Expansion units for attachment to custom patterned wound dressings and custom patterned wound dressings adapted to interface with same

• US 8,247,634 B2
• Filed: 08/22/2008
• Issued: 08/21/2012
• Est. Priority Date: 08/22/2008
• Status: Expired due to Fees

• Current Assignee: Nuvesse Skin Therapies Inc.
• Original Assignee: Polyremedy, Inc.
• Inventors: Siniaguine, Oleg
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US12/196,908
• Publication Number:
  US 20100049148A1
• Time in Patent Office: 1,460 Days
• Field of Search: 602/42, 602/44, 602 45- 46, 602/48, 602/52, 602/58, 602/41
• US Class Current: 602/41
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 13/0276 Apparatus or processes for manufacturing adhesive dressings or bandages
• 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 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61F 2013/00557 detachable absorbent pad
• CPC Class Codes: A61F 2013/00604 Multilayer
• CPC Class Codes: A61F 2013/8497 having decorations or indicia means

Abstract

A custom fabricated (e.g. custom shaped and dimensioned) primary wound dressing part that matches a corresponding, pre-mapped integumentary wound is combined with dressing extension parts to form a composite wound dressing system. The primary wound dressing part may include one or more liquid flow barriers composed for example of a hydrophobic and high viscosity liquid embedded in a layer of the primary wound dressing part. The dressing extension parts may include interconnect portals for operatively interconnecting with the primary wound dressing part so that liquids may be securely moved between primary wound dressing part and the extension parts.

Claims

1. A custom wound dressing comprising:

(a) a first layer configured to interface with a specific wound, the first layer comprising a hydrophilic material; and

(b) a second layer comprising a liquid flow blocking material impermeable to fluid, wherein a opening is formed in the second layer for allowing liquid to flow through the second layer; and

(c) a dressing extension part operatively coupled or couplable to the opening and comprising at least one of a porous solid foam and a porous microfiberous material.

2. The custom wound dressing of claim 1 wherein the dressing extension part includes:

a corresponding porous interior that can source or can absorb a predefined liquid; and

an outer skin covering the porous interior.

3. The custom wound dressing of claim 2 wherein the outer skin has at least an extension portal defined therethrough and structured to operatively couple with the opening of the custom dressing part for passing a liquid between said opening and said extension portal.

4. The custom wound dressing of claim 2 wherein the outer skin is impermeable to water vapor.

5. The custom wound dressing of claim 2 wherein the outer skin is permeable to water vapor but does not allow microbes or larger particles to pass through the outer skin.

6. The custom wound dressing of claim 1 further including:

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

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

7. The custom wound dressing of claim 6 wherein the custom positioned vertical barrier includes hydrophobic material that causes the vertical barrier to have water repelling properties.

8. The custom wound dressing of claim 7 wherein said hydrophobic material of the vertical barrier includes a silicone or a silicone oil having a viscosity in the range of 1 CentiStoke to 10,000 CentiStoke.

9. The custom wound dressing of claim 6 wherein the custom positioned vertical barrier essentially consists of a silicone or a silicone oil.

10. The custom wound dressing of claim 6 wherein the first layer is dimensioned to contact at least one of the pre-mapped wound zones and the custom positioned vertical barrier is positioned to circumscribe an interface area corresponding to the at least one pre-mapped wound zone.

11. A combination of a first package and a first custom wound dressing part enclosed in the first package, where the first custom dressing part is configured for interfacing with a first prespecified external extension part, where the first custom dressing part is further configured for treating a specific wound identified by first indicia that is at least logically coupled to the first package, where the specific wound has pre-mapped different wound zones, and where the first custom dressing part comprises:

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

(b) among said plurality of laterally extending layers, at least a second layer composed of a liquid flow blocking material that blocks bulk liquid from flowing therethrough, where the second layer has at least a first custom portal opening defined therein for allowing a first bulk liquid to flow through the first portal opening while the first bulk liquid is in communication with the first layer; and

where the first custom portal opening is operatively couplable to said first prespecified external extension part.

12. The combination of claim 11 wherein the first prespecified external extension part is enclosed in a second package.

13. The combination of claim 12 wherein the second package is logically coupled to at least one of the first package and specific wound by second indicia provided in association with the second package.

14. The combination of claim 11 wherein the first layer includes 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 material from spreading laterally from one side of the first custom positioned vertical barrier to an opposed other side of the first vertical barrier;

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

15. The combination of claim 14 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.

16. The combination of claim 14 wherein the first custom positioned vertical barrier includes a mineral oil or a vegetable oil.

17. The combination of claim 14 wherein the first custom positioned vertical barrier includes a water repelling liquid having a viscosity in the range of 1 CentiStoke to 10,000 Centistokes.

18. The combination of claim 14 wherein the first layer is a wound interfacing layer that is configured to interface with the identified wound, and where the first vertical barrier circumscribes an interface area corresponding to one of the pre-mapped zones of the wound.

19. The combination of claim 14 wherein the first custom positioned vertical barrier includes a coloring dye.

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

21. The combination of claim 14 wherein the first custom positioned vertical barrier is positioned to protectively align relative to the at least one premapped adjacent skin zone and to protect the adjacent skin zone from exposure to harmful substances.

22. The combination of claim 14 wherein the 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 region of the second layer by a predefined gas or vapor.

23. The combination of claim 22 wherein the second laterally extending layer has one or more custom patterned regions of comparatively reduced or essentially no permeability for the predefined gas or vapor in addition to having said at least one region exhibiting comparatively larger permeability to the predefined gas or vapor and wherein the one or more of the custom patterned regions correspond to zones of the identified wound.

24. The combination of claim 23 wherein a first of the custom patterned regions with reduced or essentially no permeability is positioned above the first custom positioned vertical barrier.

25. The combination of claim 23 wherein the second laterally extending layer contains intersecting nonwoven microfibers and said one or more custom patterned regions of comparatively reduced or essentially no permeability include corresponding films formed by melting of the microfibers.

26. The combination of claim 23 wherein the second laterally extending layer contains intersecting nonwoven microfibers and said one or more custom patterned regions of comparatively reduced or essentially no permeability include a laterally extending gas impermeable film deposited on the microfibers.

27. The combination of claim 23 wherein the second laterally extending layer contains intersecting nonwoven microfibers having an average pore size less than less than about 0.5 micron.

28. The combination of claim 11 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.

29. The combination of claim 28 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.

30. The combination of claim 11 wherein said first package comprises:

(c) a first packaging sheet;

(d) a second packaging sheet, attached to the first sheet so as to enclose the first custom dressing part therebetween; 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.

31. The combination of claim 30 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.

32. The combination of claim 31 wherein said graphic or schematic includes an indication of what orientation the first prespecified external extension part and the first custom dressing part are to take relative to one another and/or relative to the identified wound and/or relative to the represented body anterior or body posterior.

33. The combination of claim 31 wherein the at least first label further provides second indicia separately identifying the patient having the identified wound.

34. The combination of claim 31 wherein the at least first label further provides second indicia indicating a route and/or method by way of which said combination of the first package and the first custom dressing are to be delivered to the identified wound or patient having the identified wound.

35. The combination of claim 34 wherein the second indicia further indicates how many and/or further indicates which extension parts are to accompany the first custom dressing and its associated first package on the indicated route or by way of the indicated method of delivery of the first custom dressing to the identified wound or patient having the identified wound.

36. The combination of claim 30 wherein the at least first label provides indicia indicating at least one of a prescribed date for application or prescribed date for removal of the first custom dressing part and its associated extension parts respectively to or from the identified wound.

37. The combination of claim 30 wherein the at least first label provides indicia defining or pointing to instructions for applying or removing the first custom dressing part and its associated extension parts respectively to or from the identified wound.

38. The combination of claim 30 wherein said indicia points to a computer network site that provides instructions for applying and/or removing the first custom dressing part and its associated extension parts respectively to or from the identified wound.

39. The combination of claim 30 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.

40. The combination of claim 30 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 the first package and the first custom dressing part and one or more associated extension parts 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 first custom dressing part and one or more associated extension parts respectively to or from the identified wound, and

defining or pointing to instructions for applying and/or removing the first custom dressing part and one or more associated extension parts respectively to or from the identified wound.

41. A method for coordinating packaging and delivery of a first customized multilayer wound dressing and of one or more dressing extension parts to a patient having a wound at a corresponding wound site for which the combination of the customized wound dressing and the one or more dressing extension parts are designed, the method comprising:

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

(b) automatically enclosing the one or more of the dressing extension parts in a corresponding second or more sealed packages; and

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

identifying the wound or wound site for which the combination of the customized wound dressing and the one or more extension parts are designed,

separately identifying the patient having the identified wound or wound site,

indicating a route and/or method and/or one or more persons by way of which said first and second or more packages and the correspondingly enclosed customized wound dressing and dressing extension parts 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 customized wound dressing and its one or more extension parts respectively to or from the identified wound site, and

defining or pointing to instructions for applying and/or removing the customized wound dressing and its one or more extension parts respectively to or from the identified wound site.

42. The method of claim 41 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.

43. The method of claim 41 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 or removing the customized dressing and its associated one or more extension parts respectively to or from the identified wound site;

second information regarding applying one or more prespecified liquids to the one or more extension parts or 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 and the associated extension parts are to be delivered prior to their application to the corresponding wound site;

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 or who is responsible for producing corresponding layer designs for respective layers of the customized multilayer wound dressing or who is responsible for specifying the one or more extension parts that are to be combined with the customized wound dressing.

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

(a) providing a liquid impermeable first sheet material as defining one or more first layers of the multilayer custom wound dressing;

(b) defining through the first sheet material at least a first custom portal opening at a prespecified first location in the first sheet material, where the first custom portal opening is operatively mateable with at least a first of said one or more dressing extension parts so as to conduct a flow of liquid between the custom wound dressing and the first dressing extension part;

(c) providing a porous and hydrophilic second sheet material disposed over the first sheet material as defining one or more second layers of the multilayer custom wound dressing;

(d) depositing on the second sheet material and at a second location of the second sheet material corresponding both to a pre-mapped feature of the pre-identified wound and to the first custom portal opening defined at said prespecified first location in the first sheet material;

a viscous liquid that can penetrate into and become embedded in the porous structure of the second sheet material 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

(e) causing or allowing the deposited viscous liquid to become embedded in the second sheet material.

45. The method of claim 44 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 second sheet material after becoming embedded therein.

46. The method of claim 44 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).

47. The method of claim 46 wherein:

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

48. The method of claim 44 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.

49. The method of claim 44 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.

50. The method of claim 49 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.

51. The method of claim 44 wherein said embedded viscous liquid defines one or more fluid containment barriers in the second sheet material and where a first of the one or more fluid containment barriers is positioned to block skinharming liquids from traveling laterally through the hydrophilic second sheet material to reach skin adjacent to the pre-identified and pre-mapped wound.

52. The method of claim 51 wherein a second of the one or more fluid containment barriers is positioned to separate an exudate absorbing region of the hydrophilic second sheet material from a moisture supplying region of the hydrophilic second sheet material.

53. The method of claim 44 wherein:

(b.1) said defining of the at least first custom portal opening at the prespecified first location in the first sheet material includes forming parallel slits through the first sheet material.

54. The method of claim 44 wherein:

(b.1) said defining of the at least first custom portal opening at the prespecified first location in the first sheet material includes forming one or more holes through the first sheet material.

55. The method of claim 44 wherein:

(b.1) said defining of the at least first custom portal opening at the prespecified first location in the first sheet material includes cutting out an area of prespecified shape and dimensions from the first sheet material.

56. The method of claim 44 wherein:

(b.1) said defining of the at least first custom portal opening at the prespecified first location in the first sheet material is accompanied by a further defining of at least a second custom portal opening at a prespecified second and different location in the first sheet material.