1, wherein during the inserting step, the tips of the subcutaneous tines are arranged in a side-by-side position so that the tips are simultaneously inserted through the skin penetration point while the skin penetration point is already occupied by the medical instrument.

6. The method of claim 1, wherein the subcutaneous tines are inserted through the skin penetration point without another component of the anchoring device applying a stress to flex the subcutaneous tines.

7. The method of claim 1, wherein when the subcutaneous tines are adjusted to the anchored position in the subcutaneous region, each of the subcutaneous tines has longitudinal convexly curved portion extending toward the tip at the free end, and the longitudinal convexly curved portion abuts against the underside of the skin layer.

8. The method of claim 1, wherein the step of inserting comprises inserting the subcutaneous tines through the skin penetration point that is already occupied by the medical instrument.

9. The method of claim 1, further comprising removing the anchor device from the skin penetration point by adjusting the anchor device to the folded condition once again so that the subcutaneous tines shift from the anchored position to a removal position in which the subcutaneous tines are generally adjacent to each other and oriented to extend in substantially the same direction.

10. The method of claim 1, wherein the anchor device comprises a retainer base to releasably secure with an external portion of the medical instrument, and a cap that is releasably attachable to the retainer base so as to define a channel therebetween that is sized to retain the external portion of the medical instrument.

11. The method of claim 10, wherein the cap includes a first mounting structure to releasably attach to a first mating structure of a first body portion of the retainer base, and a second mounting structure to releasably attach to a second mating structure of a second body portion of the retainer base.

12. The method of claim 11, wherein in the folded condition the retainer base is folded about a longitudinal fold axis substantially parallel to a longitudinal axis of the anchor device, and the first and second mating structures are positioned on opposite sides of the longitudinal fold axis of the retainer base.

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

advancing an anchor device toward a skin penetration point while the anchor device is in a folded condition, the anchor device comprising;

first and second anchors each having a longitudinal shaft portion and a flexible subcutaneous tine configured to be deployed through the skin penetration point and into a subcutaneous region along an underside of a skin layer;

a retainer base that is folded along a longitudinal axis when the anchor device is in the 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; and

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 curved 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 layer so that subcutaneous tines are in an anchored position in which the free ends of the subcutaneous tines extend generally away from one another; and

securing a medical instrument to the anchor device after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region.

14. The method of claim 13, wherein the longitudinal shaft portion of each of the first and second anchors extends distally in a longitudinal direction from a distalmost end of the retainer base.

15. The method of claim 14, wherein the longitudinal shaft portion of the first anchor is positioned entirely on an opposite side of the longitudinal fold axis from the longitudinal shaft portion of the second anchor when the anchor device is in a folded condition.

16. The method of claim 14, wherein during the inserting step, the tips of the subcutaneous tines are immediately adjacent to one another so that the tips are the initial portion of the subcutaneous tines to initially advance through the skin penetration point and into the subcutaneous region.

17. The method of claim 16, wherein the subcutaneous tines have a generally non-stressed and non-flexed shape during insertion through the skin penetration point.

18. The method of claim 17, wherein the subcutaneous tines have the same generally non-stressed and non-flexed shape after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region.

19. The method of claim 18, further comprising removing the anchor device from the skin penetration point by adjusting the anchor device to the folded condition once again so that the subcutaneous tines shift from the anchored position to a removal position in which the subcutaneous tines are generally adjacent to each other and oriented to extend in substantially the same direction.

20. The method of claim 19, wherein the anchor device comprises a cap that is releasably attachable to the retainer base so as to define a channel therebetween that is sized to retain the external portion of the medical instrument.