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Dressing Device for use with a Cannula or a Catheter

a dressing device and cannula technology, applied in the field of wound devices, can solve the problems of adversely affecting wound healing, not the case, and achieve the effect of not adversely affecting the function

Inactive Publication Date: 2020-03-05
BARD ACCESS SYST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention is a wound dressing that prevents bacteria and bleeding while promoting wound healing. It contains a broad spectrum antimicrobial agent and a hemostatic agent, which helps control bleeding and prevent infection. The dressing is made with an absorbent polymer foam matrix that is compliant and can be easily inserted into wounds. The dressing attains antimicrobial, hemostatic, and wound-healing promoting characteristics in a single system, which is difficult to achieve with separate devices.

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.

Method used

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  • Dressing Device for use with a Cannula or a Catheter
  • Dressing Device for use with a Cannula or a Catheter
  • Dressing Device for use with a Cannula or a Catheter

Examples

Experimental program
Comparison scheme
Effect test

example 1

Hemostatic and Antimicrobial Polyurethane Foam Preparations

[0048]To prepare hemostatic and antimicrobial foam the hemostat polyanhydroglucuronic acid (PAGA) (HemCon Medical Technologies Europe Ltd, Dublin) and the antimi-crobial compound chlorhexidine di-gluconate (CHG) (Kapp Technologies LLC, New Jersey) were used. Polyurethane foam dressings were prepared with varying concentrations of PAGA and CHG relative to the final dry weight of polyurethane foam. The polyurethane foam used is type MS50P(w) Lendell medical foam available from Filtrona Porous Technologies (www.filtronaporoustechnologies.com)

Usable Width:15 inches (381 mm)Thickness:0.22 inches (5.6 mm)% Moisture:2%Density:6.0 pcf (96 Kg / m3)Tensile Strength:51.0 psi (352 kPa)Target Elongation:194%Tear Strength:5.6 pli (0.98 kN / m)CDF@50%:0.74 psi (5.14 kPa)Durometer:47 shoreCell Size:131 ppiAbsorption:15 g / gExpansion75%Wrung Retention:1.2 g / g

[0049]The polyurethane foam was produced by firstly producing a prepolymer comprising a p...

example 2

Antibacterial Efficacy of Prepared Formulations Calcium Sodium Salt Polyanhydroglucuronic Acid and Chlorhexidine Di-Gluconate in a Polyurethane Foam

[0050]Polyurethane foam matrix dressings were prepared with the calcium sodium salt of polyanhydroglucuronic acid (15% w / w) and w / w percentages of CHG at 0%, 5%, 11%, 15%, 23% and 30% as presented in Example 1. These formulations were investigated for their antibacterial efficacy against methicillin-resistant Staphylococcus aureus (MRSA) using AATCC Test Method 100 “Assessment of Antibacterial Finishes on Textiles”.

[0051]Analysis of FIG. 1 indicates that the acceptable minimum low range of chlorhexidine di-gluconate percentage weight fraction in the polyurethane foam matrix is 9% (20 mg) to 16% (35 mg) w / w since this range achieves the acceptable>Log 4 reduction.

[0052]The results for gamma-irradiated sterilized testing and non-gamma-irradiated testing are presented in Table 2.

TABLE 2Formulations of PAGA impregnated PU foamwith increasing...

example 3

Device Assembly

[0053]A catheter access site dressing device to control bleeding was prepared by impregnating calcium sodium salt of polyanhydroglucuronic acid into polyurethane foam. CHG was incorporated to achieve an antimicrobial efficacy of greater than 4 log in 24 hours. A formulation as described in Table 3 was prepared and a moisture vapor permeable backing that comprised of polyurethane film with a MVTR of 1000 gm / m2 / 24 hour (3M) was adhered.

TABLE 3IV site device compositionFormulation (% w / w)Ingredientsfinal formulationChlorhexidine gluconate11Calcium-sodium polyanhydroglucuronic acid8Hydrophillic flexible polyurethane foam81

[0054]The polyurethane foam matrix was die cut into 25. mm diameter disks with a central 4 mm diameter section removed from each disk. A radial slit was also punched from the center of the disk to the outside of the disk. The slit and 4 mm punch are designed to allow catheter access. The dressing is sterilized by gamma irradiation between 25 and 45 kGy, ...

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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...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F13/00A61L15/46A61L15/26
CPCA61L15/46A61L15/26A61F13/00063A61L2300/206A61L2300/404A61L2400/04A61L2300/232A61L2300/45A61L2300/418C08L75/04
Inventor DONNELLAN, PETERNI BEILIU, MARIEREAL, KEITH
Owner BARD ACCESS SYST
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