专利摘要:
catheter set. it is a catheter set comprising a urinary catheter and a packaging with flexible walls. a coupling means in the form of a first coupling member in the catheter and a second coupling member in the package is further provided. the coupling means are in the form of a projection or a depression in the second coupling member and a corresponding depression or projection in the first coupling member. the user can move the catheter in and out of the package without touching the catheter itself, thereby eliminating or minimizing the risk of contamination of the catheter.
公开号:BR112013013518B1
申请号:R112013013518-2
申请日:2011-12-13
公开日:2020-10-06
发明作者:Henrik Lindenskov Nielsen
申请人:Coloplast A/S;
IPC主号:
专利说明:

[0001] The invention relates to a urinary catheter assembly comprising a urinary catheter and a package. The urinary catheter has a first coupling member adapted for cooperation with a second coupling member in the package. Thereby, the catheter can be removed from the package by the coupling members. BACKGROUND
[0002] Urinary catheter sets are generally known to provide a user with an easy to use set that allows the user to empty their urinary bladder easily and conveniently.
[0003] One of the most common disadvantages affecting a user of urinary catheters is an increased tendency to contract a urinary tract infection as a side effect of inserting a foreign object into the urethra. One of the most critical problems that may concern the user when inserting a urinary catheter into the urethra is the need to keep the insertable part of the catheter assembly as sterile as possible, in order to minimize the risk of contracting urinary tract infections. One of the methods used to reduce the risk has been to develop catheter assemblies, which ensure the user can remove a catheter from its packaging and insert the catheter without having to touch the insertable part of the catheter assembly with the fingers before or during insertion. of the catheter. DESCRIPTION OF THE RELATED TECHNIQUE
[0004] Patent document WO98 / 11932 discloses a way to allow uncontaminated insertion of a catheter by providing a catheter package made of two layers of film which are joined along its periphery providing a detachable joint, which allows the two layers to be detached from each other to expose the catheter from the package and the package can be used as an applicator to be handled by the user. This way of allowing an uncontaminated insertion can be difficult for users who have reduced dexterity in their hands or fingers, since separating the layers may require fine movements.
[0005] Document No. W005 / 092419 discloses a catheter and a tubular package in which the catheter can be extended out of the package without touching the insertable part of the catheter. The distal end of the catheter is provided with a metal and the outside of the package is provided with a magnet, in which the movement of the magnet is transferred to the distal end of the catheter, which allows the catheter to be extended out of the package. Such a package can be seen as not being environmentally friendly for a single-use catheter set since the catheter package contains metals in the form of a magnet and the magnetic part of the catheter. SUMMARY OF THE INVENTION
[0006] The invention relates to a catheter assembly comprising a urinary catheter and a packaging with flexible walls. The catheter assembly is provided with a coupling means in the form of a first coupling member in the catheter and a second coupling member in the package. The coupling means is in the form of a projection or a depression in the second coupling member and a corresponding depression or projection in the first coupling member. The user can move the catheter in and out of the package without touching the catheter itself, thereby eliminating or minimizing the risk of contamination of the catheter. Furthermore, the catheter set can be seen as ecological. DETAILED DESCRIPTION OF THE INVENTION
[0007] And a first aspect, the invention relates to a urinary catheter assembly comprising: - a urinary catheter that has a proximal end for insertion into the urethra and a distal end that comprises a first coupling member - a package of a catheter comprising a tubular member having walls of a flexible material, and having a proximal end and a distal end defining a longitudinal geometric axis of the catheter package in which the flexible tubular member comprises a cavity for accommodating the urinary catheter to the along the longitudinal geometric axis of the catheter package and the catheter package and where the proximal end of the catheter package is arranged to allow exposure of the proximal end of the urinary catheter, and - a second coupling member that is arranged on a surface outside of the catheter packaging wall on which the second coupling member is provided with a coupling means for to engage the first coupling member through the flexible wall of the catheter package, so that the catheter can be maneuvered along the longitudinal geometric axis of the catheter package, the coupling means being in the form of a protrusion or a depression in the internal surface area that communicates with a corresponding depression or projection on the first coupling member.
[0008] The user can hold the tubular package with one hand and the second coupling member with the other hand and move the second coupling member in relation to the catheter package along the longitudinal geometric axis of the catheter package. This means that the catheter can be maneuvered out of the end of the package during and / or before insertion of the catheter into the urethra without having to come into direct contact with the insertable part of the catheter. When the insertable part of the catheter extends outside the package, the user can hold the catheter package and use the catheter package to maneuver the insertable part of the catheter into the urethra.
[0009] Another advantage of the present invention is that the user can position the catheter assembly so that insertion of the insertable part of the catheter can be performed while extending the catheter out of the package by positioning the proximal end of the tubular member close to the urethra and inserting the catheter by extending the catheter out of its packaging.
[00010] By allowing the catheter to be extended out of the package without having to touch the insertable part of the catheter, insertion of the catheter can be performed in almost any environment without the user having to prepare beforehand, for example, having to wash your hands or put on clean gloves, and still perform a catheter insertion under sterile conditions, or at least close to sterile conditions.
[00011] Furthermore, a catheter assembly according to the present invention allows the catheter to be retracted into the tubular member after an insertion without having to touch the inserted or used part of the catheter, in order to keep the user's hands free contamination of urine.
[00012] In addition, by arranging the catheter assembly according to the present invention, the tubular member can be used as an extension to the insertable catheter allowing the user to diverge the flow of urine from the distal end of the catheter to the distal end of the tubular member. This allows the user to position himself or herself at a distance from a toilet or drainage facility, which will assist users who may have reduced dexterity such as para- or quadriplegics.
[00013] The coupling means between the first and the second coupling members can be seen providing a mechanical correspondence between the first and the second coupling members, so that any longitudinal movement from one coupling member is transferred to the other member coupling. This means that an outer surface of the first coupling member that is in indirect contact with an inner surface of the second coupling member can be constructed in such a way that the first and second coupling members may not separate along the longitudinal geometric axis of the catheter packaging. Such a construction can be seen as a plug and socket configuration, in which the first coupling member is confined by the second coupling member so that when the second coupling member is moved the mechanical matching of the coupling members causes the first coupling member moves together with the second coupling member, relative to the tubular member of the catheter package.
[00014] In an embodiment of the present invention, the second coupling member can be arranged to surround the tubular member in a direction that is perpendicular to the longitudinal geometric axis of the catheter package. The indirect coupling between the first coupling member and the second coupling member, which occurs through the tubular member, can in some cases be depending on the stiffness or integrity of the first and / or the second coupling member. Thus, by providing a second coupling member surrounding the tubular member, it may be possible to construct a second coupling member that is rigid enough to provide continuous and uninterrupted pressure to the first coupling member during the movement of the two coupling members. coupling. In addition, a second coupling member surrounding the tubular member may be easier to access through the user in order to provide movement in the longitudinal direction of the catheter package.
[00015] In one embodiment, the first coupling means may be at least one radially inwardly extending protrusion that extends from an internal surface of the second coupling member. Such a projection can be constructed to engage a portion of the first coupling member, where the projection can decrease the maximum diameter of the second coupling member and where the first coupling member has an outer area that has a diameter that is greater than than the maximum diameter of the second coupling means. Thus, the projection may engage a depression in the first coupling member, or a projection may engage with an end portion of the first coupling member or the like. This construction allows the second coupling member to transfer pressure to the first coupling member through the tubular member where the force direction can be in the longitudinal direction of the catheter package, and this pressure transfer allows the first coupling member to move within the tubular member or catheter package as directed by the second coupling member.
[00016] In one embodiment, the first coupling means can be at least two radially inward protrusions which extend substantially diametrically facing each other from an internal surface of the second coupling member. By arranging the protrusions in said manner, the protrusions engage the first coupling member from opposite sides and can thereby reduce the risk that the first coupling member and the second coupling member may be disconnected from each other during the movement of the second coupling member. In addition, this allows the inner diameter of the second coupling member to be reduced in the direction in which the protrusions are facing each other, while maintaining a larger diameter in the direction that is substantially perpendicular in the radial direction to that of the protrusions. Such an arrangement allows the second coupling member to transfer pressure to certain areas of the first coupling member and is not in communication with the first coupling member in any other areas. Thus, the amount of surface area of the second coupling member that communicates with the first coupling member through the tubular member is small and this arrangement can reduce the friction between the outer surface of the tubular member and the inner surface of the second coupling member. coupling, which in turn reduces the forces required to maneuver the second coupling member along the longitudinal geometric axis of the catheter package.
[00017] In one embodiment of the present invention, a surface area of the second coupling member that is adjacent to the tubular member can be provided with a low friction surface. One of the problems affecting the ease of use of the catheter assembly according to the present invention is the frictional forces that occur between the inner surface of the second coupling member and the outer surface of the tubular member. High frictional forces or friction coefficients between the two surface areas may result in the user having to apply a considerable amount of force to move the second coupling member along the longitudinal geometric axis of the catheter package or the tubular member. This force / friction coefficient can be reduced by having a smaller surface area, where the two surfaces are in contact with each other, while another method of solving the same is by providing a low friction surface to the surface. second coupling member. Such a low friction surface can be provided in the form of a hydrophilic coating, a Teflon ™ coating, a wax coating or any type of suitable surface treatment that reduces frictional forces. Another means of reducing friction may be to provide the second coupling member and / or the tubular member with materials that, when in direct contact, have a low coefficient of friction.
[00018] Another means of reducing friction is to provide the tubular member with a similar surface area that has a reduced coefficient of friction, while maintaining at least a part of the surface area of the tubular member with a high friction area in which the user can manipulate the tubular member or the catheter package.
[00019] In an embodiment of the present invention, friction between the tubular member and the second coupling member can be provided by applying a layer of friction reduction lubricant, for example, silicone oil, to the outer surface of the tubular member , or a similar friction reduction lubricant. Alternatively, the friction-reducing lubricant can be applied to the inner surface of the second coupling member so that the amount of lubricant can be reduced and the risk that the lubricant contaminates fingers, hands, clothes, etc. it is reduced, since the tubular member is not covered in a playful material. In addition, both the tubular member and the inner surface of the second coupling member can be provided with a friction-reducing lubricant.
[00020] The tubular member of the present invention can be provided with a material as disclosed in patent applications - PA201070351 and PA201070350, which are incorporated by reference in this document.
[00021] In an embodiment of the present invention, the first coupling member can be provided with a second coupling means that engages the first coupling means of the second coupling member. The second coupling means can be arranged to conform to the first coupling means, such as in a plug and socket configuration. An example of this can be when the first coupling means is made in the form of at least one protrusion and the second coupling means can be made in the form of at least one depression. The actual amount of the coupling coupling means can vary and can be any one of two corresponding parts, three corresponding parts, four corresponding parts and so on. The actual choice of corresponding parts can be dependent on the surface area of the first coupling means that is in contact with the tubular member, the flexibility of the tubular member, the thickness of the walls of the tubular member and so on. Such choice of materials or design is obvious to the person skilled in the art based on the teachings of the present invention, and the person skilled in the art will recognize how to combine the design of the first coupling means and / or the second coupling means with the choice of material for the tubular member.
[00022] In one embodiment, the second coupling means can be at least one radially extending protrusion extending from an external surface of the first coupling member. Such a protrusion can be made in the form of a circumferential ring, a single protrusion that allows the first coupling means to engage with the protrusion or in the form of two or more protrusions that are circumferentially arranged around the first coupling member, and can be radially spaced. The first coupling member can also be provided with numerous protrusions which are arranged along a geometric axis that is parallel to the longitudinal geometric axis of the catheter package. Such protrusions placed longitudinally can provide a redundancy feature which means that if the first coupling means misses a first protrusion of the second coupling means, the first coupling means can engage a second protrusion of the second coupling means.
[00023] In an embodiment of the present invention, the first coupling means and the second coupling means can be provided with cooperative protrusions. As an example, the first coupling member can be provided with asymmetric protrusions in the radial direction while the second coupling member can be provided with symmetrical protrusions in the radial direction, or vice versa. This ensures that the protrusions of the first and second coupling members will continually have parts that are in cooperation with each other. Asymmetric protrusions can advantageously be used to reduce the friction between the protrusion and the inner and / or outer surface of the tubular member.
[00024] The catheter assembly of the present invention can be supplied as a pre-moistened or gel-lubricated hydrophilic coated catheter assembly, where the gel or wetting fluid can provide lubrication within the catheter package. By providing such lubrication, the friction between the inner surface of the tubular member and the outer surface of the first coupling member can be significantly reduced, and this allows the first coupling member to move within the tubular member without encountering a frictional force. great. Thus, by having lubrication within the tubular member, the forces required to extend the catheter out of the package can be reduced, and if combined with reduced friction between the outer surface of the tubular member and the inner surface of the second coupling member , the forces required to extend the catheter can be further reduced.
[00025] In an embodiment of the present invention, the second coupling means can be a first distal area and a second proximal area of the first coupling member that has a diameter that is greater than the diameter of a central area of the first coupling member. coupling. Thus, the second coupling means can be made in the form of two protrusions which are spaced in the longitudinal direction. The first coupling means can be arranged between the two protrusions, allowing the second coupling member to engage the first coupling member in both directions on the longitudinal geometric axis of the catheter assembly. This means that the second coupling member can either be used to extend the catheter out of the package or to retract the catheter back into the package after use. The specific design of the interaction of the second coupling member and the first coupling member can be varied from that described above, while ensuring that the second coupling member and the first coupling member engage in both directions.
[00026] In an embodiment of the present invention, an outer diameter of the first coupling member can be greater than an inner diameter of the second coupling member. Providing the first coupling member as having a diameter that is greater than the inner diameter of the second coupling member, the second coupling member cannot pass the first coupling member in the longitudinal direction, and any movement of the second coupling member coupling in one direction towards the first coupling member will propel the first coupling member and move the first coupling member together with the second coupling member. The diameter of the first and / or the second coupling member need not be uniform in the radial direction, as it is advantageous that the diameter of the first and second couplings is arranged in such a way that one coupling member is not able to pass through the other coupling member.
[00027] In one embodiment, the second coupling member can be provided with an external surface area that provides a handle for the user. As the user has to maneuver the second coupling member in relation to the tubular member or the catheter package, the user may need to have an area on the second coupling member that is arranged to allow the second coupling member to be manipulated. Countless users of urinary catheters have reduced dexterity in their hands and / or fingers and may have difficulty handling the second coupling member in order to extend the catheter out of the package. Thus, by providing a manipulation area, which can be made in the form of an ergonomic surface that increases the friction between the second coupling member and the skin surface that comes in contact with the second coupling member, the use of the set can become easier for the user. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows a side sectional view of a catheter assembly according to the present invention, Figure 2 shows a perspective sectional view of a first and a second coupling member according to the present invention , Figure 3 shows a side sectional view of a catheter assembly according to the present invention. Figures 4a and 4b show a side sectional view of a catheter assembly according to the present invention showing the interaction between the first and second coupling members. DETAILED DESCRIPTION OF THE DRAWINGS
[00028] Figure 1 shows a cross-sectional view of a catheter assembly 1 that has a tubular member 2 that defines a cavity 3 to contain a urinary catheter 4. Urinary catheter 4 has a proximal end 5 that has an insertable tip that closes an internal lumen 6 of the catheter to drain urine from a bladder. Catheter 4 is provided with at least one opening 7 which allows urine to enter the internal lumen 6 of catheter 4. The distal end 8 of catheter 4 is provided with a first coupling member 9 which is provided with an internal lumen 10 which extends the inner lumen 6 of the catheter, and in which the coupling member 9 is provided with a diameter that is greater than the diameter of the catheter 4.
[00029] The tubular member 2 has a proximal end 11 which is provided with an opening 12 which allows the catheter 4 to be extended out of the opening 12 and a distal end 13 which has an opening 14 which allows a urine to be drained into out of catheter package 1 while catheter 4 is extended into the user's urethra. During packaging of the catheter assembly 1 the distal end 13 and the proximal end 11 are closed, sealing the catheter 4 within the tubular member 2. In advantageous embodiments of the catheter assembly, the closed tubular member may contain a gel and / or a humidification fluid when catheter 4 is the hydrophilic catheter, and the closed ends of the catheter assembly ensure that the gel or water does not come out of the package during storage.
[00030] The catheter assembly is also provided with a second coupling member 15, which is allocated on the outer surface of the tubular member 2. The second coupling member is provided with a first coupling means 16 and 17 in the form of protrusions that they reduce the diameter of the inner surface of the second coupling member by extending from the inner surface of the second coupling member. The second coupling member 15 is arranged on the tubular member 2 in such a way that the protrusions 16,17 incline the flexible wall 18 of the tubular member 2 and reduce the inner diameter of the tubular member 2 by transmitting the protrusions on the tubular wall 19, 20. When the first coupling member 9 is arranged between the two protrusions 16,17 in a longitudinal direction, the protrusions close the first coupling member 9, and when the second coupling member 15 is maneuvered in the longitudinal direction, the protrusions engage the first member coupling 9 through the flexible wall 18 of the tubular member 2 in the transmitted protrusions 19,20 and propel the first coupling member 9 in the same direction as the second coupling member 15 is operated. This movement causes the catheter 4 to extend from the package when the second coupling member is maneuvered towards the proximal end 11 of the tubular package 2 and the catheter 4 to retract into the tubular member 2 when the second coupling member is maneuvered in the direction towards the distal end 13 of the tubular member 2.
[00031] The modality shown in Figure 1 can be changed by providing a single protrusion 16 close to the distal end of the second coupling member 9 which allows the catheter 4 to be extended out of the package, when the second coupling member does not allow retraction of the catheter into the package, and the catheter assembly is discarded in an extended manner.
[00032] Figure 2 shows a perspective cross-sectional view of an embodiment of a first coupling member 21 and a second coupling member 22 according to the present invention. The first and second coupling members are shown without the tubular member of the catheter assembly, for clarity, while in use the tubular member would be arranged between the two coupling members. The first coupling member is provided with a distal protrusion 23 and a proximal protrusion 24 and a central part 25 which has a diameter that is smaller than the distal and proximal protrusions. The second coupling member is provided with two diametrically opposed protrusions 26, 27 arranged on the inner surface 28 of the second coupling member 22. When the first and second coupling members are arranged as shown in Figure 2 in a combined position, the protrusions 26,27 of the second coupling member 22 are disposed between the distal protrusion 23 and the proximal projection 24 of the first coupling member 21. Thus, when the second coupling member is moved in a longitudinal direction along the tubular member (not shown) ) protrusions 26,27 of the second coupling member 22 engage either the distal protrusion 23 or the proximal projection 24 of the first coupling member, and the movement of the second coupling member 22 is transferred to the first coupling member 21. In the embodiment shown in Figure 2, the catheter can be connected to the first coupling member 21 using the connection member 28 which can be attached to the inner lumen catheter.
[00033] The shape, positioning and quantity of protrusions of the second coupling member can be varied as long as the protrusions transfer the movement from the second coupling member to the first coupling member.
[00034] Figure 3 shows another embodiment of the present invention, similar to that shown in Figure 1, in which protrusions 16,17 of the second coupling member are provided having a tapered angle in the surface area that fits the first coupling member 9. This tapered surface angle increases the surface area of the protrusions that are in direct contact with the flexible wall 18 of the tubular member 2, and ensures that there are no sharp edges (=> than 90 degrees) that come into contact with the tubular member . Thus, the protrusion will slide more easily along the tubular member since there will be no sharp inclination or bending in the flexible wall 18 of the tubular member 2. In this embodiment, the angle is adjusted to approximately 75 degrees, however, this angle can be varied to achieve a smooth transition between the protrusions and the tubular member.
[00035] Figure 4a shows a sectional view of an embodiment of the present invention, in which the second coupling member 15 is moved in a longitudinal direction A with respect to the tubular member 2 to extend the catheter 4 out of the tubular member 2 The first coupling member 9 engages with the distal protrusion 17 of the second coupling member 15 through the flexible wall 18 of the tubular member and the distal protrusion 17 transfers the forces used to move the second coupling member 15 to the first coupling member 9 and the catheter extends out of the tubular member 2.
[00036] Figure 4b shows a sectional view of an embodiment of the present invention, in which the second coupling member 15 is moved in a longitudinal direction B with respect to the tubular member to retract catheter 4 back into the tubular member 2. The first coupling member 9 engages with the proximal projection 17 of the second coupling member 15 through the flexible wall 18 and the forces required to move the second coupling member 15 are transferred to the first coupling member 9.
权利要求:
Claims (10)
[0001]
1. Catheter assembly (1) comprising: - a urinary catheter (4) that has a proximal end (5) for insertion into the urethra and a distal end (8) that comprises a first coupling member (9,21) , - a catheter package comprising a tubular member (2) that has walls (18) of flexible material, and that has a proximal end (11) and a distal end (13) that define a longitudinal geometric axis of the packaging of catheter, where the flexible tubular member (2) comprises a cavity (3) for accommodating the urinary catheter (4) along the longitudinal geometric axis of the catheter package and the catheter tube and where the proximal end (11) of the catheter packaging is arranged to allow exposure of the proximal end (5) of the urinary catheter, and - a second coupling member (15, 22) which is arranged on an external surface of the catheter packaging wall (18) - where the second coupling member (15,22) is provided with a first coupling means (16, 17) to engage the first coupling member (9, 21) through the flexible wall (18) of the catheter package so that the catheter (4) can be maneuvered along the longitudinal geometric axis of the catheter packaging, characterized by the fact that - the coupling means (16, 17) are in the form of a protrusion or a depression in the internal surface area that communicates with a depression or a corresponding protrusion in the first coupling member (9, 21).
[0002]
2. Urinary catheter assembly (1) according to claim 1, characterized by the fact that the second coupling member (15, 22) is arranged to surround the tubular member in a direction that is perpendicular to the longitudinal geometric axis of the package catheter.
[0003]
3. Urinary catheter assembly (1) according to either of claims 1 or 2, characterized by the fact that the first coupling means (16, 17) is at least one protruding radially inwardly extending to from an internal surface of the second coupling member (15, 22).
[0004]
4. Urinary catheter assembly (1) according to any one of claims 1 to 3, characterized by the fact that the first coupling means (16, 17) is at least two protrusions extending radially inward that extend substantially diametrically facing each other from an internal surface of the second coupling member (15, 22).
[0005]
5. Urinary catheter assembly (1) according to any one of claims 1 to 4, characterized by the fact that a surface area of the second coupling member (15, 22) that is adjacent to the tubular member is provided with a surface low friction.
[0006]
6. Urinary catheter assembly (1) according to any one of claims 1 to 5, characterized by the fact that the first coupling member (9, 21) is provided with a second coupling means that engages the first coupling means coupling (16, 17) of the second coupling member.
[0007]
7. Urinary catheter assembly (1), according to claim 6, characterized by the fact that the second coupling means is made of at least one protrusion extending radially outward (23, 24) extending from an outer surface of the first coupling member (9, 21).
[0008]
8. Urinary catheter assembly according to claims 6 or 7, characterized by the fact that the second coupling means is a first distal area and a second proximal area of the first coupling member (9, 21) which has a diameter that is greater than the diameter of a central area of the first coupling member (9, 21).
[0009]
9. Urinary catheter assembly (1) according to any one of claims 1 to 8, characterized by the fact that an outer diameter of the first coupling member is greater than an inner diameter of the second coupling member (15, 22) .
[0010]
10. Urinary catheter assembly (1) according to any one of claims 1 to 9, characterized by the fact that the second coupling member (15, 22) is provided with an external surface area that provides a handle for the user.
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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|
2019-09-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
2020-05-12| 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 13/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
DKPA201070549|2010-12-15|
DKPA201070549|2010-12-15|
PCT/DK2011/050478|WO2012079581A1|2010-12-15|2011-12-13|Urinary catheter assembly|
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