Intermittent urinary catheter products with rigid collection case

Abstract

Urinary catheter products (10) that have a rigid case (12) that defines an inner cavity (24) for storing a urinary catheter (14) and collecting urine from the urinary catheter.

Description

Intermittent Urinary Catheter Products With Rigid Collection CaseThe present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 623,105, filed January 19, 2024, 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 urinary catheter products having a rigid case that stores the urinary catheter and serves as a urine collection receptacle. Even more particularly, the present disclosure relates to intermittent urinary catheter products having an expandable rigid case that stores the urinary catheter and serves as a urine collection receptacle.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 includes advancing a urinary catheter shaft through the urethra and into the bladder. Urine drains from the bladder into an eyelet of the catheter shaft and through a drainage lumen of the catheter shaft. Some urinary catheter products include a collection bag associated with the distal drainage end of the catheter. When such a collection bag is included, urine drains from the lumen of the urinary catheter shaft into the collection bag.

[0004] Urine collection bags are typically made from thin, flexible polymer sheets. There is a risk of breakage or spillage of these bags.

[0005] Accordingly, there is a need for improved urine collection containers.SUMMARY

[0006] In one aspect, a urinary catheter product includes an expandable rigid case having an initial configuration and an expanded configuration. The product also includes an expandable inner cavity defined by the expandable rigid case and in communication with a case opening of the expandable rigid case, wherein the expandable inner cavity has a first volume when the expandable rigid case is in the first configuration and a second volume when the expandable rigid case is in the second configuration. The expandable inner cavity is configured for collecting urine when the expandable case is in the second configuration. The product further includes an intermittent urinary catheter with a catheter shaft at least partially located within the expandable inner cavity. The catheter shaft having an initial position within the expandable inner cavity and a deployed position wherein at least a portion of the catheter shaft extends through the case opening.

[0007] In another aspect, a urinary catheter product includes a rigid case comprising a case opening and an inner cavity in communication with the case opening. The inner cavity having a volume of at least 310 ml. The product also includes an intermittent urinary catheter having a catheter shaft at least partially located within the inner cavity. The catheter shaft having an initial position within the inner cavity and a deployed position wherein at least a portion of the catheter shaft extends through the case opening.BRIEF DESCRIPTION OF DRAWINGS

[0008] Fig. 1 is an elevated side view of an intermittent urinary catheter product in accordance with the present disclosure, shown with the expandable rigid case in the initial configuration.

[0009] Fig. 2 is a cross-sectional view of the intermittent urinary catheter product of Fig 1 , shown with the expandable rigid case in the initial configuration.

[0010] Fig. 3 is an elevated side view of the intermittent urinary catheter product of Fig. 1 , shown with the expandable rigid case in the expanded configuration, the cap removed, and the urinary catheter in the deployed position.

[0011] Fig. 4 is a cross-sectional view of the intermittent urinary catheter product of Fig. 1 , shown with the expandable rigid case in the expanded configuration, the cap removed, and the urinary catheter in the deployed position.

[0012] Fig. 5 is a cross-sectional view of the intermittent urinary catheter product of Fig. 1 , shown with the expandable rigid case in the expanded configuration and the cap used to put the urinary catheter back into the case.

[0013] Fig. 6 is a cross-sectional view of the intermittent urinary catheter product of Fig. 1 , shown with the expandable rigid case in the expanded configuration, the cap placed back on the case, and the catheter back in the stored position.

[0014] Fig. 7 is an elevated side view of the intermittent urinary catheter product of Fig. 1 , shown with the expandable rigid case in the expanded configuration, the cap placed back on the case, and the catheter in the stored position.

[0015] Fig. 8 is a perspective view of another embodiment of an intermittent urinary catheter product in accordance with the present disclosure.

[0016] Fig. 9 is a perspective view of the intermittent urinary catheter product of Fig. 8, shown with the cap removed and the urinary catheter in the deployed configuration.DETAILED DESCRIPTION

[0017] 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.

[0018] Fig. 1 illustrates an embodiment of an intermittent urinary catheter product 10 in accordance with the present disclosure. Urinary catheter product 10 includes a case 12 and an intermittent urinary catheter 14 within case 12. In some embodiments, case 12 is an expandable rigid case. Urinary catheter 14includes a catheter shaft 16 having a shaft proximal insertion end portion 18, a shaft distal drainage end portion 20, and an internal drainage lumen (not shown). Drainage holes 22, such as eyelets, are located in shaft proximal insertion end portion 18. Drainage holes 22 are in fluid communication with the internal drainage lumen of the catheter shaft 16. A drainage opening is associated with shaft distal drainage end portion 20 and communicates with the drainage lumen.

[0019] The outer surface of catheter shaft 16 may be made of a lubricious material or coated with a lubricious material for ease of insertion and movement of catheter shaft 16 into and within the urethra. The lubricious material may be a hydrophilic polymer that becomes highly lubricious when hydrated with a hydration medium. In one alternative, catheter shaft 16 may be made from a hydrophilic polymer. In another alternative, the outer surface of catheter shaft 16 may be coated with a hydrophilic polymer. In other alternatives, a lubricious gel may be applied to the outer surface of catheter shaft 16.

[0020] Case 12 may be a rigid case that serves as a package of catheter product 10 and is used as a rigid urine collection receptacle. Case 12 includes an inner cavity 24 for storing at least a portion of urinary catheter 14 and collecting urine drained by urinary catheter 14. The material(s) that case 12 is made from one or more rigid materials that are relatively inflexible under regular use of the catheter product 10.

[0021] Referring to Figs. 1 -7, rigid case 12 is an expandable rigid case with an initial configuration (Figs. 1 and 2) and an expanded configuration (Figs. 3-7). In the illustrated embodiment, case 12 includes a top section 26 and a bottom section 28, which are moveable relative to one another to move case 12 from the initial configuration to the expanded configuration. In this embodiment, the top and bottom sections 26, 28 are telescopically attached. It will be understood that the terms “top” and “bottom” are used herein for reference purposes only.

[0022] Top section 26 includes a top wall 30 and a sidewall 32 extending downward from top wall 30. Top wall 30 has a top opening 34 from which catheter shaft 16 is deployed. Top opening 34 is in communication with inner cavity 24. Sidewall 32 defines a body 32a that includes a bottom opening 36.Top section 26 also includes an inner surface 38 that at least partially defines inner cavity 24 of case 12. Bottom section 28 includes a bottom wall 40 and a bottom section sidewall 42 extending upward from bottom wall 40. Bottom section sidewall 42 defines a body 42a with a top opening 44. In the illustrated embodiment, the top section 26 and bottom section 28 are telescopically connected with body 32a defined by bottom section sidewall 42 being moveable through bottom opening 36 of body 42a of top section sidewall 32. Body 32a defined by bottom section sidewall 42 is nested within and moves along body 42a defined by top section sidewall 32. In another embodiment, body 32a may be nested within body 42a. In one alternative, body 32a and body 42a have the same general shape. For example, body 32a and body 42a have cylindrical shapes. In other alternatives, bodies 32a and 42a may have polygonal shapes, such as cubical shapes.

[0023] The outer surface 46 of bottom wall 40 may be flat to serve as a base for case 12. Additionally, in the illustrated embodiment, the periphery of bottom wall 40 may extend beyond the periphery of body 42a, which may assist in stabilizing catheter product 10 when bottom wall 40 is placed on a surface, such as a floor.

[0024] Referring to Figs. 2 and 4, in one alternative, catheter product 10 may have locking mechanisms that lock catheter product 10 in the initial configuration and / or the extended configuration. In one embodiment, optionally, an initial locking mechanism 48 that releasably locks catheter product 10 in the initial configuration. For example, initial locking mechanism 48 includes one or more grooves or detents 50 in the inner surface 38 of top section 26. The groove(s) or detent(s) may be a continuous groove that extends around inner surface 38. In other alternatives, locking mechanism 48 may include a plurality of spaced-apart detents. Locking mechanism 48 also may include one or more projections, such as latch(es) 52 associated with the bottom section sidewall 42. In the initial configuration, latch 52 engages groove 50 to releasably lock catheter product 10 in the initial configuration. To move catheter product 10 into the expanded configuration, top section 26 and bottom section 28 are pulled apart with sufficientforce for latch 52 to disengage groove 50. After latch 52 and groove 50 disengage, the top section 26 and bottom section 28 can be telescopically moved apart to move catheter product 10 into the expanded configuration.

[0025] Optionally, catheter product 10 may include an expanded locking mechanism 54 to lock catheter product 10 in the expanded configuration. Inner surface 38 of top section 26 may include one or more grooves or detents 56 adjacent to opening 36 in body 32a. The groove(s) or detent(s) may be a continuous groove that extends around inner surface 38. In other alternatives, locking mechanism 54 may include a plurality of spaced-apart detents. When catheter product 10 moves into the expanded configuration, latch 52 of bottom section 28 engages groove 56 to lock catheter product 10 in the expanded configuration.

[0026] Catheter product 10 may include a liquid-tight seal, such as a dynamic liquid-tight seal, between top section 26 and bottom section 28. For example, a seal may be associated with top section sidewall 32 or bottom section sidewall 42. In one alternative, a wiper seal may be located on one or both of top section sidewall 32 and bottom section sidewall 42. For example, the seal may be located along the rim of the side walls defining one or both of openings 36 and 44. The seal prevents leakage of liquid from case 12. In some alternatives, the seal is both liquid-tight and gas-tight.

[0027] As catheter product 10 is moved from the initial configuration to the expanded configuration, the volume of inner cavity 24 increases. Accordingly, inner cavity 24 may be an expandable inner cavity defined by case 12. The expandable inner cavity 24 has a first volume when the expandable rigid case 12 is in the first configuration and a second volume when the case 12 is in the second configuration. The volume of the inner cavity 24 increases so that case 12 can be used as a urine collection receptacle. In some alternatives, the volume of inner cavity 24 may increase by at least 25%, at least 50%, or at least 75% from the initial volume (when case 12 is in the initial configuration). In some alternatives, the volume of inner cavity 24 increases by 100% of the initial volume. In some alternatives, the initial volume of inner cavity 24 may be between 250 mland 1 ,125 ml, and the volume of the cavity when catheter product 10 or case 12 is in the expanded configuration may be between 310 ml and 1500 ml. In some embodiments, the volume of inner cavity 24, when catheter product 10 / case 12 is in the expanded configuration, may be at least 310 ml, at least 500 ml, at least 750 ml, at least 1300, or at least 1500 ml.

[0028] Case 12 may include a replaceable cap 58 that covers and / or closes opening 34 in top section of case 12. Optionally, cap 58 also may be employed to deploy catheter shaft 16 out of case 12. For example, cap 58 may releasably mates or engage catheter shaft 16 to pull the catheter shaft out of case 12. In the illustrated embodiment, cap 58 includes a protrusion 60, such as a hook, that mates or engages the proximal end of the catheter. For example, the hook mates with a drainage hole 22 of catheter shaft 16. When cap 58 is removed from case 12, the engagement between protrusion 60 and drainage hole 22 results in cap 58 pulling catheter shaft 16 out of case 12 through opening 34. In some embodiments, cap 58 forms a liquid-tight and / or gas-tight seal with case 12.

[0029] Referring to Figs. 1 and 2, catheter product 10 is distributed to the user with case 12 in the initial configuration and urinary catheter 14 within inner cavity 24, in a stored position. If urinary catheter 14 includes a hydrophilic material for lubricity, a hydration medium, such as water or saline, may be located within inner cavity 24. The hydration medium may be in contact with the hydrophilic material of catheter 14 while it is stored in inner cavity 24.

[0030] In use, the user removes cap 58, which pulls catheter shaft 16 out of opening 34 in top section 26 of case 12. The user moves top section 26 and bottom section 26 of case 12 away from one another to the position shown in Figs. 3 and 4. The user can perform these steps in any order. For example, the user could remove cap 58 first or expand case 12 first. A stop 62 may be associated with catheter shaft distal drainage end portion 20. Stop 62 prevents shaft 16 from being pulled all the way out of case 12.

[0031] Turning to Figs. 3 and 4, catheter shaft 16 is inserted into and advanced through the urethra to the bladder. Urine is drained from the bladder through drainage holes 22 and into the drainage lumen of the catheter shaft 16. The urinedrains from catheter shaft 16 into inner cavity 24 of case 12, where the urine is collected. Referring to Figs. 5-7, after the bladder has been emptied, optionally, catheter shaft 16 is inserted through opening 34 in top section 26 of case 12 and back into inner cavity 24. Cap 58 is placed back over opening 34 in the top section 28 to close or reseal opening 34. The user may immediately discard case 12 or retain it with them and discard case 12 later without worrying about the risk of spillage.

[0032] Figs. 8 and 9 illustrate another embodiment of a catheter product 110 with a rigid case 112. Case 112 is a rigid case made of any of the materials discussed above. However, case 112 is not expandable and has an inner volume of at least 310 ml, at least 500 ml, at least 750 ml, at least 1300 ml, or at least 1500 ml. In one alternative, the inner cavity has an inner volume of 310 ml to 1500 ml. Catheter product 110 also includes a urinary catheter 114 with a catheter shaft 116 that is deployed out an opening 134 at the top of case 112. Case 112 includes a cap 158 that may have similar features as described above to pull catheter shaft 116 out of case 112. Furthermore, catheter 114 may have similar characteristics to catheter 14 described above.

[0033] 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: an expandable rigid case having an initial configuration and an expanded configuration; an expandable inner cavity defined by the expandable rigid case and in communication with a case opening of the expandable rigid case, wherein the expandable inner cavity has a first volume when the expandable rigid case is in the initial configuration and a second volume when the expandable rigid case is in the second configuration, and wherein the expandable inner cavity is configured for collecting urine when the expandable case is in the second configuration; an intermittent urinary catheter having a catheter shaft at least partially located within the expandable inner cavity, the catheter shaft having an initial position within the expandable inner cavity and a deployed position wherein at least a portion of the catheter shaft extends through the case opening.

2. The urinary catheter product of claim 1 , wherein the expandable inner cavity has a volume of at least 250 ml when the expandable rigid case is in the initial configuration.

3. The urinary catheter product of any one of claims 1 and 2, wherein the expandable inner cavity has a volume of at least 500 ml when the expandable rigid case is in the expanded configuration.

4. The urinary catheter product of any one of claims 1 and 2, wherein the expandable inner cavity has a volume of at least 750 ml when the expandable rigid case is in the expanded configuration.

5. The urinary catheter product of any one of claims 1 and 2, wherein the expandable inner cavity has a volume of at least 1300 ml when the expandable rigid case is in the expanded configuration.

6. The urinary catheter product of any one of claims 1 and 2, wherein the expandable inner cavity has a volume of at least 1500 ml when the expandable rigid case is in the expanded configuration.

7. The urinary catheter product of any one of claims 1-5, wherein the expandable rigid case has a top section and a bottom section.

8. The urinary catheter product of claim 7, wherein the top section and the bottom section are movable relative to one another to move the expandable rigid case from the initial configuration to the expanded configuration.

9. The urinary catheter product of any one of claims 7 and 8, wherein the top section comprises a top section wall having an inner surface at least partially defining the expandable inner cavity, the top section having a body defining a bottom opening; the bottom section comprising a bottom wall section having an inner surface at least partially defining the expandable inner cavity, the bottom section defining a body having a top opening.

10. The urinary catheter product of claim 9, wherein the body of the bottom section is located in the bottom opening defined by the body of the top section so that bottom section and top section are telescoped.11 . The urinary catheter product of claim 9, wherein the body of the top section is located in the top opening of defined by the body of the bottom section so that bottom section and top section are telescoped.

12. The urinary catheter product of any one of claims 7-11 , further including a dynamic liquid-tight seal between the top section and bottom section.

13. The urinary catheter product of any one of claims 1-6, further including an expanded locking mechanism to lock the expandable rigid case in the expanded configuration.

14. The urinary catheter product of any one of claims 1-6, further including an initial locking mechanism to releasably lock the expandable rigid case in the initial configuration.

15. The urinary catheter product of any one of claims 7-12, further including an expanded locking mechanism to lock the expandable rigid case in the expanded configuration, wherein the locking mechanism comprises a groove in one of the top section and the bottom section, and a latch on the other of the top section and the bottom section, wherein the groove and latch mate to lock the expandable rigid case in the expanded configuration.

16. The urinary catheter product of claim 7-15, further including an initial locking mechanism to releasably lock the expandable rigid case in the initial configuration, wherein the initial locking mechanism comprises a groove or detent on one of the top section and the bottom section, and a protrusion on the other of the top section and the bottom section, wherein the protrusion and the groove or detent mate to releasably lock the expandable rigid case in the initial configuration.

17. The urinary catheter product of any one of claims 1 -16, further including a cap that covers the case opening.

18. The urinary catheter product of claim 17, wherein the cap releasably mates with a proximal end of the catheter shaft and the catheter shaft is pulled out of the expandable inner cavity through the case opening as the cap is removed.

19. The urinary catheter product of claim 18, wherein the cap includes a protrusion that releasably engages an eyelet of the proximal end of the catheter shaft.

20. The urinary catheter product of any one of claims 17-19, wherein the cap is configured to reseal the expandable rigid case opening after urine has been collected in the expandable rigid case.21 . A urinary catheter product, comprising: a rigid case comprising a case opening and an inner cavity in communication with the case opening, and wherein the inner cavity has a volume of at least 310 ml; and an intermittent urinary catheter having a catheter shaft at least partially located within the inner cavity, the catheter shaft having an initial position within the inner cavity and a deployed position wherein at least a portion of the catheter shaft extends through the case opening.

22. The urinary catheter product of claim 21 , wherein the inner cavity has a volume of at least 500 ml.

23. The urinary catheter product of claim 21 , wherein the inner cavity has a volume of at least 750 ml.

24. The urinary catheter product of claim 21 , wherein the inner cavity has a volume of at least 1300 ml.

25. The urinary catheter product of claim 21 , wherein the inner cavity has a volume of at least 1500 ml.

26. The urinary catheter product of any one of claims 21 -25, further including a cap that covers the case opening.

27. The urinary catheter product of claim 26, wherein the cap releasably mates with a proximal end of the catheter shaft and the catheter shaft is pulled out of inner cavity through the case opening as the cap is removed.

28. The urinary catheter product of claim 27, wherein the cap includes a hook that releasably engages an eyelet of the proximal end of the catheter shaft.

29. The urinary catheter product of any one of claims 26-28, wherein the cap is configured to reseal the rigid case opening after urine has been collected in the rigid case.

Images