Intermittent catheter

Abstract

A catheter assembly (1) comprising an outer housing (10) and an inserter tip (15), where the outer housing (10) comprises a deformable bore (42) through which the inserter tip (15) extends from an interior of the outer housing to an exterior of the outer housing, where the inserter tip (15) is movable between a retracted position and an extended position; and the inserter tip (15) comprises one or more protrusions (23) larger in size than the aperture (42) wherein, after extension, the aperture (42) can limit movement of the one or more protrusions (23) towards the interior of the outer housing.

Description

Technical Field

[0001] The present invention relates to an intermittent catheter (eg a urinary catheter). Background Art

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

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

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

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

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

[0007] It would therefore be advantageous to provide a catheter that includes a mechanism for supplying a wetting agent only to the catheter tubing to improve the user experience.

[0008] In another prior art solution, the catheter can be packaged in a package that includes a wetting device. In use, when the catheter is removed from the package, the catheter can be moved through the wetting device and wet the catheter body while doing so. An example of such a catheter is shown in PCT Application No. PCT / IB2018 / 001539 of ConvaTec Co., Ltd.

[0009] However, due to packaging limitations, the amount of wetting agent that can be included in such wetting devices is low, so there is still the possibility that the catheter tubing will not be fully wetted in such a solution, especially if the catheter is near the end of its shelf life and some solution may have evaporated.

[0010] For mechanisms that wet the catheter tube distally, an insufficient volume of wetting agent may result in the tip not being wetted at all, which is undesirable because the tip will be introduced into the urethra first and is therefore most likely to cause injury if not adequately wetted prior to use.

[0011] It is an object of one or more embodiments of the present invention to overcome or at least partially alleviate one or more problems of the prior art and / or to provide an improved intermittent catheter. Summary of the invention

[0012] The present invention provides a catheter assembly according to the accompanying claims.

[0013] One aspect of the present disclosure provides a catheter assembly, comprising: an outer shell, the outer shell comprising a body; and a cover. The outer shell and the cover may form a cavity for accommodating at least a portion of the catheter. The outer shell may include a wetting agent storage chamber. The wetting agent storage chamber may be defined by a chamber wall and an inserter tip. The inserter tip may be movable between a first position and a second position relative to the chamber wall. In the first position, the inserter tip may be retracted. In the first position, the inserter tip may be aligned with the chamber wall to seal the storage chamber. In the second position, the inserter tip may be deployed / deployed / extended / extended. In the second position, the inserter tip may not be aligned with the chamber wall to open the storage chamber. Removing the cover may move the inserter tip from the first position to the second position.

[0014] One aspect of the present disclosure provides a catheter assembly comprising an outer shell and a cover; wherein the outer shell and the cover form a cavity for accommodating at least a portion of the catheter; the outer shell includes a wetting agent storage chamber defined by a chamber wall and an inserter tip, wherein the inserter tip is movable between a first position and a second position relative to the chamber wall; wherein in the first position, the inserter tip is retracted and aligned with the chamber wall to seal the storage chamber; and in the second position, the inserter tip is extended and not aligned with the chamber wall to open the storage chamber; wherein removing the cover moves the inserter tip from the first position to the second position.

[0015] Advantageously, both the initial opening of the wetting agent reservoir (and thus wetting of the catheter) and the extension of the inserter tip are achieved by moving the cover. This means that a clear indication is provided to the user that wetting has occurred. Furthermore, it allows the device to be extended for use in a single motion.

[0016] The cavity may be a sterile cavity.

[0017] The inserter tip may include one or more ribs extending circumferentially. The ribs may extend to the chamber wall. The inserter tip may include at least two ribs. The inserter tip may include at least one upper rib and at least one lower rib. For example, the inserter tip may include a pair of upper ribs and a pair of lower ribs. Alternatively (or additionally), the chamber wall may include one or more ribs extending circumferentially. The ribs may extend to the inserter tip. The chamber wall may include two ribs. One of the inserter tip or the chamber wall preferably includes one or more ribs extending circumferentially and protruding into the other of the chamber wall or the inserter.

[0018] In the first position, the one or more ribs may define the axial extension of the wetting agent storage chamber. In the case where the inserter tip includes an upper rib and a lower rib, the distance between the upper rib and the lower rib may define the axial extension of the storage chamber. In the case where the chamber wall includes two ribs, the two ribs may define the axial extension of the storage chamber.

[0019] In the first position, one or more or each rib of the inserter tip is preferably aligned with a corresponding sealing surface on the chamber wall to seal the storage chamber. Alternatively, in the first position, one or more or each rib of the chamber wall is preferably aligned with a corresponding sealing surface on the inserter tip to seal the storage chamber. In the second position, at least one rib of the inserter tip is preferably not axially aligned with the sealing surface on the chamber wall. In the case where the assembly includes an upper rib and a lower rib, in the second position, the upper rib can remain aligned with the sealing surface on the chamber wall. In an alternative, in the second position, at least one rib of the chamber wall is not axially aligned with the sealing surface on the inserter tip.

[0020] The storage chamber may be sealed with a sealing element. One or more ribs may include a sealing element. The sealing element may be integrally formed with the inserter tip. The sealing element may be integrally formed with the outer housing. The sealing element may be mounted between a pair of ribs.

[0021] The sealing element may be an elastomeric material. For example, the sealing mechanism may be a rubber sealing mechanism or some other suitable material. The sealing element may be an annular sealing element. The sealing element may include an O-ring. The sealing element may include an X-ring. The sealing element may include a U-cup. The sealing element may be located in a radial plane, such as a normal plane to the longitudinal axis of the catheter assembly. The sealing element may extend between radially opposed sealing surfaces. The O-ring may be located in a radial plane, such as a normal plane to the longitudinal axis of the catheter assembly. The sealing element may be provided in the form of a gasket.

[0022] The sealing element may be compressible.

[0023] The sealing element may be located in a sealing element accommodating portion in one of the chamber wall or the inserter tip. The sealing element accommodating portion may include a groove or channel arranged in the chamber wall or the inserter tip. The groove or channel may be provided in part by a radially outer wall / radially outer wall, an axial end wall and / or one or more catheter guiding feature structures arranged in the storage chamber. The sealing element may be overmolded, thereby becoming an integral / integral part of the storage chamber or the inserter tip. One or more of the sealing surfaces may be provided by a sealing element accommodating portion. The at least one sealing surface is slidably opposed to the sealing element. The at least one sealing surface may be referred to as a primary sealing surface.

[0024] At least one of the inserter tip and the chamber wall may include an expansion portion, and when switching between the first position and the second position, the rib passes over the expansion portion, so that when in the second position, the distance between the chamber wall and the inserter tip at the axial position of the rib is increased compared to when in the first position. The distance can be a radial distance relative to the longitudinal axis. The expansion portion may include a widened portion of the adjacent sealing surface of the cavity. The cavity can be a cavity of a storage chamber and / or an adjacent chamber. The adjacent chamber can be arranged in an external housing. The adjacent chamber can accommodate a catheter tube body. The adjacent chamber can be a perfusion chamber or a wetting chamber.

[0025] The expansion portion may include a step, a taper, or a ramp in the wall surface adjacent to the sealing surface. The sealing surface may include a cylindrical surface having a first diameter. An adjacent wall portion of the chamber wall or the inserter tip 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 near the insertion end of the catheter. The adjacent wall portion may be a secondary surface.

[0026] The catheter assembly may also include a wetting agent. In the first position, the wetting agent may be sealed in the wetting agent storage chamber. When in the second position, a flow path may be provided between the sealing surface and the rib so that the wetting agent can flow out of the storage chamber when in the second position. The flow path may lead the wetting agent from the storage chamber to the catheter.

[0027] The catheter assembly may further include a wetting chamber. In the second position, the wetting chamber may be in fluid communication with the storage chamber. The storage chamber and the wetting chamber may be two separate / independent chambers.

[0028] The catheter assembly may also include a sheath. The moistening chamber may be at least partially defined by the sheath. The sheath may define a cavity. The catheter may be arranged in the sheath cavity. In the second position, the sheath cavity may be in fluid communication with the moistening agent storage chamber. In this regard, the sheath cavity may be a moistening chamber.

[0029] The conduit may be at least partially disposed within the sheath. The sheath and conduit may define a flow path. The flow path may extend along an axial length of the conduit. The flow path may be disposed between an outer surface of the conduit and an inner surface of the sheath.

[0030] The catheter assembly may further include a storage bag. The storage bag may be configured to receive fluid discharged from the catheter in use. In the second position, the storage bag may be in fluid communication with the wetting agent storage chamber. The storage bag may be in fluid communication with the wetting agent storage chamber via the sheath flow path.

[0031] When in the second position, the seal may be separated from the at least one sealing surface to provide a flow path for the wetting agent through the rib.

[0032] When in the second position, the wetting agent may be provided within the wetting chamber, or may be able to flow into the wetting chamber.

[0033] The inserter tip may include an inserter stop. The inserter stop may limit the extent to which the inserter tip can be inserted into the urethra. The inserter tip may be irreversibly movable to an extended position. The outer shell may include a deformable hole through which the inserter tip extends from the interior of the catheter body assembly to the exterior of the catheter body assembly. The inserter tip may include one or more protrusions that are larger in size than the hole. When the inserter tip is extended, the hole may be deformable to allow the protrusion to move from the interior of the outer shell to the exterior. After extension, the hole may limit the movement of the one or more protrusions toward the interior of the outer shell.

[0034] Advantageously, the protrusion on the inserter tip can be used to limit the insertable length of the inserter tip to ensure user comfort and to ensure that the movable inserter tip does not retract into the outer housing. In the case where the inserter tip can be retracted, there may be a risk that the inserter tip is insufficient and thus hinders catheter insertion.

[0035] Therefore, in a preferred embodiment of the present disclosure, a catheter assembly is provided, comprising an outer shell and a cover; the outer shell comprises a wetting agent storage chamber defined by a chamber wall and an inserter tip, wherein the inserter tip is movable between a first position and a second position relative to the chamber wall; wherein in the first position, the inserter tip is retracted; and in the second position, the inserter tip is extended; wherein the outer shell comprises a deformable hole, through which the inserter tip extends from the interior of the outer shell to the exterior of the outer shell, and the inserter tip comprises one or more protrusions having a size larger than the hole, wherein after extension, the hole can limit the movement of the one or more protrusions toward the interior of the outer shell.

[0036] The catheter assembly may include a plurality of sealing mechanisms. The plurality of sealing mechanisms may include a proximal sealing mechanism, which is close to the insertion end of the catheter. The plurality of sealing mechanisms may include a second sealing mechanism. The second sealing mechanism may be axially separated / spaced apart from the proximal sealing mechanism on the distal side of the proximal sealing mechanism. The distal sealing mechanism and the proximal sealing mechanism may be radially located between the movable inserter tip and the chamber wall. The distal sealing mechanism and the proximal sealing mechanism may include respective distal and proximal sealing elements and sealing surfaces.

[0037] The first sealing mechanism / seal may be disposed on or near the inserter tip.The second sealing mechanism / seal may be disposed on the inserter tip.

[0038] The distal sealing mechanism may maintain sealing contact in the first and second positions.

[0039] The catheter may include a catheter tube providing an insertion end for insertion into a patient and an exit end including one or more external manipulation features.

[0040] The catheter may be an intermittent catheter. The catheter may be a urinary catheter. The catheter may be a female intermittent catheter.

[0041] The catheter assembly may be configured to provide mechanical feedback to the user. The mechanical feedback may indicate the end of the first step. The mechanical feedback may indicate that the catheter assembly is in the second position. The mechanical feedback may be between the first step and the second step.

[0042] The provision of a feedback mechanism allows the user to know that the wetting process has occurred without having to visually inspect the catheter.

[0043] The catheter may comprise an insertable portion. Prior to the first step, the insertable portion may not be in contact with the wetting agent.

[0044] Advantageously, the insertable portion of the catheter is not in contact with the wetting agent prior to deployment of the catheter, for example during transport and storage. The insertable portion of the catheter is typically made of a material that interacts with the wetting agent, and this interaction should only occur prior to use.

[0045] The inserter tip may also include an insertion guide.

[0046] The inserter tip may be disposed on the inserter. The inserter may include a catheter holder. The term catheter holder should be understood as the portion of the inserter that holds the catheter (not the portion that the user uses to hold the catheter). The inserter may be tubular. The catheter holder may be disposed at one end of the inserter. The catheter holder and the inserter tip may be disposed at opposite ends of the inserter.

[0047] When the inserter is in the first position, the catheter clamp can be engaged with the catheter. When the inserter is in the second position, the catheter clamp can be disengaged from the catheter.

[0048] Therefore, in another aspect of the present disclosure, a catheter assembly is provided, comprising: a catheter assembly body, a removable insert and a catheter tube body. The catheter assembly body may include a receptacle. The removable insert may include a tubular body. The tubular body may have a deformable first end. In a first position, the removable insert may be arranged radially inward / inside the catheter assembly body. In the first position, the catheter tube body may be arranged radially inward of the removable insert. In the first position, the receptacle may abut against the first end of the removable insert. In the first position, the first end of the removable insert may be deformed so that the first end of the removable insert clamps the catheter tube body. In a second position, the removable insert may be disengaged from the receptacle so that the first end of the removable insert releases the catheter tube body.

[0049] In another aspect of the present disclosure, a catheter assembly is provided, comprising: a catheter assembly body, the catheter assembly body including a receptacle; a removable insert, the removable insert including a tubular body having a deformable first end; and a catheter tube body; wherein, in a first position, the removable insert is arranged radially inwardly of the catheter assembly body, and the catheter tube body is arranged radially inwardly of the removable insert, wherein the receptacle presses against the first end of the removable insert, thereby deforming the first end of the removable insert so that the first end of the removable insert clamps the catheter tube body; wherein in a second position, the removable insert is disengaged from the receptacle so that the first end of the removable insert releases the catheter tube body.

[0050] The catheter assembly body may be an outer housing. The removable insert may be an inserter or an inserter tip.

[0051] The deformable first end may be elastically deformable.

[0052] Therefore, in another aspect of the present disclosure, a catheter assembly is provided, comprising: a catheter assembly body, the catheter assembly body including a receptacle; a removable insert, the removable insert including a tubular body having a first end that is elastically deformable; and a catheter tube body; wherein, in a first position, the removable insert is arranged radially inwardly of the catheter assembly body, and the catheter tube body is arranged radially inwardly of the removable insert, wherein the receptacle presses against the first end of the removable insert, thereby deforming the first end of the removable insert so that the first end of the removable insert clamps the catheter tube body; wherein in a second position, the removable insert is disengaged from the receptacle so that the first end of the removable insert releases the catheter tube body.

[0053] Advantageously, by clamping the catheter when the assembly is in the first position, the catheter can be ensured to be in place relative to the wetting agent reservoir, and this can improve the consistency during the wetting process. In addition, it hinders or constrains the extension / deployment of the catheter until the wetting agent reservoir is opened (so that the catheter is wetted).

[0054] The deformable first end may be formed by structurally weakening the tubular body. The first end may have a thinner wall than the rest of the tubular body. The deformable first end may include one or more grooves. The one or more grooves may provide a gap into which the first end may deform. The first deformable end may include two grooves. The two grooves may define a gap between the two arms. In a first position, the two arms may press against the receptacle to reduce the spacing between the two arms. The arms may include a protrusion that presses against the receptacle. The two arms may be provided with a hole. The hole may extend between a radially inner surface that engages with the conduit and a radially outer surface that engages with the receptacle.

[0055] The receptacle may include an expansion portion, and when switching between the first position and the second position, the deformable first end crosses over the expansion portion, so that when in the second position, the distance between the removable insert and the receptacle at the axial position of the rib increases compared to the first position. The distance can be a radial distance relative to the longitudinal axis. The expansion portion may include a widening portion of a cavity adjacent to the receptacle. The cavity may be a cavity of a storage chamber and / or an adjacent chamber. The adjacent chamber may be arranged in the catheter assembly body. The adjacent chamber may accommodate a catheter body. The adjacent chamber may be a perfusion chamber or a moistening chamber.

[0056] The expanded portion may include a step or a chamfer.

[0057] The catheter assembly may also include a wetting agent storage chamber. The wetting agent storage chamber may be defined by the catheter assembly body and the removable insert. In a first position, the wetting agent storage chamber may be sealed. In a second position, the wetting agent storage chamber may be open.

[0058] The catheter tube may be grasped with the insertion end proximate the opening in the wetting agent reservoir.

[0059] The movable insert is movable relative to the catheter assembly body along the axis between a first position and a second position.

[0060] The cover may be configured to be disengaged from the inserter tip in the second position.

[0061] Therefore, in another aspect of the present disclosure, a catheter assembly is provided, which includes a cover, a catheter assembly body and a removable insert. The cover may include a tubular body. The cover may have a closed end. The cover may have an open end. The open end may be deformable. The catheter assembly body may include a receptacle. The cover and the removable insert may be configured to move between a first position and a second position along an axis relative to the catheter body. In the first position, the open end of the cover may be constrained to abut against the receptacle. In the first position, the open end of the cover may be constrained to abut against the removable insert. In the first position, the cover and the removable insert may be coupled together. In the second position, the open end of the cover may be removed from the receptacle. In the second position, the cover and the removable insert may be disengaged.

[0062] Therefore, in another aspect of the present disclosure, a catheter assembly is provided, comprising: a cover, the cover comprising a tubular body having a closed end and an open end, wherein the open end is deformable; a catheter assembly body including a receptacle; and a movable insert; wherein the cover and the movable insert are configured to be movable along an axis relative to the catheter body between a first position and a second position; wherein, in the first position, the open end of the cover is constrained to abut against the receptacle and the movable insert, so that the cover and the movable insert are coupled together; and in the second position, the open end of the cover is moved away from the receptacle, so that the cover and the movable insert are decoupled.

[0063] Advantageously, by coupling the cover and the removable insert, a wetting operation can be initiated in the same action as removing the cover. Furthermore, since the cover and the removable insert are only decoupled in the second position, the cover can only be removed when in the second position. Movement to the second position can result in wetting of the catheter, so the cover can only be removed when wetting has occurred, thereby reducing the risk of injury to the user from using an unlubricated catheter.

[0064] The cover may include a deformable portion. The cover may be formed of an elastically deformable material. The cover may be formed of linear low density polyethylene. The cover may be formed of low density polyethylene. The cover may be formed of polypropylene. The cover may be formed of a thermoplastic elastomer. The cover may be formed of thermoplastic polyurethane. The cover may be formed of ethylene vinyl acetate.

[0065] The cover can be elastically deformed in the first position. The cover can relax to the original shape in the second position. Alternatively, the cover can be deformed in the second position.

[0066] The cover may include an internal cavity. The internal cavity may be shaped to conform to / fit a portion of the inserter tip. The cover may include a grip ring. The grip ring may be shaped to facilitate removal of the cover.

[0067] The open end of the cover may be deformable. The open end of the cover may be formed of a deformable material. The open end of the cover may be provided with one or more features that facilitate deformation. For example, the open end of the cover may include one or more grooves extending axially from the open end. The structure that facilitates deformation may be two grooves. The open end of the cover may include one or more engagement tabs. The cover may be provided with two engagement tabs. The one or more engagement tabs may extend axially from the open end. The engagement tab may be configured to be able to bend radially.

[0068] The cover and the removable insert may include corresponding engagement mechanisms. The removable insert may be an inserter tip. The engagement tab may engage with the inserter tip. The inserter tip may include a protrusion. The removable insert may include a recess. The corresponding engagement mechanisms, such as protrusions and recesses, may be configured to remain engaged when subjected to a first predetermined force and to disengage when subjected to a second predetermined force.

[0069] The engagement mechanism may include a protrusion on the removable insert and a corresponding hole on the cover. When the cover and the removable insert are engaged, the protrusion may be disposed in the hole. The cover may be deformed to remove the protrusion from the hole. The cover may be removed to decouple from the removable insert.

[0070] The catheter assembly may include an airtight sealing mechanism for maintaining the sterility of the interior volume prior to use.In a first position, the cover may provide a sterile seal for the cavity within the catheter assembly body.

[0071] When in the sealed configuration, the hermetic seal may be intact. When in the irrigated configuration or the wetted configuration, the hermetic seal may be disrupted, such that the cavity within the catheter assembly body is at least partially open to the outside air, such that the sterile environment may be considered to be breached.

[0072] The catheter assembly may also include a hole through which the removable insert extends from the interior of the catheter body assembly / catheter assembly body to the exterior of the catheter body assembly. The hole may be a receptacle.

[0073] The catheter can be functionalized. For example, it can include, or be integrated with or coated with a hydrophilic component (e.g., a hydrophilic polymer). The hydrophilic component is used to further reduce friction when a wetting agent is applied. At least the outer surface of the catheter body can be functionalized, for example, a hydrophilic component can be provided on at least the outer surface of the catheter body (which contacts the urethra during use). The catheter can include a main flow path for urine to pass through. The main flow path can extend along the longitudinal axis of the catheter and define the longitudinal axis. The main flow path can be provided by the wall of the catheter body. The main flow path can have a distal outlet and a proximal inlet at the insertion end of the catheter.

[0074] The conduit may include an outlet body. The outlet body may be coupled to the end of the conduit body. The outlet body may include an external steering surface of the conduit. The outlet body may include one or more flow enhancement features for assisting flow from the conduit body. For example, the one or more flow enhancement features may include a funnel.

[0075] The outlet body may include or be referred to as a connector that connects the outlet end (eg, the funnel and / or the external steering feature) and the catheter tube.

[0076] The sheath may be a retractable sheath. A retractable sheath may be configured to be retracted during catheter insertion so that it provides a temporary enclosure around the catheter prior to insertion.

[0077] According to another aspect of the present disclosure, a catheter assembly is provided, which includes an outer shell and an inserter tip. The outer shell may include a deformable hole. The inserter tip may extend from the interior of the outer shell to the exterior of the outer shell through the hole. The inserter tip may be movable. The inserter tip may move between a retracted position and an expanded position / extended position / deployed position. The inserter tip may include one or more protrusions. The size of the one or more protrusions is determined to be larger than the size of the hole. After extension, the hole may limit the movement of the one or more protrusions toward the interior of the outer shell.

[0078] According to another aspect of the present disclosure, a catheter assembly is provided, which includes an outer shell and an inserter tip, wherein the outer shell includes a deformable hole, and the inserter tip extends from the interior of the outer shell to the exterior of the outer shell through the hole, wherein the inserter tip can move between a retracted position and an extended position; and the inserter tip includes one or more protrusions having a size larger than the hole, wherein after extension, the hole can limit the movement of the one or more protrusions toward the interior of the outer shell.

[0079] The inserter tip may include at least two protrusions. The inserter tip may include at least three protrusions. The inserter tip may include at least four protrusions. The protrusions may protrude radially outward from the inserter tip.

[0080] The one or more protrusions may have a rectangular cross-section.The long side of the rectangular cross-section may be arranged perpendicular to the longitudinal axis of the catheter assembly.

[0081] The one or more projections may include a radially outer end face. The one or more projections may have a radial extension. The radial extension may be defined as the distance between the radially outer end face and the radial center of the inserter tip. The radial extension of the projection may be greater than the radius of the hole. In the case where the catheter assembly includes two projections, the two projections may be arranged on opposite sides of the inserter tip. The spacing between the radially outer end faces of the two projections may be greater than the diameter of the hole.

[0082] The catheter assembly may also include one or more chamfered sections. The chamfered sections may be configured to deform the hole. The chamfered sections may be configured to deform the hole when the inserter tip moves from the retracted position to the extended position. The hole may be elastically deformable.

[0083] The one or more projections may include a chamfered section. One or more or each projection may include a front face. The front face may be the end face of the projection that faces the urethra in use. One, more or each projection may include a chamfer between the front face and the radially outer end face.

[0084] The inserter tip may include an insertion end. The insertion end may be configured to be inserted into the urethra. The protrusion may be arranged 1 mm to 20 mm from the insertion end. The protrusion may be arranged 5 mm to 15 mm from the insertion end. The protrusion may be arranged 8 mm to 12 mm from the insertion end.

[0085] The catheter assembly may also include a cover. The cover may engage with the inserter tip. The cover may engage with the one or more projections. When the inserter tip is in a retracted position, the cover may engage with the one or more projections. When the inserter tip is in an extended position, the cover may disengage from the one or more projections. The cover may include one or more slots through which the projections extend. The cover may include a number of slots equal to the number of projections. The cover may include one or more recesses into which the projections extend. The cover may include a number of recesses equal to the number of projections.

[0086] The cover may be configured to move axially. The inserter tip may be configured to move axially. Axial movement of the cover may be transmitted to the inserter tip. Axial movement of the cover may be transmitted to the inserter tip via the groove and the protrusion.

[0087] The cover may include a chamfered section. The chamfered section may be arranged between the narrow section and the wide section. The radius of the narrow section may be less than the radius of the hole. The radius of the wide section may be approximately equal to or greater than the radial extension of the protrusion. When the inserter tip is in the retracted position, the chamfered section may be arranged inside the outer housing. When the inserter tip is in the extended position, the chamfered section may be arranged outside the outer housing.

[0088] The optional features set out above may apply to any aspects of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0089] In order that the present invention may be more clearly understood, one or more embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0090] Figure 1 shows a perspective view of a catheter assembly according to an embodiment of the present disclosure;

[0091] Figure 2 Shown in a closed or sealed configuration Figure 1 A longitudinal cross-sectional view of a catheter assembly;

[0092] Figure 3 Shows Figure 1 An enlarged longitudinal cross-sectional view of the catheter assembly of FIG. 1 , showing the storage chamber in detail;

[0093] Figure 4 Shows Figure 1 an enlarged longitudinal cross-sectional view of the catheter assembly of FIG. 1 , showing the cover in detail; and

[0094] Figure 5 a to 5c show Figure 1 A series of longitudinal cross-sectional views of a catheter assembly highlighting the catheter wetting procedure. DETAILED DESCRIPTION

[0095] refer to Figure 1-5 , an exemplary catheter assembly 1 according to the present invention is described.

[0096] refer to Figure 1 and Figure 2 , the catheter assembly 1 includes an outer housing 10, a cover 40, a sheath 80, and a catheter 120. The catheter assembly 1 may be configured such that the catheter 120 may be wetted before being extracted from the outer housing 10. A wetting mechanism may be provided within the outer housing 10.

[0097] The outer housing or catheter assembly body 10 has a tubular shape having a radially outer surface 8, a radially inner surface 9, an open cover end 11, and an open catheter end 12. The outer surface 8 of the outer housing includes a textured portion 13 to improve grip, which in this embodiment is provided by a plurality of ribs extending circumferentially and radially outwardly around the outer surface 8. The textured portion 13 extends from the cover end 11 to the catheter end 12. In some embodiments, the textured portion 13 can be integrally formed with the outer surface 8, and in various other embodiments, the textured portion 13 can be formed of a different material, such as a material that provides increased grip when wetted.

[0098] Within the outer housing 10 and extending from each open end 12, 13 is an inserter 14 having an overall / generally tubular shape and including an inserter tip 15 and a catheter clamp 16. The outer housing 10 and the inserter 14 are arranged concentrically so that the inserter 14 is located within the outer housing 10 in a radially nested configuration. The inserter tip 15 is disposed at a first end of the inserter 14 and closes the tubular body with a hemispherical end 15a, which is provided with one or more holes or openings such as slits (not shown) that allow the end 15a to flare / open to allow a catheter to pass therethrough. The opposite end of the inserter 14 is provided with a catheter clamp 16, the structure and operation of which will be described in detail below.

[0099] In this embodiment, the inserter 14 is arranged within the outer housing 10 so that in a storage position (as will be described in detail below), the inserter tip 15 extends from the cover end 11 of the outer housing 10 and the catheter clamp 16 extends from the catheter end 12 of the outer housing 10.

[0100] In this embodiment, the cover 40 is formed of two parts, namely a connecting part 41 and a removable part 50. The connecting part 41 has an annular shape with a hole 42 passing through the center, and the connecting part is connected to the cover end 11 of the outer shell 10. The removable part 50 has a tubular shape with an open end 51 and a closed end 52, and the interior of the removable part 50 defines a cavity 53 shaped to receive the inserter tip 15. The size and shape of the cavity are determined to fit / fit the inserter tip 15 tightly. The exterior of the removable part 50 is shaped to engage with the hole 42 in the connecting part 41. On the exterior of the removable part 50, at the closed end 52, a grip ring 54 is provided, by which the user can grip the cover 40. The two parts 41, 50 of the cover 40 are connected together by a retaining band 45.

[0101] The catheter 120 is of a type known in the art and includes a catheter body 121 having an insertion end 122 and an opposite discharge end (not shown). The catheter body 121 has a longitudinal axis AA, which can be considered the main axis of the catheter assembly 10. Near the insertion end 122, one or more drainage holes 133 may be provided, and in this embodiment, the drainage holes 133 are elliptical / oblong, with their major axes parallel to the main axis AA. It should be understood that the size and shape of the drainage holes 133 may vary.

[0102] As is known in the art, the outer surface of the catheter tube 121 can be functionalized so that when wetted by a wetting agent, the coefficient of friction of the catheter tube 121 is reduced. The outer surface of the catheter tube 121 can be composed of a functionalized material or coated with a functionalized material; for example, the outer surface of the catheter tube 121 can have a hydrophilic property. When a wetting agent is introduced, the hydrophilic property serves to reduce the coefficient of friction of the outer surface.

[0103] The catheter 120 and the inserter 14 are coaxially arranged such that the insertion end 122 of the catheter 120 engages the catheter clamp 16, wherein the distal end of the catheter 120 extends away from the inserter 14, which will be described in further detail below.

[0104] The sheath 80 is arranged at the catheter end 12 of the outer housing 10. The sheath 80 extends away from the outer housing 10 so as to surround at least a portion of the catheter tube 120. The sheath 80 is formed of a flexible material. In some embodiments, the sheath 80 is attached to the outer housing in a manner that provides a leak-proof seal. In some embodiments, the distal end (not shown) of the sheath can be connected to a bag for collecting fluid discharged from the catheter, or the sheath 80 and the bag can be integrally formed. The sheath can allow fluid communication from the outer housing 10 to the bag.

[0105] refer to Figure 3 and Figure 4 , describes in more detail the arrangement of the outer housing 10, the inserter 14 and the cover 40. The radial inner wall 9 of the outer housing 10 is provided with a step near the catheter end 12, so that the diameter of the inner wall 9 is reduced near the catheter end 12. The first wider portion 9a of the inner wall 9 provides a first sealing surface 18, and the second narrower portion 9b of the inner wall 9 provides a second sealing surface 19. The inner diameter of the inner wall 9 is further reduced by another step 34 at the edge of the catheter end 12 to form a third narrowest portion 9c.

[0106] The inserter 14 fits radially with the outer housing 10. In this embodiment, to ensure alignment of the inserter 14 in the outer housing, the inserter 14 is provided with two pairs of ribs 21, 22. In various other embodiments, the outer housing may be provided with protrusions such as ribs.

[0107] In this embodiment, the first (upper) pair of ribs 21 protrude radially outwardly from the inserter 14 around the circumference at a point approximately one-third of the distance from the inserter tip 15a to the catheter clamp 16. The first pair of ribs 21 are sized so that they extend radially to the first sealing surface 18 of the outer housing 10, and are formed by a single wider protrusion, the outer periphery of which is provided with a groove 21a having a depth equal to the radial extension range / radial extension length of the protrusion, which divides the protrusion into two ribs 21 of equal size.

[0108] In this embodiment, the second pair of (lower) ribs 22 protrude circumferentially radially outward from the inserter 14 at a point proximate the catheter clamp 16. The second pair of ribs are sized so that they extend radially to the second sealing surface 19 of the outer housing 10. The two ribs 22 of the second pair protrude from the inserter 14 separately / independently / spaced apart / respectively.

[0109] In this embodiment, two cover blocks 23 are provided near the first pair of ribs 21, which are two protrusions on opposite sides of the inserter 14. The cover blocks 23 have a rectangular base, and their long edges / main edges are perpendicular to the main axis AA of the catheter assembly 10. The radially outer surface 23a defines the radial extension / radial extension length of the cover blocks 23.

[0110] In this embodiment, at the end of the inserter where the catheter clamp 16 is located, two slots 30 extend from the edge of the inserter 14 parallel to the main axis AA of the catheter assembly 10. The two slots 30 define a gap between two clamp arms 31, which are configured to engage with the catheter tube 121 when the assembly 10 is in the storage configuration, as will be described in detail below. Each clamp arm 31 is provided with a hole 32 extending from the radial inner surface to the radial outer surface.

[0111] By providing the slot 30 in the inserter 14, the structural rigidity of the inserter 14 near the clamp arms 31 is reduced, and the clamp arms 31 are deformable to change the interval between the two arms 31. At the base of each arm 31, a small ridge 33 is arranged on the radially outer side.

[0112] As described above, the cover 40 is formed of two parts, wherein the inner surface of the connector portion 41 is attached to the outer surface of the cover end 11 of the outer housing 10. The connector portion forms an end wall 64 of the outer housing through which the hole 42 is provided. In this embodiment, the connector portion 41 and the outer housing 10 are joined by a cantilever snap-fit ​​connection, which is achieved using corresponding protrusions and recesses on the connector portion 41 and the outer housing 10. In various other embodiments, other attachment methods may be used, such as bonding, welding / fusion or interference fit.

[0113] In this embodiment, the open end 51 of the removable portion 50 is provided with a pair of grooves 55 on opposite sides of the opening. The grooves 55 extend from the opening lip 56 of the open end 51 to about one-third of the way to the closed end 52. The grooves 55 widen at their closed ends 57 so that they have a "T" shape. The two grooves 55 define a gap between two engagement tabs 58.

[0114] Each of the two engagement tabs 58 is provided with a rectangular hole 59, the major axis of which extends circumferentially around the cover. The hole 59 is sized and shaped to receive the cover block 23 of the inserter 14. Around the hole 59, the thickness of the wall of the connector part 41 increases with a chamfered step 60 provided on the radial outer surface. The chamfered step 60 is sized so that the diameter at the widest point (the point adjacent to the hole 59) is approximately equal to the distance between the two radial outer surfaces 23a of the cover block 23.

[0115] In this embodiment, the housing seal 61 is provided on the radially outer surface of the removable portion 42 at a point corresponding to approximately half of the axial extension of the cavity 53. The housing seal 61 comprises a beveled / inclined protrusion 62 extending circumferentially around the removable portion 42, which is provided with a small notch 63 on one side near the open end 51.

[0116] When provided in a sealed configuration, e.g. for storage and transport, the inserter 14 is provided in a retracted position within the outer housing 10. The first pair of ribs 21 and the second pair of ribs 22 press against the sealing surfaces 18, 19 of the radial inner wall 9 to align the inserter 14 within the outer housing 10 such that they are radially nested.

[0117] The inner wall 9 of the outer shell 10, the outer surface of the inserter 14 and the ribs 21, 22 together define a wetting agent storage chamber 70, the inserter 14 and the outer shell 10 define a radial extension, and the upper and lower ribs 21, 22 define an axial extension. The wetting agent storage chamber 70 contains a wetting agent, which is water in this embodiment.

[0118] In the sealed configuration, the inserter 14 is maximally inserted into the outer housing 14 and the second pair of ribs 22 abut against the other step 34, thereby limiting any further insertion.

[0119] The removable portion 50 of the cover 40 is arranged on the inserter 14 so that the inserter tip 15 is located within the cavity 53. The cover nub 23 protrudes into the hole 59 in the engagement tab 58 and the opening lip 56 abuts the first pair of ribs 21.

[0120] The removable portion 50 of the cover 40 is also arranged through the hole 42 in the connecting portion 41; the housing seal 61 abuts the hole 42, wherein the lip 42a of the hole engages the recess 63. The housing seal 61 and the hole 42 provide a gas-tight seal to ensure the sterility of the interior of the outer housing 10.

[0121] During storage and transport, the catheter 120 is retained within the outer housing 10 by the catheter clamp 16. The insertion end 122 is nested between the clamp arms 31. The small ridge 33 has a larger diameter than the surrounding third inner wall portion 9c, so the clamp arms 31 deform radially inwardly and abut against the insertion end 122, thereby retaining the catheter 120 in place. Securing the catheter 120 during storage is advantageous because it ensures that the catheter 120 is in the optimal position before wetting, and also ensures that the catheter cannot be stretched without wetting.

[0122] refer to Figure 5 (a)-(c), depict the extension of the catheter for use. Figure 5 (a)-(c) show the side view, but during extension, the catheter assembly is generally arranged vertically, with the cover 40 uppermost (eg, Figure 1 and 2 4 and 5. The user then moves the removable portion 50 of the cover 40 axially away from the outer housing 10 (as shown), such that the catheter 120 is below the moistening agent reservoir 70. Grasping the textured portion 13 and the grip ring 54, the user pulls the removable portion 50 of the cover 40 axially away from the outer housing 10. As the removable portion 50 moves axially away from the outer housing 10, the lip 42a of the aperture disengages from the notch 63, thereby breaking the housing seal / housing seal portion 61; the catheter assembly 10 is no longer hermetically sealed.

[0123] As the axial displacement continues, the cover blocks 23 abut against the edges of their respective holes 59, whereby the inserter 14 begins to be axially displaced. Figure 5 As shown in (a), as the inserter 14 is displaced, the small protrusion 33 passes through the step 34 and becomes axially misaligned with the third inner wall portion 9c. Since the small protrusion 33 is no longer pressed against the third inner wall portion 9c, the clamp arm 31 is no longer maintained in the deformed position and relaxes in a radially outward manner, thereby increasing the spacing between the two arms 31. This increase in spacing causes the clamp arm 31 to disengage from the catheter 120, allowing the catheter to move freely and the entire functionalized surface of the catheter body 121 is exposed. The movement of the inserter 14 within the outer housing 10 is guided by the first pair of ribs 21 and the second pair of ribs 22 that press against / abut against the sealing surfaces 18, 19 and move along the sealing surfaces 18, 19.

[0124] In this embodiment, as the removable portion 50 of the cover 40 and the inserter 14 continue to shift, the second pair of ribs pass the first step 17 and become axially misaligned with the second sealing surface 19, as shown in FIG. Figure 5 (b). Thus, a flow path is opened between the reservoir 70 and the cavity defined between the catheter 120 and the sheath 80, and in this regard, the interior of the sheath can be considered to be the wetting chamber 71. The wetting agent flows from the reservoir 70 to the catheter 120 around the second pair of ribs 22. The holes 32 in the clamp arms 31 ensure that the wetting agent contacts the insertion end of the catheter 120. In this embodiment, any excess wetting agent that does not contact the catheter flows through the sheath 80 and is discharged into the bag.

[0125] In this embodiment, as the storage chamber 70 is opened, the engagement tab 58 and the cover block 23 are pulled through the hole 42. Although the cover block 23 is wider than the hole 42, the chamfered step 60 elastically deforms the hole 42, increasing the diameter, which allows the cover block 23 to pass through the hole 42. In various alternative embodiments, the cover block may alternatively or additionally be provided with a chamfer, or be tapered so that the leading edge will have a reduced radial extension so that the cover block can deform the hole.

[0126] The inserter 14 continues to move axially until the first pair of ribs 21 abut the end wall 64, at which point the gripper arms 31 have passed through the apertures 42 and are outside the outer housing 10. Throughout the movement of the inserter 14, the first pair of ribs 21 remain in contact with the first sealing surface 18, thereby ensuring that no wetting agent leaks from the cover end 11 of the outer housing 10.

[0127] When the clamp arms 31 are no longer radially nested within the bores 42 or the outer housing 14, one or both may deform (plastically or elastically, depending on the material) such that the cover nubs 23 are no longer within the bores 59 and the cover may be removed, as shown. Figure 5 (c) as shown.

[0128] With the removable portion 50 of the cover 40 removed, the inserter tip 15 is exposed, and grasping the textured portion 13, the user can introduce the inserter tip 15 into the urethra, the extent to which this can be done being limited by the cover nub 23. Although the inserter 14 is movable, it will not be fully retracted into the outer housing when inserted into the urethra because during extension, the aperture 42 has been elastically deformed, the aperture 42 has returned to a diameter that is smaller than the spacing / space between the radially outer surfaces 23a of the cover nub 23, and therefore the cover nub 23 cannot be returned through the aperture 42. The inserter 14 can be moved a small amount into the outer housing from where the cover nub 23 has been brought outside of the aperture 42 to allow the engagement tab 58 of the cover to release.

[0129] Once the inserter tip 15 is in place, the user can grasp the catheter 120 by the sheath 80, introduce it into the urethra, and empty the bladder in the usual manner.

[0130] The one or more embodiments described above are described by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

[0131] For example, although these embodiments are female intermittent urinary catheters, their exemplary lengths are in the range of 90mm to 200mm, such as in the range of 130mm to 155mm, such as about 135mm, and the catheter assembly has a length corresponding to the catheter length, such as a housing closure length in the range of 2mm to 10mm longer than the catheter length (e.g. 10-25cm; in the range of 140mm to 165mm, such as 142mm), it is believed that this teaching can be applied to male intermittent urinary catheters (which are generally longer) or even other types of urinary catheters. Similarly, although these embodiments have functionalized hydrophilic surfaces that become smooth when wetted by a wetting agent such as water, the wetting agent can also be a lubricant instead.

Claims

1. A catheter assembly comprising an outer housing and an inserter tip, wherein the outer shell includes a deformable hole through which the inserter tip extends from the interior of the outer shell to the exterior of the outer shell, wherein the inserter tip is movable between a retracted position and an extended position; And the inserter tip includes one or more protrusions having a size larger than the aperture, wherein the aperture is capable of limiting movement of the one or more protrusions toward the interior of the outer housing after expansion.

2. The catheter assembly according to claim 1, wherein: The one or more projections project radially outward from the inserter tip.

3. The catheter assembly according to claim 2, wherein: The one or more protrusions include a radially outer end surface, wherein a radial extension of the protrusion, defined as a distance between the radially outer end surface and a radial center of the inserter tip, is greater than a radius of the aperture.

4. A catheter assembly according to any one of the preceding claims, wherein: There are two protrusions disposed on opposite sides of the inserter tip, each of the two protrusions comprising a radially outer end surface, wherein a spacing between the two radially outer end surfaces is greater than a diameter of the hole.

5. A catheter assembly according to any one of the preceding claims, wherein: In the retracted position, the one or more protrusions are disposed within an interior of the outer housing.

6. The catheter assembly of any of the preceding claims, further comprising one or more chamfered sections, wherein the chamfered sections are configured to deform the aperture when the inserter tip moves from the retracted position to the extended position.

7. The catheter assembly according to claim 6, wherein: The hole is elastically deformable.

8. The catheter assembly according to any one of the preceding claims, further comprising a cover, wherein: The cover engages the one or more projections when the inserter tip is in the retracted position, and the cover disengages the one or more projections when the inserter tip is in the extended position.

9. The catheter assembly according to claim 8, wherein: The cover includes one or more slots through which the protrusions extend.

10. The catheter assembly according to claim 9, wherein: The cover and the inserter tip are configured to be axially movable, wherein axial movement of the cover is converted into axial movement of the inserter tip from the retracted position to the extended position via the slot and the protrusion.

11. A catheter assembly according to any one of claims 8 to 10 as appended to claim 3, wherein: The cover includes a chamfered section between a narrow section and a wide section, wherein the radius of the narrow section is smaller than the radius of the hole and the radius of the wide section is approximately equal to or larger than the radial extension of the protrusion.

12. The catheter assembly of claim 11, wherein: The chamfered section is disposed inside the outer housing when the inserter tip is in the retracted position, and the chamfered section is disposed outside the outer housing when the inserter tip is in the extended position.

13. A catheter assembly according to any one of the preceding claims, wherein: The inserter tip includes an insertion end configured to be inserted into the urethra, wherein the protrusion is arranged 5-15 mm from the insertion end.

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