IE20140129A1 - Dual and negative pressure wound therapy dressings for the prevention and management of tissue fluid, seroma and lymphoedema - Google Patents

Abstract

The present invention relates to dual pressure therapy assisted dressings designed for, though not exclusively, to fit anatomical body contours which may overly any tissue containing fluid, lymph glands and lymphatics, for the treatment and prevention of lymphoedema, seroma and build up of tissue fluid. Specific dressing shapes designed to fit the contour of different body regions, either on the surface of the skin, enveloping the limb or appendage, or placed in body cavities or wounds and described in this invention. In some embodiments, the dressing provides an enclosure, some enveloping the portion of the body to be treated for purposes of applying in various modes and at different pressure, negative and or positive pressure therapy to that part of the body. <Figure 1>

Description

Title Dual and Negative Pressure Wound Therapy Dressings for the Prevention and 5 Management of Tissue Fluid, Seroma and Lymphoedema.

Background While it is almost 500 years since Asellius first described lymphatics in 1627, it is only recently that the importance of lymphatics and tissue fluid have been recognised. Lymphoedema is a very troublesome condition, difficult to treat and may arise for example, following surgery, in patients with tropical infections and following degenerative or congential diseases.

It has major social and economic impact globally and is associated with life limiting morbidity for those affected. It may increase the risk of cancer in the affected part of the body. Lymphoedema occurs following lymph node surgery in of between 10 and 30% of patients especially when performed in the axilla or inguinal region. Currently there are no known effective preventative and treatment regimens. Treatment including massage and manual compression are relatviley ineffective.

It is increasingly recognised that Negative Pressure Wound Therapy (NPWT) is beneficial in wound healing and fluid management (Moues.Bond). This effect is not confined to difficult or complex traumatic wounds. Evidence now exists that NPWT exerts beneficial effects on many wounds including elective closed incisions ( Blackam, Karlaki). This beneficial action is multifactoiral in origin, but alteration in wound’s biochemical milieu and fluid clearance appear to be fundamental to the effective mechanism NPWT (Oh).

Optimising outcomes is the foremost concern and any improvement in wound care with reduced risk of lymphoedema would be a great step forward. While negative pressure devices are commercially available they have not been adapted to treated the condition, as shown herein in this invention.

Key facilitators of the lymphatic regeneration are vascular endothelial growth fators, in particular VEGF-C and VEFG-D. These activate VEGF receptor which is expressed in the lymphatic endothelial cell. VEGFR-3 a tyrosine kinase inhibitor promotes lymphangiogenesis, generating new lymphatic vessels from pre-existing lymphatics or lymphatic endothelial progenitors. Gao and colleagues suggest that there is synergism in both angio and lymphangiesis especially between FGF-2 and VEGF-A and -C (Cao). These concepts are relatively new and in evolution.

Other physiological surfactants such as SDF-1 may play a role as well as fibroblast growth factor, platelet derived growth factor and many others. TGFp, interleukin 8, and interleukin 10 are produced and their role in lymphangiogenesis is umproven. ΤΟΕβ acts as an initiating substance in the in the cytokine reaction because it also contributes to upregulation of interleukin 10. Conversely, interleukin 10 and TGFp both stimulate each other in a positive feedback. Both cytokines are highly immunosuppressive and act through inhibition of interleukin-12 production from APCs.The role of NPWT has not been published in series of patients with lympoedema NWPT exerts many actions, in particular promotions angiogenesis and lymphangiogenesis. NWPT appears to induce both morphologcial and quantitative alterations in lymph vessel networks in a wound (Labanaris). The combination of foam interface with NPT leads to mechanical microdeformations and resultant expression of angiogenic factors. NPWT may also remove inhibitory angiogenic factors such as matrix metalloproteinases. NWPT will increase VEGF (Kilpadi) While NPWT has gained international acceptance in the treatment of certain conditions such as burns, open abdomen, difficult wounds, thee have been no reported tiral in of its use in lymphoedema. Current dressings available are not suitable for application in lymph bearing areas. In addition to promoting new lymphatic formation NPWT may also reduce wound seroma which are frequent following surgery. This invention will allow combinations of pressures applied through embodiments of dressings at various pressures and cycles with or without the incorporation of graduated pressure through combinations of positive and or negative pressure..

The addition of external graduated compression to this invention may further enhance the clincal efficacy of the invention The invention will aid overcome the problems of lymphoedema, Statement of Invention 100 In an embodiment of the present invention, a dual pressure, variable positive and negative treatment device including a flexible contoured dressing size, with or without additional external positive pressure dressing chamber in a contour to accomodate its application to body area. The advantage of the invention is that is will reduce lymphoedema and fluid and promote lymphatic generation and fluid transmision in the 105 tissue.

Brief description of the drawings The various objects, advantages and features of this invention will be more apparent from a reading of the following detailed descriptionm, in conjunction with the included drawings, in which like reference numerals refer to like parts and in which; Figure 1 is a frontal and lateral schematic view of a negative pressure wound therapy dressing being coupled to a negative pressure device through a conduit to an embodiment of the present invention. The pressure device may contain a collection reservoir or cannnester, which may be portable.

Figure 2 is a front and lateral perspective of a both positive and negative wound pressure dressings, which for the purpose of this invention may take any size, shape or from, to apply directly to skin, contour or wound. The chambers of each dressing are separate with the positive dressing enclosure on top of the negative therapy dressing.

Figure 3 is a perspective view of another embodiment of the dual pressure therapy dressing arrangment, which herein it is in a trouser shape designed for the lower abdomen, inguinal and upper thigh regions.

Figure 4 is a frontal view of another embodiment of potential arrangements of multiple interlinked dual postive and negative wound presssure therapy dressings .

Figure 5 is an anterior perspective of different embodiments and potential location of simple and complex arrangements of the dual or single positve or negative pressure therapy dressings.

Detailed Description Field of the Invention The present invention relates generally to the field of medical devices and wound dressing, and more specifically to the field of treating and preventing lymphoedema and fluid build up.

The following statement is a full description of the invention and includes the best method of performing it. Numerous embodiments related to dermal application are disclosed herein. Further the embodiments disclosed herein relate to devices and dressing of variable size, form and consistency.

In accordance with the present invention a treatment dressing and pressure appliance is provided for treating all parts of the body with and without wounds The invention relates particularly to a manner of use of variable pressure therapy in patients in any part of the body, limbs and torso.

This invention will have particular relevance in the management of fluid, healing of tissue and lymphoedema. The invention will treat patients with established lymphoedema and be used to manage patients with potential fluid and limb problems in the lymphatics in any part of the body. Through promotion of lymphatic generation it will prevent lymphoedema in high risk patients.

Currently there are no reported series of use of negative or positive or a combination of either as wound pressure therapy in the prevention and management of lymphoedema. This invention provides a flexible option for the dressing application to facilitate treatment. Referring now to illustrations and where the same features are denoted by common reference numerals.

Figure 1 shows a schematic section having an embodiment of the dressing according to the present invention applied over an area which may or may not contain lymphatics in the skin for the purpose of applying negative pressure therapy. The dressing is slightly elevated off the skin with the contact dressing sealed creating an enclosure. The contact layer 1 may be formed by perforated material and may contain different layers of various material and absorptive quality. The porous nature of the contact layer will allow pressure transmission to the underlying tissue and lymphatics and also permit fluid or exudate to pass from the skin 4 or wound bed. The contact layer may be made up different compound depending on the patient’s skin and clinical situation. The dressing has an aperture in the area on the top of the dressing. A valve is positioned with a flange in the aperture 5 and connected to a pressure generating source and canister 20, capable of generating either a negative or positive pressure by a connection tubing 3 or conduit and a cup shaped connection member having an aperture to accept the end of the pressure connection tube or conduit 3. The cupshaped member has a flange which rests on the upper surface of the dressing. A feature of this invention is the shape and form of this dressing placement relative to underlying lymphatic drainage. The tubing is then connected to the pressure device which may contain a collection device for fluid 20. An adhesive on a least a part of the under surface of the flange may be used to give a mechanism for affixing the vacuum port to the dressing contact layer. Any material may be used for the conduit or tubing to the pressure generator 3. The reservoir or collection canister may be formed of any type of contained which is suitable to hold fluid 20. The canister may contain absorptive material.

Referring to Figure 2 the dressing shown generally now included a second dressing 6 which in one embodiment has the second dressing applied on its superior surface of the negative pressure dressing 1. The second dressing 6 has a pressurized enclosure allowing through is port 5 and conduit 3 to the pressure device 20, the ability to deliver positive pressure. The pressure within the dressing may be gradated from minimal to maximal to create a tiered gradient across the dressing. This may be achieved by variable diameters and one way valve mechanisms I the confined space.

Referring to Figure 3 in one embodiment the dressing had been formed to take the shape of a body region contour 7, in this case the lower abdomen inguinal and upper thigh region. The dressing worn like a garment enveloped the area with a seals provided at the edge of the dressing.

Referring to Figure 4 there is coupling connection 8 in between single or multiple of either negative or positive dressings or combinations of the same, to provide a broader treatment area. . Any material may be used for the conduit or tubing between the dressings. The sealed dressing are interconnected with a conduits to permit 205 transfer of the pressure to great area. The channels or a plurality of longitudinal or transverse openings may permit the pressure to be applied to great areas. The dressing may be used over wound or incisions. In addition to the multiple dressings shown in Figure 4 serial and or parallel applications may be used. Some potential locations of these dressing are shown in Figure 5, 9 in the axilla, 10 the limb, 11 the abdomen and 210 12 lower limb. 215 References Awad T, Butcher M. Handling the sequelae of breast cancer treatment: use of NPWT to enhance patient independence. J Wound Care. 2013 Mar;22(3):162, 164-6.

Blackham AU, Farrah Jp, McCoy TP Schmidt BS Shen P Prevention of surgical infections in high risk patients with laparotomy incisions using negative pressure therapy Am J Surg 2013;205:647-654 Bonds AM, Novick TK, Dieted JB, Araghizadeh FY, Olson CH. Incisional negative pressure wound therapy significantly reduces surgical site infection in open colorectal surgery. Dis Colon Rectum. 2013;56(12):1403-1408.

Dian D, Bodungen V, Himsl I, Drinovac V, Myionas I, Sommer H, Friese K.

Worldwide first experiences with vacuum-assisted closure as alternative treatment method to repair defects of an extended thoracic wall recurrence of breast cancer. Arch Gynecol Obstet. 2010 May;281(5):927-32 Dustagheer S, Tohill M, Khan K. Vacuum-assisted closure dressing as an aid to salvage breast following severe postoperative infection. Breast J. 2009 Mar-Apr; 15(2):214-5 Erba P, Oawa R, Ackermann M et al Angiogenesis in wounds treated by microdeformational wound therapy Ann Surg 2011,253,402-409 Erba P, Rieger UM, Pierer G, Kalbermatten DF. Vacuum-assisted closure (VAC) for venous congestion of the nipple-areola complex. J Plast Reconstr Aesthet Surg. 2008 61(7):852-4 Karlakki S, Brem M, Giannini S, Khanduja V, Stannard J, Martin R. Negative pressure wound therapy for managementof the surgical incision in orthopaedic surgery: A review of evidence and mechanisms for an emerging indication. Bone Joint Res. 2013;2(12):276-84.

Kendrick AS, Chase CW. Salvage of an infected breast tissue expander with an implant sizer and negative pressure wound management. Plast Reconstr Surg. 2008;121(3):138e-139e.

Kilpadi DV, Cunningham MR (2011) Evaluation of closed incision management with negative pressure wound therapy (CIM): Hematoma/seroma and involvement of the lymphatic system. Wound Rep Reg 19: 588-96 Krumboeck A, Giovanoli P, Plock JA (2013) Fat grafting and stem cell enhanced fat grafting to the breast under oncological aspects-Recommendations for patient selection. The Breast 2013;1-6 Labler L Rancan M Ladislav Mica L Luc Harter L Daniela Mihic-Probst D Keel M Vacuum-Assisted Closure Therapy Increases Local lnterleukin-8 and Vascular Endothelial Growth Factor Levels in Traumatic Wounds J Trauma. 2009; 66:749-757.

Liao EC, Breuing KH (2007) Breast mound salvage using vacuum-assisted closure device as bridge to reconstruction with inferolateral AlloDerm hammock. Annals of Plastic Surgery 59: 218-224 A, Dittmer C, Diedrich K, Thill M Successful application of vacuum-assisted closure therapy for treatment of mastitis-associated chronic breast wounds. Archives of Gynecology and Obstetrics 283: 1357-1362 Meeker J, Weinhold P, Dahners L (2011) Negative pressure therapy on primarily closed wounds improves wound healing parameters at 3 days in a porcine model. J Orthop Trauma 25: 756-761 Mohammed RA, Ellis IO, Elsheikh S, Paish EC, Martin SG (2007) Lymphatic and angiogenic characteristics in breast cancer: morphometric analysis and prognostic implications. Breast Cancer Res Treat 113:261-273 Moues CM Heule F Hovius S. E. R A review of topical negative pressure therapy in wound healing: sufficient evidence? Am J Surg 2011 201, 544-556 Oh BH Lee SH,Nam KA Lee HB Chung KY Comparison of negative pressure wound therapy and secondary intention healing after excision of acral lentiginous melanoma on the foot Brit J Dermatol 2013 168, 333-338 Pavlista D, Eliska O (2012) Analysis of direct oil contrast lymphography of upper limb lymphatics traversing the axilla-A lesson from the past-Contribution to the concept of axillary reverse mapping. EJSO 38: 390-394 Raff I AB. The use of negative pressure under skin flaps after radical Mastectomy. Ann Surg. 1952 Dec;136(6):1048 Ricci WM, Gardener M, Jo M, McAndrew C (2012) What’s new in orthopaedic trauma J Bone Joint Surg Am 94: 1525-35 Richards AJ, Hagelstein SM, Patel GK, Ivins NM, Sweetland HM, Harding KG.

Early use of negative pressure therapy in combination with silver dressings in a difficult breast abscess. Int Wound J. 2011 Dec;8(6):608-11 Stoeckel WT, David L, Levine EA, Argenta AE, Perrier ND (2006) Vacuum-assisted closure for the treatment of complex breast wounds. The Breast 15: 610-613 Stolier A, Skinner J (2000) A prospective study of seeding of the skin after core biopsy of the breast. Am J Surg 180: 104-107 Storr SJ, Safuan S, Mitra A, Elliott F, Walker C, Vasko MJ, Ho B, Cook M, Mohammed RA, Patel PM, Ellis IO, Newton-Bishop JA, Martin SG Objective assessment of blood and lymphatic vessel invasion and association with macrophage infiltration in cutaneous melanoma. (2012) Modern Pathology 25: 493-504

Claims (22)

1. The invention claimed is:

1 . A device for the application and administration of variable, both positive and negative or a combination of both pressures through a dressing that can be applied to any part of the body as treatment in mammals, comprising: of a dressing chamber, or chambers, to include an inner surface, an outer surface, and a sealing portion that creates an isolated treatment space, the chamber being made of a flexible impermeable material, placed on top or separately; (Figure 1, Figure 2)) a plurality of material on the inner surface side, with the embossed structures defining a concave shape relative to the outer surface, the structures deigned to directly contact the surface of the skin and or wound and deigned to allow pressure to be applied and maintained in the isolated treatment space, the plurality of structures intruding from the inner surface of the chamber into the isolated treatment space; wherein all of the pathways for distributing either negative or positive pressure are between the inner surface and the skin and wound and the second chamber positioned if wished on the first chamber being made of a flexible impermeable material; (Figure 1) A plurality of material on the inner surface side; and a tube multiple tubing or conduit connected to the either chamber, via a port or sealed connection, the tube being in flexible connection, with the isolated treatment spaces so as to enable at least one selected from the group of applying pressure to the treatment space and using as a therapeutic modality

2. . The device of claim 1, wherein the plurality of structures are arranged in patterns to define a channel on the inner surface of the chamber

3. , The device of claim 2, wherein the plurality of structures intrudes into the isolated treatment space in a direction generally perpendicular to the inner surface

4. . The device of claim 3, wherein each embossed structure has a shape selected, variable in size, malleable and flexible, rectangular, square, folding parallel rectangles, a pyramid, a pentagon, a hexagon, a half sphere, a dome, a rod, an elongated shape to fit all skin crease shapes with square sides

5. . The device of claim 4, wherein the shape has the same shape as external body part to be enclosed (Figure 3)

6. . The device of claim 5, wherein the shape has the same shape as lower limb

7. The device of claim 6, wherein the shape has the same shape as groin crease

8. The device of claim 7, wherein the shape has the same shape as axilla

9. The device of claim 8, wherein the shape has the same shape as lower torso

10. The device of claim 9, wherein the shape has the same shape as the hand

11. The device of claim 10, wherein the shape has the same shape as the breast

12. The device of claim 11, wherein the shape has the same shape as the penis

13. The device of claim 12, wherein the shape has the same shape as scrotum

14. The device of claim 13, wherein the shape has the same shape as the neck and supraclavicular fossa and fashioned according the individuals skin and skin crease anatomy

15. An appliance for creating and administering negative, reduced or positive pressure, or combination of pressure, either in cycles or constantly, for treatment to part of the body, the appliance comprising of; An enclosure consisting of a malleable flexible material and a port, wherein the enclosure has an opening and a confined volume adjacent to the opening and the enclosure is sized and positioned over and encloses the part of the body or cavity to be treated and the enclosure is managed to allow reduced negative pressure under the enclosure, with an outer enclosure allowing alternative pressure to applied be this position of negative, wherein part or all of the enclose will form the shape of the external skin or cavity contours, when negative or positive pressure or combinations and variations of pressure are applied, with the tubing and controls set to facilitate the flow of fluid and lymph from the portion of the body to be treated, the wound interface material is separate from the enclosure; A seal to functionally create the enclosure to the external part about the opening and wherein the seal is shaped and made to maintain the applied pressure and Wherein the port is attached to the generator device for negative or positive pressure to supply the pressure therapy

16. The appliance of claim 15, wherein: The flow and pressure control is operably connected to the port and the flow control permits variable fluid and lymph to flow under the single or multiple enclosures

17. An appliance claim of 16, with the addition of flow control by variable pressure in the continuity of the tube and the external vacuum or positive pressure pump.

18. The appliance of claim 17 wherein the port is located adjacent to the opening of the enclosure

19. The appliance of claim 18 wherein the port is located adjacent to the middle of the enclosure (figure 2)

20. The appliance of claim 19 wherein there are multiple ports located over the enclosure

21. The appliance of claim 20 wherein there are multiple ports located over the enclosure and the dressings are applied in different locations and directions or in combination.

22. The appliance of claim 20 wherein there are multiple ports located over the enclosure and the dressing’s enclosure are linked (figure 4)