Urethral catheter product with sleeve and insertion aid

Abstract

A urethral catheter product (10) comprising a sleeve (22) having a proximal end (24) and a distal end (26), wherein the sleeve defines a sleeve cavity (21). A catheter tube (12) is at least partially located within the sleeve cavity. An insertion aid (28) is associated with the proximal end of the sleeve. The insertion aid has an insertion tip (30), a grommet (32), and a lumen (29) for receiving the catheter tube. The grommet is located within the sleeve cavity, and the insertion tip is outside the sleeve cavity, with the grommet and the insertion tip fitting together.

Description

Technical Field

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 510,215, filed on Jun. 26, 2023, and incorporates the above provisional patent application herein by reference.

[0002] This disclosure generally relates to urinary catheter products. More particularly, this disclosure generally relates to sleeve-equipped intermittent urinary catheter products having an insertion aid.

Background Art

[0003] Intermittent catheter insertion is an appropriate intervention for some users who have difficulty urinating from the bladder. Urinary catheters used for intermittent catheter insertion are typically provided as disposable, individually packaged articles and may include a gel lubricant or a hydrophilic coating to reduce friction during insertion into the urethra. The advent of intermittent urinary catheters has enabled users with urinary system disorders to easily perform self-catheter insertion to urinate from the bladder. Users suffering from urinary incontinence may perform self-catheter insertion several times a day.

[0004] Self-catheter insertion involves removing the catheter assembly from its package and inserting and advancing the catheter tube into the urethra. Some catheter assemblies include an insertion aid. The insertion aid includes a proximal insertion tip configured to be inserted into the urethral opening before advancing the catheter tube. After inserting the insertion tip into the urethra, the catheter tube is advanced through and beyond the leading end (i.e., the most proximal end) of the insertion aid.

[0005] In some cases, the catheter tube is surrounded by a sleeve. The sleeve is attached to an insertion aid and extends distally to cover the catheter tube. The sleeve provides a hygienic barrier, and the user grasps the catheter tube using the sleeve. 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 and manipulates the catheter assembly to advance the catheter into the urethra and withdraw the catheter from the urethra. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, it is desirable to provide a urethral catheter assembly with an improved insertion aid / sleeve configuration. [Means for solving the problem]

[0007] In one embodiment, the urethral catheter product includes a sleeve having a proximal end and a distal end, the sleeve defining a sleeve cavity. The product includes a catheter tube at least partially located within the sleeve cavity. The product also includes an insertion aid associated with the proximal end of the sleeve. The insertion aid has an insertion tip, a grommet, and a lumen for receiving the catheter tube. The grommet is located within the sleeve cavity, and the insertion tip is outside the sleeve cavity, with the grommet and insertion tip fitting together.

[0008] In another embodiment, the urethral catheter product includes an insertion aid having an insertion tip and a grommet. The insertion aid defines a lumen for receiving the catheter tube, and the grommet and insertion tip are fitted into it. The product also includes a sleeve configured to surround the catheter tube, at least a portion of which is located between the grommet and the insertion tip. [Brief explanation of the drawing]

[0009] [Figure 1]This is a perspective view of the intermittent urethral catheter product disclosed herein. [Figure 2] Figure 1 is a perspective view of one embodiment of an introduction aid and sleeve for an intermittent urethral catheter product. [Figure 3] Figure 1 is an exploded view of the proximal end of the catheter product shown. [Figure 4] Figure 1 is a cross-sectional view of one embodiment of the proximal end of the catheter product shown. [Figure 4A] Figure 1 is an enlarged cross-sectional view showing one alternative connection between the insertion tip of the introduction aid shown and the grommet. [Figure 5] Figure 1 is a cross-sectional view of another embodiment of the proximal end of the catheter product shown. [Modes for carrying out the invention]

[0010] The subject matter of this disclosure can take various forms, but this specification describes currently preferred embodiments below. This disclosure should be considered illustrative and should be understood as not intended to limit this disclosure to any particular embodiment illustrated. The words "a" or "an" (one) should be interpreted as including both singular and plural forms. Conversely, any reference to multiple elements should include the singular form where appropriate.

[0011] Referring to Figure 1, this figure illustrates one embodiment of a urethral catheter assembly 10 according to the present disclosure, which may be part of a catheter product. In some catheter products, the catheter assembly 10 may be provided in an external package (not shown) for distribution to the end user. In some embodiments, the catheter product is an intermittent urethral catheter product, and the catheter assembly 10 is an intermittent urethral catheter assembly. The catheter assembly 10 includes an elongated urethral catheter tube 12 having side walls 19 defining a drainage cavity (not shown). The catheter tube 12 also includes a proximal end 14 and a distal end 16. The catheter tube 12 is sized and configured to advance through the patient's urethra. In some alternative embodiments, the outer surface of the catheter tube 12 is coated with a hydrophilic coating that becomes lubricating when hydrated. The hydrophilic coating facilitates the insertion of the catheter tube 12 into the urethra and the withdrawal of the catheter tube from the urethra. In other alternative embodiments, a lubricating gel may be applied to the outer surface of the catheter tube 12.

[0012] The proximal end 14 includes a proximal end drain hole or eyelet 18 (Figure 3) that penetrates the side wall 19 for draining urine from the bladder into a drainage cavity (not shown) of the catheter tube 12. The drainage member 20 may be associated with the distal end 16 of the catheter tube 12. The drainage member 20 may be connected to a free end used to guide the urine to a collection member such as a bag or a container such as a toilet.

[0013] The catheter assembly 10 also includes a sleeve 22 (which may be a protective or barrier sleeve) having a proximal end 24 and a distal end 26. The sleeve 22 may be made from a flexible polymer. In some embodiments, the sleeve 22 may be impermeable to liquids and gases, and in other embodiments, the sleeve 22 may be permeable to gases and impermeable to liquids. The sleeve 22 surrounds at least a portion of the catheter tube 12, separating and / or enclosing that portion of the catheter tube 12 from the external environment. In other words, the sleeve 22 defines an internal cavity 21 in which at least a portion of the catheter tube 12 may be located, or the catheter tube 12 may be at least partially located within the internal cavity 21. In some embodiments, the sleeve 22 extends along the length of the catheter tube 12. In other embodiments, the sleeve 22 extends over a portion of the catheter tube 12. Furthermore, in some embodiments, a hydrating medium (such as water or water vapor) and / or a lubricating gel are located within the cavity of the sleeve 22. The hydration medium may contain a liquid such as water and various other components. The hydration solution may be in a foaming or non-foaming state.

[0014] In some embodiments, the distal end 26 of the sleeve 22 is attached to the distal end of the catheter assembly 10. For example, the distal end 26 of the sleeve 22 may be attached to the drainage member 20 or the distal end 16 of the catheter tube 12. In other embodiments, the distal end 26 of the sleeve 22 is a free end that is not attached to the catheter assembly 10.

[0015] The catheter assembly 10 includes an insertion aid 28 associated with the proximal end 24 of the sleeve 22. The insertion aid 28 includes an insertion aid lumen 29 for passing through the catheter tube 12 (Figure 4). Referring to Figures 2-4, the insertion aid 28 includes at least two components that fit together to form the insertion aid 28, namely an insertion tip 30 and a grommet 32. The insertion tip 30 may be made from a material that is relatively more flexible than the grommet 32, and the grommet 32 ​​may be made from a material that is relatively more rigid than the insertion tip 30.

[0016] The insertion tip 30 includes a body 34 having a proximal insertion tip 36 sized and configured to be inserted into the user's urethral opening. The terminal end 38 of the insertion tip 36 (which is the end of the introduction aid 28 and the body 34) includes an opening 40 for passing the catheter tube 12 through. The opening 40 may be defined by a plurality of petals 42 and slits 44. The opening 40 is shown closed in Figure 2 and open in Figure 3.

[0017] In some embodiments, the main body 34 optionally includes a shoulder 46 located distal to the proximal insertion tip 36. The proximal surface 48 of the shoulder 46 is configured to abut against the urethral opening and functions as a stopper to limit the insertion of the insertion tip 36. The distal surface 50 may be configured to be contacted by the user's fingers for holding and manipulating the insertion aid 28.

[0018] The main body 34 also includes a gripping portion 52 located distal to the shoulder 46. In the illustrated embodiment, the gripping portion 52 has a substantially cylindrical shape, but it may have other shapes. The distal end 54 of the insertion tip 30 includes an insertion tip distal end opening 56 (Figure 3), which is configured to receive a grommet 32. Optionally, the outer contour of the distal end 54 widens radially outward from the gripping portion 52 to the insertion tip distal end opening and has a frustoconical shape. This widening may help position the user's finger on the gripping portion 52 between the shoulder 46 and the distal end 54. The widening of the distal end 54 may also help position the grommet 32.

[0019] In the exemplary embodiments, the grommet 32 ​​is configured to be inserted into the distal end opening 56 of the insertion tip 30. In some embodiments, the distal end 54 of the insertion tip 30 is configured to be inserted into the opening of the proximal end 58 of the grommet 32. Referring to Figures 3 and 4, the grommet 32 ​​has a lumen 57 extending between the proximal end 58 and the distal end 60. The grommet 32 ​​also includes an intermediate portion 62. At least a portion of the outer contour of the grommet 32 ​​may have a contour that coincides with or corresponds to the inner contour of the insertion tip 30. In the exemplary embodiments, the outer contour of the proximal end 58 of the grommet 32 ​​has a substantially cylindrical shape that coincides with the substantially cylindrical shape of the inner contour of the gripping portion 52 of the insertion tip 30. The intermediate portion 62 of the grommet 32 ​​has a generally flared outer contour that coincides with the distal end 54 of the insertion tip 30.

[0020] Referring to Figure 3, the grommet 32 ​​is located within the internal cavity 21 of the sleeve 22, and the insertion tip 30 is located outside or on the outside of the sleeve cavity 21. In some embodiments, the proximal end 64 of the sleeve 22 is closed. For example, the proximal end 64 may include a seal that closes the proximal end of the sleeve 22, thereby sealing or having a sealed portion of the proximal end. In other embodiments, the proximal end 64 may be a continuous portion of the sleeve material. In other embodiments, the proximal end 64 may be open or may include one or more openings.

[0021] Referring to FIGS. 4 and 4A, grommet 32 and insertion tip 30 are configured to fit together. 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 fitted together and sleeve 22 is positioned between grommet 32 and insertion tip 30. In some embodiments, grommet 32 and insertion tip 30 are connected. In some alternative forms, the connection is a snap fit. In other alternative forms, the fit may be by an adhesive, welding, friction fit, or any other suitable fit. In some embodiments, one of insertion tip 30 and grommet 32 includes groove 66 and the other of the insertion tip and grommet includes ridge 68. Ridge 68 is received in groove 66 to connect 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 inwardly from distal end 54 of insertion tip 30. In other alternative forms, ridge 68 may be at any position along the inner surface of insertion tip 30 and may extend into the lumen of insertion tip 30. Ridge 68 may be continuous or may include a plurality of ridge sections with interruptions therebetween. Further, ridge 68 can extend circumferentially around insertion tip 30 or can extend around at least a portion of insertion tip 30. For example, ridge 68 may extend around at least a portion of the inner surface of insertion tip 30 or around distal end 54 of insertion tip 30.

[0022] Groove 66 is shown positioned between distal end 60 and intermediate portion 62 of grommet 32. In other alternative forms, groove 66 may be at any position along the outer surface of grommet 32. Depending on the configuration of groove 66, the groove may be continuous or may include a plurality of groove sections with interruptions therebetween. Further, groove 66 can extend around grommet 32 or can extend around at least a portion of grommet 32.

[0023] To assemble the introducer aid 28 and the sleeve 22, the grommet 32 is placed or positioned within the cavity 21 or the sleeve 22. Next, the grommet 32 is inserted into the distal end opening 56 of the insertion tip 30. In some alternative forms, the ridge 68 is made of an elastic material that flexes to be received within the groove 66. Alternatively or additionally, the distal end 54 of the insertion tip 30 can be made of an elastic material and the grommet 32 can be made of a relatively rigid material. When the more rigid grommet 32 is inserted into the distal end opening 56 of the insertion tip 30, the elastic material of the insertion tip 30 expands to receive the grommet 32 and allows the ridge 68 to engage the groove 66, thereby connecting the grommet 32 and the insertion tip 30. Referring to FIGS. 4 and 4A, the sleeve 22 is positioned between the grommet 32 and the insertion tip 30 and is mechanically held in a predetermined position. In the illustrated embodiment, the sleeve 22 is positioned between the groove 66 and the ridge 68 and is thereby held or maintained in a predetermined position. As shown in FIG. 4, the distal end 64 of the sleeve 22 can abut the proximal end 58 of the grommet 32. Referring to FIG. 5, the distal end 64 of the sleeve 22 can be spaced from the proximal end 58 of the grommet 32. This can allow the catheter to be pre-loaded into the introducer aid 28 prior to use. When the proximal end 64 of the sleeve 22 is closed, a sanitary barrier can be provided to the sleeve cavity.

[0024] Referring to FIGS. 4 and 5, the proximal end 58 of the grommet 32 is positioned within the gripping portion 52 of the insertion tip 30. The proximal end 58 of the grommet 32 is relatively rigid and supports the gripping portion 52 of the insertion tip 30 to prevent the gripping portion 52 from crushing the catheter tube 12 when the user grips the gripping portion 52.

[0025] When using the catheter assembly 10, the user handles and manipulates the catheter assembly 10 by grasping the catheter tube 12 through the sleeve 22. The user inserts the insertion tip 30 of the introduction aid 28 into the urethra. The user then grasps the catheter tube 12 through the sleeve 22 and advances the catheter tube 12 through the introduction aid 28. When the proximal end 64 of the sleeve 22 is closed, the proximal end 14 of the catheter tube 12 punctures, breaks, or otherwise opens the closed proximal end 64 of the sleeve 22. In some embodiments, the closed proximal end 64 may have a weak point such as a score. The catheter tube 12 is then inserted through the urethra until the eyelet 18 enters the bladder. After emptying the bladder, the user withdraws the catheter tube 12 using the sleeve 22.

[0026] It should be understood that various changes and modifications to the currently preferred embodiments described herein will be obvious 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

1. A sleeve having a proximal end and a distal end, comprising a sleeve defining a sleeve cavity, A catheter tube located at least partially within the sleeve cavity, An insertion aid associated with the proximal end of the sleeve, comprising an insertion tip, a grommet, and a lumen for receiving the catheter tube, wherein the grommet is located within the sleeve cavity, the insertion tip is located outside the sleeve cavity, and the grommet and the insertion tip engage with each other. A urethral catheter product equipped with the following features.

2. The urethral catheter product according to claim 1, wherein the sleeve includes a closed proximal end.

3. The urethral catheter product according to claim 2, wherein the closed proximal end portion comprises a sealed portion.

4. The urethral catheter product according to claim 2, wherein the closed proximal end portion comprises a continuous portion of the sleeve.

5. The urethral catheter product according to any one of claims 2 to 4, wherein the closed proximal end of the sleeve abuts against the proximal end of the grommet.

6. The urethral catheter product according to any one of claims 2 to 4, wherein the closed proximal end of the sleeve is spaced apart from the proximal end of the grommet.

7. The urethral catheter product according to claim 1, wherein the sleeve includes an open proximal end portion.

8. The urethral catheter product according to any one of claims 1 to 7, wherein the insertion tip has an opening at the distal end of the insertion tip, and the proximal end of the grommet is located within the opening at the distal end of the insertion tip.

9. The urethral catheter product according to any one of claims 1 to 7, wherein the grommet has a proximal end opening, and the distal end of the insertion tip is located within the proximal end opening of the grommet.

10. The urethral catheter product according to claim 8 or 9, wherein the insertion tip and the grommet are connected.

11. The urethral catheter product according to claim 10, wherein one of the insertion tip and the grommet is provided with a groove, and the other of the insertion tip and the grommet is provided with a raised portion, and the raised portion and the groove are connected.

12. The urethral catheter product according to claim 11, wherein a portion of the sleeve is located between the raised portion and the groove.

13. An insertion aid having an insertion tip and a grommet, wherein the insertion aid defines a lumen for receiving a catheter tube, and the grommet and the insertion tip are fitted together. A sleeve configured to surround the catheter tube, wherein at least a portion of the sleeve is located between the grommet and the insertion tip. A urethral catheter product equipped with the following features.

14. The urethral catheter product according to claim 13, wherein the sleeve includes a closed proximal end.

15. The urethral catheter product according to claim 14, wherein the closed proximal end portion comprises a sealed portion.

16. The urethral catheter product according to claim 14, wherein the closed proximal end portion comprises a continuous portion of the sleeve.

17. The urethral catheter product according to any one of claims 14 to 16, wherein the closed proximal end of the sleeve abuts against the proximal end of the grommet.

18. The urethral catheter product according to any one of claims 14 to 16, wherein the closed proximal end of the sleeve is spaced apart from the proximal end of the grommet.

19. The urethral catheter product according to claim 13, wherein the sleeve includes an open proximal end portion.

20. The urethral catheter product according to any one of claims 13 to 19, wherein the insertion tip has an opening at the distal end of the insertion tip, and the proximal end of the grommet is located within the opening at the distal end of the insertion tip.

21. The urethral catheter product according to any one of claims 13 to 19, wherein the grommet has a proximal end opening, and the distal end of the insertion tip is located within the proximal end opening of the grommet.

22. The urethral catheter product according to claim 20 or 21, wherein the insertion tip and the grommet are connected.

23. The urethral catheter product according to claim 22, wherein one of the insertion tip and the grommet is provided with a groove, and the other of the insertion tip and the grommet is provided with a raised portion, and the raised portion and the groove are connected.

24. The urethral catheter product according to claim 23, wherein a portion of the sleeve is located between the raised portion and the groove.

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