Dressing device for use wtih 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: 2013-05-02
BARD ACCESS SYST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025]The invention disclosure described herein identifies a novel device composition which allows for the singular important advantage in being able to attain antimicrobial, haemostatic 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.

Method used

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  • Dressing device for use wtih a cannula or a catheter
  • Dressing device for use wtih a cannula or a catheter
  • Dressing device for use wtih a cannula or a catheter

Examples

Experimental program
Comparison scheme
Effect test

example 1

Haemostatic and Antimicrobial Polyurethane Foam Preparations

[0049]To prepare haemostatic and antimicrobial foam the haemostat polyanhydroglucuronic acid (PAGA) (HemCon Medical Technologies Europe Ltd, Dublin) and the antimicrobial 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 / gExpansion:75%Wrung Retention:1.2 g / g

[0050]The polyurethane foam was produced by firstly producing a prepolymer comprisin...

example 2

Antibacterial Efficacy of Prepared Formulations Calcium Sodium Salt polyanhydroglucuronic Acid and Chlorhexidine di-gluconate in a polyurethane Foam

[0051]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”.

[0052]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.

[0053]The results for gamma-irradiated sterilized testing and non gamma-irradiated testing are presented in Table 2.

TABLE 2Formulations of PAGA impregnated PU foam with increas...

example 3

Device Assembly

[0054]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 vapour permeable backing that comprised of polyurethane film with a MVTR of 1000 gm / m2 / 24 hr (3M) was adhered.

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

[0055]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 centre 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, s...

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Abstract

A wound dressing device for use with a transcutaneous medical device such as a cannula or a catheter comprises a polyurethane matrix which may be covered with a film backing. Chlorhexidine di- gluconate and a polyanhydroglucuronic salt are contained in the polymer matrix. The wound dressing device prevents microbial colonization of the dressing and stops bleeding from the insertion site. The device provides combined haemostatic and antimicrobial effects at the insertion site but without adversely affecting wound healing.

Description

[0001]“A DRESSING DEVICE FOR USE WITH A CANNULA OR A CATHETER”[0002]This is a national stage of PCT / IE11 / 000034 filed Jul. 4, 2011 and published in English, claiming benefit of US provisional application No. 61 / 344,403, filed Jul. 14, 2010, hereby incorporated by reference.INTRODUCTION[0003]The present invention relates to a wound device, particularly for use with IV catheters and other percutaneous devices.[0004]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 million require central venous catheterization (Bouza et al., 2002)[0005]Mechanical complications such as haemorrhage and thrombosi...

Claims

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Application Information

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