Spinal Cord Stimulation Lead with Pain Reduction Assembly
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Solution Overview
Problem
Current spinal cord stimulation (SCS) trial systems have low accessibility and success rates due to patient apprehension and invasiveness, with only about 20% of chronic pain patients undergoing trials, and significant post-operative pain masking potential pain relief.
Innovation Solution
The development of an SCS system that includes a lead body with distal electrodes for electrical stimulation, a pain reduction assembly to address post-operation pain, and a drug delivery system using iontophoresis or a slidable sheath with pain-relieving drugs to reduce incision site pain, along with peripheral nerve field stimulation to target dermatomes and dorsal root ganglia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an epidural needle is used to puncture the patient's skin and back musculature to implant the SCS lead, then the SCS lead can be successfully implanted into the epidural space, but tissue damage occurs causing inflammation and pain for several days
Solution Approach 1:
The patent applies preliminary action by delivering pain-relieving drugs (such as local anesthetics or anti-inflammatory agents) through the lead body or pain reduction assembly immediately upon implantation, before post-operative pain and inflammation can fully develop. This preemptive treatment reduces the severity and duration of pain without affecting the implantation success.
Solution Approach 2:
The patent uses a pain reduction assembly or drug delivery system as an intermediary between the traumatic implantation process and the patient's tissue. This intermediary delivers pharmacological agents that mediate the harmful effects of tissue puncture, reducing inflammation and pain while allowing the SCS lead to function properly.
2Measurement precision
If patients undergo an SCS trial to determine whether SCS will be successful in reducing pain, then pain relief can be assessed, but post-operative pain from the trial may mask SCS-generated improvements
Solution Approach 1:
The patent delivers pain-relieving drugs through the lead body or pain reduction assembly immediately upon implantation during the trial period, before the patient's natural post-operative pain response can mask the true effectiveness of SCS therapy. This allows for more accurate assessment of pain relief benefits.
Solution Approach 2:
The patent converts the harmful post-operative pain into a benefit by using the same implantation pathway to deliver pain-relieving medications. The trauma of implantation is transformed into an opportunity for targeted drug delivery that actually enhances the trial's ability to measure true SCS effectiveness.
3Ease of operation
If a large fraction of patients who undergo an SCS trial do not successfully convert to a permanent SCS system due to discomfort and pain, then trial accessibility is maintained, but the trial-to-permanent success rate decreases
Solution Approach 1:
The patent delivers pain-relieving drugs immediately upon implantation during the trial, preventing post-operative pain and discomfort that would otherwise cause patients to abandon the trial. This maintains accessibility while improving conversion rates to permanent systems.
Solution Approach 2:
The patent introduces a pain reduction assembly or drug delivery system as an intermediary that mediates between the traumatic implantation and the patient's comfort level. This intermediary ensures patients remain comfortable during the trial period, increasing likelihood of successful conversion to permanent systems.
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 system effectively reduces post-operation pain at the incision site, improving the trial-to-permanent SCS system success rate by using local peripheral nerve stimulation and drug delivery methods, allowing for more effective pain management and increased accessibility of SCS therapy.
Implementation Method 1
peripheral nerve field stimulation to target dermatomes and dorsal root ganglia
Implementation Method 2
a drug delivery system using iontophoresis or a slidable sheath with pain-relieving drugs
Data Source
AI summary
The present disclosure provides a spinal cord stimulation (SCS) system. The system includes at least one SCS lead including a lead body, at least one distal electrode located at a distal end of the lead body, the at least one distal electrode configured to apply electrical stimulation to a stimulation target of a patient, and a pain reduction assembly coupled to the lead body and configured to reduce post-operation pain at an incision site associated with implantation of the at least one SCS lead. The system further includes a pulse generator coupled to the at least one SCS lead and configured to control electrical stimulation delivered to the patient via the at least one SCS lead.