Intermittent catheter

Abstract

An intermittent catheter (16), preferably a female intermittent catheter, is provided in an assembly (10). The assembly can include a cap (20) attachable to the assembly base in use, and / or a seal not aligned with the sealing surface of the chamber wall and movable insert (14) in use. It can have a two-step deployment, and / or a sheath that pulls out of a storage chamber. An inner housing (14) and an outer housing (12) can define the storage chamber. The housing can have a fill hole and / or the storage chamber can include an insert configured to move axially in response to rotation.

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] One aspect of this disclosure provides a catheter assembly including: an outer housing comprising a body and a cap. The body and cap are configured to form a sterile cavity for receiving a catheter. The catheter is configured to be removed from the outer housing in use. The body may be elongated, having an open end and a closed end. The closed end of the body and the cap may include corresponding mating surfaces such that the cap can be mounted on the closed end of the body.

[0015] One aspect of the present invention provides a catheter assembly comprising: an outer housing including a body and a cap, wherein the body and the cap form a sterile cavity for receiving a catheter configured to be removed from the outer housing in use; wherein the body is elongated and has an open end and a closed end; and wherein the closed end of the body and the cap include corresponding mating surfaces such that the cap can be mounted on the closed end of the body.

[0016] The cap, which can be installed on the closed end of the main body, provides a convenient location for storing the cap when using the conduit.

[0017] The cap is configured to be attached to the closed end of the outer housing during use of the conduit. Therefore, during use, the cap can be removed from the body to expose the conduit for removal from the outer housing, and the cap can be placed on the closed end of the body. When the conduit is in use, the cap can remain on the closed end of the body. After use, the conduit can be returned to the body, and the cap returned to its original position to accommodate the conduit for disposal / disposal.

[0018] The temporary mounting that covers the main body can be flexible enough to withstand the amount of manipulation reasonably expected when removing and using the conduit. For example, the outer housing can be temporarily placed on the surface when the conduit is in use.

[0019] The mating surface can be any surface that allows the cover to be reliably mounted on the closed end of the body. The mating surface can be provided by the inner surface of the cover and the outer surface of the body.

[0020] The inner surface of the cap may include one or more radial protrusions. These radial protrusions may be ribs, or they may be pipes, pins, fins, etc. Ribs may extend longitudinally. Radial protrusions may provide at least a portion of a mating surface. When the cap is mounted on the body, the radial protrusions may mate with the outer surface of the body. When the cap and body form a sterile cavity, the radial protrusions may be arranged to engage with a conduit within the outer housing. The radial protrusions may be arranged to rotate the conduit when the cap is removed from the body.

[0021] One or both of the mating surfaces may include overmolded elements. Overmolded elements may include layers, rings, or inserts disposed on the inner surface of the cover. Overmolded elements may include layers, rings, or protrusions disposed on the outer surface of the body. Overmolded elements may be made of a material softer than the corresponding mating surface (that is, overmolded elements disposed on the inner surface of the cover may be made of a material softer than the body, or overmolded elements disposed on the outer surface of the body may be made of a material softer than the cover).

[0022] Mating surfaces can be joined by an interference fit. An interference fit can be provided by a suitably large contact area between the mating surfaces to allow for a frictional engagement suitable for holding the cover on the body. An interference fit can also be referred to as a resistance fit.

[0023] The inner surface of the cover and the outer surface of the body can correspond to each other. The mating surfaces may include corresponding tapered / gradiented profiles. The tapered profile can be a uniform cone such that the angle of the cone is constant along its length.

[0024] The outer shell is suitable for intermittent catheters. This catheter can be a female intermittent catheter. The catheter length can range from 90mm to 200mm. The catheter length can range from 100mm to 150mm, or for example, from 130mm to 155mm, such as approximately 135mm. The length of the catheter assembly can correspond to the length of the catheter. For example, the length of the catheter assembly, i.e., the closed length of the outer shell, can be 2mm to 20mm longer than the length of the catheter, such as 2mm to 15mm, such as 2mm to 10mm. The catheter assembly (when closed) can have a length of 10cm to 25cm; its length can range from 11cm to 16cm, such as from 140mm to 165mm, such as 142mm.

[0025] An outer housing may be used in catheter assemblies. The outer housing may be manufactured, imported, and sold independently of the catheter. Catheter assemblies may include catheters.

[0026] The body and / or cover can be rigid. The rigidity of the body and cover can be configured to be elastically deformable to facilitate an interference fit of the cover at the closed end of the body.

[0027] The outer casing may be made of plastic. The outer casing may be made of thermoplastic. The cover and body may be made of different materials. The outer casing (optional cover or body) may be made of polycarbonate; the outer casing (optional cover or body) may be made of polyethylene; the outer casing (optional cover or body) may be made of nylon. Preferably, the outer casing (optional cover or body) may be made of polypropylene.

[0028] In one aspect, this disclosure provides a method of using a catheter assembly including an outer housing comprising a cap and a body. The body may have a first end and a second end, the cap being sealably attached to the first end prior to use. The method may include the steps of: removing the cap from the first end of the body to expose the catheter for use; and attaching the cap to the second end of the body. The method may further include inverting the cap before attaching it to the second end of the body. The method may further include removing the catheter from the body after (or before) attaching the cap to the second end of the body. The method may further include repositioning the catheter back into the body after removing the catheter from the body. The method may further include removing the cap from the second end of the body and repositioning the cap back onto the first end of the body. The method may include the step of twisting the cap to unscrew it from the body. Twisting the cap may rotate the catheter in the assembly. The catheter may rotate under the action of radial protrusions on the cap, which may engage with the catheter, for example, with a corresponding radial protrusion of the catheter. When the cap is attached to the second end of the body, the radial protrusions on the cap may also engage with the second end of the body.

[0029] One aspect of this disclosure provides a catheter assembly having a longitudinal axis. The catheter assembly may include a catheter and a wetting agent reservoir. The wetting agent reservoir may include a chamber wall and a movable insert. The movable insert may be configured to be axially movable relative to the chamber wall along the longitudinal axis between a first position and a second position.

[0030] The first position may correspond to a sealed configuration in which the storage chamber is sealed by a sealing element. The sealing element may be located between the chamber wall and the movable insert. The sealing element may be configured to align with the sealing surfaces of the chamber wall and the movable insert in the first position.

[0031] The second position can be a position in which the sealing element is configured to be axially misaligned with at least one of the sealing surfaces.

[0032] One aspect of this disclosure provides a conduit assembly having a longitudinal axis, the conduit assembly comprising: a conduit; and a wetting agent reservoir including a chamber wall and a movable insert, wherein the movable insert is configured to be axially movable relative to the chamber wall along the longitudinal axis between a first position and a second position, wherein in the first position the reservoir is sealed by a sealing element located between the chamber wall and the movable insert; and wherein the sealing element is configured in the first position to be aligned with sealing surfaces of the chamber wall and the movable insert; and wherein in the second position the sealing element is configured to be axially misaligned with at least one of the sealing surfaces.

[0033] Advantageously, the sealing mechanism of the sealed reservoir reduces the amount of wetting agent lost due to evaporation or leakage before use. This is beneficial because it increases the certainty that there is sufficient wetting agent at the end of the shelf life. Since a smaller margin is required, this also allows the storage compartment to contain less wetting agent, thus the reservoir and therefore the entire package can be smaller.

[0034] A conduit assembly with a storage chamber is provided, the storage chamber being sealed using a sealing element configured to be aligned with a sealing surface in a first position and misaligned with the sealing surface in a second position. Providing such a conduit assembly with a storage chamber provides a seal with improved functionality.

[0035] For example, in some embodiments, the sealing mechanism can be opened in a second position, creating a flow path for the wetting agent to flow to another chamber, such as a wetting chamber or a filling chamber. Therefore, the sealing element can be configured to function as a valve to open the storage chamber.

[0036] In some embodiments, the sealing mechanism may remain intact in the second position, maintaining a functional seal in the storage chamber, but with reduced contact pressure applied by the sealing element. This allows the movable insert to be more easily withdrawn from the storage chamber in the second position, while providing a tighter seal for transport and storage purposes in the first position.

[0037] The sealing element can be made of an elastic material. For example, the sealing mechanism can be a rubber sealing mechanism or some other suitable material. The sealing element can be an annular sealing element. The sealing element may include an O-ring. The sealing element may include an X-ring. The sealing element may include a U-cup seal. The sealing element can be located in a radial plane, such as in the normal plane of the longitudinal axis of the conduit assembly. The sealing element can extend between radially opposite sealing surfaces. The O-ring can be located in a radial plane, such as in the normal plane of the longitudinal axis of the conduit assembly. The sealing element can be provided in the form of a gasket.

[0038] The sealing element can be compressible. The compression of the sealing element in the first position can be greater than the compression in the second position.

[0039] A sealing element may be located in a sealing element receptacle within one of the chamber wall or the movable insert. The sealing element receptacle may include a recess or channel disposed within the chamber wall or the movable insert. The recess or channel may be provided in part by a radially outer wall / radially outer wall, an axial end wall, and / or one or more conduit guiding features disposed within the storage chamber. The sealing element may be overmolded to become an integral / monolithic part of the storage chamber or the movable insert. One or more of the sealing surfaces may be provided by the sealing element receptacle. The at least one sealing surface is slidably opposed to the sealing element. The at least one sealing surface may be referred to as the primary sealing surface.

[0040] The conduit assembly may also include a wetting agent. When in the second position, the wetting agent can be sealed within the storage chamber by a sealing element that maintains sealed contact with a secondary sealing surface adjacent to the (primary) sealing surface. Alternatively, in some embodiments, a flow path may be provided between the sealing surface and the sealing element when in the second position, allowing the wetting agent to flow out of the storage chamber.

[0041] At least one of the movable insert and the chamber wall may include an expansion portion over which the sealing element extends when switching between a first position and a second position, such that the distance between the chamber wall and the movable insert at an axial position of the sealing element increases when in the second position compared to the first position. This distance may be a radial distance relative to a longitudinal axis. The expansion portion may include a widened portion of the cavity adjacent to the sealing surface. The cavity may be a cavity of a storage chamber and / or an adjacent chamber. The adjacent chamber may be disposed within the body. The adjacent chamber may accommodate the catheter body. The adjacent chamber may be an infusion chamber or a wetting chamber.

[0042] The expansion portion may include a stepped, tapered, or inclined portion located in the wall surface adjacent to the sealing surface. The sealing surface may include a cylindrical surface having a first diameter. The adjacent wall portion of the chamber wall or the movable insert may have a second diameter different from the first diameter. The first diameter may be larger than the second diameter. The adjacent wall portion may be close to the insertion end of the conduit. The adjacent wall portion may be a secondary surface.

[0043] The at least one sealing surface may be a primary sealing surface. The portion of the chamber wall or the movable insert including the second diameter may be a secondary sealing surface. Therefore, when in the second position, the sealing element can contact and abut against the secondary sealing surface for sealing. Because the gap / separation between the movable insert and the chamber wall increases at the positions of the secondary sealing surface and the sealing element, the contact pressure between the secondary sealing surface and the sealing element can be reduced. That is, the sealing element can be in a compressed state in the first position and in a decompressed state in the second position.

[0044] The conduit can be located within the storage chamber. The conduit can be nested coaxially within the storage chamber. The conduit can be nested within the chamber wall to provide a portion of the storage cavity. The conduit can extend sealed through the chamber via an opening at one of its axially opposite ends.

[0045] The movable insert can be configured to move relative to the chamber wall to a third position, in which the catheter is wetted with a wetting agent. The movable insert can be configured to move from a first position to a second position in a first direction, and from the second position to a third position. The first direction can be a rotational direction and / or an axial direction. The movable insert can move from the first position to the second position in a second direction, and from the second position to the third position in a third direction. The second and third directions can be opposite to each other. The second and third directions can be axial. The movable insert can be configured to rotate and move axially simultaneously.

[0046] The conduit assembly may also include a wetting chamber. The wetting chamber may be located radially inside the storage chamber. The conduit may be coaxially nested within the wetting chamber. The outer housing, storage chamber, wetting chamber, and conduit may be concentrically arranged and axially aligned along the longitudinal axis.

[0047] The catheter assembly may also include an infusion chamber. This infusion chamber is in flow series with the storage chamber and the wetting chamber. The infusion chamber may be located proximal to the storage chamber and the wetting chamber. The infusion chamber and / or the wetting chamber may be separated from the storage chamber by a sealing element. The infusion chamber may receive wetting agent from the storage chamber before the wetting agent is pumped into the wetting chamber.

[0048] The storage chamber and the wetting chamber can be separate chambers. The storage chamber and the wetting chamber can be separated by an inner shell. The inner shell can be spaced apart within an outer shell to provide the storage chamber.

[0049] A storage chamber can be a wetting chamber. A wetting chamber can be defined as a cavity within a catheter assembly from which a wetting agent can contact the outer surface of the catheter body. A wetting agent can be applied to the catheter body when the catheter is removed from the storage chamber, in which case the storage chamber can be considered as or include a wetting chamber.

[0050] Alternatively, where the storage chamber and wetting chamber are separate chambers, the wetting agent can flow and / or can be pumped into and / or flow and pump along the length of the wetting chamber and conduit. In this case, the wetting agent can flow through the sealing element. A filling chamber can be located between the storage chamber and the wetting chamber, receiving the wetting agent before it passes through the wetting chamber. The filling chamber can be located near the proximal end of the outer housing body.

[0051] In the second position, the sealing element can maintain a seal between the chamber wall and the movable insert. In the second position, the sealing element can also be separated from at least one of the sealing surfaces, thereby providing a flow path for the wetting agent through the sealing element.

[0052] The wetting agent may be provided in the wetting chamber and / or may be provided in the filling chamber when in the second position.

[0053] The movable insert may include an internal housing. The internal housing may be a housing that defines a storage chamber and a wetting chamber.

[0054] The catheter assembly may include multiple sealing mechanisms. These multiple sealing mechanisms may include a proximal sealing mechanism located near the insertion end of the catheter. The multiple sealing mechanisms may include a second sealing mechanism. The second sealing mechanism may be axially separated / spaced apart from the proximal sealing mechanism distal to it. The distal and proximal sealing mechanisms may be radially located between the movable insert and the chamber wall. The distal and proximal sealing mechanisms may include their respective distal and proximal sealing elements and sealing surfaces.

[0055] The distal sealing mechanism can maintain sealing contact in both the first and second positions.

[0056] The conduit assembly may also include a pump configured to pump a wetting agent into a wetting chamber. A movable insert may include the pump. An internal housing may include the pump. The internal housing may include one or more pumping enhancement features. The internal housing may include a plurality of circumferentially extending fins. The movable insert can be moved from a second position to a first position to pump a wetting agent into the wetting chamber.

[0057] The catheter may include a catheter body that provides an insertion end for insertion into a patient and an exit end that includes one or more external manipulation features.

[0058] The movable insert may be provided by a catheter. For example, a portion of the catheter may provide the movable insert. This portion of the catheter may be a part other than the catheter body, such as a funnel-shaped piece or an attachment. The storage chamber may be adjacent to the outlet end of the catheter.

[0059] The catheter assembly may also include an actuator for moving a movable insert relative to the storage chamber. The actuator may be referred to herein as an priming mechanism. The actuator may include a rotatable actuator. Rotating the rotatable actuator can move the movable insert relative to the chamber wall. The movement of the movable insert can be one or both of rotational and axial movement. Axial movement can be caused by rotation of the rotatable actuator. Rotation of the rotatable actuator can be converted into axial movement between the movable insert and the chamber wall.

[0060] The conduit assembly may also include a cam driver for converting rotation of the rotatable actuator into axial movement. The conduit assembly may also include a threaded portion for converting rotation of the rotatable actuator into axial movement. The cam driver may include the threaded portion or a portion thereof. The actuator may include one or more drive surfaces and one or more corresponding drive elements that are drivably engaged with each other to provide rotational-axial movement.

[0061] The conduit assembly may also include an outer housing that includes a removable cover. A rotatable actuator may include the cover.

[0062] The cover can be engaged with the movable insert in a non-rotatable manner, such that rotating the cover allows the movable insert to rotate.

[0063] The movable insert can be configured to reciprocate as the rotatable actuator rotates.

[0064] The second position can be a wetting position, in which the conduit is configured to be wetted by a wetting agent. Therefore, when in the second position, the wetting agent can be in fluid communication with the outer surface of the conduit body. The second position can also be a filling position. The conduit can be configured to be withdrawn from the storage chamber when in the filling position. In some embodiments, the filling position may correspond to a pre-pumping configuration, wherein the wetting agent is pumped or otherwise moved into the wetting chamber.

[0065] One aspect of this disclosure provides a catheter assembly including a wetting mechanism. The catheter assembly may have at least a two-step deployment. The two-step deployment may include: a first step of breaking the hermetic seal and injecting at least the wetting mechanism to place the catheter assembly in a leak-proof injection configuration; and a second step of removing the catheter body from the catheter assembly. The first stage and / or the second step may additionally wet the catheter body.

[0066] One aspect of this disclosure provides a catheter assembly including: a catheter and a housing having an internal cavity, within which the catheter is housed. The housing may be an outer housing. The housing may include a sealing mechanism / airtight sealing mechanism for maintaining the sterility of the internal cavity before use. A wetting chamber may be located within the internal cavity.

[0067] One aspect of this disclosure provides a catheter assembly including a catheter. The catheter assembly may further include an outer housing having an internal volume in which the catheter is housed. The outer housing may include an airtight sealing mechanism for maintaining the internal volume in a sterile state before use. The catheter assembly may include a wetting chamber, which may include one or more wetting sealing mechanisms for retaining wetting agent within the wetting chamber. The catheter assembly may be configured to include: an airtight sealing configuration in which the airtight sealing mechanism is sealed and the wetting agent sealing mechanism is sealed; and an infusion configuration in which the airtight sealing mechanism is open and the one or more wetting agent sealing mechanisms are sealed.

[0068] One aspect of this disclosure provides a catheter assembly comprising: a catheter; a housing having an internal cavity in which the catheter is housed, the housing including an airtight sealing mechanism for maintaining the internal cavity aseptic before use; a wetting agent chamber located in the internal cavity; and wherein the catheter assembly is configured to deploy the catheter in a first step and a subsequent second step, wherein the first step includes breaking the airtight sealing mechanism and infusing the wetting agent chamber to place the catheter assembly in a leak-proof infusion configuration in which the catheter is configured to be wetted by the wetting agent; and the second step includes removing the catheter from the housing.

[0069] A sealing configuration that maintains the aseptic state of the internal volume and an infusion configuration in which the catheter assembly is held in a potentially non-sterile but leak-proof infusion configuration allow for interruption of catheter deployment without the risk of wetting agent leakage from the catheter assembly. This is advantageous if the user is required to temporarily place the catheter before removing it but after breaking the airtight seal.

[0070] The housing may include an outer housing. The outer housing may include a body and a cover. An airtight sealing mechanism may be attached to the body and / or the cover. The airtight sealing mechanism may attach the cover to the body. The airtight sealing mechanism may include the outer surface of the conduit assembly. Therefore, the outer housing may include a cover, a body, and an airtight sealing mechanism. The airtight sealing mechanism may be a tear strip that breaks during use, allowing the cover to be removed by hand. The airtight sealing mechanism can be broken and a wetting agent can be injected by rotating the cover relative to the body.

[0071] The first and / or second steps may additionally wet the catheter body. Therefore, placing the catheter assembly in the infusion configuration allows the catheter to be wetted without the wetting agent being in external fluid communication with the catheter assembly. Additionally or alternatively, a leak-proof configuration prevents fluid communication between the wetting agent and the portion of the catheter including the operating surface that is manipulated by the user during use. Therefore, the operating surface can remain dry before the catheter is removed from the outer housing. The operating surface may be provided at the catheter's outlet end.

[0072] The catheter can be an intermittent catheter. The catheter can be a urinary catheter. The catheter can be a female intermittent catheter.

[0073] The catheter assembly may also include an infusion initiation mechanism. This infusion initiation mechanism may be referred to herein as an actuator. The infusion initiation mechanism may be configured to perform a first step by a single action of the user. Thus, the user may manipulate the infusion initiation mechanism by moving, for example rotating or pulling a portion of the catheter assembly, to break the hermetic seal and infuse the catheter assembly by a single action or movement. The first step may include simultaneously breaking the hermetic seal and infusing the wetting agent chamber to position the catheter assembly in a leak-proof infusion configuration.

[0074] The housing can be an outer housing. The housing can be rigid. The housing can include a cover and a body. In the first step, the cover and the body can remain engaged. The engagement of the cover and the body can be a mechanical engagement, wherein the cover is directly or indirectly attached to the body. For example, the cover can be attached to the body via an inner housing or some other intermediate member.

[0075] The filling initiation mechanism may include a cap. The cap may be rotatably rotated relative to the body, such that the rotatable rotation of the cap breaks the airtight seal and fills the wetting agent chamber.

[0076] Therefore, one aspect of this disclosure provides a catheter assembly comprising: a catheter; a housing having an internal cavity in which the catheter is housed, the housing including an airtight sealing mechanism for maintaining the internal cavity aseptic before use; a wetting agent chamber located in the internal cavity; and wherein the catheter assembly is configured to deploy the catheter in a first step and a subsequent second step, wherein the first step includes breaking the airtight sealing mechanism and infusing the wetting agent chamber to place the catheter assembly in a leak-proof infusion configuration, wherein the catheter is configured to be wetted by the wetting agent; and the second step includes removing the catheter from the housing; the catheter assembly further includes an infusion initiation mechanism configured to perform the first step using a single action of a user, wherein the infusion initiation mechanism includes the cap, wherein the cap is rotatably drivable relative to the body such that rotatably rotating the cap breaks the airtight sealing mechanism and infuses the wetting agent chamber.

[0077] The infusion initiation mechanism may include: a drive surface; and a drive element that engages with the drive surface such that rotational movement of the drive element or the drive surface causes axial translation of the other of the drive element and the drive surface, or vice versa.

[0078] The drive surface may extend axially and circumferentially. The drive surface may include inclined and / or helical surfaces. The drive surface may include a first axial end surface / first surface facing the axial direction provided by radially projecting flanges, ribs, threads, rails or guides or end wall surfaces.

[0079] The drive element may include a second axial end surface / second axially facing surface formed by a radially extending flange, rib, thread, rail, guide or pin, or end wall surface.

[0080] The end wall surface can be the end wall surface of the chamber wall.

[0081] A combination of a driving element and a driving surface can be called a cam driver.

[0082] The infusion initiation mechanism may include a movable insert that partially defines a wetting agent chamber. The movable insert may be configured to move between a sealing configuration and an infusion configuration during a first step. The movable insert may be configured to move axially during rotation.

[0083] The wetting agent chamber may include a wetting agent storage chamber. Additionally or alternatively, the wetting agent chamber may include a wetting chamber and / or an infusion chamber. The wetting agent chamber may include chamber walls and movable inserts.

[0084] The chamber wall or movable insert may include a drive element or a drive surface. The other of the chamber wall and the movable insert may include another of the drive element and drive surface.

[0085] The drive element may include a plug for sealing the orifice. This orifice may be a filler orifice. The filler orifice may be located in the outer wall of the housing.

[0086] The movable insert may be configured to move axially during rotation. The cover may engage with the movable insert in a non-rotatable manner, such that rotating the cover causes the movable insert to rotate and translate axially.

[0087] The non-rotatable engagement between the cap and the movable insert can be disengaged after the first step. Disengagement of the non-rotatable engagement can be caused by further rotation of the cap. Thus, the user can rotate the cap in the first direction to infuse the catheter assembly, and the user can further rotate the cap in the first direction to disengage the cap. Disengagement of the non-rotatable engagement allows the cap to be removed from the catheter assembly to expose the catheter for removal.

[0088] Therefore, one aspect of this disclosure provides a catheter assembly comprising: a catheter; a housing having an internal cavity in which the catheter is received, the housing including an airtight sealing mechanism for maintaining the internal cavity aseptic before use; a wetting chamber located in the internal cavity; and wherein the catheter assembly is configured to deploy the catheter in a first step and a subsequent second step, wherein the first step includes breaking the airtight sealing mechanism and infusing the wetting chamber to place the catheter assembly in a leak-proof infusion configuration in which the catheter is configured to be wetted by the wetting agent; and the second step includes removing the catheter from the housing. The catheter assembly further includes an infusion initiation mechanism configured to perform a first step using a single action of the user, wherein the infusion initiation mechanism includes the cap, wherein the cap is drivably rotatable relative to the body such that drivably rotating the cap breaks the hermetically sealed mechanism and infuses the wetting agent chamber; wherein the infusion initiation mechanism includes a movable insert that partially defines the wetting agent chamber, the movable insert being configured to move between a sealed configuration and an infusion configuration during the first step, wherein the cap is non-rotatably engaged with the movable insert by a non-rotatable engagement mechanism.

[0089] The movable insert can be provided by a catheter (as described above).

[0090] The movable insert may include an inner housing located radially inside the outer housing. The conduit may be located radially inside the inner housing.

[0091] The inner housing may be located radially inside the outer housing to provide a storage chamber between the inner and outer housings.

[0092] The catheter assembly can be configured to provide mechanical feedback to the user. This mechanical feedback can indicate the end of the first step. Mechanical feedback can also occur between the first and second steps.

[0093] Therefore, one aspect of this disclosure provides a catheter assembly comprising: a catheter; a housing having an internal cavity in which the catheter is housed, the housing including an airtight sealing mechanism for maintaining the internal cavity aseptic before use; a wetting agent chamber located in the internal cavity; and wherein the catheter assembly is configured to deploy the catheter in a first step and a subsequent second step, wherein the first step includes breaking the airtight sealing mechanism and infusing the wetting agent chamber to place the catheter assembly in a leak-proof infusion configuration in which the catheter is configured to be wetted by the wetting agent; and the second step includes removing the catheter from the housing; wherein the catheter assembly is also configured to provide mechanical feedback to a user between the first step and the second step.

[0094] The first step may require a first actuating force, and the second step may require a second actuating force. The first and second actuating forces can be different. Therefore, the conversion between the first and second actuating forces can provide mechanical feedback to the user. The first and second actuating forces can be one or both of different directions and different magnitudes.

[0095] Mechanical feedback may be provided by one or more stops, at which a change in the direction of actuation is required. Therefore, the catheter assembly may include one or more limiters that restrict movement of the movable insert or the actuator associated with the movable insert.

[0096] Actuation of the catheter assembly required for the first and second steps may require the movement and / or removal of one or more components. Therefore, the first step can be initiated using the subsequently removed cap before the user axially removes the catheter.

[0097] The wetting agent chamber may include a wetting agent storage chamber. In some embodiments, the wetting agent storage chamber may include a portion of a conduit. In some embodiments, the wetting agent chamber may include a storage chamber and / or a wetting chamber, and / or an infusion chamber.

[0098] The wetting agent sealing mechanism can be any sealing mechanism or combination of sealing mechanisms used to seal a storage chamber, wetting chamber, or filling chamber. The wetting agent sealing mechanism may include sealing elements and sealing surfaces as described herein.

[0099] In some embodiments, the conduit assembly may be configured to provide a wetting agent to the wetting chamber. The conduit assembly may include a third configuration in which the airtight sealing mechanism is open, and at least one of the wetting agent sealing mechanisms is open.

[0100] The infusion configuration may involve a reservoir being infused, allowing the catheter to be removed from the reservoir while passing through a wetting agent provided within it.

[0101] The outer housing may include a cover and a body to which the cover is attached. This attachment may be achieved by an airtight sealing mechanism. Rotating the cover relative to the body may disrupt the airtight sealing mechanism.

[0102] The wetting agent chamber may include a wetting agent storage chamber wall and a movable insert. A wetting agent sealing mechanism may be disposed between the wetting agent storage chamber wall and the movable insert. The sealing mechanism may include a sealing element.

[0103] The catheter may include an insertable portion. Prior to the first step, the insertable portion may not come into contact with the wetting agent.

[0104] Advantageously, the insertable portion of the catheter does not come into contact with the wetting agent before deployment, such as during transport and storage. The insertable portion of the catheter is typically made of a material that interacts with the wetting agent, and this interaction should only occur before use.

[0105] The catheter assembly may also include a wetting chamber. When the catheter assembly is in the perfusion configuration, the wetting agent can be in fluid communication with the wetting chamber. In the third position, the wetting agent can be in the wetting chamber.

[0106] The conduit assembly may also include a wetting chamber sealing mechanism disposed between the storage chamber and the wetting chamber. The wetting chamber sealing mechanism can be opened when the conduit assembly is in the infusion configuration.

[0107] The movable insert can be an inner housing in which the catheter is located. The movable insert can be a catheter. The catheter can be configured to be removed from the wetting chamber and the outer housing when the catheter assembly is in the infusion configuration.

[0108] The catheter assembly may also include an actuator for moving a movable insert relative to the wetting chamber wall. The actuator may include a rotatable actuator. Rotation of the rotatable actuator can be converted into axial movement between the movable insert and the chamber wall.

[0109] The conduit assembly may further include a cam driver for converting rotation of the rotatable actuator into axial movement. The conduit assembly may also include a threaded portion for converting rotation of the rotatable actuator into axial movement. The conduit assembly may further include a cap, wherein the rotatable actuator includes the cap. The cap may engage with a movable insert in a non-rotatable manner, such that rotating the cap allows rotation of the movable insert.

[0110] The cover can be engaged with the movable insert in a non-rotatable manner, such that rotating the cover allows the movable insert to rotate. Rotating or pulling the cover may disrupt the airtight seal.

[0111] Further rotation of the cap or removal of the conduit can open the at least one wetting agent sealing mechanism. Further rotation of the cap can be the same rotation that disrupts the airtight seal.

[0112] One aspect of this disclosure provides a catheter assembly including a catheter having a distal outlet end and a proximal insertion end. The catheter assembly may further include a wetting agent reservoir and a housing. The housing may be an outer housing. The outer housing may at least partially enclose the catheter and the reservoir. The catheter assembly may further include a sheath connected between the catheter and the reservoir, such that removal of the catheter from the outer housing results in the reservoir being removed from the outer housing via the sheath.

[0113] One aspect of this disclosure provides a catheter assembly including: a catheter having a distal outlet end and a proximal insertion end; a wetting agent reservoir; an outer housing that at least partially encloses the catheter and the reservoir; and a sheath connected between the catheter and the reservoir, such that removal of the catheter from the outer housing results in the reservoir being removed from the outer housing via the sheath.

[0114] The sheath connecting the catheter and the storage chamber provides a convenient way to remove the storage chamber from the catheter after it has been retrieved through the storage chamber. Therefore, the insertable catheter body can be moistened with the wetting agent stored in the storage chamber before / during its removal from the housing, as the catheter is being withdrawn, to help maintain the sterility of the catheter body before insertion into the patient. Furthermore, when the catheter is subsequently inserted into the urethra, it can pass through the wetting agent storage chamber a second time, thereby improving the wetting of the catheter surface.

[0115] Furthermore, the design of the wetting mechanism, which can be removed from the outer housing through a sheath, allows the user to manipulate the conduit wetted through the storage chamber without the risk of contaminating the conduit. Providing the storage chamber in this way as an insertion guide offers an efficient way to utilize the space within the outer housing and allows for a greater supply of wetting agent.

[0116] The sheath can be a retractable sheath. The retractable sheath can be stowed in a retractable configuration and deployed to an extended configuration. The sheath can be extended from a retractable configuration to an extended configuration, in which the sheath is stowed between the outlet end and the storage chamber, and in the extended configuration, the sheath is extended and contains the conduit body therein.

[0117] The conduit and storage chamber may be retained within (e.g., attached to) the outer housing, such that a first predetermined force is required to remove the conduit from the outer housing, and a second predetermined force is required to disengage the storage chamber for removal from the outer housing. The first and second predetermined forces may be different. The second predetermined force may be greater than the first predetermined force.

[0118] The catheter assembly may also include an insertion guide that can be deployed to the insertion tip of the catheter for use. The insertion guide may include an external manipulating surface and is configured to facilitate positioning the insertion tip in the patient's urethra. A storage compartment may contain the insertion guide.

[0119] The catheter assembly may also include a release mechanism configured to releasably retain the storage chamber.

[0120] The release mechanism may include a releasable coupling between the outer housing and the storage chamber. The release mechanism provides mechanical feedback to the user removing the catheter and / or storage chamber. Therefore, the release mechanism may require a predetermined amount of force to actuate the releasable coupling. This predetermined force may be a second predetermined force.

[0121] The releasable coupling may include one or more protrusions extending from either or both of the outer housing and the wetting chamber. The protrusions may be received in one or more corresponding recesses provided on the other of the outer housing and the wetting chamber.

[0122] There may be an equal number of releasable protrusions and recesses. The protrusions and recesses may be configured to remain engaged when subjected to a first predetermined force, and to disengage when subjected to a second predetermined force.

[0123] The first and second predetermined forces can be axial forces. The axial force can be applied by the user through a conduit.

[0124] The protrusion may be elongated and have a longitudinal axis. The protrusion may be configured to deviate from the longitudinal axis when a second predetermined force is applied or when the second predetermined force is exceeded.

[0125] The catheter can be elongated and can define the main longitudinal axis of the catheter assembly. The longitudinal axis of the protrusion can extend in the direction of the main longitudinal axis.

[0126] The catheter assembly may include a plurality of protrusions and recesses circumferentially distributed around a main axis. The plurality of protrusions and recesses may be combined to provide an annular snap-fit ​​connection structure.

[0127] The deviation of the protrusion can be in the radially outward direction.

[0128] The release mechanism can be configured to prevent relative rotation between the outer casing and the wetting agent chamber. Therefore, rotating the movable insert located within the storage chamber or formed as a first part of the storage chamber will not cause relative rotation between the storage chamber and the outer casing.

[0129] The conduit assembly may also include a sealing element within a storage chamber and a movable insert received within the storage chamber. The sealing element may be located between the storage chamber and the movable insert, and may be radially inwardly and axially aligned with the plurality of protrusions and / or recesses. The axial alignment of the sealing element and the releasable coupling positioning the storage chamber relative to the housing help maintain the seal provided by the sealing element.

[0130] One aspect of this disclosure provides a catheter assembly including: a catheter; and a wetting agent reservoir therein. The wetting agent reservoir may include at least one protrusion configured to guide the catheter within the wetting agent reservoir.

[0131] The at least one protrusion can guide the catheter within the wetting chamber during catheter removal. The at least one protrusion can also guide the catheter within the wetting chamber during reinsertion of the catheter through the wetting chamber.

[0132] One aspect of this disclosure provides a catheter assembly including a catheter; and a wetting agent reservoir in which the catheter is located, wherein the wetting agent reservoir includes at least one protrusion configured to guide the catheter within the wetting agent reservoir, wherein the at least one protrusion retains the sealing element within the wetting agent reservoir.

[0133] A storage chamber with one or more features, such as a protrusion that positions the catheter within the wetting chamber during catheter removal or reinsertion, allows for controlled catheter positioning, providing improved wetting of the catheter body. During reinsertion, it also ensures the catheter does not become stuck in the wetting chamber.

[0134] One aspect of this disclosure provides a catheter assembly including: a catheter; and a wetting agent reservoir therein. The wetting agent reservoir may include at least one protrusion configured to retain a sealing element within the wetting agent reservoir. The at least one protrusion may be configured to retain the sealing element within the wetting agent reservoir during catheter removal.

[0135] Providing a reservoir with one or more feature structures, such as protrusions for positioning the sealing element therein, offers a convenient way to position the sealing element and maintain its relationship with the catheter during catheter body removal. This is advantageous because it ensures that the sealing element is correctly positioned when the catheter is reinserted into the wetting reservoir, thus ensuring that the seal remains after reinsertion. It also avoids implementing the sealing element on the catheter itself, which would obviously cause problems when inserting the catheter into the urethra.

[0136] The at least one protrusion configured to retain the sealing element within the wetting chamber may be the at least one protrusion configured to guide the conduit within the wetting chamber.

[0137] The at least one protrusion may include multiple ribs or fin-like portions. The multiple ribs or fin-like portions may extend axially and radially. The at least one protrusion may include multiple pins or fin-like portions. The at least one protrusion may include multiple posts. The at least one protrusion may include multiple flanges. The multiple protrusions may include any combination of ribs and / or fin-like portions and / or pins and / or posts and / or flanges.

[0138] The storage chamber may include an axially extending wall that is radially outward and at least one radially extending end wall. The storage chamber may include a first radially extending end wall and a second radially extending end wall. Both end walls may include one or more tubular flanges extending axially from them.

[0139] The plurality of protrusions may extend from either or both of the radially outer wall or the at least one end wall.

[0140] The plurality of protrusions may extend radially inward from the radially outer wall of the wetting agent storage chamber. The plurality of protrusions may be circumferentially distributed. At least two protrusions may be present. At least three protrusions may be present. At least four protrusions may be present. At least six protrusions may be present. At least eight protrusions may be present. Four protrusions may be present.

[0141] The conduit and storage chamber can be concentrically aligned.

[0142] The protrusion may be shaped to define a gap. This gap may be defined by interruptions / discontinuities in the protrusion. The protrusion may extend only partially along the axial direction of the storage chamber. The gap may be partially defined by the axial edge of the protrusion. The gap may be partially defined by the end wall of the storage chamber. Discontinuities may be provided by a first portion of a radially inwardly extending first amount for each protrusion and a second portion of a smaller radially inwardly extending second amount for each protrusion.

[0143] The wetting agent storage chamber may include at least one radially extending end wall and at least one axially extending protrusion within the wetting agent storage chamber, the at least one protrusion terminating before reaching the end wall to define a gap.

[0144] The catheter may define a longitudinal axis, and each of the plurality of protrusions may be located in a plane defined by the longitudinal axis. The plurality of protrusions may be arranged in pairs radially opposite each other.

[0145] The sealing element may be elastic. The sealing element may be an annular sealing element. The sealing element may include an O-ring. The sealing element may include an X-ring. The sealing element may include a U-cup seal. The sealing element may be located in a radial plane, such as in the normal plane of the longitudinal axis of the conduit assembly.

[0146] An O-ring may be disposed in the gap. This gap may define a seat for a sealing element. The axial edge of the protrusion may define the seat for the sealing element. During the transition of the catheter from the retracted position to the wetted position, the seat may axially restrict the sealing element. During catheter removal, the seat may axially restrict the sealing element. This is advantageous because it ensures that the sealing element is properly positioned when the catheter is reinserted into the wetting reservoir, thereby ensuring that the seal remains after reinsertion. It also avoids implementing a sealing element on the catheter, which would obviously cause problems when inserting the catheter into the urethra.

[0147] The storage chamber may include two openings disposed at opposite axial ends of the storage chamber, through which a conduit may pass. A protrusion may define a channel located between the two openings. The radially inner edge of the protrusion may define a guide portion for guiding the conduit through during removal or re-insertion / re-accession of the conduit.

[0148] The radially inner edge of the protrusion may define a guide portion for guiding the catheter through during catheter removal or re-insertion / re-insertion. The guide portion may extend at least 50% of the distance between the two openings, preferably at least 80%. The guide portion may extend at least 40% of the distance between the two openings. The guide portion may extend at least 50% of the distance between the two openings. The guide portion may extend at least 60% of the distance between the two openings. The guide portion may extend at least 70% of the distance between the two openings.

[0149] The spacing between the radially inner edges of adjacent protrusions can be smaller than the diameter of the conduit. By ensuring that the spacing between the radially inner edges of adjacent protective elements is smaller than the diameter of the conduit, deviation of the conduit from the channel defined by the protrusions is limited.

[0150] The diameter of the guide section can be approximately equal to the diameter of one or more openings of the wetting chamber.

[0151] The diameter of the guide portion can be approximately equal to the diameter of the sealing surface of the movable insert. The diameter of the guide portion can also be larger than the diameter of the sealing surface of the movable insert.

[0152] One aspect of the present invention provides a conduit assembly comprising: an outer housing; a conduit located within the outer housing; and a movable insert. The movable insert may be an inner housing disposed between the outer housing and the conduit. An outer surface of the inner housing and an inner surface of the outer housing together define a wetting agent reservoir.

[0153] One aspect of the present invention provides a conduit assembly comprising: an outer housing; a conduit located within the outer housing; and a movable insert including an inner housing disposed between the outer housing and the conduit, wherein an outer surface of the inner housing and an inner surface of the outer housing together define a wetting agent storage chamber.

[0154] Providing an inner shell between the outer shell and the conduit offers an advantageous location for storing the wetting agent. This location allows for a large volume of wetting agent. Furthermore, the location adjacent to the outer shell provides a convenient location for filling purposes after the conduit assembly is assembled. The inner shell can also be advantageously used to provide a wetting chamber around the conduit.

[0155] The inner housing may include an elongated tubular member. The elongated tubular member may be concentrically mounted within the outer housing.

[0156] The inner housing may be located within the outer housing in a radially spaced relationship to provide a storage chamber between the inner and outer housings. Either or both of the inner and outer housings may include at least one protrusion extending between the inner and outer housings.

[0157] The at least one protrusion may be an elongated rib. The at least one protrusion may extend circumferentially around the inner shell.

[0158] The at least one protrusion may include an axial flow channel therethrough. The at least one protrusion may extend only partially around the inner housing to provide the axial flow channel therethrough. The at least one protrusion may include annular ribs. The annular ribs may be discontinuous to provide the flow channel therethrough. The axial flow channel allows the protrusion to extend between the inner and outer housings to facilitate the positioning of the inner housing within the outer housing, while still allowing fluid to flow along the length of the storage chamber. Additionally or alternatively, the flow channel may control the degree of axial flow, allowing the inner housing to function as a pump.

[0159] The conduit assembly may include multiple protrusions. The multiple protrusions may be distributed along the longitudinal axis of the inner or outer housing.

[0160] The at least one protrusion may extend from the inner housing so as to be movable relative to the outer housing. Axial movement of the inner housing and the protrusion against the wetting agent along the longitudinal axis will cause the at least one protrusion to push the wetting agent in the direction of travel. Therefore, the at least one protrusion may be configured to pump the wetting fluid out of the storage chamber during axial movement of the inner housing.

[0161] The at least one protrusion can extend between the outer and inner housings with minimal clearance. Thus, the at least one protrusion can be configured to radially position the inner housing while allowing its axial movement.

[0162] The outer housing may include a filling port in fluid communication with the storage chamber. The outer housing may include a cover and a body. The filling port may be located in the outer wall of the body. The filling port may be configured to receive a plug. The conduit assembly may also include a plug.

[0163] The conduit assembly may also include an actuator for moving the inner housing. This actuator may be referred to as a perfusion initiation mechanism. The actuator may include a drive surface against which a drive element acts to move the inner housing. The drive element may include a plug.

[0164] A drive element or drive surface may be disposed on the chamber wall of the storage chamber or on a movable insert housed within the chamber wall. The other of the drive element and drive surface may be disposed on the other of the chamber wall and the movable insert. The drive surface and drive element may be configured such that relative rotation between the movable insert and the chamber wall results in axial movement of the movable insert or the chamber wall.

[0165] The conduit assembly may also include a wetting agent that comes into contact with the outer and inner housings within the storage chamber.

[0166] The movable insert can move between a sealed configuration and a filling configuration. During movement to the filling configuration, the reservoir can open to provide a flow path for the wetting agent to exit the reservoir. The flow path can extend into the filling or wetting chamber where the catheter is located.

[0167] The conduit assembly may include one or more vents. A storage chamber may include the one or more vents. The one or more vents may be air inlet vents configured to allow gas to enter the storage chamber to displace the wetting agent as it leaves the storage chamber. The one or more vents may be inside or outside the outer housing. Movement of a movable insert may open the one or more vents. Moving the movable insert from a sealed configuration to an open configuration may open the one or more vents. Moving the movable insert from a sealed configuration to a filling configuration may open the one or more vents. The one or more vents and flow path openings may be arranged at axially opposite ends of the storage chamber.

[0168] The flow path can be provided by opening a sealing mechanism that defines the storage chamber. This sealing mechanism can be a proximal sealing mechanism.

[0169] The outer surface of the movable insert can be an outer peripheral surface. The outer surface of the movable insert can be an outer circumferential surface. The inner surface of the outer casing can be an inner circumferential surface.

[0170] One aspect of this disclosure provides a conduit assembly including an outer housing comprising a filling orifice and a wetting agent reservoir. The filling orifice is in fluid communication with the reservoir. The filling orifice is configured to allow the conduit assembly to be assembled prior to the reservoir being filled with wetting agent.

[0171] One aspect of this disclosure provides a conduit assembly including an outer housing with a filling orifice and a wetting agent storage chamber, the filling orifice being in fluid communication with the storage chamber; wherein the filling orifice is configured to allow the conduit assembly to be assembled prior to filling the storage chamber with wetting agent.

[0172] A filling orifice is provided in the outer housing, offering a convenient location for filling the storage chamber. This orifice can be easily plugged after the filling process to provide a sealed, sterile assembly.

[0173] One aspect of this disclosure provides a method for assembling a catheter assembly (specifically, for example, a catheter assembly as described above), the method comprising: a) inserting a catheter body and a wetting agent storage chamber into an internal cavity of an outer housing; b) filling the storage chamber with wetting agent through a filling hole disposed on the outer housing; c) sealing the outer housing; and d) sterilizing the internal cavity.

[0174] Steps a and b are preferably performed in this order. Further steps may also be included. Sealing the outer housing may include inserting a plug into the filling hole. The plug may then be welded to the outer housing.

[0175] A sealed outer housing may include a cover placed on the outer housing. A sealed outer housing may include an airtight sealed outer housing.

[0176] Sterilization can be achieved through radiation sterilization, such as gamma-ray sterilization, X-ray sterilization, or EB (electron beam) sterilization.

[0177] The outer housing may include a cover and a body. The outer housing may include a filling port in fluid communication with the storage chamber. The outer housing may include a cover and a body. The filling port may be located in the outer wall of the body. The filling port may be configured to receive a plug. The conduit assembly may also include a plug.

[0178] The conduit assembly may also include an actuator for moving the inner housing. This actuator may be referred to as a perfusion initiation mechanism. The actuator may include a drive surface against which a drive element acts to move the inner housing. The drive element may include a plug.

[0179] A drive element or drive surface may be disposed on the chamber wall of the storage chamber or on a movable insert housed within the chamber wall, wherein the other of the drive element and drive surface is disposed on the other of the chamber wall and the movable insert. The drive surface and drive element may be configured such that relative rotation between the movable insert and the chamber wall results in axial movement of the movable insert or the chamber wall.

[0180] The movable insert can be a catheter.

[0181] The conduit assembly may also include an inner housing within an outer housing. A storage chamber may be disposed between and defined by the outer and inner housings. The inner housing may be a movable insert configured to move axially and / or rotatably relative to the outer housing.

[0182] The drive surface may include at least one drive surface outlet for providing a flow path between the filling orifice and the storage chamber.

[0183] The driving surface may include at least one track. The track may include discontinuities to provide flow channels through the track.

[0184] The drive surface may include a pair of axially spaced tracks. The spacing between the tracks may correspond to the diameter of the drive element.

[0185] The inner housing may be spaced apart within the outer housing to provide storage compartments. The inner housing may include multiple ribs on its radially outer wall to extend between the inner and outer housings.

[0186] Ribs can extend circumferentially. Each rib may include an axial flow channel passing through it.

[0187] One aspect of this disclosure provides a conduit assembly having a longitudinal axis, the conduit assembly comprising: a conduit; a wetting agent reservoir; and an outer housing, the conduit and the reservoir being housed within the outer housing. The reservoir may include a movable insert configured to be axially movable relative to the outer housing along the longitudinal axis as the movable insert rotates.

[0188] One aspect of this disclosure provides a conduit assembly having a longitudinal axis, the conduit assembly comprising: a conduit; a wetting agent storage chamber; and an outer housing, the conduit and the storage chamber being housed within the outer housing; wherein the storage chamber includes a movable insert configured to be axially movable relative to the outer housing along the longitudinal axis as the movable insert rotates.

[0189] Providing a movable insert that can translate axially during rotation allows the storage chamber to be conveniently configured for use. For example, the movable insert can be configured to change the storage chamber from a sealed configuration to an infusion configuration by rotating the movable insert, thereby allowing the catheter assembly to be infused with a single action by the user.

[0190] The movable insert can move between a sealed configuration and an infusion configuration. The sealed configuration may correspond to a configuration in which the catheter assembly is sealed before use. This sealing mechanism can be an airtight or sterile sealing mechanism, wherein the internal cavity of the outer housing is sterile, or a leak-proof seal in which the wetting agent is sealed within the internal cavity of the outer housing to prevent leakage. A leak-proof seal may mean that the wetting agent is sealed within one or more of a storage chamber, a wetting chamber, and an infusion chamber. A leak-proof seal may mean preventing leakage from the outer housing or preventing the wetting agent from contacting one or more operating surfaces of the catheter.

[0191] The filling configuration may correspond to a configuration in which the catheter is prepared to be wetted. Therefore, when in the wetting configuration, the catheter can be configured for removal / retraction by the user. In some embodiments, (e.g., in the sealing configuration), a sealing mechanism may retain the catheter to restrict / prevent removal. When in the filling configuration, the pressure applied to the catheter by the retaining sealing mechanism may be reduced to allow the catheter to be sealably removed / retracted from the storage chamber, thereby wetting the catheter body. In some embodiments, the filling configuration may include opening the storage chamber sealing mechanism, thereby opening a flow path between the storage chamber and a subsequent chamber.

[0192] The storage chamber may include chamber walls. The movable insert and the chamber walls may be sealably joined to seal the storage chamber via a sealing mechanism.

[0193] The movable insert may be located radially inside the chamber wall. The sealing mechanism may include a sealing element held by the movable insert or the chamber wall and a relative sealing surface provided by the other of the movable insert and the chamber wall.

[0194] The sealing element can be adapted to be aligned with the sealing surface when in a sealing configuration. The sealing element can also be adapted to be axially misaligned with the sealing surface when in a potting configuration.

[0195] The sealing element may include an elastic material. The sealing element may be annular. The sealing element may be an O-ring. The sealing element may be an X-ring. The sealing element may be a U-cup seal.

[0196] The sealing element may be located in a sealing element receptacle provided by the chamber wall or a movable insert.

[0197] At least one of the movable insert and the chamber wall may include an expansion portion through which the sealing element passes when switching between a sealing configuration and a filling configuration. Thus, when in the filling configuration, the distance between the chamber wall and the movable insert at the axial position of the sealing element can be increased.

[0198] The expansion portion may include a stepped portion, a tapered portion, or a slope adjacent to the sealing surface.

[0199] The sealing surface can be a primary sealing surface. The conduit assembly may also include a secondary sealing surface. In a pre-filled configuration, the sealing element may abut against the secondary sealing surface for sealing.

[0200] The chamber wall or movable insert may include one or more axially and circumferentially extending drive surfaces. The other of the chamber wall and movable insert may include a drive element that engages with the drive surface to provide axial movement of the movable insert as the movable insert and the chamber wall rotate relative to each other.

[0201] The driving surface may include a first axial surface provided by a radially projecting flange, rib, thread, track or guide, or end wall surface of the corresponding movable insert or chamber wall.

[0202] The drive element may include a radially extending flange, rib, thread, track, guide rail or pin of the corresponding movable insert or chamber wall, or a second axial surface provided by the end wall surface.

[0203] The drive element may include a plug for sealing the orifice. This orifice may be a filler orifice. The filler orifice may be located in the outer wall of the outer housing.

[0204] The actuation surface may be provided by the chamber wall. The actuation surface may be provided by the end wall surface of the chamber wall.

[0205] The movable insert can move between the infusion configuration and the wetting configuration.

[0206] The outer housing may include a body and a cover. The cover engages with a movable insert in a non-rotatable manner, such that rotation of the cover causes rotation of the movable insert to provide axial movement. This non-rotatable engagement may be provided by one or more interlocking mechanisms that non-rotatably connect the cover to the inner housing.

[0207] The rotating cap allows the movable insert to be switched from a sealing configuration to a filling configuration. Further rotating the cap allows the movable insert to be switched from a filling configuration to a wetting configuration. The rotating cap allows the movable insert to be switched from a sealing configuration to a wetting configuration.

[0208] The movable insert can be configured to reciprocate axially along a longitudinal axis. The movable insert can also be configured to reciprocate while rotating in a continuous common direction. Reciprocating movement may include distal movement followed by proximal movement.

[0209] The cover can be sealably attached to the body via an external housing sealing mechanism. The cover and sealing mechanism can be configured such that the cover breaks the external housing sealing mechanism. The external housing sealing mechanism can be an airtight seal.

[0210] The chamber sealing mechanism can be a proximal sealing mechanism. The catheter assembly may also include a distal (chamber) sealing mechanism. The distal and proximal sealing mechanisms may be spaced apart along the length of the movable insert and the chamber wall to define a cavity for wetting agent.

[0211] The distal sealing mechanism may include a distal sealing element and an opposing distal sealing surface, wherein the distal sealing surface and the distal sealing element are sealed in a sealing configuration and a filling configuration.

[0212] The movable insert can be a catheter.

[0213] The movable insert may include an inner housing. The inner housing may at least partially define a storage chamber, and the conduit is located within the inner housing.

[0214] The inner housing may be located radially within the outer housing to provide a storage chamber between the inner and outer housings.

[0215] The catheter assembly may also include a rotation limiter for the movable insert. The rotation limiter may be configured to restrict rotation of the movable insert to less than a predetermined amount.

[0216] The inner housing is attached to the cover in a non-rotatable manner via a torque-activated release interlock mechanism. The release interlock mechanism can be configured to release while the movable insert continues to rotate, when the movable insert rotation limiter is engaged.

[0217] The driving surface may include a track. The track may be cosine-shaped.

[0218] When the driving surface is a track, the track can extend between a first endpoint and a second endpoint, and has a midpoint between the first endpoint and the second endpoint. The first endpoint and the second endpoint can be located axially distal to the midpoint. The second endpoint may include a rotation limiter.

[0219] The track can extend circumferentially by at least 180 degrees and less than 360 degrees. The track can also extend circumferentially by 270 degrees. After rotating 270 degrees, the cap can disengage from the movable insert. After a further 90-degree rotation, the cap can be released from the catheter assembly. Therefore, a single complete rotation of the cap relative to the body can transform the catheter assembly from a sealed configuration to a filling configuration, and then to an open / wetting configuration from which the catheter can be removed. The transition from the sealed configuration to the filling configuration can also disrupt the hermetic seal mechanism.

[0220] The outer surface of the conduit may be disposed in a wetting chamber, which exists between the inner surface of the outer housing and the outer surface of the conduit; such wetting chamber may be defined by a sheath, or the sheath may be disposed within the wetting chamber.

[0221] The catheter assembly may include an airtight sealing mechanism for maintaining the internal volume in a sterile state before use.

[0222] When in a sealed configuration, the airtight seal can remain intact. When in a filled or humidified configuration, the airtight seal can be compromised, causing at least a partial opening of the internal volume of the outer housing to the outside air, thus potentially disrupting the sterile environment.

[0223] When in a sealed configuration, the wetting agent chamber may be sealed by one or more wetting agent sealing mechanisms. The wetting agent storage chamber may include a wetting agent storage chamber and / or a filling chamber and / or a wetting chamber, with the conduit located in the wetting chamber to be wetted.

[0224] When in the infusion and / or wetting configurations, the wetting seal mechanism can remain intact to provide a leak-proof seal, thereby preventing the wetting agent from escaping to the outside of the catheter assembly or the catheter outlet end with an external operating surface.

[0225] The conduit assembly may include a third configuration in which both the hermetic sealing mechanism and the wetting agent sealing mechanism are open. The conduit may be configured to be removed from the outer housing when the wetting agent sealing mechanism is open.

[0226] The outer housing may include a cover and a body, the cover being attached to the body via an airtight sealing mechanism. The airtight sealing mechanism may include a tear strip that can be removed by hand before use, allowing the cover to be removed manually. The airtight sealing mechanism can be broken by rotating the cover relative to the body.

[0227] The wetting agent chamber may include a wetting agent storage chamber. The storage chamber may include chamber walls and a movable insert. A wetting agent sealing mechanism may be disposed between the wetting agent storage chamber wall and the movable insert.

[0228] The catheter assembly may also include a wetting chamber. When the catheter assembly is in a perfusion configuration, the wetting agent can be in fluid communication with the wetting chamber.

[0229] The conduit assembly may include a wetting chamber sealing mechanism disposed between a storage chamber and a wetting chamber. When the conduit assembly is in an infusion configuration, the wetting chamber sealing mechanism may be open.

[0230] The movable insert can be an internal housing in which a catheter is located.

[0231] The catheter can be configured to be removed from the wetting chamber and the outer housing when the catheter assembly is in the infusion configuration.

[0232] The conversion between the sealing configuration and the filling configuration may include moving the movable insert. Movement of the movable insert may include rotating the movable insert and / or axially moving the movable insert.

[0233] The catheter assembly may include an actuator for moving a movable insert. Optional features of the actuator are described herein.

[0234] The catheter includes a catheter body and an outlet body. The catheter may include an insertion end for insertion into a patient and an outlet end from which fluid exits during use. The outlet end may include one or more flow-enhancing features, such as a funnel-shaped portion expanding along the flow direction. The outlet end may include an external manipulatory surface. When the cap is removed, the external manipulatory surface may be exposed to the user for manipulation. The external manipulatory surface may include one or more surface features to enhance the user's grip. The one or more surface features may include one or more grooves. The catheter body may include one or more inlets at its insertion end for receiving urine.

[0235] The catheter may be functionalized. For example, it may include, be integrated with, or be coated with a hydrophilic component (e.g., a hydrophilic polymer). The hydrophilic component is used to further reduce friction when a wetting agent is applied. At least the outer surface of the catheter body may be functionalized, for example, by providing a hydrophilic component on at least the outer surface of the catheter body (which contacts the urethra during use). The catheter may include a main flow path for the passage of urine. The main flow path may extend along and define the longitudinal axis of the catheter. The main flow path may be provided by the wall of the catheter body. The main flow path may have a distal outlet and a proximal inlet located at the insertion end of the catheter.

[0236] 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 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.

[0237] The outlet body may include, or be referred to as, a connector that connects the outlet end (e.g., the funnel-shaped portion and / or the external manipulation feature structure) to the conduit body.

[0238] The outer surface of the conduit may be located in a wetting chamber, which exists between the inner surface of the outer shell and the outer surface of the conduit body.

[0239] The sheath can be a retractable sheath. A retractable sheath can be configured to retract during catheter insertion, thereby providing a temporary seal around the catheter prior to insertion.

[0240] The sheath provides 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. The sheath can tether / attach the insertion guide and / or reservoir to the exit end of the catheter, such that retraction of the catheter body deploys the sheath, and complete removal of the catheter from the outer housing results in the removal of the insertion guide and / or reservoir from the outer housing.

[0241] The storage chamber may include an insertion guide. The insertion guide may be provided at the proximal end of the storage chamber.

[0242] The catheter assembly may include a wetting chamber, which may be defined by a sheath, or the sheath may be disposed within the wetting chamber.

[0243] The storage chamber may include an annular chamber in which the catheter is located. The storage chamber may be located at the distal end of the catheter. The storage chamber may surround the catheter between the outlet end of the catheter and the catheter body. The catheter outlet may be connected to the catheter body via a connecting portion. The catheter, such as the connecting portion, may include one or more sealing surfaces against which a sealing element may abut during use for sealing.

[0244] The storage chamber may include a chamber wall and the surface of a conduit. The conduit may be a movable insert. The chamber wall may include an axially extending radially outer wall / a wall located radially outward. The chamber wall may include an end wall extending radially inward from the radially outer wall toward the conduit. The end wall may include a radially extending portion and an annular flange extending along the conduit. The annular flange may include a reduced radius compared to the radius of the radially outer wall.

[0245] The storage chamber may include multiple protrusions defining a guide tube through which the catheter passes. The multiple protrusions can guide the catheter during removal, thereby maintaining concentricity. The multiple protrusions may include multiple axially extending ribs. The multiple protrusions may extend from the distal wall of the storage chamber wall. The multiple protrusions may extend radially inward from a radially outer wall. A sealing reservoir may be defined within the radially outer wall. The sealing reservoir may be defined by the multiple protrusions and the end walls of the chamber wall.

[0246] The storage chamber can be configured to have a sealing position and a filling position. The sealing position and the filling position can be referred to as the sealing configuration and the filling configuration, respectively. The sealing position corresponds to the sealing element on the main sealing surface. The filling position corresponds to the sealing element on the second sealing surface. The sealing contact pressure in the sealing position can be greater than the sealing contact pressure in the filling position.

[0247] The sealing configuration can correspond to the sealing configuration of the conduit assembly, in which the conduit assembly is hermetically sealed by an hermetically sealing mechanism.

[0248] The storage chamber may include at least two sealing elements that are axially separated along the conduit to provide a distal sealing mechanism including a distal sealing element and a proximal sealing mechanism including a proximal sealing element.

[0249] A distal sealing element may be disposed on a sealing surface having a constant profile between a sealing configuration and a filling and / or wetting configuration. The sealing surface of the distal sealing mechanism may be defined by one or more radial protrusions defining a recess in which the distal sealing element is retained. The distal sealing element may remain within the recess when the conduit is removed from the outer housing.

[0250] The proximal sealing mechanism may include a proximal sealing surface. The proximal sealing surface may be raised relative to the proximal and / or distal portions of the sealing surface. Therefore, the proximal sealing mechanism may include an expansion portion through which the sealing element passes when switching between a sealing configuration and a filling and / or wetting configuration, such that when in the wetting configuration, the distance between the chamber wall and the movable insert at the axial position of the sealing element increases.

[0251] The proximal sealing mechanism can be arranged in the proximal sealing reservoir. The proximal sealing reservoir can be located within the radially outer wall. The proximal sealing reservoir can be provided by the end walls of the plurality of protrusions and the chamber wall.

[0252] The storage chamber can be configured to have one or both of a filling position and a wetting position, as well as a sealing position. The sealing position, filling position, and wetting position can be referred to as configurations. An actuator can be used to switch between the sealing configuration and the filling and / or wetting configurations. This actuator can be referred to as a filling actuation mechanism.

[0253] The actuator may include a rotatable actuator, wherein a user can rotate a rotor, such as a cover of an outer housing or a conduit, to switch between a sealing configuration, a filling configuration, and / or a wetting configuration and / or a conduit assembly and / or a wetting chamber and / or a storage chamber. Rotation of the rotatable actuator can be converted into axial movement between a movable insert and the chamber wall of the wetting chamber.

[0254] The actuator may include a drive surface that is drivably engaged with a drive element. The drive surface may include one or more helical members that push against a corresponding drive element to axially drive a movable insert relative to the storage chamber. The helical members may be fin-like portions extending circumferentially and axially around the catheter. The drive surface and drive element may be positioned toward the outlet end of the catheter.

[0255] The drive surface may extend only partially around the longitudinal axis. For example, the drive surface may extend at approximately 90 degrees. There may be multiple drive surface components distributed circumferentially. The drive surface and drive element may be referred to as a cam driver, used to convert the rotation of a rotatable actuator into axial movement.

[0256] The rotatable actuator may include a cap. The cap may engage with a movable insert in a non-rotatable manner, such that rotating the cap causes the movable insert to rotate. The movable insert may be a conduit.

[0257] The cap may include one or more radially extending cap protrusions that engage with corresponding radially extending catheter outlet end protrusions to provide a non-rotatable engagement. One or both of the cap protrusions and the catheter outlet protrusions may be axially extending radial fins. Each fin may lie in a plane defined by a longitudinal axis. The non-rotatable engagement between the cap and the catheter may be configured to allow axial movement such that the cap can be axially removed from the non-rotatable engagement by rotating the cap through a predetermined angle.

[0258] The movable insert can be an inner housing. The inner housing can be configured to move axially when the rotatable actuator rotates. The inner housing can be configured to reciprocate when the rotatable actuator rotates. Therefore, rotating the rotatable actuator can move the inner housing in a first axial direction and subsequently in a second axial direction. The rotation direction of the rotatable actuator can be the same direction. The first axial direction can be distal relative to the insertion end of the conduit. The second direction can be proximal.

[0259] The drive surface may include a track that engages with the drive element. This track may be referred to as a reciprocating track. The track may be disposed on the inner housing or the body of the outer housing. The drive element may include a protrusion, which may be disposed on the other of the inner and outer housings.

[0260] A track and a drive element may be disposed within the storage chamber. The drive element may include a plug received within a filling orifice of the storage chamber. Therefore, the body may include at least one orifice extending through its outer wall, providing an inlet to the storage chamber through which wetting fluid can be received. The orifice may be configured to receive the drive element after the filling process. Thus, the orifice may be opposite to the track in which the drive element is received.

[0261] The track extends from a first end point corresponding to the sealing configuration to a midpoint corresponding to the filling configuration, and then to a third end point corresponding to the wetting configuration. The track extends between the first end point and the midpoint along a first circumferential direction and a first axial direction, and between the midpoint and the end point along a first circumferential direction and a second axial direction. The first axial direction and the second axial direction can be opposite to each other. The first axial direction can be a proximal direction. The second axial direction can be a distal direction.

[0262] The track may include one or more track walls. The track walls may be discontinuous to provide an outlet for the wetting agent in the track. Thus, the track can receive the wetting agent from the filling orifice before the wetting agent flows into the internal volume of the storage chamber.

[0263] The optional features described above can be applied to any aspect of the invention. Thus, for example, the preferred lengths of the catheters and components are described only once above, but apply to all aspects and combinations of these aspects and other optional features. Invention Details Attached Figure Description

[0265] 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:

[0266] Figure 1a An exploded view of a catheter assembly according to an embodiment of the present disclosure is shown;

[0267] Figure 1b Showing in closed or sealed configuration Figure 1a Side view of the catheter assembly;

[0268] Figures 2a to 2c The steps of removing the cap from the catheter assembly and placing the cap on the opposite end of the outer housing of the catheter assembly are shown;

[0269] Figure 3 It shows Figure 1a A longitudinal sectional view of the catheter assembly;

[0270] Figure 4 It shows Figure 3 An enlarged longitudinal sectional view of the proximal end of the catheter assembly, showing in detail the storage chamber and the wetting chamber;

[0271] Figure 5 It shows Figure 3 Enlarged longitudinal sectional view of the distal end of the catheter assembly;

[0272] Figures 6a to 6c It shows Figure 1a A series of longitudinal sectional views of the catheter assembly highlight the catheter wetting process;

[0273] Figure 7 It shows that it can be used Figure 1a A perspective view of the inner housing within the conduit assembly;

[0274] Figure 8a and 8b The following are respectively shown by Figure 7 The internal housing provides a side view and a front plan view of the reciprocating track;

[0275] Figures 9a to 9c The upper part of the inner casing is shown, and it can be used for... Figure 1a Details of the cap of the catheter assembly shown;

[0276] Figures 10a to 10f A series of side view images of a catheter assembly according to an embodiment of the present invention are shown, illustrating the main steps of wetting the catheter and removing the catheter from the outer housing;

[0277] Figure 11 An exploded longitudinal view of a catheter assembly according to an embodiment of the present disclosure is shown;

[0278] Figure 12 It shows Figure 11 A perspective view of the conduit assembly;

[0279] Figure 13 It shows Figure 11 A partial cross-sectional view of the conduit assembly, showing the wetting agent storage chamber;

[0280] Figure 14a and 14b They are shown respectively Figure 13 Schematic longitudinal sectional view of the catheter assembly in sealed and infusion configurations;

[0281] Figure 15 An exploded longitudinal view of a rotatable actuator, a storage chamber, and a movable insert according to one embodiment is shown;

[0282] Figure 16a and 16b A storage compartment according to one embodiment is shown;

[0283] Figure 17 and 18 An example of a storage compartment and a releasable connector is shown;

[0284] Figure 19 A partial longitudinal sectional view of the retractable sheath in its stowed configuration is shown.

[0285] Figure 20 An exploded view of the catheter assembly according to the present invention is shown;

[0286] Figure 21a It shows Figure 20 Side view of the catheter assembly;

[0287] Figure 21b It shows Figure 20 A side view of the conduit assembly, with the outer shell / outer housing removed;

[0288] Figure 21c It shows Figure 20 A side view of the catheter assembly, including the sheath, with the outer shell / outer housing removed.

[0289] Figure 22a The closed configuration is shown. Figure 20 A cross-sectional view of the wetting mechanism of the conduit assembly; and

[0290] Figure 22b It shows the open configuration. Figure 20 A cross-sectional view of the wetting mechanism of the conduit assembly. Detailed Implementation

[0291] Figure 1a An axial exploded view of a catheter assembly 10 according to the present invention is shown. The catheter assembly includes an outer housing 12, an inner housing 14, and a catheter 16. The outer housing 12, the inner housing 14, and the catheter 16 are arranged concentrically such that the catheter 16 is located within the inner housing 14, which is located within the outer housing 12 in a radially nested configuration.

[0292] The conduit assembly 10 may be configured such that the conduit 16 can be wetted before being removed from the outer housing 12. A wetting agent is used to wet the conduit 16 before use and may be stored in a wetting agent storage chamber defined between the outer housing 12 and the inner housing 14. The wetting agent can be delivered to the conduit 16 through the wetting chamber defined between the inner housing 14 and the conduit. The wetting agent may be pumped or driven from the storage chamber into the wetting chamber. The wetting agent may be water or some other suitable reagent as known in the art.

[0293] refer to Figure 1a , 1b 3, 4, 9b, and 9c, the outer housing 12 includes a body 18 and a cover 20, in which a portion of the inner housing 14 and the conduit 16 are housed. The cover 20 is removable so that it can be removed by the user before use of the conduit. Removing the cover 20 exposes the conduit 16, allowing it to be removed from the outer housing 12.

[0294] The outer housing 12 provides a closed volume in which the catheter 16 can be housed for storage and transport prior to use. The body 18 and the cap 20 provide a sterile cavity in which the catheter 16 is located. The outer housing 12 is generally elongated and has a longitudinal axis 22, which serves as the main axis of the catheter assembly 10 and also provides a longitudinal axis for the inner housing 14 and the catheter 16, etc. Unless otherwise stated, references to longitudinal axes (axial or radial) in this disclosure should be understood as referring to longitudinal axis 22.

[0295] The enclosed volume provided by the outer housing 12 is defined by the outer wall of the housing 12, which extends from the first proximal end 13 of the insertion end 24 of the receiving catheter 16 to the second distal end 15 of the outlet end 26 of the receiving catheter. In the illustrated embodiment, the second end 15 is provided by a cap 20. Thus, removing the cap 20 exposes the outlet end 26 of the catheter 16, allowing the user to grasp the catheter 16 and remove it from the housing 12 for use.

[0296] The outer contour of the housing 12 can be any contour required for aesthetic or functional 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 20.

[0297] The cover 20 includes a generally cylindrical shell with an end opening, the shell having a circumferential outer wall extending coaxially along a longitudinal axis 22, and a radially extending axial end wall providing a closed end at the ends of the cover 20 and the outer housing 12. The cover 20 mates with the distal end of the body 18 such that the body 18 is received within the open end of the cover 20. However, it should be understood that in some embodiments, the cover 20 may be received within the open end of the body.

[0298] An airtight seal can be provided between the cover 20 and the body 18 to maintain the internal volume of the outer housing 12 aseptic before use. The airtight seal of the embodiment includes one or more (in this case, two) internal sealing mechanisms 66 and 68, such as... Figure 3 and 5 As shown, and further described below. Alternatively / alternatively, an airtight seal may be provided by a tamper-proof connection or band between the body 18 and the cover 20.

[0299] The outer housing 12 can be used to transport the tubing 16 ready for use, and also for handling / disposing of the tubing after use. To prevent the cap 20 from being misplaced or separated from the body 18 when the tubing 16 is in use, and to avoid storing additional items in environments unsuitable for hygiene (such as public restrooms), the cap 20 can be temporarily attached to the body 18. Therefore, the cap 20 can be removed from the open end of the body 18 to expose the tubing 16 for removal and use, and can be installed on the closed end of the body 18. Once the tubing 16 has been used, it can be returned to the body 18, and the cap 20 is reconnected to the open end of the body 18 to enclose the used tubing 16 for disposal / disposal.

[0300] This process can be performed Figures 2a to 2c As seen in the text, among them Figure 2a The catheter assembly 10 is shown, wherein the cap 20 is removably attached before use. Figure 2b This shows the cover 20 being removed from the body 18 and moved to the opposite end (as indicated by the arrow). Figure 2c The cap 20 is shown attached to the opposite end of the body 18. The conduit 16 is not shown, but it should be understood that when the conduit 16 is present, it will be exposed at the uppermost end of the body 18, as shown.

[0301] In order to temporarily mount the cover 20 onto the closed end of the body 18, the outer surface of the closed end of the body 18 and the inner surface of the cover 20 may include corresponding mating surfaces. These mating surfaces are... Figure 2a The main body 18 is indicated by reference numeral 21 in the accompanying drawings, and... Figure 9c The cover portion 20 is indicated by reference numeral 21'. The mating surfaces 21, 21' can be configured to provide an interference fit, wherein the frictional engagement between the cover portion 20 and the closed end of the body 18 is sufficient to temporarily hold the cover portion 20. The interference fit can be achieved by providing a suitably shaped, in this embodiment, appropriately large contact surface area between the inner surface of the cover portion 20 and the outer surface of the body 18. Thus, the axial portion of the outer surface of the body 18 can have a profile corresponding to the inner surface of the cover portion 20. Figures 2a-2c In the example shown, the profile can be a uniform cone, where the cone angle along the mating surface is constant, but other profiles are also possible.

[0302] The cap 20 and / or body 18 are generally substantially rigid in order to provide protection for the catheter 16 during transport and to maintain the integrity of the closed container and preserve sterility. However, it should be understood that the cap 20 and / or body 18 may have sufficient elasticity to allow for a small amount of deformation, thereby facilitating the interference fit between the cap 20 and body 18.

[0303] As an addition or alternative to the inner surface of the cover 20 and the outer surface of the body 18 having corresponding contours, one or both of the cover 20 and the body 18 may include mating surfaces 21, 21', which include one or more molded structures providing or reinforcing an interference fit and / or attachment between the cover 20 and the body 18. For example, the cover 20 may use radial protrusions, such as those described below. Figure 15 The rib 286b described in the embodiment is fitted to the closed end of the body 18 via a snap-fit ​​engagement. In the snap-fit ​​engagement, the cover 20 elastically engages with one or more interlocking features, such as circumferentially extending ribs or a number of circumferentially distributed pipes. Providing a snap-fit ​​engagement helps to give the user feedback that the cover 20 is securely attached. Alternatively or additionally, the cover 20 and / or the body 18 may include one or more inserts, coatings (e.g., overmolding with a softer material), gaskets, threads, or other features that enhance one or more of the elasticity, contact surface area, coefficient of friction, or engagement between the cover 20 and the body 18.

[0304] The body 18 and the cover 20 can be made of thermoplastics such as polypropylene. Other polymers, such as polycarbonate, polyethylene, or nylon, can also be used. Similarly, overmolding designs using a softer material on the inside of the cover or a portion of the outside of the body can help hold the cover to the body.

[0305] The cover 20 can be removed axially from the body 18 and then positioned inverted and along the same axial direction on the closed end of the body 18. The cover 20 can be linearly pulled off the body 18, or, for example, rotated or unscrewed if the cover 20 is threaded. Figure 9a and 9c Examples of threaded portions 62b and 62a can be seen in the diagram.

[0306] Part or all of the inner surface of the cover 20 may provide a mating surface 21'. Figure 9c The embodiment includes three parts that provide independent functions. The first part is the mating surface 21', which is located at the farthest end and extends from the closed end to the open proximal end, terminating midway along the internal length of the cover 20. The second part includes a threaded portion 62a for engaging with the inner housing 14 of the conduit assembly 10, and the third part provides an anti-rotation feature 60b, which will be described further below. It should be understood that other configurations of the cover 20 are also possible, and in other embodiments, the arrangement and corresponding positions of the various parts may differ.

[0307] As described above, the outline of the outer housing 12 may be longitudinally tapered. The cross-sectional profile of the outer surface of the cover 20 may be any desired shape. The cross-sectional profile may be annular, such as circular or elliptical. In some embodiments, the lateral profile may be polygonal, such as triangular or square. Figure 9b One embodiment is shown in which the outer surface 20' of the cover 20 is a rounded square to facilitate the user's gripping to rotate the cover 20 during the actuation and / or removal steps.

[0308] Reference Figure 1a , 3 4. The body 18 may provide a casing defining a reservoir for a wetting fluid (not shown). The reservoir is formed between the body 18 and the inner housing 14. Thus, the inner housing 14 may be disposed within the outer housing 12 in a spaced-apart relationship to define a cavity 28 therebetween. The cavity 28 may be referred to as a wetting fluid storage chamber 28, or simply as storage chamber 28 herein. Storage chamber 28 may include a first chamber wall provided by the body 18 and a movable insert provided by the inner housing 14. Thus, the inner housing 14 may provide a second storage chamber wall.

[0309] The storage chamber 28 is sealed in the first configuration so that the wetting agent is retained therein, and is opened in the second configuration so that the wetting agent can flow out of the cavity 28 to flow into communication with the outer surface of the conduit body 32 of the conduit 16, and in some embodiments, directly contact the outer surface of the conduit body 32 of the conduit 16.

[0310] When in the open configuration, the internal volume of the storage chamber 28 is in fluid communication with the wetting chamber 30, and a conduit is located in the wetting chamber 30, allowing the wetting agent to flow from the storage chamber 28 to the wetting chamber 30 and the conduit body 32. In some embodiments, the fluid communication between the storage chamber 28 and the wetting chamber 30 may be achieved via one or more valves, inlet channels, or intermediate chambers, such as an infusion chamber. An example of an infusion chamber will be further described below.

[0311] like Figure 1a , 3 As shown in Figure 4, the enclosed volume of the outer housing 12 can be divided by an inner housing 14, which may be referred to as a movable insert. The inner housing 14 may include a tubular wall configured to define a wetting agent storage chamber 28 on its radially outer side and a wetting chamber 30 on its radially inner side.

[0312] like Figure 4As shown, the inner housing 14 may include an elongated, thin-walled structure extending longitudinally along the main axis 22 of the conduit assembly 10. The inner housing 14 includes a first end remote from the insertion end of the conduit 16 and a second proximal end adjacent to and surrounding the insertion end 24 of the conduit 16. It should be understood that the length of the inner housing 14 and the positions of the respective distal and proximal ends of the inner housing 14, as well as its spacing from the outer housing chamber wall, may vary in various embodiments and are determined to provide the required volume for the wetting agent storage chamber 28. Further design considerations may arise where the inner housing 14 is configured as a pump to pump the wetting agent from the storage chamber 28 and / or the filling chamber to the wetting chamber during the wetting process.

[0313] The wetting chamber 30 includes an elongated cavity between the inner surface of the inner housing 14 and the outer surface of the conduit body 32, such that a wetting agent (not shown) can be supplied to the wetting chamber 30 to wet the outer surface of the conduit body 32 prior to use. The wetting chamber 30 may be wholly or partially defined by the inner surface of the inner housing 14 and / or an intermediate member such as a sheath 34, which is located within the inner housing 14 and surrounds the conduit body 32 during wetting.

[0314] Storage chamber 28 may be an elongated annular cavity surrounding longitudinal axis 22 and conduit body 32, extending axially between a first distal end and a second proximal end. One or more sealing mechanisms 36, 38 may be used to seal the cavity at the first and second ends. The sealing mechanisms may include sealing elements 36a, 38a, which may be located between or abut against corresponding sealing surfaces 36b, 38b. Sealing surfaces 36b and 38b may be provided by corresponding portions of the inner housing 14 and the outer housing 12. Sealing elements 36a, 38a may be resilient seals, such as O-rings, X-rings, or U-cup seals. The sealing elements may extend radially between the inner housing 14 and the body 18.

[0315] To open the storage chamber 28, the conduit assembly 10 may incorporate one or more valves that can be opened to fluidly connect the storage chamber 28 and the wetting chamber 30. The valves may be operated by moving a movable insert, such as the inner housing 14. The movable insert may be moved by direct manipulation of the user's hand or by actuating the cap 20. For example, rotating or pulling the cap 20 may cause the valves to open, thereby fluidly connecting the storage chamber 28 and the wetting chamber 30, allowing wetting agent to flow from the storage chamber 28 to the wetting chamber 30 and the outer surface of the conduit body 32. The valves may be partially provided by the inner housing 14.

[0316] The inner housing 14 is axially movable along the main axis 22 of the conduit assembly 10. Axial movement can cause opening at one or more sealing mechanisms 36, 38 of the sealed storage chamber 28, such that the opposing sealing elements 36a, 38a and sealing surfaces 36b, 38b of the respective sealing mechanisms 36, 38 move from an aligned sealed (or closed) position to an misaligned unsealed (or open) position. Thus, for example, partially removing the inner housing 14 from the body 18 can result in axial movement of the sealing mechanisms 36 of the respective opposing surfaces relative to each other, and increase the separation of the inner housing 14 and the outer housing 12 across the sealing mechanisms 36, providing an opening. In this way, one or more of the sealing mechanisms 36, 38 can function as the aforementioned valve.

[0317] In the described embodiment, the sealing mechanism 36, configured as a valve, can be located proximally, allowing the wetting agent in the storage chamber 28 to flow from the proximal end of the storage chamber 28 into the closed end of the body 18 of the housing 12. This can be referred to as the filling chamber. From there, fluid is supplied in direct or via one or more inlets to the wetting chamber 30, either directly or through the exterior of the conduit body 32.

[0318] Figure 3 and 4 An optional insertion guide 25 is also shown. The insertion guide 25 is a short, elongated annular sleeve that is positioned around the proximal end of the catheter body 32. The catheter body 32 is slidably received within the insertion guide 25 such that the insertion guide 25 can be moved distally when the catheter body 32 is inserted. This will be described in more detail below.

[0319] As described above, the storage chamber 28 is sealed by a proximal sealing mechanism 36 and a distal sealing mechanism 38 to provide an elongated annular cavity in which wetting fluid can be stored away from the conduit 16. The sealing mechanisms 36, 38 of the embodiment include resilient seals in the form of O-rings located between opposing sealing surfaces. It should be understood that the sealing mechanisms 36, 38 can be alternative annular seals, such as X-rings or U-cup seals. The sealing surfaces are provided by corresponding and radially opposing portions of the inner housing 14 and the outer housing 12. It should be understood, more generally, that the conduit assembly 10 and the storage chamber 28 may be provided with more than one distal sealing mechanism 38 or proximal sealing mechanism 36 to provide the necessary sealing function.

[0320] One of the sealing surfaces may form a portion of the sealing receptacle 36d, 38d that retains the sealing element 36a, 38a and prevents axial movement of the sealing element 36a, 38a. In some embodiments, the sealing receptacle 36d, 38d may be provided by overmolding / overmolding the sealing mechanism 36, 38 such that it is molded within a wall portion of the inner housing 14 or the outer housing 12. In the example shown, the sealing receptacle 36d, 38d is provided by the wall of the inner housing 14. Therefore, the sealing receptacle 36d, 38d restricts the axial ends of the sealing element 36a, 38a such that axial movement of the inner housing 14 relative to the outer housing 12 allows the sealing mechanism 36, 38 to slide along the opposing sealing surface of the outer housing 12 together with the inner housing 14. It should be understood that in some embodiments, the sealing receptacle 36d, 38d may be provided by the outer housing 12.

[0321] As described above, axial movement of the sealing mechanism 36 can expose or provide one or more outlets to allow fluid communication between the storage chamber 28 and the wetting chamber 30. Furthermore, one or more sealing mechanisms can open one or more vents. The vents can serve as air inlets configured to allow gas to enter the storage chamber 28 to replace the wetting agent when it leaves the storage chamber 28. The vents can be internal to open the storage chamber 28 to another internal cavity, or they can be external to draw air directly from the outside of the assembly 10.

[0322] like Figure 4 As shown in the embodiment, the proximal sealing mechanism 36 may be located in the storage chamber 28 near the expansion portion 36c. The expansion portion corresponds to the increased gap between the outer housing 12 and the inner housing 14, which may be provided by stepped or tapered portions in the contours of the respective surfaces of the inner housing 14 and the outer housing 12. Therefore, the sealing mechanism 36 of the storage chamber 28 may be located at a local confinement between the opposing walls of the storage chamber 28.

[0323] The expansion section provides space into which the sealing mechanism 36 can move when the storage chamber 28 is opened. Therefore, when... Figure 4 As the inner housing 14 moves distally (to rise in the image shown), the sealing mechanism 36 moves into the wider chamber portion, thereby opening the flow path from the storage chamber 28 to the proximal end of the body 18. In this way, the sealing mechanism 36 functions as a valve, and the insertion end 24 of the conduit 16 can be immersed in the wetting agent flowing from the storage chamber 28. Figure 4 As shown, although both the inner and outer housing walls include stepped / conical sections that facilitate the expansion of the storage chamber 28, the wall that provides separation includes a sealing surface 36b against which the sealing element 36a is pushed and moved.

[0324] The distal sealing mechanism 38 of the storage chamber 28 is axially spaced from the proximal sealing mechanism 36 along the inner housing 14 and is positioned in a fixed position relative to the proximal sealing mechanism 36. The distal sealing mechanism 38 may include a sealing reservoir 38d similar to that provided for the proximal sealing mechanism 36, such that axial movement of the inner housing 14 causes the sealing element 38a to translate along the length of the outer housing 12. Figure 4 The difference between the distal sealing mechanism 38 and the proximal sealing mechanism 36 in the embodiment is that the sealing surfaces are substantially uniformly spaced, and the sealing surface 38b, which is opposite to the active sealing surfaces of the sealing receptacle 38d and the sealing element 38a, remains in contact with the sealing element 38a when the inner housing 14 is displaced. Thus, the distal sealing mechanism 36 can remain unchanged when the inner housing 14 is displaced and the proximal sealing valve is opened. As described above, axial movement of the proximal sealing mechanism 38 can result in the exposure and / or opening of one or more vents.

[0325] The inner housing 14 can be configured to provide a pump for pumping wetting agent into the wetting chamber 30. Thus, the distal sealing mechanism 38 can be configured to maintain a higher pressure than the proximal sealing mechanism 36, which is configured to maintain the integrity of the storage chamber 28 when the component is stored and transported prior to use. Figure 4 As shown, the distal sealing element 38a can be larger than the proximal sealing element 36a.

[0326] from Figure 5 As can be seen, the distal sealing mechanism 38 of the storage chamber 28 can be axially spaced from the distal end of the opening of the main body 18. This distance can correspond to or exceed the travel (axial movement) of the inner housing 14 during wetting or filling operations. Therefore, after the inner housing 14 has fully moved, the distal sealing mechanism 38 can remain in contact with the wall of the outer housing 12.

[0327] Figure 7 An exploded view of one embodiment of the inner housing 14 is shown, which includes a first component 14a and a second component 14b connected together by a threaded portion 14c. It will be understood that the specific structure of the inner housing 14 may vary, and in some embodiments, it may be provided by an integral structure or component that uses alternative methods of connection, such as push-fit or bayonet structures.

[0328] from Figure 7 As can be seen, one or more vents 40 may be provided in the side wall of the inner housing 14. The one or more vents 40 may provide an outlet for the wetting chamber 30, so that air discharged from the wetting chamber 30 can escape when the wetting agent flows upward or into the wetting chamber 30.

[0329] In some embodiments, opening the storage chamber 28 may be sufficient to wet the conduit, in which case, once the wetting chamber 28 has been opened, it is sufficient to remove the conduit 16 for use (optionally, the assembly is inverted between opening the chamber and removing the conduit to ensure adequate distribution of the wetting agent). In some embodiments, the wetting procedure for wetting the conduit 16 may include pumping or reciprocating action, wherein the wetting agent is pneumatically and / or hydraulically driven from the storage chamber 28 into the wetting chamber 30 and driven along the wetting chamber 30.

[0330] exist Figure 1a In the illustrated embodiment, the pumping action can be provided by axial movement of the inner housing 14 within the outer housing 12. The inner housing 12, which acts as a movable insert, can be configured to move axially to reduce the volume of the storage chamber 28, thereby pumping / driving the flow of wetting agent into the proximal end and wetting chamber 30 to wet the conduit.

[0331] Figures 6a to 6c The wetting operation of the catheter assembly 10 is shown, wherein the inner housing 14 moves axially from a first position to a second position along the longitudinal axis 22, causing the storage chamber 28 to open, and then driving the wetting agent distally along the catheter body 32. Figures 6a to 6c Actuation of the assembly with the cap 20 attached is shown; however, it should be understood that this may not be the case in some embodiments, and the cap 20 may be completely removed. Furthermore, the conduit assembly 10 is shown horizontally, but the assembly can be operated in a vertical orientation.

[0332] The wetting process consists of three main stages. Figure 6a The first stage shown is a closed or sealed configuration / position, wherein, for storage and transport purposes, the cover 20 is held onto the body 18 of the outer housing 12, and the storage chamber 28 is sealed and contains a wetting agent. Figure 6b In this phase, the cap 20 is released from the body 18, and the inner housing 14 moves axially distally through the cap 20, causing the proximal sealing mechanism 36 to move away from the opposing sealing surface provided by the body 18, and the flow path 42 opens to allow the wetting agent 44 contained in the storage chamber 28 to move to the proximal end of the body 18. This may be referred to as the infusion stage or filling stage, in which the wetting chamber 30 or the associated pre-infusion chamber 46 is prepared for wetting agent infusion driven along the catheter body 32. Figure 6b This can be referred to as the infusion configuration or infusion location.

[0333] When the movable insert, i.e., the inner housing, is in the filling position, care should be taken to ensure that the distal sealing mechanism 38 remains in contact with the inner wall of the body 18, thereby preventing the wetting agent from leaking from the storage chamber 28 to the outside of the conduit assembly 10. However, one or more vents may be provided at the distal end of the storage chamber 28, configured to allow gas communication between the storage chamber 28 and the rest of the conduit assembly 10. When the inner housing is in the filling position, one or more channels arranged between the storage chamber 28 and the vents are opened, allowing gas (i.e., air) to enter the storage chamber to displace the wetting agent. Typically, the assembly will be held vertically, or at least the closed end of the body will be lower than the cap, such that gravity helps allow the wetting agent to move to the closed end of the body and into the filling chamber. The optional rib 64, discussed below, also helps allow the wetting agent to move from the storage chamber 28 to the filling chamber.

[0334] Once the wetting agent 44 has moved into the closed end and filling chamber of the body 18, the inner housing 14 can be reinserted into the body 18, causing the wetting agent to be forced upwards along the fluid path 48 through the inlet into the wetting chamber 30 between the inner housing 14 and the conduit body 32. Air displaced from the wetting chamber 30 can be discharged from a suitable outlet that removes the displaced air from the conduit assembly. Figure 6c and 7 Examples of suitable outlets in the form of opening 40 are provided, which are disposed within the inner housing wall and located between the distal end of the inner housing 14 and the distal end of the body 28, so as to be exposed to the outside. In the illustrated embodiment, there are two radially opposing openings 40; however, there may be fewer or more than two openings 40. It should be understood that the size, shape, and location may also vary. The opening 40 shown in the embodiment is elliptical with a circumferentially extending major axis to allow for a larger aperture for a reduced axial length.

[0335] An inlet from the storage chamber 28 / infusion chamber 46 to the wetting chamber 30 is provided through the gap between the inner shell 14 and the conduit body 32. Figures 6a to 6c In the illustrated embodiment, a sheath 34 surrounds the catheter body 32, which may form and at least partially define a wetting chamber 30, or may be disposed within the wetting chamber. In this case, the inlet of the wetting chamber may be located between the catheter body 32 and the sheath 34. Additionally or alternatively, if an insertion guide 25 is included, the inlet may be determined by the gap between the insertion guide 25 and the catheter body 32. In another alternative, such as in a configuration without the sheath 34, the wetting chamber may be formed and defined at least partially by the inner surface of the inner housing 14. The inlet may be defined by the gap between the bottom end of the inner housing 14 and the catheter body 32.

[0336] In some embodiments, the inner housing 14 may reciprocate as the actuator rotates, thus moving back and forth several times. However, typically, a single distal-proximal circulation is sufficient to adequately wet the conduit body 32, thereby using the inner housing as a plunger.

[0337] As described above, the reciprocating motion of the inner housing 14 can be achieved by hand, allowing the user to directly manipulate the inner housing 14 distally and proximally along a linear axial path by pulling and pushing the inner housing 14 while restricting the outer housing 12. However, in some embodiments, it may be preferred to drive the movement of the inner housing 14 with an actuator.

[0338] The actuator, which may be referred to as the infusion actuation mechanism, can be any device capable of causing the desired axial movement of the inner housing 14. The inner housing 14 may be configured to move axially during rotation. In some embodiments, the actuator may include a cam drive or a crank, wherein the rotational movement of the inner housing 14 drives linear axial movement of the inner housing 14 relative to the body 18. The rotational movement of the inner housing 14 may be provided by a rotatable actuator, for example, in the form of a rotating cover 20.

[0339] In some embodiments, rotation of the cover 20 can be used to drive linear movement of the inner housing 14 and also to remove the cover 20 from the body 18. Therefore, rotation of the cover 20 may include a first stage and a second stage. The first stage may correspond to driving the inner housing 14 to open the storage chamber 28 and pumping wetting fluid around the conduit body 32. The second stage may correspond to releasing the cover 20 from the body 18 to expose the conduit 16 for use.

[0340] Simultaneous rotation and axial movement of the inner housing can be provided by one or more drive surfaces, which are driven by corresponding drive elements. For example, the chamber wall provided by the outer or inner housing may include one or more axially and circumferentially extending drive surfaces. The other of the chamber wall and the movable insert may include a drive element that engages with the drive surface to provide axial movement of the movable insert as the movable insert and the chamber wall rotate relative to each other. The drive surface may include a first axially facing surface / first axial end face provided by a radially projecting flange, rib, thread, rail, or guide. The drive element may include a second axially facing surface / second axial end face of a radially extending flange, rib, thread, rail, guide, or pin. The drive surface and drive element may be referred to as a cam driver.

[0341] Now we will combine Figure 7 , 8a 8b describes an embodiment of an actuator / injection starting mechanism having a drive surface and a drive element. Figure 7 An exploded perspective view of the inner housing 14 described in the above section is shown. Figure 8aA side view showing the drive surface in the form of a reciprocating track section of the inner housing. Figure 8b A schematic plan view of the reciprocating track 50 is shown, illustrating the general shape that a reciprocating track may have.

[0342] Figure 7 A perspective view of the inner housing 14 is shown, in which an elongated, thin-walled enclosure is provided, the enclosure having corresponding sealing seats 36d and 38d at opposite ends of a storage chamber 28 for a proximal sealing mechanism 36 and a distal sealing mechanism 38. The outer surface of the inner housing 14 includes a drive surface in the form of a track 50, which may be referred to as a plunger-type track / reciprocating track, and a corresponding drive element 52 attached to the outer housing 12 (not shown). Figure 8a The reciprocating track 50 may include a channel for receiving a drive element 52, which is in the form of a protrusion, such as a pin, extending from the inner surface of the outer housing 12 or an intermediate member. This channel may be provided by a pair of axially separated guide rails in the form of radially projecting walls 50a, 50b extending from the outer surface of the inner housing 14. The walls 50a, 50b may be parallel and joined to form a closed track. However, in some embodiments, the track 50 may include partial walls, depending on the desired actuation direction. That is, when the inner housing is driven distally, only the distal wall may be needed to provide the necessary drive surface, and vice versa.

[0343] It should be understood that in some embodiments, the track 50 may be disposed on the inner surface of the outer housing 12, and correspondingly, the drive element 52 may be attached from the outside of the inner housing 14. It should also be understood that the reciprocating track 50 and drive element 52 may include any suitable features to allow the necessary drive engagement, which converts rotational movement of the inner housing 14 into axial movement. Therefore, the track 50 and drive element 52 may include any combination of channels, grooves, ridges, protrusions, slots, notches, bearings, and gears to provide the drive surface and drive element.

[0344] The track 50 is positioned proximal to the distal sealing mechanism 38, such that it is located within the storage chamber 28. Positioning the reciprocating track 50 within the storage chamber 28 is optional, and in some embodiments, it may be positioned distal to or proximal to the distal sealing mechanism 38 and the proximal sealing mechanism 36. However, providing a reciprocating track within the storage chamber 28 allows for a shorter overall length of the assembly 10 and provides a convenient point for filling the storage chamber 28 with a wetting agent, as discussed further below.

[0345] In some embodiments, the conduit assembly 10 may include a filling hole in the outer housing such that a wetting agent can be introduced into the storage chamber 28 once the conduit assembly 10 is assembled. Therefore, the hole may be configured to be in fluid communication with the storage chamber 28. Back Figure 4 The diagram shows an opening 52a extending through the wall of the outer housing 12 (e.g., body 18) to provide an inlet to a storage chamber outside the conduit assembly 10. The opening 52a can be configured to receive any suitable nozzle or accessory connected to a wetting agent source and may be referred to as a port. However, it should be understood that the opening 52a can be a conventional circular through-hole.

[0346] In the described embodiment, the filling hole 52a is positioned such that it covers the track 50, allowing the drive pin 52 to be inserted (and optionally welded in place) after the filling process to plug the filling hole 52a, extending into the track 50 to achieve the function of the drive element 50. It should be understood that in other embodiments, the filling hole may simply be plugged, and the plug may not provide a drive element 52 for the actuator used to move the movable insert.

[0347] like Figure 4 As shown, although the inner housing 14 is typically spaced apart from the outer housing 12, the inner housing 12 can be tightly accommodated within the outer housing 12 such that the gap between the outer edge of the track 50 and / or rib and the inner surface of the outer housing 12 is minimized. Providing a minimum gap allows the track 50 and / or rib 64 to maintain concentricity between the inner and outer housings as the inner housing moves.

[0348] To allow the wetting agent to flow from the orifice 52a into the storage chamber 28, the proximal guide rail of the track 50 may include an interruption, such as the orifice 52b, as shown below. Figure 7 As schematically shown. Multiple interruptions may be present to provide a "hyphen" guide. It should be understood that any holes or interruptions will generally be located on a non-driven surface that does not require contact with the drive element 52 to actuate axial movement of the inner housing 14. In some embodiments, there may be no drive surface near the hole, particularly where a reaction force for axial translation of the movable insert is required on the distal side of the drive element 52.

[0349] As in Figure 8b As best seen in the schematic diagram, the reciprocating track 50 is elongated and extends from a first end point 54 corresponding to the closed configuration or position to a midpoint 56 corresponding to the filling configuration or position, and to a second end point 58 corresponding to the wetting configuration or position after the return trip. The track 50 may be generally cosine or U-shaped, extending from the first end 54 at the farthest position to the second point 56 at the nearest position, and then to the third point 58 at the farthest position, the third point 58 being circumferentially spaced from the first point.

[0350] The spacing between adjacent points 54, 56, and 58 provides for the axial movement of the inner housing 14 as it rotates. Therefore, the section 55 between the first end point 54 and the midpoint 56 at least partially defines the filling movement of the inner housing 14, where the proximal sealing mechanism 36 is open. The end section 59 between the midpoint or filling position 56 and the second end point or return wetting position 58 corresponds to the pumping movement, where the inner housing 14 is reinserted to drive the wetting agent from the filling chamber to the wetting chamber 30. The intermediate section 57 corresponds to the filling position, where the inner housing 14 extends beyond the outer housing 12, and the proximal sealing mechanism is open, allowing the wetting agent to flow into the filling chamber 56.

[0351] Track 50 can be continuously curved or include one or more straight sections. For example, as shown... Figure 8b As shown, track 50 includes straight sections for the first section 55 and the last section 59, which represent most of the transition between the farthest and nearest positions of the inner housing 14. The lower portion of track 50 is generally flat with little axial displacement, thus providing a dwell time during which the inner housing 14 rotates in an open configuration, thereby allowing sufficient time for the wetting fluid to drain from the storage chamber 28 into the infusion chamber 46 located near the proximal end of the body 18.

[0352] It should be understood that the term "straight section" used above refers to the axial trajectory of track 50 as shown in the front view when track 50 is leveled, such as... Figure 8b As shown. Track 50 itself will be continuously curved because it extends circumferentially around the longitudinal axis 22.

[0353] The ends 54 and 58 of track 50 may have trajectory variations, allowing the axial speed of movement along longitudinal axis 22 to be reduced at the start and end of movement, thereby providing an improved tactile experience for the user. In other words, introducing and withdrawing actuation with reduced acceleration and deceleration provides a less abrupt start and end to the actuation, offering an improved user experience. Furthermore, the lower axial speed provides a mechanical advantage at the start of movement against the axial movement resistance caused by the sealing mechanism.

[0354] In use, the inner housing 14 rotates, causing the drive element 52 to travel along the track 50. Since the drive element 52 remains fixed relative to the outer housing 12, the rotation of the inner housing 14 results in linear movement along the longitudinal axis 22 of the conduit assembly 10. As described above, the initial phase of movement in the proximal extension of the track 50 causes the inner housing 14 to move distally, thereby opening the proximal sealing mechanism 36. From there, the drive element 52 enters the rotating section 57, in which the wetting agent 44 is discharged from the storage chamber 28 with a reduced axial movement, and is then followed by a third section 59 of the track, which drives the inner housing distally and toward the infusion chamber.

[0355] The arrangement of the tracks 50 allows the inner housing 14 to rotate within a predetermined angular range in a single direction, i.e., a given rotation of the cover 20, resulting in a complete linear cycle of movement. The predetermined angular range can be any angle considered suitable for the cover 20 and the user experience.

[0356] The end of track 58 is provided with a closed end, so that once the drive element 52 contacts the closed end, the inner housing cannot rotate further. Thus, the actuator can be provided with a mechanical stop or rotation limiter to restrict the rotation of the inner housing. This provides mechanical feedback to the user to indicate that the infusion and / or wetting phase of the catheter has been completed and that the catheter can be removed. After the mechanical feedback, the cap 50 can be removed, and the catheter 16 can be taken out for use.

[0357] It should be understood that the degree / range of rotation will determine the magnitude of the force required to move the inner housing. Therefore, a shorter angular range, such as 90 degrees, will result in a faster movement of the inner housing and will require a greater force compared to a longer rotation, such as 270 degrees. The range of angular movement can be from 90 degrees to 360 degrees.

[0358] In embodiments where rotation of the inner housing 14 relative to the body 18 is achieved via the cover 20, the cover 20 and / or the inner housing may include one or more interlocking mechanisms to prevent the cover 20 and the inner housing 14 from being rotatably engaged. Multiple interlocking mechanisms may be present, and these interlocking mechanisms may be circumferentially distributed around the cover 20 on its inner surface.

[0359] Reference Figures 9a to 9cAs can be seen, the interlocking mechanism can be provided by corresponding interlocking protrusions 60a on the outer surface of the inner housing 14, received within corresponding grooves 60b in the inner surface of the cover 20. It can be seen that multiple interlocking mechanisms 60a, 60b can be evenly distributed around the outer periphery of the cover 20 and the inner housing 14 to provide multiple engagement points. This embodiment shows four interlocking mechanisms; however, there can be more or fewer. The grooves 60b are shown as being disposed in thicker sections of the wall of the cover 20 to maintain minimum thickness near the edge and provide necessary circumferential strength. However, this is not a limitation, and the grooves 60b can be disposed in different or other circumferential locations.

[0360] Interlocking mechanisms 60a and 60b may include torque-activated release devices such that when the rotational torque on the cover reaches a predetermined threshold, the interlocking mechanism releases, thereby allowing the cover 20 to rotate relative to the inner housing 14. Therefore, once the travel of the drive element 52 reaches the end of the drive surface and engages the rotation limiter, the increased torque and continued rotation of the cover 20 overcome the interlocking mechanism and allow the cover 20 to rotate relative to the inner housing 14. Once released, further rotation of the cover 20 allows it to be removed.

[0361] To provide torque-activated release, the interlocking mechanism may include a shaped portion configured to disengage when a given torque is exceeded. The shaped portions, consisting of a protrusion 60a and a recess 60b, may correspond to each other such that the surface of the recess 60b is in close contact with the protrusion 60a. When viewed in a plan view, the contact surfaces can be seen to be inclined relative to the tangent at the corresponding locations, making the protrusion triangular. Providing the tangentially inclined surfaces of the contact surfaces in this way provides a convenient way to control the torque threshold that the interlocking mechanism can withstand before release, allowing the interlocking mechanism to release when the drive element 52 reaches the end 58 of the reciprocating track 50.

[0362] The groove 60b and protrusion 60a can be configured to prevent rotational separation only; the axial engagement between the inner housing 14 and the cover 20 is provided by other features. Therefore, as... Figure 9c As shown, a groove 60b may be provided on the proximal edge of the cover portion 20 adjacent to the opening end. This provides an axial opening end for the groove 60b.

[0363] To prevent the cover 20 from being axially pulled away from the inner housing 14 in a distal direction, the cover 20 and / or the inner housing 14 may include an axially retaining feature that maintains a relative axial position to the inner housing 14 as the cover 20 rotates. In the described embodiment, the axially retaining feature is provided by a threaded portion 62a that engages with a threaded portion 62b on the outer surface of the inner housing 14. The threaded portion can be used to remove the cover 20 from the inner housing 14 after the reciprocating motion is completed and a torque threshold has been overcome. Removing the cover 20 from the threaded portion exposes the conduit for user manipulation.

[0364] The threaded portions 62a and 62b may include partial or full threads. Partial threads may include, for example, quarter-turn threads, wherein the cover 20 is removed after being rotated off from the inner housing 14 and after being rotated a quarter turn.

[0365] As described above, rotation of the cap 20 may include multiple stages. Rotation of the cap 20 may include an infusion step and a removal step. The infusion and removal steps may be sequential and achieved by rotating the cap 20 in the same direction of rotation. The sum of the first and second steps may correspond to the number of rotations required to wet the catheter and remove the cap 20. For example, a complete 360-degree rotation of the cap 20 may result in both wetting and removal of the cap 20. The wetting stage may include 270 degrees or three-quarters of a rotation, and the removal of the cap 20 may include a further quarter-turn. Other combinations of rotation numbers and rotation steps are also possible.

[0366] The drive element may include a plug received within a filling orifice of the storage chamber 28. Therefore, the body 18 may include at least one hole extending through its outer wall, providing an inlet to the internal volume of the storage chamber 28 through which wetting fluid may be received. The hole may be configured to receive the drive element / plug 52 after the filling process. Therefore, the hole may be opposite the first end 54 of the track.

[0367] The internal volume of the catheter assembly can be sterilized after assembly. To maintain the sterility of the internal volume, the catheter assembly may include an airtight sealing mechanism. The airtight sealing mechanism may include the outer surface of the catheter assembly, or may include one or more sealing mechanisms located within the cap 20 and / or the body 18. The airtight sealing mechanism can be disrupted by rotation of the cap relative to the body. Back Figure 5 The diagram illustrates airtight sealing mechanisms 66 and 68 disposed on either side of the joint between the body 18 and the cover 20. Sealing mechanisms 66 and 68 may be similar to other sealing mechanisms described herein and include a resilient sealing element retained within a sealing reservoir.

[0368] When the cap 20 is removed from the body 18, the airtight sealing mechanisms 66 and 68 can be destroyed. Therefore, rotating the cap 20 to initiate the transition from a sealed configuration to an infusion configuration can destroy (i.e., open) sealing mechanisms 66 or 68. As the inner housing 14 moves distally with the rotation of the cap 20, sealing mechanism 68 will open first, thus destroying the airtight seal before the cap 20 is actually separated from the inner housing. However, the distal sealing mechanism 38 will prevent the wetting agent from leaving the distal end of the storage chamber, thereby placing the catheter assembly in a leak-proof infusion configuration. This is advantageous because it allows the catheter assembly 10 to be temporarily set aside once infused, allowing the user to briefly set the catheter aside after opening, for example, to adjust position and / or clothing before removing the catheter from the outer housing (or even longer, for example, to open the door before returning to catheter insertion).

[0369] Back Figure 7 As can be seen, the inner housing 14 may be provided with optional ribs 64. Ribs 64 may be included to maintain the separation of the inner housing 14 and the outer housing 12 defining the storage chamber 28. Therefore, ribs 64 can help guide the inner housing 14 during axial and rotational movement. Ribs 64 can also assist in the pumping action of the inner housing 14 when the inner housing 14 is reinserted into the outer housing 12. Thus, ribs 64 can drive the wetting agent proximal into the closed end and upward into the wetting chamber 30.

[0370] Ribs 64 may extend circumferentially around the inner housing 14. Ribs 64 may be discontinuous in the circumferential direction, allowing flow paths to be maintained between adjacent ribs 64. It can be seen that these ribs 64 may be arranged along the length of the inner housing 14. In the illustrated embodiment, three sets of ribs 64 are arranged at regular intervals along the length of the inner housing 14. Each set of ribs 64 includes four separate circumferential sub-ribs, which are positioned at a common axial location above the circumferential line, wherein the ribs have the same angular length. It should be understood that the specific arrangement of the ribs may vary in other embodiments.

[0371] exist Figures 10a to 10f The figures illustrate the sequence of infusion, wetting, and cap removal rotation, showing the main steps involved in removing the catheter from the embodiment catheter assembly.

[0372] Figure 10a The catheter assembly 10 is shown in a closed, pre-activated configuration, wherein the airtight sealing mechanism is intact and the internal cavity of the outer housing 12 is sterile. Figure 10bThe first step is illustrated, in which the cover 20 rotates through an initial rotation phase. This initial rotation of the cover 20 causes the inner housing 14 to rotate via a non-rotatable engagement provided by interlocking mechanisms 60a and 60b. This rotation of the inner housing 14 results in the inner housing 14 and the cover 20 moving axially distally along the drive surfaces provided by the track 50 and drive element 52. Figure 10c As shown, the distal movement of the inner housing 14 opens the airtight sealing mechanism 68, and the proximal sealing element 36a transitions into the expansion portion, thereby opening the flow path of the wetting agent, as... Figure 10d As shown. At this point, the wetting agent flows into the infusion chamber 44 located near the proximal end of the body 18, and the conduit assembly is infused. Continued rotation of the cap 20 moves the inner housing 14 back into the body 18, at which point the rib 64 pumps the wetting agent upward from the infusion chamber 44 to the wetting chamber inlet, which is located between the inner housing and the insertion guide (if present) and the conduit body 32. Once the drive element 52 reaches the end of the drive surface provided by the track 50, further rotation is impossible without increasing torque. Thus, some mechanical feedback is provided to the user that the conduit 16 has become wet. The above actions are performed by a single user action, namely by rotating the cap 20 in a common direction using a substantially constant torque.

[0373] Following this first rotation of the cap 20, the cap 20 is further rotated to release the torque that activates the interlocking mechanism, thereby allowing the cap 20 to move relative to the inner housing 12 via the threaded portions 62a, 62b. After removing the cap 20, the catheter 16 can be gripped and axially removed via the external manipulating surface on the outlet end 26 of the catheter 16 for use. With the sheath 34 in place, the sheath 34 will be in the deployed position, with the catheter 16 contained therein, to maintain its sterility during manipulation.

[0374] refer to Figure 1a and 3 The catheter 16 can be any suitable catheter known in the art. As shown, the catheter 16 may include a catheter body 32 and a funnel-shaped member 26.

[0375] The catheter body 32 may be an elongated, thin-walled structure extending longitudinally along the main axis 22 of the catheter assembly 10. The catheter body 32 may be made of a flexible material. The first end of the catheter body 32 may be closed with a hemispherical cap, forming the insertion end 24 of the catheter 16, the hemispherical shape facilitating insertion.

[0376] Near the insertion end 24, one or more drainage holes / discharge holes 33 may be provided. In this embodiment, the drainage holes 33 are elliptical, with their major axis parallel to the main axis 22. It should be understood that the size and shape of the drainage holes 33 may vary.

[0377] As is known in the art, the outer surface of the conduit body 32 can be functionalized to reduce the coefficient of friction of the conduit body 32 when wetted by a wetting agent. The outer surface of the conduit body 32 can be composed of or coated with a functionalized material; for example, the outer surface of the conduit body 32 can have hydrophilic properties. When a wetting agent is introduced, the hydrophilic properties are used to reduce the coefficient of friction of the outer surface.

[0378] The end of the conduit 16 furthest from the insertion end 24 is provided with a conduit outlet end 26. In this embodiment, the conduit outlet end 26 is configured as a funnel-shaped member 26 and is a separate component of the conduit body; in other embodiments, they may be integrally formed. The funnel-shaped member is cylindrical and has a first open end and a second open end. The first open end is configured to receive the conduit body 32 through the end furthest from the insertion end 24. The conduit 16 is configured to provide fluid communication between the drainage orifice 33 and the conduit outlet end 26.

[0379] One or more protruding ribs may project radially from the outer surface of the funnel-shaped member 26. Figure 4 In one embodiment, two protruding ribs are provided; a first rib 35a is arranged proximally to the second end of the funnel-shaped member, and a second rib 35b is arranged between the first rib 35a and the first end of the funnel-shaped member. The second rib 35b is sized such that its outer diameter corresponds to the inner diameter of the distal end of the inner housing 14. The first rib 35a is sized such that its outer diameter is larger than the inner diameter of the distal end of the inner housing 14 and smaller than the inner diameter of the opening end of the cover 20. The arrangement of the two protruding ribs 35a, 35b can be provided to maintain the position of the conduit 16 relative to the inner housing 14; the second rib 35b ensures that the conduit 16 and the inner housing 14 are arranged coaxially, and the first rib 35a limits the extent to which the conduit 16 can be inserted proximally into the inner housing 14 along the main axis 22.

[0380] The outer surface of the funnel-shaped member in the area between the second end of the funnel-shaped member and the first rib 35a can be textured to provide a gripping surface for the user. When the outer surface of the funnel-shaped member between the second end of the funnel-shaped member and the first rib 35a is used as a gripping surface, the protruding rib 35 provides an additional function, providing separation between the user's fingers and the (wetted) conduit body 32.

[0381] As mentioned above, Figure 1a and 3 An optional sheath 34 is also shown. The sheath is formed of a flexible material and is arranged around the conduit body 32. A first end of the sheath is coupled to the funnel-shaped member near the first open end of the funnel-shaped member, and a second end of the sheath is coupled to the insertion guide 25. The insertion guide 25, or a portion thereof, is made of an elastically deformable material.

[0382] In use, after completing the wetting cycle and removing the cap 20, the user removes the wetted catheter 16 from the catheter assembly 10. By holding the gripping surface of the funnel-shaped piece 26 and the insertion guide 25 (if present), the user inserts the catheter body 32 into a tube, vessel, channel, body cavity, etc., to remove fluid from it.

[0383] With the sheath 34 and insertion guide 25 in place, the user grasps the insertion guide 25 to guide the catheter body 32. The user squeezes the insertion guide 25, deforming it to engage with the catheter body 32, restricting axial movement of the catheter body 32 through the insertion guide 25, and inserting the first portion of the catheter body 32 exposed from the sheath 34 into the tube, vessel, channel, body cavity, etc. Once the first portion of the catheter body 32 has been inserted, the user releases their grip on the insertion guide 25, allowing it to return to its original shape, and slides the insertion guide 25 away from the insertion end 24 along the catheter body 16, retracting a portion of the sheath 34 and exposing the second portion of the catheter body 16. This process is then repeated, with the user squeezing the insertion guide 25 to restrict movement of the insertion guide 25 relative to the catheter body 16 and movement of the second portion of the inserted catheter body. This process is repeated until the catheter body is fully inserted into the tube, vessel, channel, body cavity, etc.

[0384] Figure 11 An axial exploded view of the catheter assembly 210 according to the present invention is shown. Figure 12 An external view of the conduit assembly 210 in a sealed configuration is shown. The conduit assembly 210 includes an outer housing 212, a wetting agent reservoir 228, and a conduit 216. The outer housing 212, the wetting agent reservoir 228, and the conduit 216 are arranged concentrically such that the conduit 216 is located within the reservoir 228, which is radially nested within the outer housing 212.

[0385] The outer housing 212 includes a body 218 and a cover 220. At least a portion of the storage chamber 228 and the conduit 216 are housed in the body 218. The cover 220 is removable so that it can be removed by the user before use. Removing the cover 220 exposes the conduit 216 for removal from the outer housing 212 for use.

[0386] The main body 218 may also include a catheter body section 219 and a storage chamber section 221. The catheter body section 221 receives the catheter body 232 of the catheter 216. The storage chamber section 221 receives a storage chamber 230. The catheter body section 219 and the storage chamber section 221 may be separate components attached together to provide the main body portion 218, or may be provided as part of an integral / combined structure. It should be understood that a portion of the storage chamber section 219 may receive a portion of the catheter body 232, and the catheter body section 221 may receive a portion of the storage chamber 228. Typically, the catheter body section 221 will provide the proximal end of the outer housing 212.

[0387] The outer housing 212 provides a closed volume in which the catheter 216 can be housed for storage and transport prior to use. The body 218 and the cap 220 provide a sterile cavity in which the catheter 216 is located. The outer housing 212 is generally elongated and has a longitudinal axis 222, which serves as the main axis of the catheter assembly 210 and is coaxial with the longitudinal axis of the storage chamber 228 and the catheter 216.

[0388] The enclosed volume provided by the outer housing 212 is defined by the outer wall of the outer housing 212, which extends from a first proximal end 213 of the insertion end 224 of the receiving catheter 216 to a second distal end 215 of the outlet end 226 of the receiving catheter. In the illustrated embodiment, the second end 215 is provided by a cap 220. Therefore, removal of the cap 220 exposes the outlet end 226 of the catheter 216, allowing the user to grasp the catheter 216 and remove it from the outer housing 212 for use.

[0389] The outer contour of the outer casing 212 can be any contour required for aesthetic or functional purposes, and can incorporate external features similar to those of the outer casing 12 described above. Therefore, the outer casing 212 can be generally cylindrical, for example, tapering towards a first end to facilitate insertion of a storage container or bag, and tapering towards a second end along the length of the cap 220. Furthermore, as... Figures 2a to 2c As shown, the cover 220 can be temporarily stored on the opposite end of the outer casing 212.

[0390] An airtight sealing mechanism can be provided between the cover 220 and the body 218 to maintain the internal volume of the outer housing 212 aseptic before use. The airtight sealing mechanism may include a sealing element, such as an O-ring seal / sealing mechanism 297b disposed between the body 218 and the cover 220, as... Figure 13 As best illustrated, in this case, the O-ring seal is located on the circumferential sealing surface on the outside of the body 218, and when the cover 220 is sealed, this circumferential sealing surface faces the corresponding circumferential sealing surface on the inside of the cover.

[0391] Alternatively, the airtight sealing mechanism may be provided by a tamper-proof connection or band between the body 218 and the cover 220. Figure 12 An example of an airtight sealing mechanism 297a formed as a tamper-proof strip is provided. The sealing mechanism 297a includes a portion of the outer surface of an outer housing 212. Thus, the outer housing 212 may include a body 218, a cover 220, and the airtight sealing mechanism 297a. The airtight sealing mechanism 297a / b may be configured such that rotating the cover 220 destroys the sealing mechanism 297a. Destroying the sealing mechanism 297a / b can be performed during an infusion step, which places the catheter assembly in an infusion configuration.

[0392] Storage chamber 228 provides a reservoir for storing wetting agent before wetting conduit body 232. Storage chamber 228 is located at the distal end of conduit body 232 such that when the conduit is removed from housing 212, conduit body 232 can be drawn out through the wetting agent held within storage chamber 228. Alternatively or additionally, when storage chamber 228 is opened, the wetting agent can flow along the outer surface of conduit body 232 (as in the preceding embodiments, conduit body 232 may be functionalized to be hydrophilic) towards the closed end of body 218.

[0393] Reference Figure 13 Storage chamber 228 surrounds conduit 216 and includes chamber walls 231, 235 sealed against sealing surfaces 239, 241 provided on conduit 216, providing an annular closed volume in which the wetting agent is stored before use. First and second sealing mechanisms 233, 237 are used to seal the storage chamber walls 231, 235 against conduit 216, the first and second sealing mechanisms 233, 237 being axially separated and potentially positioned at the distal and proximal ends of storage chamber 228. Since conduit 216 seals storage chamber 228, it can be considered to form part of storage chamber 228.

[0394] Therefore, the conduit 216 includes a movable insert that allows it to move relative to the storage chamber wall 231. The conduit 216 may be configured to move axially during rotation. Rotation of the conduit 216 can be achieved by rotating the cover 220. In this way, the cover 220 and the conduit 216 can be engaged non-rotatably.

[0395] The chamber walls 231, 235 may include multiple components that are combined together to provide a sealed outer wall, thereby providing a closed volume that is sealed against the conduit 216.

[0396] The storage chamber section 219 may be configured to prevent relative rotation of the storage chamber 228. Therefore, when the conduit 216 is forced to rotate within the storage chamber 228, the storage chamber section 219 prevents the storage chamber 228 from rotating about the longitudinal axis 222. Thus, the conduit 216 passing through the storage chamber 228 may rotate relative to the outer housing 212 and the storage chamber 228 during release and / or wetting.

[0397] Storage chamber section 219 may also be configured to prevent axial movement of storage chamber 228 during release and / or wetting. The axial holding force of storage chamber 228 may be limited below a predetermined threshold such that when the axial tensile force exceeds the predetermined threshold, storage chamber 228 is released from housing 212 and can move axially.

[0398] from Figure 13 As can be seen, the storage chamber 228 can be an elongated structure extending coaxially along the longitudinal axis 222 to define an annular cavity for storing wetting agent. The annular cavity is defined by a radially outer wall and an axial end wall extending between the radially outer wall and the conduit 216. The end wall may extend from the end of the radially outer wall in the normal plane of the longitudinal axis 222, but this is not limiting, and other configurations are contemplated. The end wall may include or terminate at the radially inner edge of an axially extending annular flange at either end or both ends of the storage chamber. Embodiments of these will be described in more detail below.

[0399] As described above, the movable insert is configured to move axially relative to the chamber wall 231 along the longitudinal axis 222. Movement of the conduit 216 allows it to switch between a first position and a second position. In the first position, the storage chamber 228 is sealed by a sealing element 233a located between the chamber wall 231 and the conduit 216. The sealing element 233a is aligned with the sealing surface 233b in the first position. In the second position, the sealing element 233a is configured to be axially misaligned with the sealing surface 233b. Thus, the sealing mechanism 233 can be opened in the second position, or, as described below, the compression of the sealing element 233a can be reduced, allowing the storage chamber 228 to remain sealed, but the conduit 216 can be more easily removed to wet the conduit body 232. Although the sealing element 233a and the sealing surface 233b are shown positioned on the chamber wall 231 and the conduit body 243 respectively, different configurations are possible, and they can be reversed.

[0400] The first and second sealing mechanisms 233 and 237 are axially separated and seal against a portion of the conduit 216. At least one of the movable insert (e.g., a portion of the conduit 216) and the chamber wall 231 may include an expansion portion over which the sealing element 233a passes when switching between a first sealing position and a second infusion position. The expansion portion increases the distance between the chamber wall 231 and the movable insert at the axial position of the sealing element 233a when in the second infusion position. This distance may be a radial distance relative to the longitudinal axis 222. The expansion portion may include a widened cavity adjacent to the sealing surface 233a. The expansion may be provided by a stepped or tapered portion adjacent to the sealing surface.

[0401] Figure 14a and 14b A side view of the conduit 216 is shown, in which the first sealing mechanism 233 and the second sealing mechanism 237 are shown in cross section. Figure 14a The location of conduit 216 in the sealing / storage configuration is shown. Figure 14b The catheter 216 is shown in a perfusion configuration. The perfusion configuration is a configuration in which the catheter 216 is configured to be removed from the outer housing during the second stage of catheter 216 deployment (the first stage is perfusion).

[0402] Reference Figure 13 , 14a In 14b, the first sealing mechanism 233 and the second sealing mechanism 237 can be provided by opposing sealing elements 233a and 237a positioned abutting their respective sealing surfaces 233b and 237b on the conduit 216. The sealing surfaces 233b and 237b can be considered as the primary sealing surfaces.

[0403] In the described embodiment, sealing surfaces 233b and 237b are provided by the catheter body 243. Therefore, the body 243 constitutes a movable insert and is disposed between the outlet end 236 of the catheter 216 and the catheter body 232. As shown, the catheter body 243 may have an increased radius compared to the catheter body 232 and is shaped to provide sealing surfaces 233b and 237b.

[0404] The catheter body 243 may extend to the distal end of the catheter 216 and is an extension thereof. The distal end of the catheter body 243 may provide an outlet for the catheter 216, which may be shaped externally and internally to provide an external manipulating surface and internal flow-enhancing features. Therefore, the exterior of the catheter body 243 may include an external manipulating surface comprising a plurality of grooves that facilitate manipulation of the catheter by a user's fingertips. The inner surface may also include a funnel-shaped portion that expands in the flow direction. These features of the catheter 216 are combined... Figure 1a and Figure 3 The above has already been described, so it will not be described further here.

[0405] A first sealing surface 233b is disposed at the proximal end of the catheter body 243 and the storage chamber 228, and provides a raised portion against which the sealing element 233a abuts when in a sealed configuration. The raised portion includes a first diameter D233, which is larger than the diameter d233 of adjacent portions of the catheter body 243 on the proximal and optionally distal sides. Thus, the sealing surface 233b is separated by a stepped portion or chamber in the contour of the catheter body 243.

[0406] In the example shown, the sealing surface 233b and the adjacent portion are shown as cylindrical. Therefore, the sealing surface 233b includes a cylindrical surface with a first radius, and the adjacent proximal surface is provided by a second radius smaller than the first radius. Thus, as... Figure 14b As shown, relative axial movement between the conduit 216 and the sealing element 233a held by the storage chamber 228 causes the sealing element 233a to move away from the sealing surface 233b and reach the proximal adjacent surface defined by the diameter d233. This results in either separation between the sealing element 233a and the adjacent surface, or reduced contact that allows the storage chamber to be sealed but makes the conduit easier to withdraw. Figure 14b As shown, the sealing contact is maintained while the compressive forces on the conduit body 243 and conduit 216 are reduced, thereby reducing the axial holding force. At this point, the proximal axis of the conduit body 243 can provide a second proximal sealing surface 233c. Therefore, in the sealing configuration, the sealing mechanism 233 can be used to provide increased sealing pressure, which helps reduce evaporation losses in the storage chamber 228.

[0407] The distal sealing mechanism 237 includes a distal sealing element 237a that is sealably positioned against a sealing surface 237b provided by the conduit body 243. In contrast to the proximal sealing mechanism 233, the distal sealing surface 237b is provided with a constant cross-section, such that the sealing mechanism 237 remains constant when there is relative axial movement between the conduit 216 and the storage chamber 228.

[0408] As shown, the distal sealing surface 237b may be defined by a radially upright portion that positions the sealing element 237a within a defined axial range of the catheter body 243. The radially upright portion may be provided as part of a groove in the surface of the catheter body 237, one or more flanges, or an increase in the diameter of the catheter body 243. Figure 14a and 14b A distal sealing surface 237b is shown, which has a combination of a radial flange disposed on the right proximal side and a diameter enlargement disposed on the left distal side, wherein the seat of the sealing surface 237b is configured as a groove extending between the first sealing mechanism 233 and the second sealing mechanism 237 in the surface of the axial section of the conduit body 243.

[0409] like Figure 13 and 14b As shown, when the catheter 216 is moved distally to be removed from the outer housing 212 (as indicated by the arrow at the center of the catheter body 243), the distal sealing element 237a is held by the radial upright portion to remain around the catheter body 243. When the catheter is withdrawn / removed, the proximal sealing element 233a is held by the storage chamber 228.

[0410] It should be understood that the storage chamber 228 may include a feature structure that holds the sealing elements 233a and 237a in place and radially pushes the sealing elements 233a and 237a inward to provide a seal. For example, the sealing elements 237a and 233a may be held by a sealing reservoir and may be overmolded. The following is in conjunction with... Figure 16a Specific embodiments regarding the retention sealing element 233a are provided.

[0411] Sealing elements 233a and 237a may be of different sizes. More specifically, the proximal sealing mechanism 233 may include a larger sealing element 233a to allow for increased compression and increased contact area with the sealing surface 233b in the first sealing configuration.

[0412] Sealing elements 233a and / or 237a may comprise an elastic material. Sealing elements 233a and 237b may be O-rings. Alternatively, sealing elements 233a and 237a may be X-rings or U-cup seals.

[0413] The conduit 216 is configured to move axially relative to the outer housing 212 and the storage chamber 228. This allows the conduit 216 to be removed from the outer housing 212 for use, and also allows the conduit body 232 to pass through the wetting agent contained in the storage chamber 228. Therefore, the conduit 216 has a sealed (or storage) configuration and a filling configuration from which it is removed / withdrawn / retracted and wetted. The sealed configurations of the conduit assembly 210 and the conduit 216 are as follows: Figure 2a and 14a As shown. As mentioned above, Figure 13 and 14b The perfusion configuration before catheter 216 is removed is shown.

[0414] The movement of catheter 216 from a sealed configuration to an infusion configuration can be achieved by the user axially withdrawing catheter 216 in a distal direction. Withdrawal can be achieved by the user directly or indirectly (e.g., via cap 220) grasping the outlet end 226 of the catheter.

[0415] Axial retraction can be achieved using an actuator. This actuator may be referred to as an infusion actuation mechanism. The infusion actuation mechanism includes any means capable of causing the desired axial movement of the conduit 216 relative to the outer housing 212 and the storage chamber 228. In some embodiments, the infusion actuation mechanism may include a conduit configured to be rotatable such that rotation causes axial movement. The infusion actuation mechanism may include a cam drive or crank, wherein a drive surface engages a drive element such that relative rotation of the drive element or drive surface causes axial movement of the conduit 216 relative to the body 218. Rotational movement may be provided by a rotatable actuator such as a cap 220, which may engage non-rotatably with the conduit 216 as a movable insert.

[0416] Figure 15 One embodiment is shown in which the conduit body 243 is provided with a cam actuator 281. The cam actuator includes a drive surface in the form of a ramp structure provided by an axially facing end wall surface / axial end wall surface of the storage chamber wall 231, and a drive element including circumferentially extending fin-like portions 282, which extend axially and circumferentially to provide helical protrusions serving as threads / cams. The fin-like portions 282 engage with a corresponding ramp structure 284 disposed on the storage chamber 228, such that rotating the conduit 216 causes the fin-like portions 282 to travel along the ramp structure 284 and push the conduit 216 distally relative to the storage chamber 228.

[0417] Pushing the distal end of the conduit 216 causes axial sliding of the conduit 216 relative to the storage chamber sealing mechanisms 233 and 237, and movement of the proximal sealing element 233a and the associated sealing surface 233b, as described above. Figure 14a and 14b As stated above.

[0418] Rotation of catheter 216 can be achieved by the user grasping and rotating the external operating surface of catheter outlet end 226, or by rotating cap 220. Rotation of cap 220 can be achieved by providing a non-rotatable engagement between cap 220 and catheter body 243.

[0419] like Figure 13 and 15 As shown, a non-rotatable engagement can be provided by corresponding radial protrusions 286a and 286b on the catheter body 243 and inside the cap 220. The protrusions can take any suitable form and may include radially extending members in the form of ribs, flanges, projections, pins, posts, etc. As mentioned above, the protrusions serve a dual purpose, also helping to retain the cap 220 on the base of the body 218 during catheter insertion.

[0420] Reference Figure 11 and 15The cover 220 is also shown to include a threaded portion 288a that engages with a corresponding threaded portion 288b located on the outer side of the distal end of the body 218, so that the cover 220 can be releasably attached to the body 218.

[0421] When the conduit 216 is engaged with the cap 220 in a non-rotatable manner, rotating the cap 220 to remove it from the body 218 via threads 288a and 288b causes the conduit 216 to rotate and retract from the storage chamber 228 via the cam actuator 281. Therefore, rotation of the cap 220 relative to the body 218 causes rotation of the conduit 216. It can be understood that the pitch of the cam-driven rib / bevel structure will be the same as the pitch of the threads 288a and 288b.

[0422] Once the rotation of the cover 220 is complete, causing the threaded portions 288a and 288b to disengage, the cover 220 can be axially moved away from the body 218, and the protrusions 286a and 286b become axially separated. Once the rotation of the conduit 216 is complete, the fin-shaped portion 282 moves circumferentially at the end of the inclined structure and no further axial movement occurs.

[0423] although Figure 15 The illustrated infusion initiation mechanism includes multiple, for example, two helical fin-like portions 282 that engage with a corresponding number of inclined structures 284 on the storage chamber 228; however, it should be understood that the number of drive surfaces / drive elements can vary. Furthermore, the helical surface providing a cam-like action can be provided by any suitable structure, and the embodiments of fin-like portions and inclined structures are provided only as examples. For example, both the storage chamber 228 and the conduit 216 may be provided with inclined structures and / or fin-like portions, or some combination thereof. Other cam-like arrangements that convert rotational movement into linear axial movement can be provided, such as threaded portions similar to those provided for the engagement of the cover 220 and the body 218.

[0424] Figure 13 , 16a An embodiment of how the storage chamber 228 is constructed is shown in more detail in 16b. Thus, a storage chamber 228 provided by a multi-part structure is shown, wherein a first part 231 and a second part 235 are combined to provide the storage chamber wall. Figure 13 A two-part structure is shown, in which a first distal portion 231 is fitted onto a second proximal portion 235. The proximal portion 235 includes a radially extending wall that provides an axial end wall for a storage chamber compartment in which most of the wetting agent is located. The distal portion 231 includes a distal end wall for the storage chamber compartment and a wall that is radially outward.

[0425] The inner surface of the storage chamber wall includes a plurality of radial protrusions in the form of fins 290. The fins 290 are circumferentially distributed so as to be angularly separated from each other about a longitudinal axis 222. The fins 290 extend axially and radially, thereby lying in a plane defined by the longitudinal axis 222 of the conduit assembly. The fins 290 may be arranged in pairs radially opposite each other.

[0426] As can be seen, the radial inner edge 291 of the fin-shaped portion 290 can be located at a common radial distance from the central longitudinal axis 222 of the conduit 216, such that, when combined, the radial inner edge 291 of the fin-shaped portion 290 provides a guide tube to keep the conduit 216 and the storage chamber 228 concentrically aligned. The radius of the guide tube can correspond to or be larger than the proximal sealing surface 233b, so that the sealing surface 233b can pass through it unimpeded while maintaining concentricity.

[0427] The proximal axial edge 292 defining the axial range of the finned portion 290 may terminate without reaching the proximal end wall of the storage chamber 228, thus providing an edge 292 defining a gap in which the proximal sealing element 233a may be disposed. Therefore, the proximal axial edge 292 of the finned portion 290 collectively provides a seat against which the sealing element 233a can be positioned during assembly of the storage chamber 228 and during use, such that the proximal sealing mechanism is axially restricted during the transition of the conduit 216 from the stored position to the wetted position and during the retraction of the conduit 216.

[0428] although Figure 16a Only four finned portions 290 are shown in the sectional view, but it should be understood that fewer or more finned portions 290 may be used. It should also be understood that while the finned portions 290 provide a convenient structure where wetting agent can be stored between the finned portions 290, while providing suitable strength and surface area for guiding conduits and / or providing sealing seats, other structures may also be used. For example, the structure may be provided by any combination of protrusions such as ribs, pins, posts, or flanges.

[0429] As described above, the distal end of the storage chamber 228 may be provided with one or more feature structures that serve as part of the filling initiation mechanism 281. Therefore, as shown in the figure, Figure 16a and 16b The distal end of the storage chamber 228 includes a beveled structure 284 that engages with a spiral fin-like portion 282 disposed on the conduit body 243.

[0430] A beveled structure 282 is disposed at the end of an annular flange 293 extending from the main storage compartment. In the illustrated embodiment, the beveled structure 282 is provided by a triangular cutout in the annular flange 282, with the beveled side of the triangle providing a mating surface. The use of the annular flange 282 allows the beveled structure to be located radially near the conduit 216, which allows for a smaller corresponding fin portion 282. The annular flange 282 also provides a convenient location for a distal sealing mechanism 237, which is located between the beveled structure 284 and the distal radial wall of the main storage compartment of the storage chamber 228.

[0431] The attachment of the first part 231 and the second part 235 of the storage chamber 228 can be achieved by any suitable connection, such as: interference fit, such as push-in fit or click fit; by adhesion; welding; such as thread or clamp. Figure 13 , 16a The embodiment of 16b is shown as a snap-fit ​​connection, wherein components 231 and 235 are pushed and snapped together such that the circumferential ribs are located in the corresponding grooves.

[0432] The outer surface of the proximal portion 235 is configured to provide an insertion guide / insertion guide 225. Therefore, the outer surface can be circular and / or tapered, so that it can be used to comfortably position the insertion guide 225 at the entrance of the urethra.

[0433] More specifically, in some embodiments, the insertion guide 225 (which may be referred to as a gripper) may be an annular member that, when retracted, is located radially outside the catheter body 232 or catheter body 243. The radially outer surface of the insertion guide 225 may be configured to be gripped by a user's fingers and may include one or more surface features, such as annular grooves (not shown), to improve grip and user dexterity.

[0434] The insertion guide 225 is configured to remain outside the urethra when the catheter body 232 is inserted, and is therefore retractable. Thus, the catheter body 232 can pass through the insertion guide 225, allowing the insertion guide 225 to move posteriorly toward the outlet end 226 during insertion. When fully retracted, the insertion guide 225 can abut against the distal end of the catheter body 243.

[0435] Therefore, when the storage chamber contains the insertion guide 225, the storage chamber 228, together with the insertion guide 225, can be released from the outer housing when the conduit 216 is withdrawn.

[0436] The general procedures related to the insertion of catheter 216 and insertion guide 225 have been described previously and will not be repeated here.

[0437] In order to ensure that the insertion guide 225 can be correctly positioned at the insertion end 226 of the catheter to be used (e.g. Figure 11 As shown, when catheter 216 is removed and the proximal end of catheter body 232 is aligned with insertion guide 225, storage chamber 228 can be retained within outer housing 212. To facilitate removal of insertion guide 225 from outer housing 212 along with catheter 216, catheter assembly 210 may include an optional retractable sheath 234 located radially outside catheter body 232. Alternatively, insertion guide can be simply pulled out by hand.

[0438] Figure 11 and 19 A retractable sheath 234 in a retracted configuration is shown. The sheath 234 extends from an attachment 234a on the catheter body 243 to an attachment 234b on the distal side of the storage chamber 228. The sheath 234 is flexible and retracts with the insertion guide 225. Therefore, when the catheter 216 and the insertion guide 225 are located within the outer housing 212, the sheath 234 retracts as shown... Figure 11 The retracted configuration shown is provided, and when the conduit 216 is withdrawn / removed, the sheath unfolds from the retracted configuration to the unfolded configuration, in which the sheath is fully extended and used to secure the storage chamber to the conduit, such that continued withdrawal of the sheath 234 results in withdrawal of the storage chamber and the insertion guide 225.

[0439] It should be understood that in embodiments where the insertion guide 225 is not provided, the storage chamber 228 may not include the proximal annular flange formed as part of the proximal portion 235, and the storage chamber 228 may not be retained within the outer housing 212 when the conduit 216 is removed. In this case, the sheath 234 may also be omitted.

[0440] In order to remove storage chamber 228, storage chamber 228 can be removed via a releasable connector 295 (e.g., Figure 18 The storage chamber 228 (best shown in the diagram and described below) is held within the outer housing 212. When a predetermined amount of axial tension is applied or exceeded, i.e., an outward pulling force on the storage chamber, the releasable coupling 295 can release the storage chamber 228. Once the predetermined amount of axial tension has been applied or exceeded, the storage chamber can be released by the releasable coupling and removed from the outer housing.

[0441] Axial tension can be applied directly or indirectly to the storage chamber 228. Therefore, in some embodiments, a user can grasp the storage chamber 228 or a portion thereof and remove it together with the conduit 216. In some embodiments, the storage chamber 228 and the conduit 216 can be coupled together such that removal of the conduit 216 causes the storage chamber 228 to be removed from the outer housing 212. In some embodiments, the coupling between the storage chamber and the conduit can be provided by a connection device such as a retractable sheath 234.

[0442] To prevent the storage chamber 228 from rotating with the conduit 216 during the transition between the sealing and filling configurations, the storage chamber 228 can be fixed to the body 218 without relative rotation. Figure 16b An embodiment of the connector 295 configured to prevent relative rotation is described. Figure 16b The exterior of storage chamber 228 is shown; Figure 17 Storage section 219 is shown, which does not contain storage room 228; Figure 18 The combined storage chamber 228 and storage chamber section 219 are shown. As described below, the connector 295 can be configured to be a releasable connector, such that the connector 295 is released once a predetermined force threshold is exceeded in the axial direction.

[0443] The exterior of storage chamber 228 may be provided by an outer surface 294, which, in the described embodiment, is generally cylindrical. The outer surface 294 may include one or more anti-rotation and / or axially retaining features, such as one or more grooves. Multiple circumferential recesses may be provided, such as those provided by castellated annular grooves 296.

[0444] Storage chamber section 219 may include an elongated tubular member extending from a proximal end to a distal end. The outer surface of storage chamber section 219 may provide a portion of the outer surface of the outer housing 212 and / or provide one or more features for attaching the cover 220 to the body 218, such as the aforementioned threaded portion 288b, and / or provide for receiving... Figure 11 One or more feature structures 297 of the airtight sealing mechanism 297a shown may be disposed between the respective ends of the cover 220 and the body 218, and the airtight sealing mechanism 297a is irreversibly removed or broken when the cover 220 is removed, as is known in the art.

[0445] The interior of the storage chamber section 219 includes a cylindrical cavity 219a in which the storage chamber 228 is housed, and the interior of the storage chamber section 219 may include one or more features of the connector 295 for engaging the storage chamber 228 to prevent axial and / or radial movement of the storage chamber 228 relative to the housing 212.

[0446] The connector 295 portion provided by the storage chamber section 219 includes a plurality of circumferentially distributed claws 298, which are sufficiently rotationally rigid to prevent rotation of the storage chamber when engaged in the crenellated annular grooves 296. The claws are radially compliant, such that when the storage chamber 228 and the storage chamber section 219 are axially separated, the claws 298 bend outwards, thereby releasing the storage chamber 228. When the axial force is below a predetermined threshold, the claws 298 remain engaged with the crenellated / toothed grooves 296 on the outer surface 295 of the storage chamber wall.

[0447] Figure 17 and 18 The number of claws is eight. However, in some embodiments, this number may be greater or less than this number.

[0448] The crenellated groove 296 includes an annular groove extending around the outer surface 294 of the storage chamber 228 and is spaced / segmented to provide a circular array of recesses into which the tips of the claw portions 298 can be received. It should be understood that in other embodiments, the number of recesses may be fewer and more dispersed than shown.

[0449] The claw portion 298 includes a protrusion having a limb-like portion 298a and a distal portion 298b. The limb-like portion 298a extends axially from the radially extending inner surface of the storage chamber section 219 toward the proximal end of the body 218. The limb-like portion 298a extends from the distal fixed end to the proximal free end. The free end includes the distal portion 298b, which extends radially inward to provide a hook, which is received in a recess on the outer surface 294 of the storage chamber to provide a hook-and-loop connection. The radially inner surface of the receiving storage chamber 228 of the storage chamber section is flush with the inner surface of the receiving storage chamber of the cylindrical / cylindrical housing.

[0450] When viewed along the longitudinal axis in the direction toward the distal end, the radially inner edge of the proximal end of the claw tip portion 298b is tapered / recessed, so that when the storage chamber 228 is inserted into the storage chamber section 219 along the longitudinal axis, the claw 298 can more easily receive the storage chamber 228 and be pushed away by the storage chamber 228.

[0451] As described above, the releasable connection requires an increased axial force to initiate. This increased force ensures that the catheter body is fully removed, the storage chamber 228 / insertion guide 225 is correctly positioned relative to the insertion end, and the retractable sheath is fully extended. It also provides mechanical feedback to the user, indicating that the catheter has been fully removed and can be reinserted if necessary.

[0452] In some embodiments, where the storage chamber 228 remains within the outer housing 212 after the conduit 216 is removed, the storage chamber 228 may be attached to or formed as part of the outer housing 212, and the connector 295 may not be required.

[0453] During use, refer to Figure 2a As shown in the catheter assembly, the user can rotate the cap 220 to break the airtight sealing mechanism 297a / 297b. Rotation of the cap 220 causes rotation of the catheter 216 via a non-rotatable engagement provided by radial protrusions 286a and 286b. Rotation of the catheter 216 causes the drive surface and drive element provided by the cam driver 281 to axially separate the reservoir 228 and the catheter 216, and axially slide the proximal sealing element 233a to provide the catheter assembly in an infusion configuration. This requires a first step, in which a single action by the user, namely the rotation of the cap 220 in a first direction, changes the catheter assembly from a sealed configuration to an infusion configuration.

[0454] After the sealing mechanism 233 is disengaged, the conduit 216 can be axially withdrawn through the storage chamber 228, which functionally acts as a wetting chamber during withdrawal. If necessary, the conduit can be reinserted into the storage chamber 228 and withdrawn multiple times to ensure that the conduit body 232 is fully wetted before removal.

[0455] When the conduit 216 is combined with the insertion guide 225, the insertion guide 225 can be formed as part of the storage chamber 228 and can be removed from the outer housing 212 together with the conduit 216.

[0456] It should be understood that in the above embodiments, the catheter includes a movable insert that can be rotated to partially or fully axially release the sealing mechanism of the reservoir. This is advantageous because the mechanical advantages of using the infusion actuation mechanism allow for a tighter seal. Without the mechanical advantages of the infusion actuation mechanism, a tighter and more effective sealing mechanism would be difficult to move by hand, especially for weaker or less capable users.

[0457] According to another embodiment of the present invention, a catheter assembly 310 is provided.

[0458] Reference Figure 20 , 21a 21b and 21c, the catheter assembly 310 includes an outer housing 312 and a catheter 316. The catheter 316 includes a catheter body 332 and a sheath 334. The outer housing 312 and the catheter 316 are arranged concentrically such that the catheter 316 is located within the outer housing 312 in a radially nested configuration.

[0459] The catheter assembly 310 may be configured such that the catheter 316 can be wetted before being removed from the outer housing 312. A wetting agent is used to wet the catheter 316 before use and may be stored in a wetting agent storage chamber defined between the outer housing 312 and a first portion of the catheter 316. The wetting agent may be delivered to the catheter 316 through a wetting chamber defined between the outer housing 312 and a second portion of the catheter 316. The catheter 316 may be movable and may include a movable insert.

[0460] Refer again Figure 20 , 21a 21b and 21c, the outer housing 312 includes a body 318 and a cover 320, a portion of the catheter 316 is housed in the body 318, and the cover 320 contains a portion of the catheter 316, that is, it remains integrated with the catheter even during the insertion of the catheter and the release of urine from the body.

[0461] The outer housing 312 provides a closed volume in which the catheter 316 can be housed for storage and transport prior to use. The body 318 and the cap 320 provide a sterile cavity in which the catheter 316 is located. The outer housing 312 is generally elongated and has a longitudinal axis 322, which serves as the main axis of the catheter assembly 310. In this embodiment, unless otherwise stated, axial or radial should be considered relative to the longitudinal axis 322.

[0462] The enclosed volume provided by the outer housing 312 is defined by the outer wall of the outer housing 312, which extends from a first proximal end 313 of the insertion end 324 of the receiving conduit 316 to a second distal end 315 of the outlet end 326 of the receiving conduit. In the illustrated embodiment, the second end 315 is provided by a cap 320 and the outlet end 326, the cap 320 including a portion of the conduit 316. The cap 320 may provide an external operating surface that allows a user to remove the conduit 316 from the body 318.

[0463] The outer contour of the housing 312 can be any contour required for aesthetic or functional 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 320.

[0464] The cover 320 includes a generally cylindrical body with an end opening, the generally cylindrical body having a circumferential outer wall extending coaxially along a longitudinal axis 322, the circumferential outer wall being open at both ends. The cover 320 mates with the distal end of the body 318 such that the cover 320 is received within the distal end of the opening of the body 318. However, it should be understood that in some embodiments, the cover 320 may receive the open end of the body 318.

[0465] The outer housing 312 can be used to transport the conduit 316 ready for use, or to handle / dispose of the conduit 316 after use.

[0466] Reference Figure 20 , 22a 22b, the cap 320 may provide a sealing shell defining a wetting agent storage chamber 321 for a wetting agent (not shown). The wetting agent storage chamber 321 is formed between the cap 320 and a movable insert, in this embodiment provided by a connector 323, which includes a portion of a conduit 316 connecting a conduit body 332 to a conduit outlet 326, as will be described in detail below. Therefore, the connector 323 may be spaced apart within the outer housing 312 to define a cavity 321 between the connector and the outer housing.

[0467] The axial boundary of the wetting agent storage chamber 321 may be defined by a first radial protruding wall 327 and a second radial protruding wall 329 projecting from the inner wall of the cover 320. The first wall 327 may be arranged closer to the insertion end 324 of the conduit 316 than the second wall 329, and the second wall 329 may be arranged closer to the second distal end 315 of the body.

[0468] The first wall 327 and the second wall 329 may include one or more stepped portions. For example... Figure 22a and 22b As shown, the first wall 327 is formed as a component separate from the rest of the cover 320 and includes two stepped portions, namely a first stepped portion 327a and a second stepped portion 327b; the second stepped portion 327b is arranged radially inward and axially toward the insertion end 324 of the first stepped portion 327a. The two stepped portions in the first wall include a first section projecting radially inward and a second section extending axially toward the insertion end 324, thereby forming two tubular portions arranged coaxially with the cover 320. The second tubular section 327b' can form a first sealing surface 327b' for sealing the wetting agent storage chamber 321 (described in detail below). The second wall 329 may include one or more stepped portions. Figure 22a , 22b As shown, the second wall 329 includes a single stepped portion, a first portion 329a protruding radially inward from the inner wall of the cover 320, and a second portion 329b extending perpendicularly to the first portion 329a and axially toward the insertion end 324, thereby forming a tubular section coaxial with the cover 320 and arranged radially inward. The second portion 329b of the second wall can form a second sealing surface 329b for sealing the wetting agent storage chamber 321 (described in detail below). This cavity can be referred to as the wetting agent storage chamber 321 or reservoir 321.

[0469] Wetting agent storage chamber 321 in the first configuration (e.g.) Figure 22aThe first configuration is sealed, allowing the wetting agent to remain within, and is open in the second configuration (as shown). Figure 22b (As shown), this allows the wetting agent to flow out of the wetting agent storage chamber 321 and contact the conduit body 332. When in the open configuration, the internal volume of the wetting agent storage chamber 321 is in fluid communication with the wetting chamber 330, wherein the conduit body 332 is positioned such that the wetting agent can flow from the wetting agent storage chamber 321 to the wetting chamber 330, and thus to the conduit body 332.

[0470] Reference Figure 22a , 22b The connector 323 is radially nested within the cover portion 320, and these two components define a wetting agent reservoir 321. The connector 323 may include a tubular wall configured to form part of the wetting agent reservoir 321 defined on its radially outer side and part of a drainage path defined on its radially inner side (as described in detail below).

[0471] Connector 323 may include an elongated, thin-walled structure extending longitudinally along the main axis 322 of conduit assembly 310. Connector 323 includes an open first end and a closed second end near an outlet end 326, the open first end configured to receive conduit body 332. The second end of the connector may include a discharge port 331, an end wall 337, and a tab 339 for opening the discharge port 331. The end wall 337 may be a radially extending, axially facing disc having a first face that closes the second end of connector 323 and a second face opposite the first face. On the second face of end wall 337, the tab 339 may be provided in the form of a pull ring flexibly connected to end wall 337. Distributed on connector 323 near end wall 337 are one or more holes forming discharge port 331, which provides fluid connection between the interior of connector 323 and the exterior of conduit assembly 310.

[0472] As previously described, connector 323 is located radially within cover 320. To facilitate this, the shape and size of the radially outer surface of connector near the first opening end can be configured to rest within the second tubular section 327b' of cover, thereby forming a corresponding portion of the first sealing surface. To improve the sealing of the wetting agent reservoir, a sealing device, such as sealing element 370, can be provided. In the illustrated embodiment, the sealing element is provided in the form of an O-ring 370, which is arranged on the radially outer surface of connector within recess 371 to restrict movement of O-ring 370 relative to connector 323. Those skilled in the art will understand that the sealing element can also be provided on the first wall 327, or on both connector 323 and first wall 327.

[0473] To ensure that the wetting agent storage chamber 321 remains sealed during transport and storage, and to ensure that it is not accidentally deployed into the second configuration, the connector 323 and the first wall 327 may also include a retaining mechanism 380. The retaining mechanism 380 includes: a retaining clip 380a circumferentially disposed within the first sealing surface 327b' and projecting radially inward; and a corresponding groove 380b disposed on the radially outer surface of the connector 323. It should be understood that the shape and material of the retaining mechanism 380 can be selected to ensure that the retaining mechanism 380 disengages when a predetermined force is applied.

[0474] To further facilitate the arrangement of the cover 320 and the connector 323, the connector 323 may be provided with a plurality of protruding ribs 345 that project radially outward around the outer surface of the connector. For example... Figure 22a , 22b As shown, three ribs 345 are provided. A first rib 345a is arranged approximately halfway along the axial length of the connector 323, and a second rib 345b and a third rib 345c are arranged between the first rib 345a and the outlet 331. The first rib 345a extends such that its radial diameter is greater than the radial inner diameter of the second sealing surface 329b. The second rib 345b and the third rib 345c are configured such that they can slide axially within the second sealing surface.

[0475] The combination of the larger first stop rib 345a and the two smaller guide ribs 345b, 345c provides multiple functions. First, they provide a seal to prevent wetting agent leakage from the conduit assembly 310 during storage and transportation. Second, the guide ribs 345b, 345c guide the connector in a sealed configuration (such as...). Figure 22a (as shown) and open configuration (such as) Figure 22b As shown, the third rib 345c abuts against the second sealing surface 329b in the sealed configuration and the second rib 345b abuts against the second sealing surface 329b in the open configuration. The stop rib 345a limits the degree of distal axial movement of the connector 323 and the conduit body 332, preventing them from moving beyond the open configuration and being pulled out of the cover 320.

[0476] In use, the user pulls the tab 339. Once a predetermined force is applied, the retaining mechanism 380 disengages, causing the connector 323 and the conduit body 332 to move axially distally relative to the cover 320, thereby moving the wetting agent reservoir 321 from a sealed configuration to an open configuration. The O-ring 370 moves axially away from the first sealing surface 327b', thereby breaking the seal of the wetting agent reservoir 321.

[0477] As the connector 323 moves axially through the cover 320, it remains aligned by the second rib 345b and the third rib 345c, with at least one rib consistently abutting against the second sealing surface 329b. The extent to which the wetting agent reservoir can be opened is defined by the contact of the first rib 345a with the second sealing surface 329b.

[0478] Once the conduit 316 is in the open configuration, the wetting agent is released from the wetting agent storage chamber 321 into the wetting chamber 330, thereby wetting the conduit 316, as described below.

[0479] refer to Figures 21a-21c And 22a-22b, the conduit 316 can be any suitable conduit known in the art. In this embodiment, the cover 320 includes a portion of the conduit 316, and the cover 320 is formed by two components: a top cover 320a defining a radially outer wall / radially outer wall defining a wetting agent storage chamber and a bottom cover 327 forming a first wall 327.

[0480] As shown in the figure, the catheter 316 also includes a catheter body 332.

[0481] The catheter body 332 may be an elongated, thin-walled structure extending longitudinally along the main axis 322 of the catheter assembly 310. The catheter body 332 may be made of a flexible material. The first end of the catheter body 332 may be hemispherically closed, forming the insertion end 324 of the catheter 316, and the hemispherical shape facilitates insertion.

[0482] Near the insertion end 324, one or more drainage holes 333 may be provided, which serve as inlets for receiving urine from the patient's bladder. In this embodiment, the drainage holes 333 are elliptical, with their major axis parallel to the principal axis 322. It should be understood that the size and shape of the drainage holes 333 may vary.

[0483] As described in the previous embodiments, the outer surface of the conduit body 332 can be functionalized so that the coefficient of friction of the conduit body 332 is reduced when it is wetted by a wetting agent.

[0484] The end of the conduit 316 away from the insertion end 324 is provided with a conduit outlet end 326. In this embodiment, the conduit outlet end 326 is provided as part of a connector; in other embodiments, it may be a separate component. The conduit 316 is configured to provide fluid communication between the drainage port 333 and the discharge port 331.

[0485] Figure 20 and 21cOptional sheath 334 is also shown in 22a and 22b. The sheath is formed of a flexible material and is arranged around the conduit body 332. The sheath is attached at a first end to a first wall 327 of the cap 320 and at a second end to an insertion guide 325. The insertion guide 325, or a portion thereof, is made of an elastically deformable material.

[0486] In use, after completing the wetting cycle as described above, the user removes the wetted catheter 316 from the catheter assembly 310. By grasping the gripping surface of the cap 320 and the insertion guide 325 (if present), the user inserts the catheter body 332 into a tube, vessel, channel, body cavity, etc., to remove fluid from it.

[0487] With the sheath 334 and insertion guide 325 in place, the user grasps the insertion guide 325 to guide the catheter body 332. The user squeezes the insertion guide 325 to deform it, thereby engaging it with the catheter body 332 to restrict axial movement of the catheter body 332 through the insertion guide 325 and inserting the first section of the catheter body 332 exposed from within the sheath 334 into a tube, vessel, channel, body cavity, etc. Once the first portion of the catheter body 332 has been inserted, the user releases their grip on the insertion guide 325, allowing it to return to its original shape, and slides the insertion guide 325 away from the insertion end 324 along the catheter body 316, retracting a portion of the sheath 334 and exposing a second section of the catheter body 316. This process is then repeated, with the user squeezing the insertion guide 325 to restrict movement of the insertion guide 325 relative to the catheter body 316, and then inserting the second section of the catheter body. Repeat this process until the catheter body 316 is fully inserted into the tube, blood vessel, channel, body cavity, etc.

[0488] In this embodiment, catheter 316 is a female urinary catheter 316 configured for insertion into the bladder of a female patient via the urethra. After insertion into the patient's bladder, fluid enters the interior of the catheter body 16 through drainage hole 333, flows through catheter 316 to discharge port 326, and is discharged at discharge port 326.

[0489] Once the bladder is emptied, the catheter 316 can be removed from the bladder and urethra and returned to the body 318 for disposal / disposal as described above.

[0490] 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.

[0491] For example, although these embodiments are all female intermittent catheters, with exemplary lengths ranging from 90 mm to 200 mm, such as from 130 mm to 155 mm, for example, approximately 135 mm, and the catheter assembly has a length corresponding to the catheter length, such as a shell closure length ranging from 2 mm to 10 mm longer than the catheter length (e.g., 10-25 cm; in the range of 140 mm to 165 mm, for example, 142 mm), it is believed that this teaching can be applied to male intermittent catheters (which are typically longer) or even other types of catheters. Similarly, although these embodiments have functionalized hydrophilic surfaces that become smooth when wetted with a wetting agent such as water, the wetting agent can alternatively be a lubricant.

Claims

1. A catheter assembly, comprising: catheter; A housing having an internal cavity, the catheter being housed within the internal cavity, the housing including an airtight sealing mechanism for maintaining the internal cavity in a sterile state before use; The wetting agent chamber is located in the internal cavity; and, The catheter assembly is configured to deploy the catheter in both the first and subsequent second steps. The first step includes breaking the airtight seal and filling the wetting agent chamber to place the conduit assembly in a leak-proof filling configuration, the conduit being configured to be wetted by the wetting agent in the leak-proof filling configuration; and... The second step includes removing the conduit from the housing; The catheter assembly further includes an infusion initiation mechanism configured to perform the first step using a single action of the user, wherein the infusion initiation mechanism includes a movable insert that partially defines the wetting chamber, the movable insert being movable between a sealing configuration and an infusion configuration during the first step, wherein the movable insert is provided by the catheter.

2. The catheter assembly according to claim 1, wherein, The first step and / or the second step additionally wets the catheter body of the catheter.

3. The catheter assembly of claim 1 further includes an infusion initiation mechanism configured to perform the first step using a single action of the user.

4. The catheter assembly according to claim 1, wherein, The housing includes a cover and a body, wherein the cover and the body remain engaged during the first step.

5. The catheter assembly according to claim 3, wherein, The infusion initiation mechanism includes a movable insert that partially defines the wetting agent chamber, the movable insert being configured to move between a sealing configuration and an infusion configuration during the first step.

6. The catheter assembly according to claim 1, wherein, The wetting agent chamber includes a wetting agent storage chamber.

7. The catheter assembly according to claim 5, wherein, The movable insert is configured to move axially during rotation.

8. The catheter assembly according to claim 5, wherein, The movable insert is provided by the catheter.

9. The catheter assembly according to claim 1, wherein, The first step requires a first actuating force, and the second step requires a second actuating force, wherein the first actuating force and the second actuating force are different, and wherein the first actuating force and the second actuating force are one or both of the following: in different directions and with different amounts.

10. The catheter assembly of claim 1, wherein, The catheter includes an insertable portion that is not in contact with the wetting agent prior to the first step.

Images