Drainage member with energy directors

Abstract

A urinary catheter product (10). More particularly, an intermittent sleeved urinary catheter product. Even more particularly, a drainage member (20) with energy directors (40) configured to assist in attaching a sleeve (22) to an intermittent urinary catheter.

Description

DRAINAGE MEMBER WITH ENERGY DIRECTORSThe present application claims the benefit of and priority to U.S. Provisional Application 63 / 711 ,729, filed October 25, 2024, which is hereby incorporated by reference.FIELD OF THE INVENTION

[0001] This disclosure generally relates to a urinary catheter. In particular, the disclosure relates to a sleeved intermittent urinary catheter and method of making and using the same.BACKGROUND

[0002] Patients with spinal cord injuries (SCI) or other neurogenic bladder conditions typically need to empty their bladders by intermittent urinary catheterization. In some instances, intermittent catheterization is a good option for many users who suffer from various abnormalities of the urinary system. With the advent of intermittent urinary catheters, individuals with problems associated with the urinary system can conveniently self-catheterize to drain the individual’s bladder.

[0003] Intermittent urinary catheters typically include a drainage member at the distal drainage end of the catheter tube. Such drainage members may be, but are not necessarily, funnel shaped. The drainage member may be used to direct urine draining from the catheter to a waste receptacle, such as a toilet. The drainage member also may be configured for attachment to a urine collection system, such as a urine collection bag.

[0004] In some instances, an intermittent urinary catheter includes a sleeve surrounding a portion or the entirety of the catheter tube. The sleeve can be used to retain a hydrating solution to hydrate a hydrophilic coating on the catheter tube and to maintain sterility when handling the catheter.

[0005] Often, the sleeve is attached at one end to the drainage member of the catheter. Generally, the sleeve can be attached by adhesion, bonding, with mechanical fasteners, or by heat sealing. Existing attachment methods may be timeconsuming, may form unreliable attachment, or may deform a portion of the drainage member affecting performance of the catheter.

[0006] Therefore, there is a need for improved drainage members and methods for attaching a sleeve to a catheter.SUMMARY OF INVENTION

[0007] 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 combination as set forth in the claims appended hereto.

[0008] In one aspect, a drainage member for a sleeved urinary catheter is provided. The drainage member includes a proximal portion, a distal portion, and a lumen extending through the proximal portion and the distal portion. The drainage member also includes an outer surface and an inner surface defining the lumen and at least one energy director located on the outer surface.

[0009] In another aspect, a urinary catheter product is provided. The urinary catheter product includes an intermittent urinary catheter including a catheter tube with a tube proximal insertion end and a tube distal drainage end and a tube lumen extending between the tube proximal insertion end and the tube distal drainage end. The catheter product also includes a drainage member located at the tube distal drainage end and a collapsible sleeve defining a compartment that contains at least a portion of the catheter tube, the sleeve distal end being attached to the drainage member. The drainage member includes a drainage member proximal portion, a drainage member distal portion, and a drainage member lumen extending through the drainage member proximal portion and the drainage member distal portion. The drainage member also includes an outer surface and an inner surface defining the drainage member lumen and at least one energy director located on the outer surface.

[0010] In another aspect, a method of manufacturing a sleeved urinary catheter is provided. The method includes obtaining a urinary catheter including a catheter tube with a tube proximal insertion end and a tube distal drainage end and a tube lumen extending between the tube proximal insertion end and the tube distal drainage end. The urinary catheter also includes a drainage member located at the tube distal drainage end. The drainage member includes a drainage member proximal portion, a drainage member distal portion and a drainage member lumen extending through the drainage member proximal portion and the drainage memberdistal portion. The drainage member also includes an outer surface and an inner surface defining the drainage member lumen and at least one energy director located on the outer surface. The method also includes ultrasonically welding a collapsible sleeve to the drainage member outer surface. The collapsible sleeve includes a sleeve distal end and sleeve proximal end.BRIEF DESCRIPTION OF DRAWINGS

[0011] FIG. 1 is a perspective view of an example of a urinary catheter.

[0012] FIG. 2 is a perspective view of an example of a drainage member.

[0013] FIG. 3 is a perspective view of another example of a drainage member.

[0014] FIG. 4 is a perspective view of another example of a drainage member.

[0015] FIG. 5 is a perspective view of another example of a drainage member.

[0016] FIG. 6A is a cross-sectional view of an example of the drainage member of FIG. 2, taken along line A-A.

[0017] FIG. 6B is a cross-sectional view of an example of the drainage member of FIG. 2, taken along line B-B of FIG 2.

[0018] FIG. 6C is a cross-sectional view of another example of a drainage member.

[0019] FIG. 6D is a cross-sectional view of another example of a drainage member.

[0020] FIG. 7 is a perspective view of another example of a drainage member.

[0021] FIG. 8 is a cross-sectional view of the drainage member of FIG. 7, taken along line C-C.

[0022] FIG. 9 is a perspective view of an example of a drainage member including an unattached sleeve.

[0023] FIG. 10 is a perspective view of the drainage member and the unattached sleeve of FIG. 9 and an ultrasonic welding device configured to attach the drainage member and sleeve.

[0024] FIG. 11 is a perspective view of the drainage member and sleeve of FIG.9 being ultrasonically welded to one another.

[0025] FIG. 12 is an enlarged perspective view of the drainage member and sleeve of FIG. 9 welded to one another.

[0026] FIG. 13 is a cross-sectional view of the drainage member and sleeve of FIG. 12, taken along line D-D.DETAILED DESCRIPTION

[0027] 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 or embodiments that would occur to persons of ordinary skill.

[0028] Turning to FIG. 1 , the figure illustrates an example of an intermittent urinary catheter 10. In an example, urinary catheter 10 is a sleeved urinary catheter. Urinary catheter 10 includes a catheter tube 12 having a tube proximal insertion end 14 and a tube distal drainage end 16. A tube lumen extends from the tube proximal insertion end 14 to the tube distal drainage end 16. The tube proximal insertion end 14 includes one or more openings 18 for receiving urine in communication with the tube lumen. In an example, the one or more openings 18 for receiving urine may be an eyelet. In another example, the one or more openings 18 for receiving urine may be multiple eyelets. The size, shape and location of the one or more openings 18 for receiving urine may vary without departing from the scope of the disclosure.

[0029] The tube distal drainage end 16 includes a drainage opening for draining urine from the tube lumen. In an example, a drainage member 20 is associated with the tube distal drainage end 16. The drainage member 20 may include or be a connector or a funnel.

[0030] In some examples, the catheter tube 12 may include a hydrophilic surface. For example, a hydrophilic polymer coating may be applied to the outer surface of the catheter or the material forming the catheter tube may include a hydrophilic polymer. The hydrophilic surface is configured to absorb a hydrating medium to lubricate the catheter tube 12 to aid in insertion into a urethra. In other examples, the catheter tube 12 may be lubricated with a gel lubricant or any other sufficient lubrication material or mechanism.

[0031] The urinary catheter 10 includes a sleeve 22. In an example, the urinary catheter 10 may also include an insertion aid 24. The sleeve 22 may be a protective or barrier sleeve. The sleeve 22 has a sleeve proximal end 26 and a sleeve distal end 28. The sleeve 22 may define an internal cavity in which the catheter tube 12 may be located. In an embodiment, the sleeve 22 surrounds at least a portion of thecatheter tube 12. In another embodiment, the sleeve 22 extends over and surrounds the length of the catheter tube 12.

[0032] In an example, the insertion aid 24 may be located at the sleeve proximal end 26. When an insertion aid 24 is present, the sleeve proximal end 26 may be attached to a distal portion 30 of the insertion aid 24 by, for example, welding, adhesion, bonding, or any other suitable attachment means.

[0033] Additionally, the sleeve distal end 28 is attached to the drainage member 20. In particular, the sleeve distal end 28 can be ultrasonically welded to the drainage member 20 as described herein.

[0034] The sleeve 22 may be made of a flexible material which may be vapor permeable or vapor impermeable, depending on the desired use and packaging. The material of the sleeve 22 also may be liquid impermeable or liquid permeable. The sleeve 22 may be formed of any of a variety of thin, flexible polymeric film materials, such as polyethylene, plasticized PVC, or polypropylene, but elastomeric film materials such as polyurethane, and particularly elastomeric hydrogel materials, may be suitable. In some embodiments, the sleeve 22 may contain a hydration medium.

[0035] In an example the sleeve can be formed of two layers of flexible material attached to each other along a first longitudinal edge 23a and a second longitudinal edge 23b. The edges 23a and 23b can be attached by, for example, but not limited to, heat sealing, adhesion, welding, or any other suitable attachment method. In another example, the sleeve may be one continuous unitary piece of material, such as an extruded tube.

[0036] In some examples, a removeable cap 32 can be located at the insertion aid 24. The cap 32 includes a cavity configured to receive at least a portion of the insertion aid 24. The cap 32 may be attached to the insertion aid 24 via, for example, but not limited to, a friction fit. Additionally, the cap 32 can include a ring 34 configured to be gripped by a user to pull the cap 32 off of the insertion aid 24.

[0037] As disclosed above, drainage member 20 can be located at the tube distal drainage end 16. FIGS. 2-5 and 7 illustrate examples of a drainage member 20. For instance, as shown in FIGS. 2-5 and 7, drainage member 20 can include a funnel. In another example, the drainage member 20 can include a connector configured to attach and / or fluidly connect the catheter 10 to a collection container or other suitable accessory.

[0038] The drainage member 20 includes a proximal portion 36, a distal portion 38, a drainage member inner surface 37, and a drainage member outer surface 39. A drainage member lumen extends through the drainage member 20 between the proximal portion 36 and distal portion 38. The drainage member lumen is defined by the drainage member inner surface 37. The drainage member 20 can be made of a moldable material. For instance, the drainage member 20 can be made of flexible medical grade polymers including, but not limited to, polyethylene, polypropylene, polyvinyl chloride, polyurethane, and various combinations thereof. In an example, the drainage member 20 is a single, unitary piece. For instance, the drainage member proximal portion 36 and the drainage member distal portion 38 are integrally formed. Alternatively, in another example, the drainage member 20 can be formed of multiple pieces attached to one another. For instance, the drainage member proximal portion 36 can be attached to the drainage member distal portion 38 during manufacturing of the drainage member 20.

[0039] The proximal portion 36 is configured to receive and be attached to the urinary catheter tube 12. In particular, the tube distal drainage end 16 is inserted into the drainage member proximal portion 36 and is attached therein. The tube distal drainage end 16 can be attached to the drainage member proximal portion 36 by, for example, ultrasonic welding, adhesion, bonding, or any other suitable manner of attachment without departing from the scope of the disclosure. In an example, the drainage member inner surface 37 can include an inner surface annular rib. The inner surface annular rib can assist in attaching the catheter tube 12 to the drainage member 20. For instance, the catheter 12 can be ultrasonically welded to the drainage member 20 by welding the inner surface annular rib to the tube distal drainage end 16, as described in International Patent Publication No. WO 2025 / 096618 filed on October 30, 2024, the disclosure of which is incorporated by reference in its entirety herein.

[0040] The drainage member distal portion 38 includes an outlet at the distal end for urine to exit the drainage member 20. In an example, the drainage member distal portion 38 includes a funnel. For instance, as shown in FIGS. 2-5 and 7, the drainage member distal portion 38 tapers from the distal end towards the drainage member proximal portion 36. The funnel can be used to direct urine flowing from the catheter tube to a suitable receptacle such as a toilet. In another example, thedrainage member distal portion 38 can be a connector (not shown). For instance, the drainage member distal portion 38 can be configured to attach the drainage member 20 to a collection container or other suitable accessory.

[0041] As discussed above, the drainage member 20 is configured to be attached to the sleeve 22. In particular, the drainage member 20 is configured to have a sleeve 22 ultrasonically welded thereto. For instance, the sleeve 22 can be ultrasonically welded to the drainage member proximal portion 36. Additionally, the drainage member 20 includes energy directors 40 configured to assist with ultrasonically welding the sleeve 22 to the drainage member. In an example, as shown in FIGS. 2-5 and 7, the energy directors 40 can be located at the drainage member proximal portion 36. Alternatively, the energy directors 40 can be located anywhere on the drainage member 20 without departing from the scope of the disclosure.

[0042] Turning to FIGS. 2-5 and 7, the outer surface 39 of drainage member proximal portion 36 can include the at least one energy director 40. The at least one energy director 40 can be a raised portion of the outer surface 39 providing an area for the sleeve 22 to be welded to. For example, the energy director 40 can be additional material attached or molded to the drainage member outer surface 39. Alternatively, the energy director 40 can be integral with the drainage member 20. In one alternative, the drainage member 20 can be shaped to include raised portions located at the drainage member proximal portion 36.

[0043] In some examples, as shown in FIGS. 2-5, the at least one energy director 40 is an annular rib 41. For instance, the drainage member 20 can include at least three, four, five, or six annular ribs 41 located on the drainage member outer surface 39 of the drainage member proximal portion 36. In particular, the drainage member 20 can include three annular ribs 41 (shown in FIG. 2), four annular ribs 41 (shown in FIG. 3), five annular ribs 41 (shown in FIG. 4), or six annular ribs 41 (shown in FIG. 5).

[0044] In an example, the annular ribs 41 can have a height “H” of about 0.2-1.0 mm (FIG. 6B) from the base of the rib to the tip of the rib. Preferably, the annular ribs 41 can have a height “H” of about 0.3 mm. For instance, the annular ribs 41 can protrude about 0.3 mm from where the base adjoins the drainage member outer surface 39. The annular ribs 41 may also have a width “W” of about 0.4-2.0 mm(FIG. 6B). Preferably, the annular ribs 41 can have width “W” of about 0.6 mm at the base. In some examples, the annular ribs 41 include a triangular cross-section, and tapers from the base of the rib 41 at the drainage member outer surface 39 to the tip of the rib 41. Without departing from the scope of the disclosure, the triangular crosssection can be any type of triangular shape, including, but not limited to, an equilateral triangle, a right triangle, an isosceles triangle, etc. In this instance, the width diminishes from the base towards the tip. Additionally, when the drainage member 20 includes more than one annular rib 41 , the annular ribs 41 can be spaced a distance “D” apart from one another. The distance between annular ribs 41 can depend on the number of total annular ribs. In some instances, the annular ribs 41 can be uniformly spaced between one another. In an example, the annular ribs can be spaced 2 mm apart from one another. In another example, the annular ribs can be spaced as close as possible to one another without the ribs 41 overlapping. In a particular example, the annular ribs 41 can include a width of 1 mm at their bases and can be spaced at a minimum of 1 mm apart from one another from their respective centers. It will be understood that the distance between the annular ribs 41 can vary without departing from the scope of the disclosure.

[0045] Turning to FIGS. 6A, 6C, and 6D, the figures illustrate cross-sections of examples of the drainage member 20 at dotted line A-A (shown for illustrative purposes), viewing the drainage member 20 in a direction from the drainage member distal portion 38 towards the drainage member proximal portion 36. In an example, as illustrated in FIG. 6A, the annular ribs 41 can extend entirely around the circumference of the drainage member 20. For instance, the annular ribs 41 can extend around the entire circumference of the drainage member proximal portion 36.

[0046] Alternatively, the annular ribs 41 may partially extend around the circumference of the drainage member proximal portion 36, as shown in FIG. 6C. For example, the annular ribs 41 can cover about 95% of the circumference of the drainage member proximal portion 36. When the drainage member proximal end portion 36 is a cylinder, the annular ribs may extend from about 180° to about 340° around the outer surface 39 as measured from the central longitudinal axis of the drainage member proximal portion 36. In particular, an annular rib 41 can extend about 340° around the circumference of the drainage member proximal portion 36. Accordingly, the annular rib 41 can include a gap.

[0047] In another example, as shown in FIG. 6D the annular rib 41 can include multiple gaps within the rib 41 , thus creating annular rib segments 43 located on the drainage member proximal portion 36. The annular rib segments 43 can cover about 95% of the circumference of the drainage member proximal portion 36. For instance, when the drainage member proximal end portion is a cylinder, the sum of the arcs of each segment 43 of an annular rib 41 may extend from about 180° to about 340°. The circumferential extension of the annular rib segments 43 can vary depending on the number of segments 43. In a particular example, the annular rib 41 includes two annular rib segments 43. The sum of the arcs of the two annular rib segments 43 may be about 180° with each annular rib segment 43 including an angle of about 90°. Additionally, the segments 43 are located on opposite sides of the drainage member proximal portion 36. In another example, the annular rib 41 can include segments 43, wherein each segment includes an arc with an angle 44 of about 45°, the segments 43 being spaced equidistantly from one another.

[0048] The annular rib segments 43 can include a uniform shape and size or the size and shape can vary from one another. Additionally, when the drainage member 20 includes multiple rows of annular rib segments 43, the annular rib segments 43 can be positioned one behind the other or they may be staggered from one another.

[0049] Turning to FIGS. 7 and 8, FIG. 7 illustrates another example of the drainage member 20 with energy directors 40 and FIG. 8 illustrates a cross-section of the drainage member 20 at dotted line C-C (shown for illustrative purposes), viewing the drainage member 20 in a direction from the drainage member distal portion 38 towards the drainage member proximal portion 36. In this example, the at least one energy director 40 can include a longitudinal rib 45 extending along an axis extending from the drainage member proximal portion 36 towards the drainage member distal portion 38. For instance, the drainage member 20 can include multiple longitudinal ribs 45 on the drainage member outer surface 39 located around the circumference of drainage member proximal portion 36. The longitudinal ribs 45 can have a height of about 0.2-1.0 mm. Preferably, the longitudinal ribs 45 can have a height of about 0.3 mm. In an example, the longitudinal ribs 45 can protrude from the outer surface 39. The longitudinal ribs 45 may also have a width of about 0.4-2.0 mm. Preferably, the longitudinal ribs 45 can have a width of about 0.6 mm at the base. In some examples, the longitudinal ribs 45 can be triangular prisms and / orhave triangular cross-sections. Without departing from the scope of the disclosure, the triangular cross-section can be any type of triangular shape, including, but not limited to, an equilateral triangle, a right triangle, an isosceles triangle, etc. As such, the longitudinal ribs taper from the base of the rib 45 to the tip of the rib 45. In this instance, the width diminishes from the base towards the tip. Additionally, regardless of the shape, the longitudinal ribs can be about 5-10 mm long. For example, the longitudinal ribs 45 can be about 10 mm long.

[0050] The size, shape, and orientation of the energy director(s) 40 on the drainage member proximal portion 36 can vary without departing from the scope of the disclosure. For instance, the energy directors can include a squared shape as shown in FIG. 6B (i.e., the energy directors 40 include a flat top surface).Alternatively, as shown in FIGS. 7-8, the energy directors 40 include a triangular shape (i.e., the energy directors 40 include a pointed top). Additionally, the at least one energy director 40 can be one or many raised portions on the drainage member outer surface 39 in a variety of shapes and orientations.

[0051] Turning to FIGS. 9-12, the figures illustrate an example of a method of attaching the sleeve 22 to the drainage member 20. For illustrative purposes, FIGS.9-12 show the sleeve 22 being attached to the drainage member 20 without a catheter tube 12. It will be understood that the sleeve 22 can be attached to the drainage member 20 after the catheter tube 12 has been attached to the drainage member 20.

[0052] To attach the sleeve 22 to the drainage member 20, the drainage member proximal portion 36 and sleeve 22 can be ultrasonically welded to one another. The drainage member proximal portion 36 can be inserted into the sleeve distal end 28. An ultrasonic welding device 46, as shown in FIGS. 10-11 can be placed around the drainage member 20 and sleeve 22 to weld the sleeve 22 to the drainage member 20. As illustrated, the ultrasonic welding device 46 can be a two-piece device configured to receive the drainage member 20 and sleeve 22. For example, the ultrasonic welding device 46 can include a first sonotrode 46a and a second sonotrode 46b, each with a groove 47. When brought together, the grooves 47 form an aperture configured to substantially surround the drainage member 20 and sleeve 22, as shown in FIG. 11. Ultrasonic vibrations from the device 46 weld the sleeve 22 to the drainage member 20. In particular, the sleeve 22 is welded to the at least oneenergy director 40. The ultrasonic welding device can vary without departing from the scope of the disclosure. For instance, a differently configured ultrasonic welding device can be used.

[0053] During welding, the at least one energy director 40 may become deformed. For example, the at least one energy director may be melted. In one alternative, the at least one energy director 40 can become flattened, as shown in FIG. 12. In an example, the at least one energy director 40 may become substantially flush with the rest of the drainage member outer surface 39.Alternatively, the at least one energy director may slightly protrude beyond the drainage member outer surface 39. For instance, after welding, the at least one energy director 40 can be flattened up to 100% of its original height. In an example, after welding, the at least one energy director 40 can be flattened from about 0% to about 100% its original height.

[0054] By including energy directors as described herein, the sleeve 22 can be welded to the drainage member 20 while preventing deformation of the drainage member lumen as defined by the drainage member inner surface 37. For instance, the raised portion of the at least one energy director 40 provides an additional surface / material that can withstand an amount of deformation without affecting the shape of the rest of the drainage member outer surface 39. Accordingly, the drainage member inner surface 37, and in turn, the drainage member lumen and catheter tube 12 (located therein if previously attached), may retain its shape.

[0055] Additionally, the sleeve 22 can be attached to the drainage member 20 such that air can escape the sleeve 22. By allowing egress for air entrapped in the sleeve 22, the sleeve 22 is prevented from ballooning as the sleeve 22 is collapsed when inserting the catheter tube 12 into the urethra. For instance, to use catheter 10 after manufacture, a user can insert the proximal insertion end 14 of the catheter tube 12 into the urethra (with the insertion aid 24, if present). The user can then grip the catheter tube 12 through the sleeve 22 and push the tube 12 further into the urethra until the at least one opening 18 enters the bladder. As the tube is inserted, the sleeve proximal end 26 and sleeve distal end 28 are moved towards one another.

[0056] In an example, the ultrasonic welding device 46 can be configured to leave a portion of the sleeve unwelded to the drainage member 20 to allow air toescape the sleeve as it is collapsed. For instance, as shown in FIGS. 12-13, the ultrasonic welding device 46 can be configured to leave an unsealed channel 48 defined by the sleeve 22 and drainage member 20. In an example, the ultrasonic welding device 46 is configured to leave unsealed channels 48 on opposite sides of the drainage member 20. FIG. 13 illustrates a cross-section of the drainage member 20 with a sleeve 22 welded thereto at dotted line D-D (shown for illustrative purposes), viewing the drainage member 20 and sleeve 22 in a direction from the drainage member distal portion 38 towards the drainage member proximal portion 36. As illustrated in FIG. 13, the at least one energy director 40 can be deformed during welding such that the energy director 40 forms a bump 52 on opposite sides of the drainage member 20. The bump 52 can form a gap between the material forming the sleeve. For instance, when the sleeve is formed of two layers of flexible material, the bump 52 can form a gap between a top layer 54a and a bottom layer 54b of the sleeve 22. In another example, the grooves 47 of the ultrasonic welding device 46 can be slightly wider than the diameter of the drainage member proximal portion 36. Accordingly, the sleeve 22 would be sealed to substantially the entire top and bottom semi-circular perimeters of the drainage member 20 while opposite side portions of the drainage member would remain unsealed to the sleeve 22. The unsealed portion of the drainage member 20 and internal cavity of the sleeve 22 can define the channel 48.

[0057] In another example, entrapped air in the sleeve can escape through a gap in the annular rib 41 , gaps between annular rib segments 43, or the spaces between longitudinal ribs 45. For instance, the ultrasonic welding device 46 can weld the sleeve 22 to the annular rib(s) 41 , annular rib segments 43, or longitudinal ribs 45, leaving the drainage member outer surface 39 unsealed to the sleeve 22 at the gaps / spaces. As the catheter tube 12 is inserted into the urethra, air entrapped in the sleeve 22 can escape between the drainage member outer surface 39 and the sleeve 22 through the unsealed portions located at the gaps / spaces.

[0058] 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. Forthese 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 drainage member for a sleeved urinary catheter comprising:a proximal portion, a distal portion and a lumen extending through the proximal portion and the distal portion;an outer surface and an inner surface defining the lumen; andat least one energy director located on the outer surface.

2. The drainage member of claim 1 , wherein the at least one energy director is located on the proximal portion.

3. The drainage member of any one of claims 1 -2, wherein the at least one energy director is configured to assist in ultrasonic welding of a sleeve to the drainage member.

4. The drainage member of any one of claims 1 -3, wherein the at least one energy director is a raised portion of the outer surface.

5. The drainage member of any one of claims 1 -4, wherein the at least one energy director comprises an annular rib.

6. The drainage member of claim 4, wherein the outer surface includes three annular ribs.

7. The drainage member of claim 4, wherein the outer surface includes four annular ribs.

8. The drainage member of claim 4, wherein the outer surface includes five annular ribs.

9. The drainage member of claim 4, wherein the outer surface includes six annular ribs.

10. The drainage member of any one of claims 1 -4, wherein the at least one energy director is a longitudinal rib.

11. The drainage member of any one of claims 4-10, wherein the at least one energy director is configured to be substantially flattened.

12. The drainage member of any one of claims 4-11 , wherein the at least one energy director is configured to melt.

13. The drainage member of any one of claims 1 -12, wherein the lumen at the proximal portion is configured to receive a urinary catheter tube.

14. The drainage member of any one of claims 1 -13, wherein the distal portion includes a funnel.

15. The drainage member of any one of claims 1 -13, wherein the distal portion includes a connector.

16. The drainage member of any one of claims 1 -15, wherein the drainage member is made of a molded material.

17. A urinary catheter product comprising:an intermittent urinary catheter including a catheter tube with a tube proximal insertion end and a tube distal drainage end and a tube lumen extending between the tube proximal insertion end and the tube distal drainage end;a drainage member located at the tube distal drainage end;a collapsible sleeve defining a compartment that contains at least a portion of the catheter tube, a sleeve distal end being attached to the drainage member; and wherein the drainage member comprisesa drainage member proximal portion, a drainage member distal portion, and a drainage member lumen extending through the drainage member proximal portion and the drainage member distal portion;an outer surface and an inner surface defining the drainage member lumen; andat least one energy director located on the outer surface.

18. The product of claim 17, wherein the at least one energy director is located on the drainage member proximal portion.

19. The product of any one of claims 17-18, wherein the at least one energy director is configured to assist in ultrasonic welding of the sleeve distal end to the drainage member.

20. The product of any one of claims 17-19, wherein the at least one energy director comprises a raised portion of the outer surface.

21. The product of any one of claims 17-20, wherein the at least one energy director comprises an annular rib.

22. The product of claim 21 , wherein the outer surface includes three annular ribs.

23. The product of claim 21 , wherein the outer surface includes four annular ribs.

24. The product of claim 21 , wherein the outer surface includes five annular ribs.

25. The product of claim 21 , wherein the outer surface includes six annular ribs.

26. The drainage member of any one of claims 17-20, wherein the at least one energy director comprises a longitudinal rib.

27. The drainage member of any one of claims 20-25, wherein the at least one energy director is substantially flattened.

28. The drainage member of any one of claims 20-27, wherein the at least one energy director is melted.

29. The product of any one of claims 17-28, wherein the drainage member proximal portion is configured to receive the tube distal drainage end.

30. The product of any one of claims 17-29, wherein the drainage member distal portion includes a funnel.

31. The product of any one of claims 17-30, wherein the drainage member distal portion includes a connector.

32. The product of any one of claims 17-31 , wherein the drainage member is made of a molded material.

33. The product of any one of claims 17-32, further comprising an insertion aid located at a sleeve proximal end.

34. A method of manufacturing a sleeved urinary catheter comprising:obtaining a urinary catheter includinga catheter tube with a tube proximal insertion end and a tube distal drainage end and a tube lumen extending between the tube proximal insertion end and the tube distal drainage end;a drainage member located at the tube distal drainage end wherein the drainage member comprisesa drainage member proximal portion, a drainage member distal portion and a drainage member lumen extending through the drainage member proximal portion and the drainage member distal portion; an outer surface and an inner surface defining the drainage member lumen; andat least one energy director located on the outer surface; and ultrasonically welding a collapsible sleeve to the drainage member outer surface, wherein the collapsible sleeve includes a sleeve distal end and a sleeve proximal end.

35. The method of claim 34, wherein the at least one energy director is located on the drainage member proximal portion.

36. The method of any one of claims 34-35, wherein the at least one energy director is configured to assist in ultrasonic welding of the sleeve to the drainage member.

37. The method of any one of claims 34-36, wherein the at least one energy director comprises a raised portion of the outer surface.

38. The method of any one of claims 34-37, wherein the at least one energy director comprises an annular rib.

39. The method of claim 38, wherein the outer surface includes three annular ribs.

40. The method of claim 38, wherein the outer surface includes four annular ribs.

41. The method of claim 38, wherein the outer surface includes five annular ribs.

42. The method of claim 38, wherein the outer surface includes six annular ribs.

43. The method of any one of claims 34-37, wherein the at least one energy director comprises a longitudinal rib.

44. The method of any one of claims 34-43, wherein the drainage member proximal portion is configured to receive the tube distal drainage end.

45. The method of any one of claims 34-44, wherein the drainage member distal portion includes a funnel.

46. The method of any one of claims 34-45, wherein the drainage member distal portion includes a connector.

47. The method of any one of claims 34-46, wherein the drainage member is made of a molded material.

48. The method of any one of claims 34-47, wherein the urinary catheter further includes an insertion aid located at a sleeve proximal end.

49. The method of any one of claims 34-48, comprising ultrasonically welding the sleeve distal end to the drainage member proximal portion.

50. The method of any one of claims 34-49, comprising ultrasonically welding the sleeve distal end to the at least one energy director.

51. The method of any one of claims 45-50, wherein the at least one energy director is deformed during ultrasonic welding.

52. The method of any one of claims 45-51 , wherein the at least one energy director becomes substantially flush with the outer surface during ultrasonic welding.

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