Bioabsorbable Polymer Sleeve for Controlled Testosterone Release
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Solution Overview
Problem
Current hormonal therapy methods for treating low testosterone, such as testosterone pellet implants, have a short duration of action (up to 3 months) and are prone to pellet migration, leading to patient discomfort and non-compliance with regular implantation visits.
Innovation Solution
A bioabsorbable polymer sleeve delivery system that encapsulates pharmaceutical pellets, allowing for controlled timed release of hormones like testosterone over extended periods (up to 12 months) while preventing pellet migration and facilitating easier removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If loose testosterone pellets are implanted without a containment structure, then the implantation process is simple, but the pellets migrate or are extruded from the injection site
Solution Approach 1:
The patent applies nesting by placing testosterone pellets inside a biodegradable polymer sleeve or capsule. The sleeve contains multiple pellets in a nested configuration, preventing their migration while allowing simple insertion through a single incision. The pellets are nested within the sleeve structure, which degrades over time to release them controllably.
Solution Approach 2:
The patent uses a flexible biodegradable polymer sleeve or thin film capsule to contain the pellets. This flexible containment structure can be easily inserted through a small incision and then holds the pellets securely at the injection site. The polymer material is sufficiently flexible for insertion but provides adequate containment to prevent pellet extrusion or migration.
2Speed
If the polymer sleeve degrades quickly to release pellets, then the pharmaceutical is released faster, but the duration of action is shortened to require frequent re-implantation
Solution Approach 1:
The patent applies parameter changes by using polymers with different degradation rates or by varying the thickness of the polymer sleeve. This allows control over the release kinetics of the pharmaceutical - thicker or more resistant polymers provide slower release for extended duration, while thinner or more labile polymers provide faster release. The parameters of the polymer material can be selected to match desired therapeutic profiles.
Solution Approach 2:
The patent segments the polymer structure into multiple layers or zones with different degradation characteristics. This allows different portions of the sleeve to degrade at different rates, creating a controlled progression of pellet release over time. The segmented structure enables both initial release and sustained release phases within a single implant.
3Quantity of substance
If multiple implantation visits are scheduled quarterly, then the pharmaceutical can be replenished, but patient compliance decreases due to trauma and discomfort at the injection site
Solution Approach 1:
The patent applies preliminary action by loading a sufficient quantity of pharmaceutical pellets into the polymer sleeve during manufacturing, allowing the device to provide therapeutic effect for extended periods (6-12 months or longer). This preliminary preparation eliminates the need for frequent patient visits, as the pre-loaded device sustains therapy throughout its duration.
Solution Approach 2:
The patent achieves continuity of useful action through the sustained release mechanism of the biodegradable polymer sleeve. The continuous degradation of the polymer provides a steady, continuous release of pharmaceutical over months rather than discrete dosing events. This continuous action maintains therapeutic levels without requiring repeated interruptions for re-implantation.
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 system enables longer-lasting hormone therapy with reduced patient trauma and increased compliance, allowing for sustained stamina, aggression, and wound recovery benefits over a year without the need for frequent implantation visits.
Implementation Method 1
a bioabsorbable polymer sleeve delivery system that encapsulates pharmaceutical pellets, allowing for controlled timed release of hormones
Implementation Method 2
bioabsorbable material
Implementation Method 3
A bioabsorbable polymer sleeve delivery system that encapsulates pharmaceutical pellets, allowing for controlled timed release of hormones like testosterone over extended periods (up to 12 months) while preventing pellet migration
Data Source
AI summary
The invention is a delivery system device and method for implantation of pharmaceuticals, such as hormones, including testosterone for military forces to increase stamina and aid in wound recovery, for timed release into a patient to be determined by a medical professional. This timed-release device will consist of an axially containing and longitudinally flexible elongated member having an axial wall of varying material, that wall consisting of a polymer dissolving according to a pre-determined schedule regulated by the dissolution rate of the polymer or polymer blend. The delivery system and method further prevents the extrusion or migration of the pellets from the site of implantation and allows for easier removal after the time of implant.