SYSTEMS AND METHODS FOR ANCHORING MEDICAL DEVICES

• US 20140107584A1
• Filed: 10/11/2012
• Published: 04/17/2014
• Est. Priority Date: 10/11/2012
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Christianson, Mark R.
• Granted Patent: US 9,314,596 B2
• Time in Patent Office: Days
• US Class Current: 604/178
• 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 pivotably coupled to a second body portion about a longitudinal fold axis, and one or more anchor engagement portions being configured to releasably receive one or more corresponding apertures defined by a hub of a catheter; 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 pivotable relative to the second body portion about the longitudinal fold axis 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.

2. The anchor device of claim 1, wherein the one or more anchor engagement portions each comprise a retention post that extends from the retainer body at an angle that is generally transverse to the longitudinal fold axis.

3. The anchor device of claim 2, wherein the retention post comprises a stem portion that is connected to the retainer body and that has a first lateral width, and a bulbous end portion that has a second lateral width greater than the first lateral width of the stem portion.

4. The anchor device of claim 3, wherein the bulbous end portion comprises a substantially planar face on one side of the bulbous end portion.

5. The anchor device of claim 1, wherein the retainer body further comprises sloped nose region have 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.

6. The anchor device of claim 1, wherein the retainer body comprises a flexible web portion positioned generally centrally between the first and second body portions and extending extend 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 the longitudinal fold axis.

7. The anchor device of claim 6, wherein the first body portion and the second body portion include first and second tabs, respectively, at a proximal end of the retainer body, wherein the first and second tabs define cutout region 165 therebetween to provide visualization and access to a surface under the retainer body.

9. The anchor device of claim 1, wherein the one or more anchor engagement portions comprise a first retention post extending upwardly from the retainer body on a first side of the longitudinal fold axis and a second retention post extending upwardly from the retainer body on a second side of the longitudinal fold axis.

8. 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 pivotably coupled to a second body portion about a longitudinal fold axis, and one or more anchor engagement portions being configured to mate with an external structure of a medical instrument to releasably secure the medical instrument to the retainer body; 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 pivotable relative to the second body portion about the longitudinal fold axis 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.

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

an adapter including;

a hub portion that is elastically deformable and configured to substantially surround and releasably engage with the outer surface of medical instrument, and a second portion having one or more engagement members extending outwardly from the hub portion; and

an anchor device comprising;

a retainer body comprising a first body portion that is pivotably coupled to a second body portion, and one or more anchor engagement portions being configured to releasably couple with the one or more engagement members extending outwardly from the hub portion of the adapter;

first and second anchors that extend distally from a distal end of the retainer body, each anchor comprising a flexible time 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 pivotable relative to the second body portion so that the first and second anchors are adjustable from one another to a removal configuration in which the flexible tines extend generally in the same direction.

11. The system of claim 10, wherein the hub portion of the adapter is configured to releasably engage with the outer surface of a catheter using a friction grip.

12. The system of claim 11, wherein the hub portion of adapter comprises a longitudinal slit that is configured to open to receive a portion of the catheter.

13. The system of claim 11, wherein the one or more anchor engagement portions each comprise a retention post that extends from the retainer body at an angle that is generally transverse to the longitudinal fold axis.

14. The system of claim 13, wherein the retention post comprises a stem portion that is connected to the retainer body and that has a first lateral width, and a bulbous end portion that has a second lateral width greater than the first lateral width of the stem portion.

15. The system of claim 14, wherein the bulbous end portion comprises a substantially planar face on one side of the bulbous end portion.

16. The system of claim 13, wherein the second portion of the adapter comprises one or more apertures that are configured to receive the retention post of the one or more anchor engagement portions.

17. The system of claim 11, wherein the retainer body further comprises sloped nose region have 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.

18. The system of claim 11, wherein the retainer body comprises the flexible web portion positioned generally centrally between the first and second body portions and extending extend 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 the longitudinal fold axis.

19. The system of claim 18, wherein the first body portion and the second body portion include first and second tabs, respectively, at a proximal end of the retainer body, wherein the first and second tabs define cutout region therebetween to provide visualization and access to a surface under the retainer body.

20. A kit of components for securing the position of a catheter relative to a penetration point, the kit comprising:

a sterile package containing two or more adapters having a hub portion with differently shaped or sized longitudinal lumens, each of the two or more adapters in the sterile package comprising;

an elastically deformable material to permit access to the respective longitudinal lumen, a one or more flanges extending outwardly away from the hub portion, wherein the hub portion includes a longitudinal slit through a wall portion to permit access to the respective longitudinal lumen, and wherein the one or more flanges each include an adapter engagement portion configured to releasably engage with retention posts of an anchor device.

21. The kit of claim 20, further comprising an anchor device contained in the sterile package, the anchor device comprising:

a retainer body with a first body portion that is pivotably coupled to a second body portion, and one or more anchor engagement portions configured to releasably couple with one or more corresponding adapter engagement portions, and

first and second anchors that extend distally from a distal end of the retainer body, each anchor comprising a flexible time 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 pivotable relative to the second body portion so that the first and second anchors are adjustable from one another to a removal configuration in which the flexible tines extend generally in the same direction.

22. A kit of components for securing the position of a catheter relative to a penetration point, the kit comprising a sterile package containing an anchor device and a catheter including a hub having one or more apertures configured to releasably mate with the anchor device, wherein the anchor device comprising:

a retainer body including a first body portion that is pivotably coupled to a second body portion, and one or more anchor engagement portions being configured to releasably couple with the one or more apertures on the hub of the catheter, and

first and second anchors that extend distally from the retainer body, each anchor comprising a flexible time 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 pivotable relative to the second body portion so that the first and second anchors are adjustable from one another to a removal configuration in which the flexible tines extend generally in the same direction.

23. 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 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, wherein the securing comprises coupling one or more protrusions extending from the anchor device with one or more apertures located on the medical instrument.