Biodegradable Bladder Implant for Self-Eliminating Drug Delivery
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Solution Overview
Problem
Existing drug delivery devices for implantation in body cavities, such as the bladder, require invasive procedures for retrieval after drug payload depletion, and pose risks due to infection and inadvertent dislodgement, especially for longer deployment periods.
Innovation Solution
An implantable medical device with a deformable structure that transitions from a retention shape to a low profile shape for deployment, utilizing biodegradable components that degrade in response to physiological fluids, allowing for spontaneous excretion from the body without the need for invasive retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a drug delivery device is implanted in the bladder for long-term deployment, then the drug payload can be delivered over an extended period, but the device requires invasive retrieval procedures which pose infection risks and risk of inadvertent dislodgement
Solution Approach 1:
The device employs a biodegradable structure that is designed to degrade and be excreted naturally after delivering its drug payload. The biodegradable polymer material breaks down over time through hydrolysis and enzymatic degradation, allowing the device to be disposed of naturally without requiring invasive retrieval procedures, thereby eliminating infection risks associated with long-term implantation and retrieval operations
Solution Approach 2:
The device utilizes changes in physiological parameters (pH levels, enzyme presence, hydrolysis conditions) within the bladder environment to trigger controlled degradation of the biodegradable polymer structure. This parameter-based degradation mechanism allows the device to maintain structural integrity during the deployment period and then automatically degrade when the drug delivery is complete, enabling natural excretion without invasive procedures
2Ease of operation
If a retrieval string is attached to the deployed device to enable removal, then the device can be retrieved, but the device is at risk of inadvertent dislodgement during deployment
Solution Approach 1:
The device is designed as a disposable, biodegradable implant that naturally degrades and is excreted after drug delivery. This eliminates the need for retrieval strings and associated retrieval procedures, while the biodegradable structure provides reliable retention during the deployment period through its mechanical properties and anchoring mechanisms, preventing inadvertent dislodgement
Solution Approach 2:
The device performs self-service by automatically degrading and being excreted through natural bodily functions after completing its drug delivery mission. This self-eliminating mechanism removes the need for external retrieval operations and associated hardware like retrieval strings, while providing reliable retention during the operational phase through its structural design
3Ease of repair
If an additional medical procedure is required to retrieve the drug-depleted device, then the device can be removed, but the complexity and invasiveness of the procedure increases
Solution Approach 1:
The device is designed as a biodegradable, disposable implant that naturally degrades and is excreted through the body's natural elimination processes. This eliminates the need for additional medical procedures for device removal, significantly reducing procedural complexity and invasiveness while maintaining ease of device elimination through natural bodily functions
Solution Approach 2:
The device performs self-service by automatically degrading through hydrolysis and enzymatic processes and being excreted naturally after drug delivery completion. This self-eliminating capability removes the need for complex retrieval procedures, making device removal as simple as natural bodily excretion processes
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
Enables controlled drug delivery with self-elimination of the device after the drug payload is released, avoiding invasive retrieval procedures and minimizing infection risks, while ensuring timely and safe excretion of the device from the body.
Implementation Method 1
the device structure includes at least one portion that is degradable upon contact with a physiological fluid adjacent to the device structure when deployed in vivo
Data Source
AI summary
Implantable medical devices and treatment methods are provided, particularly for use in the bladder. The device is configured for retention in the bladder for at least a portion of the drug delivery period and includes at least one biodegradable component such that following a biodegradation at a selected time, the retention function is lost and the device or portions thereof are resorbed and/or excreted. The method may include deploying into the bladder of a patient a device having a device structure housing a drug formulation comprising at a drug; releasing drug from the device structure into the bladder; and then, changing the composition of urine in the bladder, e.g., by altering the pH, to trigger degradation of at least part of the device structure to enable the device structure or parts thereof to be excreted from the bladder.