Devices and funnels with guidance devices for manufacturing catheters

Abstract

A urinary catheter configured to be ultrasonically welded to a drainage member. More particularly, a urinary catheter with a drainage member associated with a mandrel guidance device. More particularly, a urinary catheter with a drainage member including a mandrel guidance device and welding devices associated with the drainage member.

Description

Devices and Funnels with Guidance Devices for Manufacturing CathetersThe present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 595,464, filed November 2, 2023, which is hereby incorporated herein by reference.FIELD OF THE INVENTION

[0001] This disclosure generally relates to devices, systems, and methods for manufacturing a urinary catheter. More particularly, this disclosure relates to devices, systems, and methods for centering a mandrel through a drainage member of a urinary catheter.BACKGROUND

[0002] Generally, urinary catheters are manufactured to include a drainage member, such as a funnel or connector, at a distal drainage end of a urinary catheter tube. Typically, after attaching the catheter tube to the funnel, a mandrel may be inserted inside the tubing to provide structural integrity during different manufacturing processes, for example, eyelet punching. The funnel usually includes a gradual taper from the drainage opening to the tubing chamber, which aids in guiding a mandrel that is off-centered into the tubing without damaging the mandrel, tubing, or funnel.

[0003] The catheter tube may be attached to a funnel by solvent bonding. Another method of bonding a catheter tube to a funnel is by ultrasonic welding. Ultrasonic welding includes heat sealing the catheter tube to the funnel with an ultrasonic welding device, such as a sonotrode. Generally, to increase the success of ultrasonic welding, a 1 mm by 1 mm radial rib is located within thefunnel, extending 90° from the inner surface of the drainage member. The catheter tube is inserted into the drainage member at the proximal end, such that the tube abuts the proximal side of the rib, and the ultrasonic tip of the welding device configured to fit through an aperture defined by the radial rib is inserted through the drainage opening of the funnel to ultrasonically weld the catheter tube to the drainage member. The presence of the rib inside the drainage member maximizes the energy of the sonotrode to bond the tube to the drainage member ( / .e., the energy travels at 90° to the sonotrode anvil).

[0004] However, the 90° radial rib may cause damage to a mandrel that is inserted into the catheter after welding, particularly if the mandrel is not centered with the aperture defined by the radial rib.

[0005] Therefore, there is a need for improved drainage members, systems, and methods for ultrasonically welding a catheter tube to a drainage device.SUMMARY OF INVENTION

[0006] There are several aspects of the present subject matter which may be embodied separately or together in the subject matter claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto.

[0007] In one aspect, a urinary catheter is provided. The urinary catheter includes a catheter tube having a catheter tube distal portion. The urinary catheter also includes a drainage member. The drainage member includes adrainage member proximal portion with an inner surface defining a tubing chamber configured to receive the catheter tube distal portion. Additionally, the drainage member includes a drainage member distal portion including a funnel with a distal drainage opening. The funnel includes an inner surface defining a drainage chamber. The drainage member also includes a radial rib within the drainage member separating the tubing chamber and drainage chamber, wherein the radial rib defines a radial rib aperture configured to receive a mandrel. The urinary catheter further includes a guidance device associated with the drainage member, wherein the guidance device is configured to center the mandrel through the radial rib aperture.

[0008] In another aspect, a method of manufacturing a urinary catheter is provided. The method includes obtaining a urinary catheter including a catheter tube and a drainage member. The drainage member includes a drainage member proximal portion with an inner surface defining a tubing chamber, a drainage member distal portion with a distal opening at a distal end and an inner surface defining a drainage chamber, and a radial rib within the drainage member separating the tubing chamber from the drainage chamber and the radial rib defining a radial rib aperture. The method further includes using a guidance device associated with the drainage member to insert a mandrel within the urinary catheter.

[0009] In another aspect, a system for manufacturing a urinary catheter is provided. The system includes a catheter tube having a catheter tube distal portion. The system also includes a drainage member including a drainage member proximal portion with an inner surface defining a tubing chamberconfigured to receive the catheter tube distal portion and a drainage member distal portion including a funnel with a distal drainage opening. The funnel includes an inner surface defining a drainage chamber. The drainage member also includes a radial rib within the drainage member separating the tubing chamber and drainage chamber, wherein the radial rib defines a radial rib aperture configured to receive a mandrel. The system further includes an ultrasonic welding device configured to weld the catheter tube distal portion to the drainage member. The system includes a guidance device associated with the drainage member, wherein the guidance device is configured to center the mandrel through the radial rib aperture.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 A is a perspective view of an example of a urinary catheter.

[0011] FIG. 1 B is a cross-sectional plan view of the drainage member of the urinary catheter of FIG. 1 A configured to be ultrasonically welded to a catheter tube with a catheter tube and a welding device inserted therein.

[0012] FIG. 2 is a cross-sectional side view of an example of a drainage member after welding to a catheter tube, including an example of a mandrel guidance device inserted therein.

[0013] FIG. 3 is a cross-sectional side view of an example of a drainage member including another example of a mandrel guidance device inserted therein.

[0014] FIG. 4A is a cross-sectional side view of an example of a drainage member including a mandrel guidance device according to the present disclosure.

[0015] FIG. 4B is a cross-sectional side view of another example of thedrainage member of FIG. 4A.

[0016] FIG. 5A is a perspective view of another example of a drainage member including a mandrel guidance device according to the present disclosure.

[0017] FIG. 5B is a cross-sectional side view of the drainage member of FIG.5A.

[0018] FIG. 5C is a cross-sectional side view of the drainage member of FIG. 5A with a catheter tube and an example of a welding device inserted therein.

[0019] FIG. 6A is a perspective view of another example of a drainage member including a mandrel guidance device according to the present disclosure.

[0020] FIG. 6B is a rear view of an example of a drainage member including a mandrel guidance device according to the present disclosure.

[0021] FIG. 6C is a cross-sectional side view of an example of a welding device that may be associated with the drainage members of FIGS. 6A-6B.

[0022] FIG. 7A is a cross-sectional perspective view of another example of a drainage member including a mandrel guidance device according to the present disclosure.

[0023] FIG. 7B is a cross-sectional view of the drainage chamber of the drainage device of FIG. 7A taken along line 7B-7B in FIG. 7A.

[0024] FIG. 7C is a perspective view of an example of a welding device and an enlarged inset of the proximal tip of the welding device that may be associated with the drainage member of FIG. 7A.

[0025] FIG. 8A is a cross-sectional side view of a portion of an example of the drainage member including a mandrel guidance device according to the present disclosure with a catheter tube and an example of a welding device insertedtherein.

[0026] FIG. 8B is a cross-sectional side plan view of a portion of another example of the drainage member of FIG. 8A with a catheter tube inserted therein.

[0027] FIG. 9A is a cross-sectional side view of another example of the drainage member including a mandrel guidance device according to the present disclosure before being welded.

[0028] FIG. 9B is a rear view of the drainage member of FIG. 9A.

[0029] FIG. 9C is a perspective view of a portion of an example of a welding device that may be associated with the drainage member of FIG. 9A.

[0030] FIG. 9D is a cross-sectional side view of the drainage member of FIG. 9A with a catheter tube and the welding device of FIG. 90 inserted therein.

[0031] FIG. 9E is a cross-sectional side view of the drainage member of FIG. 9A illustrating the radial rib after welding with an embodiment of the welding device of FIG. 90.

[0032] FIG. 9F is a rear view of the drainage member of FIG. 9E.

[0033] FIG. 9G is a cross-sectional side view of the drainage member of FIG. 9A illustrating the radial rib after welding with another embodiment of the welding device of FIG. 90.

[0034] FIG. 9H is a rear view of the drainage member of FIG. 9G.

[0035] FIG. 10 is a cross-sectional side view of a portion of an example of a drainage member including a mandrel guidance device according to the present disclosure with a catheter tube and welding device inserted therein.

[0036] FIG. 1 1 A is a rear view of another example of a drainage member including a mandrel guidance device of the present disclosure.

[0037] FIG. 1 1 B is a rear view of the drainage member of FIG. 11 A in a squeezed / compressed configuration.

[0038] FIG. 12A is a cross-sectional side view of an example of a two-piece drainage member.

[0039] FIG. 12B is a cross-sectional side view of a first piece of the two-piece drainage member of FIG. 12A welded to a catheter tube and a mandrel inserted therein.

[0040] FIG. 13 is a cross-sectional perspective view of another example of a two-piece drainage member.

[0041] FIG. 14 is a cross-sectional exploded view of the two-piece drainage member of FIG. 13.

[0042] FIG. 15 is a cross-sectional side view of a first piece of the two-piece drainage member of FIG. 13 including a catheter tube and a mandrel inserted therein.

[0043] FIG. 16 is a perspective view of the two-piece drainage member of FIG. 13 including a split ring associated with the drainage member.

[0044] FIG. 17 is a cross-sectional perspective view of the two-piece drainage member of FIG. 13 including a split ring associated with the drainage member.DETAILED DESCRIPTION

[0045] A more detailed description of the device in accordance with the present disclosure is set forth below. It should be understood that the description of the specific devices below is intended to be exemplary and not exhaustive of all possible variations or applications. Thus, the scope of the disclosure is not intended to be limiting and should be understood to encompass variations orembodiments that would occur to persons of ordinary skill.

[0046] The present disclosure is generally directed to a drainage member of a medical device associated with a guidance device, wherein the guidance device is particularly useful for guiding a mandrel through the drainage member during manufacturing of the medical device. For example, the guidance device may be useful in guiding a mandrel through a urinary catheter.

[0047] Generally, urinary catheters, such as intermittent urinary catheters, include a catheter tube 11 including a proximal insertion end 15 and a distal drainage end at a catheter tube distal portion 14. A lumen extends from the proximal insertion end to the distal drainage end. The catheter tube distal portion 14 may be attached to a drainage member 12 by solvent bonding, adhering, welding, or other methods of attachment known in the art.

[0048] FIG. 1 A generally illustrates an intermittent urinary catheter 10 having a catheter tube 11 and a drainage member 12 associated with the distal end portion 14 of the catheter tube 11 . The proximal end portion 15 is configured to be advanced through the urethra of a user and into the bladder. FIG. 1 B generally illustrates an example of urinary catheter drainage member 12 configured to be ultrasonically welded to catheter tube 11 to form urinary catheter 10. In general, drainage member 12 includes a drainage member proximal portion 16 and a drainage member distal portion 18. Herein, proximal will be understood to mean a location towards the insertion end 15 of catheter tube 11 , and distal will be understood to mean a location towards the drainage end of catheter tube 11 . The drainage member proximal portion 16 includes an inner surface 20 that defines a tubing chamber 19. The tubing chamber 19 is configured to receive catheter tubedistal portion 14. The drainage member distal portion 18 includes a distal end opening 17 and an inner surface 22 defining a drainage chamber 21 . In an example, the drainage member distal portion 18 may be a funnel, as shown in FIG. 1 B. Alternatively, drainage member 12 may be a connector configured to be connected to a receptacle such as a collection bag (not shown). Inner surface 22 of the drainage member distal portion 18 may be tapered inwardly from the distal end opening 17 towards the proximal portion 16. The distal end of drainage member 12 may also include a lip / flange 23.

[0049] The tubing chamber 19 and drainage chamber 21 are separated by a radial rib 24. Radial rib 24 protrudes from the inner surface of drainage member 12 and defines a radial rib aperture 25. The radial rib aperture 25 provides a passageway between the tubing chamber 19 and the drainage chamber 21 , placing the chambers 19 and 21 in fluid communication with one another. The radial rib 24 may protrude from the inner surface of the drainage member 12 at a 90° angle with the inner surfaces of the drainage member proximal and distal portions 16 and 18.

[0050] The radial rib 24 aids in maximizing bond strength between the catheter tube distal portion 14 and drainage member 12 when ultrasonically welding them together. To ultrasonically weld the pieces together, the catheter tube distal portion 14 is inserted into the tubing chamber 19 such that catheter tube distal end 13 abuts the radial rib proximal side 27 and the ultrasonic welding device 26 is inserted through the distal end opening 17 of the drainage member 12 into the drainage chamber 21 to abut the radial rib distal side 29. The welding device 26 may be a sonotrode including a body 30 and an ultrasonic tip 28extending from the body 30. The ultrasonic tip 28 is configured to fit through the radial rib aperture 25 and the body 30 is configured to abut the radial rib distal side 29. For example, the ultrasonic tip 28 includes a diameter configured to pass through the radial rib aperture 25 and the body 30 includes a diameter larger than the radial rib aperture 25. By passing the ultrasonic tip 28 through the radial rib aperture 25, the ultrasonic tip 28 may contact the inner surface of the catheter tube 11 and press the catheter tube 11 against the inner surface 20 of the drainage member proximal portion 16. This configuration allows energy from the body 30 to weld the catheter tube 11 to drainage member 12. In particular, body 30 creates a heat seal between the catheter tube distal end 13 and the radial rib proximal side 27. Optionally, welding device 26 may create additional welds between inner surface 20 of the drainage member 12 and the outer surface of the catheter tube 11 .

[0051] After welding, catheter 10 may undergo other manufacturing processes. Some of these processes, for instance, eyelet punching, amongst other processes, require the welded catheter 10 to maintain its shape and structural integrity. To maintain structural integrity, a mandrel may be inserted through the drainage member distal portion 18 and passed through the radial rib aperture 25 and the catheter tube 11 . Because the radial rib 24 protrudes from the inner surface of drainage member 12, the mandrel risks being damaged if the mandrel is not centered or properly aligned with the radial rib aperture 25.

[0052] To minimize the risk of damaging the mandrel, drainage member 12 may be configured to be associated with a mandrel guidance device. For example, drainage member 12 may be associated with an independent mandrelguidance device or drainage member 12 may include a mandrel guidance device.The mandrel guidance device is configured to center the mandrel with the radial rib aperture 25 as the mandrel is inserted through the drainage chamber 21 .

[0053] Turning to FIGS. 2 and 3, these figures illustrate an example of drainage member 12 associated with a mandrel guidance device. In particular, the mandrel guidance device is an insertable mandrel guide 40a, 40b. The insertable mandrel guides 40a, 40b include a body and a lumen extending from a body proximal end 42a, 42b to a body distal end 44a, 44b. The lumens are configured to receive a mandrel 41 a, 41 b. The lumens of the insertable mandrel guides 40a, 40b are positioned to correspond with the position of the radial rib aperture 25, such that when the mandrels 41 a, 41 b are passed through the lumens, they are centered with the radial rib aperture 25.

[0054] As shown in FIG.2, the body may be shaped to correspond with the shape of the drainage chamber 21 . For instance, the insertable mandrel guide 40a is tapered from the distal end 44a to the proximal end 42a. The taper of the insertable mandrel guide 40a may correspond to the taper of the drainage chamber 21 . Additionally, the insertable mandrel guide 40a may be shaped to at least partially fill the drainage chamber 21 . Alternatively, the insertable mandrel guide 40a may fill the entire drainage chamber 21 such that when the insertable mandrel guide 40a is inserted into the drainage chamber 21 , the body proximal end 42a abuts the radial rib distal side 29. The mandrel guide 40a may also include a lip / flange 46 located at the body distal end 44a. The lip 46 may be sized to have a larger diameter than the distal end opening 17 of drainage member 12. The lip 46 provides a gripping portion that may be used to remove the mandrelguide 40a from the drainage chamber 21 and may ensure that the insertable mandrel guide 40a is not inserted too deep into the drainage chamber 21 .

[0055] To use the insertable mandrel guide 40a, the insertable mandrel guide 40a may be inserted into the drainage chamber 21 of the drainage member 12, and then mandrel 41 a may be passed through the lumen of the body and the radial rib aperture 25. After any processes requiring mandrel 41 a have been completed, mandrel 41 a may be pulled out of the insertable mandrel guide 40a. The insertable mandrel guide 40a may then be removed from the drainage chamber, for example, by gripping the lip 46 and pulling the insertable mandrel guide 40a out. Alternatively, mandrel guide 40a and mandrel 41 a may be removed simultaneously.

[0056] As shown in FIG. 3, the body may be bullet-shaped. For example, the mandrel guide 40b may be generally cylindrical with a rounded, tapered body proximal end 42b. Insertable mandrel guide 40b may be fully inserted into the drainage chamber 21 .

[0057] A mandrel 41 b including a proximal tip 48 having a larger diameter than the diameter of the lumen of the body of mandrel guide 40b may be associated with mandrel guide 40b. To use mandrel guide 40b, a distal end 49 of the mandrel 41 b may be inserted into the lumen at the body proximal end 42b. Guide 40b and mandrel 41 b can then be inserted into the drainage chamber 21 , and mandrel 41 b can be guided through the radial rib aperture 25. Using a mandrel 41 b with a proximal tip 48 with a larger diameter than that of the lumen of the insertable mandrel guide 40b assists with removing the insertable mandrel guide 40b. For example, when pulling the mandrel 41 b out of drainage member12, the proximal tip 48 will catch the body proximal end 42b of the mandrel guide 40b instead of passing through the mandrel guide lumen. The mandrel proximal tip 48 will remove the mandrel guide 40b from the drainage chamber. The mandrel 41 b may also be associated with other insertable mandrel guides, including but not limited to, mandrel guide 40a without departing from the scope of the disclosure.

[0058] In another example, a drainage member 112 including the mandrel guidance device may be used to center a mandrel with a radial rib aperture 125. FIGS. 4A-11 B illustrate examples of drainage member 112 including a mandrel guidance device, in addition to welding devices that may be associated with drainage member 112.

[0059] Drainage member 112 may include similar components as described herein. Turning to FIG. 4A as an exemplary illustration of drainage member 112, drainage member 112 includes a drainage member proximal portion 1 16 and a drainage member distal portion 118. The drainage member proximal portion 116 includes an inner surface 120 that defines a tubing chamber 119. The tubing chamber 119 is configured to receive a catheter tube distal portion 114 (not shown in FIGS. 4A and 4B). The drainage member distal portion 118 includes a distal end opening 117 and an inner surface 122 defining a drainage chamber 121. In an embodiment, the drainage member distal portion 118 may be a funnel or a connector. Inner surface 122 of the drainage member distal portion 118 may be tapered inwardly from the distal end opening 117 towards the proximal portion 1 16. The distal end of drainage member 112 may also include a lip 123.

[0060] The tubing chamber 1 19 and drainage chamber 121 are separated bya radial rib 124. Radial rib 124 protrudes from the inner surface of drainage member 112 and defines a radial rib aperture 125. The radial rib aperture 125 provides a passageway between the tubing chamber 119 and the drainage chamber 121 , placing the chambers 119 and 121 in fluid communication with one another.

[0061] As shown in FIGS. 4A-5C, the mandrel guidance device included with drainage member 112 is a radial ring 150 protruding from the inner surface 122 of the drainage member distal portion 1 18.

[0062] In particular, FIGS. 4A and 4B show an example of drainage member 1 12 including the radial ring 150 located on the inner surface 122 of the drainage member distal portion 118. The radial ring 150 may be molded on the inner surface 122. For instance, the radial ring 150 may be integrally molded with the drainage chamber 121 during one-shot or two-shot molding of drainage member 1 12. Alternatively, the radial ring 150 may be attached to the inner surface 122 of the drainage member distal portion 1 18. The radial ring 150 may be attached via various attachment means including, but not limited to, adhesion, bonding, or welding.

[0063] The location of the radial ring 150 may vary within the drainage chamber 121. Additionally, the height and slope of the radial ring 150 may vary depending on its location within the drainage chamber 121. If the radial ring 150 is located closer to the distal end of drainage member 1 12, the radial ring 150 may include a gradual slope, as shown in FIG. 4A. For instance, the radial ring 150 can resemble a gradually rising bump within the drainage chamber 121 . Due to the distance from the radial rib 124, a gradually rising radial ring 150 will guidean inserted mandrel at a smaller angle to center the mandrel through the radial rib aperture 125. This may prevent the mandrel from being guided at too sharp of an angle and contacting the radial rib distal side 129. In an embodiment, the radial ring 150 is an arc of a circle with a 10 mm radius, the beginning of the arc being located 15 mm from the drainage member distal end. In some alternative embodiments, the radius may be between 3 mm and 6 mm. Additionally, the top of the radial ring 150 may be at a plane parallel to the inner surface 122 at the proximal end of the drainage member distal portion 118, thus providing enough clearance for a welding device to reach the radial rib 124.

[0064] Alternatively, if the radial ring 150 is located closer to the radial rib 124, the radial ring 150 may include a steeper slope, as shown in FIG. 4B. In an embodiment, the distal side 151 of the radial ring 150 may have a slope of 30° relative to inner surface 122. The slope of the distal side 151 of radial ring 150 may vary without departing from the scope of the disclosure. With less distance to cover, using a steeper slope when the radial ring 150 is closer to the radial rib 124 assists with the mandrel being appropriately centered with the radial ring aperture 125. In some embodiments, the slope of the radial ring may be between 10° and 40°.

[0065] Regardless of the location of the radial ring 150 within drainage chamber 121 , in some embodiments, the height of the radial ring 150 does not exceed the width of the radial rib 124 as measured between the inner surface of drainage member 112 and radial ring aperture 125, thus providing enough clearance for a welding device to be inserted.

[0066] FIGS 5A-5C illustrate another example of drainage member 112 withradial ring 150. The radial ring 150 may be formed by providing a pinched shape in the drainage member distal portion 118. For instance, during manufacturing of drainage member 112, a part of the drainage member distal portion 118 may be pinched inwardly to provide an internal radial ring / bump 150 within the drainage chamber 121. In an embodiment, the distal side 151 of the radial ring 150 produced by the pinched shape may have a slope of 30°. The slope of the radial ring 150 may vary without departing from the scope of the disclosure and the slope may be in the above-described range.

[0067] Additionally, radial rib 124 may include a sloped distal side 129. For example, the rib may include a slope of 20°. In an embodiment, both the distal side 129 and proximal side 127 of the radial rib 124 may be sloped.

[0068] As shown in FIG. 5C, a welding device 152 may be used to weld drainage member 112 to catheter tube distal portion 114. In this instance, the welding device 152 may include a body 154 and an ultrasonic tip 156 extending from the body 154. A proximal portion 155 of the body 154 may include a slope that corresponds with the slope of the radial rib distal side 129.

[0069] During welding, welding device 152 may deflect the radial ring 150 provided by the pinched shape of the drainage member 112. Welding device 152 may be configured to deflect the pinched shape of the drainage member 112 outwardly and / or the radial ring 150 may be configured to be deflected outwardly. For example, a portion of the drainage member 112 providing the pinched shape / radial ring 150 may be made of a resilient material such as, but not limited to, a thermoplastic elastomer, PVC, polypropylene, or SEBS-based thermoplastic elastomers. During insertion and welding, welding device 152 may deflect thepinched shape / radial ring 150 outwardly and the radial ring 150 may return towards its initial configuration upon removal of the welding device 152. In an embodiment, the radial ring 150 may partially or fully return to its initial configuration.

[0070] Accordingly, after welding, a mandrel may be inserted into the drainage member 1 12 and may be centered with the radial rib aperture 125 when the mandrel contacts the radial ring 150. In an embodiment, the mandrel may be centered by both the radial ring 150 and sloped radial rib distal side 129.

[0071] FIGS. 6A-B and FIGS. 7A-B show another example of drainage member 1 12 including a mandrel guidance device. In this instance, the mandrel guidance device may include a plurality of longitudinal ribs 160a (FIGS. 6A-B), 160b (FIGS. 7A-B) located within the drainage chamber 121 . For example, at least three longitudinal ribs 160a, 160b, and more preferably, at least four longitudinal ribs 160a, 160b are located in drainage chamber 121 . The number of longitudinal ribs 160a, 160b may vary without departing from the scope of the disclosure.

[0072] In an embodiment, as shown in FIG. 6A, the longitudinal ribs 160a may extend from the drainage member distal opening 1 17 partially into the drainage chamber 121. The longitudinal ribs 160a may have a rounded shape as illustrated in FIG. 6A-6B, but the shape may vary without departing from the scope of the disclosure.

[0073] To weld drainage member 1 12 to a catheter tube distal portion 1 14, a welding device 162 as shown in FIG. 6C may be used. Welding device 162 includes a body 164 and an ultrasonic tip 166 extending from a body proximalportion 168. The proximal portion 168 is configured to fit within the drainage chamber 121. In particular, the proximal portion 168 has a diameter that is smaller than the diameter of a circle 161 (shown in FIG. 6B) defined by the tops of the longitudinal ribs 160a. In an embodiment, each rib has a height of 150 pm from the inner surface 122 of the drainage member 112 and the diameter of the body proximal portion 168 of the welding device 162 is 3.7 mm.

[0074] Alternatively, as shown in FIG. 7A, the longitudinal ribs 160b may extend from the drainage member distal opening 117 to the radial rib 124. In this instance, the longitudinal ribs 160b define slots 163 between one another.Additionally, the longitudinal ribs 160b may have a squared top, yet other shapes may be used without departing from the scope of the disclosure. The distal ends of the longitudinal ribs 160b may include a slope to guide a mandrel into the drainage chamber 121 .

[0075] The longitudinal ribs 160b may have a height no taller than the height of the radial rib 124. In an embodiment, the tops of the longitudinal ribs 160b may be parallel to one another. In this instance, the height of the longitudinal ribs 160b from the inner surface 122 may decrease as the longitudinal rib 160b extends from the distal opening 117 to the radial rib 124, due to the tapered shape of the drainage chamber 121 .

[0076] Additionally, the distance between the top of one longitudinal rib 160b to the top of an adjacent longitudinal rib 160b is smaller than the diameter of a mandrel. This prevents the mandrel from falling within a slot 163 defined by the longitudinal ribs.

[0077] In this instance, to weld drainage member 112 to catheter tube distalportion 114, a welding device 170 as shown in FIG. 7C may be used. Welding device 170 includes a body 172 and an ultrasonic tip 174 extending from a body proximal portion 176. The proximal portion 176 is configured to fit within the drainage chamber 121. In particular, the proximal portion 176 includes fins 178 configured to correspond with the shape of the slots 163 defined by the longitudinal ribs 160b. For example, proximal portion 176 may include generally triangular fins 178 (shown in FIG. 7C) that correspond with the generally triangular slots 163 (shown in FIG. 7B) defined by the longitudinal ribs 160b. By shaping the proximal portion 176, the proximal portion 176 may fit inside the drainage chamber 121 to insert the ultrasonic tip 174 through the radial rib aperture 125 to weld the catheter tube to drainage member 1 12.

[0078] After welding the catheter tube to drainage member 112, a mandrel may be slid along the longitudinal ribs 160a, 160b to guide the mandrel through the radial rib aperture 125.

[0079] FIGS. 8A-9H show another example of drainage member 112 including a mandrel guidance device. In particular, the mandrel guidance device may include the radial rib 124.

[0080] As shown in FIG. 8A, in one embodiment, the radial rib distal side 129 is sloped. By sloping the radial rib distal side 129, a mandrel may contact the sloped radial rib distal side 129 and be guided through the radial rib aperture 125. This allows the radial rib proximal side 127 to maintain a 90° angle with the catheter tube distal portion 114 to maximize the bond strength. The radial rib distal side 129 can have an angle between 20° and 40°. In an embodiment, the radial rib 124 may be molded to include a sloped distal side 129. In anotherembodiment, the shape of drainage member 112 may include an indent forming the radial rib 124 with a sloped distal side 129.

[0081] In the instance that the radial rib distal side 129 is sloped, to weld drainage member 112 to the catheter tube distal portion 1 14, a welding device 180 with a sloped proximal portion 186 corresponding to the slope of the radial rib 124 may be used. For example, the proximal portion 186 of the welding device 180 may have a slope between 20° and 40°. Additionally, the welding device 180 includes a body 182 and an ultrasonic tip 184 extending from a proximal portion 186 of the welding device 180.

[0082] Alternatively, while maintaining a sloped radial rib distal side 129, the radial rib proximal side 127 can be angled to form an acute angle with the inner surface 120 of the tubing chamber 1 19, as shown in FIG. 8B. For instance, the radial rib proximal side 127 can have an angle of 20 ° - 40° with the tubing chamber 1 19. In particular, the angled radial rib proximal side 127 may have the same angle as the slope of the radial rib distal side 129. A welding device, such as welding device 180, with a sloped proximal portion corresponding to the slope of the radial rib distal side 129 may be used to weld drainage member 1 12 to the catheter tube distal portion 114. Additionally, the distal end of the catheter tube may be cut to correspond to the angle of the radial rib proximal side 127.

[0083] In another example, both the radial rib distal side 129 and the radial rib proximal side 127 are sloped (not shown). The radial rib distal side 129 can have a slope of 20° - 40° and the radial rib proximal side 127 can have a slope of 20° - 40°. Regardless of if the radial rib proximal side 127 is sloped or angled, the distal end of the catheter tube may be cut to correspond with the shape of theradial rib proximal side 127.

[0084] Turning to FIGS. 9A-9H, the figures illustrate another example of drainage member 112 including a radial rib 124 with a sloped radial rib distal side 129. In this instance, the sloped radial rib distal side 129 may be molded / deformed away using a welding device 190 including machined fins 198. By molding / deforming the sloped radial rib distal side 129, 90° slots 199a, 199b may be formed in the radial rib distal side 129 to maximize bond strength between drainage member 112 and the catheter tube distal portion 1 14.

[0085] The welding device 190 includes a body 192 and an ultrasonic tip 194 extending from a body proximal portion 196. The body proximal portion 196 includes a plurality of machined fins 198 extending therefrom. In an embodiment, the machined fins 198 may have a squared shape. In another embodiment, the machined fins 198 may have an inverted triangle shape. The shape of the machined fins 198 may vary without departing from the scope of the disclosure.

[0086] The height of the fins 198 on the welding device do not exceed the diameter of the tubing chamber 119. Additionally, the machined fins 198 have a thickness smaller than the diameter of the mandrel. Accordingly, the fins 198 would provide slots 199a, 199b with a smaller thickness than the diameter of the mandrel, thus preventing the mandrel from entering the slots 199a, 199b. This way, the mandrel is guided up the remaining sloped portions of sloped radial rib distal side 129 and through the radial rib aperture 125. In an embodiment, the fins 198 are 1 mm thick and accordingly form 1 mm thick slots 199a, 199b.

[0087] FIGS. 9A and 9B show drainage member 1 12 including a sloped radial rib distal side 129 before welding. The diameter of the drainage chamber 121distal to the sloped radial rib distal side 129 is larger than the diameter of the tubing chamber 119. This allows relief for sonotrode material deformation when the tubing is melted during the ultrasonic welding process.

[0088] To weld drainage member 112 to the catheter tube, catheter tube distal portion 114 is inserted into the tubing chamber 119 and the welding device 190 is inserted into the drainage chamber 121 such that the ultrasonic tip 194 passes through the radial rib aperture 125. During welding, the machined fins 198 mold portions of the sloped radial rib distal side 129 away to provide slots 199a, 199b with an angle of approximately 90° to the inner surface 122 of the drainage chamber 121 .

[0089] FIGS. 9E-9H show exemplary views of drainage member 112 after welding. After welding, the radial rib distal side 129 includes alternating sloped and slotted portions. Although FIGS. 9E and 9G do not show the catheter tube distal portion 114 within the tubing chamber 119, it will be understood that the figures are merely exemplary, and a catheter tube would be present during and after welding. In particular, FIGS. 9E and 9F illustrate an embodiment where the machined fins 198 include a squared shape. The squared fins 198 provide squared slots 199a in the sloped radial rib distal side 129. Alternatively, FIGS. 9G and 9H illustrate an embodiment where the machined fins 198 include a generally inverted triangular shape. In this instance, the machined fins 198 provide triangular slots 199b in the sloped radial rib distal side 129.

[0090] Another example of drainage member 112 including a guidance device is shown in FIG. 10. In this example, the drainage member 112 includes a plurality of convex curves and / or bumps 200 protruding into the drainage chamber121 . Additionally, the radial rib distal side 129 may be sloped. The height of the curves / bumps 200 are no taller than the height of the radial rib 124. In other words, the crests of the curves / bumps 200 do not protrude beyond a plane parallel with the top the radial rib 124. When inserting the mandrel, the mandrel may contact the crests of the curves / bumps 200 to be guided through the radial rib aperture 125.

[0091] To weld drainage member 112 to a catheter tube distal portion 1 14, a welding device 202 as shown in FIG. 10 may be used. Welding device 202 includes a body 204. A disk-shaped ultrasonic tip 206 extends from a body proximal portion 208. Additionally, the proximal portion 208 may include a sloped portion corresponding to the slope of the radial rib distal side 129. For instance, both the slope of the radial rib distal side 129 and of the proximal portion 208 of the welding device 202 may be 20 °- 40°.

[0092] When inserted, the disk-shaped ultrasonic tip 206 provides pressure against the catheter tube distal portion 114 to ensure firm contact is maintained against the inner surface 120 of the tubing chamber 119 during the welding process.

[0093] FIGS. 1 1 A-11 B show another example of drainage member 112 including a mandrel guidance device. In particular, FIGS. 1 1 A-11 B show drainage member 112 including two notches 210 located at the drainage member distal end. The notches 210 extend from the inner surface 122 of the drainage member distal portion 118 and are located opposite from one another such that when the drainage member distal portion 1 18 is squeezed together, the notches 210 define a mandrel aperture 211. The notches 210 may be semicircular or any othershape configured to form an aperture 211 without departing from the scope of the disclosure. The mandrel aperture 211 is sized to receive a mandrel and configured to maintain a mandrel in a centered position relative to the radial rib aperture 125. Additionally, at least the drainage member distal portion 118 may be made of a resilient material such that once the drainage member distal portion 1 18 is released after squeezing, it will return to its original shape. In an embodiment, the entire drainage member 1 12 is made of a resilient material.

[0094] Drainage member 112 may be welded to a catheter tube with a welding device as described herein or any other welding device known in the art. To guide a mandrel through the radial rib aperture 125 after welding drainage member 112 to the catheter tube, the drainage member distal portion 118 may be squeezed together to form the mandrel aperture 211 . While squeezing the drainage member distal portion 1 18 together, the mandrel may be inserted through the mandrel aperture 211 and passed through the radial rib aperture 125. Alternatively, the mandrel may be first inserted into the drainage chamber 121 of drainage member 112. After insertion of the mandrel, the drainage member distal portion 118 may be squeezed together to trap the mandrel within the mandrel aperture 211. The mandrel may then be guided through the radial rib aperture 125.

[0095] FIGS. 12A and 13 show additional examples of a two-piece drainage member 220, 230. In particular, drainage member 220, 230 may be a two-piece drainage member configured to assist in inserting a mandrel 41 through a radial rib aperture 125. The two-piece drainage member 220, 230 includes a first piece 221 , 231 configured to be welded to the catheter tube distal portion 114 and asecond piece 222, 232 configured to be connected to the first piece 221 , 231 . The first piece 221 , 231 includes at least the tubing chamber 1 19 and the radial rib 124 at or near the first piece distal end 223, 233. The second piece 222, 232 includes at least a drainage chamber 121 .

[0096] By providing a two-piece drainage member 220, 230, a mandrel 41 may be inserted into the catheter after welding the first piece 221 , 231 to the catheter tube distal portion 114, but before attaching the second piece 222, 232, thus eliminating the need to center the mandrel 41 within a drainage chamber 121 . For instance, catheter tube distal portion 114 can be welded to first piece 221 , 231 using a welding device described herein. In some embodiments, first piece 221 , 231 can include an energy deflector 237 located on radial rib proximal side 127. Energy defector 237 protrudes from radial rib proximal side 127 and can direct energy from a welding device towards the catheter tube and provides an increased surface area to which the catheter tube can bond. Alternatively, the catheter tube distal portion 114 can be attached to the first piece 221 , 231 by overmolding the first piece 221 , 231 over the catheter tube distal portion 114.

[0097] FIG. 12B generally shows a mandrel 41 inserted into first piece 221 of drainage member 220 before attaching second piece 222. Referring to Fig. 15, centering the mandrel 41 using drainage member 230 is similar to that shown in Fig. 12B. That is, after welding first piece 231 of drainage member 230 to the catheter tube distal end 114, mandrel 41 may be inserted through radial rib aperture 125 located at the first piece distal end 233 before attaching second piece 232 to first piece 231 . Because the radial rib 124 is located at or near the first piece distal end 223, 233, the mandrel 41 may be more easily centered to theradial rib aperture 125 than if the mandrel were to be inserted through the drainage chamber 121 .

[0098] Turning to FIG. 12A, drainage member 220 includes first piece 221 and second piece 222. The first piece 221 is configured to receive the second piece 222. For instance, first piece 221 includes the tubing chamber 1 19 and the radial rib 124. First piece 221 also includes a receiving chamber 225 (shown in FIG.12B) defined by first piece distal end 223 and the radial rib 124. The receiving chamber 225 is configured to receive a second piece proximal portion 224. Additionally, the two-piece drainage member 220 may include a retaining element. For instance, a retaining ring 226 may be located in the receiving chamber 225 and a retaining groove 228 may be located on the second piece proximal portion 224 or vice versa. The retaining groove 228 is configured to receive the retaining ring 226 to secure the first piece 221 and second piece 222 together. Other means of attaching the pieces may be used without departing from the scope of the disclosure, such as, but not limited to other mechanical attachments or permanent attachments methods such as adhesion, bonding, or welding.

[0099] To assemble the two-piece drainage member 220, the first piece 221 is welded to the catheter tube distal portion 114. The first piece 221 may be welded to the catheter tube distal portion 1 14 using the welding devices described herein or other welding devices known in the art. After welding, the mandrel 41 may be inserted through the radial rib aperture 125 and any manufacturing processes requiring the mandrel 41 may be performed, as well as other processes. The second piece 222 may then be attached to the first piece 221 after the mandrel 41 has been removed following any manufacturing processes requiring the mandrel.In particular, second piece proximal portion 224 can be inserted into receiving chamber 225 and attached to first piece 221 .

[0100] Turning to FIGS. 13 and 14, these figures show a two-piece drainage member 230. Two-piece drainage member 230 includes first piece 231 and second piece 232. In an embodiment, second piece 232 is configured to cover first piece 231 . In an embodiment, first piece 231 includes a tubing chamber 119 and the radial rib 124 located at the first piece distal end 233. Second piece 232 includes drainage chamber 121 .

[0101] In an embodiment, second piece 232 may be an elastomeric sock including a funnel. For instance, the second piece 232 may be made of a soft thermoelastic material, for example, but not limited to, a 55A / 75A thermoelastic material. In an embodiment, the inner surface of second piece 232 can include a distal holding member 238 to retain first piece 231 within second piece 232. The distal holding member 238 may be a shoulder, projection, or undercut. In the illustrated embodiment, first piece 231 is retained or held between the distal holding member 238 and the proximal end 234 of second piece 232. Additionally, second piece 232 can include a slot 236. In some embodiments, second piece 232 is formed in a molding process, which includes forming second piece 232 around a mold core (not shown). Slot 236 is provided to serve as a relief during mold core removal. In some instances, during mold core removal, the slot 236 provides a relief that allows room for the mold core to be released and / or slid past holding member 238. For example, the slot also provides a means for the second piece 232 to expand without deformation of the second piece 232 in order to release the mold core after molding.

[0102] Referring to FIG. 15, to assemble the two-piece drainage member 230, the first piece 231 is welded to the catheter tube distal portion 114. The first piece 231 may be welded to the catheter tube distal portion 114 using the welding devices described herein or other welding devices known in the art. After welding, the mandrel 41 may be inserted through the radial rib aperture 125 and any manufacturing processes requiring the mandrel 41 may be performed. The second piece 232 may then be attached to the first piece 231 after the mandrel has been removed following any manufacturing processes requiring the mandrel. In an embodiment, second piece 232 can be attached to first piece 231 by inserting the proximal end of the catheter tube through drainage opening 117 and drainage chamber 121 of the second piece 232. The catheter tube and first piece 231 can be pulled through the second piece 232 until the catheter tube exits the second piece through a proximal aperture 240. The first piece 231 catches the second piece proximal end 234 and is secured by holding member 238. As illustrated in FIG. 14, the holding member 238 may be ramped to assist in sliding and placement of the first piece 232 proximally past the holding member 238. In an embodiment, catheter tube and first piece 231 may be removed from second piece 232 through slot 236. In such an embodiment, the catheter tube and first piece 231 may be discarded and the second piece 232 could be reused with a new first piece 231 and catheter tube.

[0103] In an embodiment, first piece 231 and second piece 232 can be further held together by a split ring 242 (shown in FIGS. 16 and 17). Split ring 242 can aid in providing catheter retention. When the second piece 232 includes slot 236 providing relief and the first piece 231 is retained in second piece 232, the splitring 242 applies a force or pressure to counteract the relief provided by slot 236. The split ring’s counteracting force assists in retaining the first piece 231 within second piece 232. The split ring 242 may be attached to the second piece 232, concentrically placed at or near the second piece proximal end 234. The split ring may include a projection 244 protruding from the bottom surface of split ring 242. To hold the first piece 231 and second piece 232 together, after inserting first piece 231 into second piece 232, split ring 242 may be attached to second piece 232 to partially surround second piece 232, providing a tight grip around second piece 232 and first piece 231 . Additionally, split ring 242 may be placed around second piece 232 such that projection 244 is inserted into slot 236, contacting first piece 231 , and thus aiding in the retention of the catheter into the second piece 232.

[0104] It will be understood that drainage members 12, 112, 220, and 230 may be associated with one or a combination of the mandrel guidance devices described herein. Additionally, one of ordinary skill in the art will recognize that depending on the mandrel guidance device associated with the drainage member 12, 1 12, 220, and 230, the various welding devices described herein, amongst others known in the art, may be used to weld drainage member 12, 112, 220, and 230 to a catheter tube distal portion 14, 114.

[0105] It will be understood that the embodiments and examples described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein.For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.

Claims

What is Claimed:1 . A urinary catheter comprising: a catheter tube having a catheter tube distal portion; a drainage member comprising a drainage member proximal portion with an inner surface defining a tubing chamber configured to receive the catheter tube distal portion and a drainage member distal portion comprising a funnel with a distal drainage opening, wherein the funnel includes an inner surface defining a drainage chamber, and a radial rib within the drainage member separating the tubing chamber and drainage chamber, wherein the radial rib defines a radial rib aperture configured to receive a mandrel; and a guidance device associated with the drainage member, wherein the guidance device is configured to center the mandrel through the radial rib aperture.

2. The urinary catheter of claim 1 , wherein the guidance device comprises an insertable mandrel guide including a body with a lumen therethrough configured to receive a mandrel.

3. The urinary catheter of claim 2, wherein the body of the insertable mandrel guide is shaped to correspond with the drainage chamber.

4. The urinary catheter of any one of claims 2-3, wherein a distal end of the insertable mandrel guide includes a flange, wherein the flange has a larger diameter than the distal opening of the funnel.

5. The urinary catheter of claim 2, wherein the insertable mandrel guide is bullet-shaped.

6. The urinary catheter of any one of claims 2-5, wherein the lumen includes a diameter that is smaller than a diameter of a proximal portion of the mandrel.

7. The urinary catheter of claim 1 , wherein the guidance device comprises a radial ring protruding from the inner surface of the funnel.

8. The urinary catheter of claim 7, wherein the radial ring is molded onto the inner surface of the funnel.

9. The urinary catheter of claim 7, wherein the radial ring is formed by a pinch in the shape of the funnel.

10. The urinary catheter of any one of claims 7-9, wherein the height of the radial ring is at most the height of the radial rib.1 1 . The urinary catheter of claim 1 , wherein the guidance device comprises a plurality of convex curves on the inner surface of the funnel, wherein crests of the curves are configured to center a mandrel when the mandrel contacts the curves.

12. The urinary catheter of claim 11 , wherein the crests of the curves are no taller than the radial rib.

13. The urinary catheter of claim 1 , wherein the guidance device comprises a plurality of longitudinal ribs in the drainage chamber.

14. The urinary catheter of claim 13, wherein the plurality of longitudinal ribs comprises at least three longitudinal ribs, preferably at least four longitudinal ribs.

15. The urinary catheter of any one of claims 13-14, wherein the longitudinal ribs extend at least partially from the drainage opening towards the radial rib.

16. The urinary catheter of any of claims 13-15, wherein the longitudinal ribs extend from the drainage opening to the radial rib.

17. The urinary catheter of any of claims 13-16, wherein the ribs are parallel to one another.

18. The urinary catheter of any of claims 13-17, wherein the height of the ribs is no taller than the radial rib.

19. The urinary catheter of any of claims 13-18, wherein a distance between the top of a longitudinal rib to a top of an adjacent longitudinal rib is smaller than a diameter of the mandrel.

20. The urinary catheter of any of claims 13-19, wherein the ribs have a rounded shape.21 . The urinary catheter of any of claims 13-19, wherein the ribs have a squared shape.

22. The urinary catheter of claim 1 , wherein the guidance device comprises the radial rib, wherein at least a distal side of the rib is sloped.

23. The urinary catheter of claim 22, wherein the distal side of the radial rib is sloped at an angle of about 20 °- 40°.

24. The urinary catheter of any one of claims 22-23, wherein a proximal side of the radial rib is angled.

25. The urinary catheter of claim 24, wherein the proximal side of the radial rib is sloped at an angle of about 20°-40°.

26. The urinary catheter of any one of claims 24-25, wherein the angle of the proximal side of the radial rib is the same as the angle of the distal side of the radial rib.

27. The urinary catheter of claim 24, wherein the proximal side of the radial rib forms an acute angle relative to the tubing chamber.

28. The urinary catheter of claim 27, wherein the proximal side of the radial rib forms an angle of about 20°-40° relative to the tubing chamber.

29. The urinary catheter of any one of claims 27-28, wherein the angle formed by the proximal side of the radial rib relative to the tubing chamber is the same as the angle of the slope of the distal side of the radial rib.

30. The urinary catheter of any one of claims 24-29, wherein a distal end of the catheter tube is cut to correspond with the angle of the proximal side of the radial rib.31 . The urinary catheter of any of claims 22-23, wherein the sloped distal side of the rib includes a plurality of slots, such that the distal side of the rib includes alternating sloped portions and slotted portions.

32. The urinary catheter of claim 31 , wherein the slots have a thickness that is smaller than a diameter of the mandrel.

33. The urinary catheter of any of claims 31 -32, wherein the slots have a triangular shape.

34. The urinary catheter of any of claims 31 -32, wherein the slots have a squared shape.

35. The urinary catheter of claim 34, wherein the slots have a thickness of 1 mm.

36. The urinary catheter of claim 1 , wherein funnel includes a distal end including two notches located opposite one another extending from the inner surface of the funnel.

37. The urinary catheter of claim 36, wherein the notches are semicircular.

38. The urinary catheter of any of claims 36-37, wherein the notches form an aperture configured to receive and center a mandrel when the funnel is squeezed together.

39. The urinary catheter of any of claims 36-38, wherein the funnel is made of a resilient material.

40. The urinary catheter of claim 1 , wherein the drainage member is a two- piece drainage member comprising a first piece configured to be welded to the catheter tube distal portion, wherein the first piece includes at least the tubing chamber and the radial rib, and a second piece configured to be connected to the first piece, wherein the second piece includes at least the funnel.41 . The urinary catheter of claim 40, wherein the guidance device includes a distal end of the first piece, wherein the distal end of the first piece includes the radial rib aperture and is configured to receive a mandrel before receiving the second piece.

42. The urinary catheter of claim 41 , wherein the second piece is received by the distal end of the first piece.

43. The urinary catheter of claim 42, wherein one of the first piece or the second piece includes a retaining element and the other of the first piece or the second piece includes a groove configured to receive the retaining element.

44. The urinary catheter of claim 41 , wherein the second piece is an elastomeric sock configured to cover the first piece.

45. The urinary catheter of claim 44, wherein the second piece includes a slot configured to release the first piece from the second piece.

46. A method of manufacturing a urinary catheter comprising:obtaining a urinary catheter including a catheter tube and a drainage member, wherein the drainage member includes a drainage member proximal portion with an inner surface defining a tubing chamber, a drainage member distal portion with a distal opening at a distal end and an inner surface defining a drainage chamber, and a radial rib within the drainage member separating the tubing chamber from the drainage chamber and the radial rib defining a radial rib aperture; and using a guidance device associated with the drainage member to insert a mandrel within the urinary catheter.

47. The method of claim 46, wherein obtaining the urinary catheter comprises inserting a catheter tube distal portion into the tubing chamber and welding the catheter tube distal portion to the drainage member with an ultrasonic welding device.

48. The method of any one of claims 46-48, comprising centering the mandrel through the radial rib aperture with the guidance device.

49. The method of any one of claims 46-48, wherein the distal portion of the drainage member includes a funnel.

50. The method of any one of claims 46-48, wherein the guidance device comprises an insertable mandrel guide including a body with a lumen therethrough configured to receive a mandrel.51 . The method of claim 49, comprising inserting the insertable mandrel guide into the drainage member distal portion.

52. The method of any one of claims 49-50, wherein the body of the insertable mandrel guide is shaped to correspond with the drainage chamber.

53. The method of any one of claims 49-51 , wherein a distal end of the insertable mandrel guide includes a flange, wherein the flange has a larger diameter than the distal opening of the drainage member distal portion.

54. The method of claim 49, wherein the insertable mandrel guide is bulletshaped.

55. The method of any one of claims 49-53, wherein the lumen includes a diameter that is smaller than a diameter of a proximal portion of the mandrel.

56. The method of any one of claims 46-49, wherein the guidance device comprises a radial ring protruding from the inner surface of the drainage member distal portion.

57. The method of claim 56, wherein the radial ring is molded onto the inner surface of the drainage member distal portion.

58. The method of claim 56, wherein the radial ring is formed by a pinch in the shape of the drainage member distal portion.

59. The method of any one of claims 56-58, wherein the height of the radial ring is at most the height of the radial rib.

60. The method of any one of claims 46-49, wherein the guidance device comprises a plurality of convex curves on the inner surface of the drainage member distal portion, wherein crests of the curves are configured to center a mandrel when the mandrel contacts the curves.61 . The method of claim 60, wherein the crests of the curves are no taller than the radial rib.

62. The method of any one of claims 46-49, wherein the guidance device comprises a plurality of longitudinal ribs in the drainage chamber.

63. The method of claim 62, wherein the plurality of longitudinal ribs comprises at least three longitudinal ribs, preferably at least four longitudinal ribs.

64. The method of any one of claims 62-63, wherein the longitudinal ribs extend at least partially from the drainage opening towards the radial rib.

65. The method of any of claims 62-64, wherein the longitudinal ribs extend from the drainage opening to the radial rib.

66. The method of any of claims 62-65, wherein the ribs are parallel to one another.

67. The method of any of claims 62-66, wherein the height of the ribs is no taller than the radial rib.

68. The method of any of claims 62-67, wherein a distance between the top of one longitudinal rib to a longitudinal rib adjacent to it is smaller than a diameter of the mandrel.

69. The method of any of claims 62-68, wherein the longitudinal ribs have a rounded shape.

70. The method of any of claims 62-68, wherein the longitudinal ribs have a squared shape.71 . The method of any one of claims 46-49, wherein the guidance device comprises the radial rib, wherein at least a distal side of the rib is sloped.

72. The method of claim 71 , wherein the distal side of the radial rib is sloped at an angle of about 20 °- 40°.

73. The method of any one of claims 71-72, wherein a proximal side of the radial rib is angled.

74. The method of any one of claims 71-73, wherein a proximal side of the radial rib is angled.

75. The method of claim 74, wherein the proximal side of the radial rib is sloped at an angle of about 20 °- 40°.

76. The method of any one of claims 74-75, wherein the angle of the proximal side of the radial rib is the same as the angle of the distal side of the radial rib.

77. The method of claim 74, wherein the proximal side of the radial rib forms an acute angle relative to the tubing chamber.

78. The method of claim 77, wherein the proximal side of the radial rib forms an angle of about 20 °-40° relative to the tubing chamber.

79. The method of any one of claims 77-78, wherein the angle formed by the proximal side of the radial rib relative to the tubing chamber is the same as the angle of the slope of the distal side of the radial rib.

80. The method of any one of claims 71-79, wherein a distal end of the catheter tube is cut to correspond with the angle of the proximal side of the radial rib.81 . The method of any one of claims 71-72, wherein the sloped distal side of the rib includes a plurality of slots, such that the distal side of the rib includes alternating sloped portions and slotted portions.

82. The method of claim 81 , wherein the slots have a thickness that is smaller than a diameter of the mandrel.

83. The method of any one of claims 81-82, wherein the slots have a triangular shape.

84. The method of any one of claims 81-82, wherein the slots have a squared shape.

85. The method of claim 84, wherein the slots have a thickness of 1 mm.

86. The method of any one of claims 46-49, wherein the distal end of the drainage member includes two notches located opposite one another extending from the inner surface of the drainage member.

87. The method of claim 86, wherein the notches are semicircular.

88. The method of any of claims 86-87, wherein the drainage member distal portion is made of a resilient material.

89. The method of any one of claims 86-88, comprising inserting a mandrel into the drainage chamber and squeezing the drainage member distal portion together to form an aperture defined by the notches, wherein the notches trap the mandrel and center the mandrel to the radial rib aperture.

90. The method of claim 49, wherein the drainage member includes a first piece and a second piece, wherein the first piece includes at least the tubing chamber and the radial rib defining the radial rib aperture.91 . The method of claim 90, wherein the second piece includes at least a funnel and a proximal portion of the second piece is received by a distal portion of the first piece.

92. The method of claim 91 , wherein one of the distal portion of the first piece or the proximal portion of the second piece includes a retaining element and the other of the distal portion of the first piece or the proximal portion of the second piece includes a groove configured to receive a retaining element.

93. The method of claim 90, wherein the second piece is an elastomeric sock configured to cover the first piece.

94. The method of claim 93, wherein the second piece includes a slot configured to release the first piece from the second piece.

95. The method of any one of claims 90-94, comprising attaching the second piece to the first piece after inserting the mandrel through the radial rib aperture.

96. A system for manufacturing a urinary catheter comprising: a catheter tube having a catheter tube distal portion; a drainage member comprising a drainage member proximal portion with an inner surface defining a tubing chamber configured to receive the catheter tube distal portion and a drainage member distal portion comprising a funnel with a distal drainage opening, wherein the funnel includes an inner surface defining a drainage chamber, and a radial rib within the drainage member separating the tubing chamber and drainage chamber, wherein the radial rib defines a radial rib aperture configured to receive a mandrel; an ultrasonic welding device configured to weld the catheter tube distal portion to the drainage member; and a guidance device associated with the drainage member, wherein the guidance device is configured to center the mandrel through the radial rib aperture.

97. The system of claim 96, wherein the ultrasonic welding device comprises a sonotrode including an ultrasonic tip and a sonotrode body, wherein the ultrasonic tip extends from a proximal portion of the sonotrode body.

98. The system of claim 97, wherein the ultrasonic tip is configured to fit through the radial rib aperture.

99. The system of any one of claims 96-98, wherein the guidance device comprises an insertable mandrel guide including a body with a lumen therethrough configured to receive the mandrel.

100. The system of claim 99, wherein the body of the insertable mandrel guide is shaped to correspond with the drainage chamber.101 . The system of any one of claims 99-100, wherein a distal end of the insertable mandrel guide includes a flange, wherein the flange has a larger diameter than the distal drainage opening of the funnel.

102. The system of claim 99, wherein the insertable mandrel guide is bulletshaped.

103. The system of any one of claims 99-102, wherein a proximal end of the mandrel has a larger diameter than the lumen.

104. The system of any one of claims 96-98, wherein the guidance device comprises a radial ring protruding from the inner surface of the funnel.

105. The system of claim 104, wherein the radial ring is molded onto the inner surface of the funnel.

106. The system of claim 104, wherein the radial ring is formed by a pinch in the shape of the funnel.

107. The system of any one of claims 104-107, wherein the height of the radial ring is at most the height of the radial rib.

108. The system of any one of claim 97-98, wherein the guidance device comprises a plurality of convex curves on the inner surface of the funnel, whereincrests of the curves are configured to center a mandrel when the mandrel contacts the curves.

109. The system of claim 108, wherein the crests of the curves are no taller than the radial rib.1 10. The system of any one of claims 108-109, wherein the sonotrode body is rounded and the ultrasonic tip is disk-shaped, wherein the ultrasonic tip is configured to press the catheter tube distal portion against the inner surface of the drainage member proximal portion.1 11. The system of any one of claims 97-98, wherein the guidance device comprises a plurality of longitudinal ribs in the drainage chamber.1 12. The system of claim 11 1 , wherein the plurality of longitudinal ribs comprises at least three longitudinal ribs, preferably at least four longitudinal ribs.1 13. The system of any one of claims 111 -112, wherein the longitudinal ribs are parallel to one another.1 14. The system of any one of claims 111 -113, wherein the height of the longitudinal ribs is no taller than the radial rib.1 15. The system of any one of claims 111 -114, wherein a distance between the top of a longitudinal rib to a top of an adjacent longitudinal rib is smaller than a diameter of the mandrel.1 16. The system of any one of claims 111 -115, wherein the ribs have a rounded shape.1 17. The system of any one of claims 111 -115, wherein the ribs have a squared shape.1 18. The system of any one of claims 111 -117, wherein the longitudinal ribs extend at least partially from the drainage opening towards the radial rib.1 19. The system of any one of claims 111 -118, wherein a diameter of the proximal portion of the sonotrode body is less than a diameter of a circle defined by the tops of the longitudinal ribs.

120. The system of any of claims 1 11-118, wherein the longitudinal ribs extend from the drainage opening to the radial rib, wherein the longitudinal ribs define slots between the longitudinal ribs.121 . The system of claim 120, wherein the proximal portion of the sonotrode body is shaped to correspond with the slots defined by the longitudinal ribs.

122. The system of any one of claims 97-98, wherein the guidance device comprises the radial rib, wherein at least a distal side of the rib is sloped.

123. The system of claim 122, wherein the distal side of the radial rib is sloped at an angle of about 20 °- 40°.

124. The system of any one of claims 122-123, wherein the proximal portion of the sonotrode body includes a slope corresponding with the sloped distal side of the radial rib.

125. The system of any one of claims 122-124, wherein a proximal side of the radial rib is angled.

126. The system of claim 125, wherein the proximal side of the radial rib is sloped at an angle of about 20 °- 40°.

127. The system of any one of claims 125-126, wherein the angle of the proximal side of the radial rib is the same as the angle of the distal side of the radial rib.

128. The system of claim 125, wherein the proximal side of the radial rib forms an acute angle relative to the tubing chamber.

129. The system of claim 128, wherein the proximal side of the radial rib forms an angle of about 20 ° - 40 “ relative to the tubing chamber.

130. The system of any one of claims 128-129, wherein the angle formed by the proximal side of the radial rib relative to the tubing chamber is the same as the angle of the slope of the distal side of the radial rib.131 . The system of any one of claims 125-130, wherein a distal end of the catheter tube is cut to correspond with the angle of the proximal side of the radial rib.

132. The system of any one of claims 122-123, wherein a distal portion of the ultrasonic tip includes a plurality of machined fins, wherein the machined fins are configured to mold the sloped distal side of the radial rib away such that the distal side of the rib includes alternating sloped and slotted portions.

133. The system of claim 132, wherein the thickness of the machined fins is smaller than a diameter of the mandrel.

134. The system of claim 133, wherein the thickness of the machined fins is 1 mm.

135. The system of any one of claims 132-134, wherein the fins have a triangular shape.

136. The system of any one of claims 132-134, wherein the fins have a squared shape.

137. The system of any one of claims 96-98, wherein the funnel includes a distal end including two notches located opposite one another extending from the inner surface of the funnel.

138. The system of claim 137, wherein the notches are semicircular.

139. The system of any one of claims 137-138, wherein the notches form an aperture configured to receive and center the mandrel when the distal drainage opening is squeezed together.

140. The system of any one of claims 137-139, wherein the funnel is made of a resilient material.141 . The system of any one of claims 96-98, wherein the drainage member is a two-piece drainage member comprising a first piece configured to be welded to the catheter tube distal portion, wherein the first piece includes at least the tubing chamber and the radial rib and a second piece configured to be connected to the first piece, wherein the second piece includes at least the funnel.

142. The system of claim 141 , wherein the first piece is configured to receive the second piece.

143. The system of claim 142, wherein one of the first piece or second piece includes a retaining element and the other of the first piece or second piece includes a groove configured to receive the retaining element.

144. The system of claim 141 , wherein the second piece is an elastomeric sock configured to cover the first piece.

145. The system of claim 144, wherein the second piece includes a slot configured to release the first piece from the second piece.

146. The system of any one of claims 141 -145, wherein the mandrel is insertedthrough the radial rib aperture before attaching the second piece.

Images