Microstimulator Delivery Tool for Pelvic Floor Dysfunction
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Solution Overview
Problem
Current treatments for overactive bladder, such as sacral nerve stimulation and percutaneous tibial nerve stimulation, are invasive or non-invasive but face challenges with variability in electrode placement and discomfort, limiting their effectiveness and patient compliance.
Innovation Solution
A minimally invasive method and apparatus for delivering an electrical microstimulator to a target site above the deep fascia using a delivery tool with a microstimulator docking feature and anchor tester, allowing precise placement and secure anchoring of the device to improve pelvic floor dysfunction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sacral nerve stimulation or percutaneous tibial nerve stimulation is used, then pelvic floor dysfunction can be treated, but electrode placement variability and discomfort occur
Solution Approach 1:
The electrode array is divided into multiple independently controllable electrode segments that can be selectively activated. This segmentation allows precise targeting of specific nerve fibers while avoiding areas causing discomfort, thereby improving placement precision and reducing variability in therapy effectiveness.
Solution Approach 2:
Different portions of the electrode array are configured with different electrical characteristics and stimulation parameters tailored to specific anatomical regions. This local quality approach ensures optimal stimulation of target nerves while minimizing discomfort from non-target tissue activation, enhancing both placement precision and therapy reliability.
2Ease of operation
If transcutaneous tibial nerve stimulation with external electrodes is used, then non-invasive treatment is achieved, but inconsistent therapy delivery occurs
Solution Approach 1:
The electrode array is nested within a flexible catheter that can be minimally invasively inserted and positioned adjacent to the target nerve. This nested configuration maintains patient convenience while ensuring consistent electrode-nerve contact, thereby improving therapy delivery consistency without sacrificing ease of operation.
Solution Approach 2:
The electrode array is pre-positioned adjacent to the target nerve through minimally invasive insertion before formal therapy begins. This preliminary positioning action ensures consistent electrode-nerve interface is established in advance, eliminating variability during actual therapy delivery while maintaining patient convenience.
3Power
If electrode is placed close to target nerve, then direct stimulation is achieved, but discomfort and variability in placement occur
Solution Approach 1:
The electrode array incorporates flexible elements that can dynamically adjust their position and conform to the anatomical structures surrounding the target nerve. This dynamic adaptability allows the electrode to maintain optimal proximity for efficient stimulation while automatically adjusting to avoid sensitive areas that cause discomfort, resolving the contradiction between stimulation power and patient comfort.
Data Source
AI summary
An apparatus for delivering an electrical microstimulator is provided. The apparatus comprises a handle having a handle body. An elongate delivery rod includes a delivery sheath for reciprocal movement with respect to the handle body. The delivery rod extends longitudinally from the handle body. A microstimulator docking feature is provided for selectively maintaining the electrical microstimulator on the delivery rod. The microstimulator docking feature includes at least one arm which engages the electrical microstimulator. An anchor tester is associated with the handle body for selectively sensing motion of the electrical microstimulator under influence of an applied predetermined longitudinal testing force. A method of delivering an electrical microstimulator to a target implant site of a patient's body is also provided.