![]() COUPLER DEVICE FOR USE IN TREATING INJURY WITH SUBPRESSION
专利摘要:
invention patent: "device for use in the treatment of wounds with underpressure". the present invention relates to a coupling device (2) to be used in the treatment of wounds with underpressure, with a conductive means (4) that can be subjected to underpressure, with a vehicle (6) sealed against underpressure, in a special way , in whose upper face (9) away from the wound, the conductive means (4) are attached to the tightness of the sub-pressure, and the vehicle (6) can be applied in a sub-pressure bandage that overcomes the wound and closes sealing in relation to the atmosphere, preferably by using an additional adherent laminate (10), the conductive means (4) communicating through openings (22) in the vehicle (6) and in the underpressure bandage, with the wound area, with the conducting medium (4) having a flexible and flat shape and in a longitudinal end segment (8) on the side of the wound with at least 70% of its face projected perpendicularly on the vehicle (6), with this vehicle (6) is attached - for intended use sto - inseparably and spatially, the conductive medium (4) being formed of a flexible elastomeric material with a maximum shore-a * hardness of 60 and the thickness d projection of the joint formed by the conductive medium (4) and the vehicle (6) is a maximum of 7 mm. 公开号:BR112012015654B1 申请号:R112012015654-3 申请日:2010-12-07 公开日:2020-02-11 发明作者:Axel Eckstein;Jürgen Hofstetter;Pierre Croizat 申请人:Paul Hartmann Aktiengesellschaft; IPC主号:
专利说明:
Report of Invention Patent for COUPLING DEVICE FOR USE IN TREATING INJURIES WITH SUBPRESSION. [0001] The present invention relates to a coupling device to be used in the treatment of wounds with underpressure, with a conductive medium that can be subjected to underpressure, with an airtight, space-tight vehicle, on whose upper side away from the the pressure-tight conductive medium is attached to the wound, and the vehicle can be applied in a pressure-reducing joint that overcomes the wound and closes in a sealing manner against the atmosphere, preferably using an additional adhesive laminate, and the conducting medium establishes contact with the wound area through openings in the vehicle and in the underpressure bandage. [0002] In more recent times, treatment with underpressure of wounds, especially with deep wounds, and therefore, a priori difficult to heal, has acquired increasing importance. In this case, treatment with underpressure means that a region of the body or region of injury that is exposed to the surrounding atmosphere, by means to be described in more detail, is closed in a pressure-tight manner, that is, to seal the pressure, against the environment, or that is, against the atmosphere in which we live and breathe, and within the region of the closed wound, in a way that will also be explained, a smaller reduction is applied in comparison with the atmospheric pressure, that is, therefore, a relatively low atmosphere and can be permanently preserved. When subpressure is mentioned here in the field addressed, then this means a pressure region that is typically between 0 and 500 mm Hg (mm of mercury column) below the surrounding atmospheric pressure. This has been shown to promote the healing process Petition 870190106111, of 10/21/2019, p. 6/25 2/11 of injuries. For the watertight closure the underpressure is provided with an underpressure bandage, which, for example, can cover a layer of pressure-sealed laminate, that is, underpressure, which is typically glued to a preserved body region that surrounds the wound, in a way that in this sense a watertight closure can be achieved. So that, starting from a sub-pressure generating unit, that is, a sub-pressure pump in the broadest sense of the word, to carry a sub-pressure to the wound area and preserve it there, in the systems addressed here for the therapy of wounds with sub-pressure, they can be conductive means are used which can be subjected to underpressure and which through a coupling device cooperates with the underpressure bandage in order to bring the underpressure up to or within the wound space. Such a coupling device, initially mentioned, became known in document W0 2006/052338 A2. Tubular hose will be used to bring the pressure down to the wound. [0003] The purpose of the present invention is to create a coupling device of the kind initially mentioned, which for the patient is comfortable to use, that is, it causes little pain in application or contact and in which the sealing of the components can be achieved with a technical effort and justified economic, as well as being of comfortable use. [0004] In a coupling device of the type mentioned, this task will be solved according to the invention, by the fact that the conductive medium is shaped flexible and flat and in a longitudinal segment on the side of the wound, with less than 70% of its surface projected perpendicularly to the vehicle, this vehicle is joined inseparably and spatially for the intended use, and the conducting medium consists of an elastomeric material, flexible of a Shore-A - maximum hardness of 60 (determined according to DIN 53505 in Petition 870190106111, of 10/21/2019, p. 7/25 3/11 August 2000) and the projection of the bandage thickness of the driver and vehicle medium is a maximum of 7 mm, especially a maximum of 6 mm and additionally in a special way a maximum of 5 mm. [0005] The conductive medium, therefore, is not shaped in a tubular direction with an essentially round cross section, but it has a flattened shape whose projection in width is essentially greater than its projection in thickness. Together with the choice of material, this results in a flexible conductive medium that is more comfortable for the patient when contact pressure is applied to the coupling device or the conductive medium. Therefore, there is, to a lesser extent, a punctual subjection that can naturally generate pain and especially in recent wounds, sensitive to pain, is highly problematic. In addition, due to the flattened conformation, there is less danger of hooking or retention. Due to the fact that the conductive medium, in that longitudinal segment, with which it is attached to the vehicle, is spatially united with the flattened vehicle with less than 70% of its surface perpendicularly projected on the vehicle (the opening or openings being for this purpose) on the wall of the conductive medium must be added), when a pressure subjection is distributed over a large area of the wound bandage, which in relation to the problem explained above, has a very advantageous effect. Preferably the conductive means, in the longitudinal segment that serves for the fixation, is joined with the vehicle with at least 80%, especially with less than 90% and especially with less than 95% of its surface projected perpendicularly on the vehicle. [0006] The projection in the aforementioned width of the flattened conductive medium is at least 10 mm, especially less than 15 mm and, in addition, especially less than 18 mm and especially at most 30 mm and moreover, especially at most 25 mm . Petition 870190106111, of 10/21/2019, p. 8/25 4/11 [0007] The elastomeric material from which the conductive medium is formed, preferably has a Shore-A hardness of 50 - 60, especially 10 - 60, especially 15 - 50, especially 15 - 40 and, in addition, especially 15 - 35. As previously mentioned, Shore-A hardness in accordance with DIN 53505 of August 2000 is thus determined and at 23 ° C in a test body as described in said standard, flat and in shape plate thickness 6 mm. According to a preferred embodiment of the invention the conductive medium is formed on the basis of silicone. [0008] As the flattened and flexible conformable conductive medium serves to apply sub-pressure to the wound area and eventually to approach washing fluids, the washing gas and to remove wound segregations, that is, preferably has only one channel-forming communication function, it is proposed to conform the conductive medium not similar to a blade with several components or layers, however - despite its flat shape - in the shape of a hose, that is, considered in a cross section, in a circumferential direction of a single and continuous material. [0009] Furthermore, it has proved to be advantageous that the conductive medium has profiled means inside it, especially shaped in one piece with the material of the conductive medium, intended to prevent collapse, can be formed, for example, by ribs or protrusions. In an extension of this idea of the invention, it has been shown to be advantageous to extend it continuously. The conducting medium can then advantageously be formed as a stretched part. [0010] It can also be advantageous if the conductive medium involves several reciprocally separated channels that are watertight, the conductive medium also in this case preferably being formed in one piece, that is, it does not present a junction Petition 870190106111, of 10/21/2019, p. 9/25 5/11 from various separate channel forming media. The multiple channels can comprise a washing channel, which can lead a washing medium towards the end of the coupling device facing the wound and a conductive under-pressure channel that can cover an under-pressure feed, that is, for the removal of segregation of the wound. In this way, any clogging within the conductive medium can also be dissolved. In this case, each channel communicates with at least one opening in the conducting medium. [0011] Preferably, the flat conductive medium extends over a certain longitudinal distance and can then, through a passage element or coupler shown, which can constitute a fitting or adhesion connection, can converge on a more rigid conventional round hose torsion, which leads to an underpressure generating device that can be shaped like a stationary device or a mobile device that can be used on the patient's body. The passage element or coupler may also be shaped for the coupling of a multi-channel conductive medium such as a round multi-channel hose. It proved to be convenient a 10 to 60 cm stretch as a convenient longitudinal projection of the flat conductive medium. [0012] The spacecraft of the coupled device, with which the conductive medium flattened already at the factory is pressure-sealed, preferably also consisting of a flexible elastomeric material with a Shore-A hardness of 5 - 60, especially 10 - 60 , especially 15 - 50, especially 15 - 40 and more especially 15 - 35. The flattened support advantageously has a thickness of 0.75 - 3 mm, especially 1-3 mm. According to a preferred embodiment of the invention, it is shaped on the basis of silicone. According to another preferred embodiment, the driving medium and the vehicle are formed from the same elastomeric material. The vehicle serves to Petition 870190106111, of 10/21/2019, p. 10/25 6/11 hold the conductive medium flat in a longitudinal end segment that communicates with the wound space and provides uniform support. Its spatial projection is, therefore, greater than the spatial projection of the conductive medium in the longitudinal terminal segment of the respective wound. It proves to be advantageous that the spatial projection of the vehicle represents at least 1.5 times, preferably twice, of the face projected on the vehicle by the conductor, since in this way the forces induced through the conductor at the time of contact are diffused over a larger surface and also moments of flexion, exerted on the conducting medium are not transferred, or only to a lesser extent, for the underpressure bandage, therefore, they will be better accommodated by the plate-shaped vehicle. It seems sufficient that the surface ratio mentioned above is a maximum of 5, especially a maximum of 4, and a 2 - 3 ratio has proven to be advantageous. [0013] The flat conductive medium - considered in a cut could have, for example, a rectangular shape, and the two narrow sides could also and preferably be shaped in a round shape. According to another embodiment of the invention, the conductive medium, considered in section, is trapezoidal in shape. The narrow sides then extend as an exemplary inclination angle to the space vehicle plane from 25 ° to 60 °, especially 35 ° and 50 ° in an oblique direction, and the flanks of the unilateral or preferably bilateral trapezoidal shape may not necessarily be straight, but they can also perfectly project in a rounded shape. [0014] The leak-tight connection of the flattened conductive medium with the upper side removed in relation to the vehicle's injury acquires decisive importance in a functional sense. Here, basically, an adherent union is considered, by means of Petition 870190106111, of 10/21/2019, p. 11/25 7/11 use of an adherent in the widest sense. In addition, it is advantageous to join thermal joints that can correspond to a kind of vulcanized joint. For example, the conductive medium previously produced separately can be applied to the vehicle which has just been poured in a fresh state and which is only partially rigid, so that in this sense an intimate bonding with material closure of the two components is achieved without using an additional adherent. [0015] It proves to be advantageous that the openings that intercommunicate in the conducting environment and in the vehicle conceal each other, that is, that they are reciprocally aligned. This procedure proves to be simpler to be produced when these openings are made only after the watertight connection between the flattened conductive medium and the space vehicle is sealed, being simultaneously formed in the two components. This can, for example, be achieved by a material die-stamping process. [0016] Regarding the number and size of the openings in the conducting medium and in the space vehicle, it would be imaginable that only a single opening is foreseen. However, it proves to be advantageous that, in the region of the connection, the underpressure of the conductive medium and the vehicle is provided with several openings, especially at least two, especially at least four openings per centimeter in length of the conductive medium. [0017] It also proves to be advantageous that the free surface of the openings is 5 - 50% of the area of the flat sides reciprocally joined inseparably from the driver and the vehicle. [0018] The coupling device according to the invention therefore comprises, as main components, the flattened and flexibly formed conducting medium and the space vehicle which holds the conducting medium and at the same time supports it. In order to preferably connect the pressure-tight coupling device Petition 870190106111, of 10/21/2019, p. 12/25 8/11 the underpressure bandage, which closes the wound to be treated in a watertight manner against the atmosphere, requires another adherent agent. For example, it could be imagined that on the underside of the spacecraft facing in the direction of the underpressure bandage, a sealing element with adherent action is provided, for example, a coating of an adherent layer or an adherent sheet. According to another idea of the invention, it proves to be advantageous that the vehicle, using an additional adherent laminate, can be fixed on the underpressure bandage, with the additional adherent laminate being provided on the side of the spacecraft away from the injury and the vehicle , along its edge / periphery is exceeded, however the conductive medium will preferably be excluded by the cover-up, that is, it will not be covered up. Due to the fact that the conductive medium will not be covered, no folds will be formed in the adhering sheet that would be problematic from an optical and functional point of view in view of the sealing function. With the region of the adherent blade, which continually extends the periphery of the vehicle in a circumferential direction, the coupling device can then be secured, tightening the underpressure, on the outside of the underpressure bandage, away from the wound. [0019] This region of the adherent lamina that extends beyond the periphery, is preferably covered with a removable layer, which preserves the adherent lining before the use of the coupling device, also promoting support and protection. [0020] The support effect - in extension of the invention - can also be predicted by the fact that the vehicle or the adhering blade that peripherally exceeds the vehicle, is stabilized by an additional support means, forming a frame. This frame-forming support means will then be advantageously provided on the side of the vehicle away from the wound or from the adhering blade. Petition 870190106111, of 10/21/2019, p. 13/25 9/11 When provided for on the adhering sheet, then it will preferably be arranged outside the vehicle. It can be shaped to remain continuously in the coupling device or for the intended separation after application of the coupling device, in the underpressure bandage. [0021] All the characteristics described above will be considered as essential for the invention both considered separately and in random combinations reciprocally and with other characteristics. Further details and advantages of the invention will result from the appended claims and drawings and the following description of a preferred embodiment of the invention. [0022] The figures show: [0023] Figure 1 - perspective view of a coupling device according to the invention to be used in the treatment of under pressure wounds. [0024] Figure 2 - top view of the coupling device of figure 1. [0025] Figure 3 - bottom view of the coupling device of figure 1 (protective laminate removed). [0026] Figure 4 - schematic section view and not to scale of the coupling device of figure 1. [0027] Figure 5 a, b - cross-sectional views of other modalities of conductive means of the coupling device of the invention. [0028] Figures 1 to 4 show different views of a coupling device according to the invention, altogether designated with reference number 2, to be used in the treatment of wounds with under pressure. The coupling device 2 shown is applied, preferably in a separable manner, on one side - away from the wound - of an unseen underpressure bandage which involves a wound to be treated and which closes the underpressure in the direction of the atmosphere. The coupling device 2 comprises a conductive means 4 Petition 870190106111, of 10/21/2019, p. 14/25 10/11 flattened with a flexible elastomeric material and a spatially extending vehicle 6 that holds and supports the flattened conductive medium 4 so that the pressure or flexing forces exerted on the conductive medium 4 are uniformly induced in the vehicle 6 and through it can be welcomed. [0029] The conductive medium 4 is so shaped in a flattened direction that in a longitudinal end segment 8 with almost 100% of its surface it projects perpendicularly over the medium on the vehicle 6, it is joined with the vehicle 6. The conductive medium 4 , with its corresponding flattened side, can be glued or vulcanized, that is, thermally applied with its corresponding flattened side on the upper side 9 of the vehicle 6, away from the wound. [0030] Vehicle 6 flattened and in the form of a plate is covered in all its circumference by an adhering sheet 10 which, in the circumferential direction, continually extends a circumferential edge 12 of the vehicle 6 towards the outside. The adherent blade 10 has an adherent coating 14 by means of which the entire coupling device 2 can be applied on the external side - away from the wound - of a sub-pressure bandage not shown, in a way to seal the sub-pressure, preferably separable. The region of the adhering foil 10 that extends beyond the circumferential edge 12 of the vehicle 6 as the protruding region of the adhering foil 10, is covered from below by a protective laminate 16 that can be removed. On the opposite side of the adherent laminate 10 in an external radial situation, a frame-forming support means 18 is provided. The adherent laminate 10 has an internal cutout 20 in that region where the conductive medium 4 is joined with the vehicle 6, that is, in the region of the longitudinal end segment 8 of the conductive medium 4. As long as it is technically feasible, the adherent laminate 10 could also pass the entire vehicle 6, so that it extends between the driving environment 4 and the Petition 870190106111, of 10/21/2019, p. 15/25 11/11 vehicle 6, being included in the joint between conductive medium 4 and vehicle 6. [0031] Preferably, after the tight junction the underpressure of the conductive medium 4 with the vehicle 6, by the vehicle 6 and the conductive medium 4, the transfixing openings 22 communicating with openings not shown in the underpressure bandage will be formed when the coupling device 2 is applied over the underpressure bandage in order to apply underpressure to the wound area. [0032] In the figures the conductive medium 4 is shaped in a trapezoidal shape and along its longitudinal projection it involves two flanks 24 in slope obliquely in the direction of the vehicle, whose angle α in the direction of the plane of the projection of the conductive medium 4, that is, of vehicle 6, is about 40 - 50 °. In the conducting medium 4 according to figures 1 4, a single channel 26 is formed that can be subjected to under pressure. In the alternative embodiments according to figures 5a and 5b 2 are formed, that is, 3 channels 26, one or both of which are externally smaller channels that can serve as a washing line to bring a washing medium. Channels 26 communicate at their end in a manner not shown to each other. [0033] The projection of the thickness D of the bandage composed of the conductive medium 4 and the vehicle 6 is a maximum of 7 mm, preferably a maximum of 5 mm and even more preferably only a 3 - 4 mm. [0034] The flattened conductive medium 4 is formed of a flexible material, preferably based on silicone, and even more preferably one-piece, has on its inner side means 28 to prevent the collapse of the conductive medium 4. These means 28 are formed by continuous ribs 30 in the longitudinal direction which are produced in one piece as conductive means 4. In the mode of conductive means 4 according to figures 5a and 5b these means 28 are formed by the walls (Spten) between channels 26.
权利要求:
Claims (15) [1] 1. Coupling device (2) to be used in the treatment of wounds with underpressure, with a conductive medium (4) that can be subjected to underpressure, with a space vehicle (6) and watertight against underpressure, on whose upper side away from the conductive medium (4) is sealed to the wound, under pressure, in which the vehicle (6) can be applied in an under pressure bandage, preferably by using an additional adhesive sheet (10), which bandage exceeds the injury and that seals and closes against the atmosphere, with the conductive medium (4) communicating through openings (22) in the conductive medium (4) and in the support (16) and in the underpressure bandage, with the wound area, characterized due to the fact that the conductive medium (4) is shaped flexible and flat and the projection in the width of the conductive medium (4) is at least 10 mm and the conductive medium (4) in a longitudinal segment (8) on the side of the wound with at least 70% of its perpendicularly projected surface is on the vehicle (6), it is joined inseparably and spatially with said vehicle (6) for the intended purpose, and in which the vehicle (6) and the conducting medium (4) in the region of the flattened areas and reciprocally joined in inseparably, they have openings (22) that are covered and are, therefore, reciprocally aligned, with the conductive medium (4) being formed of a flexible elastomeric material with a maximum Shore-A hardness of 60 and the projection of the thickness D of the the union of the conductive medium (4) and the vehicle (6) is a maximum of 7mm, and in which the conductive medium (4) has means (28) profiled inside, specially formed integral with the material of the conductive medium, intended to avoid the collapse of the conductive medium (4) when subjected to under pressure. [2] Coupling device according to claim 1, characterized by the fact that the conductive medium (4) is joined inseparably and spatially in the longitudinal segment (8) on the wound side Petition 870190106111, of 10/21/2019, p. 17/25 2/4 with at least 80%, especially with at least 90% and still in a special way with at least 95% of its face projected perpendicularly on the vehicle (6), this union being with the vehicle (6) for use destined. [3] Coupling device according to claim 1 or 2, characterized by the fact that the projection in the width of the conducting medium (4) is especially at least 15 mm and moreover, especially at least 18 mm and especially at most 30 mm and moreover, especially at most 25 mm. [4] Coupling device according to any one of the preceding claims, characterized in that the material from which the conductive medium (4) is produced has a Shore-A hardness of 5-60, especially 10 - 60, especially 15 - 50, especially from 15 - 40 and especially from 15 - 35. [5] 5. Coupling device according to any one of the preceding claims, characterized by the fact that the conductive means (4) when viewed in a cut, in the circumferential direction, is shaped like a continuous hose. [6] Coupling device according to any one of the preceding claims, characterized in that the means (28) for preventing collapse are formed by ribs (30) or protrusions, which continuously extend in the longitudinal direction of the conductive means (4 ) and especially continuously. [7] Coupling device according to any one of the preceding claims, characterized in that the conductive medium (4) comprises several channels (26) which are reciprocally pressurized, the conductive medium (4) being specially formed in one-piece mode. [8] 8. Coupling device according to any one of the preceding claims, characterized by the fact that the vehicle (6) Petition 870190106111, of 10/21/2019, p. 18/25 3/4 space is made of a flexible elastomeric material with a Shore-A hardness of 5 - 60, especially 10 - 60, especially 15 - 50, especially 15 - 40 and also especially 15 - 35, with a thickness preferably of 0.75 - 3 mm, especially 1 - 3 mm. [9] Coupling device according to any one of the preceding claims, characterized in that the spatial projection of the vehicle (6) constitutes at least 1.5 times of the surface of the conducting medium (4) projected perpendicularly on the vehicle (6). [10] Coupling device according to any one of the preceding claims, characterized by the fact that the conductive means (4) considered in the cut - is trapezoidal in shape. [11] Coupling device according to any one of the preceding claims, characterized in that the conductive means (4) is glued or thermally applied against the upper side (9) of the vehicle (6) away from the injury. [12] 12. Coupling device according to any one of the preceding claims, characterized by the fact that in the area of the connection between the conducting medium (4) and the vehicle (6) at least two openings (22) are provided for each centimeter of compliance with the medium conductor (4). [13] Coupling device according to any one of the preceding claims, characterized in that the free opening face of the openings (22) is 5 - 50% the area of the flat sides of the conductive medium (4) and the support (6 ) that are joined separately. [14] Coupling device according to any one of the preceding claims, characterized by the fact that the space vehicle (6), using an additional adhesive sheet (10), can be attached to the underpressure bandage, in which the adhesive laminate ( 10) Petition 870190106111, of 10/21/2019, p. 19/25 An additional 4/4 is provided on the upper side (9) of the vehicle (6) away from the injury, and peripherally exceeds the vehicle (6), but it is preferably not covering the conducting medium (4). [15] Coupling device according to any one of the preceding claims, characterized in that the vehicle (6) or an adherent laminate (10) that exceeds the vehicle (6) especially peripherally, has a support means (18) provided peripherally and that forms a picture.
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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2019-12-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2020-02-11| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/12/2010, OBSERVADAS AS CONDICOES LEGAIS. |
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申请号 | 申请日 | 专利标题 DE102009060596A|DE102009060596A1|2009-12-23|2009-12-23|Connection device for use in the vacuum treatment of wounds| DE102009060596.7|2009-12-23| PCT/EP2010/007413|WO2011076340A1|2009-12-23|2010-12-07|Connecting device for use in negative pressure wound therapy| 相关专利
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