• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    CATHETER KIT The invention relates to a catheter kit comprising a catheter and a urine bag stored in a package in which flow is impeded between the catheter and urine bag when stored, but allowed when the kit is used.
    公开号:BR112014003044B1
    申请号:R112014003044-8
    申请日:2012-08-28
    公开日:2020-10-13
    发明作者:Benny Matthiassen；Bo Kjaer Vigant Lorentsen；Helle Haraldsted；Stephen Glibbery
    申请人:Coloplast A/S.；
    IPC主号:
    专利说明:

    [0001] The invention relates to a catheter kit comprising a catheter and a urine bag stored in a package in which the flow between the catheter and the urine bag is impeded when stored, but allowed when the kit is used . BACKGROUND
    [0002] Catheter packs exist in which a hydrophilically coated catheter is stored in a liquid swelling medium. When such a catheter package is combined with a urine collection bag in a catheter kit, it is undesirable for the swelling medium to enter the bag. This makes it uncertain how much of an amount is present in the container to moisten the catheter. If there is not enough swelling present, then the catheter may dry out. In addition, the swelling medium generally evaporates into a crystalline structure that can clog the construction, thus preventing liquid from flowing through the catheter and into the bag. Finally, the swelling medium in the urine bag is considered unhygienic and, for a user for whom hygiene is important, this perception can prevent him from using the product.
    [0003] Therefore, there is a need for a catheter kit as described in which the liquid is prevented from flowing from the catheter into the urine bag prior to the use of the catheter kit. DESCRIPTION OF RELATED TECHNIQUE
    [0004] WO9811932 discloses a urinary catheter assembly comprising a urinary catheter that has, on at least part of its surface, a hydrophilic surface layer, intended to produce a low friction surface characteristic of the catheter by treatment with a fluid swelling prior to the use of the catheter and a catheter package that has a cavity for accommodating the catheter. DESCRIPTION OF THE INVENTION
    [0005] The invention relates to a catheter kit comprising a urinary catheter, a urine collection bag and a container, the urinary catheter having a hydrophilic coating and comprising a tubular element having a proximal end and a distal end , with the proximal end provided with holes to allow urine to enter the urinary catheter, the distal end is equipped with a handle to handle the catheter, the urine collection bag is connected to the handle, the container is adapted to store the catheter and to contain a liquid swelling medium to moisten the hydrophilic coating on the catheter, the catheter kit additionally comprising a cap detachably attached to the container to cover the catheter handle and the urine collection bag, the kit of catheter additionally comprises sealing means, in which - in the sealing configuration, flow is impeded between the catheter and the urine bag, and - in the configuration flow ration, flow is possible between the catheter and the urine bag.
    [0006] The invention relates to a catheter kit that comprises a container with a urinary catheter connected to a urine collection bag. When the catheter kit is in the seal configuration - typically when stored, or just before use - then the liquid swelling medium in the container is prevented from entering the urine collection bag. When the catheter kit is in the flow configuration - typically when the kit is ready to be used - urine is able to flow into the catheter through the holes and out through an outlet opening arranged in the handle and into the catheter. inside the urine collection bag. In the flow configuration, the urinary catheter, together with the handle and the urine collection bag, is removed from the container.
    [0007] The typical transformation from the seal configuration to the flow configuration will take place when the user prepares the storage catheter kit for use. When the catheter kit is stored, the cap is attached to the container and the catheter is stored in the container, and the handle and urine collection bag are also covered by the container and / or cap. When the user wishes to use the product, the cap is initially removed from the container and the urinary catheter, which includes the urine collection bag, is removed from the container, typically by holding the catheter handle. Removing the urinary catheter from the container can disable the sealing means on the handle or between the cap and the handle and thus transform the catheter kit from the sealing configuration to the flow configuration. Therefore, in one embodiment, the sealing means is arranged on the handle or between the cap and the handle. Alternatively, the user has to remove or disable the sealing medium at the entrance of the urine collection bag, therefore, in the alternative mode, the sealing medium is provided at an entrance of the urine collection bag. The entrance to the urine collection bag is defined as the transition between the handle and the urine collection bag.
    [0008] Next, whenever referring to the proximal end of an element of the invention, the reference is to the end adapted for insertion. Whenever referring to the distal end of an element, the reference is to the end opposite the insertion end. In other words, the proximal end is the end closest to the user, when the catheter is about to be inserted and the distal end is the opposite end - the end farthest from the user when the catheter is about to be inserted.
    [0009] The longitudinal direction is the direction from the distal to the proximal end. The transverse direction is the direction perpendicular to the longitudinal direction, which corresponds to the direction through the axis or tubular element of the catheter.
    [00010] The catheter described in this application can be used as a urinary catheter.
    [00011] The catheter comprises a generally tubular member that extends from the distal end to the proximal end. The tip is positioned at the proximal end of the catheter and can be supplied as a closed rounded end of the tube that forms the main part of the catheter. The connector is provided at the distal end and may, in one embodiment, comprise an enlarged end of the catheter, so that the diameter of the connector increases in relation to the remaining tubular element.
    [00012] Usually, catheters used as urine drainage devices are from size 8 FR to size 18 FR. FR (or French size or Charriere (Ch)) is a standard measurement for catheters that roughly corresponds to the outer circumference in millimeters. More precisely, the outside diameter of the catheter in millimeters corresponds to FR divided by 3. Therefore, 8 FR correspond to a catheter with an outer diameter of 2.7 mm and 18 FR corresponds to a catheter with an outer diameter of 6 mm.
    [00013] Catheters of this invention are, before use, provided with a hydrophilic coating in order to grant a low friction insertion.
    [00014] The catheter can be a compact telescopic catheter, for example, as SpeediCath ® Compact Female or Male, marketed by Coloplast UM / S.
    [00015] In one embodiment, the handle is attached to the container. Preferably, it is coupled by a firm liquid coupling, so that the swelling medium is prevented from leaving the container. Therefore, the liquid tight coupling must be able to contain the liquid swelling medium inside the container during the storage period, which can be up to 3 to 5 years. When the handle and therefore also the catheter are removed from the container, the flow of liquid is established between the catheter and the urine bag.
    [00016] In one embodiment, the catheter kit is moved from the seal configuration to the flow configuration by axial displacement of the urinary catheter and the manipulator in relation to each other. This allows flow to be established between the handle and the urinary catheter when the handle is pulled, unscrewed or otherwise moved axially in relation to the urinary catheter. This type of seal provides a particularly secure seal that will not be inadvertently activated.
    [00017] In a related modality, axial displacement occurs as a result of extracting the handle in the axial direction. In that case, the coupling between the handle and the catheter can be provided as a plug-in coupling.
    [00018] In another related modality, axial displacement occurs as a result of the rotation of the handle in relation to the urinary catheter. In the latter embodiment, the coupling between the handle and the urinary catheter can, for example, be provided as a threaded coupling with a high pitch ratio.
    [00019] In another embodiment, the catheter kit is moved from the seal configuration to the flow configuration by rotating the urinary catheter and the handle in relation to each other. This allows the flow between the handle and the catheter to be established by moving the handle.
    [00020] In a related embodiment, a first sealing disc is provided at the proximal end of the handle and a second sealing disc at the distal end of the catheter. The sealing discs are coaxially aligned and arranged in a tight fit.
    [00021] The rotational connection between the handle and the catheter results in the fact that the sealing discs are capable of rotating in relation to each other.
    [00022] At least one flow opening is provided on each sealing disc. The flow openings are provided so that they are aligned in a rotational position between the handle and the catheter and therefore flow is allowed to pass from the catheter into the urine bag, and in another position in which the flow openings are misaligned. and the flow is interrupted (or prevented) between the catheter and the urine bag.
    [00023] In other modalities, the kit is moved from the seal configuration to the flow configuration by removing the cover.
    [00024] As an example, the cap can provide a seal against the distal end of the handle when the catheter kit is in the seal configuration. Alternatively, a valve can be arranged between the cap and the catheter handle and in which the valve is opened and the kit is moved from the seal configuration to the flow configuration when the cap is removed.
    [00025] Other modalities refer to the provision of a sealing element that provides a liquid impermeable seal at the distal end of the handle, corresponding to the entrance of the urine collection bag. This sealing element seals the catheter kit when it is in the seal configuration and allows flow through the catheter and into the urine collection bag when the kit is in the flow configuration.
    [00026] In still other modalities, the kit can be moved from the sealing configuration to the flow configuration by directly removing a sealing element that provides a liquid impermeable seal and is disposed at the entrance of the urine collection bag.
    [00027] Alternatively, the seal can be broken, for example, by torsion, compression or other way of handling the sealing element by the user.
    [00028] In one embodiment, the handle is rotationally connected to the container. The handle is provided with an external thread for fitting by thread with a corresponding thread on the container.
    [00029] If the handle is able to rotate in relation to the catheter and at the same time be rotationally connected to the container, a particularly easy to use modality can be achieved. In such modality, the user must just rotate the handle and, with this rotation, the same, in the first place will allow the flow (transform the catheter kit from the sealing configuration to the flow configuration) and second, it will remove the catheter urine and the urine collection bag of the recipient. Therefore, the user will hold the container with one hand (or between the elbow and the body or in any other way) and handle it with the other hand (or use the teeth or in any other way) and rotate the two parts in relation to one another. the other. BRIEF DESCRIPTION OF THE DRAWINGS
    [00030] Figures 1 to 4 show a modality of a catheter kit in which the flow can be controlled,
    [00031] Figure 5 shows an embodiment of a seal between the catheter and the urine bag,
    [00032] Figures 6 and 7 show an embodiment of a seal configuration that is opened by removing the catheter from the container,
    [00033] Figures 8 to 12 show another embodiment of a seal configuration that is opened by removing the catheter from the container,
    [00034] Figures 13a, 13b and 13c show the principles of yet other modalities of seal configurations that are opened by removing the catheter from the container, and
    [00035] Figures 14, 15 and 16 show different ways of providing a seal between the catheter and the urine bag using the cap as a retainer. DETAILED DESCRIPTION OF THE DRAWINGS
    [00036] Figures 1 to 4 show in a sequence of steps, a catheter kit 1 and how the catheter is prepared for use. The different modalities disclosed in the present document can be incorporated into the catheter kit 1 by a person skilled in the art.
    [00037] The catheter kit comprises a container 2 and a cap 3 to close and cover an opening of the container. The cap is removed by twisting the cap around in the direction of the arrow, as shown in Figure 1. This releases the coupling cap on thread 4a, 4b as shown in Figure 2, which exposes a urine bag 5 that has been folded inside the cap 3. The cap can be discarded or stored to later close the catheter kit 1.
    [00038] The urine bag 5 is unfolded, exposing a catheter handle 6 around which it was left, as seen in Figure 3. The handle is attached to the distal end of a catheter 7. The handle is coupled with a neck portion 8 of the container, which defines an opening of the container through which the catheter can be inserted and retrieved.
    [00039] Finally, catheter 7 and urine bag 5 are removed from the container by pulling handle 6, as shown in Figure 4, in which the catheter is ready for insertion into the urethra.
    [00040] The catheter is hydrophilically coated and stored together with a swelling medium (not shown) in the container.
    [00041] As will be understood, the catheter can be attached to the container in different ways. In one embodiment, there may be a threaded coupling between the container and the catheter handle, or in another embodiment, the coupling may, for example, be a friction coupling. It is therefore preferred that the coupling is liquid-tight, so that the swelling medium does not leak from the container.
    [00042] Figure 5 illustrates a break part 20 formed at the distal end of the handle, that is, at the end opposite the catheter 7. In order to move the catheter kit from the seal configuration to the flow configuration, the break 20 is manually broken by the user. With the breaking part 20 inside the urine bag, it will remain there and will not fall to the floor and create debris.
    [00043] Another closure means, which must be manually removed separately, in order to move the catheter kit to the flow configuration can be provided. In one embodiment, such a manual means may, for example, be a clamp arranged around the bag, near the distal end of the handle, a wire or rubber base. These are easy to identify and therefore easy for the user to remove.
    [00044] In another set of modalities, the catheter kit can be moved from a seal configuration to a flow configuration by manipulating the handle as described in Figures 6 to 13. This has the advantage that the catheter kit can be moved to the flow configuration when it is removed from the container and thus can be incorporated into the removal step, in which the user will not have to perform additional operations.
    [00045] Figures 6 and 7 illustrate a handle 30 that has a double threaded coupling structure that serves to, first, move the catheter kit in the flow configuration and second, to separate the handle and catheter from the neck of container 8.
    [00046] The handle is formed of a rigid tubular inner part 31, covered with a soft layer of rubber 32. The rubber layer provides a grip area that is comfortable to tighten and has good grip characteristics, such as high friction.
    [00047] The handle extends longitudinally along an axis A - A, which corresponds to the longitudinal axis of the catheter. At a distal end 33, the handle has two outlet openings 34 ’, 34”. The catheter extends out of the proximal end 35 of the handle.
    [00048] The handle is formed with an internal thread 36 provided on the internal surface of the tubular part 31. The internal thread engages with a corresponding catheter thread 42 provided on the external surface of the distal end of the catheter 7.
    [00049] An external thread 37 is additionally provided at the proximal end of the handle on the outer surface of the tubular part. The external thread engages with a corresponding container thread 38 provided on the inner surface of the neck 8 of the container.
    [00050] In the sealed configuration, the distal end 39 of the catheter closes the passage to the outlet openings 34 ’, 34”, so that the flow is prevented, from the lumen of the catheter 7 ’and into the urine bag 5.
    [00051] When the catheter kit is opened, the handle is disposed about the longitudinal axis A - A relative to the container as indicated by the arrow. This activates the threaded coupling between the handle and the catheter by moving the handle axially in relation to the catheter, thus moving the distal end 39 of the catheter away from the outlet openings 34 ', 34 ”as shown in Figure 7, thus allowing urine flows through the catheter and into the urine bag.
    [00052] This action goes unnoticed by the user, who moves in order to obtain the catheter for use. With the catheter kit in the flow configuration, the user continues to move, so that the threaded coupling between the outer surface of the handle 37 and the inner surface of the neck 38 is activated. This unscrews the handle and, therefore, the catheter, out of the container.
    [00053] In order to prevent leaks when the product is stored, an outer sealing ring 40 prevents the liquid from leaking between the handle and the neck and an internal sealing ring 41 prevents the liquid from leaking between the handle and the catheter.
    [00054] In another embodiment as shown in Figures 8 to 12, the handle 50 and, therefore, the catheter 51, is removed from the container 2 by a pulling and turning action.
    [00055] The handle comprises a plug 52 which is used to seal the lumen of the catheter 7 'at the distal end of the catheter. As long as the plug seals the catheter, the handle is free to rotate around the catheter in the groove 53. This prevents the coupling means in the form of a catheter thread 54 on the outer surface of the catheter and a container thread 55 on the inner surface neck is activated.
    [00056] When the handle is pulled on the longitudinal axis, the plug 52 is moved out of the lumen of the catheter 7 ', thus establishing the flow between the catheter and the urine bag. At the same time that rib 56 is moved from groove 53 to locking groove 57. In the locking groove, the rib is prevented from rotating freely by means of locking ribs 58. Therefore, when the handle is moved, the thread of catheter 54 and the container thread 55 are activated and the handle can be unscrewed from the container, thus releasing the catheter.
    [00057] In Figure 13a, b and c it is illustrated, in general, how the catheter device can be moved to the flow configuration by rotating two parts in which the openings are aligned.
    [00058] For example, the proximal end of the catheter handle 6 can be provided with a handle disk 60 which has two diametrically opposed openings 61, 62 and the distal end of the catheter 7 is provided with a catheter disk 63 which also has two diametrically opposed openings 64, 65 similar to those of the manipulator disk.
    [00059] The handle and the catheter are rotatable in relation to each other, which provides a rotation around the A - A axis, as shown in Figure 13b. Therefore, the openings can be moved in a flow configuration in which the openings of the respective discs are aligned to each other and, likewise, the openings can be moved to a sealing configuration in which the openings are moved in relation to the others, thus closing the flow.
    [00060] Figure 13c shows another modality of the discs described in relation to Figures 13a and 13b, in which the openings are formed as slits. The principle and function of the slots and discs are, however, the same as in Figures 13a and 13b.
    [00061] In another set of modalities illustrated in Figures 14 to 17, the catheter kit is moved to the flow configuration when the cap is removed, since the removal simultaneously breaks a seal between the catheter lumen and the urine.
    [00062] In Figure 14, a seat valve 70 is provided between the cap 3 and the catheter handle 6. The seat valve comprises a valve component 71. The valve component 71 is pushed into engagement with the valve seat. 72 through cap 3. This engagement prevents liquid from flowing out of handle 6. When cap 3 is removed, the seat valve relaxes and flow can be established.
    [00063] Figure 15 shows a ball valve 80 provided between the cover 3 and the catheter handle 6. A valve seat cover 81 is provided inside the cover and a valve seat handle 81 is provided in the handle 6. When closed, a ball 83 engages with the cap and handle valve seal and stops the flow. When the cap is removed, the ball valve relaxes and flow is established.
    [00064] The modalities of Figures 14 and 15 show valves that have a separate spare part, for example in the shape of valve component 71 and ball 83. When the kit is opened, the part will fall out of the valve, typically into the bag . This prevents the valve from being reused.
    [00065] However, if it is desired to reuse the valve, a modality according to Figure 16 can be used, for example. Figure 16 shows a valve construction 90 formed of an elastic valve seal 91 which is attached to the inside of the cap 3. The valve seal can, for example, be formed of silicone or another elastomer. The valve seal 91 has a valve seat 92 which engages with a handle seat 93 on the distal part of handle 6 when the kit is closed. The urine bag 5 attached to the handle extends outwardly between valve seat 92 and handle seat 93. However, due to the pressure between the two seats, the urine bag is firmly pressed, preventing the liquid will flow through the valve seal even through the urine bag. When the cover is removed, the seal is broken and flow can be established. However, if the cap is put back on the valve assembly 92, it will re-establish contact with the handle seat 93, thereby interrupting the flow.
    [00066] In another embodiment, a foil is provided on the distal part of the handle and, when the cap is twisted, in order to remove it from the container, a protruding pin cuts and opens at least part of the foil.
    [00067] As described in this document, many different ways of moving the catheter kit between a seal configuration and a flow configuration have been disclosed, and the person skilled in the art will understand that many others can be employed within the scope of this invention. For example, principles like torsion can also be used.
    权利要求:
    Claims (13)
    [0001]
    1. Catheter kit (1) comprising a urinary catheter (7, 51), a urine collection bag (5) and a container (2) in which the urinary catheter (7, 51) has a hydrophilic coating and comprises an element tubular that has a proximal end and a distal end, with the proximal end having holes to allow urine to enter the urinary catheter, the distal end is equipped with a handle (6, 30, 50) to handle the catheter, the urine collection bag (5) is connected to the handle (6, 30, 50), the container (2) is adapted to store the catheter and to contain a liquid swelling medium to moisten the hydrophilic coating on the catheter, the catheter kit (1) additionally comprises a cap (3) detachably attached to the container during storage to cover the catheter handle and the urine collection bag, characterized by the fact that the catheter kit (1) additionally comprises a sealing means, in which - in a sealing configuration, flow is impeded between the catheter and the urine collection bag and - in a flow configuration, flow is possible between the catheter and the urine collection bag - and in which the sealing medium is provided in the handle (6, 30, 50) or between the cover (3) and the handle (6, 30, 50).
    [0002]
    2. Catheter kit (1), according to claim 1, characterized by the fact that the handle (6, 30, 50) is coupled to the container in a liquid impermeable coupling.
    [0003]
    Catheter kit (1) according to either of claims 1 or 2, characterized in that the catheter kit (1) is movable from the seal configuration to the axial displacement flow configuration of the urinary catheter ( 7.51) and the handle (6, 30, 50) in relation to each other.
    [0004]
    4. Catheter kit (1), according to claim 3, characterized by the fact that axial displacement is provided by pulling the handle (6, 30, 50) in the axial direction.
    [0005]
    5. Catheter kit (1), according to claim 3, characterized by the fact that axial displacement is provided by the rotation of the handle (6, 30, 50) in relation to the urinary catheter (7, 51).
    [0006]
    6. Catheter kit (1) according to either of claims 1 or 2, characterized in that the catheter kit (1) is movable from the seal configuration to the flow configuration by moving through rotational displacement the urinary catheter (7, 51) and the handle (6, 30, 50) in relation to each other.
    [0007]
    7. Catheter kit (1) according to any one of claims 1 to 6, characterized in that a first sealing disc (60) is provided at a proximal end of the handle and a second sealing disc (63) at the distal end of the catheter.
    [0008]
    8. Catheter kit (1) according to any one of claims 1 to 7, characterized in that the cap (3) provides a seal against the distal end of the handle when the catheter kit (1) is in its seal configuration.
    [0009]
    9. Catheter kit (1) according to any one of claims 1 to 8, characterized in that a valve (70, 80, 90) is disposed between the cap (3) and the handle (6, 30, 50) of the catheter and where the valve (70, 80, 90) is configured to open to move the kit (1) from the seal configuration to the flow configuration when the cap (3) is removed.
    [0010]
    10. Catheter kit (1) according to any one of claims 1 to 9, characterized in that a sealing element that provides a liquid impermeable seal is provided at the entrance of the urine collection bag.
    [0011]
    11. Catheter kit (1), according to claim 10, characterized by the fact that the catheter kit is movable from the sealing configuration to the flow configuration by removing the sealing element.
    [0012]
    12. Catheter kit (1) according to claim 10, characterized in that the catheter kit is movable from the sealing configuration to the flow configuration by twisting or compressing the sealing element.
    [0013]
    13. Catheter kit (1) according to any one of claims 1 to 12, characterized in that the handle (6, 30, 50) is rotationally connected to the container (2).
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-08-11| B09A| Decision: intention to grant|
    2020-10-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DKPA201170471|2011-08-29|
    DKPA201170471|2011-08-29|
    PCT/DK2012/050312|WO2013029620A1|2011-08-29|2012-08-28|Catheter activation by handle removal|
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