Laser fusion of catheter assembly components

Abstract

A method of manufacturing a catheter assembly, the method comprising: providing a catheter (1) and a drainage element (5, 6); arranging the drainage element (5, 6) such that fluid can flow along the catheter (1) to the drainage element (5, 6); and directing a laser beam onto the drainage element (5, 6) to form a laser weld. The laser weld can be formed between the catheter (1) and the drainage element (5, 6), or between first and second drainage elements (5, 6). The drainage element (5) can comprise a plurality of protrusions (21) extending from a tube. The protrusions and the tube can together define an outer profile of the drainage element. The drainage element (5) can comprise a weld zone (A) that is larger than a spacing between adjacent protrusions, and has a similar inner profile and outer profile, to enable laser welding of the drainage element (5) to the catheter (1).

Description

Technical Field

[0001] This invention relates to a method for manufacturing catheter assemblies using laser welding. The invention also relates to components of the catheter assembly, such as drainage elements for the catheter, like funnel-shaped elements, optimized for laser welding. In particular, this invention relates to intermittent urinary catheter assemblies. Background Technology

[0002] Many people suffer from urinary tract diseases, which can lead to difficulty urinating. Intermittent catheter kits can provide a convenient and portable solution to this problem, as users can insert the catheter themselves as needed. This reduces the impact of their urinary conditions on their lives and allows them to enjoy a relatively normal lifestyle.

[0003] Known catheter assemblies include a funnel-shaped component that guides fluid out of the catheter during use. For example, the funnel-shaped component can be used to direct fluid from the catheter into a toilet bowl or other suitable container. This makes the catheter assembly easier and more hygienic to use, as the user is less likely to spill urine or allow urine to come into contact with their hands or clothing. When a catheter assembly is used in this way without collecting urine, it is referred to as an "open" catheter assembly.

[0004] Alternatively, the catheter assembly may be a “closed” catheter assembly and include a fluid collection bag or other suitable container fluidly connected to the catheter to collect urine flowing along the catheter. In closed catheter assemblies, a connector is typically provided to connect the urine bag to the catheter; for example, the connector may be directly attached to the catheter, or it may be a separate device fluidly connected to the catheter by attachment to a funnel-shaped element.

[0005] To ensure that catheter assemblies are easy, hygienic, and comfortable to use, it is important that the different components are securely attached to each other without any significant risk of fluid leakage between components. Existing methods of manufacturing catheter assemblies use adhesives to bond the different components together, or use solvents to bond catheter components that are typically made of plastic.

[0006] While the combination of adhesives and solvents can provide strong and hermetically sealed attachments to components, alternative methods for attaching conduit components together are needed. For example, using adhesives or solvents requires liquid / gel handling / loading / transportation during manufacturing, which can be problematic and difficult to automate. Furthermore, adhesives or solvents themselves are additional consumables that need to be purchased and stored, increasing the complexity of the manufacturing process and raising environmental costs due to the hazardous nature of the consumables and / or the additional energy used in the process.

[0007] The purpose of this invention is to at least partially overcome or mitigate the above-mentioned problems and / or provide an improved method for manufacturing catheter assemblies and an improved catheter assembly. Summary of the Invention

[0008] In summary, the present invention relates to a method for manufacturing a catheter assembly, the method comprising: providing at least two catheter assembly components; and directing a laser beam onto two of the at least two catheter assembly components to form a laser fusion joint therebetween.

[0009] The catheter assembly component may be a catheter. The method may include providing the catheter. The catheter may include a proximal end for insertion into the body. The catheter may include a distal end.

[0010] A catheter assembly component may be a drainage element. A drainage element may include any one or more features of the catheter assembly component as described above and herein. The method may include providing one or more drainage elements. The method may include providing a first drainage element and a second drainage element. The first drainage element may be arranged to receive fluid flowing along the catheter.

[0011] The method may include arranging a first drainage element and a second drainage element such that fluid can flow along a conduit to the first drainage element and then to the second drainage element.

[0012] The method may include guiding a laser beam onto a first drainage element and a second drainage element to form a laser fusion joint between the first drainage element and the second drainage element.

[0013] Therefore, in some aspects, the present invention provides a method of manufacturing a catheter assembly, comprising the steps of: providing a catheter including a distal end and a proximal end for insertion into a body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser fusion portion between the first drainage element and the second drainage element.

[0014] Therefore, laser welding is advantageous for firmly attaching two or more conduit components (e.g., drainage elements) together without the need for any additional materials, such as adhesives or solvents.

[0015] The first drainage element can be provided at the distal end of the catheter. The second drainage element can be a funnel-shaped piece. The first drainage element can be a funnel-shaped piece that can be attached to the distal end of the catheter. The second drainage element can be a connector. Therefore, this method facilitates the flexible attachment of different catheter assembly components to provide open and closed assemblies.

[0016] In a first aspect of the invention, a method of manufacturing a catheter assembly is provided, comprising the steps of: providing a catheter including a distal end and a proximal end for insertion into a body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser fusion portion between the first drainage element and the second drainage element, wherein: the first drainage element is provided by the distal end of the catheter, and the second drainage element is a funnel-shaped member; or the first drainage element is a funnel-shaped member connectable to the distal end of the catheter, and the second drainage element is a connector.

[0017] Advantageously, laser welding offers a convenient and novel method for attaching different drainage elements of a catheter assembly together. This technology enables the formation of a robust weld between different components of the catheter assembly without requiring additional raw materials, and offers high precision and repeatability. Furthermore, it eliminates the need for careful placement of liquid between components during manufacturing, as the components can simply be placed adjacent to each other and then laser-welded. Laser welding is also suitable for creating leak-proof seals between components, which is particularly important in the field of catheter assemblies.

[0018] The catheter may be a urinary catheter. The catheter may be a male urinary catheter (i.e., a catheter used for male catheterization). The catheter may be a female urinary catheter (i.e., a catheter used for female catheterization). The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent urinary catheter. The catheter may be tubular. The distal end of the catheter may be tubular.

[0019] One of the first and second drainage elements can be an external element. The other of the first and second drainage elements can be an internal element. For example, the first drainage element can be an external element and the second drainage element can be an internal element, or vice versa. Preferably, in the case where the drainage element is a funnel-shaped piece, it is an external element. Thus, the funnel-shaped piece can be designed to surround other drainage elements and ensure a strong and effective laser weld between them, as described below with respect to the third aspect of the invention.

[0020] This method may include guiding a laser beam to an internal element via an external element. Thus, the laser beam can be incident on the external element and then on the internal element. The method may also include guiding the laser beam through the entire thickness of the external element and then to the internal element. This allows the method to be performed non-invasively while the laser beam penetrates the guiding element to create a laser weld.

[0021] The first and / or second drainage element may include a non-reflective coating. The outer element may include a non-reflective coating on its outer surface. The laser may be directed to the outer surface of the outer element. The interface between the first and second drainage elements may be non-reflective. The refractive indices of the first and second drainage elements may be similar, or preferably substantially the same. Therefore, the welding process is more efficient due to minimized reflection.

[0022] This method may include absorbing a portion of a laser beam into an external element, preferably to melt the external element during the formation of the laser weld. The method may include heating the external element by having it absorb the laser beam. Therefore, the laser is absorbed by the external element to the extent that it melts, which is beneficial for forming a strong weld. The method may include melting a significant portion of the thickness of the external element during the formation of the laser weld. The method may also include melting the entire thickness of the external element during the formation of the laser weld. Therefore, a larger portion of the external element can contribute to the weld, thereby further increasing the weld strength.

[0023] This method may include having an external element absorb no more than 50%, 40%, or 30% of the laser beam. Alternatively, the method may include having an external element absorb at least 10%, 20%, or 30% of the laser beam. Or, the method may include having an external element absorb 10-40% or 20-30% of the laser beam. Therefore, most of the beam can be absorbed by the internal element.

[0024] This method may include absorbing a portion of the laser beam into the internal element. This method may include heating the internal element by absorbing the laser beam. This method may include transferring sufficient energy to the internal element through laser absorption to heat it, but preferably without melting the internal element. This method may include softening the internal element. Therefore, the laser beam is absorbed by the internal element to heat and soften it, but not necessarily melt it. This ensures that the structural stability of the internal element is maintained, allowing it to retain the typical tubular structure of the associated drainage element without collapsing or becoming blocked. When both elements are heated, this method may include increasing the welding pressure through the thermal expansion of the elements.

[0025] This method may include heating an external element to a higher temperature than the internal element using a laser beam. The method may include melting the internal element through heat conduction from the external element. The method may include melting the surfaces of the internal element that contact the external element (e.g., the outer surface), preferably by heat conduction from the external element. Surfaces of the internal element away from the external element (e.g., the inner surface) preferably do not melt during laser weld formation. Therefore, the external element can advantageously heat the internal element, and a more localized weld can be formed without compromising the structural properties of the draining element. Advantageously, the melting of the internal element can be driven by a combination of heat conduction from the external element and laser absorption. This is preferably superior to laser absorption alone, because if the entire thickness of the draining element were melted, this could damage the structure of the draining element. It is also preferably superior to heat conduction alone, as it reduces the temperature difference in the material during welding.

[0026] External components may include inner and outer surfaces. Internal components may include inner and outer surfaces. The method may include arranging the inner surface of the external component in contact with the outer surface of the internal component. The inner surface of the external component may mate with the outer surface of the internal component in the region where the laser weld joint is formed. Before welding, the gap between the internal and external components in the region where the laser weld joint is formed may be no greater than 0.4 mm, no greater than 0.3 mm, no greater than 0.2 mm, or no greater than 0.1 mm. Before welding, the internal and external components may be in close contact in the region where the laser weld joint is formed. Before welding, the internal and external components may be held together by an interference fit. Close contact and / or interference fit ensure that the laser weld joint can be effectively formed.

[0027] The thickness of the components can be defined between the inner and outer surfaces. The thickness of the outer components can not exceed 5 mm, 4 mm, or 3 mm. The thickness of the outer components can be at least 0.5 mm or at least 1 mm. Preferably, the thickness of the outer components is 0.8 mm to 0.9 mm. The thickness of the inner components can not exceed 2 mm, 1 mm, or 0.5 mm. The thickness of the inner components can be at least 0.1 mm, at least 0.2 mm, or at least 0.5 mm. The thickness of the inner components is preferably 0.5 mm to 1 mm. The thickness of the draining elements can be substantially constant across the laser weld. Therefore, due to the suitable and preferably constant wall thickness, the weld is formed more effectively.

[0028] The method may include melting a first draining element and / or a second draining element (at least partially) during laser fusion splice formation. Preferably, both the first and second draining elements are partially melted during laser fusion splice formation. The method may include melting a molten region of the first and / or second draining elements. The molten region may surround a portion of the first and second draining elements. The method may include positioning the inner surface of an outer element in contact with the outer surface of an inner element. The method may include partially melting the inner surface of the outer element. The molten region may include the outer surface of the inner element. The method may include partially melting the outer surface of the inner element. The molten region may extend through at least 50%, or at least 80%, or at least 90% of the thickness of the outer element. The molten region may include the outer surface of the outer element. The molten region may span substantially the entire thickness of the outer element. The molten region may not include surfaces of the inner element remote from the outer element (e.g., the inner surface). The molten region may extend through no more than 50%, or no more than 40%, or no more than 30% of the thickness of the inner element. The molten zone may extend through at least 5%, at least 10%, or at least 20% of the thickness of the internal component. The method may include allowing the first and / or second guiding elements to solidify to form a laser-fused portion. Thus, a strong and permanent bond is formed between the first and / or second guiding elements through the laser-fused process without compromising the structure of the internal component.

[0029] This method may include placing an external fastener / clamp against the outer surface of an external component. The method may include using the external fastener to control the shape of the outer surface. The external fastener may be substantially transparent to the laser beam. The external fastener may be formed of glass, quartz, or a fluoropolymer. Therefore, the aesthetic appearance of the outer surface can be controlled and improved if desired.

[0030] The laser-welded portion can be configured to provide a leak-proof seal, for example, between the first and second drainage elements. The laser-welded portion can also be configured to prevent the first and second drainage elements from separating from each other. The first and second drainage elements can be secured together without the application of adhesive, for example, by securing them together in the overlapping area between the first and second drainage elements. Therefore, the laser-welded portion ensures that neither gas nor liquid will inadvertently leak from the conduit assembly, preventing unpleasant odors and liquid leaks. Furthermore, the laser-welded portion provides structural integrity to the conduit assembly by preventing the first and second drainage elements from separating from each other without the need for adhesives.

[0031] The drainage element may be tubular. The drainage element may include an axis along its tubular shape. The drainage elements may be configured to be coaxially assembled with each other. The method may include coaxially arranging the drainage elements. The method may include pressing the inner and outer elements together, preferably during laser fusion formation. Without deformation of the inner and / or outer elements, the outer surface of the inner element may not be able to fit within the inner surface of the outer element. The method may include deforming the inner and / or outer elements to assemble the inner element within the outer element. When the inner and outer elements are arranged together, the diameter or width of the inner element (or outer element) may be reduced (or increased) by at least 1%, at least 2%, or at least 3%. When the inner and outer elements are arranged together, the diameter or width of the inner element (or outer element) may be reduced (or increased) by no more than 10%, no more than 8%, or no more than 6%. Preferably, when the inner and outer elements are arranged together, the diameter or width of the inner element (or outer element) may be reduced (or increased) by 3% to 8%. These changes may be due to compression of the inner element and / or stretching of the outer element. The inner surface of the outer element can be tapered / gradient. The inner element can be formed of an elastic material. The inner / outer elements can rest against the outer / inner elements. Therefore, these elements deform and press against each other, which enables a tight fit and achieves ideal conditions for forming a laser-welded section.

[0032] The method may include forming a weld that extends around the periphery of the drainage element when viewed along its axis. Preferably, the laser weld may extend around the entire periphery of the drainage element when viewed downwards along its axis. Therefore, a leak-proof seal can be formed using the laser weld. The laser weld can provide a leak-proof seal between drainage elements.

[0033] The laser-welded portion can be of any suitable shape or size, but is preferably a continuous ring. The area of ​​the welded region / welded portion at the interface between the first and second drainage elements can be defined by the total area of ​​the interface between the drainage elements, including the laser-welded portion. The welded region can extend along the axis of the drainage element by no more than 10 mm, no more than 8 mm, or no more than 6 mm. The welded region can extend along the axis of the drainage element by at least 2 mm, at least 3 mm, or at least 4 mm. The welded region can extend along the axis of the drainage element by at least the thickness of the drainage element. The welded region can extend along the axis of the drainage element by at least twice the thickness of the drainage element. The thickness can be measured as an average value of the entire welded region. The welded region can include multiple independent laser-welded portions. The welded region can define a welded area. Therefore, the laser-welded portion more firmly holds the drainage elements together.

[0034] The method may include forming laser-fused portions spaced apart from the edges of the first and second drainage elements. The laser-fused portions may be spaced at least 1 mm, at least 2 mm, or at least 5 mm apart. Therefore, the edges of the drainage elements do not melt, which helps maintain their structure and shape.

[0035] The method may include forming two or more laser-welded portions between a first drainage element and a second drainage element. Each of the two or more laser-welded portions may have any or any of the optional features of the aforementioned welded portions, and may be formed according to the method described herein and any or any of the optional features of the method. Each of the two or more laser-welded portions may be different or may be formed differently. Each of the two or more laser-welded portions may be independent. Therefore, the drainage elements can be held together more firmly through multiple welded portions.

[0036] The method may include forming a laser-welded portion configured to resist / prevent separation of the drainage elements. The laser-welded portion resists / prevents movement of the drainage elements relative to each other. The laser-welded portion may include a weld strength defining the forces it can resist. The weld strength may be at least 10 N, at least 15 N, at least 20 N, at least 40 N, or at least 60 N. The weld strength may not exceed 200 N, not exceed 100 N, or not exceed 80 N. Preferably, the weld strength is 60 N or greater. Optionally, the weld strength is 60 N to 200 N, or 60 N to 150 N, or 60 N to 100 N, or 60 N to 80 N. The laser-welded portion resists axial separation of the drainage elements, and optionally axial movement. Axial movement / separation may be movement / separation along the axial direction of the drainage elements. Therefore, the weld strength may be tensile strength. Therefore, the tensile strength of the welded joint is high enough to ensure the structural integrity of the conduit assembly during use, but not so high that it negatively affects the overall function and manufacturing complexity.

[0037] The guiding elements (e.g., a first guiding element and a second guiding element) can be arranged to absorb the laser beam volumetrically. Volumetric absorption of the laser beam can account for the majority, or preferably substantially all, of the heat generated during the welding process. Surface or interfacial absorption can account for a small portion, or preferably substantially none, of the heat generated during the welding process. Therefore, the laser beam is absorbed volumetrically, which helps to provide uniform heating of the guiding elements without requiring specific additives to drive the absorption process.

[0038] Each drainage element may comprise a thermoplastic material. The thermoplastic material can absorb the laser beam in volume, preferably causing heating and, optionally, melting of the material. External elements may comprise a material with a higher absorption coefficient than internal elements. Therefore, external elements may be preferentially heated compared to internal elements.

[0039] In this method, the laser weld joint can be formed primarily due to volumetric absorption of the laser beam. The laser beam, as well as the first and second diversion elements, can be configured such that during the formation of the laser weld joint, the volumetric absorption in the first and / or second diversion elements generates more heat than the interfacial absorption at the interface between the first and second diversion elements. Many suitable configurations are described here, such as the use of thermoplastic materials and the selection of specific laser wavelengths. This makes the welding more efficient because more diversion element material participates in the welding process.

[0040] Thermoplastic materials may include materials suitable for laser welding. Thermoplastic materials may include polyethylene (high-density polyethylene (HDPE) and low-density polyethylene (LDPE)), ethylene-vinyl acetate copolymer (EVA), ethylene methyl acrylate (EMA), thermoplastic elastomers (TPE), etc. The first and second drainage elements may be formed of the same material, or alternatively, they may be formed of different materials. When the first and second drainage elements are formed of different materials, they are preferably formed of materials that allow for the formation of a laser weld portion therebetween upon melting. The conduit may be formed of TPE. The funnel-shaped element may be formed of LDPE or EVA. The connector may be formed of LDPE or EVA. The conduit may be formed of a material different from that of the funnel-shaped element and / or the connector. The funnel-shaped element and the connector may be formed of the same material. Preferably, both drainage elements are formed of a material containing polyethylene. Therefore, the drainage elements can be formed of a wide variety of materials.

[0041] The melting zone may be free of additives configured to absorb visible light. Such additives may be absent between and / or within any of the flow-guiding elements. Therefore, the laser is selected so that the visible color of the flow-guiding elements does not need to be altered by adding additives such as carbon black, which would render the product unacceptable from a quality / user appeal perspective.

[0042] The laser used to form the laser weld can have a wavelength other than visible light. The method may include using invisible light to form the weld. The laser can be a microwave laser. The laser can have a wavelength exceeding 1000 nanometers. The laser wavelength can exceed 1.1 micrometers, preferably exceeding 1.2 micrometers. The laser can have a wavelength exceeding 1.4 micrometers. The laser can have a wavelength exceeding 1.6 micrometers. The laser can have a wavelength exceeding 1.8 micrometers. The laser can have a wavelength exceeding 1.9 micrometers. The laser can have a wavelength not exceeding 3 micrometers. The laser can have a wavelength not exceeding 2.5 micrometers. The laser can have a wavelength not exceeding 2.3 micrometers. The laser can have a wavelength not exceeding 2.2 micrometers. The laser can have a wavelength not exceeding 2.1 micrometers. The laser can have a wavelength between 1.2 and 2.2 micrometers. The laser can have a wavelength between 1.6 and 2.2 micrometers. The laser can have a wavelength of about 2 micrometers, preferably about 2.0 micrometers, and most preferably 1,940 nanometers. Therefore, the laser wavelength can be selected such that it is easily absorbed by the thermoplastic material in volume to ensure effective heating through the substrate thickness. Wavelengths above 1.1 micrometers are preferred because this is outside the selective heating window of about 0.8 to 1.1 micrometers. Within this selective heating window, thermoplastic materials exhibit very low volume absorption and require additives to absorb sufficient energy to melt. Laser wavelengths in the range of 1.2 to 2.2 micrometers are preferred because thermoplastic materials have moderate volume absorption characteristics at these wavelengths. Laser wavelengths in the range of 1.6 to 2.2 micrometers are more preferred because they provide further improved absorption in thermoplastics compared to wavelengths below 1.6 micrometers. Around 2 micrometers, especially 1940 nanometers, are most preferred due to the widespread commercial availability of inexpensive laser sources at these wavelengths.

[0043] Of course, different wavelengths can be selected in several alternative embodiments. In this case, one or both draining elements may include additives to facilitate laser welding. Preferably, the internal element may include additives configured to absorb laser light and generate heat. The additives may include carbon black. In such embodiments, the internal element may be heated more than the external element. The internal element may melt by absorbing the laser beam through the additives. The external element may melt through heat conduction from the internal element.

[0044] The laser can be a continuous wave laser. The laser power density incident on the external component during fusion can be at least 20 W / mm². -2 At least 40 Wmm -2 At least 60 Wmm -2 Or at least 80 Wmm -2 The laser power density incident on the external component during welding can not exceed 80 W / mm². -2 Not exceeding 60 Wmm-2 No more than 40 Wmm -2 or not exceeding 20 Wmm -2 Preferably, the laser power density is 60-65 W / mm². -2 The beam width can be at least 2 millimeters. Therefore, laser fusion can be effectively formed without burning the material.

[0045] The method may include forming a first drainage element and / or a second drainage element. The method may include injection molding the first drainage element and / or the second drainage element. The funnel-shaped component can be formed by injection molding. The connector can be formed by injection molding.

[0046] The method may include forming a laser weld between a catheter and a funnel-shaped member. The method may also include forming a laser weld between the funnel-shaped member and a connector. The method may include: forming a first laser weld between the catheter and the funnel-shaped member; and forming a second laser weld between the funnel-shaped member and the connector. Therefore, if desired, laser welding can be used to attach multiple catheter assembly components together.

[0047] The method may include providing a cannula. The method may include positioning a catheter within the cannula. The method may include attaching a funnel-shaped element and / or connector to one end of the cannula. The cannula may be configured to surround at least a portion of the catheter from proximal to distal. The cannula may be configured to surround a large portion of the catheter from proximal to distal. The cannula may be configured to surround substantially the entire catheter from proximal to distal. The cannula may be made of a flexible plastic material. Therefore, the catheter is protected and easier to manipulate.

[0048] The conduit assembly may include a fluid collection bag. The method may include providing the fluid collection bag. The method may include arranging the fluid collection bag in fluid connection with the conduit. The fluid collection bag may include an inlet allowing fluid to enter the bag. The fluid collection bag may be directly connected to a funnel-shaped member. The funnel-shaped member may be provided with an inlet. Therefore, the assembly may be arranged to allow fluid to flow out of the conduit, through the funnel-shaped member, and directly into the fluid collection bag. Thus, the funnel-shaped member may function as a connector if needed.

[0049] The liquid collection bag can be directly connected to the connector. The connector may be provided with an inlet. Therefore, the assembly can be arranged to allow fluid to flow out of the conduit, through the funnel-shaped piece, through the connector, and then into the fluid collection bag.

[0050] The fluid collection bag can be any suitable shape or size, such as rectangular, circular, elliptical, cubic, spherical, etc. The liquid collection bag may include a front panel and a back panel. The liquid collection bag may include a peripheral joint connecting the peripheries of the front and back panels to form the liquid collection bag. The peripheral joint may define a base, two lateral edges, and a top edge of the liquid collection bag. The two lateral edges may include a right-side edge and a left-side edge. When the bag is viewed with the back panel behind the front panel, the base at the bottom of the bag, and the top edge at the top of the bag, the right-side edge and left-side edge can be defined as the right side and left side of the bag. The width of the bag between the left-side edge and the right-side edge may be at least 10 cm, at least 12 cm, at least 15 cm, or at least 20 cm. The width of the bag may not exceed 25 cm, 20 cm, or 15 cm. Preferably, the width is 10 cm to 20 cm, most preferably 12 cm to 15 cm. The base may define the bottom of the bag. The top edge may define the top of the bag. The height of the bag from its base to its top edge can be at least 25 cm, at least 30 cm, at least 35 cm, or at least 40 cm. The bag height can not exceed 45 cm, 40 cm, 35 cm, or 30 cm. The height can be between 25 cm and 40 cm, 30 cm and 35 cm, or most preferably 33 cm and 35 cm. The bag can be configured to hold at least 500 ml, at least 700 ml, or at least 1000 ml of fluid, and can hold no more than 1000 ml of fluid; for example, it can hold at least 700 ml of fluid.

[0051] The fluid collection bag and / or cannula may comprise a flexible plastic material, such as polypropylene (PP), polyethylene terephthalate (PET), low-density polyethylene (LDPE), metallized polyester (MET PET), oriented polypropylene (OPP), or polyvinyl chloride (PVC). Therefore, in some embodiments, the method may include attaching the fluid collection bag and / or cannula to another conduit assembly component via laser welding.

[0052] The peripheral joint can provide a waterproof seal. Preferably, the peripheral joint provides a sterile seal. The peripheral joint can include any one or more of the following: a welded joint; a mechanical seal; a heat-sealed joint; a pressure seal; an adhesive; a solvent-bonded joint; a UV-sealed joint; an ultrasonic welded joint; a laser welded joint; a pulsed welded joint; or a friction welded joint. This ensures that the catheter remains in a sterile environment before use and also ensures that any fluid contained in the bag will not leak unintentionally once the catheter is used.

[0053] According to a broad aspect of the invention, a catheter assembly is provided by means of a method comprising the steps of: providing at least two catheter assembly components; and guiding a laser beam onto two of the at least two catheter assembly components to form a laser fusion joint therebetween.

[0054] According to a second aspect of the present invention, a catheter assembly manufactured according to the method of the first aspect of the present invention is provided.

[0055] Therefore, in a broader sense, the present invention also provides a catheter assembly comprising a catheter and a first drainage element and a second drainage element, wherein the first and second drainage elements are arranged such that fluid can flow along the catheter to the first drainage element and then to the second drainage element, and the first and second drainage elements are attached to each other by a laser-fused portion. Such a catheter assembly may, of course, include any one or more features of the methods described herein, catheter assemblies, catheter assembly components, and drainage elements.

[0056] In summary, the present invention also relates to a catheter assembly component optimized for laser welding. The catheter assembly component may include a welding area to facilitate the formation of a laser weld between it and another catheter component.

[0057] The catheter assembly component may have an internal contour. The catheter assembly component may have an external contour. In the weld zone, the external and internal contours of the catheter assembly component may be similar to each other. The catheter assembly component may include multiple protrusions. The protrusions may define the external contour. The catheter assembly component may include a tube. The tube may define the internal contour. The tube may define the external contour, preferably together with the protrusions. The catheter assembly component may be a drainage element for a catheter.

[0058] In one aspect, a drainage element for a catheter is provided, the drainage element including a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external contour of the drainage element; the drainage element includes an inlet portion configured to receive a catheter; the inlet portion includes a fusion zone to facilitate the formation of a laser fusion joint between the drainage element and the catheter.

[0059] The plurality of protrusions may be arranged such that there is a spacing between the centers of adjacent protrusions in a first direction. The weld zone may at least span the spacing in the first direction.

[0060] According to a third aspect of the invention, a drainage element for a catheter is provided, the drainage element comprising a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external contour of the drainage element; the drainage element includes an inlet portion configured to receive a catheter; the inlet portion includes a fusion region; the external and internal contours of the drainage element are similar to each other in the fusion region to facilitate the formation of a laser fusion portion between the drainage element and the catheter; the plurality of protrusions are arranged to have a spacing between the centers of adjacent protrusions in a first direction; and the fusion region at least spans the spacing in the first direction.

[0061] Advantageously, the draining element thus has a substantially constant thickness within the weld zone. This facilitates the formation of the weld because the shape of the draining element is unlikely to change significantly or its surface deform as it melts during the welding process. This helps ensure a strong weld and makes it difficult to see once formed.

[0062] By including protrusions, the weld area can be recessed relative to the top of the protrusions. This helps ensure that the weld is not easily visible to the user, and the outer contour can be adapted to ensure that the user can easily manipulate the drainage element. Due to the protrusions, the drainage element is also suitable for manufacturing by injection molding without significant risk of shrinkage marks.

[0063] As described above, the weld zone spans at least the distance between the protrusions in the first direction. In other words, the weld zone extends at least over the entire distance in the first direction. Therefore, the distance across the weld zone is not measured / defined. When the weld zone is positioned between two protrusions, the two protrusions are not adjacent. Therefore, the weld zone provides a region suitable for welding, the size of which in the first direction is at least as large as the distance. Therefore, the weld zone is typically positioned on one side of at least two spaced-apart protrusions.

[0064] The drainage element may include two adjacent protrusions spaced apart in a first direction, and then a welded area extends from said two adjacent protrusions. Thus, the drainage element may include two adjacent protrusions on one side of the welded area. The drainage element may include two adjacent protrusions on the other side of the welded area. For example, along the first direction, the drainage element may include two adjacent protrusions spaced apart, then the welded area, then two more adjacent protrusions spaced apart, and the welded area spans at least the distance between either of the two adjacent protrusions in the first direction. In cases where the drainage element includes multiple welded areas, this arrangement can be provided for each welded area. This helps ensure that the welded portion is less likely to be seen by the user, as the welded area is recessed between the protrusions, and also makes the drainage element easier to manipulate.

[0065] The drainage element may be open at the end. The drainage element may include an inlet end. The inlet end may be configured to connect to a conduit. The drainage element may include an outlet end. The drainage element may have a length measured between the inlet end and the outlet end. The outlet end may be configured to allow liquid to flow out of the drainage element during use. The drainage element may include an outlet portion. The outlet portion may be configured to drain liquid out of the drainage element. The outlet end may be located in the outlet portion. The outlet portion may be generally tubular. The outlet portion may be tapered / gradiented. The outlet portion may have a substantially constant wall thickness. The outlet portion may be a truncated cone.

[0066] The drainage element may include a locator. The locator may be configured to identify the orientation of the catheter. The locator may be positioned to correspond to a curve / bend / surface in the catheter. A locator may be provided when the catheter is a coudé catheter. The locator may be positioned upwards during use. The locator may include a positioning rib. The positioning rib may extend along at least a portion of the length of the drainage element. The locator may include a locator mark. Thus, once inserted into the body, the locator assists the user in using the catheter and aligning it with their bladder.

[0067] The drainage element may include an inlet portion. An inlet end may be disposed within the inlet portion. An outlet portion may be connected to the inlet portion. The outlet portion may be narrowest at its junction with the inlet portion. The inlet portion may be narrowest at its junction with the outlet portion. The outlet portion may cover at least 40%, at least 50%, at least 60%, at least 70%, or at least 80% of the length of the drainage element. The outlet portion may cover no more than 80%, no more than 70%, no more than 60%, or no more than 50% of the length of the drainage element. Preferably, the outlet portion covers 60-70% of the length of the drainage element. Preferably, the outlet portion is longer than the inlet portion.

[0068] The inlet portion can be configured to receive the catheter. The inlet portion can be configured to provide a fluid path from inside the catheter into the drainage element. The inlet portion can be configured to engage the catheter. The inlet portion can be configured to receive the distal end of the catheter. Therefore, the catheter can be securely attached to the drainage element.

[0069] Multiple gaps can be provided between the plurality of protrusions. In the region outside the weld zone, the spacing between adjacent protrusions can be substantially constant. The inlet portion may include an actuation zone. The actuation zone may include at least two of the plurality of protrusions. In the actuation zone, the tips of the protrusions may together define an actuation surface. In the actuation zone, the outer and inner contours may differ. The actuation surface may extend through the gaps. Thus, the tips of the protrusions allow the actuation surface to be defined using the size of the protrusions and its tactile feel and shape to ensure ease of use of the drainage element. Advantageously, the drainage element is easier to grip when held because the alternating gaps and protrusions provide a wavy surface. However, since the actuation surface is defined by the tips of the protrusions, the appearance and feel of the drainage element remain enhanced.

[0070] The welding area and the actuation area may not overlap. Within the actuation area, the spacing between adjacent protrusions may be at least 0.5 mm, at least 1 mm, or at least 2 mm. Within the actuation area, the spacing between adjacent protrusions may not exceed 5 mm, 3 mm, or 2 mm. Preferably, within the actuation area, the spacing between adjacent protrusions is approximately 2 mm. The spacing between protrusions may be at least the thickness of the drainage element. The spacing between protrusions may not exceed twice the thickness of the drainage element. The thickness may be measured at the midpoint between the protrusions. The spacing across three or more protrusions may be substantially constant. This spacing may be substantially constant within the actuation area. This helps to provide a more ergonomic feel to the actuation area.

[0071] The internal profile of the drainage element may include stepped regions. The area of ​​the actuating surface corresponding to the stepped regions may be smooth. Therefore, the external profile / actuating surface can be significantly different from the internal profile. This allows additional design freedom to optimize the internal and external profiles, as well as the actuating surface, for different functions. While the stepped region is given as an example, the internal profile may alternatively be chamfered, tapered, or have different irregular shapes, and the corresponding portion of the actuating surface may be smooth or have different shapes defined by protruding tips.

[0072] Furthermore, due to the protrusions, the drainage element can be manufactured inexpensively and easily using injection molding, without suffering from the shrinkage defects associated with injection molding of objects with different wall thicknesses. The protrusions also reduce the total material required, thus lowering weight and cost. This also provides a more pleasant experience for users manipulating the drainage element with a stepped internal profile. Because of the design freedom provided to change the internal profile independently of the manipulating surface, the same drainage element can be used for different types / sizes of catheters. This means that manufacturing is cheaper and simpler, as fewer types of drainage elements need to be produced for all the different types / sizes of catheters.

[0073] When received in the inlet portion, the first direction can be substantially parallel to the axis of the conduit. In the first direction, the weld zone can be at least 50%, at least 75%, or at least 100% larger than the spacing. In the first direction, the weld zone can be no more than 5 times, no more than 4 times, or no more than 3 times the spacing. Preferably, in the first direction, the weld zone is approximately twice the spacing, for example, spanning approximately 4 mm in the first direction. The weld zone can extend a distance at least equal to, at least twice, or at least three times the thickness of the drainage element. The distance the weld zone can extend does not exceed four times, three times, or twice the thickness of the drainage element. The thickness can be measured as an average value across the entire weld zone. This ensures that the weld zone provides a widened band around the drainage element.

[0074] The tube can have a substantially constant wall thickness. The wall thickness of the protrusion can be substantially the same as the wall thickness of the tube. The wall thickness of the tube can be at least 0.5 mm, at least 0.7 mm, or at least 1 mm. The wall thickness of the protrusion can be no greater than 1.5 mm, no greater than 1 mm, or no greater than 0.7 mm. The wall thickness of the protrusion can be at least 0.5 mm, at least 0.7 mm, or at least 1 mm. The wall thickness of the tube can not exceed 1.5 mm, not exceed 1 mm, and not exceed 0.7 mm. Therefore, the wall thickness is the same, which means that the drainage element can be efficiently manufactured by injection molding without shrinkage defects.

[0075] The radial length of the protrusion is defined as the distance the protrusion extends radially from the inner tube. The radial length can vary along the length of the drainage element. Variations in the radial length can offset variations in the internal profile. The radial length can be at least 1 mm, at least 1.5 mm, or at least 2 mm. The radial length can also not exceed 3 mm, 2 mm, or 1.5 mm. Therefore, the length of the protrusion can be easily adjusted to ensure the correct operating surface of the drainage element, regardless of the internal profile.

[0076] The inlet section may include one or more catheter receiving areas. The inlet section may include two or more catheter receiving areas, preferably only two. Each catheter receiving area may be configured to receive different catheters, such as catheters of different sizes, shapes, and / or types. The catheter receiving areas may be arranged in series. The catheter receiving areas may be arranged substantially coaxially. This allows drainage elements of the same specification to be used with different catheters in the production line, simplifying the manufacturing process of a series of catheters.

[0077] The stepped region may include at least two steps in its internal contour. The internal contour of the inlet portion may include a step between adjacent catheter receiving areas. This step may provide a stop or flange at one end of the catheter receiving area. This helps ensure that the catheter is not over-inserted into the inlet portion.

[0078] The inlet portion may include two or more weld zones. These weld zones may be spaced apart from each other. They may be spaced apart along the axis of the tube. These weld zones may correspond to areas of the tube with different diameters. A separate weld zone may be provided for each conduit receiving area. Therefore, regardless of the type of conduit used, it can be securely welded in place.

[0079] The weld zone can be divided into multiple spaced-apart weld zone portions, such that a single weld portion spanning these portions can be formed. The thickness of each weld zone portion can be substantially constant. The internal profile can be substantially constant throughout the weld zone. The internal profile can be substantially constant in the region spanning adjacent weld zone portions. Adjacent weld zone portions can be spaced no more than 2 mm, 1.5 mm, or 1 mm apart to facilitate the formation of a weld portion spanning these two weld zone portions. A single protrusion can be provided between adjacent weld zone portions. The height of this single protrusion can be no more than 5 mm, 4 mm, 3 mm, or 2 mm. The height of this single protrusion can be no more than three times the thickness of the drainage element (or the combined thickness of drainage elements), no more than twice the thickness of the drainage element (or the combined thickness of drainage elements), or no more than the thickness of the drainage element (or the combined thickness of drainage elements). The thickness of the drainage element can be measured near the protrusion. The protrusion can have a thickness defined by the aforementioned protrusion wall thickness. The thickness of a single protrusion may not exceed twice the thickness of the drainage element (or the combined thickness of drainage elements), or may not exceed the thickness of the drainage element (or the combined thickness of drainage elements). Conversely, the weld zone may be separated by recesses. The recesses may have similar characteristics to the protrusions described above. The depth of the recesses may not exceed the thickness of the drainage element, or may not exceed half the thickness of the drainage element. In the weld zone or weld zone portion, the inner and outer contours may be shaped such that the thickness of the drainage element increases by no more than 200%, or no more than 150%, or no more than 100%, or no more than 50%, or no more than 25% over a distance equivalent to the thickness of the drainage element. Therefore, this ensures that the outer and inner contours remain sufficiently similar to facilitate laser welding, even with small differences in the contours.

[0080] The absolute thickness of the lead element in the weld zone can be defined as described above for external elements. This helps ensure that the thickness is suitable for welding.

[0081] The weld zone extends from each step. The weld zone does not extend through the steps or stepped areas of the internal profile. Therefore, the conduit is securely welded near the step. This is typically the area where the conduit fits most tightly within the inlet section, thus helping to ensure effective laser welding.

[0082] The tube may include a flange. The flange may be located at one end of the inlet portion. The flange may be configured to prevent over-insertion of the catheter into the drainage element. The flange may provide a stepped portion within the internal contour of the drainage element. A weld zone may extend from the flange along the inlet portion. Thus, as in this step, the catheter is more securely welded into place by the location of the weld zone located at / adjacent to the flange.

[0083] The weld zone can be spaced apart from the inlet end. By separating the weld zone from the inlet end, the weld is protected from the higher shear and lateral forces present on the conduit at the inlet end, as these forces are borne by the conduit itself around the inlet end. This helps ensure that the weld only provides significant resistance to axial movement of the conduit along the inlet section.

[0084] The internal profile may taper near the inlet end. The internal profile may converge from the inlet end towards the outlet portion. The internal profile may taper inward from the inlet end to the one or more catheter receiving areas. The inlet end may have an inner diameter of at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, or at least 7 mm. The inlet end may have an inner diameter not greater than 8 mm, not greater than 7 mm, not greater than 6 mm, or not greater than 5 mm. Preferably, the inlet end has an inner diameter of about 6 mm or about 5 mm. The diameter of the catheter receiving area near the inlet end may be about 0.5 mm to 1.5 mm smaller than the inlet end, for example, 0.7 mm smaller. Therefore, when the catheter is fitted into the funnel-shaped piece, this taper helps guide the catheter to the one or more catheter receiving areas so that it can be held by the funnel-shaped piece.

[0085] The internal profile may preferably be defined solely by the tube. The internal profile may taper at each catheter receiving area. The internal profile may taper to deform the catheter as it is received in the catheter receiving area. The internal profile may taper across the fusion zone. This ensures that the catheter is effectively wedged into each fusion zone. The internal profile may have a width across its measured dimension perpendicular to an axis perpendicular to the drainage element. The internal profile may be reduced by no more than 5%, or no more than 4%, throughout the fusion zone. The internal profile may be reduced by at least 1%, or at least 2%, throughout the fusion zone. The internal profile may be reduced by approximately 2% to 3%, throughout the fusion zone. The external profile may also reduce along with the internal profile. This helps to provide appropriate catheter deformation to ensure a tight fit and effective fusion without damaging or obstructing the catheter.

[0086] The thickness of the current-draining element can be substantially constant over most of the weld zone, such as at least 50%, 60%, 70%, 80%, or 90% of the weld zone area. Preferably, the thickness of the current-draining element is constant throughout the weld zone. This makes welding more efficient because the laser beam setup does not need to be changed to accommodate varying thicknesses, and a more consistent thickness ensures higher quality welding.

[0087] In the weld zone, the inner and outer contours can match each other. This provides a constant tube thickness throughout the weld zone. With a constant tube thickness, the inner contour is also preferably constant. The outer contour of the tube in the weld zone can be defined solely by the tube. The weld zone or weld zone portion can be substantially free of protrusions. This helps ensure that the laser weld can be effectively formed throughout the weld zone; large fluctuations in thickness once the guiding element melts and then solidifies can lead to problems such as material transport, deformation, and uneven final weld strength.

[0088] The weld zone may extend around at least 50%, at least 75%, or at least 95% of the circumference of the drainage element in a plane perpendicular to its axis. Alternatively, the weld zone may extend around substantially the entire circumference of the drainage element in a plane perpendicular to its axis. Therefore, the weld prevents accidental fluid leakage from the drainage element.

[0089] The plurality of protrusions may include one or more ribs. Each rib may be elongated and extend around and / or along the drainage element. Each rib may have a length measured along its length as it extends around and / or along the drainage element. Each rib may have a thickness defined perpendicular to its length. The thickness of each rib may be substantially the same as the wall thickness of the tube. The thickness of each rib may be from 0.5 mm to 3 mm, or preferably from 0.5 mm to 1.5 mm. The thickness of each rib may be tapered. The thickness of each rib may be minimum at its tip. The tip may have a thickness of 0.5 mm to 1 mm. Therefore, the ribs provide a more robust structure to the protrusions while helping to ensure uniform injection molding and making it easier to remove the drainage element from the mold once formed.

[0090] The one or more ribs may include two or more ribs. At least two of the two or more ribs may be intersecting ribs. Intersecting ribs may intersect each other at substantially perpendicular angles. Therefore, the ribs can provide structural support to each other and also help to create a drainage element that is easier to grip and provides good gripping action in multiple directions.

[0091] The one or more ribs may include one or more circumferential ribs extending around the circumference of the drainage element. The circumferential ribs may extend around the circumference of the drainage element by at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 100%. The circumferential ribs may be evenly spaced along the length of the drainage element. The drainage element may include at least five or at least six circumferential ribs. The drainage element may include no more than ten or no more than eight circumferential ribs. Therefore, the circumferential ribs help ensure that the drainage element is easy to grasp and that force is applied along the length of the drainage element to move the catheter into and out of the body.

[0092] A circumferential rib may be provided around the inlet end. The circumferential rib around the inlet end can provide an inlet flange. The outer diameter of the inlet flange can be at least 8 mm, at least 10 mm, or at least 12 mm. Alternatively, the outer diameter of the inlet flange can be no greater than 15 mm, no greater than 12 mm, or no greater than 10 mm. Preferably, the outer diameter of the inlet flange is approximately 10 mm. A sleeve may be attached to the rib providing the inlet flange. Therefore, a flange is provided around the inlet end to help ensure that the drainage element is easier to use and manufacture as part of the catheter assembly.

[0093] In cases where the drainage element comprises two or more welded zones, at least one protrusion may be positioned between adjacent welded zones. Preferably, an actuating zone comprising at least two protrusions is provided between adjacent welded zones. In one embodiment, the drainage element may comprise two welded zones and two actuating zones. The actuating zone (e.g., a first actuating zone) may extend from the inlet end. The first welded zone may extend from the inlet actuating zone. The second welded zone may be positioned between the first welded zone and the outlet portion. An actuating zone (e.g., a second actuating zone) may be provided between the first and second welded zones. The first actuating zone may be longer than the second actuating zone. The first actuating zone may comprise more protrusions than the second actuating zone. The first actuating zone may comprise at least twice the number of protrusions as the second actuating zone. The spacing between the protrusions in the first and second actuating zones may be substantially the same. Thus, the drainage element is optimally arranged to receive two different catheters while maintaining an ergonomic actuating surface.

[0094] Circumferential ribs can be provided between adjacent weld zones. At least two circumferential ribs can be provided between adjacent weld zones. Each operating zone may include at least two circumferential ribs. This ensures that the drainage element is easier and more comfortable to hold, while facilitating the provision of different weld zones.

[0095] The one or more ribs may include one or more axial ribs extending along the length of the drainage element. The radial length of the axial ribs may vary along the length of the drainage element. The one or more axial ribs may be evenly spaced around the circumference of the drainage element. The axial ribs may intersect with at least two other ribs, preferably with at least two circumferential ribs. The axial ribs may extend along the majority of the length of the drainage element covered by the protrusion. The axial ribs preferably extend along the entire length of the drainage element covered by the protrusion. The axial ribs may extend from the inlet end. The length of each axial rib may be substantially the same. The axial ribs may extend through each operating zone. The weld zone may be without axial ribs. Therefore, the axial ribs provide structural support for the circumferential ribs.

[0096] The one or more ribs may include at least four ribs. The at least four ribs may include at least four axial ribs. Each axial rib may include any or any of the features of the ribs or axial ribs described herein. The drainage element may include two or more weld zone portions arranged at the same point along the length of the drainage element. The two or more weld zone portions may be separated by a single axial rib. The drainage element may include four weld zone portions, with adjacent weld zone portions separated by a single axial rib. The axial rib may have a height not exceeding 200% of the thickness of the drainage element in the weld zone. The width of the axial rib may not exceed twice the thickness of the drainage element in the weld zone. Therefore, adjacent weld zone portions may be spaced apart to facilitate the formation of a laser weld between adjacent weld zone portions.

[0097] The drainage element can be funnel-shaped. The drainage element / funnel-shaped member may include a weld zone disposed on its outlet portion. The drainage element / funnel-shaped member can be configured to receive a connector into its outlet portion. The drainage element / funnel-shaped member may include a weld zone for forming a laser-welded portion with the connector. A positioning rib may be disposed between the weld zone for the connector and the weld zone for the catheter. The drainage element / funnel-shaped member may have three weld zones. Each weld zone may be configured to weld the drainage element / funnel-shaped member to different catheter assembly components, such as different types / sizes of catheters or connectors. Each weld zone may have any one or more of the features described above; for example, the weld zone for the connector may have a tapered internal profile as described above regarding the catheter receiving area. Therefore, the funnel-shaped member can be welded to the catheter at one end and optionally to the connector at its other end. This means that a single open catheter assembly can be manufactured and then, when needed, optionally used to manufacture a closed catheter assembly by welding it to a connector. This simplifies manufacturing and reduces economic and environmental costs.

[0098] The funnel-shaped member may include a skirt. The skirt may be part of the outlet portion. The skirt may be located at the outlet end. The skirt may include a widened section of the outlet portion. The skirt may be about 0.5 mm, about 1 mm, or about 1.5 mm wider than the rest of the outlet portion. The skirt may span at least 5%, at least 10%, or at least 15% of the length of the outlet portion. The skirt may span no more than 20%, no more than 15%, or no more than 10% of the length of the outlet portion. The skirt preferably spans about 10% of the length of the outlet portion. The skirt may be configured to engage the wetting mechanism. Therefore, the skirt provides a structure that enables better engagement of the wetting mechanism.

[0099] The funnel-shaped member may include multiple positioning protrusions. These positioning protrusions may be configured to engage conduit assembly components, such as wetting mechanisms. The positioning protrusions are preferably arranged in pairs. The pairs of positioning protrusions may be spaced apart around the circumference of the funnel-shaped member. The positioning protrusions may be located at approximately 10-30% of the length of the funnel-shaped member starting from the outlet end.

[0100] Positioning ribs may be provided between the skirt and the inlet portion. Positioning ribs may be provided between the positioning protrusion and the inlet portion. A weld zone may be provided on the outlet portion. A weld zone may be provided between the positioning rib and the outlet end. A weld zone may be provided between the positioning protrusion and the inlet portion. A weld zone may be provided between the positioning protrusion and the positioning rib. Therefore, the weld zone may be located in a substantially flat / constant thickness area of ​​the outlet portion.

[0101] The drainage element may be a connector. The connector may be integrally formed with the fluid collection bag or operatively connected to the fluid collection bag. The connector may include an inlet portion. The inlet portion may be received by an outlet portion of the funnel-shaped element. The inlet portion may have a shape corresponding to the internal contour of the funnel-shaped element. The connector may include an outlet portion. The connector may include a stop portion. The stop portion may be configured to prevent the connector from being over-inserted into the funnel-shaped element.

[0102] In a broader sense, a catheter assembly is provided, comprising a catheter and a drainage element, wherein the drainage element includes an inlet portion configured to receive the catheter and a fusion zone, wherein the catheter is disposed in the inlet portion, and the drainage element and the catheter are attached to each other by a laser fusion portion in the fusion zone.

[0103] In a broader sense, a catheter assembly is provided, comprising a catheter and a drainage element, wherein the drainage element includes an inlet portion attached to the catheter and a welding zone, wherein the assembly further includes a connector disposed in an outlet portion of the drainage element, the connector being arranged to receive fluid from the catheter via the drainage element, and the drainage element and the connector being attached to each other via a laser welding portion in the welding zone.

[0104] According to a fourth aspect of the invention, a catheter assembly is provided, comprising a catheter and a drainage element of the third aspect, wherein the catheter is disposed in an inlet portion, and the drainage element and the catheter are attached to each other by a laser fusion portion in a fusion zone.

[0105] The drainage element may be funnel-shaped. The catheter assembly may include a connector. The connector and the funnel-shaped element may be attached to each other via laser welding.

[0106] According to a fifth aspect of the invention, a method for draining a catheter using a drainage element is provided. The drainage element may be the drainage element described in the third aspect above. The method may include attaching the drainage element to the catheter via a laser fusion joint, such as as described above with respect to the first aspect. The method may include allowing fluid to flow out of the catheter through the drainage element. The method may include introducing fluid into a container. The method may include attaching a second drainage element to the drainage element, for example via a laser fusion joint as described above with respect to the first aspect. The method may include using a catheter assembly of the fourth aspect. The method may include inserting the catheter into the body until fluid flows through the catheter.

[0107] The methods, catheter assemblies, catheter assembly components, and drainage elements described herein in general / broad terms and relating to the first through fifth aspects above may of course include any or any of any of their optional or other features. For example, in one example, a drainage element for a catheter may be provided, comprising a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external contour of the drainage element; the drainage element includes an inlet portion configured to receive a catheter; the inlet portion includes a fusion zone; the external and internal contours of the drainage element are similar to each other in the fusion zone to facilitate the formation of a laser fusion between the drainage element and the catheter; the plurality of protrusions are arranged to have a spacing between the centers of adjacent protrusions in a first direction; and according to the third aspect, the fusion zone at least spans the spacing in the first direction, wherein the drainage element includes a non-reflective coating as described with respect to the third aspect.

[0108] In another example, a catheter assembly including a conduit and a drainage element is provided, wherein the drainage element includes an inlet portion configured to receive the conduit and a welding region, wherein the conduit is disposed in the inlet portion, and the drainage element and the conduit are attached to each other by a laser welding portion in the welding region, wherein the drainage element includes an actuation region comprising at least two circumferential ribs, wherein the actuation region and the welding region do not overlap.

[0109] The following describes some specific and preferred embodiments of the present invention. Each of these embodiments is generally applicable to the other embodiments and therefore may include any or any of the features of the first to fourth aspects described above, or may be interchangeable with each other.

[0110] In a preferred embodiment, a method of manufacturing a catheter assembly is provided, the method comprising the steps of: providing an intermittent urinary catheter including a distal end and a proximal end for insertion into the body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser fusion portion between the first drainage element and the second drainage element, wherein: the first drainage element is provided by the distal end of the catheter, and the second drainage element is a funnel-shaped element; or, the first drainage element is a funnel-shaped element connectable to the distal end of the catheter, and the second drainage element is a connector.

[0111] In another preferred embodiment, a method of manufacturing a catheter assembly is provided, comprising the steps of: providing a catheter including a distal end and a proximal end for insertion into a body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser-fused portion between the first drainage element and the second drainage element, wherein: the first drainage element is provided by the distal end of the catheter, and the second drainage element is a funnel-shaped element; or, the first drainage element is a funnel-shaped element connectable to the distal end of the catheter, and the second drainage element is a connector, wherein the method includes melting a substantial portion of the thickness of an outer element during the formation of the laser-fused portion, and preferably, wherein the method includes melting the entire thickness of the outer element during the formation of the laser-fused portion.

[0112] In another preferred embodiment, a method of manufacturing a catheter assembly is provided, comprising the steps of: providing a catheter including a distal end and a proximal end for insertion into a body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser fusion between the first drainage element and the second drainage element, wherein: the first drainage element is provided by the distal end of the catheter, and the second drainage element is a funnel-shaped element; or, the first drainage element is a funnel-shaped element connectable to the distal end of the catheter, and the second drainage element is a connector, wherein the method includes heating an outer element to a higher temperature than an inner element using the laser beam.

[0113] In another preferred embodiment, a method of manufacturing a catheter assembly is provided, comprising the steps of: providing a catheter including a distal end and a proximal end for insertion into a body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser fusion portion between the first drainage element and the second drainage element, wherein: the first drainage element is provided by the distal end of the catheter, and The second drainage element is a funnel-shaped piece; or, the first drainage element is a funnel-shaped piece connectable to the distal end of a conduit, and the second drainage element is a connector, wherein the first drainage element and / or the second drainage element comprises a thermoplastic material that absorbs the laser beam in volume to cause the first drainage element and / or the second drainage element to melt, and preferably, wherein the laser beam and the first and second drainage elements are configured such that: during the formation of the laser weld, the volume absorption in the first drainage element and / or the second drainage element generates more heat than the interfacial absorption at the interface between the first and second drainage elements.

[0114] In another preferred embodiment, a method of manufacturing a catheter assembly is provided, comprising the steps of: providing a catheter including a distal end and a proximal end for insertion into a body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser fusion portion between the first drainage element and the second drainage element, wherein: the first drainage element is provided by the distal end of the catheter, and the second drainage element is a funnel-shaped element; or, the first drainage element is a funnel-shaped element connectable to the distal end of the catheter, and the second drainage element is a connector, wherein the laser beam has a wavelength of more than 1.1 micrometers and not more than 3 micrometers, preferably wherein the laser beam has a wavelength of about 2 micrometers.

[0115] In another preferred embodiment, a method of manufacturing a catheter assembly is provided, comprising the steps of: providing a catheter including a distal end and a proximal end for insertion into a body; providing a first drainage element and a second drainage element, wherein the first drainage element is arranged to receive fluid flowing along the catheter; arranging the first drainage element and the second drainage element such that fluid can flow along the catheter to the first drainage element and then to the second drainage element; and directing a laser beam onto the first drainage element and the second drainage element to form a laser fusion portion between the first drainage element and the second drainage element, wherein: the first drainage element is provided by the distal end of the catheter, and the second drainage element is a funnel-shaped member; or, the first drainage element is a funnel-shaped member connectable to the distal end of the catheter, and the second drainage element is a connector, and optionally, the method includes forming a first laser fusion portion between the funnel-shaped member and the catheter, and preferably also forming a second laser fusion portion between the funnel-shaped member and the connector.

[0116] In another preferred embodiment, a drainage element for a catheter is provided, the drainage element comprising a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external contour of the drainage element; the drainage element includes an inlet portion configured to receive the catheter; the inlet portion includes a fusion zone; the external and internal contours of the drainage element are similar to each other in the fusion zone to facilitate the formation of a laser fusion joint between the drainage element and the catheter; the plurality of protrusions are arranged to have a spacing between the centers of adjacent protrusions in a first direction; and the fusion zone at least spans the spacing in the first direction, wherein the inlet portion includes two or more catheter receiving areas and two or more fusion zones, each catheter receiving area being configured to receive a different catheter, wherein a fusion zone is provided for each catheter receiving area.

[0117] In another preferred embodiment, a drainage element for a catheter is provided, the drainage element comprising a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external contour of the drainage element; the drainage element includes an inlet portion configured to receive the catheter; the inlet portion includes a fusion region; the external and internal contours of the drainage element are similar to each other in the fusion region to facilitate the formation of a laser fusion joint between the drainage element and the catheter; the plurality of protrusions are arranged to have a spacing between the centers of adjacent protrusions in a first direction; and the fusion region at least spans the spacing in the first direction, wherein the tube includes a flange disposed at one end of the inlet portion, the flange being configured to prevent the catheter from being over-inserted into the drainage element, and the fusion region extending from the flange along the inlet portion.

[0118] In another preferred embodiment, a drainage element for a catheter is provided, the drainage element comprising a tube defining an internal profile of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external profile of the drainage element; the drainage element includes an inlet portion configured to receive the catheter; the inlet portion includes a fusion region; the external and internal profiles of the drainage element match each other in the fusion region to provide a constant tube thickness across the fusion region and facilitate the formation of a laser fusion joint between the drainage element and the catheter; the plurality of protrusions are arranged to have a spacing between the centers of adjacent protrusions in a first direction; and the fusion region at least spans the spacing in the first direction.

[0119] In another preferred embodiment, a drainage element for a catheter is provided, the drainage element comprising a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external contour of the drainage element; the drainage element includes an inlet portion configured to receive the catheter; the inlet portion includes a fusion region; the external and internal contours of the drainage element are similar to each other in the fusion region to facilitate the formation of a laser fusion between the drainage element and the catheter; the plurality of protrusions are arranged to have a spacing between the centers of adjacent protrusions in a first direction; and the fusion region at least spans the spacing in the first direction, wherein the inlet portion includes an actuation region including at least two of the plurality of protrusions, and in the actuation region, the external contour differs from the internal contour.

[0120] In another preferred embodiment, a catheter assembly is provided comprising a catheter and a drainage element for the catheter, the drainage element comprising a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: the tube and the protrusions together define an external contour of the drainage element; the drainage element includes an inlet portion configured to receive the catheter; the inlet portion includes a fusion region; the external and internal contours of the drainage element match each other in the fusion region to provide a constant tube thickness across the fusion region and facilitate the formation of a laser fusion joint between the drainage element and the catheter; the plurality of protrusions are arranged to have a spacing between the centers of adjacent protrusions in a first direction; and the fusion region at least spans the spacing in the first direction, wherein the catheter is inserted into the inlet portion and a laser fusion joint is provided between the drainage element and the catheter. Preferably, in this embodiment, the catheter is an intermittent urinary catheter. Invention Details Attached Figure Description

[0122] To better understand the present invention, one or more embodiments of the invention will now be described by way of example only, with reference to the accompanying drawings, in which:

[0123] Figure 1 This is a perspective view of the catheter, funnel-shaped member, and connector of a first embodiment of the catheter assembly;

[0124] Figure 2 yes Figure 1 A cross-sectional view of the funnel-shaped component before it is welded to the conduit and connector;

[0125] Figure 3 yes Figure 1 A cross-sectional view of the conduit, funnel-shaped component, and connector after welding, with sleeves attached;

[0126] Figures 4a-4c yes Figure 1 Different stages of the laser welding manufacturing process for conduit assemblies Figure 3 Sectional view of detail A;

[0127] Figure 5 It shows the use of Figure 1 A flowchart of the laser welding manufacturing process for conduit assemblies;

[0128] Figure 6 This is a perspective view of the catheter, funnel-shaped member, and connector of a second embodiment of the catheter assembly; and

[0129] Figure 7 yes Figure 6 A cross-sectional view of the component. Detailed Implementation

[0130] Reference Figures 1 to 4c A first embodiment of the catheter assembly 100 includes the following catheter assembly components: a catheter 1 having a proximal end (not shown) and a distal end 3 for insertion into the body; a cannula 4; a funnel-shaped member 5; and a connector 6. The cannula 4 surrounds the catheter 1 from the proximal end to the distal end 3, which helps to protect and manipulate the catheter 1 during use.

[0131] The funnel-shaped member 5 is tubular and located at the distal end 3 of the conduit 1, and is attached to both the conduit 1 and the sleeve 4. The connector 6 is configured to connect the funnel-shaped member 5 to a fluid collection bag (not shown), allowing fluid to flow from the conduit 1 into the bag, as described further below. Therefore, the conduit assembly 100 is a closed conduit assembly; however, in some embodiments, the connector 6 and the bag are simply not provided, and the assembly is an open conduit assembly.

[0132] In this embodiment, the sleeve 4 comprises a liquid-impermeable flexible plastic material, such as thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). The conduit 1 is formed of thermoplastic elastomer (TPE).

[0133] Compared to catheter 1 and cannula 4, funnel-shaped member 5 and connector 6 are relatively rigid, and in this embodiment, each comprises a flexible plastic material, such as low-density polyethylene (LDPE). Funnel-shaped member 5 is configured to receive liquid from the distal end 3 of catheter 1, and then guide the liquid flow out of funnel-shaped member 5, for example, into connector 6, as further described below. The distal end 3, funnel-shaped member 5, and connector 6 thus each provide a drainage element for the catheter.

[0134] In this embodiment, the funnel-shaped member 5 is generally tubular and is formed by a tube 7 extending between an inlet end 8 and an outlet end 9. The funnel-shaped member 5 includes an inlet portion 10 extending from the inlet end 8 and an outlet portion 11 extending from the outlet end 9, the inlet portion 10 and the outlet portion 11 converging at the narrowest point along the tube 7. The inlet portion 10 is configured to receive the distal end 3 of the conduit 1 and provide a liquid path from inside the conduit 1 into the funnel-shaped member 5. The outlet portion 11 is configured to discharge liquid out of the funnel-shaped member 5.

[0135] In this embodiment, the outlet portion 11 is longer than the inlet portion 10, and the outlet portion 11 covers approximately 60-70% of the length of the funnel-shaped member 5.

[0136] In this embodiment, the tube 7 has a substantially constant wall thickness of approximately 0.8-0.9 mm. In the outlet portion 11, the tube 7 defines the inner and outer contours of the funnel-shaped member 5 and tapers in a truncated cone shape diverging from the inlet portion 10 toward the outlet end 9. The outlet portion 11 is widest at the outlet end 9, with an outer diameter of approximately 12 mm and an inner diameter of approximately 8-9 mm.

[0137] A positioning rib 12 is provided on the outer surface of the outlet portion 11, extending along the length axis of the funnel-shaped member 5 and the outlet portion 11. The positioning rib 12 is centered relative to the length of the outlet portion 11 and is configured to align with the curved surface in the catheter 1, allowing the user to properly position it inside the body, for example, when using a coudé catheter.

[0138] In this embodiment, at the junction of the inlet portion 10 and the outlet portion 11, the tube 7 is widened by approximately 3-5 mm on the outlet portion 11 side. Therefore, a flange 13 is provided to connect the inlet portion 10 to the outlet portion 11, which facilitates a step change in the internal profile of the funnel-shaped member 5.

[0139] In this embodiment, the funnel-shaped member 5 is configured to receive and hold more than one type and / or size of catheter. Specifically, the funnel-shaped member 5 is configured to receive and hold two different sizes of catheter 1. The funnel-shaped member 5 therefore includes two catheter receiving zones (CRZs): a first catheter receiving zone 14 and a second catheter receiving zone 15. Each catheter receiving zone is configured to receive and hold a specific type / size of catheter.

[0140] In this embodiment, the inner contour of the inlet portion 10 is defined by the tube 7, and the inner contour, along the variation in length of the inlet portion 10 / funnel-shaped member 5, provides first and second conduit receiving areas 14, 15. These two conduit receiving areas are arranged in series and are coaxial with the tube 7 extending from the inlet end 8 to the first conduit receiving area 14, then to the second conduit receiving area 15, and finally to the outlet portion 11.

[0141] In this embodiment, the inner profile of the funnel-shaped member 5 narrows from the inlet end 8 to the outlet portion 11. The inner profile tapers from a diameter of approximately 6 mm at the inlet end 8 to approximately 2 mm at the first conduit receiving area 14. Then, the inner profile tapers gently over the first conduit receiving area 14, so that the overall diameter of the inlet portion is reduced by 2% over the entire first conduit receiving area 14. The inner profile then descends to the second conduit receiving area 15, whose diameter is approximately 1 mm smaller than that of the first conduit receiving area 14. The inner profile also tapers gently over the second conduit receiving area 15, so that the diameter is also reduced by 2% before narrowing again before encountering the outlet portion 11.

[0142] As described above, a catheter stop is provided in the form of a catheter flange 16 at the end of each catheter receiving area away from the inlet end 8. The catheter flange 16 provides a stepped portion in the inner contour of the funnel-shaped member 5 and helps to prevent the catheter from being over-inserted into the corresponding catheter receiving areas 14, 15. Therefore, the inlet portion 10 includes a stepped region of the inner contour of the funnel-shaped member 5.

[0143] In this embodiment, the conduit 1 is tubular and its dimensions are adapted to fit into the second conduit receiving area 15. Therefore, the distal end 3 of the conduit 1 can move through the first conduit receiving area 14 to be received into the second conduit receiving area 14, so that liquid can pass from the conduit 1 through the distal end 3 and into the funnel-shaped member 5, as further described below.

[0144] In this embodiment, the inlet portion 10 of the funnel-shaped member 5 includes a first welding region and second welding regions 17, 18, in which the inner and outer contours of the funnel-shaped member are substantially the same to facilitate the formation of a laser weld 27 between the funnel-shaped member 5 and the conduit 1. Each welding region 17, 18 corresponds to a corresponding conduit receiving region 14, 15, and each welding region extends from the conduit flange 16 of each conduit receiving region 14, 15 toward the inlet end 8. Each welding region extends around the tubular funnel-shaped member 5 to provide a leak-proof seal between the funnel-shaped member and the conduit once the weld is formed. Furthermore, each welding region extends approximately 4 mm along the axis of the tube 7 from each flange. Thus, the welding regions 17, 18 provide a welding area suitable for retaining the conduit 1 in the funnel-shaped member 5, which has sufficient strength for normal use. Of course, the exact size, shape, and construction of the welding regions can be varied according to the requirements of the embodiment. For example, where a leak-proof seal is not required or is provided by an alternative method, the weld zone may not extend around the entire circumference of the pipe.

[0145] In this embodiment, the funnel-shaped member 5 includes first and second operating regions 19, 20 defined by protrusions in the form of a plurality of circumferential ribs 21. Each rib 21 extends outward from the tube 7 and includes an end distal to the tube 7, the ends of which together define an operating surface of the funnel-shaped member 5 in the inlet portion 10, such as... Figure 2 As shown by the dashed lines. This allows the maneuvering surface of the funnel-shaped member 5 to differ from its internal contour, which is constrained by the need to provide the first and second conduit receiving areas 14, 15. Furthermore, a gap 22 is provided between adjacent ribs 21. This allows the funnel-shaped member 5 to be constructed with less material than a full-fill design, while also avoiding the artifacts of shrinkage that may occur in injection-molded articles of varying thicknesses. The ribs 21 and gaps 22 also provide an easier-to-grip outer surface, making the funnel-shaped member easier to maneuver.

[0146] In this embodiment, the ribs 21 are slightly tapered, with their ends being the narrowest parts of each rib 21. The ribs 21 are approximately 1.5 mm wide at their base and approximately 0.5 mm to 1 mm wide at their ends. This makes them easier to manufacture by injection molding. Furthermore, the ends of each rib 21 are substantially flat, which helps them define a smoother and more comfortable handling surface for the funnel-shaped member 5, without sharp edges.

[0147] In this embodiment, circumferential ribs 21 are provided at the inlet end 8, and an inlet flange 23 is provided to form the inlet end 8. In this embodiment, the inlet flange 23 has an outer diameter of approximately 10 mm. A first operating region 19 extends from the inlet end 8 and includes four circumferential ribs 21, starting from a circumferential rib defining the inlet flange 23 at the inlet end 8, and then evenly spaced in the inlet portion 10 until reaching the first welding region 17. A second welding region 18 extends from the outlet portion 11 along the inlet portion 10, and a second operating region 20 is provided between the first and second welding regions 17, 18. The second operating region 20 includes two ribs 21 spaced at the same distance as the spacing between the ribs 21 of the first operating region 19. The spacing of the ribs 21 is defined as the distance between the centers of adjacent ribs 21 in a first direction parallel to the axis of the tube 7, and this spacing is approximately 2 mm in this embodiment. In this embodiment, each welding region 17, 18 spans approximately twice the spacing of the ribs 21 in the first direction, which ensures that a strong and simple weld can be formed to retain the conduit 1 in the funnel-shaped member 5. Therefore, the welded portion extends approximately 3-4 mm along the axis of the tubular funnel-shaped member 5 and, once formed, provides a tensile strength of 60-80 N to prevent axial separation / movement of the funnel-shaped member 5 and the conduit 1.

[0148] In this embodiment, four axial ribs 24 are provided, extending from the inlet flange 23 to the outlet portion 11. Therefore, the axial ribs 24 also define the operating surface of the funnel-shaped member 5 along the inlet portion 10. Each axial rib 24 intersects all the circumferential ribs 21, which helps the ribs 21, 24 support each other and prevents damage to them during use. The four axial ribs 24 are evenly spaced around the circumference of the funnel-shaped member 5. Figure 1 As shown, ribs 21 and 24 divide the welding zones 17 and 18 into four parts 17a and 18a, each of which can also be considered a welding zone. Regarding the second welding zone 18 and the associated second welding zone portion 18a, the axial rib 24 has a height of approximately 1 mm. Furthermore, adjacent welding zone portions 18a are separated by a gap of approximately 1.5 mm, thus ensuring that the shapes of the outer and inner contours within the second welding zone 18 remain sufficiently similar to facilitate the formation of a laser weld around the entire circumference of the conduit 3. Moreover, since the welding zone portions 18a have a substantially constant tube thickness and cover at least 5% of the area of ​​the welding zone 18, this also helps ensure that the inner and outer contours of the entire second welding zone 18 are sufficiently similar to facilitate the formation of a laser weld throughout the welding zone 18.

[0149] Conversely, as it extends through the first weld zone 17, the axial rib 24 is higher, for example, at least 3 mm, and has a similar width. This creates a difference in the outer and inner profiles between adjacent weld zone portions 17a, which prevents the formation of a continuous weld extending between adjacent weld zone portions 17a. For example, the rib introduces a funnel-shaped thickness variation of more than 200% over a very short distance (e.g., a height of about 2-3 mm), which is unsuitable for welding at said very short distance. Of course, each weld zone portion 17a is still suitable for welding because the thickness is constant in these areas, so the conduit 1 can be welded into the first conduit receiving area 14; however, the leak-proof seal provided in the second conduit receiving area 15 may be more difficult / impossible to achieve in the first conduit receiving area. Of course, in many other embodiments, the outer profile may not precisely match the inner profile across any weld zone, but laser welding is advantageous because the outer profile still remains similar to the inner profile, for example, the thickness increases by no more than 100% over a distance equal to the thickness. For example, the outer contour may increase / decrease slowly, or may have surface roughness, undulations, or protrusions on a short length scale, which are effectively averaged / removed once the material melts during welding.

[0150] In this embodiment, the operating surfaces 19 and 20 of the inlet portion 10 are shaped to provide a superior appearance through smoothly varying features that avoid unnecessary abrupt changes in size. Therefore, the operating surfaces are smooth over the stepped areas of the inner contour of the inlet portion 10.

[0151] The second operating surface 20 of the inlet portion 10 is shaped to match the outer contour of the outlet portion 11. Therefore, the ribs 21, 24 have a radial length adjacent to the flange 13, measured as the radial distance from the tip of the ribs 21, 24 to the tube 7, which is substantially the same as the dimension of the flange 13. The length of the ribs 21, 24 then increases towards the inlet end 8, causing the second operating surface 20 to diverge. This provides a shape that is easier for the user to grip and is more suitable for applying force along the axis of the conduit 1 for inserting / removing the conduit from the body.

[0152] In this embodiment, the ribs 21, 24 of the first operating surface 19 are shaped to provide a constant outer profile over the remainder of the inlet portion 10 to the inlet end 8. Because the tube 7 tapers at its maximum at the inlet end 8, the radial length of the ribs 21, 24 decreases slightly as they approach the inlet end 8. This constant region can be more suitable for engaging the sleeve 4, for example, at the portion of the sleeve that mates with the funnel-shaped member 5.

[0153] In this embodiment, the funnel-shaped member includes a skirt 25 located at the outlet end 9. The skirt 25 includes a widened portion of the outlet portion 11, the diameter of which is approximately 1 mm wider than the rest of the outlet portion 11. The skirt 25 extends approximately 10% of the length of the funnel-shaped member 5 from the outlet end 9.

[0154] In this embodiment, the funnel-shaped member includes a plurality of positioning protrusions in the form of six positioning protrusion pairs 26. The protrusions in each pair 26 are arranged adjacent to each other along the length of the funnel-shaped member 5. These pairs 26 are all located at the same position along the length of the funnel-shaped member, approximately 20% of the length of the funnel-shaped member from the outlet end 9. The pairs 26 are evenly spaced around the circumference of the funnel-shaped member 5. Each positioning protrusion is hemispherical and extends outward from the surface of the funnel-shaped member by approximately 0.6 mm. Therefore, the positioning protrusion extends beyond the outer contour of the outlet end 9 and the skirt 26. In several other embodiments, the positioning protrusions are configured to retain a wetting mechanism or other conduit assembly component on the end of the funnel-shaped member 5 by an interference fit / push-in fit.

[0155] In this embodiment, the conduit 1 is tubular and arranged to allow liquid to flow downwards along its center and out of the distal end 3. The conduit 1 is C12 size (4 mm diameter), and the second conduit receiving area 15 of the funnel-shaped member 5 is sized to allow the conduit 1 to be inserted therein. The second conduit receiving area 15 tapers slightly, with a diameter reduction of approximately 2%, so that the conduit 1 is compressed / deformed when fully inserted into the second conduit receiving area 15. A first laser weld portion 27 is disposed between the distal end 3 of the conduit 1 and the funnel-shaped member 5 at a position corresponding to the second weld area 18. The laser weld portion 27 is mainly slightly spaced from the tip of the distal end 3 of the conduit 1 and extends from the tip along the distal end 3 of the conduit 1, which helps to maintain the shape of the conduit 1 during manufacturing. The conduit 1 is thus secured in the funnel-shaped member 5, and the process of forming the laser weld portion 27 will be further described below.

[0156] In different embodiments, the same funnel-shaped member 5 can be used, but in conjunction with a C14-sized conduit, which will be fitted into the first conduit receiving area 14 in the same way, instead of providing a laser weld at the position corresponding to the first weld area 17.

[0157] In this embodiment, connector 6 is tubular and includes an inlet portion 28 sized to fit within the outlet portion 11 of funnel-shaped member 5. In this embodiment, the outer contour of connector 6 matches the inner contour of the funnel-shaped member in the outlet portion 11, providing a tight fit between them. This facilitates the formation of a second laser weld portion 29 between funnel-shaped member 5 and connector 6. The second laser weld portion 29 is spaced approximately 5 mm from the end of the inlet portion 28 of connector 6, which helps maintain the shape of connector 6 during manufacturing, as described below. In this embodiment, a third weld zone 30 is thus provided by the outlet portion 11 of funnel-shaped member 5. The third weld zone 30 includes a band of outlet portion 11 where the outer and inner contours are substantially the same; for example, it does not correspond to the location of the positioning rib 12 or positioning protrusion 26 that would obstruct welding. In this embodiment, the third weld zone 29 is located along funnel-shaped member 5 between the positioning rib 12 and the positioning protrusion 26.

[0158] In this embodiment, the connector 6 further includes an outlet portion 31 configured to connect to a fluid collection bag and facilitate fluid transfer from the funnel-shaped member into the bag. The outlet portion 31 includes a circumferential stop 32 that extends outward at the junction of the outlet portion 31 and the inlet portion 28 of the connector 6. This prevents the connector 6 from being over-inserted into the funnel-shaped member 5.

[0159] Therefore, as Figure 3 As shown, the catheter assembly 100 provides a liquid path from the catheter 1 through the distal end 3 of the catheter 1 into the funnel-shaped member 5, and then out of the funnel-shaped member 5 through the connector 6. See [reference needed] Figure 3 The dashed arrow in the middle is represented by "LP".

[0160] To manufacture the conduit assembly 100, a conduit 1 is provided, and a funnel-shaped member 5 and a connector 6 are injection molded. The funnel-shaped member 5 is advantageously suited for injection molding due to its tapered inlet and outlet portions 10, 11 and its tapered ribs 21, 24. The distal end 3 of the conduit 1 is then inserted into the inlet portion 10 of the funnel-shaped member 5 and laser-welded into place; similarly, the connector 6 is inserted into the outlet portion 11 and laser-welded into place.

[0161] Typically, laser welding can be applied to various catheter assembly components, such as first and second drainage elements, like the distal end of a catheter and a funnel-shaped component, or a funnel-shaped component and a connector. The laser welding process for catheters and connectors is the same, therefore only the welding process for catheters will be described in detail.

[0162] refer to Figure 4a , Figure 4b , Figure 4c and Figure 5The laser welding process begins in step S1, where the distal end 3 of the conduit 1 is inserted into the inlet portion 10 until it abuts against the conduit flange 16 of the second conduit receiving area 15. In these examples, the funnel-shaped member is therefore the external element because it is external and directly exposed to the laser beam, and the conduit (or connector) is the internal element, which receives the laser beam through the external element, as described below. The external element includes an outer surface 33 located outside the funnel-shaped member and an opposing inner surface 34 facing the internal element. The internal element includes an outer surface 35 facing the external element and an opposing inner surface 36.

[0163] In this position, such as Figure 4a As shown, the distal end 3 is compressed and deformed because it is slightly larger than the inner contour of the second conduit receiving area 15. When the conduit 1 is inserted into the funnel-shaped member 5, this results in a 3% to 8% reduction in the diameter of the conduit 1. Therefore, once fully inserted, due to the elastic deformation characteristics of the conduit 1, the outer surface 35 of the conduit 1 presses outward against the inner surface 34 of the funnel-shaped member 5. This is important for laser welding because it generates pressure and reduces the possibility of any gaps between the two parts, thereby contributing to the formation of a strong weld.

[0164] In this embodiment, in step S2, the laser beam L is guided onto the outer surface 33 of the external element (funnel-shaped member 5). The laser beam is incident on the outer surface 33 at an angle close to 90 degrees, and due to the nature of the inner and outer contours of the welded area, the outer surface 33 is approximately parallel to the inner surface 34. Preferably, both the outer surface 33 and the inner surface 34 include a non-reflective coating to reduce reflection and maximize the transmission of the laser beam L to the funnel-shaped member 5 and the conduit 1.

[0165] In this embodiment, the laser beam L has a wavelength of approximately 2 micrometers or 1940 nanometers. Due to the thermoplastic material used to construct the funnel-shaped member 5 and the conduit 1, this wavelength of laser beam is absorbed by both components in volume to cause heating of the components. In this example, approximately 20-30% of the laser beam is absorbed by the funnel-shaped member 5, leaving the majority to be absorbed by the conduit 1.

[0166] In step S2, both the funnel-shaped member 5 and the conduit 1 are heated by the direct absorption of the laser beam L by each corresponding component. As they are heated, they thermally expand, thereby increasing the welding pressure.

[0167] In step S3, as Figure 4bAs shown, the energy absorbed from the laser beam L ultimately sufficiently heats the components to melt the funnel-shaped member and the conduit in the area defined by the melting zone 37. In this embodiment, the melting zone 7 spans the entire thickness of the funnel-shaped member 5 between its outer surface 33 and inner surface 34, and this melting is driven almost entirely by the volumetric absorption of the laser beam by the funnel-shaped member 5. In contrast, the melting zone 37 spans only a portion of the thickness of the conduit 1 and does not extend to its inner surface 36; for example, it may span only up to 50% of the thickness of the conduit 1. Therefore, the melting of the conduit 1 is a combination of the direct volumetric absorption of the laser by the conduit 1 to heat and soften the entire conduit 1, and the heat conduction from the funnel-shaped member 5 to locally provide additional heat on the outer surface of the conduit. This is important because it ensures that the conduit 1 retains its inner surface structure and reduces the possibility of conduit structural failure during the welding process, which could lead to blockage or other damage.

[0168] Therefore, as described above, the laser beam L, the funnel-shaped element 5, and the conduit 1 are configured such that volume absorption generates more heat during welding than other processes such as interfacial absorption.

[0169] In step S4, the laser beam L is deactivated, allowing the component to cool and solidify.

[0170] In step S5, as Figure 4c As shown, the components have been completely solidified, and due to their complementary properties, a laser weld 27 is formed between them in the region of the melting zone 37.

[0171] In this embodiment, the laser beam L has a wavelength of 2000 nm and a beam width of approximately 1.5 mm to 3 mm, resulting in a beam width of 60-65 W / mm². -2 The power density. In step S3, the laser beam L scans the surface of the funnel-shaped member 5 to continuously melt the funnel-shaped member and fuse it to the conduit 1. In several other embodiments, more advanced laser welding techniques, such as those described in US2020 / 0246916A1, may also be used.

[0172] In some embodiments, an external fastener, such as a glass transfer plate, contacts the outer surface 33 of the external element. This allows the shape of the surface to be controlled by the external fastener, thereby providing a certain aesthetic appearance for the funnel-shaped member 5.

[0173] This process can then be repeated to attach connector 6 to funnel-shaped component 5 and form a second laser-welded portion 29. During the laser welding process, the materials and absorption coefficients of the internal and external components are selected to be compatible with each other for laser welding, such that the internal component melts through a combination of direct volume absorption of the laser beam and thermal conduction from the external component. This is most easily achieved by selecting the same materials for both the internal and external components, such as funnel-shaped component 5 and connector 6 in this embodiment; however, two different but complementary materials can also be used, such as funnel-shaped component 5 and conduit 1 in this embodiment. For example, both funnel-shaped component 5 and conduit 1 comprise polyethylene, and therefore can be welded together using the method described above.

[0174] Once the connector 6, funnel-shaped member 5, and conduit 1 are fused together, the sleeve 4 is positioned around the conduit and attached to the funnel-shaped member 5. For example, it can be adhered to the inlet flange 23 with adhesive. Alternatively, laser welding can be used.

[0175] In use, the user can lubricate catheter 1 by any suitable known method; for example, they can release wetting fluid into cannula 4 to wet catheter 1. Cannula 4 is then moved to expose the proximal end, which the user then inserts into the body until fluid begins to flow along catheter 1. The fluid then flows along... Figure 3 The liquid path (LP) shown enters the funnel-shaped part 5 through the distal end 3 and continues into the connector 6 and any attached fluid collection bag.

[0176] In such Figure 6 and 7 In the second embodiment of the catheter assembly 100' shown, the components are similar to those described above with respect to the first embodiment. However, the funnel-shaped member 5' has only a single operating area 19', and the axial rib 24' extends only through the single operating area 19'. Therefore, the outer contour of the funnel-shaped member 5' in the first and second weld areas 17', 18' has no ribs, and is substantially flat around the entire circumference of the funnel-shaped member 5', and the thickness of each weld area 17', 18' is constant. This provides a funnel-shaped member 5' that is more suitable for forming a fluid-tight weld between the funnel-shaped member 5' and the catheter 1', because the inner and outer contours match each other throughout the circumference. As shown, in this embodiment, the funnel-shaped member 5' is narrower in the second weld area 18' than in the first weld area 17'.

[0177] The above description of one or more embodiments is by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims. For example, in other embodiments requiring a closed catheter assembly, the funnel-shaped element may be directly connected to the fluid collection bag without the need for a separate connector. In such embodiments, the funnel-shaped element is effectively the connector, or alternatively, the funnel-shaped element may be absent, and the connector may include features such as one or more catheter receiving areas to adapt it for direct fusion to the catheter.

Claims

1. A method for manufacturing a catheter assembly, the method comprising the following steps: A catheter is provided, comprising a distal end and a proximal end for insertion into the body; A first drainage element and a second drainage element are provided, wherein the first drainage element is arranged to receive fluid flowing along the conduit; The first drainage element and the second drainage element are arranged such that fluid can flow along the conduit to the first drainage element and then to the second drainage element; as well as The laser beam is guided onto the first and second drainage elements to form a laser fusion joint between the first and second drainage elements. Wherein: the first drainage element is provided at the distal end of the catheter, and the second drainage element is a funnel-shaped piece; or, the first drainage element is a funnel-shaped piece that can be connected to the distal end of the catheter, and the second drainage element is a connector.

2. The method according to claim 1, wherein, The catheter is an intermittent urinary catheter.

3. The method according to claim 1 or 2, wherein, One of the first drainage element and the second drainage element is an external element and the other is an internal element, and the method includes guiding a laser beam to the internal element via the external element.

4. The method according to claim 3, wherein, The method includes absorbing a portion of the laser beam into the external element to melt the external element during the formation of the laser weld.

5. The method according to claim 4, wherein, The method involves melting a large portion of the thickness of the external element during the formation of the laser weld.

6. The method according to any one of claims 3 to 5, wherein, The method involves using a laser beam to heat the external component to a higher temperature than the internal component.

7. The method according to any one of claims 3 to 6, wherein, The method includes melting the internal element via thermal conduction from the external element.

8. The method according to any one of claims 3 to 7, wherein, The surface of the internal element that is away from the external element does not melt during the formation of the laser weld.

9. The method according to any one of the preceding claims, wherein, The first drainage element and / or the second drainage element comprises a thermoplastic material that absorbs the laser beam in volume to cause the first drainage element and / or the second drainage element to melt.

10. The method according to claim 9, wherein, The laser beam, the first draining element, and the second draining element are configured such that, during the formation of the laser weld, volumetric absorption in the first draining element and / or the second draining element generates more heat than interfacial absorption at the interface between the first draining element and the second draining element.

11. The method according to any one of the preceding claims, wherein, The laser beam has a wavelength of more than 1.1 micrometers but not more than 3 micrometers.

12. The method according to claim 11, wherein, The wavelength of the laser beam is approximately 2 micrometers.

13. The method according to any one of the preceding claims, wherein, The first drainage element is a funnel-shaped piece that can be connected to the distal end of the catheter, and the second drainage element is a connector, and the method includes: forming a first laser fusion portion between the funnel-shaped piece and the catheter; and forming a second laser fusion portion between the funnel-shaped piece and the connector.

14. A catheter assembly manufactured according to the method of any one of the preceding claims.

15. A drainage element for a catheter, the drainage element comprising a tube defining an internal contour of the drainage element and a plurality of protrusions extending outwardly from the tube, wherein: The tube and the protrusion together define the outer contour of the drainage element; The drainage element includes an inlet portion configured to receive the catheter; The inlet portion includes a welding zone; The outer and inner contours of the drainage element are similar to each other in the fusion zone to facilitate the formation of a laser fusion joint between the drainage element and the conduit. The plurality of protrusions are arranged such that they are spaced apart between the centers of adjacent protrusions in a first direction; and The welded area spans at least the spacing in the first direction.

16. The drainage element according to claim 15, wherein, The inlet portion includes two or more conduit receiving areas and two or more welding areas, each conduit receiving area being configured to receive a different conduit, wherein a welding area is provided for each conduit receiving area.

17. The drainage element according to claim 16, wherein, The internal contour of the inlet portion includes a stepped section between adjacent duct receiving areas.

18. The drainage element according to claim 17, wherein, Each step has a welded area extending from it.

19. The drainage element according to any one of claims 15 to 18, wherein, The tube includes a flange located at one end of the inlet portion, the flange being configured to prevent the conduit from being over-inserted into the drainage element, and the welded area extending from the flange along the inlet portion.

20. The drainage element according to any one of claims 15 to 19, comprising an inlet end located at an end of the tube corresponding to the end of the inlet portion, and the welded area being spaced apart from the inlet end.

21. The drainage element according to any one of claims 15 to 20, wherein, In the weld zone, the inner profile and the outer profile are matched to provide a constant tube thickness across the weld zone.

22. The drainage element according to any one of claims 15 to 21, wherein, The entry portion includes an operating area, which includes at least two of the plurality of protrusions, and in the operating area, the outer contour is different from the inner contour.

23. The draining element according to any one of claims 15 to 22, further comprising an outlet portion configured as a receiving connector, the outlet portion including a fusion splice area.

24. A catheter assembly comprising a catheter and a drainage element according to any one of claims 15 to 23, wherein the catheter is inserted into the inlet portion and a laser-fused portion is provided between the drainage element and the catheter.

25. The catheter assembly of claim 24, wherein, The laser-welded portion provides a leak-proof seal between the drainage element and the conduit.

26. The method according to any one of claims 1 to 14, further comprising: Provide a drainage element according to any one of claims 15 to 23; The conduit is arranged in the inlet portion; And guide the laser beam onto the welding area to form a laser welding section between the drainage element and the conduit.

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