Sleeved urinary catheter products with introducer aid

Abstract

A urinary catheter product (10) with a sleeve (22) having a proximal end portion (24) and a distal end portion (26), the sleeve defining a sleeve cavity (21). A catheter tube (12) at least partially located in the sleeve cavity. An introducer aid (28) associated with the proximal end portion of the sleeve. The introducer aid having an insertion tip (30), a grommet (32), and a lumen (29) for receiving the catheter tube therethrough. The grommet being located within the sleeve cavity and the insertion tip being external of the sleeve cavity, wherein the grommet and insertion tip mate.

Description

Sleeved Urinary Catheter Products With Introducer AidThe present application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 510,215, filed June 26, 2023, which is hereby incorporated herein by reference.FIELD OF DISCLOSURE

[0001] The present disclosure generally relates to urinary catheter products. More particularly, the present disclosure generally relates to intermittent sleeved urinary catheter products having introducer aids.BACKGROUND

[0002] Intermittent catheterization is a suitable intervention for some users experiencing difficulty in bladder emptying. A urinary catheter used for intermittent catheterization is typically provided as a single-use, individually packaged item and may include a gel lubricant or hydrophilic coating to reduce friction during insertion into the urethra. With the advent of intermittent urinary catheters, users experiencing urinary system dysfunction can conveniently self-catheterize to drain the bladder. Users experiencing urinary incontinence may self-catheterize several times per day.

[0003] Self-catheterization involves removing the catheter assembly from its package and inserting and advancing the catheter tube through the urethra.Some catheter assemblies include an introducer aid. The introducer aid includes a proximal insertion tip configured for insertion into the urethral opening prior to advancement of the catheter tube. After inserting the insertion tip in the urethra, the catheter tube is advanced through and beyond the introducer aid's leading end (i.e., the proximal-most end).

[0004] In some instances, the catheter tube is surrounded by a sleeve. The sleeve is attached to the introducer aid and extends distally to cover the catheter tube. The sleeve provides a hygienic barrier, and the user uses the sleeve to grasp the catheter tube. That is, the sleeve provides a barrier between the user's fingers and the catheter tube. The user grasps the catheter tube through the sleeve to manipulate the catheter assembly and advance the catheter into and withdraw the catheter from the urethra.

[0005] Thus, it would be desirable to provide a urinary catheter assembly with an improved introducer aid / sleeve configuration.SUMMARY

[0006] In one aspect, a urinary catheter product includes a sleeve having a proximal end portion and a distal end portion, wherein the sleeve defines a sleeve cavity. The product includes a catheter tube at least partially located in the sleeve cavity. The product also includes an introducer aid associated with the proximal end portion of the sleeve. The introducer aid having an insertion tip, a grommet, and a lumen for receiving the catheter tube therethrough. The grommet is located within the sleeve cavity and the insertion tip is external of the sleeve cavity, wherein the grommet and insertion tip mate.

[0007] In another aspect, a urinary catheter product includes an introducer aid having an insertion tip and a grommet. The introducer aid defines a lumen for receiving a catheter tube therethrough, and the grommet and insertion tip are mated. The product also includes a sleeve configured to surround the catheter tube, wherein at least a portion of the sleeve is located between the grommet and insertion tip.BRIEF DESCRIPTION OF DRAWINGS

[0008] Fig. 1 is a perspective view of an intermittent urinary catheter product in accordance with the present disclosure.

[0009] Fig. 2 is a perspective view of one embodiment of an introducer aid and sleeve of the intermittent urinary catheter product of Fig 1 .

[0010] Fig. 3 is an exploded view of the proximal end of the catheter product shown in Fig. 1 .

[0011] Fig. 4 is a cross-sectional view of one embodiment of the proximal end of the catheter product shown in Fig. 1 .

[0012] Fig. 4A is an enlarged cross-sectional view showing one alternative interlock between the insertion tip and grommet of the introducer aid shown in Fig.1.

[0013] Fig. 5 is a cross-sectional view of another embodiment of the proximal end of the catheter product shown in Fig. 1 .DETAILED DESCRIPTION

[0014] While the subject matter of the present disclosure is susceptible to embodiments in various forms, there will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated. The words "a" or "an" are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0015] Turning to Fig. 1 , this figure illustrates an embodiment of a urinary catheter assembly 10 in accordance with the present disclosure, which may be part of a catheter product. In some catheter products, catheter assembly 10 may be provided in an outer package (not shown) for distribution to the end user. In some embodiments, the catheter product is an intermittent urinary catheter product and the catheter assembly 10 is an intermittent urinary catheter assembly. Catheter assembly 10 includes an elongated urinary catheter tube 12 with a side wall 19 defining a drainage lumen (not shown). Catheter tube 12 also includes a proximal end portion 14 and a distal end portion 16. Catheter tube 12 is sized and configured to be advanced through the urethra of a patient. In some alternatives, the outer surface of catheter tube 12 has a hydrophilic coating thereon that becomes lubricious when hydrated. The hydrophilic coating eases the insertion of catheter tube 12 into and withdrawal of the catheter tube from the urethra. In other alternatives, a lubricious gel may be applied to the outer surface of catheter tube 12.

[0016] Proximal end portion 14 may include proximal end portion drainage holes or eyelets 18 (Fig. 3) through side wall 19 for draining urine from the bladder and into the drainage lumen (not shown) of catheter tube 12. A drainage member 20 may be associated with distal end portion 16 of catheter tube 12. Drainage member 20 may be connected to a collection member, such as a bag, or a free end used to direct urine drainage to a receptacle, such as a toilet.

[0017] Catheter assembly 10 also includes a sleeve 22, which may be a protective or barrier sleeve, with a proximal end portion 24 and a distal end portion 26. Sleeve 22 may be made from a flexible polymer. In some embodiments, sleeve 22 may be liquid and gas impermeable, and in other embodiments, sleeve22 may be gas permeable and liquid impermeable. Sleeve 22 surrounds at least a portion of catheter tube 12 to separate and / or enclose the portion of catheter tube 12 from the outside environment. In other words, sleeve 22 defines an internal cavity 21 where at least a portion of catheter tube 12 may be located, or catheter tube 12 is at least partially located in internal cavity 21 . In some embodiments, sleeve 22 extends over the length of catheter tube 12. In other embodiments, sleeve 22 extends over a portion of catheter tube 12. In addition, in some embodiments, a hydration medium (such as water or water vapor) and / or a lubricious gel are located in the cavity of sleeve 22. The hydration medium may include a liquid, such as water, along with various other components. The hydration liquid may be in a foamed or unfoamed state.

[0018] In some embodiments, distal end portion 26 of sleeve 22 is attached to the distal end portion of catheter assembly 10. For example, distal end portion 26 of sleeve 22 may be attached to drainage member 20 or distal end portion 16 of catheter tube 12. In other embodiments, distal end portion 26 of sleeve 22 is a free end that is unattached to catheter assembly 10.

[0019] Catheter assembly 10 includes introducer aid 28 that is associated with proximal end portion 24 of sleeve 22. Introducer aid 28 includes an introducer aid lumen 29 for the passage of catheter tube 12 (Fig. 4). Referring to Figs. 2-4, introducer aid 28 includes at least two components - insertion tip 30 and grommet 32 that mate with each other to form introducer aid 28. Insertion tip 30 may be made from a relatively more flexible material than grommet 32, and grommet 32 may be made from a relatively more rigid material than insertion tip 30.

[0020] Insertion tip 30 includes a body 34 with a proximal insertion tip 36 sized and configured to be inserted into the user's urethra opening. The terminal end 38 of insertion tip 36 (which is the terminal end of introducer aid 28 and body 34) includes an opening 40 for passage of catheter tube 12 therethrough. Opening 40 may be defined by a plurality of petals 42 and slits 44. Opening 40 is shown closed in Fig. 2 and open in Fig. 3.

[0021] In some embodiments, body 34 optionally includes a shoulder 46 located distal of proximal insertion tip 36. The proximal surface 48 of shoulder 46 is configured to abut the urethral opening and acts as a stop to limit insertion ofinsertion tip 36. The distal surface 50 may be configured to be contacted by the user's fingers to hold and maneuver introducer aid 28.

[0022] Body 34 also includes a gripping portion 52 located distal of shoulder 46. In the illustrated embodiment, gripping portion 52 has a generally cylindrical shape, but it could also have other shapes. Distal end portion 54 of insertion tip 30 includes an insertion tip distal end opening 56 (Fig. 3), which is configured to receive grommet 32. Optionally, the outer contour of the distal end portion 54 flares radially outwardly from gripping portion 52 to the insertion tip distal end opening so as to have a truncated conical shape. The flaring may assist in positioning a user's fingers on gripping portion 52 between shoulder 46 and distal end portion 54. The flare of distal end portion 54 may also assist in positioning grommet 32.

[0023] In the illustrated embodiment, grommet 32 is configured to be inserted into distal end opening 56 of insertion tip 30. In some embodiments, distal end portion 54 of insertion tip 30 is configured to be inserted into an opening of the proximal end portion 58 of grommet 32. Referring to Figs. 3 and 4, grommet 32 has a lumen 57 extending between proximal end portion 58 and distal end portion 60. Grommet 32 also includes a middle portion 62. At least a portion of the outer contour of grommet 32 may be commensurate or have a corresponding contour to the inner contour of insertion tip 30. In the illustrated embodiment, the outer contour of proximal end portion 58 of grommet 32 has a generally cylindrical shape that is commensurate with the generally cylindrical shape of the inner contour of gripping portion 52 of insertion tip 30. Middle portion 62 of grommet 32 has a generally flared outer contour commensurate with distal end portion 54 of insertion tip 30.

[0024] Referring to Fig. 3, grommet 32 is located within internal cavity 21 of sleeve 22, and insertion tip 30 is located externally or outside of sleeve cavity 21 . In some embodiments, proximal terminal end 64 of sleeve 22 is closed. For example, proximal terminal end 64 may include a seal that closes the proximal terminal end of sleeve 22 so that the proximal terminal end is sealed or has a sealed portion. In other embodiments, proximal terminal end 64 may be a continuous portion of sleeve material. In other embodiments, proximal terminal end 64 may be open or include one or more openings.

[0025] Referring to Figs. 4 and 4A, grommet 32 and insertion tip 30 are configured to mate. In some embodiments, grommet 32 and insertion tip 30 are mechanically attached to each other. As illustrated in the drawings, grommet 32 and insertion tip 30 are mated, with sleeve 22 being positioned between grommet 32 and insertion tip 30. In some embodiments, grommet 32 and insertion tip 30 are interlocked. In some alternatives, the interlock is a snap-fit. In other alternatives, mating may be by adhesive, welding, friction fit, or any other suitable mating. In some embodiments, one of insertion tip 30 and grommet 32 includes a groove 66, and the other of insertion tip and grommet includes a ridge 68. Ridge 68 is accepted into groove 66 to interlock grommet 32 and insertion tip 30. In the illustrated embodiment, insertion tip 30 includes ridge 68, and grommet 32 includes groove 66. Ridge 68 is shown extending inward from distal end portion 54 of insertion tip 30. In other alternatives, ridge 68 may be at any location along the inner surface of insertion tip 30 and extending into the lumen of insertion tip 30. Ridge 68 may be continuous or include a plurality of ridge sections with interruptions therebetween. Furthermore, ridge 68 could extend circumferentially about insertion tip 30 or could extend about at least a portion of insertion tip 30. For example, ridge 68 may extend about at least a portion of the inner surface of insertion tip 30 or distal end portion 54 of insertion tip 30.

[0026] Groove 66 is shown located between distal end portion 60 and middle portion 62 of grommet 32. In other alternatives, groove 66 could be at any location along the outer surface of grommet 32. Depending on the configuration of groove 66, the groove could be continuous or include a plurality groove sections with interruptions therebetween. Furthermore, groove 66 could extend circumferentially about the grommet 32 or could extend about at least a portion of grommet 32.

[0027] To assemble the introducer aid 28 and sleeve 22, grommet 32 is placed or located within cavity 21 or sleeve 22. Grommet 32 is then inserted into distal end opening 56 of the insertion tip 30. In some alternatives, ridge 68 is made of an elastic material that flexes so that it can be accepted into groove 66. Alternatively, or in addition to, distal end portion 54 of insertion tip 30 may be made of an elastic material, and grommet 32 may be made of a relatively more rigid material. As the more rigid grommet 32 is inserted into distal end opening 56of insertion tip 30, the elastic material of insertion tip 30 expands to accept grommet 32 and allow ridge 68 to engage the groove 66, thereby interlocking grommet 32 and insertion tip 30. Referring to Fig. 4 and 4A, sleeve 22 is positioned between grommet 32 and insertion tip 30 to mechanically hold sleeve 22 in place. In the illustrated embodiment, sleeve 22 is positioned between groove 66 and ridge 68, which holds or maintains sleeve 22 in place. As shown in Fig. 4, terminal end 64 of sleeve 22 may abut proximal end portion 58 of the grommet 32. Referring to Fig. 5, terminal end 64 of sleeve 22 may be spaced from proximal end 58 of grommet 32. This may allow the catheter to be preloaded into the introducer aid 28 before use. When proximal terminal end 64 of sleeve 22 is closed, it may provide a hygienic barrier for the sleeve cavity.

[0028] Referring to Figs. 4 and 5, proximal end portion 58 of grommet 32 is located in gripping portion 52 of insertion tip 30. Proximal end portion 58 of grommet 32, being relatively rigid, supports gripping portion 52 of insertion tip 30 so that gripping portion 52 does not collapse onto catheter tube 12 when a user grasps gripping portion 52.

[0029] When using catheter assembly 10, the user grasps catheter tube 12 through sleeve 22 to handle and manipulate catheter assembly 10. The user inserts insertion tip 30 of introducer aid 28 into the urethra. The user then grasps catheter tube 12 through sleeve 22 and advances catheter tube 12 through introducer aid 28. When proximal terminal end 64 of sleeve 22 is closed, proximal end portion 14 of catheter tube 12 pierces, breaks, or otherwise opens closed proximal terminal end 64 of sleeve 22. In some embodiments, closed proximal terminal end 64 may have a weakened portion such as a score or the like. Catheter tube 12 is then inserted into and through the urethra, until eyelets 18 enter the bladder. After emptying the bladder, the user uses sleeve 22 to withdraw catheter tube 12.

[0030] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein.

Claims

Claims1 . A urinary catheter product, comprising: a sleeve having a proximal end portion and a distal end portion, the sleeve defining a sleeve cavity; a catheter tube at least partially located in the sleeve cavity; an introducer aid associated with the proximal end portion of the sleeve, the introducer aid having an insertion tip, a grommet, and a lumen for receiving the catheter tube therethrough, the grommet being located within the sleeve cavity and the insertion tip being external of the sleeve cavity, wherein the grommet and insertion tip mate.

2. The urinary catheter product of claim 1 , wherein the sleeve includes a closed proximal terminal end.

3. The urinary catheter product of claim 2, wherein the closed proximal terminal end comprises a sealed portion.

4. The urinary catheter product of claim 2, wherein the closed proximal terminal end comprises a continuous portion of the sleeve.

5. The urinary catheter product of any one of claims 2-4, wherein the closed proximal terminal end of the sleeve abuts a proximal end of the grommet.

6. The urinary catheter product of any one of claims 2-4, wherein the closed proximal terminal end of the sleeve is spaced from a proximal end of the grommet.

7. The urinary catheter product of claim 1 , wherein the sleeve includes an open proximal terminal end.

8. The urinary catheter product of any one of claims 1 -7, wherein the insertion tip has an insertion tip distal end opening and the proximal end of the grommet is located in the insertion tip distal end opening.

9. The urinary catheter product of any one of claims 1 -7, wherein the grommet has a grommet proximal end opening and a distal end of the insertion tip is located in the grommet proximal end opening.

10. The urinary catheter product of any one of claims 8 and 9, wherein the insertion tip and the grommet interlock.11 . The urinary catheter product of claim 10, wherein one of the insertion tip and the grommet comprises a groove and the other of the insertion tip and grommet comprises a ridge, wherein the ridge and groove interlock.

12. The urinary catheter product of claim 1 1 , wherein a portion of the sleeve is located between the ridge and the groove.

13. A urinary catheter product, comprising: an introducer aid having an insertion tip and a grommet, the introducer aid defining a lumen for receiving a catheter tube therethrough, the grommet and insertion tip being mated. a sleeve configured to surround the catheter tube, at least a portion of the sleeve being located between the grommet and insertion tip.

14. The urinary catheter product of claim 13, wherein the sleeve includes a closed proximal terminal end.

15. The urinary catheter product of claim 14, wherein the closed proximal terminal end comprises a sealed portion.

16. The urinary catheter product of claim 14, wherein the closed proximal terminal end comprises a continuous portion of the sleeve.

17. The urinary catheter product of any one of claims 14-16, wherein the closed proximal terminal end of the sleeve abuts a proximal end of the grommet.

18. The urinary catheter product of any one of claims 14-16, wherein the closed proximal terminal end of the sleeve is spaced from a proximal end of the grommet.

19. The urinary catheter product of claim 13, wherein the sleeve includes an open proximal terminal end.

20. The urinary catheter product of any one of claims 13-19, wherein the insertion tip has an insertion tip distal end opening and the proximal end of the grommet is located in the insertion tip distal end opening.21 . The urinary catheter product of any one of claims 13-19, wherein the grommet has a grommet proximal end opening and a distal end of the insertion tip is located in the grommet proximal end opening.

22. The urinary catheter product of any one of claims 20 and 21 , wherein the insertion tip and the grommet interlock.

23. The urinary catheter product of claim 22, wherein one of the insertion tip and the grommet comprises a groove and the other of the insertion tip and grommet comprises a ridge, wherein the ridge and groove interlock.

24. The urinary catheter product of claim 23, wherein a portion of the sleeve is located between the ridge and the groove.

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