SET OF COMPONENTS FOR APPLYING A DRAINAGE COMPRESSION DRESSING

Abstract

TITLE: ASSEMBLY OF COMPONENTS FOR APPLYING A DRAINAGE COMPRESSION DRESSING The present invention relates to an assembly of elements for applying a draining compression dressing. The present invention further relates to an assembly comprising at least two assemblies of elements according to the present invention. Figure from the abstract: FIG. 1

Description

Title of the invention: SET OF ELEMENTS FOR INSTALLING A DRAINING COMPRESSIVE DRESSING FIELD OF THE INVENTION

[0001] The present invention relates to a set of elements for the placement of a draining compression dressing. The present invention further relates to an assembly comprising at least two sets of elements according to the present invention. STATE OF THE ART

[0002] A skin loss wound is a skin injury that involves a break or discontinuity of the epidermis and dermis, resulting in an absence of skin tissue at the site of the injury. In other words, the skin is damaged and part of it is missing, creating a cavity or opening in the skin surface. These wounds can be caused by different factors such as traumatic injuries, burns, ulcers, bedsores or surgical incisions. The healing of this type of wound can be more complex and require specific medical care to promote tissue regeneration and reduce the risk of infection.

[0003] The flap method and the suction dressing technique are commonly used for the treatment of wounds with loss of skin substance.

[0004] The flap method consists of a surgical procedure in which a section of skin and underlying tissue (the "donor" area) is moved from one part of the body to the damaged or missing tissue area (the "recipient" area), while maintaining a vascular connection (local or pedicled flap) or being reconnected to the neighboring vascular network of the recipient area via vascular anastomoses (free flap). Although this method can be very effective in reconstructing or repairing damaged tissue, it presents risks of failure of the procedure if the flap necroses or if the span of the flap is insufficient to cover the loss of skin substance. It is also possible that no flap is available. In addition, the practice of certain complex flaps is not accessible to all surgeons. Finally, taking a flap can lead to local morbidity at the donor site.

[0005] The vacuum dressing technique involves applying a specialized dressing (in the form of foam) to the wound with loss of skin substance, the dressing being connected to a vacuum pump which creates a negative pressure environment around the wound. This negative pressure helps to promote the elimination fluids and cellular debris from the wound, increase blood flow to the wound to promote healing and new tissue formation, and promote the growth of new blood vessels in the affected area to aid healing. However, this technique has some drawbacks. Changes of the suction dressing must be regular (every 2-3 days) and sometimes must be done in the operating room. In addition, the application of negative pressure to the wound can cause discomfort and pain, especially during dressing changes. Furthermore, the seal of the suction dressing can be difficult to achieve. The suction dressing can also be expensive, especially if used for a long period of time. Finally, the presence of the vacuum pump is restrictive for the patient and can hinder their movement.

[0006] Azevedo de Figueiredo et al. (Revista Brasileira de Ortopedia, English Edition, Vol. 52, No. 6, 2017, pages 685-692) describes an alternative method for healing a wound with loss of skin substance located at the ends of the fingers, this method based on the use of a prosthesis cut from a flat layer of polypropylene and then sutured to the edges of the wound. A sterile gauze, attached with micropore paper strip, is applied to the prosthesis. The gauze is changed after five or seven days, after being moistened by the exudates that manage to escape at the edges of the prosthesis, between the sutures. Although this method has many advantages compared to the flap method and the suction dressing technique, the prosthesis used does not have a structure suitable for guided drainage of wound exudates, which can slow down or even hinder the healing process.Furthermore, fixing a flat plate to a rounded physiological area has many disadvantages: a flat plate cannot perfectly match the shape of a rounded support, which results in insufficient contact points between the two surfaces and the need for a large number of stitches, which create mechanical stresses on the plate and on the patient. It is important to emphasize that minimizing the number of stitches has a decisive advantage: avoiding inflammation and patient pain at the site of the stitch and, of course, limiting the operative time of placement. The exudates and the reconstruction of the missing area will follow the topography of the fixed plate, and, when the plate is rigid, this does not allow reconstruction to the original shape, limits movement, and the stitches get caught if they are not covered with gauze and adhesive tape.Furthermore, the prior art prosthesis is not washable.

[0007] There is therefore a need not met by the prosthesis described above for a dressing, in particular for a wound with loss of skin substance, which, on the one hand, can be fixed in a less invasive manner and allow a saving in operating time and which, on the other hand, allows guided and improved drainage of exudates from the wound, which promotes healing. SUMMARY

[0008] The invention satisfies this need by proposing a set of elements for the application of a draining compression dressing, particularly suitable for the healing of wounds with loss of skin substance or more generally wounds requiring impermeable physiological coverage and improved drainage of exudate compared to the dressings of the prior art.

[0009] The set of elements according to the present invention comprises a phantom 1 and at least one elastic device 2 for holding all or part of said phantom 1, in which: - the phantom 1 is made of sterilizable biocompatible elastic material and corresponds to the physiological shape of an area of ​​the animal body, including human, said phantom 1 has a non-zero curvature and it has a superficial face 3 and a deep face 4, a. said superficial face 3 being impermeable to fluids, in particular to water and gases, b. said deep face 4 being non-absorbent, non-adherent, and provided with a raised structure which allows excess exudates to be conducted towards the periphery of the phantom 1, - the at least one elastic holding device 2 is capable of covering all or part of the phantom 1 and is capable of applying a homogeneous pressure of less than 120 mm Hg to all or part of the phantom 1 while respecting the curvature of said phantom 1, said at least one device 2 comprising a surface face 5, a deep face 6 and openings 7, said openings 7 cooperating with the phantom 1 while facing all or part of the periphery of the phantom 1 to allow excess exudates to be released.

[0010] The homogeneous pressure of less than 120 mm Hg applied by the at least one elastic device 2 to all or part of said phantom 1 makes it possible to maintain said phantom 1 at the level of the wound and therefore to reduce the number of sutures required. Thus, the risks associated with suturing are reduced. In addition, the operating time for the patient is also reduced, which makes it possible to avoid anesthesia of unnecessary length and intensity.

[0011] The homogeneous pressure below 120 mm Hg also allows for improved drainage of exudates at the periphery of the wound.

[0012] Finally, the cooperation between the openings 7 of the at least one device 2 and the phantom 1 allows for further improved drainage and prevention of obstruction of the outlets, for optimal healing. The use of gauze to absorb exudates is not necessary with the draining compression dressing of the present invention because the patient can wash the wound site directly, which improves the quality of treatment.

[0013] Advantageously, the thickness of the phantom 1 is between 0.1 and 5 mm and / or the thickness of the at least one elastic holding device 2 is between 0.1 and 5 mm.

[0014] Advantageously, the elastic material of the phantom 1 is a polymer, preferably a medical grade polymer, and more preferably a medical grade polymer chosen from a silicone, latex, a polysaccharide, or a plastic.

[0015] Advantageously, the elastic material of the phantom 1 is impregnated or covered, over its entirety, with another biocompatible elastic material, preferably a polymer, more preferably a medical grade polymer, and even better a medical grade polymer chosen from a silicone, latex, a polysaccharide, or a plastic.

[0016] Advantageously, the deep face 4 of the phantom 1 is aseptic.

[0017] Advantageously, the surface face 3 of the phantom 1 comprises a first structure relief structure, the deep face 6 of the at least one device 2 comprises a second relief structure, the first relief structure and the second relief structure cooperating to retain said surface face 3 on said deep face 6.

[0018] Advantageously, the shape of the phantom 1 is configured or solidified by means of a solid frame 8 capable of being arranged in the thickness of said phantom 1 or on its surface face 3.

[0019] The present invention also relates to an assembly for the placement of at least two draining compressive surgical dressings, comprising at least two sets of elements according to the present invention.

[0020] Advantageously, the at least two sets of elements are fixed by suturing the adjacent phantoms 1 with each other, by fitting the adjacent phantoms 1 or via at least one connection structure 9. DEFINITIONS

[0021] In the present invention, the terms below are defined as follows:

[0022] The “edges of a wound” designate the edges of a wound. In particular, in the case of a wound with loss of skin substance, the edges correspond to the contour of the wound defining the area of ​​loss of skin substance. Preferably, in the case of loss of skin substance, the contour of the wound designates a band, present on the skin surface, which surrounds the area of ​​loss of skin substance and which extends, from the edges of the area of ​​loss of skin substance, over a length less than or equal to 1 cm, preferably less than or equal to 0.5 cm and even more preferably less than or equal to 0.3 cm.

[0023] “Wound healing” refers to the process by which a wound repairs itself. In the case of a wound with loss of skin substance, this process first includes a bleeding phase, then an inflammatory phase (also called the debridement phase) in which the body, via hemostasis mechanisms, transforms the blood (and in particular the soluble fibrinogen molecule) into a blood clot (a fibrin clot) which covers the wound bed. This clot has an essential function, because it represents a primitive extracellular matrix which will serve as a receptacle to accommodate the stem cells which flow from the edges of the wound and from the wound bed. These cells are at the origin of tissue regeneration during the subsequent healing process.

[0024] “Elasticity” designates, in the context of the present invention, the ability of an object to resume, at least partially, its original shape and volume when the force exerted on them ceases to act.

[0025] “Exudates” refer to a serous, mucous or fibrinous fluid produced by a wound.

[0026] The “wound bed” means the surface of the wound whose perimeter is defined by the edges of the wound. In the case of a wound with loss of skin substance, the wound bed means the surface of the wound which includes the walls of the deficiency or cavity of the area affected by the loss and the bottom of this deficiency or cavity.

[0027] A “surgical dressing” refers to a dressing whose purpose is to cover and protect a surgical wound or a larger / deeper wound after a medical procedure. This type of dressing is generally used in a hospital or clinical setting.

[0028] A "phantom" is a physical object intended to fill the missing surface of a wound, particularly a wound with loss of skin substance. It is defined as an anatomical model whose shape imitates all or part of a limb or organ, and which can be cut to the shape and dimensions of the wound, reserving an additional peripheral edge for sutures or gluing or placement on the healthy tissue surrounding the wound.

[0029] A “biocompatible material” means a material that does not interfere with or degrade the biological environment in which (or on which) it is used. In the context of the present invention, a biocompatible material means a material capable of being applied to a wound, in particular to a wound with loss of skin substance, without inconvenience to the living cells involved in the healing of said wound.

[0030] An “inert material” means a solid, immobile substance that is neither chemically nor biologically reactive, that is denser than water, and that does not decompose.

[0031] An “aseptic surface” means a surface free from any infectious germ. BRIEF DESCRIPTION OF THE FIGURES

[0032] [Fig.l] [Fig.l] is a perspective diagram of the back of a hand of a patient having a wound with loss of skin substance. The phantom 1 according to the present invention, the shape of which corresponds to that of a human hand of dimensions comparable to that of the patient, is cut to the shape and dimensions of the wound, reserving an additional peripheral edge for sutures or gluing or placement on the healthy tissues surrounding the wound. An elastic holding device 2 is then positioned above the phantom 1 to obtain the compressive and draining effect.

[0033] [Fig.2] Figure 2A is a diagram of a phantom 1 according to an embodiment of the invention, in which its shape is configured or solidified by means of a solid reinforcement 8 arranged on the surface face 3 of said phantom 1. Figure 2B is a diagram of a phantom 1 according to an embodiment of the invention, in which its shape is configured or solidified by means of a solid reinforcement 8 arranged in the thickness of said phantom 1. Figure 2C is a diagram of a phantom 1 according to an embodiment of the invention, in which the relief structuring of its deep face 4 corresponds to grooves 10. Figure 2D is a diagram of a phantom 1 according to an embodiment of the invention, in which the relief structuring of its deep face 4 corresponds to channels 11.

[0034] [Fig.3] Figure 3A is a diagram of a set of elements according to an embodiment of the invention, in which the deep face 6 of the device 2 comprises channels 11A, the superficial face 3 of the phantom 1 comprises inverted channels 11B, the channels and inverted channels being configured to fit together. Figure 3B is a diagram of a set of elements according to an embodiment of the invention, in which the superficial face 3 of the phantom 1 comprises bumps 12, the deep face 6 of the device 2 comprises hollows 13, the hollows being configured to accommodate the bumps.

[0035] [Fig.4] Figure 4A is a perspective diagram of a hand having a wound with loss of skin substance extending over the back of said hand and over its index finger, two phantoms 1 according to the present invention being applied to the wound, the first at the level of the finger (of the index finger) and the second at the level of the back of the hand, the two phantoms 1 being fixed together by suture. Figure 4B is a perspective diagram of an assembly according to the present invention applied to the hand of Figure 4A.

[0036] [Fig.5] Figure 5A is a diagram showing two nested phantoms 1. Figure 5B is a diagram showing two phantoms 1 fixed via a connection structure 9. DETAILED DESCRIPTION

[0037] The present invention relates to a set of elements comprising a phantom 1 and at least one elastic holding device 2, capable of holding all or part of said phantom 1. According to one embodiment, the assembly according to the invention is a surgical dressing.

[0038] The phantom 1 is made of an elastic material. This characteristic has a particular advantage: when, for example, the phantom is placed on an articulated limb, it is able to follow the bending or movement of the limb at the joint level, which allows optimal recovery and immediate rehabilitation at the joint level. Advantageously, when the phantom 1 is placed on an articulated limb, extension bellows are present at the joint level to facilitate the bending of said phantom 1.

[0039] The elastic material of the phantom 1 is biocompatible. Thus, the phantom 1 is capable of being applied directly to a wound, in particular to a wound with loss of skin substance, without inconvenience for the living cells involved in the healing of said wound. The biocompatible elastic material of the phantom 1 is preferably a polymer, more preferably a medical grade polymer, and even better a medical grade polymer chosen from a silicone, latex, a polysaccharide, or a plastic.

[0040] The biocompatible elastic material of the phantom 1 is furthermore sterilizable.

[0041] Phantom 1 has a superficial face 3 and a deep face 4.

[0042] Advantageously, the deep face 4 of the phantom 1 is aseptic. Asepsis is obtained by sterilization in an aseptic environment, in particular by autoclaving, with ethylene oxide or by radiation. In the case of a surgical dressing, sterilization can take place in the operating room, at the time of application of said dressing. Advantageously, the entirety of the phantom 1 is aseptic.

[0043] Advantageously, the elastic material of the phantom 1 is impregnated or covered, over its entirety, with another sterilizable biocompatible elastic material, preferably a polymer, more preferably a medical grade polymer, and even better a medical grade polymer chosen from a silicone, latex, a polysaccharide, or a plastic. In one embodiment, the elastic material of the phantom 1 is impregnated or covered, over its entirety, with a silicone, preferably a silicone gel. Advantageously, the elastic material of the phantom 1 is silicone which is impregnated or covered, over its entirety, with a silicone gel. Advantageously, the silicone gel is of the Silbione™ RT Gels type.

[0044] In one embodiment, the elastic material of the phantom 1 is inert.

[0045] In one embodiment, the elastic material of the phantom 1 is homogeneous.

[0046] The thickness of the phantom 1 is preferably between 0.1 and 5 mm, more preferably potentially between 1 and 3 mm.

[0047] According to one embodiment, the elastic material of the phantom 1 has a hardness of between 1 and 90 Shore A, preferably between 10 and 60 Shore A. The measurement of the hardness is carried out following the method described in ASTM D2240.

[0048] According to an embodiment compatible with the previous embodiment, the elastic material of the phantom 1 has a density of between 0.5 and 5 g / cm3, preferably between 1 and 3 g / cm3. The density is measured by following the method described in the ASTM D792 standard.

[0049] According to an embodiment compatible with the preceding embodiments, the elastic material of the phantom 1 has a tear strength of between 3 and 30 kN / M, preferably between 5 and 20 kN / M. The measurement of the tear strength is carried out following the method described in the ASTM D624 standard. Thus, the phantom 1 has sufficient tear strength to reduce the risk of it being damaged during its use until the wound heals, which guarantees optimal healing.

[0050] According to an embodiment compatible with the preceding embodiments, the elastic material of the phantom 1 has an elongation at break of between 20 and 500%, preferably between 100 and 450%. The measurement of the elongation at break is carried out following the method described in the ASTM D412 standard.

[0051] According to an embodiment compatible with the preceding embodiments, the elastic material of the phantom 1 has a Mooney viscosity of between 1 and 100, preferably between 20 and 60. The measurement of the Mooney viscosity is carried out by following the method described in the ASTM DI646 standard.

[0052] According to an embodiment compatible with the preceding embodiments, the elastic material of the phantom 1 has a 100% modulus of between 1 and 5 MPa, preferably between 3 and 4 MPa. The measurement of the 100% modulus is carried out in accordance with the knowledge of a person skilled in the art.

[0053] According to an embodiment compatible with the preceding embodiments, the elastic material of the phantom 1 has a thermal resistance between -50 and 200°C. Thus, the elastic material of the phantom 1 can be exposed to temperatures ranging from -50 to 200°C continuously without its mechanical properties being negatively affected. The measurement of the thermal resistance is carried out in accordance with the knowledge of a person skilled in the art.

[0054] According to an embodiment compatible with the preceding embodiments, the elastic material of the phantom 1 has a deformation of 5 to 10 mm for a tensile force of 2 to 3 Newtons. The measurement of the deformation is carried out with a Besland AMF-500 digital dynamometer (force gauge).

[0055] The phantom 1 is defined as an artificial anatomical model, which is a replica of all or part of a limb or organ of an animal body, including human. Thus, it corresponds to the physiological shape of an area of ​​an animal body, including human. The shape of the phantom 1 is therefore preformed. For example, the preforming can be the shape of a finger, with different sizes, or of a hand, or of a forearm, a foot, an ankle, a knee, a thigh, a calf etc.. .or the preforming can be limited to reproducing the curvature of a part of the shape of these organs. As illustrated [Fig.l], in the case of a human person who has suffered a wound with loss of skin substance on the back of his hand, a phantom 1 whose shape corresponds to that of a human hand of dimensions comparable to those of the patient can be used. The phantom 1 is then cut to the shape and dimensions of the wound, reserving an additional peripheral edge for sutures or gluing or laying on the healthy tissues surrounding the wound. Alternatively, a phantom 1 whose shape corresponds directly to the shape and dimensions of the wound with loss of skin substance (for example, the back of the hand) can be used, without the need for prior cutting.

[0056] Phantom 1 has a non-zero curvature because the surface anatomy of an animal body, including human, is never flat.

[0057] Thus, in the case of a wound with loss of skin substance, the application of the phantom 1 to the wound makes it possible to reserve a three-dimensional space between the deep face 4 of said phantom 1 and the bed of the wound, the volume of said three-dimensional space being equal to the volume of the loss of skin substance. This three-dimensional space then acts, at the beginning of the healing process, as a container for the blood coming from the blood vessels affected during the loss of skin substance: this blood then evolves by hemostasis during healing into a regenerated tissue which reconstitutes the native anatomical volume (corresponding to the volume of the loss of skin substance). The use of the phantom 1 therefore makes it possible to best restore the initial surface anatomy of the limb affected by the loss of skin substance.

[0058] The phantom 1 can be fixed to the edges of the wound or to the healthy skin on the periphery of the edges of the wound, by any suitable means, in particular by a limited number of stitches. Thus, the phantom 1 is advantageously suturable.

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

[0060] The phantom 1 preferably has a mechanical strength that makes it suitable for cutting with scissors or a surgical blade such as a bistoury or scalpel, without fraying or significant deformation.

[0061] In one embodiment, the phantom 1 complies with current standards, in particular FDA 21 CFR item 177.2600 and EU 1935 / 2004.

[0062] Advantageously, the shape of the phantom 1 is configured or solidified by means of a solid frame 8 capable of being arranged on the surface face 3 of said phantom 1 as illustrated in Figure 2A, or capable of being arranged in the thickness of the phantom 1 as shown in Figure 2B.

[0063] In one embodiment, the solid frame 8, arranged in the thickness of the phantom 1, corresponds to at least two tubes whose ends do not come into contact with the exudates. In other words, in this embodiment, the phantom 1 is multitubular and the lumen of the tubes is not in contact with the exudates. Advantageously, the phantom 1 is a multitubular drain made of medical grade silicone composed of 2 to 200 tubes, preferably 3 to 16 tubes. An example of a multitubular drain made of medical grade silicone is that marketed by the company Lohmann Bauscher under the reference SF84401.

[0064] The surface face 3 of the phantom 1 is impermeable to fluids, and in particular to water and gases. Thus, the surface face 3 makes it possible to prevent dirt and germs from the outside to protect the wound during healing.

[0065] According to one embodiment, the draining compression dressing according to the present invention is washable.

[0066] The deep face 4 of the phantom 1 is non-absorbent. Thus, exudates from the wound, in particular from a wound with loss of skin substance, cannot be absorbed by the phantom 1.

[0067] The deep face 4 is also non-adherent. Thus, it does not stick to the regenerated tissue during healing.

[0068] The deep face 4 of the phantom 1 is further provided with a relief structure of the embossing, embossing or molding type, which allows the conduction or guidance of excess exudates towards the periphery of the phantom 1. Thus, the exudates present at any location of the wound, and in particular at the center of the wound, can be evacuated by means of this relief structure, which optimizes the healing time and limits maceration under the phantom 1.

[0069] In an embodiment illustrated in Figure 2C, the relief structuring of the deep face 4 of the phantom 1 corresponds to grooves 10.

[0070] In an embodiment illustrated in Figure 2D, the relief structuring of the deep face 4 of the phantom 1 corresponds to channels 11.

[0071] According to one embodiment, the entirety of the phantom 1 (comprising the surface face 3 and the deep face 4) is impermeable to fluids (in particular to water and gases), non-absorbent, and / or non-adherent.

[0072] The assembly according to the invention further comprises at least one elastic device 2 for holding all or part of the phantom 1, which is capable of covering all or part of said phantom 1. The holding is achieved by applying a homogeneous pressure of less than 120 mm Hg to all or part of the phantom 1, respecting the curvature of said phantom 1. Thus, the pressure applied by the device 2 is lower than the arterial and arteriolar pressure.

[0073] Said at least one device 2 is elastic (i.e. it is made of an elastic material). Advantageously, the elastic material constituting the at least one device 2 is a polymer, preferably chosen from a silicone, latex, a polysaccharide, or a plastic.

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

[0075] According to an embodiment compatible with the preceding embodiment, the elastic material of the at least one device 2 has a density of between 0.5 and 5 g / cm3, preferably between 1 and 3 g / cm3. The density is measured by following the method described in the ASTM D792 standard.

[0076] According to an embodiment compatible with the preceding embodiments, the elastic material of the at least one device 2 has a tear strength of between 3 and 30 kN / M, preferably between 5 and 20 kN / M. The measurement of the tear strength is carried out following the method described in the ASTM D624 standard.

[0077] According to an embodiment compatible with the preceding embodiments, the elastic material of the at least one device 2 has an elongation at break of between 20 and 500%, preferably between 100 and 450%. The measurement of the elongation at break is carried out following the method described in the ASTM D412 standard.

[0078] According to an embodiment compatible with the preceding embodiments, the elastic material of the at least one device 2 has a Mooney viscosity of between 1 and 100, preferably between 20 and 60. The measurement of the Mooney viscosity is carried out by following the method described in the ASTM D1646 standard.

[0079] According to an embodiment compatible with the preceding embodiments, the elastic material of the at least one device 2 has a 100% modulus of between 1 and 5 MPa, preferably between 3 and 4 MPa. The measurement of the 100% modulus is carried out in accordance with the knowledge of a person skilled in the art.

[0080] According to an embodiment compatible with the preceding embodiments, the elastic material of the at least one device 2 has a thermal resistance of between -50 and 200°C. Thus, the elastic material of the at least one device 2 can be exposed to temperatures ranging from -50 to 200°C continuously without its mechanical properties being negatively affected. The measurement of the thermal resistance is carried out in accordance with the knowledge of a person skilled in the art.

[0081] According to an embodiment compatible with the preceding embodiments, the elastic material of the at least one device 2 has a deformation of 5 to 10 mm for a tensile force of 2 to 3 Newton. The measurement of the deformation is carried out with a Besland AMF-500 digital dynamometer (force gauge).

[0082] Said at least one device 2 comprises a surface face 5, a deep face 6 and is provided with openings or orifices or meshes 7.

[0083] The homogeneous pressure of less than 120 mm Hg applied by the at least one device 2 to the phantom 1 makes it possible to ensure effective drainage of excess exudates at the periphery of said phantom 1. The presence of openings 7 on the device 2, said openings 7 being opposite all or part of the periphery of the phantom 1, makes it possible to relay or continue the evacuation of said exudates to the external environment and also makes it possible to prevent obstruction of the exits.

[0084] The cooperation of the phantom 1 and the at least one device 2 therefore makes it possible to obtain a compressive, draining and protective effect.

[0085] The presence of at least one device 2 also makes it possible, when the phantom 1 is fixed by suture to the edges of the wound or to the healthy skin at the periphery of the edges of the wound, to reduce the number of sutures required. Thus, the application of the draining compression dressing is accelerated. In addition, the sutures made are protected by the device 2, which prevents them from catching on clothing, for example, and the resulting pain. This protection also makes it possible to prevent the phantom 1 from being torn off.

[0086] In one embodiment, the device 2 is not a net.

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

[0088] Advantageously, the shape of the at least one device 2 is preformed. Preferably, the preforming corresponds to the shape of the limb or organ affected by a wound, in particular in the case of a wound with loss of skin substance. For example, in the case of a wound with loss of skin substance located on the back of a patient's hand, the shape of the holding device 2 may correspond to that of a human hand of dimensions comparable to those of the patient, and said device 2 may be put on like a glove, as illustrated [Fig. 1].

[0089] Advantageously, the surface face 3 of the phantom 1 comprises a first relief structure, the deep face 6 of the at least one device 2 comprises a second relief structure, the first relief structure and the second relief structure cooperating to retain the surface face 3 on the deep face 6. Thus, when the deep face 6 of the at least one device 2 is arranged above the surface face 3 of the phantom 1, any shearing or sliding movements between the phantom 1 and the at least one device 2 of the set of elements are considerably limited, or even non-existent, and the combination of the phantom 1 and the at least one device 2 is stabilized. Advantageously, this stabilization of the position of the at least one device 2 on the phantom 1 makes it possible to ensure that the or openings 7 of said at least one device 2 cooperate well with the phantom 1 at the periphery of the wound for optimized evacuation of excess exudates.

[0090] In an embodiment illustrated in Figure 3A, the second relief structuring corresponds to channels 11A and the first relief structuring corresponds to inverted channels 11B, the channels and inverted channels being configured to fit together (and therefore cooperate) when the deep face 6 of the device 2 is arranged on the superficial face 3 of the phantom 1.

[0091] In an embodiment illustrated in Figure 3B, the first relief structuring corresponds to bumps 12 and the second relief structuring to hollows 13, the hollows being configured to accommodate the bumps (and therefore cooperate) when the deep face 6 of the device 2 is arranged on the superficial face 3 of the phantom 1.

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

[0093] In a first embodiment, the at least two sets of elements according to the present invention are fixed by suturing adjacent phantoms 1 with each other, as illustrated in Figure 4A.

[0094] In a second embodiment, the at least two sets of elements according to the present invention are fixed by fitting adjacent phantoms 1. Thus, in the case of an assembly comprising two sets of elements, the two phantoms 1 may comprise raised parts and / or hollow parts which fit together allowing the two sets to be fixed, as illustrated in Figure 5A.

[0095] In a third embodiment, at least one connection structure 9 is used to fix the adjacent phantoms 1 in the assembly of the present invention. Thus, in the case of an assembly comprising two sets of elements, the two phantoms 1 may comprise recessed portions which fit into raised portions of a connection structure 9 allowing the fixing of the two sets, as illustrated in Figure 5B. DIGITAL REFERENCES

[0096] 1 - Ghost

[0097] 2 - Elastic holding device

[0098] 3 - Superficial face of the phantom

[0099] 4 - Deep face of the ghost

[0100] 5 - Surface face of the device

[0101] 6 - Deep face of the device

[0102] 7 - Device openings

[0103] 8 - Solid frame

[0104] 9 - Connection structure

[0105] 10-Grooves

[0106] 11 - Channels

[0107] 12-Bosses

[0108] 13 - Hollow

Claims

Claims

1. Set of elements for the application of a draining compressive dressing, for a wound, in particular a wound with loss of skin substance, which comprises a phantom (1) and at least one elastic device (2) for holding all or part of said phantom (1), in which: - the phantom (1) is made of sterilizable biocompatible elastic material and corresponds to the physiological shape of an area of ​​the animal body, including human, said phantom (1) has a non-zero curvature and has a superficial face (3) and a deep face (4), • said superficial face (3) being impermeable to fluids, in particular to water and gases, • said deep face (4) being non-absorbent, non-adherent, and provided with a raised structure which allows the conduction of excess exudates towards the periphery of the phantom (1),- the at least one elastic holding device (2) is capable of covering all or part of the phantom (1) and is capable of applying a homogeneous pressure of less than 120 mm Hg to all or part of the phantom (1) while respecting the curvature of said phantom (1), said at least one device (2) comprising a surface face (5), a deep face (6) and openings (7), said openings (7) cooperating with the phantom (1) while facing all or part of the periphery of the phantom (1) to allow excess exudates to be released.,

2. Set of elements according to claim 1, in which the thickness of the phantom (1) is between 0.1 and 5 mm and / or the thickness of the at least one elastic holding device (2) is between 0.1 and 5 mm.

3. A set of elements according to claim 1 or claim 2, wherein the elastic material of the phantom 1 is a polymer, preferably a medical grade polymer, and more preferably a medical grade polymer chosen from a silicone, latex, a polysaccharide, or a plastic.

4. Set of elements according to any one of claims 1 to 3, in which the elastic material of the phantom 1 is impregnated or covered, over its entirety, with another sterilizable biocompatible elastic material, preferably a polymer, more preferably a medical grade polymer, and even better a medical grade polymer chosen from a silicone, latex, a polysaccharide, or a plastic.

5. Set of elements according to any one of claims 1 to 4, in which the deep face (4) of the phantom (1) is aseptic.

6. Set of elements according to any one of claims 1 to 5, in which the surface face (3) of the phantom (1) comprises a first relief structure, the deep face (6) of the at least one device (2) comprises a second relief structure, the first relief structure and the second relief structure cooperating to retain said surface face (3) on said deep face (6).

7. Set of elements according to any one of claims 1 to 6, in which the shape of the phantom (1) is configured or solidified by means of a solid frame (8) capable of being arranged in the thickness of said phantom (1) or on its surface face (3).

8. Assembly for the placement of at least two draining compression dressings, comprising at least two sets of elements according to any one of claims 1 to 7.

9. Assembly according to claim 8, characterized in that the at least two sets of elements are fixed by suturing the adjacent phantoms (1) with each other, by interlocking the adjacent phantoms (1) or via at least one connection structure (9).

Images