Piezoelectric Pump for Spinal BMP-2 Delivery
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Solution Overview
Problem
Current methods for spinal fusion, particularly using recombinant human bone morphogenetic protein-2 (rhBMP-2), face inefficiencies in delivery, high costs, inconsistent fusion results, and potential complications such as swelling and spinal stenosis due to passive absorption and lack of precise delivery mechanisms.
Innovation Solution
A remotely activated piezoelectric pump system for controlled delivery of biological agents like BMP-2 to the spine and disc space, utilizing a micro piezoelectric actuator, inductive power source, and mechanosensors for precise infusion and monitoring, allowing for sustained release over months and adjustable dosing, with a refillable reservoir for external refilling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If passive absorption of BMP-2 is used for delivery, then the delivery process is simple, but the delivery precision and consistency are poor leading to inconsistent fusion results
Solution Approach 1:
The patent replaces passive mechanical absorption with an active piezoelectric pump system that uses electrical signals to control fluid delivery. The piezoelectric actuator converts electrical energy into precise mechanical pumping action, enabling controlled infusion of BMP-2 solution into the disc space at predetermined rates and durations, thereby achieving consistent and precise delivery.
Solution Approach 2:
The patent changes the delivery parameters from passive diffusion-based absorption to active pump-controlled infusion. The system allows programmable control of infusion rate, duration, and total volume, transforming the delivery process from uncontrolled passive absorption to precisely controlled active infusion with adjustable parameters.
2Reliability
If high doses of BMP-2 are used to ensure fusion, then fusion reliability improves, but complications such as swelling and spinal stenosis increase
Solution Approach 1:
The patent applies partial action by delivering precisely the amount of BMP-2 needed for fusion rather than excessive high doses. The pump system enables controlled delivery of lower doses over extended periods, providing sufficient biological effect while avoiding the harmful effects of excessive BMP-2 concentration such as swelling and spinal stenosis.
Solution Approach 2:
The patent uses periodic action by delivering BMP-2 in controlled pulses or continuous low-rate infusion over extended periods rather than as a single large dose. This sustained release approach maintains therapeutic levels while avoiding peak concentrations that cause complications, thereby improving the reliability-to-complication ratio.
3Ease of manufacture
If BMP-2 is delivered via absorbable collagen sponge, then the delivery method is simple, but the residence time is limited to 3-4 weeks
Solution Approach 1:
The patent achieves continuity of useful action by using a pump system that can deliver BMP-2 continuously or intermittently over extended periods. The system maintains a sustained presence of BMP-2 in the disc space for months rather than weeks, ensuring continuous biological activity throughout the fusion process without the limited residence time of collagen sponge-based delivery.
Solution Approach 2:
The patent introduces a pump system as an intermediary device between the BMP-2 source and the disc space. This intermediary enables controlled, sustained delivery of BMP-2 solution, extending the effective residence time from the 3-4 weeks limited by collagen sponge absorption to several months, while maintaining simple procedural implementation.
4Reliability
If large amounts of BMP-2 are implanted to ensure fusion, then fusion success rate improves, but cost increases significantly
Solution Approach 1:
The patent applies self-service by using a programmable pump system that automatically delivers the precise amount of BMP-2 needed for fusion. The system eliminates the need for excessive BMP-2 implantation by providing controlled, targeted delivery that ensures sufficient biological effect with minimal substance, thereby reducing cost while maintaining high fusion success rates.
Solution Approach 2:
The patent replaces the mechanical approach of implanting large amounts of BMP-2 in carriers with an electrical control system that uses a piezoelectric pump to deliver precise volumes of BMP-2 solution. This substitution enables accurate dosing that reduces the total quantity of BMP-2 required while ensuring reliable fusion outcomes.
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 consistent and controlled delivery of BMP-2, reducing the need for high doses, minimizing complications, and providing physiological monitoring for optimal fusion progress, thus improving the efficacy and safety of spinal fusion procedures.
Implementation Method 1
The pump comprises a piezoelectric actuator
Implementation Method 2
The pump is powered and controlled wirelessly by an external belt unit via a plurality of pump inductive coils
Data Source
AI summary
A remotely activated piezoelectric pump for delivery of biological agents to the intervertebral disc and spine in order to achieve spinal fusion. A spinal pump is implanted on the vertebrae of a patient and a spinal cage is inserted in between two adjacent vertebrae after removal of the vertebrae disc. A piezoelectric motor drives the pump and pushes osteogenetic agent through the spinal cage and into a sponge disposed within the cage. The pump is charged by an external removable induction belt worn by the patient. Delivery duration and delivery frequency may be changed before implantation of the spine pump according to the specific needs of the patient. The current device employs a mathematical model that enables the regulation as well as attenuation of the bone fusion process by extending and generalizing the model to enhance and optimize the delivery of osteogenetic agent in a regulated manner.