Dressing Device for use with a Cannula or a Catheter

Abstract

A method of protecting an insertion site permitting passage of a transcutaneous medical device into a patient. The method includes grasping a dressing device, positioning the dressing device over the insertion site, and adhering the dressing device to the patient over the insertion site. The dressing device may include a moisture vapor permeable backing, a polyurethane foam matrix, and an adhesive. The polyurethane foam matrix may be adhered to a first side of the moisture vapor permeable backing, and the adhesive may cover a second side of the moisture vapor permeable backing opposite of the first side. The polyurethane foam matrix can include a polyanhydroglucuronic acid or salt thereof in an amount to achieve a haemostatic effect, and chlorhexidine di-gluconate in an amount of 9% to 16% (w / w) to achieve an antimicrobial effect without adversely affecting wound healing.

Description

PRIORITY[0001]This is a division of U.S. patent application Ser. No. 13 / 808,183, filed Jan. 3, 2013, which is a U.S. national stage application of International Application No. PCT / IE11 / 00034, filed Jul. 4, 2011, claiming the benefit of priority to U.S. Provisional Application No. 61 / 344,403, filed Jul. 14, 2010, each of which is hereby incorporated by reference in its entirety into this application.INTRODUCTION[0002]The present invention relates to a wound device, particularly for use with IV catheters and other percutaneous devices.[0003]Vascular and nonvascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheters, drains, chest tubes, externally placed orthopedic pins, and epidural catheter tubes are widely used in modern day medical practice. Annually more than 20 million inpatients in hospitals in the United States receive intravenous therapy and almost 5 mi...

AI Technical Summary

Benefits of technology

[0005]Catheter use causes a semi-permanent breach of the skin that provides an access point for pathogens to enter the body, placing the patient at risk for local and systemic infectious complications. The potential for infection may be increased by proliferation of bacteria within or underneath the dressing. Studies have shown that between 5% and 25% of IV devices are colonized at the time of removal (Maki et al., 1998). Skin flora is the main source of microbial contamination and is responsible for approximately 65% of catheter related infections. Bacteria from the skin migrate along the external surface of the catheter and colonize the intravascular catheter tip leading to catheter related blood stream infections (Raad et al., 2001; Sheretz et al., 1997). Catheter-related bloodstream infection (CR-BSI) is the third most common health care-acquired infection in the United States and is considered one of the most dangerous complications for patients. In Europe the incidence and density of central venous catheter (CVC) related bloodstream infections ranges from 1-3.1 per 1000 patient days (Suetens et al., 2007). Most organisms responsible for CR-BSIs originate from the insertion site of the catheter (Timsit, 2007), therefore, decreasing bacterial colonization at the site of insertion may help reduce the incidence of CR-BSIs.

[0008]The invention provides a wound dressing device that prevents microbial colonization of the dressing and stops bleeding from the insertion site. The device provides combined hemostatic and antimicrobial effects at the insertion site but without adversely affecting wound healing.

[0020]The invention in one aspect is an absorbent polymeric wound dressing containing a broad spectrum antimicrobial agent and a hemostatic agent with a moisture vapor permeable backing and radial slit and central access hole to allow insertion of an IV catheter line or other similar percutaneous device. The device contains sufficient quantities of the broad spectrum antimicrobial agent to ensure that a clear antimicrobial zone of inhibition can be maintained around the insertion site and to prevent microbial contamination of the dressing. The device also contains sufficient quantities of hemostatic agent in order to successfully control minor bleeding at the insertion site.

[0021]The absorbent polymer foam matrix dressing of the invention rapidly addresses bleeding, prevents dermal wound site contamination and infection while at the same time promoting wound healing. Rapid wound healing and closure in a controlled aseptic (near microbe free) environment provides the optimal conditions for reduced wound site morbidity.

[0024]The invention disclosure described herein identifies a novel device composition which allows for the singular important advantage in being able to attain antimicrobial, hemostatic and wound-healing promoting characteristics in a single absorbent and compliant device system. Normally achieving such functional heterogeneity in one device is not possible due to antagonistic effects of the separate functions on one another. The unique feature of this invention is that it is able to identify and integrate effective ranges for each active component without adversely affecting the functions of the other components.

Problems solved by technology

The addition of chlorhexidine di-gluconate as an antimicrobial agent effective at preventing contamination and infection would be expected to adversely affect wound healing.

We have surprisingly found that this is not the case.

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