Custom Patterned Wound Dressings Having Patterned Fluid Flow Barriers and Methods of Manufacturing and Using Same

• US 20090326429A1
• Filed: 06/30/2008
• Published: 12/31/2009
• Est. Priority Date: 06/30/2008
• Status: Active Grant

• Current Assignee: Nuvesse Skin Therapies Inc.
• Original Assignee: Polyremedy, Inc.
• Inventors: SINIAGUINE, Oleg
• Granted Patent: US 8,237,009 B2
• Time in Patent Office: Days
• US Class Current: 602/48
• CPC Class Codes: A61F 13/0203 with fluid retention members
• CPC Class Codes: A61F 13/0283 for making adhesive or cohesive tape or fabrics therefor, e.g. coating or mechanical treatments
• CPC Class Codes: A61F 15/001 Packages or dispensers for bandages, cotton balls, drapes, dressings, gauze, gowns, sheets, sponges, swabsticks or towels A61F15/007 takes precedence
• CPC Class Codes: A61F 2013/00319 to make surface hydrophobic
• CPC Class Codes: A61F 2013/00731 with absorbing pads

Abstract

A custom fabricated (e.g. custom shaped and dimensioned) wound dressing that matches a corresponding, pre-mapped integumentary wound includes one or more liquid flow barriers composed for example of a hydrophobic and high viscosity liquid embedded in a layer of the dressing. One such embedded hydrophobic liquid barrier covers a skin section immediately adjacent to the wound opening so as to protect the skin section from harmful liquids such as exudates or water. In one embodiment, the skin protecting barrier is substantially comprised of a silicone oil having a viscosity in the range of about 100 cSt to 1000 cSt.

Claims

1. A custom wound dressing that is configured for treating a specific wound in accordance with a care provider'"'"'s corresponding prescription for the wound, where the specific wound has pre-mapped different wound zones and at least one pre-mapped adjacent skin zone with respective different pre-prescribed treatment goals assigned to the wound zones, the wound dressing comprising:

(a) a plurality of layers extending laterally in the dressing, including a wound interfacing layer that is configured to interface with the specific wound, the wound interfacing layer having a first porous hydrophilic material;

(b) at least a first custom positioned vertical barrier embedded in the wound interfacing layer for preventing or inhibiting a first liquid absorbed by the first porous hydrophilic material from spreading laterally from one side of the first custom positioned vertical barrier to an opposed other side of the first vertical barrier;

where the custom positioning of the first vertical barrier corresponds to a positioning of at least one of said pre-mapped wound and skin zones; and

wherein the first custom positioned vertical barrier includes a substantial amount of a silicone or a silicone oil for causing the first vertical barrier to have hydrophobic properties.

2. The custom wound dressing of claim 1 wherein the first custom positioned vertical barrier essentially consists of a silicone or a silicone oil.

3. The custom wound dressing of claim 1 wherein said silicone or silicone oil has a viscosity in the range of about 1 CentiStoke to about 10,000 cSt.

4. The custom wound dressing of claim 1 wherein said silicone or silicone oil has a viscosity in the range of about 100 cSt to about 1000 cSt.

5. The custom wound dressing of claim 1 wherein the first custom positioned vertical barrier substantially prevents a liquid that is harmful to skin from migrating through or out of the wound interfacing layer to contact a skin area adjacent to the wound interfacing layer.

6. The custom wound dressing of claim 4 wherein wound interfacing layer is dimensioned to contact the at least one pre-mapped adjacent skin zone and the first custom positioned vertical barrier is positioned to align over the at least one pre-mapped adjacent skin zone.

7. The custom wound dressing of claim 6 wherein the pre-mapped adjacent skin zone surrounds the wound and the first custom positioned vertical barrier is positioned to cover the entirety of the pre-mapped adjacent skin zone.

8. A combination of a package and a custom wound dressing enclosed in the package, where the dressing is configured for treating a specific wound identified by indicia that is at least logically coupled to the package, where the specific wound has pre-mapped different wound zones and at least one pre-mapped adjacent skin zone, and where the wound dressing comprises:

(a) a plurality of layers extending laterally in the dressing, including a first layer having a first porous hydrophilic material; and

(b) at least a first custom positioned vertical barrier embedded in the first layer for preventing or inhibiting a first liquid absorbed by the first porous hydrophilic material from spreading laterally from one side of the first custom positioned vertical barrier to an opposed other side of the first vertical barrier;

where the custom positioning of the first vertical barrier corresponds to a positioning of at least one of said pre-mapped wound and skin zones.

9. The combination of claim 8 wherein the first custom positioned vertical barrier includes a substantial amount of a silicone or a silicone oil for causing the first vertical barrier to have hydrophobic properties.

10. The combination of claim 8 wherein the first custom positioned vertical barrier includes a mineral oil or a vegetable oil.

11. The combination of claim 8 wherein the first custom positioned vertical barrier includes a water repelling liquid having a viscosity in the range of about 1 CentiStoke to about 10,000 cSt.

12. The combination of claim 8 wherein the first layer is a wound interfacing layer that is configured to interface with the identified wound, the wound interfacing.

13. The combination of claim 12 wherein the first custom positioned vertical barrier includes a coloring dye.

14. The combination of claim 12 wherein the first custom positioned vertical barrier is positioned to align over the at least one pre-mapped adjacent skin zone and to thus on application, protect the adjacent skin zone from exposure to harmful substances.

15. The combination of claim 8 wherein the first custom positioned vertical barrier is positioned to protectively align relative to the at least one pre-mapped adjacent skin zone and to thus on application, protect the adjacent skin zone from exposure to harmful substances.

16. The combination of claim 8 wherein a second of said plurality of laterally extending layers is a gas or vapor permeable porous and hydrophobic layer that is permeable in at least one zone of the second layer by a predefined gas or vapor.

17. The combination of claim 16 wherein the second laterally extending layer has one or more custom patterned zones of comparatively reduced or essentially no permeability for the predefined gas or vapor in addition to having said at least one zone exhibiting comparatively larger permeability to the predefined gas or vapor and wherein the one or more custom patterned zones correspond to zones of the identified wound.

18. The combination of claim 17 wherein a first of the custom patterned zones with reduced or essentially no permeability is positioned above the first custom positioned vertical barrier.

19. The combination of claim 17 wherein the second laterally extending layer contains intersecting nonwoven microfibers and said one or more custom patterned zones of comparatively reduced or essentially no permeability include corresponding films formed by melting of the microfibers.

20. The combination of claim 17 wherein the second laterally extending layer contains intersecting nonwoven microfibers and said one or more custom patterned zones of comparatively reduced or essentially no permeability include a laterally extending gas impermeable film deposited on the microfibers.

21. The combination of claim 17 wherein the second laterally extending layer contains intersecting nonwoven microfibers having an average pore size less than less than about 0.5 micron.

22. The combination of claim 8 and further comprising:

(c) within said plurality of laterally extending layers, a second layer having a second porous hydrophilic material whose bulk structure is the same as or different from that of said first porous hydrophilic material; and

(d) at least a second custom positioned vertical barrier embedded in the second layer for preventing or inhibiting a second liquid absorbed by the second porous hydrophilic material from spreading laterally from one side of the second custom positioned vertical barrier to an opposed other side of the second vertical barrier.

23. The combination of claim 22 and further comprising:

(e) between the first and second laterally extending hydrophilic layers, one or more laterally extending fluid barriers that are impermeable to a predefined liquid and/or impermeable to a predefined vapor or gas, and where there is at least one zone between the first and second laterally extending hydrophilic layers where the predefined liquid and/or predefined vapor or gas can flow between the first and second laterally extending hydrophilic layers.

24. The combination of claim 8 wherein said package comprises:

(c) a first packaging sheet;

(d) a second packaging sheet, attached to the first sheet; and

(e) at least a first label integrally formed on or attached to one of said first and second packaging sheets and providing said indicia that identifies the specific wound.

25. The combination of claim 24 wherein the first said indicia includes a graphic or schematic of at least one of body anterior and body posterior and an indication of where on the represented body anterior or body posterior the identified wound is located.

26. The combination of claim 24 wherein the at least first label further provides second indicia separately identifying the patient having the identified wound.

27. The combination of claim 24 wherein the at least first label further provides second indicia indicating a route and/or method by way of which said combination of the package and the custom dressing are to be delivered to the identified wound or patient having the identified wound.

28. The combination of claim 24 wherein the at least first label further provides second indicia indicating at least one of a prescribed date for application or prescribed date for removal of the dressing respectively to or from the identified wound.

29. The combination of claim 24 wherein the at least first label further provides second indicia defining or pointing to instructions for applying and/or removing the dressing respectively to or from the identified wound.

30. The combination of claim 29 wherein said second indicia points to a computer network site that provides instructions for applying and/or removing the dressing respectively to or from the identified wound.

31. The combination of claim 24 wherein the first packaging sheet includes a thermally printable-on layer and the at least first label is integrally formed as thermal printing on said thermally printable-on layer.

32. The combination of claim 24 and further comprising:

(f) a second label integrally formed on or attached to one of said first and second packaging sheets and providing additional indicia that performs at least one of the following functions;

indicating a route and/or method by way of which said combination of the package and the custom dressing are to be delivered to the identified wound or patient having the identified wound,

separately identifying the patient having the identified wound,

indicating at least one of a prescribed date for application or prescribed date for removal of the dressing respectively to or from the identified wound, and

defining or pointing to instructions for applying and/or removing the dressing respectively to or from the identified wound.

33. The combination of claim 24 and further comprising an adhesive ring that sealing bonds the first and second packaging sheets to one another.

34. A method for coordinating packaging and delivery of a customized multilayer wound dressing to a patient having a wound for which the dressing is custom matched, the method comprising:

(a) automatically enclosing the customized wound dressing in a sealed package; and

(b) automatically producing at least a first label that is attachable to or integrally formed on the sealed package where the first label providing additional indicia that performs at least one of the following functions;

identifying the wound for which the dressing is custom matched,

separately identifying the patient having the identified wound,

indicating a route and/or method and/or one or more persons by way of which said package and the enclosed custom dressing are to be delivered to the identified wound or patient having the identified wound,

indicating at least one of a prescribed date for application or prescribed date for removal of the dressing respectively to or from the identified wound, and

defining or pointing to instructions for applying and/or removing the dressing respectively to or from the identified wound.

35. The method of claim 34 wherein said step of automatically enclosing the customized wound dressing includes:

depositing a base packaging sheet on an assembly stage;

forming two or more layers of the customized multilayer wound dressing and depositing them above the deposited base packaging sheet;

depositing a topside packaging sheet over the customized multilayer wound dressing; and

bonding the deposited topside packaging sheet to the base packaging sheet.

36. The method of claim 35 wherein said step of automatically enclosing the customized wound dressing further includes:

automatically storing in a database, information regarding at least one of;

first information regarding applying and/or removing the dressing respectively to or from the identified wound;

second information regarding applying one or more prespecified liquids to prespecified liquid containment areas of the customized wound dressing prior to application;

third information regarding routing including that indicating how and/or into whose possession the packaged customized wound dressing is to be delivered prior to its application to the corresponding wound;

fourth information regarding responsibility including identifying who is responsible for producing a corresponding wound image map and/or who is responsible for producing a corresponding wound zones characterizing data and/or who is responsible for producing a corresponding wound zone treatment plans and/or who is responsible for producing corresponding layer designs for respective layers of the customized multilayer wound dressing.

37. A method of custom forming one or more fluid containment barriers in a given layer of a multilayer wound dressing that is associated with a pre-identified and pre-mapped wound for which the dressing is to be custom matched, the method comprising:

(a) providing a porous and hydrophilic first material layer;

(b) depositing on the first material layer and at a location corresponding to a pre-mapped feature of the pre-identified wound, a viscous liquid that can penetrate into and become embedded in the porous structure of the first material layer such that after becoming so embedded the viscous liquid blocks or substantially inhibits one or more pre-defined other liquids or pre-defined gases or vapors from passing through the embedded viscous liquid; and

(c) causing or allowing the deposited viscous liquid to become embedded in the first material layer.

38. The method of claim 37 wherein:

said step of causing or allowing the deposited viscous liquid to become embedded includes picking an included material of the viscous liquid that has a viscosity after being embedded that substantially impedes the deposited viscous liquid from spreading in the first material layer after becoming embedded therein.

39. The method of claim 38 wherein:

said step of causing or allowing the deposited viscous liquid to become embedded includes picking the included material of the viscous liquid to be a silicone with a viscosity in the range of 1 cSt to 10,000 cSt (CentiStokes).

40. The method of claim 39 wherein:

said picked silicone has a viscosity in the range of 100 cSt to 1,000 cSt.

41. The method of claim 38 wherein:

said step of causing or allowing the deposited viscous liquid to become embedded includes heating the deposited viscous liquid so as to thereby temporarily reduce its viscosity.

42. The method of claim 38 wherein:

said step of causing or allowing the deposited viscous liquid to become embedded includes depositing the viscous liquid as a mixture of a volatile solvent and one or more other dissolved liquids where viscosity of the one or more other dissolved liquids is reduced by the volatile solvent.

43. The method of claim 42 wherein:

said step of causing or allowing the deposited viscous liquid to become embedded further includes heating the deposited viscous liquid to a predetermined temperature above room temperature and at a predetermined time after the mixture of the volatile solvent and the one or more other dissolved liquids is deposited so to thereby hasten removal of the volatile solvent.

44. The method of claim 37 wherein a first of the one or more fluid containment barriers is positioned to block skin-harming liquids from traveling laterally through the hydrophilic first material layer to reach skin adjacent to the pre-identified and pre-mapped wound.

45. The method of claim 44 wherein a second of the one or more fluid containment barriers is positioned to separate an exudate absorbing region of the hydrophilic first material layer from a moisture sourcing region of the hydrophilic first material layer.

46. A manufacture that is usable by a corresponding data processing device for locating wound zones of an identified wound and adjacent skin areas thereof that are to receive treatment or protection, said manufacture providing data usable by said data processing device where the provided data includes:

first data identifying one or more first skin zones that are to be protected from harmful substances that may be present in adjacent areas.

47. The manufacture of claim 46 wherein the provided data further includes:

second data identifying one or more first wound zones of the identified wound from which first zones, or to which, substances that can be harmful to said first skin zones are expected to flow.

48. The manufacture of claim 47 wherein the provided data further includes:

third data identifying one or more second wound zones of the identified wound to which one or more moisturizers should be applied during treatment of the one or more second wound zones.

49. The manufacture of claim 46 in combination with a second manufacture that is usable by the corresponding data processing device where the second manufacture provides further data usable by said data processing device and where the further provided data includes:

second data identifying a patient having the identified wound.

50. The combination of manufactures of claim 49 where the further provided data includes:

third data identifying a location on the identified patient of the identified wound.

51. The combination of manufactures of claim 50 where the further provided data includes:

fourth data identifying one or more of a frame of reference on the identified patient relative to which the identified wound is located and an orientation and/or position that the custom wound dressing is to take relative to the identified frame of reference when the wound dressing is applied to the identified wound.

52. The first recited manufacture of claim 46 in combination with a second manufacture that is usable by the corresponding data processing device, where the first and second recited manufactures logically associate to a custom wound dressing that has been or is planned to be fabricated and applied to said identified wound, where the second manufacture provides further data usable by said data processing device and where the further provided data includes:

second data defining at least part of a route that the associated custom wound dressing is to follow or has followed when being delivered to the identified patient after fabrication of the custom wound dressing.

53. The combination of manufactures of claim 52 where the further provided data includes:

third data identifying one or more persons responsible for one or more of the following activities;

applying the custom wound dressing to the identified wound;

delivering the custom wound dressing to the identified patient;

removing the custom wound dressing from the identified patient;

formulating a digitized wound dressing design from which the associated custom wound dressing is to be or has been at least partially automatically fabricated;

formulating the data of the first recited manufacture;

creating a digitized image of the identified wound;

identifying the patient; and

identifying the wound'"'"'s location and/or orientation on the patient.

54. A data processing machine usable for coordinating creation of a custom fabricated wound dressing to be applied to an identified wound on an identified patient and delivery of the custom wound dressing to the identified wound after the dressing is fabricated, said machine comprising:

(a) first associating means for logically associating a digitized image of the identified wound with a digitized identification of the wound and a digitized identification of the patient;

(b) second associating means for logically associating a digitized mapping of characterized wound zones and characterized adjacent skin zones with the digitized identification of the wound and the patient; and

(c) third associating means for logically associating digitized routing information with the digitized characteristics mapping, where the digitized routing information includes information defining how the custom fabricated wound dressing will be or has been delivered to the identified patient.