Connection unit for vacuum-tight fluidic connection of a vacuum wound dressing to a vacuum source, vacuum wound treatment kit and vacuum wound treatment system
Patent Information
- Application Number
- EP2023821549
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-19
- Filing Date
- 2023-12-06
- Publication Date
- 2025-10-29
AI Technical Summary
Existing negative pressure wound therapy kits often prematurely clog due to wound exudate surges entering the connecting tube, leading to premature replacement of wound dressings before their absorption capacity is fully utilized.
A connecting device with a fluid guiding structure that deflects fluid flow multiple times within the suction lumen, preventing surges from reaching the proximal end and thus eliminating the need for a filter unit, which could clog, and allowing continuous use of the wound dressing until its absorption capacity is reached.
The fluid guiding structure effectively breaks surge-like fluid flows, preventing premature clogging and allowing the wound dressing to be used efficiently until its absorption capacity is fully utilized, reducing the need for premature replacements and potential contamination of the negative pressure source.
Smart Images
Figure 1.1
Abstract
Description
[0001] Title: Connection device for the vacuum-tight fluidic connection of a negative pressure wound dressing with a negative pressure source, negative pressure wound therapy kit and negative pressure wound therapy system
[0002] Description
[0003] The present invention relates to a connecting device for the vacuum-tight fluidic connection of a negative pressure wound dressing with a negative pressure source. Furthermore, the present invention relates to a negative pressure wound therapy kit with such a connecting device. Furthermore, the present invention relates to
[0004] Invention a negative pressure wound therapy system comprising a negative pressure source and such a negative pressure wound therapy kit.
[0005] Negative pressure wound therapy (NPWT) is an innovative wound treatment method for a wide range of indications. These include, for example, acute skin or soft tissue defects, impaired wound healing, chronic wounds, etc. The aim of negative pressure therapy is to stimulate the growth of granulation tissue and promote the healing process. During negative pressure therapy, negative pressure is created in the wound area, which allows wound exudate to be effectively drained from the wound. The drained wound exudate is absorbed by a negative pressure wound dressing applied to the wound.
[0006] Negative pressure wound dressings used in negative pressure therapy typically comprise an air-impermeable cover layer for airtight closure of the wound. A connection opening for the vacuum-tight fluidic connection of the wound space to a vacuum source is formed in the cover layer. When the negative pressure wound dressing is applied to a wound as intended and the vacuum source is fluidly connected to the connection opening in a vacuum-tight manner, a negative pressure can be created in the wound space by the vacuum source. Typically, a connecting device with an elongated single- or multi-lumen connecting tube is used for the vacuum-tight fluidic connection of the negative pressure wound dressing to the vacuum source.
[0007] A negative-pressure wound therapy kit with a generic connecting device is known, for example, from the published patent application WO 2016 184 916 A1. A filter unit is arranged at the distal end portion of the connecting tube of the connecting device. The filter unit is associated with the fluid inlet of the distal end portion and prevents wound exudate from entering the suction lumen of the connecting tube.
[0008] The published patent application WO 2011 135 287 A1 describes a negative-pressure wound therapy kit with another generic connection device. A filter unit is assigned to the connection opening of the associated negative-pressure wound dressing, which prevents wound exudate from escaping from the negative-pressure wound dressing.
[0009] In principle, wound exudate should be prevented from entering the negative pressure source during negative pressure therapy. This could contaminate and / or damage the negative pressure source. In the negative pressure wound therapy kits described in the documents mentioned above, this is ensured by filter units. However, it can happen that the filter units become wetted with wound exudate and consequently blocked before the absorption capacity of the negative pressure wound dressing is reached. This is particularly the case when wound exudate is transported in a gush towards the connecting device. The negative pressure wound dressing may then have to be replaced prematurely.
[0010] The invention is based on the object of providing a connecting device which, when used as intended in negative pressure therapy, enables the absorption capacity of the negative pressure wound dressing used to be used as efficiently as possible.
[0011] This object is achieved according to the invention by a connecting device according to claim 1, by a negative pressure wound therapy kit according to claim 19 and by a negative pressure wound therapy system according to claim 20.
[0012] The subclaims and the description indicate advantageous variants and embodiments.
[0013] According to the invention, a connecting device for the vacuum-tight fluidic connection of a negative pressure wound dressing to a vacuum source is provided. The connecting device comprises an elongated single-lumen or multi-lumen connecting tube. The connecting tube comprises a distal end section with a fluid inlet and a proximal end section with a fluid outlet. The fluid inlet can be fluidly connected to the negative pressure wound dressing in a vacuum-tight manner. The fluid outlet can be fluidly connected to the vacuum source in a vacuum-tight manner. A suction lumen of the connecting tube extends from the fluid inlet to the fluid outlet. When the connecting device is used as intended in negative pressure therapy, a vacuum is communicated from the negative pressure source through the suction lumen into the wound space.
[0014] A "vacuum-tight fluidic connection" is understood here to mean that, taking into account the vacuum source used, the negative pressure required for negative pressure wound therapy can be maintained in the fluidically connected cavities. Typically, during negative pressure therapy, a pressure difference is set between the air pressure within the negative pressure wound dressing and the ambient air pressure, which is at least 20 mm Hg (millimeters of mercury) and at most 250 mm Hg. 1 mm Hg corresponds to one Torr or 133.322 Pa (Pascal).
[0015] The terms "distal" and "proximal" describe the arrangement relative to the vacuum source. A proximal portion of an element is located closer to the vacuum source than a distal portion of the same element. For example, when used as intended, the proximal end portion of the connecting tube is located closer to the vacuum source than the distal end portion.
[0016] It is now planned that the suction lumen will
[0017] Fluid guide structure which is designed to repeatedly deflect a fluid flow flowing through the suction lumen before reaching the fluid outlet, that the fluid guide structure for deflecting the fluid flow comprises at least one fluid guide element extending in the suction lumen, and that the fluid guide element is formed by partially materially connecting a first wall section of a hose wall of the connecting hose to a second wall section of the hose wall opposite the first wall section.
[0018] The fluid guidance structure according to the invention effectively prevents wound exudate entering the connecting tube in a surge from reaching the proximal end section. If wound exudate enters the suction lumen in a surge, the fluid flow formed by the wound exudate is deflected several times by the fluid guidance structure. The repeated deflections result in the surge-like fluid flow being broken. Only when the absorption capacity of the negative pressure wound dressing for wound exudate has actually been reached and, as a result, the connecting tube continuously fills with wound exudate does the wound exudate reach the proximal end section. Because wound exudate entering the suction lumen in a surge does not reach the proximal end section and thus the negative pressure source, a filter unit on the distal end section of the connecting tube and on the cover layer of the negative pressure wound dressing can be dispensed with.If a filter unit arranged in this way is dispensed with, premature clogging of the filter unit also does not occur. The fluid guide structure comprises at least one fluid guide element extending in the suction lumen for deflecting the fluid flow. The fluid guide structure preferably comprises a plurality of fluid guide elements extending in the suction lumen. The fluid guide element or at least one of the fluid guide elements preferably has a straight course. However, the fluid guide element or at least one of the fluid guide elements can also have a curved course.
[0019] By partially materially connecting the first wall section to the second wall section, one or more fluid guide elements can be created with little construction effort. The materially bonded connection between the first wall section and the second wall section is preferably designed as a welded connection or as an adhesive connection. Preferably, at least one of the wall sections for forming the fluid guide element comprises an indentation which projects in the direction of the other wall section. Because the first wall section is only partially materially connected to the second wall section, the fluid guide element also extends only in a limited area of the suction lumen.
[0020] According to a preferred embodiment, the
[0021] Connecting device free of a filter unit. According to an alternative embodiment, an air-permeable and liquid-impermeable filter unit is preferably arranged in the region of the proximal end section. Because the filter unit is arranged in the proximal end section, premature clogging of the filter unit is effectively avoided by the fluid conducting structure according to the invention. Particularly preferably, the filter unit is arranged on a connecting element with an inlet and an outlet, wherein an inlet section of the connecting element comprising the inlet projects through the fluid outlet of the proximal end section into the suction lumen, and wherein the outlet of the connecting element is arranged outside the suction lumen and can be fluidically connected to a vacuum source in a vacuum-tight manner. The fluid outlet of the proximal end section can then be fluidically connected to the vacuum source in a vacuum-tight manner by means of the connecting element.
[0022] The connecting tube can be single-lumen or multi-lumen. In a single-lumen connecting tube, there is only a single tube lumen, namely the suction lumen. In a multi-lumen connecting tube, the tube lumen is divided into several partial lumens, each extending from the distal end section to the proximal end section. The partial lumens are preferably connected parallel to one another to the fluid inlet of the distal end section, with each of the partial lumens being assigned its own passage in the region of the proximal end section. In such a multi-lumen connecting tube, a first of the partial lumens serves as the suction lumen when the connecting device is used as intended. The passage assigned to this partial lumen forms the fluid outlet of the proximal end section. A second of the partial lumens can be used, for example, as a rinsing lumen and / or as a measuring lumen.
[0023] According to a preferred embodiment, the material-fit connection between the first wall section and the second wall section is designed in a seam-like manner. A seam-like material-fit connection can be formed with little effort. For example, the first wall section and the second wall section are welded to one another to form the fluid-conducting element, so that the seam-like material-fit connection is a weld seam. A seam-like connection also has the advantage over a point-like connection, for example, that an elongated fluid-conducting element can be obtained. This enables particularly precise deflection of the fluid flow.
[0024] According to a preferred embodiment, the fluid guide structure comprises at least two fluid guide elements. By increasing the number of fluid guide elements, a particularly precise multiple deflection of the fluid flow in the suction lumen can be achieved. The fluid guide structure preferably comprises at least three fluid guide elements, preferably at least four fluid guide elements. However, by increasing the number of fluid guide elements, the effort required to manufacture the connecting device is increased. In addition, the free volume of the suction lumen is reduced. Accordingly, limiting the number of fluid guide elements is also advantageous. The fluid guide structure particularly preferably comprises at least two and at most twenty fluid guide elements.
[0025] According to a preferred embodiment, the fluid conducting structure is designed to block any straight connection between an imaginary first plane arranged in the distal end section and oriented orthogonally to the longitudinal extent of the connecting tube and an imaginary second plane arranged in the proximal end section and oriented orthogonally to the longitudinal extent of the connecting tube. It is assumed that the above feature is realized when any straight connection between the two planes is blocked when the connecting tube is extended straight. By blocking any straight connection, the gush-like transfer of wound exudate from the distal end section into the proximal end section is particularly effectively avoided.
[0026] According to a preferred embodiment, the fluid guide structure is designed to deflect the fluid flow at least once, preferably multiple times, by an angle of at least 90°. By deflecting by such a large angle, a surge-like fluid flow is effectively broken, so that the surge-like fluid flow does not reach the proximal end section as such. The fluid guide structure is preferably designed to deflect the fluid flow at least once, preferably multiple times, by an angle of at least 120°, particularly preferably at least 150°.
[0027] Preferably, the flow direction of the fluid stream in a first section of the suction lumen is opposite to the flow direction of the fluid stream in a second section of the suction lumen. The fluid stream is thus deflected at least once by an angle of 180°. This particularly effectively breaks a surge-like fluid stream. Furthermore, sections with opposite flow directions lengthen the flow path in the suction lumen. This allows for a particularly precise assessment of whether the negative pressure wound therapy kit should be replaced or not.
[0028] According to a preferred embodiment, the fluid guidance structure defines a meandering or labyrinth-shaped fluid passage in the suction lumen. With such a fluid passage, the flow cross-section is significantly reduced compared to the flow cross-section of the same connecting tube without the fluid guidance structure. The reduction in the flow cross-section is accompanied by an increase in flow resistance and a reduction in the flow velocity. The reduction in the flow velocity has the advantage that wound exudate flowing through the suction lumen can be analyzed more easily. In particular, a sensor unit for analyzing the wound exudate is arranged in the suction lumen. However, the wound exudate can also be analyzed from outside the connecting tube, in particular optically.
[0029] According to a preferred embodiment, the fluid guide element or at least one of the fluid guide elements extends at least partially transversely to the longitudinal extent of the connecting hose. A section of a fluid guide element or a fluid guide element extended in this way can effectively deflect a fluid stream flowing in the longitudinal extent of the connecting hose. Preferably, a plurality of fluid guide elements extending transversely to the longitudinal extent of the connecting hose are provided, which are offset from one another and arranged one behind the other in the longitudinal extent of the connecting hose. By means of such an arrangement of fluid guide elements, a meandering or labyrinth-shaped fluid passage can be defined in the suction lumen.
[0030] According to a preferred embodiment, the fluid guide element or at least one of the fluid guide elements extends at least partially in the longitudinal extent of the connecting tube. A section of a fluid guide element or a fluid guide element extended in this way divides the suction lumen into several sections arranged next to one another and extending in the longitudinal extent of the connecting tube. With such a subdivision of the suction lumen, it can advantageously be achieved that the flow direction in one section is opposite to the flow direction in the other section.
[0031] According to a preferred embodiment, the fluid-guiding element or at least one of the fluid-guiding elements is formed by directly bonding the first wall section to the second wall section. Such a design of a fluid-guiding element is easy to realize in terms of manufacturing technology. Preferably, the first wall section and the second wall section are directly bonded to one another by welding. However, the first wall section and the second wall section can also be directly bonded to one another by gluing.
[0032] According to a preferred embodiment, the fluid conducting element or at least one of the fluid conducting elements is formed by indirect material-fit connection of the first wall section to the second wall section. A suitable fluid conducting element or suitable fluid conducting elements can also be realized by indirect material-fit connection. For example, only one further element is arranged between the first wall section and the second wall section. An indirect material-fit connection between the first wall section and the second wall section exists when the first wall section and the second wall section are each directly material-fit connected to the further element. However, several further elements can also be arranged between the first wall section and the second wall section.An indirect material-fit connection between the first wall section and the second wall section exists when the first wall section is directly material-fitted to the immediately adjacent further element, the second wall section is directly material-fitted to the immediately adjacent further element and the further elements are materially connected to one another. In the case of an indirect material-fit connection between the two wall sections, it is preferably provided that the direct material-fit connection between the first wall section and the immediately adjacent element and the direct material-fit connection between the second wall section and the immediately adjacent element at least partially overlap in a plan view of the first wall section or the second wall section.In the case of an elongated fluid-guiding element, the connections preferably extend parallel to one another. The connections are particularly preferably congruent in the plan view of the first wall section or the second wall section. This applies regardless of which of the elements listed below forms or form the material-fit connection in addition to the wall sections. According to a preferred embodiment, at least one support layer is arranged in the suction lumen, which supports the connecting hose against collapse, in particular due to negative pressure, and that the first wall section and the second wall section are each materially connected to the support layer or one of the support layers to form the fluid-guiding element or at least one of the fluid-guiding elements.The support layer ensures, when the connecting device is used as intended, that the connecting hose can withstand the negative pressure created. By incorporating the support layer into the material-fit connection between the first wall section and the second wall section, the requirements for the contour of the support layer are low. Specifically, for example, no recesses need to be provided in the support layer through which the first wall section could come into direct contact with the second wall section to form the fluid-guiding element or at least one of the fluid-guiding elements. If only one support layer is present, the first wall section and the second wall section are each directly material-fitted to the support layer.If several support layers are stacked one above the other, the wall sections are directly bonded to the immediately adjacent support layer, and the support layers are bonded to one another. According to a preferred embodiment, the support layer is made of polyvinyl chloride, polyurethane, silicone, or a mixture thereof. These materials have the advantage that the connection of the wall sections to the support layer can be realized with little manufacturing effort, particularly by means of ultrasonic welding.
[0033] According to a preferred embodiment, the support layer is formed by a flat material web section which, for supporting the connecting hose, is structured by elevations formed integrally with a plane of the flat material web section, wherein a continuous intermediate space is formed between the elevations which is permeable to fluid in the longitudinal extent of the hose lumen. A flat material web section designed as above is available at low cost. This results in particular from the fact that the formation of the elevations can be advantageously integrated into the production of the flat material web section. A flat material web section is a section of a flat material web. For example, the flat material web section is cut out of a flat material web. Preferably, the elevations are already formed in the flat material web.However, the elevations can also be formed in the flat material web section. In particular, the flat material web is a plastic film web, so that the flat material web section is formed as a plastic film. The presence of at least one supporting layer is preferred. However, the presence of the supporting layer can also be omitted. A certain support of the suction lumen can be achieved by the fluid conducting structure itself. This support may be sufficiently pronounced so that additional support, for example by a supporting layer, is not necessary.
[0034] According to a preferred embodiment, an insert part with at least one rib-shaped section is arranged in the suction lumen, and the first wall section and the second wall section are each materially connected to the rib-shaped section to form the fluid-guiding element or one of the fluid-guiding elements. An advantageous fluid-guiding element can also be realized by connecting the wall sections to the rib-shaped section of the insert part. The rib-shaped section has the particular advantage that the connecting hose can be stiffened, which is accompanied by support of the connecting hose against collapse. In addition, the first wall section and the second wall section are kept spaced apart from one another by the rib-shaped section.The result of this is that the cross-sectional area of the suction lumen is reduced to a lesser extent compared to a direct attachment of the first wall section to the second wall section. According to a preferred embodiment, the insert part comprises a plurality of interconnected and spaced-apart rib-shaped sections, and the first wall section and the second wall section are each materially connected to the rib-shaped sections to form a plurality of fluid guide elements. The formation of a plurality of fluid guide elements has the advantage that particularly precise guidance of the fluid flow can be achieved. Because the rib-shaped sections belong to a common insert part, the rib-shaped sections can be easily handled together.This facilitates the manufacture of the connecting device, for example because the positioning of the rib-shaped sections relative to one another is clearly specified.
[0035] According to a preferred embodiment, the hose wall comprises a first layer and a second layer which are connected to one another in their edge regions, the first wall section being formed by the first layer and the second wall section being formed by the second layer. The formation of the hose wall from the two layers facilitates the assembly of the connecting device. The first layer and the second layer are preferably designed as film layers. Accordingly, the connecting hose is a film hose. The layers are preferably welded or glued to one another in their edge regions.
[0036] According to a preferred embodiment, the hose wall is made of polyvinyl chloride, polyurethane, polyethylene, silicone, or a mixture thereof. These materials have the advantage that the first wall section of the hose wall can be easily bonded to the second wall section, particularly by ultrasonic welding.
[0037] The tube wall is preferably transparent or translucent. A transparent or translucent tube wall allows for visual inspection of the suction lumen. For example, it can be checked whether wound exudate has already entered the suction lumen or how far the wound exudate has already penetrated into the suction lumen. Based on this, a decision can then be made as to whether the negative pressure wound therapy kit needs to be replaced or not.
[0038] The object to be achieved is also achieved by a negative pressure wound therapy kit which comprises a negative pressure wound dressing and a connecting device with the features described above, wherein the fluid inlet of the connecting device can be fluidically connected to the negative pressure wound dressing in a vacuum-tight manner.
[0039] With regard to the advantages achievable with the negative pressure wound therapy kit, reference is made to the relevant comments on the connecting device. The features described in connection with the connecting device can be used to further refine the negative pressure wound therapy kit. The object to be achieved is also achieved by a negative pressure wound therapy system which comprises a negative pressure wound therapy kit with the features described above. The negative pressure wound therapy system according to the invention also comprises a negative pressure source, wherein the fluid outlet of the connecting device can be fluidly connected to the negative pressure source in a vacuum-tight manner.
[0040] Regarding the advantages achievable with the negative pressure wound therapy system, reference is made to the relevant information on the connecting device. The features described in connection with the connecting device can be used to further refine the negative pressure wound therapy system.
[0041] The invention is described in more detail below with reference to the figures, wherein identical or functionally identical elements are provided with reference numerals only once, if appropriate. The figures serve as examples and are not to be understood as limiting. They show
[0042] Fig. 1 a negative pressure wound therapy system with a connecting device,
[0043] Fig. 2 shows a cross section through a connecting hose of the connecting device shown in Figure 1,
[0044] Fig. 3 shows a cross section through a further embodiment of the connecting hose, Fig. 4 shows a cross section through a further embodiment of the connecting hose,
[0045] Fig. 5 is a plan view of a flat material web section arranged as a support layer in a suction lumen of the connecting hose shown in Figure 4,
[0046] Fig. 6 is a sectional view of the flat material web section shown in Figure 5 along the section line BB and
[0047] Fig. 7 shows a negative pressure wound therapy system with a connecting device according to a further embodiment.
[0048] Figure 1 shows a negative pressure wound therapy system 10 for use in the negative pressure therapy of wounds. The negative pressure wound therapy system 10 comprises a negative pressure source 12 and a negative pressure wound therapy kit 14. The negative pressure wound therapy kit 14 comprises a negative pressure wound dressing 16, which is referred to below as wound dressing 16. The wound dressing 16 comprises an air-impermeable cover layer 18 for airtightly closing a wound. The negative pressure wound therapy kit 14 also comprises a connecting device 20. The connecting device 20 comprises an elongated connecting tube 22. The connecting tube 22 comprises a distal end section 24 with a fluid inlet 26 and a proximal end section 28 with a fluid outlet 30. A suction lumen 32 of the connecting tube 22 extends from the fluid inlet 26 to the fluid outlet 30. In the present case, the connecting tube 22 is designed as a single lumen.
[0049] The fluid inlet 26 can be fluidically connected in a vacuum-tight manner to a connection opening 34 formed in the cover layer 18. In the negative pressure wound therapy system 10 shown in Figure 1, the fluid inlet 26 is already connected to the connection opening 34, so that the connection opening 34 is covered by the distal end section 24. The distal end section 24 is arranged on the wound dressing 16 such that the connection opening 34 and the fluid inlet 26 of the distal end section 24 are at least partially aligned with one another.
[0050] In the illustrated embodiment, the distal end portion 24 is broadened over a larger area than an elongated central portion 36 of the connecting tube 22. In the present case, the distal end portion 24 is widened in the shape of a circular disk. The widening of the distal end portion 24 facilitates the connection of the distal end portion 24 to the wound dressing 16.
[0051] The fluid outlet 30 of the proximal end section 28 can be fluidically connected to the vacuum source 12 in a vacuum-tight manner. In the exemplary embodiment shown, a connecting element 38 which comprises an inlet 40 and an outlet (not shown) is arranged in the fluid outlet 30. An inlet section 42 of the connecting element 38 comprising the inlet 40 projects through the fluid outlet 30 of the proximal end section 28 into the suction lumen 32. The outlet of the connecting element 38 is arranged outside the suction lumen 32 and can be fluidically connected to the vacuum source 12 in a vacuum-tight manner. The fluid outlet 30 of the proximal end section 28 can therefore be fluidically connected to the vacuum source 12 in a vacuum-tight manner by the connecting element 38.
[0052] In the illustrated embodiment, a filter unit 44, which is here designed as a PTFE membrane filter, is arranged at the inlet section 42 of the connecting element 38. The filter unit 44 is assigned to the inlet 40 and is designed to be permeable to air and impermeable to liquids. According to a further embodiment, the connecting element 38 is free of a filter unit.
[0053] When the negative pressure wound therapy system 10 is used as intended, the wound dressing 16 is applied to a wound. The negative pressure source 12 is fluidly connected to the wound dressing 16 in a vacuum-tight manner by the connecting device 20. A negative pressure can then be created in the wound space by the negative pressure source 12. The negative pressure causes wound exudate to be drained from the wound and absorbed by the wound dressing 16, for example, by an absorption layer of the wound dressing 16. Because the optionally present filter unit 44 is designed to be permeable to air, the negative pressure can be communicated through the filter unit 44 into the wound space.
[0054] The suction lumen 32 comprises a fluid guide structure 46 designed to redirect a fluid flow flowing through the suction lumen 32, for example a wound exudate flow, several times before reaching the fluid outlet 30. The design of the fluid guide structure 46 is explained in more detail below with additional reference to Figure 2. Figure 2 shows a cross-section through the connecting tube 22 along the sectional plane AA shown in Figure 1.
[0055] The fluid guide structure 46 comprises at least one fluid guide element 48 extending into the suction lumen 32. In the embodiment illustrated in Figures 1 and 2, a first fluid guide element 48-1 and a second fluid guide element 48-2 are present.
[0056] The fluid guide elements 48 are formed by the region-by-region material-to-material connection of a first wall section 50 of a hose wall 52 of the connecting hose 22 to a second wall section 54 of the hose wall 52 opposite the first wall section 50. This can be seen in Figure 2. The second wall section 54 comprises, in the region of the first fluid guide element 48-1, an indentation 56 which projects in the direction of the first wall section 50.
[0057] In the case of the system shown in Figures 1 and 2
[0058] In the exemplary embodiment, the first wall section 50 and the second wall section 54 are directly connected to one another in a materially integral manner. Accordingly, in the region of the materially integral connection, no further element is arranged between the first wall section 50 and the second wall section 54. With regard to the materially integral connection of the first wall section 50 to the second wall section 54, various types of connection are possible. In the present case, in order to form the fluid guide elements 48, the first wall section 50 and the second wall section 54 are materially integrally connected to one another in the region of the fluid guide elements 48 by welding, in particular by ultrasonic welding. The materially integral connections each comprise a weld seam whose course corresponds to the course of the relevant fluid guide element 48.
[0059] According to a further embodiment, the first wall section 50 and the second wall section 54 are materially connected to one another, for example by an adhesive connection.
[0060] The suction lumen 32 is laterally delimited by a first side wall 58 extending in the longitudinal direction of the connecting tube 22 and by a second side wall 60 extending in the longitudinal direction of the connecting tube 22. The side walls 58 and 60 are spaced apart from one another and lie opposite one another.
[0061] The first fluid guide element 48-1 has a curved shape in the present case. For this purpose, the first fluid guide element 48-1 comprises a first section 62 and a second section 64. The first section 62 is arranged adjacent to the proximal end section 28 of the connecting tube 22. The first section 62 extends from the first side wall 58 approximately transversely to the longitudinal extent of the connecting tube 22. The first section 62 ends at a distance from the second side wall 60. The second section 64 adjoins the first section 62 and extends in the longitudinal extent of the connecting tube 22 in the direction of the distal end section 24.
[0062] The second fluid guide element 48-2 also has a curved profile in the present case. For this purpose, the second fluid guide element 48-2 comprises a first section 66 and a second section 68. The first section 66 extends from the second side wall 60 at an angle to the longitudinal extent of the connecting tube 22 and ends at a distance from the first side wall 58. The second section 68 adjoins the first section 66 and extends in the longitudinal extent of the connecting tube 22 in the direction of the proximal end section 28.
[0063] The second section 68 of the second fluid guide element 48-2 is arranged between the first side wall 58 and the second section 64 of the first fluid guide element 48-1. The second section 64 of the first fluid guide element 48-1 ends at a distance from the first section 66 of the second fluid guide element 48-1. The second section 68 of the second fluid guide element 48-2 ends at a distance from the first section 62 of the first fluid guide element 48-1. In view of the course of the fluid guide elements 48-1 and 48-2 described above, the fluid guide elements 48 define a fluid passage 70 with a meandering course in the suction lumen 32. The fluid passage 70 comprises three longitudinal sections which extend in the longitudinal extent of the connecting tube 22 and are arranged next to one another. The longitudinal sections are connected by two curved sections.
[0064] When the connecting device 20 is used as intended in negative pressure therapy, drained wound exudate passes through the fluid inlet 26 into the suction lumen 32. The wound exudate flows as a fluid stream in the suction lumen 32 initially through a first longitudinal section of the fluid passage 70 in the direction of the proximal end section 28. The wound exudate is then redirected by the first section 62 of the first fluid guide element 48-1 and passes into an adjoining second longitudinal section of the fluid passage 70. In the second longitudinal section, the flow direction of the wound exudate is opposite to the flow direction in the first longitudinal section. Accordingly, the wound exudate flows in the second line section again in the direction of the distal end section 24.Upon reaching the first section 66 of the second fluid conducting element 48-2, the fluid flow is redirected again by the first section 66 and then passes through a third of the longitudinal sections to the proximal end section 28 and the fluid outlet 30. The multiple redirection of the fluid flow in the suction lumen 32 prevents the fluid flow from reaching the proximal end section 28 or the fluid outlet 30 in a surge. Instead, a surge of fluid entering is broken up by the fluid conducting structure 46, so that the wound exudate only reaches the proximal end section 28 when the absorption capacity of the wound dressing 16 has been exceeded and the suction lumen 32 consequently continuously fills with wound exudate.
[0065] If the fluid flow were to reach the proximal end section 28 in a surge, the filter element 44 could become prematurely clogged with wound exudate. The wound dressing 16 would then have to be changed before the absorption capacity of the wound dressing 16 is reached. As previously mentioned, the filter element 44 is optional. If the filter element 44 is not present, the fluid flow reaching the proximal end section 28 in a surge could enter the downstream vacuum source 12. The vacuum source 12 could thereby be contaminated and / or damaged.
[0066] In the exemplary embodiment shown in the figures, the tube wall 52 comprises a lower or first layer 75 and an upper or second layer 76. An edge region 78 of the first layer 75 is connected to an edge region 80 of the second layer 76. The layers 75 and 76 together enclose the suction lumen 32. In the present case, the layers 75 and 76 are designed as film layers. Accordingly, the connecting tube 22 is a film tube. Preferably, the layers 75 and 76 are made of polyurethane, polyvinyl chloride, polyethylene, silicone or a mixture thereof. Preferably, the edge regions 78 and 80 are connected to one another by a welded connection. The fluid inlet 26 of the distal end section 24 is formed in the first layer 75 in the exemplary embodiment shown. The fluid outlet 30 is formed between the edge region 78 of the first layer 75 and the edge region 80 of the second layer 76.
[0067] The tube wall 52 is preferably transparent or translucent. This enables a visual inspection of the suction lumen 32. For example, it can be checked whether wound exudate has already entered the suction lumen 32 or how far the wound exudate has already penetrated into the suction lumen 32. Based on this, a decision can then be made as to whether the negative pressure wound therapy kit 14 needs to be replaced or not. The extension of the flow path associated with the meandering fluid passage 70 enables a particularly precise adjustment of a suitable time for replacing the negative pressure wound therapy kit 14.
[0068] Figure 3 shows a cross-section corresponding to Figure 2 through another embodiment of the connecting hose 22. It is assumed that the course of the fluid guide elements 48 corresponds to the course shown in Figure 1.
[0069] In the embodiment shown in Figure 3, an insert part 82 with a rib-shaped section 84 is arranged in the tube lumen 32. To form the first fluid-guiding element 48-1, the wall sections 50 and 54 are each directly and materially connected to the rib-shaped section 84, preferably by a welded connection. Preferably, the insert part 82 comprises a further rib-shaped section (not shown), wherein the wall sections 50 and 54 are each directly and materially connected to the further rib-shaped section to form the second fluid-guiding element 48-2. In the embodiment shown in Figure 3, the wall sections 50 and 54 are therefore indirectly and materially connected to one another, namely by means of the rib-shaped section 84.
[0070] Figure 4 shows a cross-section corresponding to Figure 2 through another embodiment of the connecting hose 22. It is assumed that the course of the fluid guide elements 48 corresponds to the course shown in Figure 1.
[0071] In the embodiment shown in Figure 4, a support unit 86 is arranged in the suction lumen 32, which supports the connecting tube 22 against collapse, in particular due to negative pressure, and is fluid-permeable in the longitudinal extent of the suction lumen 32. The support unit 86 comprises a plurality of support layers 88, which are arranged stacked one above the other in the tube lumen 32. In the present case, four support layers 88 are present. However, a different number of support layers 88 may also be present.
[0072] To form the first fluid guide element 48-1, the first wall section 50 is partially materially connected to an immediately adjacent first support layer 88-1. The second wall section 54 is partially materially connected to an immediately adjacent second support layer 88-2. The support layers 88 are also materially connected to one another. The wall sections 50 and 54 are therefore also indirectly materially connected to one another in the embodiment shown in Figure 4, namely by means of the support layers 88.
[0073] In the following, the design of the support layers 88 is explained in more detail using a preferred exemplary embodiment with additional reference to Figures 5 and 6. Figure 5 shows a plan view of one of the support layers 88. It should be noted that Figure 5 only shows a section of the support layer 88. Accordingly, the actual outer contour of the support layer 88 deviates from the outer contour shown in Figure 5. Figure 6 shows a sectional view of the support layer 88 along the section line BB shown in Figure 5. The support layer 88 is formed by a flat material web section 90. The flat material web section 90 extends in two surface directions X and Y. To support the connecting hose 22, a first side 92 of the flat material web section 90 is structured by elevations 96 formed integrally with a plane 94 of the flat material web section 90.A continuous space 98 is formed between the elevations 96 so that fluid such as wound exudate can be transported through the space 98.
[0074] The flat material web section 90 in the present case is a plastic film 90. The plastic film 90 is preferably made of polyethylene, polyurethane, polyvinyl chloride or a mixture thereof. These plastics have the advantage that the previously described indirect material-to-material connection between the first wall section 50 and the second wall section 54 can be realized in a single process step. Preferably, the indirect material-to-material connection is realized by welding. In this case, the first wall section 50, the second wall section 54 and the support layers 88 located therebetween are heated in regions to a temperature above their melting temperature and are thereby welded together.
[0075] The aforementioned plastics also have the advantage of providing a flexible connecting tube 22, which is associated with high patient comfort. For example, the flexible design of the connecting tube 22 can prevent the occurrence of pressure ulcers. Furthermore, the aforementioned plastics also exhibit sufficient rigidity. Thus, the plastics ensure that the continuous space 98 is maintained when using the connecting device 22, despite the negative pressure created.
[0076] Figure 7 shows the negative-pressure wound therapy system 10 with a connecting device 20 according to another exemplary embodiment. The connecting device shown in Figure 7 differs from the connecting device 20 shown in Figure 1 with regard to the number and arrangement of the fluid-conducting elements 48.
[0077] In the embodiment shown in Figure 7, a plurality of fluid guide elements 48 are present which extend transversely to the longitudinal extent of the connecting hose 22 in the suction lumen 32. A group of first fluid guide elements 48-1 extends from the first side wall 58 beyond the longitudinal center axis of the connecting hose 22 and ends at a distance from the second side wall 60. A group of second fluid guide elements 48-2 extends from the second side wall 60 beyond the longitudinal center axis of the connecting hose 22 and ends at a distance from the first side wall 58. The fluid guide elements 48 are arranged in such a way that, viewed in the longitudinal extent of the connecting hose 22, a first fluid guide element 48-1 is always followed by a second fluid guide element 48-2. Accordingly, a second fluid guide element 48-2 is always followed by a first fluid guide element 48-1.
[0078] In view of the arrangement and design of the fluid-guiding elements 48 described above, the fluid-guiding structure 46 also defines a meandering fluid passage 70 in the suction lumen 32 in the embodiment shown in Figure 7. The wound exudate is deflected several times as it passes through the fluid passage 70, so that the same advantageous effect is achieved that was previously explained in connection with the embodiment shown in Figures 1 and 2.
[0079] In the embodiment shown in Figure 7, the first wall section 50 and the second wall section 54 are directly connected to one another in a materially bonded manner to form the fluid guide elements 48. Alternatively, the fluid guide elements 48 are formed by indirectly connecting the first wall section 50 to the second wall section 54, as previously described in connection with Figures 3 and 4.
Claims
Patent claims 1. A connecting device (20) for the vacuum-tight fluidic connection of a vacuum wound dressing (16) to a vacuum source (12), comprising an elongated single-lumen or multi-lumen connecting tube (22) which comprises a distal end section (24) with a fluid inlet (26) and a proximal end section (28) with a fluid outlet (30), wherein the fluid inlet (26) is vacuum-tight fluidic connectable to the vacuum wound dressing (16), wherein the fluid outlet (30) is vacuum-tight fluidic connectable to the vacuum source (12), and wherein a suction lumen (32) of the connecting tube (22) extends from the fluid inlet (26) to the fluid outlet (30), characterized in that the suction lumen (32) comprises a fluid guide structure (46) which is designed to prevent a fluid flow flowing through the suction lumen (32) from Reaching the fluid outlet (30) several times,that the fluid guide structure (46) for deflecting the fluid flow comprises at least one fluid guide element (48) extending in the suction lumen (32), and that the fluid guide element (48) is connected by means of a material-locking connection, in particular welding or gluing, of a first wall section (50) of a hose wall (52) of the connecting hose (22) to a first wall section (50), opposite second wall section (54) of the hose wall (52) is formed.
2. Connecting device (20) according to claim 1, characterized in that the material connection between the first wall section (50) and the second wall section (54) is designed in the form of a seam.
3. Connecting device (20) according to one of claims 1 and 2, characterized in that the fluid guide structure (46) comprises at least two fluid guide elements (48), preferably at least three fluid guide elements (48), preferably at least four fluid guide elements (48), preferably at least two and at most twenty fluid guide elements (48).
4. Connecting device (20) according to one of claims 1 to 3, characterized in that the fluid guide structure (46) is designed to form any straight connection between a fluid guide provided in the distal end section (24) and oriented orthogonally to the longitudinal extent of the connecting tube (22) and an imaginary second plane arranged in the proximal end section (28) and oriented orthogonally to the longitudinal extent of the connecting tube (22).
5. Connecting device (20) according to one of claims 1 to 4, characterized in that the Fluid guide structure (46) is designed to To deflect the fluid flow at least once by an angle of at least 90°, preferably at least 120°, particularly preferably at least 150°.
6. Connecting device (20) according to one of claims 1 to 5, characterized in that the flow direction of the fluid flow in a first section of the suction lumen (32) is opposite to the flow direction of the fluid flow in a second section of the suction lumen (32).
7. Connecting device (20) according to one of claims 1 to 6, characterized in that the fluid guide structure (46) defines a meandering or labyrinthine fluid passage (70) in the suction lumen (32).
8. Connecting device (20) according to one of claims 1 to 7, characterized in that the fluid guide element (48) or at least one of the fluid guide elements (48) extends at least in sections transversely to the longitudinal extent of the connecting hose (22).
9. Connecting device (20) according to one of claims 1 to 8, characterized in that the fluid guiding element (48) or at least one of the fluid guiding elements (48) extends at least in sections in the longitudinal extent of the connecting hose (22).
10. Connecting device (20) according to one of claims 1 to 9, characterized in that the fluid guiding element (48) or at least one of the fluid guiding elements (48) is formed by direct material connection of the first wall section (50) to the second wall section (54).
11. Connecting device (20) according to one of claims 1 to 10, characterized in that the fluid guiding element (48) or at least one of the fluid guiding elements (48) is formed by indirect material-locking connection of the first wall section (50) to the second wall section (54).
12. Connecting device (20) according to claim 11, characterized in that at least one support layer (88) is arranged in the suction lumen (32), which supports the connecting tube (22) against collapse, in particular due to negative pressure, and in that the first wall section (50) and the second wall section (54) are each materially connected to the support layer (88) or one of the support layers (88) to form the fluid guide element (48) or at least one of the fluid guide elements (48).
13. Connecting device (20) according to claim 12, characterized in that the support layer (88) is made of polyvinyl chloride, polyurethane, polyethylene, silicone or a mixture thereof.
14. Connecting device (20) according to one of claims 11 to 13, characterized in that an insert part (82) with at least one rib-shaped section (84) is arranged in the suction lumen (32), and that the first wall section (50) and the second wall section (54) are each materially connected to the rib-shaped section (84) to form the fluid guiding element (48) or one of the fluid guiding elements (48).
15. Connecting device (20) according to claim 14, characterized in that the insert part (82) comprises a plurality of interconnected and spaced-apart rib-shaped sections (84), and in that the first wall section (50) and the second wall section (54) are each materially connected to the rib-shaped sections (84) to form a plurality of fluid guiding elements (48).
16. Connecting device (20) according to one of claims 1 to 15, characterized in that the hose wall (52) comprises a first layer (75) and a second layer (76) which are connected to one another in their edge regions (78, 80), wherein the first wall section (50) is formed by the first layer (74), and wherein the second wall section (54) is formed by the second layer (54).
17. Connecting device (20) according to one of claims 1 to 16, characterized in that the hose wall (52) is made of polyvinyl chloride, polyurethane, polyethylene, silicone or a mixture thereof.
18. Connecting device (20) according to one of claims 1 to 17, characterized in that the hose wall (52) is transparent or translucent.
19. Negative pressure wound therapy kit (14) with a negative pressure wound dressing (16) and with a connecting device (20) according to one of claims 1 to 18, wherein the fluid inlet (26) of the connecting device (20) can be fluidly connected to the negative pressure wound dressing (16) in a negative pressure-tight manner.
20. Negative pressure wound therapy system (10) with a negative pressure wound therapy kit (14) according to claim 19 and with a negative pressure source (12), wherein the fluid outlet (30) of the connecting device (20) can be fluidly connected to the negative pressure source (12) in a negative pressure-tight manner.