Implantable Stimulation Device with Shape Memory Anchoring
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Solution Overview
Problem
Current treatments for gastro-esophageal reflux disease (GERD) and obesity lack effective, minimally invasive solutions that can provide long-term relief without adverse effects on quality of life, and existing devices face issues with pocket infections, lead dislodgment, and cumbersome deployment methods.
Innovation Solution
An implantable device with a stimulator, sensor module, anchoring unit, power source, and microcontroller that can be deployed minimally invasively to stimulate smooth muscles or nerves, using shape memory alloys for anchoring and electrode configuration to adapt to the implant site, allowing for adjustable stimulation patterns based on physiological parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical or laparoscopic fundoplication is used to correct GERD, then the lower esophageal sphincter function is improved, but significant morbidity and mortality risks increase
Solution Approach 1:
The patent replaces mechanical surgical intervention (fundoplication) with electrical stimulation therapy. The implantable device delivers electrical pulses to the lower esophageal sphincter and gastric muscles to enhance their function, thereby treating GERD without the need for invasive surgical procedures. This substitution eliminates surgical morbidity and mortality risks while maintaining therapeutic effectiveness.
Solution Approach 2:
The patent introduces an implantable electrical stimulation device as an intermediary between the diagnostic assessment and the therapeutic outcome. Rather than directly performing surgical correction, the device serves as a mediator that modulates muscle function through controlled electrical stimulation, providing a safer alternative to direct surgical intervention.
2Reliability
If endoscopic procedures with radio-frequency or suturing are used, then GERD treatment is achieved, but procedure time and technical complexity increase
Solution Approach 1:
The patent replaces complex mechanical endoscopic procedures (suturing, radio-frequency application) with electrical stimulation therapy. The implantable device delivers precisely controlled electrical pulses to the target muscles, achieving therapeutic effects without the time-consuming and technically demanding endoscopic interventions.
Solution Approach 2:
The patent changes the therapeutic parameter from mechanical intervention (suturing tension, radio-frequency energy) to electrical stimulation parameters (pulse amplitude, frequency, duration). This parameter change simplifies the procedure while maintaining treatment effectiveness, as electrical stimulation can be easily adjusted and delivered through minimally invasive means.
3Reliability
If daily pharmacological therapy with PPIs or H2RAs is used, then acid suppression is achieved, but long-term medication dependency and side effects increase
Solution Approach 1:
The patent replaces pharmacological chemical suppression of acid with electrical stimulation of the lower esophageal sphincter and gastric muscles. By enhancing the natural muscle function to prevent reflux and regulate gastric emptying, the treatment addresses the root cause rather than suppressing symptoms with long-term medication.
Solution Approach 2:
The patent enables the body's own muscular system to perform its protective function against reflux. The electrical stimulation device acts as a booster that enhances the natural peristaltic and sphincter functions, allowing the gastrointestinal system to self-regulate and prevent acid reflux without requiring external pharmacological agents.
4Duration of action of stationary object
If implantable devices are used for electrical stimulation, then long-term relief is achieved, but pocket infections and lead dislodgment risks increase
Solution Approach 1:
The patent replaces traditional surgical implantation with percutaneous delivery of an implantable device. This minimally invasive approach reduces the size of the implantation pocket and minimizes tissue disruption, thereby lowering infection risks. The device is delivered through a small puncture rather than requiring a large surgical pocket.
Solution Approach 2:
The patent introduces a catheter-based delivery system as an intermediary that guides the implantable device through the abdominal wall to the target site. This intermediary delivery mechanism allows precise placement with minimal tissue disruption, reducing both infection risk and lead dislodgment risk compared to traditional surgical implantation.
5Ease of manufacture
If traditional surgical implantation methods are used, then device placement is achieved, but invasiveness and complication risks increase
Solution Approach 1:
The patent replaces open surgical or laparoscopic implantation with percutaneous delivery through a small puncture in the abdominal wall. This substitution maintains the ability to precisely place the device while dramatically reducing invasiveness, patient morbidity, and recovery time.
Solution Approach 2:
The patent uses a catheter-based delivery system as an intermediary to transport the implantable device from the external environment to the implantation site through the abdominal wall. This intermediary mechanism enables minimally invasive delivery while ensuring accurate device placement, combining the benefits of both surgical precision and percutaneous minimal invasiveness.
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 provides effective, long-term relief for GERD and obesity by stimulating the lower esophageal sphincter and gastric muscles, reducing reflux and food intake, while minimizing invasiveness and reducing complications associated with existing treatments.
Implementation Method 1
using shape memory alloys for anchoring and electrode configuration to adapt to the implant site
Implementation Method 2
stimulator for generating pulses and delivering the generated pulses to smooth muscles or nerves through a stimulating electrode
Data Source
AI summary
An implantable stimulation device for use in stimulation based treatments for diseases such as GERD or obesity is described. The device is provided with an anchoring unit which upon deployment assumes a shape optimized for the site of deployment. Sensing electrodes and stimulating electrodes in the device are also designed to assume a suitable shape upon deployment. A novel catheter is also provided for easy and expeditious deployment of the device.


