Mechanical wound therapy for sub-atmospheric wound care system

• US 10,485,906 B2
• Filed: 06/20/2016
• Issued: 11/26/2019
• Est. Priority Date: 11/01/2011
• Status: Active Grant

• Current Assignee: J & M Shuler Medical, Inc.
• Original Assignee: J&m Shuler, Inc.
• Inventors: Freedman, Brett A., Shuler, Michael S.
• Primary Examiner(s): Mensh, Andrew J
• Application Number:
  US15/187,335
• Publication Number:
  US 20170007752A1
• Time in Patent Office: 1,254 Days
• Field of Search: 604305
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61F 13/00 Bandages or dressings radioactive dressings A61N5/1029; Absorbent pads
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• CPC Class Codes: A61F 13/00085 having means for facilitating the application on the skin, e.g. single hand handling facilities A61F13/0259 takes precedence; bandage applicators separate from the bandage or the packaging A61F15/005
• CPC Class Codes: A61F 13/01021 characterised by the structure of the dressing
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 13/0279 by attaching individual patches on moving webs
• 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 2013/00357 implanted wound fillings or covers membranes for covering bone defects A61F2/2846
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• 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 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• 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 1/918 for multiple suction locations
• CPC Class Codes: A61M 1/92 with liquid supply means
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 3/0279 : Cannula; Nozzles; Tips; their connection means
• CPC Class Codes: A61M 3/0283 : with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 5/0624 : for eliminating microbes, germs, bacteria on or in the body
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

A mechanical wound therapy (MWT) system includes a connection for a vacuum source, which is routed through an airtight covering to a porous material positioned over the wound. The porous material may be a tubing network interspaced by a netting material constructed of biologically inert or bioabsorbable material. Alternatively, the porous material may be a layered unified dressing in which layers of mesh, netting or thin perforated film are separated and fixedly attached to functional elements of the dressing (e.g., irrigation tubing) or spacers. The vacuum and irrigation systems may be completely separated. An airtight sealing layer or foldable adhesive sealing layer may seal the dressing and facilitate sealing the dressing to the wound margins. Additional modular devices such as a wound approximating system, positive pressure bladders and adjuvant therapy modules as well as enhanced monitoring technology can be added to synergistically increase the capabilities of each dressing.

Claims

1. A unified dressing assembly for a negative pressure wound care system, the assembly comprising:

one or more layers for dispersing irrigant to a wound surface, the one or more layers being initially configured to cover a first surface area, wherein said one or more layers for dispersing irrigant comprises an irrigation layer;

a sealing layer configured to serve as an outer dorsal surface of said unified dressing assembly, wherein the sealing layer, in an unfolded state, is configured to cover a second surface area which is larger than the first surface area;

connection means for connecting a vacuum line from a vacuum source and an irrigant line from an irrigant source;

means for holding the unified dressing assembly together for placement on the wound surface as a single unit; and

a multi-layered dressing stack mechanically attached to said means for holding the unified dressing assembly together for placement on the wound surface as the single unit, the multi-layered dressing stack comprising;

an intermediate layer positioned below the sealing layer and mechanically mounted directly to a portion of said means for holding the unified dressing assembly together for placement that is positioned below the sealing layer;

a ventral layer positioned below the intermediate layer and mechanically mounted to said means for holding the unified dressing assembly together for placement; and

said irrigation layer defined between the intermediate layer and the ventral layer and including a plurality of irrigation flow paths in fluid communication said connection means.

2. The unified dressing assembly of claim 1, wherein the sealing layer is configured to be folded within a packaging wrapper in a folded state;

and wherein the sealing layer is configured to be unfolded to the unfolded state to create a seal between the dressing and the wound margins.

3. The unified dressing assembly of claim 1, wherein the means for holding the unified dressing assembly together comprises a vacuum interface chamber attached to the one or more layers and the sealing layer, the vacuum interface chamber serving as the means for holding the unified dressing assembly together.

4. The unified dressing assembly of claim 1, further comprising:

a vacuum accessory tube configured to be in fluidic communication with the vacuum source via the connection means.

5. The unified dressing assembly of claim 1, further comprising:

a disk-shaped central suction cavity configured with side wall pores and a floor with pores, the central suction cavity being one of said one or more layers, and configured to be in fluidic communication with the vacuum source via the connection means.

6. The unified dressing assembly of claim 1, further comprising:

a layer of vacuum lines among the one or more layers, the layer of vacuum lines being in fluidic communication with the vacuum source; and

a layer of irrigation lines among the one or more layers, the layer of irrigation lines being in fluidic communication with the irrigant source.

7. The unified dressing assembly of claim 1, further comprising:

a tubing connection point configured with a one-way valve to prevent back-flow of wound effluent, the tubing connection point serving as the connection means.

8. The unified dressing assembly of claim 1, wherein the sealing layer is initially packaged in a folded state which covers less surface area than the first surface area of said one or more layers.

9. The unified dressing assembly of claim 8, wherein the sealing layer, initially packaged in the folded state, is configured to be unfolded to the unfolded state to cover the second surface area which is larger than the first surface area.

10. The unified dressing assembly of claim 9, wherein the sealing layer in the unfolded state extends beyond said one or more layers in each lateral direction.

11. The unified dressing assembly of claim 10, wherein at least a portion of a ventral surface of the sealing layer is covered with an adhesive portion configured to stick to a patient'"'"'s skin around the wound surface for forming an air tight seal.

12. The unified dressing assembly of claim 11, further comprising:

one or more peel-away paper backing pieces configured to be removably affixed to the adhesive portion.

14. The unified dressing assembly of claim 1, wherein said means for holding the unified dressing assembly together for placement on the wound surface as the single unit comprises:

a central hub having interior walls defining a ventral-facing chamber to distribute a negative pressure to the wound surface; and

wherein said connection means comprises;

a manifold of the central hub having a first fluid connector configured to connect to the irrigant line from the irrigant source and a second fluid connector in communication with the ventral-facing chamber and configured to connect to the vacuum line from the vacuum source.

16. The unified dressing assembly of claim 1, wherein the plurality of irrigation flow paths extend laterally outward from a longitudinal axis of said means for holding the unified dressing assembly together so as to deliver irrigation fluid to a periphery of the wound surface.

18. The unified dressing assembly of claim 1, wherein the unified dressing assembly consists of a sponge-free construction without a sponge wound filler material.

19. The unified dressing assembly of claim 18, wherein the unified dressing assembly has an elliptical periphery shape defined by a major axis diameter and a minor axis diameter.

20. The unified dressing assembly of claim 19, wherein the major axis diameter of the multi-layered dressing assembly is 12 inches and the minor axis diameter of the multi-layered dressing assembly is 6 inches, and wherein the unified dressing assembly has a thickness in the longitudinal direction of 3 mm to 10 mm.

21. The unified dressing assembly of claim 1, wherein the irrigation layer is integrated into at least one of the intermediate layer or the ventral layer.

22. The unified dressing assembly of claim 1, wherein the ventral layer is a thin perforated material.

23. The unified dressing assembly of claim 1, wherein the intermediate layer is a thin perforated or nonperforated material.

13. A unified dressing assembly for a negative pressure wound care system, the assembly comprising:

one or more layers for dispersing irrigant to a wound surface, the one or more layers being initially configured to cover a first surface area, wherein said one or more layers for dispersing irrigant comprises an irrigation tube layer;

a sealing layer configured to serve as an outer dorsal surface of said unified dressing assembly, wherein the sealing layer, in an unfolded state, is configured to cover a second surface area which is larger than the first surface area;

connection means for connecting a vacuum line from a vacuum source and an irrigant line from an irrigant source;

means for holding the unified dressing assembly together for placement on the wound surface as a single unit; and

a multi-layered dressing stack mechanically attached to said means for holding the unified dressing assembly together for placement on the wound surface as a single unit, the multi-layered dressing stack comprising;

said sealing layer comprising an airtight film material and having an adhesive configured to bond with a region of skin surrounding a wound, at least a portion of said means for holding the unified dressing assembly together passing through an aperture in a central region of the sealing layer;

an intermediate netting layer positioned below the sealing layer and mechanically mounted directly to a portion of said means for holding the unified dressing assembly together for placement that is positioned below the sealing layer;

a ventral netting layer positioned below the intermediate netting layer and mechanically mounted to said means for holding the unified dressing assembly together for placement; and

said irrigation tube layer positioned between the intermediate netting layer and the ventral netting layer and including a plurality of irrigation tubes in fluid communication said connection means.

15. The unified dressing assembly of claim 13, wherein a periphery of the netting layers and the irrigation tube layer of the multi-layered dressing stack is configured to be cut to size of the wound while the netting layers and the irrigation tube layer are collectively mounted to said means for holding the unified dressing assembly together for placement on the wound surface as the single unit.

17. The unified dressing assembly of claim 15, wherein the irrigation tubes extend laterally outward in a pattern of radial spokes between an intermediate netting layer and a ventral netting layer of the unified dressing assembly.