Catheter assembly

Abstract

A catheter assembly includes a catheter having a proximal end and a distal end for insertion into a body and a wetting mechanism including a base and a body. The body includes a fluid reservoir. The base and the body are rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism. The fluid reservoir includes an opening configured to allow fluid to exit the fluid reservoir to wet the conduit when in the second configuration. The fluid reservoir includes a sealing element configured to provide a fluid-tight seal between the opening and the base when in the first configuration. The sealing element elastically deforms by being compressed between the base and the body and inhibits unexpected rotation of the base relative to the body. The catheter is preferably an intermittent male catheter. The sealing element is preferably an O-ring.

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 male urinary catheter assemblies, especially "closed" 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-moistened 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 includes 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 may 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 it 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 body. The wetting mechanism may be arranged at the proximal end of the catheter. The wetting mechanism may include a base and a body. The body may include a fluid reservoir. The base and the body may be rotated relative to each other to define a first configuration and a second configuration of the wetting mechanism. In the second configuration, the wetting mechanism may allow fluid to be released from the fluid reservoir to wet the catheter.

[0011] According to a broad aspect, a catheter assembly is provided, comprising: a catheter including 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 includes a base and a body, the body including a fluid reservoir, and the base and the body can be rotated relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein in the second configuration, the wetting mechanism allows fluid to be released from the fluid reservoir to wet the catheter.

[0012] The catheter assembly may include a cannula configured to surround the catheter.In the second configuration, the wetting mechanism may allow fluid to be released from the fluid reservoir into the cannula to wet the catheter.

[0013] According to a first 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; a sleeve configured to surround the catheter; and a wetting mechanism arranged at the proximal end of the catheter, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, and the base and the body are rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein in the second configuration, the wetting mechanism allows fluid to be released from the fluid reservoir into the sleeve to wet the catheter.

[0014] Advantageously, because the wetting mechanism is placed at the proximal end of the catheter, the first portion of the catheter that enters the body is the portion most likely to be wetted by the wetting mechanism. In addition, the wetting mechanism is easier and more intuitive to use because the user can simply rotate the base and the body relative to each other to release the wetting fluid from the fluid reservoir. This is an easier and simpler task that can be accomplished in a more controlled manner even for users with reduced manual dexterity. This increases the likelihood that the user will use the wetting mechanism as intended, rather than attempting to access the catheter by other means that may not result in the catheter being adequately wetted and kept clean prior to use. This helps reduce the likelihood of discomfort, injury, and infection during use.

[0015] In the first configuration, the wetting mechanism may inhibit the release of fluid from the fluid reservoir into the cannula to wet the catheter. Thus, the release of the wetting fluid is controlled to ensure that the catheter is not wetted prematurely.

[0016] The wetting mechanism can be tubular. The axial direction can be defined along the axis of the wetting mechanism. The main body and the base can rotate relative to each other in a plane perpendicular to the axial direction. The wetting mechanism can have a peripheral shape in a plane perpendicular to the axis (e.g., axial direction) of the wetting mechanism. The peripheral shape can have a rotational symmetry of 2 or more orders. The peripheral shape can have a rotational symmetry of less than infinite order, or less than 10 orders, or less than 8 orders, or less than 6 orders. The wetting mechanism can have the same peripheral shape in the first and second configurations. The wetting mechanism can have a cross section that defines the peripheral shape of the wetting mechanism. Unless otherwise specified, the cross section described herein generally refers to the peripheral shape of the object in a plane perpendicular to the axial direction. The rotational symmetry of the peripheral shape / cross section is preferably 2 orders. The wetting mechanism can have a cross section of any suitable shape or size that defines the peripheral shape, such as an ellipse, rectangle, square, or irregular shape, preferably an ellipse in cross section. The peripheral shape can have a major axis and a minor axis. The major axis can be defined by the widest point of the peripheral shape. The minor axis can be limited by the narrowest point of the peripheral shape. The major axis and the minor axis can preferably be orthogonal, but can be arranged at an acute angle relative to each other. The major axis and the minor axis can be limited by the elliptical cross section of the wetting mechanism. The major axis can include vertices at each end. The minor axis can include common vertices at each end. The major axis can be no more than 2cm, 3cm, 4cm or 5cm. The major axis can be no less than 1cm, 2cm, 3cm or 4cm. Preferably, the major axis is 2-4cm, for example 3.5cm. The minor axis is less than the major axis, for example, 5%, 10%, 15% or 20% less than the major axis or 1.5-3.5cm, for example 3.1cm. Preferably, the minor axis is 10% less than the major axis. Therefore, the wetting mechanism can have a comfortable shape that the user is easy to hold, and due to the rotational symmetry of the wetting mechanism, the user easily identifies whether the wetting mechanism is in the first configuration or the second configuration.

[0017] The body may be tubular. The body may include a cross section that is identical to the cross section of the wetting mechanism. The body may have a major axis corresponding to the major axis of the wetting mechanism. The body may have a minor axis corresponding to the minor axis of the wetting mechanism. The length of the body may be greater than its major axis, for example 3-10% greater, preferably 5% greater, for example 4 cm. The body may include a tubular housing that forms the tubular shape of the body. The tubular housing may have a thickness of 3-5%, for example 4%, of the major axis or a thickness of 0.5 mm.

[0018] The base may be tubular. The base may include a cross section that is the same as the cross section of the wetting mechanism. The base may have a major axis corresponding to the major axis of the wetting mechanism. The base may have a minor axis corresponding to the minor axis of the wetting mechanism. The length of the base may be less than its major axis. The body may be longer than the base. The length of the base may be less than the length of the body, for example, the length of the base may be 50% or 45% of the length of the body, for example, 2 cm. The body base includes a tubular shell that forms the tubular shape of the base. The thickness of the tubular shell may be 3-5% of the major axis, for example 4% or 0.5 mm.

[0019] The length of the body and the base may be measured in an axial direction parallel to the axis of rotation of the body relative to the base. The length of the body and the base may be measured along the direction in which the conduit passes through the wetting mechanism. The length of the body and the base may be measured along a direction parallel to the conduit when it is located inside the wetting mechanism. The length of the body / base may include all elements of the body / base, respectively, such as all parts that are integrally formed with the body / base.

[0020] The wetting mechanism may be symmetrical about the long axis. In a first configuration, the long axis of the base and the long axis of the body may be aligned. In a second configuration, the long axis of the base and the long axis of the body may be aligned, wherein one of the base and the body points in a direction opposite to the first configuration. When not in the first or second configuration, the long axis of the base may not be aligned with the long axis of the body. Therefore, a user can easily identify whether the wetting mechanism is in the first configuration or the second configuration, or is neither in the first configuration nor in the second configuration.

[0021] The body may include a body hole. The body hole may be configured to allow a catheter to pass into and / or out of the body. The body hole may be a body guide tube. The body guide tube may extend through the body in an axial direction. The body hole / body guide tube may be configured to guide a catheter through the body. The guide tube may be open-ended. The guide tube may be cylindrical. The diameter of the guide tube may be 20-40% of the major axis, for example 30% or 1 cm. The guide tube may be located between the center of the body and the apex of the major axis, preferably, the guide tube is located in the middle / midpoint between the center and the apex. Therefore, the guide tube can easily and safely pass through the body.

[0022] The body may include a separator. The separator may extend through the body in an axial direction. The separator may define a fluid reservoir. The separator may be configured to separate / divide the internal volume / internal volume of the body. The separator may be configured to separate the guide tube from the fluid reservoir. The separator may extend around the guide tube, for example, in a plane perpendicular to the axial direction. The separator may have an arched cross-section. The separator may extend from the tubular housing of the body, preferably from both sides of the guide tube. The separator may extend to a point that is located at 55-65% or 57%-62.5% of the distance along the long axis of the body from the vertex of the adjacent guide tube (or the edge in the case where the wetting mechanism is not elliptical), for example, 60% or 2 cm. The tip of the separator may be defined at the point where it intersects the long axis. The curvature of the separator may be maximum at the tip. The separator may extend tangentially from both sides of the guide tube. The curvature of the separator may be minimum where it meets the tubular housing of the body. The partition and the guide tube may be separate. The partition and the guide tube may be integrally formed. Thus, the fluid reservoir and the guide tube are separated within the body.

[0023] The body may include a body wall. The body wall may cover one end of the body. The other end of the body may be open-ended, i.e., uncovered. The body aperture may be located in the body wall. The body guide tube may extend from the body wall. The divider may extend from the body wall. The body guide tube may extend less than 100%, 98%, 95%, or 90% of the length of the body. The divider may extend less than 100%, 98%, 95%, or 90% of the length of the body. The body guide tube and the divider may have substantially the same length.

[0024] The body may include an axis. The axis may be configured to allow the body and the base to rotate relative to each other, preferably around an axis defined by the axial direction. The axis may engage the base. The axis may extend parallel to the axial direction. The axis may be arranged at the center of a cross-section of the body. The axis may be arranged at the center of a wall of the body. The axis may be cylindrical. The diameter of the axis may be 15-25% of the major axis of the body, such as 20% or 7 mm. The axis may have two open ends. The length of the axis may be 20-40%, such as 30%, of the body.

[0025] The shaft may include at least two slots, such as four slots. The at least two slots may be arranged at equal intervals around the circumference of the shaft, such as 90° in the case of four slots. Each slot may extend in an axial direction from an end of the shaft away from the body. Each slot may extend 35-40%, such as 37.5%, of the length of the shaft. A locking projection may be present between two adjacent slots. The shaft may include at least one locking projection. Each locking projection may be configured to engage the base. Preferably, there is a locking projection between each pair of adjacent slots. Preferably, there are the same number of slots and locking projections. Each locking projection may be arranged at the end of the shaft away from the body. Each locking projection may span 15-25%, such as 20%, of the length of the shaft or span about half of the length of the slot. Each projection is narrowest at the end of the shaft away from the body. Each projection may be wedge-shaped. Due to the one or more locking projections, the effective diameter of the shaft may increase linearly by 35-45%, such as 40%. Therefore, as described below, the slots allow the locking projections to move and engage the base.

[0026] The base may include a base hole configured to allow a catheter to enter, pass through and / or leave the base. The base hole may be sized to allow a catheter to pass therethrough. The base hole may be provided by a base guide tube. The base guide tube may extend through the base in an axial direction. The base guide tube may be configured to guide the catheter through the base. The base guide tube may be open-ended. The base guide tube may be cylindrical. The base guide tube may have a diameter substantially the same as the main body hole / main body guide tube, i.e., 20-40% of the major axis, such as 30% or 1 cm. The base guide tube may be located between the center of the base and the vertex of the major axis, preferably, the base guide tube is located in the middle / midpoint between the center and the vertex. Therefore, the catheter can easily and safely pass through the base.

[0027] The base may include a base wall. The base wall may cover one end of the base. The other end of the base may be open, i.e. without a cover. The base guide tube may extend from the base wall. The base guide tube may extend from the base wall over the entire length of the base.

[0028] The base may be configured to receive the shaft. The base may include a locking hole configured to receive the shaft. The locking hole may be disposed on the base wall. The locking hole may be centrally disposed on the base wall. The locking hole may be tubular, such as cylindrical. The locking hole may extend in an axial direction. The locking hole may extend within the body. The locking hole may extend away from the base wall. The length of the locking hole in the axial direction may be equal to the distance between the body wall and the locking protrusion of the shaft. Thus, the body and the base may be attached together using the shaft and the locking hole.

[0029] As described above, the shaft and locking hole work together to secure the base and body together. Although the shaft is described as being part of the body and the locking hole is part of the base, this relationship can of course be reversed, and the shaft is part of the base and extends from the base wall, and the locking hole is provided in the body, such as in the body wall.

[0030] The fluid reservoir may include an opening to allow the wetting fluid to be released from the fluid reservoir. The opening may be provided in the body. The opening may be provided in a wall of the body. The opening may be an outlet. The outlet may be circular. The diameter of the outlet may be 60-70%, for example 65%, of the diameter of the body hole / body guide tube. The opening may be located at an intermediate / midpoint between the common vertex and the center of the body. The opening may form an angular interval of 80°-100°, for example 90°, with the body hole / body guide tube around the cross section of the body.

[0031] The fluid reservoir may include a sealing element. Preferably, the sealing element is not formed integrally with any other part of the wetting mechanism, such as the base and the main body. The sealing element, the main body and the base may be formed independently of each other. The sealing element may be configured to seal the opening. The sealing element may be configured to provide a seal between the opening and the base, such as when the wetting mechanism is in the first configuration. The sealing element may be configured to prohibit fluid from passing between the base and the main body. The sealing element may be formed by a flexible material such as a flexible plastic material, rubber or silicone / organic silicon / polysiloxane (silicone). Preferably, the sealing element is formed by a material different from the main body and the base. The sealing element may be any suitable shape or size to prohibit fluid from flowing out of the fluid reservoir until the wetting mechanism is in the second configuration. The sealing element may be an O-ring. When the sealing element is an O-ring, the sealing channel may be annular. Therefore, the sealing element is simple and easy to manufacture while providing effective sealing.

[0032] 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, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element is elastically deformed by being compressed between the base and the body and prohibits unintentional rotation of the base relative to the body, wherein the sealing element, the body and the base are each independently formed.

[0033] 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, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element being elastically deformed by being compressed between the base and the body and prohibiting unintentional rotation of the base relative to the body, wherein the sealing element is formed of a material different from that of the body and the base.

[0034] The sealing element may be compressed between the base and the body. The sealing element may be compressed in the axial direction. The shaft may urge the body into the base so as to compress the sealing element. Each locking protrusion may force the sealing element to be compressed between the body and the base. The sealing element may be compressed in the axial direction by at least 1%, at least 5%, at least 10%, at least 20% or at least 30%. The sealing element may be compressed in the axial direction by no more than 40%, no more than 30%, no more than 20%, no more than 10%, no more than 5% or no more than 1%.

[0035] 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, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element being elastically deformed by being compressed between the base and the body and prohibiting unintentional rotation of the base relative to the body, wherein the sealing element is compressed in an axial direction perpendicular to a plane in which the body and the base rotate relative to each other.

[0036] Sealing element can be configured to provide frictional force, to forbid the rotation of base relative to main body.Sealing element can provide frictional force between base and main body, and this frictional force is equivalent to at least 0.05Nm, at least 0.1Nm, at least 0.2Nm, at least 0.3Nm, at least 0.4Nm, at least 0.5Nm or at least 1Nm torque of the center (i.e. the center of wetting mechanism) that rotates around base relative to main body.Sealing element can provide frictional force between base and main body, and this frictional force is equivalent to no more than 1Nm, no more than 0.5Nm, no more than 0.4Nm, no more than 0.3Nm, no more than 0.2Nm, no more than 0.1Nm or no more than 0.05Nm torque of the center (i.e. the center of wetting mechanism) that rotates around base relative to main body.Preferably, sealing element provides frictional force between base and main body, and this frictional force is equivalent to no more than 0.35Nm torque of the center (i.e. the center of wetting mechanism) that rotates around base relative to main body. Thus, the wetting mechanism cannot inadvertently change configuration, which would otherwise result in premature wetting of the catheter.

[0037] The wetting mechanism may include a retainer. The retainer may be configured to limit movement of the sealing element relative to the body or base. The sealing element may be substantially fixed relative to the body or base.

[0038] Therefore, in a preferred embodiment, a catheter assembly is provided, comprising: a catheter including a distal end and a proximal end for insertion into a body; and a wetting mechanism, wherein the wetting mechanism includes a base and a body, the body including a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir includes an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir including a sealing element configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element is elastically deformed by being compressed between the base and the body, and inhibits unintentional rotation of the base relative to the body, wherein the body includes a retainer configured to limit movement of the sealing element relative to the body. This ensures that the sealing element does not slip or shift, which would otherwise cause leakage.

[0039] The body may include a retainer. The retainer may be configured to limit the movement of the sealing element relative to the body. The sealing element may be substantially fixed relative to the body. The fluid reservoir may include a retainer. The retainer may be configured to limit the movement of the sealing element relative to the opening. The retainer may be disposed in the body. The retainer may be disposed in a wall of the body. The retainer may be configured to push the sealing element into a compression seal between the base and the body. The retainer may be a sealing channel. The sealing element may be disposed in the sealing channel. The sealing channel may be arranged around the opening, preferably concentrically around the opening. The sealing channel may overlap with the tubular housing of the body. The tubular housing may be thinned to accommodate the sealing channel. The retainer may be independent of the opening. The sealing channel may be configured to receive the sealing element. The depth of the sealing channel may be less than the thickness of the sealing element. Therefore, a reliable seal is provided by the retainer.

[0040] Therefore, in a preferred embodiment, a catheter assembly is provided, 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 base and a body, the body including a fluid reservoir, the base and the body can be rotated relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir includes an opening, the opening is configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir includes a sealing element, the sealing element is configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element is elastically deformed by being compressed between the base and the body, and prohibits unintentional rotation of the base relative to the body, wherein the body includes a retainer, the retainer is configured to limit the movement of the sealing element relative to the body. This ensures that the sealing element does not slide or shift, otherwise it will cause leakage. In addition, by maintaining the sealing element relative to the body, greater design freedom can be achieved in the base, and the base can have a more complex opening arrangement to achieve better function during use.

[0041] The base may include an outlet opening. The outlet opening may be configured to provide a fluid connection between the base and the fluid reservoir. When the wetting mechanism is in the second configuration, the outlet opening may provide a fluid connection between the base and the fluid reservoir. When the wetting mechanism is in the first configuration, the outlet opening may not be aligned with the opening. When the wetting mechanism is in the second configuration, the outlet opening may be aligned with the opening. The outlet opening may include an arc-shaped opening in the base wall. The outlet opening may extend around the base center through an arc equal to an angle of up to 160°, 150°, 140°, 130°, 120°, 110° or 100°, such as an arc extending through an angle equal to 150°-160° around the axis of rotation of the body and the base relative to each other. When measured from the center of the base guide tube, the outlet opening may start from 40° on one side of the base guide tube. When measured from the center of the base guide tube, the outlet opening may end at 110° on the other side. The outlet opening may span a radius corresponding to the opening position. The outlet opening may span from a radius of 40% of the minor axis of the base to a radius of 60% of the minor axis of the base. Thus, as described below, when the body is rotated relative to the base, the outlet opening is aligned with the outlet.

[0042] The outlet opening may overlap with the base hole / base guide tube. The outlet opening may be a size / shape different from the base hole / base guide tube. The outlet opening may be a size / shape different from the opening. The outlet opening may not overlap with the base hole / base guide tube at least partially. The base hole / base guide tube may intersect with the outlet opening. The base hole / base guide tube may divide the outlet opening into two or more parts. The base hole / base guide tube may divide the outlet into three parts. One of the parts may be the base hole / base guide tube itself. One of the parts may be located on one side of the base hole / base guide tube. Another part may be located on the opposite side of the base hole / base guide tube. The base hole / base guide tube and the outlet opening may not provide a continuous volume in the base. Therefore, the base guide tube remains a cylindrical tube and is not affected by the shape of the outlet opening, which ensures that the catheter can effectively pass through the base guide tube.

[0043] As described above, the opening, outlet opening and retainer work together to selectively allow the fluid reservoir to drain / discharge into the base. Although the opening and retainer are described as a part of the main body, and the outlet opening is a part of the base, this relationship can certainly be changed. For example, the retainer can be arranged on the main body, on the base, or on both the main body and the base. In addition, the relative size and shape of the opening and the outlet opening can be reversed and the same or equivalent functions can be obtained. In addition, the sealing element can include a plurality of sealing elements, such as one is retained on the main body and one is retained on the base, which work together to provide a required fluid-tight seal in the first configuration.

[0044] The wetting mechanism may include a rotating guide configured to limit the linear movement of the base relative to the body during the rotation of the base relative to the body. The rotating guide may include at least two interlocking members. The body may include one interlocking member. The base may include one interlocking member. The at least two interlocking members may include a pin and a groove. The body may include a pin. The body wall may include a pin. The pin may extend from the body wall in an axial direction. The pin may extend away from the body. The pin may be cylindrical. The pin may have a capped end / covered end / closed end. The diameter of the pin may be 5-10%, such as 7.5%, or 5 mm of the major axis of the body. The length of the pin may be 30-40%, such as 35%, of the shaft length. The pin may be spaced at an angle of 110°-150°, such as 130°, around the cross section of the body with the body hole / body guide tube. The pin may be spaced at an angle of 120°-160°, such as 140°, around the cross section of the body with the opening. The pin may be positioned at approximately 30-50%, for example 40%, of the distance from the centre of the shaft to the tubular housing of the body as measured through the pin.

[0045] The base may include a groove. The groove may be configured to receive the pin. The groove may be disposed in the base wall. The depth of the groove may be equal to the length of the pin. The groove may be configured to allow the pin to travel along the groove as the base and the body rotate relative to each other. The groove may be arc-shaped. The groove may span a radius corresponding to the diameter of the pin. The groove may span from a radius of 30% of the minor axis of the base to a radius of 55% of the minor axis of the base. The groove may cover an arc length of at least 180° around the base, for example an arc length of 210°-220°. The groove may cover an arc length of 180° plus the angular dimension of the pin. The groove may start on one side of the base guide tube. The groove may overlap the outlet opening. The groove and the outlet opening may define a continuous volume. Thus, the pin and the groove may allow the body and the base to rotate up to 180° relative to each other.

[0046] The rotating guide can be configured to provide a force, preferably a friction force, that prohibits the rotation of the base relative to the main body. The rotating guide and the sealing element can be configured to independently provide a force to prohibit the rotation of the base relative to the main body. The rotating guide can be configured to provide a force that prohibits the rotation of the base relative to the main body only on a part of the rotation range of the main body relative to the base, and preferably on a small part of the rotation range. When the mechanism enters and / or leaves the second configuration, the rotating guide can provide a maximum force to prohibit the rotation of the base relative to the main body. When the mechanism leaves the second configuration, the rotating guide can provide a maximum force to prohibit the rotation of the base relative to the main body. The rotating guide can provide a force between the base and the main body, which is equivalent to a torque of at least 0.05Nm, at least 0.1Nm, at least 0.2Nm, at least 0.3Nm, at least 0.4Nm, at least 0.5Nm or at least 1Nm around the center (i.e. the center of the wetting mechanism) of the rotation of the base relative to the main body. The rotating guide can provide a force between the base and the body that is equivalent to a torque of no more than 1 Nm, no more than 0.5 Nm, no more than 0.4 Nm, no more than 0.3 Nm, no more than 0.2 Nm, no more than 0.1 Nm, or no more than 0.05 Nm about the center of rotation of the base relative to the body (i.e., the center of the wetting mechanism). Therefore, the wetting mechanism will not inadvertently enter the second configuration or move away from the second configuration, otherwise it will cause damage to the catheter. In addition, the user can tell when the wetting mechanism is about to enter the second configuration because they must overcome the additional force provided by the rotating guide to enter the second configuration.

[0047] The wetting mechanism may be configured to provide audible / tactile feedback when the wetting mechanism enters and / or leaves the second configuration. The rotation guide may be configured to provide audible / tactile feedback when the wetting mechanism enters and / or leaves the second configuration. The at least two interlocking members may be configured to provide audible / tactile feedback when the wetting mechanism enters and / or leaves the second configuration. The groove may include one or more groove protrusions. The groove protrusion may be configured to prohibit the pin from moving along the groove beyond the groove protrusion. The groove protrusion may be configured to apply a force on the pin to prohibit the rotation of the body relative to the base. When the pin passes through the groove protrusion, the groove protrusion may provide audible / tactile feedback, such as due to the deformation of the groove protrusion, the pin, the body and / or the base. The groove protrusion may extend into the groove in a direction perpendicular to the axial direction. The groove protrusion may extend in a plane parallel to the rotation plane of the body relative to the base. The groove protrusion may be positioned toward / adjacent to the end of the groove away from the base guide tube. The groove protrusion may be separated from the end of the groove by a distance equivalent to the diameter of the pin, for example an angular distance of 30°-40°. Thus, feedback is provided to the user to let them know that the wetting mechanism is in the second configuration, and it is also ensured that the wetting mechanism neither inadvertently enters the second configuration nor inadvertently leaves the second configuration. In addition, since the groove protrusion extends into the groove in a direction perpendicular to the axial direction, the groove protrusion does not require the pin to move axially to overcome them. This avoids the groove protrusion causing unexpected axial forces that they need to overcome at the same time, which may cause separation of the base and the body and damage to the wetting mechanism.

[0048] As described above, the pin and groove work together to guide the rotation of the base and body and provide audible / tactile feedback. Although the pin is described as being part of the body and the groove is part of the base, of course this relationship can be reversed and the pin is part of the base and extends from the base wall and the groove is provided in the body, for example in the body wall. In addition, other aspects of the wetting mechanism can be adapted to provide audible / tactile feedback, such as through dedicated detents / protrusions.

[0049] In a first configuration, the pin may be disposed at the end of the groove adjacent to the base guide tube. In the first configuration, the wetting mechanism may prevent the proximal end of the catheter from passing therethrough. In the first configuration, the body aperture / body guide tube may not be aligned with the base aperture / base guide tube. In the first configuration, the opening may be sealed by a sealing element, for example, the sealing element may provide a seal between the outlet and the base wall.

[0050] In a second configuration, the pin may be disposed at the end of the groove away from the base guide tube. In a second configuration, the wetting mechanism may allow the proximal end of the catheter to pass therethrough. In a second configuration, the pin may be held in place by the groove protrusion. In a second configuration, the body hole / body guide tube may be aligned with the base hole / base guide tube. In a second configuration, the opening may be aligned with one end of the outlet opening.

[0051] The wetting mechanism may include a third configuration between the first configuration and the second configuration. In the third configuration, the fluid reservoir may be configured to release fluid into the cannula to wet the catheter. In the third configuration, the wetting mechanism may prevent the proximal end of the catheter from passing therethrough. In the third configuration, the pin may be arranged between the two ends of the groove. In the third configuration, the opening / outlet may be aligned with at least a portion of the outlet opening. In the third configuration, the body hole / body guide tube may not be aligned with the base hole / base guide tube.

[0052] The wetting mechanism may include an adapter. The adapter may be configured to provide a fluid connection between the wetting mechanism and the cannula. The adapter may be configured to be attached to the base. The adapter may be configured to be attached to the base away from the body. The adapter may be configured to be attached to the base away from the base wall. The cannula may be attached to the adapter, for example, by any suitable means, such as 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 adapter ensures that the cannula is securely attached to the wetting mechanism.

[0053] The base may be arranged between the body and the sleeve. The sleeve may be attached to the base, for example, via an adapter. For example, as described above, the body may be attached to the base. The body may be attached to the sleeve via the base. The base may be fixed relative to the sleeve. Of course, the sleeve is usually flexible so that a part of the sleeve can move relative to the base, however, in the case where the base is fixed relative to the sleeve, it is fixed at least relative to the end of the sleeve. The body can rotate on the base.

[0054] The adapter can be configured to guide the catheter into the wetting mechanism, such as into the base guide tube. This facilitates the passage of the catheter through the wetting mechanism and improves the efficiency of the catheter wetting process.

[0055] The adapter may include an adapter wall. The adapter wall may have an outer edge corresponding to the cross-section of the tubular housing of the body and / or the cross-section of the wetting mechanism. Thus, the adapter may have a major axis corresponding to the major axis of the wetting mechanism. The adapter may have a minor axis corresponding to the minor axis of the wetting mechanism. Thus, the adapter together with other components of the wetting mechanism provides a smooth look and feel to the wetting mechanism.

[0056] The adapter may direct the wetting fluid onto the catheter and / or into the cannula. The adapter wall may direct the wetting fluid onto the catheter and / or into the cannula. The adapter wall may include a flat portion. The adapter wall may include a recessed portion. The shape of the recessed portion may be determined to direct the wetting fluid into the cannula and / or onto the catheter. The recessed portion may extend away from the base. The flat portion may be perpendicular to the axial direction. The outer edge of the adapter wall may be in a plane defined by the flat portion. The flat portion and the recessed portion may be separated along a line approximately connecting the common vertices of the adapter. The line may be a smooth arc. The flat portion may include one vertex and the recessed portion may include another vertex. The flat portion may include two common vertices. The recessed portion may include the center of the adapter.

[0057] The adapter may include an adapter tube. The adapter tube may be attached to the recessed portion. The adapter tube may provide a passage for the catheter through the adapter, optionally provided via the recessed portion. The adapter tube may provide a passage for the wetting fluid through the adapter, optionally provided via the recessed portion. The adapter tube may be cylindrical. The adapter tube may be open-ended. The diameter of the adapter tube may be greater than the diameter of the base guide tube. The diameter of the adapter tube may be 20-30%, such as 25%, of the major axis. The length of the adapter tube may be 45-55%, such as 50%, of the major axis of the adapter. The adapter tube may extend from the recessed portion. The adapter tube may extend in an axial direction. The adapter tube may extend away from the flat portion. The adapter tube may be aligned with the base guide tube. The adapter tube may be located between the vertex contained by the recessed portion and the center of the adapter. The adapter tube may be located at 70-90%, such as 80%, of the distance between the two vertices of the adapter. Therefore, the adapter tube ensures smooth and efficient transmission of the catheter and the wetting fluid between the cannula and the wetting mechanism.

[0058] The maximum distance that the recessed portion may be recessed from the flat portion is 20-30%, for example 25%, of the major axis of the adapter. The distance from the flat portion to the end of the adapter tube remote from the flat portion may be equal to 65-85%, for example 75%, of the major axis of the adapter. The recessed portion may have a continuous smooth surface. The recessed portion may extend smoothly between the adapter tube and the flat portion. The adapter tube may be arranged at a position / point on the recessed portion where the distance from the flat portion is the greatest. The recessed portion may be curved / curved, for example due to an arcuate interface between the recessed portion and the flat portion. Advantageously, the curved / curved shape helps to guide the wetting fluid into the adapter tube and into the cannula and / or onto the catheter.

[0059] The adapter may include one or more sealing ribs. The one or more sealing ribs may be configured to provide a fluid-tight seal between the adapter and the base. Each sealing rib may be arranged on the inner side of the outer edge of the adapter wall. Each sealing rib may extend in an axial direction. Each sealing rib may extend away from the adapter tube. Each sealing rib may terminate at the same distance from the flat portion as measured in the axial direction, for example, at a distance that is 10% of the major axis of the adapter. Each sealing rib may be chamfered. Each sealing rib may engage the base. Each sealing rib may extend along an arc length extending around the center of the adapter. Each sealing rib may extend 10°-360° around the adapter. Preferably, the one or more sealing ribs include two smaller sealing ribs. Each smaller sealing rib may extend for an arc length of approximately 30°. A smaller sealing rib may be provided on each side of the adapter tube. The smaller sealing ribs may be separated by an angle of 60°. The one or more sealing ribs may include a larger sealing rib. The larger sealing rib may extend for an arc length of approximately 160°. The larger sealing rib may be centered at a vertex contained by the flat portion. Each smaller sealing rib may be separated by 40° from the edge of the larger sealing rib. Thus, the sealing rib may be used to effectively seal the adapter to the base by pushing the adapter and base together.

[0060] The wetting mechanism may include an inserter tip. Therefore, the inserter tip may have a long axis corresponding to the long axis of the wetting mechanism. The inserter tip may have a short axis corresponding to the short axis of the wetting mechanism. The inserter tip may be configured to seal the end of the body away from the base. The inserter tip may be configured to allow the catheter to leave the wetting mechanism and enter the body. The inserter tip may include an insertion tube. The insertion tube may be cylindrical. The inner diameter of the insertion tube may be greater than the outer diameter of the catheter, for example, 20-30% of the long axis, for example 25% or 7mm. The length of the insertion tube may be 50-60% of the long axis, for example 55%. The insertion tube may have a constant thickness of 1mm, which is also the same as the wall thickness of the other parts of the inserter tip and the remaining parts of the optional wetting mechanism. The insertion tube may be arranged parallel to the axial direction. The insertion tube may be aligned with the main body hole / main body guide tube. The insertion tube may be configured to be inserted into the urethra during use so that the catheter enters the user's body directly from the wetting mechanism. Thus, the introducer tip helps reduce the risk of infection and discomfort as the catheter is smoothly introduced into the body by the insertion tube.

[0061] The insertion tube may be capped at one end. The insertion tube may be covered by a semi-cylindrical / hemispherical dome. The semi-cylindrical / hemispherical dome may include at least one slit, such as two orthogonal slits. The at least one slit may be arranged in the center of the dome. The at least one slit may define at least one wing, such as four wings. The at least one slit may be configured to allow the at least one wing to be separated. The at least one wing may be separated to allow the proximal end of the catheter to leave the wetting mechanism through the insertion tube. Therefore, if necessary, the dome shape helps to comfortably insert the insertion tube into the body, and the catheter can easily enter the body via the slit / wing.

[0062] The inserter tip may include a tip wall. The tip wall may be configured to cover the end of the body away from the body wall. The thickness of the tip wall may be 5% of the length of the insertion tube. The insertion tube may extend from the proximal surface of the tip wall away from the body. The insertion tube may not extend in the opposite direction from the tip wall, for example, not extend from the opposite distal surface of the tip wall. Therefore, the tip wall helps to prohibit the insertion tube from being over-inserted into the body while also sealing the inserter tip to the body.

[0063] The inserter tip may include a receptacle. The receptacle may be configured to be received by the body. The receptacle may abut / abut the body guide tube and / or the divider. The receptacle may extend from the tip wall, preferably from the distal surface of the tip wall. The receptacle may be located on the tip wall around the insertion tube. The receptacle may provide a tip wall area that is 60-100% thicker than the rest, for example 80% thicker. The receptacle may guide the catheter into the insertion tube. The receptacle may have chamfered edges, for example having chamfered edges where it surrounds the insertion tube. Thus, the receptacle facilitates entry of the proximal end of the catheter into the insertion tube and facilitates secure sealing of the inserter tip to the body.

[0064] The receptacle may have a shape that matches the shape of the divider and / or the guide tube. The receptacle may have an overall / rough shape of an isosceles triangle. The receptacle may have convex sides. The receptacle may have rounded corners. A gap may be provided between the receptacle 2126 and the outer edge of the distal wall to accommodate the tubular housing of the body, for example, the gap may be about 3-5%, such as 4%, of the long axis of the distal wall 2125. The receptacle may extend into and beyond the center of the distal wall. The height of the receptacle in a direction parallel to the long axis may be 55-60%, such as 57%, of the long axis of the distal wall 2125. The receptacle may have a width perpendicular to its height, the maximum value of which is roughly / approximately consistent with the center of the insertion tube along the long axis of the distal wall. The receptacle width may be 70-80%, such as 75%, of the height of the receptacle 2126. Thus, the receptacle matches the shape of the divider and ensures a tight seal between the receptacle and the divider.

[0065] The inserter tip may include a sealing rib. The sealing rib may extend from the distal surface of the distal wall. The sealing rib may form a continuous ring. The sealing rib may follow / follow the shape of the receptacle and / or the divider into the center of the distal wall. The sealing rib may extend around the periphery / periphery of the distal wall that is not occupied by the receptacle. A gap between the receptacle and the edge of the distal wall may also exist / maintain between the sealing rib and the edge of the distal wall. The distance that the sealing rib extends from the distal surface may be 2-3 times, for example 2.5 times, the thickness of the distal wall 2125. The sealing rib may have a chamfered edge away from the distal surface. Therefore, the sealing rib may engage with the tubular housing of the body and the divider to provide a tight seal and define a portion of the fluid reservoir.

[0066] The inserter tip may include a stop / detent. As described below, the stop may be configured to engage the cover. The stop may be a through hole extending through the tip wall. The stop may also extend through a portion of the tip wall. The stop may be located approximately midway between the apex and the center of the inserter tip. The stop may be located on the side of the inserter tip opposite the insertion tube. The stop may be circular, with a diameter approximately one-half to one-third the diameter of the insertion tube.

[0067] The wetting mechanism may include a cover. The cover may be configured to cover the inserter tip. The cover may be configured to protect the inserter tip before use. The cover may include a housing having the same shape as the inserter tip. The cover may be larger than the inserter tip so that it can enclose the inserter tip.

[0068] The cover may include a cover tube. The cover tube may be configured to cover / overlap the insertion tube. The cover tube may be cylindrical. The inner diameter of the cover tube may match the outer diameter of the insertion tube, or be larger than the outer diameter of the insertion tube. The cover tube may be capped at one end, for example with a semi-cylindrical / hemispherical dome as a cap / to cover to fit over the dome of the insertion tube.

[0069] The cover may include a cover portion. The cover portion may extend from the open end of the cover tube. The cover portion may be configured to cover / overlap the tip wall. The cover portion may have an outer circumference just outside the outer circumference of the inserter tip and / or body, for example, the major axis of the cover may be 10% larger than the major axis of the inserter tip and body.

[0070] The cover may include a cover flange. The cover flange may extend from an outer edge of the cover portion. The cover flange may extend in an axial direction to overlap / cover the inserter tip and the optional body. The cover flange may have a length such that when the cover is placed on the inserter tip, the cover flange extends downwardly beyond the distal surface of the tip wall by about 50-70%, such as 60%, of the distance that the sealing rib extends from the distal surface.

[0071] The free end of the cover flange may include a gripping protrusion. The gripping protrusion may extend around the periphery of the cover flange. The gripping protrusion may occupy the bottom 20-30%, for example the bottom 25%, of the cover flange and have a semicircular cross-section. In the area of ​​the gripping protrusion, the cover flange may have a major axis that is 3% larger than the rest of the cover flange. Thus, the gripping protrusion helps ensure that the cover remains attached to the wetting mechanism and also helps the user remove the cover when necessary.

[0072] The cover may include a plug. The plug may extend from the cover. The plug may be configured to be received by a stop. In the case where the stop is a through hole, the plug may be configured to seal the through hole. The shape of the plug may be determined so that its size at the junction / meeting with the cover is slightly larger than the size of the stop. The plug may have a frustoconical shape. Once the plug is received in the stop, the plug may be pressed against the inner side of the stop. Therefore, the through hole may be sealed to prohibit the wetting fluid from leaking out of the fluid reservoir. In addition, removing the plug from the through hole allows the user to provide an air inlet for the fluid reservoir, which helps to release the wetting fluid into the sleeve because air can enter the fluid reservoir to displace the wetting fluid that is leaving. The plug also helps to keep the cover on the inserter tip.

[0073] The cover can include a pull ring. The pull ring can be configured to allow a user to grasp the cover and pull it away from the wetting mechanism. The pull ring can be attached to any suitable part of the dome, the cover tube, the cover portion, or the cover. In the case where the pull ring is attached to the dome and / or the cover tube, the pull ring can be arranged eccentrically relative to the cover tube. The pull ring can be positioned centrally relative to the center of the cover. This helps the user to remove the cover because the position of the pull ring reduces shear forces that are not parallel to the axial direction, which can cause the cover to get stuck on the wetting mechanism. Of course, in a number of other embodiments, different easy-to-grip features such as tabs can be used to replace the pull ring, and the pull ring or equivalent features can be placed in different positions, such as directly attached to the cover portion or the cover flange.

[0074] The pull ring may include a reinforced area. The reinforced area may include half of the pull ring, for example the half of the pull ring away from the cover. The reinforced area may include a reinforced area of ​​the pull ring. Thus, the reinforced area may allow the user to exert greater force on the cover. The reinforced area may have a widened cross-section compared to the rest of the pull ring. The reinforced area may have a square cross-section.

[0075] The cover, inserter tip, body, base and / or adapter may each comprise a material more rigid than the sealing element, such as a hard plastic material such as high density polyethylene (HDPE). The body and base may have a different stiffness than the sealing element. Preferably, the body and base are more rigid than the sealing element.

[0076] 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, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element being elastically deformed by being compressed between the base and the body and prohibiting unintentional rotation of the base relative to the body, wherein the body and the base are formed of a material that is more rigid than the sealing element.

[0077] 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 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.

[0078] The catheter may include a funnel-shaped member disposed at the distal end of the catheter. The funnel-shaped member may be attached to a fluid collection bag. The funnel-shaped member may be disposed within the fluid collection bag. A fluid-tight seal may be provided between the funnel-shaped member and the fluid collection bag. The funnel-shaped member may be configured to deliver liquid from the distal end of the catheter to the fluid collection bag. A cannula may be attached to the funnel-shaped member. A fluid-tight seal may be provided between the cannula and the funnel-shaped member. The funnel-shaped member may include a shunt / bypass / diverter 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.

[0079] 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). Therefore, the cannula is cheap and easy to produce, and is easy to manipulate by the user during use.

[0080] 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.

[0081] 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.

[0082] Preferably, the conduit is formed from a polyolefin material, in particular polyethylene and / or polypropylene.

[0083] Preferably, the conduit is made of a thermoplastic elastic material.

[0084] 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.

[0085] The fluid reservoir may include an opening configured to allow fluid to exit the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration. The fluid reservoir may include a sealing element configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration. The sealing element may be elastically deformable by being compressed between the base and the body. The sealing element may inhibit accidental rotation of the base relative to the body.

[0086] According to a 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 body; and a wetting mechanism, wherein the wetting mechanism includes a base and a body, the body including a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir includes an opening configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir including a sealing element configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element being elastically deformed by being compressed between the base and the body. The sealing element can inhibit accidental rotation of the base relative to the body.

[0087] 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, wherein the wetting mechanism comprises a base and a main body, the main body comprises a fluid reservoir, the base and the main body can be rotated relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening is configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprises a sealing element, the sealing element is configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element is elastically deformed by being compressed between the base and the main body, and prohibits accidental rotation of the base relative to the main body.

[0088] Advantageously, the wetting mechanism is easier and more intuitive to use, as the user can simply rotate the base and the body relative to each other to release the wetting fluid from the fluid reservoir. This is an easier and simpler task, and can be accomplished in a more controlled manner, even for users with reduced hand dexterity. In addition, the sealing element ensures that the wetting fluid is not released from the fluid reservoir prematurely, and also helps the user to better control the fluid release process by providing resistance to the rotation of the base relative to the body. This increases the likelihood that the user will use the wetting mechanism as intended, and the likelihood that the wetting mechanism will not be activated prematurely, which would make the catheter unsafe to use. In addition, since the sealing element is simply compressed between the base and the body to form a seal between them, the manufacture of the wetting mechanism is simple and effective.

[0089] The catheter assembly may include a housing. The housing may include a base and a body. The base and the body may rotate relative to each other to define a first configuration and a second configuration of the housing. In the first configuration, the housing may prevent the proximal end of the catheter from passing therethrough. In the second configuration, the housing may allow the proximal end of the catheter to pass therethrough.

[0090] According to a third 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 shell, wherein the shell comprises a base and a body, and the base and the body can be rotated relative to each other to define a first configuration and a second configuration of the shell, wherein in the first configuration, the shell prevents the proximal end of the catheter from passing therethrough, and in the second configuration, the shell allows the proximal end of the catheter to pass therethrough.

[0091] Advantageously, the housing is easier and more intuitive to use, as the user can simply rotate the base and body relative to each other to open the housing and allow passage / access of the catheter. This is an easier and simpler task that can be accomplished in a more controlled manner, even for users with reduced manual dexterity.

[0092] The housing may comprise any one or more of the features of the wetting mechanism as described in relation to the first and second aspects of the invention.

[0093] 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 any other features according to the first to third aspects mentioned above. The catheter assembly of the first to third aspects may include any optional features of the other aspects of the first to third aspects, without having to include all the features required by them. That is, the optional features set forth following a particular aspect are not necessarily only applicable to that aspect, therefore, for example, the present disclosure provides a catheter assembly, which includes: a catheter, which includes a distal end and a proximal end for inserting into a body; and a housing, wherein the housing includes a base and a main body, and the base and the main body can rotate relative to each other to define a first configuration and a second configuration of the housing, wherein in the first configuration, the housing prevents the proximal end of the catheter from passing therethrough, and in the second configuration, the housing allows the proximal end of the catheter to pass therethrough, as described in the third aspect, and wherein the main body includes a separator described in relation to the first aspect.

[0094] According to a fourth aspect of the present invention, a method for manufacturing a catheter assembly is provided, comprising the following steps: providing a catheter comprising a distal end and a proximal end for insertion into a body, and a wetting mechanism, the wetting mechanism comprising a base and a main body, the main body comprising a fluid reservoir, the base and the main body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein in the second configuration, the wetting mechanism allows fluid to be released from the fluid reservoir to wet the catheter; and arranging the wetting mechanism at the proximal end of the catheter.

[0095] The method of the fourth aspect of the invention may be a method of manufacturing the catheter assembly of the first aspect of the invention, which method may of course include any of the optional features outlined above.

[0096] The method may include providing an adapter. The method may include providing a base. The method may include assembling the adapter to the base. The method may include sealingly attaching the adapter to the base. The method may include coaxially aligning the adapter tube with the base bore / base guide tube. The method may include aligning the adapter wall with the base wall so that they completely overlap each other. The method may include moving the adapter in an axial direction toward the base. The method may include receiving at least one sealing rib within the base.

[0097] The method may include providing a sealing element. The method may include providing a body. The method may include forming a sealing element, a base and a body independently of each other. The method may include forming a wetting mechanism by arranging the sealing element between the body and the base. The method may include assembling the sealing element to a retainer so that the retainer limits the movement of the sealing element relative to the opening. The method may include attaching the body to the base. The method may include attaching the body to the base, wherein the sealing element is located between the body and the base. The method may include inserting a shaft into a locking hole, for example until a locking protrusion engages with the locking hole. The method may include aligning a pin with a groove. The method may include receiving the pin in the groove.

[0098] The method may include providing a fluid-tight seal between the body and the base. The method may include rotating the body relative to the base until the opening is sealed by the sealing element. The method may include rotating the body relative to the base until the opening corresponds to a flat section of the base wall. The method may include moving / rotating the pin to one end of the groove, preferably an end near the base hole / base guide tube. The method may include moving / rotating the body hole / body guide tube to the side of the wetting mechanism opposite to the base hole / base guide tube. The method may include aligning the outer edge of the base with the outer edge of the body, for example, so that they completely overlap. The method may include moving / rotating the wetting mechanism into a first configuration.

[0099] The method may comprise providing a wetting fluid.The method may comprise introducing the wetting fluid into a fluid reservoir, such as into the body to fill the fluid reservoir.

[0100] The method may include attaching the inserter tip to the body. The method may include aligning the inserter tip with the body. The method may include aligning the insertion tube with the body hole / body guide tube. The method may include fitting a sealing rib into the body to seal against the divider.

[0101] The method may include adding a cover to the inserter tip. The method may include sealing the fluid reservoir. The method may include sealing the through hole with a plug.

[0102] The method may include arranging the proximal end of the catheter inside the adapter tube. The method may include arranging a sleeve around the catheter. The method may include attaching the sleeve to the outside of the adapter tube.

[0103] The method may include providing a funnel. The method may include providing a fluid collection bag. The method may include arranging the funnel within the fluid collection bag. The method may include providing a fluid-tight seal between the funnel and the fluid collection bag. The method may include providing a bypass / shunt / diverter in the funnel to allow liquid in the cannula to enter the fluid collection bag.

[0104] According to a fifth aspect of the present invention, a method for manufacturing a catheter assembly is provided, comprising providing 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 base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element being elastically deformed by being compressed between the base and the body and prohibiting accidental rotation of the base relative to the body.

[0105] The method of the fifth aspect of the invention may be a method of manufacturing the catheter assembly of the second aspect of the invention, which method may of course include any of the optional features outlined above.

[0106] The method may include forming a sealing element, a base and a body independently of one another. The method may include forming a wetting mechanism by arranging the sealing element between the body and the base. The method may include attaching the body to the base, wherein the sealing element is located between the body and the base.

[0107] In a preferred embodiment, 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 the body, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element being elastically deformed by being compressed between the base and the body and prohibiting accidental rotation of the base relative to the body, wherein the method comprises forming the sealing element, the base and the body independently of each other.

[0108] The method may include disposing a wetting mechanism at a proximal end of the catheter.

[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 comprising a distal end and a proximal end for insertion into a body and a shell, wherein the shell comprises a base and a body, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the shell, wherein in the first configuration, the shell prevents the proximal end of the catheter from passing therethrough, and in the second configuration, the shell allows the proximal end of the catheter to pass therethrough.

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

[0111] The method may include disposing a housing at a proximal end of the catheter.

[0112] According to a seventh aspect, 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 in a first configuration; and arranging the wetting mechanism at the proximal end of the catheter, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein in the second configuration, the wetting mechanism allows fluid to be released from the fluid reservoir into a sleeve to wet the catheter, wherein the method comprises moving the wetting mechanism from the first configuration to the second configuration.

[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 method 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 removing the cover from the inserter tip. The method may include grasping and pulling the pull ring. The method may include disengaging the plug from the stopper / through hole.

[0115] The method may include rotating the body relative to the base. The method may include overcoming the friction provided by the sealing element. The method may include aligning the opening / outlet with the outlet opening. The method may include allowing the wetting fluid to flow out of the fluid reservoir. The method may include allowing the wetting fluid to flow through the base and into the cannula, optionally via the adapter and / or the recessed portion into the cannula. The method may include directing the wetting fluid toward the adapter tube and the catheter using the recessed portion.

[0116] The method may include continuing to rotate the body and the base relative to each other. The method may include moving the wetting mechanism through a third configuration. The method may include aligning the opening / outlet with the base hole / base guide tube. The method may include allowing the wetting fluid to flow into the base hole / base guide tube. The method may include allowing the wetting fluid to flow directly onto the catheter and / or into the cannula.

[0117] The method may include contacting the pin with the recessed protrusion. The method may include overcoming the recessed protrusion.

[0118] The method may include retaining the pin at one end of the groove, preferably at an end distal to the base hole / base guide tube. The method may include aligning the opening / outlet with one end of the outlet opening, preferably distal to the end of the base hole / base guide tube. The method may include aligning the body hole / body guide tube with the base hole / base guide tube.

[0119] The method may include inserting an insertion tube into the urethra. The method may include gradually moving the proximal end of the catheter through a wetting mechanism, such as through a base and a body. 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.

[0120] According to an eighth aspect, 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 in a first configuration, wherein the wetting mechanism comprises a base and a main body, the main body comprising a fluid reservoir, the base and the main body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, and the sealing element being elastically deformed by being compressed between the base and the main body, and prohibiting unintentional rotation of the base relative to the main body, thereby moving the wetting mechanism from the first configuration to the second configuration.

[0121] The method of the eighth aspect of the invention may be a method of wetting a catheter from a catheter assembly of the second aspect of the invention, which method may of course include any of the optional features described above, and may be manufactured according to the fifth aspect of the invention.

[0122] The wetting mechanism / housing may be provided in a first configuration.

[0123] The method may include introducing a catheter into the urethra through the proximal end of the catheter. The method may include allowing fluid from the body to enter a fluid collection bag via the catheter and / or cannula. Thus, the method may be a method of using a catheter assembly.

[0124] According to a ninth aspect of the present invention, a method for opening a shell containing a catheter is provided, wherein the shell includes a base and a body, and the base and the body can be rotated relative to each other to define a first configuration and a second configuration of the shell, wherein in the first configuration, the shell prevents the proximal end of the catheter from passing therethrough, and in the second configuration, the shell allows the proximal end of the catheter to pass therethrough, the method comprising: providing the shell in a first configuration; and moving the shell from the first configuration to the second configuration.

[0125] The method of the ninth aspect of the invention may be a method of wetting a catheter from a catheter assembly of the third aspect of the invention, which method may of course include any of the optional features described above, and may be manufactured according to the sixth aspect of the invention.

[0126] The method may include introducing a catheter into the urethra through the proximal end of the catheter. The method may include allowing fluid from the body to enter a fluid collection bag via the catheter and / or cannula. Thus, the method may be a method of using a catheter assembly.

[0127] 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

[0128] 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:

[0129] Figure 1 is a side view of a catheter assembly having a wetting mechanism in a first configuration;

[0130] Figure 2 yes Figure 1 A bottom view of a cover of a catheter assembly;

[0131] Figure 3 yes Figure 2 A bottom perspective view of a cover;

[0132] Figure 4 yes Figure 1 a top view of an introducer tip of a catheter assembly;

[0133] Figure 5 yes Figure 4 A side view of the inserter tip;

[0134] Figure 6 yes Figure 4 A bottom view of the inserter tip;

[0135] Figure 7 yes Figure 1 a top perspective view of a main body of a catheter assembly;

[0136] Figure 8 yes Figure 7 A side view of the subject;

[0137] Fig. 9 yes Figure 7 A bottom-up perspective view of the subject;

[0138] Fig.10 yes Figure 1 A top view of a base of a catheter assembly;

[0139] Fig.11 yes Fig.10 A top perspective view of the base;

[0140] Fig.12 yes Fig.10 A bottom view of the base;

[0141] Fig.13 yes Fig.10 A bottom-up perspective view of the base;

[0142] Fig.14 yes Figure 1 A bottom view of an adapter of a catheter assembly;

[0143] Fig.15 yes Fig.14 A bottom perspective view of the adapter;

[0144] Fig.16 yes Fig.14 A side view of the adapter;

[0145] Fig.17 yes Fig.14 A top view of an adapter;

[0146] Fig.18 yes Figure 1 An exploded view of a wetting mechanism of a catheter assembly;

[0147] Fig.19 yes Figure 1 The wetting mechanism of the catheter assembly in the first configuration during the period when the wetting mechanism is open Figure 1 an enlarged perspective view of a top portion of a catheter assembly;

[0148] Fig. 20 is in the first configuration Figure 1 A cross-sectional view of a wetting mechanism of a catheter assembly;

[0149] Fig.21 yes Figure 1 A top perspective view of the catheter assembly of FIG. 1 , wherein the wetting mechanism is in a third configuration;

[0150] Fig. 22 It is in the third configuration Figure 1 A cross-sectional view of a wetting mechanism of a catheter assembly;

[0151] Fig.23 yes Figure 1 A side view of the catheter assembly of FIG. 1 , wherein the wetting mechanism is in a second configuration;

[0152] Fig.24 It is in the second configuration Figure 1 a cross-sectional view of a wetting mechanism of a catheter assembly; and

[0153] Fig.25 yes Figure 1 Side view of the catheter assembly with the catheter passing through the wetting mechanism. DETAILED DESCRIPTION

[0154] refer to Figure 1-25 In this embodiment, the catheter assembly 2000 includes a housing, a catheter 2200, a sleeve 2300 and a fluid collection bag 2400, in which the housing is in the form of a wetting mechanism 2100. The catheter 2200 includes a proximal end 2201 and a distal end 2202 for insertion into the user's body. In this embodiment, the catheter 2201 is a male urinary catheter made of a hydrophilic thermoplastic elastomer (TPE). The sleeve 2300 of this embodiment is a thermoplastic polyurethane (TPU) or a low-density polyethylene (LDPE). The fluid collection bag 2400 is configured to receive liquid from the distal end of the catheter 2200 and includes two panels, which are connected around their periphery to form a rectangular bag, the volume of which can store 700-1000ml of liquid. Obviously, those skilled in the art will be able to select suitable alternative materials.

[0155] In this embodiment, the wetting mechanism 2100 is generally tubular and includes a cover 2110, an inserter tip 2120, a body 2130, a sealing element 2140, a base 2150, and an adapter 2160, all of which are independently formed and configured to fit together in an axial direction to form the wetting mechanism 2100, the axial direction being defined from one end to the other end along the axis of the tubular wetting mechanism 2100. Thus, each of the cover 2110, the inserter tip 2120, the body 2130, the base 2150, and the adapter 2160 constitutes a section of the tubular wetting mechanism 2100 along the length.

[0156] In this embodiment, the wetting mechanism 2100 has a peripheral shape in a plane defined by a cross section perpendicular to the axial direction. The cross section has a 2nd order rotational symmetry, i.e. it is rotationally symmetric about 180°. The wetting mechanism has an elliptical cross section defined by a minor axis and a major axis, with vertices at both ends of the major axis and co-vertices at both ends of the minor axis, as conventionally.

[0157] In this embodiment, the major axis of the inserter tip 2120, the body 2130, the base 2150, and the adapter 2160 are all the same and are 2-4 cm, e.g., 3.5 cm, and their respective minor axes are approximately 10% smaller than their major axes. Of course, these shapes / sizes are purely exemplary and other shapes / sizes may be selected or used as needed / desired.

[0158] In this embodiment, the sealing element 2140 is formed of a flexible material, such as a flexible plastic material, rubber or silicone / polysiloxane / silicone, and in this embodiment, the sealing element 2140 is an O-ring, preferably composed of silicone. The cover 2110, the inserter tip 2120, the body 2130, the base 2150 and the adapter 2160 each include a more rigid material than the sealing element 2140, and preferably together include a different material, such as a hard plastic material such as high-density polyethylene (HDPE).

[0159] In this embodiment, the inserter tip 2120 includes an insertion tube 2121, through which the proximal end 2201 of the catheter 2200 passes to leave the wetting mechanism 2100 and enter the user's body. The insertion tube 2121 is cylindrical, and its inner diameter is larger than the outer diameter of the catheter 2200, for example, the inner diameter of the insertion tube is 20-30% of the long axis of the wetting mechanism 2100, for example, 25% or 7mm. The length of the insertion tube 2121 is 50-60% of the long axis of the wetting mechanism 2100, for example, 55%. The insertion tube 2121 has a constant thickness, which is also the same as the wall thickness of other parts of the inserter tip 2120, for example, 1mm. The insertion tube 2121 is arranged parallel to the axial direction and is configured to be inserted into the urethra during use so that the catheter 2200 enters the user's body directly from the wetting mechanism 2100, which helps reduce the risk of infection and discomfort because the catheter 2200 is smoothly guided into the body by the insertion tube 2121.

[0160] In this embodiment, the insertion tube 1121 is covered / capped at one end with a semi-cylindrical / hemispherical dome 2124, which includes two orthogonal slits 2122 arranged in the center of the dome 2124 to define four fins 2123. The slits 2122 are configured to allow the fins 2123 to separate as the proximal end 2201 of the catheter 2200 passes outward from the interior of the insertion tube 2121 through the dome 2124. The dome shape also helps to comfortably insert the insertion tube 2121 into the body if necessary.

[0161] In this embodiment, the inserter tip 2120 includes a tip wall 2125 that extends across the entire wetting mechanism 2100 perpendicular to the axial direction and helps prevent over-insertion of the insertion tube 2121 into the body while also sealingly attaching the inserter tip 2120 to the body 2130, as described below. Thus, the tip wall 2125 has a shape that matches the cross-section of the wetting mechanism 2100 and has a thickness of 5% of the length of the insertion tube 2121. The insertion tube 2121 extends from a proximal surface 2125a of the tip wall 2125 and does not extend from the tip wall 2125 in the opposite direction, i.e., does not extend from the opposite distal surface 2125b of the tip wall 2125. In this embodiment, the insertion tube 2121 is eccentrically arranged, and specifically, is arranged along the major axis of the elliptical tip wall 2125 at a position approximately midway / midpoint between the apex and the center of the tip wall 2125.

[0162] In this embodiment, the inserter tip 2120 also includes a receptacle 2126 extending from the distal surface 2125b of the tip wall 2125. The receptacle 2126 surrounds the insertion tube 2121 and provides an area of ​​the tip wall 2125 that is 60-100% thicker than the rest, such as 80% thicker, to assist in the engagement of the inserter tip 2120 and the body 2130, as described below. The receptacle 2126 also has a chamfered edge, wherein the chamfered edge surrounds the insertion tube 2121 to assist in the entry of the proximal end 2201 of the catheter 2200 into the insertion tube 2121.

[0163] In this embodiment, the receptacle 2126 has the general shape of an isosceles triangle with convex sides and rounded corners. A gap 2127 is provided between the base 2126a of the receptacle 2126 and the outer edge 2125c of the distal wall 2125, which gap is about 3-5%, such as 4%, of the long axis of the distal wall 2125. From either end / both ends of the base 2126a, the receptacle 2126 extends toward and beyond the center of the distal wall 2125. The height of the receptacle 2126 from the base 2126a to the distal vertex 2126b distal to the base 2126a is 55-60%, such as 57%, of the long axis of the distal wall 2125. The receptacle 2126 has a width perpendicular to its height, which is greatest at a point along the long axis of the distal wall 2125 that is approximately consistent / identical with the center of the insertion tube 2121. The width of the receptacle 2126 is 70-80%, such as 75%, of the height of the receptacle 2126 .

[0164] In this embodiment, the inserter tip 2120 includes a sealing rib 2128 extending from the distal surface 2125b of the distal wall 2125. The sealing rib 2128 forms a continuous ring and follows the shape of the receptacle 2126 into the center of the distal wall 2125 before extending around the periphery / outer periphery of the distal wall 2125 not occupied by the receptacle 2126. A gap 2127 between the base 2126a of the receptacle 2126 and the edge 2125a of the distal wall 2125 is also maintained between the sealing rib 2128 and the edge 2125c of the distal wall 2125. The distance that the rib 2128 extends from the distal surface 2125b is 2-3 times, for example, 2.5 times, the thickness of the distal wall 2125. The rib 2128 has a chamfered edge away from the distal surface 2125b to facilitate engagement between the sealing rib 2128 and the body 2130, as described below.

[0165] In this embodiment, the inserter tip 2120 also includes a stop / detent in the form of a through hole 2129 that is configured to engage the cover 2110, as further described below. The through hole 2129 extends through the tip wall 2125 along the major axis and is approximately midway / midpoint between the apex and the center of the tip wall 2125, but on the side opposite to the insertion tube 2121. The through hole 2129 is circular and has a diameter that is approximately half to one-third the diameter of the insertion tube 2121.

[0166] In this embodiment, the cover 2110 is configured to cover the inserter tip 2120 and protect it before use. Thus, the cover 2110 is a housing having the same shape as the inserter tip 2120, but having a larger size so that it can effectively enclose it, and similar reference numerals are used to represent similar features.

[0167] In this embodiment, the cover 2110 includes a cover tube 2111 that is cylindrical with an inner diameter that matches the outer diameter of the insertion tube 2121. The cover tube 2111 is capped at one end with a semi-cylindrical / hemispherical dome 2114 to fit over the dome 2124 of the inserter tip 2120.

[0168] In this embodiment, the cover 2110 includes a cover portion 2115 extending outward from the open end of the cover tube 2111, and the cover portion 2115 is configured to cover the tip wall 2125. Therefore, the outer periphery of the cover portion 2115 is just outside the outer periphery of the inserter tip 2120 and the body 2130, for example, the major axis of the cover 2110 can be 10% larger than the major axis of the inserter tip 2120 and the body 2130.

[0169] In this embodiment, the cover 2110 includes a cover flange 2117 extending from the outer edge of the cover portion 2115 in the axial direction to cover the inserter tip 2120 and the body 2130. The length of the cover flange 2117 is such that when the cover 2110 is placed on the inserter tip 2120, the distance that the cover flange 2117 extends downward beyond the distal surface 2125b of the tip wall 2125 is approximately 50-70%, such as 60%, of the distance that the sealing rib 2128 extends from the distal surface 2125b.

[0170] In this embodiment, at the free end of the cover flange 2117, a gripping protrusion 2118 extends around the periphery of the cover flange 2117. The gripping protrusion 2118 occupies the bottom 20-30%, for example the bottom 25%, of the cover flange 2117 and has a semicircular cross-section. In the region of the gripping protrusion 2118, the cover flange 2117 has a major axis that is 3% larger than the rest of the cover flange 2117. The gripping protrusion 2118 thus helps ensure that the cover 2110 remains attached to the moistening mechanism 2100 and also helps the user remove the cover 2110 when necessary.

[0171] In this embodiment, the cover 2110 includes a plug 2119 extending from the cover portion 2115, and the plug 2119 is configured to be received by the through hole 2129 of the inserter tip 2110. The plug 2119 is shaped so that it has a frustoconical shape and its size where it meets the cover portion 2115 is slightly larger than the size of the through hole 2129, so that once received in the through hole 2129, the plug 2119 presses against the inside of the through hole 2129. This allows the plug 2119 to seal the through hole 2129 and also retains the cover 2110 on the inserter tip 2120.

[0172] In this embodiment, the cover 2110 also includes a pull ring 2112 attached to the dome 2114. The pull ring 2112 is configured to allow a user to grasp the cover 2110 and pull it away from the wetting mechanism 2110. The pull ring 2112 is eccentrically arranged relative to the cover tube 2111 so that the pull ring 2112 is centrally located relative to the axis of the wetting mechanism 2100. This helps the user remove the cover 2110 because the position of the pull ring 2112 reduces shear forces that are not parallel to the axial direction, which may cause the cover 2110 to remain stuck on the wetting mechanism 2100 due to the side of the plug 211. Of course, in various other embodiments, different easy-to-grip features such as tabs can be used instead of pull rings, and pull rings or equivalent features can be placed in different locations, such as directly attached to the cover or cover flange.

[0173] In this embodiment, the pull ring 2112 includes a reinforced area 2112a. The reinforced area 2112a surrounds the half of the pull ring 2112 away from the cover 2110 and is reinforced to allow the user to apply more force to the cover 2110. In this embodiment, the reinforced area 2112a has a widened square cross-section compared to the narrower circular cross-section of the rest of the pull ring 2112.

[0174] In this embodiment, the body 2130 is tubular, having an oval cross-section of the same size as the inserter tip 2120, a closed end and an open end, the open end being covered by the inserter tip 2120 in use, as described below. The length of the body 2130 from one end to the other is greater than its major axis, for example 3-10% greater, for example 5% greater. The thickness of the tubular shell of the body 2130 is equal to the gap 2127 provided between the base 2126a of the sealing rib 2128 / receptacle 2126 and the edge of the tip wall 2125c, respectively, so that the receptacle 2126 and the sealing rib 2128 abut the body 2130 and form a seal therebetween.

[0175] In this embodiment, the body 2130 includes a body hole in the form of a body guide tube 2131, which extends through the body 2130 in the axial direction and is configured to ensure that the proximal end 2201 of the catheter 2200 can smoothly pass through the body 2130 and enter the insertion tube 2121. The guide tube 2131 is an open-ended cylindrical shape, and its diameter is larger than the diameter of the insertion tube 2121, for example, 20-30% larger, for example, 25% larger. The guide tube 2131 is also coaxially positioned with the insertion tube 2121 to ensure smooth passage of the catheter 2200 therethrough.

[0176] In this embodiment, the body 2130 includes a partition 2132 that extends through the body 2130 in an axial direction around the guide tube 2131. The partition 2132 is arcuate and extends from the periphery of the body 2130 on both sides of the guide tube 2131 and follows the shape taken by the sealing rib 2128 around the receptacle 2126. Thus, the guide tube 2131 is separated from the rest of the interior of the body 2130 and the fluid reservoir 2101 as described below.

[0177] In this embodiment, the guide tube 2131 and the divider 2132 extend from the closed end of the body 2130 to about 95% of the way to the open end, and thus leave room for accommodating the receptacle 2126 inside the body 2130 when the wetting mechanism 2100 is put together as described below. Of course, in many other embodiments, the divider can have different forms to perform the same function as the divider described here. In some embodiments, the divider and guide tube can be integrated into the same feature that provides the functions of both the divider and the guide tube.

[0178] In this embodiment, the body 2130 includes a body wall 2135 that provides a closed end of the body 2130 as described above. The guide tube 2131 extends from and through the body wall 2135 so that the catheter 2200 can pass through the body wall 2135 into the body 2130.

[0179] In this embodiment, the body wall 2135 includes a shaft 2133 configured to allow the body 2130 and the base 2150 to rotate relative to each other around an axis defined by the axial direction. The length of the shaft 2133 is 20-40%, for example 30%, of the length of the body 2130, and is arranged at the center of the elliptical body wall 2135 and extends away from the body 2130 in the axial direction. The shaft 2133 is cylindrical, its diameter is 15-25%, for example 20%, of the major axis of the body 2130, and has (two) open ends.

[0180] In this embodiment, the shaft 2133 includes four slots arranged at equal intervals (e.g., at 90° intervals) around the circumference of the shaft 2133. The slots 2134 each extend 35-40%, for example 37.5%, of the length of the shaft in the axial direction from the end away from the body 2130. There are four locking protrusions 2136 extending between two adjacent slots 2134 around the circumference of the end of the shaft 2133. Each locking protrusion 2136 spans 15-25% of the length of the shaft 2136, for example 20% from the end of the shaft 2133. Each protrusion is wedge-shaped so that the effective diameter of the shaft 2133 increases linearly by 35-45%, for example 40%, due to the narrowest locking protrusion 2136 at the tip of the shaft 2133 away from the body 2130. Thus, due to the presence of the slots 2134, each locking protrusion 2136 can bend inward when they are received by the locking holes 2156 of the base 2150, and then bend outward once within the locking holes 2156 to hold the body 2130 and the base 2140 together, as further described below.

[0181] In this embodiment, the wetting mechanism 2100 includes a rotation guide in the form of two interlocking members: a pin 2137 and a groove 2157. The body wall 2135 includes a pin 2137 extending in an axial direction away from the body wall 2135 and away from the body 2130. The pin 2137 is cylindrical with a capped end and a diameter of 5-10%, for example 7.5%, of the major axis of the body wall 2135. The length of the pin 2137 is 30-40%, for example 35%, of the length of the shaft 2133. As described below, the pin 2137 is configured to be received in the groove 2157.

[0182] In this embodiment, fluid reservoir 2101 is defined by inserter tip 2120, body 2130, partition 2132, and body wall 2135. Fluid reservoir 2101 is configured to retain a wetting fluid therein and then release the wetting fluid when the surface of catheter 2200 is ready to be activated for use, as described further below.

[0183] In this embodiment, in order to allow the wetting fluid to leave the fluid reservoir 2101, the body wall 2135 comprises an opening in the form of an outlet 2138. The outlet 2138 is circular and has a diameter of 60-70% of the diameter of the guide tube 2131, for example 65%.

[0184] In this embodiment, the body wall 2135 also includes a retainer in the form of an annular / circular sealing channel 2139 that is separate from the outlet 2138 but concentrically disposed about the outlet 2138. The sealing channel 2139 is sized to receive the sealing element 2140 such that the sealing element 2140 is compressed between the body 2130 and the base 2150 to form a fluid-tight seal about the outlet 2138 and between the base 2150 and the body 2130 when the base 2150 and the body 2130 are coupled together as described below. The sealing channel 2139 thereby also prevents the sealing element 2140 from moving relative to the body 2130.

[0185] In this embodiment, the guide tube 2131 is disposed between the apex and the center of the elliptical cross section of the body 2130 to align with the insertion tube 2121 of the inserter tip 2120. The outlet 2138 is positioned at the middle / midpoint between the common apex and the center of the cross section of the body 2130, such that when the body 2130 is viewed in the axial direction with the axis 2133 pointing toward the viewer, the outlet 2138 is positioned 90° clockwise from the guide tube 2131 around the axis of the body 2130. Due to the size of the sealing channel 2139, the sealing channel 2139 extends to a point outside the normal inner perimeter of the body 2130, and as such, the thickness of the outer shell of the body 2130 is slightly reduced adjacent the sealing channel 2139. The pin 2137 is positioned another 140° clockwise from the outlet 2138 around the axis of the body 2130. The pin 2137 is located adjacent to the shaft 2133 and is at 40% of the distance between the center of the shaft 2133 and the edge of the body 2130 measured through the pin 2137. Of course, in various other embodiments, the exact location of the guide tube 2131, the outlet 2138, and the pin 2137 may vary depending on the configuration of the base 2140 and the body 2130.

[0186] In this embodiment, the base 2150 is tubular and has the same cross section as the body 2130, but the length is 40-50%, for example 45%, of the length of the body 2130. The base 2150 has one end covered by the base wall 2155 and an opposite open end. The locking hole 2156 is arranged at the center of the base wall 2155 and is circular, and its diameter is just larger than the diameter of the shaft 2133. In this embodiment, the locking hole is tubular with a certain length, and the locking hole extends away from the base wall 2155 in the axial direction inside the base 2150 by a distance equal to the distance between the body wall 2135 and the locking protrusion 2136 of the shaft 2133.

[0187] In this embodiment, the base 2150 includes a base hole in the form of a base guide tube 2151, which has a similar function to the main body guide tube 2131. The base guide tube 2151 has the same size and shape as the main body guide tube 2131, and both are arranged between the vertex and the center of the cross section of the wetting mechanism 2100 so that the conduit 2200 can easily pass therethrough. The base guide tube 2151 extends the entire length of the base 2150 from the base wall 2155 in the axial direction.

[0188] In this embodiment, the base 2150 includes an outlet opening 2158 configured to provide a fluid connection between the base 2150 and the fluid reservoir 2101 via the outlet 2158. The outlet opening 2158 includes an arcuate opening in the base wall 2155 that extends around the center of the base wall 2155 through an arc equivalent to an angle of 150°-160°, for example, starting at 40° on one side of the guide tube 2151 and ending at 110° on the other side (both times measured from the center of the guide tube 2151). The outlet opening 2158 spans from a radius of 40% of the minor axis of the base wall 2155 to a radius of 60% of the minor axis of the base wall 2155. As described below, when the body 2130 is rotated relative to the base 2150, the outlet opening 2158 is thereby aligned with the outlet 2138.

[0189] In this embodiment, where the guide tube 2151 corresponds to the position of the outlet opening 2158, the guide tube 2151 intersects the outlet opening 2158, and the volume contained by the guide tube 2151 is therefore isolated from the rest of the outlet opening 2158 to ensure that the catheter 2200 does not inadvertently leave the guide tube 2151 during use. This results in the outlet opening 2158 being formed by the following three separate parts: two parts on either side of the guide tube 2151: a smaller part 2158a terminating at 40° from the center of the guide tube 2151 and a larger part 2158b terminating at 110° from the center of the guide tube 2151; and a third part that is the guide tube 2151 itself. In this embodiment, the outlet opening 2158 is tubular, and the edge of the outlet opening 2158 extends through the entire length of the base 2150 in the axial direction like the guide tube 2151. This helps to ensure that the wetting fluid passes through the base 2150 to effectively wet the catheter 2200.

[0190] In this embodiment, the above-mentioned groove 2157 is arcuate in a manner similar to the outlet opening 2158 and is configured to receive the pin 2127 to assist the body 2130 and the base 2150 in rotating relative to each other. The depth of the groove 2157 corresponds to the length of the pin 2137. The groove 2157 spans from a radius of 30% of the minor axis of the base wall 2155 to a radius of 55% of the minor axis of the base wall 2155. The groove 2157 covers an arc length equal to 210°-220° around the base wall 2155, starting from the edge of the guide tube 2151 corresponding to the larger portion 2158b of the outlet element 2158, and extending around the base wall 2155 away from the guide tube 2151. Therefore, the inclusion of the groove 2157 allows the body 2130 and the base 2150 to rotate relative to each other by up to 180°. In areas where both the larger portion 2158b and the groove 2157 are present, both the larger portion 2158b and the groove 2157 merge and form a continuous volume.

[0191] In this embodiment, a pair of groove protrusions 2159 are located at 30°-40° of the arc length around the base wall 2155 from the end of the groove 2157 away from the guide tube 2151. The groove protrusions 2159 narrow the width of the groove 2157 to provide resistance to the movement of the pin 2137 through the groove protrusions 2159, thereby providing audible / tactile feedback for the corresponding rotation of the body 2130 relative to the base 2150. In addition, as described above, the pin 2137 and the groove protrusions 2159 prohibit the rotation of the body 2130 relative to the base 2150, thereby helping the user to identify when the wetting mechanism 2100 is about to enter and leave the second configuration. In this embodiment, the torque required to move the pin 2137 through the groove protrusions 2159 does not exceed 0.35Nm.

[0192] In this embodiment, the base guide tube 2151, the outlet opening 2158 and the groove 2157 are all arranged so that when the main body 2130 is attached to the base 2150 and the pin 2137 is located at the end of the groove 2157 corresponding to the groove protrusion 2159, the main body guide tube 2131 corresponds to the position of the base guide tube 2151, and the outlet 2158 corresponds to the end of the larger portion 2158b of the outlet opening 2158.

[0193] In this embodiment, when the pin 2137 is located at the end of the groove 2157 away from the groove protrusion 2159, the body guide tube 2131 and the base guide tube 2151 are not aligned, and the passage of the catheter 2200 out of the base guide tube 2151 is blocked by the body wall 2135. In addition, the outlet 2158 is not aligned with the outlet opening 2158, and the sealing element 2140 prevents the wetting fluid from flowing out of the outlet 2158.

[0194] In this embodiment, the adapter 2160 is configured to provide a fluid connection between the base 2150 and the sleeve 2300, and to allow the catheter 2200 to smoothly enter the base guide tube 2151. The adapter 2160 includes an adapter wall 2165 having an outer edge 2165a that corresponds to the outer edge of the base 2150 and is configured to seal against the open end of the base 2150, as described below.

[0195] In this embodiment, the adapter wall 2165 includes a flat portion 2166 and a recessed portion 2167, which in use extends away from the base 2150. The flat portion 2166 is perpendicular to the axial direction, and the edge 2165a of the adapter wall 2165 is also in the plane defined by the flat portion 2166. The flat portion 2166 and the recessed portion 2167 are separated generally along a line connecting the common vertices of the elliptical adapter wall 2165, except that the line is smoothly arcuate so that the flat portion 2166 contains one vertex and two common vertices, while the recessed portion contains the other vertex and the center point of the adapter wall 2165.

[0196] In this embodiment, the adapter 2160 includes an adapter tube 2161 that is attached to the recessed portion 2166 and provides a passage for fluid and the conduit 2200 through the adapter 2160 via the recessed portion 2166. The adapter tube 2161 is cylindrical and open-ended, with a diameter slightly larger than the diameter of the base guide tube 2151 and 20-30%, for example 25%, of the major axis of the adapter wall 2165. The adapter tube 2161 is positioned so that the conduit 2200 can enter the base guide tube 2151 from the adapter tube 2161 and is therefore positioned between the vertex contained by the recessed portion 2167 and the center of the adapter wall 2165, for example, 80% of the way between the two vertices of the adapter wall 2165.

[0197] In this embodiment, the length of the adapter tube 2161 is 45-55%, such as 50%, of the long axis of the adapter wall 2165, and the adapter tube 2161 extends away from the flat portion 2166 from the recessed portion 2167. The recessed portion 2167 itself is recessed 20-30%, such as 25%, of the long axis of the adapter wall 2165, such that the tip of the adapter tube 2161 away from the flat portion 2166 is a distance from the flat portion equal to 65-85%, such as 75%, of the long axis of the adapter wall 2165. From where the adapter tube 2161 extends from the recessed portion 2167, the recessed portion 2167 smoothly extends back to the flat portion 2166 and is therefore slightly curved / curved due to the arcuate interface between the recessed portion 2167 and the flat portion 2166 and the curved / curved adapter tube 2161. Advantageously, this curved / curved shape facilitates the flow of the wetting fluid from the outlet opening 2158 into the adapter tube 2161, as described below.

[0198] In this embodiment, the adapter 2160 includes one larger sealing rib 2168a and two smaller sealing ribs 2168b that are configured to provide a fluid-tight seal between the base 2150 and the adapter 2160 by engaging the base 2150 and preventing the base 2150 and the adapter 2160 from separating. The larger sealing rib 2168a and the smaller sealing rib 2168b are therefore chamfered to provide a tight fit with the base 2150, as described below. The larger sealing rib 2168a extends away from the flat portion 2166 in the opposite direction from the adapter 2160 to the adapter tube 2161 by a distance equal to 10% of the major axis of the adapter wall 2165. The larger sealing rib 2168a is located just inside the edge 2165a of the adapter 2160 and extends around the adapter wall 2165 for an arc length approximately equivalent to 160°, with the vertex contained by the flat portion 2166 as the midpoint / center.

[0199] In this embodiment, the smaller sealing ribs 2168b extend from the recessed portion 2167 so that they terminate at the same position as the larger sealing ribs 2168a when measured parallel to the axial direction. Each smaller sealing rib 2168b is arcuate and covers an arc length equivalent to 30° around the adapter wall 2165. The smaller sealing ribs 2168b are positioned on each side / both sides of the vertex contained by the recessed portion 2167 and are spaced apart from each other at 60° angular intervals around the adapter wall 2165 or 40° from the corresponding edges of the larger sealing ribs 2168a.

[0200] In this embodiment, the wetting mechanism 2100 is constructed by first independently forming the different components, such as the base 2130, the sealing element 2140, and the body 2150, etc., each of which is independently formed; then coaxially arranging the cover 2110 and the inserter tip 2120 on one side of the body 2130, and coaxially arranging the base 2150 and the adapter 2160 on the other side of the body 2130, wherein the sealing element 2140 is in the channel 2139 between the body 2150 and the base 2130; and moving all the components of the wetting mechanism 2100 together in the axial direction as described below. Of course, this can be done in a variety of different ways, and the method described below is purely exemplary.

[0201] In this embodiment, the adapter 2160 is fitted onto the base 2150. To this end, the adapter tube 2161 is coaxially aligned with the base guide tube 2151 so that the adapter wall 2165 and the base wall 2155 completely overlap each other. The adapter 2160 is then moved in the axial direction toward the base 2150 so that the larger sealing rib 2168a and the smaller sealing rib 2168b are received inside the base 2150 and seal the adapter 2160 to the base 2150. Rotation of the adapter 2160 relative to the base 2150 about the axis defined by the axial direction is prohibited by the sealing ribs 2168a, 2168b that will contact the base guide tube 2151 and the outlet opening 2158 in the event of an attempted rotation. Once the sleeve is attached to the adapter as described below, the base 2150 is thereby fixed relative to the sleeve.

[0202] In this embodiment, the sealing element 2140 is then assembled into the channel 2139 of the body 2130, and the body 2130 is attached to the base 2150. To do this, the shaft 2133 is inserted into the locking hole 2156 until the locking protrusion 2136 engages the locking hole 2156, thereby fixing the body 2130 to the base 2150. In order for the shaft 2133 to be fully inserted into the locking hole 2156, the pin 2137 must be aligned with the groove 2157 so that the pin 2137 is fully received in the groove 2157.

[0203] In this embodiment, a fluid-tight seal is formed between the body 2130 and the base 2150 by rotating the body 2130 relative to the base 2150 until the outlet 2138 corresponds to a flat section of the base wall 2155 and the sealing element 2140 is able to seal the outlet 2138. In this example, this corresponds to a position where the pin 2137 presses against one end of the groove 2157 and presses against the base guide tube 2151 and the body guide tube 2131 is located on the side of the long axis of the wetting mechanism 2100 opposite the base guide tube 2151. Once sealed, the outer edges of the base 2150 and the body 2130 are completely aligned with each other, so that the exterior of the wetting mechanism 2100 is continuous and smooth. The position of the base 2150 and the body 2130 as described above defines a first configuration of the wetting mechanism 2100, in which the wetting mechanism is closed. The relative positions of the base 2150 and the body 2130 in the first configuration are Fig. 20 is best shown in Fig. 20 When the wetting mechanism 2100 is in the first configuration, the Fig.19 ) cross section.

[0204] In this embodiment, a wetting fluid can now be introduced into the body 2130 to fill the fluid reservoir 2101. In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 2200 to lubricate the hydrophilic surface. In a number 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 the catheter. In this embodiment, 12 ml of wetting fluid is placed inside the body 2130, although more or less wetting fluids may be required in a number of other embodiments.

[0205] In this embodiment, the inserter tip 2120 is then attached to the body 2130 by aligning the inserter tip 2120 with the body 2130 so that the insertion tube 2121 is aligned with the body guide tube 2131 and the sealing rib 2128 is assembled into the body 2130 to seal against the partition 2132.

[0206] In this embodiment, the cover 2110 is then added to the inserter tip 2120 so that it seals the fluid reservoir 2101 by causing the plug 2119 to seal the through hole 2129.

[0207] In this embodiment, the catheter 2200 is then arranged so that the proximal end 2201 of the catheter 2200 is just inside the adapter tube 2161. The sleeve 2300 is then arranged around the catheter 2200 and attached to the outside of the adapter tube 2161 by any suitable means to form a fluid-tight seal between the sleeve 2300 and the adapter 2160, such as by welding / fusion; mechanical sealing; heat sealing; pressure sealing; adhesives; solvent bonding; ultraviolet bonding; ultrasonic welding / fusion; laser welding / fusion; pulse welding / fusion; or friction welding / fusion.

[0208] In this embodiment, the distal end 2202 of the catheter 2200 includes a funnel 2203, and the funnel 2203 is disposed within the fluid collection bag 2400. A fluid-tight seal is provided between the funnel 2203 and the fluid collection bag 2400 to inhibit fluid leakage. A fluid-tight seal is also provided between the cannula 2300 and the funnel 2203 to ensure that fluid does not leak out of the cannula 2300.

[0209] In this embodiment, the funnel 2203 includes a bypass / shunt tube 2204 that is configured to allow liquid within the cannula 2300 to enter the fluid collection bag 2400.

[0210] refer to Figure 1 and Figure 19-25 In this embodiment, to prepare the catheter 2200 for use, the user rotates the body 2130 relative to the base 2150 to move the wetting mechanism 2100 from closed to open, that is, from its first configuration to its second configuration. To do this, the base 2150 and the body 2130 must be rotated 180° relative to each other until the pin 2137 contacts and overcomes the groove protrusion 2159 and moves all the way to the end of the groove 2157 away from the base guide tube 2151, as described below.

[0211] In this embodiment, the cover 2110 is first removed from the inserter tip 2120 by grasping and pulling the tab 2112 before rotating the base 2150 and the body 2130. This disengages the plug 2119 from the through hole 2129, which ensures that air can flow into the fluid reservoir 2101 to allow the wetting fluid to exit the fluid reservoir 2101 via the outlet 2158, as described below.

[0212] In this embodiment, the body 2130 is then rotated relative to the base 2150. The rotation is inhibited by a sealing element 2140 that is compressed between the base 2150 and the body 2130 to provide friction between the base and the body that the user must overcome. This friction is advantageous because it inhibits the accidental opening of the wetting mechanism 2100 before use. In this embodiment, the sealing element 2140 provides a friction force that requires a torque of 0.35 Nm around the edge of the wetting mechanism 2100 to overcome. Once the friction is overcome, rotation can begin, and after only 40° of rotation, the outlet 2138 becomes aligned with the smaller portion 2158a of the outlet opening 2158, thereby allowing the wetting fluid to flow out of the fluid reservoir 2101, through the base 2150, and into the cannula via the adapter 2160 and the recessed portion 2167, which directs the wetting fluid to the adapter tube 2161 and the catheter 2200. Advantageously, since the proximal end 2201 of the catheter 2200 is located in the adapter tube 2161, it is ensured that the first portion of the catheter 2200 that enters the body, i.e., the proximal end 2201, is the portion most likely to be wetted by the wetting mechanism 2100. This helps reduce the possibility of discomfort or injury during use.

[0213] In this embodiment, with further rotation of the body 2130 and the base 2150 , the outlet 2138 then becomes aligned with the base guide tube 2151 and the wetting fluid flows directly onto the proximal end 2201 of the catheter 2200 and into the cannula 2300 .

[0214] In this embodiment, further rotation aligns the outlet 2138 with the larger portion 2158b of the outlet opening 2158 and eventually causes the pin 2137 to contact the groove protrusion 2159, as described above. The user must then overcome the groove protrusion 2159 to fully open the wetting mechanism 2100 and move the wetting mechanism 2100 to the second configuration. This provides audible / tactile feedback as the pin 2137 / locking protrusion 2159 is slightly deformed by the action. The relative position of the base 2150 and the body 2130 in the second configuration is Fig.24 is best shown in Fig.24 When the wetting mechanism 2100 is in the second configuration, the Fig.19 ) cross section.

[0215] In this embodiment, the third configuration of the wetting mechanism 2100 is defined as the above position, wherein the outlet 2138 is in fluid communication with the outlet opening 2158, and the wetting mechanism 2100 is not in the second configuration. Fig. 22 is best shown in Fig. 22 When the wetting mechanism 2100 is in the third configuration, the Fig.19) cross section.

[0216] In this embodiment, once in the open state, the groove protrusion 2159 prevents rotation out of the open position, and the groove protrusion 2159 acts to retain the pin 2137 at the end of the groove 2157 away from the base guide tube 2151. The outlet 2138 is also aligned with one end of the larger portion 2158b of the outlet opening 2158 to ensure that all the wetting fluid flows out of the fluid reservoir 2101, thereby wetting the catheter 2200.

[0217] In this embodiment, in the second configuration, the main body guide tube 2131 and the base guide tube 2151 are now also fully aligned, whereas in the first and third configurations, the main body guide tube 2131 and the base guide tube 2151 are not aligned. In the second configuration, the adapter tube 2161, the base guide tube 2151, the main body guide tube 2131, and the insertion tube 2121 form a continuous inner hole for the catheter 2200 to pass through the wetting mechanism 2100. The user can now insert the insertion tube 2121 into the urethra and then gradually move the proximal end 2201 of the catheter 2200 through the wetting mechanism 2100 and into the body via the insertion tube 2121 until urine flows from the bladder through and into the fluid collection bag 2400.

[0218] 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, 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 base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, the sealing element being elastically deformed by being compressed between the base and the body and inhibiting accidental rotation of the base relative to the body.

2. The catheter assembly according to claim 1, wherein: The catheter is an intermittent male urinary catheter.

3. The catheter assembly according to claim 1 or 2, further comprising a retainer configured to limit movement of the sealing element relative to the body or the base.

4. The catheter assembly according to claim 3, wherein: The body includes a retainer configured to limit movement of the sealing element relative to the body.

5. The catheter assembly according to claim 4, wherein: The retainer is a sealing channel provided in the body, and the sealing element is provided in the sealing channel.

6. A catheter assembly according to any one of the preceding claims, wherein: The body and the base are formed of a more rigid material than the sealing element.

7. A catheter assembly according to any one of the preceding claims, wherein: The sealing element is formed of a different material than the body and the base.

8. A catheter assembly according to any one of the preceding claims, wherein: The sealing element, the body and the base are each independently formed.

9. A catheter assembly according to any one of the preceding claims, wherein: The sealing element is compressed in an axial direction perpendicular to a plane in which the body and the base rotate relative to each other.

10. The catheter assembly according to claim 9, wherein: The sealing element is compressed in the axial direction by no more than 10%.

11. A catheter assembly according to any one of the preceding claims, wherein: The body includes a shaft configured to allow the body and the base to rotate relative to each other, the shaft including at least one locking protrusion configured to engage the base and urge the body into the base to compress the sealing element.

12. A catheter assembly according to any one of the preceding claims, wherein: The sealing element is configured to provide a friction force to inhibit rotation of the base relative to the body.

13. The catheter assembly of claim 12, wherein: The sealing element provides a frictional force between the base and the body equivalent to a torque of no more than 0.35 Nm about the center of rotation of the base relative to the body.

14. A method of manufacturing a catheter assembly, the method comprising: A catheter and a wetting mechanism are provided, the catheter comprising a distal end and a proximal end for insertion into a body, wherein the wetting mechanism comprises a base and a body, the body comprising a fluid reservoir, the base and the body being rotatable relative to each other to define a first configuration and a second configuration of the wetting mechanism, wherein the fluid reservoir comprises an opening, the opening being configured to allow fluid to leave the fluid reservoir to wet the catheter when the wetting mechanism is in the second configuration, the fluid reservoir comprising a sealing element, the sealing element being configured to provide a fluid-tight seal between the opening and the base when the wetting mechanism is in the first configuration, the sealing element being elastically deformed by being compressed between the base and the body and inhibiting accidental rotation of the base relative to the body.

15. The method of claim 14, further comprising forming the sealing element, the base, and the body independently of one another.

16. The method of claim 14 or 15, further comprising attaching the body to the base, wherein the sealing element is located between the body and the base.

17. The method of claim 16, comprising providing a retainer and fitting the sealing element into the retainer such that the retainer restricts movement of the sealing element relative to the opening.

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