Nonsurgical Implant Tissue Modifier Delivery System
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Solution Overview
Problem
Existing implant technologies, such as sensors, face challenges in long-term functionality due to inflammatory and immune responses, leading to protein fouling and the formation of avascular capsules that reduce sensor sensitivity and require frequent recalibration or replacement.
Innovation Solution
A method involving a nonsurgical delivery system that positions a tissue response modifier outside the body to direct a localized biological response, using agents like collagen inhibitors and anti-inflammatory drugs to minimize tissue response and prolong implant lifespan.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sensor is implanted into the body to provide continuous monitoring, then continuous measurement of biochemical analytes is achieved, but inflammatory and immune responses are initiated leading to protein fouling and capsule formation
Solution Approach 1:
A tissue response modifier is introduced as an intermediary substance between the implant and the body's immune system. This modifier acts as a mediator that modifies the biological response, preventing direct harmful interactions while allowing the implant to function. The modifier is delivered via a delivery system positioned adjacent to the implant, releasing the tissue response modifier to control the local biological environment.
Solution Approach 2:
The tissue response modifier is delivered to the implant site before the harmful inflammatory response can fully develop. By positioning the delivery system adjacent to the implant and releasing the modifier proactively, the system prevents protein fouling and capsule formation before they can occur, rather than reacting after damage has occurred.
2Object-affected harmful factors
If therapeutic agents are implanted with the sensor to control foreign body response, then the foreign body response is reduced, but the device cannot remain fully functional for long-term use due to limited drug delivery capacity
Solution Approach 1:
The system separates the implant from the drug delivery function by positioning the delivery system externally adjacent to the implant. This segmentation allows the implant to remain purely functional while the delivery system handles the therapeutic agent supply. The delivery system can be replaced or replenished independently, extending the overall functional duration beyond the limitations of implanting large drug quantities directly with the sensor.
Solution Approach 2:
The delivery system acts as an intermediary that provides continuous or extended-term therapeutic agent delivery without requiring the implant itself to contain the drugs. This intermediary approach allows for long-term functionality by decoupling the implant's sensing function from the drug delivery function, enabling the therapeutic agents to be supplied through the external delivery system for extended periods.
3Reliability
If sensors are placed intravascularly to avoid capsule formation, then continuous contact with blood is achieved, but the recipient is at risk for thrombophlebosis, thromboembolism, and thrombophlebitis
Solution Approach 1:
The delivery system positioned adjacent to the implant serves as an intermediary that provides the necessary therapeutic intervention without requiring direct intravascular placement of the sensor. By delivering tissue response modifiers through this external intermediary system, the patent achieves continuous analyte contact while avoiding the thrombotic risks associated with direct vascular insertion.
Data Source
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AI summary
The invention provides methods for directing a localized biological response of a mammalian body to an implant disposed within the body. In one embodiment, a delivery system is positioned outside the body and adjacent to the implant within the body. The delivery system comprises a first tissue response modifier effective for directing a localized biological response of the body to the implant. The tissue response modifier is nonsurgically delivered from the delivery system into the body in a quantity effective to direct the localized biological response of the body to the implant. The invention also provides an implant system for long-term use comprising an implant and nonsurgical means for delivering a tissue response modifier through the epidermis of the body, the tissue response modifier effective for directing a localized biological response of the body to the implant.