Intravesical Drug Delivery Retention Shape for Bladder Tolerability
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Solution Overview
Problem
Existing intravesical drug delivery devices are large, causing discomfort and pain, and require frequent surgical or interventional procedures for extended drug delivery, which is undesirable for conditions where tolerability is a primary concern.
Innovation Solution
A small, elastic drug delivery device with a retention shape that prevents voiding through the urethra and is buoyant, allowing for controlled drug release over an extended period without noticeable discomfort, suitable for deployment through the urethra and retention within the bladder.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a large volume device is used to contain sufficient drug solution and valve mechanism, then the device can provide extended drug delivery, but the device size increases causing patient discomfort and pain
Solution Approach 1:
The device is divided into separate components: a small implantable reservoir for drug storage and a separate infusion mechanism that can be externally controlled. This segmentation allows the drug delivery function to be extended over time without requiring a large single integrated device, thereby reducing patient discomfort while maintaining prolonged drug delivery capability.
Solution Approach 2:
The device employs periodic or intermittent drug delivery through controlled infusion cycles rather than continuous delivery. This allows the same small device volume to provide extended drug delivery by releasing drug in periodic bursts, reducing the required device size while maintaining therapeutic duration.
2Reliability
If frequent instillations are performed to achieve sustained relief, then effective drug delivery is maintained, but patient inconvenience and discomfort increase
Solution Approach 1:
The implantable device provides self-service drug delivery functionality, automatically maintaining therapeutic drug levels in the bladder without requiring repeated patient visits for manual instillation. The device contains sufficient drug supply to maintain effectiveness over extended periods, eliminating the need for frequent patient intervention while ensuring reliable drug delivery.
Solution Approach 2:
The device provides continuous or near-continuous drug delivery to the bladder through the implantable reservoir and controlled infusion system, maintaining therapeutic effectiveness without the interruptions and repeated procedures required by traditional intermittent instillation methods.
3Reliability
If catheterization is used to deliver drugs to the bladder, then drug delivery is achieved, but the risk of infection and patient discomfort increase
Solution Approach 1:
The device extracts the need for repeated catheterization by implanting a permanent reservoir directly in the bladder. The drug delivery system is integrated into the bladder wall, eliminating the requirement for external catheters and the associated infection risks while maintaining effective drug delivery capability.
Solution Approach 2:
The implantable reservoir acts as an intermediary between the external environment and the bladder interior, providing a sterile, controlled interface for drug delivery that eliminates the need for repeated catheter penetration and reduces infection risk associated with frequent catheterization procedures.
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
The device provides effective, prolonged drug delivery to the bladder with minimal patient discomfort and reduced need for invasive procedures, improving treatment efficacy and patient quality of life.
Implementation Method 1
an elastic body having a retention shape... The device is deformable between a deployment shape for passage of the device through the urethra and a retention shape for preventing voiding of the device through the urethra
Implementation Method 2
dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters
Data Source
AI summary
Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1 N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.