MX2008004463A

MX2008004463A - Externally-applied patient interface system and method

Info

Publication number: MX2008004463A
Application number: MX/A/2008/004463A
Authority: MX
Inventors: K Bubb Stephen; S Zamierowski David
Original assignee: Kci Licensing Inc
Priority date: 2005-10-03
Filing date: 2008-04-03
Publication date: 2008-10-03

Abstract

A tissue closure treatment system and method are provided with an external patient interface. A first fluid transfer component FTCl comprises a strip of porous material, such as rayon, with liquid wicking properties. FTCl can be placed directly on a suture line for transferring fluid exuded therethrough. An underdrape is placed over FTCl and includes a slot exposing a portion of same. FTC.2 comprises a suitable hydrophobic foam material, such as polyurethane ether, and is placed over the underdrape slot in communication with FTCl. Negative pressure is applied to FTC2 through a connecting fluid transfer component FTC.3. A negative pressure source can comprises a manual device or a power-operated suction device. The tissue closure method includes a manual operating mode using a manual suction device with an automatic shutoff for discontinuing suction when a predetermined volume of fluid has been drained. An automatic operating mode utilizes a microprocessor, which can be preprogrammed to respond to various patient and operating conditions. The method proceeds through several phases with different components in place and different patient interface functions occurring in each.

Description

SYSTEM. AND METHOD OF PATIENT INTERFACE EXTERNALLY APPLIED Technical Field The present invention relates in general to medical devices and methods for the treatment of wounds and closed incisions and for the management of moisture in them, and in particular to a system and method for draining and / or irrigating tissue separations, such as surgical incisions, and for compressing and stabilizing a dissected or traumatized field with ambient air pressure created by an external patient interface component and a vacuum source. Prior art Tissue separations can be the result of surgical procedures and other causes, such as traumatic or chronic wounds. Various medical procedures are employed to close the tissue separations. An important consideration relates to securing the tissue portions separated from one another in order to promote closure and healing. The incisions and wounds can be closed with sutures, staples and other medical closure devices. The "first intention" (scarring of primary intention) in surgery is to "close" the incision. For load-bearing fabrics, such as bone, fascia, and muscle, this requires substantial material, either - - suture, staples, or plates and screws. For the wound to "close", the epithelial layer must seal. To achieve this, the "load bearing" areas of the cutaneous and subcutaneous layers (ie, the deep dermal elastic layer and the superficial fascia or the fibrous layers of adipose tissue, respectively) must also at least be supported in a sufficiently large approximation. so that the deposition of collagen takes place to join the separated parts. Other important considerations include controlling bleeding, reducing pathological scarring, eliminating the potential for hematoma, seroma, and "dead space" formation and managing pain. The problems of dead space are more apt to occur in the subcutaneous closure. The relatively superficial incisions can be closed normally with closing techniques applied on the surface, such as sutures, staples, glues and strips of adhesive tape. However, deeper incisions may require not only the closure of the skin surface, but also the delayed placement of multiple layers of sutures in the load bearing planes. The prevention of infection is another important consideration. Localized treatments include various antibiotics and dressings, which control or prevent bacteria at the incision or wound site. Infections can also be treated and controlled systemically with - suitable antibiotics and other drugs. Other objectives of tissue separation treatment include minimizing the traumatic and pathological healing effects of surgery and minimizing edema. Accordingly, various closure techniques, post-operative procedures and drugs are used to reduce postoperative inflammation, bleeding, seroma, infection and other unwanted postoperative side effects. Given that separate tissue considerations are so prevalent in the medical field, including most surgeries, effective, timely, infection-free, and aesthetic tissue closure is highly desirable from the point of view of both patients and patients. health care professionals. The system, inferred and method of the present invention can therefore be widely practiced and potentially provide broad benefits to many patients. Fluid control considerations are typically involved in the treatment of tissue separations. For example, subcutaneous bleeding occurs in the fascia and muscle layers in surgical incisions. Accordingly, deep drainage tubes are commonly installed for the purpose of draining such incisions. Autotransfusion has experienced increased popularity in recent years as equipment and techniques forReinfuse the patient's whole blood have advanced considerably. Such procedures have the advantage of reducing dependence on blood donations and their inherent risks. Serous fluids are also typically exuded from the incision and wound sites and require drainage and disposal. Fresh incisions and wounds typically exude blood and other fluids on the surface of the patient's skin for several days during initial healing, particularly along the lines of stitches and staples along which the tissue portions are closed. separated. Another area of fluid control refers to irrigation. Several irrigators are provided in areas of separate tissue to counteract infection, anesthetize, introduce growth factors and otherwise promote healing. An effective fluid control system preferably adapts both drainage and irrigation functions sequentially or simultaneously. Common orthopedic surgical procedures include total joint replacements (TJRs) of the hip, knee, elbow, shoulder, foot and other joints. The resulting tissue separations are frequently subjected to flexion and movement associated with the joint replacement joints. Although the joints can be immobilized as an option of Treatment, atrophy and stiffness tend to appear and prolong the rehabilitation period. A better option is to restore the functions of the joint as soon as possible. Therefore, an important goal of orthopedic surgery is to promptly restore to patients the maximum use of their extremities with maximum ranges of movement. Similar considerations arise in relation to various other medical procedures. For example, arthrotomy, reconstructive and cosmetic procedures, including revisions of flaps and scars, also require tissue closures and are subject to frequent movement and stretching. Other examples include incisions and wounds in areas of unstable thick or subcutaneous tissue, where the splinting of skin and subcutaneous tissue can reduce the dehiscence of deep sutures. The mobilization demands of the extremity and the total conflict of the patient with the restrictions of the currently available methods of external compression and tissue stabilization. For example, various types of compression apparel and hosiery covers are commonly used for these purposes, but none provide the advantages and benefits of the present invention. The aforementioned procedures, as well as a number of other applications discussed below, can benefit from a system and method of tissue closure treatment with a patient interface applied to the. surface for fluid control and external compression. Post-operative fluid drainage can be achieved with various combinations of tubes, sponges, and porous materials adapted to collect and drain body fluids. The prior art includes technologies and methodologies to assist drainage. For example, the Zamierowski Patents of E.U. No. 4,969,880; No. 5,100,396; No. 5,261,893; No. 5,527,293; and No. 6,071,267 describe the use of slopes, pressure, i.e., vacuum and positive pressure, to assist in the drainage of wound fluid, including surgical incision sites. Such pressure slopes can be established by applying porous sponge material either internally or externally to a wound, covering it with a permeable, semi-permeable, or impermeable membrane, and connecting a suction vacuum source thereon. The drained fluid from the patient is collected for disposal. Such fluid control methodologies have been shown to achieve significant improvements in patient healing. Another aspect of fluid management, post operative and otherwise, refers to the application of fluids to wound sites for irrigation purposes, infection control, pain control, application of growth factor, etc. They are also used wound drainage devices to achieve fixation and immobility of tissues, thus helping healing and closure. This can be achieved by means of both closed internal wound and external open wound drain devices applied to the wound surface. The fixation of tissues in juxtaposition can also be achieved by bolus attachments tied (stent apposite), taped, taped and plaster (contact). Wounds and surgical incisions can benefit from tissue stabilization and fixation, which can facilitate cell migration and cell-collagen binding. Such benefits of tissue stabilization and fixation can occur in relation to many procedures, including the fixation of bone fractures and suture for purposes of skin-side fixation. Moisture management is another critical aspect of surgical wound care that involves blood and exudate in deep tissue and transudate at or near the surface of the skin. For example, a wet phase must first be provided in the epithelial layer to facilitate cell migration. Next, a tissue drying phase must occur in order to facilitate the development of the functional keratin layer. Humidity management can also - - effectively control the bacteria, which can be extracted together with the discharged fluids. The residual bacteria can be significantly reduced by wound drying procedures. In some cases such sequential wet-dry two-stage treatments can provide satisfactory bacterial control and eliminate or reduce dependence on antibiotic and antiseptic agents. Crrently with such phases, an effective treatment protocol will maintain stabilization and fixation while avoiding the forces of disruption within the wound. The treatment protocol should also handle varying amounts of wound exudate, including maximum amounts that are typically exuded during the first 48 hours after surgery. Closed drainage procedures commonly involve tubular drainages placed within the surgical incisions. Open drainage procedures can employ gauze and other absorbent products to absorb fluids. However, many prior fluid handling procedures and products tend to require additional cleaning steps, expose patients and health care professionals to fluid contaminants and require regular dressing changes. In addition, insufficient drainage can result in the residual blood, exudate and transudate being isolated in the plans of tissue in proximity to surgical incisions. Still further, certain hemorrhages and other subdermal conditions can be treated with hemostats by applying compression on the surface of the skin. Resorption of free fluid edema can be delivered by the same. Up to now, there is no system and method of patient interface applied externally available with the advantages and characteristics of the present invention. DESCRIPTION OF THE INVENTION In the practice of the present invention, there is provided a system and method for improving the closure of separate tissue potions using an externally applied patient interface. The subsurface drainage, the irrigation and the autotransfusion components can optionally be used in conjunction with the external interface applied to the surface. The external interface can advantageously be placed on a dotted line or staple and includes a primary transfer component comprising a strip of porous material, such as rayon, applied directly to the patient to divert or transfer the fluid to a secondary transfer component. comprising a sponge or foam material. A lower cloth is placed between the transfer elements to pass the fluid between them through of an opening of the lower cloth, such as a slot. An upper cloth is placed on the secondary transfer component and the surrounding skin surface. The patient's inferia is connected to a source of negative pressure, such as a vacuum-assisted closure device, a suction wall, or a mechanical suction valve. A manual control mode utilizes a finite capacity fluid reservoir with an occlusion valve to discontinue draining when a predetermined amount of fluid has been collected. An automatic control mode uses a microprocessor, which is adapted to be programmed to respond to several inputs to control the operation of the negative pressure source. A closed wound or incision treatment method of the present invention involves three phases of fluid control activity, corresponding to different stages of the healing process. In the first phase, active drainage is managed. In a second phase the components can be disengaged independently or sequentially. In a third phase the secondary transfer component can optionally be left in place for protection and to assist in the evacuation of any fluid residue from the suture / staple line through the primary transfer component. In other embodiments of the invention, the Padding system components can be prefabricated for efficient application. A piece of foam can be provided with a full or partial rayon cover and a closed top adjusting cloth. An access panel can be installed with a re-sealable seal strip on the upper cloth for access to the foam pieces and the wound area. An external prefabricated dressing can be provided with a sheath that receives a piece of foam, which is accessible through a re-sealable seal strip for replacement or reorientation. Access to the treatment area is also provided through the seal strip. The system can also be used as a hemostat. BRIEF DESCRIPTION OF THE DRAWINGS The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. Figure 1 is a block diagram, schematic of a treatment and tissue closure system embodying the present invention. Figure 2 is a perspective view of a tissue separation by incision with a deep drainage tube installed. Figure 3 is a perspective view thereof, showing the separate sutured tissue attached at the skin . Figure 4 is a perspective view thereof, showing the separate sutured tissue attached in the deep dermal layer below the surface of the skin. Figure 5 is a perspective view thereof, showing a primary rayon strip fluid transfer component (FTC.l) and a lower cloth placed in the dotted line. Figure 6 is a perspective view thereof, showing the FTC.l and the lower cloth placed on the dotted line. Figure 7 is a perspective view thereof, showing a secondary fluid transfer component (FTC.2) in place. Figure 8 is a perspective view thereof, showing an upper cloth in place. Figure 9 is a perspective view thereof, showing a connection fluid transfer component (FTC.3) placed to connect the system to a source of negative pressure. Figure 10 is a cross-sectional view thereof, taken generally along the line 10-10 in Figure 9 and showing particularly the FTC.3. Figure B1 is a perspective view of it, showing the removed FTC.3 and the upper cloth marked for ventilation. Figure 11b is a perspective view thereof, showing a patient interface removed along a perforated tear line on the lower cloth and a cut line on the upper cloth. Figure 11c is a perspective view of a patient interface adapted for pre-packaging, application to a patient and connection to a source of negative pressure. Figures 12a-d show the elbow connection devices FTC.3a-d respectively, of an alternative embodiment. Figures 12e-f show a modified FTC.2 with removable wedges to facilitate articulation, such as flexion of a patient's joint. Figures 12g-h show external patient interface facilities of an alternative modality. Figures 13a-c comprise a flow diagram showing a method of tissue closure treatment embodying the present invention. Figure 14 is a block diagram, schematic of an automated tissue closure treatment system comprising an alternative embodiment of the present invention. Figure 15 is a cross-sectional view of an automated tissue closure treatment system of an alternative modality. Figure 16 is a partial flow diagram of an automated tissue closure treatment method of an alternative embodiment embodying the present invention. Figure 17 is an exploded perspective view of a tissue closure treatment system comprising an alternative embodiment of the present invention, with a re-sealable access panel. Figure 18 is a perspective view of the re-sealable access panel. Figure 19 is a cross-sectional view of the tissue closure treatment system taken generally along line 19-19 in Figure 18. Figure 20 is an enlarged cross-sectional view of the tissue closure system , which particularly shows a re-sealable seal strip thereof. Figure 21 is a perspective view of a tissue closure system, showing the open seal strip. Figure 22 is a perspective view of a tissue closure system, showing the open seal strip and a piece of foam removed. Figure 23 is a cross-sectional view of an external dressing facility, comprising a alternative embodiment of the present invention. Figure 24 is a cross-sectional view of a tissue closure system of an alternative embodiment with internal and external foam pieces. Figure 25 is a cross-sectional view of the system shown in Figure 24, showing the progressive healing of tissue in the wound. Figure 26 is a cross-sectional view of the system shown in Figure 24, showing the re-epithelialization of the wound. Figure 27 is a cross-sectional view of a piece of foam partially enclosed in rayon. Figure 28 is a cross-sectional view of a tissue closure system of an alternative embodiment, with an installation of one piece of external foam and one piece of internal foam. Figure 29 is a cross-sectional view thereof, shown partially collapsed under ambient atmospheric pressure. Figure 30 is a perspective view of a dressing of an alternative construction with a re-sealable seal strip and fluid access ports. Figure 31 is a perspective view of the lower cloth of the apposite, showing a middle strip of backing removed.

Figure 32 is a perspective view of the dressing, showing the removed backing side strips. Figure 33 is a perspective view of the dressing, shown with a compression bulb evacuator attached to a fluid port thereof. Figure 34 is a perspective view of the dressing, shown partially collapsed under atmospheric pressure. Figure 35 is a perspective view of the dressing, shown with the seal strip open. Figure 36 is a perspective view of the dressing, shown with the piece of foam removed. Figure 37 is a cross-sectional view of a piece of foam completely enclosed in rayon. Figure 38 is a perspective view of a dressing of an alternative embodiment with a separate liner and piece of foam. Figure 39 is a perspective view of the dressing, shown with the piece of foam removed. Figure 40 is a perspective view of the dressing, shown with the liner removed. Figure 41 is a cross-sectional view of a dressing of an alternative embodiment with a lower sheath panel comprising an absorbent material.

Figure 42 is a cross-sectional view of a dressing system of an alternative embodiment with a covered foam-core transfer element. Figure 43 is a cross-sectional view thereof, showing the dressing compressed under pressure. Figure 44 is a top silver view thereof. Figure 45 is a cross-sectional view thereof, showing the apposite configuration of the application to the patient and taken generally along line 45-45 of Figure 44. Figure 46 is a top plan view of an application that involves multiple dressings that cover an elongated tissue separation, such as a surgical incision. Figure 47 is a perspective view of a wound with drainage strips installed in preparation for closure. Figure 48 is a cross-sectional view of a dressing comprising an alternative embodiment of the present invention with upper and lower rayon layers. Figure 49 is a cross-sectional view thereof, with the dressing compressed. Figure 50 is a cross-sectional view of the dressing comprising an alternative embodiment of the present invention with a rayon cover enclosing a core of cross-linked foam. Figure 51 is a cross-sectional view thereof, with the dressing compressed. Figure 52 is a cross-sectional view of the dressing comprising an alternative embodiment of the present invention with a sensor connected to a controller. Figure 53 is a perspective view of an experimental model of the dressing to observe the flow of fluid therethrough. Figure 54 is a graph showing the wetted surface area of the crosslinked foam core with respect to the volume of the liquid for different conditions. Figure 55 is a cross-sectional view of a hemostat comprising an alternative embodiment of the present invention. BEST MODE FOR CARRYING OUT THE INVENTION I. Introduction and Environment As is required, the detailed embodiments of the present invention are described herein; however, it should be understood that the embodiments described are merely exemplary of the invention, which may be incorporated in several ways. Therefore, the specific structural and functional details described herein should not be construed as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in various ways in virtually any properly detailed structure. II. Tissue Closure System 2 With reference to the drawings in greater detail, reference number 2 generally designates a tissue closure treatment system embodying the present invention. As shown in Figure 1, system 2 is adapted for use in a patient 4 with an incision or wound 6, which can be closed by a dotted line 8 consisting of sutures 10, staples or other suitable medical fasteners. A patient interface 12 consists of an optional deep drain 14 connected to a deep draining negative pressure source 15 associated with a deep drain reservoir 17 and an external patient interface 16 that includes a primary fluid transfer component FTC.l comprising a strip of rayon or other suitable porous material, a lower cloth 20 generally covering the FTC.ly and including a slot 20a, a secondary fluid transfer component FTC .2 comprising a hydrophobic sponge and an upper cloth 24. A fluid handling subsystem 26 includes a deep draining negative pressure source 15 and a - - Negative surface drainage pressure source 28, which can be combined for applications where a common negative pressure source and a collection receptacle are required. The negative pressure sources 15, 28 can be operated either manually or by motive power. Examples of both types are well known in the medical art. For example, a manually operable portable vacuum source (MOPVS) is shown in the U.S. Patent. No. 3,115,138, which is incorporated herein by reference. The MOPVS is available from Zimmer, Inc. of Dover, Ohio under the HEMOVAC® trademark. Bulb-type activators, such as the one shown in the U.S. Patent. No. 4,828,546 (incorporated herein by reference) and available from Surgidyne, Inc. of Eden Paririe, Minnesota, can be used on ler wounds, for shorter durations or in multiples. In addition, the drive-activated vacuum may be provided by vacuum assisted closure equipment available under the trademark THE VAC® from Kinetic Concepts, Inc. of San Antonio, Texas. Still further, many of the health care facilities, particularly hospitals and clinics, are equipped with suction systems with suction sources available in closed facilities. A reservoir of finite capacity 30 of fluidly to a source of negative pressure 28 and adapted to discharge to a waste receptacle 32. An occlusion valve 34 is associated with the reservoir 30 and adapted to discontinue drainage automatically when the reservoir 30 is filled to a predetermined volume . An optional autotransfusion subsystem 36 may be connected to deep drain 14 and is adapted to reinfuse patient 4 with his own blood. The U.S. Patent No. 5No. 785,700 describes such an autotransfusion system with a removable portable vacuum source, which is available from Zimmer, Inc. and is incorporated herein by reference. Figure 2 shows an incision 6 forming the first and second separate tissue portions 38a, b with incision edges 40a, b. The incision 6 extends from and is open in the skin 42, through the deep dermal layer 44 and the subcutaneous layer 46, to approximately the fascia 48. A deep drainage tube 50 is placed in a lower part of the incision 6 and penetrates the skin 42 in an opening 52. Figure 3 shows the incision edges 40a, b secured together by the sutures 54 forming a dotted line 56 on the surface of the skin 42. As an alternative to the sutures 54 , various other medical fasteners, such as staples, can be used. Figure 4 shows sutures 55 located in the deep dermal layer 44 below the surface of the skin 42. Figure 5 shows the application of the FTC.l at the top of the dotted line 8. The FTC.l preferably comprises a suitable porous absorbent material. , such as rayon, which is very suitable for absorbing the fluid exuding along the dotted line 8. Also, the rayon tends to dry relatively quickly, and therefore efficiently transfers the fluid therethrough. The lower cloth 20 is placed on the FTC.l and the adjacent skin surface 42. Its opening 20a is generally centered along the centerline of the FITC.ly and directly above the dotted line 8. The FTC.ly and the lower cloth 20 can be preassembled into a roll or some other suitable configuration adapted to facilitate the Placement on dotted line 8 at any desired length. Figure 6 shows the FTC.l and the lower cloth 20 in place. The secondary fluid transfer component FTC.2 is shown installed in Figure 7. Preferably it comprises a suitable hydrophobic foam material, such as polyurethane ether (PUE), comprising a cross-linked, mesh-like material (foam) capable of collapsing by vacuum force (negative pressure) in order to exert positive compression type "shrink wrap" in the surface of the skin and still maintain channels that allow the passage of fluid. As shown, its footprint is slightly smaller than that of the lower cloth 20, thereby providing a lower cloth margin 20b. The absorbing layer of the FTC.l can, as an alternative, be equal or almost equal to the footprint of the FTC.2. This configuration allows it to be prefabricated as a single, pre-assembled pad that can be employed by simply removing a backing portion of the release layer from a bottom cloth covered with adhesive. This configuration also allows for easy total removal and replacement of the central part of the installation without removing the cloth already adhered to the skin if the desired clinical option is to remove it and replace it instead of a phased removal or prolonged single application. Figure 8 shows the upper cloth 24 applied on the FTC.2 and the lower cloth 20, with a margin 24a extending beyond the margin of the lower cloth 22b and coming into contact with the skin surface of the patient (dermis). 42. Figures 9 and 10 show a patch connector 58 installed in FTC.2 and comprising a core of hydrophobic foam material (PUE) 58a sandwiched between the cloth layers 58b. A vacuum drain tube 60 includes an inlet end 60a embedded in the foam core 58a and extending between the cloth layers 58b to an outlet end 60b connected to the pressure source - - negative surface drainage 28. Figure Ia shows the FTC.3 removed, eg, by cutting portions of the upper cloth 24 to provide an upper cloth opening 54. In addition, the upper cloth 54 can be cut at 55 to further ventilate the FTC. 2. Draining the FTC.2 under negative pressure, and also drying it with air circulation (Figure 1a) can provide significant healing benefits by reducing the growth of various microbes that require humid environments in the FTC.2. Such microbes and various toxins produced by them can then be evaporated, neutralized and prevented from entering the patient in some way. Microbe control can also be achieved by introducing antiseptics and irrigating various components of patient interface 12, including drapes 20, 24; the FTC.l; the FTC.2 and the FTC.3. Figure 11b shows the patient interface 12 removed along the tear lines 56 punched in the lower cloth and the cut lines 59 in the upper cloth 24. It will be appreciated that the patient interface 12 substantially complete, except for the lower cloth and upper cloth margins 20b, 24a can therefore be removed to provide access to the dotted line 8 and the dermis 42 for visual inspection, evaluation, cleaning, removal of spots, dressing change (eg, with the interface of pre-packaged patient 12a as shown in Figure 11c), consideration of other additional treatment options, etc. For example, the upper cloth 24 can be cut around the perimeter of the FTC.2 footprint to allow its removal. Preferably the FTC.2 can be easily removed from the upper cloth 20 and from the FTC.l whereby the FTC.2 can be taken and lifted towards the top to facilitate the travel of a scalpel through the upper cloth 24 and within a distance between the lower cloth of the FTC.2 and the lower cloth 20. The FTC.l can then optionally be removed by tearing the lower cloth 20 along its tear lines 56 and removing it as shown in Figure 11b. Figure 11c shows a pre-packaged patient interface 12a adapted for the initial application or "dressing change". Optionally, the rayon strip of the FTC.l may have the same configuration or "footprint" as the foam sponge of the FTC.2, thereby eliminating the lower panel 20. The pre-packaged patient interface 12a may be packaged sterile for facilitating placement directly on a dotted line 8. Alternatively, the components of the patient interface may be pre-packaged individually or in suitable groups comprising sub-facilities of the complete patient interface. For example, cloth sub-installations bottom / FTC .1 and top cloth / FTC .2 respectively can be pre-packaged individually. Various sizes and configurations of components of the patient interface may be packaged for application as indicated by the particular conditions of the patient. Preferably, certain sizes and configurations will tend to be relatively "universal" and therefore applicable to particular medical procedures, such as TJRs, wherein the patient interface of the invention can be simplified. Alternatively, the individual components can be assembled in various sizes and configurations for "custom" applications. Figures 12a-d show the alternate connection fluid transfer components FTC.3a-d to connect the FTC.2 to the source of surface drainage negative pressure 28. The FTC.3a (Figure 12a) shows a connector for patch with a construction similar to FTC.3 and adapted for placement at any location on the top cloth 24. FTC.3 is provided with a Leur 62 lock connector. FTC.3b (Figure 12b) comprises a strip of material of hydrophobic foam (PUE) partially covered by an upper cloth 64, which can be configured as a wrap around a member or limb of patient 66. FTC.3c (Figure 12c) is a elbow type connector. The FTC.3d (Figure 12d) is a bellows-type elbow connector, which is adapted to accommodate the deflection of the vacuum drain tube 60. Figures 12 e, f show an alternative construction of the FTC.2 with multiple removable wedges 57 formed therein and adapted to accommodate a joint, such as an articulation bend. . The flexibility of FTC.2 can therefore be considerably improved for purposes of patient comfort, mobility and flexibility. Such wedges may extend transversely and / or longitudinally with respect to FTC.2a. The FTC.2a works similarly with and without the wedges 57 placed or removed. Figure 12g shows a patient interface 312 modified with the lower cloth 20 located below the FTC.l. This configuration allows removal of the FTC.l without affecting the lower panel 20. Figure 12h shows an additional patient interface 412 modified having the FTC.l the same configuration or footprint as the FTC.2, whereby they can be fabricated and joined each. In this configuration the lower cloth 20 can be omitted. III. Treatment Method Figures 13a-c comprise a flow diagram for a method embodying the present invention. From the beginning 70 the method comes for the diagnosis and evaluation of the patient in 72 and the treatment plan in 74. deep drains 14 are installed at 76 as necessary, and the incision is sutured at 78. Surface interface components 12 are applied at 80 and connected to external components (ie, negative pressure sources 15, 28) at 82. The collection capacity of the deposit is preset at 84 based on factors such as the nature of the wound / incision, blood flow, etc. Phase I Deep draining occurs at 86 and active surface drainage occurs at 88, both of which are influenced by negative pressure sources 15, 28. The source of negative pressure 28 causes the PTC foam of FTC.2 to partially collapse, which correspondingly brings towards the lower part the upper cloth 24 and exerts a positive compressive force on the wound or closed incision 6. In the closed environment of the patient interface 12, such force is effectively limited to the ambient atmosphere. This limiting control feature protects the patient from excessive force exerted by the patient interface 12. The constant force of up to one atmosphere applied through the wound or closed incision 6 functions in a manner similar to a splint or plaster in the control of the patient. edema and the promotion of scarring. A "full tank" condition is detected at 90 and bifurcates to an interruption of negative surface drainage pressure at 92, after which the contents of the deposit are inspected and discarded at 94. If a superficial surface bleeding is detected by visual inspection in decision box 96, the method bifurcates to a stage of "Active Drain Discontinuous Surface" at 98. If the suture line is actively draining in the decision box 100, the method is linked to the active surface draining stage 88 and continues, otherwise, active surface drainage is discontinued at 98, ie, when the wound / incision does not bleed or exude fluid. Phase I is generally characterized by deep drainage (interactive or passive) and active surface drainage under the influence of manual suction or by motive force. The normal duration is approximately two or three days, during which post-operative or post-traumatic inflammation normally reaches its maximum and begins to subside. Phase 2 Figure 13b shows Phase 2 starting with a "Removal of Component by Stages" decision box 102. An affirmative decision leads to deactivate and independently remove the components in 103, including discontinuing the active suction in 104, which transforms the pressure of the hydrophobic PUE foam (FTC.2) of negative to positive and allows the collapsed FTC.2 to expand to 106, potentially increasing the surface pressure of the composite from ambient to positive. Preferably this transition occurs without applying undue pressure to the surface from the decompressed FTC.2 that expands. During Phase 1, the negative pressure (i.e., suction / vacuum) tends to compress the FTC.2 and correspondingly contracts the upper cloth 24, adding to the compression exerted by the FTC.2. When the application of negative pressure is discontinued, either manually or automatically, the FTC.2 is expanded against the limits of the upper cloth 24, and in an equal and opposite reaction is pressed against the skin 42, particularly along the dotted line 8. FTC.2 can therefore automatically transform from ambient to positive pressure by simply discontinuing the application of the vacuum source. The positive pressure exerted on the skin 42 continues to compress and stabilize the tissue along the suture line 8 (step 108) in order to reduce inflammation and cooperate with the operation of the FTC.ly and of the FTC.2 to continue draining by evaporation in the suture line 8 in step 110. A negative determination in the decision box 102 leads to the withdrawal of the inferred in 112 and, unless the treatment is finished, the inspection and treatment of the dotted line in 113 and the replacement of the interface at 114, may involve all or part of the patient interface 12. The method then proceeds to Phase 3. Phase 3 Figure 13c shows Phase 3 of the treatment method where deep draining is discontinued and the ) tube (s) is removed at 118. The upper cloth 24 and the FTC.2 are removed at 120, 122 respectively. The lower cloth 20 and the FTC.l are preferably configured to allow visual inspection of the suture line 8 through it at 124. When the suture line 8 has been closed sufficiently, the lower cloth 20 and the FTC.l they are removed in 126 and the treatment ends in 128. alternatively and if indicated by the patient's condition, all or part of the interface 12 can be replaced in Phase 3 and continue treatment. IV. Tissue Closing System 202 of an Alternative Modality Figure 14 schematically shows a tissue closure system 202 comprising an alternative embodiment of the present invention, including a microprocessor or controller 204, which can be connected to one or more sensors 206 coupled to the patient interface 12 to detect various conditions associated with the patient 4. The microprocessor 204 can be programmed to operate a solenoid 208 coupled to a valve 210 associated with the reservoir 30 and which controls the fluid flow induced by the negative pressure source 228 through its connection to the patient interface 12. Figure 15 shows the tissue closure system 202 with the microprocessor 204 connected to multiple sensors 206a, b, c each of which is associated with a flow control component, such as a valve 210a, b, c respectively. Each component of flow control 210a, b, c is associated with a respective negative pressure source 228a, b, c which in turn controls the discharge of the fluid into cans 212a, b, c respectively. For example, the patient interface 12 may comprise an external patient interface 16 as described above and a pair of deep drain tubes 50a, b. The patient interface 12 includes an optional supply component 214, which may comprise one or more fluid reservoirs, pumps (manual or motive) and associated controls, which may be connected to the microprocessor 204 for system control. The delivery component 214 optionally takes one or more of the tubes 50, 60 to deliver fluid to the patient through the deep drain tubes 50 or through the external patient interface 16. Such fluids may comprise, for example, antibiotics, and anesthetics, irrigation agents, factor of growth, and any other beneficial fluid to promote healing, counteract infections and improve patient comfort. The methodology of the treatment with the tissue closure system 202 of the alternative modality is shown in Figure 16 and generally involves the modified pre-treatment 230 and the procedures of Phase 1. From the "start" the method proceeds to the stage of diagnosis / evaluation 234, a treatment planning stage 236, deep drainage installation 238, suture in 240, application of external inferium component 242, programming of microprocessor 244 and connection of application components in 246, such as the connection of the pipe. Phase 1 begins with deep drainage at 248, inferred from active suction at 250, and an "Active drainage from the Suture Line?" decision box 252. If the suture line is in active drainage, the method returns to the active suction inferring stage 250, otherwise (negative determination in 252) proceeds to Phase 2. V. Applications No limitation in the generality of the useful applications of the tissue closure systems 2 and 202 of the present invention, the following partial list represents the conditions and potential procedures of the patient, which may indicate the application of the present invention. • On closed tissue separations, such as surgical incisions. On joints where the incision is subject to movement and stretching, such as arthrotomy, reconstructive procedures, cosmetic procedures, flaps, scar revisions, Total Joint Replacement (TJR) procedures, ie, hip, knee, elbow, shoulder and foot. • Any wound in an area of thick or unstable subcutaneous tissue, where the splinting of the skin and subcutaneous tissue can reduce the dehiscence of deep sutures. • Wounds on reconstructive procedures in which irregular cavities are created. These include resection of tumors, implants, bone, and other tissues. Changes in length and limb geometry, and changes in size, position, and contour of bones and other deep structures. • Wounds in which the elimination and prevention of dead space is important. • Treatment of bruises and seromas. • Amputation stumps. • Abdominal, thoracic, side, and other wounds in which the splinting of the wound can assist - - to close and mobilize the patient during the post-operative interval. • Wounds in areas of fragile or sensitive skin, where repeated removal and replacement of tape or other adhesives can cause pain, irritation, or blistering of the skin in the vicinity of the wound. Also, when the dressing changes can produce cutting or displacement of the tissue to compromise primary wound healing. • Wounds in cases where the patient wishes to shower before the skin has healed sufficiently to allow protection from contamination with bath or shower water. • Wounds subjected to contamination with feces, urine, and other body fluids. • Pediatric, geriatric, psychiatric, and neurological patients, and other patients likely to affect the dressings and wounds. • Patients with multiple consultants and caregivers, where repeated inspection of the wound can compromise healing. • Sutures and staples for deep and surface closure. • Any surgical or traumatic incision that is clean, open, or completely or partially closed by sutures, or where the edges of the skin may overlap a gap no wider than the width of the negative pressure zone of the dressing, ie, where the maximum separation is less than or equal to the width of the FTC.l ( rayon strip). • In cosmetic and reconstructive surgery, the systems and methods of the present invention can control and mask the effects of early bleeding, exudation, ecchymosis, and wound edema. • In limb surgery, where compression and drainage by this method can eliminate or reduce the need for circumferential compression wrap. • Separations of tissue prone to prolonged drainage, such as hip and knee incisions, and tissue separations in patients with health conditions, such as diabetes, that tend to inhibit healing. Reduction of inflammation and drainage control can result in shortened hospital stays. SAW. Case Studies • General concept: sequential application of foam material surface (FTC.2) to a surgical site and other wounds. Air drying is facilitated in the suture line by the rayon strip (FTC.l). • Phase 1: deep drainage (drainage tube (S)), active or passive; active suction applied to the PUE foam surface (located at the top of the surgical incision, draining the bleeding and exudate from the suture line); the active suction compresses the PUE foam, thus applying a positive compression to the entire dissection field; lower cloth coated with adhesive film with a VTR of 3-800 over the PUE foam underlying the skin; Strip of rayon (or other suitable absorbent porous material) over the suture line; a similar type of adhesive film upper cloth (MVTR of 3-800) superimposed on the PUE foam material. • Duration: approximately 2-3 days, i.e., effective time to stop the active drainage of the incision line / points and for the suture line to dry and heal. • Phase 2: Remove the active suction by cutting the connector (elbow) and leaving the FTC.2 in place. Released from the suction, the FTC.2 expands against the upper cloth and exerts differential positive pressure on the operation site. A slight continuous compression can be maintained throughout Phase 2; the function of residual drainage through the rayon strip and inside the FTC .2 provides continuous drying of the suture line. The deep drainage tubes remain in place during Phase 2 for active deep drainage. • Duration: approximately three days, i.e., the 3-6 days after the operation. Phase 3: removal of the upper cloth and FTC.2; leave the bottom cloth and the rayon strip in place; visually observe the healing progress of the wound; desirable transparency. • Duration: several weeks (e.g., up to three). • Confirmation of clinical trial: closure of the surgical site in the upper chest area in the patient with severe healing problems showed excellent results and rapid wound healing. Subcuticular (subepidermal) sutures prevent conflict with the rayon strip and require the early removal of the suture, or pressure on the skin sutures below the black compressive sponge. · Option: use a pressure transducer for the planning of the interface pressure of the wound site and automatic control and monitor the pressure, flow, etc. VII. Tissue Closure System 302 of the Alternative Modality. A tissue closure system 302 comprising an alternative embodiment of the present invention is shown in Figures 17-22. The system 302 is adapted to close a wound 304 with an undercut area 306 just above the fascia and a superior tissue separation 308 located mainly in the dermis and in the subcutaneous layer. An internal wedge-shaped fluid transfer component (foam piece) 310 is placed in the tissue separation area 308 and is installed between the side panels 312 on each side of the wound 304. An external component of the tissue 304 is placed. fluid transfer (foam piece) 314 on top of inner component 310 and the side wipes 312, and covered with an outer cloth 316. An optional innermost foam piece 330 can be placed and sized to fit the undercut area 306 and fluid and forces of slope to and from the inner foam piece 310 can be transferred. A re-sealable access panel 318 is placed over an opening formed in the outer cloth 316 and includes a perimeter covered with adhesive 320 surrounding a central area. adhesive-free 322 with a re-sealable seal strip 324 extending longitudinally below the center line thereof. The seal strip 324 includes a flange 326, which is releasably captured in a channel 328 (Figure 20). In operation, the re-sealable access panel 318 is adhesively secured around its perimeter 322 to the outer cloth 316 and provides access to the foam pieces 310, 314 of the dressing system 302. For example, the pieces of foam 310, 314 can be changed (Figures 21 and 22), treatments can be applied and the progress of wound healing can be monitored visually. VIII. Alternative apron 402. Figures 23-27 show an external apposite 402, which can be pre-fabricated or pre-assembled and used for various wound treatments and closure applications. The dressing 402 includes a piece of foam 404 partially enclosed in a rayon cover 406, which includes an open top 408 secured to an upper perimeter 410 of the foam piece 404, for example, by sutures, staples, adhesive or some other suitable mechanical fastener as shown at 412. The apposite 402 is pre-assembled preferably with an outer cloth 414 including a central portion covering the foam 416 and a perimeter edge portion 418 in contact with the patient. A plagued margin 420 is formed at the intersection of the cloth portions 416, 418 and partially underlies the foam piece 404 in order to protect the skin and prevent the formation of low pressure vacuum spaces around the edge of the work piece. foam 404 where otherwise a blister could be formed. In operation, the dressing 402 can be easily changed by cutting around the margin 420, removing the piece of foam 404 and the outer portion of the cloth 416. Thus, the wound can be inspected, cleaned, purified, - - treat, etc. and place a new dressing 402 on the site. The skirt portion in contact with patient 418 of the original apposite can remain in place. Figure 28 shows a directional arrow of fluid flow (discharge) 421 from an elbow coupling 417 and a discharge tube 419. Alternatively, the fluid can be injected into the dressing 402 through tube 419 and coupling 417. hydraulic / pneumatic compressive force arrows 423 in Figure 23 and represent the descending forces (ie, inside the patient), which can be established by compressing the piece of foam 404 under suction, and then releasing the negative pressure differential, transporting the dressing to a positive pressure differential. In a positive pressure differential operating mode, dressing 402 controls edema by pressing foam piece 404 against tissue adjacent to the wound. There are many potential medical benefits from this way of edema control. For example, healing is promoted, tissue scarring is minimized, and patient discomfort can be reduced. Figure 24 shows an external pad 402 used in conjunction with a piece of internal foam 422, which is located below the dermis at the top of the subcutaneous layer. The piece of internal foam 422 fits to apply a pressure differential within the subcutaneous layer, thereby promoting tissue growth and closure. The internal / external configuration of the dressing system shown in Figure 24 can rehabilitate and flex a wound edge 424 that has contracted and hardened, immobilized and is edematous, applying pressure differentials through the external and internal foam pieces 404 , 422, such as compression (positive pressure differential) for the control of edema. Figure 25 shows the wound confined to the dermis 426 with another piece of internal foam 428 in place. The subcutaneous layer is substantially healed. Figure 26 shows the external foam piece 404 in its place alone to attract the wound edges 430 to each other in the epidermis. Figure 27 shows the external foam piece 404 covered on the sides and the lower part by the rayon cover 406, leaving an open top 408. IX. Apostille System 502 of the Alternative Modality. Figure 28 shows yet another configuration of the external / internal dressing system 502 of an alternative embodiment with an external foam piece 504 similar to the foam piece 404 described above and an internal foam installation 506 located in the dermis and in the layer subcutaneous Installation 506 consists of a piece of proximal inner foam 508, which can be placed in the lower part of the subcutaneous layer at the top of the fascia in an undercut cavity 510 formed by the wound, and a piece of distant internal foam 412 located mainly in the dermis and portions of subcutaneous layer of the wound between the outer foam piece 504 and the proximal inner foam piece 508. The configuration of the dressing system 502 can be configured and reconfigured as necessary to accommodate various wound configurations in various stages of healing. For example, the next inner foam piece 508 can be removed when the undercut cavity 510 closes. In the same manner, the piece of distant inner foam 512 can be removed when the subcutaneous layer and the dermis have healed. In addition, the foam pieces 504, 508 and 512 can be replaced with as many pieces of foam of different dimensions as necessary in relation to the changes of the dressing and as the wound configuration changes. Such dimensions and configurations can be selected to optimize the beneficial effects of pressure slopes (both positive and negative), fluid control, edema control, antibacterial measurements, irrigation and other treatment protocols. Still further, the access panel 318 described above can be used in conjunction with the apposite system 502 in order to provide access to the foam pieces thereof and the wound itself. Figure 29 shows the internal / external dressing 502 compressed under the vacuum effect of an external vacuum source with the cloth 316 tightly stretched over the compressed outer foam piece 504. Thus compressed, the 502 system is adapted to transfer the compressive forces, from positive pressure differential to the wound area. X. Installation of Apostille 602 of an Alternative Modality. Figures 30-37 show a pre-assembled, re-sealable external dressing facility 602, comprising an alternative embodiment of the present invention. The dressing installation 602 includes a piece of foam 604, which may be completely covered in rayon 606 or some other suitable material with the desired absorbent and / or absorbent capabilities. The piece of foam 604 also includes a core 605 comprising a suitable material, such as hydrophobic polyurethane foam. Alternatively, other foam materials with hydrophobic or hydrophilic properties may be used. Various dimensions and shapes of the foam piece 604 may also be employed, including cutting and edging the size during the course of a medical procedure. The piece of foam 604 is removably placed in a re-sealable liner 608 that includes a bottom pa610 selectively covered by removable backing strips 612, 614 and 616 that form a central opening 618. As shown in Figure 31, a central opening 618 in the bottom pa610 it is initially covered by the central backing strip 614. Removal of the central backing strip 614 exposes the piece of foam 604 through the opening 618. The re-sealable liner 608 also includes a top pa620 with a seal strip re-sealable 622 extending from end to end and generally longitudinally centered. The seal strip 622 may be similar in construction to the re-sealable seal strip 324 described above. The top pa620 also includes fluid ports 324, 326, which may comprise, for example, Leur lock connectors or some other suitable fluid connection device. The coating 608 may comprise polyethylene or some other suitable material selected on the basis of performance criteria such as permeability, flexibility, biocompatibility and antibacterial properties. Various permeable and semi-permeable materials are commonly used as skin pads in medical applications where scarring can be promoted by exposure to air circulation. The liner 608 may be formed of such materials for applications where the suction of Continuous vacuum is available and the 602 dressing is not required to be airtight. According to one embodiment of the method of the present invention, a dressing installation 602 may be prefabricated, or custom-made from suitable components for the particular applications. In a prefabricated version, the dressing 602 is preferably pre-sterilized and packaged in a sterile package. A common application of dressing 602 is in a recently closed surgical incision to control bleeding and other fluid exudate. For example, the dressing 602 can be placed on the patient with its lower paopening 618 located on a dotted line 636 (Figure 36). The central backing strip 614 is detached from the bottom pa610 to expose the opening 618 and the adhesive 628 in the bottom pa610 (Figure 33). The opening 618 provides a fluid transfer, which can also be provided by constructing the lower sheath pa610 from a permeable material, or by providing other passage configurations therethrough. The dressing 602 can then be placed on the patient, the adhesive of the lower paproviding a temporary fixation. The side backstrips 612, 616 can then be removed, as shown in Figure 32, and the bottom pa610 completely secured to the patient.

The fluid ports 624, 626 are adapted for either the extraction or the infusion of fluids, or both, depending on the particular treatment methodology. For extraction purposes, a vacuum source may be attached to one or both ports 624, 626 and may comprise a source of mechanical, mechanical force pressure differential, such as wall suction. Alternatively, manually operated mechanical suction may be provided, such as a suction bulb 630 (Figure 33) or a Hemovac device available from Zimmer Corp. of Warsaw, Indiana. Such manually operated suction devices can provide mobility to the patient and tend to be relatively simple to operate. The motive and fluid pump suction devices can be preprogrammed to provide intermittent and alternating suction and infusion, and to automatically respond to feedback signals from the patient's condition. As shown in Figure 33, the application of a negative pressure differential (suction) collapses the lining 608 on the foam piece 604. The various dynamic fluid forces and fluid motion effects described above can therefore be carried to the operation and be controlled. Figure 34 shows the liner 608 collapsing further on the piece of foam 604 as a result of the evacuation from both fluid ports 24, as indicated by the fluid flow arrows 632. The ambient air pressure force arrows 634 show the application of this force, which tends to collapse the liner 608 over the piece of foam 604. Figure 35 shows the opening of the seal strip 622 to access the interior of the dressing 602. The foam piece 604 can then be removed, as shown in Figure 36, whereby the dotted line 636 can visually inspected and / or treated. The piece of foam 604 can be turned over or replaced as needed. Figure 37 shows a cross section of the foam piece 604, which can be completely covered with rayon or some other suitable absorbent material 606 in order to accommodate the placement of each side against the dotted line 636. XI. Installation of Apostil 702 of an Alternative Modality. Figures 38-40 show a dressing facility 702 comprising an alternative embodiment of the present invention and including a piece of foam 704 comprising any suitable hydrophobic or hydrophilic foam material. The piece of foam 704 is selectively and removably placed in a sheath 708, which may be similar to the sheath 608 described above. A liner 706 may comprise a piece of rayon or some other suitable material adapted to absorb the fluid from the line of points 636 within the foam piece 704, and further adapted to isolate the patient from direct contact with the foam piece 704. The liner 706 can be dimensioned to lie flat against the bottom panel of the sheath 708. In operation, the installation 702 is adapted to use readily available components, such as foam piece 704 and liner 706, in a dressing adapted for wound inspection, wound treatment and component replacement procedures, all without having to remove the cover or disturb its adhesive bond to the patient. Figure 39 shows the removal of foam piece 704, which can be turned over for reuse or replacement. Figure 40 shows the removal of liner 706, which can also be easily replaced. With the liner 706 removed, the dotted line 636 is exposed for point removal, inspection, treatment, irrigation and other procedures. The sheath 708 can then be re-sealed and the assisted assisted by vacuum and / or other treatment continued. XII. Installation of Apostil 802 of an Alternative Modality A dressing facility 802 comprising an alternative embodiment of the present invention is shown in Figure 41 and includes a piece of foam 804 and a cover 806 adapted to open and close by a re-sealable seal strip 808. The cover 806 includes a piece of cloth - - upper 810, which may comprise a suitable semi-permeable or impermeable cloth material. The sheath 806 includes a perimeter 812, which may be provided with an optional perimeter adhesive seal 813 adapted to provide a relatively hermetic fluid seal around the sheath 806. The perimeter seal 813 may be relatively narrow in order to minimize the discomfort of the sheath. patient, skin maceration, etc. A bottom panel 814 comprises a suitable absorbent material, such as rayon, and extends to the perimeter of sheath 812. The materials comprising the dressing 802 can be selected by permeability, occlusivity, biocompatibility, hydrophobic or hydrophilic reaction to liquids, bacteriostatic properties and antimicrobial, and other properties and criteria related to performance. In operation, the dressing 802 is placed on the patient over a wound or dotted line. The perimeter adhesive 813 can provide temporary fixation and sealing. A strip of tape 816 can be placed on the perimeter of sheath 812 to secure sheath 806 in place. The fluid is transferred through the layer of absorbent material 814 to the piece of foam 804 for evacuation through suitable fluid connectors, as described above, which can be attached to a vacuum source. In addition, the dressing 802 is adapted to provide a Positive pressure slope, also as described above. The seal strip 808 allows access to the piece of foam 804 to be turned or changed, as indicated. Piece of foam 804, the upper portion of cloth 810 and the layer of absorbent material 814 can be assembfor independent movement whereby the only joint between these components occurs around the perimeter 812 where the upper portion of cloth 810 is connected to the layer of absorbent material 814. Such freedom of movement independent allows the 802 dressing facility to reconfigure itself and conform to the patient and the various forces applied, such as pressure slopes. The individual components can therefore expand and contract independently from each other without disturbing the other components or interfering with the performance and comfort of the 802 apposition installation. XIII. Apostille System 902 of the Alternative Modality. A dressing system 902 comprising another aspect or alternative embodiment of the present invention is shown in Figures 42-46 and includes a dressing 904 adapted to control the application of positive compression forces and / or negative suction forces to a patient with a separation of tissue type incision 906. Without limiting the generality of the useful applications of the system 902, incision 906 may comprise a surgical incision, which may optionally be closed with points 908 or other suitable wound closure procedures, including staples, adhesives, tapes, etc. Incision 906 may include a closed suction drainage tube 910 at the base of the incision, which can be carried to the surface of the skin through a puncture incision, using well-known surgical procedures. The dressing 904 includes a cover 909 with an optional perimeter base ring 912, comprising a semi-permeable material with a layer of skin compatible adhesive 914 applied to a lower surface thereof. Prior to the application of the dressing 904, the base ring adhesive 914 is instalon a release paper backing 916 (Figure 45) with a peel-away flap 917 (Figure 44). The base ring 912 defines a proximal central opening 918, through which the apposite 904 opens in a downward manner. A cover superstructure 920 includes a distal panel 922, a perimeter 924 generally defining a collapsible collapsible edge, and a near return ring 926 secured to the base ring 912 around the central opening 918 in another collapsible edge, which can collapse The base and return rings 912, 926 thus form a double-thickness base structure, sheathed 928 adapted to expand and collapse. A distal cover opening 930 is formed in distal panel 922 and communicates with a flexible sheath, which can be collapsed into a bellows, which in turn is installed in a length of rigid tubing 934 that distally terminates in a connector 936 comprising , for example, a read cap, no needle or other suitable connecting / closing piping device, such as an air valve. The pipe 934 includes a proximal end 935 communicating with the interior of the seal cover 909. An optional installation or transfer element 938 is placed within the cover 909 and is exposed through the central opening 918 thereof. The transfer facility 938 optionally includes a cross-linked compressible core 940, which may comprise, for example, polyurethane ether foam material selected for its hydrophobic, elastic and memory performance characteristics. The transfer facility 938 also includes a flexible porous liner 942 comprising a material such as Owens® rayon surgical dressing with liquid-absorbing properties and biocompatibility for direct contact with the patient's skin. Without limitation in the generality of useful applications of the dressing system 902, post operative incision dressing applications are particularly well suited thereto. The 904 dressing can pre - - assembled and packaged in a sterile manner to open under sterile conditions, such as those typically maintained in operating rooms. The central opening 918 can be sized to accommodate tissue separation 906 with sufficient overlap whereby the perimeter base ring adhesive 914 adheres to healthy skin around the area of tissue separation 906 and beyond the area of underlying internal operational dissection. Multiple appendices 904 can be placed end to end (Figure 46) or side to side in order to effectively cover relatively large incisions 950. In such multiple-wrap applications, the dotted line 952 may be covered with an intervening barrier layer strip 948 at locations where the base ring coated with adhesive crosses the same for purposes of patient comfort. The barrier layer strips 948 may comprise, for example: Xeroform® gauze available from Integrity Medical Devices, Inc. of Elwood, New Jersey; Vaseline® gauze; or Owens® rayon strips. The base ring adhesive 914 preferably forms a relatively hermetic fluid bond around the treatment area. Optionally, the base ring 912 may comprise a suitable semi-permeable membrane material, with characteristics of adequate breathing capacity to improve patient comfort and avoiding maceration in the contact areas. A source of suitable differential pressure 944 is coupled to the pipe connector 936. Without limitation, the pressure source 944 may comprise automatic and manual pressure sources. For example, automatic wall suction is commonly available in operating rooms and in any health care facility. For postoperative incision gaps, the wall suction of the operating room can be attached to the 936 connector, the 904 apposite can be evacuated, and the wall suction disconnected whereby the 936 connector seals the system. It will be appreciated that a condition of "steady state" of equilibrium can be achieved with positive ambient air pressure acting externally on the cover 909 and the transfer facility 938 internally compressed, and thereby exerting compression forces on the incision 906 and the surrounding area by compression force arrows 939 (Figure 43). For example, Figure 43 shows the collapsed apposite 904 with the rayon dressing liner 942 extending beyond the polyurethane ether foam core 940 and forming a double thickness liner perimeter 946 positioned within the perimeter of the cover. double fold 924. In this configuration any liquid exuding from incision 906 is effectively transferred by the absorbent action of rayon liner 942 away from the incision 906 by means of the fluid transfer arrows 941. Emissions of serum-blood fluid can be expected from the incision line for a short period, commonly a day or two, after an operation. The absorbent action of the rayon liner 942, coupled with the light circulation of ambient air admitted through the semi-permeable base ring 912, cooperate to maintain the incision 906 and the healthy skin around it relatively dry in order to prevent maceration. The pressure differential provided by the components of the 904 dressing can also contribute to the removal and removal of wound exudates, in cooperation with the absorbent action described above. With the dressing 904 in its compressed configuration (Figure 43), the proximal pipe end 935 can be engaged and urged into the transfer member 938 to direct fluid transfer therebetween. The evacuated dressing 904 provides a number of benefits of medical incision closure and healing. The stabilizing and fixation effects on the incision and the surrounding tissue resulting from the forces applied by the 904 dressing tend to promote contact healing, as opposed to scarring or scar healing where the opposite edges slip and move one over the other. the other. In addition, the control of edema and ecchymosis are achieved by exerting a compression force of positive pressure, by means of the compression force arrows 939 in the compressed core 940, which tends to regain its pre-compression shape and volume as the pressure is released within the pocket 904. Therefore, the effects of restricted or controlled filtration, for example around the base ring 912, tend to be compensated by controlled expansion of the core 940. The movement of limited air through the 904 dressing can be beneficial to control internal humidity, reduce maceration, etc. The 902 system is adapted for adjustment and replacement, as needed, during closure and healing of an incision. An additional air displacement can be applied through the 936 connector from automatic or manual sources. Wall suction, mechanized pumps and other automatic sources can be applied. Manual vacuum sources include: squeezable type bulbs (630 in Figure 33); Hemovac® (Zinder) evacuators available from Zimmer, Inc. De arsaw, Indiana; and vacuum tubes. Inspection of the incision 906 can be achieved by making an L-shaped cut in the apron cover superstructure 920 and removing or lifting the transfer facility 938, thereby exposing the incision 906. The 938 transfer facility can be flipped over or replaced. The apposite 904 can then reseal by applying a replacement portion of the cover 909, after which the dressing 904 can be evacuated as described above. After completing the treatment, the cover superstructure 920 can be cut and the transfer facility 938 can be discarded. The base ring 912 can be peeled off from the skin, or simply left in place until the adhesive 914 is released. Stabilization, fixation and closure forces associated with apposite 904 tend to facilitate healing by keeping the tissue portions separated in contact with each other, and controlling and / or eliminating lateral movement of the tissue, which can prevent healing. The positive pressure compressive force components associated with the forces in the dressing 902 tend to close the tissue separation 906 and to retain the opposing tissue edges in fixed contact with each other thereby promoting healing. Various other dynamic forces that tend to displace the edges of the wound in one in relation to the other can effectively resist. XIV. External Deposits 1002.1012 of the Alternative Modality. Figures 47-49 show another external apposite 1002 of the alternative mode. As shown in Figure 47, a wound 6 can be prepared by placing optional drainage strips 1004 between the wound edges and folding the distant strip ends on the surface of the adjacent skin. The use of such strips is well known. A latex version, referred to as Penrose drainage, is available from Davol Inc. of Cranston Rhode Island. A silastic version, referred to as Swanson incision drainage, is available from Wright Medical Technology, Inc. of Arlington, Tennessee. Alternative deep wound devices for fluid extraction include drainage tubes, such as those described above, and other devices. Alternatively, such drainage devices can be omitted from incisions that do not require improved drainage. In addition, the drainage strips 1004 can be placed on a liquid transfer liner strip, such as rayon, "veil" padding or liner, "N-terface" lining, etc. to increase efficiency and avoid maceration of the skin. Figure 48 shows the dressing 1002, which includes a fluid transfer component 1006 with a cross-linked foam core or block 1008 (eg, polyurethane ether as described above) with a surface 1009 and layers of distant / upper absorbent material and next / lower (eg, rayon or other suitable absorbent material) 1010, 1012, which can optionally be attached to or loosely placed in the core 1008. A membrane cloth 1014 is placed over the fluid transfer component 1006 and releasably adheres to healthy skin adjacent to the incision 6. An elbow joint 417 is placed over an opening 1016 forming a discharge port in the membrane cloth 1014. The coupling 417 is attached to a suction source or negative pressure, also described above. During activation of the negative pressure source, the movement of the fluid tends to be concentrated laterally (horizontally) along the lower absorbent layer 1012 towards the perimeter of the fluid transfer component 1006. The pressure differential between the component fluid transfer 1006 and the ambient atmosphere compresses the core 1008 as shown in Figure 49. For example, compression within the range of about 20% to 80% is feasible. The rayon layers 1010, 1012 are thus attracted in close proximity, particularly around the perimeter of the fluid transfer component 1006, whereby the transfer of fluid therebetween is facilitated. Still further, the upper rayon layer 1010 tends to be directed laterally towards the inner part under negative pressure, while the upper rayon layer 1012, since it is located on the skin, tends to retain its original shape and dimension. The upper rayon layer 110, which is less compressible than the foam core 1008, therefore tends to deviate towards the bottom around the - - its perimeter edges, further facilitating fluid flow to the upper rayon layer 1010 and the discharge coupling 417. The exposed perimeter edges of the core 1008 facilitate movement of air within the core 1008, e.g. through the membrane 1014, which may comprise a semi-permeable material. Figures 50 and 51 show another dressing 1022 of the alternative embodiment with a foam core 1024 completely enclosed in a layer of absorbent material 1026 (e.g., rayon or other suitable absorbent material). Figure 51 shows the dressing 1022 after the application of negative suction pressure, which may cause the rayon layer 1026 to deform or collapse adjacent to the lower portions of the perimeter edges of the core, thereby providing an edge of double layer of extended deformed absorbent material 1028. Edge 1028 can provide an additional interface with the skin of the patient, thereby avoiding or reducing pressure related problems such as blisters by shearing force. The edge 1028 can provide another benefit in the form of improved airflow for the skin maturation drying mode, which is a requirement of a long-term post-operative dressing (from three days to three weeks). Still another system of apposition of the modality Alternative comprises the use of the dressing 1012 facility during a heavy initial exudative phase, which typically occurs approximately 48-72 hours after surgery. Subsequently, the dressing 1002 can be removed and the apposition installation enclosed in rayon 1022 applied during a post-operative long-term transudative phase (typically around three days to three weeks). Alternatively, a single layer of rayon absorbent material can be applied to continue the drainage of transudate fluid assisted by the absorbent material. The tissues are therefore stabilized for a critical premature gain of collagen strength and to remove the transudate, thereby allowing the "sealing" of the incision 6 and the drainage sites, and promoting the drying of the skin surface. Figure 52 shows still another embodiment of the wound dressing 1032 with a sensor 1034 in communication with the dressing 1032 and providing an input signal to a controller 1036, which may include a feedback loop 1038 for controlling the various operating parameters of a system that includes a wound dressing 1032. For example, hemoglobin levels can be monitored, as well as pressures, fluid flow, temperatures, patient conditions, and various exudate and transudate characteristics.

Figure 53 shows an experimental model 1042 of the dressing, which is vertically oriented to the model fluid flow in the system. The fluid tends to be present in areas shown at the bottom 44 and along the sides 46, 48 of the cross-linked polyurethane foam core 1050 and define a fluid transfer zone 1051. An air retention zone 1052 , ie, the upper and middle part of the foam core 1050 tends to trap the air whereby the fluid tends to be directed towards the outer edges. The polyurethane ether reticulated foam material therefore tends to trap the air inside and to move the liquid to the outside. In this configuration the breaking point for the ability to move liquid to the discharge elbow 417 occurs at a volume of liquid equal to or approximately 10% of the volume of the 1050 foam core not compressed. The absorption of liquid in the reticulated foam can be improved by coating its passages with proteins. Table I shows the compression effect in the cross-linked polyurethane ether foam material under various levels of negative pressure.

TABLE I COMPRESSION EFFECT Figure 54 shows a totally wet surface area of the crosslinked polyurethane foam as a function of the total volume of liquid added at different pressures, with foam conditions both uncoated and protein coated. Figure 55 shows an active positive pressure hemostat 1062 comprising an alternate embodiment of the present invention and including a patient interface 1064 with a transfer component 1066 to be placed against a patient and an upper cloth 1068 located thereon and secured to the patient. the surrounding skin. The transfer component 1066 may include an optional liner or cover 1070 for direct attachment to the patient's skin if the material comprising a 1069 core is compatible with direct contact with the skin. The transfer component 1066 communicates with a pressure source 1067 by an elbow coupling 417 over an opening or discharge port 1072 in the upper cloth 1068. The application of negative pressure to the transfer component 1066 results in the application of a positive pressure to the patient's skin by the transfer component 1066. The hemostat 1062 is adapted to provide localized compression for the speedy reabsorption of free fluid edema. Applications may include subdermal hemorrhage (e.g. 1074) and re-absorption of free edema in body cavities, internal organs and joints. Other applications may also use the 1062 active pressure hemostasis device, which includes cataplasm-like applications to improve the absorption of pharmaceuticals applied to the surface. As shown, the sensor 1034 and the controller 1036 can monitor various operating parameters to provide automatic control, particularly in relation to varying positive pressures exerted by the transfer component 1066. For example, the visible, thermal and infrared indications of conditions The subdermal can be detected by the sensor 1034, which emits corresponding signals for the input of the controller 1036. The pressure can be appropriately cyclic, and completed once certain predetermined conditions have been achieved, e.g. the re-absorption of free edema corresponding to the achievement of treatment objectives. It should be understood that although certain embodiments and / or aspects of the invention have been shown and described, the invention is not limited thereto and encompasses several other modalities and aspects. For example, various other suitable materials can be used in place of those described above. The configurations can also be adapted as needed to accommodate particular applications. Still further, various control systems can be provided and pre-programmed to automatically respond in an appropriate manner to different operating conditions. Still further, the systems and methods described above can be combined with several other protocols, pharmaceuticals and treatment devices.

Claims

CLAIMS 1. A dressing facility for a wound or incision, comprising: an external patient interface that includes an external fluid transfer component, said fluid transfer component being adapted to transfer the fluid from the wound or incision; said external patient interface including a top cloth placed on said fluid transfer component in contact with a surrounding skin surface; and said fluid transfer component including a porous core with a surface and a layer of absorbent material bonded thereto. The dressing installation according to claim 1, including: said upper cloth having an opening in said fluid transfer component; and said opening forming a discharge port for discharging the fluid from said dressing facility. The dressing installation according to claim 1, which includes: an internal fluid transfer component positioned in said wound or incision in fluidic communication with said external fluid transfer component. 4. The dressing installation according to claim 3, wherein said internal fluid transfer component comprises a drainage strip with an internal portion located within said wound or incision and an external portion externally thereto. The dressing installation according to claim 4, including: multiple of said draining strips each comprising a flat, flexible material; and each of said outer portions of drainage strip being bent on the surface of the skin adjacent said wound or incision. The dressing installation according to claim 2, including: said core including proximal and distal surfaces and a perimeter edge extending therebetween; said layer of absorbent material comprising a layer of proximal absorbent material which attaches to said proximal core surface and is adapted to be overlapping said wound or incision; and a layer of distal absorbent material that joins said distal core surface and said upper cloth. The dressing installation according to claim 2, wherein said core comprises a material of cross-linked compressible foam selected from the group comprising polyurethane ether (PUE) and polyvinyl acetate (PVA). The dressing installation according to claim 2, wherein said absorbent material comprises rayon. 9. The dressing installation according to claim 1, including a pressure source connected to said fluid transfer component. 10. The dressing installation according to claim 9, including: a fluid port installed on said upper cloth and connected to said pressure source. The dressing installation according to claim 9, wherein said pressure source comprises a manually operated vacuum type device. The dressing installation according to claim 1, including: a cover of absorbent material enclosing said core and including said layer of absorbent material; said cover including a perimeter edge; said fluid transfer component having compressed and uncompressed configurations; and said edge of absorbent material rippling and forming a lateral projection edge with said component - - of fluid transfer in its compressed configuration. The dressing installation according to claim 2, including: said core forming an interior air retention area with the application of negative pressure thereto; said core forming a fluid transfer zone on its outer surface and adjacent said cover of absorbent material; and said fluid transfer zone adapted to direct fluid from said wound or incision to said discharge port. The dressing installation according to claim 9, including: a sensor connected to said fluid transfer component and adapted to detect a characteristic thereof and to provide an output signal corresponding to said characteristic; a controller connected to said sensor and receiving input signals thereof and providing an output signal to said pressure source; and a feedback loop connected to said controller output and said controller to provide a feedback signal corresponding to said controller output and inputting said same to said controller. 15. A dressing facility for a wound or incision, comprising: an external patient interface that includes an external fluid transfer component, said fluid transfer component being adapted to transfer the fluid from the wound or incision; said external patient interface including a top cloth placed on said fluid transfer component in contact with a surrounding skin surface; said fluid transfer component including a porous core with a surface; said upper cloth having an opening towards said fluid transfer component; said opening forming a discharge port for discharging the fluid from said dressing installation; an internal fluid transfer component positioned in said wound or incision in fluid communication with said external fluid transfer component and comprising multiple drainage strips each having an internal portion located within said wound or incision and an external portion located externally to it; each of said drainage strips comprising a flat, flexible material; each of said external portions being drawn drainage strip on the surface of the skin adjacent said wound or incision; a pressure source connected to said fluid transfer component; a cover of absorbent material enclosing said core and including a perimeter edge; said fluid transfer component having compressed and uncompressed configurations; said edge of absorbent material bending and forming a laterally projecting edge with said fluid transfer component in its compressed configuration; said core forming an interior area of air retention with the application of negative pressure thereto; said core forming a fluid transfer zone on its outer surface and adjacent said cover of absorbent material; and said fluid transfer zone adapted to direct fluid from said wound or incision to said discharge port; a sensor connected to said fluid transfer component and adapted to detect a characteristic thereof and which provides an output signal corresponding to said characteristic; a controller connected to said sensor and receiving input signals thereof and providing an output signal to said pressure source; and a feedback loop connected to said controller output and said controller to provide a feedback signal corresponding to said controller output and inputting said same into said controller. 16. A method for treating a wound or incision externally, comprising the steps of: providing an external patient interface that includes an external fluid transfer component; placing said external patient interface on a patient on the wound or incision; providing a top cloth and placing the same on said fluid transfer component in contact with the surrounding skin surface; providing said fluid transfer component with a porous core including a surface and a layer of absorbent material bonded thereto; and transferring the fluid from the wound or incision to the fluid transfer component. 17. A hemostat comprising: an external patient interface that includes an external transfer component; including said external patient interface a upper cloth placed on said transfer component in contact with a surrounding skin surface and including a port; said transfer component including a porous core with a surface; and a pressure source connected to said fluid transfer component through said port. The hemostat according to claim 16, which includes: a sensor connected to said transference component and adapted to detect a characteristic thereof and to provide an output signal corresponding to said characteristic; a controller connected to said sensor and receiving input signals thereof and providing an output signal to said pressure source; and a feedback loop connected to said controller output and said controller to provide a feedback signal corresponding to said controller output and input to said controller. 19. A method of hemostasis, comprising the steps of: providing an external patient interface that includes an external transfer component; applying said transfer component to a patient; providing said external patient interface with an upper cloth and placing the same on said transfer component in contact with a surrounding skin surface; providing said upper cloth with a port; providing said transfer component with a porous core including a surface; provide a source of pressure; connecting said pressure source to said fluid transfer component through said port; and applying a subdermal hemostatic pressure to said patient through said patient interface. SUMMARY A system and method for the treatment of tissue closure with an external interface for patient are provided. A first fluid transfer component FTC1 comprises a strip of porous material, such as rayon, with liquid absorbing properties. The FTC1 can be placed directly on a suture line to transfer exudate fluid through it. A lower cloth is placed over the FTC1 and includes a slot that exposes a portion of it. The FTC2 comprises a suitable hydrophobic foam material, such as polyurethane ether, and is placed over the groove of the lower cloth in communication with the FTC1. Negative pressure is applied to the FTC2 through a connection fluid transfer component FTC 3. A source of negative pressure may comprise a hand-held device or a suction device operated by motive force. The tissue closure method includes a manual mode of operation that uses a manual suction device with an automatic switch to discontinue. the suction when a predetermined volume of fluid has been drained. An automatic mode of operation uses a microprocessor, which can be programmed to respond to various patient and operation conditions. The method proceeds through several phases with different components in place and different patient interface functions that are presented in each one.