• 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 assembly. it is a catheter assembly (1) comprising a catheter (8) that has a proximal end (1 o) adapted to be inserted into a body cavity and a distal end (11) that has a drainage outlet (13 ), a catheter package (2) that has a cavity for accommodating the catheter and an opening for removing the catheter from the package, and extraction means (17) that are coupled to the catheter for extraction of the distal end of the catheter for outside the packaging.
    公开号:BR112013022325B1
    申请号:R112013022325-1
    申请日:2012-03-16
    公开日:2020-10-06
    发明作者:Allan Tanghoej
    申请人:Coloplast A/S；
    IPC主号:
    专利说明:

    [001] The invention relates to a catheter assembly comprising a catheter that has a proximal end adapted to be inserted into a body cavity and a distal end that has a drainage outlet, a catheter package that has a cavity for the accommodation of the catheter and an opening for removing the catheter from the package. BACKGROUND
    [002] Especially intermittent urinary catheters or catheters are medical devices that are used to drain urine from the urinary bladder in situations where users are unable to empty their bladders or where users have conditions that cause problems in emptying their bladders. bladders.
    [003] Intermittent urinary catheters are often single-use catheters that are provided with a lubricant, such as a gel lubricant, or the catheters may be provided with a surface coating that provides a low-friction surface on the catheter, such as a catheter that has a hydrophilic coating. A frequent side effect of using catheters, including single-use catheters, is that users are at increased risk of acquiring a urinary tract infection, which can often be caused by bacteria that come into contact with the catheter before insertion. In an attempt to reduce the risk of contracting a urinary tract infection, single-use catheters are often supplied in sterile packages that keep the catheters sterile until the user intends to use the catheter and opens the package.
    [004] When a sterile catheter package is opened, there will be several different scenarios that the user may have to face. If the catheter is a gel-lubricated catheter, the user must remove the catheter and apply the gel to the catheter surface before insertion. In a different situation, where the catheter is a dry hydrophilic catheter, the user has to pour water on the packaging to activate the coating and then remove the catheter from the packaging. In another situation, where the catheter is a ready-to-use catheter, the user takes the catheter out of its packaging and prepares it for insertion.
    [005] Conventional catheter packs are usually supplied in the form of one or two sheets of film that must be opened to access the catheter. This means that the user is forced to handle the catheter prior to use in order to remove the catheter from its packaging.
    [006] A large group of intermittent catheter users are individuals who have reduced motor skills, as they may have lost voluntary bladder control due to illnesses, such as spina bifida, or accidents that have caused spinal cord damage, resulting in in para- or quadriplegia. This group of users may have reduced dexterity in their hands or fingers and often may have to deal with the preparation and / or removal of catheters from their packaging, which can additionally lead to contamination of the catheter due to the lack of control of their movements. fingers and hand. Related technique description
    [007] Patent document DE 2005 20009947 U discloses a catheter assembly comprising a package and a catheter, in which the proximal end (insertable end) is pulled out of the package using a cord that is attached to the end distal to the catheter, where the package is used as a urine container and the user does not need to touch the insertable part of the catheter before inserting the catheter. However, the use of such packaging requires that the packaging be attached to the distal end of the catheter, as the user must not touch the catheter. SUMMARY
    [008] The invention relates to a catheter package that has the extraction means attached to the catheter, so that it is easier for the user to remove the catheter from the package. Many catheter users have poor or at least reduced manual dexterity and may not have the ability to pinch with their fingers. They will therefore find it difficult to hold and grasp a distal end of a catheter (for example, a connector) when the catheter has to be removed from the package. Consequently, the invention provides a catheter assembly, which, among other objectives, alleviates the above problem. DETAILED DESCRIPTION OF THE INVENTION
    [009] In a first aspect, the invention relates to a catheter assembly comprising a catheter that has a proximal end adapted to be inserted into a body cavity and a distal end that has a drain outlet, a catheter package which has a cavity for accommodating the catheter and an opening for removing the catheter from the package, and extraction means that are coupled to the catheter for extracting the distal end of the catheter out of the package.
    [0010] The extraction means can be used to assist the user in extracting the catheter from the package, as some users have dexterity in their fingers or reduced hand and it may be difficult for them to operate the package, so that the end distal is accessible. This can be especially advantageous when the catheter package is of the type that the package is formed in such a way that the opening of the package only partially exposes the distal end of the urinary catheter. When the distal end is only partially exposed, the user may be required to fold, bend, cut or stretch the package, so that the distal end becomes exposed, or the user may have to insert his fingers into a small opening to access the distal end. According to the present invention, the extraction means are advantageous and readily accessible to the user, so that the user can pull the distal end of the catheter out of the package before the complete extraction of the catheter from the package. By pulling the distal end out of the package, the distal end becomes completely accessible to the user and even users with reduced dexterity will have the ability to hold the distal end, so that the catheter can be completely extracted from the package.
    [0011] Next, whenever it refers to a proximal end of an element of the invention, the indication is for the end adapted for insertion. Whenever referring to the distal end of an element, the indication is for the end opposite the insertion end. In other words, the proximal end is the end closest to the user, when the catheter has to be inserted and the distal end is the opposite end - the farthest end from the user when the catheter is to be inserted. The same definitions apply to the packaging and container - the proximal end is the end that stores the proximal end of the catheter and the distal end is the opposite end.
    [0012] The longitudinal direction is distal to the proximal end. The transverse direction is the direction perpendicular to the longitudinal direction, which corresponds to the direction through the catheter shaft.
    [0013] The catheter described in this application can be used as a urinary catheter.
    [0014] 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 provided as a rounded closed end of the tube that forms the main part of the catheter. The catheter may comprise a connector 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. The catheter may also comprise a handle at the distal end, which is of a length that allows the user to manipulate the catheter.
    [0015] Normally, the catheters are from size 8 FR to size 18 FR.
    [0016] The catheters of this invention can, before use, be provided with a hydrophilic coating in order to transmit a low friction insert.
    [0017] The hydrophilic coating can only be provided on the insertable part of the catheter. The hydrophilic surface coating is the type that, when hydrated or swollen using a swelling medium, reduces friction in the catheter's surface area that is intended to be inserted into a user's urinary channel that corresponds to the insertable part of the catheter. catheter.
    [0018] An intermittent hydrophilic catheter differs from a resident catheter in that the hydrophilic surface coating of such a catheter is not suitable for resident use, because the surface coating tends to stick to the inside of the urethral mucosa if left inside the body for a period exceeding 5 to 20 minutes, due to the hydrophilic coating transforming from being highly lubricated when completely humidified (95% by weight of water) to being adhesive when the hydration level of the coating is reduced (<75%, by weight of water).
    [0019] The catheter package may comprise a means for activating the hydrophilic surface coating of the catheter. The activation medium can be a water-based substance, such as sterile water, saline or any water-based liquid. In addition, the activation medium can be in the form of a vapor-contributing material, such as a humidified sponge, non-woven material or fabric comprising a vapor-contributing liquid. By introducing a steam-contributing material into the package, the steam will hydrate the hydrophilic coating over time ensuring that the coating is activated and that the hydrophilic coating provides a low friction surface for the catheter.
    [0020] In one embodiment of the invention, the drain outlet may have a cross-sectional diameter that is larger than the part of the catheter proximal to the drain outlet. Thus, the coupling between the catheter and the extraction means can be in the form of a frictional or similar coupling using the increased diameter of the catheter. Consequently, the coupling part will stop near the drain outlet and will not pass the drain outlet and, pulling on the extraction means and coupling will transfer the traction force to the catheter and the catheter will be lifted using the means extraction.
    [0021] In an embodiment of the invention, the extraction means can be arranged at a distal end of the catheter package. By disposing the extraction means at the distal end of the package, the catheter can be extracted from the package along the longitudinal axis of the package. This means that the package can be opened at the distal end using a predefined opening in the packaging material or peeling opening from a film layer package. Consequently, when the extraction means are at the distal end of the package, the opening can be formed such that the opening has only a part of the distal end of the catheter or no part of the distal end of the catheter and the distal end of the catheter is exposed when the extraction means were used to pull the catheter out of the package. This simplifies the design and production of the catheter package, as the package does not need to have an opening that has complex features that expose the distal end of the catheter when opened.
    [0022] In an embodiment of the invention, the extraction means can be coupled to a part of the catheter that is distal to the proximal end and proximal to the distal end. This means that the extraction means are coupled to the catheter in different areas than the extreme end of the catheter, which means that important parts of the catheter, such as the insert tip or the drain outlet are not blocked by the coupling part of the catheters. extraction means.
    [0023] In an embodiment of the invention, the extraction means can be coupled to a distal part of the catheter that is approximately between 50 to 99 percent of the length of the catheter. Consequently, the extraction means can be arranged to assist in pulling to the distal end of the catheter. When the extraction means are pulled in a longitudinal direction away from the distal end, the transfer of force from the extraction means to the catheter will have an equilibrium point that is in the distal half of the catheter and the risk of tipping the catheter while the pull to it is minimized.
    [0024] In an embodiment of the invention, the extraction means can be in the form of a strip that has at least one length extending from a proximal end coupled to a catheter coupling area and a distal end that is in contiguity with the opening of the catheter package. This means that when the catheter package is open, the extraction means are readily accessible to the user when opening the package. Consequently, after opening the package, the user can hold on to the extraction means and pull on the extraction means to expose the distal end of the catheter, so that the distal end of the catheter can be secured by the user for insertion. In other embodiments of the present invention, the distal end may be arranged to extend beyond the opening of the package, thus, when the package is opened, the extraction means will extend beyond the opening.
    [0025] In an embodiment of the invention, the extraction means can be in the form of a strip having a proximal end surrounding the catheter and a free distal end. The strip can surround the catheter in such a way that when the extraction means are maneuvered in a direction away from the distal end of the catheter, the force of movement is transferred to the catheter. In addition, when the user grasps the distal end of the catheter and pulls the catheter away from the extraction means, the extraction means will release their coupling to the catheter and the catheter will move freely in relation to the extraction means. This means that when the user maneuvers the catheter from the package, the extraction means will release the catheter and the extraction means can remain inside the package while the catheter is pulled out of the package.
    [0026] In an embodiment of the invention, the proximal end of the strip surrounding the catheter can have a diameter that is smaller than at least the distal end of the catheter. This means that when the extraction means are pulled, the extraction means will not slip from the catheter, as the reduced diameter will prevent the catheter from slipping from the extraction means.
    [0027] In an embodiment of the invention, the opening of the catheter package can be provided with opening means capable of opening that seal the cavity of the catheter package from the ambient space. This means that during storage and before use, the closing means will close the catheter package, so that the catheter cannot be accessed by the user or any external contaminants. Such closing means may be in the form of a plug, peeling opening means or the like.
    [0028] In an embodiment of the invention, the extraction means can be coupled to the closing means that can be opened. Coupling the extraction means to the closing means that can be opened, it is possible to expose the distal end of the catheter in a simple movement, that is, the opening of the package. Consequently, when the closing means is pulled from the package, the pulling movement will be transferred to the extraction means and through the extraction means to the catheter. This can be advantageous for users who have low dexterity in their fingers or hands, as a movement of the closing means has a dual function, that is, opening the package and exposing the catheter to remove the package.
    [0029] In an embodiment of the present invention, the end of the extraction means can be coupled to the package. By coupling the extraction means to the package, the extraction means can be attached to the package so that the extraction means can lift the distal end of the catheter from the opening of the package and the extraction means will not be releasable from the package and the extraction means will therefore not be removable from the packaging without the use of excessive force.
    [0030] In one embodiment of the present invention, the end of the extraction means can be displacably coupled to the package, so that the extraction means can be maneuvered in a longitudinal direction along the longitudinal geometric axis of the package, while the extraction means are coupled to the packaging. This means that the extraction means will slide along the package until the distal end of the catheter has been exposed and, on exposure, the extraction means will remain in position while the catheter is being extracted.
    [0031] In an embodiment of the present invention, the closing means can be provided with fastening means for fixing the closing means to a surface area. This means that the closure means can be attached to a surface and the opening means can be attached directly to the package or attached to the extraction means, so that the attached closure means can support the total weight of the catheter assembly. This allows the user to position the catheter assembly in a location where it can have easier access to extract the catheter from the package, as the user does not need to keep the catheter assembly in their hands or store it. before catheterization, as the assembly is already arranged in a location far from the user. BRIEF DESCRIPTION OF THE DRAWINGS
    [0032] In the following drawings, the invention is explained in additional details, in which
    [0033] Figure 1 is a side section view of a catheter assembly, according to the present invention, in a closed state,
    [0034] Figure 2 is a side section view of a catheter assembly, according to the present invention, in an open state,
    [0035] Figures 3a and 3b are seen in perspective of a distal end of a catheter package seen from the front and the back, respectively,
    [0036] Figure 4 is a perspective view of a distal end of a catheter package seen from the front, where the package has been opened, and
    [0037] Figure 5 is a perspective view of it, fixed to a surface area of a drain. DETAILED DESCRIPTION OF THE DRAWINGS
    [0038] Figure 1 shows a cross-sectional side view of a catheter assembly 1, in which the catheter assembly is in the form of a catheter package 2 having a side wall 3, a proximal end 4 and a distal end 5 , wherein an opening 6 in the side wall 3 is arranged close to the distal end of the catheter package. The catheter package 2 has an internal cavity 7 for holding a catheter 8. The catheter package is advantageously provided in a material that is flexible, so that the side walls of the package can be folded and flexed.
    [0039] Catheter 8 is a conventional intermittent urinary catheter that has a catheter tube 9 for draining a user's urinary bladder urine where a proximal end 10 of catheter 8 is adapted to be inserted into a body cavity of a user. The opposite end of the catheter 8, the distal end 11 is provided with a connector 12 that acts as an outlet for the urine drained through the catheter tube 9 and is in fluid communication through an internal lumen of the catheter tube 9 through the at least one eyelet 13 arranged close to the proximal end of the catheter 8.
    [0040] Opening 6 provides an entrance into the internal cavity 7 of the catheter package 2 and when the catheter assembly is in its closed configuration, as shown in this Figure, opening 7 is sealed using a closing means under the in the form of a peeling flap 14. The peeling flap 14 closes sealingly the opening 6 and is connected to the side wall 3 of the catheter package on the periphery of the opening 6. The flap 14 is provided with a gripping portion 15 which can be arranged in such a way that the user can easily grasp the gripping portion with the use of his fingers, or it can be provided with a finger hole into which the user can insert his finger to obtain firm control of the gripping portion 15. The flap 14 is releasably connected in most of its periphery to the side wall 3 of the package 2, while in an area 16 which is close to the distal end 5 of the package 2, the flap 14 is more tightly connected, so that the flap 14 remains in the packaging 2 in the area to 16 after the flap has been peeled away 14 from the opening of package 2 to provide access to the inner cavity 7 of package 2.
    [0041] The catheter assembly is additionally provided with an extraction member 17 which is arranged at one end 18 around the distal end 11 of the catheter tube 8 and at the other end 19 is fixed to an internal wall of the peeling flap 14 in the fixation zone 20. The extraction member 17 mechanically engages the peeling tab 14 to the distal end 11 of the catheter tube 8, so that when the peeling tab 14 is pulled from the package 14, the extraction member pulls towards the distal end 11 of catheter tube 8 and pull connector 12 out of the package, so that the user has easy access to catheter connector 12 in order to remove the catheter from the package before use. The open position of the catheter assembly is shown in Figure 2. The extraction member therefore moves the catheter in a longitudinal direction, lifting it upwards from the inner cavity of the package, so that the distal end of the catheter is easily accessible by the user.
    [0042] The extraction member 17 is advantageously disposed behind the connector, as shown in Figures 1 and 2, in which the extraction member passes the connector inside the cavity close to the side wall of the package that is opposite the opening of the package. This means that when the peeling tab 14 is opened in a manner as shown in Figure 2, that is, pulled away from the package, a tension is applied to the extraction member and the center of the extraction member pushes the connector towards outside the opening in the side wall in a direction that is orthogonal to the longitudinal geometric axis of the catheter packaging. In related embodiments, it is not the exact center of the extraction member that pushes the connector out of the opening, but a position close to the center of the extraction member.
    [0043] Figure 3a represents another embodiment of the present invention, in a perspective view from the front, showing a distal end 102 of a catheter assembly 101. The distal end 102 of the catheter assembly 101 is provided with an opening 103 which provides access to the internal cavity 104 of the catheter assembly 101. In this embodiment, the opening 103 is provided at the extreme distal end of the catheter package, giving free access in a longitudinal direction to the internal cavity 104 of the catheter package. Opening 103 is closed using a lid 105, which closes opening 104 in at least one hermetic manner, and possibly in a gas-tight seal as well. The lid 105 is provided with a gripping member 106 in the form of a protrusion that facilitates the gripping of the lid 105 in order to propel the lid 105 from the opening. In addition, the lid 105 can be provided with an adhesive area 107 which is arranged on the outer surface of the lid 105 in order to securely attach the outer surface of the lid 105 to a surface area of a drain, table or similar structure available to the user using the catheter assembly 101.
    [0044] The distal end 102 of the catheter assembly is arranged in a funnel shape, so that the distal end has an internal diameter that is large enough to retain a connector end 108 of a catheter 109 and to facilitate the whole the catheter can be disposed inside the catheter package. In this embodiment, catheter 109 is additionally provided with an insertion aid 110 which is slidably arranged around catheter 109 and catheter connector 108, so that the insertion aid can be maneuvered along the longitudinal geometric axis of the catheter 109 during insertion of catheter 109 into the body. Insertion aid 110 is in the form of a generally tubular member coaxially disposed outside and around catheter 109.
    [0045] As shown in Figure 3b, which is a perspective view from the rear, the catheter assembly is additionally provided with an extraction means 111 which is in the form of a flexible strip 111 which is at one end 112 securely attached to the cap 105 and at the opposite end 113 is coupled to the insertion aid 110, so that the opposite end 113 is rotated around the insertion aid 110. This means that the cap 105 is mechanically coupled to the distal end from catheter 109 or to catheter connector 108, so when the cap is removed and maneuvered in a direction away from the package, the extraction medium will transfer force from the cap to the catheter, causing the catheter to lift from opening, giving the user access to the distal end of the catheter to remove the catheter from the catheter assembly, as shown in Figure 4.
    [0046] The opposite end 113 of the extraction means or flexible strip can, in a different way, be arranged around the catheter 109 or the connector 108 of the catheter, in modalities in which the insertion aid is not required or in modalities where insertion aid is arranged in a different way.
    [0047] As shown in Figure 5, when the catheter assembly 101 was opened, the adhesive area of the cap 105 can be used to secure the cap 105 to the surface area of a drain 114, so that the cap retains the catheter 109 and the catheter assembly 101 within easy reach for the user to extract the catheter 109 from the opening 103 by grasping a distal end or the connector 108 of the catheter. Consequently, the user can prepare the catheter assembly for use by removing the cap from the catheter assembly, and removing the cap will cause the extraction member to push into the catheter, so that the catheter rises from the catheter assembly. catheter, making the catheter easy to reach and easily grasped by the user.
    [0048] Within the meaning of the present invention, any features that are shown in one embodiment can be applied to a different embodiment of the invention, such as the shape and shape of the extraction members. In addition, the modalities shown in the present invention can be adapted, so that the extraction member is not fixed to the opening means of the package, but can be arranged separately inside the package, so that the user can open the package and then, reaching the package to grasp the extraction member to lift the distal end of the package catheter.
    权利要求:
    Claims (12)
    [0001]
    1. Catheter assembly (1, 101) comprising - a catheter (8, 109) which has a proximal end (10) adapted to be inserted into a body cavity and a distal end (11) which has a drainage outlet, - a catheter package (2) that has a cavity (7, 14) for accommodating the catheter and an opening (6, 103) for removing the catheter from the package, and - extraction means (17, 111) that are coupled to the catheter (8, 109) for extracting the distal end of the catheter out of the package, characterized by the fact that the extraction means (17, 111) are coupled to a part of the catheter that is distal to the proximal (10) and proximal end to the distal end (11).
    [0002]
    2. Catheter assembly (1, 101), according to claim 1, characterized by the fact that the drainage outlet has a cross-sectional diameter that is larger than the part of the catheter proximal to the drainage outlet.
    [0003]
    Catheter assembly (1, 101) according to either of the preceding claims 1 or 2, characterized by the fact that the extraction means (17, 111) are arranged at a distal end (5, 102) of the packaging of catheter.
    [0004]
    4. Catheter assembly (1, 101), according to any of the preceding claims 1, 2 or 3, characterized by the fact that the extraction means (17, 111) are coupled to a distal part of the catheter who is approximately between 50 to 99 percent of the catheter length.
    [0005]
    5. Assembly of catheter (1, 101) according to any of the preceding claims 1, 2, 3 or 4, characterized by the fact that the extraction means (17, 111) are in the form of a strip that has at least at least one length extending from a proximal end coupled to a catheter coupling area and a distal end which is contiguous with the opening (6, 103) of the catheter package.
    [0006]
    6. Catheter assembly (1, 101) according to any one of the preceding claims 1, 2, 3, 4 or 5, characterized by the fact that the extraction means (17, 111) are in the form of a strip that it has a proximal end surrounding the catheter and a free distal end.
    [0007]
    7. Catheter assembly (1, 101), according to claim 6, characterized by the fact that the proximal end of the strip surrounding the catheter has a diameter that is smaller than at least the distal end of the catheter.
    [0008]
    8. Catheter assembly (1, 101) according to any of the preceding claims 1, 2, 3, 4, 5, 6 or 7, characterized by the fact that the opening (6, 103) of the catheter package is provided openable closing means (14, 105) that seal the catheter package cavity from the ambient space.
    [0009]
    9. Assembly of catheter (1, 101), according to claim 8, characterized by the fact that the extraction means (17, 111) are coupled to the closing means that can be opened (14, 105).
    [0010]
    10. Catheter assembly (1, 101) according to any of the preceding claims 1, 2, 3, 4, 5, 6, 7, 8 or 9, characterized by the fact that the extraction means are coupled to the packaging.
    [0011]
    11. Catheter assembly (1, 101) according to any one of the preceding claims 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10, characterized in that one end of the extraction means it is movably coupled to the packaging.
    [0012]
    12. Catheter assembly (1, 101) according to any one of claims 9, 10 or 11, characterized by the fact that the closing means (14, 105) are provided with fixing means to fix the closing means to a surface area.
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    同族专利:
    公开号 | 公开日
    RU2598811C2|2016-09-27|
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    BR112013022325A2|2016-12-06|
    RU2013145510A|2015-04-27|
    US20130327664A1|2013-12-12|
    EP2686054A1|2014-01-22|
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    法律状态:
    2018-12-18| 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|
    2020-10-06| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DKPA201170128|2011-03-18|
    DKPA201170128|2011-03-18|
    PCT/DK2012/050080|WO2012126474A1|2011-03-18|2012-03-16|A catheter assembly|
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