Barrier system to reduce the rates of line-related infections

• US 8,945,062 B2
• Filed: 12/12/2008
• Issued: 02/03/2015
• Est. Priority Date: 12/12/2007
• Status: Active Grant

• Current Assignee: University of Kansas
• Original Assignee: University of Kansas
• Inventors: Waller, Stephen
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US12/334,056
• Publication Number:
  US 20090157000A1
• Time in Patent Office: 2,244 Days
• Field of Search: 604/174, 604/180, 604/179, 604/389, 602/52
• US Class Current: 604/180
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/0253 where the catheter is attached by straps, bands or the like secured by adhesives
• 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 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 2039/0294 having a specific shape matching the shape of a tool to be inserted therein, e.g. for easy introduction, for sealing purposes, guide
• CPC Class Codes: A61M 2039/0297 at least part of it being inflatable, e.g. for anchoring, sealing or removing
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• 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
• CPC Class Codes: A61M 5/1418 Clips, separators or the like for supporting tubes or leads
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A barrier system is provided for use in reducing infections associated with a percutaneous medical device, such as a catheter, that is disposed within a percutaneous incision. Such a barrier system can include: a barrier device having a skin-contacting surface and a catheter-receiving surface; and an adhesive composition configured for adhering to skin, the barrier device, and/or the catheter so as to form a barrier at or adjacent to an incision in the skin where the catheter is percutaneously inserted through the skin. The barrier device can include a conduit configured to receive the catheter. Alternatively, the barrier device can include a groove in a base surface that is configured to receive the catheter. A system that includes a medical device, the barrier device, and adhesive can also be provided.

Claims

1. A barrier system for reducing infections associated with a percutaneous medical device, said barrier system comprising:

a barrier device having a skin-contacting surface with an adhesive-receiving surface and a percutaneous medical device-receiving surface;

one or more of an expandable bladder or release cord for releasing the barrier device from skin associated with the skin-contacting surface, the expandable bladder is disposed on the barrier device, or the release cord is disposed on the skin-contacting surface of the barrier device; and

a cyanoacrylate adhesive composition configured for adhering to skin, the barrier device, the one or more of an expandable bladder or release cord, and/or the percutaneous medical device so as to form an antimicrobial barrier at or adjacent to an incision in the skin where the percutaneous medical device is percutaneously inserted through the skin, and wherein the one or more of an expandable bladder or release cord is capable of breaking a cyanoacrylate adhesive-skin bond.

2. The barrier system as in claim 1, wherein the barrier device includes a conduit configured to receive the percutaneous medical device.

3. The barrier system as in claim 2, wherein the barrier device includes a base surface having a base opening that is in fluid communication with the conduit and an opposite surface having an opposite opening that is in fluid communication with the base opening via the conduit.

4. The barrier system as in claim 3, wherein the conduit is substantially orthogonal with the base surface.

5. The barrier system as in claim 3, wherein the conduit is at an angle from about 0 degrees to about 90 degrees with respect to the base surface.

6. The barrier system as in claim 1, wherein the cyanoacrylate is selected from the group consisting of methyl-2-cyanoacrylate, 2-octyl cyanoacrylate, and n-butyl-cyanoacrylate.

7. The barrier system as in claim 1, wherein the barrier device includes a groove in a base surface that is configured to receive the percutaneous medical device.

8. The barrier system as in claim 1, further comprising at least one of the following:

a fastener disposed on the barrier device that is configured for receiving the percutaneous medical device;

one or more fastener straps on the barrier device that is configured to be affixed to the skin outward from the barrier device;

a tapered base opening or opposite opening;

a uniform conduit cross-sectional profile;

a tapered conduit cross-sectional profile;

a recess in the conduit configured for receiving the adhesive;

a recess in the base surface configured for receiving the adhesive;

a groove adjacent with the opposite opening;

an O-ring;

or

a chilling fluid conduit in the barrier device that communicates with a location for receiving the adhesive.

9. A barrier system as in claim 1, wherein the barrier device is disposed on the skin with the adhesive and the one or more of an expandable bladder or release cord therebetween so as to receive the percutaneous medical device protruding from the incision.

10. A catheter system for reducing infections associated with catheters, said catheter system comprising:

a catheter medical device;

a barrier device having a skin-contacting surface with an adhesive-receiving surface and a catheter-receiving surface;

one or more of an expandable bladder or release cord for releasing the barrier device from skin associated with the skin-contacting surface, the expandable bladder is disposed on the barrier device, or the release cord is disposed at least partially in contact with the adhesive composition; and

a cyanoacrylate adhesive composition configured for adhering to skin, the barrier device, the one or more of an expandable bladder or release cord, and/or the catheter so as to form a barrier at or adjacent to an incision in the skin where the catheter is percutaneously inserted through the skin, and wherein the one or more of an expandable bladder or release cord is capable of breaking a cyanoacrylate adhesive-skin bond.

11. The catheter system as in claim 10, wherein barrier device includes a conduit configured to receive the catheter.

12. The catheter system as in claim 11, wherein the barrier device includes a base surface having a base opening that is in fluid communication with the conduit and an opposite surface having an opposite opening that is in fluid communication with the base opening via the conduit.

13. The catheter system as in claim 12, wherein the conduit is substantially orthogonal with the base surface.

14. The catheter system as in claim 12, wherein the conduit is at an angle from about 0 degrees to about 90 degrees with respect to the base surface.

15. The catheter system as in claim 10, wherein the cyanoacrylate is selected from the group consisting of methyl-2-cyanoacrylate, 2-octyl cyanoacrylate, and n-butyl-cyanoacrylate.

16. The catheter system as in claim 10, wherein the barrier device includes a groove in a base surface that is configured to receive the catheter.

17. The catheter system as in claim 10, further comprising at least one of the following:

a fastener disposed on the barrier device that is configured for receiving the catheter;

one or more fastener straps on the barrier device that is configured to be affixed to the skin outward from the barrier device;

a tapered base opening or opposite opening;

a uniform conduit cross-sectional profile;

a tapered conduit cross-sectional profile;

a recess in the conduit configured for receiving the adhesive;

a recess in the base surface configured for receiving the adhesive;

a groove adjacent with the opposite opening;

an O-ring;

a chilling fluid conduit in the barrier device that communicates with a location for receiving the adhesive;

a secondary conduit lined with another material;

or

a secondary conduit filled with another material.

18. A catheter system as in claim 10, wherein the barrier device is disposed on the skin with the adhesive and release member therebetween so as to receive the catheter protruding from the incision.

19. A method for reducing infections associated with percutaneous medical devices, said method comprising:

inserting, percutaneously, a medical device into skin of a subject;

applying a cyanoacrylate adhesive composition to the skin and/or the adhesive-receiving surface of a barrier device having a skin-contacting surface with an adhesive-receiving surface, a percutaneous medical device-receiving surface and one or more of an expandable bladder or release cord, wherein the adhesive receiving surface of the barrier device is separate from the percutaneous medical device-receiving surface such that the adhesive does not simultaneously contact the skin and medical device;

adhering the barrier device to the skin with the cyanoacrylate adhesive composition so as to form an anti-microbial barrier spaced apart from the medical device with respect to the incision and the barrier device, the one or more of an expandable bladder or release cord, and/or the percutaneous medical device medical device to inhibits microbes from infecting the incision, and

breaking a cyanoacrylate adhesive-skin bond by expanding the one or more expandable bladder or pulling the release cord.

20. A method as in claim 19, wherein the adhesive is applied to at least one of the following:

a junction between the barrier device and skin;

a junction between the barrier device, skin, and air;

a junction between the barrier device and medical device;

or

a junction between the barrier device, medical device, and air.

21. A method as in claim 20, wherein the medical device is inhibited from pistoning within the incision.

22. A method as in claim 20, wherein the medical is inhibited from pistoning more than about 2 mm to about 3 mm within the incision.

23. A method as in claim 20, wherein a sterile environment is maintained in and/or proximal to the incision site in the skin while the percutaneous medical device is disposed therein.

24. A method as in claim 19, further comprising applying the cyanoacrylate adhesive composition to the medical device so as to adhere the medical device to the barrier device so as to form an anti-microbial barrier that inhibits microbes from infecting the incision.

25. A method as in claim 19, further comprising applying the cyanoacrylate adhesive onto at least one of the skin-contacting surface or medical device-contacting surface of the barrier device.