Intravesical Trospium Delivery for Bladder Dysfunction
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Solution Overview
Problem
Current treatments for lower urinary tract disorders such as overactive bladder and urinary incontinence often suffer from inadequate efficacy, significant side effects, and invasive procedures, with systemic drug therapies and surgical interventions being costly and invasive, and lacking targeted solutions for urothelial sensory system dysfunction.
Innovation Solution
Local administration of trospium into the bladder using an intravesical drug delivery device or mucoadhesive formulation to achieve sustained therapeutic concentrations, reducing systemic exposure and adverse effects while effectively modulating urothelial sensory activation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If systemic drug therapy is administered orally or trans-dermally, then treatment coverage is provided, but efficacy is inadequate due to dose limiting side effects or low potency
Solution Approach 1:
The patent applies local quality by transitioning from systemic administration to intravesical administration, concentrating the antimuscarinic agent directly in the bladder. This localized delivery achieves high efficacy at the target site while minimizing systemic exposure and associated side effects. The device ensures the drug is delivered precisely where needed - in the bladder - rather than throughout the entire body.
2Reliability
If Botox injections are administered directly into the bladder wall, then symptom relief is provided, but prolonged urinary retention requiring self-catheterization occurs
Solution Approach 1:
The patent applies parameter changes by using a different mechanism of action - intravesical antimuscarinic therapy rather than Botox injections. This changes the pharmacological parameters (using trospium chloride instead of botulinum toxin) and the delivery parameters (intravesical fluid administration vs. muscle injection), resulting in symptom relief without the harmful effect of prolonged urinary retention.
3Reliability
If neurosacral stimulation is surgically implanted, then symptomatic relief is provided, but the procedure is expensive, highly invasive, and carries a 30% adverse event rate
Solution Approach 1:
The patent applies the taking out principle by extracting the essential therapeutic function (symptomatic relief) from the complex surgical implant system. Instead of requiring neurosacral stimulation with surgical implantation, the invention uses a simple intravesical device that can be inserted through the urethra, eliminating the need for complex surgery while maintaining therapeutic effectiveness.
Solution Approach 2:
The patent employs disposable intravesical devices that can be easily inserted and removed without surgery. These single-use or limited-use devices replace expensive, permanent surgical implants, reducing both the cost and invasiveness of the procedure while providing the same symptomatic relief.
4Reliability
If intravesical administration of anti-muscarinic agents is used, then different pharmacological response is produced, but the delivery system must achieve sustained therapeutic concentrations
Solution Approach 1:
The patent applies continuity of useful action by designing a delivery system that maintains therapeutic concentrations of trospium chloride in the bladder over an extended period. The device ensures continuous or near-continuous drug release, preventing the waning of therapeutic effect that occurs with single-dose intravesical administration.
Solution Approach 2:
The patent applies preliminary action by pre-loading the delivery device with a sustained-release formulation of trospium chloride. This preliminary preparation of the drug delivery system ensures that therapeutic concentrations are maintained from the outset, eliminating the need for repeated dosing and ensuring continuous therapeutic effect.
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
Trospium demonstrates a unique urodynamic profile, increasing intercontraction intervals and normalizing urothelial sensory function without causing urinary retention, providing effective symptom relief for lower urinary tract disorders with reduced systemic exposure and side effects.
Implementation Method 1
The device may be used to release trospium chloride or another pharmaceutically acceptable salt of trospium into the bladder in amount therapeutically effective for the treatment of bladder dysfunction
Implementation Method 2
Trospium is a muscarinic receptor antagonist. It is known for use in the treatment of overactive bladder, where it is formulated for oral administration
Implementation Method 3
mucoadhesive formulation to achieve sustained therapeutic concentrations
Data Source
AI summary
Methods, devices, and medicaments that include trospium are provided for use in the treatment of bladder dysfunction by locally administering the trospium into the bladder to achieve a sustained concentration of trospium in urine in the bladder sufficient to produce a therapeutic concentration of trospium in bladder tissue. The drug may be delivered into the bladder from an intravesical drug delivery device inserted into the bladder, wherein the device continuously releases the drug into the urine in the bladder over an extended period of hours or days.