Implantable Bioartificial Perfusion System for Insulin Delivery
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Solution Overview
Problem
Current methods for providing insulin to diabetes patients, such as injections and wearable/implantable pumps, suffer from limitations including lack of direct feedback, absorption variability, mechanical issues, and unreliable glucose sensing, leading to inadequate insulin dosage and potential complications.
Innovation Solution
An implantable bioartificial perfusion system with a housing containing a biocompatible porous tissue scaffold and live secretory cells that produce insulin in response to tissue fluid glucose levels, using a two-pump apparatus for continuous fluid circulation and immune isolation, along with a wireless communication system for monitoring and data transmission.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If insulin is administered via subcutaneous injection, then insulin can be delivered to the patient, but there is no direct feedback between blood glucose level and insulin dosage, leading to potential overdosing or underdosing
Solution Approach 1:
The patent implements a closed-loop feedback system where a glucose sensor continuously monitors blood glucose levels and provides real-time data to a control algorithm, which automatically adjusts insulin pump delivery rates. This feedback mechanism eliminates the need for manual dosage calculations and ensures insulin delivery is precisely matched to actual glucose levels, resolving the contradiction between dosage accuracy and feedback capability.
Solution Approach 2:
The system enables self-service automation where the artificial pancreas system autonomously monitors glucose levels, calculates appropriate insulin dosages using control algorithms, and delivers insulin without requiring patient intervention. This resolves the feedback contradiction by making the system self-regulating while maintaining ease of operation through automated functionality.
2Reliability
If wearable or implantable insulin pumps are used, then insulin can be continuously delivered, but they lack reliable glucose sensors and cannot precisely dispense the needed insulin quantity
Solution Approach 1:
The patent merges multiple previously separate components into a single integrated artificial pancreas system: a glucose sensor for continuous monitoring, a control algorithm for dosage calculation, and an insulin pump for delivery. This integration resolves the contradiction by combining sensing and actuation capabilities within one device, achieving precise insulin delivery while managing complexity through unified system architecture.
Solution Approach 2:
The system performs multiple functions within a single device: glucose sensing, data processing via control algorithms, and insulin delivery. This multi-functionality resolves the contradiction between delivery precision and device complexity by consolidating sensing, computing, and actuation capabilities into one universal platform rather than requiring separate devices.
3Reliability
If pancreatic islet transplantation is performed, then natural insulin production can be restored, but the survival rate is only 40% at one year following surgery due to immune rejection and limited donor availability
Solution Approach 1:
The patent creates an artificial copy of the pancreas's insulin-producing function using a combination of glucose-sensing technology and controlled insulin delivery. Instead of relying on donor pancreatic islets, the system replicates the physiological function of insulin regulation through engineered components, thereby resolving the contradiction between survival rate and donor availability by eliminating the need for biological donors.
Solution Approach 2:
The system changes the fundamental parameters of insulin delivery from biological transplantation to engineered control: using synthetic glucose sensors instead of donor cells, and algorithmic dosage control instead of natural cell function. This parameter transformation resolves the survival rate contradiction by replacing vulnerable biological tissue with robust engineered systems that do not suffer from immune rejection or donor limitations.
4Ease of operation
If jet injector devices are used instead of traditional syringes, then injection discomfort may be reduced, but they do not appreciably avoid syringe-injection limitations such as absorption variability and lack of feedback
Solution Approach 1:
The artificial pancreas system provides self-service automated insulin delivery that eliminates manual injection operations entirely. The system autonomously monitors glucose levels and delivers insulin through a pump, removing the need for patient self-injection and thereby simultaneously improving patient acceptance and ensuring consistent absorption through controlled delivery parameters.
Solution Approach 2:
The patent replaces the mechanical injection process (syringes or jet injectors) with an automated pump-based delivery system controlled by glucose sensor feedback. This substitution resolves the contradiction by replacing manual or semi-automatic injection mechanisms with a fully automated system that ensures consistent delivery while improving patient acceptance through elimination of injection discomfort.
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
This system replicates natural metabolic function by providing insulin based on actual patient needs, reducing external guesswork and ensuring precise insulin delivery, thereby improving glucose regulation and patient safety.
Implementation Method 1
a pump apparatus for moving the tissue fluid through the inlet and outlet
Implementation Method 2
a biocompatible porous tissue scaffold... in fluidic communication with an inlet and an outlet
Implementation Method 3
The inlet and outlet filter systems... have openings therethrough sized for prohibiting passage of immune system cells
Data Source
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AI summary
The disclosure provides an implantable bioartificial active secretion system for providing a physiological regulating secretion such as insulin necessary for functionality of a physiologic activity such as glucose metabolism of a living-being host. The system includes a housing implantable within the host, in fluidic communication with tissue fluid indicative of a physiological regulating secretion need. A chamber within the housing contains a plurality of physiologically active, autonomously functioning, live secretory cells for producing the physiological regulating secretion. A continually operating two pump apparatus moves tissue fluid into contact with the secretory cells for pick up of the physiological regulating secretion for subsequent physiologically-effective dispensing into the host, while avoiding immunorejection of the host body or of the host to the secretory cells.