WO2013050640A1

WO2013050640A1 - Improved vacuum dressing and the use thereof in vacuum-assisted therapy

Info

Publication number: WO2013050640A1
Application number: PCT/ES2012/070690
Authority: WO
Inventors: Juan Marquez Cañada
Original assignee: Marquez Canada Juan
Priority date: 2011-10-04
Filing date: 2012-10-04
Publication date: 2013-04-11

Abstract

Vacuum dressing (1) for oedema-prevention vacuum therapy for open or closed lesions or wounds, which comprises: a sealing adhesive sheet (5); a core, under said sheet (5), that comprises an external component (2) with pores (2a) and a protective internal component (3), of variable permeability and which may be adhesive or non-adhesive; and an aspiration tube (4) that creates tangential centripetal pressures under the surface (10) of said dressing (1). Said dressing (1) is sufficiently thick to incorporate a drainage device using Redon drains (9) provided with holes (9a) at the ends thereof, one inserted in said external component (2) and the opposite one in the operating field (8). A second internal component (3b) with a second drainage device may be incorporated. The dressing provides selective, controlled, centripetal "aspirating" compression; contact thereof with the perilesional skin provides a significant time-saving and enhanced, sealed fixing; it gives rise to a greater expansion effect on the perilesional skin; and it may be used in wound therapy (phases I, II and III).

Description

IMPROVED VACUUM TANK AND ITS USE IN THERAPY ASSISTED BY

EMPTY

OBJECT OF THE INVENTION

The present invention relates to an improved vacuum dressing, applicable in any lesion, open or closed, and in which anti-edema therapy, as in the case of vacuum-assisted therapy, hereinafter (TAV) may be beneficial. Improved vacuum dressing provides the function to which several advantages and innovative features are destined, which will be reported in detail later, thanks to which it is configured as a better alternative to the systems currently known in clinical practice for the same purpose.

More particularly, the object of the invention focuses on a vacuum dressing, of the type that incorporates, under its sealing sheet, a core with an external component of open pores and an internal component of variable permeability, whose structural design makes it suitable to be applied not only on the bed of wounds or loss of substance, but also directly on the skin surface and potentially also on the noble structures of said wounds or loss of substance, unlike the vacuum dressings currently used. It also has the possibility of incorporating a drainage device with modified rounds to directly transmit the reduced pressures from the bloody plane (surgical or lesional) to the open pores component of the dressing.

FIELD OF APPLICATION OF THE INVENTION

The field of application of the present invention is part of the technical sector of the industry dedicated to the manufacture of medical medical equipment, particularly dressings, bandages and similar devices for wounds and / or surgical plans. BACKGROUND OF THE INVENTION

With regard to the Pathophysiology of Wounds, it is important to keep in mind that one of its fundamental bases for a wound to evolve favorably is to combat edema

In general, there would be two different types of injuries or injuries: 1. Injuries or closed wounds. In them, the edema would be produced by the causal agent itself (blow, fall, ... or even by the aggression of the surgical act itself).

2. Injuries or open wounds. In them, edema would respond to a double aggression:

o An initial aggression, already referred to, produced by the causal agent itself o An aggression added and derived from the exposure or direct contact of the wound bed open with the air or the environment, including, in the case of associated necrosis, with the necrotic tissue itself.

Consequently, basically, to combat edema:

1. In Injuries or closed wounds, anti-edema therapy will consist mainly of compression therapy (ie, positive pressure);

2. In open lesions or wounds, the first measure to combat edema, in the absence of necrosis, will be to protect them from the outside by means of dressings that contribute to creating a favorable, non-hostile environment that promotes tissue regeneration, favoring the elimination of lesion exudate, as well as the formation of granulation tissue and proper epithelization; while in the presence of necrosis, the actions, together with the protection of the outside wound, should be directed to the debridement or elimination of the detritus material found in the wound bed. Bearing in mind that, in both cases, the healing effect can be increased if we associate compression; because we will be enhancing the anti-edema effect.

Thus, in the healing process of an open wound, in general, 3 phases could be considered:

• Phase I. Debridement.

• Phase II. Granulation.

Phase III Epithelialization

If we analyze the methods used for the treatment of wounds over time we find that from the second half of the twentieth century, a great advance in the healing of wounds begins with the appearance and development of different types of dressings New-generation atraumatic or protective calls, which will try to mimic the characteristics of human skin in order to allow more effective wound isolation; maintaining a physiological environment while its internal surface (intended to contact both the wound and perilesional skin) will "pamper" the wound and perilesional skin; These "atraumatic or protective" dressings will allow the exudate to be absorbed, but will prevent the macropenetration of the neoformed granulation tissue from the wound inside them, so that its withdrawal will also be "atraumatic" and, therefore, will protect the epithelialization Also, in the case of associated necrosis, they will contribute to the debridement or elimination of the detritus material found in the wound bed. However, despite their advantages, they still have a limited absorption capacity (so that, depending on the exudate, sometimes they can remain in situ even more than 7 days and others, on the contrary, require more frequent changes) and also, they still need complementary compression bandages; which, despite the progress made in wound healing, have not undergone significant changes as they remain circular.

In the last decade of the twentieth century, at the hands of the firm KCI (Kinetic Concepts Inc. San Antonio, Texas), a new concept in the treatment of wounds will begin to rise, with the "Reduced Pressure Therapy or Negative". The system introduced / proposed by KCI, showed that with the application of vacuum pressure on the wound bed, both experimentally and clinically, tissue repair processes were accelerated.

Thus, at present, one of the most used devices for vacuum-assisted wound therapy is the "VAC®" (Vacuum-Assisted Closure) system, manufactured by KCI. This system consists of placing a sterile cross-linked polyurethane (PU) foam dressing with open pores (400-600 μηι) covering the wound over its entire surface. On this sponge a suction tube is applied that connects to a programmable vacuum pump. The vacuum pump is provided with a reservoir to store the fluid that is extracted from the wound. The sponge and the tube outlet are sealed and insulated from the outside by an adhesive sheet that adheres to the surrounding skin, creating a closed system. The high porosity of the polyurethane foam dressing used by this system, due to its regular open macropore structure, makes the pressure distributed over the entire surface of the wound uniform; For this, it is essential to ensure that the system is airtight and there are no leaks through the insulating plastic dressing. With this, this "aggressive" dressing of large open pores (consisting of a sponge similar to those used in filter systems) will allow to directly transmit the Reduced or Negative Pressure (vacuum) generated from a suction source, to the wound ; conferring, in theory, unlimited absorption capacity (unlike the previous "atraumatic" stakes).

According to the manufacturer (KCI), the mechanisms by which the application of Reduced Pressure, lower than atmospheric or suction, on a wound made it possible to reduce its edema and promote tissue repair processes, would be macro-tension (at the level of tissues) and microtension (at the cell level) that would act together. These mechanisms would be caused by the application of pressure reduction and direct contact between the open pore foam and the wound bed.

However, the KCI hypothesis to explain the anti-edema effect of Reduced Pressure Therapy was in direct contradiction with the fact that the basic mechanism for the reduction of edema is compression (that is, positive pressure, higher than atmospheric ). In addition, the Conventional Void Disposal (hereinafter, AVC) introduced by KCI presented a series of inconveniences that prevented it from contacting the noble parts of the wounds (tendons, bone, visceral tissue, ...) or with the perilesional skin , as well as that it could be kept "in situ" more than 2-3 days. For what they meant a "loss of opportunity" since the unlimited absorption capacity of the system did not necessarily translate into a smaller number of changes in the cost of "atraumatic or protective" stakes, nor that they required less time to its placement (not to be trimmed according to the shape of the wound).

In fact, what the clinical experience has always shown is that when removing the AVC at each change of cure, under it, an imprint on the body surface was produced; which implied, not only that under the AVC, the KCI system also generated positive pressures, higher than atmospheric; but, even, that the final result of the Reduced Pressure Therapy was of Positive sign. Well, although it is true that the application of vacuum therapy on the body surface generates reduced pressures at the level of the pores of the dressing, it is not less than at the level of the contact points of the solid components of the foam (walls of the pores) with the wound bed, the system generates positive pressures.

This is missing a TAV dressing that allowed us to expand the indications of this Vacuum Therapy, not only to promote healing in substance losses, but also as a tool in situations that require compression, whether or not there is a loss of substance, such as: - lipoaspiration in areas of difficult compression with conventional pressure therapy garments / girdles (for example, cervical-dorsal lipomatosis, lipomatosis located in morbid obesities, etc.),

- Surgical interventions in general (for example, tummy tucks) to minimize the risk of postoperative morbidity, since the TAV, compared to conventional belts / bandages, would constitute an "active" compression system, which, among others, would combine the properties of be able to be aspirational, selective, controlled and centripetal; and with the possibility of also incorporating a system of integrated rounds in it; therefore, in addition to reducing the tension in the suture lines, it would allow dispensing with conventional bandages and external rounds; which would facilitate the immediate postoperative mobilization of the patient,

- prevention / treatment of pathological scars

- treatment of edema of non-surgical origin,

- stabilization or splinting after sprains or dislocations.

But, the importance of the Negative or Positive sign of pressure was fundamental not only to be able to better understand what was the mechanism of action of the so-called "Reduced or Negative Pressure Therapy" and thus be able to extend its applications, but also to prevent its effects Adverse In fact, in lesions with established ischemic damage (eg in ischemic vascular ulcers or in positive pressure ulcers, among others), the lack of knowledge that the fundamental mechanism of action of this Therapy is Positive Pressure or Compression (and not Pressure Negative), may be a source of complications / adverse effects.

Along these same lines, there are currently publications about the "paradox" that the final result of Reduced or Negative Pressure Therapy is Positive; as well as warning of the risks that this fact may involve:

• Negative-Pressure Wound Therapy I: The paradox of Negative-Pressure Wound

Therapy (Plast. Reconstr. Surg. 123: 589-598, 2009)

• Negative-Pressure Wound Therapy II: Negative-Pressure Wound Therapy and

Increased Perfusion. Just an lllusion? (Plast. Reconstr. Surg. 123: 601-612, 2009)

• The paradox of Negative-Pressure Wound Therapy - in vitro studies (JPRAS.

63: 174-179, 2010)

In addition, the fact that the final result is Positive will imply that the KCI dressing, together with the loss of time for having to be trimmed (and thus avoiding its contact with the perilesional skin), will also mean a loss of opportunity and of effectiveness; since, since it cannot also be applied to the perilesional skin, it does not it will allow to optimize the reduction of perilesional edema (present in every wound or injury) or the approximation of the edges of the wound.

There are other systems that, instead of PU foam, simply use gauze; but its effect on the contraction of the lesion bed is minor; and they also cannot contact perilesional skin.

There is also a dressing also marketed by KCI and which is called VAC WhiteFoam® (also open-pore foam but instead of PU is polyvinyl alcohol, PVA) that seems to protect more noble parts of the wound; nevertheless its contraction power and therefore its effectiveness is lower; and like that of PU, it cannot contact the skin, so it is practically obsolete.

So, such open-pore dressings have been conceived / designed to be applied only on substance / ulcer losses and should not contact healthy skin. In fact, the most frequent complication of these systems is irritation, maceration and even ulceration of the skin or also of the noble structures of the wound that may accidentally remain in contact with the foam. Therefore, it is necessary to interpose between this macroporous polyurethane sponge and the body surface a type of atraumatic dressing, of variable permeability that protects healthy skin. There are multiple stores on the market that can serve as a basis for satisfying these conditions (Tielle®, Mepilex®, Biatain®, Epifoam®, skinfoam®, allevyn®, therafoam®, etc.

These dressings are generally made up of three layers:

- an outer layer generally of oxygen-permeable polyurethane, impervious to liquids under atmospheric pressure conditions (760mmhg), and with a variable permeability to water vapor after the application of vacuum suction.

- a central hydroponic middle layer with high absorption capacity (usually polyurethane foam) of liquids (hydrophilic)

- a microperforated inner layer (adherent or not) generally of polyurethane or silicone.

The absolute permeability range of the vacuum dressing of the invention varies between 100 and 5000 g / m ² in 24 hours.

However, such state-of-the-art dressings as well as vac® foam, having not been conceived as a postoperative compression treatment, have the disadvantage that their available dimensions in the case of large operative areas do not make them suitable for this purpose. and, although for his use as part of a "vacuum" compression system by vacuum, which together with the suction of the exudate, will be selective, controlled and centripetal, there is the possibility of coupling them together, the procedure is not very effective, it is tedious and supposes lengthen the surgical procedure. In addition, the risks of overlapping or shearing between them and / or with VAC® foam prevent them from being in situ for more than 48 hours to avoid possible adverse effects.

The applicants have submitted applications U200900931 from 05-20-2009, PCT2010000221 from 05-20-2010, P2010000364 from 03-18-10, and PCT201 1000086 from 03-18-1, 1, in which there are described some superior features; where said stakes already:

- allow to increase the overall permeability of the dressing and facilitate the incorporation of different types of drains.

- They can have a different configuration and composition depending on the topography and the type of lesion on which they will be applied.

- can be applied to complex lesions for which they incorporate suction devices, connected to machines, or even

- they allow the connection with vacuum system of bottle or by bellows.

It is therefore, the main objective of the present invention, the creation of a new integrated or integrated improved vacuum dressing, which:

- is suitable for wounds or injuries in which vacuum-assisted anti-edema therapy may be beneficial, and

- be fit to be in contact with healthy skin,

- present adequate dimensions for larger body areas, taking into account the geometric configuration of the application area, and

- has a sufficient thickness to optimize postoperative compression, and that

- allow to incorporate a drainage device with modified tubes or rounds to directly transmit the reduced pressures from the underlying bloody area of the wound to the open pore component of the dressing. In addition, the fact that it is an integrated or integrable dressing and that its innermost layer can be adherent, would increase its effectiveness, since it would allow developing centripetal tangential pressures not only at the periphery of the dressing (by the adhesive sheet external that adheres to the surrounding skin), but also central centripetal tangential pressures under the adherent surface of the dressing, providing a greater effect of cutaneous retraction and reduction of tension in the suture lines. DESCRIPTION OF THE INVENTION

AVM APPOSITION AND ASSISTED THERAPY BY VACUUM TAV

Thus, the present application develops the vast potential offered by the TAV, that is, the one carried out at reduced pressure in the treatment of injuries or open or closed wounds. The applicant considers that the designation "Vacuum Assisted Therapy, would induce less error than the current one of" Negative Pressure Therapy ", whose use is nevertheless more widespread in the event that it could also be applied to the perilesional skin; since the TAV would allow to provide a selective, controlled and centripetal compression, and also, with the conceptual advance of this "unlimited" absorption therapy system that, instead of accumulating the exudate in the dressing, directed it towards a deposit located in an external device

For this, the present invention proposes a vacuum dressing applicable in any type of lesion, open or closed, with or without loss of substance, regardless of its etiology and in which vacuum-assisted anti-edema therapy can be beneficial, which is configured as a novelty within its field of application, since, according to its implementation, the aforementioned objectives are satisfactorily achieved, its characteristic details being adequately included in the claims that accompany this specification.

Specifically, the invention focuses on an Enhanced Vacuum Disposal (hereinafter, AVM) applicable for surgical planes or lesion areas of different configurations that require anti-edema therapy, a dressing which comprises, under its sealing foil, a constituted core by an area or external component (hereinafter, CE) of open pores, as a retraction vector by allowing the vacuum inside to be effectively and uniformly transmitted by its open pore structure; and an internal component (hereinafter, Cí) of different permeability according to its designation, as a body surface protection factor, which will also be retracted by being "dragged" by said CE; and that will be the one that directly contacts the body surface, thus preventing the EC from doing so, said internal component CI being able to be adherent or not, and on said core is a suction tube connected to a vacuum pump, being sealed Hermetically the union of said tube to the dressing. In principle, any element of open pores, which is not hydrophilic and that does not attract water regardless of being made of foam or any other material (eg: 3d nylon fabric, ...), provided it maintains a susceptibility to retract by applying the vacuum; as well as having an area or simply an internal surface permeable to oxygen and impervious to liquids under atmospheric pressure conditions, capable of minimizing or protecting the body surface from the direct action of vacuum, could constitute the core of an AVM.

In addition, the greater thickness of the EC of open pores enhances the sagittal positive pressures, providing a greater compression effect and also allowing it to incorporate, additionally, a drainage device consisting of modified evacuation tubes or rounds to which it has been practiced ( in a manufactured way) multiple holes in its two ends, and that directly transmit the reduced pressures from the surgical plane or the lesional bloody area to the open pores area, promoting tissue adhesion and avoiding the placement of external tubes or rounds.

In view of the foregoing, an object of the present invention is an integrated and improved vacuum dressing for vacuum-assisted therapy intended for the anti-edema therapy of any lesion or wound, open or closed, comprising a sealing adhesive sheet on the that a suction tube connected to a vacuum pump is coupled, a core located under said sealing adhesive sheet, consisting of an area, or external component, of open pore structure, which allows uniform distribution of the vacuum inside of said vacuum dressing, and of an area or, which internal component, protective or "atraumatic attic", of varying or different permeability according to its designation, adherent surface or not, optimize said anti-edema therapy by vacuum regulation; said suction tube, which conditions tangential centripetal pressures on the skin surface or not, not only on the periphery of said dressing, but also under the surface of said dressing; wherein said vacuum dressing has a sufficient thickness, preferably a thickness between 0.1 and 20cm, to enable the incorporation of a drainage device; and wherein said drainage device is constituted by tubes provided with a plurality of holes in its two ends, of which ends, one is inserted in said external component of open pores of said dressing, and the opposite is intended to be inserted in the operative plane.

According to particular embodiments, the vacuum dressing for Vacuum Assisted Therapy in a manufactured way, in its final configuration, already consists of all its components: the adhesive sealing sheet, the suction tube, the vacuum pump, the core constituted by an external area or component of open pore structure and an internal area or component of variable permeability, and the drainage device constituted by the tubes provided with a plurality of holes (9a) at both ends.

according to additional particular embodiments in the vacuum dressing, said drainage device constituted by the tubes provided with said plurality of holes at both ends, is presented in a manner manufactured independently of said other components of said vacuum dressing.

According to additional particular embodiments of the dressing, it is presented in a manufactured manner at least said core constituted by the external component and the internal component, and one or more of said other components of said vacuum dressing may be absent in the manufacture. According to this embodiment and preferably, said dressing is presented in a manufactured manner with said core constituted by the external component and the internal component, one or more of the rest of said other components may be absent in the manufacture, and the union between said external component and said irreversible internal component; either the core of monobloc manufacturing from the same material and having different morphology or structure said external component and internal component; or because the bonding / adhesion is highly supportive between the different constituent materials of said external component and internal component. Another alternative of these embodiments is that the dressing is presented in a manufactured manner with said core constituted by the external component and the internal component, one or more of said other components of said vacuum dressing may be absent in the manufacture; and the union or integration between said external and internal components is reversible, either because the contact surfaces between them have been provided with a more labile adhesive in one or both directions, allowing their take off and stuck repeatedly, either because it is a reversible adhesive bond of the type protected by reversible adhesive flaps or even one of the "sailboat" type.

According to additional particular embodiments of the dressing, said dressing may present various specific geometric configurations of the shapes of the surfaces of its body contact around the wounds. Preferably, it has a semi-cylindrical configuration for adaptation to semi-cylindrical surfaces such as legs and arms. Another alternative is a concave configuration for adaptation to concave articular surfaces such as knee and elbow. Another additional alternative is to present a chair configuration of mount for best adaptation to curved prism surfaces such as the neck. Another alternative is a custom configuration for adaptation to the surfaces of even more complex body sites.

According to additional particular embodiments of the dressing, it is presented with said core integrated in a manufactured manner and independent of said other components of said vacuum dressing, the union or integration between the external component and the internal component, reversible or irreversible, and presenting said external component, at the level of its external face, complete oblique cuts, and being attached to said internal component, said internal component will serve as a support so that the pieces of said external component are not separated and presenting said cuts in one or more directions , so as to adapt said vacuum dressing in situ to complex curved or convex surfaces, and said internal component having a surface equal to or greater than that of said external component in order to prevent contact of said external component with the skin.

According to additional particular embodiments of the dressing, said external component, presents on both sides, subtotal oblique cuts in several directions, or is cut following a spiral pattern, to allow the adaptation of said dressing to both curved and concave, convex or irregular surfaces and said internal component having a surface equal to or greater than that of said external component, to prevent contact of said external component with the skin.

According to additional particular embodiments of the dressing, said dressing may have various dimensions depending on the dimensions of the body contact surfaces so as not to cut them according to the shape or dimensions of said wound.

According to additional particular embodiments of the dressing, said dressing is applied to very small areas, where said dressing is manufactured in the form of "mini" vacuum cups - up to 1 cm ² of surface - and presenting surfaces of different diameters even lower 1 cm, and where said aspiration tubes are presented in a manufactured way in the form of "mini" aspiration tubes for application to anatomical areas of very small size, be fixed as the nasal tip, pulp and others, such as mobile of the type of joints, fingers and others. According to these embodiments, preferably said dressing will not include in its manufacture the vacuum pump and the drainage device constituted by said modified rounds, and wherein said dressing is presented in a manufactured manner in the form of said "mini" vacuum cups, and presenting different surfaces diameters even less than 1 cm, and with these "minr suction tubes - up to 1cm ² of surface - incorporated for application to anatomical areas of very small size, be fixed as the nasal tip, pulp and other, such as mobile type of joints, fingers and others.

According to additional particular embodiments of the dressing, said external component has a greater thickness that can reach more than double that of the current vacuum dressings even exceeding 6 cm.

According to additional particular embodiments of the dressing, the permeability of said internal component of said vacuum dressing is minimal, where "minimum" means that the absolute permeability value is 100 to 5000 gr / m ² in 24 h of treatment; without risk of leakage, and where the vacuum is established only inside said vacuum dressing between its adhesive sealant sheet and said internal component of minimum permeability.

According to additional particular embodiments of the dressing, said dressing comprises a second deeper internal component manufactured in an integrated or integrable manner with said vacuum dressing such that the two internal components of said vacuum dressing would contact each other at the level of their central area that it would coincide with the maximum permeability of the first surface internal component to allow drainage from the deep internal component) which would also be permeable at its periphery, to enable drainage even from the retroperitoneal areas. Preferably, said second deeper internal component further incorporates tubular drainage elements or devices inside. Even more preferably, said tubular drain elements or devices of said second deeper internal component can have various geometric configurations to optimize drainage. According to other alternatives for these embodiments, said CE incorporates tubular drainage elements or devices with adaptation elements to the retraction of the dressing or, even, said drainage devices being spiroid to further optimize said adaptation to the contraction of the dressing and ensure an optimal level of drainage between the most peripheral areas of the dressing and the suction or aspiration tube.

A second object of the invention is the use of vacuum dressing to minimize the risks of bleeding and infections, associated with conventional vacuum dressings, allow greater wound contraction, and achieve a more effective reduction of perilesional edema through Vacuum Assisted Therapy, in where said vacuum dressing is applied on open lesions, such as primary or secondary dressing; it is applied in all its periphery on the perilesional skin - or periphery of the aposito - and even beyond said perilesional skin by means of the surface, adherent or not; of said vacuum dressing, and where according to the characteristics of the wound, said dressing is not trimmed or trimmed following the shape of said wound, is introduced or not introduced interposed between the edges of the open wounds and does not limit the approximation of said edges; and wherein said dressing is applied by means of said surface and a greater contraction of the wound is performed; it is applied with larger dimensions and greater surface of distribution of the vacuum than the current vacuum vats, and the development of centripetal tangential pressures is carried out not only on the periphery of said aposite under the adherent surface of the sealing sheet, but also under said surface of said internal component of said dressing.

Vacuum dressing for Vacuum Assisted Therapy can be applied in both Phase I Debridement; as in Phase II of Granulation; and in Phase III of Wound Epithelialization.

The vacuum dressing can be used on closed wounds to optimize compression, achieve a more effective reduction of lesion and perilesional edema, or allow greater wound contraction and decrease the tension of the edges of said closed wounds by means of of Vacuum Assisted Therapy, wherein said vacuum dressing is applied by means of said surface on wounds or closed lesions, as well as on the cutaneous surface corresponding to the underlying lesional and perilesional area; and it is applied with greater dimensions and greater surface of distribution of the vacuum than the conventional vacuum dressings, and the compression and development of tangential centripetal pressures is carried out not only on the periphery of said position under the adherent surface of the sealing sheet, but also under said surface of said internal component of said dressing.

Another additional object is the use of vacuum dressing in plastic operations. Another additional object is the use of the dressing in plastic surgery operations associated with grafts, and where a single vacuum dressing is applied over the totality of both, said plasty and said graft.

Another additional object is the use of the dressing in the direct closure of surgical wounds.

Another additional object is the use of dressing in the postoperative management of neck surgery

Another additional object is the use of dressing in the prevention and treatment of pathological scars. Another additional object is the use of dressing on donor areas of skin grafts.

Another additional object is the use of dressing in the treatment of bedsores.

Another additional object is the use of the dressing in the treatment of fistulas in communication with organic cavities, such as digestive, thoracic, and cerebrospinal cavities.

Another additional object is the use of the dressing for the treatment of an injured area with multiple concomitant wounds, which alternate with areas of integral skin.

Another additional object is the use of the dressing for the prevention and treatment of dehiscent wounds.

Another additional object is the use of the dressing in the treatment of the open abdomen.

Another additional object is the use of the dressing to increase the safety or comfort of postoperative treatment.

Another additional object is the use of the dressing for deferred closure or reconstruction of wounds.

Another additional object is the use of the dressing for the treatment of edema of non-surgical origin.

Another additional object is the use of the dressing for stabilization or splinting in joint or osteo-articular pathology, closed or open, with or without loss of substance, with or without prosthetic replacement.

Another additional object is the use of the dressing in the reduction of surgical requirements.

Another additional object is the use of dressing in early postoperative mobilization.

Another additional object is the use of the dressing as an "active" dressing-girdle and to provide an aspiration, selective, controlled and centripetal compression where said dressing (1) incorporates an integrated rounding system, whereby bandages are dispensed with and Current external networks.

Another additional object is the use of the dressing to favor compression; and preferably in areas of difficult compression with the current methods, or in areas where the current circular methods or systems are not recommended, or are contraindicated, for the pathology of the patient. ADVANTAGES OF THE APPOSITION OF THE INVENTION.

Likewise, it should be noted that the fact that it is an integrated or integrable dressing, also applicable on the skin surface, and that its internal component Cl can be adherent, allows to develop centripetal tangential pressures on the entire skin surface, not only in the periphery of the dressing (at the level of the external adhesive sheet that adheres it to the surrounding skin), but also directly under the inner surface of the core of said dressing; providing a greater effect of cutaneous retraction and reduction of tension in the suture lines or contraction of the lesion bed. Something that with AVCs is not possible, since they cannot directly contact the skin surface. And it will be even more enhanced in the case of AVMs with nuclei whose internal surface are also adherent.

Another advantage of this AVM is that its permeability is easily "individualizable" or adaptable "in situ", to the needs, depending on the type of injury. Thus, if it is applied in potential or highly exudative lesions, it will be enough to cross the Cl with a sterile needle (or with the blade of a scalpel, if a more permeable dressing is required) in the areas that are desired (eg: in the In the case of open wounds, it will usually be at the level of the central area of the same) to increase its permeability; on the contrary, if it is applied on closed wounds, it will generally not be necessary to do it (although it could be done along the path of the incision).

Another of the advantages or possibilities of the dressing of the present invention in clinical practice is that in the case of an AVM with Cl hydroregulators or even semipermeable, under the application of a suction source, they can behave as self-regulating "permeability" ", so that without the need for perforations or punctures in the Cl, if the wound turns out to be very exudative, a dilation of the micropores of the Cl-limiting membrane could occur (initially designed to pass only gases or steam of water), so that it could also become permeable to liquids, depending on the hydrostatic pressure of the wound.

Also, while the mechanism of action of the Vacuum Gates

Conventional (AVCs) has been conceived for Phase II or Wound Granulation (hence another name given to this KCI foam: "granufoam"), the AVMs of the present invention, due to the atraumatic or protective nature of its internal component Cl, respect wounds and protect the neoformation of the epithelium, so they would also be indicated in Phase III or Epithelialization. But, in addition, the AVMs can be used both as primary dressings (that is, directly on the injury) or as secondary dressings, on almost all of the primary supplies available on the market; and, in addition, they also allow them to be used in Phase I or Debridement of injuries (in which AVCs would be contraindicated); being compatible, among others, with products such as hydrogels, hydrofibers and alginates; and even with ointments or creams of debriding enzymes; allowing to enhance different types of debridement (ex: surgical, enzymatic, autolytic, ...). Thus, by way of example, they enable the primary hydrofiber dressings to absorb large amounts of exudate and wound bacteria, forming a soft and cohesive gel that adapts perfectly to the surface of the wound while maintaining moisture; However, given the limited absorption capacity of these primary stakes, the application of the AVMs on them (as secondary stakes), due to their hydroregulatory potential with unlimited absorption capacity (excess exudate is led to an external reservoir) and controlled (depending on the pressure parameters applied), it will allow to optimize the autolytic debridement.

Thus, the advantages of the dressing of the present invention are confirmed, since with it there is a greater rapidity of placement and greater safety and comfort for the patient, improving efficiency and effectiveness, since, in addition to being able to be applied directly to the skin surface, it can be maintained for a longer period of days than with the current dressing system, by allowing the distribution of a uniform pressure in the application area (without risks of hyper or hypopress due to overlapping or shear between juxta / overlapping dressings) providing a greater effect of cutaneous retraction and reduction of tension in the suture lines.

Thus, while the AVMs of the present invention, due to the protective nature of their internal component (Cl), respect the wounds, the mechanism of action of the AVC ^' s has been designed to cause stress or irritation on the lesion bed with in order to stimulate the proliferation of granulation tissue. However, this same stress is the one that, in addition to being able to end up producing the "exhaustion" in the body's response to it, which would force to suspend this type of therapy, prevents them from coming into contact with healthy perilesional skin or with other noble organs or tissues of the wound sinus. All this implies the dedication of extra time, not only to cut them and adapt them to the shape of the wound, but also to avoid their contact with the noble structures present in it. Thus, the structure of open pores of the AVCs, intended to stimulate-stress the wound bed, favors the macroinvasion of said pores by the granulation tissue present in the lesion bed, which makes maintenance "in situ "more than 2-3 days, both for the risk of superinfection (when the drainage of the wound is blocked, for the obstruction of the pores of the AVC) and, in addition, for a series of consequences, which must be borne in mind: withdraw the dressing, the cures are usually painful, since in many cases the AVC has to be literally "torn" from the bed of the wound; which implies a damage to the neoformed granulation tissue that supposes a recoil in the healing process of the same. In addition, such "removal" carries a real risk of bleeding; Therefore, these AVCs should be used with caution (especially in patients with coagulation disorders); In addition, another of the dangers of the aforementioned "uprooting" is that fragments of the AVC itself can be retained within the lesion, with the risk of infection or sepsis; In fact, recently an FDA report (February 24, 2011. FDA Safety Communication: UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems), has warned of the potential dangers associated with this type of dressing, with the communication of cases of deaths, due to possible hemorrhages or infections, linked to them.

Instead, as mentioned, the atraumatic nature of the AVM Cl of the present invention protects the system from depletion, since it protects the granulation tissue; preventing it from contacting the open pore structure of the EC; For this reason, it prevents the blockage of the drainage of the lesion exudate, does not cause recoil in the wound healing process during the changes of this dressing, such that the interval between these changes can be extended even more than a week, compared to the 2-3 days of the AVCs, and in addition, being the atraumatic AVM unlike the AVCs, it favors epithelialization and even allows it to be enhanced by making it possible to associate complementary therapies, such as stem cells, growth factors, among others.

Thus, the AVM object of the present invention differs from the AVCs in that it also incorporates an internal component whose contact surface with the organism makes it suitable to contact not only with the lesion bed but also with the skin, as well as potentially on noble tissues or structures of the wound. This allows the indications of this vacuum therapy to be extended not only to promote healing in substance losses, but also as a valuable tool in situations that require compression, whether or not there is a loss of substance. In addition, the fact that it is an integrated or integrable dressing and also applicable on the entire cutaneous surface will increase its effectiveness, since it will allow the development of tangential centripetal pressures, on the entire cutaneous surface, also directly under the internal surface of the core of said dressing; providing a greater effect of cutaneous retraction and reduction of tension in the suture lines, that is, also enhancing centripetal compression. Likewise, in order to favor drainage, the AVM can additionally incorporate a device consisting of modified internal rounds that will prevent the placement of external rounds.

The form of the dressing of the invention can take various configurations such as flat, curved, or other specific shapes depending on the shapes of the surfaces of your body contact; for example, a semi-cylindrical configuration for better adaptation to semi-cylindrical surfaces such as legs, arms, thighs ...; a concave configuration for better adaptation to the cranial vault, heel, concave articular surfaces such as knee, elbow, ...; a saddle-shaped configuration for better adaptation to surfaces such as the neck; and finally, other configurations suitable for different even more complex body sites that are well understood by those skilled in the art.

The AVM of the invention, being able to also contact the perilesional skin, does not need to be cut according to the shape of the wound unlike the AVCs, which if they contact the skin cause irritation and maceration; in addition to the implications of saving time and learning curve much faster; It has the beneficial effect that, being able to be applied beyond the injury itself, it serves as a greater safety seal for the fixation of the dressing, less risk of leaks or separation of the dressing; and produces a greater perilesional cutaneous expander effect due to the aforementioned centripetal tangential forces. Thus, in open wounds or loss of substance, the dressing of the present invention allows a wound contraction effect greater than that of the AVC ^' s, while in closed wounds, the decrease in tension at the level of the skin sutures

The traditional "passive" compression therapy, carried out using conventional belts or bandages, despite its benefits, produces a potentially dangerous compression by being: circular, or non-selective on the area to be treated, since it is of intensity of difficult control, by not being technically measurable; and not centripetal, being able to even produce distraction or separation of the edges of the wound under the surface of the dressing, by "ram effect", and also does not allow to integrate into it the system of rounds or drains from the lesion bed.

On the contrary, the "Aspiration" Compression Therapy of the AVM of the present invention not only allows a selective, centripetal and controlled compression depending on the pressure parameters to be applied; but also, through its own suction system through modified rounds, which allows us to dispense with external rounds, which will allow us to further optimize the patient's safety and comfort, favoring early ambulation and reducing the risks associated with prolonged immobilization. such as pulmonary thromboembolism and others. The dressing of the present invention is evidenced as a tool in all those situations in which an anti-edema therapy may be beneficial, whether in open or closed lesions, either postoperatively or for any other reason, e.g. posttraumatic Derived from the above, the AVM can be used simultaneously on plastias associated with grafts, contributing not only to safety but to a more aesthetic result, by allowing both surfaces to be homogenized. _

Another very important consideration about the AVM of the present invention is that since the Cl of the AVM of variable permeability it is possible to have semi-occlusive or minimum permeability C / s, for application even over orificial or juxtaorificial areas, without risk of aspiration of intestinal fluid or air leakage; since the vacuum is established only inside the AVM between its outer sealing sheet and its Cl, without being transmitted to the space between the skin surface and the vacuum dressing.

A complementary advantage of the AVM is to be able to have all its constituent elements in its commercial delivery form (Cl + CE + sealing sheet + other specific elements); therefore, since it does not need to be cut according to the shape of the wound, they can, unlike the AVCs that are assembled piece by piece at the time of placement, be manufactured with all its elements in an integrated way; so they would not need a learning curve. This also has other implications; Thus, it allows expanding the indications of vacuum pressure therapy to appendixes or anatomical areas of very small size, even with irregular body surfaces both fixed (eg nasal tip, pulps, ...) and mobile (such as loss of substance at the level of the finger joints); and that they can present losses of substance of very small diameter (sometimes less than one centimeter), although complex (eg, bone, tendon, chondral or articular exposure) and that, however, "due to space conflict" are not accessible to any vacuum therapy system currently existing or described in the literature, by way of For example, only the size of the KCI connection system board with the AVC is about 4 cm in diameter; thus, in its application on the pulp of a finger it would exceed the limits of the distal interphalangeal joint; with the patient's discomfort and the risk of subsequent joint stiffness. However, it might be feasible to have "mini" AVMs integrated with "mini" suction tubes built in a manufactured way (it would be enough to remove the protective flaps from their adhesive surface and apply them on the body surface); advantageously interesting in the case of these complex substance losses of small diameter; which, in addition to facilitating faster placement, would allow the selective application of vacuum therapy in areas where it is not yet operational today. Thus, integrated "mini" AVMs of different cm diameter (eg: 1, 2, ...) could be available; and that they could even be concave or other geometric configurations for a better adaptation to the application surface.

In this sense, there would also be the possibility that the integrated core, constituted by the union of CE and Cl, would be manufactured independently from the rest of the components of the AVM and there should also be the possibility that the union or integration between the CE and The Cl could be reversible, either because the contact surfaces between them have been provided with a more labile adhesive in one or both directions, allowing it to take off and stuck repeatedly, or because it is a reversible adhesive bond of the type protected by reversible adhesive flaps or even one of the "sailboat" type, either because the contact surfaces between them have been provided with a more labile adhesive or of the type protected by reversible adhesive flaps, or even as a "sailboat" type joint . There may be complete oblique cuts at the CE level (in one or more directions) since being attached to the Cl, this would act as a bridge so that the segments of the ce were not separated, the adaptation of the improved vacuum dressing to convex surfaces or even concave For this last case, a suppression of material is required that allows the deformation of the dressing and the adaptation to this type of surfaces.

In the same way, to favor a greater versatility of the AVM in its adaptation to surfaces with greater irregularities (ex .: concave convexes, ...) it could be useful the fact that the oblique cuts were presented both at the level of the external and internal face of the CE. In this case, the oblique cuts should be subtotal, to prevent the EC from separating into several pieces. However, there would also be the possibility that the EC would be completely cut following a pattern in spiral; what would confer on it the property of adapting to both concave and convex surfaces, simply turn it in one direction or another.

This could also be useful for adaptation in anatomical areas, in which "for aesthetic or functional reasons" p. eg, face, hands, foot support areas, it is important that the AVM does not excessively exceed the dimensions of the defect to be covered p. eg, not to hinder vision, hand mobilization, ambulation.

PERMEABILITY OF THE POST

The permeability of the Cl of the AVMs can vary or be adapted according to the needs; Thus, its variable permeability can be established manually on site at the time of placement, or pre-established in a manufactured way:

1) "in situ":

a) to increase its permeability:

i. performing at the time of placement on the wound the aforementioned perforations that cross the Cl; being able to match these perforations ("in mirror") with the potentially more exudative areas of the lesion.

b) to decrease its permeability:

i. incorporating to the Cl a layer of lower permeability to that of the latter (eg: an adhesive sheet, permeable to O ² , impervious to liquids and with a water permeability of less than 1000g / m ² in 24 hours of treatment, which could even be same material as those used for sealing vacuum cups).

2) manufactured:

a) to increase its permeability:

I. Cl with "manufactured" perforations similar to that of section 1) a. p. eg: linear, to be applied on a sutured wound; central sheets, for application on a loss of substance.

II. modifications at the level of its layers p. ex .: Manufacturamente increasing the permeability of the outermost layer of Cl; may even have

AVMs of variable "self-regulating" permeability that in the absence of aspiration would not be permeable to liquids, but subjected to the source of aspiration and on a wound with significant exudative potential, would become permeable to liquids. If the wound has a high level of exudation, and a vacuum pressure is being applied to the dressing, it can increase its permeability in a self-regulating manner, in order to absorb the wound exudate, and thereby regulate the treatment of the same.

Regarding the pathology of the so-called "open abdomen", it should be noted that the AVM (unlike the AVC used by KCI, which is interposed between the edges of the abdominal wound, limiting the approximation of them), to be able to be applied directly on the perilesional skin and also at a distance, it allows developing the centripetal approach forces of the edges of the abdominal wound; allowing a true expanding effect on the abdominal wall that will contribute to direct fascial closure; as well as to obviate the use of the so-called dynamic sutures for traction and with it its industriousness and adverse effects, cutaneous necrosis, major scar sequelae. In addition, unlike the AVC, the AVM could potentially contact the visceral surface; since it would be protected by the atraumatic nature of Cl.

CLASSIFICATION OF INDICATIONS OF VACUUM ASSISTED THERAPY

Thus, as a scheme, some of the indications of the two main lines of this Anti-Edema Therapy, which we refer to for a better understanding of its mechanism of action as Vacuum Assisted Therapy (TAV) would be:

1. TAV to be applied on wounds or closed injuries

A. - To increase the safety or comfort of the treatment

postoperative.

B.- Prevention / Treatment of pathological scars

C- Treatment of edema of non-surgical origin

D. - Stabilization or splinting after sprains or dislocations

D.- Stabilization or splinting of closed bone or joint injuries.

E. - As an "active" compression dressing-girdle

2. TCAV to be applied on injuries or open wounds

A.- To increase the safety or comfort of the treatment

postoperative. B. - In order to promote healing by second intention, that is, that the lesion ends up closing without the need for reconstructive surgery.

C. - In order to perform a deferred closure or reconstruction:

• To reduce surgical requirements, that is, lesions improve and so reconstructive surgery may be less aggressive

• Awaiting histological, bacteriological confirmation, ...

D. - Stabilization or splinting after open bone or joint injuries, with or without loss of substance.

E. - As an "active" compression dressing-girdle

APPLICATION ON PLASTICS (FLAGS).

The application of traditional compression therapy on plastias has as its main objective to achieve an anti-edema effect that favors vascularization; however, since it is not a compression of controlled intensity, or centripetal, there is a possibility that excess compression may have the opposite effect and cause vascular compromise; as well as the distraction in the suture lines (which may cause dehiscence or necrosis).

On the contrary, as already mentioned, the TCAV has the advantage of always providing a controlled intensity compression and relaxation of the suture lines and, in addition, selective, unlike traditional compression; which contributes to increase the safety of reconstruction.

An example of this would be the application of postoperative compression therapy in abdominal stretching surgery also called abdominal plasty or tummy tuck. The purpose of this intervention is, among others, to eliminate excess skin from the abdomen so that the skin of the abdomen is aesthetically tense. For this, a horizontal incision is made in the lower abdomen, so that it is hidden by the swimsuit. And then, we must proceed to take off all the skin of the abdomen (including the subcutaneous cellular tissue) until reaching the costal flange and the sternum, thus creating the so-called abdominal flap (or also called plasty); Then it stretches slightly, we measure and trim the excess tissue so that it is with discreet / slight tension when performing the suture (so that the result is more aesthetic). This is one of the interventions with the highest risk of thrombosis or pulmonary embolism and its best postoperative prevention would be to allow early ambulation of the patient. However, the poor reliability of the traditional postoperative treatment that by means of the placement of conventional circular compressive belts or bandages produces a low quality, non-selective compression. controlled and not centripetal, it is recommended to avoid ambulation or postoperative mobilization, not only immediate but, during the first 24 h. postoperatively But, this implies having to administer anticoagulant medication to prevent thrombosis which, in turn, increases the risk of producing a bruise on the abdominal flap and which is, after embolism, the second most feared complication in tummy tucks. In addition, this type of compression, in addition to covering the operated area, also includes the back and extends to the proximal part of the thighs where it also exerts a circular compression that could cause thrombosis in the lower limbs; which would exponentially increase the risk of pulmonary embolism. In addition, this type of traditional compression would not avoid dispensing with the placement of external rounds.

There is a dressing "for surgical incisions" marketed by KCI and called "Prevision Incision Management System"; however, its application would not cease to be anecdotal; Since KCI does not consider the positive compression component of Reduced Pressure Therapy, it restricts the application of the dressing only to the area of the sutured surgical incision without extending it to the rest of the surgical or operative dissection area. In addition, its internal component, being permeable to liquids, does not protect the skin, nor prevents the maceration of the treated area. APPLICATION OF THE AVM WITH TWO INTERNAL COMPONENTS.

As indicated above a relevant property of the AVM of the present invention unlike the KCI AVC is that it can also be applied directly to the entire skin. A very good application is the case of the open abdomen, in fact vacuum pressure therapy represents the "gold standard 'for the treatment of open abdomen pathology. In the document of the applicant P201000364, it is shown how the Cl of the AVM it is the one that contacts the noble surfaces of the abdominal cavity and the drainage component of the abdominal exudate is enhanced by establishing a direct drainage system with the suction tube. This system avoids the drawbacks of the so-called "visceral protection layer "in currently marketed systems, such as the well-known ABThera® of the KCI company whose mechanism of action is still inaccurate due to:

1. It is not possible to establish a direct connection between said visceral protection layer and the suction-suction tube.

2. It is an imperfect and not very valid system for remote drainage from retroperitoneal areas, since the core of said layer is a structure of star shaped graph foam. That is why the effectiveness of its drainage not only decreases exponentially when we move away from the center, but also that the density of the drainage is minimal in the peripheral areas existing between the vertices, since the separation is maximum at their level.

Although the use of AVM, as described in P201000364, partially avoids these inconveniences, the approach of the edges of the abdominal wall was also limited as the EC of the AVM interposed between them. Thus, to avoid the interposition of the CE between the edges of the wound, the AVM could have been placed so that its Cl was applied on its periphery on the outer face of the abdominal wall and in its central area on the corresponding central area of the KCI ABThera® System Visceral Protection Layer. However, as already mentioned, drainage through this layer is imprecise.

Therefore, in this patent a system for the treatment of the open abdomen is recommended in which, unlike KCI vacuum dressing, the applicant's AVM would not interpose between the edges of the abdominal wound, but would be applied on them and also at a distance. In addition, in the recommended case of being its internal adhesive surface, it will allow to further enhance the centripetal approach forces of the edges of the abdominal wound, allowing a true expanding effect on the abdominal wall that will contribute to the primary / direct fascial closure. the AVM may incorporate a second internal component in an integrated manner, or integrable with it, at least in its central area; in this way, an AVM would be constituted that would consist of at least two internal components, one superficial and the other deep. These internal components would contact each other at the level of their central area and, while the superficial internal component would be applied in the periphery on the external face of the abdominal wall, the deep internal component would do so between the internal face of the abdominal wall and the visceral surface. Both internal components would be, as said, at least in contact at the level of their central area, which could be the maximum permeability of the surface internal component; As for the deep internal component, it will have greater permeability at both the center and the periphery levels, to allow drainage even from the retroperitoneal areas.

It should be noted that the deep Cl could be available in different diameters to allow a better adaptation to the interior of the abdominal cavity, depending on its dimensions. Although a cutter-sealer system (for example thermal) or a biological glue, or any other sealing system, under sterile conditions, is recommended so that in the event that the Internal component will incorporate an open pores area and its trimming will be required for a better adaptation to the contents of the abdominal cavity, also facilitate its sealing; so that it allowed obliterating the structure of open pores and thus avoiding the direct action of the vacuum on noble structures or that fragments thereof could be retained inside the lesion.

Likewise, to favor the contraction of the dressing and further optimize the management of abdominal exudate drainage, both the EC of the AVM nucleus and the second Cl of said AVM, could also incorporate, in their bosom, their own elements or devices of drainage and, in addition, said second Cl of the AVM could also be presented in an integrated manner in said AVM or independently.

Likewise, it would also be possible to improve the drainage of the 'visor protection layer?' also incorporating tubular elements or drainage devices along the core of its open pore structure in the form of a crashed graph that would allow transmitting the suction pressure to the most peripheral (retroperitoneal) areas in a more effective way. problem derived from its configuration of crashed graph, and in order to increase drainage at the peripheral level, there would be the possibility either to increase the number of beams of the crashed graph either to provide ramifications in its vertices or to establish interconnections between the beams ; although it could also be done by giving it another configuration; by way of illustrative, although not limiting, examples: spiroid or even mixed radial-spiroid configuration.

RELATIONSHIP OF ADVANTAGES BY SUMMARY

Thus, the improved vacuum dressing, AVM, object of the present invention has a number of characteristics in its application with respect to the state-of-the-art AVCs due to its design and the protective or atraumatic nature of its internal component (Cl), which You can even contact healthy perilesional skin, its fundamental characteristics being:

1) Although the AVM could be trimmed following the forms of the wounds and be applied in the same way as the AVCs (even interposing between the edges of said wounds) however, it does not need to be cut according to said forms of said wounds; therefore, it is not necessary to interpose between said edges of said wounds and, therefore, does not limit the approximation of said edges. Its contact with the perilesional skin provides significant time savings and a greater seal of fixation, reducing the risk of leakage or detachment. 2) Its contact with the perilesional skin provides a significant saving in time and a greater seal of fixation, reducing the risk of leakage or degassing

3) Produces a greater perilesional cutaneous expander effect due to the potentiation of centripetal tangential forces, thus, in open wounds or loss of substance; allows a greater effect of wound contraction; while in closed wounds, the decrease in tension at the level of the skin sutures is enhanced.

4) The atraumatic nature of its internal component (Cl) protects the granulation tissue; prevents its contact with the open pore structure of the external component and the blockage of the drainage of the lesion exudate; thus, it avoids the recoil of the healing process during the changes of dressing. As a result, the interval between these changes reaches 1-2 weeks, compared with 2- 3 days of the AVC ^' s.

5) Another advantage of the AVM ^' s is that they can even be used in Phase I wound therapy to enhance / accelerate the debridement of the detritus / necrosis material present in the wound bed; since, they can be associated / combined with both debriding enzymes and with products of minimum permeability, hydrofibers, alginates and hydrogels, which, on the contrary, are incompatible with AVCs.

6) A relevant advantage of the present AVM, being atraumatic, is to favor Phase III or Epithelialization, and to allow it to be enhanced by associating it with complementary therapies, such as the use of stem cells, growth factors, among others.

7) Another relevant property of the AVM is to allow "aspiration" compression that, among others, combines the properties of being selective, centripetal and controlled; as well as, through the use of internal modified rounds to dispense with external rounds. Which optimizes the safety and comfort of the patient with respect to the current belts or bandages.

8) A greater flexibility of application consists in the possibility of a second internal component, possibly with a second, its own, drainage device.

DESCRIPTION OF THE DRAWINGS

To complement the present description and in order to help a better understanding of the features of the invention, this is accompanied Descriptive report, as an integral part thereof, figures, in which the following has been represented as an illustrative and non-limiting nature:

Figure N ° 1 shows a schematically and disproportionately enlarged representation, for ease of understanding, of a sectional view of the improved vacuum dressing (AVM) of the present invention applied in this case on a closed surgical wound as a therapy assisted by empty, in which the main parts and elements that it comprises are appreciated, as well as their configuration and arrangement.

Figure 2 shows a schematic view of the AVM of Figure 1, also on a closed surgical wound in which a drainage device has been incorporated into the AVM.

Figure N ° 3 (= A) shows a schematic view of an AVM dressing of the present invention applied in a case of complex open wound, with loss of substance and dehiscent edges, in which a drainage device has been incorporated into the AVM .

Figure 4 (= D) shows a schematic view of an AVM dressing of the present invention located on the knee of a patient.

Figure 5 (= C) shows a schematic view of an AVM dressing of the present invention located on the neck of a patient.

Figure 6 (= B) shows a schematic view of an AVM dressing of the present invention located on the limb of a patient.

Figures 7 and 8 show two embodiments of AVM for open abdomen that incorporate a second internal component in an integrated or pre-integrated manner; Possible forms are included where this internal component is adapted by trimming, not to the wound, but, according to its characteristics, to the lesion area taken as a whole.

Figure 9 shows a preferred embodiment of the invention, where a dressing is shown with the realization of a suppression of material along its entire perimeter in order to adapt to concave treatment areas, since in this way the compression of the material is better and there is a greater transmission of the vacuum throughout the perimeter of the dressing of the invention.

LIST OF REFERENCES USED IN THE FIGURES

1. Little emptiness

2. external component

2nd. open pores 3. internal protective component

3rd. second superficial internal component,

3b second deep internal component

4. suction tube

5. sealant adhesive sheet or external adhesive sheet,

6. perilesional skin or periphery of the aposito

7. surgical wound

8. operating plane

9. rounds or tubes

9th holes in the rounds or tubes

10. internal component surface

1 1. skin

12. the "virtual" space 12 between the skin 11 and the internal component C / 3,

13 area where the inner surface joins sheet 5

14. space between the deep internal component 3b of the dressing and the viscera,

15. viscera

16. tubular drainage devices

PREFERRED EMBODIMENTS OF THE INVENTION

In view of the aforementioned figures, and in accordance with the numbering adopted, examples of preferred embodiments of the invention can be observed therein, which, without being limiting, comprise the constituent parts and elements indicated and described in detail to continuation.

REALIZATION N ° 1. COMPONENTS

A general configuration for application on a closed surgical wound is shown in Figure 1. Thus, as can be seen in said figures, the dressing 1 in question is sealed by an adhesive sheet 5 and said dressing adheres to the skin of the perimeter 6 or periphery, around the surgical wound 7 and the operative plane 8, being coupled to this adhesive sheet, a suction tube 4 connected to a vacuum pump not shown.

This improved vacuum dressing is configured, under its sealing foil, essentially from:

- an external component 2 of open pores 2a - and an internal component 3 of variable permeability, which can be adherent or not.

Both in this Figure 1, as in the next Figure 2, the positive or sagittal compression pressures exerted by the external 2 and internal components 3 of the dressing 1, the centripetal tangential pressures exerted by the external adhesive sheet 5 that have been indicated with arrows adheres to the skin at the periphery 6 of the dressing; as well as the central centripetal tangential pressures developed under the adherent surface 10 of the dressing. REALIZATION N ° 2 - DRAIN OF CLOSED WOUNDS.

The use of AVMs, compared to traditional bandages and dressings, allows to optimize the reduction of postoperative edema, favoring early mobilization and decreasing the risk of dehiscence of the surgical wound (that is, it is reopened by early mobilization). In addition, the modified round system (with holes 9a) of Figure 2 allows eliminating the risk of infection associated with the placement of traditional outer rings.

Thus, Figure 2 shows the dressing of Figure 1, which shows an external component 2, which has the particularity of having a certain thickness, which can be different depending on the type of injury and the extent of the surface to be treated, which favors a more effective anti-edema therapy, and the possibility of incorporating a drainage device which, as seen in the Figure, is made up of rounds or tubes 9 that have a plurality of manufactured materials holes 9a at its two ends, of which ends, one is inserted in the external area or component 2 of open pores, and the opposite is intended to be inserted in the surgical plane 8, such that said tubes 9 directly transmit the reduced pressures from said plane to the external component 2 of open pores, promoting tissue adhesion.

In Figure 2, in addition, the reduced pressures exerted by the holes 9a of the end of the rounds 9 inserted in the underlying surgical plane 8 have been indicated with arrows. Also, the arrows indicating the positive or sagittal compression pressures exerted by the external 2 and internal components 3 of the dressing 1, the centripetal tangential pressures exerted by the external adhesive sheet 5 that adheres to the skin at the periphery 6 of the dressing; as well as the central centripetal tangential pressures developed under the adherent surface 10 of the dressing. REALIZATION Ν ^ο 3. DRAIN OF OPEN WOUNDS

Figure 3 shows a schematic view of the same AVM dressing of Figures 1 and 2 of the present invention applied in a case of complex open wound, with loss of substance and dehiscent edges, in which the AVM is also it has incorporated a drainage device constituted by rounds or tubes 9 that have in a manufactured way a plurality of holes 9a at its two ends, of which ends, one is inserted in the external area or component 2 of open pores, and the opposite, it is intended to be inserted in the surgical plane 8, such that said tubes 9 directly transmit the reduced pressures from said plane to the external component 2. The skin 1 1, the "virtual" space 12, too enlarged for clarity, existing between the skin 11 and Cl 3, and zone 13 where the internal surface 10, adherent or non-adherent, of the dressing 1 joins the sealing adhesive sheet 5.

In both Figure 1 and Figures 2 and 3, the positive or sagittal compression pressures exerted by the external 2 and internal components 3 of the dressing 1, the centripetal tangential pressures exerted by the external adhesive sheet 5 which are indicated adheres to the skin at the periphery of the dressing; as well as the central tangential centripetal pressures developed under the adherent surface 10 of the dressing, and in addition, in Figure 3, since it is an open wound with loss of substance, the reduced sagittal pressures on the lesion bed have also been indicated.

REALIZATION N ° 4. APPLICATION ON PLASTICS

The vacuum dressing used 1 is of the same type of dressing shown in embodiments 1 and 2 and Figures 1 and 2 with their corresponding constituent elements, that is, the adhesive sheet 5 having an attachment for suction tube 4; an external foam component 2 with open pores 2a and internal component 3 of variable permeability, both located under said adhesive sheet 5; periphery and an adherent surface 10 of said dressing. The dressing 1 acts as an "active" compression belt (selective, controlled and centripetal) with an optionally draining device with rounds or tubes 9, provided with a plurality of holes 9a at its ends. By way of example, said AVM dressing used could consist of a semipermeable inner Cl component and its approximate dimensions, for a horizontal surgical incision of about 35 cm in length and flap dimensions of about 35 cm wide X 25 cm high, and said dressing being able to be of a thickness sufficiently higher than the AVC ^'s current, p. eg: about 6 cm, compared to 3 cm thick of the AVCs; also, given its large area of application, said CE could incorporate tubular drainage devices with adaptive elements to the retraction of the dressing or, even, said drainage devices being spiroid in order to further optimize said adaptation to the contraction of the dressing; all this in order to ensure an optimal level of drainage between the most peripheral areas of the dressing and the suction tube; for greater potentiation of anti-edema compression therapy and relaxation of suture lines. This increases the safety of the reconstruction by favoring the adhesion of the abdominal plasty to the underlying fasciomuscular area and the decrease in the risk of hematomas or seromas, which together with the possibility through the system of internal modified rounds to dispense with the External rounds further favor the immediate postoperative ambulation. This coupled with the absence of circular compression in the thighs, further minimizes the risk of PE (Pulmonary Thromboembolism).

REALIZATION N ° 5. APPLICATION ON PLASTIZES ASSOCIATED WITH GRAINTS

Traditionally, conventional compression therapy for being of uncontrolled intensity, in the case of a plasty associated with a graft is performed independently for each of them; since although the intensity of the physiopathologically required compression, for each of them, may be similar, in the graft it is preferable to sin excessively; while on the flap, it is preferable to do it by default. Therefore, the sealing of the interline between the two constitutes the Achilles heel of the reconstruction. Its importance is often only aesthetic; but sometimes, such as the case of tracheal or neurosurgical reconstruction, among others, it may imply the failure of the reconstruction because it is a source of leakage, salivary or cerebrospinal fluid, respectively, and even endanger the life of the patient.

The application of the same dressing of embodiment 2 and Figure 2, that is, of a single dressing of the present invention on all of both, allows not only a more solidary seal at the level of the junction between plasty and graft with a more surface homogeneous and aesthetic, but also very important, a more controlled and safe compression.

In addition, in the case of neurosurgical reconstruction, it is very useful to have AVM ^' s dressings with a concave internal surface for a better adaptation to the convexity of the cranial vault. REALIZATION Ν ^Ο 6. KNEE RECONSTRUCTION

Figure 4 shows a schematic view where an external dressing 1 of the invention can be seen externally with the external component 2, internal 3, suction tube 4 and adhesive sheet 5 of embodiment No. 2, located on the knee of a patient . In the case of prosthetic knee reconstruction, the recommended AVM dressing would be concave, could have a Cl 3, semipermeable, and its internal contact surface could be oval concave of vertical diameter greater than horizontal, for better adaptation to the oval convex morphology of the knee; thus, on the surgical wound, vertical and central, of the anterior aspect of the knee, of approx. 14 cm, an AVM concave with an oval concave surface, vertical diameter of about 20 cm and horizontal of about 16 cm could be applied. In addition, it allows selective dynamic stabilization or splinting, being able to incorporate expansions or lateral, upper and lower reinforcement tongues to reinforce its adhesion during flexion-extension movements of the knee, which could give it a "butterfly wings" configuration. .

REALIZATION N ° 7. CORRECTION SURGERY OF DORSO-LUMBAR SCHOLIOSIS

Another example of the use of AVM according to embodiments No. 1 and No. 2 as "vacuum-assisted dressing-girdle" is its postoperative use after the correction surgery of the dorso-lumbar scoliosis with a midline approach to the back and about 30 cm in length. The surgery would involve the detachment and retraction of the paravertebral musculature towards the lateral parts of the trunk; so the dressing, to be able to exercise an efficient compression, should not only cover these areas but even extend even more laterally. This AVM dressing could also be semipermeable Cl, and have a quadrangular morphology with dimensions extending beyond the surgical wound to include, not only the sutured wound, but to encompass, at a minimum, the entire underlying intervened area to act as a " dressing-girdle "controlled compression.

Being able to be the CE of said dressing of a thickness much greater than that of the current AVCs (eg: about 6 cm, compared to 3 cm thick of the AVCs); also, given its large application area, said CE could incorporate tubular drainage devices similar to those referred to in embodiment 4.

REALIZATION N ° 8. POSTOPERATIVE MANAGEMENT OF THE NECK SURGERY

Figure N ° 5 shows a schematic view of a dressing 1 of the invention, where the external component 2 and internal component 3 are appreciated, as well as the suction tube 4 and the sealing sheet 5, located on the neck of a patient. An example of this embodiment is its application after cervical emptying. The current postoperative compression method consists of a circular compression bandage on the neck that causes patient discomfort and even facial edema or respiratory distress; and also, it requires the placement of external rounds and their corresponding bottles.

With the new AVM dressing of the invention, it would be sufficient to apply a dressing according to embodiment No. 2, provided with a semi-permeable C / 2, which could incorporate the modified rounds 9a, see Figure 2, inside. In addition, for a better adaptation to the morphology of the anterior region of the neck and lower jaw that resembles that of a mount, it would be advisable for the AVM's internal face to adopt a "saddle" shape.

REALIZATION N ° 9. POST LIPOASPIRATION COMPRESSION

The AVM dressing of the invention can also be used to act as a true "vacuum assisted compression belt". This is especially useful in those areas subject to lipoaspiration in which conventional belts are difficult to apply due to their non-selective action.

An example is the use of the same AVM dressing (1) of embodiments 1 and 2 after lipoaspiration of a lipomatosis located in the posterior region of the neck and upper back, which constitutes a sequel characteristic of retroviral treatment. In this body area, conventional belts perform an additional unwanted compression on the axillary, anterior neck, anterior thorax and lower back regions; with the consequent discomfort of the patient, aggravated in the case of a female patient due to the superimposed breast oppression. In this case, for a lipoma of about 12 cm in diameter, the AVM dressing used would also be a semi-permeable C / 2, which could have a diameter of about 18 cm, and would be applied selectively on the area to be treated.

Being able to be the CE of said dressing of a thickness much greater than that of the current AVCs (eg: about 6 cm, compared to 3 cm thick of the AVCs); also, in cases of application on a large body surface, said CE could incorporate tubular drainage elements or devices of the type referred to in embodiment 4. REALIZATION Ν ^ο 10. PREVENTION AND TREATMENT OF PATHOLOGICAL SCARS

Hypertrophic or keloid pathological scar is understood as a scar that remains raised, red and widened, months or even years after surgery. It should be noted that there is no wound, because the skin is intact. Aesthetic alterations and pruritus or itching frequently associated with them, are the main causes for which the patient is consulted. Among its causes, we find tension surgical closures, as well as certain risk areas, for example, the area over the sternum, which constitutes the body area with the highest risk of developing this type of pathology,

Currently, his treatment is compression; and for reasons that are still unknown there are products such as silicone or polyurethane that favor its resolution; so that at present, the most effective conservative treatment for the treatment thereof are the adherent sheets of microporous polyurethane, for example: Trofolastin, manufactured by Novartis; or silicone, Mepilex, manufactured by Molnlycke Health Care. The dressing provides a certain degree of compression that can be enhanced in the extremities by circular bandages or tubular belts; while in other areas, such as the presternal, given the discomfort or difficulty in establishing this type of compression using belts or bandages, manual, at least periodic, compression on the sheets is recommended to enhance their effect. However, this type of compression has, as an adverse effect, the ram effect, already referred to, which will cause a greater tension-distraction of the scar, this is one of the etiopathogenic mechanisms of this type of abnormal scarring. The Prevena of KCI is not indicated in these cases, being a dressing that has been designed to drain wounds; since the pathological scars are not wounds.

On the contrary, the AVM dressing of embodiment 2 when developing a centripetal compression, will simultaneously allow the decrease of tangential tension in the scar area. To further enhance its effect, a dressing with a semipermeable Cl 2 and without perforations is used, since it is not necessary to drain, since it is not a wound; the innermost layer being adherent, and of silicone or polyurethane; although, it can also be of any other compound of the polymer technique that is useful in this type of pathologies.

A practical example is the application of the same dressing 1 of Figures 1 and 2 on a pre-sternal keloid scar of about 13 cm in length and about 2 cm in width; For this, an AVM dressing is used that will exceed at least two centimeters the length of the scar and extend to the sides of it a minimum 2 cm, taking into account that the more it extends the greater the relaxation of the scar. Thus, the minimum AVM dressing would be 15 X 7 cm.

REALIZATION N ° 1 1. APPLICATION ON DONOR AREAS OF CUTANEOUS GRAFT In patients in whom coagulation could not be suspended, either by urgent intervention, or by contraindication, obtaining a graft is a great tendency to bleed in the donor area.

In Figure N ° 6, an example of AVM dressing with the same components of embodiment 2 is shown, see Figure 2, with a hemicylindrical configuration and applied in the anterior and posterior regions of the leg.

The AVM dressing of the present invention allows, in contrast to circular compression bandages contraindicated in this type of patients due to thrombotic risk, a more effective and selective, non-circular compression. One of the most frequent donor areas is the front of the thigh; given the curved shape of the thigh, the AVM will be used with a hemicylindrical configuration _and in this case, in addition, AVM can be used with a semipermeable Cl 2, not even adherent, and without drilling, so as not to stimulate bleeding; for example, before a donor area of 10 X 20 cm, the AVM could be approx. 18 x 28 cm with which, the dressing would protrude about 4 cm per side.

REALIZATION N ° 12. ULCERS BY DECUBIT

The etiology of pressure ulcer is positive pressure. Therefore, the placement of the prior art AVC inside it can even aggravate the lesion; since, as already described, the final resulting pressure of Reduced Pressure Therapy is Positive, e. d., superior to the superior part.

However, the AVM dressing of embodiment No. 3 (with or without built-in rounds) being able to be applied even at a distance, ie, beyond the edges of the lesion, allows the compression generated by the dressing to be distributed over a larger surface, and the positive pressures on the depressed bed of the ulcer are minimized in contrast to the current AVC, which would exert a positive and selective pressure on the bed, only to be applied on it. Therefore, at the same time that the AVM dressing of the invention minimizes the compression effect on the ulcerated bed, maximizes the effects of approaching the edges, which is equivalent to the reduction of the ulcer diameter and possibly perilesional sealing, with the corresponding decrease in the risk of leaks. By way of illustration, a current AVC of 19.5 cm in diameter would be used for the closure by stakes of a pressure ulcer of 20 cm in diameter, while the AVM dressing of Figure 3, embodiment No. 3, with or without Built-in rounds, typically used with a diameter of 30 cm or even larger.

REALIZATION N ° 13. DIGESTIVE FISTULES

Intestinal fistulas are a pathology traditionally refractory to vacuum pressure therapy. This is essentially due to the fact that with the systems currently available, there is a risk of uncontrolled aspiration of intestinal secretions, and even of repermeabilization of others that may be without debit or silence, risk due to a paradoxical effect: if we increase the pressure of aspiration to enhance the contraction effect of the dressing in order to favor its adhesion to the body surface and thus contribute to the sealing of the fistulas, it could cause their aggravation or, even, enhance the awakening or reactivation of other fistulas, that could be silent, leading the patient even to a vital risk. On the contrary, if we reduce the suction pressure to decrease the fistula debit, we will also decrease the contraction effect of the dressing, thereby increasing the risk of detachment of the dressing 1 and also reducing the compression sealing effect of the ( s) fistula (s).

To solve this problem, the current practice is to individually isolate each of these fistulas to refer them to other external drainage systems. However, this implies, not only an extremely laborious and tedious procedure, with multiple connections that reduce patient comfort and increase the risk of leakage; but also, it is possible that the fistulas are perpetuated.

Thus, among its possible forms of application, and by way of non-limiting example, an AVM 1 dressing of embodiment No. 2 whose adherent Cl 2 was semipermeable, or even semi-occlusive, or of minimal permeability, similar to the sealing sheet could be used adhesive 5 that also covers the dressing; while on the peripheral bloody surface a primary dressing could be applied preferably with antimicrobial activity and that it could be limited or on the contrary protrude, by way of wicking, by the bottom of said dressing. Thus, this system would allow either to isolate the fistula (s) by sealing or, on the contrary, to channel the debit of the same (s) towards the "wick" of the primary dressing, so that said exit from the "wick" with this colostomy bag, regardless of the number of fistulas and without the need to be isolated individually, so that such debit, for example, could even be led to a colostomy bag. So that the compression component on the fistula (s) and approach of the wound edges could be increased, to promote the sealing of said fistula (s), without risk of uncontrolled aspiration of intestinal secretions, or of repermeabilization of other fistulas that could be without debit or silent.

REALIZATION N ° 14. TREATMENT OF PATCHED SUBSTANCE LOSSES.

A relevant application of the AVM dressing of the present invention is the treatment of an injured area with multiple concomitant wounds, alternating with areas of whole skin.

A non-limiting example of the use of the dressing would be several traumatic back injuries, with loss of substance, over an area of approx. 30 X 40 cm, and that include: a loss of substance of 15 cm in diameter, another of 10 cm, another of 8 cm and, finally, a last of 5 cm.

The use of current AVC would imply cutting a different dressing for each of the lesions: 14.5, 9.5, 7.5 and 4.5 cm, respectively; having also to establish bridges of connection between them to be able to transmit the vacuum to the source of aspiration, with the consequent loss of time and increase of the duration of the operation.

On the other hand, using the dressing 1 of Figures 1 and 2, it will be enough to apply a single dressing provided with a semi-permeable or water-regulable Cl 2 of about 35 X 45 cm over the whole of a lesion area of 30 X 40 cm and, optionally, cross the Cl, for example, with a needle or a scalpel blade in the areas corresponding to the bloody areas where it is desired to further enhance the aspiration of the exudate. REALIZATION N ° 15. PREVENTION AND TREATMENT OF DEHISCENT WOUNDS.

Dehiscent wounds consist of pathological openings of the wound, produced mainly after an early withdrawal of the stitches, in cases of wound closures made under too much tension and / or in cases of underlying inflammation / edema. A relevant case is the open abdomen

Current AVCs, unable to contact healthy skin, cannot be used to prevent these injuries. As for their treatment, they are not very effective; since, being interposed between the edges of the wound, they prevent their approach.

Instead, the dressing 1 of Figures 1 and 2 is applied on the edges of the lesion and at a distance; allowing a greater perilesional cutaneous expander effect than It will facilitate the closure of the wound. So the AVM is useful both in the treatment and in the prevention of this type of lesions.

REALIZATION N ° 16. DEFERRED RECONSTRUCTION AFTER TUMOR RESECTION

Delaying the reconstruction of the defect created after removing a tumor has a double advantage: on the one hand it allows waiting for the result of the histological report to assess the need to expand the resection or not, and on the other to improve the conditions of the wound so that the reconstruction be more conservative or even allow its closure by second intention).

A non-limiting example is the use of the AVM of embodiment No. 2 after resection of a tumor in the sole of the foot. The AVM dressing not only allows the interval between priests to be increased compared to the current AVCs of the prior art, but, by providing a more effective seal, will allow the support or ambulation to be carried out with a lower risk of leakage.

REALIZATION N ° 17. OPEN ABDOMEN TREATMENT

The treatment of Mild Open Abdomen or with minimal visceral exposure could, in general, be treated similarly to that considered in embodiment 15 (prevention / treatment of dehiscent wounds). as a large dehiscent wound Thus, for the treatment of the Slight Open Abdomen, the dressing 1 used in the realization No. 2, unlike the AVC currently used that cannot be applied directly on the entire skin, or contact the visceral surface, Yes it can be applied directly to the whole skin. Thus, the dressing 1, would have an internal adhesive surface 10, allows to further enhance the centripetal approach forces of the edges of the abdominal wound, allowing a true expanding effect on the abdominal wall that contributes to the primary and direct fascial closure, allowing to obviate the use of the so-called dynamic sutures for traction and with it its industriousness and adverse effects, such as cutaneous necrosis, greater scarring sequelae, etc. REALIZATION N ° 18. TREATMENT OF THE OPEN ABDOMEN WITH DOUBLE INTERNAL COMPONENT

There are frequent cases of use of the AVM dressing of the present invention where it is necessary to use two internal components C / s, the deep Cl being generally intended to seal or be introduced into a cavity area. A preferred characteristic example is the treatment of moderate or severe open abdomen. In Figure 7, an example of application to an Open Abdomen case is shown, in which it is shown how the AVM 1 dressing of the invention does not interpose between the edges of the abdominal wound as in the current AVC dressings, but rather It is applied over them and also at a distance. In addition, the present AVM dressing incorporates a second internal component 3b in an integrated or pre-integrated / integrable manner; so that the two internal components 3a and 3b of the dressing 1 of the present invention would contact each other at the level of their central area that would coincide with the maximum permeability of the surface internal component 3a to allow the drainage to be channeled from the deep internal component 3b which would also be permeable on its periphery, to enable drainage even from the retroperitoneal areas. The space 14 can be seen between said deep internal component 3b of the dressing 1 and the viscera, as well as the skin 1 1, the "virtual" space 12 between the skin 1 1 and the surface Internal component 3a of the dressing 1.

In Figure 8, a second example of application to another case of Open Abdomen is also shown; the skin 1 1, the visors 15, and the dressing 1 whose second internal component 3b also incorporates tubular drainage elements or devices 16 in its interior are appreciated, allowing the drainage from the retroperitoneal areas to be enhanced more than the configuration of Figure 7. SUMMARY

one . The AVM is a tool designed to optimize Vacuum Assisted Compression Therapy and can be used in any lesion, open or closed, therapy that among other properties, can be "aspirational", selective, controlled and centripetal; and that also makes it possible to dispense with conventional belts and the placement of external rounds.

2. The AVM can be used simultaneously on plastias associated with grafts, contributing both to safety, and to a more aesthetic result, by allowing more homogenization of both surfaces

3. As the internal component (Cl) of the AVM of variable or different permeability according to its designation, it is possible to have semi-occlusive or minimal permeability internal components for application even over orificial or juxtaorificial areas, eg, perianal, juxtatrakeostomas and others, or even orificials such as digestive, thoracic, cerebrospinal and other fistulas, without risk of aspiration of intestinal fluid, cerebrospinal fluid, and others, and without risk of air entry or loss of vacuum; and, in addition, with possibility even to establish "wicks" under its surface; since the void is established only inside the AVM between its outer sealing sheet and its C /, without being transmitted to the space between the cutaneous surface and the vacuum dressing. The AVM of the invention, unlike the AVC currently employed by different signatures that stands between the edges of the abdominal wound limiting its approach, can be used successfully in the pathology of the

"open abdomen". By being able to directly apply the AVM dressing on the perilesional skin, and also at a distance, centripetal approach forces develop at the edges of the abdominal wound, which cause a true expanding effect on the abdominal wall that will contribute to favor fasci closure. direct

Due to the atraumatic or protective nature of its Cl, the AVM of the present invention, in addition to being able to contact the skin surface, is able to contact different organs or noble tissues present in the lesion bed, among which the visceral surface itself would be found .

Unlike the current AVC ^' s, the permeability of the AVM ^' s of the invention is easily adaptable "in situ" to the needs of the lesion bed The AVM ^' s of the present invention for its variable permeability as a function of the needs they can be applied potentially in any of the three phases of healing of open wounds (unlike AVC ^'so also called "GranuFoam" having been conceived only for Phase II or

Granulation.

The AVM ^'s of the invention may be used in the prevention and treatment of pathological scars.

The AVM dressing does not need to be cut following the shape of the wound; Therefore, it is possible to have a dressing that has all its components manufactured in order to be applied directly to the body surface, both on open and closed wounds, with significant savings in time and increased safety.

. Derived from the above, it is also possible to have in a manufactured way of "mini" integrated and improved vacuum cups, and with "mini" built-in suction tubes, to extend the indications of vacuum pressure therapy to appendixes or anatomical areas of very small size, in which at present it is not yet operational.

. The AVM dressing of the invention can be maintained "n situ" significantly more days compared to the AVC ^' s; for what it can be It is recommended that your skin sealing adhesive sheet may optionally have antimicrobial impregnation.

12. In addition there is, for greater flexibility of application of the AVM, it has the possibility of incorporating a second internal component, possibly with a second, its own, drainage device.

13. In cases where it is desired to further enhance the compression effect, the CE can be provided with the dressing of the invention of a thickness much greater than that of the current AVCs, eg: about 6 cm, or even more, compared to the 3 cm thick of the AVCs.

14. Likewise, the CE of the dressing of the invention, especially in cases of large surface dressing or with said CE of great thickness, said CE could incorporate tubular drainage devices with adaptive elements to the shrinkage of the dressing or, even, configuring said drainage devices with a spiroid shape to further optimize said adaptation to the contraction of the dressing; all this in order to ensure an optimal level of drainage between the most peripheral areas of the dressing and the suction tube.

Thus, the improved vacuum dressing of the present invention intended for Vacuum Assisted Therapy (TAV) thus represents a novel and innovative structure of structural and constitutive characteristics unknown until now for this purpose, vacuum dressing that involves practical utility. indisputable that it will undoubtedly positively influence the further development of some operative techniques.

Described sufficiently the present invention, as well as the way of putting it into practice, it is not considered necessary to make its explanation more extensive since for any expert in the field its scope and the advantages that derive from it are evident; finally stating that, within its essentiality, it may be put into practice in other embodiments that differ in materials and detail from those indicated by way of non-limiting example, and to which it will also achieve the protection that is sought as long as it does not alter, change or modify its fundamental principle described in the following claims.

Claims

1. An integrated and improved vacuum dressing for vacuum-assisted therapy intended for the anti-edema therapy of an open or closed lesion or wound, comprising a sealant adhesive sheet on which an aspiration tube connected to a pump is coupled. vacuum, a core located under said adhesive sealant sheet, said core comprising an area, or external component, of open pore structure, which allows for uniform distribution of the vacuum inside said dressing, and an area or internal component of variable permeability, said vacuum dressing has a thickness between 0.1 and 20cm, to enable the incorporation of a drainage device and wherein said drainage device is constituted by rounds or tubes provided with a plurality of holes in its two ends, one of said ends being inserted in said external component of open pores of said dressing, and the opposite end is of stoned to be inserted in the operative plane.

2. - The vacuum dressing according to claim 1, characterized in that said dressing is presented in its final configuration, manufactured, with all components, so that it comprises: the adhesive sealing sheet, suction tube, the vacuum pump , the core constituted by an external component of open pore structure and an internal component of variable permeability, and the drainage device constituted by the modified rounds provided with a plurality of holes at both ends.

3. - The vacuum dressing according to claim 1, wherein the drainage device is constituted by modified rounds provided with said plurality of holes at both ends and said drainage device is presented in a manner manufactured independently of the other components. of said emptiness.

4. - The vacuum dressing according to claim 1, characterized in that said dressing is manufactured in a manner and in which at least said core is constituted by the external component and the internal component, and one or more are absent in the manufacture of said other components of the vacuum dressing.

5. - The vacuum dressing according to one of claims 1 or 4, characterized in that said external component and said internal component are irreversibly connected selected from: - a joint in which the core is a monobloc manufacturing core from the same material, said external and internal component having different morphology; Y

- a joint connection between the constituent materials of said external and internal components.

6. The vacuum dressing according to one of claims 1 or 4, characterized in that said external component and said internal component are reversibly connected selected from:

- a joint in which the contact surfaces between them have been provided with a more labile adhesive in one or both directions, allowing them to take off and stick repeatedly, and

- a reversible adhesive bond selected between a union of the type protected by reversible adhesive flaps and a joint of the "sailboat" type.

1 - The vacuum dressing according to claim 1, wherein said dressing has a geometric configuration adapted to the surface of body contact around the wounds.

8. The vacuum dressing according to claim 1 or 7, wherein said dressing has a configuration selected from: semi-cylindrical, concave and saddle configuration.

9. The vacuum dressing according to one of claims 1, 2, 4 to 6, characterized in that said dressing is presented with said core integrated in a manufactured manner and independent of said other components of said vacuum dressing, and presenting said component external, at the level of its external face, complete oblique cuts, and because being attached to said internal component, and presenting said cuts in one or more directions, and presenting said internal component (3) a surface equal to or greater than that of said external component

10. - The vacuum dressing according to one of claims 1, 2, 4 to 6, or 9, characterized in that said external component has subtotal oblique cuts on both sides in several directions, or is cut following a spiral pattern, and said internal component presenting a surface equal to or greater than that of said external component.

1 1. - The vacuum dressing according to one of claims 1, or 7 to 10, characterized in that it has dimensions depending on the dimensions of the body contact surfaces.

12. The integrated vacuum dressing according to one of claims 1, 2 or 1, characterized in that said dressing is manufactured in the form of a "minf vacuum chamber, presenting surfaces of different diameters, and comprising suction tubes incorporated in a manufactured way in the form of" minf aspiration tubes for application to anatomical areas of very small size.

13. The vacuum dressing according to one of claims 1, 2 or 12, characterized in that said dressing does not include in its manufacture the vacuum pump and the drainage device constituted by said modified rounds, and wherein said dressing is presented so manufactured in the form of said "minf vacuum cups, and presenting surfaces of different diameters, and with said" mini "built-in suction tubes.

14. - The vacuum dressing according to one of claims 1 or 2, characterized in that said external component has a thickness greater than 6 cm.

15. - The vacuum dressing according to claim 1, characterized in that the absolute value permeability is between 100 and 5,000 g / m ² in 24 hours of treatment; of said internal component is such that it does not present a risk of leakage, and where vacuum is established only between the adhesive sealant sheet and said internal component.

16. - The vacuum dressing according to one of claims 1 to 8, characterized in that it comprises a second deeper internal component manufactured integrally or integrably with said vacuum dressing, and comprises a superficial internal component and a deep internal component, such that these two internal components contact each other at the level of their central area that coincides with an area of maximum permeability of the surface internal component and in which the deep internal component is also permeable at its periphery.

17. The vacuum dressing according to claim 16 wherein said second deeper internal component further comprises tubular drainage elements or devices therein.

18. - The vacuum dressing according to claim 17 characterized in that said external component comprises tubular drainage elements or devices with elements adapted to the retraction of the aposite or spiroid drainage devices.

19. - The vacuum dressing according to claim 1 characterized in that it comprises a Visceral Protection layer, which comprises drainage elements or devices along the core of its core, the core having open pores structure in the form of a star graph. .

20. - Use of the vacuum dressing defined in claim 1 to minimize the risks of hemorrhages and infections associated with conventional vacuum dressings, allow greater wound contraction, and achieve a more effective reduction of perilesional edema by means of the Vacuum Assisted Therapy, where said vacuum dressing is applied over open lesions.

21. - Use of the vacuum dressing defined in claim 1 wherein said vacuum dressing is applied both in Phase I of Debridement; as in Phase II of Granulation; and in Phase III of Wound Epithelialization.

22. - Use of the vacuum dressing defined in claim 1 in closed wounds to optimize compression, achieve a more effective reduction of lesion and perilesional edema, or allow greater wound contraction and decrease tension of the edges of said wounds closed by means of Vacuum Assisted Therapy, wherein said vacuum dressing is applied by means of said surface of the dressing on wounds or closed lesions, as well as on the cutaneous surface corresponding to the underlying lesional and perilesional area; and it is applied with greater dimensions and greater surface of distribution of the vacuum than the conventional vacuum dressings, and the compression and development of tangential centripetal pressures is carried out not only on the periphery of said position under the adherent surface of the sealing sheet, but also under said surface of said internal component of said dressing.

23. - Use of the vacuum dressing according to one of claims 20 to 22 in plastic operations.

24. - Use of the vacuum dressing according to one of claims 20 to 23 in plasty operations associated with grafts, and wherein a single vacuum dressing is applied on all of both, said plasty and said graft.

25. - Use of the vacuum dressing according to claim 22 in the direct closure of surgical wounds.

26. - Use of the vacuum dressing according to claim 22 in the postoperative management of neck surgery

27.- Use of the vacuum dressing according to claim 22 in the prevention and treatment of pathological scars.

28. - Use of the vacuum dressing defined in claim 1 on donor areas of skin grafts.

29. - Use of the vacuum dressing defined in claim 1 in the treatment of bedsores.

30. - Use of the vacuum dressing defined in claim 1 in the treatment of fistulas in communication with organic cavities.

31. - Use of the vacuum dressing defined in claim 1 for the treatment of an injured area with multiple concomitant wounds, which alternate with areas of integral skin.

32. - Use of the vacuum dressing defined in claim 1 for the prevention and treatment of dehiscent wounds.

33. - Use of the vacuum dressing defined in claim 1 in the treatment of the open abdomen.

34.- Use of the vacuum dressing defined in claim 1 to increase the safety or comfort of postoperative treatment.

35.- Use of the vacuum dressing defined in claim 1 for the closure or delayed reconstruction of wounds.

36-. Use of the vacuum dressing defined in claim 1 for the treatment of edema of non-surgical origin.

37. - Use of the vacuum dressing defined in claim 1 for stabilization or splinting in joint or osteo-articular pathology, closed or open, with or without loss of substance, with or without prosthetic replacement.

38. - Use of the vacuum dressing defined in claim 1 in reducing surgical requirements.

39. - Use of the vacuum dressing defined in claim 1 in early postoperative mobilization.

40. - Use of the vacuum dressing defined in claim 1 as an "active" dressing-girdle and to provide aspiration, selective, controlled and centripetal compression wherein said dressing incorporates a system of integrated rounds, which dispenses with the current external bandages and rounds.

41. - Use of the vacuum dressing defined in claim 1 to promote compression.