• 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:
    SET A set comprising a catheter package (1), a catheter (7) and a collection bag (3) is provided. The assembly has means to prevent the flow of liquid through the catheter during storage. A sealing element (11) is provided which closes the eyelets. A cone closure (23) extended in a telescopic catheter is also provided.
    公开号:BR112014002399B1
    申请号:R112014002399-9
    申请日:2012-08-28
    公开日:2020-12-08
    发明作者:Lars Olav Schertiger；Helle Haraldsted
    申请人:Coloplast A/S；
    IPC主号:
    专利说明:

    [0001] The invention relates to a set comprising a catheter stored in a package and a urine collection bag. The catheter is stored in a liquid expansion medium in the package. The catheter or package comprises means to close the flow, through the catheter, before use. Background
    [0002] There are catheter packs in which a coated hydrophilic catheter is stored in a liquid expansion medium. When such a catheter package is combined with a urine collection bag in a catheter assembly, it is undesirable for the liquid expansion medium to enter the bag. This makes it uncertain how much liquid is present in the container or package to wet the catheter. If there is not enough dilation medium present, then the catheter can dry out. In addition, many types of expansion media evaporate a crystalline structure that can clog the construction, thus preventing liquid from flowing through the catheter and into the urine collection bag when the catheter is to be used. Finally, the average dilation in the urine collection bag is perceived as not being hygienic, and for a user for whom hygiene is important, this perception can prevent him from using the product.
    [0003] Thus, there is a need for a device, as described, in which liquid is prevented from flowing from the catheter and into the urine collection bag before using the catheter set. Description of the Related Art
    [0004] International publication no. WO2011011023 discloses a catheter assembly that includes a tubular member having a first end and a second end. A catheter has a first end and a second end. At least a portion of the catheter is disposed within the tubular member. The first end of the tubular component can be opened by the axial movement of the catheter. A sealing engagement is provided between the tubular member and the catheter. Summary of the Invention
    [0005] The invention relates to a set with a package for a catheter, a catheter stored in a cavity and a urine collection bag that communicates with the catheter. The catheter is a coated hydrophilic catheter stored in a liquid expansion medium. During storage, the liquid expansion medium must be prevented from moving from the cavity through the catheter and into the collection bag. Thus, this invention provides a means to prevent liquid flow through the catheter during storage.
    [0006] Detailed Description of the Invention
    [0007] In a first aspect, the invention relates to a set comprising a catheter package, a coated hydrophilic catheter and a urine collection bag, the collection bag being connected or in communication with the catheter in order to that, in use, the urine is able to flow through the catheter and into the collection bag, in which the set comprises a cavity in the package adapted to store the coated hydrophilic catheter and liquid expansion means to wet the coating on the catheter e-a stop of liquid in the cavity or catheter so that the liquid expansion medium is prevented from flowing from the cavity, through the catheter and into the urine collection bag, during storage.
    [0008] When providing a set with a stop of liquid in the cavity or catheter, the liquid is prevented from flowing through the catheter during storage. This has the effect that the liquid expansion medium is prevented from escaping from the cavity and, furthermore, prevented from soiling the urine collection beaker before use. Thus, the drawbacks mentioned above are eliminated.
    [0009] In the following, whenever referring to the proximal end of an element of the invention, the reference is the end adapted for insertion. Whenever referring to the distal end of an element, the reference is the end opposite the insertion end. In other words, the proximal end is the end closest to the user when the catheter is being inserted and the distal end is the opposite end - the end most distant from the user when the catheter is being inserted.
    [00010] The longitudinal direction is the direction from the distal end to the proximal end. The transverse direction is the direction perpendicular to the longitudinal direction, which corresponds to the direction on the other side of the catheter axis.
    [00011] The catheter described in the present application can be used as an intermittent urinary catheter.
    [00012] The catheter comprises a main tubular part that extends from the distal end to the proximal end. The tip is positioned at the proximal end of the catheter and is supplied as a rounded closed 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 tubular part.
    [00013] Normally, catheters used as urinary drainage devices range from size 8 FR to size 18 FR. FR (or French size or Charriere (Ch)) is a catheter level indicator, which corresponds approximately to the external circumference, in mm. More precisely, the external diameter of the catheter in mm corresponds to FR divided by 3. Thus, 8 FR corresponds to a catheter with an external diameter of 2.7 mm and 18 FR corresponds to a catheter with an external diameter of 6 mm.
    [00014] The catheters of the present invention are, before use, provided with a hydrophilic coating in order to impart a low friction insertion.
    [00015] The invention provides for a stop of the liquid in the cavity or the catheter. This liquid stop acts as a means to prevent flow through the catheter during storage. The liquid stop is adapted, either to prevent the flow of liquid into the catheter when the catheter is stored, or to prevent the flow of liquid through the catheter during storage. In the latter case, the liquid is prevented from moving from the proximal end of the catheter and out through the distal end. However, when the catheter is to be used and removed from the package, then urine must be able to flow through the catheter from the proximal end to the distal end and from there into the urine collection bag. Thus, when the catheter is to be used, the liquid stop is inactivated. In other words, the stopping of liquid is only able to prevent the flow of liquid during storage and will allow the flow of liquid when the catheter is to be used.
    [00016] The set can be in the storage position and in the use position. In the storage position, the catheter is packed inside the packaging cavity and the flow of liquid from the cavity into the urine collection bag, through the catheter is prevented due to the liquid stopping. In the use position, the catheter is removed from the cavity of the package and the liquid is able to flow from the proximal end of the catheter, through the catheter and out through the distal end of the catheter into the urine collection bag.
    [00017] The assembly of the invention comprises a urine collection bag that communicates with the catheter. In the simplest form, the collection bag can be welded or glued directly to the catheter. However, the urine collection bag can also be connected via a connecting piece.
    [00018] The urine collection bag may be made of sheet material, for example polyethylene, and may be able to contain an amount of up to about 750 ml.
    [00019] The stoppage of liquid may comprise a closure that prevents urine from flowing into the catheter through the eyelets when the catheter is stored.
    [00020] In an embodiment of the invention, the cavity of the package is provided with a sealing element, which is adapted to seal the eyelets to the catheter.
    [00021] A closure or sealing element in the eyelets is a simple solution that is easy to incorporate. It also has the effect that the liquid expansion medium is completely prevented from entering the catheter, therefore, the risk of crystallization of the liquid expansion medium inside the catheter is reduced.
    [00022] The sealing element can take the form of a closed cell foam element (for example PU foam) provided with a hole for insertion of the proximal end of the catheter with the eyelets. The dimension of the sealing element in the longitudinal direction must be greater than the distance from the extreme proximal end of the catheter to the most distal part of the eyelets. This ensures that the sealing element covers the eyelets completely and, thus, prevents the liquid expansion medium from entering through the eyelets in the catheter.
    [00023] A very soft polymeric material can also be used for the sealing element.
    [00024] In one embodiment of the invention, the catheter is a telescopic catheter comprising an outer catheter part and an internal catheter part, which are provided with a locking cone between the two parts. The locking cone can be, as described in the "Detailed Design Description" section. In this embodiment, the seal is provided as an extension of the cone element, which can cooperate with a sealing element on an internal surface of a distal end of the outside of the catheter to prevent the flow of liquid through the catheter. Alternatively, an extension can be provided with a sealing member adapted to seal on an internal surface of a distal end of the outside of the catheter to prevent liquid flow through the catheter.
    [00025] The distal end of the outside of the catheter can be provided with a handle. In this case, the sealing element can be provided on the internal surface of the handle. Alternatively or additionally, the handle can be provided with a reduced internal diameter in relation to the internal diameter of the external catheter. This allows for a secure seal, while still allowing free movement of the internal catheter in relation to the external part of the catheter.
    [00026] In this embodiment, the internal part of the catheter, as well as the external part of the catheter are adapted for insertion into the urethra. This means that both parts of the catheter have dimensions within the regular French sizes - that is, between 8 FR and 18 FR. In addition, both parts of the catheter are provided with a hydrophilic coating.
    [00027] The sealing ring can be made of TPE for example Santoprene (R).
    [00028] The outside diameter of the extended cone closure should be less than the inside diameter of the outside of the catheter. Otherwise, the extension will prevent movement of the outside of the catheter in relation to the inside of the catheter.
    [00029] In an embodiment of the invention, the cone closure extension can be provided with an urine outlet. Brief Description of the Drawing
    [00030] Figures 1-4 illustrate a set according to the invention
    [00031] Figure 5 illustrates a closure of the eyelets by a foam element
    [00032] Figure 6 illustrates a telescopic catheter with an extended cone closure in the storage configuration ie when the assembly is in the storage position
    [00033] Figure 7 illustrates a telescopic catheter with an extended cone closure in the extended configuration (ready to use) ie the configuration when the set is in the use position. Detailed Description of the Drawing
    [00034] Figures 1-4 show the step-by-step sequence of a catheter assembly 1 and how the catheter is prepared for use. The different embodiments disclosed herein can be incorporated into the catheter assembly 1 by a person skilled in the art. Fig.l shows the assembly in the storage position.
    [00035] The catheter assembly comprises a container 2 and a lid 3 to close and cover an opening of container 2. Container 2 defines cavity 2a for storing the catheter. The cover 3 is removed by rotating the cover 3 in the direction of the arrow, as shown in fig. 1. This releases the cap 3 from the screw connection 4a, 4b as shown in fig. 2, which has a urine collection bag 5 that has been folded into the lid 3. The lid 3 can be discarded or stored for later re-closing the catheter assembly 1.
    [00036] The urine collection bag 5 is unfolded exposing a catheter handle 6 around which it was folded as shown in figure 3. The handle 6 is connected to the distal end 7 of a catheter 8. The identifier is coupled with a neck portion 9 of the container, which defines an opening of the container 2, through which the catheter 8 can be inserted and retrieved.
    [00037] Finally, catheter 8 and urine collection bag 5 are removed from container 2 by pulling handle 6, as shown in fig. 4, so that catheter 8 is ready for insertion into the urethra. Thus, fig. 4 shows the assembly in the use position.
    [00038] The catheter is hydrophilic coated and stored together with an expansion medium (Fig. 5) in container 2.
    [00039] Fig. 5 illustrates a cross section of part of catheter assembly 1, shown in fig. 1 to fig.4. The set 1 has a cavity 2a including a catheter 8 and the liquid expansion medium 9. The catheter is provided with eyelets 10, which in use conduct the urine from the bladder and through the catheter. A sealing element 11 is inserted in the cavity 2a, so that the liquid expansion medium 9 contained in the cavity 2a is prevented from entering the catheter 7, through the eyelets 10. The sealing element 11 can be made of foam closed cells or a soft polymeric material. The sealing element 11 is provided with a hole 12 adapted to the size of the external dimension of the catheter.
    [00040] Figs. 6 and 7 illustrate a telescopic catheter 20. In fig. 6, the catheter is shown in the closed configuration (the stored configuration) and in fig. 7, the catheter is shown in the extended configuration, when the catheter is ready for use.
    [00041] The catheter comprises an inner portion of catheter 21 and an outer portion of catheter 22 which are connected through a cone closure 23. The cone closure is connected to the distal end 21a of the inner portion of the catheter through a piece of connection 24 extending into the catheter part. A first brake 25 is provided at the distal end 21a from the inside of the catheter. Distally from this first brake, the cone closure comprises a cone element 26 followed by a second brake 27. Between the two brakes, a closing element 28 is provided. This closing element engages by friction with the inner surface of the outside of the catheter, when the closing element 28 is positioned on the first brake 25. On the second brake 26, the closing element 28 is not engaged with the inner surface of the outside of the catheter, therefore, when the element 28 is in this position, the the inner part of the catheter 21 can move with respect to the outer part of the catheter 22. These parts, the two brakes 25, 27, the cone element 26, the connecting part 24 and the closing element 28 constitute a cone closure known in the prior art. However, the present invention provides an extension of this cone closure generally indicated at 30. The extension is provided with a urine outlet port 31 which communicates with the inner channel 29 by means of the cone closure. This allows the urine to flow through the catheter when the catheter is used. At the proximal end 21b, the inside of the catheter 21 is provided with eyelets 32 to allow urine to enter the catheter.
    [00042] The outside of catheter 22 is provided with a handle 33 at its distal end 22a. A urine collection bag (not shown) can be attached or attached to the handle 33 in order to collect the urine. The handle 33 is provided with a sealing element 34, which cooperates with the extension 30 to prevent liquid from flowing through the catheter and out through the handle 33, when the catheter is stored.
    [00043] When the catheter is stored (as shown in Fig. 2), the inside of the catheter is almost completely inserted inside the outside of the catheter. The locking element 28 is positioned on the second brake 27, so that the external part of the catheter 22 can move with respect to the internal part of the internal catheter 21. In this catheter configuration, any liquid (for example, dilatation) that enters the catheter through the eyelets will be able to enter completely through the internal part of the catheter 21, through the internal channel 29, through the cone closure and out through the urine exit hole 31 in extension 30 However, the sealing member 34 will prevent it from flowing out through the distal end 33a of the handle and into a collection bag (not shown) that is attached to it.
    [00044] When the catheter is to be used, it is removed from the package (indicated in dashed 40 in fig. 2), and the catheter is extended to its fully extended position. In this catheter configuration, urine can flow into the catheter through eyelets 32, through the inner part of catheter 21, through the inner channel 29 of the cone closure, through the outer part of catheter 22 and out through handle 33 for a collection bag (not shown) attached to it. This results from the fact that, in the extended position, the sealing element 34 is disengaged from extension 30.
    权利要求:
    Claims (6)
    [0001]
    1. Set (1) comprising a catheter package, a coated hydrophilic catheter (8) and a urine collection bag (5), with the urine collection bag (5) attached or in communication with the catheter (8) so that, in use, the urine can flow through the catheter (8) and into the collection bag (5), in which set (1) it comprises a cavity (2a) in the package adapted to store the catheter coated hydrophilic and liquid expansion medium for moistening the coating on the catheter; e-a liquid brake on the catheter (8) so that the liquid expansion medium is prevented from flowing from the cavity (2a), through the catheter (8) and into the urine collection bag (5) during storage-the catheter is a telescopic catheter comprising an external catheter part (22) and an internal catheter part (21) connected via a cone closure (23), characterized by the fact that the cone closure (23) is provided with an extension element (30) and where the distal end (22a) of the outside of the catheter is provided with a sealing element (34) that, in a shrunk position of the telescope catheter, cooperates with the extension element (30) to provide a seal that prevents liquid from flowing through the catheter (8); or-the extension element (30) is provided with a sealing element (34) which, in the shrunk position of the telescopic catheter, cooperates with a distal end (22a) of the outside of the catheter in order to provide a seal that prevents the liquid flows through the catheter.
    [0002]
    2. Assembly (1) according to claim 1, characterized in that a distal end (22a) of the external catheter portion is provided with a handle (33) with the sealing element (34) which, in a position shrunk from the telescopic catheter, it cooperates with the extension element (30) to provide the seal that prevents liquid from flowing through the catheter (8).
    [0003]
    3. Assembly (1) according to claim 1, characterized in that the extension element (30) is provided with the sealing element (34) which, in a shrunk position of the telescopic catheter, cooperates with a handle ( 33) present at a distal end (22a) of the external portion of the catheter in order to provide the seal that prevents liquid from flowing through the catheter (8).
    [0004]
    4. Assembly (1) according to claim 2 or 3, characterized in that the handle (33) has a reduced internal diameter in relation to the internal diameter of the external portion of the catheter.
    [0005]
    Assembly (1) according to any one of claims 1 to 4, characterized in that the extension element (30) comprises one or more outlets (31) for urine.
    [0006]
    6. Assembly (1) according to any one of claims 1 to 5, characterized in that the extension element (30) has an external diameter smaller than the internal diameter of the external portion of the catheter.
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-12-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DKPA201170472|2011-08-29|
    DKPA201170472|2011-08-29|
    PCT/DK2012/050313|WO2013029621A1|2011-08-29|2012-08-28|Closing of flow through catheter|
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