Intermittent catheter

Abstract

The intermittent catheter (16), preferably a female intermittent catheter, is provided in an assembly. The assembly may include a cap (15) that may be attachable to the body of the assembly during use, and / or a seal that is offset against the chamber wall and the sealing surface of the movable insert during use. The assembly may have a two-step deployment and / or a sheath that is withdrawn from the storage chamber. The inner housing (14) and outer housing (12) may define a storage chamber. The housing may have a fill hole, and / or the storage chamber may have an insert configured to move axially in response to rotation.

Description

[Technical field]

[0001] The present invention relates to intermittent catheters (eg, urinary catheters). [Background technology]

[0002] A catheter is a medical device having a hollow catheter tube intended for insertion into a lumen, blood vessel, passageway or body cavity to allow the infusion, drainage or withdrawal of fluids or substances therefrom, or to hold open said tube, blood vessel, passageway, etc. Urethral catheters are designed for use in insertion through the urethra into a user's bladder to drain the bladder.

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

[0004] Some catheters are supplied pre-wet in the packaging, e.g., the catheter is at least partially immersed in a wetting agent in the packaging. While this may ensure that the catheter tube is sufficiently wetted before use, this arrangement is disadvantageous in that components of the catheter other than the catheter tube, such as the gripping element or funnel, also get wet. This negatively impacts the user's experience, in which it may be difficult to hold the catheter tube and orient it as required. This is particularly problematic when the user is performing self-catheterization. Furthermore, submerging the catheter in water may substantially shorten the shelf life of the catheter, as the catheter components are exposed to moisture for extended periods of time.

[0005] It would therefore be advantageous to provide a catheter that can be wetted at or shortly before use.

[0006] In an attempt to address this, some catheters are provided in packaging that includes a rupturable container or pouch within the packaging that the user can burst to release the wetting agent. Typically, the user squeezes the packaging to break the container or pouch. However, such an arrangement creates problems similar to those described above if the wetting agent is allowed to come into contact with other components of the catheter. Such an arrangement also introduces the possibility that the catheter tube may not be fully wetted, or may not be wetted at all, prior to use, which may be detrimental to the user.

[0007] It would therefore be advantageous to provide a catheter that includes a means for delivering wetting agent only to the catheter tube, improving the user experience.

[0008] In a further prior art solution, the catheter may be packaged within a packaging which includes a wetting device. During use, when the catheter is removed from the packaging, the catheter tube is moved through the wetting device, thereby allowing the catheter tube to be wetted. An example of such a catheter is shown in PCT application number PCT / IB2018 / 001539 in the name of ConvaTec Limited. Summary of the Invention [Problem to be solved by the invention]

[0009] However, due to packaging constraints, such wetting devices can only contain a small amount of wetting agent, and therefore it remains possible that the catheter tube may not be completely wetted in such a solution, especially if the catheter is near the end of its shelf life and some of the solution has evaporated.

[0010] In the case of mechanisms that wet the catheter tube from the distal end, an insufficient amount of wetting agent may result in the tip not being wetted at all, which is undesirable since the tip is introduced into the urethra first and insufficient wetting prior to use is most likely to cause injury.

[0011] Additionally, a minimum catheter length is required for regulatory approval, and it is desirable to ensure that length can be wetted while minimizing impact on package size.

[0012] It is an object of an embodiment or embodiments of the present invention to overcome or at least partially alleviate one or more problems of the prior art and / or to provide an improved intermittent catheter. [Means for solving the problem]

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

[0014] One aspect of the present disclosure provides a catheter assembly having an outer housing having a body and a cap. The body and cap may form a sterile cavity for receiving a catheter. The catheter may be configured to be removable from the outer housing during use. The body may be elongate having an open end and a closed end. The cap and the closed end of the body may have corresponding mating surfaces such that the cap is attachable to the closed end of the body.

[0015] One aspect of the invention provides a catheter assembly having an outer housing having a body and a cap, the body being elongated with an open end and a closed end, the cap and the closed end of the body having corresponding mating surfaces such that the cap is attachable to the closed end of the body.

[0016] The body and the cap may form a sterile cavity for receiving the catheter. The catheter may be configured to be removed from the outer housing when in use.

[0017] One aspect of the invention provides a catheter assembly including an outer housing having a body and a cap, the body and cap forming a sterile cavity for receiving a catheter configured to be removed from the outer housing during use, the body being elongated in shape with an open end and a closed end, the cap and the closed end of the body having corresponding mating surfaces such that the cap is attachable to the closed end of the body.

[0018] Providing a cap that can be attached to the closed end of the body provides a convenient place to store the cap while the catheter is in use.

[0019] The cap may be configured to be attached to the closed end of the case during use of the catheter. Thus, during use, the cap may be removed from the body to expose the catheter, and then pulled from the outer housing and placed over the closed end of the body. The cap may be retained over the closed end of the body while the catheter is in use. After use, the catheter may be replaced within the body and the cap may be replaced to store the catheter for disposal.

[0020] The temporary attachment of the cap to the body may be resilient enough to withstand a reasonably expected amount of handling during removal and use of the catheter, for example, the outer housing may be temporarily placed on a surface during use of the catheter.

[0021] The mating surface may be any surface that allows the cap to be retainably attached to the closed end of the body. The mating surface may be provided by an inner surface of the cap and an outer surface of the body.

[0022] The inner surface of the cap may have a radial projection. The radial projection or projections may be ribs or may be pips, pins, fins, etc. The ribs may extend longitudinally. The radial projection may provide at least a portion of a mating surface. The radial projection may mate with an outer surface of the body upon installation of the cap on the body. The radial projection may be arranged to engage a catheter within the outer housing when the cap and body form a sterile cavity. The radial projection may be arranged to rotate the catheter upon removal of the cap from the body.

[0023] One or both of the mating surfaces may have an overmold element. The overmold element may have a layer, ring, or insert disposed on the inner surface of the cap. The overmold element may have a layer, ring, or protrusion disposed on the outer surface of the body. The overmold element may be constructed of a softer material than the corresponding mating surface (i.e., an overmold element disposed on the inner surface of the cap may be constructed of a softer material than the body, or alternatively, an overmold element disposed on the outer surface of the body may be constructed of a softer material than the cap).

[0024] The mating surfaces may engage via an interference fit. The interference fit may be provided by a suitable amount of contact area between the mating surfaces to allow a frictional engagement suitable for retaining the cap on the body. An interference fit may also be referred to as a resistance fit.

[0025] The inner surface of the cap and the outer surface of the body may correspond in shape to one another. The mating surfaces may have a corresponding taper. The taper may be a uniform taper such that the angle of taper is constant along its length.

[0026] The outer housing may be suitable for an intermittent catheter. The catheter may be a female intermittent catheter. The length of the catheter may be between 90mm and 200mm. The catheter may have a length between 100mm and 150mm, such as between 130mm and 155mm, such as about 135mm. The catheter assembly may have a length corresponding to the length of the catheter. For example, the length of the catheter assembly, i.e. the closed length of the casing, may be between 2mm and 20mm, such as between 2mm and 15mm, such as between 2mm and 10mm, longer than the length of the catheter. The catheter assembly (when closed) may have a length between 10cm and 25cm, or may have a length between 11cm and 16cm, such as between 140mm and 165mm, such as 142mm.

[0027] The outer housing may be suitable for a catheter assembly. The outer housing may be manufactured, imported and sold separately from the catheter. The catheter assembly may include the catheter.

[0028] The body and / or the cap may be rigid. The rigidity of the body and cap may be configured to be resiliently deformable to facilitate an interference fit of the cap onto the closed end of the body.

[0029] The outer housing may be constructed of plastic. The outer housing may be constructed of thermoplastic. The cap and body may be constructed of different materials. The outer housing (optionally cap or body) may be constructed of polycarbonate, the outer housing (optionally cap or body) may be constructed of polyethylene, the outer housing (optionally cap or body) may be constructed of nylon. Preferably, the outer housing (optionally cap or body) may be constructed of polypropylene.

[0030] In an aspect, the disclosure may provide a method of using a catheter assembly having an outer housing having a cap and a body. The body may have a first end to which the cap is sealably attached prior to use, and a second end. The method may include 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 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 replacing the catheter within the body following removal of the catheter from the body. The method may further include unscrewing the cap from the second end of the body and replacing the cap on the first end of the body. The method may include twisting the cap to loosen it from the body. Twisting the cap may rotate the catheter within the assembly. The catheter may be rotated by a radial protrusion on the cap, which may engage a corresponding radial protrusion on the catheter, e.g., the catheter. The radial projection of the cap may further engage the second end of the body when the cap is attached to the second end of the body.

[0031] One aspect of the present disclosure provides a catheter assembly having a longitudinal axis. The catheter assembly may include a catheter and a wetting agent storage chamber. The wetting agent storage chamber may include a chamber wall and a movable insert. The movable insert may be configured to move axially along the longitudinal axis relative to the chamber wall between a first position and a second position.

[0032] The first position may correspond to a closed configuration in which the storage chamber is sealed by a sealing element. The sealing element may be between the chamber wall and the movable insert. The sealing element may be configured to align a sealing surface of the chamber wall with the movable insert in the first position.

[0033] The second position may be a position in which the seal is configured to be axially offset from at least one of the sealing surfaces.

[0034] One aspect of the disclosure provides a catheter assembly having a longitudinal axis, the catheter assembly including a catheter and a wetting agent storage chamber, the wetting agent storage chamber having a chamber wall and a movable insert, the movable insert configured to move axially along the longitudinal axis relative to the chamber wall between a first position and a second position, in the first position the storage chamber is sealed by a sealing element located between the chamber wall and the movable insert, the sealing element configured to align with sealing surfaces of the chamber wall and the movable insert in the first position, and in the second position the seal is configured to be axially offset from at least one of the sealing surfaces.

[0035] Advantageously, providing a seal to enclose the reservoir reduces the amount of wetting agent that is lost through evaporation or leakage prior to use. This is beneficial in that it increases the certainty that sufficient humectant will be present at the end of the shelf life, and because less margin is required, the storage chamber may contain less humectant, resulting in a smaller reservoir and therefore a smaller overall package.

[0036] Providing a catheter assembly having a storage chamber that is sealed with a configurable sealing element such that it is aligned with a sealing surface in a first position and misaligned with a sealing surface in a second position provides a seal with improved functionality.

[0037] For example, in some embodiments, the seal may be open in the second position to allow a flow path for the wetting agent to flow to a further chamber, such as a wetting chamber or a priming chamber, and thus the sealing element may be configured to act as a valve to open the storage chamber.

[0038] In some embodiments, the seal may remain in place in the second position such that the storage chamber remains functionally sealed, but the contact pressure exerted by the sealing element is reduced, allowing the mobile insert to be more easily extracted from the storage chamber when in the second position, while providing a tighter seal for transport and storage purposes when in the first position.

[0039] The sealing element may be an elastomeric material. For example, the seal may be a rubber seal or other suitable material. The sealing element may be an annular sealing element. The sealing element may comprise an O-ring. The sealing element may comprise an X-ring. The sealing element may comprise a U-cup. The sealing element may lie in a radial plane, e.g., a plane normal to a longitudinal axis of the catheter assembly. The sealing element may extend between diametrically opposed sealing surfaces. The O-ring may lie in a radial plane, e.g., a plane normal to a longitudinal axis of the catheter assembly. The sealing element may be provided in the form of a gasket.

[0040] The sealing element may be compressible. The compression of the sealing element in the first position may be greater than the compression in the second position.

[0041] The sealing element may be disposed in a sealing element housing, either in the chamber wall or in the movable insert. The sealing element housing may have a groove or channel provided in the chamber wall or in the movable insert. The groove or channel may be provided in part by one or more catheter guide mechanisms provided in the radially outer wall, the axial end wall, and / or in the storage chamber. The sealing element may be overmolded to be an integral part of the storage chamber or the movable insert. One or more of the sealing surfaces may be provided by the sealing element housing. At least one sealing surface may slidably oppose the sealing element. The at least one sealing surface may be referred to as a primary sealing surface.

[0042] The catheter assembly may further comprise a wetting agent. When in the second position, the wetting agent may be sealed in the storage chamber by the sealing element maintaining sealing contact with a secondary sealing surface adjacent the (primary) sealing surface. Alternatively, in some embodiments, a flow path may be provided between the sealing surface and the sealing element such that when in the second position, the wetting agent may flow out of the storage chamber.

[0043] At least one of the movable insert and the chamber wall may define a diverging portion through which the sealing element passes when transitioning between the first and second positions such that a distance between the chamber wall and the movable insert at an axial position of the sealing element is increased in the second position compared to the first position. This distance may be a radial distance relative to the longitudinal axis. The diverging portion may comprise a widening of the cavity adjacent the sealing surface. The cavity may be of a storage chamber and / or an adjacent chamber. The adjacent chamber may be provided within the body. The adjacent chamber may house a catheter tube. The adjacent chamber may be a priming chamber or a wetting chamber.

[0044] The bifurcated portion may have a step, taper, or chamfer in the wall surface adjacent the sealing surface. The sealing surface may have 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 greater than the second diameter. The adjacent wall portion may be proximate the insertion end of the catheter. The adjacent wall portion may be a secondary surface.

[0045] At least one sealing surface may be a primary sealing surface. A portion of the chamber wall or the movable insert having a second diameter may be a secondary sealing surface. Thus, when in the second position, the sealing element may contact and seal with the secondary sealing surface. Due to the increased spacing between the movable insert and the chamber wall at the location of the secondary sealing surface and the sealing element, the contact pressure between the secondary sealing surface and the sealing element may be reduced. That is, the sealing element may be provided in a compressed state in the first position and in a decompressed state in the second position.

[0046] A catheter may be disposed within the storage chamber. The catheter may be coaxially nested within the storage chamber. The catheter may be nested within a chamber wall to provide a portion of the storage chamber. The catheter may sealably extend within the chamber through openings at axially opposed ends of the storage chamber.

[0047] The movable insert may be configured to move relative to the chamber wall to a third position where the catheter is wetted with the wetting agent. The movable insert may be configured to move in a first direction from the first position to the second position and from the second position to the third position. The first direction may be rotational and / or axial. The movable insert may move in a second direction from the first position to the second position and in a third direction from the second position to the third position. The second and third directions may be opposite to each other. The second and third directions may be axial. The movable insert may be configured to move simultaneously in a rotational and axial direction.

[0048] The catheter assembly may further include a wet chamber. The wet chamber may be located radially inward of the storage chamber. The catheter may be coaxially nested within the wet chamber. The outer housing, the storage chamber, the wet chamber and the catheter may be concentrically disposed on the longitudinal axis and axially aligned.

[0049] The catheter assembly may further include a priming chamber. The priming chamber is in flow sequence with the storage chamber and the wet chamber. The priming chamber may be located proximal to the storage chamber and the wet chamber. The priming chamber and / or the wet chamber may be separated from the storage chamber by a sealing element. The priming chamber may receive the wetting agent from the storage chamber prior to delivery to the wet chamber.

[0050] The storage chamber and the wet chamber may be separate chambers. The storage chamber and the wet chamber may be separated by an inner housing. The inner housing may be disposed in spaced apart relationship within the outer housing to provide the storage chamber.

[0051] The storage chamber may be a wet chamber. The wet chamber may be defined as a cavity in the catheter assembly in which a wetting agent can contact the outer surface of the catheter tube. The wetting agent may be applied to the catheter tube as it is withdrawn from the storage chamber, in which case the storage chamber may be considered to be or may include a wet chamber.

[0052] Alternatively, if the storage chamber and the wet chamber are separate chambers, the wetting agent may flow and / or be pumped along the wet chamber and the portion of the catheter tube. In that case, the wetting agent may flow through the sealing element. A priming chamber may be located between the storage chamber and the wet chamber and may receive the wetting agent before it passes through the wet chamber. The priming chamber may be provided at a proximal end of the body of the outer housing.

[0053] When in the second position, the sealing element may maintain a seal between the chamber wall and the movable insert.When in the second position, the sealing element may be separated from the at least one sealing surface to provide a flow path for the wetting agent through the sealing element.

[0054] A wetting agent may be provided in the wetting chamber when in the second position and / or in the priming chamber.

[0055] The movable insert may have an inner housing that may define a storage chamber and a wet chamber.

[0056] The catheter assembly may include a plurality of seals. The plurality of seals may include a proximal seal proximal to an insertion end of the catheter. The plurality of seals may include a second seal. The second seal may be axially spaced distally from the proximal seal. The distal and proximal seals may be located radially between the movable insert and the chamber wall. The distal and proximal seals may have respective distal and proximal seal elements and sealing surfaces.

[0057] The distal seal may maintain sealing contact in the first position and in the second position.

[0058] The catheter assembly may further include a pump configured to pump a wetting agent into the wet chamber. The movable insert may include a pump. The inner housing may include a pump. The inner housing may include one or more pump strengthening features. The inner housing may include a plurality of circumferentially extending fins. The movable insert may be movable from a second position to a first position and may pump a wetting agent into the wet chamber.

[0059] The catheter may have a catheter tube providing an insertion end for insertion into a patient, and an exit end having one or more external handling mechanisms.

[0060] The movable insert may be provided by the catheter. For example, a portion of the catheter may provide the movable insert. The portion of the catheter may be a portion other than the catheter tube, for example a funnel or an additional body. The storage chamber may be adjacent the outlet end of the catheter.

[0061] The catheter assembly may further include an actuator for moving the movable insert relative to the storage chamber. The actuator may be referred to herein as a priming mechanism. The actuator may include a rotatable actuator. Rotating the rotatable actuator may cause the movable insert to move relative to the chamber wall. The movement of the movable insert may be either or both of a rotational motion and an axial motion. The axial motion may be induced by rotation of the rotational actuator. The rotation of the rotatable actuator may be translated into an axial motion between the movable insert and the chamber wall.

[0062] The catheter assembly may further include a cam drive for translating rotation of the rotatable actuator into axial motion. The catheter assembly may further include a thread for translating rotation of the rotatable actuator into axial motion. The cam drive may include a thread or a portion of a thread. The actuator may include one or more drive surfaces and one or more corresponding drive elements that drivingly engage each other to provide the rotational-axial motion.

[0063] The catheter assembly may further include an outer housing having a removable cap. The rotatable actuator may include a cap.

[0064] The cap may be rotatably engaged to the movable insert such that rotating the cap rotates the movable insert.

[0065] The mobile insert may be configured to reciprocate upon rotation of the rotatable actuator.

[0066] The second position may be a wetting position configured such that the catheter is wetted with a wetting agent. Thus, when in the second position, the wetting agent may be in fluid communication with an outer surface of the catheter tube. The second position may be a priming position. When in the priming position, the catheter may be configured to be withdrawn from the storage chamber. In some embodiments, the priming position may correspond to a pre-pump configuration in which the wetting agent is pumped or otherwise displaced into the wetting chamber.

[0067] One aspect of the present disclosure provides a catheter assembly having 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 an airtight seal and priming at least the wetting mechanism to place the catheter assembly in a leak-proof primed configuration, and a second step of removing the catheter tube from the catheter assembly. The first and / or second steps may further wet the catheter tube.

[0068] One aspect of the present disclosure provides a catheter assembly including a catheter and a housing having an internal cavity in which the catheter is received. The housing may be an external housing. The housing may have an airtight seal to maintain sterility of the internal cavity prior to use. A wetting agent chamber may be disposed in the internal cavity.

[0069] Aspects of the present disclosure may provide a catheter assembly having a catheter. The catheter assembly may further include an outer housing having an interior volume in which the catheter is housed. The outer housing may have an airtight seal to maintain sterility of the interior volume prior to use. The catheter assembly may include a wetting agent chamber, which may have one or more wetting agent seals to maintain the wetting agent in the wetting agent chamber. The catheter assembly may be configurable to have a closed configuration in which the airtight seal is sealed and the wetting agent seal is sealed, and a priming configuration in which the airtight seal is opened and the one or more wetting agent seals are sealed.

[0070] One aspect of the disclosure provides a catheter assembly comprising a catheter and a housing having an internal cavity in which the catheter is received, the housing having an airtight seal for preserving sterility of the internal cavity prior to use and a wetting agent chamber disposed within the internal cavity, the catheter assembly configured to deploy the catheter in a first step followed by a second step, the first step including breaking the airtight seal and priming the wetting agent chamber to place the catheter assembly in a leak-proof primed configuration configured to wet the catheter with the wetting agent, and the second step including removing the catheter from the housing.

[0071] Providing a sealed configuration in which sterility of the internal volume is maintained and a primed configuration in which the catheter assembly is potentially not sterile but is maintained in a leak-proof primed configuration allows catheter deployment to be interrupted without risk of wetting agent leaking from the catheter assembly, which is advantageous if the user needs to temporarily place the catheter before withdrawing it and after breaking the airtight seal.

[0072] The housing may comprise an outer housing. The outer housing may comprise a body and a cap. The airtight seal may be attached to the body and / or the cap. The airtight seal may attach the cap to the body. The airtight seal may comprise an outer surface of the catheter assembly. Thus, the outer housing may comprise a cap, a body and an airtight seal. The airtight seal may be a tear strip that is broken during use so that the cap is manually removable. By rotating the cap relative to the body, the airtight seal may be broken and the wetting agent may be primed.

[0073] The first and / or second steps may further wet the catheter tube of the catheter. Thus, placing the catheter assembly in the primed configuration may wet the catheter even though the wetting agent is not in fluid communication with the exterior of the catheter assembly. Additionally or alternatively, the leak-proof condition may prevent fluid communication between the wetting agent and a portion of the catheter that constitutes a handling surface that is handled by the user in use. Thus, the handling surface may be maintained in a dry state before the catheter is removed from the housing. The handling surface may be provided by the outlet end of the catheter.

[0074] The catheter may be an intermittent catheter.The catheter may be a urinary catheter.The catheter may be a female intermittent catheter.

[0075] The catheter assembly may further include a priming mechanism. The priming mechanism may be referred to herein as an actuator. The priming mechanism may be configured to perform a first step with a single user operation. Thus, a user may operate the priming mechanism with a single actuation or motion, for example by moving a portion of the catheter assembly, for example by rotating or pulling, to break the airtight seal and prime the catheter assembly. The first step may include simultaneously breaking the airtight seal and priming the wetting agent chamber to place the catheter assembly in a leak-proof primed configuration.

[0076] The housing may be an external housing. The housing may be rigid. The housing may have a cap and a body. The cap and body may remain engaged during the first step. The engagement between the cap and the body may be a mechanical engagement where the cap is directly or indirectly attached to the body. For example, the cap may be attached to the body via an internal housing or other intermediate member.

[0077] The priming mechanism may include a cap that may be drivably rotatable relative to the body such that drivably rotating the cap breaks the air-tight seal and primes the wetting agent chamber.

[0078] The priming mechanism may have a drive surface and a drive element that engages the drive surface, such that rotational movement of the drive element or drive surface causes the other of the drive element or drive surface to translate axially, or vice versa.

[0079] The drive surface may extend axially and circumferentially. The drive surface may have a ramp and / or helical surface. The drive surface may have a first axially opposing surface or end wall surface provided by a radially projecting flange, rib, thread, track, or rail.

[0080] The drive element may have a second axially facing surface or end wall surface of a radially extending flange, rib, thread, track, rail, or pin.

[0081] The end wall surface may be an end wall surface of a chamber wall.

[0082] The drive element and drive surface are sometimes collectively referred to as a cam drive.

[0083] The priming mechanism may have a movable insert that partially defines the wetting agent chamber. The movable insert may be configured to move between a sealed configuration and a priming configuration during the first step. The movable insert may be configured to move axially upon rotation.

[0084] 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 a priming chamber. The wetting agent chamber may include a chamber wall and a movable insert.

[0085] Either the chamber wall or the movable insert may comprise the drive element or drive surface, and the other of the chamber wall and the movable insert may comprise the other of the drive element and drive surface.

[0086] The drive element may have a plug for blocking the hole. The hole may be a fill hole. The fill hole may be provided in an outer wall of the housing.

[0087] The mobile insert may be configured to move axially upon rotation. The cap may be rotatably engaged to the mobile insert such that rotation of the cap causes the mobile insert to rotate and translate axially.

[0088] The rotatable engagement between the cap and the movable insert may be disengaged following the first step. Disengagement of the rotatable engagement may be induced by further rotation of the cap. Thus, a user may rotate the cap in a first direction to prime the catheter assembly and further rotate the cap in the first direction to disengage the cap. Disengagement of the rotatable engagement may configure the cap for removal from the catheter assembly to expose the catheter for withdrawal.

[0089] The movable insert may be provided by the catheter (as outlined above).

[0090] The movable insert may have an inner housing located radially inward of the outer housing. The catheter may be disposed radially inward of the inner housing.

[0091] The inner housing may be radially disposed within the outer housing to define a storage chamber between the inner housing and the outer housing.

[0092] The catheter assembly may be configured to provide mechanical feedback to a user. The mechanical feedback may be an indication of the end of the first step. The mechanical feedback may be between the first step and the second step.

[0093] The first step may require a first actuation force and the second step may require a second actuation force. The first actuation force and the second actuation force may be different. Thus, transitioning between the first actuation force and the second actuation force may provide mechanical feedback to the user. The first actuation force and the second actuation force may be in different directions and / or of different magnitudes.

[0094] Mechanical feedback may be provided by one or more stops at which a change in actuation direction is required. Thus, the catheter assembly may have one or more limiters that limit the movement of the moveable insert or an actuator associated with the moveable insert.

[0095] The actuation of the catheter assembly required for the first and second steps may require the movement and / or removal of one or more parts. Thus, the first step may be actuated using a cap that is then removed before the catheter is axially withdrawn by the user.

[0096] The wetting agent chamber may comprise a wetting agent storage chamber. In some embodiments, the wetting agent storage chamber may comprise a portion of the catheter. In some embodiments, the wetting agent chamber may comprise a storage chamber and / or a wetting chamber and / or a priming chamber.

[0097] The wetting agent seal may be any seal or combination of seals used to seal a storage chamber, a wetting chamber, or a priming chamber. The wetting agent seal may have the sealing elements and sealing surfaces described herein.

[0098] In some embodiments, the catheter assembly may be configured to provide a wetting agent to the wetting chamber.The catheter assembly may have a third configuration in which the airtight seal is open and at least one wetting agent seal is open.

[0099] The priming configuration may relate to the storage chamber being primed so as to allow passage of a wetting agent disposed therein while the catheter is removed from within the storage chamber.

[0100] The outer housing may have a cap and a body to which the cap is attached. The attachment may be via an airtight seal. Rotating the cap relative to the body may break the airtight seal.

[0101] The wetting agent chamber may have a wetting agent storage chamber wall and a movable insert. A wetting agent seal may be provided between the wetting agent storage chamber wall and the movable insert. The seal may have a sealing element.

[0102] The catheter may have an insertable portion. Prior to the first step, the insertable portion may not be in contact with the wetting agent.

[0103] Prior to deployment of the catheter, e.g., during shipping and storage, it is advantageous for the insertable portion of the catheter not to be in contact with the wetting agent. The insertable portion of the catheter is often made of a material that interacts with the wetting agent, but this interaction should only occur immediately prior to use.

[0104] The catheter assembly may further include a wet chamber. The wetting agent may be in fluid communication with the wet chamber when the catheter assembly is in the primed configuration. The wetting agent may be in the wet chamber when the catheter assembly is in the third position.

[0105] The catheter assembly may further include a wet chamber seal disposed between the storage chamber and the wet chamber, the wet chamber seal being capable of opening when the catheter assembly is in the priming configuration.

[0106] The movable insert may be an inner housing in which the catheter is disposed. The movable insert may be a catheter. The catheter may be configured to be withdrawn from the wetting agent chamber and the outer housing when the catheter assembly is in the priming configuration.

[0107] The catheter assembly may further include an actuator for moving the moveable insert relative to the wetting agent chamber wall. The actuator may include a rotatable actuator. Rotation of the rotatable actuator may be translated into axial motion between the moveable insert and the chamber wall.

[0108] The catheter assembly may further include a cam drive for translating rotation of the rotatable actuator into axial motion. The catheter assembly may further include threads for translating rotation of the rotatable actuator into axial motion. The catheter assembly may further include a cap, and the rotatable actuator has a cap. The cap may be rotatably engaged with the movable insert such that rotating the cap rotates the movable insert.

[0109] The cap may be rotatably engaged with the moveable insert such that rotating the cap rotates the moveable insert. Rotating or pulling on the cap may break the airtight seal.

[0110] Further rotation of the cap or withdrawal of the catheter may open at least one wetting agent seal. Further rotation of the cap may be the same rotation that breaks the airtight seal.

[0111] One aspect of the present disclosure provides a catheter assembly having a catheter with a distal exit end and a proximal insertion end. The catheter assembly may further include a wetting agent storage chamber and a housing. The housing may be an external housing. The external housing may at least partially surround the catheter and the storage chamber. The catheter assembly may further include a sheath connected between the catheter and the storage chamber, such that retracting the catheter from the external housing retracts the storage chamber from the external housing via the sheath.

[0112] One aspect of the present disclosure provides a catheter assembly including a catheter having a distal exit end and a proximal insertion end, a wetting agent storage chamber, an outer housing at least partially enclosing the catheter and the storage chamber, and a sheath connected between the catheter and the storage chamber such that withdrawal of the catheter from the outer housing withdraws the storage chamber from the outer housing via the sheath.

[0113] Providing a sheath connected between the catheter and the storage chamber provides a convenient way to remove the storage chamber from the catheter after the catheter has been withdrawn through the storage chamber. Thus, the catheter tube insertable into the patient may be moistened with a wetting agent contained in the storage chamber while the catheter is withdrawn from the housing before / between storing the withdrawn catheter tube to help maintain sterility of the catheter tube prior to insertion into the patient. Furthermore, once the catheter is introduced into the urethra, it may be passed through the wetting agent storage chamber a second time to improve wetting of the surface of the catheter.

[0114] Furthermore, by providing a wetting mechanism that can be withdrawn from the outer housing by the sheath, the storage chamber allows the user to handle the wet catheter tube without risking contamination of the catheter tube. By providing the storage chamber as an insertion guide in this manner, space in the outer housing can be used efficiently and a supply of wetting agent can be increased.

[0115] The sheath may be a retractable sheath that may be stored in a stored configuration and deployed to an expanded configuration. The sheath may be expandable from a stored configuration in which the sheath is folded between the outlet end and a storage chamber to an expanded configuration in which the sheath is unfolded and includes a catheter tube of a catheter disposed therein.

[0116] The catheter and storage chamber may be held (e.g., attached) within the outer housing such that a first predetermined force is required to withdraw the catheter from the outer housing and a second predetermined force is required to disengage the storage chamber for withdrawal 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.

[0117] The catheter assembly may further include an insertion guide deployable at the insertion end of the catheter for use. The insertion guide may have an exterior handling surface and may aid in placement of the insertion end in the patient's urethra. The storage chamber may include an insertion guide.

[0118] The catheter assembly may further include a release mechanism arranged to releasably retain the storage chamber.

[0119] The release mechanism may include a releasable coupling between the outer housing and the storage chamber. The release mechanism may provide mechanical feedback for the user to withdraw the catheter and / or the storage chamber. Thus, the release mechanism may require a predetermined amount of force to actuate the releasable coupling. The predetermined amount of force may be a second predetermined force.

[0120] The releasable coupling may include one or more protrusions extending from either or both of the outer housing and the wetting agent chamber, which may be received in one or more corresponding recesses in the other of the outer housing and the wetting agent chamber.

[0121] There may be an equal number of releasable projections and recesses. The projections 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.

[0122] The first and second predetermined forces may be axial forces. The axial forces may be applied by a user via a catheter.

[0123] The protrusion may be elongate having a longitudinal axis. The protrusion may be configured to deflect away from the longitudinal axis when a second predetermined force is applied or exceeded.

[0124] The catheter may be elongate and may define a major longitudinal axis of the catheter assembly. The longitudinal axes of the projections may extend in the direction of the major longitudinal axis.

[0125] The catheter assembly may have a plurality of projections and recesses circumferentially distributed about the main shaft, which may combine to provide an annular clasp.

[0126] The deflection of the protrusions may be radially outward.

[0127] The release mechanism may be configured to prevent relative rotation of the outer housing and the wetting agent chamber such that rotation of a moveable insert within or forming part of the storage chamber does not result in relative rotation between the storage chamber and the outer housing.

[0128] The catheter assembly may further include a sealing element in the storage chamber and a movable insert received in the storage chamber. The sealing element may be disposed between the storage chamber and the movable insert, may be radially inward, and may be axially aligned with the plurality of protrusions and / or recesses. Axial alignment of the sealing element with a releasable coupling that positions the storage chamber relative to the housing may help maintain a seal provided by the sealing element.

[0129] One aspect of the present disclosure provides a catheter assembly having a catheter and a wetting agent storage chamber in which the catheter is disposed. The wetting agent storage chamber may have at least one protrusion configured to guide the catheter within the wetting chamber.

[0130] The at least one protrusion may guide the catheter through the wet chamber upon withdrawal of the catheter. The at least one protrusion may guide the catheter through the wet chamber upon reinsertion of the catheter through the wet chamber.

[0131] One aspect of the present disclosure provides a catheter assembly having a catheter and a wetting agent storage chamber in which the catheter is disposed, the wetting agent storage chamber having at least one protrusion configured to guide the catheter within the wetting chamber, the at least one protrusion retaining a sealing element within the wetting chamber.

[0132] By providing the storage chamber with one or more features, such as protrusions, for positioning the catheter within the wet chamber upon withdrawal or reinsertion, positioning of the catheter can be controlled, which provides improved wetting of the catheter tube of the catheter, and also ensures that the catheter does not get caught in the wet chamber upon reinsertion.

[0133] One aspect of the present disclosure provides a catheter assembly having a catheter and a wetting agent storage chamber in which the catheter is disposed. The wetting agent storage chamber may have at least one protrusion configured to retain a sealing element within the wetting agent storage chamber. The at least one protrusion may be configured to retain the sealing element within the wetting agent storage chamber upon withdrawal of the catheter.

[0134] Providing a storage chamber with one or more features, such as protrusions, for positioning a sealing element therein can provide a convenient way to position the sealing element and maintain its relationship with the catheter when the catheter tube of the catheter is withdrawn. This is beneficial because it ensures that the sealing element is correctly positioned when the catheter is reinserted into the wetting agent storage chamber and that the seal is maintained after reinsertion. It also avoids implementing a sealing element on the catheter, which can be obviously problematic when inserting the catheter into the urethra.

[0135] The at least one protrusion configured to retain the sealing element within the wet chamber may be at least one protrusion configured to guide a catheter within the wet chamber.

[0136] At least one of the protrusions may be a plurality of ribs or fins. The plurality of ribs or fins may extend axially and radially. At least one of the protrusions may have a plurality of pins or fins. At least one of the protrusions may have a plurality of seats. At least one of the protrusions may have a plurality of flanges. The plurality of protrusions may have any combination of ribs and / or fins and / or pins and / or seats and / or flanges.

[0137] The storage chamber may have an axially extending radially outer wall and at least one radially extending end wall. The storage chamber may have a first radially extending end wall and a second radially extending end wall. The end walls may have one or more tubular flanges extending axially therefrom.

[0138] The plurality of protrusions may extend from either or both of the radially outer wall or the at least one end wall. 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 distributed circumferentially. There may be at least two protrusions. There may be at least three protrusions. There may be at least four protrusions. There may be at least six protrusions. There may be at least eight protrusions. There may be four protrusions.

[0139] The catheter and the storage chamber may be concentrically aligned.

[0140] The projections may be shaped to define a gap. The gap may be defined by a discontinuity in the projection. The projections may extend only partially along an axial extent of the storage chamber. The gap may be partially defined by an axial edge of the projection. The gap may be partially defined by an end wall of the storage chamber. The discontinuity may be provided by a first portion of each projection extending radially inwardly a first amount and a second portion of each projection extending radially inwardly a second, lesser amount.

[0141] The wetting agent storage chamber may have at least one radially extending end wall and at least one protrusion extending axially within the wetting agent storage chamber, the at least one protrusion terminating short of the end wall to define a gap.

[0142] The catheter may define a longitudinal axis and each of the plurality of protrusions may lie in a plane defined by the longitudinal axis. The plurality of protrusions may be provided in diametrically opposed pairs.

[0143] The sealing element may be elastomeric. 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.

[0144] The O-ring may be disposed in the void. The void may define a seat for the sealing element. The axial edge of the projection may define a seat for the sealing element. The seat may axially restrain the sealing element during transition of the catheter from the stored position to the wetting position. The seat may axially restrain the sealing element during withdrawal of the catheter. This is beneficial as it ensures that the sealing element is correctly positioned during reinsertion of the catheter into the wetting agent storage chamber and maintains a seal after reinsertion. It also avoids implementing a sealing element on the catheter, which is obviously problematic during catheter insertion into the urethra.

[0145] The storage chamber may have two openings located at opposite axial ends of the storage chamber through which the catheter may pass. The protrusion may define a channel between the two openings. A radially inner edge of the protrusion may define a guide for guiding the passage of the catheter during withdrawal or repassage / reinsertion of the catheter.

[0146] The radially inner edge of the protrusion may define a guide for guiding passage of the catheter during withdrawal or repassage / reinsertion of the catheter. The guide may extend at least 50% of the distance between the two openings, preferably the guide may extend at least 80% of the distance between the two openings. The guide may extend at least 40% of the distance between the two openings. The guide may extend at least 50% of the distance between the two openings. The guide may extend at least 60% of the distance between the two openings. The guide may extend at least 70% of the distance between the two openings.

[0147] The spacing between the radially inner edges of adjacent protrusions may be less than the diameter of the catheter. Ensuring that the spacing between the radially inner edges of adjacent protection is less than the diameter of the catheter limits deviation of the catheter from the flow path defined by the protrusions.

[0148] The diameter of the guide may be approximately equal to the diameter of the opening or openings in the wet chamber.

[0149] The diameter of the guide may be approximately equal to the diameter of the sealing surface of the movable insert.The diameter of the guide may be greater than the diameter of the sealing surface of the movable insert.

[0150] One aspect of the present invention provides a catheter assembly having an outer housing, a catheter disposed within the outer housing, and a movable insert. The movable insert may be an inner housing disposed between the outer housing and the catheter. An outer surface of the inner housing and an inner surface of the outer housing together may define a lubricant storage chamber.

[0151] One aspect of the present invention provides a catheter assembly having an outer housing, a catheter disposed within the outer housing, and a movable insert having an inner housing disposed between the outer housing and the catheter, the outer surface of the inner housing and the inner surface of the outer housing together defining a wetting agent storage chamber.

[0152] Providing an internal housing between the external housing and the catheter may provide a convenient location for storage of a wetting agent. Such a location may provide a large volume for the wetting agent. Additionally, the location adjacent to the external housing may provide a convenient location for filling purposes following assembly of the catheter assembly. The internal housing may also be advantageously used to provide a wetting chamber around the catheter.

[0153] The inner housing may have an elongated tubular member that may be concentrically mounted within the outer housing.

[0154] The inner housing may be radially spaced within the outer housing to define a storage chamber therebetween. Either or both of the inner and outer housings may have at least one projection extending between the inner and outer housings.

[0155] The at least one protrusion may be an elongated rib.The at least one protrusion may extend circumferentially around the inner housing.

[0156] At least one protrusion may include an axial flow passage therethrough. At least one protrusion may extend only partially around the inner housing to provide an axial flow passage therethrough. At least one protrusion may have an annular rib. The annular rib may be discontinuous to provide a flow passage therethrough. The axial flow passage allows the protrusion to extend between the inner and outer housings to aid in positioning 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 passage may control the extent of axial flow such that the inner housing may be utilized as a pump.

[0157] The catheter assembly may have a plurality of protrusions, which may be axially distributed along the extent of the inner housing or the outer housing.

[0158] The at least one protrusion may extend from the inner housing such that the at least one protrusion is movable relative to the outer housing. When the inner housing and the protrusion are moved axially along the longitudinal axis relative to the wetting agent, the at least one protrusion urges the wetting agent in an advancing direction. Thus, the at least one protrusion may be configured to draw the wetting fluid from the storage chamber during axial movement of the inner housing.

[0159] The at least one protrusion may extend between the outer housing and the inner housing with minimal clearance, and thus the at least one protrusion may be configured to radially position the inner housing while permitting axial movement therein.

[0160] The outer housing may have a fill hole in fluid communication with the storage chamber. The outer housing may have a cap and a body. The fill hole may be provided in an outer wall of the body. The fill hole may be configured to receive a plug. The catheter assembly may further include a plug.

[0161] The catheter assembly may further include an actuator for moving the inner housing. The actuator may be referred to as a priming mechanism. The actuator may include a drive surface against which the drive element acts to move the inner housing. The drive element may include a plug.

[0162] Either the drive element or the drive surface may be provided on either a chamber wall of the storage chamber or on a movable insert received within the chamber wall. The other of the drive element and the drive surface may be provided on the other of the chamber wall and the movable insert. The drive surface and the drive element may be configured such that relative rotation of the movable insert and the chamber wall results in axial movement of the movable insert or the chamber wall.

[0163] The catheter assembly may further include a wetting agent in the storage chamber and in contact with the outer housing and the inner housing.

[0164] The movable insert may be movable between a sealed configuration and a priming configuration. Upon movement to the priming configuration, the storage chamber may open to provide a flow path for the wetting agent to exit the storage chamber. The flow path may extend into the priming chamber or the wetting chamber in which the catheter is disposed.

[0165] The catheter assembly may have one or more vents. The storage chamber may have one or more vents. The one or more vents may be air inlet vents configured to allow gas to enter the storage chamber to replace the wetting agent upon exiting the storage chamber. The one or more vents may be internal to the outer housing or external to the outer housing. Movement of the movable insert may open the one or more vents. Moving the movable insert from a closed configuration to an open configuration may open the one or more vents. Moving the movable insert from a closed configuration to a priming configuration may open the one or more vents. The one or more vents and the opening of the flow passage may be located at axially opposite ends of the storage chamber.

[0166] The flow path may be provided by opening a seal that defines the storage chamber. The seal may be a proximal seal.

[0167] The outer surface of the movable insert may be an outer circumferential surface. The outer surface of the movable insert may be an outer circumferential surface. The inner surface of the outer housing may be an inner circumferential surface.

[0168] One aspect of the present disclosure provides a catheter assembly having an outer housing, the outer housing having a fill hole and a wetting agent storage chamber. The fill hole may be in fluid communication with the storage chamber. The fill hole may be configured to allow the catheter assembly to be assembled before the storage chamber is filled with the wetting agent.

[0169] One aspect of the present disclosure provides a catheter assembly having an outer housing having a fill hole and a wetting agent storage chamber, the fill hole being in fluid communication with the storage chamber, and the fill hole being configured such that the catheter assembly can be assembled before the storage chamber is filled with the wetting agent.

[0170] The provision of a fill hole in the outer housing provides a convenient location for filling the storage chamber, which may be conveniently plugged after the filling procedure to provide a sealed, sterile assembly.

[0171] One aspect of the present disclosure may provide a method of assembling a catheter assembly (e.g., particularly a catheter assembly as defined immediately above), the method comprising: a) inserting a catheter tube and a wetting agent storage chamber into an internal cavity of an outer housing, b) filling the storage chamber with a wetting agent through a fill hole disposed in the outer housing, c) sealing the outer housing, and d) sterilizing the internal cavity. Steps a-d are preferably performed in that order. Of course, further steps may also be included. Sealing the outer housing may include inserting a plug into the fill hole. The plug may then be welded to the outer housing.

[0172] Sealing the outer housing may include placing a cap on the housing. Sealing the outer housing may include hermetically sealing the housing.

[0173] The sterilization may be radiation sterilization, for example gamma sterilization, X-ray sterilization, or EB (electron beam) sterilization.

[0174] The outer housing may have a cap and a body. The outer housing may have a fill hole in fluid communication with the storage chamber. The outer housing may have a cap and a body. The fill hole may be provided in an outer wall of the body. The fill hole may be configured to receive a plug. The catheter assembly may further include a plug.

[0175] The catheter assembly may further include an actuator for moving the inner housing. The actuator may be referred to as a priming mechanism. The actuator may include a drive surface against which the drive element acts to move the inner housing. The drive element may include a plug.

[0176] Either the drive element or the drive surface may be provided on either a chamber wall of the storage chamber or a movable insert received within the chamber wall, and the other of the drive element and the drive surface may be provided on the other of the chamber wall and the movable insert. The drive surface and the drive element may be configured such that relative rotation of the movable insert and the chamber wall results in axial movement of the movable insert or the chamber wall.

[0177] The movable insert may be a catheter.

[0178] The catheter assembly may further include an inner housing within the outer housing. The storage chamber may be disposed between and defined by the outer housing and the inner housing. The inner housing may be a movable insert configured to be axially and / or rotationally movable relative to the outer housing.

[0179] The drive surface may have at least one drive surface outlet to provide a flow path between the fill hole and the storage chamber.

[0180] The drive surface may have at least one rail. The rail may have discontinuities to provide a flow path through the rail.

[0181] The drive surface may have a pair of axially spaced rails, the spacing between which may correspond to a diameter of the drive element.

[0182] The inner housing may be spaced apart within the outer housing to provide a storage chamber. The inner housing may have a plurality of ribs on a radially outer wall thereof extending between the inner housing and the outer housing.

[0183] The ribs may extend circumferentially. Each rib may include an axial passage therethrough.

[0184] One aspect of the present disclosure may provide a catheter assembly having a longitudinal axis, the catheter assembly including a catheter, a wetting agent storage chamber, and an outer housing in which the catheter and the storage chamber are housed. The storage chamber may have a movable insert configured to move axially along the longitudinal axis relative to the outer housing when the movable insert rotates.

[0185] One aspect of the present disclosure may provide a catheter assembly having a longitudinal axis, the catheter assembly including a catheter, a wetting agent storage chamber, and an outer housing in which the catheter and the storage chamber are contained, the storage chamber having a movable insert configured to move axially along the longitudinal axis relative to the outer housing when the movable insert is rotated.

[0186] Providing a movable insert that translates axially upon rotation allows the storage chamber to be conveniently configured for use. For example, the movable insert may be configured such that rotating the movable insert transforms the storage chamber from a sealed configuration to a priming configuration, thereby allowing the catheter assembly to be primed with a single user action.

[0187] The movable insert may be movable between a closed configuration and a priming configuration. The closed configuration may correspond to a configuration in which the catheter assembly is sealed prior to use. The seal may be a closed or sterile seal in which the internal cavity of the external housing is sterile, or a leak-proof sealed state in which the wetting agent is sealed within the internal cavity of the external housing to prevent leakage of the wetting agent. The leak-proof sealed state may mean that the wetting agent is sealed within one or more of the storage chamber, the wetting chamber, and the priming chamber. The leak-proof sealed state may mean that leakage from the external housing is prevented, or that the wetting agent is prevented from contacting one or more handling surfaces of the catheter.

[0188] The priming configuration may correspond to a configuration in which the catheter is ready to be wetted. Thus, when in the wetted configuration, the catheter may be configured to be withdrawn by the user. In some embodiments, a seal may retain the catheter (e.g., in the sealed configuration) to limit / prevent withdrawal. In the priming configuration, the retaining seal may reduce pressure on the catheter to allow the catheter to be sealably withdrawn from the storage chamber, thereby wetting the catheter tube of the catheter. In some embodiments, the priming configuration may have an opening in the seal of the storage chamber such that a flow path between the storage chamber and the subsequent chamber is opened.

[0189] The storage chamber may have a chamber wall. The movable insert and the chamber wall may be sealably engaged to seal the storage chamber via the seal.

[0190] The movable insert may be located radially inward of the chamber wall.The seal may include a sealing element carried by the movable insert or the chamber wall and a counter sealing surface provided by the other of the movable insert and the chamber wall.

[0191] The sealing element may be adapted to align with the sealing surface when in the sealed configuration.The sealing element may be adapted to be axially offset with the sealing surface when in the priming configuration.

[0192] The sealing element may comprise an elastomeric material. 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.

[0193] The seal element may be located within a seal element housing provided by the chamber wall or a moveable insert.

[0194] At least one of the movable insert and the chamber wall may have a diverging portion through which the seal element passes when transitioning between the sealed configuration and the priming configuration, such that the distance between the chamber wall and the movable insert at the axial position of the seal element may be increased when in the priming configuration.

[0195] The diverging portion may have a step, taper, or chamfer adjacent the sealing surface.

[0196] The sealing surface may be a primary sealing surface.The catheter assembly may further include a secondary sealing surface.The sealing element may seal against the secondary sealing surface when in the priming configuration.

[0197] The chamber wall or the mobile insert may have one or more axially and circumferentially extending drive surfaces, and the other of the chamber wall and the mobile insert may have a drive element that engages the drive surface to provide axial movement of the mobile insert upon relative rotation of the mobile insert and the chamber wall.

[0198] The drive surface may comprise a first axially facing surface provided by a radially protruding flange, rib, thread, track or rail, or an end wall surface of the respective moveable insert or chamber wall.

[0199] The drive element may comprise a second axially facing surface of a radially extending flange, rib, thread, track, rail or pin, or an end wall surface of the respective moveable insert or chamber wall.

[0200] The drive element may have a plug for blocking the hole. The hole may be a fill hole. The fill hole may be provided in an outer wall of the outer housing.

[0201] The drive surface may be provided by a chamber wall.The drive surface may be provided by an end wall surface of the chamber wall.

[0202] The movable insert may be movable between a primed configuration and a wetted configuration.

[0203] The outer housing may have a body and a cap. The cap may be rotatably engaged to the movable insert such that rotation of the cap rotates the movable insert to provide the axial movement. The rotatable engagement may be provided by one or more interlocks rotatably coupling the cap to the inner housing.

[0204] Rotating the cap may transition the movable insert from a sealed configuration to a priming configuration. Rotating the cap may also transition the movable insert from the priming configuration to a wetted configuration. Rotating the cap may transition the movable insert from the sealed configuration to a wetted configuration.

[0205] The mobile insert may be configured for axial reciprocating motion along the longitudinal axis. The mobile insert may be configured for reciprocating motion while being rotated in a continuous common direction. The reciprocating motion may include a distal motion followed by a proximal motion.

[0206] The cap may be sealably attached to the body via an outer housing seal. The cap and seal may be configured such that the cap breaks the outer housing seal. The outer housing seal may be an airtight seal.

[0207] The chamber seal may be a proximal seal. The catheter assembly may further include a distal (chamber) seal. The distal and proximal seals may be axially spaced apart along the length of the movable insert and the chamber wall to define a cavity for the wetting agent.

[0208] The distal seal may have a distal seal element and an opposing distal seal face, the distal seal face and the distal seal element being sealed in the sealed configuration and the priming configuration.

[0209] The movable insert may be a catheter.

[0210] The movable insert may have an inner housing that at least partially defines the storage chamber, and the catheter is disposed within the inner housing.

[0211] The inner housing may be radially disposed within the outer housing such that there is a storage chamber therebetween.

[0212] The catheter assembly may further include a moveable insert rotation limiter. The rotation limiter may be configured to limit rotation of the moveable insert to no more than a predetermined amount.

[0213] The inner housing may be rotatably attached to the cap via a torque actuated release interlock. The release interlock may be configured to release upon continued rotation of the mobile insert when the mobile insert rotation limiter is engaged.

[0214] The drive surface may have a track. The track may be cosine shaped.

[0215] When the drive surface is a track, the track may extend between a first end point and a second end point having an intermediate point therebetween. The first end point and the second end point may be axially distal to the intermediate point. The second end point may have a rotation limiter.

[0216] The track may extend circumferentially through at least 180 degrees and less than 360 degrees. The track may extend circumferentially 270 degrees. The cap may disengage from the moveable insert after 270 degrees of rotation. The cap may be released from the catheter assembly after an additional 90 degrees of rotation. Thus, a single rotation of the cap relative to the body may transition the catheter assembly from a sealed configuration to a priming configuration and to an open / wet configuration from which the catheter can be removed. Transitioning from the sealed configuration to the priming configuration may also disrupt the airtight seal.

[0217] The outer surface of the catheter may be provided with a wet chamber that exists between the inner surface of the outer housing and the outer surface of the catheter, and such a wet chamber may be defined by a sheath or the sheath may be provided within the wet chamber.

[0218] The catheter assembly may have an airtight seal to preserve sterility of the interior volume prior to use.

[0219] When in the sealed configuration, the airtight seal may be intact. When in the priming or wet configuration, the airtight seal may be broken such that the interior volume of the outer housing is at least partially open to the atmosphere and the sterile environment is considered to be breached.

[0220] When in the closed configuration, the wetting agent chamber may be sealed by one or more wetting agent seals. The wetting agent storage chamber may comprise a wetting chamber in which the wetting agent storage chamber and / or the priming chamber and / or the catheter are arranged to be wetted.

[0221] When in the primed and / or wetted configuration, the wetting agent seal may be intact so as to be sealed in a leak-proof manner, thereby preventing the wetting agent from leaking to the exterior of the catheter assembly or to the catheter outlet end having an exterior handling surface.

[0222] The catheter assembly may have a third configuration in which the airtight seal is opened and the wetting agent seal is opened. When the wetting agent seal is open, the catheter may be configured to be withdrawn from the outer housing.

[0223] The outer housing may have a cap and a body to which the cap is attached via an airtight seal. The airtight seal may have a tear strip that is manually removed prior to use such that the cap is manually removable. The airtight seal may be broken by rotation of the cap relative to the body.

[0224] The wetting agent chamber may include a wetting agent storage chamber. The storage chamber may include a chamber wall and a movable insert. A wetting agent seal may be provided between the wetting agent storage chamber wall and the movable insert.

[0225] The catheter assembly may further include a wet chamber. A wetting agent may be in fluid communication with the wet chamber when the catheter assembly is in the priming configuration.

[0226] The catheter assembly may have a wet chamber seal disposed between the storage chamber and the wet chamber. The wet chamber seal may be open when the catheter assembly is in the priming configuration.

[0227] The movable insert may be an inner housing in which the catheter is placed. The movable insert may be a catheter.

[0228] The catheter may be configured to be withdrawn from the wetting agent chamber and the outer housing when the catheter assembly is in the priming configuration.

[0229] Transitioning between the sealed configuration and the priming configuration may include moving the mobile insert. Moving the mobile insert may include rotating the mobile insert and / or axially moving the mobile insert.

[0230] The catheter assembly may include an actuator for moving the moveable insert, optional mechanisms for the actuator being described herein.

[0231] The catheter has a catheter tube and an outlet body. The catheter may have an insertion end for insertion into a patient and an outlet end through which fluid is drained during use. The outlet end may have one or more flow enhancing features, such as a funnel that branches along the flow direction. The outlet end may have an exterior handling surface. The exterior handling surface may be exposed for handling by a user when the cap is removed. The exterior handling surface may have one or more features to enhance a user's grip. The one or more surface features may include one or more grooves. The catheter tube may have one or more inlets at its insertion end for receiving urine.

[0232] The catheter tube may be functionalized. For example, it may have a hydrophilic component (such as a hydrophilic polymer), may be integrated with a hydrophilic component, or may be coated with a hydrophilic component. The hydrophilic component serves to further reduce friction when a wetting agent is added. At least the outer surface of the catheter tube may be functionalized, for example, a hydrophilic component may be provided at least on the outer surface of the catheter tube (which contacts the urethra in use). The catheter may define 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 tube. The main flow path may have a proximal inlet at the insertion end of the catheter and a distal outlet.

[0233] The catheter may have an outlet body. The outlet body may incorporate the terminus of the catheter tube. The outlet body may comprise an exterior handling surface of the catheter. The outlet body may have one or more flow enhancing features to aid in flow from the catheter tube. The one or more flow enhancing features may include, for example, a funnel.

[0234] The outlet body may have or be referred to as a connector that connects the outlet end, such as a funnel and / or an external handling mechanism, with the catheter tube.

[0235] The outer surface of the catheter may be provided within a wet chamber that exists between the inner surface of the outer housing and the outer surface of the catheter tube.

[0236] The sheath may be a retractable sheath configured to be retracted during insertion of the catheter to provide a temporary enclosure around the catheter tube prior to insertion.

[0237] The sheath may be provided at the proximal end of the catheter towards the insertion end to provide a restraint for a retractable insertion guide used to position the catheter tube at the entrance to the urethra. The sheath may lock the insertion guide and / or storage chamber to the exit end of the catheter such that withdrawal of the catheter tube expands the sheath and allows the insertion guide and / or storage chamber to be withdrawn from the outer housing when the catheter is fully withdrawn from the outer housing.

[0238] The storage chamber may have an insertion guide, which may be provided by a proximal end of the storage chamber.

[0239] The catheter assembly may have a wet chamber that may be defined by or provided with a sheath.

[0240] The storage chamber may have an annular chamber in which the catheter is disposed. The storage chamber may be disposed at a distal end of the catheter. The storage chamber may surround the catheter between the outlet end of the catheter and the catheter tube. The catheter outlet may be connected to the catheter tube by a connecting portion. The catheter, e.g., the connecting portion, may have one or more sealing surfaces against which the sealing element seals in use.

[0241] The storage chamber may have a chamber wall and a surface of the catheter. The catheter may be a movable insert. The chamber wall may have an axially extending radially outer wall. The chamber wall may have an end wall extending radially inward from the radially outer wall towards the catheter. The end wall may have a radially extending portion and an annular flange extending along the catheter. The annular flange may have a reduced radius compared to a radius of the radially outer wall.

[0242] The storage chamber may have a plurality of protrusions defining a guide tube through which the catheter passes. The plurality of protrusions may guide the catheter during withdrawal of the catheter to maintain concentricity. The plurality of protrusions may have a plurality of axially extending ribs. The plurality of protrusions may extend from a distal end wall of the storage chamber wall. The plurality of protrusions may extend radially inward from the radially outer wall. A seal housing may be defined within the radially outer wall. The seal housing may be defined by the plurality of protrusions and an end wall of the chamber wall.

[0243] The storage chamber may be configured to have a sealed position and a priming position. The sealed position and the priming position may also be referred to as a sealed configuration and a priming configuration. The sealed position may correspond to a sealing element on the primary sealing surface. The priming position may correspond to a sealing element on the second sealing surface. A seal contact pressure may be greater in the sealed position than in the priming position.

[0244] The sealed configuration may correspond to a sealed configuration of the catheter assembly, in which the catheter assembly is hermetically sealed by an air-tight seal.

[0245] The storage chamber may have at least two sealing elements axially spaced along the catheter to provide a distal seal having a distal sealing element and a proximal seal having a proximal sealing element.

[0246] The distal seal element may be provided on a seal surface having a constant shape between a sealed configuration and a priming and / or wetted configuration. The distal seal surface may be defined by one or more radial projections that define a recess in which the distal seal element is retained. The distal seal element may be retained in the recess when the catheter is removed from the outer housing.

[0247] The proximal seal may have a proximal seal surface. The proximal seal surface may be raised relative to the proximal and / or distal portions of the seal surface. Thus, the proximal seal may have a diverging portion through which the seal element passes when transitioning between the sealing configuration and the priming and / or wetting configuration such that a distance between the chamber wall and the movable insert at an axial position of the seal element increases when in the wetting configuration.

[0248] The proximal seal may be disposed in a proximal seal housing. The proximal seal housing may be provided within the radially outer wall. The proximal seal housing may be provided by a plurality of projections and an end wall of the chamber wall.

[0249] The storage chamber may be configured to have a sealed position, one or more priming positions, and a wetting position. The sealed position, priming position, and wetting position may be referred to as configurations. The transition between the sealed configuration and the priming and / or wetting configurations may be achieved using an actuator. The actuator may also be referred to as a priming mechanism.

[0250] The actuator may include a rotatable actuator in which a user rotates a rotor, e.g., an outer housing or a cap of the catheter, to transition the catheter assembly and / or the wetting agent chamber and / or the storage chamber between the sealed configuration, the priming configuration and / or the wetting configuration. Rotation of the rotatable actuator may be translated into axial motion between the movable insert and a chamber wall of the wetting agent storage chamber.

[0251] The actuator may have a drive surface that drivingly engages the drive element. The drive surface may have one or more helical members that bias against a corresponding drive element to axially drive the movable insert relative to the storage chamber. The helical members may be fins that extend circumferentially and axially around the catheter. The drive surface and drive element may be disposed toward the exit end of the catheter.

[0252] The drive surface may extend only partially around the longitudinal axis. For example, the drive surface may extend 90 degrees around. There may be multiple drive surface members distributed circumferentially. The drive surface and drive elements may be referred to as a cam drive for converting rotation of a rotatable actuator into axial motion.

[0253] The rotatable actuator may have a cap. The cap may be rotatably engaged with the moveable insert such that rotation of the cap rotates the moveable insert. The moveable insert may be a catheter.

[0254] The cap may have one or more radially extending cap projections that engage corresponding radially extending catheter outlet end projections to provide the rotational engagement. Either or both of the cap projections and the catheter outlet projections may be axially extending radial fins. Each of the fins may lie in a plane defined by the longitudinal axis. The 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 rotatable engagement after being rotated a predetermined angle.

[0255] The movable insert may be an inner housing. The inner housing may be configured to move axially upon rotation of the rotatable actuator. The inner housing may be configured to reciprocate upon rotation of the rotatable actuator. Thus, rotating the rotatable actuator may move the inner housing in a first axial direction, followed by a second axial direction. The directions of rotation of the rotating actuator may be in the same direction. The first axial direction may be distal to the insertion end of the catheter. The second direction may be proximal.

[0256] The drive surface may have a track that engages the drive element. The track may be referred to as a plunger track. The track may be provided on either the inner housing or the body of the outer housing. The drive element may have a protrusion that may be provided on the other of the inner and outer housings.

[0257] The track and the drive element may be provided in the storage chamber. The drive element may have a plug that is received in a filling orifice for the storage chamber. The body may therefore have at least one hole extending through its outer wall, the hole providing access to the storage chamber such that wetting fluid may be received through the hole. The hole may be configured to receive the drive element following the filling procedure. The hole may therefore be opposite the guide track in which the drive element is received.

[0258] The track may extend from a first end point corresponding to the sealed configuration, to an intermediate point corresponding to the priming configuration, to a third end point corresponding to the wetted configuration. The track extends in a first circumferential direction and a first axial direction between the first end point and the intermediate point, and in a first circumferential direction and a second axial direction between the intermediate point and the end point. The first axial direction and the second axial direction may be opposite to each other. The first axial direction may be a proximal direction. The second axial direction may be a distal direction.

[0259] The track may have 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 may receive the wetting agent from the fill hole before it flows into the interior volume of the storage chamber.

[0260] Any of the features described above may be applied to any aspect of the invention, thus for example the preferred lengths of the catheters and assemblies once described above, apply to all aspects and combinations of aspects with any other feature. [Brief description of the drawings]

[0261] [Figure 1a] FIG. 1a shows an exploded view of a catheter assembly according to an embodiment of the present disclosure. [Figure 1b] FIG. 1b shows a side view of the catheter assembly in a closed or sealed configuration. [Figure 2a] 2a-2c show the steps of removing the cap from the catheter assembly and storing the cap at the opposite end of the catheter assembly outer housing. [Figure 2b] 2a-2c show the steps of removing the cap from the catheter assembly and storing the cap at the opposite end of the catheter assembly outer housing. [Figure 2c] 2a-2c show the steps of removing the cap from the catheter assembly and storing the cap at the opposite end of the catheter assembly outer housing. [Diagram 3] FIG. 3 shows a longitudinal cross section of the catheter assembly of FIG. [Figure 4] FIG. 4 shows an enlarged longitudinal cross-sectional view of the proximal end of the catheter assembly of FIG. 3, detailing the storage chamber and the humidity chamber. [Diagram 5] FIG. 5 shows an enlarged longitudinal cross-sectional view of the distal end of the catheter assembly of FIG. [Figure 6a] 6a-6c show a series of longitudinal cross-sectional views of the catheter assembly of FIG. 1 highlighting a wetting procedure for the catheter. [Figure 6b] 6a-6c show a series of longitudinal cross-sectional views of the catheter assembly of FIG. 1 highlighting a wetting procedure for the catheter. [Figure 6c] 6a-6c show a series of longitudinal cross-sectional views of the catheter assembly of FIG. 1 highlighting a wetting procedure for the catheter. [Figure 7] FIG. 7 shows a see-through view of an inner housing that can be used in the catheter assembly of FIG. [Figure 8a] 8a and 8b are schematic side and flattened front views, respectively, of the plunger track provided by the inner housing of FIG. [Figure 8b]8a and 8b are schematic side and flattened front views, respectively, of the plunger track provided by the inner housing of FIG. [Figure 9a] 9a to 9c show details of the top and cap of an inner housing that may be used with the catheter assembly shown in FIG. [Figure 9b] 9a to 9c show details of the top and cap of an inner housing that may be used with the catheter assembly shown in FIG. [Figure 9c] 9a to 9c show details of the top and cap of an inner housing that may be used with the catheter assembly shown in FIG. [Figure 10a] 10a through 10f are a series of side view images of a catheter assembly according to an embodiment of the present invention showing the main steps for wetting and removing the catheter from the outer housing. [Figure 10b] 10a through 10f are a series of side view images of a catheter assembly according to an embodiment of the present invention showing the main steps for wetting and removing the catheter from the outer housing. [Figure 10c] 10a through 10f are a series of side view images of a catheter assembly according to an embodiment of the present invention showing the main steps for wetting and removing the catheter from the outer housing. [Figure 10d] 10a through 10f are a series of side view images of a catheter assembly according to an embodiment of the present invention showing the main steps for wetting and removing the catheter from the outer housing. [Figure 10e] 10a through 10f are a series of side view images of a catheter assembly according to an embodiment of the present invention showing the main steps for wetting and removing the catheter from the outer housing. [Figure 10f] 10a through 10f are a series of side view images of a catheter assembly according to an embodiment of the present invention showing the main steps for wetting and removing the catheter from the outer housing. [Figure 11]FIG. 11 shows a longitudinal exploded view of a catheter assembly according to one embodiment of the present disclosure. [Figure 12] FIG. 12 shows a perspective view of the catheter assembly of FIG. [Figure 13] FIG. 13 shows a partial cross-sectional view of the catheter assembly of FIG. 11 showing the wetting agent storage chamber. [Figure 14a] 14a and 14b show schematic longitudinal cross-sectional views of the catheter assembly of FIG. 13 in a closed configuration and a priming configuration, respectively. [Figure 14b] 14a and 14b show schematic longitudinal cross-sectional views of the catheter assembly of FIG. 13 in a closed configuration and a priming configuration, respectively. [Figure 15] FIG. 15 illustrates an exploded longitudinal view of a rotatable actuator, a storage chamber, and a movable insert according to one embodiment. [Figure 16a] 16a and 16b show a storage chamber according to one embodiment. [Figure 16b] 16a and 16b show a storage chamber according to one embodiment. [Figure 17] 17 and 18 show an example of a storage chamber and a releasable coupling. [Figure 18] 17 and 18 show an example of a storage chamber and a releasable coupling. [Figure 19] FIG. 19 shows a partial longitudinal cross-sectional view of the retractable sheath in the retracted configuration. [Figure 20] FIG. 20 shows an exploded view of a catheter assembly according to the present invention. [Figure 21a] FIG. 21a shows a side view of the catheter assembly of FIG. [Figure 21b] FIG. 21b shows a side view of the catheter assembly of FIG. 20 with the case removed. [Figure 21c] FIG. 21c shows a side view of the catheter assembly of FIG. 20, including the sheath, with the case removed. [Figure 22a]FIG. 22a shows a cross-sectional view of the wetting mechanism of the catheter assembly of FIG. 20 in the closed configuration. [Figure 22b] FIG. 22b shows a cross-sectional view of the wetting mechanism of the catheter assembly of FIG. 20 in the open configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0262] In order that the invention may be more clearly understood, one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0263] 1 shows an axial exploded view of a catheter assembly 10 according to the present invention. The catheter assembly includes an outer housing 12, an inner housing 14, and a catheter 16. The outer housing 12, inner housing 14, and catheter 16 are concentrically arranged such that the catheter is located within the inner housing 14, which is located in a radially nested configuration within the outer housing 12.

[0264] The catheter assembly 10 may be configured so that the catheter 16 may be wetted before it is withdrawn from the outer housing 12. The wetting agent used to wet the catheter 16 prior to use may be held in a wetting agent storage chamber defined between the outer housing 12 and the inner housing 14. The wetting agent may be delivered to the catheter 16 via a wetting chamber defined between the inner housing 14 and the catheter. The wetting agent may be pumped or moved from the storage chamber to the wetting chamber. The wetting agent may be water or other suitable agent, as is well known in the art.

[0265] 1a, 1b, 3, 4, 9b and 9c, the outer housing 12 has a body 18 in which a portion of the inner housing 14 and the catheter 16 are housed, and a removable cap 20 so that the catheter can be removed by a user prior to use. By removing the cap 20, the catheter 16 can be exposed so that it can be withdrawn from the outer housing 12.

[0266] The outer housing 12 provides an enclosed volume in which the catheter 16 may be housed for storage and transport prior to use. The body 18 and cap 20 may provide a sterile cavity in which the catheter 16 is located. The outer housing 12 is generally elongated in shape having a longitudinal axis 22 which may be considered to be the major axis of the catheter assembly 10 and the longitudinal axis of the inner housing 14, catheter 16, etc. References to longitudinal axis, axial or radial in this disclosure should be considered as references to the longitudinal axis 22 unless otherwise noted.

[0267] The enclosed volume provided by the outer housing 12 is defined by an outer wall of the housing 12 that extends from a first proximal end 13 that receives an insertion end 24 of the catheter 16 to a second distal end 15 at which a catheter exit end 26 is received. In the illustrated embodiment, the second end 15 is provided by a cap 20. Thus, removal of the cap 20 exposes the exit end 26 of the catheter 16 so that a user can grasp and remove the catheter 16 from the housing 12 for use.

[0268] The exterior shape of the housing 12 can be any desired for aesthetic or functional purposes, being generally cylindrical with a taper toward a first end to aid in insertion into a storage container or pocket, e.g., tapering toward a second end along the length of the cap 20.

[0269] Cap 20 has a generally open-ended cylindrical housing having a circumferential outer wall extending coaxially along longitudinal axis 22 and a radially extending, axially facing end wall which terminates cap 20 and provides a closed end at outer housing 12. Cap 20 conforms to the distal end of body 18 such that body 18 is received in the open end of cap 20. However, it will be understood that cap 20 may be received in the open end of the body in some embodiments.

[0270] An airtight seal may be provided between the cap 20 and the body 18 prior to use to maintain sterility of the interior volume of the outer housing 12. The airtight seal in the described embodiment includes one or more (in this case two) internal seals 66, 68 shown in Figures 3 and 5 and described further below. Additionally / alternatively, the airtight seal may be provided by a tamper-evident connection or strip between the body 18 and the cap 20.

[0271] The outer housing 12 may be used to transport the catheter 16 ready for use, and may also be used to dispose of the catheter after use. To prevent the cap 20 from being left behind or separated from the body 18 during use of the catheter 16, and to avoid having an additional item to store in an environment not suitable for hygienic storage (such as a public restroom), the cap 20 may be temporarily attached to the body 18. Thus, the cap 20 may be removed from the open end of the body 18 to expose the catheter 16 for removal and use, or may be attached to the closed end of the body 18. Once the catheter 16 has been used, the catheter 16 may be replaced within the body 18, and the cap 20 may be reconnected to the open end of the body 18 to enclose the used catheter 16 therein for disposal.

[0272] This process can be seen in Figures 2a through 2c, where Figure 2a shows the catheter assembly 10 with the cap 20 removably attached prior to use, Figure 2b shows the cap 20 being removed from the body 18 and moved to the opposite end (illustrated by the arrows), and Figure 2c shows the cap 20 attached to the opposite end of the body 18. The catheter 16 is not shown, but it will be understood that when present, it will be exposed at the top end of the body 18 as shown.

[0273] To allow temporary attachment of the cap 20 to the closed end of the body 18, the outer surface of the closed end of the body 18 and the inner surface of the cap 20 may have corresponding mating surfaces. These are indicated by reference numeral 21 in FIG. 2a for the body 18 and by reference numeral 21' in FIG. 9c for the cap 20. The mating surfaces 21, 21' may be configured to provide an interference fit that is sufficient to temporarily retain the cap 20 by frictional engagement between the cap 20 and the closed end of the body 18. The interference fit may be achieved by providing a suitably shaped, in this embodiment, suitable amount of contact surface area between the inner surface of the cap 20 and the outer surface of the body 18. In this way, the axial portion of the outer surface of the body 18 may have a shape that corresponds to the inner surface of the cap 20. In the example shown in FIGS. 2a to 2c, the shape may be a uniform taper, with a constant angle of taper along the mating surfaces, although other shapes are possible.

[0274] The cap 20 and / or body 18 are generally substantially rigid to provide protection for the catheter 16 during shipping and to preserve the integrity of the closed volume to maintain sterility. However, it is understood that the cap 20 and / or body 18 may be sufficiently resilient to allow for a small amount of deformation to assist in the interference fit between the cap 20 and body 18.

[0275] Additionally or alternatively, with respect to the inner surface of the cap 20 and the outer surface of the body 18 having a corresponding shape, either or both of the cap 20 and the body 18 may have mating surfaces 21, 21' having one or more configurations that provide or enhance an interference fit and / or attachment of the cap 20 to the body 18. For example, the cap 20 may be mated to the closed end of the body 18 using radial protrusions such as rib 286b described below in connection with the embodiment of FIG. 15 using a click-fit engagement in which the cap 20 resiliently engages one or more interlocking features such as a circumferentially extending rib or a number of circumferentially distributed pips. The click-fit engagement may help provide feedback to the user that the cap 20 is securely attached. Alternatively or additionally, the cap 20 and / or body 18 may have one or more of an insert, coating (such as overmolding with a soft material), liner, threads, or other features that enhance one or more of the resiliency, contact surface area, coefficient of friction, or engagement between the cap 20 and body 18.

[0276] The body 18 and cap 20 may be made of a thermoplastic, such as polypropylene. Other polymers such as polycarbonate, polyethylene, or nylon may be used. Similarly, an overmolded design may be used, with a softer material on the inside of the cap or on a portion of the outside of the body to help hold the cap to the body.

[0277] The cap 20 may be removed from the body 18 in the same axial direction before being turned over and axially placed on the closed end of the body 18. The cap 20 may be pulled linearly from the body 18 or may be rotated or twisted, for example if the cap 20 is attached via threads, for example. An example of threads 62b, 62a can be seen in Figures 9a and 9c.

[0278] Part or all of the interior surface of the cap 20 may provide the mating surface 21'. The embodiment of FIG. 9c includes three portions that provide separate functions. The first portion is the mating surface 21', which is located most distally and extends from the closed end toward the open proximal end, terminating midway along the interior length of the cap 20. The second portion is threads 62a that engage the inner housing 14 of the catheter assembly 10, and the third portion provides a detent mechanism 60b, which are described further below. It will be understood that other configurations of the cap 20 are possible and that the provision of the various portions and their respective locations may vary in other embodiments.

[0279] As mentioned above, the shape of the outer housing 12 may be tapered in the longitudinal direction. The cross-sectional shape of the outer surface cap 20 may be any desired one. The cross-sectional shape may be round, e.g., circular or elliptical. In some embodiments, the transverse shape may be polygonal, such as triangular or rectangular. Figure 9b shows an embodiment in which the outer surface 20' of the cap 20 is rectangular with rounded edges to facilitate a user's grip to rotate the cap 20 during activation and / or removal steps.

[0280] 1a, 3 and 4, the body 18 may provide an enclosure defining a reservoir for wetting fluid (not shown). The reservoir is formed between the body 18 and the inner housing 14. The inner housing 14 may thus be provided in a spaced apart relationship within the outer housing 12 to define a cavity 28 therebetween. The cavity 28 may be referred to as a wetting agent storage chamber 28 or simply as the storage chamber 28 herein. The storage chamber 28 may have a first chamber wall provided by the body 18 and a movable insert provided by the inner housing 14. The inner housing 14 may thus provide a second storage chamber wall.

[0281] In a first configuration, the storage chamber 28 is sealed so that the wetting agent is retained therein, and in a second configuration, is open to allow the wetting agent to flow out of the cavity 28 in fluid communication with, and in some embodiments directly contact, the outer surface of the catheter tube 32 of the catheter 16.

[0282] In the open configuration, the interior volume of the storage chamber 28 may be in fluid communication with a wet chamber 30 in which the catheter is disposed such that wetting agent can flow from the storage chamber 28 to the wet chamber 39 and catheter tube 32. In some embodiments, the fluid communication between the storage chamber 28 and the wet chamber 30 may be via one or more valves, inlet channels, or intermediate chambers such as, for example, a priming chamber. An example of a priming chamber is described further below.

[0283] 1a, 3, and 4, the enclosed volume of the outer housing 12 may be bounded by an inner housing 14, which may be referred to as a movable insert. The inner housing 14 may have a tubular wall configured to define a wetting agent chamber 28 radially outward and a wetting agent chamber 30 radially inward.

[0284] As best seen in FIG. 4, the inner housing 14 may have an elongated, thin-walled structure extending longitudinally along the major axis 22 of the catheter assembly 10. The inner housing 14 may have a first end that is distal to the insertion end of the catheter 16 and a second proximal end that is proximal to and may surround the insertion end 24 of the catheter 16. The length of the inner housing 14 and the location of each of the distal and proximal ends of the inner housing 14, as well as the separation from the outer housing chamber wall, may vary from embodiment to embodiment and may be determined to provide a suitable volume for the wetting agent storage chamber 28. Further design considerations may arise if the inner housing 14 is configured to act as a pump to pump the wetting agent from the storage chamber 28 and / or the priming chamber to the wetting chamber during the wetting procedure.

[0285] The wet chamber 30 has an elongated cavity between the inner surface of the inner housing 14 and the outer surface of the catheter tube 32 so that a wetting agent (not shown) can be provided to the wet chamber 30 for wetting the outer surface of the catheter tube 32 prior to use. The wet chamber 30 may be defined completely or partially by the inner surface of the inner housing 14 and / or an intermediate member, such as a sheath, that is located within the inner housing 14 and surrounds the catheter tube 32 during the wetting procedure.

[0286] The storage chamber 28 may be an elongated annular cavity surrounding the longitudinal axis 22 and the catheter tube 32 and extending axially between a first distal end and a second proximal end. The cavity may be sealed at the first and second ends using one or more seals 36, 38. The seals may have seal elements 36a, 38a that may be disposed between or facing corresponding seal surfaces 36b, 38b. The seal surfaces 36b, 38b may be provided by corresponding portions of the inner housing 14 and the outer housing 12. The seal elements 36a, 38a may be elastomeric seals, for example in the form of O-rings, X-rings, or U-cup seals. The seal elements may extend radially between the inner housing 14 and the body 18.

[0287] To open the storage chamber 28, the catheter assembly 10 may incorporate one or more valves that open to fluidly connect the storage chamber 28 and the wet chamber 30. The one or more valves may be actuated by moving a movable insert, such as the inner housing 14. The movable insert may be actuated by direct manual manipulation by a user or by actuating the cap 20. For example, rotating or pulling the cap 20 may open the one or more valves to fluidly connect the storage chamber 28 and the wet chamber 30, thereby allowing the wetting agent to flow from the storage chamber 28 to the wet chamber 30 and the outer surface of the catheter tube 32. The valves may be provided in part by the inner housing 14.

[0288] The inner housing 14 may be axially movable along the major axis 22 of the catheter assembly 10. The axial movement may include openings in one or more seals 36, 38 that seal the storage chamber 28 such that the opposing sealing elements 36a, 38a and sealing faces 36b, 38b of each seal 36, 38 move from an aligned sealed position (or closed position) to an offset non-sealed position (or open position). Thus, for example, by partially withdrawing the inner housing 14 from the body 18, each opposing face seal 36 may move axially relative to one another to increase the spacing between the inner housing 14 and the outer housing 12 across the seal 36 that provides the opening. In this manner, one or more seals 36, 38 may act as a valve as described above.

[0289] A seal 36, configured to act as a valve in this described embodiment, may be positioned proximally to allow wetting agent in the storage chamber 28 to flow from the proximal end of the storage chamber 28 to the closed end of the body 18 of the housing 12. This may be referred to as a priming chamber. From there, fluid is provided in fluid communication with the outside of the catheter tube 32, either directly or via one or more inlets to the wetting chamber 30.

[0290] Also shown in Figures 3 and 4 is an optional insertion guide 25. The insertion guide 25 is a short, elongated, annular cuff that is placed around the proximal end of the catheter tube 32. The catheter tube 32 is slidably received within the insertion guide 25 such that the insertion guide 25 can move distally upon insertion of the catheter tube 32, as will be described in more detail below.

[0291] As mentioned above, the storage chamber 28 provides an elongated annular cavity that is sealed by the proximal and distal seals 36, 38 to contain the wetting fluid away from the catheter 16. The seals 36, 38 in this embodiment include elastomeric seals in the form of O-rings located between opposing sealing surfaces. It will be appreciated that the seals 36, 38 may be alternative annular seals, such as X-rings or U-cup seals. The sealing surfaces are provided by corresponding diametrically opposed portions of the inner and outer housings 14, 12. More generally, it will be appreciated that the catheter assembly 10 and storage chamber 28, in particular, may include multiple distal and proximal seals 38, 36 to provide the required sealing functions.

[0292] One of the sealing surfaces may form part of a seal housing 36d, 38d that holds the seal elements 36a, 38a and prevents axial movement of the seal elements 36a, 38a. In some embodiments, the seal housing 36d, 38d may be provided by overmolding the seals 36, 38 such that the seals 36, 38 are molded into the walls of the inner housing 14 or the outer housing 12. In the illustrated example, the seal housing 36d, 38d is provided by the wall of the inner housing 14. The seal housing 36d, 38d thus restrains the axial ends of the seal elements 36a, 38a such that axial movement of the inner housing 14 relative to the outer housing 12 causes the seals 36, 38 to slide with the inner housing 14 along the opposing sealing surface of the outer housing 12. It will be appreciated that the seal housing 36d, 38d may be provided by the outer housing 12 in some embodiments.

[0293] As mentioned above, axial movement of the seal 36 may expose or provide one or more outlets to allow fluid communication between the storage chamber 28 and the wetting chamber 30. Additionally, one or more seals may open one or more vents. The vents may act as air inlets configured to allow gas to enter the storage chamber 28 to replace the wetting agent as it exits the storage chamber 28. The vents may be internal to open the storage chamber 28 to another internal cavity or external to draw air directly from outside the assembly 10.

[0294] 4, the proximal seal 36 may be disposed adjacent a diverging portion 36c of the storage chamber 28. The diverging portion corresponds to an increased spacing between the outer housing 12 and the inner housing 14, which may be provided by a step or taper in the shape of the respective surfaces of the inner housing 14 and the outer housing 12. Thus, the seal 36 of the storage chamber 28 may be located at a localized constriction between opposing walls of the storage chamber 28.

[0295] The bifurcated portion provides a space through which the seal 36 can move when the storage chamber 28 is open. Thus, moving the inner housing 14 shown in FIG. 4 distally (up in the image as shown) causes the seal 36 to move into the wider chamber portion, thereby opening a flow path from the storage chamber 28 to the proximal end of the body 18. In this manner, the seal 36 acts as a valve, allowing the insertion end 24 of the catheter 16 to be immersed in the wetting agent flowing from the storage chamber 28. As can be seen in FIG. 4, both the inner and outer housing walls have steps / tapered portions that contribute to the bifurcation of the storage chamber 28, but it is the wall that provides the separation that constitutes the sealing surface 36b against which the seal element 36a moves.

[0296] The distal seal 38 of the storage chamber 28 is axially spaced along the inner housing 14 from the proximal seal 36 and is provided at a fixed position relative to the proximal seal 36. The distal seal 38 may include a seal housing 38d similar to that provided for the proximal seal 36 such that axial movement of the inner housing 14 results in translation of the seal element 38a along the length of the outer housing 12. The distal seal 38 in the embodiment of FIG. 4 differs from the proximal seal 36 in that the seal faces are substantially uniformly spaced and the seal face 38b opposite the seal housing 38d and the active seal face of the seal element 38a remains in contact with the seal element 38a upon displacement of the inner housing 14. In this manner, the distal seal 36 remains intact even as the inner housing 14 is displaced and the proximal seal valve opens. As discussed above, axial movement of the proximal seal 38 may result in the exposure and / or opening of one or more vent holes.

[0297] The inner housing 14 may be configured to provide a pump for pumping the wetting agent into the wetting chamber 30. As such, the distal seal 38 may be configured to maintain a higher pressure than the proximal seal 36, which is configured to maintain the integrity of the storage chamber 28 when the assembly is stored and shipped prior to use. As can be seen in FIG. 4, the distal seal element 38a may be larger than the proximal seal element 36a.

[0298] 5, the distal seal 38 of the storage chamber 28 may be axially spaced from the open distal end of the body 18. The amount of distance may correspond to or be greater than the reach (axial movement) of the inner housing 14 when undergoing a wetting or priming operation. Thus, following the entire movement of the inner housing 14, the distal seal 38 may remain in contact with the wall of the outer housing 12.

[0299] 7 illustrates an exploded view of one embodiment of an inner housing 14 having a first portion 14c and a second portion 14b joined by threads 14c. It is understood that the specific construction of the inner housing 14 can vary and in some embodiments may be provided by a unitary structure or pieces joined using alternative methods such as a push-fit or bayonet structure.

[0300] 7, one or more vents 40 may be provided in the sidewall of the inner housing 14. The one or more vents 40 may provide an outlet for the wet chamber 30 so that air displaced from the wet chamber 30 as the wetting agent rises up or flows into the wet chamber 30 can escape.

[0301] In some embodiments, opening the storage chamber 28 may be sufficient to wet the catheter, in which case it may be sufficient to withdraw the catheter 16 for use once the wetting chamber 28 is opened (optionally inverting the assembly between opening the chamber and withdrawing the catheter to ensure sufficient distribution of the wetting agent). In some embodiments, the wetting procedure for wetting the catheter 16 may include a pumping or plunging action in which the wetting agent is pneumatically and / or hydraulically driven from the storage chamber 28 into and along the wetting chamber 30.

[0302] 1, the pumping action may be provided by axial movement of the inner housing 14 within the outer housing 12. The inner housing 12, acting as a movable insert, may be configured to move axially to pump / drive a flow of wetting agent into the proximal end and wetting chamber 30 to reduce the volume of the storage chamber 28, thereby wetting the catheter.

[0303] Figures 6a-6c illustrate wetting operation of the catheter assembly 10 in which the inner housing 14 is moved distally and axially along the longitudinal axis 22 from a first position to a second position, thereby opening the storage chamber 28 and then driving the wetting agent distally along the catheter tube 32. Although Figures 6a-6c illustrate operation of the assembly with the cap 20 in place, it will be understood that in some embodiments this is not the case and the cap 20 may be completely removed. Additionally, although the catheter assembly 10 is shown as being horizontal, the assembly may be operated in a vertical orientation.

[0304] There are three main stages in the wetting operation. The first stage, shown in Figure 6a, is a closed or sealed configuration / position in which the cap 20 is retained on the body 18 of the housing 12 for storage and transport purposes and the storage chamber 28 is sealed and contains the wetting agent. In Figure 6b, the cap 20 is released from the body 18 and the inner housing 14 is moved axially and distally through the cap 20 such that the proximal seal 36 element is away from the opposing sealing surface provided by the body 18, opening the flow passage 42 and allowing the wetting agent 44 held in the storage chamber 28 to be moved to the proximal end of the body 18. This may be referred to as the priming or filling stage, in which the wetting chamber 30 or associated priming sub-chamber 46 is primed with wetting agent ready to be driven along the catheter tube 32. Figure 6b may be referred to as the priming configuration or priming position.

[0305] It should be noted that when the movable insert or inner housing is in the priming position, the distal seal 38 maintains contact with the inner wall of the body 18 such that leakage of the wetting agent from the storage chamber 28 to the exterior of the catheter assembly 10 is prevented. However, the distal end of the storage chamber 28 may be provided with one or more vents configured to allow gas communication between the storage chamber 28 and the remainder of the catheter assembly 10, and when the inner housing is in the priming position, one or more channels disposed between the storage chamber 28 and the vents are opened to allow gas (i.e., air) to enter the storage chamber and displace the wetting agent. Typically, the assembly is held vertically or at least with the closed end of the body lower than the cap, thereby aiding in the transfer of the wetting agent by gravity to the closed end of the body and the priming chamber. Optional ribs 64, described below, also aid in the transfer of the wetting agent from the storage chamber 28 to the priming chamber.

[0306] Once the wetting agent 44 has migrated to the closed end of the body 18 and into the priming chamber, the inner housing 14 is reinserted into the body 18 such that the wetting agent is forced up the flow path 48 via an inlet to the wetting chamber 30 between the inner housing 14 and the catheter tube 32. Air evacuated from the wetting chamber 30 can exit through a suitable outlet that evacuates the evacuated air to the outside of the catheter assembly. Figures 6c and 7 provide examples of suitable outlets in the form of openings 40 in 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 diametrically opposed openings 40, but there may be fewer or more than two openings 40. It is understood that the size, shape and location may also vary. The openings 40 shown in this embodiment are ellipses with major axes extending in the circumferential direction such that the openings are large despite their short axial length.

[0307] An entrance to the wet chamber 30 from the storage chamber 28 / priming chamber 46 may be provided through a gap between the inner housing 14 and the catheter tube 32. In the embodiment illustrated in Figures 6a-6c, there is a sheath 34 surrounding the catheter tube 32 and forming or at least partially defining the wet chamber 30 or disposed within the wet chamber. In this case, an entrance to the wet chamber may be provided between the catheter tube 32 and the sheath 34. Additionally or alternatively, if an insertion guide 25 is included, the entrance may be determined by the gap between the insertion guide 25 and the catheter tube 32. In a further alternative, for example in the absence of a sheath 34, the wet chamber may be at least partially formed and defined by the inner surface of the inner housing 14. The entrance may be defined by the gap between a bottom end of the inner housing 14 and the catheter tube 32.

[0308] In some embodiments, the inner housing 14 may be reciprocated upon rotation of the actuator, and may therefore be retracted and advanced several times, however, a single distal-proximal cycle is typically sufficient to produce sufficient wetting of the catheter tube 32, thereby using the inner housing as a plunger.

[0309] As mentioned above, the plunging motion of the inner housing 14 may be accomplished manually, such that a user directly manipulates the inner housing 14 distally and proximally along a linear axial path by pulling and pushing the inner housing 14 while constraining the outer housing 12. However, in some embodiments, it may be preferable to drive the movement of the inner housing 14 with an actuator.

[0310] The actuator, referred to as a priming mechanism, may 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 when rotated. In some embodiments, the actuator may include a cam drive or crank where rotational movement of the inner housing 14 is used to drive 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 cap 20.

[0311] In some embodiments, rotation of the cap 20 may be used to drive linear motion of the inner housing 14 and may also be used to remove the cap 20 from the body 18. Thus, rotation of the cap 20 may have 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 deliver wetting fluid around the catheter tube 32. The second stage may correspond to releasing the cap 20 from the body 18 to expose the catheter 16 for use.

[0312] The simultaneous rotation and axial movement of the inner housing may be provided by one or more drive surfaces driven by corresponding drive elements. For example, a chamber wall provided by the outer housing or the inner housing may have one or more axially and circumferentially extending drive surfaces. The other of the chamber wall and the mobile insert may have a drive element that engages the drive surface to provide axial movement of the mobile insert upon relative rotation of the mobile insert and the chamber wall. The drive surface may have a first axially opposed surface provided by a radially projecting flange, rib, thread, track, or rail. The drive element may have a second axially opposed surface of a radially extending flange, rib, thread, track, rail, or pin. The drive surface and drive element may be referred to as a cam drive.

[0313] An embodiment of an actuator / priming mechanism having a drive surface and drive element will now be described with reference to Figures 7, 8a and 8b. Figure 7 is a perspective exploded view of inner housing 14, some of which has been described above. Figure 8a shows a side view of a drive surface in the form of a plunger track portion of the inner housing, and Figure 8b shows a schematic flattened front view of plunger track 50, illustrating the general shape the plunger track may have.

[0314] FIG. 7 shows a perspective view of the inner housing 14, which is provided with an elongated thin-walled enclosure having seal housings 36d and 38d for the proximal and distal seals 36 and 38 of the storage chamber 28, respectively, provided at opposite ends of the housing 14. The outer surface of the inner housing 14 has a drive surface in the form of a track 50, which may be referred to as a plunger track, that engages a corresponding drive element 52 (FIG. 8a) attached to the outer housing 12 (not shown). As shown, the plunger track 50 may include a channel that receives the drive element 52 in the form of a protrusion, e.g., a pin or intermediate member, extending from the inner surface of the outer housing 12. The channel may be provided by a pair of axially spaced 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 join to form a closed track. However, in some embodiments, the track 50 may have partial walls according to the required direction of actuation. That is, when the inner housing is biased in a distal direction, only the distal wall may be required to provide the necessary drive surface, and vice versa.

[0315] It is understood that in some embodiments, the track 50 may be provided on an inner surface of the outer housing 12 and the drive element 52 may correspondingly be applied from an outer surface of the inner housing 14. It is also understood that the plunger track 50 and drive element 52 may include any suitable mechanism for providing the necessary driving engagement to convert rotational motion of the inner housing 14 into axial motion. Thus, the track 50 and drive element 52 may have any combination of channels, grooves, ridges, protrusions, recesses, notches, bearings, gears, and the like to provide a driving surface and drive element.

[0316] The track 50 is provided proximal to the distal seal 38 such that it is located within the storage chamber 28. The provision of the plunger track 50 within the storage chamber 28 is optional, and in some embodiments may be provided either distal or proximal to the distal seal 38 and the proximal seal 36. However, providing a plunger track within the storage chamber 28 may allow for a shorter overall length of the assembly 10 and may provide a convenient point for filling the storage chamber 28 with a wetting agent, as described further below.

[0317] In some embodiments, the catheter assembly 10 may have a fill hole in the outer housing so that the wetting agent may be introduced into the storage chamber 28 once the catheter assembly 10 is assembled. The hole may therefore be provided in fluid communication with the storage chamber 28. Returning to FIG. 4, a hole 52a is shown extending through the wall of the outer housing 12, e.g., the body 18, to provide access to the storage chamber outside of the catheter assembly 10. The hole 52a may be configured to receive any suitable nozzle or attachment connected to a wetting agent source and may be referred to as a port. However, it is understood that the hole 52a may be a conventional round through hole.

[0318] The positioning of the fill hole 52a in the described embodiment is such that it overlaps the track 50 and extends into the track 50 such that, following the filling procedure, a drive pin 52 is inserted (and optionally welded in place) to block the fill hole 52a while acting as the drive element 50. It will be appreciated that in other embodiments the fill hole may simply be blocked and the plug may not provide a drive element 52 for an actuator to move the moveable insert.

[0319] 4, the inner housing 14 is generally spaced from the outer housing 12, but the inner housing 12 may be snugly received within the outer housing 12 such that there is a minimal clearance between the outer edges of the track 50 and / or ribs and the inner surface of the outer housing 12. Providing a minimal clearance may allow the inner housing to remain concentric with respect to the outer housing as the track 50 and / or ribs 64 are moved.

[0320] To allow wetting agent to flow into storage chamber 28 from bore 52a, the proximal rail of track 50 may have a discontinuity, such as bore 52b, which can be seen conceptually in FIG. 7. There may be multiple discontinuities to provide an "interlocking" guide rail. It is understood that any bore or discontinuity is typically provided on a non-drive surface that does not need to contact drive element 52 to actuate axial movement of inner housing 14. In some embodiments, there may be no drive surface on the proximal side of the bore, particularly if a reaction force is required distal to drive element 52 to axially translate the mobile insert.

[0321] As best seen in the schematic diagram of Figure 8b, the plunger track 50 is elongate and extends from a first end point 54 corresponding to an occluded configuration or position, to an intermediate point 56 corresponding to a primed configuration or position, and to a second end point 58 corresponding to a wetted configuration or position after plunging. The track 50 may be generally cosine- or U-shaped, extending from a distal-most first end 54, to a proximal-most second point 56, to a distal-most third point 58 angularly (circumferentially) spaced from the first point.

[0322] The distance between each adjacent point 54, 56, 58 provides the axial movement of the inner housing 14 when the inner housing 14 is rotated. Thus, the portion 55 between the first end point 54 and the midpoint 56 defines, at least in part, a priming movement of the inner housing 14 in which the proximal seal 36 is opened. The end portion 59 between the midpoint or priming position 56 and the second end or post-plunging wetting position 58 corresponds to a pumping movement in which the inner housing 14 is reinserted to drive the wetting agent from the prime chamber into the wetting chamber 30. The midpoint 57 corresponds to a priming position in which the inner housing 14 extends outwardly from the outer housing 12 with the proximal seal open to allow wetting agent to flow into the prime chamber 56.

[0323] The track 50 may be continuously curved or may have one or more straight sections. For example, as can be seen in FIG. 8b, the track 50 has a first section 55 and a last section 59 that make up most of the transition between the most distal and most proximal positions of the inner housing 14. The lower portion of the track 50 is broad and flat with little axial displacement, providing a dwell period that provides sufficient time for the inner housing 14 to rotate in an open configuration and for the wetting fluid to drain from the storage chamber 28 into the priming chamber 46 at the proximal end of the body 18.

[0324] It will be understood that the term "straight portion" used above refers to the axial trajectory of the track 50 as revealed by a front view taken when the track 50 is flattened, as provided in Figure 8b. The track 50 itself is continuously curved as it extends circumferentially about the longitudinal axis 22.

[0325] The ends 54, 58 of the track 50 may include a change in trajectory such that the rate of axial motion along the longitudinal axis 22 is reduced at the beginning and end of travel to provide an improved tactile experience for the user. That is, by accelerating and decelerating less into and out of actuation, the beginning and end of actuation may be less abrupt, potentially improving the user experience. Additionally, the lower axial motion may provide a mechanical advantage at the beginning of movement, against resistance to axial manipulation by the seal.

[0326] In use, the inner housing 14 is rotated such that the drive element 52 moves along the track 50. Because the drive element 52 is held in stationary relationship relative to the outer housing 12, rotation of the inner housing 14 results in linear motion along the longitudinal axis 22 of the catheter assembly 10. An initial stage of motion in the proximally extending portion of the track 50 results in distal movement of the inner housing 14 to open the proximal seal 36 as described above. From there, the drive element 52 enters a rotating portion 57 where the wetting agent 44 flows out of the storage chamber 28 with a decreasing amount of axial motion, followed by a third portion 57 of the track which drives the inner housing distally, towards the priming chamber.

[0327] The arrangement of the track 50 causes a complete linear cycle of movement when the inner housing 14 is rotated in one direction through a predetermined angular range, i.e., for a given rotation of the cap 20. The predetermined angular range can be anything deemed appropriate for the cap 20 and the user experience.

[0328] The end 58 of the track is provided with a closed end such that when the drive element 52 contacts the closed end, further rotation of the inner housing is not possible. Thus, the actuator may be provided with a mechanical stop or rotation limiter that limits rotation of the inner housing. This can provide mechanical feedback to the user indicating that the priming and / or wetting phase of the catheter has been achieved and the catheter can be removed. Following the mechanical feedback, the cap 50 can be removed and the catheter 16 withdrawn for use.

[0329] It will be appreciated that the range of rotation will determine the amount of force required to move the inner housing. Thus, a shorter angular range, such as 90 degrees, will move the inner housing faster and require more force than a longer rotation, such as 270 degrees. The range of angular movement may be between 90 degrees and 360 degrees.

[0330] In embodiments where rotation of inner housing 14 relative to body 18 is accomplished via cap 20, cap 20 and / or inner housing may have one or more interlocks for rotationally engaging cap 20 with inner housing 14. There may be multiple interlocks circumferentially distributed about the inner surface of cap 20.

[0331] 9a-9c, it can be seen that the interlocks may be provided by respective interengaging protrusions 60a on the outer surface of the inner housing 14 that are received in corresponding recesses 60b on the inner surface of the cap 20. As can be seen, there may be multiple interlocks 60a, 60b evenly distributed around the circumference of the cap 20 and the inner housing 14 to provide multiple engagement points. While this embodiment shows four interlocks, there may be more or less. The recesses 60b are shown to be located in the thicker portion of the cap 20 to maintain a minimum thickness at the proximal edge to provide the necessary hoop strength. However, this is not a limitation and the recesses 60b may be located at different or other circumferential locations.

[0332] The interlocks 60a, 60b may have a torque activated release such that when the rotational torque of the cap reaches a predetermined threshold, the interlock is released, allowing the cap 20 to rotate relative to the inner housing 14. Thus, once the travel of the drive element 52 reaches the end of the drive face and engages the rotation limiter, the increased torque and continued rotation of the cap 20 will release the interlock, allowing the cap 20 to rotate relative to the inner housing 14. Once released, further rotation of the cap 20 may allow the cap 20 to be removed.

[0333] To provide a torque-activated release device, the interlock may have a shape configured to disengage when a predetermined torque is exceeded. The shapes of the projection 60a and recess 60b may correspond to one another such that the surface of the recess 60b is brought into intimate contact with the projection 60a. When viewed in plan, it can be seen that the contact surfaces are inclined relative to the tangent at each location such that the projection is triangular. Providing such tangentially inclined contact surfaces provides a convenient way of controlling the torque threshold that the interlock can withstand before disengaging, allowing the interlock to be released when the drive element 52 reaches the end 58 of the plunger track 50.

[0334] The recess 60b and protrusion 60a may be configured to prevent rotational separation only with axial engagement provided by other features between the inner housing 14 and the cap 20. Thus, as shown in Figure 9c, the recess 60b may be provided on the proximal edge of the cap 20 adjacent the open end. This provides the recess 60b with an open end along the axial direction.

[0335] To prevent the cap 20 from being axially withdrawn distally from the inner housing 14, the cap 20 and / or inner housing 14 may have an axial retention mechanism that maintains the cap 20 in a relative axial position with the inner housing 14 while it is being rotated. In the illustrated embodiment, the axial retention mechanism is provided by threads 62a that engage threads 62b on the outer surface of the inner housing 14. The threads may be used to remove the cap 20 from the inner housing 14 once the plunging motion is completed and a torque threshold is overcome. Removing the cap 20 from the threads may expose the catheter for handling by the user.

[0336] The threads 62a, 62b may have partial or full turn threads. Partial turn threads may include, for example, quarter turn threads, whereby the cap 20 is removed following a quarter turn of the cap 20 after it has been rotationally disengaged from the inner housing 14.

[0337] As mentioned above, the rotation of the cap 20 may have multiple steps. The rotation of the cap 20 may have a priming step and a removal step. The priming step and the removal step may be in series and may be accomplished by rotating the cap 20 in the same rotational direction. The sum of the first and second steps may correspond to the number of rotations required to remove the wetted catheter and remove the cap 20. For example, a full 360° rotation of the cap 20 may result in wetting and removal of the cap 20. The wetting step may have 270° or 3 / 4 rotation and the removal of the cap 20 may have an additional 1 / 4 rotation. Other combinations of rotations and rotation steps may be possible.

[0338] The drive element may have a plug that is received in the fill orifice of the storage chamber 28. The body 18 may therefore have at least one hole extending through the outer wall, providing access to the interior volume of the storage chamber 28 such that wetting fluid may be received through the hole. The hole may be configured to receive the drive element / plug 52 following the filling procedure. The hole may therefore face the first end 54 of the track.

[0339] The interior volume of the catheter assembly may be sterilized following assembly. To maintain sterility of the interior volume, the catheter assembly may have an airtight seal. The airtight seal may have an outer surface of the catheter assembly or may have one or more seals located within the cap 20 and / or the body 18. The airtight seal may be broken by rotation of the cap relative to the body. Returning to FIG. 5, airtight seals 66, 68 are shown provided on either side of the joint between the body 18 and the cap 20. The seals 66, 68 may be similar to other seals described herein or may have elastomeric seal elements held within a seal housing.

[0340] The airtight seals 66, 68 may be broken when the cap 20 is removed from the body 18. Thus, rotating the cap 20 to initiate the conversion of the sealed configuration to the primed configuration may break (open) the seals 66, 68. When the inner housing 14 is moved distally by rotation of the cap 20, the seal 68 opens first, thereby breaking the airtight seal before the cap 20 is actually separated from the inner housing. However, the distal seal 38 prevents the wetting agent from leaving the distal end of the storage chamber, thereby placing the catheter assembly in a primed leak-proof configuration. This is advantageous because it allows the catheter assembly 10 to be left alone temporarily once it has been primed, e.g., to adjust position and / or clothing before removing the catheter from the outer housing (or longer, e.g., to leave for an appointment before returning to catheterization).

[0341] Returning to FIG. 7, it can be seen that the inner housing 14 may include optional ribs 64. The ribs 64 may be included to maintain the distance between the inner housing 14 and the outer housing 12 that defines the storage chamber 28. The ribs 64 may therefore assist in guiding the inner housing 14 as it moves axially and rotationally. The ribs 64 may also assist in the pumping action of the inner housing 14 as it is reinserted into the outer housing 12. The ribs 64 may therefore act to drive the wetting agent into the closed end and up into the wetting chamber 30.

[0342] The ribs 64 may extend circumferentially around the inner housing 14. The ribs 64 may be discontinuous in the circumferential direction so that a flow path may be maintained between adjacent ribs 64. As can be seen, the ribs 64 may be provided along the length of the inner housing 14. In the illustrated embodiment, there are three sets of ribs 64 spaced at regular intervals along the length of the inner housing 14. Each set of ribs 64 includes four individual circumferential sub-ribs provided at a common axial location above a circumferential line with the ribs having the same angular length. It is understood that the specific arrangement of the ribs may differ in other embodiments.

[0343] The sequence of priming, wetting, and cap removal rotation is illustrated in Figures 10a to 10f, which show the main steps in removing the catheter from a catheter assembly according to one embodiment.

[0344] FIG. 10a shows the catheter assembly 10 in a closed pre-activation configuration in which the airtight seal remains intact and the inner cavity of the outer housing 12 is sterilized. FIG. 10b shows a first step in which the cap 20 is rotated through an initial rotation stage. The initial rotation of the cap 20 rotates the inner housing 14 via the rotational engagement provided by the interlocks 60a, 60b. By rotating the inner housing 14, the drive surface provided by the track 50 and the drive element 52 moves the inner housing 14 together with the cap 20 in an axial distal direction. As seen in FIG. 10c, the distal movement of the inner housing 14 opens the airtight seal 68 and the transition of the proximal seal element 36a of the bifurcation to open a flow path for the wetting agent, as seen in FIG. 10d. At this point, the wetting agent flows into the priming chamber 44 at the proximal end of the body 18 and the catheter assembly is primed. Continued rotation of the cap 20 causes the inner housing 14 to move back into the body 18, at which point the ribs 64 drive the wetting agent from the priming chamber 44 to a wetting chamber inlet provided between the inner housing and insertion guide (if present) and the catheter tube 32. When the drive element 52 reaches the end of the drive surface provided by the track 50, further rotation is not possible without an increase in torque. Thus, the user is provided with some mechanical feedback that the catheter 16 is wetted. The above actions are performed by a single user action, i.e., rotating the cap 20 in a common direction with a substantially constant torque.

[0345] Following this first rotation step of the cap 20, the cap 20 is further rotated to release the interlock of the torque actuated release device, thereby allowing the cap 20 to move relative to the inner housing 12 via the threads 62a, 62b. Following removal of the cap 20, the catheter 16 may be grasped by the exterior handling surface at the outlet end 26 of the catheter 16 and axially withdrawn for use. If a sheath 34 is employed, the sheath 34 will be in a deployed position with the catheter 16 disposed therein to maintain sterility of the catheter 16 during manipulation.

[0346] 1 and 3, the catheter 16 may be any suitable catheter known in the art. As shown, the catheter 16 may include a catheter tube 32 and a funnel 26.

[0347] The catheter tube 32 may be an elongated, thin-walled structure extending longitudinally along the major axis 22 of the catheter assembly 10. The catheter tube 32 may be constructed of a flexible material. A first end of the catheter tube 32 may be closed with a hemispherical cap and may form the insertion end 24 of the catheter 16, with the hemispherical shape aiding in insertion.

[0348] Proximate the insertion end 24, one or more drainage holes 33 may be provided, which in this embodiment are elliptical with their major axis parallel to the major axis 22. It is understood that the size and shape of the drainage holes 33 may vary.

[0349] The outer surface of the catheter tube 32 may be functionalized, as known in the art, so that the coefficient of friction of the catheter tube 32 is reduced when the catheter tube 32 is wetted with a wetting agent. The outer surface of the catheter tube 32 may be constructed of or coated with a functionalized material, for example, the outer surface of the catheter tube 32 may have hydrophilic properties. The hydrophilic properties serve to lower the coefficient of friction of the outer surface when a wetting agent is introduced.

[0350] The end of the catheter 16 distal to the insertion end 24 includes a catheter outlet end 26. In this embodiment, the catheter outlet end 26 is provided as a funnel 26, which is a separate piece from the catheter tube, although in other embodiments they may be integrally formed. The funnel is cylindrical having a first open end and a second open end. The first open end is configured to receive the catheter tube 32 by the distal end of the insertion end 24. The catheter 16 is configured to provide fluid communication between the drainage hole 33 and the catheter outlet end 26.

[0351] There may be one or more protruding ribs projecting radially from the outer surface of the funnel 26. In the embodiment of FIG. 4, two protruding ribs are provided, a first rib 35a disposed proximate the second end of the funnel and a second rib 35b disposed between the first rib 35a and the first end of the funnel. 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 greater than the inner diameter of the distal end of the inner housing 14 and less than the inner diameter of the open end of the cap 20. The arrangement of the two protruding ribs 35a, 35b may be provided to maintain the position of the catheter 16 relative to the inner housing 14, with the second rib 35b ensuring that the catheter 16 and the inner housing 14 are coaxially disposed and the first rib 35a limiting the extent to which the catheter 16 can be proximally inserted into the inner housing 14 along the main axis 22.

[0352] The area of ​​the funnel's outer surface between the funnel's second end and the first rib 35a may be textured to provide a gripping surface for the user. When the funnel's outer surface between the funnel's second end and the first rib 35a is used as a gripping surface, the protruding rib 35 serves the additional function of providing spacing between the user's fingers and the (wetted) catheter tube 32.

[0353] As mentioned above, an optional sheath 34 is also shown in Figures 1 and 3. The sheath is formed of a flexible material and is disposed to surround the catheter tube 32. The sheath is coupled at a first end to the funnel adjacent the first open end of the funnel and at a second end to the insertion guide 25. The insertion guide 25, or a portion thereof, is made of an elastically deformable material.

[0354] In use, after completing the wetting cycle and removing the cap 20, the user withdraws the wetting catheter 16 from the catheter assembly 10. Holding the gripping surface of the funnel 26 and, if present, the insertion guide 25, the user inserts the catheter tube 32 into a duct, vessel, passageway, body cavity, etc., for the removal of fluid from the duct, vessel, passageway, body cavity, etc.

[0355] With the sheath 34 and insertion guide 25, the user grasps the insertion guide 25 to guide the catheter tube 32. The user grasps the insertion guide 25, deforms it to engage the catheter tube 32, restricts axial movement of the catheter tube 32 via the insertion guide 25, and inserts a first portion of the catheter tube 32 exposed from within the sheath 34 into a lumen, blood vessel, passageway, body cavity, or the like. Once the first portion of the catheter tube 32 is inserted, the user releases their grip on the insertion guide 25 to return it to its original shape, and slides the insertion guide 25 along the catheter tube 16 away from the insertion end 24, fluffing a portion of the sheath 34 and exposing a second portion of the catheter tube 16. The user then grasps the insertion guide 25 to restrict movement of the insertion guide 25 relative to the catheter tube 16, inserts the second portion of the catheter tube, and so forth, repeating the process. This process is repeated until the catheter tube is fully inserted into a lumen, blood vessel, passageway, body cavity, or the like.

[0356] Figure 11 shows an axial exploded view of a catheter assembly 210 according to the present invention. Figure 12 shows an external view of the catheter assembly 210 in a sealed configuration. The catheter assembly 210 includes an outer housing 212, a wetting agent storage chamber 228, and a catheter 216. The outer housing 212, the wetting agent storage chamber 228, and the catheter 216 are concentrically arranged such that the catheter 216 is located within the storage chamber 228 which is radially nested within the outer housing 212.

[0357] The outer housing 212 has a body 218 in which a storage chamber 228 and at least a portion of the catheter 216 are housed, and a removable cap 220 that can be removed by a user prior to use. Removal of the cap 220 exposes the catheter 216, which can then be removed from the outer housing 212 for use.

[0358] The body 218 may further include a catheter tube portion 219 and a storage chamber portion 221. The catheter tube portion 221 houses a catheter tube 232 of the catheter 216. The storage chamber portion 221 houses the storage chamber 230. The catheter tube portion 219 and the storage chamber portion 221 may comprise separate parts that are attached together to provide the body portion 218, or may be provided by a unitary piece. It will be understood that a portion of the storage chamber portion 219 houses a portion of the catheter tube 232, and the catheter tube portion 221 houses a portion of the storage chamber 228. Typically, the catheter tube portion 221 provides the distal proximal end of the housing 212.

[0359] The outer housing 212 provides an enclosed volume in which the catheter 216 can be housed for storage and transport prior to use. The body 218 and cap 220 may provide a sterile cavity in which the catheter 216 is placed. The outer housing 212 is generally elongated and has a storage chamber 228 and a longitudinal axis 222 that can be considered a major axis of the catheter assembly 210 that is coaxial with the longitudinal axis of the catheter 216.

[0360] The enclosed volume provided by the outer housing 212 is defined by an outer wall of the housing 212 that extends from a first proximal end 213, which receives an insertion end 224 of the catheter 216, to a second distal end 215, which receives a catheter exit end 226. In the illustrated embodiment, the second end 215 is provided by a cap 220. Thus, removal of the cap 220 exposes the exit end 226 of the catheter 216, allowing a user to grasp and remove the catheter 216 from the housing 212 for use.

[0361] The exterior shape of the housing 212 may be any desired for aesthetic or functional purposes and may incorporate similar exterior features as the outer housing 12 described above. Thus, the outer housing 212 may be generally cylindrical, tapered toward a first end to aid in insertion into a storage container or pocket, for example, and tapered toward a second end along the length of the cap 220. Additionally, the cap 220 may be temporarily stored in the opposite end of the outer housing 212, as shown in Figures 2a-2c.

[0362] To maintain sterility of the interior volume of outer housing 212 prior to use, an airtight seal may be provided between cap 220 and body 218. The airtight seal may include a sealing element, such as O-ring seal 297b, provided between body 218 and cap 220, as best seen in FIG. 13, where the O-ring seal seats against a circumferential sealing surface on the outside of body 218 and faces a corresponding circumferential sealing surface on the inside of cap 220 when the cap is sealed.

[0363] Alternatively, the airtight seal may be provided by a tamper-evident connection or strip between the body 218 and the cap 220. FIG. 12 provides an example of an airtight seal 297a formed as a tamper-evident strip. The seal 297a comprises a portion of the outer surface of the outer housing 212. Thus, the outer housing 212 may comprise the body 218, the cap 220, and the airtight seal 297a. The airtight seal 297a / 297b may be configured such that the seal 297a is broken upon rotation of the cap 220. Breaking the seal 297a / 297b may occur during a priming step that places the catheter assembly in a primed configuration.

[0364] The storage chamber 228 provides a reservoir for storing the wetting agent prior to wetting of the catheter tube 232. The storage chamber 228 is provided at the distal end of the catheter tube 232 such that as the catheter is withdrawn from the housing 212, the catheter tube 232 may be withdrawn through the wetting agent held within the storage chamber 228. Alternatively or additionally, upon opening the storage chamber 228, the wetting agent may flow down the outer surface of the catheter tube 232 (which may be functionalized to be hydrophilic, as in the previous embodiment) towards the closed end of the body 218.

[0365] 13, the storage chamber 228 surrounds the catheter 216 and has chamber walls 231, 235 that seal against sealing surfaces 239, 241 on the catheter 216 to provide an annular enclosed volume in which the wetting agent is stored prior to use. The storage chamber walls 231, 235 are axially spaced apart and are sealed to the catheter 216 using first and second seals 233, 237 which may be provided at distal and proximal ends of the storage chamber 228. The catheter 216 seals the storage chamber 228 and may therefore be considered to form part of the storage chamber 228.

[0366] The catheter 216 thus has a moveable insert such that it can move relative to the storage chamber wall 231. The catheter 216 may be configured to be axially moveable upon rotation. Rotation of the catheter 216 may be achieved via rotating the cap 220. In this manner, the cap 220 and the catheter 216 may be rotatably engaged.

[0367] The chamber walls 231 , 235 may have multiple pieces joined together to provide a sealed outer wall that provides a sealed closed volume for the catheter 216 .

[0368] The storage chamber portion 219 may be configured to prevent relative rotation of the storage chamber 228. Thus, when the catheter 216 is biased to rotate within the storage chamber 228, the storage chamber portion 219 prevents the storage chamber 228 from rotating about the longitudinal axis 222. In this manner, the catheter 216 passing through the storage chamber 228 can be rotated relative to the housing 212 and the storage chamber 228 during the release and / or wetting procedures.

[0369] The storage chamber portion 219 may also be configured to prevent axial movement of the storage chamber 228 during the release and / or wetting procedures. The axial retention of the storage chamber 228 may be limited below a predetermined threshold such that when an axial pull force above the predetermined threshold is achieved, the storage chamber 228 is released from the housing 212 and allowed to move axially.

[0370] As can be seen in FIG. 13, the storage chamber 228 may be an elongated structure extending coaxially along the longitudinal axis 222 to define an annular cavity in which the wetting agent may be stored. The annular cavity is defined by a radially outer wall with axially opposed end walls extending between the radially outer wall and the catheter 216. The end walls may extend from the ends of the radially outer wall in a plane normal to the longitudinal axis 222, although this is not limiting and other configurations are envisioned. The end walls may terminate or terminate at radially inner edges in axially extending annular flanges at either or both ends of the storage chamber. These embodiments are described in more detail below.

[0371] As described above, the movable insert is configured to move axially along the longitudinal axis 222 relative to the chamber wall 231. Movement of the catheter 216 may transition the catheter 216 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 catheter 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 offset with the sealing surface 233b. In this manner, the seal 233 may be opened in the second position, or, as described below, compression of the sealing element 233a may be reduced to allow the catheter 216 to be more easily withdrawn while the storage chamber 228 remains sealed, to effect wetting of the catheter tube 232. Although the sealing element 233a and the sealing surface 233b are shown as being disposed on the chamber wall 231 and the catheter body 243, respectively, this may instead be reversed.

[0372] The first seal 233 and the second seal 237 are axially spaced apart and seal against a portion of the catheter 216. At least one of the movable insert, e.g., a portion of the catheter 216, and the chamber wall 231 may have a bifurcated portion through which the seal element 233a passes when transitioning between the first sealing position and the second priming position. The bifurcated portion is such that when in the second priming position, the distance between the chamber wall 231 and the movable insert at the axial position of the seal element 233a increases. This distance may be a radial distance relative to the longitudinal axis 222. The bifurcated portion may comprise an expansion of the cavity adjacent the sealing surface 233a. The bifurcated portion may be provided by a step or taper adjacent the sealing surface.

[0373] Figures 14a and 14b show side views of catheter 216 with first seal 233 and second seal 237 shown in cross section. Figure 14a shows the position of catheter 216 in a sealed / stored configuration, and Figure 14b shows catheter 216 in a primed configuration, where catheter 216 is configured to be removed from the outer housing during the second stage of catheter 216 deployment (the first stage being priming).

[0374] 13, 14a and 14b, first seal 233 and second seal 237 may be provided by respective sealing elements 233a and 237a disposed against opposing sealing surfaces 233b and 237b on catheter 216. Sealing surfaces 233b and 237b may be considered to be primary sealing surfaces.

[0375] In the illustrated embodiment, the sealing surfaces 233b and 237b are provided by the catheter body 243. The body 243 thus constitutes a movable insert and is disposed between the outlet end 236 of the catheter 216 and the catheter tube 232. As shown, the catheter body 243 has an increased radius compared to the catheter tube 232 and is contoured to provide the sealing surfaces 233b and 237b.

[0376] The catheter body 243 may extend to or be an extension of the distal end of the catheter 216. The distal end of the catheter body 243 may provide an outlet for the catheter 216, which may be externally and internally shaped to provide an external handling surface and internal flow enhancing features. Thus, the exterior of the catheter body 243 may include an external handling surface that includes a number of grooves that aid in handling of the catheter by the user's fingertips. The internal surface may also include a funnel that branches in the direction of flow. These features of the catheter 216 have been described in connection with Figures 1 and 3 and will not be described further here.

[0377] The first sealing surface 233b is provided 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 the sealed configuration. The raised portion includes a first diameter D233 that is greater than a diameter d233 of the adjacent proximal and optionally distal portions of the catheter body 243. As such, the sealing surfaces 233b are separated by steps or chambers in the shape of the catheter body 243.

[0378] In the illustrated example, the sealing surface 233b and adjacent portions are shown as cylindrical. Thus, the sealing surface 233b has 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 shown by FIG. 14b, the relative axial movement between the catheter 216 and the sealing element 233a held by the storage chamber 228 moves away from the sealing surface 233b on the proximal adjacent surface defined by the diameter d233, and there is either a gap between the sealing element 233a and the adjacent surface, or a reduced contact that allows the storage chamber to be sealed but the catheter to be more easily withdrawn. As shown in FIG. 14b, the axial retention force on the catheter body 243 and the catheter 216 is reduced, since the sealing contact is maintained in compression. In this regard, the proximal shaft of the catheter body 243 may provide a secondary proximal sealing surface 233c. Thus, in the closed configuration, the seal 233 may act to provide an increased seal pressure that helps reduce evaporative loss from the storage chamber 228 .

[0379] The distal seal 237 has a distal seal element 237a sealably disposed against a seal surface 237b provided on the catheter body 243. In contrast to the proximal seal 233, the distal seal surface 237b is provided with a constant cross-section such that a constant seal 237 is maintained when there is relative axial movement between the catheter 216 and the storage chamber 228.

[0380] As shown, the distal seal surface 237b may be defined by a radial rise that positions the seal element 237a at a defined axial extent of the catheter body 243. The radial rise may be part of a groove in the surface of the catheter body 237, one or more flanges, or an increase in diameter of the catheter body 243. Figures 14a and 14b show a distal seal surface 237b having a combination of a radial flange on the proximal side on the right and an increase in diameter on the distal side on the left, with the seat of the seal surface 237b being provided as a groove in the surface of the catheter body 243 shaft extending between the first seal 233 and the second seal 237.

[0381] 13 and 14b, when the catheter 216 is moved distally to be withdrawn from the 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 uprights so as to be held about the catheter body 243. The proximal sealing element 233a is held by the storage chamber 228 as the catheter is withdrawn.

[0382] It is understood that the storage chamber 228 may include mechanisms for retaining the seal elements 233a and 237a in place and biasing the seal elements 233a and 237a radially inward to provide a seal. For example, the seals 237a, 233a may be retained by and overmolded with a seal housing. A specific embodiment for retaining the seal element 233a is provided below in connection with FIG. 16a.

[0383] The seal elements 233a, 237a may be of different sizes. More specifically, the proximal seal 233 may have a larger seal element 233a to allow for increased compression and increased contact area with the seal surface 233b when in the first sealed configuration.

[0384] The sealing element 233a and / or the sealing element 237a may comprise an elastomeric material. The sealing elements 233a, 237b may be O-rings. Alternatively, the sealing elements 233a, 237b may be X-rings or U-cup seals.

[0385] The catheter 216 is configured to move axially relative to the outer housing 212 and the storage chamber 228. This not only allows the catheter 216 to be withdrawn from the outer housing 212 for use, but also allows the catheter tube 232 to pass through a wetting agent contained in the storage chamber 228. The catheter 216 therefore has a sealed (or storage) configuration and a primed configuration in which the catheter 216 is withdrawn and wetted. The sealed configurations of the catheter assembly 210 and catheter 216 are shown in Figures 2 and 14a, respectively. As mentioned above, the primed configuration of the catheter 216 prior to withdrawal is shown in Figures 13 and 14b.

[0386] Moving the catheter 216 from the sealed configuration to the priming configuration may be accomplished by the user axially withdrawing the catheter 216 in a distal direction. Withdrawal may be accomplished by the user grasping the outlet end 226 of the catheter directly or indirectly, for example, via the cap 220.

[0387] Axial withdrawal may be accomplished using an actuator, sometimes referred to as a priming mechanism. The priming mechanism includes any device capable of causing the necessary axial movement of the catheter 216 relative to the outer housing 212 and the storage chamber 228. In some embodiments, the priming mechanism may include a catheter configured to be rotatable such that rotation induces axial movement. The priming mechanism may include a cam drive or crank with a drive surface engaging a drive element such that relative rotation of the drive element or drive surface results in axial movement of the catheter 216 relative to the body 218. The rotational movement may be provided by a rotatable actuator, such as a cap 220 that rotationally engages the catheter 216 as a movable insert.

[0388] 15 illustrates an embodiment in which the catheter body 243 includes a cam drive portion 281. The cam drive has a drive surface in the form of a ramp formation provided by the axially facing end wall surface of the storage chamber wall 231, and a drive element having a circumferentially extending fin 282 that extends axially and circumferentially to provide a helical projection that functions as a thread / cam. The fin 282 engages a corresponding ramp formation 284 provided on the storage chamber 228 such that rotation of the catheter 216 causes the fin 282 to move along the ramp formation 284, urging the catheter 216 distally relative to the storage chamber 228.

[0389] Biasing the catheter 216 distally causes axial sliding of the catheter 216 relative to the storage chamber seals 233, 237 and movement of the proximal seal element 233a and associated seal surface 233b, as described above in connection with Figures 14a and 14b.

[0390] Rotation of the catheter 216 may be accomplished by a user grasping and rotating an exterior handling surface of the catheter outlet end 226, or via rotation of the cap 220. Rotating the cap 220 may be accomplished by providing a rotational engagement between the cap 220 and the catheter body 243.

[0391] As seen in Figures 13 and 15, the rotational engagement may be provided via corresponding radial protrusions 286a, 286b on the interior of the catheter body 243 and cap 220. The protrusions may take any suitable form and, as discussed above, may include radially extending members in the form of ribs, flanges, projections, pins, seats, etc., and may also serve the dual purpose of helping to retain the cap 220 to the base of the body 218 during catheter insertion.

[0392] 11 and 15, cap 220 is also shown as including threads 288a that engage corresponding threads 288b on the exterior of the distal end of body 218 such that cap 220 can be releasably attached to body 218.

[0393] Because catheter 216 is rotatably engaged to cap 220, rotating cap 220 to remove it from body 218 via threads 288a, 288b rotates catheter 216 and withdraws it from storage chamber 228 via cam drive 281. Thus, rotation of cap 220 relative to body 218 results in rotation of catheter 216. From this, it will be appreciated that the pitch of the cam drive rib / ramp arrangement is the same as the pitch of threads 288a, 288b.

[0394] Once rotation of cap 220 is complete such that threads 288a, 288b are free, cap 220 may be axially removed from body 218 with projections 286a, 286b axially separated. Once rotation of catheter 216 is complete, fins 282 move circumferentially around the end of the ramp arrangement with no further axial movement occurring.

[0395] 15 has a number of helical fins 282, e.g., two, that engage a corresponding number of ramp formations 284 on the storage chamber 228, although it is understood that the number of drive surfaces / drive elements may vary. Furthermore, the helical surface providing the camming action may be provided by any suitable formation, and the fin and ramp formation embodiment is provided only as an example. For example, both the storage chamber 228 and the catheter 216 may be provided with ramp formations and / or fins, or a combination thereof. Other camming arrangements that convert rotational motion into linear axial motion may be provided, such as threads similar to those provided for the engagement of the cap 220 and the body 218.

[0396] Figures 13, 16a and 16b show in more detail an embodiment of how the storage chamber 228 is constructed. Thus, the storage chamber 228 is shown to be provided by a multi-part construction with a first part 231 and a second part 235 joined to provide the storage chamber walls. Figure 13 shows a two-part construction with a first distal part 231 mated to a second proximal part 235. The proximal part 235 has a radially extending wall that provides the axial end wall of the storage chamber compartment in which the majority of the wetting agent is located. The distal part 231 comprises the distal end wall and the radially outer wall of the storage chamber compartment.

[0397] The inner surface of the storage chamber wall has a plurality of radial protrusions in the form of fins 290. The fins 290 are circumferentially distributed so as to be angularly spaced apart from one another about the longitudinal axis 222. The fins 290 extend axially and radially so as to lie in a plane defined by the longitudinal axis 222 of the catheter assembly. The fins 290 may be provided in diametrically opposed pairs.

[0398] As can be seen, the radially inner edges 291 of the fins 290 may be disposed at a common radial distance from the central longitudinal axis 222 of the catheter 216 such that the radially inner edges 291 of the fins 290 provide a guide tube for maintaining the catheter 216 and the storage chamber 228 in concentric alignment. The radius of the guide tube may correspond to or be greater than the radius of the proximal sealing surface 233b such that the sealing surface 233b can pass unimpeded therethrough while maintaining concentricity.

[0399] A proximal axial edge 292 of the fin 290, which defines the axial extent of the fin 290, may terminate short of the proximal end wall of the storage chamber 228 to provide an edge 292 that defines a gap in which the proximal seal element 233a may be located. The proximal axial edge 292 of the fin 290 thus, in combination, provides a seat in which the seal element 233a may be located during assembly and use of the storage chamber 228, thereby axially restraining the proximal seal during transition of the catheter 216 from the stored position to the wetted position and during withdrawal of the catheter 216.

[0400] 16a shows only four fins 290 in cross section, it being understood that a fewer or greater number of fins 290 may be used. It is also understood that while the fins 290 provide a convenient structure between which a wetting agent may be stored while providing adequate strength and surface area to guide the catheter and / or provide a sealing seat, other configurations may be used. For example, the configurations may be provided by any combination of protrusions such as ribs, pins, seats, or flanges.

[0401] As mentioned above, the distal end of the storage chamber 228 may include one or more features that are used as part of the priming mechanism 281. Thus, as can be seen, the distal end of the storage chamber 228 in Figures 16a and 16b has a ramp arrangement 284 that engages a helical fin 282 provided on the catheter body 243.

[0402] The ramp arrangement 282 is provided at the end of an annular flange 293 that extends from the main storage compartment. In the illustrated embodiment, the ramp arrangement 282 is provided by a triangular cut in the annular flange 282, with the hypotenuse of the triangle providing the engagement surface. The use of the annular flange 282 allows the ramp arrangement to be located radially closer to the catheter 216, thereby allowing the corresponding fins 282 to be smaller. The annular flange 282 also provides a convenient location for a distal seal 237 that resides between the ramp arrangement 284 and the distal radial wall of the main storage compartment of the storage chamber 228.

[0403] Attachment of the first 231 and second 235 parts of the storage chamber 228 can be via an interference fit, such as a push fit or click fit, for example by gluing, welding, threading, or clamping. The embodiment of Figures 13, 16a and 16b is shown as being a click-fit attachment where the parts 231, 235 are pushed and clicked together so that the circumferential ribs sit in the corresponding grooves.

[0404] The outer surface of the proximal portion 235 is configured to provide an insertion guide 225. Thus, the outer surface may be rounded and / or tapered to facilitate locating the insertion guide 225 comfortably at the entrance of the urethra.

[0405] More specifically, in some embodiments, the insertion guide 225 (sometimes referred to as a gripper) may be an annular member that is located radially outward of the catheter tube 232 or catheter body 243 when retracted. 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 enhance gripping and user dexterity.

[0406] The insertion guide 225 is retractable because it is configured to remain outside the urethra as the catheter tube 232 is inserted. The catheter tube 232 can therefore pass through the insertion guide 225 during insertion such that the insertion guide 225 moves rearward towards the exit end 226. When fully retracted, the insertion guide 225 may abut against the distal end of the catheter body 243.

[0407] Therefore, if the storage chamber has an insertion guide 225, the storage chamber 228 with the insertion guide 225 may be released from the outer housing when the catheter 216 is withdrawn.

[0408] The general procedure for inserting catheter 216 and insertion guide 225 has been described above and will not be repeated here.

[0409] To ensure that the insertion guide 225 is properly positioned at the insertion end 226 of the ready-to-use catheter (as shown in FIG. 11 ), the storage chamber 228 may be retained within the outer housing 212 while the catheter 216 is removed and the proximal end of the catheter tube 232 is aligned with the insertion guide 225. To conveniently withdraw the insertion guide 225 from the housing 212 along with the catheter 216, the catheter arrangement 210 may have an optional retractable sheath 234 located radially outward of the catheter tube 232. Alternatively, the insertion guide may simply be withdrawn by hand.

[0410] 11 and 19 show the retractable sheath 234 in a stored configuration. The sheath 234 extends from an attachment 234a on the catheter body 243 to an attachment 234b distal to the storage chamber 228. The sheath 234 is flexible and retractable along with the insertion guide 225. Thus, when the catheter 216 and insertion guide 225 are disposed within the housing 212, the sheath 234 is provided in the stored configuration illustrated in FIG. 11, and when the catheter 216 is withdrawn, the sheath deploys from the stored configuration to a fully extended, deployed configuration, acting to lock the storage chamber to the catheter such that subsequent withdrawal of the sheath 234 results in withdrawal of the storage chamber and the insertion guide 225.

[0411] It will be appreciated that in embodiments where insertion guide 225 is not provided, storage chamber 228 may not have a proximal annular flange forming part of proximal portion 235 and may not be retained within housing 212 when catheter 216 is removed. In such cases, sheath 234 may also be omitted.

[0412] To enable its removal, the storage chamber 228 may be held within the outer housing 212 by a releasable coupling 295 (best seen in FIG. 18 and described below). The releasable coupling 295 may release the storage chamber 228 when a predetermined amount of axial tension, i.e., pull-out force, on the storage chamber is applied or exceeded. Once the predetermined amount of axial tension is applied or exceeded, the storage chamber is released by the releasable coupling and pulled out of the outer housing.

[0413] The axial tension may be applied directly or indirectly to the storage chamber 228. Thus, in some embodiments, a user may grasp the storage chamber 228 or a portion thereof and withdraw the storage chamber 228 along with the catheter 216. In some embodiments, the storage chamber 228 and the catheter 216 may be coupled such that withdrawing the catheter 216 withdraws the storage chamber 228 from the outer housing 212. In some embodiments, the coupling between the storage chamber and the catheter may be provided by a lock, such as a retractable sheath 234.

[0414] To prevent rotation of the storage chamber 228 with the catheter 216 during the transition between the sealed and priming configurations, the storage chamber 228 may be rotatably fixed relative to the body 218. An embodiment of the coupling 295 configured to prevent relative rotation is described in relation to FIG. 16b, which shows an exterior view of the storage chamber 228, FIG. 17, which shows the storage chamber portion 219 without the storage chamber 228 contained therein, and FIG. 18, which shows the storage chamber 228 and the storage chamber portion 219 assembled together. As described below, the coupling 295 may be configured to be a releasable coupling such that the coupling 295 is released upon exceeding a predetermined axial force threshold.

[0415] The exterior of the storage chamber 228 may be provided by an outer surface 294 that, in the illustrated embodiment, is generally cylindrical. The outer surface 294 may have one or more anti-rotational and / or axial retention features, such as one or more recesses. A number of circumferential recesses may be provided, such as provided by a locking grooved annular groove 296.

[0416] The storage chamber portion 219 may have an elongated tubular member extending from a proximal end to a distal end. The outer surface of the storage member portion 219 may provide a portion of the outer surface of the outer housing 212 and / or one or more features for attaching the cap 220 to the body 218, such as the threads 288b described above, and / or one or more features 297 for receiving an airtight seal 297a, shown in FIG. 11, between corresponding ends of the cap 220 and the body 218 that is irreversibly removed or destroyed as the cap 220 is removed, as is well known in the art.

[0417] The interior of the storage chamber portion 219 has a cylindrical cavity 219a in which the storage chamber 228 is received and may include one or more mechanisms of a coupling 295 for engaging the storage chamber 228 to prevent axial and / or radial movement of the storage chamber 228 relative to the housing 212.

[0418] The portion of the coupling 295 provided by the storage chamber section 219 has a plurality of circumferentially arranged prongs 298 that are substantially rotationally rigid such that when they engage the annular anti-rotation groove 296, they act in combination to prevent rotation of the storage chamber, and are radially compliant such that when the storage chamber 228 and the chamber storage section 219 are forced axially apart, the prongs 298 flex outwardly, thereby releasing the storage chamber 228. Under a predetermined axial force threshold, the prongs 298 remain engaged with the anti-loosening groove 296 on the outer surface 295 of the storage chamber wall.

[0419] The number of protrusions in Figures 17 and 18 is 8. However, in some embodiments the number may be more or less than this.

[0420] The locking groove 296 comprises an annular groove that extends around the outer surface 294 of the storage chamber 228 and is partitioned to provide a circular array of recesses that can receive the tips of the prongs 298. It will be appreciated that in other embodiments the recesses may be fewer in number and more dispersed than shown.

[0421] The prongs 298 have projections with rims 298a and tips 298b. The rims 298a extend axially from the radially extending inner surface of the storage chamber portion 219 toward the proximal end of the body 218. The rims 298a extend from a distal fixed end to a proximal free end. The free end includes a radially inwardly extending tip portion 298b providing a hook that is received in a recess in the storage chamber outer surface 294 to provide a fastener. The radially inner surface of the storage chamber portion that receives the storage chamber 228 is flush with the inner surface of the cylindrical housing in which the storage chamber is received.

[0422] When viewed distally along the longitudinal axis, the radially inner edge of the proximal end of the prong tip portion 298b is tapered so that the prong 298 can more easily receive and be biased by the storage chamber 228 when the storage chamber 228 is inserted into the storage chamber portion 219 along the longitudinal axis.

[0423] As previously discussed, the releasable coupling requires increased axial force to actuate. This increased force ensures that the catheter tube is fully withdrawn so that the storage chamber 228 / insertion guide 225 is in the correct position relative to the insertion end and the retractable sheath is fully extended. Mechanical feedback may also be provided to the user indicating that the catheter is fully withdrawn and can be reinserted if desired.

[0424] In some embodiments, when the storage chamber 228 is left within the housing 212 following withdrawal of the catheter 216, the storage chamber 228 may be attached to or form part of the housing 212 and the connection 295 may not be required.

[0425] In use, and referring to the catheter assembly shown in FIG. 2, a user may rotate the cap 220 to break the airtight seal 297a / 297b. Rotation of the cap 220 results in rotation of the catheter 216 via the rotational engagement provided by the radial projections 286a, 286b. Rotation of the catheter 216 causes the drive surface and drive element provided by the cam drive 281 to axially separate the storage chamber 228 and the catheter 216, causing the proximal seal element 233a to slide axially to provide the catheter assembly in the primed configuration. This requires a single user action, namely, rotation of the cap 220 in a first direction, which is the first step in transitioning the catheter assembly from the sealed configuration to the primed configuration.

[0426] Following separation of the seal 233, the catheter 216 may be withdrawn axially through the storage chamber 228, which functions as a wet chamber during withdrawal. If necessary, the catheter may be reinserted into the storage chamber 228 and withdrawn multiple times to ensure complete wetting of the catheter tube 232 before removal.

[0427] If the catheter 216 incorporates an insertion guide 225 , the insertion guide 225 may form part of the storage chamber 228 and may be removed from the housing 212 along with the catheter 216 .

[0428] It will be appreciated that the above-described embodiments in which the catheter includes a moveable insert that is rotated to axially release the seal of the storage chamber, either partially or completely, are advantageous because the mechanical advantage of using a priming mechanism allows for a tighter seal that, without the mechanical advantage of the priming mechanism, would be more difficult to displace by hand, especially for weaker or frail users.

[0429] According to a further embodiment of the present invention, a catheter assembly 310 is provided.

[0430] 20, 21a, 21b, and 21c, catheter assembly 310 includes an outer housing 312 and a catheter 316. Catheter 316 includes a catheter tube 332 and a sheath 334. Outer housing 312 and catheter 316 are concentrically arranged such that catheter 316 is radially nested within outer housing 312.

[0431] The catheter assembly 310 may be configured so that the catheter 316 is wetted before it is withdrawn from the outer housing 312. The wetting agent used to wet the catheter 316 prior to use may be held 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 via a wetting chamber defined between the outer housing 312 and a second portion of the catheter 316. The catheter 316 may be movable or may have a movable insert.

[0432] 20, 21a, 21b, and 21c, the outer housing 312 has a body 318 in which a portion of the catheter 316 is housed, and a cap 320 which contains a portion of the catheter 316, i.e., the portion which remains integral with the catheter during catheter insertion and during the release of urine from the body.

[0433] The outer housing 312 provides an enclosed volume in which the catheter 316 can be housed for storage and transport prior to use. The body 318 and cap 320 may provide a sterile cavity in which the catheter 316 is placed. The outer housing 312 is generally elongated and has a longitudinal axis 322, which may be considered the major axis of the catheter assembly 310. In this embodiment, axial or radial directions are referenced to the longitudinal axis 322 unless otherwise noted.

[0434] The enclosed volume provided by the outer housing 312 is defined by an outer wall of the housing 312 that extends from a first proximal end 313 that receives an insertion end 324 of the catheter 316 to a second distal end 315 at which a catheter exit end 326 is received. In the illustrated embodiment, the second end 315 is provided by a cap 320 that has a portion of the catheter 316 and the exit end 326. The cap 320 may provide an exterior handling surface for a user to withdraw the catheter 316 from the body 318.

[0435] The exterior shape of the housing 312 can be any desired for aesthetic or functional purposes, and in the illustrated example is generally cylindrical, tapered toward a first end to aid in insertion into a storage container or pocket, for example, and tapered toward a second end along the length of the cap 320.

[0436] Cap 320 has a generally cylindrical body open at both ends having a circumferential outer wall extending coaxially along longitudinal axis 322. Cap 320 is fitted to the distal end of body 318 such that cap 320 is received within the open distal end of body 318. However, it is understood that cap 320 may receive the open end of body 318 in some embodiments.

[0437] The outer housing 312 may be used for transporting the catheter 316 when ready for use and for disposing of the catheter 316 after use.

[0438] 20, 22a and 22b, the cap 320 may provide an enclosure 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, which in this embodiment is provided by a connector 323 having a portion of the catheter 316 and connecting the catheter tube 332 to the catheter outlet 326, as described in more detail below. The connector 323 may thus be provided within the outer housing 312 in spaced apart relationship to define a cavity 321 therebetween.

[0439] The axial boundary of the wetting agent storage chamber 321 may be defined by a first radially protruding wall 327 and a second radially protruding wall 329 protruding from an inner wall of the cap 320. The first wall 327 may be disposed closer to the insertion end 324 of the catheter 316 than the second wall 329, which may be disposed closer to the second distal end 315 of the body.

[0440] The first wall 327 and the second wall 329 may have one or more steps. As shown in Figures 22a and 22c, the first wall 327 is formed as a separate piece from the rest of the cap 320 and has two steps, a first step 327a and a second step 327b, the second step 327b being arranged radially inward and axially towards the insertion end 324 of the first step 327a. Both steps of the first wall have a first part projecting radially inward and a second part extending axially towards the insertion end 324, thus forming two tubular parts arranged coaxially with the cap 320. The second tubular part 327b' may form a first sealing surface 327b' for sealing the wetting agent storage chamber 321 (described in more detail below). The second wall 329 may have one or more steps. 22a and 22b, the second wall 329 has a single step with a first portion 329a projecting radially inward from the inner wall of the cap 320 and a second portion 329b extending axially toward the insertion end 324 perpendicular to the first portion 329a to form a tubular portion disposed coaxially and radially inwardly relative to the cap 320. The second portion 329b of the second wall may form a second sealing surface 329b for sealing the wetting agent storage chamber 321 (described in more detail below). The cavity may be referred to as the wetting agent storage chamber 321 or reservoir 321.

[0441] The wetting agent storage chamber 321 is sealed in a first configuration (as shown in FIG. 22a) so that the wetting agent is retained therein, and is open in a second configuration (as shown in FIG. 22b) so that the wetting agent can flow out of the wetting agent storage chamber 321 and contact the catheter tube 332. When in the open configuration, the interior volume of the wetting agent storage chamber 321 may be in fluid communication with the wetting chamber 330 in which the catheter tube 332 is disposed, so that the wetting agent can flow from the wetting agent storage chamber 321 to the wetting chamber 330 and thus to the catheter tube 332.

[0442] 22a-b, the connector 323 is radially nested within the cap 320, the two parts defining the wetting agent storage chamber 321. The connector 323 may have a tubular wall configured to define a portion of the wetting agent storage chamber 321 on its radially outer side, and a portion of a drainage channel (described in more detail below) on its radially inner side.

[0443] The connector 323 may have an elongated thin-walled structure extending longitudinally along the major axis 322 of the catheter assembly 310. The connector 323 has an open first end configured to receive the catheter tube 332 and a closed second end proximate the outlet end 326. The second end of the connector may have a drain 331, an end wall 337, and a tab 339 for opening the drain 331. The end wall 337 may be a radially extending, axially opposed disk having a first surface that closes the second end of the connector 323 and a second surface opposite the first surface. The second surface of the end wall 337 may have a tab 339 disposed thereon that is flexibly joined to the end wall 337 in the form of a ring pull. The connector 323 proximate the end wall 337 has one or more holes disposed therein that form the drain 331 and provide a fluid connection between the interior of the connector 323 and the exterior of the catheter assembly 310.

[0444] As mentioned above, the connector 323 is radially disposed within the cap 320, and to facilitate this, the radially outer surface of the connector proximate the first open end may be shaped and sized to rest within the second tubular portion 327b' of the cap, forming a corresponding portion of the first sealing surface. To improve sealing of the wetting agent storage chamber, a sealing means such as a sealing element 370 may be provided. In the illustrated embodiment, the sealing element is provided in the form of an O-ring 370 disposed on the radially outer surface of the connector in a recess 371 for limiting movement of the O-ring 370 relative to the connector 323. It will be understood by those skilled in the art that the sealing element may also be provided on the first wall 327, or on both the connector 323 and the first wall 327.

[0445] To ensure that the wetting agent storage chamber 321 remains sealed during shipping and storage and is not accidentally deployed to the second configuration, the connector 323 and first wall 327 may also have a retention feature 380. The retention feature 380 has a radially inwardly projecting retention clip 380a disposed circumferentially within the first sealing surface 327b' and a corresponding groove 380b disposed in the radially outer surface of the connector 323. It will be appreciated that the shape, and optionally the material, of the retention feature 380 can be selected to ensure that the retention feature 380 disengages when a predetermined force is applied.

[0446] To further facilitate positioning of the cap 320 and the connector 323, the connector 323 may include a number of protruding ribs 345 that protrude radially outwardly around the circumference of the outer surface of the connector. As seen in Figures 22a and 22b, three ribs 345 are provided, with a first rib 345a disposed along approximately half of the axial length of the connector 323 and a second rib 345b and a third rib 345c disposed between the first rib 345 and the drain 331. The first rib 345a extends such that its radial diameter is greater than the inner radial diameter of the second sealing surface 329b. The second rib 345b and the third rib 345c are configured for axial slidable movement within the second sealing surface.

[0447] The combination of the first large stop rib 345a and the two smaller guide ribs 345b, 345c serves a number of functions. First, it provides a seal to prevent leakage of wetting agent from the catheter assembly 310 during storage and shipping. Second, the guide ribs 345b, 345c guide the movement of the connector between a closed configuration (shown in FIG. 22a) in which the third rib 345c is disposed against the second sealing surface 329b, and an open configuration (shown in FIG. 22b) in which the second rib 345b is disposed against the second sealing surface 329b. The stop rib 345a limits the range of distal axial movement of the connector 323 and catheter tube 332 so that the connector 323 and catheter tube 323 cannot be moved beyond the open configuration and withdrawn from the cap 320.

[0448] In use, a user pulls tab 339 and, when a predetermined force is applied, the retention mechanism 380 disengages and the connector 323 and catheter tube 332 move axially distally relative to the cap 320, moving the wetting agent storage chamber 321 from a closed configuration to an open configuration. The O-ring 370 moves axially away from the first sealing surface 327b', breaking the seal of the wetting agent storage chamber 321.

[0449] As the connector 323 moves axially through the cap 320, alignment is maintained by the second rib 345b and the third rib 345c such that at least one is always positioned opposite the second sealing surface 329b. The extent to which the wetting agent storage chamber can be opened is defined by the contact of the first rib 345a with the second sealing surface 329b.

[0450] When the catheter 316 is in the open configuration, the wetting agent is released from the wetting agent storage chamber 321 into the wetting chamber 330 to wet the catheter 316 as described below.

[0451] 21 and 22Aa and 22c, the catheter 316 may be any suitable catheter known in the art. In this embodiment, a cap 320 comprises a portion of the catheter 316, and the cap 320 is formed in two parts, an upper cap 320a that defines the radially outer wall of the wetting agent storage chamber, and a lower cap 327 that forms a first wall 327.

[0452] As shown, the catheter 316 also includes a catheter tube 332 .

[0453] The catheter tube 332 may be an elongated, thin-walled structure that extends longitudinally along the major axis 322 of the catheter assembly 310. The catheter tube 332 may be constructed of a flexible material. A first end of the catheter tube 332 may be closed with a hemispherical shape and may form the insertion end 324 of the catheter 316, which aids in insertion.

[0454] Proximate the insertion end 324 may be one or more drain holes 333 which act as inlets for receiving urine from the patient's bladder. In this embodiment, the drain holes 333 are elliptical with their major axis parallel to the major axis 322. It is understood that the size and shape of the drain holes 333 may vary.

[0455] The outer surface of the catheter tube 332 may be functionalized to reduce the coefficient of friction of the catheter tube 332 when wetted with a wetting agent, as outlined in the previous embodiment.

[0456] At the end of the catheter 316 distal to the insertion end 324 is a catheter outlet end 326. In this embodiment, the catheter outlet end 326 is provided as part of the connector, although in other embodiments they may be separate components. The catheter 316 is configured to provide fluid communication between the drainage hole 333 and the drain 331.

[0457] Also shown in Figures 20, 21c, 22a and 22b is an optional sheath 334. The sheath is made of a flexible material and is disposed to surround the catheter tube 332. The sheath has a first end coupled to the first wall 327 of the cap 320 and a second end coupled to the insertion guide 325. The insertion guide 325, or a portion thereof, is constructed of an elastically deformable material.

[0458] In use, after completing the wetting cycle as described above, the user withdraws the wetted catheter 316 from the catheter assembly 310. Holding the gripping surface of the cap 320, if present, the user guides the catheter tube 332 into a duct, vessel, passageway, body cavity, etc., to remove fluid therefrom.

[0459] When the sheath 334 and insertion guide 325 are present, the user grasps the insertion guide 325 to guide the catheter tube 332. The user grasps the insertion guide 325 and deforms it to engage the catheter tube 332, restricting axial movement of the catheter tube 332 via the insertion guide 325, and inserts a first portion of the catheter tube 332 exposed from within the sheath 334 into a lumen, vessel, passageway, body cavity, or the like. Once the first portion of the catheter tube 332 has been inserted, the user releases their grip on the insertion guide 325 to return it to its original shape and slidably pulls the insertion guide 325 along the catheter tube 316 away from the insertion end 324, fluffing a portion of the sheath 334 and exposing a second portion of the catheter tube 316. The process is then repeated, with the user squeezing the insertion guide 325 to restrict movement of the insertion guide 325 relative to the catheter tube 316, and then inserting the second portion of the catheter tube. This process is repeated until the catheter tube 316 is fully inserted into the lumen, vessel, passageway, body cavity, etc.

[0460] In this embodiment, the catheter 316 is a female urinary catheter 316, which is configured to be inserted through the urethra into the bladder of a female patient. When inserted into the patient's bladder, bodily fluids enter the interior of the catheter tube 16 through the drainage holes 333, flow through the catheter 316 and are drained at the drain 326.

[0461] Once the bladder has been emptied, the catheter 316 is withdrawn from the bladder and urethra, replaced within the body 318, and discarded as described above.

[0462] One or more embodiments have been described above by way of example only - many variations are possible without departing from the scope of protection provided by the appended claims.

[0463] For example, the embodiments are all female intermittent urinary catheters, with exemplary lengths between 90 mm and 200 mm, e.g., between 130 mm and 155 mm, such as 135 mm, and the catheter assembly has a length corresponding to the length of the catheter, e.g., the closed length of the casing is 2 mm to 10 mm longer than the length of the catheter (e.g., 10 to 25 cm; 140 mm to 165 mm, e.g., 142 mm), and it is believed that the teachings may also be applied to male intermittent urethral catheters (which are typically longer), or other types of catheters. Similarly, the embodiments have a functionalized hydrophilic surface that becomes slippery when wetted with a wetting agent such as water, although the wetting agent may alternatively be a lubricant.

Claims

1. 1. A catheter assembly comprising: an outer housing having a body and a cap; the body is elongated in shape having an open end and a closed end; A catheter assembly, wherein the cap and the closed end of the body have corresponding mating surfaces such that the cap is attachable to the closed end of the body.

2. The body and the cap form a sterile cavity for receiving a catheter. The catheter assembly of claim 1.

3. The catheter is configured to be removed from the outer housing during use. The catheter assembly of claim 2.

4. The cap is configured to be attached to the closed end of the body when the catheter is in use. The catheter assembly of claim 1.

5. the mating surfaces engage one another via an interference fit; The catheter assembly of claim 1.

6. The mating surfaces have corresponding tapered portions. The catheter assembly of claim 5.

7. the mating surfaces being provided by an inner surface of the cap and an outer surface of the body, respectively; The catheter assembly of claim 1.

8. the inner surface of the cap has one or more ribs, the ribs comprising at least a portion of the mating surface; The catheter assembly of claim 7.

9. The body and / or cap are rigid; The catheter assembly of claim 1.

10. The body and / or the cap are made of polypropylene. The catheter assembly of claim 1.

11. One or both of the mating surfaces have an overmolded element. The catheter assembly of claim 1.

12. The cap and the open end of the body have corresponding threads such that the cap can be removably attached to the open end of the body; the mating surfaces are configured to provide an interference fit such that frictional engagement between the cap and the closed end of the body is sufficient to temporarily retain the cap. The catheter assembly of claim 1.

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