IP Library › Granted Patent US 12,076,215
Granted Patent B2
US 12,076,215 · App. 16/891,632 · Granted Sep 3, 2024

Methods and devices to disrupt and contain pathogens

Inventors: Daniel Metcalf (Deeside, GB); Manjunath Penagondla (Deeside, GB)
Assignee: CONVATEC LIMITED
A61F13/0213A61F13/00063A61F13/0206A61F13/0223A61F13/0226A61L15/28A61L15/425A61L15/48A61L15/56A61L15/60A61F2013/0094A61L2300/404
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Quick Facts
Patent No.
US 12,076,215
App. No.
16/891,632
Filed
Jun 3, 2020
Granted
Sep 3, 2024
Kind
B2
Art Unit
3781
USPC
604/543
Abstract

Provided herein are fabric materials and debridement devices comprising gel-forming hydrofibres for disrupting a biofilm, loosening, or sequestering unwanted materials from wounds, and uses thereof. In particular, debridement and detection devices for selective and atraumatic removal of unwanted tissues and for detection of a wound infection are provided.

Claims (43)

1. A debridement device having a wound contacting layer for debridement of a wound, the debridement device comprising:

a stick comprising an end portion defining a base layer, wherein the base layer is flat;

a layer of gel-forming fibres surrounding the base layer; and

a layer of bristles in direct contact with the gel-forming fibres, wherein the layer of bristles surrounds the layer of gel-forming fibres;

wherein the layer of bristles is configured to directly contact the wound and is directly adjacent the layer of gel-forming fibres; and

wherein the layer of gel-forming fibres is partially positioned on opposite sides of the flat base layer.

2. The device of claim 1 , wherein the layer of bristles comprises a pile of monofilaments or fibres.

3. The device of claim 2 , wherein the layer of bristles comprises nylon, acetal, polypropylene, acrylic, polyvinyl chloride (PVC), polycarbonate, silicone, wool, or any combination thereof.

4. The device of claim 1 , wherein the layer of bristles comprises filaments arranged perpendicular to the wound contacting layer.

5. The device of claim 1 , wherein the layer of gel-forming fibres are woven or knitted.

6. The device of claim 1 , wherein the layer of gel-forming fibres have an absorbency between 10 g/g and 50 g/g, and resists lateral spread of a fluid upon absorption.

7. The device of claim 1 , further comprising anti-biofilm agents, metal chelators, surfactants, or any combination thereof.

8. The device of claim 1 , further comprising one or more support layers in contact with the layer of gel-forming fibres, wherein the support layer comprises foam, fabric, blended fabric, paper, polymer, plastic, or any combination thereof.

9. The device of claim 1 , further comprising a diagnostic unit in fluid communication with the layer of gel-forming fibres, wherein the diagnostic unit comprises at least one of an enzyme-based assay or an electronic sensor.

10. The device of claim 9 , wherein the diagnostic unit comprises one or more diagnostic disks, comprising:

a) a reaction layer comprising one or more reagents configured to interact with a target enzyme indicative of a microbial infection, wherein the reagents are affixed to a solid phase;

b) each reagent is sprayed, printed, or deposited in a reagent area separated by impermeable separators;

c) each reagent area comprises a reporter area wherein a color, color change, or other detectable signal is observed; and

d) a transparent cover comprising a window for visualizing the signal in the reporter area.

11. The device of claim 9 , wherein the fluid communication comprises one or more of a wicking material that comprises hydrophilic fibres, gelling fibres, or filter paper.

12. The device of claim 1 , wherein the layer of gel-forming fibres is configured to absorb material dislodged by the bristles during debridement of the wound.

13. The device of claim 12 , wherein the material is operable to pass through the bristles directly from the wound to the layer of gel-forming fibres.

14. The device of claim 1 , wherein the layer of gel-forming fibres circumferentially surrounds the base layer.

15. A method of detecting a wound infection, comprising:

providing the debridement device of claim 1 ;

debriding a wound using the debridement device;

extracting a sample of wound tissue from the debridement device; and

analyzing the sample for presence of a microbial infection using a diagnostic assay.

16. The method of claim 15 , wherein the extracting and analyzing step comprises utilizing one or more diagnostic disk that utilizes a wicking material to be in fluid communication with the debridement device, the diagnostic disks comprising a reaction layer with one or more reagents that are configured to interact with a target enzyme indicative of a microbial infection, wherein each reagent is aligned with a reporter area wherein a color, color change, or other detectable signal is observable as part of the analyzing step.

17. The method of claim 15 , further comprising applying a wound dressing with an antimicrobial agent according to the diagnostic assay.

18. A kit for debridement of a wound, comprising:

the debridement device of claim 1 ;

a solution for assisting in debridement of the wound comprising one or more of antimicrobial agents, anti-biofilm agents, metal chelators, or surfactants; and

a treating agent comprising at least one of an antimicrobial or an anti-biofilm composition.

19. The kit of claim 18 , further comprising: a diagnostic unit in fluid communication with the debridement device, wherein the diagnostic unit comprises at least one of an enzyme-based assay, an electronic sensor, or one or more reagents for indicating infection of the wound.

20. The kit of claim 18 , further wherein the wound contacting layer comprises one or more foams.

21. A debridement device, comprising:

a stick comprising an end portion having an outer perimeter; and

a wound-contacting layer for debridement of a wound, the wound-contacting layer consisting essentially of:

a plurality of bristles operable to directly contact the wound; and

a layer of gel-forming fibres in direct contact with the plurality of bristles;

wherein the layer of gel-forming fibres completely circumferentially surrounds the outer perimeter of the end portion.

22. A debridement device comprising the wound-contacting layer of claim 21 , the debridement device further comprising a support layer positioned behind the layer of gel-forming fibres.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 17, 2020
From: METCALF, DANIEL; PENAGONDLA, MANJUNATH
To: CONVATEC LIMITED
Reel/Frame 052960/0778 →
Continuity (2)
Provisional Application 62856676 · Jun 3, 2019
Related Publication 20200375802A1 · Dec 3, 2020