Wound cleansing apparatus with scaffold

• US 20070066945A1
• Filed: 10/28/2004
• Published: 03/22/2007
• Est. Priority Date: 10/28/2003
• Status: Active Grant

• Current Assignee: Smith & Nephew PLC
• Original Assignee: Smith & Nephew PLC
• Inventors: Martin, Robin
• Granted Patent: US 7,699,830 B2
• Time in Patent Office: Days
• US Class Current: 604/313
• 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: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/917 specially adapted for covering whole body parts
• CPC Class Codes: A61M 1/92 with liquid supply means
• CPC Class Codes: A61M 1/94 with gas supply means
• CPC Class Codes: A61M 1/96 Suction control thereof
• 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: A61M 3/0212 after use
• CPC Class Codes: A61M 3/0216 Pressure
• CPC Class Codes: A61M 3/0229 Devices operating in a closed circuit, i.e. recycling the irrigating fluid
• CPC Class Codes: Y10T 137/6055 With head and stem collections
• CPC Class Codes: Y10T 137/789 Central mount

Abstract

An apparatus for cleansing and applying therapy or prophylaxis to wounds, in which irrigant fluid containing a physiologically active material from a reservoir connected to a conformable wound dressing and wound exudate from the dressing are recirculated by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing. A biodegradable scaffold underlies the dressing on the wound bed to promote tissue growth. The cleansing means (which may be a single-phase, e.g. micro-filtration, system or a two-phase, e.g. dialytic system) removes materials deleterious to wound healing, and the cleansed fluid, still containing materials that are beneficial in promoting wound healing, is returned to the wound bed. The dressing, an assembly comprising the dressing and scaffold, and a method of treatment using the apparatus.

Claims

1. An apparatus for aspirating, irrigating and/or cleansing wounds, characterised in that it comprises

a) a fluid flow path, comprising

i) a conformable wound dressing, having

a backing layer which is capable of forming a relatively fluid-tight seal or closure over a wound and

at least one inlet pipe for connection to a fluid supply tube, which passes through and/or under the wound-facing face, and

and at least one outlet pipe for connection to a fluid offtake tube, which passes through and/or under the wound-facing face,

the point at which the or each inlet pipe and the or each outlet pipe passes through and/or under the wound-facing face forming a relatively fluid-tight seal or closure over the wound,

at least one inlet pipe being connected to a fluid recirculation tube,

and at least one outlet pipe being connected to a fluid offtake tube:

ii) a means for fluid cleansing having at least one inlet port connected to a fluid offtake tube and at least one outlet port connected to a fluid recirculation tube; and

iii) a biodegradable scaffold located under the backing layer and configured to be placed in contact with a wound bed in use;

b) a fluid reservoir connected by a fluid supply tube to an integer of the flow path (optionally or as necessary via means for flow switching between supply and recirculation);

c) a device for moving fluid through the wound dressing and means for fluid cleansing, and optionally or as necessary the fluid supply tube; and

e) means for bleeding the flowpath,

such that fluid may be supplied to fill the flowpath from the fluid reservoir via the fluid supply tube (optionally or as necessary via the means for flow switching) and recirculated by the device through the flow path.

2. An apparatus according to claim 1, characterised in that the biodegradable scaffold comprises a three-dimensional mesh, sponge or felt.

3. An apparatus according to claim 1, characterised in that the biodegradable scaffold comprises a poly(hydroxy acid) or ester thereof selected from poly(glycolic acid), poly(L-lactic acid), poly(D-lactic acid) and esters thereof, or copolymers or blends thereof.

4. An apparatus according to claim 1, characterised in that the biodegradable scaffold comprises a biologically sourced biodegradable substantially protein based polymer selected from collagens, fibronectins, or fibrins, as whole molecules or derivatives thereof from proteolytic or chemical treatments, or blends thereof;

or a biodegradable substantially protein based polymer selected from collagens, fibronectins, or fibrins, or fragments thereof, produced through recombinant DNA techniques, or blends thereof.

5. An apparatus according to claim 1, characterised in that it comprises a means for fluid cleansing that is a single-phase system, in which the circulating fluid from the wound passes through the means for fluid cleansing and materials deleterious to wound healing are removed, without the circulating fluid coming into direct or indirect contact with another fluid in the means for fluid cleansing.

6. An apparatus according to claim 1, characterised in that it comprises a means for fluid cleansing that is a two-phase system, in which the circulating fluid from the wound passes through the means for fluid cleansing and materials deleterious to wound healing are removed, by the circulating fluid coming into direct or indirect contact with another fluid in the means for fluid cleansing.

7. An apparatus according to claim 3, characterised in that in the means for fluid cleansing, the circulating fluid from the wound and the other fluid in the means for fluid cleansing are separated by an integer which is selectively permeable to materials deleterious to wound healing.

8. An apparatus according to claim 3, characterised in that in the means for fluid cleansing, the circulating fluid from the wound and the other fluid in the means for fluid cleansing are separated by an integer which is not selectively permeable to materials deleterious to wound healing, and the other fluid comprises and/or is in contact with a material that removes materials deleterious to wound healing.

9. A conformable wound dressing assembly for use in an apparatus according to claim 1, characterised in that it comprises a dressing as recited in claim 1 and a biodegradable scaffold.

10. A method of treating wounds to promote wound healing using the apparatus for aspirating, irrigating and/or cleansing wounds according to claim 1.