Bladder Botulinum Toxin Delivery Through Urothelium
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Solution Overview
Problem
Current treatments for overactive bladder using botulinum toxin injections are invasive, painful, and costly, with significant side effects, and there is a need for a more effective and less invasive delivery method.
Innovation Solution
Transmucosal delivery of botulinum toxin through the urothelium of the bladder using a positively charged or lipophilic carrier, such as a polymeric backbone with covalently attached efficiency groups, allowing non-covalent association with the toxin for topical administration without injection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If botulinum toxin is administered via injection to treat bladder disorders, then the treatment effectiveness is achieved, but the procedure becomes invasive, painful, and costly with significant side effects
Solution Approach 1:
The patent uses a carrier system comprising a positively charged polymeric backbone with covalently attached efficiency groups as an intermediary to deliver botulinum toxin transmucosally. This carrier enables the toxin to penetrate the urothelium and reach the detrusor muscle without direct injection, thereby maintaining treatment effectiveness while eliminating the harmful effects of invasive procedures
Solution Approach 2:
The patent changes the delivery parameter from parenteral injection to transmucosal delivery. By modifying the administration route and using a specialized carrier formulation, the toxin can effectively cross the mucosal barrier and reach the target tissue, resolving the contradiction between effectiveness and invasiveness
2Reliability
If botulinum toxin is administered via injection, then muscle paralysis is achieved, but the procedure requires 20-30 injections and typically requires sedation
Solution Approach 1:
The patent segments the delivery mechanism into two functional components: a positively charged polymeric backbone for structural support and charge, and covalently attached efficiency groups for enhancing transmucosal transport. This segmentation allows the single complex carrier to perform multiple functions, replacing the need for multiple separate injections
Solution Approach 2:
The carrier system performs multiple functions simultaneously: it protects the botulinum toxin from degradation, enhances transmucosal transport across the urothelium, and delivers the toxin to the target tissue. This multi-functionality consolidates what would otherwise require multiple separate injection procedures into a single administration
3Reliability
If botulinum toxin is administered via injection, then treatment is achieved, but the treatment is expensive and painful
Solution Approach 1:
The carrier acts as an intermediary that enables non-invasive transmucosal delivery, eliminating the need for painful injection procedures while maintaining treatment effectiveness. This intermediary approach significantly improves patient comfort and accessibility
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Provides a less invasive and more effective treatment for bladder disorders by ensuring even distribution and complete coverage of the bladder wall, reducing pain and side effects associated with injections.
Implementation Method 1
a positively charged carrier comprising a positively charged polymeric backbone with covalently attached groups that enhance transmucosal transport across the urothelium
Implementation Method 2
a lipophilic carrier comprising a hydrophobic oligomeric or polymeric backbone with covalently attached groups that enhance transmucosal transport across the urothelium
Data Source
AI summary
The present invention provides methods, compositions, and kits for treating bladder disorders or conditions, in which botulinum toxin is topically administered to the mucosal inner lining or urothelium of the bladder, of a subject in need thereof, for transmucosal delivery across the urothelium to surrounding bladder wall musculature and/or neuronal tissue. Rather than requiring injection, the toxin instead may be administered by instillation in solution via the urethra. In particular, the botulinum toxin is administered in conjunction with a positively charged or lipophilic carrier comprising a positively charged polymeric backbone or a hydrophobic backbone with covalently attached groups that enhance transmucosal transport across the urothelium and may also stabilize the botulinum toxin in aqueous formulations.