Intermittent catheter

Abstract

A catheter wetting agent storage chamber (1) is defined by a first end wall (11), a second end wall (12) and a radially outer wall (13) extending therebetween along a longitudinal axis. The catheter wetting agent storage chamber (1) comprises a first section (20) comprising a first portion (21) of the outer wall and a first end wall (11) and a second section (50) comprising a second portion (51) of the outer wall and a second end wall (12). One of the first section (20) and the second section (50) is disposed radially inward of the other such that the two sections overlap axially. One of the first section (20) and the second section (50) includes at least one protrusion (54) extending axially into a corresponding recess (28) in an outer surface of an outer wall of the other of the first section (20) and the second section (50).

Description

Technical Field

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

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

[0003] To maximize comfort and minimize the risk of trauma and / or infection, the outer surface of the catheter tubing is typically moistened with a wetting agent prior to insertion by the user. In a further development, the catheter tubing itself includes, incorporates, 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 come pre-moistened in their packaging; for example, the catheter is at least partially immersed in a wetting agent within the packaging. While this ensures that the catheter is fully moistened before use, a disadvantage of this arrangement is that catheter components other than the catheter tubing, such as the gripping element or funnel, may also become wet. This negatively impacts the user experience, making it difficult to hold and guide the catheter tubing as desired. This is particularly problematic when users are performing self-catheterization. Furthermore, immersing the catheter in water effectively reduces its shelf life, as the catheter components are exposed to moisture for extended periods.

[0005] Therefore, it would be considered 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 packaging that is configured to release a wetting agent upon activation of the mechanism. Prior art mechanisms can be actuated in different ways; in some cases, rotation of a component of the packaging initiates the wetting action, while in many other cases, it is axial movement. Mistakenly using the wrong motion when attempting to activate the wetting action can damage the catheter packaging and frustrate the user.

[0007] 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

[0008] The present invention provides a catheter assembly according to the accompanying claims.

[0009] One aspect of the present disclosure provides a catheter lubricant storage chamber defined by a first end wall, a second end wall, and a radially outer wall extending between the first and second end walls. The radially outer wall may extend along a radial axis. The catheter lubricant storage chamber may include a first section comprising the first end wall and a first portion of the outer wall. The catheter lubricant storage chamber may include a second section comprising the second end wall and a second portion of the outer wall. One of the first and second sections may be positioned radially inward of the other section. The first and second sections may overlap axially. One of the first and second sections may include at least one protrusion. The at least one protrusion may extend axially into a corresponding recess in an outer surface of an outer wall of the other of the first and second sections.

[0010] One aspect of the present disclosure provides a catheter wetting agent storage chamber defined by a first end wall, a second end wall, and a radial outer wall extending along a longitudinal axis between the first and second end walls, wherein the catheter wetting agent storage chamber includes: a first section and a second section, the first section including the first end wall and a first portion of the outer wall, the second section including the second end wall and a second portion of the outer wall; wherein one of the first section and the second section is radially positioned within the other section such that the two sections overlap axially; and wherein one of the first section and the second section includes at least one protrusion extending axially into a corresponding recess in an outer surface of an outer wall of the other of the first section and the second section.

[0011] Advantageously, where the catheter lubricant reservoir is provided in at least two segments, providing corresponding protrusions and recesses allows for a discontinuous circumferential connection between the two segments. This discontinuous connection is visible during normal use, providing a visual cue to the user or healthcare professional (HCP) not to rotate the chamber.

[0012] The second section may be positioned inside the first section. The first section may be positioned inside the second section. The second section may include the at least one protrusion.

[0013] The catheter lubricant reservoir may include an equal number of protrusions and recesses. The catheter lubricant reservoir may include two protrusions and two recesses. The catheter lubricant reservoir may include three protrusions and three recesses. The catheter lubricant reservoir may include four protrusions and four recesses. The or each recess may extend through the outer wall of the corresponding segment. The or each recess may extend radially through the outer wall of the corresponding segment. The or each protrusion may be disposed on the outer surface of the outer wall. The or each protrusion may be disposed on the outer surface of the outer wall of the corresponding segment.

[0014] The or each protrusion may have the same profile as the or each recess.The or each protrusion may have the same profile as the or each corresponding recess.

[0015] Protrusions and recesses having the same profile provide a clear joining line between the two sections, which improves the aesthetics of the chamber.

[0016] The second portion of the outer wall may include a distal section having a first diameter. The second portion of the outer wall may include a proximal section having a second diameter. The first diameter may be smaller than the second diameter. The first diameter may be equal to the inner diameter of the first wall. The second diameter may be equal to the outer diameter of the first wall. The protrusion may have the second diameter.

[0017] The protrusion may have a curved distal end. The protrusion may have a textured outer surface. The textured surface allows the HCP or user to better grip.

[0018] The first and second segments may be joined using a snap-fit ​​structure. The first and second segments may be joined using a cantilevered snap-fit ​​structure. The cantilevered snap-fit ​​structure may include corresponding protrusions and recesses. The snap-fit ​​structure may include radially extending protrusions. The snap-fit ​​structure may include radially extending recesses. The snap-fit ​​structure may include radially extending protrusions on one of the first segment and the second segment, and the other of the first segment and the second segment may include corresponding recesses.

[0019] The cantilevered snap fit arrangement provides a secure joint between the two components but does not necessarily allow rotational movement between the two parts of the chamber. If rotation is attempted, the cantilevered protrusion may be easily damaged, so providing corresponding protrusions and recesses reduces the risk of damage.

[0020] The first and second sections may include complementary alignment features. One of the first and second sections may include one or more slots, and the other of the first and second sections may include one or more protrusions. The one or more slots may include a tapered opening. The one or more protrusions may include ribs. The ribs may be disposed on the first section. The ribs may be disposed on a radially inner surface of the first section. The ribs may be disposed on a radially inner surface of the first portion of the outer wall. The ribs may extend axially. The slot may be disposed on the second section. The slot may extend through the second portion of the outer wall.

[0021] The catheter lubricant reservoir may be a wetting chamber. The wetting chamber may be disposed in the outer housing. The catheter lubricant reservoir may include one or more filling holes. The one or more filling holes may be configured to be sealed when the first and second sections are coupled.

[0022] The wetting agent storage chamber may be further defined by a removable insert. The removable insert is movable relative to the radially outer wall between a first position and a second position. In the first position, the removable insert is aligned with the chamber wall to seal the storage chamber. In the second position, the removable insert is offset from the chamber wall to open the catheter wetting agent storage chamber. Removing the cap allows the removable insert to be moved from the first position to the second position. The chamber wall may be the first end wall, the second end wall, and / or the radially outer wall.

[0023] Removable inserts offer an alternative way to deploy catheters without rotation.

[0024] The wetting agent storage chamber may include a removable insert. The wetting chamber may also include a removable insert. The removable insert may include one or more ribs extending circumferentially. The ribs may extend to the chamber wall. The removable insert may include at least two ribs. The removable insert 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 of the chamber wall may extend to the inserter tip. The chamber wall may include two ribs. One of the inserter tip and the chamber wall preferably includes one or more ribs that extend circumferentially and protrude into the other of the chamber wall and the insert.

[0025] The removable insert may be configured to move between a first position and a second position. The removable insert may be configured to move axially between the first position and the second position. The removable insert may be movable between the first position and the second position. The removable insert may be axially movable between the first position and the second position. The first position may be a sealing position. The second position may be a catheter wetting position. In the first position, the catheter wetting agent reservoir may be sealed. In the second position, the catheter wetting agent reservoir may be open.

[0026] In the first position, the one or more ribs may define the axial extent of the moisturizing agent reservoir. If the removable insert comprises an upper rib and a lower rib, the distance between the upper rib and the lower rib may define the axial extent of the reservoir. If the chamber wall comprises two ribs, the two ribs may define the axial extent of the reservoir.

[0027] In the first position, the 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, the or each rib of the chamber wall is preferably aligned with a corresponding sealing surface on the removable insert to seal the storage chamber. In the second position, at least one rib of the removable insert is preferably axially misaligned with the sealing surface on the chamber wall. Where the assembly comprises an upper rib and a lower rib, in the second position the upper rib may remain aligned with the sealing surface on the chamber wall. Alternatively, in the second position, at least one rib of the chamber wall is axially misaligned with the sealing surface on the removable insert.

[0028] 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 pairs of ribs.

[0029] The sealing element can be a resilient material. For example, the seal can be a rubber seal or some other suitable material. The sealing element can be an annular sealing element. The sealing element can include an O-ring. The sealing element can include an X-ring. The sealing element can include a U-cup. The sealing element can be located in a radial plane, for example, in a plane normal to the longitudinal axis of the catheter assembly. The sealing element can extend between diametrically opposed sealing surfaces. The O-ring can be located in a radial plane, for example, in a plane normal to the longitudinal axis of the catheter assembly. The sealing element can be provided in the form of a gasket.

[0030] The sealing element may be compressible.

[0031] The sealing element may be located in a sealing element receptacle in one of the chamber wall or the removable insert. The sealing element receptacle may include a groove or channel disposed in the chamber wall or the removable insert. The groove or channel may be provided in part by a radially outer wall, an axial end wall, and / or one or more catheter guide feature structures disposed within the storage chamber. The sealing element may be overmolded so as to become an integral part of the storage chamber or the inserter tip. One or more sealing surfaces may be provided by the sealing element receptacle. The at least one sealing surface may be slidably opposed to the sealing element. The at least one sealing surface may be referred to as a primary sealing surface.

[0032] At least one of the removable insert and the chamber wall may include a diverging portion over which the rib passes when transitioning between the first position and the second position such that the distance between the chamber wall and the inserter tip at the axial location of the rib is increased in the second position compared to the first position. The distance may be a radial distance relative to the longitudinal axis. The diverging portion may include a widening of the cavity adjacent the sealing surface. The cavity may be a storage chamber and / or a cavity of an adjacent chamber. The adjacent chamber may be disposed within the outer housing. The adjacent chamber may accommodate a catheter tube. The adjacent chamber may be an infusion chamber or a wetting chamber.

[0033] The diverging portion may include a step, a taper, or a bevel 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 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 proximal to the insertion end of the catheter. The adjacent wall portion may be an auxiliary surface / second surface.

[0034] The catheter wetting chamber may further include a wetting agent. In a first position, the wetting agent may be sealed within the wetting agent reservoir. When in a second position, a flow path may be provided between the sealing surface and the rib, allowing the wetting agent to flow out of the reservoir when in the second position. The flow path may direct the wetting agent from the reservoir to the catheter.

[0035] A catheter lubricant reservoir may be provided in the catheter assembly.The catheter assembly may also include a catheter.

[0036] Therefore, another aspect of the present disclosure provides a catheter assembly comprising a catheter and a catheter wetting agent storage chamber, wherein the catheter wetting agent storage chamber is defined by a first end wall, a second end wall, and a radially outer wall extending along a longitudinal axis between the first end wall and the second end wall. The radially outer wall may extend along a radial axis. The catheter wetting agent storage chamber may include a first section comprising the first end wall and a first portion of the outer wall. The catheter wetting agent storage chamber may include a second section comprising the second end wall and a second portion of the outer wall. One of the first and second sections may be positioned radially inwardly of the other section. The first and second sections may overlap axially. One of the first and second sections may include at least one protrusion. The at least one protrusion may extend axially into a corresponding recess in the outer surface of the outer wall of the other of the first and second sections.

[0037] One aspect of the present disclosure provides a catheter assembly comprising a catheter and a catheter wetting agent storage chamber, the catheter wetting agent storage chamber being defined by a first end wall, a second end wall, and a radial outer wall extending along a longitudinal axis between the first end wall and the second end wall, wherein the catheter wetting agent storage chamber comprises: a first segment and a second segment, the first segment comprising the first end wall and a first portion of the outer wall, the second segment comprising the second end wall and a second portion of the outer wall; wherein one of the first segment and the second segment is radially positioned within the other segment such that the two segments overlap axially; and wherein one of the first segment and the second segment comprises at least one protrusion extending axially into a corresponding recess in an outer surface of an outer wall of the other of the first segment and the second segment.

[0038] Advantageously, where the catheter lubricant reservoir is provided in at least two segments, providing corresponding protrusions and recesses allows for a discontinuous circumferential connection between the two segments. This discontinuous connection is visible during normal use, providing a visual cue to the user or healthcare professional (HCP) not to rotate the chamber.

[0039] The catheter assembly may further comprise 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 chambers.

[0040] The catheter assembly may further include a sheath. The wetting chamber may be at least partially defined by the sheath. The sheath may define a cavity. The catheter may be disposed within the cavity of the sheath. In the second position, the sheath cavity may be in fluid communication with the wetting agent storage chamber. In this regard, the sheath cavity may be the wetting chamber.

[0041] The catheter may be at least partially disposed within the sheath. The sheath and the catheter may define a flow path. The flow path may extend along the axial length of the catheter. The flow path may be provided between an outer surface of the catheter and an inner surface of the sheath.

[0042] The catheter assembly may further include a storage bag. The storage bag may be configured to receive fluid discharged from the catheter during 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.

[0043] 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.

[0044] 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.

[0045] The catheter may include a catheter tubing providing an insertion end for insertion into a patient and an exit end including one or more external manipulation features.

[0046] The catheter may be an intermittent catheter. The catheter may be a urinary catheter. The catheter may be a female intermittent catheter.

[0047] The catheter assembly may further include a cap. The cap may seal the wetting agent storage chamber. The cap may provide a sterile seal for the wetting agent storage chamber.

[0048] The catheter assembly can be configured to provide mechanical feedback to the user. The mechanical feedback can indicate the end of the first step. The mechanical feedback can indicate that the catheter assembly is in the second position. The mechanical feedback can be between the first step and the second step.

[0049] The provision of a feedback mechanism allows the user to know that the wetting process has occurred without having to visually inspect the catheter.

[0050] The catheter may include an insertable portion. Prior to the first step, the insertable portion may not be in contact with the wetting agent. In the first position, the catheter may not be in contact with the wetting agent. In the second position, the wetting agent may be in contact with the catheter.

[0051] 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.

[0052] The cap may be configured to engage the removable insert in a first position. The cap may be configured to disengage the removable insert in a second position. The cap may be releasably coupled to the removable insert.

[0053] Advantageously, by releasably coupling the cap and the removable insert, a wetting operation can be initiated in the same motion as removing the cap. Furthermore, because the cap and the removable insert are only decoupled in the second position, the cap can only be removed once in the second position. Because movement to the second position may cause the catheter to become wet, the cap can be removed only when wetting occurs, thereby reducing the risk of injury to the user from using an unlubricated catheter.

[0054] The cap may include a deformable portion. The cap may be made of an elastically deformable material. The cap may be made of linear low-density polyethylene. The cap may be made of low-density polyethylene. The cap may be made of polypropylene. The cap may be made of a thermoplastic elastomer. The cap may be made of thermoplastic polyurethane. The cap may be made of ethylene vinyl acetate.

[0055] The cap may be elastically deformable in the first position. The cap may relax to its original shape in the second position. Alternatively, the cap may be deformable in the second position.

[0056] The cap may include an internal cavity. The internal cavity may be shaped to conform to a portion of the removable insert. The cap may include a grip ring. The grip ring may be shaped to facilitate removal of the cap.

[0057] The open end of the cap may be deformable. The open end of the cap may be made of a deformable material. The open end of the cap may be provided with one or more features that facilitate deformation. For example, the open end of the cap may include one or more grooves / slots extending axially from the open end. The deformation-assisting features may be two grooves / slots. The open end of the cap may include one or more engagement tabs. The cap may be provided with two engagement tabs. The one or more engagement tabs may extend axially from the open end. The engagement tabs may be configured to bend radially.

[0058] The cap and the removable insert may include corresponding engagement mechanisms. 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 the protrusion and recess, may be configured to remain engaged when subjected to a first predetermined force and to disengage when subjected to a second predetermined force.

[0059] The engagement mechanism may include a protrusion on the movable insert and a corresponding hole in the cap. When the cap and movable insert are engaged, the protrusion may be disposed in the hole. The cap may be deformable to remove the protrusion from the hole. The cap may be removed to decouple from the movable insert.

[0060] The catheter assembly may include an airtight seal for maintaining the sterility of the interior volume prior to use.In a first position, the cap may provide a sterile seal for the cavity within the catheter assembly body.

[0061] When in the sealed configuration, the hermetic seal can be intact. When in the irrigated or wetted configuration, the hermetic seal can be broken, such that the cavity within the catheter assembly body is at least partially open to the outside air, and the sterile environment can be considered to be broken.

[0062] The catheter body can be functionalized. For example, it can include a hydrophilic component (for example, a hydrophilic polymer), or be integrated with the hydrophilic component, or be coated with the hydrophilic component. The hydrophilic component is used to further reduce friction when applying a wetting agent. 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 (the outer surface 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 located at the insertion end of the catheter.

[0063] The catheter may include an outlet body. The outlet body may be coupled to a terminal end of the catheter tube. The outlet body may include an external control surface of the catheter. The outlet body may include one or more flow-enhancing features to facilitate flow from the catheter tube. For example, the one or more flow-enhancing features may include a funnel.

[0064] 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 tubing.

[0065] The sheath may be a retractable sheath. A retractable sheath may be configured to retract during catheter insertion, thereby providing a temporary seal around the catheter prior to insertion.

[0066] According to another aspect of the present disclosure, a method of assembling a catheter wetting agent storage chamber is provided, the catheter wetting agent storage chamber being defined by a first end wall, a second end wall, and a radial outer wall extending along a longitudinal axis between the first end wall and the second end wall, wherein the catheter wetting agent storage chamber comprises: a first section and a second section, the first section comprising the first end wall and a first portion of the outer wall, the second section comprising the second end wall and a second portion of the outer wall; wherein one of the first section and the second section comprises at least one protrusion, and the other of the first section and the second section comprises a corresponding recess in an outer surface of the outer wall; the method comprising axially inserting one of the first section and the second section into the other such that the protrusion protrudes axially into the recess.

[0067] The optional features set out above may apply to any aspect of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] 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:

[0069] Figure 1 An orthographic side view of a catheter wetting agent reservoir according to an embodiment of the present disclosure is shown;

[0070] Figure 2 Shown Figure 1 An orthographic front view of a catheter wetting agent storage chamber;

[0071] Figure 3 Shown Figure 1 An exploded perspective view of a catheter lubricant storage chamber;

[0072] Figure 4 A longitudinal cross-sectional view of a catheter assembly is shown, the catheter assembly including a Figure 1 a catheter lubricant reservoir; and

[0073] Figure 5 Shown in deployed configuration Figure 4 Longitudinal cross-sectional view of the catheter assembly. DETAILED DESCRIPTION

[0074] refer to Figure 1-5 , an exemplary catheter wetting chamber 1 according to the present invention is described.

[0075] refer to Figures 1 to 3 The catheter wetting chamber 1 includes an outer housing 10 having a generally cylindrical shape with a first end wall 11, a second end wall 12, and a radially outer wall 13. The outer housing 10 is constructed of two parts: an upper first section 20 and a lower second section 50. It should be understood that the terms "upper" and "lower" are used merely to aid description and do not imply any orientation. To further aid in describing the wetting chamber, a longitudinal axis A is shown. Unless otherwise specified, all positions and axes are relative to these axes.

[0076] The upper section 20 includes a first portion 21 of the radial outer wall 13, which terminates at one end at the first end wall 11 and is open at a second end. Centrally located in the first end wall 11 is a circular insertion port 22 through which a conduit (not shown) can pass. The first end wall 11 may have an elliptical shape, with its semi-minor axis having the same length as the radius of the outer surface 23 of the first portion 21 of the radial outer wall 13. The semi-major axis has a length greater than the radius of the outer surface 23 of the first portion 21 of the radial outer wall 13. Because the first portion 21 of the radial outer wall 13 is circular and the first end wall 11 is elliptical, the first end wall 11 protrudes radially outward beyond the outer wall 13 at two points to form tabs 24, thereby facilitating gripping of the wetting chamber, as will be explained in more detail below. The tabs 24 may be reinforced by a plurality of ribs 24a extending from the ribs 24 to the radial outer wall 13.

[0077] Disposed beneath the two tabs 24 is a rectangular slot 25 (only one is shown here, but those skilled in the art will appreciate that additional slots are provided on the opposite side) extending through the first portion 21 of the radially outer wall 13. The major axes of the two slots 25 extend circumferentially around the radially outer wall, and the minor axes extend axially along the radially outer wall 13. The rectangular slots 25 constitute the first part of the coupling mechanism 65 between the upper segment 20 and the lower segment 50, as described in detail below. In various other embodiments, the rectangular slots 25 may not extend through the radially outer wall, but may instead be recessed into one side of the wall.

[0078] As described above, the second end of the first portion 21 is open, and the radially outer wall 13 terminates at an edge 27. Two recesses 28 are provided on opposite sides of the edge 27 aligned with the tab 24 (only one is shown, but those skilled in the art will understand that another recess is provided on the opposite side). The recess 28 may have a "D"-shaped profile and extend through the first portion 21 of the radially outer wall 13.

[0079] Two axially extending ribs 29 are arranged on the inner surface of the radially outer wall 13, the two ribs 29 being located on opposite sides of the radially outer wall 13 midway between the two recesses 28. The two axially extending ribs 29 extend from the first end wall 11 to midway towards the open second end, and the two ribs form a first part of an alignment mechanism described in detail below.

[0080] The lower section 50 includes a second portion 51 of the radially outer wall 13, which terminates at the second end wall 12 at one end and opens at an opposite open end 52. The second portion 51 of the radially outer wall 13 is provided in two parts, namely an outer wall portion 51A and an overlapping portion 51B. The outer wall portion 51A is close to the second end wall 12, and the overlapping portion 51B is away from the second end wall 12. The inner surfaces of the two parts have the same diameter, thereby providing a single continuous surface of the inner wall 51'. The overlapping portion 51B has a thinner wall than the outer wall portion 51A, which results in the radial outer surfaces of the outer wall portion 51A" and the overlapping portion 51B" being separated by a step 53, wherein the outer surface of the overlapping portion 51B" is located radially inwardly of the outer surface of the outer wall portion 51A".

[0081] Two protrusions 54 extend axially from outer wall portion 51A above step 53 to overlapping portion 51B. The protrusions have the same radial outer diameter as outer wall portion 51A and thus form a continuation of that portion into overlapping portion 51B. The protrusions have curved distal ends 55, i.e., the middle of the protrusions extends most deeply into overlapping portion 51B. The curved distal ends 55 have a profile corresponding to recess 28 in first portion 21, and the two features are shaped to engage together, as described in detail below.

[0082] A gripping feature 56 is disposed on a radially outer surface of the protrusion 54, extending beyond the protrusion 54 to the outer surface of the outer wall portion 51A". The gripping feature 56 defines an elliptical area having a portion of an edge adjacent to the curved distal end 55. In some embodiments, the gripping feature 56 may be integrally formed with the outer surface of the outer wall portion 51A", and in various other embodiments, the gripping feature 56 may be formed from a different material, such as a material that provides enhanced grip when wet.

[0083] The diameter of the radially outer surface of the overlapping portion 51B" is equal to the diameter of the radially inner wall 21' of the first portion 21, so that the overlapping portion 51B can be placed inside the first portion 21, which will be described in detail below.

[0084] Four axial slots 58 extend axially from the edge 22 of the open end 52 of the second portion 51. The axial slots 58 are equally spaced around the edge 57 and are equally spaced adjacent to each protrusion 54. The four axial slots 58 divide the open end 53 of the second portion 51 into four tabs 59, with the protrusions 54 extending into two opposing attachment tabs 59A. Between the two attachment tabs 59A are two alignment tabs 59B, each of which includes a triangular notch 60 that tapers away from the open end 53 and terminates at a point from which an axially extending slot 61 extends. The axially extending slots 61 form the second portion of the alignment mechanism, the operation of which will be described in detail below.

[0085] A circumferentially extending rectangular groove 63 is provided between the two axially extending slots 61 and the outer wall portion 51 A. The groove 63 provides fluid communication between the interior and exterior of the catheter wetting agent reservoir 1 as will be described in detail below.

[0086] The edge 57 near the open end 52 of the second portion is provided with a projection 64 at the distal end of the two attachment tabs 59A, which has a chamfered edge 64A facing the edge 57. The two projections 64 are configured to engage with the rectangular slot 25 and form a second part of the engagement mechanism 65.

[0087] On the side of the second end wall 12 opposite the second portion 51 of the radially outer wall 13 are three concentrically / coaxially arranged tubular sections: a first tubular section 66, a second tubular section 67, and a third tubular section 68. The first tubular section 66 is adjacent to the second end wall 12 and has a smaller diameter than the radially outer wall 13. The second tubular section 67 is arranged outside the first tubular section 66 and has a smaller diameter than the first tubular section 66. The third tubular section 68 is arranged outside the second tubular section 67 and has a smaller diameter than the second tubular section 67. A chamfered section is provided between each tubular section to reduce the diameter. The distal ends of the tubular sections are open, providing a lower opening 69 aligned with the insertion port 22.

[0088] refer to Figure 3 and 4 , describes a method of assembling the moistening agent reservoir 1. The upper section 20 and the lower section 50 are rotated so that the recess 28 on the upper section 20 is aligned with the protrusion 54 on the lower section 50.

[0089] The overlapping portion 51B of the lower segment 50 is axially inserted into the upper segment 20. Any misalignment of the two segments can be corrected by an alignment mechanism comprising notches 60 in the alignment tabs 59B that will engage corresponding ribs 29 on the inner surface of the first portion 21 of the radially outer wall 13, rotating the two segments 20, 50 relative to each other until they are in the correct alignment.

[0090] As two sections 20,50 are brought together, projection 54 is inserted in recess 28, and projection 64 contacts the edge 27 of the open end of the first portion 21 of radially outer wall 13, and causes two attachment tabs 59A to deflect radially inward.As two sections 20,50 are almost completely connected, the wetting agent storage chamber is filled with wetting agent (water in this embodiment). Wetting agent is supplied by rectangular groove 63.As two sections 20,50 continue to come together, projection 64 will enter their respective rectangular groove 25, and two attachment tabs 59A will return to their initial position.Protrusion 64 will engage with their respective groove 25, thereby two sections 20,50 are kept together, to form the wetting agent storage chamber 1, and the first portion 21 of radially outer wall is with sealing groove 63.

[0091] The arrangement of the respective protrusions 54 and recesses 28 provides a discontinuous connecting line 70 between the two sections 20, 50 of the reservoir. That is, the connecting line 70 between the two sections visible to the user on the radially outer surface 23 is not a circumferentially extending circular line, but rather has an axial component. This provides a visual indication to the user that the deployment of the catheter, and in particular the catheter wetting agent reservoir 1, does not require rotation.

[0092] The catheter lubricant reservoir 1 can be used as Figure 4 A portion of a catheter assembly 100 is shown. The catheter assembly 100 includes a catheter lubricant reservoir 1 , a removable insert 114 , a catheter 120 , a cap 150 , and a sheath 180 .

[0093] The catheter assembly 100 may be configured such that the catheter 120 may be wetted before being withdrawn from the outer housing 10. A wetting mechanism may be provided within the outer housing 10.

[0094] Within the outer housing 10 and extending from each open end 22, 69 is a removable insert in the form of an inserter 114 having an overall tubular shape and including an inserter tip 115 and a catheter clamp 116. The outer housing 10 and the inserter 114 are concentrically arranged so that the inserter 114 is located within the outer housing 10 in a radially nested configuration. The inserter tip 115 is disposed at a first end of the inserter 114 and closes the tubular body with a hemispherical end 115a that is provided with one or more holes or openings, such as slits (not shown), that allow the end 115a to be open to allow a catheter to pass therethrough. The opposite end of the inserter 114 is provided with a catheter clamp 116, the structure and operation of which will be described in detail below.

[0095] In this embodiment, the inserter 114 is arranged within the outer housing 10 such that in a storage position (as will be described in detail below), the inserter tip 115 extends out of the first end wall 11 and the catheter grip 116 extends out of the second end wall 12 of the outer housing 10.

[0096] In this embodiment, the cap 150 has a tubular shape with an open end 151 and a closed end 152, with the interior of the cap 150 defining a cavity 153 shaped to receive the inserter tip 115. The cavity is sized and shaped to fit snugly around the inserter tip 115. On the exterior of the cap 150, at the closed end 152, a grip ring 154 is provided by which a user can grasp the cap 150. The cap 150 extends through the inserter port aperture 22, with a housing seal 161 disposed between the aperture 22 and the cap 150 to hermetically seal the moistening agent reservoir.

[0097] The catheter 120 is of a type known in the art and includes a catheter body 121 having an insertion end 122 and an opposing drainage end (not shown). The catheter body 121 has a longitudinal axis corresponding to the longitudinal axis A of the catheter's wetting agent reservoir. One or more drainage holes 133 may be provided near the insertion end 122. In this embodiment, the drainage holes 133 are elliptical in shape, with their major axes parallel to the longitudinal axis A. It will be appreciated that the size and shape of the drainage holes 133 may vary.

[0098] As is known in the art, the outer surface of the catheter tubing 121 can be functionalized so that when wetted by a wetting agent, the coefficient of friction of the catheter tubing 121 is reduced. The outer surface of the catheter tubing 121 can be composed of a functionalized material or coated with a functionalized material; for example, the outer surface of the catheter tubing 121 can have hydrophilic properties. When a wetting agent is introduced, the hydrophilic properties serve to reduce the coefficient of friction of the outer surface.

[0099] The catheter 120 and the inserter 114 are concentrically arranged such that the insertion end 122 of the catheter 120 engages the catheter clamp 116 and the distal end of the catheter 120 extends away from the inserter 114, as will be described in further detail below.

[0100] The sheath 180 is disposed at the catheter end 112 of the outer housing 10. The sheath 180 extends away from the outer housing 10 so as to surround at least a portion of the catheter tubing 120. The sheath 180 is formed of a flexible material. In some embodiments, the sheath 180 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 120, or the sheath 180 and the bag can be integrally formed. The sheath can allow fluid communication from the outer housing 10 to the bag.

[0101] The radially inner wall 21' of the outer housing 10 is provided with a step near the conduit end 112, so that the diameter of the inner wall 21' decreases near the conduit end 12 and is located radially inward of the tubular sections 66, 67, and 68. A first, wider portion 21'a of the inner wall 21' provides a first sealing surface 118, and a second, narrower portion 21'b of the inner wall 21' provides a second sealing surface 119. The inner diameter of the inner wall 21' is further reduced by the third tubular section 68 at the edge of the conduit end 112 to form a narrowest third portion 21'c.

[0102] The inserter 114 is radially nested in the outer housing 10. In this embodiment, to ensure alignment of the inserter 114 in the outer housing, the inserter 114 is provided with two pairs of ribs 121, 122. In various other embodiments, the outer housing 10 may be provided with protrusions such as ribs.

[0103] In this embodiment, a (upper) first pair of ribs 121 circumferentially surrounds the inserter 114 and projects radially outwardly from the inserter 114 at a point approximately one-third of the distance from the inserter tip 115a to the catheter holder 116. The first pair of ribs 121 are sized so that they extend radially to the first sealing surface 118 of the outer housing 10. The first pair of ribs 121 are formed from a single, wider protrusion whose outer circumference is provided with a groove 121a having a depth equal to the radial extension of the protrusion, which divides the protrusion into two ribs 121 of equal size.

[0104] In this embodiment, a (lower) second pair of ribs 122 circumferentially surrounds the inserter 114 and projects radially outward from the inserter 114 at a point proximate the catheter holder 116. The second pair of ribs 122 are sized such that they extend radially to the second sealing surface 119 of the outer housing 10. The two ribs 122 of the second pair project independently from the inserter 114.

[0105] In this embodiment, disposed adjacent the first pair of ribs 121 are two cap tabs 123, which are two protrusions on opposite sides of the inserter 114. The cap tabs 123 have a rectangular base with major edges perpendicular to the longitudinal axis A of the catheter assembly 100.

[0106] In this embodiment, the open end 151 of the cap 150 is provided with two engagement tabs 158. Each of the two engagement tabs 158 is provided with a rectangular hole 159, the major axis of which extends circumferentially around the cap. The hole 159 is sized and shaped to receive the cap tab 123 of the inserter 114. Around the hole 159, the wall thickness of the connector portion 141 increases with a chamfered step provided on the radially outer surface.

[0107] When provided in a sealed configuration (e.g., for storage and transport), the inserter 114 is in a retracted position within the outer housing 10. The first and second pairs of ribs 121, 122 press against the sealing surfaces 118, 119 of the radially inner wall 21' to align the inserter 114 within the outer housing 10 such that they are radially nested.

[0108] The inner wall 21 ′ of the outer shell 10 , the outer surface of the inserter 114 and the ribs 121 , 122 together hold the wetting agent (water in this embodiment) in the wetting agent storage chamber 1 , the inserter 114 and the outer shell 10 defining a radial extent, and the upper and lower ribs 121 , 122 defining an axial extent.

[0109] In the sealed configuration, the inserter 114 is maximally inserted into the outer housing 10 and the second pair of ribs 122 abut against the chamfered section 67 , limiting any further insertion.

[0110] The cap 150 is positioned over the inserter 114 such that the inserter tip 115 is positioned within the cavity 153. The cap tabs 123 extend into the holes 159 in the engagement tabs 158, and the open lip 156 abuts the first pair of ribs 121. The catheter gripping portion 116 is provided with a small protrusion 134 that presses against the narrowest portion 21'c of the inner wall. This support of the small protrusion 134 causes the gripping end 116 to deform and compress into engagement with the insertion end 122 of the catheter 120, thereby holding the catheter 120 in place.

[0111] Reference Figure 4 and 5, describes a method for deploying and using a catheter. When deploying the catheter 120 for use, the user can grasp the outer housing 10 with one hand by the gripping feature 56 and grasp the cap 150 with the other hand, for example, by the gripping ring 154 (if present). The discontinuous connecting line 70 indicates to the user that the catheter 120 is not deployed by a rotational motion, but rather by pulling the cap 150 axially relative to the outer housing 10.

[0112] During deployment, the catheter assembly 100 is positioned generally vertically with the cap 150 uppermost (e.g., Figure 4 63 , thereby breaking the housing seal 161; the catheter assembly 100 is no longer hermetically sealed.

[0113] As the axial displacement continues, the cap tabs 123 abut against the edges of their corresponding holes 159, and the inserter 114 begins to displace axially. As the inserter 14 shifts, the small protrusion 133 passes the chamfered section 67 and becomes axially misaligned with the third inner wall portion 21'c. Since the small protrusion 133 no longer presses against the third inner wall portion 21'c, the clamping end 116 is no longer compressed and relaxes in a radially outward manner, thereby creating a gap between the clamping end 116 and the catheter 120. This increase in spacing causes the clamping end 116 to disengage from the catheter 120, allowing the catheter to move freely and exposing the entire functionalized surface of the catheter body 121. The movement of the inserter 14 within the outer housing 10 is guided by the first and second pairs of ribs 121, 122 that contact and move along the sealing surfaces 118, 119.

[0114] In this embodiment, as the cap 150 and inserter 114 continue to shift, the second pair of ribs 122 penetrate the second wall 12 and become axially misaligned with the second sealing surface 119. Consequently, a flow path is opened between the moistening agent reservoir 10 and the cavity defined between the conduit 120 and the sheath 180. In this regard, the interior of the sheath can be considered the moistening chamber. Moistening agent flows from the moistening agent reservoir 10 to the conduit 120 around the second pair of ribs 122. The moistening agent in the moistening agent reservoir 10 is replaced by air through the rectangular slot 63. In this embodiment, any excess moistening agent that does not contact the conduit flows through the sheath 80 and is discharged into the bag.

[0115] In this embodiment, when the reservoir 10 is opened, the engagement tab 158, and therefore the cap tab 123, is pulled through the insertion end aperture 22. Although the cap tab 123 is wider than the aperture 22, the chamfered step deforms the aperture 22, increasing its diameter, which allows the cap tab 123 to pass through the aperture 22. The inserter 114 continues to move axially until the first pair of ribs 121 abuts the first end wall 11, at which point the engagement tab 158 has passed through the aperture 22 and is located outside the outer housing 10. Throughout the movement of the inserter 114, the first pair of ribs 121 remains in contact with the first sealing surface 118, ensuring that no wetting agent leaks from the first end 11 of the outer housing 10.

[0116] When the engagement tab 158 is no longer radially nested within the aperture 22 or the outer housing 10, one or both may deform (plastically or elastically, depending on the material) such that the cap tab 123 is no longer within the cap aperture 159 and the cap may be removed, as shown. Figure 5 shown.

[0117] With the cap 150 removed, the inserter tip 115 is exposed and, using the gripping features 56, the user can introduce the inserter tip 115 into the urethra, the extent to which this can be done being limited by the cap tabs 123. Although the inserter 114 is removable, it will not retract into the outer housing 10 when inserted into the urethra because the cap tabs 123 cannot return through the insertion end aperture 22.

[0118] Once the inserter tip 15 is in place, the user can grasp the catheter 120 by the sheath 180 and introduce it into the urethra to empty the bladder in the usual manner.

[0119] 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.

[0120] For example, although the embodiments are all female intermittent urinary catheters (with exemplary lengths ranging from 90 mm to 200 mm, such as from 130 mm to 155 mm, for example, about 135 mm, and with catheter assemblies having a length corresponding to the length of the catheter, such as a cannula closure length that is 2 mm to 10 mm longer than the length of the catheter (e.g., 10-25 cm; ranging from 140 mm to 165 mm, for example, 142 mm), it is contemplated that the teachings may be applied to male intermittent urinary catheters (which are typically longer) or even other types of urinary catheters. Similarly, although the embodiments have functionalized hydrophilic surfaces that become slippery when wetted by a wetting agent, such as water, the wetting agent may also be a lubricant.

Claims

1. A catheter lubricant storage chamber, defined by a first end wall, a second end wall, and a radially outer wall extending along a longitudinal axis between the first end wall and the second end wall, wherein the catheter lubricant storage chamber comprises: a first section including a first portion of the outer wall and the first end wall; a second section including a second portion of the outer wall and the second end wall; wherein one of the first segment and the second segment is positioned radially inward of the other segment such that the two segments overlap axially; And wherein one of the first segment and the second segment includes at least one protrusion extending axially into a corresponding recess in an outer surface of an outer wall of the other of the first segment and the second segment.

2. The catheter lubricant storage chamber according to claim 1, wherein: The second section is positioned inside the first section, and the second section includes the at least one protrusion.

3. The catheter wetting agent storage chamber according to claim 1 or 2, wherein: The catheter lubricant reservoir includes an equal number of protrusions and recesses.

4. The catheter lubricant reservoir according to any one of the preceding claims, wherein: The catheter lubricant reservoir includes two protrusions.

5. The catheter lubricant reservoir according to any one of the preceding claims, wherein: The or each recess extends radially through the outer wall of the respective segment.

6. The catheter lubricant reservoir according to any one of the preceding claims, wherein: The or each protrusion has the same profile as the or each recess.

7. The catheter lubricant reservoir according to any one of the preceding claims, wherein: The protrusion is provided on the outer surface of the outer wall.

8. The catheter wetting agent storage chamber according to any one of claims 2 to 7, wherein: The second portion of the outer wall includes a distal section having a first diameter and a proximal section having a second diameter, wherein the first diameter is smaller than the second diameter.

9. The catheter lubricant storage chamber according to claim 8, wherein: The first diameter is equal to the inner diameter of the first wall.

10. The catheter wetting agent storage chamber according to claim 8 or 9, wherein: The second diameter is equal to the outer diameter of the first wall.

11. The catheter wetting agent storage chamber according to any one of claims 8 to 10, wherein: The protrusion has the second diameter.

12. The catheter lubricant reservoir according to any one of the preceding claims, wherein: The or each protrusion may have a curved distal end.

13. The catheter lubricant reservoir according to any one of the preceding claims, wherein: The or each protrusion may have a textured outer surface.

14. The catheter lubricant reservoir according to any one of the preceding claims, wherein: The first section and the second section are joined using a snap-fit ​​structure.

15. The catheter wetting agent storage chamber according to claim 14, wherein: The snap-fit ​​structure includes a radially extending protrusion on one of the first segment and the second segment, and the other of the first segment and the second segment includes a corresponding recess.

16. A catheter assembly comprising a catheter and a catheter wetting agent reservoir defined by a first end wall, a second end wall, and a radially outer wall extending along a longitudinal axis between the first end wall and the second end wall, wherein the catheter wetting agent reservoir comprises: a first section including a first portion of the outer wall and the first end wall; a second section including a second portion of the outer wall and the second end wall; wherein one of the first segment and the second segment is positioned radially inward of the other segment such that the two segments overlap axially; And wherein one of the first segment and the second segment includes at least one protrusion extending axially into a corresponding recess in an outer surface of an outer wall of the other of the first segment and the second segment.

17. The catheter assembly of claim 16, wherein: The catheter lubricant storage chamber is the catheter lubricant storage chamber according to any one of claims 1 to 15.

18. The catheter assembly of claim 16 or 17, further comprising a movable insert axially movable between a first position and a second position.

19. The catheter assembly of claim 18, wherein: In the first position, the catheter lubricant reservoir is sealed, and in the second position, the catheter lubricant reservoir is open.

20. The catheter assembly according to claim 18 or 19, wherein The removable insert includes a rib, wherein in the first position the rib is aligned with a corresponding sealing surface on an inner wall of the catheter lubricant reservoir, and in the second position the rib is axially offset from the corresponding sealing surface.

21. The catheter assembly according to any one of claims 18 to 20, further comprising a wetting agent, wherein In the first position, the conduit is not in contact with the wetting agent, and in the second position, the wetting agent is in contact with the conduit.

22. A method of assembling a catheter wetting agent reservoir defined by a first end wall, a second end wall, and a radially outer wall extending along a longitudinal axis between the first end wall and the second end wall, wherein the catheter wetting agent reservoir comprises: a first section including a first portion of the outer wall and the first end wall; a second section including a second portion of the outer wall and the second end wall; wherein one of the first segment and the second segment comprises at least one protrusion and the other of the first segment and the second segment comprises a corresponding recess in the outer surface of the outer wall; the method comprising: One of the first segment and the second segment is axially inserted into the other such that the protrusion protrudes axially into the recess.

23. The method of assembling a catheter lubricant reservoir according to claim 22, wherein: The catheter lubricant storage chamber is the catheter lubricant storage chamber according to any one of claims 1 to 15.

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