Group of elements for applying drainage pressurized dressing

Abstract

The invention relates to an element set for applying a drainage pressurized dressing. The invention also relates to an assembly comprising at least two groups of elements according to the invention.

Description

Technical Field

[0001] This invention relates to an assembly of elements for applying a drainage pressure dressing. The invention also relates to an assembly comprising at least two sets of elements according to the invention. Background Technology

[0002] Skin defects refer to skin injuries involving ruptures or discontinuities in the epidermis and dermis, resulting in the loss of skin tissue at the wound site. In other words, the skin is damaged and some tissue is missing, creating cavities or openings on the skin surface. These types of wounds can be caused by a variety of factors, such as traumatic wounds, burns, ulcers, pressure sores, or surgical incisions. The healing process for these wounds can be more complex, requiring specific medical care to promote tissue regeneration and reduce the risk of infection.

[0003] Skin flap technique and vacuum-assisted dressing technique are common methods for treating skin defects and wounds.

[0004] Flap surgery is a surgical procedure that involves transferring a piece of skin and underlying tissue from one part of the body (the “donor site”) to a damaged or missing tissue area (the “recipient site”), while preserving vascular connections (local flaps or pedicled flaps) or reconnecting it to the adjacent vascular network of the recipient site via vascular anastomosis (free flap). Although this method is highly effective in reconstructing or repairing damaged tissue, there is a risk of failure if the flap necrosis occurs or if the flap area is insufficient to cover the skin defect. Furthermore, no flap may be available. Some complex flap techniques are not suitable for all surgeons. Finally, harvesting a flap can also lead to local complications at the donor site.

[0005] Vacuum-assisted dressing technology involves covering a skin defect wound with a specialized dressing (such as a foam dressing) connected to a vacuum pump, creating a negative pressure environment around the wound. This negative pressure helps to promote the removal of wound fluid and cellular debris, increases blood flow to the wound to promote healing and new tissue formation, and promotes angiogenesis to aid healing. However, this technology has several drawbacks: vacuum-assisted dressings need to be changed regularly (every 2 to 3 days), sometimes requiring an operating room procedure; applying negative pressure to the wound can cause discomfort and pain, especially during dressing changes; achieving a tight seal with vacuum-assisted dressings is difficult; the dressing is expensive, especially with long-term use; and the presence of the vacuum pump can cause psychological stress for the patient and restrict their movement.

[0006] Azevedo de Figueiredo et al. (Brazilian Journal of Orthopaedics, Vol. 52, No. 6, 2017, pp. 685–692) disclosed an alternative method for healing fingertip skin defects. This method uses a prosthesis cut from a planar polypropylene layer and sutured to the wound edge. Sterile gauze is then secured to the prosthesis using microporous tape. The gauze is changed on day 5 or 7 after exudate has soaked through the prosthesis edge and suture gaps. While this method has many advantages over flap techniques and vacuum-assisted dressing techniques, the prosthesis used lacks a structure adapted to guide and drain the exudate from the wound, potentially delaying or even hindering the healing process. Furthermore, fixing a flat plate to a physiologically curved area has several drawbacks: the plate cannot perfectly conform to the shape of the curved support surface, resulting in insufficient contact points between the two surfaces, and requiring numerous sutures, thus creating mechanical stress on the plate and the patient. It is important to emphasize that reducing the number of sutures has a decisive advantage: it avoids inflammation and pain at the suture site and shortens the implantation surgery time. The distribution of exudate and the reconstruction of the defect area will follow the shape of the fixed plate; if the plate is rigid, it cannot restore its original shape, restricts movement, and without covering with gauze and plaster, the sutures are prone to entrapment / abrasion. Furthermore, prostheses in existing technologies cannot be washed.

[0007] Therefore, the aforementioned prostheses still cannot meet the needs, and there is an urgent need for a dressing, especially suitable for skin defects and wounds. This dressing can fix the wound in a minimally invasive manner, shortening the operation time; on the other hand, it can optimize the drainage of wound exudate, thereby promoting wound healing. Summary of the Invention

[0008] The present invention addresses the above-mentioned needs by providing an assembly of components for applying a drainage pressure dressing, which is particularly suitable for promoting the healing of skin defect wounds, or more broadly, for wounds that require an impermeable physiological covering and optimized drainage of exudate compared to prior art dressings.

[0009] The component assembly according to the invention includes a model body and at least one elastic device for fixing all or part of the model body, wherein: The model body is made of a sterilizable biocompatible elastic material and is adapted to the physiological shape of a certain part of an animal body (including the human body); the model body has a non-zero curvature and is provided with an outer surface and an inner surface; a. The outer surface is impermeable to fluids (especially water and gas); b. The inner surface is non-absorbent and non-adhesive, and has a raised structure that can guide excess exudate to the periphery of the model body; At least one of the elastic fixing devices is capable of covering all or part of the model body and applying a uniform pressure of less than 120 mmHg to all or part of the model body while maintaining the curvature of the model body; at least one of the devices includes an outer surface, an inner surface, and an opening; the opening cooperates with the model body when facing all or part of the periphery of the model body to allow excess exudate to drain.

[0010] At least one of the elastic devices applies a uniform pressure of less than 120 mmHg to all or part of the mannequin body, which fixes the mannequin body to the wound, thereby reducing the number of sutures required and lowering suture-related risks. Furthermore, it can shorten the patient's surgical time and avoid unnecessary anesthesia duration and intensity.

[0011] Uniform pressure of less than 120 mmHg can also improve drainage of exudate around the wound.

[0012] Finally, the engagement of at least one opening of the device with the model body further improves drainage and prevents outlet blockage, thus achieving optimal healing. The use of gauze to absorb exudate is not necessary for the drainage pressure dressing of this invention, as the patient can directly clean the wound site, thereby improving the quality of treatment.

[0013] Advantageously, the thickness of the model body is 0.1 mm to 5 mm, and / or the thickness of at least one of the elastic fixing devices is 0.1 mm to 5 mm.

[0014] Advantageously, the resilient fastening device may be made of neoprene or polyurethane.

[0015] Advantageously, the elastic material of the model body is a polymer, preferably a medical-grade polymer, more preferably a medical-grade polymer selected from silicone, latex, polysaccharides or plastics.

[0016] Advantageously, the elastic material of the model body is entirely impregnated or covered with another elastic biocompatible material, preferably a polymer, more preferably a medical-grade polymer, and particularly preferably a medical-grade polymer selected from silicone, latex, polysaccharides or plastics.

[0017] Advantageously, the inner surface of the model body is a sterile surface.

[0018] Advantageously, the outer surface of the model body includes a first protrusion structure, and at least one inner surface of the device includes a second protrusion structure; the first protrusion structure and the second protrusion structure cooperate with each other to hold the outer surface of the model body on the inner surface of the device.

[0019] Advantageously, the shape of the model body is shaped or solidified by a rigid reinforcement member, which may be disposed in the thickness of the model body or on its surface.

[0020] The present invention also relates to an assembly for placing at least two drainage pressure surgical dressings, comprising at least two sets of elements according to the invention.

[0021] Advantageously, the at least two sets of elements are connected by stitching adjacent model bodies together, interlocking them, or by at least one connecting structure.

[0022] Terminology Definition In this invention, the following terms are defined as follows: "Wound edge" refers to the boundary or edge of a wound. Especially for skin defect wounds, the wound edge corresponds to the wound contour that defines the area of ​​skin defect. Preferably, in the case of skin defect, the wound contour refers to a band-shaped area existing on the skin surface and surrounding the area of ​​skin defect, the length of which extends outward from the edge of the skin defect is less than or equal to 1 cm (preferably less than or equal to 0.5 cm, more preferably less than or equal to 0.3 cm).

[0023] "Wound healing" refers to the process by which a wound repairs itself. For skin defects, this process first includes a bleeding phase, followed by an inflammatory phase (also known as the debridement phase): during this period, the body uses hemostasis to transform blood (especially soluble fibrinogen molecules) into a blood clot (fibrin clot) covering the wound bed. This clot plays a crucial role because it represents the primitive extracellular matrix and serves as a carrier for stem cells flowing in from the wound edges and wound bed. These stem cells are the source of tissue regeneration during the subsequent healing process.

[0024] Within the scope of this invention, "elasticity" refers to the ability of an object to at least partially recover its original shape and volume after the external force applied to it has disappeared.

[0025] "Exudate" refers to serous, mucous, or fibrinous fluid produced by a wound.

[0026] The "wound bed" refers to the surface of a wound, its perimeter defined by the wound edge. For wounds with skin defects, the wound bed refers to the wound surface including the defect or the walls and floor of the defect cavity.

[0027] "Surgical dressings" refer to dressings used to cover and protect surgical wounds or large / deep postoperative wounds. These dressings are typically used in hospitals or clinical settings.

[0028] A “model body” refers to a physical component used to close a wound (especially a skin defect wound). It is defined as an anatomical model whose shape simulates all or part of a limb or organ. It can be cut to match the shape and size of the wound and has peripheral edges reserved for suturing, bonding or applying to healthy tissue around the wound.

[0029] "Biocompatible materials" refer to materials that do not interfere with or damage the biological environment in which they exist (or come into contact with). Within the scope of this invention, biocompatible materials refer to materials that can be applied to wounds, especially skin defects, without adversely affecting the living cells involved in wound healing.

[0030] "Inert materials" refer to solid substances that are chemically and biologically inactive. Typically, inert materials have a density greater than that of water and do not decompose in water.

[0031] "Sterile surface" refers to a surface that does not contain any infectious pathogens.

[0032] Brief description of the attached figures Figure 1 This is a three-dimensional view of a skin defect wound on the back of a patient's hand. According to the invention, the model body 1 is shaped to approximate the size of a human hand, cut to the shape and size of the wound, and with an additional peripheral edge reserved for suturing, bonding, or application to healthy tissue surrounding the wound. Then, an elastic fixation device 2 is placed on top of the model body 1 to achieve pressure and drainage effects.

[0033] Figure 2 A is a schematic diagram of a model body 1 according to an embodiment of the present invention, wherein its shape is shaped or solidified by a rigid reinforcement 8 disposed on the outer surface 3 of the model body 1. Figure 2 B is a schematic diagram of a model body 1 according to an embodiment of the present invention, the shape of which is shaped or solidified by a rigid reinforcement 8 disposed in the thickness of the model body 1. Figure 2 C is a schematic diagram of a model body 1 according to an embodiment of the present invention, wherein the protrusion structure of its inner surface (4) is a groove 10. Figure 2 D is a schematic diagram of a model body 1 according to an embodiment of the present invention, wherein the protruding structure on its inner surface 4 is a flow channel 11.

[0034] Figure 3 A is a schematic diagram of a component group according to an embodiment of the present invention, wherein the inner surface 6 of the device 2 includes a flow channel 11A, and the outer surface 3 of the model body 1 includes an inverted flow channel 11B, the flow channel and the inverted flow channel being configured to fit together. Figure 3 B is a schematic diagram of an element assembly according to one embodiment of the present invention, wherein the outer surface 3 of the model body 1 includes a protrusion 12, and the inner surface 6 of the device 2 includes a recess 13, which are configured to accommodate the protrusion.

[0035] Figure 4 A is a three-dimensional view of a hand with a skin defect extending to the back of the hand and the index finger. Two model bodies (1) according to the invention are applied to the wound: the first is applied to the finger (index finger) and the second is applied to the back of the hand. The two model bodies 1 are connected to each other by suturing. Figure 4 B is applied to Figure 4 A is a perspective view of the hand component of the present invention.

[0036] Figure 5 A is a schematic diagram of two interlocking model bodies 1. Figure 5 B is a schematic diagram of two model bodies 1 connected by the connecting structure 9. Detailed Implementation

[0037] This invention relates to an assembly of components comprising a model body 1 and at least one elastic fixation device 2 capable of securing all or part of the model body 1. According to one embodiment, the assembly of this invention is a surgical dressing.

[0038] The model body 1 is made of an elastic material. This characteristic has particular advantages: for example, when the model body is applied to a jointed limb, it can deform in accordance with the limb's bending or movement at the joint, thereby achieving optimal joint recovery and immediate rehabilitation. Advantageously, when the model body 1 is applied to a jointed limb, a telescopic corrugated tube is provided at the joint to facilitate the bending of the model body 1.

[0039] The elastic material of model body 1 is biocompatible. Therefore, model body 1 can be directly applied to wounds, especially skin defects, without adversely affecting the living cells involved in wound healing. The biocompatible elastic material of model body 1 is preferably a polymer, more preferably a medical-grade polymer, and even more preferably a medical-grade polymer selected from silicone, latex, polysaccharides, or plastics.

[0040] The biocompatible elastic material of model body 1 can be further sterilized.

[0041] Model 1 has an outer surface 3 and an inner surface 4.

[0042] Advantageously, the inner surface 4 of the model body 1 is a sterile surface. Sterility is achieved through sterilization in a sterile environment, particularly by autoclaving, ethylene oxide sterilization, or radiation sterilization. For surgical dressings, sterilization can be performed in the operating room during application. Advantageously, the entire model body 1 is sterile.

[0043] Advantageously, the elastic material of model body 1 is entirely impregnated or covered with another sterilizable biocompatible elastic material, preferably a polymer, more preferably a medical-grade polymer, and even more preferably a medical-grade polymer selected from silicone, latex, polysaccharides, or plastics. In one embodiment, the elastic material of model body 1 is entirely impregnated or covered with silicone, preferably a silicone gel. Advantageously, the elastic material of model body 1 is silicone, which is entirely impregnated or covered with a silicone gel. Advantageously, the silicone gel is a Silbione™ RT gel.

[0044] In one embodiment, the elastic material of the model body 1 is an inert material.

[0045] In one embodiment, the elastic material of model body 1 is a homogeneous material.

[0046] The thickness of the model body 1 is preferably 0.1 mm to 5 mm, more preferably 1 mm to 3 mm.

[0047] According to one embodiment, the hardness of the elastic material of the model body 1 is 1 to 90 Shore A, preferably 10 to 60 Shore A. Hardness is measured according to the method described in ASTM D2240.

[0048] According to an embodiment compatible with the foregoing embodiments, the density of the elastic material of model body 1 is 0.5 to 5 g / cm³, preferably 1 to 3 g / cm³. Density measurement is performed according to the method described in ASTM D792.

[0049] According to an embodiment compatible with the foregoing embodiments, the tear strength of the elastic material of the model body 1 is 3 to 30 kN / m, preferably 5 to 20 kN / m. Tear strength measurement is performed according to the method described in ASTM D624. Therefore, the model body 1 has sufficient tear strength to reduce the risk of damage during use before wound healing, thereby ensuring optimal healing outcomes.

[0050] According to an embodiment compatible with the foregoing embodiments, the elongation at break of the elastic material of model body 1 is 20% to 500%, preferably 100% to 450%. The elongation at break is measured according to the method described in ASTM D412.

[0051] According to an embodiment compatible with the foregoing embodiments, the Mooney viscosity of the elastic material of model body 1 is 1 to 100, preferably 20 to 60. The Mooney viscosity is measured according to the method described in ASTM D1646.

[0052] According to an embodiment compatible with the foregoing embodiments, the 100% modulus of the elastic material of the model body 1 is 1 to 5 MPa, preferably 3 to 4 MPa. The 100% modulus is measured according to methods known to those skilled in the art.

[0053] According to an embodiment compatible with the foregoing embodiments, the heat resistance temperature range of the elastic material of model body 1 is -50°C to 200°C. Therefore, the elastic material of model body 1 can be continuously exposed within a temperature range of -50°C to 200°C without adversely affecting its mechanical properties. The heat resistance performance was measured according to methods known to those skilled in the art.

[0054] According to an embodiment compatible with the foregoing embodiments, the elastic material of model body 1 deforms by 5 to 10 millimeters under a tensile force of 2 to 3 Newtons. The deformation is measured using a Besland AMF-500 digital force gauge (force sensor).

[0055] Model 1 is defined as an artificial anatomical model that replicates all or part of a limb or organ of an animal body (including a human body). Therefore, it is adapted to the physiological shape of the part of the animal body (including a human body). The shape of Model 1 is pre-formed; for example, the pre-formed shape may be fingers, hands, forearms, feet, ankles, knees, thighs, calves, etc., of different sizes, or it may only be pre-formed to replicate the curvature of these organ parts. Figure 1 As shown, for patients with skin tissue defects on the back of the hand, a mannequin 1 with a shape and size comparable to the patient's hand can be used. The mannequin 1 is then cut to the shape and size of the wound, leaving the outer edges for suturing, bonding, or application to healthy tissue around the wound. Alternatively, a mannequin 1 whose shape directly matches the shape and size of the skin tissue defect (e.g., the back of the hand) can be used directly without pre-cutting.

[0056] Model body 1 may have non-zero curvature to conform to the original anatomical surface morphology of an animal body (including the human body). In fact, most of these anatomical morphologies are curved surfaces.

[0057] Therefore, for skin defect wounds, placing the mannequin 1 on the wound allows for a three-dimensional space between the inner surface 4 of the mannequin 1 and the wound bed. The volume of this three-dimensional space is equal to the volume of the skin tissue defect. In the early stages of the healing process, this three-dimensional space serves as a container for blood flowing from damaged blood vessels during skin defect formation. Subsequently, this blood is transformed into regenerated tissue through hemostasis during the healing process, reconstructing the original anatomical volume (corresponding to the volume of the skin tissue defect). Therefore, using the mannequin 1 can optimally restore the initial surface anatomy of the limb affected by skin tissue defects.

[0058] Model 1 can be fixed to the edge of the wound or the surrounding healthy skin in any adaptable manner, especially with a small number of sutures. Therefore, model 1 is preferably suture-compatible.

[0059] In one embodiment, the model body 1 is fixed by 2 to 10 stitches, preferably 3, 4, 5, 6, 7, 8 or 9 stitches. Preferably, the model body 1 is fixed by 4 to 6 stitches.

[0060] Model body 1 preferably has mechanical strength that allows it to be cut with scissors or a scalpel (such as a scalpel or a surgical blade) without noticeable burrs or deformation.

[0061] In one implementation, model body 1 conforms to current standards, particularly US FDA 21 CFR 177.2600 and EU 1935 / 2004.

[0062] Advantageously, the shape of the model body 1 is shaped or solidified by a rigid reinforcement 8, which can be disposed on the outer surface 3 of the model body 1 (e.g., Figure 2 As shown in A), or embedded in the thickness of model body 1 (such as...). Figure 2 As shown in B).

[0063] In one embodiment, the rigid reinforcement 8 embedded in the thickness of the model body 1 consists of at least two catheters, the ends of which do not contact the exudate. In other words, in this embodiment, the model body 1 is multi-tube type, and the lumen of its catheters does not contact the exudate. Advantageously, the model body 1 is a medical-grade silicone multi-tube drainage tube, comprising 2 to 200 catheters, preferably 3 to 16 catheters. An example of a medical-grade silicone multi-tube drainage tube is a product sold by Lohmann Bauscher under model number SF84401.

[0064] The outer surface 3 of the model body 1 is impermeable to fluids (especially water and gas). Therefore, the outer surface 3 acts as a barrier against the invasion of external dirt and bacteria, protecting the wound during the healing process.

[0065] According to one embodiment, the drainage pressure dressing of the present invention is washable.

[0066] The inner surface 4 of model body 1 does not absorb liquid. Therefore, wound exudate (especially exudate from wounds with skin tissue defects) will not be absorbed by model body 1.

[0067] The inner surface 4 is not adhesive. Therefore, it will not adhere to the regenerating tissue during the healing process.

[0068] The inner surface 4 of the model body 1 is also provided with a raised structure (especially an embossed, relief, or molded structure) which can guide excess exudate to the periphery of the model body 1. Therefore, exudate present at any location on the wound, especially in the center of the wound, can be drained through this raised structure, optimizing healing time and reducing maceration below the model body 1.

[0069] exist Figure 2In the embodiment shown in C, the protruding structure on the inner surface 4 of the model body 1 corresponds to the groove 10.

[0070] exist Figure 2 In the embodiment shown in D, the protruding structure on the inner surface 4 of the model body 1 corresponds to the flow channel 11.

[0071] According to one embodiment, the entire model body 1 (including the outer surface 3 and the inner surface 4) is impermeable, non-absorbent, and / or non-adhesive to fluids (especially water and gas).

[0072] The components of this invention also include at least one elastic fixation device 2 for securing all or part of the mannequin 1, the device 2 being capable of covering all or part of the mannequin 1. Fixation is achieved by applying uniform pressure to the mannequin 1, typically applying a pressure of less than 120 mmHg to all or part of the mannequin 1 while adhering to the curvature of the mannequin 1. Therefore, the pressure applied by the device 2 is lower than the pressure of arteries and arterioles. More generally, the pressure applied by the elastic fixation device 2 is sufficient to keep the mannequin 1 in contact with the wound without affecting the patient's blood circulation.

[0073] The at least one device 2 is elastic (i.e., made of an elastic material). Advantageously, the elastic material constituting the at least one device 2 is a polymer, preferably selected from silicone, latex, polysaccharides, or plastics.

[0074] According to one embodiment, the hardness of the elastic material of the at least one device 2 is 1 to 90 Shore A, preferably 10 to 60 Shore A. The hardness is measured according to the method described in ASTM D2240.

[0075] According to an embodiment compatible with the foregoing embodiments, the density of the elastic material of the at least one device 2 is from 0.5 g / cm³ to 5 g / cm³, preferably from 1 g / cm³ to 3 g / cm³. The density is measured according to the method described in ASTM D792.

[0076] According to an embodiment compatible with the foregoing embodiments, the tear strength of the elastic material of the at least one device 2 is from 3 kN / m to 0 kN / m, preferably from 5 kN / m to 20 kN / m. This tear strength is measured according to the method described in ASTM D624.

[0077] According to an embodiment compatible with the foregoing embodiments, the elongation at break of the elastic material of the at least one device 2 is 20% to 500%, preferably 100% to 450%. The elongation at break is measured according to the method described in ASTM D412.

[0078] According to an embodiment compatible with the foregoing embodiments, the Mooney viscosity of the elastic material of the at least one device 2 is from 1 to 100, preferably from 20 to 60. The Mooney viscosity is measured according to the method described in ASTM D1646.

[0079] According to an embodiment compatible with the foregoing embodiments, the 100% modulus of the elastic material of the at least one device 2 is from 1 MPa to 5 MPa, preferably from 3 MPa to 4 MPa. The 100% modulus is measured according to methods known to those skilled in the art.

[0080] According to an embodiment compatible with the foregoing embodiments, the heat resistance temperature of the elastic material of the at least one device 2 is -50 to 200°C. Therefore, the elastic material of the at least one device 2 can be continuously exposed within a temperature range of -50°C to 200°C without adversely affecting its mechanical properties. The heat resistance is measured according to methods known to those skilled in the art.

[0081] According to an embodiment compatible with the foregoing embodiments, the elastic material of the at least one device 2 has a deformation of 5 mm to 10 mm under a tensile force of 2 to 3 Newtons. The deformation is measured using a Besland AMF-500 digital force gauge.

[0082] The at least one device 2 includes an outer surface 5, an inner surface 6, and is provided with an opening, hole, or mesh 7.

[0083] The uniform pressure of less than 120 mmHg applied to the model body 1 by at least one device 2 enables effective drainage of excess exudate around the model body 1. The opening 7 on the device 2 faces all or part of the periphery of the model body 1, enabling further drainage of exudate to the outside and preventing blockage of the outlet.

[0084] Therefore, the combination of model body 1 and at least one device 2 can achieve the effects of drainage, protection and pressurization.

[0085] When the mannequin 1 is fixed to the edge of the wound or the healthy skin surrounding the wound edge by sutures, the at least one device 2 can also reduce the number of sutures required. This speeds up the application of drainage pressure dressings. Furthermore, the sutures are protected by the device 2 to prevent pain caused by, for example, snagging on clothing, and to prevent the mannequin 1 from being torn off.

[0086] In one embodiment, device 2 is not a mesh cover.

[0087] The thickness of the at least one device 2 is preferably 0.1 mm to 5 mm, more preferably 1 mm to 3 mm.

[0088] Advantageously, the shape of the at least one device 2 is pre-formed. Preferably, the pre-formed shape is adapted to the shape of the limb or organ affected by the wound (especially a skin defect wound). For example, for a skin defect wound located on the back of a patient's hand, the shape of the fixation device 2 can be adapted to the size of the patient's hand, and as... Figure 1 As shown, the device 2 can be worn on the hand like a glove.

[0089] Advantageously, the outer surface 3 of the model body 1 includes a first protruding structure, and the inner surface 6 of the at least one device 2 includes a second protruding structure. The first and second protruding structures cooperate to hold the outer surface 3 on the inner surface 6. Therefore, when the inner surface 6 of the at least one device 2 is positioned above the outer surface 3 of the model body 1, possible shearing or sliding movements between the model body 1 and the at least one device 2 in the component assembly are significantly limited or even essentially eliminated, and the combination of the model body 1 and the at least one device 2 is stabilized. Advantageously, this stability of the position of the at least one device 2 on the model body 1 ensures that the opening 7 of the at least one device 2 mates with the model body 1 around the wound to optimize the drainage of excess exudate.

[0090] In the embodiment shown in Figure 3A, the second protrusion structure is a flow channel 11A, and the first protrusion structure is an inverted flow channel 11B. When the inner surface 6 of the device 2 is disposed above the outer surface 3 of the model body 1, the flow channel and the inverted flow channel are configured to fit together (thereby cooperating).

[0091] In the embodiment shown in Figure 3B, the first protrusion structure is a bump 12 and the second protrusion structure is a recess 13. When the inner surface 6 of the device 2 is positioned above the outer surface 3 of the model body 1, the recess is configured to accommodate the bump (and thus fit).

[0092] The present invention also relates to an assembly for applying at least two drainage pressure dressings, the assembly comprising at least two sets of elements as described in the present invention. According to one embodiment, the at least two drainage pressure dressings are surgical dressings. An example of the assembly of the present invention comprising two sets of elements is shown in Figure 4B.

[0093] In a first embodiment, at least two sets of elements of the present invention are connected by stitching adjacent model bodies 1 together, as shown in FIG4A.

[0094] In a second embodiment, at least two sets of components as described in this invention are connected by interlocking adjacent model bodies 1. Therefore, for an assembly comprising two sets of components, the two model bodies 1 may include interlocking protrusions and / or recesses to achieve the connection of the two sets of components, as shown in FIG5A.

[0095] In a third embodiment, at least one connecting structure 9 is used to connect adjacent model bodies 1 in the component described in this invention. Therefore, for a component comprising two sets of elements, these two model bodies 1 may include recesses that engage with protrusions of the connecting structure 9 to achieve connection between the two sets of elements, as shown in FIG5B.

[0096] Explanation of reference numerals in the attached figures: 1-Model Body 2-Elastic fixing device 3-Model in vitro surface 4-Model body surface 5-Outer surface of the device 6-Inner surface of the device 7- Device opening 8- Rigid reinforcement 9-Connection Structure 10-groove 11-flow channel 12-protrusion 13-Depression

Claims

1. An assembly of components for applying a drainage pressure dressing to a wound, particularly a skin defect wound, the assembly comprising a mannequin (1) and at least one elastic fixation device (2) for fixing all or part of the mannequin (1), wherein: The model body (1) is made of a sterilizable biocompatible elastic material and is adapted to the physiological shape of a certain region of an animal body, including the human body; the model body (1) has a non-zero curvature and has an outer surface (3) and an inner surface (4). o The outer surface (3) is impermeable to fluids, especially water and gas; o The inner surface (4) is non-absorbent and non-adhesive, and has a raised structure that can guide excess exudate to the periphery of the model body (1); At least one of the elastic fixing devices (2) is capable of covering all or part of the model body (1) and applying a uniform pressure of less than 120 mmHg to all or part of the model body (1) while maintaining the curvature of the model body (1); at least one of the devices (2) includes an outer surface (5), an inner surface (6) and an opening (7); the opening (7) engages with the model body (1) when facing all or part of the periphery of the model body (1) to allow the excess exudate to drain.

2. The component assembly according to claim 1, wherein the thickness of the model body (1) is between 0.1 mm and 5 mm, and / or at least one of the elastic fixing devices (2) has a thickness between 0.1 mm and 5 mm.

3. The component assembly according to claim 1 or 2, wherein the elastic material of the model body (1) is a polymer, preferably a medical-grade polymer, more preferably a medical-grade polymer selected from silicone, latex, polysaccharides or plastics.

4. The component group according to any one of claims 1 to 3, wherein the elastic material of the model body (1) is entirely impregnated or covered with another sterilizable biocompatible elastic material, preferably a polymer, more preferably a medical grade polymer, and particularly preferably a medical grade polymer selected from silicone, latex, polysaccharides or plastics.

5. The component group according to any one of claims 1 to 4, wherein the inner surface (4) of the model body (1) is a sterile surface.

6. The component group according to any one of claims 1 to 5, wherein the outer surface (3) of the model body (1) includes a first protrusion structure, and the inner surface (6) of at least one of the devices (2) is provided with a second protrusion structure; the first protrusion structure and the second protrusion structure cooperate with each other to hold the outer surface (3) of the model body (1) on the inner surface (6) of the device (2).

7. The component group according to any one of claims 1 to 6, wherein the shape of the model body (1) is shaped or solidified by a rigid reinforcement (8), the rigid reinforcement (8) being disposed in the thickness of the model body (1) or on the outer surface (3) of the model body (1).

8. An assembly for applying at least two drainage pressure dressings, the assembly comprising at least two groups of elements according to any one of claims 1 to 7.

9. The component according to claim 8, characterized in that, At least two groups of said elements are connected by stitching adjacent model bodies (1) together, fitting them together, or by at least one connecting structure (9).

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