Pointed-tip Stylet for Minimally Invasive Sacral Lead Implantation
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Solution Overview
Problem
Current minimally invasive implant methods for neural stimulation leads, such as sacral nerve stimulation, require multiple steps and disposable components, leading to increased trauma and time during the implantation process.
Innovation Solution
A minimally invasive implant method using a pointed-tip lead assembly that is inserted directly into tissue, with a stylet for precise placement and subsequent removal, allowing for simplified implantation and reduced trauma, utilizing fixation elements like fins or tapered coils to anchor the lead in place.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a dilator and multiple components are used to implant the stimulation lead, then the lead can be implanted into tissue, but the procedure becomes more complex and causes increased trauma
Solution Approach 1:
The patent combines the stylet and stimulation lead into a single integrated assembly that is inserted together as one unit. The stylet is received within a lumen of the lead, and both components are advanced through the insertion path simultaneously, eliminating the need for separate insertion steps and multiple disposable components.
Solution Approach 2:
The implantation procedure is segmented into distinct phases: first inserting the pointed-tip assembly to create the path and position the lead, then removing the stylet component while leaving the lead in place. This segmentation allows the complex function of path creation and lead placement to be achieved through coordinated action of separate components that are later separated.
2Reliability
If multiple steps and disposable components are used, then the stimulation lead can be implanted, but the procedure takes more time and creates extra trauma
Solution Approach 1:
The stylet with its pointed tip performs the preliminary action of creating the insertion path through tissue and positioning the distal portion of the assembly alongside the sacral nerve before the lead is finalized in place. This preliminary path creation and positioning action is performed by the stylet-lead assembly as a unit, ensuring accurate placement before the stylet is removed.
3Ease of operation
If a dilator is used to dilate the insertion path, then the lead can be advanced through tissue, but the procedure causes increased trauma around the stimulation lead
Solution Approach 1:
The patent changes the parameter of insertion path diameter by using a pointed-tip stylet that creates a narrow initial path, then gradually enlarging it as the lead is advanced. The stylet diameter is smaller than the lead outer diameter, allowing the path to be progressively dilated during lead advancement rather than requiring pre-dilation to the full lead size, thereby reducing trauma.
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 method simplifies the implant procedure, reduces patient trauma and recovery time, and decreases healthcare costs by eliminating the need for multiple steps and disposable components, while ensuring accurate lead placement and stability.
Implementation Method 1
The stylet is inserted through an entry point of the skin or a skin incision posterior to the sacrum. The stylet is guided along an insertion path into a foramen to locate at least a distal portion thereof extending alongside a sacral nerve.
Implementation Method 2
A fixation element is advanced over the stylet to engage tissue and anchor the lead in place.
Data Source
AI summary
Methods and apparatus for implanting a neural stimulation lead in a patient's body are described. A lead assembly comprises a pointed-tip stylet, a stimulation lead, and an optional tube to deploy a fixation element attached to the lead. One embodiment of the implant methods starts with inserting the pointed-tip lead assembly directly into tissue. After the desired implant position is determined, the pointed-tip component is separated from the stimulation lead and removed from the tissue, leaving the stimulation lead implanted. After confirmation that the stimulation lead is in the right tissue location, the pointed-tip component is removed from the body, leaving the stimulation lead in place. The stimulation lead can be connected to a neurostimulator to delivery therapies to treat neural disorders, such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain, etc.