Adjustable Neurostimulator Implantation via Dynamic Length
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Solution Overview
Problem
Existing implantable neural stimulators are limited by their fixed length and inability to be adjusted during placement, which can lead to suboptimal pain relief and require extensive surgery, resulting in potential side effects and reduced effectiveness.
Innovation Solution
A minimally invasive method for implanting a neurostimulator system with a passive antenna that receives electrical energy and waveform parameters via electric radiative coupling, allowing for adjustable length and optimized electrode placement, using X-Ray fluoroscopy and ultrasound for guidance, and anchoring the device with sutures for customized fit and enhanced therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a fixed-length neural stimulator is implanted through traditional surgery, then the device can be placed in the epidural space, but the device cannot be adjusted for optimal positioning and requires extensive surgical intervention
Solution Approach 1:
The neural stimulator is designed with a flexible body portion that can be dynamically adjusted in length during implantation. The device transitions from a fixed configuration to an adjustable one, allowing the practitioner to customize the exposed length at the incision site to optimize electrode positioning while minimizing surgical intervention.
Solution Approach 2:
The neural stimulator is divided into distinct segments: a fixed enclosure housing the electronics, a flexible adjustable-length body portion, and electrode contacts. This segmentation allows independent adjustment of the body portion length while maintaining the integrity of the functional components, enabling customized implantation without compromising device functionality.
2Ease of manufacture
If the neural stimulator body length is fixed during manufacturing, then production is simplified, but the device cannot be customized for individual patient needs
Solution Approach 1:
The device incorporates a dynamically adjustable body portion that maintains manufacturing simplicity through standardized components while enabling post-manufacturing customization. The flexible body can be adjusted to various lengths during implantation without requiring complex custom manufacturing processes for each patient.
Solution Approach 2:
The physical parameter of body length is made changeable after manufacturing. The device allows modification of the exposed body length at the incision site through simple mechanical adjustment or cutting, transforming a fixed manufacturing parameter into a customizable clinical parameter without complicating the original manufacturing process.
3Reliability
If extensive surgery is performed to implant the stimulator, then the device can be securely placed, but patient side effects increase and recovery time extends
Solution Approach 1:
The adjustable-length design enables minimal invasive placement by allowing the device to be inserted in a compact form and then extended to the optimal length after placement. This dynamic adjustment capability eliminates the need for extensive surgical exposure, reducing tissue trauma and patient side effects while maintaining secure device placement.
Solution Approach 2:
The neural stimulator body can be partially inserted into the epidural space through a small incision, with the flexible body portion extending through the incision site. This nested configuration allows secure placement deep in the epidural space while minimizing the surgical incision size, thereby reducing surgical side effects and facilitating faster recovery.
4Ease of manufacture
If the stimulator is implanted with fixed electrode positioning, then manufacturing is simplified, but optimal pain relief coverage cannot be achieved
Solution Approach 1:
The flexible body portion allows dynamic repositioning of the electrode array relative to the patient's anatomy after implantation. The electrodes maintain their fixed configuration on the device, but the entire electrode array can be adjusted to achieve optimal positioning for pain relief coverage, combining manufacturing simplicity with placement precision.
Solution Approach 2:
The device allows local adjustment of the body length at the incision site, which changes the relative positioning of the electrode array with respect to the target tissue. This localized adjustment enables precise electrode placement for optimal therapeutic effect while maintaining the simplified fixed electrode configuration during manufacturing.
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 approach enables precise placement and adjustment of the neurostimulator system for improved pain relief, reducing side effects and allowing for on-site customization of the device length, enhancing the effectiveness of the therapy and simplifying the implantation process.
Implementation Method 1
the at least one passive antenna configured to receive, via electric radiative coupling, electrical energy and waveform parameters from an antenna placed exterior to the patient
Data Source
AI summary
Some implementations provide a method for implanting a neurostimulator system that includes: placing an introducer through an incision site on a patient into an epidural space of the patient, the introducer including a sheath and the patient having a primary area of pain; placing a neurostimulator system through the introducer into the epidural space of the patient, the neurostimulator system comprising an enclosure housing at least one pair of electrodes and at least one passive antenna; advancing the neurostimulator system through the epidural space such that the electrodes are placed at a targeted tissue of the patient; removing the introducer sheath from the epidural space of the patient; adjusting the neurostimulator system enclosure to leave a customized length of the device body enclosure in the epidural space; and anchoring the customized length of the neurostimulator system enclosure in tissue of the patient.