Method of attaching connector element to tubular element
By using a waveguide arrangement in the manufacturing of ureters to transmit light radiation to the inner passage surface of the connector element, the cumbersome and potential damage problems caused by the use of adhesives in the prior art are solved, and a simplified manufacturing process and efficient connection effect are achieved.
Patent Information
- Application Number
- CN202380079582.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-11-16
- Filing Date
- 2023-11-16
- Publication Date
- 2025-06-27
AI Technical Summary
Existing methods for manufacturing catheters require the use of adhesives, resulting in a cumbersome manufacturing process that can cause damage to the inner surface of the catheter and require additional cleaning and ventilation procedures.
The second polymer material is partially melted by using a waveguide arrangement to transmit light radiation to the inner passage surface of the connector element, thereby connecting the connector element to the tubular element, avoiding the use of adhesive.
This method simplifies the manufacturing process, improves workers' safety and health, reduces resource consumption, and achieves instant connection effect, avoiding the waiting time for adhesive curing.
Smart Images

Figure CN120225239A_ABST
Abstract
Description
[0001] This disclosure relates to a method of attaching a connector element to a tubular element in a catheter, and a catheter manufactured by the method. BRIEF DESCRIPTION OF THE DRAWINGS
[0002] The drawings are included to provide a further understanding of aspects and embodiments of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate examples and, together with the specification, are used to explain the principles of the aspects and examples. Many other examples and many of the intended advantages of the examples will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding like parts.
[0003] Figure 1 A cross-sectional view of a catheter including a connector element and a tubular element is shown,
[0004] Figure 2 Method steps according to an example of the present disclosure are shown,
[0005] Figure 3 A cross-sectional view of a connector element for a catheter is shown,
[0006] Figure 4 A cross-sectional view of a portion of a tubular element for a catheter is shown,
[0007] Figure 5 A cross-sectional view of a waveguide arrangement for guiding light radiation is shown,
[0008] Figures 6a to 6c Attaching the connector element to the tubular element by transmitting light radiation through the waveguide arrangement is shown,
[0009] Figures 7a to 7h Various examples of the waveguide arrangement and the delivery of light radiation are schematically shown, and
[0010] Figure 8 A manufacturing apparatus for attaching a connector element to a tubular element in a catheter is schematically shown. DETAILED DESCRIPTION
[0011] In the following, various examples of the present disclosure are described without reference to specific drawings.
[0012] An example of a first aspect of the present disclosure relates to a method for attaching a connector element to a tubular element in a catheter, wherein the tubular element is made of a first polymeric material and extends axially between a proximal portion and a distal portion, the tubular element including an inner surface and an outer surface, the inner surface defining a lumen extending in the axial direction, wherein the distal portion includes an opening that provides an entrance to the lumen.
[0013] Wherein the connector element is made of a second polymeric material and includes a connector conduit between a connector opening and a receiving passage, the receiving passage having an inner passage surface.
[0014] Wherein the method comprises the following steps:
[0015] - Providing an elongate waveguide arrangement extending between a first end and a second end, the waveguide arrangement being configured to guide optical radiation between the first end and the second end to emit the optical radiation at the second end;
[0016] - Arranging the distal portion of the tubular element inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage surface of the connector element; and
[0017] - Transmitting the optical radiation through the waveguide arrangement to deliver the optical radiation to the inner passage surface of the connector element such that the second polymeric material at the inner passage surface is at least partially melted to thereby connect at least a portion of the portion of the inner passage surface to at least a portion of the portion of the outer surface of the tubular element.
[0018] Providing delivery of optical radiation to the inner passage surface of the connector element via a waveguide arrangement to connect the connector element to the tubular element can potentially improve the manufacture of catheters.
[0019] In the conventional manufacture of catheters, the distal portion of the tubular element is immersed in an adhesive, and then the connector element is arranged on this distal portion to thereby attach the connector element to the tubular element via the adhesive. An example of such an adhesive is a cyclohexanone-based adhesive.
[0020] Such a conventional method may thus require a worker to manually apply the adhesive, which can be a tedious task. Further, in view of the catheter being intended to be used as a medical device, using an adhesive may impose additional flushing, cleaning, or venting procedures on the catheter manufacturing process. In particular, when the tubular element is immersed in the adhesive and / or due to capillary action, the adhesive will typically enter the lumen of the tubular element.
[0021] A method for attaching a connector element to a tubular element according to the present disclosure can avoid the use of adhesives. Thereby, the safety and health of manufacturing workers can be improved, and additional cleaning, rinsing, or ventilation steps can potentially be simplified or avoided. Moreover, the resources required in manufacturing can be reduced because the use of adhesives can potentially be completely avoided. In addition, the bond between the connector element and the tubular element is almost immediate compared to the bond provided by adhesives that may have to cure or harden for several hours.
[0022] A challenge in developing a new connection method is the size of the relatively small urinary catheter.
[0023] Furthermore, the tubular element is typically at least partially transparent to light radiation in, for example, the visible light spectrum because it is desirable for the user of the catheter to be able to visually inspect any contents of the tubular element. In contrast, the connector element is typically at least partially opaque and can even have different colors for different versions of the urinary catheter, and accordingly, the connector element is not suitable for transmitting light radiation for welding. Under typical given conditions where the portion of the outer surface of the tubular element that contacts the connection element is typically hidden within the connector element, welding via light radiation is generally considered infeasible.
[0024] However, the inventors have recognized that light radiation transmitted via a waveguide arrangement can be adapted to the size of the urinary catheter. By specifically targeting the inner passage surface of the connector element via the waveguide arrangement, the tubular element can be effectively connected to the connector element, even though the tubular element is potentially not suitable for absorbing light radiation and the connection element is not suitable for transmitting light radiation. The waveguide arrangement enables light radiation to be specifically delivered to the inner passage surface.
[0025] In an example of the present disclosure, the method includes the step of inserting a second end of the waveguide arrangement into the inner cavity, which is performed before the step of transmitting light radiation through the waveguide arrangement.
[0026] By inserting the second end of the waveguide arrangement into the inner cavity, light radiation can be accurately and effectively delivered to the inner passage surface. In particular, the insertion of the waveguide arrangement allows light radiation to be provided at an incident angle that allows the light radiation to effectively transmit through the inner surface of the tubular element. In contrast, light radiation provided at a large incident angle may suffer a relatively large proportion of the radiation being reflected.
[0027] Preferably, the second end of the waveguide arrangement is inserted into the tubular element such that during the step of transmitting light radiation through the waveguide arrangement, the second end of the waveguide arrangement is positioned within the receiving passage of the connector element.
[0028] In an example of the present disclosure, the step of inserting the second end of the waveguide arrangement into the inner cavity is performed after the step of disposing the distal portion of the tubular element inside the receiving passage.
[0029] By inserting the waveguide arrangement into the lumen after disposing the tubular element inside the receiving passage of the connector element, the presence of the connector element can facilitate the insertion of the waveguide arrangement. Typically, the connector duct of the connector element can have an inner funnel surface terminating at a connector opening for the purpose of connecting the connector element to, for example, a catheter bag. During manufacture according to the present disclosure, this inner funnel surface can guide the waveguide arrangement into the distal portion of the tubular element in the case where the second end of the waveguide arrangement is misaligned with the axial direction of the tubular element before insertion.
[0030] In an example of the present disclosure, the second end of the waveguide arrangement is inserted into the lumen via an opening in the distal portion of the tubular element.
[0031] The opening in the distal portion of the tubular element is located near a portion of the outer surface of the tubular element to be welded. Thus, inserting the second end of the waveguide arrangement through this opening can serve as a simple and effective insertion process.
[0032] In an example of the present disclosure, a portion of the inner passage surface is joined to a portion of the outer surface by a continuous weld extending circumferentially around the outer surface of the tubular element.
[0033] The continuous weld advantageously provides a fluid-tight seal between the connector element and the tubular element. Preferably, the continuous weld extends completely around the outer surface of the tubular element.
[0034] In an example of the present disclosure, the first polymer material and the second polymer material include TPU.
[0035] TPU can also be referred to as thermoplastic polyurethane. This material can be melted to join the connector element to the tubular element while allowing the tubular element to be at least partially transparent, while the connector element is opaque.
[0036] In an example of the present disclosure, light radiation is delivered to the inner passage in a lateral delivery orientation transverse to the axial direction of the lumen.
[0037] The lateral delivery orientation ensures that the light radiation is delivered at an incident angle that allows the light radiation to effectively transmit through the inner surface of the tubular element.
[0038] Preferably, the light radiation delivered to the inner passage in the lateral delivery orientation corresponds to at least 70% of the power provided at an incident angle (relative to the normal of the inner surface) of less than 60 degrees, such as less than 50 degrees, such as less than 40 degrees, such as less than 30 degrees, such as 20 degrees (e.g., less than 10 degrees). In this context, power is the amount of energy transferred per unit time, measured, for example, in watts (i.e., joules / second).
[0039] A lateral delivery orientation does not exclude the delivery of light radiation in more than one radial direction or circumferentially with respect to the axial direction of the tubular element.
[0040] In an example of the present disclosure, the method includes performing a relative rotation about the axial direction of the tubular element during the step of transmitting light radiation through the waveguide arrangement.
[0041] The relative rotation about the axial direction of the tubular element can be implemented, for example, by rotation of the waveguide arrangement or the tubular element, such that the delivery of the light radiation rotates about the axial direction with respect to the tubular element and / or the connector element.
[0042] Providing the relative rotation during the step of transmitting the light radiation can ensure the establishment of a continuous and uniform weld seam around the entire circumference of the outer surface portion and the inner passage surface portion.
[0043] In an example where the light radiation is guided along one or more radial directions, i.e., an example where the light radiation is not circumferentially guided within the receiving passage, performing the relative rotation is particularly relevant. However, the relative rotation is not limited to such examples. Even if the light radiation is redirected circumferentially within the tubular element, rotation can improve the uniformity of the weld seam. This can be relevant, for example, in the case of a non-uniform intensity distribution of the light radiation provided by the waveguide arrangement, in the case of misalignment between the waveguide arrangement and the optical element, or in the case of imperfect redirection by the optical element.
[0044] In an example of the present disclosure, performing the step of relative rotation causes the lateral delivery orientation of the light radiation to rotate with respect to the outer surface of the tubular element and the inner passage surface of the connector element.
[0045] Accordingly, the outer surface and the inner passage surface of the tubular element are continuously joined.
[0046] The relative rotation causing the rotation of the lateral delivery orientation can be implemented, for example, by rotation of the waveguide arrangement or rotation of the connector element and the tubular element.
[0047] In an example of the present disclosure, performing the step of relative rotation includes rotating the waveguide arrangement or the tubular element.
[0048] In the case of rotating the tubular element, the connector element can typically also rotate with the tubular element.
[0049] In an example of the present disclosure, the method includes:
[0050] - Providing an optical element configured to redirect the light radiation;
[0051] - Inserting the optical element into the lumen such that the optical element is positioned within the receiving passage and the distal portion of the tubular element,
[0052] Therein, after the light radiation has passed through the waveguide arrangement, the light radiation is delivered to the inner passage surface by redirecting the light radiation via the optical element.
[0053] Providing the optical element positioned within the receiving passage allows the optical element to effectively redirect the light radiation delivered thereto. Further, the waveguide arrangement itself does not necessarily need to be aimed at the inner passage surface, but only has to transmit the light radiation into the receiving passage, and the optical element can redirect the light radiation from the receiving passage accordingly.
[0054] Examples of suitable optical elements are reflective elements (such as mirrors), dispersive elements (such as lenses and prisms), diffractive elements (such as gratings), and diffusive elements (such as engineered diffusers configured to diffusely and scatter light radiation in a controlled manner). Metasurfaces can also constitute an optical element that is configured to redirect light radiation, for example, by modulating the wave of the light radiation via the boundary conditions of the metasurface. Another example of an optical element is a waveguide end assembly, such as a shaped fiber end.
[0055] In an example of the present disclosure, the optical element is a waveguide end assembly attached to the second end of the waveguide arrangement.
[0056] Providing the optical element in the form of a waveguide end assembly can ensure simple and effective redirection of the light radiation. In particular, the attachment between the waveguide arrangement and the optical element can ensure that the optical element is always correctly aligned with the waveguide assembly during use, and the waveguide arrangement and the optical element can be quickly inserted together into the tubular element.
[0057] Examples of waveguide end assemblies are shaped fiber ends, mirror elements attached to the second end of the waveguide arrangement, and dispersive elements attached to the second end of the waveguide arrangement.
[0058] In an example of the present disclosure, the optical element redirects the light radiation from the axial direction of the inner cavity to a transverse delivery orientation.
[0059] Thus, the waveguide arrangement can transmit the light radiation into the receiving passage of the connector element, and the optical element can redirect the light radiation from the receiving passage along the transverse delivery orientation to the inner passage surface.
[0060] In an example of the present disclosure, the optical element is conical to redirect the light radiation radially circumferentially.
[0061] Conical optical elements can redirect light radiation radially circumferentially such that the inner passage surface of the connector element and the outer surface of the tubular element can potentially be joined along a weld seam that extends circumferentially, at least in part, or completely around the outer surface of the tubular element. In contrast, waveguide arrangements or optical elements that deliver light radiation in only one or a few different radial directions may require, for example, relative rotation to ensure an appropriate weld seam.
[0062] Examples of conical optical elements are conical mirrors and axicon lenses.
[0063] In examples of the present disclosure, the optical element is configured to redirect light radiation directionally in at least one radial direction.
[0064] Preferably, the at least one radial direction is a different radial direction such that the light radiation is not redirected circumferentially with respect to the axial direction of the tubular element, but rather with respect to one or more different radial directions. Compared to circumferentially redirected light radiation, this approach may reduce the power of the light radiation required to melt the second polymeric material as the light radiation is distributed over a smaller area of the inner passage surface.
[0065] In examples of the present disclosure, the step of performing relative rotation includes rotating the optical element.
[0066] Preferably, the optical element rotates relative to the tubular element and the connector element.
[0067] In examples of the present disclosure, a first polymeric material is associated with a first attenuation coefficient of light radiation and a second polymeric material is associated with a second attenuation coefficient of light radiation, wherein the second attenuation coefficient is greater than the first attenuation coefficient.
[0068] In examples of the present disclosure, the second attenuation coefficient is at least 2 times, such as at least 5 times, for example at least 10 times the first attenuation coefficient.
[0069] Since the first polymeric material has a lower attenuation than the second polymeric material, light radiation can effectively penetrate to the inner passage surface of the connector element. Further, since the second polymeric material has a greater attenuation than the first polymeric material, the second polymeric material may be able to effectively absorb light radiation and, correspondingly, focusing optics configured to focus the light radiation to a specific focus near the interface between the connector element and the tubular element can be avoided.
[0070] The attenuation coefficient can be understood as the (relative) attenuation of light radiation per unit propagation distance in a given material.
[0071] In examples of the present disclosure, the light radiation only penetrates through the inner surface of the tubular element once after being emitted from the waveguide arrangement.
[0072] An alternative method is to provide light radiation from outside the tubular element through the opening of the receiving passage of the connector element. With this alternative method, the light radiation passes through the circumferential wall of the tubular element twice. For example, after passing through the waveguide arrangement, the light radiation will pass through the outer surface of the tubular element, the circumferential wall of the tubular element, the inner surface of the tubular element, and then enter the receiving passage of the connector element. The light radiation will pass through the inner surface and the circumferential wall of the tubular element again from this receiving passage and then be delivered to the inner passage surface of the connector element. Each time the light radiation passes through a surface, a small portion of the light radiation is scattered.
[0073] In contrast, the scattering of the light radiation before being delivered to the inner passage surface can potentially be reduced in the case where the light radiation is only transmitted through the inner surface once (i.e., once). This method can be implemented, for example, by inserting the second end of the waveguide arrangement into the inner cavity of the waveguide arrangement, from which the light radiation only has to pass through the inner surface of the tubular element once to reach the inner passage surface of the connector element.
[0074] In an example of the present disclosure, the second polymeric material of the connector element includes an optical absorption additive to provide an optical absorption band to the inner passage surface, wherein the central wavelength of the light radiation lies within the optical absorption band.
[0075] Providing the optical absorption additive to or on the second polymeric material of the connector element allows the light radiation to be effectively absorbed mainly by the connector element.
[0076] In an example of the present disclosure, the optical absorption band has an upper boundary below 2000 nm, such as below 1600 nm (for example, below 1200 nm).
[0077] Providing that the optical absorption band has an upper boundary allows the light radiation to be sufficiently spaced apart from the natural absorption peak in the first polymeric material of the tubular element. Accordingly, the light radiation can pass through the tubular element and be effectively absorbed by the connector element. This is particularly advantageous in the context of a urinary catheter, where a smooth inner surface of the tubular element is desired. If too much light radiation is absorbed by the first polymeric material, the inner surface may be damaged.
[0078] The optical absorption band can be defined, for example, by the (second) attenuation coefficient of the second polymeric material. For example, the optical absorption band can be defined by an optical range in which the penetration depth of the light radiation is less than 1 mm. The penetration depth can be defined as the distance at which the intensity of the light radiation inside the material (due to absorption) drops to 1 / e (corresponding to approximately 37%) of its original value.
[0079] In an example of the present disclosure, the radius of the outer surface of the tubular element is greater than the radius of the inner passage surface of the connector element such that in the step of disposing the distal portion of the tubular element inside the receiving passage of the connector element, the connector element is press-fitted onto the tubular element.
[0080] Compared to conventional manufacturing methods that rely on the use of adhesives, the present disclosure provides for the joining of the connector element and the tubular element by means of light radiation. As a result, the previously adopted dimensions of the connector element and the tubular element are not necessarily optimal.
[0081] When using an adhesive, a small gap between the two parts may be desirable to ensure that a certain amount of adhesive can actually be present between the two parts. In contrast, when welding and joining via light radiation, a gap between the outer surface of the tubular element and the inner passage surface of the connector element is generally disadvantageous.
[0082] Providing that the radius of the outer surface of the tubular element is greater than the radius of the inner passage surface of the connector element ensures that any gap between the outer surface and the inner passage surface is minimized. Furthermore, this provision can also establish a press-fit between the tubular element and the connector element, which can serve as a preliminary attachment between the connector element and the tubular element until they have been joined by welding via light radiation. Accordingly, an independent procedure for fixing the two parts to each other during the transmission of light radiation can be avoided.
[0083] The radius of the outer surface being greater than the radius of the inner passage surface can be achieved by the material of the catheter. Generally, polymer materials suitable for catheters (such as thermoplastic polyurethane) are relatively soft. Therefore, the implementation of minimizing the gap between the relevant surfaces and providing a sufficient press-fit radius can be relatively simple.
[0084] The radius of the outer surface of the tubular element can be measured from the central axis extending in the axial direction of the tubular element. The radius of the inner passage surface can be measured from the central axis of the receiving passage. When the tubular element and the connector element are attached such that the distal portion of the tubular element is disposed inside the receiving passage of the connector element, the central axis of the tubular element and the central axis of the receiving passage overlap. However, these radii should be measured when the tubular element and the connector element are not attached to each other.
[0085] Preferably, the radius of the outer surface of the tubular element is between 1% and 20% greater than the radius of the inner passage surface of the connector element, such as between 2% and 15% (for example, between 3% and 10%).
[0086] An example of the second aspect of the present disclosure relates to a catheter manufactured by the method according to the first aspect of the present disclosure.
[0087] A catheter manufactured by the method according to the first aspect of the present disclosure can potentially avoid the use of adhesives, such as cyclohexanone. In particular, the use of adhesives may corrode, damage, or deteriorate the inner surface, causing the surface to become corrugated. Due to the absence of an adhesive disposed on the inner surface of the tubular element, it is easier to avoid bacterial growth on the inner surface and potentially improve fluid flow.
[0088] An example of the third aspect of the present disclosure relates to a catheter comprising:
[0089] - a tubular element made of a first polymeric material and extending axially between a proximal portion and a distal portion, the tubular element including an inner surface and an outer surface, the inner surface defining a lumen extending in the axial direction, wherein the distal portion includes an opening providing an entrance to the lumen; and
[0090] - a connector element made of a second polymeric material and including a connector conduit between a connector opening and a receiving passage, the receiving passage having an inner passage surface,
[0091] wherein the distal portion of the tubular element is disposed inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage surface of the connector element,
[0092] wherein at least a portion of the portion of the inner passage surface of the connector element is joined to at least a portion of the portion of the outer surface of the tubular element by a continuous weld extending circumferentially completely around the outer surface of the tubular element.
[0093] Compared to a conventional catheter in which the connector element is joined to the tubular element by an adhesive (such as cyclohexanone), a catheter in which the connector element is joined to the tubular element by a continuous weld can potentially provide several advantages. The content of the adhesive in the catheter is naturally reduced. The use of the adhesive may potentially cause the inner surface of the tubular element to become corrugated, and by reducing or omitting the adhesive, it is easier to avoid bacterial growth on the inner surface and potentially improve fluid flow.
[0094] Typically, the axial length of the portion of the tubular element disposed inside the receiving passage of the connector is greater than the axial length of the continuous weld. As an example, the axial length of the portion of the tubular element disposed inside the connector is 10.0 mm, while the axial length of the continuous weld is 2.0 mm.
[0095] Preferably, the continuous weld is displaced from the outer boundary of the receiving passage and from the outer boundary of the distal portion of the tubular element. In other words, the continuous weld can be (axially) centered somewhere between the outer boundary of the receiving passage and the outer boundary of the distal portion of the tubular element, rather than at the outer boundary of the receiving passage and the outer boundary of the distal portion of the tubular element. Thereby, the continuous weld can potentially ensure that the gap between the outer surface of the tubular element and the inner passage surface of the connector element is not too large at the outer boundaries of the receiving passage and the distal portion. Otherwise, such a gap may easily accumulate bacteria or unwanted debris.
[0096] In an example of the present disclosure, the inner surface of the tubular element is homogeneous along the axial direction.
[0097] This homogeneity can be quantified, for example, in terms of surface roughness and surface roughness parameters. Of particular interest is that, along the axial direction, the surface roughness (parameters) of the inner surface of the portion of the tubular element disposed inside the receiving passage of the connector element is substantially no greater than the surface roughness (parameters) of the remaining portion of the tubular element.
[0098] Thereby, in a preferred example, the surface roughness parameter of the inner surface of the portion of the tubular element disposed inside the receiving passage is at most 50% greater, such as at most 40% greater, such as 30% greater, such as 20% greater, such as 10% greater, such as 5% greater, than the surface roughness parameter of the inner surface of the remaining portion of the tubular element.
[0099] The surface roughness parameter can be measured according to the ISO 21920-2:2021 standard.
[0100] In an example of the present disclosure, the tubular element is not exposed to an adhesive.
[0101] In an example of the present disclosure, the inner surface of the tubular element is not exposed to an adhesive.
[0102] In an example of the present disclosure, the catheter is manufactured by the method according to the first aspect of the present disclosure.
[0103] An example of the fourth aspect of the present disclosure relates to a manufacturing apparatus for attaching a connector element to a tubular element in a catheter,
[0104] wherein the tubular element is made of a first polymeric material and extends axially between a proximal portion and a distal portion, the tubular element includes an inner surface and an outer surface, the inner surface defining a lumen extending along the axial direction, wherein the distal portion includes an opening that provides an entrance to the lumen,
[0105] Wherein, the connector element is made of a second polymer material and includes a connector conduit between the connector opening and the receiving passage, the receiving passage having an inner passage surface,
[0106] The manufacturing apparatus includes:
[0107] - A catheter fixture configured to hold a catheter pre-assembly including the connector element and the tubular element, wherein a distal portion of the tubular element is disposed inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage surface of the connector element;
[0108] - A light radiation source configured to emit light radiation;
[0109] - An elongate waveguide arrangement extending between a first end and a second end, wherein the first end is optically coupled to the light radiation source;
[0110] - A relative actuator configured to move the second end of the waveguide arrangement relative to the catheter fixture; and
[0111] - A control arrangement configured to control the relative actuator to insert the second end of the waveguide arrangement into the lumen when the catheter pre-assembly is held in the catheter fixture, and configured to subsequently control the light radiation source to transmit the light radiation through the waveguide arrangement to deliver the light radiation to the inner passage surface of the connector element.
[0112] The fourth aspect presented above proposes that the relative actuator is configured to move the second end of the waveguide arrangement relative to the catheter fixture. Within the scope proposed herein, the relative actuator can, for example, move the second end of the waveguide arrangement, move the catheter fixture, or move both the second end of the waveguide arrangement and the catheter assembly. In each of these examples, the second end of the waveguide arrangement moves relative to the catheter fixture. In any case, this relative movement should preferably ensure that when the catheter pre-assembly is held in the catheter fixture, the second end of the waveguide arrangement can be inserted into the lumen of the tubular element.
[0113] The fourth aspect presented above further mentions a catheter pre-assembly. The catheter pre-assembly includes the connector element and the tubular element, wherein a distal portion of the tubular element is disposed inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage surface of the connector element. The catheter pre-assembly can thus be, for example, a connector element press-fitted onto the tubular element, where the connector element has not yet been joined to the tubular element by transmitting light radiation to the inner passage surface.
[0114] The control arrangement can be implemented, for example, as a programmable logic controller, such as an industrial microprocessor-based controller having a programmable memory for storing program instructions and various functions. The control arrangement can be part of a larger industrial control system.
[0115] In an example of the present disclosure, the manufacturing device is configured to attach a connector element to a tubular element by a method according to the first aspect of the present disclosure.
[0116] Various concepts of the present disclosure are explained below.
[0117] In the context of the present disclosure, whenever reference is made to the proximal end or proximal portion of a tubular element, reference is made to the end that is closest to the user when the urinary catheter is in use. Whenever reference is made to the distal end or distal portion, reference is made to the end that is furthest from the user in use. The axial direction is the direction from the proximal end to the distal end and vice versa; that is, for a urinary catheter, the axial direction corresponds to the longitudinal direction. The radial direction is the direction transverse to the axial direction.
[0118] In the context of the present disclosure, a urinary catheter is a catheter adapted to be inserted into the urethra. The catheter typically includes a tubular element, the outer diameter of which corresponds to the catheter size. For intermittent urinary catheters, the catheter size typically ranges between CH6 and CH18; CH stands for charrier and is a common indicator of catheter size. The CH size represents the outer diameter of the catheter, where the diameter is the number divided by three, meaning that CH6 has an outer diameter of 2 mm and CH18 has an outer diameter of 6 mm. The tubular element of the catheter is typically enclosed in a rounded hemispherical tip at the proximal end; this is also referred to as a Nelaton tip. Other types of tips can be used, such as coudé or Tiemann tips, which are tips angled relative to the tubular element. Another example is the so-called flexible tip, where the tip includes a necked-down portion followed by a rounded spherical or olive-shaped portion in the proximal direction. In the distal portion of the tubular element, the catheter can be provided with a connector element adapted to connect the catheter to a drainage tube. The connector element typically has a funnel-shaped inner surface near the connector opening such that the drainage tube can be attached by a friction fit coupling. Typically, the connector element further has a receiving passage where the distal portion of the tubular element is arranged when the urinary catheter has been manufactured.
[0119] The size of the catheter can vary according to the exact application, such as whether the catheter is intended for use by males or females, or according to the user's urinary system condition. An exemplary length of the catheter along the axial direction of the tubular element is 200 mm. The typical inner diameter of the tubular element ranges from 1 mm to 4 mm, for example 1.2 mm, 1.7 mm, 2.3 mm, 2.7 mm, 3.2 mm, and 3.8 mm. In contrast, a waveguide arrangement (such as an optical fiber) can have a size of less than 1 mm, thereby allowing such a waveguide arrangement to be inserted into the lumen of the tubular element.
[0120] Typically, if the waveguide arrangement is to be inserted into the tubular element, the waveguide arrangement can be inserted at the proximal part or the distal part of the tubular arrangement. Depending on the manufacturing process, the tubular element can be open or not open at the proximal part. A feasible manufacturing procedure is to cut the tubular element from a tubular element stock, then the proximal part of the tubular element is sealed and rounded, and subsequently, the proximal part is provided with a drainage opening or orifice for draining urine from the user's bladder. Given these conditions, the waveguide arrangement can in principle be inserted through the opening of the distal part at any stage, inserted at the opening of the proximal part before sealing, or inserted via a subsequently provided drainage opening or orifice. However, typically, inserting through the opening of the distal part is the simplest to implement in practice.
[0121] An elongate waveguide arrangement can generally be referred to as a waveguide arrangement.
[0122] The catheter of the present disclosure can be intermittent or indwelling. What the two types of catheters have in common is that they are inserted through the urethra until the tip reaches the bladder and urine starts to drain. The difference lies in the indwelling time in the bladder and the retention device in the case of an indwelling catheter. The intermittent catheter is only indwelling in the bladder for the time required to empty the bladder. These types of catheters maintain normal bladder function in such a way that the bladder fills naturally and empties in a rhythm that mimics normal bladder emptying. The intermittent catheter is typically used 4 to 6 times a day. On the other hand, the indwelling catheter is inserted into the bladder, and a retention device in the form of, for example, an inflatable balloon or a malecot or other device is used to hold the catheter tip in the bladder for a period of several days, weeks, or even up to several months. During this indwelling period, the catheter continuously empties the bladder by allowing urine to continuously drain through the catheter. Between these two types of catheters, there will typically be a difference in the type of material used to manufacture the tubular element. Typically, compared with the indwelling catheter, the intermittent catheter is slightly more rigid because the intermittent catheter has to be inserted through the urethra several times a day without causing too much effort in the insertion procedure, while the insertion of the indwelling catheter is less important, but rather the softness and flexibility of the catheter during the indwelling period are important so that it stimulates the user as little as possible.
[0123] In an example, the catheter may be provided with a hydrophilic coating.
[0124] The hydrophilic coating may be provided only on the insertable part of the catheter, which means that for example the connector element is not coated. The hydrophilic surface coating is such that when hydrated or swollen using a swelling medium, it will reduce the friction on the surface area of the catheter (corresponding to the insertable part of the catheter) intended to be inserted into the user's urinary tract.
[0125] The intermittent hydrophilic catheter differs from the indwelling catheter in that the hydrophilic surface coating of this catheter is not suitable for indwelling use because if left in the body for a period exceeding 5 to 20 minutes, the surface coating tends to stick within the urethral mucosa, due to the hydrophilic coating transitioning from highly lubricated when fully wetted (95% by weight of water) to being sticky when the hydration level of the coating decreases (<75% by weight of water).
[0126] Generally, aspects of the present disclosure rely on using light radiation to join the inner passage surface of the connector element to the outer surface of the tubular element. Since polymer materials are used, the first polymer material of the tubular element and the second polymer material of the connector element can be effectively joined or welded together while the two materials are arranged against each other.
[0127] From the perspective of the propagation path of the light radiation, the second polymer material is typically located behind the first polymer material. Typically, it is mainly the second polymer material that absorbs the light radiation. Accordingly, the light radiation can preferably propagate through the first polymer material, where a relatively small portion of the light radiation is absorbed in this first polymer material.
[0128] This can be achieved for example by making the first polymer material at least partially transparent to the light radiation while the second polymer material is at least partially opaque to the light radiation. Here, transparent and opaque should of course be understood with respect to the frequency and wavelength of the light radiation, rather than with respect to the electromagnetic radiation visible to the human eye.
[0129] Appropriate absorption in the second polymer material can be obtained for example by embedding appropriately selected optical absorption additives in the second polymer material. Thereby, the second polymer material can be customized to absorb the light radiation while the first polymer material does not absorb the light radiation.
[0130] Generally, the central wavelength of the light radiation can preferably be in the range of 400 nm to 10,000 nm, more preferably in the range of 600 nm to 2,000 nm, and even more preferably in the range of 800 nm to 1,200 nm.
[0131] Further, the power of the light radiation can preferably be at least 5 W, such as at least 10 W, for example at least 30 W. Naturally, the required power of the light radiation depends on the area over which the light radiation is distributed. Thus, the required amount of light radiation can alternatively be expressed in terms of the spatial peak intensity of the light radiation at the inner passage surface. The spatial peak intensity of the light radiation can preferably be at least 20 W / cm 2 , such as at least 50 W / cm 2 , for example at least 200 W / cm 2 .
[0132] Such wavelength, power, and intensity can be obtained by using a laser as the light radiation source to provide the light radiation. Suitable lasers are diode lasers, Nd:YAG lasers, and CO2 lasers. Typically, diode lasers are preferred, such as diode lasers with a wavelength of 808 nm or 940 nm.
[0133] Appropriately selected power and wavelength can ensure that a portion of the second polymeric material melts. This can in turn cause a portion of the first polymeric material to melt. The melted portions of the first material and the second material are joined, and when the delivery of light radiation to the melted portions is terminated, the melted portions solidify to thereby form a weld.
[0134] Generally, the light radiation is delivered to the inner passage surface of the connector element by using a waveguide arrangement to transmit the light radiation. Such a waveguide arrangement can be any kind of structure suitable for guiding the light radiation from the first end and the second end of the waveguide arrangement. Since light radiation is employed, examples of suitable waveguide arrangements include optical fiber waveguides, transparent dielectric waveguides, and hollow tubular structures that internally reflect the light radiation. The waveguide arrangement can also be, for example, a bundle of optical fibers that are arranged such that individual optical fibers can provide light radiation to individual portions of the inner passage surface.
[0135] Detailed Description of the Drawings
[0136] Figure 1 Shows a cross-sectional view of a urinary catheter 10 including a connector element 20 and a tubular element 13. The plane of the cross-sectional view extends along the longitudinal and axial directions of the tubular element 13 and the urinary catheter 10.
[0137] The catheter 10 has a proximal portion 11 adapted to be inserted into a human urethra and a distal portion 12 adapted to conduct urine out of the catheter. The catheter has a tubular element 13 having a lumen 14 configured to conduct urine from the proximal portion 11 to the distal portion 12. The proximal portion 11 has a drainage opening 15 or aperture such that urine from the bladder can enter the lumen 14 through the drainage opening / aperture and travel through this lumen 14 to the distal portion. A connector element 20 is attached at the distal portion 12, which can be used to connect, for example, a drainage tube.
[0138] Figure 2 Method steps S1 to S3 according to an example of the present disclosure are shown. The example relates to attaching a connector element to a tubular element.
[0139] In this example, the tubular element is made of a first polymeric material and extends axially between a proximal portion and a distal portion. The tubular element includes an inner surface and an outer surface. The inner surface defines a lumen extending axially. The distal portion includes an opening that provides an entrance to the lumen.
[0140] Further, the connector element is made of a second polymeric material and includes a connector tube between a connector opening and a receiving passage. The receiving passage has an inner passage surface.
[0141] In a first step S1 of the method, an elongated waveguide arrangement is provided. The waveguide arrangement extends between a first end and a second end and is configured to guide light radiation between the first end and the second end to emit this light radiation at the second end.
[0142] As an example, the waveguide arrangement can be provided together with a light radiation source configured to emit light radiation. Then, the first end of the waveguide arrangement is typically optically coupled to the light radiation source such that the light radiation emitted from the light radiation source is optically coupled into the first end, transmitted through the waveguide arrangement, and emitted at the second end.
[0143] The waveguide arrangement (and optionally the light radiation source) can be provided as part of a partially or fully automated manufacturing apparatus.
[0144] In the next step S2 of the method, the distal portion of the tubular element is disposed inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage of the surface of the connector element.
[0145] This step can be performed manually or automatically. In the case of manual performance, a human operator can simply insert the distal portion into the receiving passage. In the case of automated performance, a linear actuator or other machinery can be employed to insert the distal portion into the receiving passage.
[0146] The tubular element and the connector element form a catheter pre-assembly, wherein the distal portion of the tubular element is disposed inside the receiving passage of the connector element without a weld therebetween.
[0147] In the next step S3 of the method, light radiation is transmitted through the waveguide arrangement to thereby deliver the light radiation to the inner passage surface of the connector. This delivery of the light radiation at least partially melts the second polymeric material at the inner passage surface to thereby join at least a portion of the portion of the inner passage surface to at least a portion of the portion of the outer surface of the tubular element.
[0148] Accordingly, the connector element and the tubular element are attached by welding.
[0149] Optionally, the method according to an example of the present disclosure may further include the step of inserting the second end of the waveguide arrangement into the lumen of the tubular element. This step is then performed before the step of transmitting light radiation through the waveguide arrangement.
[0150] This step of inserting the second of the waveguide arrangement into the lumen may be performed manually or automatically. In the case of automatic execution, a relative actuator may be employed that is configured to move the second end of the waveguide arrangement and / or the tubular element.
[0151] The step of transmitting the light radiation may be initiated manually or automatically. For example, automatic initiation may be performed in response to inserting the second end of the waveguide arrangement into the lumen.
[0152] Further, the method according to an example of the present disclosure may optionally include the step of performing a relative rotation about the axial direction of the tubular element during the step of transmitting light radiation through the waveguide arrangement. Such a step may be performed manually or automatically. If performed automatically, the step may be implemented, for example, by a rotary actuator (such as a stepper motor).
[0153] Generally, any automatic execution of the method steps may be controlled, for example, by a control arrangement.
[0154] It should be noted that generally, fully manufacturing a urinary catheter includes additional steps such as molding, coating, cutting, etc.
[0155] Figure 3 A cross-sectional view of a connector element 20 for a urinary catheter is shown.
[0156] The connector element 20 is formed of a second polymeric material 41. In this specific example, the second polymeric material 41 consists of thermoplastic polyurethane.
[0157] The connector element 20 includes a connector conduit 21 that fluidly connects a connector opening 22 and a receiving passage 23. The receiving passage 23 is configured to receive a tubular element, and the connector opening 22 is configured to facilitate the withdrawal of urine from the fabricated catheter. The receiving passage 23 has an inner passage surface 24 that terminates at an inner support 26, whereby the inner support defines a stop for the tubular element being inserted into the connector element 20. The connector conduit 21 has an inner funnel surface 25 for connecting the opening 22 to, for example, a drainage tube.
[0158] The receiving passage 23 and the inner passage surface 24 define a central axis 60 of the receiving passage 23. In this particular example, the inner passage has a cylindrical shape, where the central axis 60 corresponds to the axis of this cylinder. From this central axis 60, the radius 61 of the inner passage surface 24 can be measured.
[0159] Figure 4 A cross-sectional view of a portion of the tubular element 13 for a catheter is shown. In this particular illustration, only the portion of the tubular element near the distal portion 17 is shown.
[0160] The tubular element 13 is formed of a first polymeric material 40. In this specific example, the first polymeric material 40 consists of thermoplastic polyurethane.
[0161] The tubular element 13 extends in an axial direction between a proximal portion (not shown) and a distal portion 17. In this illustration, the axial direction coincides with the central axis 62 of the tubular element 13.
[0162] The tubular element 13 further has an inner surface 18 and an outer surface 17, where the inner surface 18 defines a lumen 14 that is configured to facilitate the withdrawal of urine through the tubular element 13 when the catheter is in use.
[0163] The outer surface 19 defines the central axis of the tubular element 62. In this particular example, the tubular element 13 is shaped as a hollow cylinder, where the central axis 62 corresponds to the axis of this hollow cylinder. From this central axis 62, the radius 63 of the outer surface 19 of the tubular element 13 can be measured.
[0164] Figure 5 A cross-sectional view of a waveguide arrangement 30 for guiding optical radiation is shown. The waveguide arrangement 30 extends between a first end 31 and a second 32, and the arrangement 30 is configured to guide optical radiation from the first end 31 to the second end 32.
[0165] In this particular example, the waveguide arrangement 30 includes an optical element 34 configured to redirect optical radiation. The waveguide arrangement 30 is integrally attached to this optical element 34, which is here implemented as a waveguide end component in the form of a conical end, the conical end being configured to radially circumferentially redirect optical radiation when the optical radiation is transmitted from a first end 31 through the waveguide arrangement 30 to a second end 32. Thus, the laser beam of optical radiation transmitted through the waveguide arrangement 30 can be circumferentially output at the optical element 34 in an annular pattern.
[0166] Figures 6a to 6c Shown is attaching the connector element 20 to the tubular element 13 by transmitting optical radiation 33 through the waveguide arrangement 30. The connector element 20 is substantially similar to Figure 3 the connector element shown, and the tubular element 13 is substantially similar to Figure 4 the tubular element 13 shown, and the waveguide arrangement 30 is substantially similar to Figure 5 the waveguide arrangement shown.
[0167] In Figure 6a it, the tubular element 13 is preliminarily attached to the connector element 20 to form a catheter pre-assembly. The connector conduit 21 of the connector element 20 has an inner support 26 that projects radially inwards and defines a stop for the tubular element 13. Correspondingly, the distal portion 17 of the tubular element 13 is inserted into the receiving passage 23 of the connector element 20 such that the tubular element 13 terminates at the inner support 26.
[0168] In this particular example, the connector element 20 is preliminarily attached to the tubular element 13 by a press fit. This fit is achieved by the radius of the outer surface of the tubular element 13 being slightly larger than the radius of the inner passage surface.
[0169] In Figure 6b it, the waveguide arrangement 30 is inserted into the lumen 14 of the tubular element 13. The waveguide arrangement 30 is inserted such that the second end 32 of the waveguide arrangement 30 is within the distal portion 17 of the tubular element 13 and within the receiving passage 23 of the connector element 20. Further, in this example where the waveguide arrangement 30 has the optical element 34, the optical element is also within the distal portion 17 of the tubular element 13 and within the receiving passage 23 of the connector element 20.
[0170] In Figure 6c it, optical radiation 33 is transmitted through the waveguide arrangement 30 to deliver the optical radiation 33 to the inner passage surface 24 of the connector element 20. The optical radiation 33 can be provided, for example, from an optical radiation source such as a laser source.
[0171] The optical radiation 33 transmitted through the waveguide arrangement 30 propagates along the longitudinal axial direction of the waveguide arrangement 30, which in this illustration overlaps with the central axis of the receiving passage and the central axis of the tubular element. At the second end 32 of the waveguide arrangement 30, the optical radiation 33 is output to be delivered to the inner passage surface 24 of the connector element 20. In this particular example, the optical radiation 33 is redirected from the axial direction to a lateral delivery orientation transverse to the axial direction of the inner cavity by the optical element 34 at the second end 32.
[0172] In this particular illustration, the redirection by the optical element is shown such that the propagation directions of the optical radiation before and after redirection form a right angle. However, it should be noted that the redirection of the optical radiation to the lateral delivery orientation can be performed at any angle as long as the resulting lateral delivery orientation is at least partially transverse to the axial direction of the inner cavity.
[0173] The optical radiation 33 is transmitted through the tubular element 13 and delivered to the inner passage surface 24 of the connector element. The second polymer material of the connector element absorbs the optical radiation such that the second polymer material at a portion of a part of the inner passage surface melts to form a molten polymer material 42. Typically, heat is also transferred to the first polymer material at the outer surface 19 of the tubular element 13, for example, the heat from the molten polymer material 42 formed by the second polymer material of the connector element 20. Thereby, some of the first polymer material can also be mixed into the molten polymer material 42 such that the molten polymer material 42 includes both the first polymer material and the second polymer material. In any case, the molten polymer material 42 is typically mainly formed by the second polymer material.
[0174] When a sufficient amount of the polymer material melts, the transmission of the optical radiation 33 terminates such that the molten polymer material 42 can solidify to form a weld between the connector element and the tubular element.
[0175] Figures 7a to 7h Various examples of the waveguide arrangement and the delivery of the optical radiation are schematically shown.
[0176] Figure 7a The waveguide arrangement 30 is shown, which is arranged outside the connector element 20 and the tubular element 13 to deliver the optical radiation 33 to the inner passage surface 24 of the connector element 20. The optical radiation is delivered through the opening of the receiving passage of the connector element. The waveguide arrangement can be, for example, an optical fiber, such as having a collimating or focusing output lens, for providing sufficiently strong optical radiation at the inner passage surface 24.
[0177] Figure 7bShows a waveguide arrangement 30 that is arranged outside the tubular element 13 to deliver optical radiation 33 at the inner passage surface of the connector element 20. In this example, the waveguide arrangement 30 delivers the optical radiation 33 in a lateral delivery orientation that is transverse to the axial direction of the inner cavity, relying on internal reflection. In practice, such a waveguide arrangement 30 can be implemented by a rod having an internally reflective surface, or by a dielectric material that can provide total internal reflection of the optical radiation propagating at an incident angle with respect to the circumferential surface of the dielectric material that is greater than the critical angle. As an example, for optical radiation with a wavelength of 589 nm, the critical angle of polymethyl methacrylate in air is approximately 42 degrees.
[0178] Figure 7c Shows a waveguide arrangement 30 that provides divergent optical radiation 33. The optical radiation 33 is provided within the distal portion of the tubular element 13. The waveguide arrangement can be, for example, an optical fiber provided with a waveguide end assembly in the form of an optical diffuser. In principle, an optical fiber without coupling out can also be used, which provides a highly divergent light beam.
[0179] Figure 7d Shows a waveguide arrangement 30 having a waveguide end assembly 34 that redirects the optical radiation 33 directionally from the axial direction of the waveguide arrangement 30 to a lateral delivery orientation in the radial direction.
[0180] Figure 7e and Figure 7f Provides a different cross-sectional view of another waveguide arrangement 30 for delivering optical radiation.
[0181] Figure 7e Provides a view in a cross-sectional plane perpendicular to the axial direction of the waveguide arrangement 30, while Figure 7f Provides a view in a cross-sectional plane that overlaps with the axial direction of the waveguide arrangement 30 and the tubular element 13.
[0182] The shown waveguide arrangement 30 includes an optical fiber 35 located in an optical fiber ferrule 36, which in turn is surrounded by a waveguide arrangement housing 37. At the second end 32 of the waveguide arrangement 30, the waveguide arrangement 30 is attached to a conical mirror 34. The optical radiation 33 transmitted through the optical fiber 35 irradiates this conical mirror 34, causing the optical radiation 33 to be redirected circumferentially in the radial direction.
[0183] Figure 7g and Figure 7h Provides different cross-sectional views of an additional waveguide arrangement 30 for delivering optical radiation.
[0184] Figure 7g Provides a view in a cross-sectional plane perpendicular to the axial direction of the waveguide arrangement 30, while Figure 7hA view in a cross-sectional plane overlapping the axial direction of the waveguide arrangement 30 and the tubular element 13 is provided.
[0185] The illustrated waveguide arrangement 30 includes a set of optical fibers 35 that are arranged along the axial direction of the waveguide arrangement and are distributed in a circular arrangement within the waveguide arrangement 30. An inner waveguide rod 38 is provided at the center of the waveguide arrangement 30, and the set of optical fibers 35 is arranged around the inner waveguide rod. The light radiation 33 transmitted through the optical fibers 35 irradiates the conical mirror 34, such that the light radiation 33 is redirected circumferentially in the radial direction. Optionally, the light radiation only transmits through a subset of the optical fibers 35.
[0186] Figure 8 A manufacturing device 50 for attaching a connector 13 element to a tubular element 20 in a catheter is schematically illustrated.
[0187] The manufacturing device 50 includes a catheter fixture 51 configured to hold a catheter pre-assembly 52. In this example, the catheter pre-assembly 52 includes a connector element 20 that is preliminarily attached to the tubular element 13 by a press fit, and the catheter fixture clamps onto the connector element 20.
[0188] The manufacturing device 50 further includes a light radiation source 53 and an elongate waveguide arrangement 30 extending between a first end 31 and a second end 32. The first end 31 is optically coupled to the light radiation source 53. Further, the light radiation source 53 is configured to emit light radiation such that the light radiation transmits through the waveguide arrangement 30 and is delivered at the second end 32.
[0189] The catheter fixture 51 can be actuated linearly by a relative actuator 54. Correspondingly, the catheter pre-assembly 52 can be moved such that the second end 32 of the waveguide arrangement 30 is inserted into the inner cavity of the tubular element 13. In this illustration, this movement is indicated by the horizontal arrow below the fixture 51.
[0190] The relative actuator 54 and the light radiation source 53 are controlled by a control arrangement 55, which is a programmable logic circuit in this example. The control arrangement 55 is configured to control the relative actuator 54 to insert the second end 32 of the waveguide arrangement 30 into the inner cavity of the tubular element 13 when the catheter pre-assembly 52 is held in the catheter fixture 51, and is configured to subsequently control the light radiation source 53 to transmit light radiation through the waveguide arrangement 30 to deliver the light radiation to the inner passage surface of the connector element 20. Correspondingly, at least a portion of the second polymer material at the inner passage surface of the connector element 20 is at least partially melted to thereby join at least a portion of the inner passage surface to at least a portion of the outer surface of the tubular element 13.
[0191] Unless otherwise specifically stated, the examples described in this application and the features of the respective exemplary examples can be combined with each other ("mix and match").
Claims
1. A method for attaching a connector element to a tubular element in a catheter, wherein, The tubular element is made of a first polymer material and extends in an axial direction between a proximal portion and a distal portion. The tubular element includes an inner surface and an outer surface. The inner surface defines a lumen extending in the axial direction. Wherein, the distal portion includes an opening that provides an entrance to the lumen. Wherein, the connector element is made of a second polymer material and includes a connector duct between a connector opening and a receiving passage. The receiving passage has an inner passage surface. Wherein, the method includes the following steps: - Providing an elongated waveguide arrangement extending between a first end and a second end. The waveguide arrangement is configured to guide light radiation between the first end and the second end to emit the light radiation at the second end. - Arranging the distal portion of the tubular element inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage surface of the connector element. - Transmitting the light radiation through the waveguide arrangement to deliver the light radiation to the inner passage surface of the connector element such that the second polymer material at the inner passage surface is at least partially melted to thereby connect at least a portion of the portion of the inner passage surface to at least a portion of the portion of the outer surface of the tubular element.
2. The method according to claim 1, wherein, The method includes the step of inserting the second end of the waveguide arrangement into the lumen. This step is performed before the step of transmitting the light radiation through the waveguide arrangement.
3. The method according to claim 2, wherein, The step of inserting the second end of the waveguide arrangement into the lumen is performed after the step of arranging the distal portion of the tubular element inside the receiving passage.
4. The method according to any one of claims 2 to 3, wherein The second end of the waveguide arrangement is inserted into the lumen through the opening of the distal portion of the tubular element.
5. The method according to any one of the preceding claims, wherein, The portion of the inner passage surface is connected to the portion of the outer surface by a continuous weld seam extending circumferentially around the outer surface of the tubular element.
6. The method according to any one of the preceding claims, wherein, The first polymer material and the second polymer material include TPU.
7. The method according to any one of the preceding claims, wherein, The light radiation is delivered to the inner passage in a transverse delivery orientation transverse to the axial direction of the lumen.
8. The method according to any one of the preceding claims, wherein, The method includes the step of performing a relative rotation about the axial direction of the tubular element during the step of transmitting the light radiation through the waveguide arrangement.
9. The method according to claim 8, wherein Performing the step of relative rotation causes the transverse delivery orientation of the light radiation to rotate with respect to the outer surface of the tubular element and the inner passage surface of the connector element.
10. The method according to any one of claims 8 to 9, wherein Performing the step of relative rotation includes rotating the waveguide arrangement or the tubular element.
11. The method according to any one of the preceding claims, wherein, The method includes: - Providing an optical element configured to redirect the light radiation. - Inserting the optical element into the lumen such that the optical element is positioned within the receiving passage and the distal portion of the tubular element. Wherein, after the light radiation is transmitted through the waveguide arrangement, the light radiation is delivered to the inner passage surface by redirecting the light radiation through the optical element.
12. The method according to claim 11, wherein, The optical element is a waveguide end assembly attached to the second end of the waveguide arrangement.
13. The method according to any one of claims 11 to 12, wherein, The optical element redirects the light radiation from the axial direction of the inner cavity to the lateral delivery orientation.
14. The method according to any one of claims 11 to 13, wherein, The optical element is conical so as to redirect the light radiation circumferentially in the radial direction.
15. The method according to any one of claims 11 to 13, wherein, The optical element is configured to redirect the light radiation directionally in at least one radial direction.
16. The method according to any one of claims 11 to 15 when dependent on any one of claims 8 to 9, wherein Performing the step of relative rotation includes rotating the optical element.
17. The method according to any one of the preceding claims, wherein, The first polymer material is associated with a first attenuation coefficient of the light radiation, and the second polymer material is associated with a second attenuation coefficient of the light radiation, wherein the second attenuation coefficient is greater than the first attenuation coefficient.
18. The method according to claim 17, wherein, The second attenuation coefficient is at least 2 times, such as at least 5 times, for example at least 10 times, the first attenuation coefficient.
19. The method according to any one of the preceding claims, wherein, The light radiation only passes through the inner surface of the tubular element once after being emitted from the waveguide arrangement.
20. The method according to any one of the preceding claims, wherein, The second polymer material of the connector element includes an optical absorption additive to provide an optical absorption band for the inner passage surface, wherein the central wavelength of the light radiation is located within the optical absorption band.
21. The method according to claim 20, wherein, The optical absorption band has an upper boundary below 2000 nm, such as below 1600 nm, for example below 1200 nm.
22. The method according to any one of the preceding claims, wherein, The radius of the outer surface of the tubular element is greater than the radius of the inner passage surface of the connector element, such that in the step of disposing the distal portion of the tubular element inside the receiving passage of the connector element, the connector element is press-fitted onto the tubular element.
23. A urinary catheter manufactured by the method according to any one of the preceding claims.
24. A urinary catheter, comprising: - a tubular element made of a first polymer material and extending axially between a proximal portion and a distal portion, the tubular element including an inner surface and an outer surface, the inner surface defining an inner cavity extending in the axial direction, wherein the distal portion includes an opening providing an entrance to the inner cavity; and - a connector element made of a second polymer material and including a connector duct between a connector opening and a receiving passage, the receiving passage having an inner passage surface, wherein the distal portion of the tubular element is disposed inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage surface of the connector element, wherein at least a portion of the portion of the inner passage surface of the connector element is joined to at least a portion of the portion of the outer surface of the tubular element by a continuous weld extending circumferentially around the outer surface of the tubular element.
25. The urinary catheter according to claim 24, wherein, The inner surface of the tubular element is homogeneous along the axial direction.
26. The urinary catheter according to any one of claims 24 to 25, wherein, The tubular element is not exposed to an adhesive.
27. The urinary catheter according to any one of claims 24 to 26, wherein, The inner surface of the tubular element is not exposed to an adhesive.
28. The urinary catheter according to any one of claims 24 to 27, wherein The urinary catheter is manufactured by the method according to any one of claims 1 to 22.
29. A manufacturing device for attaching a connector element to a tubular element in a urinary catheter Among them, The tubular element is made of a first polymer material and extends in an axial direction between a proximal portion and a distal portion. The tubular element includes an inner surface and an outer surface, and the inner surface defines a lumen extending in the axial direction. Wherein, the distal portion includes an opening that provides an entrance to the lumen. Wherein, the connector element is made of a second polymer material and includes a connector conduit between a connector opening and a receiving passage. The receiving passage has an inner passage surface. The manufacturing apparatus includes: - A catheter fixture configured to hold a catheter pre-assembly including the connector element and the tubular element. Wherein, the distal portion of the tubular element is disposed inside the receiving passage of the connector element such that a portion of the outer surface of the tubular element is positioned against a portion of the inner passage surface of the connector element. - A light radiation source configured to emit light radiation. - An elongate waveguide arrangement extending between a first end and a second end. Wherein, the first end is optically coupled to the light radiation source. - A relative actuator configured to move the second end of the waveguide arrangement relative to the catheter fixture; and - A control arrangement configured to control the relative actuator to insert the second end of the waveguide arrangement into the lumen when the catheter pre-assembly is held in the catheter fixture, and configured to subsequently control the light radiation source to transmit the light radiation through the waveguide arrangement to deliver the light radiation to the inner passage surface of the connector element.
30. The manufacturing apparatus according to claim 29, wherein, The manufacturing apparatus is configured to attach the connector element to the tubular element by the method according to any one of claims 1 to 22.