Intermittent catheter

Abstract

A catheter device (10) is described in which a sealed container (14) of wetting agent (16) is provided in a housing cap (24). The sealed container is pierced with a piercing member (18) so that the wetting agent is directed towards the catheter (22). The wetting agent is directed around the handling surface of the catheter to the catheter tube (28).

Description

Technical Field

[0001] This invention relates to an intermittent catheter (e.g., a urinary catheter). Background Technology

[0002] A catheter is a medical device comprising a hollow catheter body designed for insertion into a tube, vessel, channel, or body cavity to allow injection, drainage, or aspiration of fluids or substances, or to ensure that said tube, vessel, channel, etc., remains open. A urinary catheter is designed for insertion through the urethra into a user's bladder to empty it.

[0003] To maximize comfort and minimize the risk of trauma and / or infection, the outer surface of the catheter body is typically wetted with a wetting agent before insertion by the user. In further developments, the catheter body itself includes, is integrated with, or is coated with a hydrophilic component (e.g., a hydrophilic polymer) to further reduce friction when the wetting agent is applied.

[0004] Some catheters are supplied pre-wetted in the packaging; for example, the catheter is at least partially immersed in a wetting agent included in the packaging. While this ensures the catheter body is adequately wetted before use, a disadvantage of this arrangement is that catheter components other than the catheter body, such as clamping elements or funnel-shaped parts, may also become wetted. This negatively impacts the user experience, making it difficult to hold and guide the catheter body as needed. This is particularly problematic when users are performing self-insertion. Furthermore, having a pre-wetted catheter can actually reduce its shelf life due to the prolonged exposure of its components to moisture.

[0005] Therefore, it is advantageous to provide a catheter that can be moistened during or just before use.

[0006] In attempts to address this problem, some catheters are provided in packaging that includes a ruptureable container or pouch within the packaging, which the user can break to release the wetting agent. Typically, this involves the user squeezing the packaging to rupture the container / pouch. However, this arrangement encounters similar problems to those discussed above, where the wetting agent is allowed to come into contact with other parts of the catheter. This arrangement also results in the catheter body potentially not being fully wetted before use, or not being wetted at all. This can be harmful to the user.

[0007] Therefore, it is advantageous to provide a catheter that includes a mechanism that supplies wetting agent only to the catheter body to improve the user experience.

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

[0009] However, due to packaging limitations, the amount of wetting agent that can be contained in such a wetting device is very low, so there is still a possibility that the tubing body cannot be completely wetted in the solution, especially when the tubing is nearing the end of its shelf life and some of the solution may have evaporated.

[0010] Regarding the mechanism of wetting the catheter body from the distal end, insufficient volume of wetting agent may result in the tip not being wetted at all, which is undesirable because the tip will be introduced into the urethra first. Therefore, if it is not adequately wetted before use, it is most likely to cause injury.

[0011] In addition, the regulatory body approves the minimum length required for the catheter and wants to ensure that this length is wetted while minimizing the impact on packaging size.

[0012] The purpose of one or more embodiments of the present invention is to overcome or at least partially mitigate one or more problems of the prior art and / or to provide an improved intermittent catheter. Summary of the Invention

[0013] The present invention provides a catheter assembly according to the appended claims.

[0014] A key aspect of the present invention provides a catheter assembly comprising: a cap containing a wetting agent; and at least one puncture member configured to puncture a sealed container and guide the wetting agent into the catheter body.

[0015] The catheter assembly may include an outer housing. The outer housing may include a cap. The cap may include a sealed container for a wetting agent. The cap may be configured to move from a first position to a second position. The catheter assembly may also include a catheter containing a catheter body. A puncture member may be configured to puncture the sealed container in the second position and guide the wetting agent into the catheter body.

[0016] Therefore, one aspect of the present invention provides a catheter assembly comprising: an outer housing including a cap containing a sealed container of a wetting agent, wherein the cap is configured to move from a first position to a second position; the catheter assembly further comprising at least one puncture member; and a catheter comprising a catheter body, wherein the puncture member is configured to puncture the sealed container in the second position and guide the wetting agent to the catheter body.

[0017] Providing a sealing container within the cap offers a convenient location for the sealing container, facilitates loading during device assembly, and provides ample space for the required liquid volume. Furthermore, by incorporating puncture movement into the removal process, providing a sealing container within the cap allows the sealing container to be punctured during cap removal.

[0018] Another key aspect of the invention provides a catheter assembly comprising: a cap containing a wetting agent; and a catheter having a catheter body and an outlet end; the catheter assembly includes at least one fluid channel configured to guide the wetting agent to an outer surface of the catheter body, bypassing an external manipulation surface of the catheter outlet end.

[0019] The catheter assembly may include an outer housing. The outer housing may include a cap. The cap may contain a sealed container of wetting agent. The catheter assembly may include a puncture member. The cap may be configured to move from a first position to a second position. The outlet end may have an external operating surface and an internal main flow channel.

[0020] Therefore, in another aspect, the present invention can provide a catheter assembly comprising: an outer housing including a cap containing a sealed container of a wetting agent; and a puncture member wherein the cap is configured to move from a first position to a second position; the catheter assembly further comprising: a catheter including a catheter body and an outlet end having an external operating surface and an internal main flow channel; and at least one fluid channel configured to guide the wetting agent to an outer surface of the catheter body around the external operating surface of the outlet end.

[0021] Providing at least one fluid channel around the external manipulator surface that bypasses the catheter outlet end prevents the manipulator surface from becoming wet when the catheter is ready for use. This improves the user experience and allows the manipulator surface to remain grippy.

[0022] Optional features for the above aspects are now provided. It should be understood that, except in cases of mutual exclusion, optional features can be applied to any aspect in any possible combination.

[0023] In addition, the catheter assembly may include any combination of the features described above, for example, it may include at least one puncture member configured to puncture a sealed container and guide the wetting agent to the catheter body; and at least one fluid channel configured to guide the wetting agent to the outer surface of the catheter body around an external manipulating surface at the outlet end.

[0024] The catheter can be a female intermittent catheter. The catheter length can range from 9 cm to 20 cm; it can have a length from 120 mm to 200 mm; it can have a length from 10 cm to 15 cm, or for example, from 140 mm to 155 mm. The catheter assembly can have a length from 10 cm to 25 cm; it can have a length from 11 cm to 16 cm, for example, from 150 mm to 165 mm.

[0025] The catheter can be functionalized. For example, it may include a hydrophilic component (e.g., a hydrophilic polymer), or be integrated / integrated with or coated with a hydrophilic component. The hydrophilic component is used to further reduce friction when a wetting agent is applied. At least the outer surface of the catheter body can be functionalized, for example, by providing a hydrophilic component on at least the outer surface of the catheter body (which comes into contact with the urethra during use).

[0026] The outer housing may also include a body in which the conduit body is at least partially disposed. The cap may be detachably attached to the body.

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

[0028] The puncture component may also include one or more fluid channels for bypassing the catheter outlet, allowing wetting agent to be directed to the outer surface of the catheter body. In some embodiments disclosed herein, the one or more fluid channels may be referred to as bypass channels. The catheter outlet may include an external operating surface operated by a user for removing the catheter from the housing and for inserting the catheter during use. The fluid channels may bypass the external operating surface.

[0029] The puncture component may include one or more needles extending posteriorly (i.e., distally) from the catheter outlet and located at the distal end relative to the catheter. The one or more needles may include a fluid passage (partial or complete). The needles may be hollow and include a through-channel that, upon puncture, extends from a sealed container to an outlet located distal to the catheter tip, thereby guiding a wetting agent to the outer surface of the catheter body.

[0030] The one or more fluid channels may be arranged radially outside the longitudinal axis of the main flow channel. Therefore, the main flow channel is typically radially inside the wetting agent fluid channel, such that the wetting agent is directed radially outside the main flow channel in the axial extension direction.

[0031] The catheter may include one or more fluid channels (e.g., a portion of one or more fluid channels). The catheter may include an outlet body. The outlet body may be coupled to the end of the catheter body. The outlet body may include an external manipulating surface of the catheter. The outlet body may include at least a portion of a main flow channel (for the passage of urine). The outlet body may include one or more flow-enhancing features to facilitate flow from the catheter body. For example, the one or more flow-enhancing features may include a funnel-shaped portion.

[0032] A portion of the one or more fluid channels may be provided by a conduit. The one or more fluid channels may be integrally formed in the conduit. The one or more fluid channels may be integrally formed in the outlet body of the conduit. The one or more fluid channels may be located radially inside the external operating surface.

[0033] The housing, or optionally the body, may include the one or more fluid channels. Thus, a portion of the housing may include one or more fluid channels that receive a flow of wetting fluid from a sealed container to guide the wetting fluid to the outer surface of the conduit.

[0034] The one or more fluid passages may be provided by and / or in fluid communication with the one or more puncture members. A puncture member may provide a portion of the fluid passage. The fluid passage may include one or more puncture members, a flow path provided by the catheter outlet body, and a housing. Therefore, the fluid passage may include a first portion provided by the puncture member and a second portion provided by the housing and / or the catheter.

[0035] The one or more puncture components and / or fluid channels may be tubular. The tubular wall may be provided by the walls of the housing and / or the conduit.

[0036] The puncture member and the housing and / or catheter can be slidably engaged with each other to provide the fluid passage. Thus, the puncture member may include an outlet portion, such as a nozzle, which is slidably received within a corresponding fluid passage portion of the catheter or housing.

[0037] The catheter assembly may further include a sheath arranged around the catheter body. The sheath may be a flexible, retractable sheath. The sheath may provide a connection for retaining a retractable insertion guide disposed at the catheter insertion end. The sheath may provide a seal for maintaining the sterility of the catheter during insertion and / or for directing wetting fluid to the outer surface of the catheter body. A fluid channel may be configured to guide wetting agent into a volume defined by the sheath.

[0038] The cap can be removable. Therefore, the cap can be completely separated from the body that houses the catheter. Removing the cap allows for easier access to the proximal end of the catheter, which is held by the user during insertion.

[0039] The lid can be configured to retain a sealed container when the lid is removed. Therefore, the sealed container can be securely attached to the lid.

[0040] The sealed container and / or cap may be configured to retain the puncture member when in the second position, such that the puncture member can be removed together with the cap. The puncture member may mate with a puncture portion of the sealed container. The puncture portion may be configured to clamp the puncture member upon puncture.

[0041] The cap may be configured to move toward the puncture member when the cap is moved from a first position to a second position. This movement may include axial movement along the longitudinal axis of the catheter and / or housing.

[0042] The movement of the cover can be guided by a guide. The guide can be provided by a slide on one or the other of the housing and the cover, which slidably receives and guides a protrusion, such as a pin, formed on the other of the cover or housing. For example, the outer surface of the housing body may include a slide, and the inner surface of the cover includes a pin received within the slide, or vice versa.

[0043] The slide can provide a snap-fit ​​structure, which includes: a first part configured to guide the cover from a first position to a second position; and optionally move from the second position to a third position, in which the cover is removed.

[0044] The slide may include a second portion; the second portion may be configured to guide the cover from a second position to a third position. The third position may correspond to the removal of the cover.

[0045] The slide may include a third portion; the third portion connects the first and second portions, wherein the third portion is configured to be passed through when the cover is rotated relative to the body.

[0046] The puncture component can be axially positioned by the catheter. The puncture component can be axially restricted by the catheter in the proximal direction, but not axially restricted in the distal direction.

[0047] In another aspect, the present invention provides a method for preparing a catheter for use. The catheter can be any catheter disclosed herein. The method may include: moving a cap of the catheter housing from a first position to a second position to puncture a sealed container of wetting agent with a puncture member; and guiding the wetting agent from the punctured sealed container to an outer surface of the catheter body. Guiding the wetting agent from the sealed container to the outer surface of the catheter body may include bypassing an external manipulating surface of the catheter. The puncture member may guide the wetting agent from the punctured sealed container to the catheter body. The method may further include removing the cap after wetting the catheter body, wherein removing the cap includes removing the sealed container and, optionally, the puncture member together with the cap. Attached Figure Description

[0048] To better understand the present invention, one or more embodiments of the invention will now be described by way of example only, with reference to the accompanying drawings, in which:

[0049] Figure 1 A longitudinal cross-sectional view of the catheter assembly according to the present invention is provided;

[0050] Figure 2a and 2b It shows that it can be formed as Figure 1 A perspective view and longitudinal cross-sectional view of a portion of the catheter assembly;

[0051] Figure 3 A perspective view of the distal end of the housing body is shown; and

[0052] Figures 4a to 4c The stage of preparing the catheter for use is shown, particularly the stage of wetting the catheter body with a wetting agent contained in a sealed container. Detailed Implementation

[0053] In the following description, the terms "distal" and "proximal" are relative to the insertion end of the catheter. Therefore, "proximal end of catheter" refers to the insertion end of the catheter, while "distal end" refers to the end held by the user for insertion. The terms "anterior" and "rearward" are relative to the proximal end being forward and the distal end being backward. Unless otherwise stated, axial and radial refer to the longitudinal axis of the catheter.

[0054] This disclosure provides a catheter assembly. The catheter assembly includes an outer housing, a sealed container containing a wetting agent, and a puncture member for puncturing the sealed container. Puncture of the sealed container releases the wetting agent. Once released, the wetting agent is directed to a catheter housed within the outer housing to lubricate the catheter for use.

[0055] exist Figure 1 An embodiment of the catheter assembly can be seen in the image, which will be described in detail below.

[0056] The puncture member can face rearward and be positioned distally relative to the catheter so as to protrude from the catheter's tip. The sealing container is movable relative to the puncture member. Therefore, the puncture member can be fixedly mounted relative to the catheter, with the sealing container configured to move toward the puncture member during the wetting phase. Relative movement of the puncture member and the sealing container is possible when the outer housing is opened to expose the catheter for use.

[0057] In some embodiments, the sealing container may be located in a first portion of the outer housing, which is separate from and movable relative to a second portion of the outer housing. The first portion of the outer housing may be a cap of the outer housing. The second portion of the outer housing may be the body of the outer housing, to which the cap is detachably attached before (and possibly after) use. Removal of the cap by the user results in the necessary relative movement between the sealing container and the puncture member. The removal of the cap may be defined by a puncture phase, a wetting phase, and a removal phase, in which the sealing container is punctured, in which a wetting agent is directed to the outside of the catheter, and in which the cap is removed, allowing the catheter to be removed in preparation for use.

[0058] In one embodiment, the cap can be displaced from a first pre-use / sealed position toward the body before removal. The cap can be sequentially displaced from the first sealing position to a second puncture position, and then to a third removal position. The transition between the first and second positions, and between the second and third positions, may include movement along and / or about an actuation axis. The actuation axis may be aligned with the longitudinal axis of the catheter and may define a puncture direction in which the puncture member is configured to puncture the sealed container. Displacement between the first and second positions may correspond to a puncture phase, the second position may provide a wetting phase, and displacement between the second and third positions may correspond to a removal phase.

[0059] exist Figures 4a to 4c An embodiment of an exemplary catheter assembly undergoing a puncture phase, a wetting phase, and a removal phase is shown, which will be described in detail below.

[0060] The displacement of the cap is typically done manually, but can also be achieved with the aid of one or more mechanical guides that guide the movement of the cap relative to the body during all or any of the puncture, wetting, and removal phases. The mechanical guides may include, for example, a threaded or bayonet engagement between the cap and the body of the outer housing. Thus, the cap can be screwed toward the body to puncture the sealed container before removal. Alternatively, the cap can be pushed toward the body during the puncture phase to puncture the sealed container before being pulled away from the body during the removal phase. The actuation path may also include one or more intermediate steps, such as a torsion or rotation phase, to transition between the puncture and removal phases. The intermediate steps may or may not include a wetting phase, which may occur during or immediately after the puncture phase.

[0061] The mechanical guide may include one or more features in the form of channels, grooves, ridges, threads, etc., which can be used to reliably guide the travel path of the cover relative to the body under manual actuation of the cover.

[0062] Below Figures 4a to 4cAn embodiment of the outer housing cover is shown, which will be described in detail below.

[0063] When in a sealed or pre-use state, the cap can be detachably attached to the body in a manner that allows axial displacement, enabling the cap to move toward the body for puncture, while the internal volume of the outer housing remains substantially sealed. Therefore, the outer housing can be sealed before use and after the puncture and wetting stages. Thus, when the movement of the cap toward the body causes displacement of the puncture member toward the sealed container and release of the wetting agent, the wetting agent remains sealed within the outer housing, allowing the catheter to be wetted without leakage of the wetting agent. The wetting agent can be retained within the outer housing or discharged after the cap is removed.

[0064] The puncture device or sealing container can be positioned at the furthest point relative to the insertion end of the catheter.

[0065] During the puncture or removal phase, the sealed container and the puncture member can be removed together with the cap. For example, after the puncture phase, the puncture member can remain inside the sealed container. Therefore, once the puncture member has punctured the sealed container, the sealed container and the puncture member become one, so that movement of the sealed container causes the puncture member to move as well.

[0066] Before use, the puncture member can be attached to the body of the outer casing or the distal end of the catheter. This attachment allows the puncture member to move axially away from the catheter during the puncture phase, but prevents movement toward the catheter. Therefore, movement of the puncture member away from the sealed container and cap during the puncture phase is prevented, and the puncture member can be freely removed from the catheter during the removal phase.

[0067] The puncture member and / or catheter may include one or more flow-guiding features configured to guide the flow of wetting agent to the catheter during the wetting phase. The flow-guiding features may include one or more pathways arranged in flow communication with and providing a flow path to the internal volume of a sealed container storing the wetting agent. These pathways may be provided by a tubular structure, tube, channel, or groove between the internal volume of the sealed container and the catheter. The one or more pathways may be provided by a wetting agent fluid channel or flow channel, or referred to herein as a wetting agent fluid channel or flow channel.

[0068] A fluid passage can bypass the outlet of the main catheter body, thus providing a pathway from the distal end of the catheter to the outer surface of the catheter body, which provides sliding contact with the urethra during insertion. This bypass flow path may be referred to as a bypass flow path.

[0069] The conduit may include an external manipulator surface. The external manipulator surface may be located at the distal end of the conduit and provided by the conduit's outlet body. The fluid passage may bypass the external manipulator surface, preventing it from contacting the wetting agent.

[0070] The outer surface of the catheter can be located in a wetting zone, which exists between the inner wall of the outer shell and the outer surface of the catheter body.

[0071] The flow path may include a puncture member and a catheter. The puncture member and the catheter may include one or more flow tandem passages extending between a sealed container and a wetting area of ​​the catheter located within an outer housing. The wetting area may be defined by an inner surface of the outer housing or a sheath surrounding a portion of the catheter.

[0072] The sheath can be a retractable sheath. A retractable sheath can be configured to retract during catheter insertion, providing a temporary closure around the catheter body prior to insertion to aid in the wetting phase. The sheath can also provide restraint for a retractable insertion guide positioned proximal to the insertion end of the catheter and used to position the catheter body at the urethral inlet.

[0073] The catheter may include an outlet at its distal end. The outlet may include one or more shaped structures to facilitate urine flow during use, such as a funnel-shaped structure diverging along the flow direction. The catheter outlet may include one or more passages that provide a flow path for guiding flow from the sealed container to the catheter body during the wetting phase. The one or more catheter flow path passages may include an inlet and an outlet, with a channel between them. This channel may be defined by a passage wall that is part of or within the wall of the catheter outlet.

[0074] The catheter outlet may include at least one main flow channel along which urine flows during use. The main flow channel extends from the catheter inlet at the insertion end to the catheter outlet at the distal end. Therefore, the main flow channel is provided by the catheter body and is located within the catheter body. A wetting flow path extends from the catheter outlet to the outside of the catheter body. The main flow channel and the wetting fluid channel may be provided together with the catheter outlet body. Both the fluid channel and the main flow channel may extend axially along the length of the catheter. The wetting fluid channel may be radially outside the main flow channel.

[0075] The puncture component may include one or more needles extending from the catheter outlet to the sealing container. The one or more needles may be defined by a puncture end that penetrates the sealing container and a fixed end that attaches the needle to the body of the puncture component. The needles may be hollow to provide a portion of the one or more passages that constitute a wetting flow path between the sealing container and the catheter outlet. In the case of multiple needles, the needles may be arranged on radially opposite sides of the longitudinal axis of the catheter. There may be one, two, three, or more needles and associated flow paths.

[0076] The puncture component may include one or more outlet tubes. The puncture component outlet tube may be attached to and / or slidably received within the catheter outlet. The puncture component outlet tube may be retractably and slidably received within a corresponding passage of the catheter. The corresponding passage may form a portion of the one or more passages that guides wetting fluid from a sealed container to the catheter.

[0077] Figure 1 A longitudinal section of the catheter assembly 10 is shown. The catheter assembly 10 includes an outer housing 12, a sealed container 14 containing a wetting agent 16, and a puncture member 18 for puncturing the sealed container 14. Puncture of the sealed container 14 releases the wetting agent 16. Once released, the wetting agent 16 is directed to a catheter 22 housed within the outer housing 12 to lubricate the catheter 22 for use.

[0078] The outer housing includes a cover 24. Figure 1 In the illustrated embodiment, the cap 24 is shown as a sealed container 14 containing the wetting agent 16. The cap 24 may be configured to be able to open from a first sealed position (an example of which may be...) Figure 4a (See in) Move to the second puncture position (an example of which can be found in) Figure 4b (See in the image). The puncture member 18 is configured to puncture the sealed container and guide the wetting agent to the outer surface of the catheter body 28 when in the second position.

[0079] The wetting agent 16 can be any suitable fluid used to lubricate the conduit body 28, such as water.

[0080] The outer housing 12 (which may be referred to as the housing for convenience) includes a body 30 and a cover 24, a portion of which is housed. The cover 24 is removable so that it can be removed by the user before use, allowing the conduit 22 to be removed from the housing 12.

[0081] The housing 12 provides an enclosed space in which the conduit 22 can be housed for storage and transport prior to use. The housing 12 is generally elongated and has a longitudinal axis 32 arranged coaxially with the longitudinal axis of the conduit body 28. This enclosed space is defined by an outer wall of the housing 12 extending from a first proximal end of the insertion end 34 of the receiving conduit 22 to a second distal end of the receiving conduit outlet end 36. In the illustrated embodiment, the second end is provided by a cap 24. Therefore, removal of the cap 24 exposes the outlet end 36 of the conduit 22, allowing the user to grasp the conduit 22 and remove it from the housing 12 for use.

[0082] The outer contour of the housing 12 can be any contour required for aesthetic or practical purposes, and in the example shown, it is generally cylindrical, for example, tapering towards the first end to facilitate insertion into a storage container or bag, and tapering towards the second end along the length of the cap 24.

[0083] The cover 24 includes a generally cylindrical sash with an end opening, having a circumferential outer wall extending coaxially along a longitudinal axis 32, and a radially extending axial end wall providing closed ends at the ends of the cover 24 and the housing 22. The cover 24 mates with the distal end of the body 30 of the housing 12 such that the body is received within the open end of the cover 24. However, it should be understood that in some embodiments, the cover 24 may be received within the open end of the body.

[0084] The cover 24 is movable relative to the main body 30. When in such a position... Figure 1 In the first position shown, the cap 24 is axially displaced from the body 30, allowing the cap 24 and the body 30 to move toward each other. This movement of the cap 24 toward the body 30 causes the puncture member 18 to move rearward and puncture the sealed container 14, thereby releasing the wetting agent 16 for guidance to the outside of the catheter body 28.

[0085] When in the first position, housing 12 provides a sealed enclosure that prevents fluid ingress and maintains a sterile environment for catheter 22. Furthermore, the engagement of cap 24 with body 30 ensures that housing 12 remains sealed when cap 24 is moved to the second position, sufficient to retain wetting agent within housing 12.

[0086] The attachment between the cover and the body can be provided by any suitable connection, such as a push-fit, screw-on cover, or bayonet attachment. See below. Figure 3 An embodiment of the cover attachment is described in more detail.

[0087] In order to remove the cover 24, the cover 24 is as follows Figure 1The first storage position shown is shifted toward the body 30. The movement of the cap 24 can be along a puncture or actuation axis that coincides with the longitudinal axis 32 of the housing 12 and / or the catheter body 22. Thus, the cap 24 and the body 30 are configured to move axially toward or away from each other during the wetting process.

[0088] The sealing container 14 is provided in the form of a capsule, located within the cap 24, adjacent to and optionally abutting / adjacent to the axial end wall of the cap 24. This prevents the sealing container 14 from moving rearward / distally away from the insertion end 34 and maintains a fixed relationship with the cap 24, allowing the sealing container 14 to be punctured by the piercing member 28 when the cap 24 and the body 30 move toward each other / together. The sealing container 14 may be friction-fitted or adhered to the cap 24, or connected in some other way. Securely attaching the sealing container 14 to the cap 24 allows the sealing container 14 to remain within the cap 24 when the cap 24 is removed from the body 30.

[0089] The sealed container 14 includes one or more outer walls defining a closed volume in which the wetting agent 16 can be sealed to prevent leakage before being punctured by the puncture member 18. The sealed container 14 may include a puncture portion 38 for puncture by the puncture member 18 in use. Figure 1 In the illustrated embodiment, the puncture portion 38 is provided by the sealing container 14 to the axial end wall of the insertion end 34 of the catheter along the puncture axis 32. Therefore, when the cap 24 and the body 30 move toward each other, the puncture portion 38 is located in the path of the rearward-facing puncture member 18.

[0090] The puncture member 18 is located near the sealed container 14, and its movement relative to the cap 24 is stationary as the cap 24 travels along the puncture axis 32. Therefore, as the cap 24 moves along the puncture axis 32, the puncture member 18 and the sealed container 14 move toward each other to provide puncture movement.

[0091] Figure 1 The puncture member 18 shown is positioned near and distal to the outlet end of the catheter body 28, providing a posteriorly facing projection. The puncture member 18 may include one or more needles 18a, 18b extending distally toward the sealing container 14 from the outlet end of the catheter body 28. The needles 18a, 18b may be supported by the puncture member body 18c and extend from the puncture member body 18c to a distal portion facing the puncture portion 38. The distal portion may be suitably shaped to allow for puncture action. For example, the distal portion may be pointed and / or sharp to provide a puncture / cutting edge.

[0092] The piercing member 18 is constrained to not move in the first direction, but may be movable in the second direction. Therefore, during the piercing phase, the piercing member 18 can be constrained so that it resists movement of the sealed container 14 as the piercing member 18 is advanced. Thus, when a suitable force is applied, the piercing member 18 can pierce the piercing portion 38. The piercing member 18 is movable in the second direction such that after piercing the sealed container 14, the piercing member 18 can be held by the sealed container 14 so that when the cap 24 and the body 30 separate, the piercing member 18 is removed together with the cap 24. Retention of the piercing member 18 can be achieved by the piercing portion 38 being made of a suitable elastic material, such as one that can frictionally clamp the piercing member 18. It should be understood that in some embodiments, the piercing member can be removed separately from the cap 24.

[0093] Despite Figure 1 Although not explicitly shown, the puncture member 18 may be a separate component inserted into the housing 12 during the assembly of the catheter assembly 10. Therefore, the puncture member 18 may be a separate component, rather than a component integrally formed with the housing or catheter. As will be understood from the description herein, inserting the puncture member 18 into the housing may include inserting it into or otherwise attaching it to the catheter 22, or, in some embodiments, attaching it directly to the housing.

[0094] The puncture member 18 may be formed of a material different from that of the housing 12 and the cap 24; for example, metal (e.g., steel, such as surgical steel) may be more suitable for the puncture member, while plastic (e.g., thermoplastic, such as polypropylene, or alternatively such as polycarbonate, polyethylene or nylon) may be more suitable for the housing 12 and the cap 24.

[0095] The puncture member 18 includes a body 18c, which may be in the form of a plate-shaped member or a flange located in the normal plane of the longitudinal axis 32. Puncture protrusions, such as needles 18a and 18b, extend parallel to the puncture axis 32 from the distal side of the puncture member body 18c. The proximal side of the puncture member body 18c provides positioning features that may abut a corresponding surface of the housing or catheter 22, such as the distal end of the catheter outlet, thereby defining the axial position of the puncture member 18 within the housing 12.

[0096] The puncture member 18 may include one or more passages, i.e., fluid channels, for guiding the wetting agent 16 from the sealed container 14 to the outer surface of the catheter body 28. For example... Figure 1 , 2aAs shown in Figure 2b, the fluid channels may be partially provided by the needles 18a, 18b. Therefore, the needles 18a, 18b, or each of the needles 18a, 18b, may be hollow to include an internal flow channel that provides a flow path from the interior of the sealed container 14 to the exterior of the sealed container 14 and towards the exterior of the conduit body 28. The fluid channels may have an inlet located within the sealed container 14 when it is punctured, and an outlet in fluid communication with the outer surface of the conduit body 28. This fluid channel outlet, or each fluid channel outlet, may be located within the body 30 of the housing 12, and within the retractable sheath 40 when the retractable sheath 40 surrounding the conduit body 28 is present. By providing two fluid channels, one of the channels can serve as a ventilation channel. Thus, the wetting agent 16 can flow through both fluid channels, or the wetting agent can flow through one channel while gas (e.g., air) from within the housing 12 flows through the other channel to displace the wetting agent. Alternatively, a separate ventilation channel can be provided, or it can operate without a ventilation channel, for example, by pushing and twisting the cap to puncture and force water out of the capsule. The water released from the capsule will be replaced in the cap by air from the sealing shell, which flows upward through a conduit into the lumen. The air then escapes to the outside.

[0097] The wetting fluid flow path may be provided entirely by one or more needles 18a, 18b, or may include multiple segments provided by different parts of the conduit assembly. Thus, for example, as... Figure 1 , 2a As shown in embodiments 2b, the fluid channels constituting the wetting fluid flow path can be provided by one or more of the puncture member 18 and the conduit 22.

[0098] Optionally, the puncture member 18 may include one or more protrusions extending from the proximal side of the puncture member body 18c. The one or more protrusions may be in the form of pins and may include portions of a fluid passage for guiding the wetting agent 16 from the sealed container 14 to the catheter 22. The protrusions may also provide additional positioning features for axially and angularly positioning the puncture member 18 within the catheter 22.

[0099] like Figure 4c As shown, the protrusions can be provided in the form of outlet pipes 18d, 18e or nozzles, the outlet pipes being extensions of the flow channels provided by the needles 18a, 18b. The outlet pipes 18d, 18e can be received by corresponding portions of the conduit 22, as described below. Figure 2a and 2b An example is provided for the shell wall (not shown) of the main body 30.

[0100] Figure 2a and 2b An embodiment of catheter 222 is shown. Figure 2aA perspective view of catheter 222 is shown. Figure 2b A longitudinal section taken along longitudinal axis 332 is shown. Catheter 222 includes a catheter body 228 that can be inserted into a patient's urethra, thereby entering the bladder and providing a primary fluid pathway for urine expulsion. Catheter body 228 includes a first end 234, which may be referred to as the insertion end, and a second end 236, which may be referred to as the outlet end. The primary fluid pathway of catheter 222 is provided by a fluid channel / passage defined by a wall of catheter body 228 extending longitudinally between the first end 234 and the second end 236. The cross-section of catheter body 228 is generally circular to provide a cylindrical catheter body 228, but other shapes are also possible. The longitudinal axis 332 of catheter body 228 defines the primary longitudinal axis of catheter 322.

[0101] The second outlet end 236 of catheter 222 may include a catheter outlet body 242. The catheter outlet body 242 includes an outer surface that is formed to provide a handle / operation part for the user to grip during use, in the process of inserting catheter 222 into outer housing 22 and the patient, and in the process of removing catheter 222 from housing 22 and the patient. Therefore, the outer surface may be an external manipulation surface.

[0102] The inner surface of the catheter outlet body 242 provides the end of the main fluid channel and includes a funnel-shaped structure for assisting or guiding the flow of urine. Therefore, as... Figure 1 As shown, the outlet end 236 of the conduit body 228 may include a flared portion in which the inner diameter of the conduit body 228 diverges along the flow direction to provide a funnel-shaped structure. It should be understood that in some embodiments, the end of the main fluid channel may vary and may not be funnel-shaped.

[0103] The insertion end 234 of the catheter body 228 includes an inlet for receiving urine flow into the main fluid passage of the catheter body 228 for delivery to the outlet end 236 of the catheter body. The inlet may be provided by one or more holes in the catheter body wall. The inlet is not shown in the figure, but inlets are well known in the art. The distal end of the catheter may also have a rounded profile (or a bullnose-shaped structure) to facilitate insertion and patient comfort.

[0104] from Figure 2a and 2b As can be most clearly seen, the outlet end 236 may include one or more passages 244a, 244b, which may receive corresponding portions of the puncture member 18, for example... Figure 4c The outlet pipes 18d and 18e are shown. The one or more passages 244a and 244b can provide fluid channels for guiding the wetting agent 16 from the sealed container 14 to the outside of the conduit body 228. Therefore, as... Figure 2bAs shown, the wetting agent fluid passage is provided by a tubular member extending from an inlet end located at the end of the conduit outlet body 242 to an outlet end located radially outward of the conduit body 228. The conduit outlet body 242 is configured to receive fluid from the sealed container 14. Thus, as the wetting agent fluid flows from the sealed container 14 along the passage, it flows out onto the outer surface of the conduit body 228, as indicated by arrow 246. It should be understood that passage 244a can provide a similar fluid path.

[0105] As can be seen, the wetting fluid channels 244a and 244b are radially outside the main fluid channel provided by the conduit body 228 and bypass the outlet of the main fluid channel. Therefore, the wetting fluid channels 244a and 224b can be referred to as bypass channels. More generally, the bypass channel may include a first end that is open / unopened on the distal side of the conduit outlet and terminates on the proximal side of the conduit outlet, thereby bypassing the main flow path outlet and the external operating surface and extending from the outlet side to the outside of the conduit body.

[0106] Back Figure 1 An optional catheter insertion guide 48 is shown, which the user can use to position the insertion end 34 at the urethral inlet. The insertion guide 48 (which may be referred to as a gripping portion) may be an annular member located radially outward of the catheter body 38. The radially outer surface is configured to be gripped by the user's fingers and may include one or more surface features, such as... Figure 1 , 2a The annular groove shown in 2b is designed to improve grip and user flexibility. The insertion guide 48 is generally elongated, with its longitudinal axis coaxial with the longitudinal axis 32 of the catheter body 38.

[0107] The insertion guide 48 is configured to remain outside the urethra when the catheter body 38 is inserted, and is therefore retractable. Thus, the catheter body 38 can pass through the insertion guide 48, allowing the insertion guide 48 to move posteriorly toward the outlet end during insertion. When fully retracted, the insertion guide can abut against the proximal end of the catheter outlet body 42.

[0108] Figure 1 , 2a Figure 2b also shows an optional retractable sheath 40 located radially outside the catheter body 38. The sheath 40 extends from an attachment on the catheter outlet body 42 to an attachment on the insertion guide 48, providing a closed space therein for the catheter body 28. The sheath 40 is flexible and retracts with the insertion guide 48. Therefore, when the insertion guide 48 is in the pre-insertion position, the sheath 40 is in an extended, deployed state (e.g., Figure 1(As shown), and when the positioning aid is in the retracted post-insertion position, the sheath 40 retracts towards the second outlet end of the catheter body in a rolled-up / folded manner. The sheath 40 can provide a closed space for controlling the distribution of the wetting fluid 16, and / or provide a mechanical connection, i.e., a connection device, between the insertion guide 48 and the outlet body, so that the insertion guide 48 can be removed from the housing 12 together with the catheter 22. The sheath 40 can additionally or alternatively provide a sterile environment for the catheter body 28 prior to insertion.

[0109] Figure 3 An embodiment of the housing body 330 is shown, including a distal end with a guide 350, which determines the actuation path of the cover 24 when moved between first and second positions to initiate the puncture, wetting, and removal phases of the removable cover 24. Although the distal end of the body 330 is shown, it should be understood that... Figure 3 The guide slide 350 shown and described below can be provided by a removable cover 24.

[0110] As previously described, the body 312 includes a distal end with an opening in which a conduit (not shown) is received. A first wall portion 352 extends proximally away from the distal end, and a second wall portion 354 extends from the first wall portion 352 to the proximal insertion end of the housing 12. Compared to the second wall portion 354, the first wall portion 352 has a reduced radius, thus becoming narrower, allowing it to be received within the cover portion 24. It should be understood that the different diameters of the first wall portion 352 and the second wall portion 354 are optional features that allow the outer surfaces of the body 330 and the cover portion 24 to be consistent along the length of the housing 12. In some embodiments, the distal end of the body 330 may include a continuous diameter.

[0111] The cap 24 can be used to actuate puncture. Figure 1 The sealed container is shown and a wetting agent is released therefrom. To achieve this, the cap 24 and the body 330 include an interlocking structure that guides actuation of the cap 24 along an actuation path. Thus, the body 330 (or cap 24) may include one or more guides 350 for controlling the movement of the cap 24 along the actuation path. The actuation path may involve movement of the cap 24 from a first pre-use position where the sealed container 14 remains intact to a second puncture or pierced position where the sealed container 14 is pierced by the puncture member 18. The actuation path may involve movement of the cap 24 from the second puncture position to a third removal position where the cap 24 is removed from the body 330. Therefore, actuation may include a push-pull action, wherein the cap 24 is pushed / driven toward the insertion end and the puncture member before being driven backward (i.e. pulled) to remove the cap.

[0112] refer to Figure 3The cover 24 and the body 330 may include a bayonet attachment structure comprising an actuation path provided by a guide slide 350 extending along a longitudinal axis 32 from an axial midpoint of the first wall portion 352 located between the distal end of the body 330 and the proximal end of the first wall portion 352, circumferentially extending around the longitudinal axis 32 around the first wall portion 352, and then returning to an open end at the end of the body 330 to provide a passage for an end opening. The guide slide 350 engages with a corresponding sliding portion, such as a pin, in the form of a protrusion extending from the inner surface of the cover 12 and slidably received within the guide slide 350.

[0113] Therefore, as shown, the guide may include a guide slide 350, which includes a first axially extending section 350a, a second angular section 350b, and a third axial section 350c, from which a guide pin withdraws to allow removal of the cap. The first section 350a corresponds to the puncture phase in which the cap 24 moves from a first position to a second position, and the second section 350b represents the rotation of the cap, which positions the cap 24 in a withdrawn position at the third inlet. The wetting phase may occur after puncturing the sealing container 14 and before removing the cap 24, or in any or all of the portions before the sealing container 14 is emptied.

[0114] Figures 4a to 4c The actuation steps required to wet the conduit 22 and release cap 24 during use are shown. Figure 4a It shows the corresponding Figure 1 The longitudinal section of the catheter assembly 10, wherein the same reference numerals denote corresponding features, which will not be described further. Figure 4b The catheter assembly 10 is shown after the wetting phase, during which the cap moves proximally toward the insertion end, and during the wetting phase, the wetting agent is directed to the outside of the catheter body 22. Figure 4c The cover 24 is shown after the wetting and removal phases, during which the cover 24 moves distally and rearward to detach from the body.

[0115] Therefore, in Figure 4a The image shows a catheter assembly 10, which includes an outer housing 12, a sealed container 14 containing a wetting agent 16, and a puncture member 18 for puncturing the sealed container 14. Puncture of the sealed container 14 releases the wetting agent 16. Once released, the wetting agent 16 is directed to a catheter 22 housed within the outer housing 12 to lubricate the catheter 22 for use.

[0116] The outer housing includes a cover 24, which includes a sealing container 14 for the wetting agent 16. The cover 24 is configured to move from a first sealed position to... Figure 4bThe second puncture position is shown. The puncture member 18 is configured to puncture the sealing container 14 when in the second position and guide the wetting agent to the outer surface of the catheter body 28 via a passage provided by the puncture member and, in this embodiment, a passage provided by the outlet end of the catheter 22. After wetting the catheter body 28, as... Figure 4c As shown, the cap 24 can be removed and discarded, or it can be retained and returned to the body after the used catheter 22 has been reinserted. Once the cap 24 has been initially removed, the catheter 22 can be grasped and inserted into the urethra through the distal outlet end of the body 42, using an optional insertion guide 42 (if present) to manipulate the end into the correct position. Once in the correct position at the urethral inlet, the catheter body 28, lubricated with lubricant 16, can be inserted into the urethra through the insertion guide 42, bringing the outlet end close to the insertion guide 42 until the catheter body 28 is fully inserted. After use, the catheter can be withdrawn and returned to the outer housing for disposal / disposal.

[0117] The above description of one or more embodiments is by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. A catheter assembly, comprising: The catheter assembly includes a cap containing a wetting agent; and a catheter having a catheter body and an outlet end; the catheter assembly includes at least one fluid channel configured to guide the wetting agent to an outer surface of the catheter body, bypassing an external manipulating surface of the outlet end of the catheter; wherein the catheter includes an outlet body, wherein the outlet body includes at least a portion of a main flow channel for the passage of urine; wherein the outlet body also includes a portion of the at least one fluid channel.

2. The catheter assembly according to claim 1, wherein, The catheter assembly includes an outer housing, and the outer housing includes the cover.

3. The catheter assembly according to claim 1, wherein, The cap contains a sealed container of wetting agent.

4. The catheter assembly according to claim 1, wherein, The catheter assembly also includes a puncture component.

5. The catheter assembly according to claim 1, wherein, The cover is configured to move from a first position to a second position.

6. The catheter assembly according to claim 2, wherein, The outer housing also includes a body, to which the cover is detachably attached.

7. The catheter assembly of claim 6, wherein, The conduit body is arranged at least partially within the main body.

8. The catheter assembly of claim 4, wherein, The puncture component includes another portion of the at least one fluid channel.

9. The catheter assembly according to claim 1, wherein, The at least one fluid channel is arranged radially outside the main flow channel.

10. The catheter assembly of claim 1, wherein, A portion of the at least one fluid channel is integrally formed in the outlet body of the conduit.

11. The catheter assembly of claim 1, wherein, The at least one fluid channel is tubular.

12. The catheter assembly of claim 4, wherein, The puncture member is slidably received by the outlet end of the catheter to provide another portion of the at least one fluid passage.

13. The catheter assembly of claim 1, wherein, The catheter assembly also includes a sheath arranged around the catheter body.

14. The catheter assembly of claim 13, wherein, The at least one fluid channel is configured to guide the wetting agent into the volume defined by the sheath.

15. The catheter assembly of claim 1, wherein, The cover is removable.

16. The catheter assembly of claim 1, wherein, The outer surface of the catheter body includes, is integrated with, or is coated with a hydrophilic component.

17. The catheter assembly of claim 16, wherein, The wetting agent is water.

18. The catheter assembly of claim 1, wherein, The catheter in question is a female intermittent catheter.

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