Intermittent urinary catheter with a intravesical delivery system

Abstract

An intermittent urinary catheter (12) that includes a catheter shaft (14) having at least one drainage opening (24) for draining urine from the bladder through the catheter shaft. The intermittent urinary catheter also includes a detachable member (30) comprising a substance.

Description

Attorney Docket No. 3400-0356.01 (841 PCT)Intermittent Urinary Catheter With A Intravesical Delivery SystemThis Application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 719,920, filed November 13, 2024, the entirety of which is incorporated herein by reference.FIELD OF DISCLOSURE

[0001] The present disclosure relates intermittent urinary catheters that void liquids from the bladder and deliver substances to the bladder. The present disclosure also relates to delivery devices that target delivery of agents in various forms within the lower urinary tract.BACKGROUND

[0002] 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] Although intermittent catheterization may be a good option for many users, there is a risk of intermittent catheter-induced urinary tract infections.Several risk factors may contribute to urinary tract infections, including, but not limited to, contamination during handling and insertion of the catheter, anatomy of the urethra and bladder, the microbiome of the urinary tract, etc. Regardless of the causes and risks of urinary tract infections, there remains a need to reduce the risk of such infections. There also remains a need for efficient and convenient delivery of treatments, substances, agents and / or medicaments, in general, to the bladder.SUMMARY

[0004] In one aspect, an intermittent urinary catheter includes a catheter shaft comprising a shaft proximal end portion, a shaft distal end portion, and a wall defining a drainage lumen. The catheter also includes at least one drainage opening in the shaft, wherein the at least one drainage opening is in fluidAttorney Docket No. 3400-0356.01 (841 PCT)communication with the drainage lumen. The catheter includes a detachable member connected to the shaft proximal end portion, wherein the detachable member comprises a substance. The catheter also includes a release system for releasing the detachable member from the shaft proximal end portion. The release system has a pusher located within the drainage lumen, wherein the pusher moves proximally to release the detachable member.

[0005] In another aspect, an intermittent urinary catheter includes a catheter shaft comprising a shaft proximal end portion, a shaft distal end portion, and a wall defining a drainage lumen. The catheter shaft includes at least one drainage opening in fluid communication with the drainage lumen. The urinary catheter includes a detachable at least partially solid substance associated with the shaft proximal end portion and a release system for releasing the detachable solid medicament or treatment from the shaft proximal end portion.

[0006] In yet another aspect, a device for delivering a medicament or treatment to a patient's bladder includes an elongated shaft comprising a shaft proximal end portion and a shaft distal end portion. The device also includes a detachable at least partially solid substance associated with the shaft proximal end portion and a release system for releasing the detachable solid medicament or treatment from the shaft proximal end portion.BRIEF DESCRIPTION OF DRAWINGS

[0007] Fig. 1 is a perspective view of a delivery system in accordance with the present disclosure, shown with the detachable member, including a medicament or treatment, being attached to the shaft of the delivery system.

[0008] Fig. 2 is an enlarged perspective view of an embodiment of the proximal end portion of the delivery system shown in Fig. 1.

[0009] Fig. 3A is an enlarged cross-sectional view of one embodiment of a proximal end tip of the proximal end portion shown in Fig. 2.

[0010] Fig. 3B is an enlarged cross-sectional view of another embodiment of a proximal end tip of the proximal end portion shown in Fig. 2.

[0011] Fig. 4 is an enlarged perspective view of another embodiment of the proximal end portion of the delivery system shown in Fig. 1.Attorney Docket No. 3400-0356.01 (841 PCT)

[0012] Fig. 5 is a perspective view of the delivery system of Fig. 1 , shown with the detachable member detached from the shaft of the delivery system.

[0013] Fig. 6 is an enlarged perspective view of the embodiment of the proximal end portion of Fig. 2, shown with the detachable proximal end tip detached from the shaft of the delivery system.

[0014] Fig. 7 is an enlarged perspective view of the embodiment of the proximal end portion of Fig. 4, shown with the detachable member detached from the shaft of the delivery system.

[0015] Fig. 8 is a cross-sectional view of one embodiment of the delivery system.

[0016] Fig. 9 is a cross-sectional view of one embodiment of the releasing system.

[0017] Fig. 10 is a cross-sectional view of another embodiment of the releasing system, shown with the plunger separate from the barrel.

[0018] Fig. 11 is a crossing-sectional view of the releasing system of Fig. 10, shown with the plunger advanced within the barrel.

[0019] Fig. 12 is a schematic view showing the delivery system advanced into the urinary tract system with the detachable member detached from the shaft to deliver the medicament or treatment into the bladder.

[0020] Fig. 13 is a front view of one embodiment of a detachable member in accordance with the present disclosure.

[0021] Fig. 14 is a schematic illustration of a bladder having the detachable member therein.DETAILED DESCRIPTION

[0022] 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.Attorney Docket No. 3400-0356.01 (841 PCT)

[0023] The delivery devices disclosed herein may be used to deliver a substance into the bladder. The delivery devices may also serve as an intermittent urinary catheter that can void the bladder before or after the substance is detached from the device or released into the bladder. The substance may be for example a medicament or treatment. The substance may also be at least partially solid. The substance may also be in various forms, such as solid mass, solution, emulsion, vapor, etc.

[0024] Fig. 1 illustrates a delivery device 10 for delivering the substance into the lower urinary tract system. In the illustrated embodiment, the delivery device is an intermittent urinary catheter 12. However, in other embodiments, the delivery device 10 may not include the features of a urinary catheter. Urinary catheter 12 includes a catheter shaft 14 with a shaft proximal end portion 16 and a shaft distal end portion 18. The shaft also includes a drainage lumen 20 (Fig. 8) defined by the shaft wall 22. Catheter shaft 14 may have a lubricious outer surface, which helps ease the insertion of catheter shaft 14 through the urethra and into the bladder. For example, catheter shaft 14 may have a lubricious hydrophilic outer surface, or the shaft may have a lubricious hydrophilic coating deposited on the catheter shaft's outer surface. The coating may or may not be cured.

[0025] Catheter shaft 14 includes at least one drainage opening 24 through shaft wall 22. The at least one drainage opening 24 may be one or more eyelets or any other suitable opening cut, molded, melted, or otherwise formed in the shaft wall 22. When the shaft proximal end portion 16 is advanced into the bladder, liquid (e.g., urine) will flow through the at least one drainage opening 24 and into the drainage lumen 20 (Fig. 8), voiding urine from the bladder.

[0026] A drainage member 26 is associated with the shaft distal end portion 18. Drainage member 26 includes a lumen 28 (Fig. 8) in communication with drainage lumen 20 of the catheter shaft 14. Drainage member 26 may be a funnel or a connector.

[0027] A detachable member 30 is releasably associated with the shaft proximal end portion 16. The detachable member 30 includes a substance, suchAttorney Docket No. 3400-0356.01 (841 PCT)as a medicament or treatment, to promote the health of the user / patient. For example, the substance may promote the health of the urinary tract system. In some alternatives, the substance may promote the health of the bladder and / or the urethra. For instance, the substance may reduce the susceptibility of urinary tract infections and / or treat urinary tract infections. In other alternatives, the substance may promote the health of other body areas, such as the heart, liver, blood, digestive system, etc. For example, the medicament or treatment may be antibiotics, active pharmaceutical ingredients (API) , excipients, non-API agents such as peptides, proteins, hormones, ions, electrolytes, cytokines, inflammatory mediators, growth factors, cytokines, neuromodulating agents, among others. Substances may be delivered in either the solid, liquid or vapor form. Additionally, detachable member 30 may include a mixture of substances. Furthermore, detachable member 30 may include time-release characteristics, such as timerelease and / or active coatings and / or layers and / or biomaterial delivery systems.

[0028] Detachable member 30 may be a detachable, at least partially solid mass that can be detached or released from the shaft proximal end portion 16. In some alternatives, the detachable member 30 comprises a detachable, at least partially solid medicament. Detachable member 30 may be a tip, cap, plug, pill, pellet, capsule, etc. In one alternative, detachable member 30 may be a capsule that has a solid shell that contains a liquid or solution.

[0029] Turning to Figs. 2, 3A, and 3B, in some alternatives, detachable member 30 may serve as the proximal tip 32a of catheter shaft 14. In this alternative, proximal tip 32a may be bullet or dome-shaped. Proximal tip 32a may be releasable attached to shaft proximal end portion 16 by any suitable means, such as adhesive or friction fit. In one alternative, the adhesive may be water-soluble or weaken upon exposure to a specific pH, osmolality, surface charge, etc. so that the adhesive becomes weaker when the detachable member 30 is inserted into the bladder. That is, the bond between the proximal tip 32a and the shaft proximal end portion 16 is stronger as the catheter shaft 14 is advanced through the urethra but weakens when exposed to the condition in the bladder toAttorney Docket No. 3400-0356.01 (841 PCT)make it easier to detach the proximal tip 32a from the shaft proximal end portion 16.

[0030] Turning to Fig. 3A, in some alternatives, the proximal tip 32a may include a tip portion 34a that is coated with a substance 36a, such as a medicament. The tip portion 34a may be a liquid / urine soluble material (such as a water-soluble material) and / or a bioabsorbable material. The substance 36a may be any of the medicaments disclosed herein. T uring to Fig. 3B, in other alternatives, proximal tip 32b may be at least a partially solid mass containing a medicament that has been shaped into the tip by, for example, compression or pressing.

[0031] Turning to Fig. 4, in some alternatives, the detachable member 30 may be a pellet 38, such as a pill or liquid filled capsule. Shaft proximal end 16a may have an opening 40 (Fig. 7) at the proximal terminal end 42, and pellet 38 may be at least partially positioned in opening 40. In some alternatives, pellet 38 may be entirely within opening 40 and in the drainage lumen 20. Pellet 38 may be distal of proximal terminal end 42. Detachable member 30 may be releasably attached to shaft proximal end 16a by, for example, friction fit or an adhesive. The adhesive may be any of the adhesives disclosed herein.

[0032] Turning to Figs. 1 and 8, delivery device 10, and thus urinary catheter 12, includes a release system 44, which is activated to detach or detachable member 30 from catheter shaft 14. In the illustrated embodiment, release system 44 includes a barrel 46, actuator (such as plunger 48), and pusher 50. Barrel 46 is optional and is associated with drainage member 26. In the illustrated embodiment, barrel 46 is connected to drainage member 26. When optional barrel 46 is present, it may be permanently connected to drainage member 26 or releasably attached to drainage member 26. In one embodiment, barrel 46 may be integral with drainage member 26. In the illustrated embodiment, barrel 46 includes a wall 52 at least partially located in the lumen 28 of the drainage member 26. Barrel 46 may be friction fit with the drainage member or attached with an adhesive.Attorney Docket No. 3400-0356.01 (841 PCT)

[0033] Plunger 48 includes a proximal portion 54 at least partially located within a bore 56 defined by wall 52 of barrel 46. Optionally, a distal end of plunger 48 includes a flange 58 configured to be engaged by the user’s fingers or a machine to push or depress the plunger. Plunger 48 is depressible or proximally movable within bore 56 of barrel 46. When barrel 46 is absent, plunger 48 may be configured to be associated with and movable within lumen 28 of drainage member 26.

[0034] Pusher 50 is located in drainage lumen 20 of shaft 14. Pusher 50 may be an elongated wire, elongated rod, or the like that extends within the drainage lumen 20. Distal end portion 60 of pusher 50 is operatively connected to plunger 48 such that as plunger 48 is advanced proximally, pusher 50 is also advanced proximally. Pusher 50 is advanced proximally to apply force to detachable member 30 and detach it or separate it from the shaft proximal end portion 16. Optionally, the proximal end 62 of the pusher 50 includes a terminal end 64 with a cross-sectional surface area in the radial direction larger than the pusher’s distal portion. For example, the terminal end 64 may be a flange, disc, or bar.Additionally, the pusher 50 is spaced from the inner surface 66 of shaft wall 22 to allow liquid flow through the drainage lumen 20. For example, the liquid flows in a space between the pusher 50 and the inner surface 66 of the shaft wall 22.

[0035] Turning to Figs. 5-7, plunger 48 is depressed or advanced proximally within barrel 46 to move or advance pusher 50 proximally. Pusher 50 applies force to detachable member 30 to detach it from the shaft proximal end portion 16 of catheter shaft 14.

[0036] Turning to Figs. 8 and 9, optionally, plunger 48 may include one or more drainage passageways 68 for allowing the draining of liquid therethrough.Passageways 68 are in fluid communication with the lumen 28 of the drainage member 26 to allow liquid to drain out of the urinary catheter 14. Passageways 68 may be included when barrel 46 and / or plunger 48 are permanently connected to drainage member 26. In the illustrated embodiment, plunger 48 includes a support 70, such as a bar or inner wall, wherein the pusher 50 is attached to theAttorney Docket No. 3400-0356.01 (841 PCT)support 70. The one or more passageways 68 are defined between the support 70 and the inner wall of the plunger 48.

[0037] Turning to Figs. 10 and 11 , in some alternatives, plunger 48 and support 70 may be two separate components. In this embodiment, before catheterization, plunger 48 is separate from the urinary catheter 12 and not located within the barrel 46, as illustrated in Fig. 10. After the catheter 12 has been inserted into the bladder and the urine has been voided through the catheter, plunger 48 is inserted into barrel 46 and advanced to push the support 70 and advance the pusher 50 and detach the detachable member 30, as shown in Fig. 11. In this embodiment, plunger 48 may be a durable or reusable component in that it can be used with several different catheters.

[0038] Fig. 12 illustrates the delivery device 10 / urinary catheter 12 in use. The catheter shaft 14 is advanced through the urethra 72 until shaft proximal end portion 16 enters the bladder 74. Once shaft proximal end portion 16 is in the bladder 74, urine drains through the drainage opening 24 and into drainage lumen 20. When the delivery system 44 does not include passageways for the passage of urine, urine remains in the drainage lumen 20 of the catheter shaft 14. The urine is prevented from flowing out of drainage member 26. At this time, plunger 48 can be advanced proximally to advance the pusher 50 and detach the detachable member 30 from the shaft proximal end portion 16, thereby deploying the detachable member 30 into the bladder 74. Plunger 48 or the entire delivery system 44 may be removed to allow the voiding of urine out of the drainage member.

[0039] In another embodiment, when the delivery system 44 includes drainage passageways 68 (Figs. 8 and 9) or plunger 48 is a separate component from the barrel, detachable member 30 may remain attached to the shaft proximal end portion 16 as urine is voided from the bladder 74 through the catheter shaft 14. After the urine has been voided, the user may insert the plunger 48 if it is a separate component. The user may then proximally advance the plunger 48 to advance the pusher 50 and detach the detachable member 30 from the shaftAttorney Docket No. 3400-0356.01 (841 PCT)proximal end portion 16, thereby deploying the detachable member 30 into the voided bladder 74.

[0040] The medicament of the detachable member may be designed to interact with, such as dissolve in, any residual urine in the bladder or the urine made by the body after voiding. The medicaments of the detachable member may alter the urine's physical and / or chemical properties and / or be absorbed by tissue of the lower urinary tract and / or interact with bacterial and / or fungal species in the lower urinary tract towards a health benefit. Lower urinary tract health benefits may include alterations of urine pH, osmolality, mucus composition, and sediment composition, as well as effects on uropathogens and commensal bacteria.Additionally, the detachable member's shape and size can be such that the detachable member moves into a desired location and orientation within the bladder. For example, the shape and size of the detachable member may be such that the detachable member is self-orientating. For instance, the shape and size be such that the detachable member moves to a desired location and / or ordination of the detachable member within the bladder autonomously positioning itself to engage with the bladder urothelium.

[0041] Turning to Fig. 13, there is shown one alternative of detachable member 30a, which may include any of the substances disclosed herein. Detachable member 30a has an upper portion 31 and a lower portion 33. Detachable member 30a also has a shifted center of mass 39 that is not equidistant between the topmost portion 35 and bottom most portion 37 of the detachable member 30a. The center of mass 39 is closer to the bottom most portion 37 than the topmost portion 35. In the illustrated embodiment, the upper portion 31 has a higher curvature outer profile and the lower portion 33 has a lower curvature outer profile. Furthermore, the bottom 41 is flat and there is a corner 43 between the curved outer wall of the lower portion 33 and the bottom 41. When the detachable member 30a is upright and the bottom 41 is resting on tissue, the shape of the detachable member 30a makes it resistant to being pushed over. Additionally, when the detachable member 30a is not upright, its shape and center of mass helps move or orientate the detachable member 30a into an upright position.Attorney Docket No. 3400-0356.01 (841 PCT)

[0042] Referring to Fig. 14, the detachable member 30a has been deployed into the bladder is a non-upright position as shown in broken line on left side of the bladder 74. The shape and center of mass of the detachable member 30a assists the member as it rolls, moves, and / or is otherwise orientates under the forces of gravity and / or other forces in the body. The detachable member self-orientates into the upright position, as in solid line near the inner sphincter 76 of the bladder 74. In the upright position, the bottom 41 of the detachable member 30a rests against the tissue. It will be understood that the detachable member may selforientate at other locations in the bladder depending on the patient’s / user’s position. For example, if the user is laying down, the detachable member may self-orientate to be upright on the side of the bladder wall.

[0043] Detachable member 30a may also include multiple substances. For example, the portion 33 may include one medicament and the upper portion 31 may include another, different medicament.

[0044] 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

Attorney Docket No. 3400-0356.01 (841 PCT)Claims1. An intermittent urinary catheter, comprising:a catheter shaft comprising a shaft proximal end portion, a shaft distal end portion, and a wall defining a drainage lumen;at least one drainage opening in the shaft, wherein the at least one drainage opening is in fluid communication with the drainage lumen;a detachable member connected to the shaft proximal end portion, wherein the detachable member comprises a substance; anda release system for releasing the detachable member from the shaft proximal end portion, the release system comprising a pusher located within the drainage lumen, wherein the pusher moves proximally to release the detachable member.

2. The intermittent urinary catheter of claim 1 , wherein the substance is an at least partially solid mass.

3. The intermittent urinary catheter of any one of claims 1 and 2, wherein the detachable member comprises a pellet releasably attached to the shaft proximal end portion.

4. The intermittent urinary catheter of any one of claims 1 -3, wherein the shaft proximal end portion has shaft proximal terminal end with an opening, detachable member being at least partially located within the opening.

5. The intermittent urinary catheter of any one of claims 1 -4, wherein the detachable member is releasably connected to the shaft proximal end portion by friction fit.

6. The intermittent urinary catheter of any one of claims 1 -5, wherein the detachable member is releasably connected to the shaft proximal end portion by adhesive.

7. The intermittent urinary catheter of one of claims 1 -2, wherein the detachable member comprises a proximal catheter shaft tip that is releasably attached to the shaft proximal end portion.

8. The intermittent urinary catheter of claim 7, wherein the proximal catheter shaft tip is coated with the substance.Attorney Docket No. 3400-0356.01 (841 PCT)9. The intermittent urinary catheter of any one of claims 7-8, wherein the proximal catheter shaft tip is made from a water-soluble material.

10. The intermittent urinary catheter of any one of claims 1 -9, wherein the pusher comprises an elongated rod.

11. The intermittent urinary catheter of any one of claims 1-10, wherein the pusher is spaced from the wall to allow passage of liquid between pusher and the wall of the catheter shaft, thereby allowing the liquid to flow through the drainage lumen.

12. The intermittent urinary catheter of any one of claims 1-11, wherein the release system further includes an actuator for moving the pusher proximally within the drainage lumen.

13. The intermittent urinary catheter of claim 12, wherein the actuator comprises a barrel and a plunger, the pusher being connected to the plunger and the barrel being associated with a drainage member at shaft distal end portion, and wherein the plunger is movable relative to the barrel to proximally advance the pusher.

14. The intermittent urinary catheter of claim 13, wherein the actuator includes a drainage passage therethrough for the drainage of liquid.

15. The intermittent urinary catheter of any one of claims 13-14, wherein the release system is removable from the drainage member and catheter shaft.

16. The intermittent urinary catheter of claim 15, wherein the actuator has a friction fit with the drainage member.

17. The intermittent urinary catheter of any one of claims 13-14, wherein the actuator is removable from the drainage member.

18. The intermittent urinary catheter of any one of claims 1-17, wherein the substance is a medicament.

19. The intermittent urinary catheter of claim 18, wherein the medicament is in a solid form and / or solution.

20. An intermittent urinary catheter, comprising:a catheter shaft comprising a shaft proximal end portion, a shaft distal end portion, and a wall defining a drainage lumen;Attorney Docket No. 3400-0356.01 (841 PCT)at least one drainage opening in the catheter shaft and in fluid communication with the drainage lumen;a detachable at least partially solid substance associated with the shaft proximal end portion; anda release system for releasing the detachable at least partially solid substance from the shaft proximal end portion.

21. The intermittent urinary catheter of claim 20, wherein the detachable at least partially solid substance comprises a pellet releasably attached to the shaft proximal end portion.

22. The intermittent urinary catheter of claim 20, wherein the detachable at least partially solid substance is located on a proximal catheter shaft tip that is releasably attached to the shaft proximal end portion.

23. The intermittent urinary catheter of any one of claims 20-22, wherein the substance is a medicament.

24. The intermittent urinary catheter of claim 23, wherein the medicament is in a solid form and / or solution.

25. A device for delivering a medicament to a bladder of a patient, comprising:an elongated shaft comprising a shaft proximal end portion and a shaft distal end portion;a detachable at least partially solid substance associated with the shaft proximal end portion; anda release system for releasing the detachable at least partially solid substance from the shaft proximal end portion.

26. The device of claim 25, wherein the detachable at least partially solid substance comprises a pellet releasably attached to the shaft proximal end portion.

27. The device of claim 25, wherein the detachable at least partially solid substance is located on a proximal catheter shaft tip that is releasably attached to the shaft proximal end portion.Attorney Docket No. 3400-0356.01 (841 PCT)28. The device of any one of claims 25-27, wherein the substance is a medicament.

29. The device of claim 27, wherein the medicament is in a solid form and / or solution.

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