Catheter assembly

Abstract

A catheter assembly includes a housing including an outer tubular portion (20), an inner tubular portion (40), and an intermediate tubular portion (60), where the intermediate tubular portion (60) is composed of a softer material than the outer tubular portion (20) and the inner tubular portion (40).

Description

TECHNICAL FIELD

[0001] The present invention relates to a catheter assembly, in particular but not exclusively a urinary catheter, especially an intermittent female urinary catheter. BACKGROUND

[0002] A catheter is a medical device comprising a hollow catheter tube designed for insertion into a duct, vessel, passage or body lumen to allow injection, drainage or extraction of fluid or matter therefrom, or to ensure that the duct, vessel, passage or the like remains open. A urinary catheter is designed for insertion through the urethra into the bladder of a user to empty the bladder.

[0003] To maximise comfort and minimise the risk of trauma and / or infection, the outer surface of the catheter tube is typically wetted with a wetting agent prior to insertion by the user. The wetting agent can be a lubricant, such as a lubricating gel. In a further development, the catheter tube itself comprises, is integrated with or is coated with a hydrophilic component, such as a hydrophilic polymer, which is activated upon application of a wetting agent, which can for example be water, to further reduce friction.

[0004] Some catheters are supplied pre-wetted (or lubricated) in packaging, for example with the catheter at least partially submerged in a wetting or lubricating agent within the packaging. Whilst this can ensure that the catheter tube is sufficiently wetted or lubricated prior to use, a disadvantage of such a configuration is that catheter components other than the catheter tube, such as a clamping element or funnel, can also be wetted or coated with lubricant. This has an adverse effect on the user experience, in which it can become difficult to hold and guide the catheter tube as required. This is particularly problematic when the user is performing a self-catheterisation. Furthermore, having an impregnated catheter effectively reduces the shelf life of the catheter due to the prolonged exposure of the components of the catheter to moisture.

[0005] It would therefore be advantageous to provide a catheter which can be wetted or lubricated at or just prior to use.

[0006] In an attempt to address this issue, some catheters are provided in packaging which comprises a breakable container or pouch within the packaging which the user can break to release the wetting agent. Typically, this involves the user squeezing the packaging to break the container / pouch. However, such a configuration can suffer from similar issues to those described above, in which the wetting agent is allowed to come into contact with other components of the catheter. Such a configuration also results in the catheter potentially not being fully wetted, or indeed not wetted at all, prior to use. This can be detrimental to the user.

[0007] It would therefore be advantageous to provide a catheter comprising a mechanism to supply wetting agent only to the catheter tube to improve the user experience.

[0008] In another prior art solution, the catheter may be packaged within a package that includes a wetting device. In use, when the catheter is removed from the package, it can move through the wetting device, and in doing so, wet the catheter body. An example of such a catheter is shown in ConvaTec Ltd.'s PCT application number PCT / IB2018 / 001539.

[0009] Furthermore, intermittent catheters are meant to be carried by the user for use as needed, and the catheters are expected to be discrete, making them difficult to identify as a medical device. To address this issue, some catheters are stored in a housing before use, which conceals the catheter while also protecting it. However, assembling and / or accessing the catheter can be complex.

[0010] The purpose of one or more embodiments of the present invention is to overcome or at least partially mitigate one or more problems of the prior art and / or provide an improved catheter assembly. Summary of the Invention

[0011] The present invention provides a catheter assembly according to the appended claims.

[0012] One aspect of this disclosure provides a catheter assembly. The catheter assembly may include an inner tubular portion. The catheter assembly may include an intermediate tubular portion. The catheter assembly may include an outer tubular portion. The inner tubular portion and the intermediate tubular portion may be radially nested. The inner tubular portion and the outer tubular portion may be radially nested. The intermediate tubular portion and the outer tubular portion may be radially nested. The inner tubular portion, the intermediate tubular portion, and the outer tubular portion may be radially nested. The intermediate tubular portion may be disposed between the inner tubular portion and the outer tubular portion. The intermediate tubular portion may be adjacent to the inner tubular portion. The intermediate tubular portion may be adjacent to the outer tubular portion. The catheter assembly may include a housing. The housing may include one, both, or each of the inner tubular portion, the intermediate tubular portion, and / or the outer tubular portion. The inner tubular portion may contain a first material. The intermediate tubular portion may contain a second material. The outer tubular portion may contain a third material. The second material may be softer than the first material. The second material may be softer than the third material.

[0013] Therefore, a first aspect of this disclosure provides a conduit assembly including a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials.

[0014] Preferably, the housing includes an inner tubular portion, an outer tubular portion, and a middle tubular portion. Therefore, another aspect of this disclosure provides a conduit assembly including a housing comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials.

[0015] In this article, “softer than / softer” means having a lower Shore hardness as measured according to ISO 868.

[0016] Advantageously, by providing a softer intermediate tubular section between the inner and outer tubular sections, the inner and outer tubular sections can be more easily joined together to form a conduit assembly, especially its outer shell. To protect the conduit, the outer shell is typically made of a relatively rigid material, and inserting the inner section into the outer section usually requires some elastic deformation to engage the snap-fit ​​or similar joining mechanism that holds the inner and outer tubular sections together. The harder the material, the greater the force required, and the greater the risk of component damage. By using a softer intermediate section, the softer material can deform to engage with the inner and outer sections with less force.

[0017] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, and wherein a housing comprises the inner tubular portion, the middle tubular portion, and the outer tubular portion, and the housing is configured to receive a catheter.

[0018] One of the outer tubular portion and the intermediate tubular portion may include one or more recesses. The one or more recesses may be grooves, recesses, bowl-shaped indentations, indentations, etc. The recesses may be located on the radially inner wall of the outer tubular portion. The recesses may extend radially into the outer tubular portion. The recesses may extend circumferentially around the outer tubular portion. The other of the outer tubular portion and the intermediate tubular portion may include one or more protrusions. The one or more protrusions may be arranged in the recesses. The one or more protrusions may be ribs, rings, or may be pips, bumps, pins, fins, etc. The protrusions may project radially from the intermediate tubular portion. The protrusions may be located on the radially outer wall of the intermediate tubular portion. The protrusions may extend circumferentially around the intermediate tubular portion. The protrusions may project radially inward from the outer tubular portion. The protrusions may be located on the radially inner wall of the outer tubular portion. The protrusions may extend circumferentially around the outer tubular portion. For example, the protrusion can extend radially outward from the middle tubular portion and enter the recess that extends radially into the outer tubular portion.

[0019] Advantageously, the presence of corresponding protrusions and recesses on the outer tubular portion and the middle tubular portion ensures that the two components remain correctly positioned.

[0020] The internal tubular portion may include a support structure. The support structure may be aligned with recesses and protrusions. The support structure may be axially aligned with recesses and protrusions. The support structure may be disposed on the radially outer wall of the internal tubular portion. The support structure may include one or more protrusions. Protrusions may be ribs, or may be raised portions, pins, fin-like portions, etc. The support structure may extend axially along the internal tubular portion. The support structure may extend circumferentially around the internal tubular portion. The support structure may project radially outward from the radially outer wall of the internal tubular portion.

[0021] Advantageously, by providing one or more support structures on the inner tubular portion, the connection between the intermediate and outer tubular portions is strengthened, while simultaneously reducing the connection surface area between the inner and intermediate portions, thereby reducing the connection friction between them. In other words, the contact between the inner and intermediate tubular portions is restricted to the radially outer surface of the support structure, thus reducing the effective contact area and consequently the area of ​​friction. Therefore, the force required to insert the inner tubular portion is reduced, which also lowers the risk that the intermediate portion might "get stuck" or shift due to the insertion of the inner tubular portion. Thus, it allows the inner tubular portion to support a portion of the intermediate tubular portion, improving the connection between the intermediate and outer tubular portions.

[0022] Therefore, in a preferred embodiment, a conduit assembly is provided, comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, wherein one of the outer tubular portion and the middle tubular portion includes one or more recesses, and the other of the outer tubular portion and the middle tubular portion includes one or more protrusions disposed in the recesses, and wherein the inner tubular portion includes at least one support structure aligned with the recesses and protrusions.

[0023] The housing is adapted to accommodate an intermittent catheter. The catheter can be a female intermittent catheter. The catheter length can range from 90 mm to 200 mm. The catheter length can range from 100 mm to 150 mm, or for example, from 130 mm to 155 mm, such as about 135 mm. The length of the catheter assembly can correspond to the length of the catheter. For example, the length of the catheter assembly, i.e., the closed length of the housing, can range from 2 mm to 20 mm, such as from 2 mm to 15 mm, for example, 2 mm to 10 mm longer than the length of the catheter. The catheter assembly (when closed) can have a length of 10 cm to 25 cm; the length of the catheter assembly can range from 11 cm to 16 cm, such as from 140 mm to 165 mm, such as 142 mm.

[0024] The outer tubular portion may be made of plastic. The outer tube may be made of plastic with a Shore hardness in the range of 70 to 95 (i.e., in the range of 70A to 95A), the Shore hardness being measured using a Shore hardness tester "A". The outer tube may be made of plastic with a Shore hardness in the range of 70 to 80 (i.e., in the range of 70A to 80A), the Shore hardness being measured using a Shore hardness tester "A". The outer tube may be made of plastic with a Shore hardness in the range of 80 to 85 (i.e., in the range of 80A to 85A), the Shore hardness being measured using a Shore hardness tester "A". The outer tube may be made of plastic with a Shore hardness in the range of 85 to 90 (i.e., in the range of 85A to 90A), the Shore hardness being measured using a Shore hardness tester "A". The outer tube may be made of plastic with a Shore hardness in the range of 90 to 95 (i.e., in the range of 90A to 95A), the Shore hardness being measured using a Shore hardness tester "A". The outer tube may be made of plastic with a Shore hardness in the range of 85 to 95 (i.e., in the range of 85A to 95A), the Shore hardness being measured using a Shore hardness tester "A". The outer tube may be made of plastic with a Shore hardness in the range of 40 to 90 (i.e., in the range of 40D to 90D), the Shore hardness being measured using a Shore hardness tester "D". The outer tube may be made of plastic with a Shore hardness in the range of 50 to 80 (i.e., in the range of 50D to 80D), the Shore hardness being measured using a Shore hardness tester "D". The outer tube may be made of plastic with a Shore hardness in the range of 60 to 70 (i.e., in the range of 60D to 70D), the Shore hardness being measured using a Shore hardness tester "D". The outer tube may be made of plastic with a Shore hardness in the range of 40 to 50 (i.e., in the range of 40D to 50D), the Shore hardness being measured using a Shore hardness tester "D". The outer tube may be made of plastic with a Shore hardness in the range of 50 to 60 (i.e., in the range of 50D to 60D), the Shore hardness being measured using a Shore hardness tester "D". The outer tube may be made of plastic with a Shore hardness in the range of 70 to 80 (i.e., in the range of 70D to 80D), the Shore hardness being measured using a Shore hardness tester "D". The outer tube may be made of plastic with a Shore hardness in the range of 80 to 90 (i.e., in the range of 80D to 90D), the Shore hardness being measured using a Shore hardness tester "D". The outer tube may be made of plastic with a Shore hardness in the range of 80 to 95 (i.e., in the range of 80A to 95A, where the Shore hardness is measured using a Shore hardness tester "A"), and / or plastic with a Shore hardness in the range of 40 to 90 (i.e., in the range of 40D to 90D, where the Shore hardness is measured using a Shore hardness tester "D"). The outer tubular portion may be made of polyvinyl chloride or polypropylene. The outer tubular portion may be made of the same material as the inner tubular portion.

[0025] In a preferred embodiment, a conduit assembly is provided, comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, and wherein the inner tubular portion and / or the outer tubular portion have a Shore hardness in the range of 80 to 95 when measured using a Shore hardness tester "A" (i.e., in the range of 80A to 95A), and / or in the range of 40 to 90 when measured using a Shore hardness tester "D" (i.e., in the range of 40D to 90D).

[0026] The outer housing may be manufactured, imported, and sold independently of the catheter. The catheter assembly may include the catheter. The catheter may include a catheter body. The catheter body may have an outlet end and an insertion end for insertion into a patient. The outlet end may include one or more external manipulation features. The catheter may include an insertion end for insertion into a patient and an outlet end from which fluid exits during use. The outlet end may include one or more flow-enhancing features, such as a funnel-shaped element diverging along the flow direction. The outlet end may include an external manipulation surface. When the cap is removed, the external manipulation surface may be exposed to the user for manipulation. The external manipulation surface may include one or more surface features to enhance the user's grip. The one or more surface features may include one or more grooves. The catheter body may include one or more inlets for receiving urine at its insertion end. The insertion end of the catheter may define the proximal end of the catheter assembly. The outlet end of the catheter may define the distal end of the catheter assembly.

[0027] The catheter may include a main flow path for the passage of urine. The main flow path may extend along and define the longitudinal axis of the catheter. The main flow path may be provided by the wall of the catheter body. The main flow path may have a distal outlet and a proximal inlet located at the catheter insertion end.

[0028] The internal tubular portion may include a catheter retaining structure. The radially inner wall of the internal tubular portion may be configured to receive the catheter. The internal tubular portion includes end walls. The end walls may extend radially inward from the proximal end of the internal tubular portion.

[0029] According to a preferred embodiment, a catheter assembly is provided, comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, and wherein the inner tubular portion includes a catheter retention structure.

[0030] The end wall may have an extension through it. The diameter of this hole may be larger than the diameter of the catheter body. The diameter of this hole may be at least 0.1 mm larger than the diameter of the catheter body. The diameter of this hole may be at least 0.2 mm larger than the diameter of the catheter body. The diameter of this hole may be at least 0.3 mm larger than the diameter of the catheter body. The diameter of this hole may be at least 0.4 mm larger than the diameter of the catheter body. The diameter of this hole may be at least 0.5 mm larger than the diameter of the catheter body. The diameter of this hole may be no more than 0.1 mm larger than the diameter of the catheter body. The diameter of this hole may be no more than 0.2 mm larger than the diameter of the catheter body. The diameter of this hole may be no more than 0.3 mm larger than the diameter of the catheter body. The diameter of this hole may be no more than 0.4 mm larger than the diameter of the catheter body. The diameter of this hole may be no more than 0.5 mm larger than the diameter of the catheter body. The diameter of this hole may be no more than 1 mm larger than the diameter of the catheter body. The diameter of this hole may be 0.01 mm to 0.2 mm larger than the diameter of the catheter body. The diameter of the orifice can be 0.03 mm to 0.18 mm larger than the diameter of the catheter body. The diameter of the orifice can be 0.04 mm to 0.16 mm larger than the diameter of the catheter body. The diameter of the orifice can be 0.05 mm to 0.15 mm larger than the diameter of the catheter body. Preferably, the diameter of the orifice can be 0.06 mm to 0.1 mm larger than the diameter of the catheter body. More preferably, the diameter of the orifice can be 0.06 mm to 0.08 mm larger than the diameter of the catheter body. For example, the diameter of the orifice can be 0.07 mm larger than the diameter of the catheter body.

[0031] According to a preferred embodiment, a catheter assembly is provided, comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, and wherein the inner tubular portion includes an end wall extending radially inward from a proximal end of the inner tubular portion, the end wall having an aperture extending therethrough.

[0032] By providing a larger orifice than the conduit, a consistent layer of lubricant / wetting agent can be applied to the conduit body.

[0033] The hole may have one or more protrusions, such as two, or more preferably three or more. The protrusions may be ribs, or they may be raised portions, pins, fin-like portions, etc. The protrusions may be hemispherical raised portions. The protrusions may be spaced evenly around the hole. The protrusions may be configured to press against the conduit body.

[0034] The aforementioned protrusions further improve the distribution of wetting agent / lubricant on the catheter, ensuring that the catheter is centered in the orifice.

[0035] The inner tubular portion can be made of plastic. The inner tube can be made of plastic with a Shore hardness of 70 to 95 (i.e., within the range of 70A to 95A) as measured using a Shore hardness tester "A". The inner tube can be made of plastic with a Shore hardness of 70 to 80 (i.e., within the range of 70A to 80A) as measured using a Shore hardness tester "A". The inner tube can be made of plastic with a Shore hardness of 80 to 85 (i.e., within the range of 80A to 85A) as measured using a Shore hardness tester "A". The inner tube can be made of plastic with a Shore hardness of 85 to 90 (i.e., within the range of 85A to 90A) as measured using a Shore hardness tester "A". The inner tube can be made of plastic with a Shore hardness of 90 to 95 (i.e., within the range of 90A to 95A) as measured using a Shore hardness tester "A". The inner tube may be made of plastic with a Shore hardness of 85 to 95 as measured using a Shore hardness tester "A" (i.e., within the range of 85A to 95A). The inner tube may be made of plastic with a Shore hardness of 40 to 90 as measured using a Shore hardness tester "D" (i.e., within the range of 40D to 90D). The inner tube may be made of plastic with a Shore hardness of 50 to 80 as measured using a Shore hardness tester "D" (i.e., within the range of 50D to 80D). The inner tube may be made of plastic with a Shore hardness of 60 to 70 as measured using a Shore hardness tester "D" (i.e., within the range of 60D to 70D). The inner tube may be made of plastic with a Shore hardness of 40 to 50 as measured using a Shore hardness tester "D" (i.e., within the range of 40D to 50D). The inner tube may be made of plastic with a Shore hardness of 50 to 60 (i.e., 50D to 60D) as measured using a Shore hardness tester "D". The inner tube may be made of plastic with a Shore hardness of 70 to 80 (i.e., 70D to 80D) as measured using a Shore hardness tester "D". The inner tube may be made of plastic with a Shore hardness of 80 to 90 (i.e., 80D to 90D) as measured using a Shore hardness tester "D". The inner tube may be made of plastic with a Shore hardness of 80 to 95 (i.e., 80A to 95A) as measured using a Shore hardness tester "A", and / or plastic with a Shore hardness of 40 to 90 (i.e., 40D to 90D) as measured using a Shore hardness tester "D". The inner tube may be made of polyvinyl chloride or polypropylene. The inner tubular portion may be made of the same material as the outer tubular portion.

[0036] The outer diameter of the internal tubular portion can be in the range of 10 mm to 30 mm, preferably in the range of 12 mm to 20 mm, more preferably in the range of 14 mm to 18 mm, for example in the range of 15 mm to 16 mm, such as 15.5 mm.

[0037] The inner diameter of the internal tubular portion can be in the range of 6 mm to 26 mm, preferably in the range of 8 mm to 20 mm, more preferably in the range of 10 mm to 16 mm, for example in the range of 12 mm to 13 mm, such as 12.3 mm.

[0038] The wall thickness of the internal tubular portion (measured from the radial outer wall to the radial inner wall) is in the range of 1 mm to 2 mm, preferably in the range of 1.2 mm to 1.8 mm, more preferably in the range of 1.5 mm to 1.7 mm, for example 1.6 mm.

[0039] The length of the internal tubular portion can be in the range of 30 mm to 100 mm, preferably in the range of 30 mm to 50 mm, more preferably in the range of 40 mm to 45 mm, for example in the range of 42 mm to 43 mm, such as 42.5 mm.

[0040] The difference between the inner diameter of the inner tubular portion and the inner diameter of the hole in the end wall (i.e., twice the radial extension length of the end wall) can be in the range of 2 mm to 10 mm, preferably in the range of 3 mm to 8 mm, more preferably in the range of 4 mm to 6 mm, for example in the range of 4 mm to 5 mm, for example 4.4 mm.

[0041] The intermediate tubular portion can be made of plastic. The intermediate tubular portion can be made of plastic with a Shore hardness of 40 to 95 (i.e., within the range of 40A to 95A) as measured using a Shore hardness tester "A". The intermediate tubular portion can be made of plastic with a Shore hardness of 40 to 50 (i.e., within the range of 40A to 50A) as measured using a Shore hardness tester "A". The intermediate tubular portion can be made of plastic with a Shore hardness of 50 to 60 (i.e., within the range of 50A to 60A) as measured using a Shore hardness tester "A". The intermediate tubular portion can be made of plastic with a Shore hardness of 60 to 70 (i.e., within the range of 60A to 70A) as measured using a Shore hardness tester "A". The intermediate tubular portion can be made of plastic with a Shore hardness of 70 to 80 (i.e., within the range of 70A to 80A) as measured using a Shore hardness tester "A". The intermediate tubular portion may be made of plastic with a Shore hardness of 80 to 95 (i.e., 80A to 95A) as measured using a Shore hardness tester "A". Alternatively, the intermediate tubular portion may be made of plastic with a Shore hardness of 50 to 80 (i.e., 50A to 80A) as measured using a Shore hardness tester "A". A further intermediate tubular portion may be made of plastic with a Shore hardness of no more than 50 (i.e., no more than 50A) as measured using a Shore hardness tester "A". A third intermediate tubular portion may be made of plastic with a Shore hardness of no more than 60 (i.e., no more than 60A) as measured using a Shore hardness tester "A". A fourth intermediate tubular portion may be made of plastic with a Shore hardness of no more than 70 (i.e., no more than 70A) as measured using a Shore hardness tester "A". Finally, a fifth intermediate tubular portion may be made of plastic with a Shore hardness of no more than 80 (i.e., no more than 80A) as measured using a Shore hardness tester "A". The central tubular portion can be made of silicone resin / polysiloxane / silicone.

[0042] In a preferred embodiment, a conduit assembly is provided, comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, and wherein the middle tubular portion has a Shore hardness in the range of 40 to 95 as measured using a Shore hardness tester "A".

[0043] The distal end of the intermediate tubular portion may extend to the same axial length as the inner tubular portion. The proximal end of the intermediate tubular portion may extend axially beyond the proximal end of the inner tubular portion. The portion of the intermediate tubular portion extending axially beyond the proximal end of the inner tubular portion may define a wetting agent chamber. The wetting agent chamber may be further defined by the proximal wall of the inner tubular portion.

[0044] In a preferred embodiment, a conduit assembly is provided, comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, and wherein a proximal end of the middle tubular portion extends axially beyond the proximal end of the inner tubular portion, the section extending beyond the inner tubular portion defining a wetting agent chamber.

[0045] The volume of the wetting agent chamber can be in the range of 500 to 800 cubic millimeters, preferably in the range of 600 to 700 cubic millimeters, more preferably in the range of 630 to 700 cubic millimeters, for example in the range of 650 to 680 cubic millimeters. The wetting agent can be a gel, such as a polysiloxane gel.

[0046] The axial extension of the intermediate tubular portion beyond the proximal end of the inner tubular portion may taper gradually, such that the diameter decreases proximally. The proximal end of the intermediate tubular portion, for example, the proximal wall of the intermediate tubular portion, may include a hole. This hole may be configured to allow a catheter to extend through it. The shape and / or size of the hole may be adapted to provide an engineered fit for the catheter body. The hole may provide an interference fit for the catheter body.

[0047] By using the intermediate tubular section for the wetting agent storage chamber, the number of components is further reduced, and the inherent softness of the intermediate material can be utilized to provide a seal for the conduit body.

[0048] The wall thickness of the intermediate tubular portion (measured from the radial outer wall to the radial inner wall) can be in the range of 0.5 mm to 1 mm, preferably in the range of 0.7 mm to 0.9 mm, more preferably in the range of 0.75 mm to 0.75 mm, for example 0.8 mm.

[0049] The length of the intermediate tubular portion can be in the range of 30 mm to 150 mm, preferably in the range of 40 mm to 90 mm, more preferably in the range of 55 mm to 75 mm, for example in the range of 60 mm to 70 mm, such as 65 mm.

[0050] The radial inner wall of the intermediate tubular portion may have a profile corresponding to the radial outer wall of the inner tubular portion. The dimensions and / or shape of the radial inner wall of the intermediate tubular portion may be adapted to provide an engineered fit, such as an interference fit, between the inner tubular portion and the intermediate tubular portion.

[0051] The diameter of the radial inner wall of the intermediate tubular portion may be at least 0.01 mm, at least 0.05 mm, or at least 0.1 mm smaller than the diameter of the radial outer wall of the inner tubular portion.

[0052] The diameter of the radial outer wall of the intermediate tubular portion may be at least 0.01 mm, at least 0.05 mm, or at least 0.1 mm larger than the diameter of the radial inner wall of the outer tubular portion.

[0053] The conduit assembly may include a cap. The cap may define a portion of the outer housing. The cap may be removable. The cap may be attached to the remainder of the outer housing. The cap may be hingedly mounted to the outer tubular portion. It may be hingedly mounted at the distal end of the outer tubular portion. The hinge may be a molded band hinge. The hinge may be an integrally cast hinge. The outer tubular portion and the cap may be integrally formed, i.e., molded as a single component, i.e., a single-injection molded part.

[0054] The cover may include an annular protrusion. The annular protrusion may be disposed on the inner surface of the cover. The annular protrusion may be a loop / ring / ring-like structure. The outer diameter of the annular protrusion / ring may be less than or equal to the outer diameter of the intermediate tubular portion. The inner diameter of the annular protrusion / ring may be greater than or equal to the inner diameter of the intermediate tubular portion. Preferably, the outer diameter of the annular protrusion / ring is smaller than the outer diameter of the intermediate tubular portion, and the inner diameter of the annular protrusion / ring is larger than the inner diameter of the intermediate tubular portion. The annular protrusion may be configured to press against the intermediate tubular portion when the cover is in a closed configuration. The annular protrusion may be configured to axially press against the intermediate tubular portion when the cover is in a closed configuration. The annular protrusion may press against the distal end of the intermediate tubular portion.

[0055] Advantageously, the aforementioned arrangement of the cap and the intermediate tubular portion allows the intermediate tubular portion to also serve as a seal for the catheter assembly, reducing the number of components required. This also helps ensure that the catheter is resealable—even in a non-sterile manner (after the initial sterile seal has been breached)—which can be beneficial if the user wishes to temporarily postpone catheter use or to secure the catheter in a leak-proof manner for disposal after use.

[0056] Therefore, in a preferred embodiment, a catheter assembly is provided comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner and outer tubular portions, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first and third materials, wherein the outer tubular portion is an outer shell, and the outer shell further comprises a cover, wherein the cover comprises a ring configured to press against the middle tubular portion at a distal end of the middle tubular portion.

[0057] According to another broad aspect of the invention, a method for manufacturing a catheter assembly is provided. The catheter assembly may include an inner tubular portion. The catheter assembly may include an intermediate tubular portion. The catheter assembly may include an outer tubular portion. The inner tubular portion may contain a first material. The intermediate tubular portion may contain a second material. The outer tubular portion may contain a third material. The second material may be softer than the first material. The second material may be softer than the third material. The method may include inserting the intermediate tubular portion into the outer tubular portion. The method may include inserting the inner tubular portion into the intermediate tubular portion.

[0058] Therefore, in a second aspect of the invention, a method for manufacturing a catheter assembly is provided, the catheter assembly including an inner tubular portion, an intermediate tubular portion and an outer tubular portion, the inner tubular portion comprising a first material, the intermediate tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first material and the third material, the method comprising: inserting the intermediate tubular portion into the outer tubular portion; and inserting the inner tubular portion into the intermediate tubular portion.

[0059] Advantageously, the above method provides improved manufacturing of conduit assemblies, reduces the force required to assemble parts, and lowers the risk of damage to components.

[0060] The catheter assembly of the second aspect can be the catheter assembly of the first aspect, optionally including any of its optional features.

[0061] The method may include inserting the intermediate tubular portion into the outer tubular portion before inserting the inner tubular portion into the intermediate tubular portion.

[0062] The step of inserting the inner tubular portion into the middle tubular portion after inserting the middle tubular portion into the outer tubular portion can lock the middle tubular portion into the outer tubular portion. For example, inserting the inner tubular member can align the support structure of the inner tubular portion with one or more protrusions and recesses in the middle tubular portion and the outer tubular portion, thereby locking one or more protrusions into one or more corresponding recesses.

[0063] The method may also include the step of inserting a catheter into the internal tubular portion.

[0064] The method may include the step of closing a cap to seal the catheter within a catheter assembly. The cap may include a ring that presses against a central tubular portion. Pressing the ring against the central tubular portion causes the central tubular portion to expand radially against both inner and outer tubular portions. This expansion of the central tubular portion seals the catheter assembly. The catheter assembly may be sterile. This seal maintains a sterile seal.

[0065] Detailed description of the invention Attached Figure Description

[0066] To better understand the present invention, one or more embodiments of the invention will now be described by way of example only, with reference to the accompanying drawings, in which:

[0067] Figure 1 A perspective view of a catheter assembly according to an embodiment of the present disclosure in a closed or sealed configuration is shown;

[0068] Figure 2 Showing in closed or sealed configuration Figure 1 Exploded view of the catheter assembly;

[0069] Figure 3 It shows Figure 1 A perspective view of the internal tubular portion of the conduit assembly;

[0070] Figure 4 It shows a closed configuration. Figure 1 A longitudinal sectional view of the catheter assembly;

[0071] Figure 5 It shows Figure 3 An enlarged longitudinal sectional view of the distal end of the catheter assembly, showing in detail the catheter retention structure and wetting chamber;

[0072] Figure 6 It shows the open configuration. Figure 1 A longitudinal sectional view of the catheter assembly; and

[0073] Figure 7 It shows Figure 1 The conduit assembly along Figure 4 The image shows a cross-sectional view taken along line AA. Detailed Implementation

[0074] Refer to the attached figures (especially) Figures 1 to 3 The conduit assembly 10 includes a conduit 80 and an outer housing or outer shell. In this embodiment, the outer housing or outer shell is in the form of an outer tubular portion 20, an inner tubular portion 40, and an intermediate tubular portion 60. The outer tubular portion 20, the inner tubular portion 40, the intermediate tubular portion 60, and the conduit 80 are arranged concentrically such that the conduit 80 is located within the inner tubular portion 40 in a radially nested configuration, the inner tubular portion 40 is located within the intermediate tubular portion 60 in a radially nested configuration, and the intermediate tubular portion 60 is located within the outer tubular portion 20 in a radially nested configuration.

[0075] The catheter assembly 10 may be configured such that the catheter 80 can be wetted or lubricated before being withdrawn from the outer housing 20. A wetting agent is used to wet the catheter 80 before use and may be retained in a wetting agent storage chamber 41, which in this embodiment is defined by an inner tubular portion 40 and an intermediate tubular portion 60. The wetting agent can be delivered to the catheter 80 through the wetting agent storage chamber. The wetting agent may be water (particularly where the catheter has a hydrophilic surface) or some other suitable reagent known in the art. Preferably, the wetting agent is a gel, such as a polysiloxane gel or a similar viscous lubricant, which can be used for catheters that do not include a hydrophilic surface.

[0076] Throughout this application, catheter 80 defines the orientation of catheter assembly 10. Catheter 80 includes a catheter body 81 terminating at an insertion end 82 for insertion into the urethra and an opposing discharge end 83. Discharge end 83 includes a funnel-shaped member 84, which may include a textured outer surface to improve grip. The insertion end 82 defines the proximal end of the catheter assembly, and the discharge end 83 defines the distal end of the catheter assembly 10.

[0077] Reference Figures 2 to 5 An outer tubular portion 20 defines an outer housing 20 having an elongated cylindrical / cylindrical / tube-like shape, with a closed proximal end 21 and an open distal end 22. The outer housing 20 tapers slightly at its waist, thus narrowing in diameter at the midpoint relative to its two expanding ends 21, 22. The distal expansion section 22A houses a wetting agent reservoir 41, which will be described in more detail below. The proximal expansion section 21A is formed by the bifurcation of the outer tubular portion 20, an inner portion 21A' extending with a constant diameter to the hemispherical end 23, and an outwardly expanding outer portion 21A”.

[0078] A cover 24 is disposed at the distal end 22 of the outer housing 20. In this embodiment, the cover 24 is attached to the remainder of the outer housing 20 via an integrally molded band hinge 25; however, alternative connection methods for an openable cover 24 will be readily apparent to those skilled in the art. The inner surface of the cover 24 (i.e., the cover surface facing the remainder of the conduit assembly when the cover is in a closed configuration) is provided with a protrusion in the shape of a loop 26. The loop 26 extends axially from the inner surface of the cover 24 toward the remainder of the conduit assembly 10 and has a diameter approximately equal to the diameter of the intermediate tubular portion 60. The interaction between the loop 26 and the intermediate tubular portion 60 provides a seal for the conduit assembly 10, which will be described in detail below.

[0079] The radial inner wall 27 of the outer tubular portion 20 is provided with a groove 28 extending circumferentially around the inner wall. The groove 28 is positioned such that when the intermediate tubular portion 60 is fully inserted into the outer tubular portion 20, the groove 28 receives ribs on the intermediate tubular portion 60, which will be described in detail below.

[0080] The outer tubular portion 20 is made of a plastic material that is harder than the material constituting the intermediate tubular portion 60. That is, the material constituting the outer tubular portion has a higher Shore hardness value, measured under the conditions specified in ISO 868. In this embodiment, the outer tubular portion 20 is made of polyvinyl chloride (PVC) having a Shore hardness in the range of 80 to 95 measured using a Shore hardness tester "A", or in the range of 40 to 90 measured using a Shore hardness tester "D". Clearly, based on this disclosure, those skilled in the art will be able to readily select alternative materials for this and other parts of the conduit assembly.

[0081] like Figure 2 As shown, the intermediate tubular portion 60 is bullet-shaped and tapers gradually, with the diameter decreasing towards the proximal end. The intermediate tubular portion 60 is open at both ends; at the distal end 60A is an opening 61, the shape and size of which are adapted to receive the inner tubular portion 40, as will be described in detail below. At the proximal end 60B, there is an aperture 62, the size and shape of which are adapted to provide an engineering fit with the conduit body 81, as will be described in detail below.

[0082] Rib 64 is located on the radial outer wall 63 of the intermediate tubular portion 60, and the rib extends circumferentially around the intermediate tubular portion and protrudes radially outward.

[0083] The opposing radial inner wall 65 of the intermediate tubular portion 60 is provided with an insertion stop 66 formed by circumferentially extending ribs, the function of which will be described in detail below.

[0084] The intermediate tubular portion 60 is made of a softer plastic material than the materials constituting the outer tubular portion 20 and the inner tubular portion 40. That is, the material constituting this intermediate tubular portion has a lower Shore hardness value measured under the conditions specified in ISO 868. In this embodiment, the intermediate tubular portion 40 is made of silicone / polysiloxane / organosilicon with a Shore hardness in the range of 40 to 95 as measured using a Shore hardness tester "A".

[0085] from Figure 3 and 5 As can be seen most clearly, the inner tubular portion 40 has a tubular form with two open ends 41, 42 and a radial inner wall 43 and an outer wall 44. The distal end 41 of the inner tubular portion is shaped and sized to receive a funnel-shaped member 84 of a conduit. The proximal end 42 of the inner tubular portion includes an end wall 45 on which circular holes 46 are concentrically arranged. The holes 46 have an inner wall 47 extending from the interior to the exterior of the inner tubular portion, and the inner wall is provided with a plurality of hemispherical protrusions 48 (e.g.,Figure 7 As shown), these protrusions 48 are configured to press against and hold the catheter body 81. In this embodiment, there are four protrusions, but there may be fewer or more protrusions, preferably at least three protrusions, to center and align the catheter body.

[0086] like Figure 3 As shown, the radially outer wall 44 of the inner tubular portion is provided with a plurality of radially outwardly projecting ribs. Three ribs 49 extend circumferentially around the inner tubular portion. The first circumferential rib 49A is located at the distal end 41 of the inner tubular portion, the second circumferential rib 49B is located approximately two-thirds of the way from the distal end 41 to the proximal end 42, and the third circumferential rib 49B is located at the proximal end 42. Four axial ribs 50 extend axially between the first circumferential rib 49A and the third circumferential rib 49C. These four axial ribs 50 are equidistantly arranged around the circumference of the inner tubular portion 40. As will be elaborated below, the second circumferential rib 49B serves as a support structure for corresponding protrusions and recesses on the outer tubular portion and the intermediate tubular portion. The four axial ribs 50 reinforce the inner tubular portion and provide additional support for the intermediate tubular portion.

[0087] The inner tubular portion 40 is made of a plastic material that is harder than the material constituting the intermediate tubular portion 60. That is, the material constituting the inner tubular portion has a higher Shore hardness value, measured under the conditions specified in ISO 868. In this embodiment, the inner tubular portion 20 is made of polyvinyl chloride (PVC) having a Shore hardness in the range of 80 to 95 as measured using a Shore hardness tester "A", or in the range of 40 to 90 as measured using a Shore hardness tester "D".

[0088] To assemble these components into the conduit assembly 10, the proximal end of the intermediate tubular portion 60 is first inserted into the open distal end 22 of the outer tubular portion 20 until the rib 64 extending from the outer wall of the intermediate tubular portion 60 is received by the groove 28 in the inner wall of the outer tubular portion 20. The groove 28 and the rib 64 are positioned such that when the rib 64 is positioned in the groove 28, the distal end of the intermediate tubular portion 60 is slightly recessed into the outer tubular portion 20 (i.e., retracted / retracted from the end of the outer tubular portion 20). Because the intermediate tubular portion 60 is made of silicone, it is relatively easy to elastically deform during insertion compared to situations where a harder material is used and therefore greater force is required to temporarily deform the component during assembly, making insertion easier and reducing the risk of damage to the component.

[0089] Next, the proximal end 42 of the inner tubular portion 40 is first inserted into the open distal end of the intermediate tubular portion 60 until the proximal end 42 abuts against the insertion stop 66. The insertion stop 66 is positioned such that when the proximal end 42 of the inner tubular portion 40 abuts against the insertion stop 66, the distal end 41 is axially aligned with the distal end of the intermediate tubular portion.

[0090] The inner tubular portion 40 is sized such that its outer diameter is slightly larger than the inner diameter of the intermediate tubular portion 60; in this embodiment, this diameter is at least 0.01 mm larger. This causes slight deformation of the intermediate tubular portion 60, thereby helping to retain the inner tubular portion 40 within the outer tubular portion 20, and also retaining the intermediate tubular portion 60 within the outer tubular portion 20. Ribs 49, 50 provided on the radial outer wall 44 of the inner tubular portion reduce the surface area in contact with the intermediate tubular portion 60, thereby reducing friction between the two components during insertion.

[0091] Once fully inserted, the second circumferential rib (or “support structure”) 49B is axially aligned with the rib 64 and the groove 28 in the intermediate tubular portion and the outer tubular portion, respectively. The second circumferential rib 49B presses against the wall relative to the rib 64 to prevent displacement and thereby locks the intermediate tubular portion 60 in place relative to the outer tubular portion 20.

[0092] The three tubular sections 20, 40, and 60 are thus assembled to form the outer shell of the conduit 80. Providing an intermediate tubular section 60 made of a softer material sandwiched between the two harder tubular sections helps to improve the manufacturing process. The softer intermediate tubular section is more easily deformed, thereby reducing the amount of force required to assemble the components, while the outer tubular section 20 and the inner tubular section 40 provide strength to the shell.

[0093] During assembly, the proximal end of the intermediate tubular portion 60 extends axially beyond the proximal end 42 of the inner tubular member 40, thus defining the wetting agent storage chamber 41 by the end wall 45 and the radial inner wall 65. First, the insertion end 82 of the conduit 80 is inserted into the housing such that the conduit body 81 passes through the circular hole 46 in the inner tubular portion 40 and the hole 62 in the proximal end of the intermediate tubular portion 60 until the funnel-shaped member 84 abuts against the end wall 45.

[0094] The diameter of the orifice 62 is smaller than the diameter of the catheter body 81, which prevents or at least limits the leakage of wetting agent to the remainder of the catheter body outside the wetting agent reservoir 41. In this embodiment, the wetting agent is a lubricating silicone / polysiloxane gel. The bulge 48 ensures that the catheter is held centered within the housing. While the bulge 48 prevents the wetting agent reservoir from being completely sealed, the small gap between the catheter body 81 and the inner wall 47 of the orifice 46 caused by the bulge 48 (typically on the order of 0.07 mm) and the viscosity of the lubricating gel prevents or significantly limits leakage of the gel from the wetting agent reservoir through the orifice 46.

[0095] To ensure sterility of the catheter before use, an integrally supplied cap 24 is used to seal the catheter assembly. The cap 24 pivots about a hinge 25, causing a coiled ring 26 to be inserted into the open distal end 22 of the outer tubular portion 20. The radially outer wall 27 of the coiled ring 26 is provided with protrusions 28 spaced apart to engage corresponding recesses 29 on the inner edge of the open distal end 22, thereby securing the cap 24 in place. The end 30 of the coiled ring 26, away from the remainder of the cap 24, presses against and deforms the distal end 60A of the intermediate tubular portion 60. This causes radial deformation of the distal end 60A, pressing it against the outer tubular portion 20 and the inner tubular portion 40, thereby sealing the catheter assembly 10.

[0096] A wetting agent may be introduced during or after assembly via a port (not shown) in the external tubular member 20, thereby allowing access to the wetting agent chamber. Once the sealant is sealed in the sealant chamber and the port is closed, the catheter can be sterilized by known means (or each part of the assembly can be sterilized prior to assembly, and assembly can be performed in a sterile environment), thus maintaining a sterile environment within the housing of the catheter assembly once sealed.

[0097] To use catheter 80, the user, healthcare professional, or caregiver opens the cap 24 on catheter assembly 10, such as... Figure 6 As shown. In some embodiments, the cap may include a brittle indicator or the like to indicate that the sterile seal has been breached. The user can then remove the catheter 80 by pulling the funnel-shaped piece 84. When removing the catheter 80, the catheter body 81 passes through the wetting agent reservoir 41, where the catheter body 81 is coated with lubricating gel. The ridge 48 ensures a consistent and uniform coating of lubricating gel along the length of the catheter body 81. This is particularly advantageous because the insertion end 82, from which fluid is first inserted into a tube, vessel, channel, or body lumen, and therefore most in need of lubrication, passes through the final portion of the wetting agent reservoir 41, and thus controlled, consistent lubrication reduces the risk of the insertion end 82 being unlubricated.

[0098] Once catheter 80 has been used to drain fluid, it can be returned to catheter assembly 10 for later disposal. Cap 24 can be closed to reseal the housing and prevent or reduce unwanted fluid leakage before disposal.

[0099] The above description of one or more embodiments is by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

[0100] For example, although these embodiments are all female intermittent catheters, with exemplary lengths ranging from 90 mm to 200 mm, such as from 130 mm to 155 mm, for example, approximately 135 mm, and the catheter assembly having a length corresponding to the catheter length, such as a cannula closure length 2 mm to 10 mm longer than the catheter length (e.g., in the range of 10 cm to 25 cm; in the range of 140 mm to 165 mm, for example, 142 mm), it is believed that this teaching can be applied to male intermittent catheters (which are typically longer) or even other types of catheters. Similarly, although these embodiments use a lubricating gel, such as a polysiloxane gel, the catheter may alternatively have a functionalized hydrophilic surface that becomes smooth when wetted by a wetting agent such as water.

Claims

1. A catheter assembly comprising a radially nested inner tubular portion, a middle tubular portion, and an outer tubular portion, wherein the middle tubular portion is disposed between and adjacent to the inner tubular portion and the outer tubular portion, the inner tubular portion comprising a first material, the middle tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first material and the third material.

2. The catheter assembly according to claim 1, wherein, The housing includes the inner tubular portion, the intermediate tubular portion, and the outer tubular portion, and the housing is configured to receive a conduit.

3. The catheter assembly according to claim 1 or 2, wherein, The intermediate tubular portion has a Shore hardness in the range of 40 to 95, as measured using a Shore hardness tester "A".

4. The catheter assembly according to any one of the preceding claims, wherein, The intermediate tubular portion contains polysiloxane.

5. The catheter assembly according to any one of the preceding claims, wherein, The inner tubular portion and / or the outer tubular portion have a Shore hardness in the range of 80 to 95 when measured using a Shore hardness tester "A", and / or in the range of 40 to 90 when measured using a Shore hardness tester "D".

6. The catheter assembly according to any one of the preceding claims, wherein, The inner tubular portion and / or the outer tubular portion comprise polyvinyl chloride or polypropylene.

7. The catheter assembly according to any one of the preceding claims, wherein, The outer tubular portion is the outer shell.

8. The catheter assembly according to claim 7, wherein, The outer shell defines a sterile cavity.

9. The catheter assembly according to claim 7 or 8, wherein, The outer housing also includes a cover located at its distal end.

10. The catheter assembly of claim 9, wherein, The cover includes a ring configured to press against the intermediate tubular portion at its distal end.

11. The catheter assembly according to any one of the preceding claims, wherein, One of the outer tubular portion and the intermediate tubular portion includes one or more recesses, and the other of the outer tubular portion and the intermediate tubular portion includes one or more protrusions disposed in the recesses.

12. The catheter assembly of claim 11, wherein, The internal tubular portion includes at least one support structure aligned with the recess and the protrusion.

13. The catheter assembly according to any one of the preceding claims, wherein, The internal tubular portion includes a conduit retention structure.

14. The catheter assembly according to any one of the preceding claims, wherein, The internal tubular portion includes an end wall that extends radially inward from the proximal end of the internal tubular portion, and the end wall is provided with a hole extending through it.

15. The catheter assembly of claim 14, wherein, The hole is provided with one or more protrusions configured to press against the conduit body.

16. The catheter assembly according to any one of the preceding claims, wherein, The proximal end of the intermediate tubular portion extends axially beyond the proximal end of the inner tubular portion, and the section extending beyond the inner tubular portion defines a wetting agent chamber.

17. The catheter assembly of claim 16, wherein, The proximal end of the intermediate tubular portion includes a hole, wherein the shape and / or size of the hole is adapted to provide an engineering fit with the conduit body.

18. A method of manufacturing a catheter assembly, the catheter assembly comprising an inner tubular portion, an intermediate tubular portion, and an outer tubular portion, the inner tubular portion comprising a first material, the intermediate tubular portion comprising a second material, and the outer tubular portion comprising a third material, wherein the second material is softer than the first material and the third material. The method includes: The intermediate tubular portion is inserted into the outer tubular portion. The inner tubular portion is inserted into the middle tubular portion.

19. The method of manufacturing a conduit assembly according to claim 18, further comprising the step of inserting a conduit into the internal tubular portion.

20. The method of manufacturing a catheter assembly according to claim 18 or 19, wherein, The catheter assembly is the catheter assembly according to any one of claims 1 to 17.

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