Gradient wound treatment system and method

• US 7,645,269 B2
• Filed: 09/19/2006
• Issued: 01/12/2010
• Est. Priority Date: 04/30/2001
• Status: Expired due to Term

• Current Assignee: KCI Licensing Incorporated (3M Company)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Zamierowski, David S.
• Primary Examiner(s): KIDWELL, MICHELE M
• Application Number:
  US11/523,672
• Publication Number:
  US 20070038172A1
• Time in Patent Office: 1,211 Days
• Field of Search: 604304-308, 604/313, 604317-327, 604540-544, 604/378, 604/24, 604/40
• US Class Current: 604/305
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/92 with liquid supply means
• 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 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15

Abstract

A wound therapy and tissue management system utilizes fluid differentiation. Fluid is differentiated by establishing a gradient within the system. A gradient can be established with matter or energy. Patient interfaces for establishing, maintaining and varying one or more gradients include transfer elements with first and second zones having different flow coefficients. The transfer elements exchange fluid with a patient, generally through a wound site, and with external components of the system. Osmotic solution gradients are controlled by a methodology involving the present invention for extracting solutions, which can include toxins, from patients and for introducing fluids and sumping air to wound sites.

Claims

1. An osmotic transducer system, which includes:

a base element including a transducer component adapted for fluidic communication with a wound and a semi-permeable cover adapted for placement over the transducer component;

a central space formed by the cover and patient tissue structure, said transducer component being located in said central space;

an osmotic gradient formed with said base element and adapted for manipulating fluid elements whereby a pressure gradient is formed to produce useful fluid flow; and

said gradient being formed by the manipulation of osmotic, capillary, atmospheric and gas partial pressures with externally-applied fluid pressure comprising either vacuum (negative) pressure or applied (positive) pressure.

2. The system according to claim 1 wherein said cover has a configuration chosen from among the group comprising:

impervious, semi-permeable and permeable.

3. The system according to claim 1, which includes:

a vacuum source connected to said base element and forming a pressure gradient in said transducer component.

4. A gradient system for treating a wound, which system includes:

an inner pressure transducer including first and second flexible sheets positioned in generally overlying relation and forming longitudinal and transverse inner pressure transducer edges;

multiple spot connections fixedly interconnecting said first and second sheets and each including multiple perforations extending through said first and second sheets;

said sheets forming multiple, interconnected pockets therebetween whereat said sheets are adapted for separation under positive fluid pressure and said pockets define a fluid passage interstitial space between said sheets;

first and second manifolds attached to said first and second sheets along respective inner pressure transducer edges, said manifolds fluidically communicating with said pockets along respective said inner pressure transducer edges and each including an inlet/outlet port;

an outer pressure transducer comprising a porous foam material forming capillary, osmotic and atmospheric pressure gradients;

said outer pressure transducer being located over said inner pressure transducer in fluidic communication therewith;

a flexible cover placed over said outer pressure transducer and including a perimeter adapted for a adhesively securing to a patient around said wound;

said inner and outer pressure transducers and said cover forming a base element with a central space generally enclosed by said cover and patient tissue;

said manifolds extending through said central space and terminating externally of said cover; and

an external pressure source connected to said manifolds and adapted for providing positive and negative pressure to said base element through said manifolds.

5. A wound treatment and closure method, which comprises the steps of:

providing a base element with a transducer component and a semi-permeable cover;

placing said transducer component in communication with tissue in said wound;

placing said cover over said transducer component in contact with skin surface around said wound;

establishing a gradient with respect to said wound, said transducer component and said cover;

directing fluid flow to or from said tissue by controlling pressures associated with said gradient;

establishing osmotic, capillary, atmospheric and gas partial gradients with respect to said wound said transducer component and said cover; and

externally applying fluid pressure comprising either vacuum (negative) pressure or applied (positive) pressure from an external fluid pressure source.

6. The method according to claim 5, which includes the additional steps of:

providing said pressure transducer with a manifold; and

connecting said manifold to said external fluid pressure source.

7. The method according to claim 5, which includes the additional steps of:

providing a second cover; and

placing said second cover in overlying relation over said first cover.

8. An osmotic transducer system, which includes:

a base element including a transducer component adapted for fluidic communication with a wound and a cover adapted for placement over the transducer component;

a central space formed by the cover and patient tissue structure, said transducer component being located in said central space;

an osmotic gradient formed with said base element and adapted for manipulating fluid elements whereby a pressure gradient is formed to produce useful fluid flow;

said gradient being formed by the manipulation of osmotic, capillary, atmospheric and gas partial pressures;

a pair of sheets positioned in generally parallel relation and including multiple spot connections whereat said sheets are fixedly attached to each other, said spot connections having configurations chosen from among the group comprising;

impervious;

semi-permeable;

porous; and

perforated;

multiple, interconnected pockets formed between said sheets;

said pockets forming a fluid passage interstitial space between said sheets; and

a manifold connected to said sheets in communication with said interstitial space and an external pressure source.

9. The system according to claim 8, which includes:

said connections being chosen from among the group comprising;

sheet-to-sheet spot connections;

spacers;

tubules open at said sheet surfaces;

tubules closed at said sheet surfaces; and

spheres.

10. The system according to claim 8, which includes:

said connections comprising multiple spheres connected to said sheets; and

a matrix of tubes fluidically connecting said spheres and said manifold.

11. The system according to claim 8, which includes:

a plurality of hollow disks;

a matrix of tubes interconnecting said disks and said manifold; and

a plurality of conduits placed over said disks and communicating with said manifold.

12. An osmotic transducer system, which includes:

a base element including a transducer component adapted for fluidic communication with a wound and a cover adapted for placement over the transducer component;

a central space formed by the cover and patient tissue structure, said transducer component being located in said central space;

an osmotic gradient formed with said base element and adapted for manipulating fluid elements whereby a pressure gradient is formed to produce useful fluid flow;

said gradient being formed by the manipulation of osmotic, capillary, atmospheric and gas partial pressures; and

said transducer component comprising;

a first transducer component including multiple, hemispherical protrusions forming outwardly-open pockets;

an intermediate porous material layer placed over said first transducer component; and

a second transducer component comprising a plurality of spherical elements interconnected to form a sheet.

13. The system according to claim 12, which includes:

at least one of said hemispherical protrusions and said spherical elements being perforated.

14. The system according to claim 13, which includes:

an opening formed in said second transducer component; and

an external connector attached to said intermediate layer within said opening and adapted for connection to an external pressure source.

15. An osmotic transducer system, which includes:

a base element including a transducer component adapted for fluidic communication with a wound and a cover adapted for placement over the transducer component;

a central space formed by the cover and patient tissue structure, said transducer component being located in said central space;

an osmotic gradient formed with said base element and adapted for manipulating fluid elements whereby a pressure gradient is formed to produce useful fluid flow;

said gradient being formed by the manipulation of osmotic, capillary, atmospheric and gas partial pressures; and

said transducer component comprising;

an inner transducer component including multiple, discrete beads chosen from among the group comprising pharmacologicals, growth factors, living cells and inert materials; and

an outer pressure transducer comprising a foam material with hydrophobic or hydrophilic properties.

16. A wound treatment and closure method, which comprises the steps of:

providing a base element with a transducer component and a cover;

placing said transducer component in communication with tissue in said wound;

placing said cover over said transducer component in contact with skin surface around said wound;

establishing a gradient with respect to said wound, said transducer component and said cover;

directing fluid flow to or from said tissue by controlling pressures associated with said gradient;

externally applying fluid pressure comprising either vacuum (negative) pressure or applied (positive) pressure from an external fluid pressure source;

providing said pressure transducer with a manifold;

connecting said manifold to said external fluid pressure source;

forming said pressure transducer with first and second sheets;

connecting said sheets in overlying relation at multiple spot connections; and

forming multiple pockets between said sheets and interconnecting said pockets to form a fluid passage interstitial space between said sheets.

17. The method according to claim 16, which includes the additional step of:

forming said spot connections with configurations chosen from the group comprising;

sheet-to-sheet spot connections;

spacers;

tubules open at said sheet surfaces;

tubules closed at said sheet surfaces; and

spheres.

18. The method according to claim 16, which includes the additional step of:

fixedly attaching said sheets to each other at said spot connections;

forming said spot connections with configurations chosen from among the group comprising;

impervious;

semi-permeable;

porous; and

perforated.

19. The method according to claim 18, which includes the additional steps of:

providing first and second manifolds;

connecting said manifolds to said sheets in communication with said interstitial space;

providing an external pressure source; and

providing negative (vacuum) and positive (applied) pressures to said interstitial space from said external pressure source.

20. A wound treatment and closure method, which comprises the steps of:

providing a base element with a transducer component and a cover;

placing said transducer component in communication with tissue in said wound;

placing said cover over said transducer component in contact with skin surface around said wound;

establishing a gradient with respect to said wound, said transducer component and said cover;

directing fluid flow to or from said tissue by controlling pressures associated with said gradient;

forming said pressure transducer with a hydrophilic or hydrophobic foam material;

forming a first pressure transducer component with said foam material;

providing a second pressure transducer component including multiple, discrete beads chosen from among the group comprising pharmacologicals, growth factors, living cells and inert materials; and

forming a pressure gradient between said first and second pressure transducers.