• 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:
    '' urinary catheter kit ''. a catheter kit for urinary use is described in the present invention. the catheter kit includes a catheter with a widened edge and the package is provided with internal protrusions adapted for cooperation with the widened edge of the catheter. the larger outside diameter of the widened catheter edge is slightly larger than the lesser outside diameter of the widened catheter edge is slightly larger than the smallest diameter of the package in the protrusions. therefore, the protrusions will act as a backstop for the catheter. the rigidity of the catheter at the widened edge is selected, so that - depending on the angle at the widened edge - the widened edge is able to turn if subjected to a force at a predetermined level. this way, the catheter can be put back in the packaging.
    公开号:BR112012014474B1
    申请号:R112012014474
    申请日:2010-12-17
    公开日:2020-01-21
    发明作者:Becker Kim；Olav Schertiger Lars
    申请人:Coloplast As；
    IPC主号:
    专利说明:

    “URINARY CATHETER KIT” [001] The present invention relates to a catheter kit for a urinary catheter comprising a package and a catheter for urinary use. The urinary catheter is provided with an enlarged edge and the package is provided with internal protrusions adapted to cooperate with the widened edge.
    BACKGROUND OF THE PRESENT INVENTION [002] Urinary catheters are employed as tools to assist urinary bladder drainage in individuals without urinary control or reduced urinary control. The nonexistent or reduced bladder control can be either temporary or permanent, and the temporary loss of bladder control can be caused, among others, by trauma, loss of consciousness or an illness. An example of a permanent loss of bladder control can occur in cases where there is a loss of the neural connection between the brain and the spinal cord and the urinary bladder due to trauma to the spinal cord, as is often the case with paraplegic individuals and quadriplegics.
    [003] An example of a urinary catheter that is widely used for draining urine from the urinary bladder is one in which the catheter tube is inserted into a user's urethra and where the tip of the catheter tube is handled in the urinary bladder , forcing the urethral sphincter to open and thus providing a drainage channel from the urinary bladder and out of the body, through the catheter tube. There are two types of catheters that are commonly used, the permanent catheter and the intermittent catheter. The permanent catheter is a highly flexible catheter that is inserted by medical professionals in the body for an extended period of time, up to 12 weeks, and where the catheter is fixed inside the bladder. The intermittent catheter is usually a single-use catheter or a multiple-use catheter, which is inserted by the user into the urethra / bladder
    Petition 870190102112, of 10/10/2019, p. 8/34
    2/11 for immediate drainage of your urinary bladder and is removed from the urethra / bladder after drainage. The description below will mainly focus on the intermittent urinary catheter.
    DESCRIPTION OF RELATED TECHNIQUE [004] There are several different types of intermittent catheters that are currently available on the market for users, such as SpeediCath ™ and EasiCath ™ marketed by Coloplast A / S. There are conventional one-piece catheter tubes that have an outlet at their distal end that can be used to connect the catheter to a urinary collector to collect the urine drained from the urinary bladder.
    [005] Another type of catheter is that described in WO document
    03/002179 which is a telescopic catheter, where one of the telescopic elements is the catheter packaging and where another telescopic element is the catheter member that is projected telescopically from the catheter packaging. The telescopic catheter is compressed during storage and transportation and is extended for insertion into the urethra, allowing female users to have a compact and discreet catheter that can be used anywhere and without the need for significant preparation time.
    [006] Another type of catheter is presented in the document WO
    2008/138351 describing a telescopic device that features a first tubular member and an extended member that has a coupling member that limits the displacement of the extended member within the first tubular member, and in which the coupling member fits inside the first tubular member. This device is a telescopic intermittent catheter, which is also adapted for use by a male user, in which the first tubular member is adapted in such a way that both telescopic members are adapted to be inserted into the user's urethra.
    [007] Telescopic catheters known in the art, as
    Petition 870190102112, of 10/10/2019, p. 9/34
    3/11 described above, are blocked in their extended state, in order to prevent the extended member of the telescopic element from being compressed in its compacted state. This means that, with the catheter being discarded, possibly after use, either in a waste basket or returned to a storage medium, such as a hand bag or purse, it is difficult to discreetly discard the catheter.
    [008] There is therefore a need for a telescopic device in which, during extension, it can be avoided from being compressed. In addition, the device can be compressed to a compressed state. SUMMARY OF THE PRESENT INVENTION [009] The present invention relates to a urinary catheter kit that includes a package and a catheter. The catheter has an enlarged edge and the package has ribs or other protrusions that extend into the package. The extended edge is adapted in its outermost diameter to cooperate with the smallest diameter between the ribs or protrusions of the package. In its original configuration, the outermost diameter of the widened edge is found at the end of the catheter that is furthest from the tip, that is, the distal tip of the catheter. In this way, when the widened edge is subjected to a driving force in the direction opposite to the direction of removal of the catheter from the package, the widened edge will be retained against the rib or protrusion in the package. If the driving force exceeds a predetermined level, the widened edge will be adapted to bend around itself, so that it faces the opposite direction. In this position, the catheter can be pressed back into the package with virtually no resistance. However, a certain tractive force will be required to unfold the widened edge to its original configuration.
    DETAILED DESCRIPTION OF THE PRESENT INVENTION [0010] In a first aspect, the present invention relates to a urinary catheter kit comprising the following elements:
    Petition 870190102112, of 10/10/2019, p. 10/34
    4/11
    - a catheter package that has a storage space adapted to store the catheter
    - a urinary catheter that has a proximal end with a tip and a distal widened edge, where the tip is adapted to be inserted through the urethra and integrally into the user's bladder, while the widened edge is adapted to be connected to a tube for lead the urine out of the catheter,
    - where the storage space is generally tubular in shape and is provided with internal protrusions that define the smallest diameter of the storage space in the protrusions,
    - in which the widened edge has the largest diameter of the catheter being greater than the diameter of the insertable part of the catheter.
    - where the largest diameter of the catheter is greater than the smallest diameter of the storage space.
    [0011] The urinary catheter kit, as previously mentioned, will be able to prevent the catheter from being pushed back into the storage space of the package. In this way, the catheter kit will clearly indicate whether it has already been used or not. In addition, the package will be able to function as a backstop when the catheter is inserted into the urethra.
    [0012] The packaging can be made in different configurations. In a preferred embodiment, the packaging is made of a material that is impermeable to gas. If a liquid expansion medium is provided inside the package, it may be advantageous that the packaging is made of a material that is impermeable to gas, so as to be able to reduce or avoid any and all diffusion of the liquid expansion medium, so the catheter it can be kept in a humid condition for a significant period of time. A significant period of time can be, for example, the expiration date of the urinary catheter set, which can be a period ranging from approximately 6 months to approximately 5 years. An example of a
    Petition 870190102112, of 10/10/2019, p. 11/34
    5/11 material suitable for use is Polyethylene (PE).
    [0013] In a preferred embodiment, the storage space is shaped in the form of a spiral. In other words, the storage space of the package is helical and can be shaped in the form of an Archimedes spiral or arithmetic spiral. This type of packaging makes the catheter kit very compact and easy to transport and store in a hand bag, purse or similar.
    [0014] In another preferred embodiment, the packaging is elongated. In a related preferred embodiment, the package is a corrugated element with side walls that alternately include ribs and grooves.
    [0015] The alternating ribs and grooves can increase the flexibility of the side wall of the corrugated tubular element, when compared to a tubular element that does not have alternating ribs and grooves. In order to provide the packaging with a wall of flexible material, it can be provided with a side wall that has alternating ribs and grooves in a direction radial to the central longitudinal axis of the packaging. This means that the thickness of the material can be increased to promote a more gas-impermeable side wall, without having to significantly compromise the packaging flexibility.
    [0016] The packaging flexibility can be approximately 200 MPa. In this way, the packaging will be flexible, however, without being too foldable. The thickness of the packaging, in the case of Polyethylene, will normally be between about 0.5 mm and about 0.8 mm.
    [0017] The catheter can be of the regular intermittent urinary catheter type with an insertable length of approximately 80 mm to approximately 150 mm. Normally, the catheter will be provided with drain eyes at the tip end. In addition, the catheter will have an internal lumen to carry urine from the tip to the end of the connector.
    [0018] The catheter can be coated with a hydrophilic coating
    Petition 870190102112, of 10/10/2019, p. 12/34
    6/11 to promote a low friction surface. The low-friction surface reduces the risk of maceration of the inner walls of the urethra.
    [0019] In a preferred embodiment, the catheter can be packaged for storage and / or transportation with a liquid expansion medium for humidifying the hydrophilic coating and for maintaining the hydrophilic coating in a fully hydrated state during its storage and / or transportation . By providing a liquid expansion medium that keeps the hydrophilic coating in a fully hydrated state during storage and / or transportation, the user will be able to have a catheter ready for use and which can be used directly after removing the telescopic device from its packaging. In addition, the user does not need to have any accessories, such as lubrication gel or any external source of the liquid expansion medium for preparing the catheter.
    [0020] The stiffness of the catheter and the angle at the widened edge can be selected, so that the two properties together allow the widened edge of the catheter to be curved towards the tip. This means that the widened edge will be able to turn. The capacity for this purpose is controlled both by the rigidity of the material and by the inclination of the cone at the widened edge. If the angle is too low when compared to the longitudinal direction of the catheter, the stiffness must be low enough to allow the tip to turn. If the angle is high (close to 90 degrees), the stiffness can be much higher that the tip will still be able to turn.
    [0021] In this way, the widened edge of the catheter will be able to bend when subjected to an impulse force that exceeds a predetermined level. This level will normally be around 4-10 N, preferably 5 N for regular urinary catheters. The driving force may be lower in the case of thin catheters that are used in children, as it may be higher in the case of thick catheter models. This driving force corresponds to the force that is normally required
    Petition 870190102112, of 10/10/2019, p. 13/34
    7/11 for the introduction of catheters in urethra. When the required force level is selected so that the widened edge can turn, in order to correspond to the usual insertion force, the widened edge and protrusions of the package will act as a safety measure during insertion. If the pushing force on the catheter is excessively high, the widened edge will turn and send a signal to the user that there may be a constriction or other problem during insertion. Therefore, the user is prevented from pushing too hard, thereby damaging the internal mucosa of the urethra.
    [0022] The stiffness (measured in the form of a bending modulus) will normally be between about 50 MPa and about 200 MPa.
    [0023] The angle on the extended edge in relation to the longitudinal direction can be approximately 45 degrees. Values around 45 degrees are suitable for a very flexible catheter, that is, a catheter that has a flexion module at the lower end that is between 50 MPa and 100 MPa. In the case of a more rigid catheter, the angle should be more inclined, so that it can bend facing the opposite direction. In the case of this type of catheter, values of approximately 75 degrees should be selected. The adaptation of the angle and the stiffness of the catheter are within the scope of skills of a person skilled in the art. Selecting an angle other than (less than) 90 degrees has the effect that the force required to remove the catheter from the package will be less than the force required to cause the widened edge to turn, so that the catheter can be reintroduced in the packaging.
    [0024] The catheter can be made of a material, such as silicone or polyurethane.
    [0025] The widened edge of the catheter can be attached to the catheter. Alternatively, the widened edge can be made as a separate element and attached to the catheter.
    [0026] The enlarged edge attached to the catheter is easy and quick to
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    8/11 to manufacture, because the catheter and the enlarged edge can be manufactured in less steps. The catheter will be extruded from the tip. After which the tip will be heated and during the heating process the tip will be extended. This is one of the ways to shape the catheter, although other ways are also possible.
    [0027] The internal ribs of the packaging are made of the same material as the packaging. The material must be relatively rigid, it must be at least more rigid than the widened tip so that it can provide strength to the widened edge.
    [0028] The number of ribs can be between 4 and 20. For most users, about 10 ribs will be sufficient to provide the insertion aid. The ribs should be at least about 0.2 mm in the direction that extends out of the packaging wall. This value corresponds to the thickness of the catheter, thus being sufficient to provide the backstop function.
    [0029] When the package is shaped into a helical shape, the ribs only need to be present on the outermost wall of each winding. This is due to the fact that the catheter will try to unfold to a straight configuration, thus making the widened edge in contact with the outermost wall of each winding when the catheter is removed from the package.
    [0030] The package can act as an insertion guide for the catheter. This is possible because the ribs on the package act as a stop for the catheter, preventing it from being pushed back into the package.
    [0031] As it is adjusted to the package, the urine that comes out of the catheter cannot get out of the package at the front end of the package.
    [0032] The package can be provided with means to prevent the catheter from being completely removed from the package. In this way, the game of
    Petition 870190102112, of 10/10/2019, p. 15/34
    9/11 The catheter has a position in which the catheter is fully extended. The means for preventing complete removal may include means in the form of wider ribs which extend transversely in the package from the wall. In the case of a spiral-shaped package, a cavity can be provided to which the extended edge will fit. This cavity can have an extension for an outlet of the package.
    [0033] When the catheter set is used, as previously described, urine may start to flow before the catheter is fully extended to the proximal end of the package. In the case of an elongated package, this fact is not a problem, as urine flows along the length of the package, leaving the distal tip. However, in the case of a spiral-shaped package, this can be a problem if the flow of urine starts before the widened edge is adjusted in the cavity. Only in this position will the urine flow out of the container. If the widened edge is inside the spiral shape, the urine will end up in the center of the spiral. To solve this problem, the package can be provided with a bypass to allow urine to pass from the center to the outlet of the package. This by-pass can be done in the form of a channel that extends along the spiral. However, other solutions are also possible, such as a tube.
    BRIEF DESCRIPTION OF THE DRAWINGS [0034] Figure 1 and Figure 2 illustrate a catheter with a rounded edge.
    [0035] Figure 3 illustrates a preferred embodiment of a package. [0036] Figure 4 illustrates another preferred embodiment of a package.
    [0037] Figure 5a and Figure 5b illustrate a kit comprising a catheter and a package.
    DETAILED DESCRIPTION OF THE DRAWINGS
    Petition 870190102112, of 10/10/2019, p. 16/34
    10/11 [0038] Figure 1 and Figure 2 illustrate a catheter 1 with an enlarged edge 2 that is part of a kit (not shown in this figure) according to the present invention. In Figure 1, catheter 1 is presented in cross section, while in Figure 2 a photograph of the distal end of the catheter is shown. The catheter comprises a tubular element with a proximal end 3 and a distal end 4. At the proximal end 3 (the insertion end), there are eyes 5. In Figure 1, two eyes are shown 5 - however, there may be only one eye how can there be more than two eyes. The widened edge 2 is arranged at the distal end
    4. The drawing in Figure 1 is not to scale; the urinary catheter (mainly for males) will normally be longer when compared to its width. Figure 1 also illustrates the angle θ between the widened edge and the rest of the catheter.
    [0039] Figure 3 illustrates a package 20 that can be used in a game according to the present invention. This package 20 is a package with spiral-shaped storage space 21 for a catheter defined by spiral-shaped walls 22. The spiral-shaped storage space 21 starts at an inner periphery 23 near the center of the package and ends on the outer periphery 24. At the termination, the package 21 is provided with a cavity 25 adapted to receive the connector of a catheter, when it is completely extended. In this position, the catheter connector will communicate with an outlet 26 of the package through a channel 27 that connects the outlet 26 with the cavity 25. The channel 27 may be just a hole in the wall 22 that defines the storage space 21. The outlet 26 can be shaped as a conical outlet in order to define a reception space for connection to a pipe.
    [0040] The packaging 20 can also be provided with a by-pass 28 that connects the central storage space 29 in the center 23 of the packaging
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    11/11 with outlet 26. As described earlier, said by-pass allows urine, which entered storage space 21, to exit storage space 21 via bypass 28 and outlet 26. The by -pass can take the form of holes in the walls in the form of a spiral 22.
    [0041] Figure 4 illustrates another type of packaging 30 that can be part of a game, according to the present invention. This type of package 30 comprises a storage space 31 within a tubular corrugated element 32. The corrugated package 30 allows the package, including the catheter, to be folded or rolled up in a more compact configuration, as shown in the figure.
    [0042] Figure 5A and Figure 5B illustrate a game 40 according to the present invention. Kit 40 includes a corrugated package 30 as shown in Figure 4 in combination with a catheter 1, as shown in Figure 1. The catheter has an enlarged edge 2 with an outside diameter that is slightly wider than the smallest inside diameter of the package 30 as shown in Figure 5B. In Figure 5A, the widened edge 2 of the catheter is slightly compressed when passing through one of the flutes in the carton 30. If the catheter is pulled out of the carton, that is, in the direction of the arrow in the drawing, then the widened edge 2 will be slightly compressed when passing through each flute. When the user tries to push the catheter into the package, in the direction against the arrow, then the extended edge 2 will be retained against one of the ribs, initially resisting pressure. If the driving force exceeds a certain level (5-10 N) the widened edge 2 will be turned so that it is towards the tip of the catheter, so that the user will be able to push the catheter into the package.
    权利要求:
    Claims (12)
    [1]
    1. Catheter kit for urinary use, comprising the following elements:
    - a package (20) for a catheter that has a storage space (21) adapted to store the catheter,
    - a urinary catheter (1) that has a proximal end (3) with a tip and an enlarged distal edge (2), where the tip is adapted to be inserted through the urethra and integrally into the user's bladder, and where the widened edge (2) is adapted to be connected to a tube to conduct urine out of the catheter,
    - where the storage space (21) is generally tubular in shape and is provided with internal protrusions (32) that define the smallest diameter of the storage space in the protrusions,
    - where the widened edge (2) has the largest diameter of the catheter being greater than the diameter of the insertable part of the catheter,
    - in which the largest diameter of the catheter is greater than the smallest diameter of the storage space, characterized by the fact that the storage space (21) is shaped in the form of a spiral.
    [2]
    2. Urinary catheter kit according to claim 1, characterized in that the package (20) is made of a material that is impermeable to gas.
    [3]
    3. Urinary catheter kit according to claim 1, characterized by the fact that the storage space is fluted.
    [4]
    Urinary catheter kit according to any one of claims 1, 2 or 3, characterized in that the catheter (1) is coated with a hydrophilic coating to provide a low friction surface.
    [5]
    5. Urinary catheter kit according to any one of claims 1, 2, 3 or 4, characterized in that the catheter (1) can be
    Petition 870190102112, of 10/10/2019, p. 19/34
    2/2 packed for storage and / or transportation with a liquid expansion medium for humidifying the hydrophilic coating and for maintaining the hydrophilic coating in a fully hydrated state during storage and / or transportation.
    [6]
    6. Urinary catheter kit according to any of claims 1, 2, 3, 4 or 5, characterized in that the catheter stiffness and the angle at the widened edge are selected so that the two properties in combination allow that the widened edge of the catheter is curved towards the tip.
    [7]
    Urinary catheter kit according to any one of claims 1, 2, 3, 4, 5 or 6, characterized in that the widened edge (2) of the catheter is integral with the catheter.
    [8]
    Urinary catheter kit according to any one of claims 1, 2, 3, 4, 5 or 6, characterized in that the widened edge (2) is made as a separate element and attached to the catheter.
    [9]
    Urinary catheter kit according to any one of claims 1, 2, 3, 4, 5, 6, 7 or 8, characterized in that the number of ribs defining the internal protrusions (32) is between 4 and 20.
    [10]
    10. Urinary catheter kit according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8 or 9, characterized in that the package (20) is provided with means to prevent the catheter from being completely removed from the packaging.
    [11]
    11. Urinary catheter kit according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10, characterized in that the package (20) is a spiral-shaped package that it has a center (23) and an outlet (26).
    [12]
    Urinary catheter kit according to claim 11, characterized in that the package can be provided with a by-pass (28) to allow urine to pass from the center (23) to the outlet (26) of the package.
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    US11154688B2|2016-04-12|2021-10-26|Coloplast A/S|Catheter assembly with a protective sleeve inside of a package|
    WO2017185052A1|2016-04-22|2017-10-26|Hollister Incorporated|Medical device package with flip cap having a snap fit|
    EP3445435A1|2016-04-22|2019-02-27|Hollister Incorporated|Medical device package with a twist cap|
    EP3519031B1|2016-09-27|2021-09-22|Coloplast A/S|A hydrated catheter with sleeve|
    DE102016120294A1|2016-10-25|2018-04-26|Uromed Kurt Drews Kg|Catheter system for intermittent catheterization|
    US9987464B1|2017-07-20|2018-06-05|Donaco Medical Design, LLC|Urinary catheter insertion device and kit|
    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2019-12-24| B09A| Decision: intention to grant|
    2020-01-21| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 17/12/2010, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DKPA200970285|2009-12-21|
    PCT/DK2010/050346|WO2011076211A1|2009-12-21|2010-12-17|A catheter kit for a urinary catheter|
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