• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    catheter with insertion aid partially opened. a tubular insertion aid for catheter manipulation is disclosed. insertion aid is particularly suitable for urinary catheters, such as hydrophilic urinary catheters for intermittent use. the tubular insertion aid comprises a front opening (10), a rear opening (11) and a slit opening (12) extending along a portion of the side wall of the tubular insertion aid, so that a first portion ( 1a) of the tubular insertion aid in the axial direction forms a solid circumference around the tubular insertion aid, and a second portion (1b) in the axial direction is provided with the slotted opening in an axial direction of the tubular insertion aid. the tubular insertion aid further comprises a first inward protrusion (14) formed on the inner side of the tubular insertion aid in a part of the second portion being provided with the slit, wherein the first inward protrusion is disposed along a first line of protrusion, extending along the circumference into the tubular insertion aid essentially perpendicular to the axial direction of the tubular insertion aid.
    公开号:BR112014010864B1
    申请号:R112014010864-1
    申请日:2013-02-15
    公开日:2021-08-24
    发明作者:Evelina Gustavsson
    申请人:Dentsply Ih Ab；
    IPC主号:
    专利说明:

    Technical field of invention
    [001] The present invention is related to a catheter, in particular a urinary catheter, with an insertion aid to facilitate the manipulation of the catheter. Fundamentals of the Invention
    [002] Catheters, such as urinary catheters, and in particular hydrophilic-coated catheters, are relatively difficult to handle, as the surface prior to application is very slippery. Furthermore, direct contact with the insertable part of the catheter should preferably be avoided in order to avoid contamination of the catheter and thus minimize the risk of, for example, urinary tract infections. Also, many users of intermittent urinary catheterization are deficient or have little dexterity for other reasons and, consequently, there is also a need for means to make the manipulation and insertion of catheters easier and cleaner/safer.
    [003] To overcome these problems, many alternative insertion aids have been proposed in recent years. For example, EP 1 131 022 discloses an applicator which is formed as a member of an integrated and detachable hose disposed in the catheter package, in which the catheter is disposed. However, as a consequence, the catheter package becomes relatively complicated and expensive, and also, the operation using this catheter assembly is relatively complex.
    [004] Furthermore, EP 2 106 821 discloses a catheter assembly in which an insertion aid is arranged as a tubular part disposed along the connector part of the catheter. Upon use, the tubular insertion aid can be loosened from its position in the connector and moved along the catheter shaft. However, this solution is also relatively complicated and expensive, since the assembly of the product is rather complicated, and the proper connection of the tubular part to the connector and, at the same time, the easy detachment by the user is difficult to be achieved.
    [005] Therefore, there is still a need for a catheter assembly with an insertion aid that is easier to use and/or easier and more cost-effective to produce. Invention Summary
    [006] There is, therefore, an object of the present invention to provide a catheter and a production method that, at least partially, overcomes the problems of the prior art discussed above.
    [007] This objective is achieved by means of a catheter and a production method according to the claims included.
    [008] According to a first aspect of the invention, a tubular insertion aid for manipulating the catheter is provided, comprising a front opening, a rear opening and a slit opening, extending along a part of the side wall of the tubular insertion aid, so that a first portion of the tubular insertion aid in the axial direction forms a solid circumference around the tubular insertion aid, and a second portion in the axial direction is accompanied by an opening slit extending in one direction of the tubular insertion aid, the tubular insertion aid further comprising a first inward protrusion formed on the inner side of the tubular insertion aid in a part of the second portion being provided with said said slit, such first inward protrusion being disposed to the along a first line of protrusion, extending along the circumference into the tubular insertion aid essentially per perpendicularly to the axial direction of the tubular insertion aid.
    [009] The insertion aid can be used for catheter manipulation, thus avoiding the need to directly touch the catheter and in particular the insertable part of the catheter. This reduces the risk of contamination of the insertable portion of the catheter prior to insertion. It can also be used to manipulate the catheter during and after withdrawal, thus avoiding the risk of the user being contaminated by the used catheter.
    [0010] The insertion aid herein comprises a protrusion, which can be coupled with a recession or the like in the catheter and/or catheter connector, thereby firmly connecting the insertion aid to the catheter. The connection is a mechanical lock, which keeps the insertion aid conserved in an intended position. At the same time, the insertion aid is easy to mount to the catheter and easy to disassemble before intended use. This is due to the arrangement of the slot opening in the same axial section of the tubular insertion aid as the protrusion, so that the protrusion line and slot opening intersect. Hereby, the slotted opening provides greater flexibility for insertion aid in the vicinity of the protrusion, which facilitates assembly and disassembly. For example, the user can squeeze the first part of the tubular insertion aid, which forces the opening slit to be further open and thereby the mechanical connection between the protrusion and the catheter to be loosened.
    [0011] The new insertion aid is also well suited to efficient assembly and fabrication. The specific insertion aid can, for example, be injection molded. In addition, the simple and efficient connection between the insertion aid and the catheter ensures that the insertion aid remains in place on the catheter prior to use and intentional disconnection. This also facilitates packaging of the catheter and insertion aid. Thus, the insertion aid remains securely in place during packaging, sterilization, transport, storage, activation prior to use, during removal of the catheter from the package, etc. - that is, in every manipulation until a deliberate disconnection of the insertion aid. At the same time, deployment is made very simple, even for users with reduced dexterity.
    [0012] After the removal of the catheter insertion aid, the insertion aid is usable as an insertion aid to maneuver the catheter during insertion into the human cavity.
    [0013] In addition, the insertion aid will always be held securely in place before it is removed and used as an insertion aid. At the same time, if the user does not need an insertion aid to manipulate the catheter, the insertion aid can be allowed to remain in its unreleased state throughout use. Even in this way of using the catheter, where the io insertion aid remains undisconnected, the insertion aid is advantageous as it thereby provides an increased portion of adherence to the catheter, which facilitates insertion and removal of the catheter , especially for users with reduced dexterity.
    [0014] The insertion aid is easier to remove and then to move along the length of the elongated nail, thus facilitating contamination-free catheter manipulation, which reduces the risk of urinary tract infections and the like.
    [0015] In addition, the tubular insertion aid is easy and cost-effective to produce, for example, by injection molding and is also easy to mount on the catheter during fabrication, either manually or automatically.
    [0016] The slotted opening may extend entirely in the axial direction of the tubular insertion aid or, alternatively, it may extend partly in the axial direction and partly in other directions.
    [0017] The tubular insertion aid may include only the first and second portions, in which case the front opening is mounted on the first portion and the rear opening is mounted on the second portion. Preferably, the first portion is mounted between the second portion and the front opening, and the second portion is preferably mounted between the first portion and the rear opening. However, additionally, an additional portion of tubular insertion aid in the axial direction may be provided, between the front opening and the first portion, between the first portion and the second portion, and/or between the second portion and the rear opening.
    [0018] The solid circumference around the tubular insertion aid s does not need a uniform thickness around the circumference. However, this implies an unbroken connection of material around the circumference.
    [0019] The first inward protrusion may include a solid protruding line extending along the first protrusion line. However, the first inward protrusion may also include two or more protrusions arranged around said first protrusion line.
    [0020] Further, the tubular insert aid preferably comprises a second inward protrusion formed on the inner side of the tubular insert, the second protrusion being disposed along a second protrusion line, extending along the inward circumference of the tubular insertion aid essentially perpendicular to the axial direction of the tubular insertion aid, in which the second line of protrusion is separated from the first line of protrusion in the axial direction of the tubular insertion aid. Such a second protrusion or posterior protrusion may further contribute to the mechanical interlock between the catheter and the tubular insertion aid. Preferably, the second protrusion is arranged to function as an obstruction to prevent further advancement of the tubular insertion aid into the catheter connector during assembly. Too long a advance can result in a very strong connection between the tubular insertion aid and the catheter, which would make subsequent disconnection of the tubular insertion aid more difficult. Thus, the second protrusion makes fabrication and assembly simpler and more cost-effective, and also ensures that the insertion aid is easily detachable by the user. To this end, it is therefore preferable that the second protrusion line be mounted at or adjacent to the junction between the first and second portions of the tubular insertion aid. Hereby, the blocking function of the second portion becomes essentially affected by squeezing the first portion of the tubular insertion aid. However, by using somewhat greater force, it would be possible to further advance the insertion aid along the catheter connector. This can be advantageous as it makes it possible to expose the entire catheter shaft for users who need to make use of the entire length of the catheter.
    [0021] In addition, the design of the insertion aid, together with a possible relative softness and flexibility of the material from which the insertion aid is made, ensures that the catheter and, in particular, hydrophilic coatings and the like, are not damaged, or at least that such damage is minimized.
    [0022] In a preferred embodiment, the second portion of the tubular insertion aid extends between the first portion of the tubular insertion aid and the rear opening of the tubular insertion aid, and the slit opening of the second portion does not extend to the rear opening, thus forming a solid circumference around the tubular insertion aid in the vicinity of the rear opening. By this means, the slotted opening becomes a closed opening, being closed at both a front and a rear end. This ensures that the increased flexibility offered by the slit opening is only provided at an intermediate part of the tubular insertion aid and both ends of the tubular insertion aid are affected by this increased flexibility. This provides greater stability for the insertion aid and an even better connection between the catheter and the insertion aid. Also, this is an advantage during fabrication as it prevents the tubular insert aids from sticking together. Preferably, the solid circumference around the tubular insertion aid in the vicinity of the rear opening is provided with a smaller wall thickness on the extent of the slotted opening than on the rest of the circumference. Hereby, the closure of the rear end of the slotted opening acts like an elastic and is provided with greater elasticity and flexibility. However, a uniform wall thickness on the solid circumference in the vicinity of the rear opening is also feasible.
    [0023] Furthermore, the tubular insertion aid is preferably at least partially tapered. In a preferred embodiment, the first portion of the insertion aid is at least partially tapered, while the second portion has an essentially uniform diameter. It is also preferable that the rear opening has a larger transverse dimension than the front opening.
    [0024] The first portion can be provided with grip shapes on the externally oriented side. This makes handling and tightening of the first portion easier, which makes it easier to disconnect the tubular insertion aid from the catheter and use the insertion aid to maneuver the catheter. Adhesion shapes can be formed by at least one of the outer protrusions, corrugations, embossments and perforations.
    [0025] The tubular insertion aid is preferably made of a flexible plastic material. The material can be any thermoplastic and/or thermoset plastic material that is usable to provide sufficient strength and flexibility for the intended use. In one embodiment, the tubular insertion aid can be made of thermoplastic elastomer, such as the commercially available Dryflex®.
    [0026] According to another aspect of the present invention, there is provided a catheter assembly comprising a catheter and tubular insertion aid of the type discussed above, and wherein the catheter is composed of a front insertion part and a rear part of the connector, where the connector part forms a waist, having a transverse dimension of extension less than that of the portions around the connector part, and where, in a storage position, the insertion aid is arranged around the part. of the catheter connector so that the first protrusion line of the tubular insertion aid covers said catheter waist, thereby detachably connecting the tubular insertion aid to the catheter. By means of this aspect of the invention similar advantages and possible additional features are obtained as discussed above in relation to the first aspect of the invention.
    [0027] By "connector" and "connector part" is defined in this application the rear end of the catheter, which can be used to connect the catheter to the outer tube, a urine collection bag or something similar. However, namely the connector does not necessarily need to be connected to anything, but it can also serve as a discharge end itself. Furthermore, the connector may have a specific geometric shape, such as being at least partly tapered, having a conical trunk shape, being dilated, or something similar. However, in the most general sense, the connector need not have a geometric shape, distinguishing it in the catheter tube and may, for example, in its simplest form be an integrated back part of the catheter tube. In addition, the connector can be a separate component that is connected to the catheter tube during fabrication, or it can be formed as an integral, unified part of the catheter tube.
    [0028] The catheter connector portion of preferably comprises a discharge end that forms an inwardly tapered end. The externally oriented surface of the end of the connector may have an essentially uniform diameter, or it may also be tapered.
    [0029] Preferably, the connector part of the catheter and the tubular insertion aid are both made of the same material. This facilitates fabrication and also provides adequate friction between the connector and the tubular insertion aid. In addition, the elongated shaft and the tip of the catheter portion can also be of the same material. Alternatively, the various components of the catheter can be of different materials. For example, the connector part and the insertion aid can be formed from two different materials. Other parts of the catheter, such as the tip portion 5, may also optionally be formed of a different material than the rest of the elongated shaft.
    [0030] The catheter is preferably a hydrophilic catheter, wherein the front insertion portion is at least partially provided with a hydrophilic material, exhibiting low friction surface properties when wet. The hydrophilic material is preferably arranged on at least one insertable length of the catheter.
    [0031] Furthermore, the catheter is preferably a urinary catheter and preferably a urinary catheter for intermittent use.
    [0032] According to yet another aspect of the present invention, there is provided a catheter composition comprising a catheter assembly of the type discussed above and a package surrounding said catheter. By means of this aspect of the invention, similar advantages and possible additional features as discussed above in relation to the first aspect of the invention are obtainable.
    These and other aspects of the invention will be evident and elucidated with reference to the embodiments described below. Brief description of the figures
    [0034] For exemplary purposes, the invention will be described in more detail below with reference to the respective embodiments illustrated in the attached drawings, in which: Fig. 1 is a side view, in perspective of a tubular insertion aid according to an embodiment of the present invention. Fig. 2 is a top perspective view of the tubular insertion aid of Fig. 1. Figures 3A and 3B are side perspective views of 30 catheters with tubular insertion aid, shown in storage and use positions, respectively. . Fig. 4 illustrates a catheter assembly including a tubular insertion aid. Fig. 5 illustrates an expanded side view of the catheter assembly of Fig. 4 Detailed description of preferred modalities
    [0035] In the following detailed description, preferred embodiments of the present invention will be described. However, it should be understood that features of different modalities are interchangeable between modalities and can be combined in different ways, unless something else is specifically indicated. It may also be noted that, for reasons of clarity, the dimensions of certain components illustrated in the drawings may differ from the corresponding dimensions in actual implementations. Even though in the description below, numerous specific details are described to provide a deeper understanding of the present invention, it will be evident to those skilled in the art that the present invention can be practiced without such specific details. In other cases, well-known constructions or functions are not described in detail, so as not to obscure the present invention.
    [0036] The following discussion is in particular related to hydrophilic urinary catheters for intermittent use. However, the invention can also be used in connection with other types of urinary catheters, or other types of catheters in general.
    [0037] A tubular insertion aid according to an exemplary embodiment will be discussed first with reference to Figures 1 and 2. The tubular insertion aid is preferably intended to be arranged along the back or the connector portion of the catheter in storage position and to be loosened and moved along the catheter during catheter insertion, for contamination-free handling of the catheter.
    [0038] The tubular insertion aid 1 comprises a generally tubular member, comprising a forward opening 10, a rear opening 11 and a slit opening 12, extending along a part of the side wall of the tubular insertion aid. Hereby, the tubular insertion aid comprises a first portion 1A of the tubular insertion aid in the axial direction, which forms a solid circumference around the tubular insertion aid, and a second portion 1B in the axial direction is provided with the opening at slit extending in an axial direction of the tubular insertion aid. In the condition mounted on a catheter, the front opening 10 faces the insertion of the catheter, whereas the rear opening 11 faces the non-insertable rear end of the catheter.
    [0039] The slotted opening 12 can extend entirely in the axial direction of the tubular insertion aid, as in the exemplary embodiment shown. However, as an alternative it can extend partially in the axial direction and partially in other directions, that is, in an oblique direction with respect to the axial direction.
    [0040] The tubular insertion aid may comprise only the first portion 1A and the second portion 1B, in which case the front opening 10 is mounted on the first portion 1A and the rear opening 11 is mounted on the second portion 1B. However, additional portions may be provided between the front opening and the first portion, between the first and second portion, and/or between the second portion and the rear opening.
    [0041] In the exemplary embodiment, the first portion 1A is arranged between the second portion 1B and the front opening 10, and the second portion is arranged between the first portion 1A and a third portion 1C. The third portion is arranged between the second portion 1B and the rear opening 11. Similar to the first portion, the third portion 1C forms a solid circumference around the insertion aid. However, while the first portion 1A extends over a substantial part of the tubular insertion aid, the third portion 1C has a very short axial extension. Preferably, the first portion extends over 10-60% of the axial length of the tubular insertion aid and more preferably over 25-50%. The second portion preferably extends over 20-70% of the axial length of the tubular insertion aid and more preferably over 30-60%. The third portion preferably extends along 0-10% of the axial length of the axial length of the tubular insertion aid and preferably along 1-5%. Hereby, the slit opening becomes a closed opening, being closed at both the front and rear ends. This ensures that the increased flexibility offered by the slit opening is only provided at an intermediate part of the tubular insertion aid and both ends of the tubular insertion aid are affected by this increased flexibility.
    [0042] In a preferred embodiment, the third portion has a narrower thickness in the extension of the opening slit, whereby a thin, narrow cord 13 extends along the opening slit in the vicinity of the rear end 11. This wire Thin 13 in this way provides greater flexibility than the rest of the side walls that form the tubular insertion aid.
    [0043] Furthermore, the tubular insertion aid is preferably at least partially tapered. In a preferred embodiment, the first portion 1A of the insertion aid is at least partially tapered, while the second portion 1B and the optional portion 1C are of essentially uniform diameters. It is also preferable that the rear opening has a larger transverse dimension than the front opening 11.
    [0044] The tubular insertion aid further comprises a first inward protrusion 14 formed on the inner side of the tubular insertion aid in a part of the second portion 1B being provided with the slotted opening 12. The first inward protrusion 14 is arranged at the along a first line of protrusion extending along the circumference into the tubular insertion aid essentially perpendicular to the axial direction of the tubular insertion aid. This first protrusion can be engaged with a recession or similar in the catheter, thereby firmly connecting the insertion aid to the catheter, as discussed further below. The first inward protrusion 14 may include a solid protruding line extending along the first protrusion line. However, the first inward protrusion may also include two or more protrusions arranged around said first protrusion line.
    [0045] Further, the tubular insert aid preferably comprises a second inward protrusion 15 formed on the inner side of the tubular insert, the second inward protrusion being 15 arranged along a second protrusion line, extending along the circumference inward of the tubular insertion aid essentially perpendicular to the axial direction of the tubular insertion aid. This second protrusion line is separated from the first protrusion line in the axial direction of the tubular insertion aid. Preferably, the second protrusion 15 is arranged at or adjacent to the junction between the first portion 1A and the second portion 1B. It is more preferable that the second protrusion 15 is formed directly in front of the slotted opening 12. In such a position, the second protrusion can function as an obstruction to prevent the tubular insertion aid from over-advancing the connector during assembly. However, other locations of the second protrusion are also feasible, and it is also possible to have the third or later protrusion arranged along the third or later protrusion lines. Such additional protrusions can serve to provide improved mechanical locking of the catheter, or to serve as buttresses to prohibit unwanted advancement.
    [0046] The first portion 1A can be provided with externally oriented side gripping means. This makes handling and tightening of the first portion easier, which makes it easier to disconnect the tubular insertion aid from the catheter and use the insertion aid to maneuver the catheter. Adhesion forms can be composed of at least one of the externally oriented protrusions, corrugations, embossing and perforations. In the example shown, grip shapes 15 in the form of externally oriented protruding grip lines are provided. In the illustrative example, three grip lines are provided.
    [0047] However, fewer or more grip lines can also be used, and other types of grip shapes are also feasible.
    [0048] In addition, an externally oriented protruding grip line or flange 16 is also preferably arranged in proximity to the rear opening.
    [0049] The tubular insertion aid is preferably made of a flexible plastic material. The material can be any thermoplastic and/or thermoset plastic material that is usable to provide sufficient strength and flexibility for the intended use. In one embodiment, the tubular insertion aid can be made of thermoplastic elastomer, such as the commercially available Dryflex®. However, other materials are also viable. For example, the material can be one or more of: a polymer material, such as polyurethanes, thermoplastic rubbers, PVC, other vinyl polymers, polyesters, polyether-polyamide, polypropene, polyethylene polyamide and styrene-ethylene/butadiene-styrene copolymer, polyacrylates and polysiloxanes. The material can also be a combination of polymers comprising a polyolefin and a compound having molecules with active hydrogen groups and preferably a composition having molecules with active hydrogen groups. The polyolefin can include at least one polymer selected from the group: polyethylene, polypropene and styrene-ethylene-butylene-styrene copolymer (SEBS). A composition having molecules with active hydrogen groups can be a polymer having active hydrogen groups bonded to the polymer via nitrogen, such as polyamide or polyurethane.
    [0050] The insertion aid is preferably flexible enough to be compressed, for example by applying pressure between the thumb and index finger, along the elongated rod. Sufficient flexibility of the insertion aid can be obtained by forming it of a material that is sufficiently flexible, and/or that has a sufficiently narrow thickness.
    [0051] Additionally, the thickness may vary along the tubular part, making some parts more flexible than others. Preferably, the tubular part has a Shore A hardness in the range 40-80 and preferably in the range 50-70 and more preferably in the range 55-65.
    [0052] In a preferred embodiment, the Shore A hardness is above 40 and more preferably above 50. In another preferred embodiment, the Shore A hardness is preferably below 80 and even more preferable below 70. In another embodiment Preferably, the Shore A hardness is about 60.
    [0053] The tubular insertion aid can, for example, be manufactured by injection molding.
    [0054] The tubular insertion aid, as discussed above, is preferably mounted on a rearwardly facing end of a catheter and a catheter assembly comprising a catheter and a tubular insertion aid will now be discussed with reference to Figures 3A and 3B .
    [0055] The catheter 2 comprises a forward-facing insertion part 20 and a rearward-facing connector part 21, in which the connector part forms a waist 22, having a transverse dimension of lesser extension than the surrounding parts. of the connector part 21. In a preferred embodiment, the connection 21 is composed of a tapered rear end 21A tapering towards the insertion end of the catheter and a somewhat flared front end 21B. Front end 21B is preferably untapered. Front end 21B may also be provided with corrugations or the like to improve grip and bonding properties. However, other configurations of the rear connection 21 are also feasible, such as a cylindrical outer surface being provided with a similar indentation or waist, or other types of non-circular circumference.
    [0056] The front insertion portion 20 preferably comprises an elongated rod with an insertion end. The insertion end is preferably provided with one or more drainage openings, in fluid communication with an internal lumen of the catheter.
    [0057] The rear connection 21 is further composed of a discharge end and is preferably combined with an internally tapering surface, mounted to be connectable to a frusto-conical connection for an external piping or a urine collection bag.
    [0058] The catheter can be any size suitable for catheterization. For use by female users, the elongated shaft preferably has a length in the range of 5 to 20 cm, as in the 15 cm size. For male users, the elongated shank preferably has a length in the range of 18-45 cm, for example, in the size of 40 cm.
    [0059] To further facilitate catheter insertion, the elongated shaft may include a hydrophilic material on the surface, provided such hydrophilic material presents a low friction characteristic to the catheter surface when wet. For example, the elongated rod can be made essentially and entirely of a hydrophilic material. Alternatively, the elongated stem can be provided with a hydrophilic surface coating.
    [0060] The hydrophilic material can be, for example, polyvinylpyrrolidone (PVP), but many other types of hydrophilic coatings are well-versed in the art and can be used in the context of the present invention. The hydrophilic coating provides a low friction characteristic to the catheter when wet, thus facilitating insertion of the catheter into the urethra and reducing the risk of pain, etc.
    [0061] More specifically, the hydrophilic material may include material(s) selected from polyvinyl compounds, or polysaccharides, polyurethanes, polyacrylates or vinyl copolymer compounds and acrylates or anhydrides, especially polyethylene oxide, polyvinylpyrrolidone, heparin, dextran, xanthan gum, polyvinyl alcohol, hydroxypropylcellulose, methylcellulose, copolymer of vinylpyrrolidone and hydroxy ethylmethyl acrylate or copolymer of polymethylvinyl ether and maleic acid anhydride. The preferred hydrophilic polymer is polyvinylpyrrolidone.
    [0062] If the hydrophilic material is combined as a coating, the coating preferably forms a polyurea network, whereby such polyurea network forms a covalent bond with said active hydrogen groups on the substrate. Alternatively, the hydrophilic coating may form an ester bond or an epoxy bond with said active hydrogen groups on the substrate.
    [0063] The coating may also include an osmotic pressure increasing compound, as for example taught in EP 0 217 771.
    [0064] In a mounted storage position, the tubular insertion aid, as exhaustively discussed above, is arranged along the catheter connection so that the first protrusion line of the tubular insertion aid covers said catheter waist, thus, detachably connecting the tubular insertion aid to the catheter. This storage position is illustrated in Fig. 3A.
    [0065] The connection is a mechanical lock that holds the insertion aid in a desired storage position. At the same time, the insertion aid is easy to mount to the catheter and easy to disassemble before intended use. This is due to the arrangement of the slot opening in the same axial section of the tubular insertion aid as the protrusion, so that the protrusion line and slot opening intersect. Hereby, the slotted opening provides greater flexibility for insertion aid in the vicinity of the protrusion, which facilitates assembly and disassembly. For example, the user can squeeze the first part 1A of the tubular insertion aid, which forces the slit opening to be further open and thereby the mechanical connection between the protrusion and the catheter to be loosened.
    [0066] After removal of the insertion aid of the catheter, the insertion aid is usable as an insertion aid to maneuver the catheter during insertion into the human cavity, as illustrated in Fig. 3B. In this position, the insertion aid can be moved along the length of the elongated shaft, thus facilitating contamination-free handling of the catheter, which reduces the risk of urinary tract infections and the like.
    [0067] Preferably, the catheter connection and the tubular insertion aid are both made of the same material. This facilitates fabrication and also provides adequate friction between the connector and the tubular insertion aid. Furthermore, the elongated shaft and the tip portion of the catheter can also be of the same material. Alternatively, the various components of the catheter can be of different materials.
    [0068] The catheter assembly discussed above, comprising a catheter and a tubular insertion aid, can be arranged in a catheter assembly comprising a catheter assembly of the type discussed above, and a package 4 surrounding said catheter assembly. Such a catheter assembly will now be disclosed with reference to Figures 4 and 5.
    The package 4 includes a catheter 2 and a tubular insertion aid 1 mounted therein, as discussed above. The package may further include a liquid wetting agent, preferably disposed in a liquid wetting container 5, for activating the hydrophilic surface of the catheter.
    [0070] The liquid wetting can be arranged separately from the catheter, in a wetting liquid container 5, such as a bag or a sachet. The wetting fluid container is opened, for example by exerting pressure on the container, whereby the wetting liquid is released into the pack, thereby wetting the hydrophilic surface of the catheter. However, as an alternative the wetting liquid can be arranged in direct contact with the catheter and the hydrophilic surface during storage, thus providing an immediately ready-to-use catheter assembly.
    [0071] The wetting fluid is preferably an aqueous liquid such as water or saline.
    [0072] Such wetting fluid and wetting fluid containers are skilled in the art itself.
    [0073] The package can be formed from laminated materials, such as a first laminated material 41 and a second laminated material 42, connected around the edges to form an interior cavity housing the catheter and wetting liquid. The first and second laminated materials are preferably bonded around the edges by welding, forming a welded edge 6. Preferably, the first and second sheet materials comprise laminated sheets, having a weldable inner layer and a protective outer layer. However, one or both of the blades can alternatively be unlaminated and consist of, for example, extruded or co-extruded material. The laminated materials are preferably a flexible plastic material. For example, the sheets can be made of polymer materials such as polyethylene, polypropylene, polyamide, and PET, or the container can be made of a laminate of such polymer materials and/or aluminum, aluminum oxide, or oriented polypropylene ( OPP).
    [0074] One of the blades can also be molded by deep drawing in the form of a trough.
    [0075] In addition, the pack can be opened for removal of the catheter before an intended use. For this purpose, the package can be supplied with easy opening, adhesive opening or similar. For example, sheets can be arranged to be detached from each other in one or multiple locations. However, preferably the opening is arranged as a resealable opening. Such a resealable opening can, for example, be formed by forming a full or partial cut through the unclosed curve 71 in one of the sheets and to add an additional opening sheet 7 over this curve. The fixing of the sheet 7 can, for example, be done by adhesive.
    [0076] In addition, means for attaching the catheter IS package to a wall, a sink, or the like may be provided. Such means may, for example, include an adhesive area disposed on one of the blades, preferably the blade not provided with the opening and covered by a peelable cover blade 8.
    [0077] A method for producing a catheter assembly of this type 20 includes the steps of: • Mounting a tubular insertion aid to a catheter. • Arrange the catheter and a wetting liquid container on one of the slides. This sheet is preferably molded by deep drawing in the form of a gutter. • Connecting the second blade on top of the first blade, thus closing the package. • Optionally attach opening blade and cover blade to package.
    [0078] Of course, the order of these steps may be different and, for example, the package may be partially closed prior to insertion of the catheter and/or the wetting fluid container. Furthermore, fixing the opening sheet and/or the cover sheet can be carried out before or after any of the other steps.
    [0079] The present invention has now been disclosed with reference to specific exemplary embodiments. However, it will be recognized by the knowledgeable recipient that several modifications are possible. For example, the tubular insertion aid can be provided with more parts, more internal or external protrusions, more slotted openings and the like. In addition, the tubular insertion aid can be used for other types of catheters, for example, catheters having different shaped end connectors, and the catheter set can also be arranged in many different shapes of catheter sets.
    [0080] The modifications discussed above and other obvious ones are to be considered to be within the scope of the present invention as defined by the appended claims. Note that the aforementioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In claims, any reference signs enclosed in parentheses shall not be construed as limiting the claim. The word "comprising" does not exclude the presence of elements or steps other than those listed in the claim. The words "a" or "an" preceding an element do not exclude the presence of a plurality of such elements.
    权利要求:
    Claims (15)
    [0001]
    1. Tubular insertion aid (1) for manipulating the catheter, characterized in that it comprises a front opening (10), a rear opening (11) and a slotted opening (12), extending along a portion of the side wall of the tubular insertion aid, so that a first portion (1A) of the tubular insertion aid in the axial direction forms a solid circumference around the tubular insertion aid, and a second portion (1B) in the axial direction is provided with the slotted opening extending in an axial direction of the tubular insertion aid, the tubular insertion aid further comprising a first inward protrusion (14) formed on the inner side of the tubular insertion aid in a part of the second portion (1B) being provided with said slit, wherein the first inward protrusion (14) is disposed along a first protrusion line extending along the circumference into the essentially perpetual tubular insertion aid. cular to the axial direction of the tubular insertion aid (1).
    [0002]
    2. Tubular insertion aid (1), according to claim 1, characterized in that it further comprises a second inward protrusion formed on the inner side of the tubular insert, the second inward protrusion being arranged along a second line of protrusion extending along the circumference into the tubular insertion aid essentially perpendicular to the axial direction of the tubular insertion aid, wherein the second protrusion line is separated from the first protrusion line in the axial direction of the tubular insertion aid .
    [0003]
    3. Tubular insertion aid (1), according to claim 2, characterized in that the second protrusion line is arranged at or adjacent to the junction between the first and second portions (1A, 1B) of the tubular insertion aid.
    [0004]
    4. Tubular insertion aid (1) according to any one of the preceding claims, characterized in that the second portion (18) of the tubular insertion aid extends between the first portion (1A) of the tubular insertion aid and the rear opening (11) of the tubular insertion aid, and wherein the slit opening (12) of the second portion (1B) does not fully extend to the rear opening (11), thus forming a solid circumference around the tubular insert in the vicinity of the rear opening (11).
    [0005]
    5. Tubular insertion aid (1) according to claim 4, characterized in that the solid circumference around the tubular insertion aid in the vicinity of the rear opening (11) is provided with a smaller wall thickness in the extension of the slit opening (12) than in the rest of the circumference.
    [0006]
    6. Tubular insertion aid (1), according to any one of the preceding claims, characterized in that the tubular insertion aid is at least partially tapered.
    [0007]
    7. Tubular insertion aid (1), according to any one of the preceding claims, characterized in that the rear opening (11) has a transverse dimension greater than the front opening (10).
    [0008]
    8. Tubular insertion aid (1), according to any one of the preceding claims, characterized in that the first portion (1A) is provided with grip forms (15) on the externally oriented side.
    [0009]
    9. Tubular insertion aid (1), according to claim 8, characterized in that the forms of adhesion (15) are formed by at least one of the external protrusions, corrugations, relief and perforations.
    [0010]
    10. Tubular insertion aid (1), as defined by any of the preceding claims, characterized in that the tubular insertion aid is made of a flexible plastic material and preferably a thermoplastic and/or thermoset plastic material and more preferably a thermoplastic elastomer.
    [0011]
    11. Catheter set consisting of a catheter (2) and the tubular insertion aid (1), according to any one of claims 1-10, characterized in that the catheter is composed of a front insertion part (20 ) and a rear connector portion (21) wherein the connector portion forms a waist (22) having a transverse extension dimension less than that of the portions around the connector portion (21), and wherein, in a storage position, the insertion aid (1) is arranged around the connector portion (21) of the catheter so that the first protrusion line (14) of the tubular insertion aid covers said waist (22) of the catheter. thus detachably connecting the tubular insertion aid to the catheter.
    [0012]
    12. Catheter assembly according to claim 11, characterized in that the connector part (21) of the catheter and the tubular insertion aid (1) are both made of the same material.
    [0013]
    13. Catheter set according to claims 11 or 12, characterized in that the catheter (2) is a hydrophilic catheter, in which the front insertion part (20) is at least partially provided with a hydrophilic material, exhibiting low friction surface properties when wet.
    [0014]
    14. Catheter set according to claims 11 or 12, characterized in that the catheter (2) is a urinary catheter and preferably a urinary catheter for intermittent use.
    [0015]
    15. Catheter set, characterized in that it comprises a catheter set according to any one of claims 11-14 and a package (4) surrounding said catheter set
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    同族专利:
    公开号 | 公开日
    KR102087871B1|2020-03-11|
    EP2636421B1|2017-08-23|
    EP2636421A1|2013-09-11|
    RU2014115867A|2016-04-27|
    JP2015509410A|2015-03-30|
    BR112014010864A2|2021-01-26|
    CN103930155A|2014-07-16|
    KR20140139477A|2014-12-05|
    US20150141966A1|2015-05-21|
    WO2013131732A1|2013-09-12|
    HUE037137T2|2018-08-28|
    DK2636421T3|2017-12-04|
    IN2014DN03058A|2015-05-15|
    US9884167B2|2018-02-06|
    EP3272383A1|2018-01-24|
    RU2629246C2|2017-08-28|
    US20130231641A1|2013-09-05|
    JP6219319B2|2017-10-25|
    CN103930155B|2016-04-06|
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    法律状态:
    2021-02-02| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-06-01| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    2021-07-20| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-08-24| 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 15/02/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261606587P| true| 2012-03-05|2012-03-05|
    EP12158070.8|2012-03-05|
    US61/606,587|2012-03-05|
    EP12158070.8A|EP2636421B1|2012-03-05|2012-03-05|Catheter with partially slitted insertion aid|
    PCT/EP2013/053064|WO2013131732A1|2012-03-05|2013-02-15|Catheter with partially slitted insertion aid|
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