Medical article having fluid control film

• US 6,420,622 B1
• Filed: 01/22/1999
• Issued: 07/16/2002
• Est. Priority Date: 08/01/1997
• Status: Expired due to Term

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Hentzen, Charles A., Scholz, Matthew T., Johnston, Raymond P., Heinecke, Steven B.
• Primary Examiner(s): Lewis, Kim M.
• Application Number:
  US09/235,720
• Time in Patent Office: 1,271 Days
• Field of Search: 604/379, 604/380, 604/385.1, 604/383, 604/387, 604/358, 604/378, 428/167, 428/172, 428/213, 428/156, 428/212, 428/332, 428/913, 602/41-59, 128/888, 128/889
• US Class Current: 602/41
• CPC Class Codes: A47L 9/02 Nozzles suction nozzles for fluid transport B65G51/00
• CPC Class Codes: A61B 2046/236 with means for collecting drain fluid, e.g. drain tubes
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61F 13/022 having more than one layer with different fluid retention characteristics
• CPC Class Codes: A61F 13/025 having a special distribution arrangement of the adhesive
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 13/2017 specially adapted for the ear cavity
• CPC Class Codes: A61F 2013/00327 to create projections or depressions in surface
• CPC Class Codes: A61F 2013/00412 for use with needles, tubes or catheters
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/00651 tapered, bevelled or chamfered
• CPC Class Codes: A61F 2013/0077 arranged in lines
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: B01D 2313/08 Flow guidance means within the module or the apparatus
• CPC Class Codes: B01D 39/1692 Other shaped material, e.g. perforated or porous sheets
• CPC Class Codes: B01D 61/18 Apparatus therefor
• CPC Class Codes: B01D 63/08 Flat membrane modules
• CPC Class Codes: B01D 63/088 Microfluidic devices comprising semi-permeable flat membranes
• CPC Class Codes: B05C 17/002 with feed system for supplying material from an external source; Supply controls therefor B05C17/02 takes precedence
• CPC Class Codes: B29C 39/148 : characterised by the shape of the surface
• CPC Class Codes: B29C 43/222 : characterised by the shape of the surface
• CPC Class Codes: B29C 59/022 : characterised by the disposition or the configuration, e.g. dimensions, of the embossments or the shaping tools therefor
• CPC Class Codes: B43K 5/10 : with reserve ink chambers
• CPC Class Codes: C12Q 1/02 : involving viable microorganisms
• CPC Class Codes: F28F 21/065 : the heat-exchange apparatus employing plate-like or laminated conduits
• CPC Class Codes: F28F 2260/02 : having microchannels
• CPC Class Codes: F28F 3/04 : the means being integral with the element
• CPC Class Codes: F28F 3/12 : Elements constructed in the shape of a hollow panel, e.g. with channels F28D1/02, F28D1/03 take precedence
• CPC Class Codes: G01N 35/00009 : provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: Y10S 428/913 : Material designed to be responsive to temperature, light, moisture
• CPC Class Codes: Y10T 428/2457 : Parallel ribs and/or grooves
• CPC Class Codes: Y10T 428/24942 : including components having same physical characteristic in differing degree
• CPC Class Codes: Y10T 428/2495 : Thickness [relative or absolute]

Abstract

The present invention provides medical articles having a fluid control film component which comprise a sheet having microchannels that permit directional flow of a liquid. Articles incorporating the fluid control film include: wound dressings, wound drains, tympanostomy fluid wicks, intravenous access site dressings, drug delivery dressings, and sweat collection patches.

Claims

1. A medical treatment article, comprising:

at least one fluid control film component having at least one microstructure-bearing surface with a plurality of channels therein that permit directional control of a fluid along the channels to transfer the fluid from one area to another, the fluid control film component having an end portion and a fluid handling portion for fluid transfer communication with a medical treatment site that includes a wound, and

a fluid reservoir including absorbent material positioned remote from the fluid handling portion to permit fluid transfer between the absorbent material and the end portion of the fluid control film component, the absorbent material positioned without overlying the fluid handling portion and so that the fluid handling portion of the fluid control film component can be positioned in fluid transfer communication with a medical treatment site without fluid transfer through the absorbent material while allowing for fluid transfer along the plurality of channels between the medical treatment site and the fluid reservoir positioned remote from the medical treatment site.

2. The article of claim 1, wherein the article is selected from the group consisting of wound dressings, wound drains, tympanostomy fluid wicks, intravenous access site dressings, drug delivery dressings, surgical drape, and sweat collection patches.

3. The article of claim 1, wherein the microstructure-bearing surface is hydrophilic.

4. The article of claim 3, wherein the channels are open and each has an included angle Alpha, Alpha being between about 10 and 120 degrees, and the hydrophilic surface has a contact angle with water of Theta, Theta being equal to or less than the sum of 90 degrees minus one-half Alpha.

5. The article of claim 1, wherein the fluid reservoir surrounds the fluid handling portion of the fluid control film component.

6. The article of claim 1, wherein the channels have a cross-sectional geometry selected from the group consisting of V-shaped channels, rectangular-shaped channels or combination V- and rectangular-shaped channels.

7. The article of claim 1, wherein the fluid control film component comprises a plurality of primary channels having at least two secondary channels, each of the secondary channels forming at least one notch.

8. The article of claim 6, wherein the primary channels have a depth of from 50 to 3000 microns and the depth of the secondary channels is from 5 to 50 percent of the depth of the primary channels.

9. The article of claim 1, wherein the channels have an included angle between about 10 degrees and 120 degrees.

10. The article of claim 1, wherein the channels are between about 5 and 3000 microns deep.

11. The article of claim 1, wherein the channels are between about 50 and 1500 microns deep.

12. The article of claim 1, wherein the channels are between about 100 and 1000 microns deep.

13. The article of claim 1, wherein the channels are substantially parallel throughout their length.

14. The article of claim 1, wherein the channels comprise a thermoplastic material selected from the group consisting of polyolefins, polyesters, polyamides, poly(vinyl chloride), polyether esters, polyimides, polyesteramide, polyacrylates, polyvinylacetate, hydrolyzed derivatives of polyvinylacetate and combinations thereof.

15. The article of claim 1, wherein the channels comprise a thermoset material selected from the group consisting of polyurethanes, acrylates, epoxies and silicones.

16. The article of claim 1, wherein the channels comprise a pressure sensitive adhesive material.

17. The article of claim 1, wherein the channels are open along at least a major portion of their length.

18. The article of claim 1, wherein the channels are closed along at least a major portion of their length.

19. The article of claim 1, further comprising a backing layer positioned to overlie the fluid control film component and the fluid reservoir.

20. The article of claim 19, wherein the backing layer comprises an adhesive to adhere the article in position for fluid transfer communication with the medical treatment site.

21. The article of claim 20, wherein the fluid control film comprises a separate piece of film.

22. The article of claim 20, wherein the channels are formed within an adhesive layer of the dressing.

23. The article of claim 20, wherein the channels are formed within a backing layer of the dressing.

24. The article of claim 20, wherein the adhesive comprises a pressure sensitive adhesive.

25. The article of claim 1, wherein the article is a combined wound dressing and wound drain, and the fluid control film component is adapted to be inserted into the medical treatment site.

26. The article of claim 1, wherein the fluid control film component is adapted to a medicament from the fluid reservoir to the medical treatment site.

27. The article of claim 1, wherein the article is a wound drain.

28. The article of claim 27, wherein the fluid control film is branched at one end.

29. The article of claim 27, wherein the fluid control film is adapted to a vacuum generator at one end.

30. The article of claim 1, wherein the article is a tympanostomy wick.

31. The article of claim 30, wherein the wick comprises at least two pieces of fluid control film and the film is bent at one end to form an umbrella end.

32. The article of claim 1, wherein the article is a surgical drape comprising a sheet of drape material and the fluid control film component is positioned to direct fluid toward a collection device selected from the group consisting of absorbent pads and collection pouches.

33. The article of claim 32, wherein at least a portion of the drape is coated with an adhesive.

34. The article of claim 1, wherein the fluid control film component contains at least one aperture therein.

35. The article of claim 1, wherein the article is adapted for visual observation of the site through part of the fluid handling portion of the fluid control film component.

36. The article of claim 35, wherein the fluid control film component is at least translucent.

37. A medical treatment article, comprising:

at least one fluid control film component having at least one microstructure-bearing surface with a plurality of channels therein that permit directional control of a fluid along the channels to transfer the fluid from one area to another, the fluid control film component having an end portion and a fluid handling portion for fluid transfer communication with a medical treatment site, the fluid handling portion including an at least translucent viewing area; and

a fluid reservoir including absorbent material positioned remote from the fluid handling portion to permit fluid transfer between the absorbent material and the end portion of the fluid control film component without significantly obscuring the viewing area of the fluid handling portion,

so that the plurality of channels may transport a fluid between a medical treatment site in fluid transfer communication with the fluid handling portion of the fluid control film component and the fluid reservoir positioned remote from the site while also allowing visual observation of the site through the viewing area of the fluid handling portion.

38. The medical treatment article of claim 37, wherein the fluid control film component is at least translucent.

39. A medical treatment article, comprising:

at least one fluid control film component having at least one microstructure-bearing surface with a plurality of channels therein that permit directional control of a fluid along the channels to transfer the fluid from one area to another, the fluid control film component having an end portion and a fluid handling portion for fluid transfer communication with a medical treatment site;

a fluid reservoir including absorbent material positioned remote from the fluid handling portion to permit fluid transfer between the absorbent material and the end portion of the fluid control film component; and

an adhesive positioned to adhere the article to a medical treatment site so that the plurality of channels may transport a fluid between the medical treatment site in fluid transfer communication with the fluid handling portion of the fluid control film component and the fluid reservoir positioned remote from the site while reducing the influx of microbial contaminants into the medical treatment site.

40. The medical treatment article of claim 39, wherein the adhesive comprises a pressure sensitive adhesive.

41. The medical treatment article of claim 39, further comprising a backing layer overlying the fluid control film component and the fluid reservoir.