Catheter assembly

Abstract

A catheter assembly includes a catheter and a wetting mechanism. The catheter has a proximal end and a distal end for insertion into a body. The wetting mechanism is disposed at the proximal end and includes a body. The body defines a wetting chamber through which the conduit is movable to wet the conduit. The wetting mechanism may include a slit valve or sealing element configured to allow the conduit to enter the wetting chamber and inhibit release of fluid from the wetting chamber. The catheter may be an intermittent male catheter, and may be hydrophilic. The catheter assembly may include two slit valves. The sealing element may be compressed by the wetting mechanism. The sealing element may be abutted by a wetting mechanism to support the sealing element in a transverse direction and an axial direction. The sealing element may have a stepped profile.

Description

Technical Field

[0001] The present invention relates to catheter assemblies. In particular, the present invention relates to urinary catheter assemblies, and more particularly, but not exclusively, to intermittent urinary catheter assemblies. Background Art

[0002] A catheter is a medical device that includes a hollow catheter tube designed to be inserted into a tube, vessel, passageway, or body cavity to allow injection, drainage, or withdrawal of fluids or substances therefrom, or to ensure that the tube, vessel, passageway, etc. remains open. A urinary catheter is designed to be inserted through the urethra into the user's bladder to empty the bladder.

[0003] In order to maximize comfort and minimize the risk of trauma and / or infection, the outer surface of the catheter tube is typically moistened with a wetting agent prior to insertion by the user. In a further development, the catheter tube itself includes, incorporates / is integrated with, or is coated with a hydrophilic component (e.g., a hydrophilic polymer) that serves to further reduce friction when the wetting agent is applied.

[0004] Some catheters may be supplied pre-wetted in the packaging, for example, the catheter is at least partially immersed in a wetting agent within the packaging. While this can ensure that the catheter body is fully moistened before use, a disadvantage of this arrangement is that catheter components other than the catheter body, such as the gripping element or the funnel, may also be moistened. This has an adverse effect on the user's experience, in which case it may become difficult to grip and guide the catheter body as required. This is particularly problematic when the user is performing self-catheterization. Furthermore, having an impregnated catheter may actually reduce the shelf life of the catheter due to long-term exposure of the catheter's components to moisture.

[0005] It would therefore be advantageous to provide a catheter that can be wetted during or immediately prior to use.

[0006] In an attempt to address this problem, some catheters are provided in a package that includes a rupturable container or pouch within the package that the user can rupture to release the wetting agent. Typically, this involves the user squeezing the package to rupture the container / pouch. However, this arrangement encounters similar problems as discussed above, in which the wetting agent is allowed to contact other parts of the catheter. This arrangement also results in the catheter body not being fully wetted before use, or in fact not being wetted at all. This can be harmful to the user. In addition, such a system may require a certain degree of flexibility and does not provide feedback to ensure that wetting has occurred.

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

[0008] Manual dexterity can also be an issue when opening the package to access the catheter, as this can cause the user to open the package incorrectly, such as by tearing it open, which can expose the catheter to dust and make it unsafe for use. It would therefore be advantageous to provide a catheter in a package that can be easily opened by the user while keeping the catheter in a clean and usable condition.

[0009] It is an object of one or more embodiments of the present invention to overcome or at least partially alleviate one or more problems of the prior art and / or to provide an improved intermittent catheter. Summary of the invention

[0010] The present invention relates to a catheter assembly. The assembly may include a catheter and a wetting mechanism, the catheter including a distal end and a proximal end for insertion into a user's body. The wetting mechanism may include a body. The wetting mechanism may include a wetting chamber. The body may define a wetting chamber through which the catheter may move to wet the catheter. The wetting mechanism may include a valve. The valve may be configured to prohibit fluid from being released from the wetting chamber. The valve may be configured to allow the catheter to enter the wetting chamber, and may therefore be an inlet valve. The valve is preferably a slit valve, for example the inlet valve is preferably a slit valve.

[0011] The wetting mechanism may comprise a sealing element. The sealing element may comprise a valve, such as an inlet valve. The valve may define a transverse plane perpendicular to the axial direction. The sealing element may have a stepped profile. The sealing element may comprise an outer wall extending parallel to the transverse plane but offset from the valve. The sealing element may comprise an internal support extending in the axial direction. The internal support may connect the outer wall to the valve. The wetting mechanism may abut the internal support to inhibit movement of the valve in the transverse plane. The wetting mechanism may abut the outer wall to inhibit movement of the valve in the axial direction.

[0012] The sealing element may comprise a top hat profile. The top hat profile may be provided by the valve, the inner support and the outer wall. The valve may be arranged in the centre / center of the top hat profile. Thus, the sealing element may be better supported due to the multiple different parts of the top hat profile that may be abutted by the rest of the wettable mechanism.

[0013] The wetting mechanism may include a base. The wetting chamber may be tubular. The body may include an opening. The opening may be sized to allow a catheter to pass through the base. The opening may be sized to allow a catheter to enter the wetting chamber. The sealing element may include a material that is more flexible than the body and / or the base. The sealing element may be elastically deformable through the body and the base to preferably provide a fluid-tight seal between the body and the base.

[0014] According to one broad aspect of the present invention, there is provided a catheter assembly comprising: a catheter including a distal end and a proximal end for insertion into a user's body; and a wetting mechanism, wherein the wetting mechanism includes a body defining a wetting chamber through which the catheter is movable to wet the catheter, the wetting mechanism including a slit valve configured to allow the catheter to enter the wetting chamber and inhibit release of fluid from the wetting chamber.

[0015] The wetting mechanism may be arranged at the proximal end of the catheter.

[0016] According to a first aspect of the present invention, there is provided a catheter assembly comprising: a catheter comprising a distal end and a proximal end for insertion into a user's body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body defining a wetting chamber, the catheter being movable through the wetting chamber to wet the catheter, the wetting mechanism comprising a slit valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber.

[0017] Advantageously, since the catheter can pass through the wetting mechanism, it can be in direct contact with the wetting fluid and can therefore be effectively wetted by the wetting fluid. Furthermore, the use of a slit valve ensures that the wetting mechanism is simple and inexpensive to construct, while providing a robust and easy to use valve, since the catheter can simply be pushed through the valve and into the wetting chamber. Furthermore, since the wetting mechanism is arranged at the proximal end of the catheter, this helps to ensure that the proximal end of the catheter is adequately wetted, which is important since it is the first part of the catheter that enters the body in use. Therefore, the catheter assembly of the first aspect is easy to use, reduces the risk of injury / discomfort to the user, and is also easy to manufacture.

[0018] The slit valve may include at least one slit. The slit valve may include at least two slits, and preferably the slit valve includes only two slits. The length of each slit may be greater than the diameter of the catheter. Each slit may have a length of no more than 20% of the slit valve diameter, no more than 30% of the slit valve diameter, no more than 40% of the slit valve diameter, no more than 50% of the slit valve diameter, no more than 60% of the slit valve diameter, no more than 70% of the slit valve diameter, or no more than 80% of the slit valve diameter. Each slit may have a length of no less than 80% of the slit valve diameter, no less than 70% of the slit valve diameter, no less than 60% of the slit valve diameter, no less than 50% of the slit valve diameter, no less than 40% of the slit valve diameter, no less than 30% of the slit valve diameter, or no less than 20% of the slit valve diameter. Preferably, the length of each slit is 70% of the slit valve diameter, for example 5-6 mm or most preferably 5.5 mm. Each slit may have substantially the same length. Thus, the slit may provide an effective seal without negatively impacting the structural integrity of the slit valve.

[0019] One or more or each slit may be arranged to intersect with the center of the slit valve. One or more or each slit may extend from the center of the slit valve. One or more or each slit may terminate at substantially the same distance from the center of the slit valve. In the case of two or more slits, at least two slits or each slit may intersect. In the case of two or more slits, two or more angles may be defined between adjacent slits. The two or more angles may be substantially the same. Two slits (or at least two slits) may be arranged orthogonally. Two slits (or at least two slits) may be arranged in a cross shape. The cross may be located in the center of the slit valve. Therefore, the slit may be arranged to maximize the available space and ensure that the conduit effectively passes through the middle of the slit valve and enters the wetting chamber.

[0020] In some embodiments, the two or more angles between adjacent slits may be different, i.e., they may not be equal. For example, in one embodiment, two slits may be arranged in a T-shape to define three fins. In another embodiment, three slits may be arranged in a Y-shape to define three fins.

[0021] The slit valve may comprise at least two flaps. The at least one slit may define at least two flaps. The at least two flaps may be movable to allow the valve to be opened. The at least two flaps may be separable. The at least two flaps may be movable / separated under the action of a conduit to allow the conduit to pass through the slit valve. The slit valve may comprise four flaps, preferably defined by two slits. Thus, the slit valve may be easily opened and closed by the flaps.

[0022] The axial direction may be defined as the direction along which the conduit passes through the slit valve into the wetting chamber.A transverse plane may be defined by the slit valve perpendicular to the axial direction.

[0023] The slit valve can be any suitable shape or size, such as circular, oval, lens-shaped, triangular, rectangular, square or irregular. Preferably, the slit valve is circular. The slit valve can have a width larger than the diameter of the catheter, such as a diameter, such as at least 2 times, at least 3 times, at least 4 times or at least 5 times the diameter of the catheter. The slit valve can have a width of at least 5 mm, at least 10 mm or at least 15 mm. The slit valve can have a width of no more than 15 mm, no more than 10 mm or no more than 5 mm. Preferably, the width of the slit valve is 5-10 mm, most preferably about 8 mm. Therefore, the valve is easily and flexibly incorporated into various wetting mechanism designs.

[0024] The slit valve can be formed of a flexible elastic material such as a flexible plastic material, rubber or silicone resin / polysiloxane / organic silicon / silicone. The slit valve can be elastically deformable. The slit valve can be normally closed. Each wing can be elastically biased to return to the closed position. In the closed position, two or more winglets can cooperate to seal the slit valve. Therefore, the slit valve can be easily configured to automatically seal the wetting chamber and prevent fluid leakage without using complex components.

[0025] The slit valve may have a curved surface. The slit valve may be dome-shaped. The slit valve may have a dome height parallel to the axial direction. The dome height may be at least 1%, at least 2%, at least 5%, at least 10%, at least 15% or at least 20% of the slit valve diameter. The dome height may not exceed 30% of the slit valve diameter, not exceed 20% of the slit valve diameter, not exceed 15% of the slit valve diameter, not exceed 10% of the slit valve diameter, not exceed 5% of the slit valve diameter, not exceed 2% of the slit valve diameter or not exceed 1% of the slit valve diameter. Preferably, the dome height is 10% of the slit valve diameter, for example, about 1 mm. The slit valve may be concave on the side facing the wetting chamber. The slit valve may be convex on the side away from the wetting chamber. Therefore, the slit valve can more effectively prevent the wetting fluid from leaking from the wetting chamber.

[0026] The wetting mechanism may include a sealing element, which may include an inlet valve, which may be a slit valve. The inlet valve may define a transverse plane perpendicular to the axial direction. The sealing element may have a stepped profile. The sealing element may include an outer wall extending parallel to the transverse plane but offset from the inlet valve. The sealing element may include an internal support extending in the axial direction. The internal support may connect the outer wall to the inlet valve. The wetting mechanism may abut the internal support to prohibit movement of the inlet valve in the transverse plane. The wetting mechanism may abut the outer wall to prohibit movement of the inlet valve in the axial direction.

[0027] According to another broad aspect of the present invention, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism, wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprises an inlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by a wetting fluid, the inlet valve is configured to prohibit the fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises: a stepped profile, an outer wall extending parallel to the transverse plane but offset from the inlet valve, an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction.

[0028] The wetting mechanism may be arranged at the proximal end of the catheter.

[0029] According to a second aspect of the present invention, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprising an inlet valve, the inlet valve being configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by a wetting fluid, the inlet valve being configured to prohibit the release of fluid from the wetting chamber, the inlet valve defining a transverse plane perpendicular to the axial direction, the sealing element comprising: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction.

[0030] Advantageously, the inlet valve is supported by the inner support and the outer wall, which minimizes obstruction of the inlet valve by the remainder of the wetting mechanism. Thus, the inlet valve can be most efficiently sized to allow the catheter to pass therethrough. Furthermore, this arrangement allows the outer wall and the inner support to be designed in a manner that maximizes structural support for the inlet valve, so that the inlet valve can operate more efficiently. Furthermore, since the wetting mechanism is arranged at the proximal end of the catheter, this helps ensure that the proximal end of the catheter is adequately wetted, which is important because it is the first part of the catheter to enter the body in use.

[0031] The sealing element may be of any suitable shape or size, such as circular, oval, lens-shaped, triangular, rectangular, square or irregular shape, preferably the sealing element is circular. The sealing element may be sheet-like, for example it may have a substantially constant thickness.

[0032] The internal support may surround at least a portion of the inlet valve. The internal support may surround a majority of the inlet valve, preferably a majority of the inlet valve in a transverse plane. The internal support may be continuous. Thus, the internal support may be used to surround the inlet valve, which ensures that it can provide good structural support in the transverse plane and in the axial direction without obstructing the passage of the conduit through the inlet valve.

[0033] The internal support may be attached to the outer edge of the inlet valve. The inlet valve may be bent towards the internal support. The inlet valve may be concave on the side corresponding to the internal support. Thus, the internal support provides support by the edge of the valve and does not hinder the operation of the valve.

[0034] The internal support may include an internal flange. The internal flange may extend in an axial direction. The internal flange may surround the inlet valve in a transverse plane. The internal flange may be frustoconical. The narrow end of the internal flange may be attached to the inlet valve, preferably to the outer edge of the inlet valve. The diameter of the wide end of the internal flange may be at least 1%, at least 2%, at least 5% or at least 10% larger than the narrow end. The diameter of the wide end of the internal flange may be no more than 10%, no more than 5%, no more than 2% or no more than 1% larger than the narrow end. Preferably, the diameter of the wide end of the internal flange is 5% larger than the narrow end. In one example, the narrow end diameter of the internal flange is 8 mm and the wide end diameter is 8.5 mm. The length of the internal flange measured in the axial direction between the narrow end and the wide end may be at least 15%, at least 20%, at least 25% or at least 30% of the diameter of the inlet valve. The length of the inner flange may be no more than 30% of the inlet valve diameter, no more than 25% of the inlet valve diameter, no more than 20% of the inlet valve diameter or no more than 15% of the inlet valve diameter. Preferably, the length of the inner flange is 2% of the inlet valve diameter. In one example, the inner flange has a length of about 2 mm. Thus, the inner flange provides a surface extending in the axial direction and around the inlet valve. This can be abutted by the wetting mechanism to effectively inhibit the movement of the inlet valve in the transverse plane from a position outside the transverse range of the inlet valve. Therefore, the inlet valve itself is not hindered by the wetting mechanism.

[0035] The wetting mechanism may include a transverse support structure configured to abut the internal support. The transverse support structure may be configured to prohibit the movement of the internal support and the inlet valve in a transverse plane. The transverse support structure may surround at least a portion of the internal support. The transverse support structure may surround the internal support, preferably in a transverse plane. The transverse support structure may include an internal sealing tube. The internal sealing tube may be configured to abut the internal flange. The internal sealing tube may be cylindrical. The inner diameter of the internal sealing tube may be less than the diameter of the wide end of the internal flange. The inner diameter of the internal sealing tube may be greater than the diameter of the narrow end of the internal flange. The internal sealing tube may be configured to elastically deform the sealing element / internal flange. The internal sealing tube may have a longer length than the internal flange. Therefore, the transverse support structure / internal sealing tube can effectively surround the internal flange and the inlet valve to prohibit their movement in the transverse plane because the internal flange can be wedged into the internal sealing tube. Of course, in many other embodiments, variations of the lateral support structure / internal sealing tube may be used to achieve the same effect, for example, the tube is not always required, but may be replaced by, for example, a series of support members (e.g., rods) arranged around the internal support member / internal flange.

[0036] The outer wall may surround at least a portion of the inlet valve and / or the internal support. The outer wall may surround the inlet valve and / or the internal support, preferably in a transverse plane. The outer wall may be continuous. The outer wall may be annular. The outer wall may include an inner periphery corresponding to the outer periphery of the inlet valve. The inner periphery of the outer wall may be spaced apart from the outer periphery of the inlet valve in the transverse direction outside the outer periphery of the inlet valve. The inner diameter of the outer wall may be greater than the diameter of the inlet valve. The inner diameter of the outer wall may be equal to the diameter of the wide end of the inner flange. The outer diameter of the outer wall may be at least 50%, at least 60%, at least 65%, at least 70% or at least 80% larger than the diameter of the inlet valve. The outer diameter of the outer wall may be no more than 80%, no more than 70%, no more than 65%, no more than 70% or no more than 50% larger than the diameter of the inlet valve. Preferably, the outer diameter of the outer wall is about 70% larger than the diameter of the inlet valve, for example, about 14 mm. The outer wall may be offset from the inlet valve in the transverse plane due to the length of the inner support in the axial direction. Thus, the outer wall may be used to surround the inner support and the inlet valve, which ensures that it provides good structural support in the transverse plane and in the axial direction without obstructing the passage of the conduit through the inlet valve or the inner support when supporting the inlet valve.

[0037] The sealing element may comprise an external support. The external support may surround at least a portion of the outer wall. The external support may surround a majority of the outer wall, preferably a majority of the outer wall in a transverse plane. The external support may be continuous. The external support may be attached to the outer wall, preferably at an outer edge of the outer wall. The external support may extend away from the internal support in an axial direction. Thus, the external support may be used to surround the outer wall, which ensures that it can provide good structural support in a transverse plane and in an axial direction without obstructing the passage of the conduit through the inlet valve.

[0038] The external support may be attached to the outer edge of the outer wall. Thus, the external support provides support through the edge of the outer wall and does not hinder the operation of the inlet valve.

[0039] The external support may be attached to the outer edge of the outer wall.Thus, the external support provides support via the edge of the outer wall without interfering with the operation of the inlet valve.

[0040] The wetting mechanism may include an axial support structure. The axial support structure may be configured to abut the outer wall and / or the internal support. The axial support structure may be configured to prohibit the movement of the outer wall, the internal support and / or the inlet valve in the axial direction. The axial support structure may be arranged on one side or preferably on both sides of the outer wall in the axial direction. The axial support structure may include an internal sealing tube. The internal sealing tube may be configured to abut the outer wall, preferably adjacent to the inner flange abutting the outer wall around the inner diameter of the outer wall. The internal sealing tube may be configured to prevent the inlet valve from being excessively inserted into the internal sealing tube. Therefore, when the outer wall abuts the internal sealing tube, the axial support structure / internal sealing tube can effectively prohibit the movement of the inlet valve in the axial direction. This helps to ensure that the conduit can open the valve and pass through the valve, and prevents damage to the inlet valve / internal flange due to excessive insertion of the internal sealing tube.

[0041] The axial support structure may be configured to abut the outer wall at more than one location, for example at two or more independent locations. This helps to ensure that the outer wall does not bend or deform excessively when supported.

[0042] The axial support structure may include an external sealing tube. The external sealing tube may be arranged concentrically with the internal sealing tube. The external sealing tube may be configured to abut the outer wall, preferably abut the outer wall on the same side of the outer wall as the side on which the internal sealing tube abuts the outer wall. The inner diameter of the external sealing tube may be smaller than the outer diameter of the outer wall. The inner diameter of the external sealing tube may be larger than the outer diameter of the internal sealing tube. When measured in the axial direction, the external sealing tube may terminate at the same position as the internal sealing tube. Therefore, the axial support structure can effectively support the outer wall to prohibit movement in the axial direction. Of course, in many other embodiments, variations of the external sealing tube may be used to achieve the same effect, for example, the tube is not always necessary, but may be replaced, for example, by a series of supporting members arranged around the circumference of the outer wall at a position inside the outer diameter of the outer wall.

[0043] The axial support structure may include an axial stop. The axial stop may be configured to abut the outer wall to prohibit the movement of the inlet valve in the axial direction. The axial stop may be configured to abut the outer wall on a side opposite to the inner sealing tube and / or the outer sealing tube. The axial stop may abut the outer wall at a position between the outer sealing tube and the inner sealing tube. The axial stop may include one or more stops, preferably 4 or more stops, for example 8 stops. The one or more stops may be arranged at an equal distance from the center of the outer wall. Each stop may be arranged at a certain distance from the center of the outer wall between the outer sealing tube and the inner sealing tube. The one or more stops may be evenly distributed in a circular shape. The one or more stops may be evenly distributed to match the shape of the outer wall periphery. Therefore, by ensuring that the outer wall is firmly held therebetween by the axial support structure, the axial stop may provide support for the inlet valve.

[0044] The wetting mechanism may include a base. The base may include an inner seal tube. The base may include an outer seal tube. The inner seal tube may be configured to prohibit the inlet valve from moving away from the center of the body in the axial direction. The outer seal tube may be configured to prohibit the inlet valve from moving away from the center of the body in the axial direction. The body may include the axial stop. The axial stop may be configured to prohibit the inlet valve from moving towards the center of the body in the axial direction.

[0045] The wetting chamber may be tubular. The body may include an opening. The size of the opening may be determined to allow the catheter to pass through the base. The size of the opening may be determined to allow the catheter to enter the wetting chamber. The sealing element may include a material that is more flexible than the body and / or the base. The sealing element may be elastically deformed under the action of the body and the base so as to preferably provide a fluid-tight seal between the body and the base.

[0046] According to another broad aspect of the present invention, there is provided a catheter assembly comprising: a catheter including a distal end and a proximal end for insertion into the body; and a wetting mechanism, wherein the wetting mechanism includes a body, a base, and a sealing element, the body defining a tubular wetting chamber through which the catheter is movable to wet the catheter, the base including an opening sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising a material that is more flexible than the body and the base, and wherein the sealing element is elastically deformed under the action of the body and the base to provide a fluid-tight seal between the body and the base.

[0047] The wetting mechanism may be arranged at the proximal end of the catheter. The sealing element may include an inlet valve configured to allow the catheter to enter the wetting chamber. The outlet valve may be configured to prohibit the release of fluid from the wetting chamber.

[0048] According to a third aspect of the present invention, there is provided a catheter assembly comprising: a catheter including a distal end and a proximal end for insertion into the body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism includes a body, a base, and a sealing element, the body defining a tubular wetting chamber through which the catheter is movable to wet the catheter, the base including an opening sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element including an inlet valve configured to allow the catheter to enter the wetting chamber and prohibit the release of fluid from the wetting chamber, the sealing element comprising a material that is more flexible than the body and the base, and wherein the sealing element is elastically deformed under the action of the body and the base to provide a fluid-tight seal between the body and the base.

[0049] Advantageously, the body, base and sealing element provide a simple and effective three-part wetting mechanism by elastic deformation of the sealing element between the body and the base. This allows the wetting mechanism to be easily constructed without sacrificing performance, because the body and the base can be easily clamped together to structurally support the inlet valve and ensure a fluid-tight seal using the sealing element. This also allows the wetting mechanism to be constructed without welding its parts together or using adhesives, further reducing the complexity and raw material usage in the manufacturing process. In addition, since the wetting mechanism is arranged at the proximal end of the catheter, this helps to ensure that the proximal end of the catheter is fully wetted, which is important because it is the first part of the catheter to enter the body during use.

[0050] Therefore, the body, base and sealing element are preferably formed separately rather than integrally.

[0051] The outer wall / external support may be configured to provide a seal between the body and the sealing element. The outer wall / external support may be configured to provide a seal between the base and the sealing element. The external support may include an external flange. The external flange may extend in an axial direction. The external flange may surround the entire outer wall in a transverse plane. The external flange may be truncated conical. The narrow end of the external flange may be attached to the outer wall, preferably to the outer edge of the outer wall. The diameter of the wide end of the external flange may be at least 1%, at least 2%, at least 3% or at least 5% larger than the narrow end. The diameter of the wide end of the external flange may be no more than 5%, no more than 3%, no more than 2% or no more than 1% larger than the narrow end. Preferably, the diameter of the wide end of the external flange is 2% larger than the narrow end. In one example, the narrow end of the external flange has a diameter of about 13.5 mm, and the wide end has a diameter of about 14 mm. The length of the outer flange between the narrow end and the wide end measured in the axial direction may be at least 15%, at least 20%, at least 25% or at least 30% of the outer diameter of the outer wall. The length of the outer flange may not exceed 30% of the outer diameter of the outer wall, not exceed 25% of the outer diameter of the outer wall, not exceed 20% of the outer diameter of the outer wall or not exceed 15% of the outer diameter of the outer wall. Preferably, the length of the outer flange is 20% of the outer diameter of the outer wall, or is 60% longer than the length of the inner flange, for example about 3 mm. Thus, similar to the inner flange, the outer flange provides a surface extending in the axial direction and extending around the outer wall. This can advantageously be abutted by the wetting mechanism to effectively inhibit the movement of the outer wall, thereby inhibiting the movement of the inlet valve in the transverse plane and the axial direction, without the inlet valve being hindered by the wetting mechanism.

[0052] The base and / or the body may be configured to receive an external support / external flange. The external flange may be compressed by a wetting mechanism, preferably between the base and the body. The body may include a groove configured to receive the external flange. The groove may have the same shape as the external support / external flange, such as a circle. The groove may be configured to elastically deform the sealing element / external flange. The groove may include an inner diameter between the diameters of the narrow end and the wide end of the external flange, respectively. The groove may include an outer diameter, which may be greater than the inner diameter by an amount equal to or preferably less than the thickness of the external flange. The inner edge of the groove may be chamfered to help the external flange enter the groove. Therefore, when the external flange is received in the groove and compressed between the inner / outer diameter of the groove, as the external flange is squeezed inwardly, the groove can effectively seal between the body and the sealing element. This also helps to prohibit the movement of the inlet valve.

[0053] At least a portion of the sealing element may be deformed in a radial direction under the action of the base and the main body, for example, compressed. The outer wall may be compressed in a radial direction by a wetting mechanism. The radial direction may be perpendicular to the axial direction, for example, parallel to a transverse plane (and passing through an axis defining the axial direction). The inner diameter of the main body may be smaller than the outer diameter of the outer flange. The inner diameter of the inner sealing tube may be smaller than the outer diameter of the inner flange. Therefore, when abutted by the main body and the base, the inner flange and the outer flange are forced inwardly so that the outer wall is compressed. This further helps to ensure a fluid-tight seal and prohibits unintentional movement of the inlet valve.

[0054] At least a portion of the sealing element may be compressed in the axial direction by the base and / or the body. The external support and preferably the external flange may be compressed in the axial direction by the base and / or the body. The groove may have a length in the axial direction. The distance between the closed end of the groove and the external sealing tube may be less than the length of the external flange. The distance between the closed end of the groove and the internal sealing tube may be less than the length of the external flange. Therefore, the external sealing tube and / or the internal sealing tube cooperate with the groove to force the external flange into the groove and compress it in the groove, which helps to ensure a fluid-tight seal while prohibiting accidental movement of the inlet valve.

[0055] The external support may include a sealing member. The sealing member may include a protrusion extending from the external support, such as from the external flange. The sealing member may provide a wider or thicker external support area. The thickness of the sealing member may be at least 10%, at least 20%, at least 25%, at least 30% or at least 40% of the thickness of the external flange. The thickness of the sealing member may not exceed 40% of the thickness of the external flange, not exceed 30% of the thickness of the external flange, not exceed 25% of the thickness of the external flange, not exceed 20% of the thickness of the external flange or not exceed 10% of the thickness of the external flange. The external flange may have an outer diameter in the area of ​​the sealing member that is at least 5%, at least 10%, at least 15%, at least 20% or at least 25% wider than the diameter of the wide end of the external flange. The external flange may have an outer diameter in the area of ​​the sealing member that is no more than 25%, no more than 20%, no more than 15%, no more than 10% or no more than 5% wider than the diameter of the wide end of the external flange. The outer flange may have an inner diameter that is reduced by an equal / equivalent amount by the sealing member. The sealing member may be configured to be elastically deformed by the wetting mechanism. The sealing member may be elastically deformed under the action of the body, for example, elastically deformed in the groove. The sealing member may be a sealing rib. The sealing rib may extend around at least a portion of the periphery of the outer flange, and preferably around the entire periphery. The sealing rib may be a semicircular protrusion. Therefore, the sealing member can be used to ensure elastic deformation of the outer flange in the groove to help provide a fluid-tight seal and additional support for the inlet valve.

[0056] The body may be tubular. The body may be cylindrical. The body may have two open ends. The body may be configured to receive an external sealing tube. The inner diameter of the body may be substantially equal to the outer diameter of the external sealing tube. The inner diameter of the body may be substantially equal to the outer diameter of the groove. Thus, the external sealing tube may be received by the body and force the sealing element into the groove.

[0057] The body may be configured to engage the base. The base may be configured to engage the body. For example, during normal use of the wetting mechanism, the body and the base may be inseparable. Thus, the wetting mechanism may be securely held together, ensuring that the catheter can be properly wetted and used safely.

[0058] The wetting mechanism may include two or more interlocking members. The interlocking members may be configured to fix the base and the main body together. The base may include at least one interlocking member. The main body may include at least one interlocking member. At least one interlocking member may be a locking groove. At least one interlocking member may be a locking protrusion. The locking protrusion may be received in the locking groove. Each locking protrusion may correspond to a locking groove. Preferably, the wetting mechanism includes at least two locking protrusions that can engage with at least two locking grooves. Therefore, the interlocking members provide a simple and effective way to fix the main body and the base together to seal the wetting chamber.

[0059] The wetting mechanism may comprise two or more pairs of interlocking members. For example there are four or more locking members, for example there are two or more locking protrusions that can engage with two or more locking grooves. Having at least two pairs of interlocking members helps ensure that the device is more securely held and provides redundancy.

[0060] Two or more pairs of interlocking members may be spaced apart around the circumference of the wetting mechanism. One or more gaps may be provided between adjacent pairs of interlocking members to allow at least one interlocking member to move. This ensures a secure fit around the wetting mechanism and makes it easier to fit the wetting mechanism together, as the spacing, and in particular the gaps, allow the interlocking members to move more freely into engagement with each other.

[0061] At least one interlocking member may extend around a portion of the circumference of the wetting mechanism. One or preferably both interlocking members of each pair of interlocking members may extend around only a portion of the circumference of the wetting mechanism. Thus, the interlocking members may be moved during manufacture of the device to make it easier to fit the wetting mechanism together.

[0062] The at least one locking projection may be arranged on the base. The at least one locking projection may be arranged on the external sealing tube. Each locking projection may span an arc length equal to at least 50°, at least 60°, at least 70° or at least 80° around the external sealing tube. Each locking projection may span an arc length equal to no more than 80°, no more than 70°, no more than 60° or no more than 50° around the external sealing tube. The spacing between adjacent locking projections may be equal. There may be two locking projections located on opposite sides of the wetting mechanism. Preferably, each locking projection spans an arc length of 65° around the external sealing tube. The at least one locking projection may be configured to force the base to engage with the base.

[0063] Each locking projection may be wedge-shaped. Each locking projection may have a wedge-shaped profile. Each locking projection may have a minimum thickness at an end away from the base. Each locking projection may have a maximum thickness at an end close to the base. The thickness of each locking projection may vary linearly between the minimum and maximum thickness of the locking projection. Each locking projection may have a region of maximum thickness that spans at least 20%, at least 30%, or at least 40% of the length of the locking projection in a direction parallel to the axial direction. Each locking projection may have a maximum thickness region that spans no more than 40% of the length of the locking projection, no more than 30% of the length of the locking projection, or no more than 20% of the length of the locking projection. The minimum thickness of each locking projection may be substantially zero, that is, it does not increase the thickness of an object on which the locking projection is arranged, such as an external sealing tube. The maximum thickness of each locking projection may be at least 0.5 mm, at least 1 mm, at least 2 mm, or at least 4 mm. The maximum thickness of each locking projection may not exceed 4 mm, not exceed 2 mm, not exceed 1 mm, or not exceed 0.5 mm. The maximum thickness of each locking projection may be less than the thickness of the body. Each locking projection can extend only through a portion of the corresponding locking groove. Therefore, the locking projection can easily engage in each groove and fix the body to the base without affecting the clamping projection of the cover outlined below.

[0064] Each locking projection may be mounted on a locking tongue. Each locking tongue may be configured to bend to allow the locking projection to move to engage with a corresponding groove. The outer sealing tube may include one or more locking tongues corresponding to the one or more locking projections. Each locking tongue may be arranged at the free end of the outer sealing tube. Each locking tongue may be configured to abut against the outer wall of the sealing element. Each locking tongue may be defined by a pair of gaps arranged in the outer sealing tube. Each gap may extend in an axial direction from the free end of the outer sealing tube. Each gap may cover an arc length equal to at least 5°, at least 10° or at least 15° around the outer sealing tube. Each gap may cover an arc length equal to no more than 15°, no more than 10° or no more than 5° around the outer sealing tube. Each locking projection may span most of the arc length spanned by the locking tongue, preferably spanning the entire arc length. Each locking tongue may include at least one locking projection. Therefore, when the locking projections are mounted on the locking tongues, they can be easily moved to be received by the locking grooves. Each locking groove may span an arc length equal to at least 50°, at least 60°, at least 70° or at least 80° around the body. Each locking groove may span an arc length of no more than 80°, no more than 70°, no more than 60°, or no more than 50° around the body. The spacing between adjacent locking grooves may be equal. There may be two locking grooves located on opposite sides of the wetting mechanism. Preferably, each locking groove spans an arc length of 65° around the external sealing tube. The at least one locking groove may be configured to force the base to engage with the base. Therefore, by inserting the external sealing tube into the body until the locking protrusion engages the locking groove, the base and the body can be easily and securely fixed together.

[0065] Of course, while the locking recess is described as being part of the body and the locking projection is described as being part of the base, this relationship could be reversed if desired.

[0066] The base may include a skirt. The skirt may span between the inner sealing tube and the outer sealing tube. The inner sealing element may extend from the skirt. The outer sealing element may extend from the skirt. The outer diameter of the skirt may be greater than the outer diameter of the outer sealing tube. The skirt may include an outer diameter substantially equal to the outer diameter of the body. The skirt may be annular. The inner diameter of the skirt may be no greater than the inner diameter of the inner sealing tube. The outer diameter of the skirt may be at least 1.5 times, at least 2 times, or at least 2.5 times its inner diameter. The outer diameter of the skirt may be no more than 3 times, no more than 2.5 times, or no more than 2 times its inner diameter. Therefore, the skirt provides structural support to the inner sealing tube and the outer sealing tube and ensures smooth assembly of the base with the body.

[0067] The base may include an insertion tube. The insertion tube may provide an opening in the base. The insertion tube may be configured to guide a catheter through the base and a corresponding sealing element. The insertion tube may be arranged in the center of the skirt. The insertion tube may extend from the skirt, preferably on a side opposite to the inner sealing tube and / or the outer sealing tube. The insertion tube may be cylindrical. The inner diameter of the insertion tube may be larger than the outer diameter of the catheter. The inner diameter of the insertion tube may be at least as large as the outer diameter of the inlet valve. The insertion tube may have an outer diameter corresponding to the inner diameter of the skirt. Therefore, the insertion tube can be used to help the catheter pass through the base.

[0068] The skirt may be planar, for example substantially planar. The skirt may be curved. The skirt may be dome-shaped. The insertion tube may extend from a convex surface of the skirt. Thus, the skirt may be used to prevent over-insertion of an insertion tube into the extension body, wherein the insertion tube is used to deliver the catheter directly into the body.

[0069] The insertion tube may be open ended. The insertion tube may be capped. The insertion tube may be covered with a dome, such as a semi-cylindrical / hemispherical dome. The dome may include at least one slit, such as two slits. The two slits may be arranged orthogonally. The two slits may form a cross. The at least one slit may define at least two fins, such as four fins. The fins may be configured to separate to allow the catheter to pass through the dome. Therefore, the insertion tube may be capped to prevent dust from entering the insertion tube and making the catheter unsafe to use. It also helps to prevent fluid from leaking from the wetting mechanism in the event that the fluid leaks through one of the valves. In addition, the dome shape and the slits enable the insertion tube to be easily and comfortably used to introduce the catheter into the body.

[0070] Each end of the body may be configured to receive a sealing element. Each end of the body may be configured to engage the body. Each end of the body may be substantially identical. The wetting mechanism may include two sealing elements. The two sealing elements may include a proximal sealing element and a distal sealing element. The distal sealing element may include an inlet valve. The proximal sealing element may include an outlet valve. The outlet valve may be configured to allow the catheter to exit the wetting chamber. The outlet valve may have any one or more features of a valve, a slit valve, or an inlet valve as described above. Preferably, the outlet valve is the same or substantially the same as the inlet valve. Preferably, the outlet valve is a slit valve. The wetting mechanism may include two bases. The two sealing elements and the two bases may seal the two ends of the body. One of the bases may be an inserter tip. The inserter tip may include an insertion tube capped as described above. The inserter tip may be configured to engage one end of the body, wherein the proximal sealing element seals therebetween. The inserter tip may be configured to facilitate insertion of the catheter into the body, for example, its shape may be determined to facilitate insertion of the catheter into the body. The other base may be configured to engage the other end of the body, with the distal sealing element sealing therebetween. Thus, the wetting mechanism can be easily constructed with similar components and work together in a simple manner.

[0071] Each of the inlet valve and the outlet valve may have a curved surface. Preferably, each of the inlet valve and the outlet valve is dome-shaped. The inlet valve and the outlet valve may be arranged in the wetting mechanism with opposite curvatures. The inlet valve and the outlet valve may both be convex on a side away from the wetting chamber. Therefore, the inlet valve and the outlet valve are better arranged to keep the liquid in the wetting chamber and also provide additional space for the wetting fluid / liquid in the wetting chamber.

[0072] The body may have a diameter of 10-20 mm, for example, about 16 mm. The body may have a length of 20-30 mm, for example, about 25 mm. The body may include at least one rib. Each rib may extend in an axial direction along the body. The length of each rib in the axial direction may be at least 50%, at least 60%, at least 70% or at least 80% of the length of the body. The length of each rib may not exceed 80% of the length of the body, not exceed 70% of the length of the body, not exceed 60% of the length of the body or not exceed 50% of the length of the body. Preferably, the length of each rib is 65% of the length of the body. Each rib may be attached to the inside of the body. Each rib may be attached to the body along most of its length, but preferably not attached to the body over its entire length. Each rib may extend 15-25% of the inner diameter of the body from the inner diameter of the body inwardly. Preferably, the body may include at least two ribs, for example eight ribs. These ribs may be arranged at equal intervals around the inner circumference of the body. Therefore, these ribs may provide additional structural support for the body without significantly reducing the internal volume of the body.

[0073] Each rib may include a sealing groove disposed between one end of the rib and the body. Preferably, each rib includes a sealing groove at both ends of the rib. Each sealing groove may be configured to receive an external flange. The sealing grooves at the same end of the at least one rib may together form the above-mentioned groove. Therefore, the ribs may also cause the external flange to engage with the body to seal the wetting chamber.

[0074] The end of each rib may provide a stop as described above. Thus, where the body comprises at least two ribs, these ribs together may provide the above-mentioned axial stop. Thus, these ribs may be used to effectively inhibit movement of the outer wall and the inlet valve.

[0075] The wetting mechanism may include a cover. The cover may be configured to cover a base, such as an inserter tip. The cover may be disposed above the inserter tip around the inserter tip. The cover may include a housing slightly larger than the base / inserter tip so as to cover the base / inserter tip. Thus, the base / inserter tip is protected prior to use.

[0076] The cover may include a pull ring. The pull ring may be configured to allow a user to grasp the cover and pull it away from the wetting mechanism. The pull ring may of course be replaced by some other easy-to-grasp feature structure that allows the cover to be easily removed from the wetting mechanism.

[0077] The cover may include a cover flange extending around the body. The cover may include at least one interlocking member configured to engage the at least one interlocking member present on the body and / or the base. The cover may include one or more clamping projections. The one or more clamping projections may be located on the cover flange. The one or more clamping projections may be configured to engage the one or more locking grooves of the body. Each clamping projection may only extend through a portion of the corresponding locking groove. Therefore, the cover may be securely held on the wetting mechanism before the wetting mechanism needs to be used without affecting the performance of the locking projections.

[0078] The cover, base and / or body may be formed from a more rigid material than the sealing element, such as high density polyethylene. The cover, base and / or body are preferably formed from a different material than the sealing element.

[0079] The catheter assembly may include a fluid collection bag arranged to receive liquid from the distal end of the catheter. Thus, the catheter assembly may be a closed catheter assembly because the liquid released from the bladder is collected by the fluid collection bag. The fluid collection bag may include two panels connected around its periphery. The fluid collection bag may be of any suitable shape or size. The fluid collection bag may be rectangular. The fluid collection bag may be formed to have a volume capable of storing 700-1000 ml of liquid.

[0080] The catheter may include a funnel disposed at the distal end of the catheter. The funnel may be attached to a fluid collection bag. The funnel may be disposed within the fluid collection bag. A fluid-tight seal may be provided between the funnel and the fluid collection bag. The funnel may be configured to deliver liquid from the distal end of the catheter into the fluid collection bag. A cannula may be attached to the funnel. The cannula may be attached to the funnel by any suitable method, such as by welding / fusion; mechanical sealing; heat sealing; pressure sealing; adhesive; solvent bonding; ultraviolet bonding; ultrasonic welding / fusion; laser welding / fusion; impulse welding / fusion; or friction welding / fusion. A fluid-tight seal may be provided between the cannula and the funnel. The funnel may include a bypass / shunt to provide a fluid connection between the cannula and the fluid collection bag. Thus, liquid may effectively enter the fluid collection bag from the catheter and / or cannula without leaking outside the catheter assembly.

[0081] Alternatively, the catheter assembly may be configured to allow fluid to flow out of the catheter assembly. In such an embodiment, the catheter assembly is an "open catheter assembly". The funnel-shaped member may be configured to direct the fluid flow out of the catheter assembly (e.g., into a toilet, etc.). Therefore, the catheter assembly may not include a fluid collection bag.

[0082] The cannula may comprise a flexible plastic material. The cannula may be liquid-tight. The cannula may comprise thermoplastic polyurethane (TPU) or low density polyethylene (LDPE). The cannula may be attached to the base, for example to the outside of the insertion tube of the base. The cannula may be attached by any suitable method, for example by welding / fusion; mechanical sealing; heat sealing; pressure sealing; adhesive; solvent bonding; ultraviolet bonding; ultrasonic welding / fusion; laser welding / fusion; impulse welding / fusion; or friction welding / fusion. Thus, the cannula is cheap and easy to produce, and can be easily manipulated by the user during use.

[0083] The catheter can be made of a hydrophilic material. The catheter surface can be activated by a water-based fluid, such as water. The wetting chamber can be configured to contain a wetting fluid, such as water, or a polar / water-based wetting fluid. The wetting fluid can have a viscosity of no more than 10,000 centipoise, or no more than 1,000 centipoise, or no more than 100 centipoise, or no more than 10 centipoise. The slit valve can therefore be configured to prohibit the wetting fluid from being released from the wetting chamber. This ensures that the wetting liquid can effectively wet the catheter.

[0084] The catheter can be formed from a material selected from the group consisting of polyvinyl chloride, polytetrafluoroethylene, polyolefins, latex, silicone / silicone / polysiloxane, synthetic rubber, polyurethane, polyester, polyacrylate, polyamide, thermoplastic elastomeric materials, styrene block copolymers, polyether block amides, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, and water-disintegrable or enzyme-hydrolyzable materials, or any combination, blend or copolymer of the foregoing materials.

[0085] The water-disintegrable or enzyme-hydrolyzable material may include a material from the group consisting of polyvinyl alcohol, extrudable polyvinyl alcohol, polyacrylic acid, polylactic acid, polyester, polyglycolide, polyglycolic acid, polylactic-co-glycolic acid, polylactide, amine, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), starch, modified starch or derivatives, pullulan, pectin, xanthan gum, scleroglucan, dextrin, chitosan, chitin, agar, alginate, carrageenan, laminarin, sugars, polysaccharides, sucrose, polyethylene oxide, polypropylene oxide, acrylic acid, polyacrylic acid blends, poly(methacrylic acid), polystyrene sulfonate, polystyrene sulfonate, polyethylene oxide, polypropylene oxide, acrylic acid, polyacrylic acid blends, poly(methacrylic acid), polystyrene sulfonate, polystyrene sulfonate, polyethylene oxide, polypropylene oxide, polysaccharides ... olefin sulfonates, lignin sulfonates, polymethacrylamide, copolymers of aminoalkyl acrylamide and methacrylamide, melamine-formaldehyde copolymers, vinyl alcohol copolymers, cellulose ethers, polyethers, polyethylene oxides, blends of polyethylene-polypropylene glycols, carboxymethyl cellulose, guar gum, locust bean gum, hydroxypropyl cellulose, vinyl pyrrolidone polymers and copolymers, polyvinyl pyrrolidone-ethylene-vinyl acetate, polyvinyl pyrrolidone-carboxymethyl cellulose, carboxymethyl cellulose shellac, copolymers of vinyl pyrrolidone and vinyl acetate, hydroxyethyl cellulose, gelatin, polycaprolactone, poly(p-dioxanone), or any combination, blend or copolymer of the above materials.

[0086] Preferably, the conduit is formed from a polyolefin material, in particular polyethylene and / or polypropylene.

[0087] Preferably, the conduit is made of a thermoplastic elastic material.

[0088] The catheter may be a urinary catheter. The catheter may be a male urinary catheter. The catheter may be a female urinary catheter. The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent male urinary catheter. Thus, features of the present invention allow an intermittent male urinary catheter to be fully wetted prior to use, which may be more difficult to fully wet prior to use than other types of urinary catheters which are typically shorter.

[0089] The catheter assembly of the first to third aspects may include any one or more features of the catheter assembly defined in general / broad terms, or according to any other features of the first to third aspects mentioned above. The catheter assembly of the first to third aspects may include any optional features of other aspects of the first to third aspects, and need not include all features required by them. That is to say, the optional features elaborated with a particular aspect are not necessarily only applicable to this aspect, therefore, for example, the present disclosure provides a kind of catheter assembly, it includes: catheter, this catheter includes a distal end and a proximal end for inserting into a user's body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism includes a main body, this main body defines a wetting chamber, catheter can move through this wetting chamber to wet the catheter, and the wetting mechanism includes a slit valve, this slit valve is configured to allow catheter to enter the wetting chamber and prohibit fluid from releasing (as described in relation to the first aspect) from the wetting chamber, and wherein the wetting mechanism includes a base, and this base includes the curved skirt described in relation to the third aspect.

[0090] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body, which defines a wetting chamber, the catheter can be moved through the wetting chamber to wet the catheter, and the wetting mechanism comprises a slit valve, which is configured to allow the catheter to enter the wetting chamber and prohibit the release of fluid from the wetting chamber, wherein the catheter is formed of a hydrophilic material, the wetting chamber is configured to contain a wetting fluid, and wherein the slit valve is configured to prohibit the release of the wetting fluid from the wetting chamber.

[0091] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body, the main body defines a wetting chamber, the catheter can be moved through the wetting chamber to wet the catheter, wherein the wetting mechanism comprises the following two slit valves: an inlet valve and an outlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, and the outlet valve is configured to allow the catheter to exit the wetting chamber and prohibit fluid from being released from the wetting chamber, the catheter assembly also comprises an inserter tip, the inserter tip is configured to engage one end of the main body, wherein the outlet valve is located between the inserter tip and the end of the main body, and is shaped to facilitate insertion of the catheter into the body.

[0092] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body, the main body defines a wetting chamber, the catheter can be moved through the wetting chamber to wet the catheter, wherein the wetting mechanism comprises the following two slit valves: an inlet valve and an outlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, and the outlet valve is configured to allow the catheter to exit the wetting chamber and prohibit fluid from being released from the wetting chamber, wherein each of the inlet valve and the outlet valve has a curved surface, and the inlet valve and the outlet valve are arranged in the wetting mechanism with opposite curvatures.

[0093] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body defining a wetting chamber, the catheter being movable through the wetting chamber to wet the catheter, and the wetting mechanism comprising a slit valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, wherein the slit valve has a curved surface, and is preferably dome-shaped.

[0094] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body defining a wetting chamber, the catheter being movable through the wetting chamber to wet the catheter, and the wetting mechanism comprising a slit valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, wherein the slit valve has a curved surface and is convex on a side facing away from the wetting chamber.

[0095] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body defining a wetting chamber, the catheter being movable through the wetting chamber to wet the catheter, and the wetting mechanism comprising a slit valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, wherein the slit valve is dome-shaped and has a dome height that does not exceed 30% of the diameter of the slit valve.

[0096] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body, a base and a sealing element, the main body defining a tubular wetting chamber, the catheter being movable through the tubular wetting chamber to wet the catheter, the base comprising an opening sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising an inlet valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the sealing element comprising a material that is more flexible than the main body and the base, and wherein the sealing element is elastically deformed under the action of the main body and the base to provide a fluid-tight seal between the main body and the base, wherein the catheter comprises a hydrophilic material, and the wetting chamber is configured to contain a wetting liquid.

[0097] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body, a base and a sealing element, the main body defining a tubular wetting chamber, the catheter being movable through the tubular wetting chamber to wet the catheter, the base comprising an opening sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising an inlet valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the sealing element comprising a material that is more flexible than the main body and the base, and wherein the sealing element is elastically deformed under the action of the main body and the base to provide a fluid-tight seal between the main body and the base, wherein the sealing element comprises an external flange extending in an axial direction and compressed by the base and the main body.

[0098] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a main body, a base and a sealing element, the main body defining a tubular wetting chamber, the catheter being movable through the tubular wetting chamber to wet the catheter, the base comprising an opening sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising an inlet valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the sealing element comprising a material that is more flexible than the main body and the base, and wherein the sealing element is elastically deformed under the action of the main body and the base to provide a fluid-tight seal between the main body and the base, wherein the sealing element has a top hat-shaped profile.

[0099] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a body, a base, and a sealing element, the body defining a tubular wetting chamber through which the catheter can move to wet the catheter, the base comprising an opening sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising an inlet valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the sealing element comprising a material that is more flexible than the body and the base, and wherein the sealing element is elastically deformed under the action of the body and the base to provide a fluid-tight seal between the body and the base, wherein the axial direction is defined as the direction along which the conduit passes through the inlet valve and enters the wetting chamber, the sealing element includes an inner flange and an outer flange, both of which extend in the axial direction and are separated by an outer wall, the body includes a groove configured to receive the outer flange, and the base includes an inner sealing tube configured to abut the inner flange, wherein the distance between the inner diameter of the groove and the inner diameter of the inner sealing tube measured in the radial direction is greater than the distance between the outer diameter of the inner flange and the inner diameter of the outer flange.

[0100] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a urinary catheter comprising a distal end and a proximal end for insertion into the body; and a wetting mechanism arranged at the proximal end of the urinary catheter; wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprises an inlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by the wetting fluid, the inlet valve is configured to prohibit the fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction.

[0101] In a preferred embodiment, a catheter assembly is provided, comprising: an intermittent male urinary catheter, which includes a distal end and a proximal end for insertion into the body; and a wetting mechanism arranged at the proximal end of the catheter; wherein the wetting mechanism includes a wetting chamber and a sealing element, the sealing element includes an inlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by the wetting fluid, the inlet valve is configured to prohibit the fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element includes: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction.

[0102] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism arranged at the proximal end of the catheter; wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprises an inlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by a wetting fluid, the inlet valve is configured to prohibit the fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction, wherein the internal support comprises an internal flange surrounding the inlet valve in the transverse plane, and the internal flange is a truncated cone.

[0103] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into the body; and a wetting mechanism arranged at the proximal end of the catheter; wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprises an inlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by the wetting fluid, the inlet valve is configured to prohibit the fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction, wherein the outer wall is annular, and the outer wall is compressed by the wetting mechanism in a direction parallel to the transverse plane.

[0104] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter comprising a distal end and a proximal end for insertion into the body; and a wetting mechanism arranged at the proximal end of the catheter; wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprises an inlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by the wetting fluid, the inlet valve is configured to prohibit the fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction, wherein the outer wall also comprises an external flange, and the external flange is compressed by the wetting mechanism.

[0105] According to a fourth aspect of the present invention, a method for manufacturing a catheter assembly is provided, the method comprising providing a catheter and a wetting mechanism, the catheter comprising a distal end and a proximal end for insertion into a user's body, wherein the wetting mechanism comprises a body defining a wetting chamber, the catheter being movable through the wetting chamber to wet the catheter, and the wetting mechanism comprising a slit valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the method comprising arranging the wetting mechanism at the proximal end of the catheter.

[0106] The method of the fourth aspect of the invention may be a method of making a catheter assembly of the first aspect of the invention, which catheter assembly may of course include any of the optional features outlined above.

[0107] According to a fifth aspect of the present invention, a method for manufacturing a catheter assembly is provided, the method comprising providing a catheter and a wetting mechanism, the catheter comprising a distal end and a proximal end for insertion into a body, wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprising an inlet valve, the inlet valve being configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by a wetting fluid, the inlet valve being configured to prohibit fluid from being released from the wetting chamber, the inlet valve defining a transverse plane perpendicular to the axial direction, the sealing element comprising a stepped profile, the sealing element comprising an outer wall extending parallel to the transverse plane but offset from the inlet valve, the sealing element comprising an internal support extending in the axial direction and connecting the outer wall to the inlet valve, the wetting mechanism abutting the internal support to prohibit movement of the inlet valve in the transverse plane, the wetting mechanism abutting the outer wall to prohibit movement of the inlet valve in the axial direction, the method comprising arranging the wetting mechanism at the proximal end of the catheter.

[0108] The method of the fifth aspect of the invention may be a method of making a catheter assembly of the second aspect of the invention, which catheter assembly may of course include any of the optional features outlined above.

[0109] According to a sixth aspect of the present invention, a method for manufacturing a catheter assembly is provided, the method comprising providing a catheter and a wetting mechanism, the catheter comprising a distal end and a proximal end for insertion into a body, wherein the wetting mechanism comprises a body, a base and a sealing element, the body defining a tubular wetting chamber, the catheter being movable through the tubular wetting chamber to wet the catheter, the base comprising an opening, the size of the opening being determined to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising a material more flexible than the body and the base, and wherein the sealing element is elastically deformed under the action of the body and the base to provide a fluid-tight seal between the body and the base, the method comprising arranging the wetting mechanism at the proximal end of the catheter. The sealing element may comprise an inlet valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber.

[0110] The method of the sixth aspect of the invention may be a method of making the catheter assembly of the third aspect of the invention, which catheter assembly may of course include any of the optional features outlined above.

[0111] The method may include coaxially arranging a base, a sealing element and a body. The method may include assembling an inlet valve of the sealing element into the base. The method may include moving the base so that the base engages with the body, wherein the sealing element is located between the base and the body. The method may include providing a wetting fluid into the body. The method may include providing a second base and a second sealing element. The method may include assembling the second sealing element to the body. The method may include sealing two ends of the body with two sealing elements and two bases. The method may include assembling the second base to the body to seal the body and create a wetting chamber.

[0112] According to a seventh aspect of the present invention, a method for wetting a catheter is provided, the catheter comprising a distal end and a proximal end for insertion into a body, the method comprising providing a wetting mechanism at the proximal end of the catheter, wherein the wetting mechanism comprises a slit valve and a body defining a wetting chamber containing a wetting fluid, the slit valve being configured to prohibit the wetting fluid from being released from the wetting chamber, the method comprising moving the catheter through the slit valve and into the wetting chamber to wet the catheter.

[0113] The method of the seventh aspect of the invention may be a method of wetting a catheter from a catheter assembly of the first aspect of the invention, which catheter assembly may of course include any of the optional features described above and may be manufactured according to the fourth aspect of the invention.

[0114] The method may include separating flaps of the slit valve using a catheter.

[0115] The method may include inserting an insertion tube into the urethra. The method may include gradually moving the proximal end of the catheter through the wetting mechanism. The method may include introducing the catheter into the body, preferably via the insertion tube. The method may include allowing fluid from the body to enter a fluid collection bag via the catheter. Thus, the method may be a method of using a catheter assembly.

[0116] According to an eighth aspect of the present invention, a method for wetting a catheter is provided, the catheter comprising a proximal end for insertion into a body, the method comprising arranging a wetting mechanism at the proximal end of the catheter, wherein the wetting mechanism comprises a wetting chamber and a sealing element, the method comprising moving the catheter in an axial direction through an inlet valve in the sealing element and entering the wetting chamber, wherein the inlet valve is configured to prohibit fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises a stepped profile, the sealing element comprises an outer wall extending parallel to the transverse plane but offset from the inlet valve, and an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit movement of the inlet valve in the axial direction.

[0117] The method of the eighth aspect of the invention may be a method of wetting a catheter in a catheter assembly of the second aspect of the invention, which catheter assembly may of course include any of the optional features outlined above and may be manufactured in accordance with the fifth aspect of the invention.

[0118] The method may include inserting an insertion tube into the urethra. The method may include gradually moving the proximal end of the catheter through the wetting mechanism. The method may include introducing the catheter into the body, preferably via the insertion tube. The method may include allowing fluid from the body to enter a fluid collection bag via the catheter. Thus, the method may be a method of using a catheter assembly.

[0119] According to a ninth aspect of the present invention, there is provided a method for wetting a catheter, the catheter comprising a distal end and a proximal end for insertion into a body, the method comprising providing a wetting mechanism at the proximal end of the catheter, wherein the wetting mechanism comprises a body, a base and a sealing element, the method comprising moving the catheter through an opening in the base, through an inlet valve in the sealing element and into a tubular wetting chamber defined by the body, wherein the inlet valve is configured to prohibit fluid from being released from the wetting chamber, the sealing element comprises a material that is more flexible than the body and the base, and wherein the sealing element elastically deforms under the action of the body and the base to provide a fluid-tight seal between the body and the base.

[0120] The method of the ninth aspect of the invention may be a method of wetting a catheter in a catheter assembly of the third aspect of the invention, which catheter assembly may of course include any of the optional features described above and may be manufactured according to the sixth aspect of the invention.

[0121] The method may include inserting an insertion tube into the urethra. The method may include gradually moving the proximal end of the catheter through the wetting mechanism. The method may include introducing the catheter into the body, preferably via the insertion tube. The method may include allowing fluid from the body to enter a fluid collection bag via the catheter. Thus, the method may be a method of using a catheter assembly.

[0122] The methods of the fourth to ninth aspects of the present invention may of course include any one or more optional or other features of each other individually, and may also include any one or more optional or other features of the first to third aspects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0123] In order that the present invention may be more clearly understood, one or more embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0124] Figure 1 is a schematic side view of a first embodiment of a catheter assembly;

[0125] Figure 2 yes Figure 1 a side view of a distal sealing element of a catheter assembly;

[0126] Figure 3 yes Figure 2 a top perspective view of a distal sealing element of the embodiment of the present invention;

[0127] Figure 4 yes Figure 2 a bottom perspective view of a distal sealing element;

[0128] Figure 5 yes Figure 1 a top perspective view of an introducer tip of a catheter assembly of FIG.

[0129] Figure 6 yes Figure 5 A bottom perspective view of the inserter tip;

[0130] Figure 7 yes Figure 1 A top view of a main body of a catheter assembly;

[0131] Figure 8 yes Figure 7 a side cross-sectional view of a main body;

[0132] Fig. 9 yes Figure 1 a bottom perspective view of a base of a catheter assembly;

[0133] Fig.10 yes Fig. 9 A top perspective view of the base;

[0134] Fig.11yes Figure 1 A side perspective view of a cover of a catheter assembly;

[0135] Fig.12 yes Fig.11 A bottom perspective view of a cover;

[0136] Fig.13 yes Figure 1 An exploded view of a wetting mechanism of a catheter assembly;

[0137] Fig.14 yes Figure 1 A cross-sectional view of the catheter assembly prior to wetting the catheter;

[0138] Fig.15 yes Figure 1 a cross-sectional view of the catheter assembly during wetting of the catheter;

[0139] Fig.16 yes Figure 1 A cross-sectional view of a catheter assembly during wetting of the catheter;

[0140] Fig.17 With the cover removed Figure 1 a cross-sectional view of a catheter assembly during catheter wetting; and

[0141] Fig.18 is a schematic side view of a second embodiment of a catheter assembly. DETAILED DESCRIPTION

[0142] Reference Figure 1-17 , a first embodiment of the catheter assembly 1000 includes a wetting mechanism 1100, a catheter 1200, a sleeve 1300 and a fluid collection bag 1400. The catheter 1200 includes a distal end 1202 and a proximal end 1201 for insertion into a user's body. In this embodiment, the catheter 1201 is a male urinary catheter made of a hydrophilic thermoplastic elastomer (TPE). The sleeve 1301 of this embodiment is a thermoplastic polyurethane (TPU) or a low-density polyethylene (LDPE). Obviously, those skilled in the art will be able to select a suitable alternative material.

[0143] In this embodiment, the wetting mechanism 1100 includes a cover 1110 , an inserter tip 1120 , a proximal sealing element 1130 , a body 1140 , a distal sealing element 1150 , and a base 1160 .

[0144] The proximal seal element and the distal seal element 1130, 1150 are formed of a flexible material, such as a flexible plastic material, rubber, or silicone / polysiloxane / silicone / organosilicon (silicone). In this embodiment, rubber is used. The covers 1110, the inserter tip 1120, the body 1140, and the base 1160 comprise a more rigid material than the proximal seal element and the distal seal element 1130, 1150, such as a hard plastic material like high-density polyethylene (HDPE).

[0145] In this embodiment, unless otherwise specified below, the distal seal element 1150 is generally sheet-like with a constant thickness. The distal seal element 1150 includes an inlet valve 1151 disposed at the center of the distal seal element 1150. In this embodiment, the inlet valve 1151 is circular and dome-shaped, having two slits 1152 at its center. The two slits 1152 are orthogonally arranged and define an intersection at the center of the inlet valve 1151, thereby defining four movable flaps 1153. Thus, the inlet valve 1151 is a normally closed slit valve that can be opened by the movement of the flaps 1153 away from each other. When the valve is closed, the flaps 1153 are in the closed position, in which the flaps cooperate to seal the inlet valve 1151. Of course, in many other embodiments, there may be only one slit (and two flaps), or two or more slits may be arranged in a different pattern than the above and have a corresponding number of flaps, such as a T-shaped slit arrangement may be used to define three flaps.

[0146] In this embodiment, each slit 1152 spans approximately 70% of the diameter of the inlet valve 1151, for example, 5 - 6 mm, for example, 5.5 mm. In many other embodiments, slits of different lengths may be appropriately used. In this embodiment, the inlet valve 1151 has a diameter of 7 - 9 mm, for example, about 8 mm, and is dome-shaped, with the dome height being approximately 10% of the diameter of the inlet valve 1151, which is about 1 mm in this embodiment.

[0147] In this embodiment, the axial direction is defined as the direction along which the catheter 1200 enters the wetting chamber. For example, the axial direction is parallel to the dome height of the inlet valve 1151. The inlet valve 1151 also defines a transverse plane perpendicular to the axial direction.

[0148] In this embodiment, the distal sealing element 1150 also includes an annular outer wall 1154. The inner diameter of the outer wall 1154 is slightly larger than the outer diameter of the inlet valve 1151, for example, about 5% larger, so the inner diameter of the outer wall 1154 can be about 8.5 mm. The outer diameter of the outer wall 1154 is 73% larger than the outer diameter of the inlet valve 1151, for example, about 14 mm. The outer wall 1154 is coaxially arranged with the circular inlet valve 1151, but is offset from the inlet valve 1151 in the axial direction by a distance that is approximately equal to 20-25% of the diameter of the inlet valve, for example, 22% or about 2 mm. The outer wall 1154 and the inlet valve 1151 are arranged so that the dome-shaped surface of the inlet valve 1151 is bent downward toward the outer wall 1154 at the edge of the inlet valve 1151.

[0149] In this embodiment, the distal sealing element 1150 includes an internal support in the form of an internal flange 1155 that connects the outer edge of the inlet valve 1151 to the inner edge of the outer wall 1154 around the circumference of the inlet valve 1151. Since the inner diameter of the outer wall 1154 is slightly larger than the outer diameter of the inlet valve 1151, the internal flange 1155 is an open-ended truncated cone extending in the axial direction. Of course, in many other embodiments, the internal flange 1155 may not be a truncated cone and may be any suitable tubular shape, or may not extend around the inlet valve in a full circle. In some embodiments, a more general internal support may replace the internal flange, and if desired, the outer wall may not be annular, as long as they can provide the functions of the internal flange and the outer wall as described below.

[0150] As described above, the inlet valve 1151, the inner flange 1155 and the outer wall 1154 thereby form a top hat shaped profile of the distal sealing element 1150. This profile enables the sealing element 1150 to fit more securely into a wetting mechanism, as described below.

[0151] In this embodiment, an external support in the form of an external flange 1156 is attached to the outer edge of the outer wall 1154 and extends away from the outer wall 1154 in the same direction as the inner flange 1155 extends from the inlet valve 1151. In this embodiment, the external flange 1156 has a length in the direction in which it extends away from the outer wall 1154 that is 15-25%, for example 20%, of the outer diameter of the outer wall 1154, or the length is about 60% longer than the inner flange 1155, for example, the length is about 3 mm. The external flange 1156 is in the shape of an open-ended truncated cone, and the outer diameter of the external flange at the distal end (the end away from the outer wall 1154) is about 1-5%, for example 2.5% larger than the outer diameter of the outer wall 1154.

[0152] In this embodiment, the outer flange 1156 includes a sealing member in the form of a sealing rib 1157 disposed adjacent the distal end. The sealing rib 1157 is a semicircular protrusion protruding from the outer surface of the outer flange 1156, which extends around the entire periphery of the outer flange 1156. In this embodiment, the sealing rib 1157 does not protrude from the inner surface of the outer flange 1156, but it may protrude from the inner surface in a number of other embodiments. The outer diameter of the sealing rib 1157 at its widest point is approximately 13-17%, such as 15%, larger than the outer diameter of the outer wall 1154. Therefore, the thickness of the sealing rib 1157 is approximately equal to 25% of the thickness of the outer flange 1156. The sealing rib 1157 spans approximately 20-30%, such as 25%, of the length of the outer flange 1154.

[0153] Although not described in detail, the proximal sealing element 1130 is structurally identical to the distal sealing element 1150, and therefore, although only the distal sealing element 1150 is described above, the description also applies to the proximal sealing element 1130, which has corresponding features indicated by corresponding reference numerals in the figures. One exception is that the feature corresponding to the inlet valve 1151 of the distal sealing element 1150 is referred to as the outlet valve 1131 of the proximal sealing element 1130, because the catheter 1200 enters the wetting mechanism 1100 via the inlet valve 1151 and exits via the outlet valve 1131, as described below.

[0154] In this embodiment, the inserter tip 1120 includes an insertion tube 1121, through which the proximal end 1201 of the catheter 1200 passes to leave the wetting mechanism 1100 and enter the user's body. The insertion tube 1121 is cylindrical, and its inner diameter is greater than the outer diameter of the catheter 1200, but less than the outer diameter of the inlet valve 1131 of the distal sealing element 1130, and the inner diameter of the insertion tube is, for example, 7-9mm or about 8mm. The insertion tube 1121 has a constant thickness, which is also the same as the wall thickness of the other parts of the inserter tip 1120, which is about 1mm. Therefore, the insertion tube 1121 is configured to be inserted into the urethra during use, so that the catheter 1200 enters the user's body directly from the wetting mechanism 1100, which helps to reduce the risk of infection and discomfort because the catheter 1200 is smoothly introduced into the body through the insertion tube 1121.

[0155] In this embodiment, the insertion tube 1121 is covered at one end by a semi-cylindrical / hemispherical dome 1124 that includes two orthogonal slits 1122 which define four fins 1123 in an arrangement similar to the inlet valve 1151 of the distal sealing element 1150. The slits 1122 are configured to allow the fins 1123 to separate as the proximal end 1201 of the catheter 1200 passes outwards through the dome 1124 from the interior of the insertion tube 1121. If desired, the dome shape also helps to comfortably insert the insertion tube 1121 into the body.

[0156] In this embodiment, the inserter tip 1120 includes a skirt 1125 that extends away from the insertion tube 1121 at an end remote from the dome 1124. The skirt 1125 is planar and annular, having an inner diameter corresponding to the outer diameter of the insertion tube 1121 from which it extends, and an outer diameter that is approximately twice its inner diameter, for example 10 - 20 mm, for example approximately 16 mm.

[0157] In this embodiment, the insertion tube 1121 has a length from the tip of the dome 1124 to its intersection with the skirt 1125 that corresponds to the safe insertion distance of the insertion tube 1121 within the body, which length is for example 10 - 30 mm, or preferably 20 mm.

[0158] In this embodiment, the skirt 1125 provides a stop to prevent the insertion tube 1121 from being over-inserted into the body. To improve comfort in use, the proximal surface 1125a of the skirt 1125 is slightly curved away from the insertion tube 1121, and thus the skirt 1125 has a length, measured parallel to the axis of the insertion tube 1121, of 2 - 4 mm, for example 2.3 mm.

[0159] In this embodiment, a concentrically arranged inner sealing tube 1126 and an outer sealing tube 1127 are provided on the opposite distal surface 1125b of the skirt 1125. Both tubes 1126, 1127 extend away from the skirt 1125 in a direction parallel to the insertion tube 1121 and terminate at a distance from the insertion tube 1121 that is measured parallel to the insertion tube 1121 and is 4 - 8 mm, for example approximately 6 mm. Since both the inner sealing tube 1126 and the outer sealing tube 1127 terminate at the same distance from the insertion tube 1121, the inner sealing tube 1126 is slightly longer than the outer sealing tube 1127 due to the curvature of the distal surface 1125b of the skirt 1125.

[0160] In this embodiment, the inner sealing tube 1126 is configured to receive the outlet valve 1131 and the inner flange 1134 of the proximal sealing element 1130 therein to support the outlet valve 1131 in a radial direction, i.e., in a direction perpendicular to the axial direction and in a direction parallel to the length of the inner sealing tube 1126. Therefore, the inner sealing tube 1126 is cylindrical with an uncapped end, and has an inner diameter between the inner diameter and the outer diameter of the inner flange 1134, for example, about 8.0-8.5 mm.

[0161] In this embodiment, the inner sealing tube 1126 and the outer sealing tube 1127 are configured to abut against the outer wall 1135 of the proximal sealing element 1130 to inhibit the movement of the proximal sealing element 1130 in the axial direction toward the inserter tip 1120. Therefore, the diameter of the outer sealing tube 1127 is substantially equal to the diameter of the outer flange 1136 and / or the outer diameter of the outer wall 1135, so that the outer wall 1135 of the proximal sealing element 1130 can be pressed against the inner sealing tube 1126 and the outer sealing tube 1127.

[0162] In this embodiment, the outer sealing tube 1127 is cylindrical with four gaps 1128 in the tube 1127 extending about 60-70% in the axial direction from the free end of the tube 1127 toward the distal surface 1125b. Each gap 1128 covers an arc length of 5°-15°, for example 10°, around the circumference of the tube 1127. Each gap 1128 has straight sides with a semicircular end closest to the distal surface 1125b. The four gaps 1128 are spaced around the circumference of the tube 1127 at alternating angular intervals of 65° and then 115° to define two opposing locking tongues 1129, each locking tongue covering an arc length of 65° around the circumference of the tube 1127. At the free end of each locking tongue 1129, a locking protrusion 1129a extends from the tube 1127 in the radial direction, thereby increasing the thickness of the tongue 1129 in this area by 40-60%, for example 50%. Each locking protrusion 1129a also covers approximately 25% of the length of each gap 1128 in the axial direction.

[0163] In this embodiment, each locking projection 1129a is configured to engage with a locking groove 1141 of the body 1140 described further below. The gap 1128 provides a weakened line in the tube 1127 that allows each locking projection 1129a to bend in the radial direction to ensure tight engagement with the locking groove 1141. To facilitate bending, each projection 1129a is wedge-shaped across two-thirds of its length. Therefore, the effective thickness of the tube 1127 in the region of the locking projection 1129a is minimum at the free end of the tube 1127, then increases linearly to 50% greater than the minimum thickness due to the wedge-shaped nature of the projection 1129a, and finally becomes constant over the last third of the projection 1129a before the projection extends radially inward to merge with the tube 1127.

[0164] In this embodiment, the base 1160 shares many of the same features as the inserter tip 1120, so like reference numerals are used to represent like features and only the differences are described below.

[0165] In this embodiment, the base 1160 also includes an insertion tube 1161, however, the insertion tube 1161 is configured to guide the catheter 1200 from the cannula into the wetting mechanism 1100, as described below, and is therefore open-ended. The diameter of the insertion tube 1161 is also 20% larger than the insertion tube 1121 of the inserter tip 1120 to make it easier to position the proximal end 1201 of the catheter 1200 within the insertion tube 1161 of the base 1160.

[0166] In this embodiment, the body 1140 is cylindrical, has two open ends and an inner diameter that matches the outer diameter of the outer sealing tube 1127 of the inserter tip 1120, so that the outer sealing tube 1127 fits snugly within the body 1140. The outer diameter of the body 1140 is 10-15% larger than its inner diameter, for example 12.5% ​​larger, and is equal to the outer diameter of the skirts 1125 (about 16 mm), 1165 to provide a smooth outer surface of the wetting mechanism 1100 when assembled together as described below. The body 1140 has a length perpendicular to its diameter and parallel to the axial direction that is 55-65% larger than its outer diameter, for example 60% larger or about 25 mm.

[0167] In this embodiment, the body 1140 includes four locking grooves 1141 arranged in two pairs, one pair is associated with the locking projections 1129a of the inserter tip 1120, and the other pair is associated with the locking projections 1169a of the base 1160. Each groove 1141 is sized to receive the locking projections 1129a, 1169a, and thus extends around the circumference of the body 1140, with the arc length around the circumference equal to 65°. The two grooves 1141 in each pair are separated by an angle of 115° so that they are aligned with the correct locking projections 1129a, 1169a. The grooves 1141 are also separated from the open end of the body 1140 by a distance equal to the distance between each locking projection 1129a, 1169a and the skirt 1125, 1165, respectively.

[0168] In this embodiment, at each end of the body 1140, the inner diameter of the body increases linearly over a distance of 2-3% of the length of the body 1140 to merge with the outer diameter of the body 1140 and provide a wedge-shaped profile around the circumference of each end of the body 1140, which facilitates deformation of the locking protrusions 1129a, 1169a when the wetting mechanism 1100 is assembled together as described below.

[0169] In this embodiment, the body 1140 includes eight ribs 1142 extending in the axial direction along the body 1140. The length of each rib 1142 in the axial direction is equal to 60-70%, such as 65% or about 16 mm, of the length of the body 1140. Each rib 1142 is centrally arranged relative to the length of the body 1140 so that they occupy the middle 65% of the body 1140, thereby leaving a space / spacing between the end of each rib 1142 and the inserter tip 1120 or the base 1160, which is large enough to be used by the outer walls 1131, 1151 of the proximal / distal sealing elements 1130, 1150, respectively.

[0170] In this embodiment, each rib 1142 extends radially inward from the inner surface of the body 1140 by at most 15-25%, for example, about 20%, of the inner diameter of the body 1140. Each rib 1142 extends radially inward the farthest at the midpoint along the length of the rib 1142, and extends at least 10-15% less at each end than at the midpoint. This increases the strength of the rib in terms of mechanically supporting the body 1140 and the wetting mechanism 1100.

[0171] In this embodiment, each rib 1142 is joined to the body 1140 along most of its length, except at each end where a sealing groove 1143 is present to receive the outer flanges 1136, 1156 of the proximal and distal sealing elements 1130, 1150. Each sealing groove 1143 extends into the rib 1142 in the axial direction by 5-15%, for example, about 10%, of the length of the rib 1142, so that the length of the sealing groove 1143 in the axial direction plus the distance between the respective end of the rib 1142 and the locking groove 1141 is equal to or preferably slightly less than the length of the outer flanges 1136, 1156. This ensures that the inserter tip 1120 and the base 1160 can press the outer flanges 1136, 1156 into sealing engagement with the body 1140 via the sealing grooves 1143, for example, via the inner and outer sealing tubes. The sealing grooves 1143 thus together form a groove for receiving the outer flanges 1136, 1156.

[0172] In this embodiment, the width of each sealing groove 1143 in the radial direction is the same as the thickness of the outer flange 1136, 1156, but less than the thickness of the sealing ribs 1137, 1157. In addition, the inner diameter of the body 1140 is slightly smaller than the maximum diameter of the sealing ribs 1137, 1157. Therefore, when the sealing ribs 1137, 1157 are forced into the corresponding sealing grooves 1143 by the inserter tip 1120 / base 1160, the proximal / distal sealing elements 1130, 1150 are deformed to provide a fluid-tight seal therebetween with the body 1140, thereby forming a wetting chamber 1101 for the catheter 1200, as described below.

[0173] In this embodiment, to facilitate positioning of the external flanges 1136 , 1156 in the sealing grooves 1143 , the mouth of each sealing groove 1143 is tapered on a side away from the body 1140 to guide the external flanges 1136 , 1156 into the corresponding sealing grooves 1143 .

[0174] In this embodiment, ribs 1142 are attached to the inside of the body 1140, with the ribs being equally spaced angularly around the circumference of the body 1140. The end of each rib 1142 is configured to abut the outer wall 1134, 1154 of the respective proximal or distal seal element 1130, 1150 to inhibit the proximal and distal seal elements 1130, 1150 from moving toward the center of the body 1140. Thus, the end of each rib 1142 provides a stop that together provides an axial stop at each end of the body 1140. As described above, each rib 1142 abuts the corresponding outer wall 1134, 1154 at a certain distance from the center of the outer wall 1134, 1154, and the center of the outer wall 1134, 1154 is between the corresponding internal sealing tubes 1126, 1166 and external sealing tubes 1127, 1167 of the inserter tip 1120 and the base 1160.

[0175] In this embodiment, cover 1110 is configured to cover and protect the inserter tip 1120 before use. Thus, cover 1110 is a housing having the same shape as inserter tip 1120, but having a larger size so that it can effectively enclose it, and similar reference numerals are used to represent similar features.

[0176] In this embodiment, the cover 1110 includes a cover tube 1111 that is cylindrical with an inner diameter that matches the outer diameter of the insertion tube 1121. The cover tube 1111 is capped at one end with a semi-cylindrical / hemispherical dome 1114 to fit over the dome 1124 of the inserter tip 1120.

[0177] In this embodiment, the cover 1110 includes a skirt 1115 extending from the open end of the cover tube 1111 and configured to cover / overlap the skirt 1125 of the inserter tip 1120. The outer diameter of the skirt is just larger than the outer diameter of the body 1140.

[0178] In this embodiment, the cover 1110 includes a cover flange 1117 that extends from the outer edge of the skirt 1115 in the axial direction to cover the body 1140. The length of the cover flange 1117 is such that when the cover 1110 is placed on the inserter tip 1120, the cover flange 1117 extends downwardly beyond the bottom of the outer tube 1127 by 1-2 mm.

[0179] In this embodiment, at the free end of the cover flange 1117, two clamping protrusions 1119a are arranged on the inner surface of the cover flange 1117 at positions corresponding to the locking protrusions 1129a of the inserter tip 1120. Thus, the two clamping protrusions 1119a each cover an arc length of 65° and are separated by an arc of 115° around the circumference of the cover 1110.

[0180] In this embodiment, each clamping protrusion 1119a has a semicircular cross-section with a radius of 50% of the wall thickness of the cover flange 1117. Therefore, in the area of ​​the clamping protrusion 1119a, the wall thickness of the cover flange 1117 is up to 50% greater than that of other parts of the cover flange 1117.

[0181] In this embodiment, the clamping protrusion 1119a is configured to engage the groove 1141 of the body 1140 in a manner similar to the locking protrusion 1129a, however, the clamping protrusion 1119a is more easily disengaged from the groove 1141 by the user due to its semi-circular profile, as described below. Of course, in many other embodiments, the clamping protrusion 1119a can be a different shape or size, or can be formed of multiple smaller protrusions, and still function in the same manner.

[0182] In this embodiment, the cover 1110 also includes a pull ring 1112 attached to the dome 1114. The pull ring 1112 is configured to allow a user to grasp the cover 1110 and pull the cover away from the wetting mechanism 1100 by disengaging the gripping protrusions 1119a from the grooves 1141, as described below. Of course, in various other embodiments, different grippable features such as tabs may be used in place of the pull ring.

[0183] refer to Figure 13-14 , the wetting mechanism 1100 is constructed by coaxially arranging the cover 1110, the inserter tip 1120 and the proximal sealing element 1130 on one side of the body 1140, and coaxially arranging the base 1160 and the distal sealing element 1150 on the other side of the body 1140, and moving all parts of the wetting mechanism 1110 together in the axial direction as described below. Of course, this can be done in many different ways, and the method described below is purely exemplary.

[0184] In this embodiment, the distal sealing element 1150 is assembled to the base 1160. To this end, the inlet valve 1151 is coaxially aligned with the inner tube 1166 of the base 1160, and the distal sealing element 1150 is moved relative to the base 1160 so that the inlet valve 1151 is received in the inner tube 1166. In this position, the inner tube 1166 supports the inlet valve 1151 in the radial direction by the engagement between the inner tube 1166 and the inner flange 1155 of the distal sealing element 1150. In addition, the outer wall 1154 of the inner and outer tubes 1166, 1167 abutting prevents the inlet valve 1151 from being over-inserted into the inner tube 1166.

[0185] In this embodiment, the proximal sealing element 1130 is assembled to the inserter tip 1150 in the same manner as the distal sealing element 1150 is assembled to the base 1160.

[0186] In this embodiment, the body 1140 is then assembled to the base 1160, thereby capturing the distal sealing element 1150 between the body and the base. The body 1140 is coaxially aligned with the base 1160, and the body is rotated around its axis so that the locking groove 1141 is aligned with the locking protrusion 1169a of the base 1160. The locking groove 1141 and the locking protrusion 1169a are thus formed as two pairs of interlocking members of the wetting mechanism that are spaced apart around the circumference of the wetting mechanism. Then, the body 1140 is moved axially toward the base 1160, and as it moves, the locking protrusion 1169a contacts the body 1140, thereby causing the locking tongue 1169 to deform radially inwardly until the locking protrusion 1169a can be locked in the locking groove 1141 and ensure that the body 1140 and the base 1160 cannot move relative to each other.

[0187] In this embodiment, while the body 1140 is assembled to the base 1160, the outer flange 1156 of the distal seal element 1150 is received in the sealing groove 1143, and the sealing rib 1157 is driven into engagement with the inner surface of the body 1140 by deforming the distal seal element 1150 through the sealing groove 1143 and the outer tube 1167. In addition, due to the size of the inner tube 1166, the inner flange 1155 is tightly sealed against the inner tube 1166, and due to the size of the sealing groove 1143 and the body 1140, the outer flange 1156 is tightly sealed against the body 1140. Therefore, the outer wall 1154 is also compressed in the radial direction, which helps drive the sealing engagement of the body 1140 and the distal seal element 1150.

[0188] In this embodiment, base 1160 and main body 1140 are now sealed and connected together, and main body 1140 can be filled with a wetting fluid for wetting the conduit surface. In this embodiment, the wetting fluid is water, and interacts with the hydrophilic surface of conduit 1200 to lubricate it. In a plurality of other embodiments, other wetting fluids can be used, and they can be polar (e.g., water-based) or non-polar (e.g., oil-based), depending on the surface properties of conduit. In this embodiment, 12 ml of wetting fluid is placed inside main body 1140, and more or less wetting fluids may be needed in a plurality of other embodiments, of course.

[0189] Since the wetting fluid is typically a liquid, care must be taken to ensure that the body is oriented with the sealed end below the open end when filling the body 1140. In various other embodiments, alternatives to free wetting fluid may be used, for example, an applicator device loaded with the wetting fluid may be placed in or integrated with the body and may be configured to release the wetting fluid to wet the catheter.

[0190] In this embodiment, the inserter tip 1120 is then assembled to the other end of the body 1140 in the same manner as the base 1160. Once the inserter tip 1120 is assembled to the body 1140, the wetting chamber 1101 is defined by the body 1140, the proximal sealing element 1130 and the distal sealing element 1150, and the wetting fluid in the body 1140 is prevented from leaving the wetting chamber 1101 by the seals between the various components and the inlet and outlet valves 1151, 1131 being in their normally closed state and presenting a concave surface toward the wetting chamber 1101. Therefore, the wetting chamber 1101 of this embodiment has a dual role, namely as a wetting chamber in which the catheter is wetted and a fluid reservoir in which the wetting fluid is stored before the catheter is wetted. In a number of other embodiments, a separate fluid reservoir may be used that delivers the wetting fluid to the wetting chamber when the catheter needs to be wetted.

[0191] In this embodiment, the cover 1110 is then assembled to the wetting mechanism 1100 by aligning the cover 1110 with the inserter tip 1120 and moving the cover axially onto the inserter tip 1120 until the gripping protrusions 1119a engage with the locking recesses 1141 of the body 1140, thereby securing the cover 1110 against accidental removal. Thus, the gripping protrusions 1119a also form an interlocking member of the wetting mechanism.

[0192] In this embodiment, the catheter 1200 is then arranged so that the proximal end 1201 of the catheter 1200 is just inside the insertion tube 1161 of the base 1160. The sleeve 1300 is then arranged around the catheter 1200 and attached to the outside of the insertion tube 1161 by any suitable means (e.g., welding / fusion) to form a fluid-tight seal between the sleeve 1300 and the base 1160, such as welding / fusion; mechanical sealing; heat sealing; pressure sealing; adhesive; solvent bonding; ultraviolet bonding; ultrasonic welding / fusion; laser welding / fusion; pulse welding / fusion; or friction welding / fusion.

[0193] Of course, in various other embodiments, the base may already be assembled to the cover rather than the body, and then filled with the wetting fluid while sealingly connected to the inserter tip, followed by the step of sealingly connecting the base to the body to form the wetting chamber.

[0194] Therefore, when the outlet valve 1131 is received by the inner sealing tube 1126 , the inner flange 1134 contacts the inner sealing tube 1126 , and the proximal sealing element 1130 is deformed in the radial direction toward the axis of the inner sealing tube 1126 .

[0195] refer to Figure 1In this embodiment, the catheter assembly 1000 is a closed catheter assembly and further includes a fluid collection bag 1400 configured to receive fluid from the distal end 1202 of the catheter 1200. In this embodiment, the distal end 1202 includes a funnel 1203, and the funnel 1203 is disposed within the fluid collection bag 1400. A fluid-tight seal is provided between the funnel 1203 and the fluid collection bag 1400 to prevent fluid leakage. A fluid-tight seal is also provided between the cannula 1300 and the funnel 1203 to ensure that fluid does not leak out of the cannula 1300.

[0196] In this embodiment, the funnel 1203 includes a bypass / shunt tube 1203 configured to allow liquid within the cannula 1300 to enter the fluid collection bag 1400 .

[0197] Reference Figures 14 to 17 In this embodiment, to prepare for use of the catheter 1200, the user grasps the catheter 1200 via the cannula 1300 and gradually moves the proximal end 1201 of the catheter 1200 into the inlet valve 1151. The flaps 1153 separate, thereby opening the inlet valve 1151 and allowing the catheter 1200 to enter the wetting chamber 1101 to be wetted by the wetting fluid. Advantageously, this ensures that the first part of the catheter 1200 that enters the body, i.e., the proximal end 1201, is the part most likely to be wetted by the wetting mechanism 1100. This helps reduce the possibility of discomfort or injury during use.

[0198] In this embodiment, the opening of the inlet valve 1151 also allows the wetting fluid to enter the cannula 1300 to wet the rest of the catheter 1200. The wetting fluid can enter the fluid collection bag 1400 via the funnel 1203.

[0199] In this embodiment, the catheter 1200 moves through the wetting chamber 1101 until the proximal end 1201 contacts the outlet valve 1131 and moves through the outlet valve 1131 by causing the flaps 1133 to separate and open the outlet valve 1131.

[0200] In this embodiment, the cover 1110 is then removed from the wetting mechanism 1100 by grasping the wetting mechanism 1100 with one hand and then pulling the cover off the wetting mechanism 1100 to disengage the gripping protrusions 1119a from the locking recesses 1141 .

[0201] In this embodiment, the inserter tip 1120 is then inserted into the urethra and the catheter 1200 is moved through the insertion tube 1121 until it passes out of the wetting mechanism 1100 and into the body by separating the tabs 1113 located at the tip of the inserter tip 1110. The catheter 1200 can then be inserted into the body until urine flows through the catheter 1200 and into the fluid collection bag 1400.

[0202] Reference Fig.18 The second embodiment of the catheter assembly 3000 has many of the same features as the first embodiment. Therefore, similar reference numerals are used to represent similar features, and the only difference between the two embodiments is that in the second embodiment, the catheter assembly 3000 does not include a fluid collection bag. Therefore, the fluid can flow directly out of the funnel to be discarded, such as into a toilet. Therefore, the catheter assembly 3000 is an "open" catheter assembly.

[0203] One or more embodiments have been described above by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. A catheter assembly, include: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism disposed at the proximal end of the catheter, wherein the wetting mechanism includes a body defining a wetting chamber through which the catheter can move to wet the catheter, and the wetting mechanism includes a slit valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber.

2. The catheter assembly according to claim 1 or 2, in, The conduit is formed of a hydrophilic material, the wetting chamber is configured to contain a wetting liquid, wherein the slit valve is configured to inhibit release of the wetting liquid from the wetting chamber.

3. A catheter assembly according to any one of the preceding claims, in, The slit valve includes at least one slit defining at least two flaps that are separable to allow the catheter to pass through the slit valve.

4. A catheter assembly according to any one of the preceding claims, in, The wetting mechanism includes two slit valves: an inlet valve configured to allow the catheter to enter the wetting chamber and inhibit fluid release from the wetting chamber, and an outlet valve configured to allow the catheter to exit the wetting chamber and inhibit fluid release from the wetting chamber.

5. The catheter assembly according to claim 5, in, Each of the inlet valve and the outlet valve has a curved surface, and the inlet valve and the outlet valve are arranged in the wetting mechanism with opposite curvatures.

6. The catheter assembly according to claim 5 or 6 further comprises an inserter tip, wherein the inserter tip is configured to engage one end of the main body, wherein the outlet valve is between the inserter tip and the one end of the main body, and the shape of the inserter tip is determined to help insert the catheter into the body.

7. The catheter assembly according to claim 7, in, The inserter tip includes an insertion tube covered by a dome, the dome including at least one slit defining at least two tabs configured to separate to allow the catheter to pass through the dome.

8. The catheter assembly according to claim 7 or 8 further comprises a cover, the cover being disposed around the inserter tip and above the inserter tip.

9. A catheter assembly according to any one of the preceding claims, in, The slit valve has a curved surface.

10. The catheter assembly according to claim 10, in, The slit valve is dome-shaped.

11. The catheter assembly according to claim 11, in, The dome height of the slit valve does not exceed 30% of the diameter of the slit valve.

12. The catheter assembly according to any one of claims 10 to 12, in, The slit valve is convex on the side facing away from the wetting chamber.

13. A catheter assembly according to any one of the preceding claims, in, The slit valve is normally closed.

14. A catheter assembly according to any one of the preceding claims, in, The slit valve is formed of a flexible elastic material.

15. A catheter assembly according to any one of the preceding claims, in, The wetting mechanism includes a sealing element including the slit valve, wherein the sealing element has a stepped profile.

16. A catheter assembly according to any one of the preceding claims, in, The wetting mechanism is tubular and includes a sealing element, a body and a base, the base including an opening, the opening being sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element including the slit valve forming an inlet valve, the sealing element comprising a material that is more flexible than the body and the base, wherein the sealing element is elastically deformed under the action of the body and the base to provide a fluid-tight seal between the body and the base.

17. A catheter assembly, include: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism disposed at the proximal end of the catheter, wherein the wetting mechanism comprises a body, a base and a sealing element, the body defining a tubular wetting chamber, the catheter being movable through the wetting chamber to wet the catheter, the base comprising an opening, the size of the opening being determined to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising an inlet valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the sealing element comprising a material more flexible than the body and the base, wherein the sealing element is elastically deformed under the action of the body and the base to provide a fluid-tight seal between the body and the base.

18. The catheter assembly according to claim 16 or 17, in, The sealing element has a stepped profile.

19. The catheter assembly according to claim 18, in, The sealing element has a top hat shaped profile.

20. The catheter assembly according to any one of claims 16 to 19, in, At least a portion of the sealing element is compressed by the base and / or the body in an axial direction, the axial direction being defined as the direction along which the conduit passes through the inlet valve into the wetting chamber.

21. The catheter assembly according to any one of claims 16 to 22, in, The sealing element includes an outer flange extending in an axial direction and compressed by the base and the body.

22. The catheter assembly according to claim 21, in, The main body includes a groove, and the outer flange is received in the groove and elastically deformed by the groove.

23. The catheter assembly according to claim 21 or 22, in, The outer flange is compressed between the base and the body in an axial direction.

24. The catheter assembly according to any one of claims 16 to 23, in, At least a portion of the sealing element is compressed by the seat and the body in a radial direction perpendicular to the axial direction.

25. The catheter assembly of claim 24, in, The sealing element includes an inner flange and an outer flange, both of which extend in an axial direction and are separated by an outer wall, the main body includes a groove configured to receive the outer flange, and the base includes an inner sealing tube configured to abut the inner flange, wherein the distance between the inner diameter of the groove and the inner diameter of the inner sealing tube measured in the radial direction is greater than the distance between the outer diameter of the inner flange and the inner diameter of the outer flange.

26. The catheter assembly according to any one of claims 16 to 25, in, The wetting mechanism includes two or more interlocking members configured to secure the base and the body together.

27. The catheter assembly of claim 26, comprising two or more pairs of interlocking members.

28. The catheter assembly of claim 27, in, The two or more pairs of interlocking members are spaced apart around the circumference of the wetting mechanism.

29. The catheter assembly according to any one of claims 26 to 28, in, The at least two interlocking members include at least one locking protrusion and at least one locking recess.

30. A catheter assembly according to any one of the preceding claims, in, The body is tubular, and each end of the body is configured to receive a sealing element.

31. The catheter assembly of claim 30, in, The wetting mechanism includes two sealing elements and two bases for sealing the two ends of the main body.

32. A catheter assembly according to any one of the preceding claims, in, The wetting mechanism includes a sealing element, which includes an inlet valve, and the inlet valve is configured to allow the catheter to enter the wetting chamber along an axial direction to be wetted by the wetting fluid, the inlet valve defines a transverse plane perpendicular to the axial direction, and the sealing element includes: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, and an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit movement of the inlet valve in the axial direction.

33. A catheter assembly, include: a catheter comprising a distal end and a proximal end for insertion into a body; and a wetting mechanism disposed at the proximal end of the catheter; The wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprises an inlet valve, the inlet valve is configured to allow the catheter to enter the wetting chamber along an axial direction to be wetted by the wetting fluid, the inlet valve is configured to prohibit the fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises: a stepped profile, an outer wall extending parallel to the transverse plane but deviating from the inlet valve, an internal support extending along the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit the movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit the movement of the inlet valve in the axial direction.

34. A catheter assembly according to any one of the preceding claims, in, The catheter is a urinary catheter.

35. The catheter assembly of claim 35, in, The catheter is an intermittent male urinary catheter.

36. A catheter assembly according to any one of the preceding claims, in, The conduit comprises a hydrophilic material, and the wetting chamber is configured to contain a wetting liquid.

37. A catheter assembly according to any one of claims 32 to 36, in, The inner support is attached to an outer edge of the inlet valve.

38. A catheter assembly according to any one of claims 32 to 37, in, The internal support comprises an internal flange surrounding the inlet valve in the transverse plane, the internal flange being frustoconical in shape.

39. A catheter assembly according to any one of claims 32 to 38, in, The wetting mechanism includes a transverse support structure configured to abut the inner support and surround at least a portion of the inner support.

40. The catheter assembly of claim 39, in, The transverse support structure can surround the inner support in the transverse plane.

41. A catheter assembly according to claim 39 or 40, in, The transverse support structure includes an inner sealed tube having a cylindrical shape.

42. The catheter assembly according to any one of claims 32 to 41, in, The outer wall surrounds the inlet valve in the transverse plane.

43. The catheter assembly of claim 42, in, The outer wall includes an inner periphery corresponding to an outer periphery of the inlet valve.

44. The catheter assembly of claim 43, in, The inner periphery of the outer wall is spaced apart from the outer periphery of the inlet valve in a lateral direction outside the outer periphery of the inlet valve.

45. The catheter assembly of any one of claims 32 to 44, further comprising an axial support structure configured to abut the outer wall at two or more independent locations.

46. ​​A catheter assembly according to any one of claims 32 to 45, in, The outer wall is annular and is compressed in a direction parallel to the transverse plane by the wetting mechanism.

47. The catheter assembly of any one of claims 32 to 46, the outer wall further comprising an outer flange, the outer flange being compressed by the wetting mechanism.

48. The catheter assembly of claim 47, in, The wetting mechanism further includes a groove for receiving the outer flange.

49. A method for manufacturing a catheter assembly, the method comprising providing a catheter and a wetting mechanism, the catheter comprising a distal end and a proximal end for insertion into a user's body, wherein the wetting mechanism comprises a body, the body defining a wetting chamber, the catheter being movable through the wetting chamber to wet the catheter, the wetting mechanism comprising a slit valve configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the method comprising arranging the wetting mechanism at the proximal end of the catheter.

50. A method for manufacturing a catheter assembly, the method comprising providing a catheter and a wetting mechanism, the catheter comprising a distal end and a proximal end for insertion into a body, wherein the wetting mechanism comprises a body, a base and a sealing element, the sealing element comprising an inlet valve, the inlet valve being configured to allow the catheter to enter the wetting chamber and prohibit fluid from being released from the wetting chamber, the body defining a tubular wetting chamber, the catheter being movable through the tubular wetting chamber to wet the catheter, the base comprising an opening sized to allow the catheter to pass through the base and enter the wetting chamber, the sealing element comprising a material that is more flexible than the body and the base, wherein the sealing element is elastically deformed under the action of the body and the base to provide a fluid-tight seal between the body and the base, the method comprising arranging the wetting mechanism at the proximal end of the catheter.

51. The method according to claim 49 or 50, in, The body is tubular, and the method further comprises sealing two ends of the body using two sealing elements and two seats.

52. A method for manufacturing a catheter assembly, the method comprising providing a catheter and a wetting mechanism, the catheter comprising a distal end and a proximal end for insertion into a body, wherein the wetting mechanism comprises a wetting chamber and a sealing element, the sealing element comprising an inlet valve, the inlet valve being configured to allow the catheter to enter the wetting chamber in an axial direction to be wetted by a wetting fluid, the inlet valve being configured to prohibit fluid from being released from the wetting chamber, the inlet valve defining a transverse plane perpendicular to the axial direction, the sealing element comprising a stepped profile, the sealing element comprising an outer wall extending parallel to the transverse plane but offset from the inlet valve, the sealing element comprising an internal support extending in the axial direction and connecting the outer wall to the inlet valve, the wetting mechanism abutting the internal support to prohibit movement of the inlet valve in the transverse plane, the wetting mechanism abutting the outer wall to prohibit movement of the inlet valve in the axial direction, the method comprising arranging the wetting mechanism at the proximal end of the catheter.

53. A method for wetting a catheter, the catheter comprising a distal end and a proximal end for insertion into a body, the method comprising providing a wetting mechanism at the proximal end of the catheter, wherein the wetting mechanism comprises a slit valve and a body defining a wetting chamber containing a wetting fluid, the slit valve being configured to prohibit the wetting fluid from being released from the wetting chamber, the method comprising moving the catheter through the slit valve and into the wetting chamber to wet the catheter.

54. The method according to claim 53, in, The slit valve includes at least two flaps, and the method includes separating the flaps using the conduit.

55. A method for wetting a catheter, the catheter comprising a distal end and a proximal end for insertion into a body, the method comprising providing a wetting mechanism at the proximal end of the catheter, wherein the wetting mechanism comprises a body, a base and a sealing element, the method comprising moving the catheter through an opening in the base, through an inlet valve in the sealing element and into a tubular wetting chamber defined by the body, wherein the inlet valve is configured to prohibit fluid from being released from the wetting chamber, the sealing element comprises a material that is more flexible than the body and the base, wherein the sealing element elastically deforms under the action of the body and the base to provide a fluid-tight seal between the body and the base.

56. A method for wetting a catheter, the catheter comprising a proximal end for insertion into a body, the method comprising providing a wetting mechanism at the proximal end of the catheter, wherein the wetting mechanism comprises a wetting chamber and a sealing element, the method comprising moving the catheter in an axial direction through an inlet valve in the sealing element and into the wetting chamber, wherein the inlet valve is configured to prohibit fluid from being released from the wetting chamber, the inlet valve defines a transverse plane perpendicular to the axial direction, the sealing element comprises a stepped profile, the sealing element comprises an outer wall extending parallel to the transverse plane but offset from the inlet valve, and an internal support extending in the axial direction and connecting the outer wall to the inlet valve, wherein the wetting mechanism abuts the internal support to prohibit movement of the inlet valve in the transverse plane, and the wetting mechanism abuts the outer wall to prohibit movement of the inlet valve in the axial direction.

57. A method according to any one of claims 49 to 56 using a catheter assembly according to any one of claims 1 to 48.

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