Antimicrobial dressing providing percutaneous device securement and cover

Patent metadata

Field	Value
Publication number	US-9238123-B2
Application number	US-95262810-A
Country	US
Kind code	B2
Filing date	Nov 23, 2010
Priority date	Nov 23, 2010
Publication date	Jan 19, 2016
Grant date	Jan 19, 2016

Abstract

The present invention is related to a polymeric vehicle for delivery of bioactive agents, and preferably, for the delivery of one or more bioactive agents. The invention is also directed to a percutaneous device securing and drug delivery device comprising, as a component thereof, a material which delivers antimicrobial and/or other wound-healing factors at the site of the insertion of the catheter into the body. The device, when applied as described herein, provides complete anti-microbial coverage around the entry point of a percutaneous device and, preferably for a length greater than the diameter of the device. The present invention is also directed to methods for using such devices in combination with percutaneous devices primarily to reduce site infections.

First claim

We claim:

1. A percutaneous device dressing for use with a percutaneous medical device that has punctured the skin of a patient and which has a portion of the percutaneous medical device protruding from the skin, comprising:
a) a dressing body formed from a flexible material and having upper and lower surfaces and an exterior side wall, with the lower surface being skin facing in use,
b) a channel formed in a region between the lower and upper surfaces of the dressing body and extending to the exterior side wall, the channel adapted to accept the percutaneous medical device protruding from the skin, wherein the channel has a shape that surrounds at least a portion of the percutaneous medical device protruding from the skin;
c) a bioactive agent that is incorporated into the dressing body and/or onto the lower surface of the dressing body, and
d) a gap within the lower surface, the gap providing an opening of the channel to the lower surface,
wherein the gap is adapted to allow positioning of the dressing over the percutaneous medical device,
wherein the gap is adapted to allow the percutaneous medical device to be at least partially disposed within the channel,
wherein said channel is machined, cut, or molded within said dressing body, wherein said gap is aligned with said channel and runs along the entire length of said channel, and
wherein said gap is positioned in the lower surface and radiates from a substantially central point of the dressing body to the exterior side wall, and
wherein said gap is positioned symmetrically in the center of said channel.

2. A dressing according to claim 1 wherein the bioactive agent is an antimicrobial agent.

3. A dressing according to claim 2 wherein said antimicrobial agent comprises chlorhexidine.

4. A dressing according to claim 3 , wherein the dressing is secured to the skin of a patient by an adhesive disposed on the lower surface, by an overdressing layer, or combinations thereof.

5. A dressing according to claim 3 , wherein the channel has an entrance on the exterior side wall of the dressing body and an exit on the lower surface of the dressing body.

6. A dressing according to claim 5 , wherein the gap has a width equal to or less than the width of the channel.

7. A dressing according to claim 6 , wherein the entrance of the channel is flared, and wherein the entrance is adapted to accommodate coupling or connectors with the percutaneous medical device.

8. A dressing according to claim 1 , further comprising a semi-solid material disposed within the channel,
wherein the semi-solid material is a sealant, an anti-microbial ointment, or combination thereof, and
wherein the semi-solid material is optionally photo cross-linkable.

9. A dressing according to claim 8 , further comprising a compartment formed within the lower surface,
wherein the compartment is in fluid communication with the channel,
wherein the compartment is filled with the semi-solid material.

10. A dressing according to claim 1 , wherein the dressing has a plurality of grooves in the lower surface.

11. A dressing according to claim 1 , wherein the dressing body has an upper portion and a lower portion, the upper portion and the lower portion being foldably linked,
wherein for application and use, the upper portion is folded onto the lower portion,
wherein the lower portion comprises the gap and the upper portion comprises the channel.

12. A dressing according to claim 1 , wherein the dressing body comprises a lower subunit, a middle subunit, and an upper subunit,
wherein the lower subunit forms the lower surface and has the gap that radiates from a substantially central point on the lower subunit to the exterior sidewall,
wherein the middle subunit has the channel that radiates from a substantially central point on the middle subunit, wherein the upper subunit forms the upper surface, wherein the gap and the channel are aligned, and wherein the lower subunit, the middle subunit, and the upper subunit are optionally adhesively joined together.

13. A method of dressing the puncture she of a percutaneous medical device that has punctured the skin of a patient and which has a portion of the percutaneous medical device protruding from the skin, comprising the steps of
a) providing a dressing body formed from a flexible material and having upper and lower surfaces, an exterior side wall, and a channel formed in a region between the lower and upper surfaces of the dressing body and extending to the exterior side wall, said dressing body having a gap within the lower surface, the gap providing an opening of the channel to the lower surface,
wherein said channel is machined, cut, or molded within said dressing body, wherein said gap is aligned with said channel and which runs along the entire length of said channel,
wherein said gap is positioned symmetrically in the center of said channel,
wherein said gap is positioned in the lower surface and radiates from a substantially central point of the dressing body to the exterior side wall, and
wherein the gap is adapted to allow positioning of the dressing over the percutaneous medical device and adapted to allow the percutaneous medical device to be at least partially disposed within the channel,
b) positioning the dressing body over the puncture site with the lower surface facing the skin, and
c) sliding the percutaneous medical device into the channel, allowing the channel to accept at least a portion of the percutaneous medical device protruding from the skin to cover a perimeter region around the puncture site proximate to percutaneous medical device protruding from the skin with the dressing body.

14. A method according to claim 13 , wherein dressing body further comprises a bioactive agent that is an antimicrobial agent.

15. A method according to claim 14 , wherein said antimicrobial agent comprises chlorhexidine.

16. A method according to claim 15 , further comprising the step of securing the dressing body to the skin of a patient by an adhesive disposed on the lower surface, by an overdressing layer, or combinations thereof.

17. A method according to claim 16 , wherein the overdressing layer is an adhesive film.

18. A method according to claim 16 wherein the dressing body further comprises a compartment that is in fluid communication with the channel and contains a semi-solid material, further comprising the step of pressing on the upper surface of the dressing body and releasing the semi-solid material from the compartment into the channel after the step of covering a perimeter around the puncture site proximate to percutaneous medical device protruding from the skin with the dressing body, wherein the semi-solid material is a sealant, an anti-microbial ointment, or combination thereof.

19. A method according to claim 13 , further comprising the step of disposing a semi-solid material within the channel, wherein the semi-solid material is a sealant, an anti-microbial ointment, or combination thereof.

Assignees

• Weadock Kevin
• Kriksunov Leo B
• Ethicon Inc

Inventors

• Weadock Kevin
• Kriksunov Leo B

Classifications

• A61M25/02 Primary

  Holding devices, e.g. on the body · CPC title

• A61M2025/0253

  where the catheter is attached by straps, bands or the like secured by adhesives · CPC title

• A61M2025/028

  having a mainly rigid support structure · CPC title

• A61M2025/0056

  provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir · CPC title

• A61M2025/0273

  having slits to place the pad around a catheter puncturing site · CPC title