Subcutaneous Therapeutic Delivery Device with Rate-Controlled Membrane
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Solution Overview
Problem
Current antimicrobial therapies are ineffective in treating biofilm-related infections, particularly those associated with implanted devices, as they fail to maintain sufficient antibiotic concentrations at the infection site, leading to recurrent infections and prolonged recovery times.
Innovation Solution
A subcutaneously deployable therapeutic delivery device with a reservoir and rate-controlling membrane that allows for controlled release of antimicrobial agents, enabling high doses to be maintained locally at the infection site, and can be refilled without removing the device, thereby reducing trauma and improving treatment efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If systemic antibiotic therapy is administered to treat biofilm-related infections, then the therapeutic agents are distributed throughout the body, but the concentration at the infection site is insufficient to eradicate biofilms
Solution Approach 1:
The invention divides the therapeutic delivery system into segments: a reservoir containing antibiotic beads, a rate-controlling membrane, and a catheter system. This segmentation allows concentrated antibiotic delivery directly to the infection site while controlling the release rate, achieving sufficient local concentration that systemic therapy cannot provide.
Solution Approach 2:
The rate-controlling membrane acts as an intermediary between the antibiotic reservoir and the infection site. It controls the release rate of antibiotics, maintaining sustained therapeutic concentrations at the infection site while preventing excessive systemic absorption, thereby resolving the contradiction between achieving high local concentration and avoiding systemic toxicity.
2Duration of action of moving object
If the device is removed and reinserted multiple times for refilling, then the therapeutic agent can be replenished, but additional trauma is caused to the patient
Solution Approach 1:
The device enables self-service refilling through the external port and catheter system. The provider can refill the reservoir through the existing percutaneous port without removing the device, allowing multiple refills over time. This eliminates the need for repeated surgical insertions and reductions, thereby extending the duration of action while minimizing patient trauma.
3Quantity of substance
If high concentrations of therapeutic agents are administered systemically, then sufficient levels may be achieved, but severe side effects occur in non-target tissues
Solution Approach 1:
The invention implements local quality by delivering high concentrations of therapeutic agents directly to the infection site through the reservoir and rate-controlling membrane. This localized delivery achieves the necessary therapeutic concentration at the target site while avoiding high systemic concentrations that would cause side effects in non-target tissues such as the liver and kidneys.
4Ease of operation
If current antibiotic therapies are used for biofilm infections, then treatment can be administered, but the therapies are not optimized against biofilms and fail to reach sufficient blood levels
Solution Approach 1:
The device performs preliminary action by pre-loading the reservoir with antibiotic beads and establishing the rate-controlling membrane before insertion. This preliminary preparation ensures that the device is optimized for biofilm eradication from the outset, with the correct antibiotic concentration and release rate already in place, rather than requiring complex ongoing adjustments during treatment.
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 effectively eradicates both biofilm and planktonic bacteria, as demonstrated by preliminary in vitro and in vivo tests, significantly reducing biofilm burden and preventing implant-related infections, with results showing up to 10,000 times greater reduction compared to clinical standards of care.
Implementation Method 1
A rate-controlling membrane is disposed in the reservoir that allows the one or more therapeutic agents to be delivered to the mammal at a controlled rate
Data Source
AI summary
A device for delivering one or more therapeutic agents to a mammal is provided. In at least one embodiment, the device includes (1) a port for receiving one or more therapeutic agents that is to be delivered to a mammal subcutaneously, the port having a stem; (2) a reservoir that is comprised of at least a compliant elastic material and a rate-controlling membrane that allows the one or more therapeutic agents to be delivered to the mammal at a controlled rate and the rate-controlling membrane and the compliant elastic material being attached to each other and the reservoir being capable of being inflated to contain one or more therapeutic agents and deflated, the reservoir being in fluid communication with the stem of the device.