flexible connector

Abstract

A flexible connector (1) that can be connected to a device for treating a wound and removing bodily fluids from the wound using a negative pressure system, the connector (1) comprising a deformable tubular cover (2) having a first end (3) connectable to a bandage (4) to be applied to the wound and a second end (5) opposite the first end (3), the flexible connector (1) being configured to be coupled to a negative pressure source (24) such that when negative pressure is applied, fluid flows within the tubular cover (2) from the first end (3) to the second end (5), and a collapsible tubular cover (2) disposed within the tubular cover (2) 1. A flexible connector (1), comprising: an anti-collapse element (6) configured to prevent contact between the inner walls of the tubular cover (2) when a negative pressure is applied, and to allow the passage of fluid both with and without negative pressure, the anti-collapse element (6) comprising a junction part (32) having a first extreme end (40) inside the tubular cover (2) and a second extreme end (41) outside the tubular cover (2) connectable to a negative pressure source (24) by a connecting tube (15), the junction part (32) being fixed to the tubular cover (2) at a contact area (7) of the junction part (32), in particular at the first extreme end (41).

Description

[Technical Field]

[0001] The present invention relates to a flexible connector that can be connected to a device for treating wounds and removing fluids from wounds by use of a negative pressure system, for example for treating wounds resulting from metabolic diseases such as diabetes, or for treating surgical incisions. Furthermore, the present invention relates to a medical kit for treating wounds and removing fluids from wounds by use of a negative pressure system. [Background technology]

[0002] The inflammatory process that occurs during wound healing is characterized by excessive blood flow to the damaged tissue. White and red blood cells represent the so-called exudate, while platelets tend to aggregate and form new tissue with fibroblasts. When the wound is exposed to microorganisms or other external pathogens, wound infection occurs, worsening the patient's condition and inevitably prolonging the healing period. Therefore, removing these pathogens from the damaged tissue accelerates and improves the wound healing process.

[0003] The use of negative pressure devices to treat various types of wounds, in combination with the use of electric vacuum generators, has become significantly more popular over the past 30 years. Negative pressure wound therapy has been shown to be highly effective in treating acute, chronic, and exudative wounds, including ulcers (pressure, diabetic, and venous), surgical incisions, and traumatic amputations.

[0004] The application of reduced or negative pressure creates suction, which removes excess exudate from the wound, reducing the risk of maceration and infection, and stimulates the flow of fresh, oxygenated blood to the wound, promoting the formation of granulation tissue.

[0005] Negative pressure can be generated by various types of devices (with or without the use of an electric pump) connected via a system of more or less rigid tubing to a bandage that is applied directly to the wound to be treated. The tubing system may have a flexible connector (called a soft port) at the end that is applied directly to the plaster.

[0006] Negative pressure kits typically use generic plastic tubing and generic hard fittings. This type of connection is very uncomfortable for the patient and creates pressure points and tension zones on the bandage. These pressure points and tension zones are uncomfortable for the patient. These issues have created a need to create softer, more comfortable fluid connections. The softer and more flexible the connection, the more comfortable it is for the patient to wear. More advanced kits use soft connectors to reduce pressure zones and stress on the bandage.

[0007] Connectors connecting conventional tubing to bandages in negative pressure therapy typically consist of three layers: a first plastic layer, a second plastic layer, and a third or spacer layer, typically made of a textile material (three-dimensional or tubular fabric), located between the two plastic layers. The two plastic layers are usually joined along their entire periphery, forming a sort of pocket-like structure into which the spacer layer is inserted. Naturally, such structures have excellent flexibility along their longitudinal axis, but are strictly limited in the plane defined by the various layers. Therefore, known flexible connectors are very wide and flexible in one direction. It should be noted that these types of connectors are primarily designed to absorb and pass gaseous fluids and are completely unsuitable for the passage of fluids, including liquid substances. In fact, in conventional systems, the flexible connector essentially serves as an air suction device, since exudates are generally absorbed by the bandage, i.e., by at least one absorbent layer of the bandage. A hydrophobic filter may be placed between the flexible connector and the bandage to prevent liquid materials from passing beyond the flexible connector toward the negative pressure-generating device. Using a flexible connector that cannot drain fluids will concentrate all liquid material in the absorbent layers within the bandage and / or the connector itself, causing these layers to expand and reduce the effectiveness of suction over time during treatment. Additionally, deformation of the bandage itself can compromise good adhesion of the bandage to the wound.

[0008] The object of the present invention is to provide a flexible connector for a negative pressure device that partially or wholly overcomes the above-mentioned drawbacks of known systems and is effective, safe, economical, and at the same time easy to use. It is a further object of the present invention to provide a flexible connector capable of passing fluids, including liquid substances, as well as a medical kit including said connector and a bandage. Summary of the Invention

[0009] This specification discloses a flexible connector according to the independent claims, as well as a medical kit comprising said connector. Embodiments of the connector and the kit are disclosed in the corresponding dependent claims.

[0010] In one aspect of the present invention, the flexible connector can be connected to a device for treating wounds and removing bodily fluids from the wound using a negative pressure system. The device can be, for example, a conventional mechanical device with a piston that slides within a housing to generate negative pressure. However, the device can alternatively be an electric vacuum generator. For example, the device can generate a pressure of approximately -160 mmBar.

[0011] The connector includes a deformable tubular cover having a first end connectable to a bandage to be applied to the wound and a second end opposite the first end, the connector is configured to be coupled to a negative pressure source such that fluid flows within the tubular cover from the first end to the second end when negative pressure is applied, and an anti-collapse element disposed within the tubular cover prevents contact between the inner walls of the tubular cover when negative pressure is applied, allowing fluid to pass therethrough regardless of whether negative pressure is applied.

[0012] Furthermore, the anti-collapse element comprises a joint part having a first end inside the tubular cover and a second end outside the tubular cover that is connectable to a negative pressure source, in particular by a connecting tube, and the joint part is fixed to the tubular cover in a contact area of ​​the joint part, in particular at the first end.

[0013] The anti-collapse element is located between the inside and outside of the tubular cover and has an interface portion connected to a negative pressure source located outside the tubular cover. Because the interface portion is fixed to the tubular cover only at the contact area, the anti-collapse element has greater freedom of movement, allowing the connector to be easily deformed in any direction, i.e., along the longitudinal axis and along the transverse plane. Furthermore, the presence of the anti-collapse element configured in this manner prevents throttling points when negative pressure is applied or when the tubular cover is crushed or folded. Furthermore, such a flexible connector is configured to allow the flow of any type of fluid, including both gas and liquid. Therefore, this flexible connector can be advantageously connected to a negative pressure device capable of aspirating liquid.

[0014] It should be noted that the flexible connector essentially consists of only two elements: a tubular cover and an anti-collapse element. In fact, the anti-collapse element is configured to be directly connected to a negative pressure source by a joint that is an integral part of the anti-collapse element. In other words, the anti-collapse element extends from the inside to the outside of the tubular cover. As a result, the flexible connector disclosed herein has a limited number of components (only two components), reducing manufacturing costs and simplifying the structure of the connector itself.

[0015] In a second aspect of the present invention, a medical kit is used for treating a wound and removing body fluids from the wound by using a negative pressure system, the medical kit comprising a flexible connector according to the aforementioned aspect and a bandage that can be applied to the wound and is connected to the flexible connector at a first end of a deformable tubular cover of the flexible connector, in particular, the flexible connector is connected to the bandage by a connecting cover that enhances adhesion between the flexible connector and the bandage and protects the bandage when the flexible connector is pulled.

[0016] The kit is both practical and functional. Indeed, by applying the bandage to the wound to be treated and connecting the flexible connector to a negative pressure source, it is possible to effectively remove excess exudate from the wound. The kit is specially designed to absorb liquid substances as well, so that the bandage does not deform due to the absorption of exudate and maintains optimal adhesion to the wound. Furthermore, the special design of the flexible connector ensures a smooth flow of exudate throughout the entire treatment period.

[0017] The use of this connector and kit reduces the risk of infection and complications, thereby promoting wound healing.

[0018] These and other aspects of the invention will become more apparent from a reading of the following description of some preferred embodiments disclosed below. [Brief explanation of the drawings]

[0019] [Figure 1] 1 shows a schematic diagram of a bandage and a flexible connector connected to a negative pressure source according to one example. [Figure 2A] 1 is a schematic perspective view of a flexible connector according to an embodiment, showing details of a first end and a second end. [Figure 2B] 1 is a schematic perspective view of a flexible connector according to an embodiment, showing details of a first end and a second end. [Figure 2C]1 is a schematic perspective view of a flexible connector according to an embodiment, showing details of a first end and a second end. [Figure 3A] 1A and 1B show a schematic perspective view and a detailed view of a first end of a flexible connector according to an example, viewed from below. [Figure 3B] 1A and 1B show a schematic perspective view and a detailed view of a first end of a flexible connector according to an example, viewed from below. [Figure 4] 1 shows a schematic perspective view of a flexible connector and bandage according to an embodiment. [Figure 5A] 1 shows a schematic diagram of a medical kit from an example top view and an example bottom view. [Figure 5B] 1 shows a schematic diagram of a medical kit from an example top view and an example bottom view. [Figure 6] The kit in Figure 5 is shown in an exploded view. [Figure 7] A cross-sectional view of the kit of FIG. 5 is shown according to an example. [Figure 8A] 1 shows a schematic diagram of an anti-collapse element according to an embodiment. [Figure 8B] 1 shows a schematic diagram of an anti-collapse element according to an embodiment. [Figure 9A] 10 shows a schematic diagram of a flexible connector and anti-collapse element according to another example. [Figure 9B] 10 shows a schematic diagram of a flexible connector and anti-collapse element according to another example. [Figure 10A] 1 shows a schematic diagram of an anti-collapse element according to an embodiment. [Figure 10B] 1 shows a schematic diagram of an anti-collapse element according to an embodiment. [Figure 10C] 1 shows a schematic diagram of an anti-collapse element according to an embodiment. [Figure 11A] 1 shows a schematic diagram of details of an anti-collapse element according to an embodiment. [Figure 11B] 1 shows a schematic diagram of details of an anti-collapse element according to an embodiment. [Figure 12A] 10A and 10B show schematic diagrams of further exemplary details of the anti-collapse element; [Figure 12B] 10A and 10B show schematic diagrams of further exemplary details of the anti-collapse element; [Figure 13A] 10 shows a schematic diagram of a flexible connector and anti-collapse element according to a further example. [Figure 13B] 10 shows a schematic diagram of a flexible connector and anti-collapse element according to a further example. [Figure 14] 1 shows a schematic diagram of a kit according to an example. DETAILED DESCRIPTION OF THE INVENTION

[0020] 1 shows a schematic diagram of a flexible connector 1 that can be connected on one side to a negative pressure source 24 and on the other side to a bandage 4 that is applied to a patient's wound. The flexible connector 1 comprises a deformable tubular cover 2 having a first end 3 connectable to the bandage 4 and a second end 5 opposite the first end 3. The flexible connector 1 is configured to be connected to a negative pressure source 24, such as a device capable of generating negative pressure. This allows fluid to flow inside the tubular cover 2 from the first end 3 to the second end 5, as shown by the arrows in the figure.

[0021] To prevent contact between the inner walls of the tubular cover 2 when negative pressure is applied and to allow the passage of fluid regardless of whether negative pressure is present or not, the flexible connector 1 includes an anti-collapse element 6 arranged inside the tubular cover 2. The anti-collapse element 6 includes a connecting portion 32 for connection to the negative pressure source 24. The connecting portion 32 includes a first extreme end 40 located inside the tubular cover 2 and a second extreme end 41 located outside the tubular cover 2 and connected to the negative pressure source 24. The connecting portion 32 is fixed to the tubular cover 2 at a contact region 7 of the connecting portion (32).

[0022] It should be noted that the coupling between the second end 5 of the tubular cover 2 and the negative pressure source 24 can be performed indirectly, for example via the interface 32 of the anti-collapse element 6 .

[0023] The contact area 7 may be located anywhere along the extension of the interface portion 32. For example, as shown, the contact area 7 is located near or on the first extreme end 40.

[0024] In one example, the anti-collapse element 6 is fixed to the tubular cover 2 only at the second end 5 of the tubular cover 2 by the interface 32. This means that the anti-collapse element 6 may contact any area of ​​the tubular cover 2, but is not actually fixed to the tubular cover 2 at any point. The only contact point between the anti-collapse element 6 and the tubular cover 2 occurs at the interface 32 in the contact area 7. This contact point represents a fixed point between the anti-collapse element 6 and the tubular cover 2, for example, by welding. The presence of the anti-collapse element inside the tubular cover 2 configured in this manner improves the flexibility of the connector 1, since its movement (twisting, folding, rotation, etc.) is not restricted. Alternatively, the anti-collapse element 6 can additionally be fixed to the tubular cover 2 at the first end 3.

[0025] Advantageously, the connector 1 consists of only a deformable tubular cover 2 and a collapse prevention element 6. Compared to flexible connectors described in the literature, the number of components used is reduced to two, making the connector 1 of the present disclosure simpler and less expensive to manufacture. Furthermore, the limited number of components reduces the risk of damage and improves reliability compared to conventional connectors that have large weld areas (approximately 40-50 cm) along the perimeter of the connection. In conventional connectors, improperly performed welds can compromise the connector's effective pneumatic seal. The connector 1 described herein limits the number of welds to only the initial and final welds (approximately 2 cm each).

[0026] According to one example, the tubular cover 2 is made in one piece and has a circular cross section when no negative pressure is applied. In other words, unlike flexible connectors known in the literature, the tubular cover 2 in its rest state is circular rather than flat. In particular, the tubular cover is manufactured by extrusion. The tubular cover 2 is extruded in one piece in this shape, essentially for ease of manufacturing and assembly. Naturally, when negative pressure is applied, the tubular cover 2 deforms and assumes a crushed (i.e., oval) cross section. However, the presence of the anti-collapse element 6 prevents contact between the inner walls of the tubular cover 2. It should be noted that by using linear extrusion, the tubular cover 2 can be made of a highly flexible material, such as plastic.

[0027] Because the tubular cover 2 is made in one piece and only connects to the anti-collapse element 6 at its ends (e.g., only at the second end 5, or only at the first end 3 and the second end 5), assembly is easier and performance is improved. Indeed, the absence of welding / bonding along the lateral edges of the tubular cover 2 increases the effective cross-section for fluid passage, improving the flexibility of the connector 1. In other words, the entire cross-section of the tubular cover 2 is available for fluid passage, which also makes it possible to reduce the thickness and overall width of the flexible connector 1, particularly components for fluid connections. Due to its high flexibility, when mechanical stress, such as compression due to negative pressure, occurs, the cover 2 tends to flatten locally in different directions at different points, especially when external pressure is applied. This is certainly more convenient and advantageous than flexible connectors that are initially flat but instead have significant flexibility limitations in some directions.

[0028] In one example, the anti-collapse element 6 is made of a non-absorbent material. For example, the anti-collapse element 6 can be made of a plastic polymer material. This allows fluids, including liquid substances, to flow unimpeded through the tubular cover 2 because they are absorbed by the anti-collapse element 6. Additionally or alternatively, there is no absorbent material inside the tubular cover 2. This means that fluids inside the tubular cover 2, even if they contain liquid substances, can flow freely from one end to the other without being impeded by the absorbent element.

[0029] FIG. 2a shows an example of a flexible connector 1. From this figure, it can be seen that the tubular cover 2 of the connector 1 is one-piece and has a substantially circular cross section with flattened ends. A first end 3 of the tubular cover 2 is shown as a free end in the figure, but should be understood as the end that is connected to the adhesive bandage 4. Instead, a second end 5 is connected to a connecting tube 15 that can be used to connect to a negative pressure source 24. In particular, the connecting tube 15 is connected by a connector 36 to the connecting portion 32 of the anti-collapse element 6, in particular to the second extreme end 41 of said portion 32.

[0030] In one example, the anti-collapse element 6 comprises a flat, semi-rigid structure 8, in particular made of a polymer material. The purpose is to prevent the wall of the tubular covering 2 from collapsing and thus blocking fluid transmission. The fastening of the tubular covering 2 to the second end 5 is shown in FIG. 2b. At this end 5, the tubular covering 2 comprises a closure 25, where the tubular covering 2 and a connecting portion 32 are fastened, for example, by welding. Specifically, the fastening between the tubular covering 2 (e.g., made of polyurethane) and the connecting portion 32 is performed by high-frequency welding, electric welding, or adhesive bonding at the contact area 7 (the dashed area in FIG. 2b). FIG. 2b also shows that the connecting portion 32 forms a single element together with the flat, semi-rigid structure 8. In fact, at the first extreme 40, the approximately tubular connecting portion 32 widens and flattens into the flat, semi-rigid structure 8 of the anti-collapse element 6. The connecting portion 32 therefore represents the end of the anti-collapse element 6 that protrudes outside the tubular covering 2 and ensures contact / fastening with said tubular covering 2 at the contact area 7. Furthermore, the interface 32 ensures connection with the connecting tube 15 and thus the passage of fluid. FIG. 2c shows details of the tubular cover 2 and the anti-collapse element 6 at the first end 3. In particular, the tubular cover 2 is provided with a closure 26, for example, made by welding. The end of the anti-collapse element 6, or rather the flat semi-rigid structure 8, can be inserted inside the closure 26. This prevents the tubular cover 2 from being deformed during movement of the anti-collapse element 6 in the event of mechanical stress being applied along the longitudinal axis. Note that in this case, the end of the anti-collapse element is simply inserted inside the fold formed by the closure 26, holding the anti-collapse element in place, but no fixation is made between the tubular cover 2 and the anti-collapse element 6 at the first end 3. Alternatively, the end of the anti-collapse element 6 can be fixed to the tubular cover 2 at the closure 26, for example, by welding. In one example, the first end 3 of the tubular cover 2 is closed, in particular by gluing, heat sealing, high-frequency welding, and / or electric welding.

[0031] FIG. 3a shows a bottom view of the tubular cover 2. It is also clear from this view that the tubular cover 2 is made in one piece, or that it is not formed by two or more overlapping layers joined (welded), for example, along their longitudinal edges. It should be noted that the first end 3 of the tubular cover 2 is provided with a hole 16 for the passage of fluid through the connector 1. This is shown in detail in FIG. 3b. Accordingly, the hole 16 is positioned on the underside of the tubular cover 2 so that the tubular cover 2 can be easily attached to the bandage 4. FIGS. 3a and 3b show a rectangular hole 16. However, it is clear that the shape and dimensions of the hole 16 can be varied depending on the structural requirements. To attach the tubular cover directly to the bandage 4 or to a material sandwiched between the bandage 4, an adhesive layer 27 is provided in the hole 16. To enhance adhesion, the figure shows the adhesive layer 27 arranged around the hole 16 and along an adjacent strip. Of course, adhesive layer 27 may be distributed according to different configurations (e.g., distributed only at a few points along the periphery of hole 16 and / or distributed over a wide or narrow surface near hole 16). Furthermore, adhesive layer 27 may be replaced by suitable alternative fastening means.

[0032] FIG. 4 shows the tubular cover 2 of the flexible connector 1 and a bandage 4 that can be coupled to the connector 1. In particular, the bandage 4 has an inlet 38 on a portion of its upper surface. The connection between the connector 1, i.e., the tubular cover 2, and the bandage 4 is made by coupling the first end 3 of the tubular cover 2 to the inlet 38 of the bandage 4. Specifically, this is made by coupling the hole 16 to the inlet 38. An adhesive layer 27 serves to secure the connection between the tubular cover 2 and the bandage 4.

[0033] 5-7 illustrate a medical kit 17. The kit 17 represents a ready-to-use set of components, including at least one flexible connector 1 (as shown with reference to FIG. 4) and a bandage 4 that can be applied to a wound and is connected to the flexible connector 1 at a first end 3 of a deformable tubular cover 2. Note that these figures illustrate the use of a connector 1 with a collapse prevention element 6 as disclosed in FIG. 2a. However, the kit 17 is not limited to this single configuration of the collapse prevention element 6, i.e., a configuration including a flat, semi-rigid structure 8. In fact, as will be discussed below, flexible connectors 1 with different collapse prevention elements 6 can also be used in the medical kit 17. From FIG. 5a, it can be seen that the flexible connector 1 is connected to the bandage 4 at its end. Specifically, the first end 3 of the tubular cover 2 is fixed to the upper region of the bandage 4, for example, by an adhesive layer 27, as shown in FIG. 4. The other end of the connector 1 can be connected to a connecting tube 15 for connection to a negative pressure source 24.

[0034] In particular, as already shown in Figure 2a, the interface portion 32 may be fixed to the connecting tube 15 by a connector 36. The bandage 4 is easily removable and may comprise a support layer (carrier) 31 which helps to keep the bandage 4 in a flat shape during storage. As shown in Figure 5b, the carrier 31 advantageously comprises a support tab 39 which helps to facilitate assembly of the bandage 4 with the connector 1. The support tab 39 is foldable and can be crushed under the bandage 4 if necessary.

[0035] Figure 6 shows an exploded view of the medical kit 17 of Figure 5. It should be noted that the configuration of the tubular cover 2, i.e., making it as a single piece of circular cross-section, allows the flat semi-rigid structure 8 representing the anti-collapse element 6 to be easily inserted into the tubular cover 2. To increase the adhesion between the flexible connector 1 and the bandage 4 and to protect the bandage 4 if the flexible connector 1 is pulled, the flexible connector 1 can optionally be connected to the bandage 4 by a connecting cover 29. This cover 29 or "connecting patch" can be in the shape of a square or rectangle, for example with sides of 3 cm, and is applied directly to the top surface of the bandage 4.

[0036] According to one example, the bandage 4 comprises a first layer 18 made of a polymeric material, particularly polyurethane; a second layer 19 made of a silicone adhesive material (e.g., Advanced Silicone Coating's "Acrysil 150 perforated") that contacts the first layer 18 and adheres the bandage 4 to the patient's epidermis (e.g., Advanced Silicone Coating's "Acrysil 150 perforated"), which has a three-layer structure and locally perforated structure for excellent sealing; and a third layer 20 disposed between the first layer 18 and the second layer 19 to facilitate the passage of fluids. The second layer 19 may be a perforated layer.

[0037] In other words, the bandage 4 is essentially a sandwich of three elements: a polyurethane layer (first layer) 18, a perforated silicone adhesive layer (second layer) 19, and a three-dimensional spacer element (third layer 20). These layers are bonded together by lamination (e.g., cold lamination) with an acrylic adhesive 30. The acrylic adhesive 30 is typically present on the underside of the first layer 18, as illustrated in FIG. 14. However, adhesive 30 can also be present on the top surface of the second layer 19. The perforated silicone adhesive layer 19 provides a delicate yet durable adhesion to the skin, helping to allow repositioning of the bandage 4 upon initial misapplication; the adhesive initially prevents the polyurethane layer 18 from curling or sticking to itself (due to electrostatic forces, gravity, or mechanical deformation).

[0038] 7 shows a cross-sectional view of the kit 17, in particular a cross-sectional view of the tubular cover 2 of the connector 1 coupled to the bandage 4 at the inlet 38 of the bandage 4. The layered structure and reduced overall thickness of the bandage can be seen from FIG.

[0039] The advantages of using a spacer element (ie, third layer 20) inside the bandage 4 include at least the following: The acrylic adhesive 30 and the top surface in contact with the first polyurethane layer 18 are configured for optimal adhesion. The underside is designed to reduce surface tension so that it adheres less to the wound, thereby reducing the risk of damage during dressing changes. - Made of a material that does not absorb liquids, for example a silicone material, which improves the drainage of liquids from the wound to the suction device. - It is also very flexible, and generally the flexibility of the adhesive bandage 4 increases, improving its ability to adapt to the non-flatness of the human body. - the adhesive bandage 4 is formed of a single element with continuous properties over its entire surface (adhesives in which this element is formed of several layers of different materials would be less effective in this task due to the different properties of the aforementioned layers), so that a uniform pressure over the entire area of ​​the adhesive bandage 4 is determined (optimal pressure);

[0040] In one example, the flat semi-rigid structure 8 is a fishbone structure with a central longitudinal element 34 and two sets of teeth 35 extending perpendicularly from two opposite sides of the central longitudinal element 34. This configuration is shown in Figures 8a and 8b, which show how the anti-collapse element 6 comprises an interface portion 32 integrated with the fishbone-like flat semi-rigid structure 8.

[0041] The use of a fishbone structure reduces the amount of material (time and cost) used in production compared to other types of structures. A fishbone structure with only a central channel facilitates insertion into the tubular cover 2 (made of polyurethane) because the fishbone's "spine" or teeth 35 fold when the element is inserted. Furthermore, this central longitudinal element 34 with only a central core is the element that ensures maximum flexibility of the connector 1. Finally, the fishbone structure maximizes the peeling of the wall of the tubular cover 2, thereby facilitating the passage of fluids (air and / or liquids) from the bandage to the suction device.

[0042] As already mentioned above, the connecting portion 32 is made in the body of the anti-collapse element 6, in particular the flat semi-rigid structure 8, in particular by injection molding.

[0043] In one example, the connecting portion 32 is provided with a through hole 33 that extends along the entire tubular portion 32. Details of the through hole 33 are shown in Figure 8b. As a result, when negative pressure is applied, in the passage from the first end 3 to the second end 5 within the tubular cover 2, the fluid first flows around the anti-collapse element 6 and then flows through the hole 33 into the anti-collapse element 6 of the connecting portion 32.

[0044] An extreme end (first extreme end 40) of the tubular portion 32 can be secured to the tubular cover 2 at the second end 5 of the tubular cover 2, in particular by electrical welding, chemical welding, high frequency welding and / or gluing.

[0045] FIG. 9a shows a flexible connector 1 including an anti-collapse element 6 that extends inside the tubular cover 2 and has a flat semi-rigid structure 8 that is different from the flat semi-rigid structure 8 of FIG. 8a.

[0046] As already disclosed, the closure of the second end 25 allows for the fixation between the connecting portion 32 and the tubular cover 2, for example by welding. The closure of the first end 26 can be performed by welding the tubular cover 2, so that where the welding of the tubular cover 2 begins, the end of the anti-collapse element 6 (flat semi-rigid structure 8) ends.

[0047] As in the configuration described above, the tubular portion 32 is manufactured integrally with the anti-collapse element 6, in particular the flat semi-rigid structure 8, or as a single component, in particular by injection molding. This significantly simplifies assembly and eliminates the need to fasten the anti-collapse element 6 within the tubular cover 2, improving overall performance. The extreme end (first extreme end 40) of the connecting portion 32 can be fastened to the tubular cover 2 at the second end 5 (which closes at the second end 25), and the connecting portion 32 is fastened to the (integrally made) anti-collapse element 6, so that the anti-collapse element 6 is indirectly connected to the tubular cover 2 only at the second end 5 by the connecting portion 32. Alternatively, the anti-collapse element 6 can additionally be fastened to the tubular cover 2 at the first end 3 as well.

[0048] An example flat semi-rigid structure 8 is shown in detail in Figures 9b, 10a-c and 11a-b.

[0049] It should be noted that the flat semi-rigid structure 8 of Figure 9b does not include an integrated interface 32 as in the embodiment of Figure 10a. The structure of Figure 9b is merely an alternative embodiment, and interface 32 may be connected (e.g., removably secured) to one of the two ends of the flat semi-rigid structure 8 for connection with the negative pressure source 24, as described above.

[0050] Although alternatives exist, the preferred solution for the flexible connector 1 is to have the anti-collapse element 6 with a flat semi-rigid structure 8 and an interface 32 integrated into a single component.

[0051] In one example, the flat semi-rigid structure 8 is a double comb structure including a first comb element 9 having a first longitudinal element 11 from which a plurality of first teeth 12 extend, and a second comb element 10 having a second longitudinal element 13 from which a plurality of second teeth 14 extend, the first comb element 9 being connected to the second comb element 10 at the ends of the first longitudinal element 11 and the second longitudinal element 13, and the first comb element 9 being coupled to the second comb element 10 such that at least a portion of the teeth of the plurality of first teeth 12 are positioned in the space between two consecutive teeth of the plurality of second teeth 14.

[0052] The double comb structure offers advantages for industrial production, as it can be most easily and quickly formed by polymer injection molding, and has a smooth exterior without any "protrusions", making it easier to insert into the tube 2.

[0053] 9b and 10a show in particular how a flat semi-rigid structure 8 is formed by two comb-like elements 9, 10, with the teeth of one comb-like element inserted between the spaces between the teeth of the other comb-like element. FIG. 9b in particular shows a structure in which the two comb-like elements 9, 10 are symmetrically connected to each other at both ends by two contact cross members 22. FIG. 10a instead shows a configuration in which one of the two ends is integrated with a connecting portion 32 having a through hole 33. Therefore, there is only one contact cross member 22. FIGS. 10b and 10c respectively show details of the structure of the two ends of FIG. 10a.

[0054] For example, the flat semi-rigid structure 8 can be formed by double combs joined to form a ladder-like element, with pegs alternately connecting to one or the other vertical section. This allows for a fluid connection despite the possibility of partial collapse of the tubular cover 2. The use of a particularly elastic and easily deformable polymer provides excellent comfort and excellent deformability. This structure does not require a guide for insertion outside the tubular polyurethane cover 2, as is the case with systems known in the literature, thus facilitating assembly. The flat semi-rigid structure 8 can be manufactured by polymer injection molding, resulting in a component that is very low-cost, easy to reproduce, and quickly reproducible. The connection between the tubular polyurethane cover 2, the anti-collapse element 6 with the flat semi-rigid structure 8, and the connecting portion 32 can be achieved by the same methods as described above, i.e., by electric welding, high frequency, or adhesive bonding. The connecting tube 15 can be directly fixed (glued) to the connecting portion 32 by a suitable connector 36.

[0055] Figure 10b shows in particular the presence of a through hole 33 along the entire length of the joint portion 32, connecting the connecting tube 15 (when connected to the flexible connector 1 as shown in Figure 9a) to the flat semi-rigid structure 8 of the anti-collapse element 6 (e.g. together with the double comb).

[0056] According to one example, as expected, the first comb element 9 is connected to the second comb element 10 by at least one contact cross element 22, said contact cross element 22 being provided with at least one recess 23 for facilitating the passage of fluid. Figure 10c shows the presence of six recesses 23 arranged in an offset manner on either side of the contact cross element 22. The number of recesses 23 may vary depending on the construction needs.

[0057] Thus, fluids, including liquid substances, can effectively flow through the recesses 23 , along the teeth of the flat semi-rigid structure 8 , through the through holes 33 and out into the connecting tube 15 .

[0058] It should be noted from the drawing that the first teeth 12 and the second teeth 14 have a tapered shape, i.e., a gradually narrowing shape, e.g., a triangular cross section. This promotes fluid flow. Furthermore, both the first teeth 12 and the second teeth 14 connect the first longitudinal element 11 to the second longitudinal element 13. This connection can be made such that the tips of the teeth of the first teeth 12 are an integral part of the second longitudinal element 13 or simply contact the second longitudinal element 13. Similarly, the tips of the teeth of the second teeth 14 can be connected such that they are an integral part of the first longitudinal element 11 or simply contact the first longitudinal element 11.

[0059] Alternatively, the length of each of the first teeth 12 and / or second teeth 14 may be shorter than the distance between the first longitudinal element 11 and the second longitudinal element 13, so that the tips of the first teeth 12 are not in contact with the first longitudinal element 11 and / or the tips of the second teeth 14 are not in contact with the second longitudinal element 13. This may, for example, improve the flexibility of the anti-collapse element 6.

[0060] In one example, the first plurality of tines 12 are positioned in a plane that is offset from the plane in which the second plurality of tines 14 are positioned. This is shown in Figures 11a and 11b, which show details of the flat semi-rigid structure 8 from above and below. Note that the first plurality of tines 12 are positioned in a lower plane relative to the second plurality of tines 14. This offset improves fluid flow during treatment because the offset plane improves spacing of the inner walls of the flexible tube 2.

[0061] 12a and 12b show different configurations of the double-comb flat semi-rigid structure 8. FIG.

[0062] In one example, the length of the plurality of first teeth 12 is different from the length of the plurality of second teeth 14. This increases the flexibility of the anti-collapse element 6, improving the passage of fluid during treatment. In fact, this configuration strengthens the separation of the inner wall of the tube 2. Furthermore, it allows materials in the fluid (solid particles such as cell clumps or clotted blood) to pass through easily.

[0063] It should be noted that the various configurations of the flat semi-rigid structure 8 shown in Figures 8-12 may be interchangeable or combinable with one another. One or more embodiments combining some or all of the configurations are contemplated. For example, the flat semi-rigid structure 8 may include at least one double comb portion and one fishbone portion, and the double comb portion may include multiple teeth having the same or different lengths, as described above.

[0064] 13a and 13b show further configurations of the anti-collapse element 6. According to one example, the anti-collapse element 6 is deformable and comprises a tubular structure 37, in particular a circularly knitted textile element. This tubular structure 37 can be a "textile tube," a 3D spacer, or a simple circularly knitted textile element. In particular, similar to the configurations of FIGS. 3a and 3b, the first end 3 of the tubular cover 2 comprises a hole 16 for the passage of fluid inside the connector 1. To attach the tubular cover directly to the bandage 4 or to a material sandwiched between the bandage 4, an adhesive layer 27 is provided in the hole 16. To enhance adhesion, the figures show the adhesive layer 27 arranged in a series of dots distributed around the hole 16.

[0065] FIG. 14 schematically illustrates a medical kit 17. The medical kit 17 basically includes a flexible connector 1 and a bandage 4 coupled to the connector 1. FIG. 12 schematically illustrates a collapse prevention element 6 having a mesh structure connected to a connecting tube 15 at the second end 5 of the tubular cover 2. However, as noted above, the flexible connector 1 may include only some or all of the features disclosed above. For example, the flexible connector 1 may include a collapse prevention element 6 having a tubular structure 37 or a flat semi-rigid structure 8 (or both). Furthermore, the flat semi-rigid structure 8 may have a double comb shape or a fishbone shape (or both).

[0066] The bandage 4 includes a first layer 18 made of a polymeric material, particularly polyurethane, a second layer 19 made of a silicone adhesive material that contacts the first layer 18 and adheres the bandage 4 to the patient's epidermis, and a third layer 20 disposed between the first layer 18 and the second layer 19 to facilitate the passage of fluids. The second layer 19 includes a central opening 21 to ensure that a portion of the third layer 20 comes into contact with the patient's wound. The first layer 18 may be adhered to the third layer 20 by an acrylic adhesive.

[0067] The first layer 18 provides a barrier against various types of bacteria and viruses. It is also water-resistant. The thickness of the first layer 18 (excluding the 20 g / m² acrylic adhesive 30) is 20 μm to 30 μm. The breathability of this layer is MVTR 800 / 600.

[0068] The third layer 20 is made of a non-absorbent material to allow fluid to pass through when negative pressure is applied. In particular, this layer 20 has very low, almost zero, absorption and is approximately 3 mm thick.

[0069] Finally, the bandage may include a support layer (carrier) 31 which is easily removable and which serves to keep the bandage in a flat shape during storage and to prevent the third layer 20 from becoming exposed prior to use.

[0070] The kit 17 may include a connecting tube 15 and a check valve 28 at the end of the connecting tube 15 .

[0071] Those skilled in the art may make some further modifications and variations to the connector 1 and kit 17 disclosed above to meet further incidental needs, and all of these modifications and variations fall within the scope of protection of the present invention as defined by the appended claims. [Explanation of symbols]

[0072] 1 flexible connector 2 Tubular cover, flexible tube 3 First end 4 Bandages 5 Second end 6. Collapse prevention elements 7 Contact area 8 Semi-rigid structure 9 First comb-shaped member, comb-shaped part 10 second comb-like member, comb-like part, comb-like element 11 first longitudinal member, longitudinal element 12 First tooth 13 Second longitudinal member, longitudinal element 14 Second tooth 15 Connecting tube 16 holes 17 Medical Kit 18 First layer, polyurethane layer 19 Second layer, perforated silicone adhesive layer 20 Third Layer 21 Central opening 22 Contact cross member 23 Recess 24 Negative pressure source 25 Closure, second end 26 Closing part 26 First end 27 Adhesive layer 28 Check valve 29 Connection cover 30 Adhesive 31 Supporters (Careers) 32 Tubular parts, joint parts 33 Through hole 34 longitudinal elements, central longitudinal element 35 teeth 36 Connectors 37 Tubular structure 38 Entrance 39 Support tab 40 The First Extreme 41 The Second Extreme

Claims

1. A flexible connector (1) that can be connected to a device for treating wounds and removing body fluids from wounds using a negative pressure system, comprising: a deformable tubular cover (2) having a first end (3) connectable to a bandage (4) to be applied to the wound and a second end (5) opposite the first end (3), the flexible connector (1) being coupled to a negative pressure source (24) such that when negative pressure is applied, fluid flows within the tubular cover (2) from the first end (3) to the second end (5); a collapse prevention element (6) disposed inside the tubular cover (2) and preventing contact between the inner walls of the tubular cover (2) when a negative pressure is applied, the collapse prevention element (6) allowing the passage of a fluid regardless of whether a negative pressure is applied; In a flexible connector (1) comprising: The collapse prevention element (6) comprises a connecting part (32) having a first extreme end (40) inside the tubular cover (2) and a second extreme end (41) outside the tubular cover (2) connectable to the negative pressure source (24), in particular by means of a connecting tube (15), the connecting part (32) being fixed to the tubular cover (2) at a contact area (7) of the connecting part (32), in particular at the first extreme end (40).

2. a. the anti-collapse element (6) is fixed to the tubular cover (2) only at the second end (5) of the tubular cover (2) by the connecting portion (32); and / or The connector (1) according to claim 1, wherein the connector (1) is composed only of the deformable tubular cover (2) and the anti-collapse element (6).

3. 3. The connector (1) according to claim 1 or 2, wherein the tubular cover (2) is made in one piece with a circular cross section when no negative pressure is applied, in particular the tubular cover (2) is made by extrusion molding.

4. a. said anti-collapse element (6) is made of a non-absorbent material and / or b) A connector (1) according to any one of claims 1 to 3, wherein there is no absorbent material inside the tubular cover (2).

5. Connector (1) according to any one of claims 1 to 3, wherein the anti-collapse element (6) is deformable and comprises a flat semi-rigid structure (8), in particular made of a polymer material.

6. 6. The connector (1) according to claim 5, wherein the flat semi-rigid structure (8) is a fishbone structure comprising a central longitudinal element (34) and two sets of teeth (35) extending perpendicularly from two opposite sides of the central longitudinal element (34).

7. 6. The connector (1) according to claim 5, wherein the flat semi-rigid structure (8) is a double comb structure comprising a first comb element (9) having a first longitudinal element (11) from which a plurality of first teeth (12) extend, and a second comb element (10) having a second longitudinal element (13) from which a plurality of second teeth (14) extend, the first comb element (9) being connected to the second comb element (10) at ends of the first longitudinal element (11) and the second longitudinal element (13), and the first comb element (9) being coupled to the second comb element (10) such that at least some of the teeth of the plurality of first teeth (12) are arranged in the spaces between two consecutive teeth of the plurality of second teeth (14).

8. 8. The connector (1) according to claim 7, wherein the first comb-like element (9) is connected to the second comb-like element (10) by at least one contact cross member (22), the contact cross member (22) having at least one recess (23) for facilitating the passage of fluid.

9. a. the first plurality of teeth (12) lie on a plane offset from the plane in which the second plurality of teeth (14) lie, and / or 9. The connector (1) of claim 7 or 8, wherein the length of the first teeth (12) is different from the length of the second teeth (14).

10. a. said connecting portion (32) is made integrally with said anti-collapse element (6), in particular with said flat semi-rigid structure (8), in particular by injection moulding, and / or The connector (1) according to any one of claims 1 to 9, wherein the connecting portion (32) is fixable to the tubular cover (2) by electric welding, chemical welding, high frequency welding, and / or adhesive.

11. The connector (1) according to any one of claims 1 to 10, wherein the joint portion (32) of the anti-collapse element (6) is provided with a through hole (33) extending along the entire joint portion (32), and when a negative pressure is applied, in a passage from the first end (3) to the second end (5) inside the tubular cover (2), the fluid first flows around the anti-collapse element (6), and then flows through the through hole (33) and within the anti-collapse element (6) at the joint portion (32).

12. A connector (1) according to any one of claims 1 to 11, wherein the first end (3) of the tubular cover (2) is closed, in particular by gluing, heat welding and / or electric welding, and is provided with a hole (16) for the passage of a fluid within the connector (1).

13. A medical kit (17) for treating a wound and removing body fluids from the wound using a negative pressure system, comprising: A flexible connector (1) according to any one of claims 1 to 12; a bandage (4) that can be applied to a wound, the bandage (4) being connected to the flexible connector (1) at a first end (3) of the deformable tubular cover (2) of the flexible connector (1); A medical kit (17) comprising: In particular, the medical kit (17) has a flexible connector (1) connected to the bandage (4) by a connection cover (29) that enhances the adhesive strength between the flexible connector (1) and the bandage (4) and protects the bandage (4) when the flexible connector (1) is pulled.

14. 14. The kit (17) according to claim 13, wherein the bandage (4) comprises a first layer (18) made of a polymeric material, in particular polyurethane, a second layer (19) made of a silicone adhesive material in contact with the first layer (18) for adhering the bandage (4) to the patient's epidermis, and a third layer (20) arranged between the first layer (18) and the second layer (19) to facilitate the passage of fluids, the second layer (19) having a central opening (21) that allows a portion of the third layer (20) to come into contact with the patient's wound.

15. 15. A kit (17) according to claim 13 or 14, wherein the third layer (20) is made of a non-absorbent material so that fluids can pass through when negative pressure is applied.

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