Device and method for improving retention of a therapy in the bladder

Abstract

Devices that are placed within fluid filled organs, such as the bladder, which reduce the risk of bacterial infections using a combination of active agents and mechanical disruption of bacteria.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a non-provisional of provisional application No. 62 / 909,237 filed Oct. 2, 2019, this application is also a non-provisional of provisional application No. 62 / 910,104 filed on Oct. 3, 2019, this application is also a non-provisional of provisional application No. 63 / 029,296 filed May 22, 2020, the entirety of each of which is incorporated by reference.FIELD OF THE INVENTION[0002]Devices that are placed within fluid filled organs, such as the bladder, which reduce the risk of bacterial infections using a combination of active agents and mechanical disruption of bacteria.BACKGROUND OF THE INVENTION[0003]Urinary tract infections (“UTI”) are infections in any part of the urinary system, such as the kidneys, ureter, bladder, and / or urethra. The UTI typically develops in the human bladder caused by the migration of bacteria into the bladder cavity through the urethra. UTI's are one of the most common types of infections that r...

AI Technical Summary

Benefits of technology

[0026]The present disclosure also relates to devices for intravesicular drug delivery as a method for minimization or stimulation of the sensory nerves of the bladder trigone in order to provide therapeutic remedy for overactive bladder, modification of the pro-inflammatory neural cascade, or other affliction of the bladder.

[0027]The present disclosure also includes variations related to a retention of a therapy within a bladder organ such that these devices could be designed to be indwelling, at least partially, within the bladder in order to maintain a controlled release therapeutic effect over a period of time while they are indwelling in whole or in part during use. This may include devices that are retained within the bladder that degrade or adjust in configuration over time such that portions of the devices are excreted in the urine over time. Other methods of the invention may be used to extend the duration of therapy for a device within a bladder organ such as the inclusion of coatings or surface configurations which would enable the device to be retained with minimal inflammation and or complications to the bladder.

[0028]The particle-implants described herein can also improve reducing or eliminating post void residual volume from the bladder since the particles can displace urine during the voiding or contraction process.

[0029]The particle-implants described herein do not require removal using specialized tools. Moreover, the increased retention of particles solely residing in the bladder allow for increased therapeutic dosage levels that would be discouraged if administered systemically.

[0030]The present disclosure also includes particle-implants consisting of a plurality of buoyant bodies with a therapeutic agent (e.g. anti-biotic). The therapeutic agent may be present as a coating, as part or whole of the structure of the buoyant body or be contained within a cavity of the buoyant body. The coating or structure of the buoyant body may differ in thickness, composition, or structure within a single body or across the plurality of bodies so as to create a uniform or non-uniform rate of release for the therapeutic agent or a uniform or non-uniform rate of degradation of the buoyant body. The coating may degrade or not degrade as is preferred for the performance of the release profile and concentration gradient within the retained and accumulating volume of urine within the bladder. Materials that could be used to construct the buoyant bodies may include but not be limited to any of the following such as, polycaprolactone, chitosan, polyethylene glycol, poly lactic acid, poly lactic-co-glycolic acid, n′n-isopropylacrylamide, acrylamido taurate, polyethylene, polypropylene, cross linked collagen or gelatin gels, polyacrylamide gels, or glass. Therapeutic agents may comprise one or more but not be limited to, antibiotics, silver, silver ions, colloidal silver, silver nitrate, silver sulfadiazine, ascorybyl palmitate, ascorbic acid, anesthetic agents, lidocaine, bupivacaine, benzocaine, chemotherapy agents, Cisplatin, gemcitabine, methotrexate, monoclonal antibodies, cell therapeutics such as modified or unmodified CAR-T, en

Problems solved by technology

Nearly, one in five adults develops a UTI and many of these individuals are at risk for a recurring infection.

The risks associated with UTI's can be significant for persons suffering from incontinence or for older persons, as well as with traumatic changes in the central nervous system, which are accompanied by urination disorders.

In many cases, chronic urinary tract infections can require continuous medication, which, leads to progressive levels of resistance to antibiotics and ultimately to kidney problems.

UTI's and complications caused by UTI's are cost-intensive due to continuous need for medication and extended hospitalization and they can be life-threatening.

In many cases, UTI's significantly reduce the quality of life, in particular when kidney damage leads to kidney failure requiring dialysis or implantation of a donor kidney.

However, current treatment to prevent the formation of UTI's requires continuous prophylactic oral intake of medication that can potentially strain the entire body, in particular with long-term medication.

However, the increase of multi-drug resistant bacteria makes it harder to treat UTI's with a standard anti-biotic regimen as the UTI can recur since all of the bacteria causing the UTI are not eliminated.

The problems arising from bladder infections is that the infection can ascend to the k

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