WO2025188864A1

WO2025188864A1 - Indwelling catheter-free stricture treatment

Info

Publication number: WO2025188864A1
Application number: PCT/US2025/018523
Authority: WO
Inventors: Adam KADLEC
Original assignee: Aok Innovations LLC
Current assignee: Aok Innovations LLC
Priority date: 2024-03-06
Filing date: 2025-03-05
Publication date: 2025-09-12
Anticipated expiration: 2026-09-06
Also published as: WO2025188864A8

Abstract

A method of treating a urethral stricture includes: dilating a stricture in a urethra; applying an anti-proliferative or steroidal agent to a luminal wall of the urethra near the stricture; deploying a stent or scaffold within the urethra to maintain contact between the anti-proliferative or steroidal agent and the luminal wall of the urethra near the stricture; leaving the stent or scaffolding within the urethra, thereby allowing fluid to pass through a lumen of the stent or scaffolding; and removing the stent or scaffolding after a therapeutic time period.

Description

IND WELLING CATHETER-FREE STRICTURE TREATMENT

BACKGROUND

[0001] This application relates, in some embodiments, to treating urethral strictures.

SUMMARY

[0002] A system or method for treating a stricture may include any one or more of the embodiments described in the disclosure.

[0003] Male urethral strictures affect men of all ages. Although current techniques can treat some strictures, recurrence is a clinical problem. For example, while endoscopic treatment is minimally invasive, it has been plagued by high recurrence rates. Definitive surgical treatment (urethroplasty) can be effective and carries a much lower recurrence rates, but also carries the risks of reconstructive surgery and requires prolonged catheterization, weekslong recovery period, and often must be done in staged fashion (e.g., multiple operations).

[0004] Currently endoscopic treatment of strictures involves dilation or incision, followed by placement of an indwelling catheter that typically remains in place for days to weeks. Newer approaches and technologies incorporate delivery of anti-proliferative or steroidal medication, either by injection, drug-eluting stent, or drug-coated balloon. Such treatments have been shown to reduce recurrent rates, but still require placement of an indwelling catheter. In addition, “contact time” between the drug and tissue can be short, which may reduce the effectiveness of the drug.

[0005] There is an opportunity for novel drug-device combination approach, wherein drug can be injected/applied, and a multi-functional device can be used to prolong contact time and eliminate the need for post-procedure catheterization. Elimination of catheterization reduces risk and discomfort to a patient, and prolonged contact time of a bioactive agent may confer a greater therapeutic benefit.

[0006] In some aspects, the techniques described herein relate to a method of treating a urethral stricture, including: dilating a stricture in a urethra; applying an anti- proliferative or steroidal agent to a luminal wall of the urethra near the stricture; deploying a stent or scaffold within the urethra to maintain contact between the anti-prolifcrativc or steroidal agent and the luminal wall of the urethra near the stricture; leaving the stent or scaffolding within the urethra, thereby allowing fluid to pass through a lumen of the stent or scaffolding; and removing the stent or scaffolding after a therapeutic time period.

[0007] In some aspects, the techniques described herein relate to a method of treating a urethral stricture, including: dilating a stricture in a urethra; deploying a stent or scaffold within the urethra to maintain contact a luminal wall of the urethra near the stricture, wherein the stent or scaffold includes an anti -proliferative or steroidal agent coating; leaving the stent or scaffolding within the urethra, thereby allowing fluid to pass through a lumen of the stent or scaffolding; and removing the stent or scaffolding after a therapeutic time period.

[0008] In some aspects, the techniques described herein relate to a method, wherein the anti-proliferative or steroidal agent includes a film or gel.

[0009] In some aspects, the techniques described herein relate to the method of any proceeding aspect, wherein deploying includes inserting the stent or scaffold through a natural opening of the body without piercing, cutting or creating an opening in the skin.

[0010] In some aspects, the techniques described herein relate to the method of any proceeding aspect, wherein the stent includes nickel titanium, a shape memory metal, a metal, a plastic, or a dissolvable material.

[0011] In some aspects, the techniques described herein relate to the method of any proceeding aspect, wherein removing includes allowing the stent or scaffold to dissolve.

[0012] In some aspects, the techniques described herein relate to the method of any proceeding aspect, further including refraining from inserting an indwelling catheter in the urethra.

[0013] In some aspects, the techniques described herein relate to the method of any proceeding aspect, wherein removing includes employing an endoscopic technique.

[0014] In some aspects, the techniques described herein relate to a method, wherein applying includes applying using a submucosal needle.

[0015] In some aspects, the techniques described herein relate to a method, wherein applying includes using a mucosal spray with a mucosal spray actuator. [0016] In some aspects, the techniques described herein relate to a method, wherein the mucosal spray actuator is side firing, end firing, or both.

[0017] In some aspects, the techniques described herein relate to a method, wherein applying includes inserting a sheath.

[0018] In some aspects, the techniques described herein relate to a method, wherein applying includes deploying an internal patch.

[0019] In some aspects, the techniques described herein relate to a method, wherein the internal patch includes a control release agent, beads, and/or nanoparticles.

[0020] In some aspects, the techniques described herein relate to the method of any proceeding aspect, wherein the anti-proliferative or steroidal agent includes a hydrogel or an aqueous solution.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG 1 illustrates a flow chart describing a method and an alternate method of treating a stricture with a stent-drug combination without using an indwelling catheter.

[0022] FIG 2 illustrates a cross-sectional view of a stent-drug combination within the urethra.

[0023] FIG. 3 illustrates a side view of a urethra that includes a stricture region.

[0024] FIG 4 illustrates a side view of the urethra of FIG 3 post dilation of the stricture region.

[0025] FIG. 5 illustrates a side view of the urethra of FIG. 4 with a stent-drug combination inserted and spanning a dilated region of the urethra.

[0026] FIG. 6 illustrates a side view of the urethra of FIG. 5 after a sufficient time has passed to allow the drug to dissolve and treat the stricture.

[0027] FIG. 7 illustrates a side view of the urethra of FIG. 6 post removal of the stent from the urethra, the urethra lumen having been restored to a healthy diameter.

[0028] FIG. 8 illustrates various techniques to provide drug deliver to the urethral lumen. DETAILED DESCRIPTION

[0029] A urethral stricture is a narrowing of the urethra causing obstructive symptoms. Strictures usually result from injury to the urethral mucosa and tissues around it.

[0030] One embodiment of a method for indwelling-free catheter treatment of urethral structures is illustrated in FIG. 1. The method begins with dilating the stricture. For example, a traditional endoscopic device, balloon, etc., may be used. The next step is to apply an anti-proliferative or steroidal film or gel (or other clinically effective drug) to the luminal wall of the urethra, for example, at or near the stricture. The next step is to deploy a stent or other scaffold to maintain contact between the anti-proliferative or steroidal material and luminal wall. The stent/scaffold is left indwelling, allowing fluid to continue passing through the urethral lumen. For example, the patient undergoing treatment is not prevented from urinating during while the stent is left indwelling. Finally, the stent/scaffold is removed after the drug has been able to effectively treat the stricture. For example, the stent/scaffold may be removed days or weeks after insertion. The stent/scaffold may be removed via an endoscopic technique.

[0031] In another embodiment, also illustrated in FIG. 1, the method begins with dilating the stricture. For example, a traditional endoscopic device, balloon, etc., may be used. The next step is to deploy a drug-coated stent to maintain the patency of the urethra and to deliver an anti-proliferative or steroidal film or gel (or other clinically effective drug) to the luminal wall of the urethra, for example, at or near the stricture. The stent/scaffold is left indwelling, allowing fluid to continue passing through the urethra lumen. For example, the patient undergoing treatment is not prevented from urinating during while the stent is left indwelling. Finally, the stent/scaffold is removed after the drug has been able to effectively treat the stricture. For example, the stent/scaffold may be removed days or weeks after insertion. The stent/scaffold may be removed via an endoscopic technique.

[0032] FIG. 2 illustrates a cross section of the urethra once the stent has been deployed. The stent or scaffold exerts an outward radial force to press an anti-proliferative or steroidal film, gel, or matrix into the luminal wall.

[0033] FIG. 3 shows the urethra with a strictured region before treatment. At FIG. 4, the stricture has been dilated, e.g., using a balloon, endoscope, or other traditional technique. At FIG. 5 an anti-proliferative or steroidal layer and stent/scaffold has been delivered. At FIG. 6 the anti-proliferative or steroidal layer has dissolved and caused the stricture to heal or reduce in size. At FIG. 7, the stent or scaffold has been removed, and the urethra lumen has been restored to a healthy condition and normal diameter.

[0034] FIG. 8 illustrates various method to apply the anti-proliferative or steroidal layer or agent to or near the strictured region of the urethra. For example, anti-proliferative or steroidal layer or agent may be applied using an applicator or delivered intraluminally via puncture through the urethral wall.

[0035] A submucosal needle may be used to inject the layer or agent, which may include a hydrogel, anti-proliferative or steroidal component, and/or an aqueous solution and anti-proliferative or steroidal component.

[0036] A mucosal spray-on layer with anti-proliferative or steroidal component may alternatively or additional be used. An applicator may have an end-firing and/or sidefiring design to deliver the anti-proliferative or steroidal component.

[0037] A sheath insertion (e.g., a sheath containing an anti-proliferative or steroidal component) may alternatively or additional be used. The sheath may be compressed or crinkled and then decompress, expand and/or uncrinkle once deployed. An applicator (e.g., endoscope, etc.) could be used to deploy the sheath, for example, the applicator can leave the sheath in place once withdrawn from the urethra.

[0038] An internal patch may alternatively or additional be used. The patch may include a drug eluting device and/or implant with controlled anti-proliferative or steroidal component release. For example, the internal patch may include beads, nanoparticles, or similar structures.

[0039] The foregoing description and examples has been set forth to illustrate the disclosure according to various embodiments and are not intended as being unduly limiting. The headings provided herein are for organizational purposes only and should not be used to limit embodiments. Each of the disclosed aspects and examples of the present disclosure may be considered individually or in combination with other aspects, examples, and variations of the disclosure. In addition, unless otherwise specified, none of the steps of the methods of the present disclosure are confined to any particular order of performance. References cited herein are incorporated by reference in their entirety. [0040] While the methods and devices described herein may be susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the embodiments disclosed should cover modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described herein and the appended claims.

[0041] Depending on the embodiment, one or more acts, events, or functions of any of the algorithms, methods, or processes described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the algorithm). In some examples, acts or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially.

[0042] The use of sequential, or time-ordered language, such as “then,” “next,” “after,” “subsequently,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to facilitate the flow of the text and is not intended to limit the sequence of operations performed.

[0043] Conditional language used herein, such as, among others, “can,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that some examples include, while other examples do not include, certain features, elements, and/or states. Thus, such conditional language is not generally intended to imply that features, elements, blocks, and/or states are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment.

[0044] The methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any third-party instruction of those actions, either expressly or by implication.

[0045] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 1 hour” includes “1 hour.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially perpendicular” includes “perpendicular.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure. The phrase “at least one of’ is intended to require at least one item from the subsequent listing, not one type of each item from each item in the subsequent listing. For example, “at least one of A, B, and C” can include A, B, C, A and B, A and C, B and C, or A, B, and C.

Claims

WHAT IS CLAIMED IS:

1. A method of treating a urethral stricture, comprising: dilating a stricture in a urethra; applying an anti-proliferative or steroidal agent to a luminal wall of the urethra near the stricture; deploying a stent or scaffold within the urethra to maintain contact between the anti-proliferative or steroidal agent and the luminal wall of the urethra near the stricture; leaving the stent or scaffolding within the urethra, thereby allowing fluid to pass through a lumen of the stent or scaffolding; and removing the stent or scaffolding after a therapeutic time period.

2. A method of treating a urethral stricture, comprising: dilating a stricture in a urethra; deploying a stent or scaffold within the urethra to maintain contact a luminal wall of the urethra near the stricture, wherein the stent or scaffold comprises an antiproliferative or steroidal agent coating; leaving the stent or scaffolding within the urethra, thereby allowing fluid to pass through a lumen of the stent or scaffolding; and removing the stent or scaffolding after a therapeutic time period.

3. The method of Claim 1 or 2, wherein the anti-proliferative or steroidal agent comprises a film or gel.

4. The method of any proceeding claim, wherein deploying comprises inserting the stent or scaffold through a natural opening of the body without piercing, cutting or creating an opening in the skin.

5. The method of any proceeding claim, wherein the stent comprises nickel titanium, a shape memory metal, a metal, a plastic, or a dissolvable material.

6. The method of any proceeding claim, wherein removing comprises allowing the stent or scaffold to dissolve.

7. The method of any proceeding claim, further comprising refraining from inserting an indwelling catheter in the urethra.

8. The method of any proceeding claim, wherein removing comprises employing an endoscopic technique.

9. The method of Claim 1 , wherein applying comprises applying using a submucosal needle.

10. The method of Claim 1, wherein applying comprises using a mucosal spray with a mucosal spray actuator.

11. The method of Claim 10, wherein the mucosal spray actuator is side firing, end firing, or both.

12. The method of Claim 1, wherein applying comprises inserting a sheath.

13. The method of Claim 1, wherein applying comprises deploying an internal patch.

14. The method of Claim 13, wherein the internal patch comprises a control release agent, beads, and/or nanoparticles.

15. The method of any proceeding claim, wherein the anti-proliferative or steroidal agent comprises a hydrogel or an aqueous solution.