Intermittent urinary catheter assembly

Abstract

An intermittent urinary catheter assembly comprising: an intermittent urinary catheter comprising a catheter tube (4) having a proximal insertion end (3) and a distal outlet end, the catheter tube comprising a plurality of discharge openings (6) at a proximal portion; a handle connected to the distal outlet end of the catheter tube (4), wherein the handle (30) comprises a first lumen (31) and a coaxial second lumen (33), the first lumen being adapted to provide a through hole for emptying liquid (urine); and a protective tube (40) adapted to be telescopically extended in a longitudinal direction between a first proximal position and a second distal position, wherein in the first proximal position the protective tube (40) at least partly covers the catheter tube, and in the second distal position the protective tube is positioned in the second lumen of the handle, thus exposing the entire length (L) of the catheter tube for insertion.

Description

[0001] This invention relates to an intermittent urinary catheter assembly. Summary of the Invention

[0002] Catheterization assemblies for emptying the bladder are increasingly used for intermittent as well as indwelling or permanent catheterization. Typically, catheters are used by patients with urinary incontinence or individuals with disabilities (such as paraplegics or quadriplegia) who may have lost control over allowing voluntary urination and for them, catheterization may be the only way to urinate.

[0003] Urinary catheters are divided into two main groups: indwelling catheters and intermittent catheters. Indwelling catheters are typically inserted into the urethra and bladder by a healthcare professional (i.e., a trained professional, usually a nurse or doctor) and have devices for retaining the catheter in the bladder for up to two weeks or longer. Indwelling catheters are soft and flexible because they must remain in the urethra for several weeks. Indwelling catheters continuously empty the bladder.

[0004] Intermittent catheters are typically inserted by the user themselves and remain in the urethra and bladder for the time it takes to empty the bladder, for example, about 5-10 minutes. Intermittent catheters are used every 4-6 hours to empty the bladder, roughly corresponding to the time intervals at which a person without urinary problems typically goes to the bathroom. Intermittent catheters are generally more rigid than indwelling catheters because they must be inserted by the user themselves and because they do not need to remain in the urethra for days or weeks. A key feature of intermittent catheters is their ease of insertion into the urethra. This is achieved by providing a low-friction surface to the intermittent catheter. Non-limiting examples of this include hydrophilic-coated catheters that are subsequently wetted with a swelling medium to create a low-friction surface, or those wetted with an oil or water-based gel applied to the catheter before insertion into the urethra.

[0005] Intermittent urinary catheters may have a hydrophilic coating that needs to be wetted before use, thereby absorbing a large amount of fluid. This hydrophilic coating provides a very smooth surface with very low friction during catheter insertion. Hydrophilic-coated catheters (where the coating absorbs a large amount of fluid to obtain a low-friction surface) (swelling degree >100%) are not suitable for use as indwelling catheters because if left in the body for an extended period, the hydrophilic surface coating will stick to the urethral mucosa as the coating changes from a highly lubricated state when fully wetted to a sticky state when the coating's hydration level decreases.

[0006] The present invention relates to intermittent conduits having such hydrophilic coatings, which are wetted before use to absorb a considerable amount of liquid and to provide a very lubricated surface. Attached Figure Description

[0007] The accompanying drawings are included to further understand the embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and, together with the description, serve to explain the principles of the embodiments. Other embodiments and many of the anticipated advantages of the embodiments will be readily appreciated as they will become better understood by referring to the following detailed description. Elements of the drawings are not necessarily to scale. The same reference numerals indicate corresponding similar parts.

[0008] Figures 1a to 1e An intermittent urinary catheter assembly according to the present invention is shown, sequentially arranged from a storage configuration to a usage configuration.

[0009] Figure 2 An embodiment of the intermittent urinary catheter assembly is shown in a side view.

[0010] Figure 3 Showing Figure 2 The image shows an enlarged schematic side view of the handle portion of an intermittent urinary catheter.

[0011] Figure 4 Displayed in 3D Figure 2 The image shows an intermittent urinary catheter in its usage configuration.

[0012] Figure 5 Showing Figure 2 , Figure 3 and Figure 4 The intermittent urinary catheter shown in the image includes a protective tube in a second distal position.

[0013] Figure 6 A side view is shown of another embodiment of an intermittent urinary catheter including a telescopic protective tube.

[0014] Figure 7 Displayed in 3D Figure 5 The catheter shown in the image,

[0015] Figure 8 Displayed in 3D Figure 4 and Figure 5 The catheter shown in the image is fully exposed during insertion, and...

[0016] Figure 9 The handle and protective tube are shown in a side view. Detailed Implementation

[0017] This invention relates to an intermittent urinary catheter assembly, comprising: an intermittent urinary catheter including a cannula having a proximal insertion end and a distal outlet end, the cannula including at least two discharge openings at the proximal portion; a handle connected to the distal outlet end of the cannula, wherein the handle includes a first lumen and a coaxial second lumen, the first lumen being adapted to provide a through-hole for emptying fluid (e.g., urine); and a protective tube adapted to extend and retract longitudinally between a first proximal position and a second distal position, wherein in the first proximal position the protective tube at least partially covers the cannula, and in the second distal position the protective tube is positioned in the second lumen of the handle, thus exposing the entire length of the cannula for insertion.

[0018] This component provides improved catheter manipulation. It features a longer handle portion proximal to the cannula, allowing the user to move their hand closer to the proximal portion of the cannula. This makes it easier for the user to manipulate the cannula insertion tip. Additionally, the reduced free length of the cannula increases its column strength. Consequently, the cannula is less prone to bending and collapsing during insertion.

[0019] Therefore, this component provides sufficient flexibility for navigation and also incorporates column strength to provide adequate rigidity for insertion purposes. Furthermore, a protective tube provides a clamp that covers the cannula to prevent accidental access to it.

[0020] In the following text, whenever the proximal end of an element of the invention is referred to, it means the end adapted for insertion. Whenever the distal end of an element is referred to, it means the end opposite to the insertion end. In other words, the proximal end is the end closest to the user when the catheter is to be inserted, and the distal end is the opposite end (the end furthest from the user when the catheter is to be inserted). The same definition applies to packaging and containers, i.e., the proximal end is the end where the catheter is stored, and the distal end is the opposite end.

[0021] The longitudinal direction is from the distal to the proximal end. The transverse direction is perpendicular to the longitudinal direction and corresponds to the direction that crosses the axis of the duct.

[0022] The catheter described in this application is used as an intermittent urinary catheter.

[0023] The catheter includes a cannula extending from a distal portion to a proximal portion and constitutes the main part of the catheter. The tip is positioned in the proximal portion of the catheter and may be provided as a rounded, closed end. The tip may also be provided as a spherical or olive-shaped ball at the proximal end, with a constricted portion distal to the ball. In this case, the cannula extends from the constricted portion to the distal portion. The catheter includes a handle at its distal end, the length of which allows the user to manipulate the catheter.

[0024] Catheters commonly used as urination devices are sizes 8FR to 18FR. FR (or French size or Charriere(Ch)) is the standard specification for catheters, roughly corresponding to the outer circumference (in mm). More precisely, the outer diameter of the catheter (in mm) corresponds to FR divided by 3. Therefore, 8FR corresponds to a catheter with an outer diameter of 2.7 mm and 18FR corresponds to a catheter with an outer diameter of 6 mm.

[0025] The catheter of the present invention can be equipped with a hydrophilic coating before use to provide a low-friction insertion.

[0026] The hydrophilic coating may be provided only on the insertable portion of the catheter. A hydrophilic surface coating is one that, when hydrated or swollen using a swelling medium, reduces friction on the surface area of ​​the catheter (corresponding to the insertable portion of the catheter) intended for insertion into the user's urinary tract.

[0027] The difference between intermittent hydrophilic catheters and indwelling catheters is that the hydrophilic surface coating of such catheters is not suitable for indwelling use because if left in the body for more than 5-20 minutes, the surface coating is prone to sticking to the urethral mucosa. This is because the hydrophilic coating changes from being highly lubricated when fully wetted (95% water by weight) to being sticky when the hydration level of the coating decreases (<75% water by weight).

[0028] The catheter assembly may include a container for storage, which may include a medium for activating a hydrophilic surface coating of the catheter. The activation medium may be a water-based substance, such as sterile water, a saline solution, or any water-based liquid. Alternatively, the activation medium may be in the form of a vapor-contributing material, such as a wetted sponge comprising a vapor-contributing liquid, or a woven or non-woven material. By introducing the vapor-contributing material into the container, vapor will hydrate the hydrophilic coating over time, ensuring that the coating is activated and that the hydrophilic coating provides a low-friction surface for the catheter.

[0029] In the example, the second cavity is positioned coaxially with the first cavity.

[0030] In the example, the cannula of the intermittent urinary catheter is non-detachably connected to the handle.

[0031] In the example, the protective tube is made of a rigid and / or flexible material (e.g., plastic or silicone materials such as ABS, TPE, TPV, PMMA, PE (LD and HD), PP (e.g., PP homopolymer or PP copolymer)) with column strength that allows the protective tube to expand and contract between a first proximal position and a second distal position in the longitudinal direction without collapsing. The protective tube can be made of a combination of rigid and flexible materials, such that the portion of the tube closest to the handle is more rigid than the portion furthest from the handle. In the example, the protective tube can be manufactured by two-component injection molding. Due to the expansion and contraction movement, the resistance to insertion provided by the protective tube is minimized.

[0032] The protective tube features a flexible, extendable handle that allows for flexibility in both the protective tube and the cannula while still providing column strength, thus allowing the protective tube to retract into the handle with minimal resistance.

[0033] In the example, the handle includes a flange stop adapted to prevent the protective tube from extending further than the first proximal position. Here, the protective tube is prevented from extending further toward the proximal insertion end than the first proximal position.

[0034] In the example, the component includes a container adapted for use to close the cannula and protective tube of an intermittent urinary catheter during storage.

[0035] In another example, the component includes a bag adapted for sealing the cannula and protective tubing of an intermittent urinary catheter during storage.

[0036] In the example, the container and handle include snap-fit ​​elements with complementary shapes. Alternatively, the handle and container may include complementary bayonet interfaces or threads adapted for engaging and disengaging.

[0037] In the example, the protective tube includes a protruding end at the proximal end.

[0038] In the example, the container includes an inwardly projecting flange that is adapted to provide a removable snap-fit ​​engagement with the end protrusion of the protective tube.

[0039] In the example, the protective tube and container include releasable snap-fit ​​connections with complementary shapes that are adapted to extend the protective tube from the interior of the handle when the container is removed from the handle.

[0040] Alternatively, the couplings and connections can be joined by snap-fit, welding, gluing, or they can be joined by interference fit (also known as press fit or friction fit).

[0041] In the example, the complementary-shaped, releasable snap-fit ​​connection is a friction-fit coupling device. In another embodiment, the complementary-shaped, releasable snap-fit ​​connection is a clamp and a protrusion.

[0042] In the example, when the protective tube is in the second distal position, the cannula includes an exposed length of 95 mm, such as 94 mm, 93 mm, 92 mm, 91 mm, 90 mm, or even 85 mm; such as 96 mm, 97 mm, 98 mm, 100 mm, or longer.

[0043] In the example, the protective tube includes one or more protective tube sections that are capable of telescoping relative to each other along the longitudinal direction of the catheter assembly. Due to this telescoping motion, the resistance to insertion provided by the protective tube is minimized.

[0044] Another aspect relates to a method of using an intermittent catheter assembly, wherein the method includes the following steps: providing a catheter assembly comprising: an intermittent catheter having a cannula with a proximal insertion end and a distal outlet end; a handle connected to the cannula at the distal outlet end; and a protective tube; providing the protective tube at a first proximal position such that the protective tube covers a portion of the cannula to be inserted; inserting the cannula into the urethra while holding the handle and optionally the protective tube; and releasing the protective tube during insertion to allow the protective tube to retract into the handle.

[0045] In the example, the method is initiated by the following steps: removing the container while simultaneously pulling the protective tube to a first proximal position to at least partially cover the cannula.

[0046] Typically, the protective tube can be placed in the first position during manufacturing, or the protective tube can be manually placed in the first position by the user by removing the container or after the container has been removed.

[0047] Detailed description of the attached figures

[0048] First, it should be noted that these figures are intended only to illustrate the principle and function of the catheter assembly according to the invention, and are not to be considered as limiting the scope of the appended claims. Furthermore, these figures, and the elements specifically illustrated individually, are not necessarily drawn to scale (whether individually or relative to each other).

[0049] Unless otherwise specifically stated, the features of the embodiments described in this application and the various exemplary embodiments may be combined with each other (“mixed and matched”).

[0050] Figure 1 shows the intermittent urinary catheter assembly 100. The catheter assembly is shown in five different side views a through e, sequentially from the storage configuration to the usage configuration.

[0051] Component 100 includes packaging 1, which includes a container 20 and a handle 30.

[0052] Side view Figure 1a and 1b The components are shown in a storage configuration, with container 20 attached to handle 30. Package 1 includes a longitudinal ridge 28 that provides a better grip for the user and / or provides visible guidance on how to reattach the container to the handle. The two side views are rotated 90 degrees relative to each other.

[0053] Side view Figure 1c and 1d The image shows a catheter 2. The catheter 2 has a cannula 4 with a proximal insertion end 3. The proximal portion of the cannula 4 provides multiple drainage openings 6 serving as a liquid (urine) inlet. The assembly also includes a flexible protective tube 40 adapted to partially cover the cannula 4 prior to catheter use. The protective tube comprises a tube shape coaxially surrounding the cannula 4.

[0054] When the catheter is inserted into the urethra, the flexible protective tube 40 retracts into the handle to expose the full insertable length of the catheter 4 to be inserted. (Side view) Figure 1e The catheter 2 is shown, having the full insertion length L exposed by the cannula 4. The flexible protective tube 40 is retracted into the handle 30, and only the proximal end protrusion 43 of the protective tube 40 is visible.

[0055] Figure 1 shows the protective tube 40 extending and retracting between a first proximal position and a second distal position. (Side view) Figure 1c and 1d The protective tube is shown in the first proximal position, and Figure 1 shows a side view. Figure 1e The protective tube is shown in the second distal position.

[0056] In the first proximal position, the protective tube 40 partially covers the cannula 4, and in the second distal position, the protective tube 40 retracts into the cavity of the handle 30. In other words, in the first proximal position, the protective tube 40 partially covers the cannula 4, and the user can use the protective tube 40 as an extended handle. In the second distal position, the cannula 4 is fully exposed, and the protective tube 40 is positioned in the second cavity of the handle 30.

[0057] The protective tube 40 provides a flexible, extendable handle, which may be made of a material such as silicone that is flexible to allow for flexibility of the protective tube and cannula 4, while still providing column strength to allow the protective tube 40 to fold into the handle with minimal resistance.

[0058] When the protective tube is in the second distal position, the length (L) of the cannula 4 that is fully exposed can be 95 mm, for example, approximately 60 mm, 70 mm, 75 mm, 80 mm, 90 mm, 100 mm or 110 mm; for example, 50 mm to 120 mm, 60 mm to 110 mm, 70 mm to 100 mm.

[0059] In the storage configuration, the protective tube is positioned in the second distal position and is removed from the handle to the first proximal position before use. After use, the protective tube is repositioned in the second distal position, and the narrow container 20 can be reattached to the handle 30 before handling.

[0060] Figure 2 Another embodiment of the intermittent catheter assembly 100 is shown in a side view. A protective tube 40 coaxially surrounds the cannula 4 at a first proximal position. The distal outlet end 8 of the cannula is secured to the handle 30 at a first lumen 31. The container 20 is latched to the handle 30 at its distal end by an outwardly extending flange 29 of the container and a groove 39 in the handle. The handle includes a second lumen 33 adapted to receive the protective tube 40. The second lumen 33 is arranged coaxially with the first lumen 31.

[0061] The handle also includes a proximal handle portion 36 and a gap 23 on the outer surface of the proximal handle portion 36 to allow the container 20 to move inward to release the outwardly extending flange 29 from the groove 39 of the handle. Therefore, the container 20 can be removed from the assembly.

[0062] Figure 2 and Figure 3 An intermittent urinary catheter assembly with a container 20 connected to a handle 30 is shown in its storage configuration. Figure 2 In the middle, the protective tube 40 is arranged in the first proximal position, while... Figure 3 In this configuration, the protective tube is disposed within the second cavity 33, with only the proximal end protrusion 43 extending outside the handle, allowing the snap-fit ​​element 22 of the protective tube 40 to engage with the end protrusion 43. The container snaps into place on the handle. The protective tube 40 and the container 20 include releasable snap-fit ​​connections 41 and 22 of complementary shapes. When the container is removed from the handle to expose the cannula, the protective tube 40 extends from a second distal position inside the handle to a first proximal position before the container disengages from the end of the protective tube 40.

[0063] Figure 3 The handle is schematically shown, which is provided with a flange stop 35 for the outwardly extending flange 41 of the protective tube 40. The flange stop 35 is adapted to prevent movement of the protective tube toward the proximal insertion end 3.

[0064] Figure 4An intermittent urinary catheter 2 in a usage configuration is shown, with the protective tube 40 in a first proximal position. The proximal portion of the catheter 4 has multiple exposed drainage openings.

[0065] The handle 30 includes a proximal extending handle portion 36 having a notch 37 exposing a proximal end portion 43. The diameter of the proximal handle portion in the radial direction is smaller than the diameter of the handle to provide internal guidance to the container when the packaging is reclosed. The protective tube 40 includes a narrow end portion 46 to provide better stability during insertion. The smaller gap between the cannula and the protective tube provides less bending of the cannula, and thus better stability during insertion.

[0066] Figure 5 An intermittent urinary catheter 2 in a usage configuration is shown, with the protective tube in a second distal position and the insertable length of the catheter fully exposed.

[0067] Figure 6 A side view of another embodiment of an intermittent urinary catheter including telescopic protective tubes 40 and 50 is shown. Each protective tube includes a tube shape and is positioned to coaxially surround the insertion tube 4.

[0068] The cannula 4 extends longitudinally from the proximal insertion end 3 to the distal end, which forms a connection 32 with the handle 30, so that liquid (urine) can be discharged through the cannula 4 and the first cavity 31 via multiple discharge openings 6 to the distal outlet 34 at the distal end of the handle.

[0069] The handle 30 is provided with a second cavity 33 and an inwardly extending flange 35, which serves as a stop for the protective tube near the proximal end of the handle. The protective tube 40 includes a protective tube portion 50. The protective tube may be made of a rigid plastic material. The protective tube 40 and the protective tube portion 50 are adapted to slide telescopably and retractably into each other and into the second cavity 33 of the handle 30 in the longitudinal direction, also referencing... Figure 9 .

[0070] The protective tube 40 includes a narrow end portion 46 in its proximal, truncated cone shape, with an end opening 44 slightly larger than the diameter of the insertion tube 4. The protective tube has an outwardly extending flange 41 at its distal end, which serves as a stop for the inwardly projecting flange 51 of the protective tube portion 50. The protective tube portion 50 includes a radially outwardly extending flange, which serves as a stop for the inwardly extending flange 35 toward the handle.

[0071] Figure 7 Shown in 3D Figure 6 The catheter shown in the image.

[0072] Figure 8 The image is presented in 3D. Figure 6 and Figure 7The catheter shown in the image has its protective tube retracted into the handle, and the insertion cannula is fully exposed for insertion.

[0073] Figure 9 A side view of the catheter assembly is shown.

[0074] The handle 30 includes a first cavity and second cavities 31 and 33, with the second cavity 33 arranged coaxially with the first cavity 31. The protective tube 40 retracts into the second cavity 33 to a second position to fully expose the insertion cannula 4. The protective tube 40 includes two protective tube portions 50 and 60. The protective tube and protective tube portions may be made of a rigid plastic material. The protective tube 40 and the two protective tube portions 50 and 60 slide longitudinally into each other and into the second cavity 33 of the handle 30.

[0075] Typically, the second cavity may include a cylindrical cavity that surrounds the cylindrical first cavity coaxially.

Claims

1. An intermittent urinary catheter assembly (100) comprising: - an intermittent urinary catheter (2) comprising a catheter tube (4) having a proximal insertion end (3) and a distal outlet end (8), the catheter tube (4) comprising at least two discharge openings (6) located at a proximal portion; - a handle (30) connected to the distal outlet end of the catheter tube, the handle comprising a first lumen (31) and a second lumen (33), the first lumen (31) being adapted to provide a through-going hole for draining liquid; characterized in that the intermittent urinary catheter assembly further comprises - a protective tube (40) adapted to be telescopically moved in a longitudinal direction between a first proximal position, in which the protective tube (40) at least partly covers the catheter tube (4), and a second distal position, in which the protective tube (40) is positioned in the second lumen (33) of the handle, thereby fully exposing all length of the catheter tube (4) for insertion.

2. The intermittent catheter assembly (100) according to claim 1, wherein, The second lumen (33) is positioned coaxially with the first lumen (31).

3. The intermittent catheter assembly (100) according to any of the preceding claims, wherein, The catheter tube (4) of the intermittent urinary catheter is non-detachably connected to the handle (30).

4. The intermittent catheter assembly (100) according to claim 1 or 2, wherein, The protective tube (40) is made of a rigid and / or flexible material having a column strength allowing telescopic movement of the protective tube (40) in the longitudinal direction between the first proximal position and the second distal position without collapsing.

5. The intermittent catheter assembly (100) according to claim 1 or 2, wherein, The handle (30) comprises a flange stop (35) adapted to prevent telescopic movement of the protective tube (40) further than the first proximal position towards the proximal insertion end.

6. The intermittent catheter assembly (100) according to claim 1 or 2, wherein, The intermittent urinary catheter assembly comprises a container (20) adapted to enclose the catheter tube (4) of the intermittent urinary catheter and the protective tube (40) during storage.

7. The intermittent catheter assembly (100) according to claim 6, wherein, The container (20) and the handle (30) comprise complementary snap-fit elements.

8. The intermittent catheter assembly (100) according to claim 1 or 2, wherein, The protective tube (40) comprises a tip protrusion at the proximal insertion end.

9. The intermittent catheter assembly (100) according to claim 6, wherein, The container (20) comprises an inwardly protruding flange adapted to provide a detachable snap-fit with the tip protrusion (43) of the protective tube.

10. The intermittent catheter assembly (100) according to claim 6, wherein, The protective tube (40) and the container (20) comprise a complementary releasable snap-fit connection adapted to extend the protective tube out of the inner lumen of the handle when the container is removed from the handle.

11. The intermittent catheter assembly (100) according to the previous claim 10, wherein, The complementary releasable snap-fit connection is a friction fit coupling.

12. The intermittent catheter assembly (100) according to the previous claim 10 or 11, wherein, The complementary releasable snap-fit connection is a clip and protrusion.

13. The intermittent catheter assembly (100) according to claim 1 or 2, wherein, The length of the fully exposed catheter tube (4) is 60 mm, 70 mm, 75 mm, 80 mm, 90 mm, 95 mm, 100 mm or 110 mm when the protective tube (40) is in the second distal position.

14. The intermittent catheter assembly (100) according to claim 1 or 2, wherein, The protective tube (40) comprises one or more protective tube sections (50, 60) which are telescopically movable relative to each other in the longitudinal direction of the intermittent urinary catheter assembly.

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