Volume of Tissue Activation Scoring for Electrical Stimulation Therapy
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Solution Overview
Problem
Current electrical stimulation therapy systems lack an efficient method to determine the most effective therapy programs for patients, as they rely on trial and error, leading to variability in treatment outcomes and potential side effects due to the lack of precise quantification of tissue activation and therapeutic efficacy.
Innovation Solution
The system generates a volume of tissue activation (VTA) based on a therapy program and selects an efficacy map specific to the patient's condition or symptom, determining an efficacy score by associating clinical rating scale scores with voxels overlapped by the VTA, allowing for the selection of optimal therapy programs that maximize therapeutic benefit while minimizing side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If trial and error method is used to determine therapy programs, then therapy programs can be generated, but treatment outcomes vary and side effects occur due to lack of precise quantification
Solution Approach 1:
The patent replaces the mechanical trial-and-error programming method with a computational model that calculates Volume of Tissue Activation (VTA) based on electrical stimulation parameters. This substitution enables precise quantification of tissue activation volumes, allowing clinicians to predict treatment outcomes before delivery and select optimal therapy programs without relying on iterative trial and error approaches.
2Productivity
If multiple therapy programs are evaluated through trial and error, then comprehensive coverage of parameter space is achieved, but time and resources are consumed
Solution Approach 1:
The patent performs preliminary calculation of VTA for multiple candidate therapy programs before actual therapy delivery. By computing the volume of tissue activation for each program in advance using electrical stimulation parameters and tissue conductivity models, the system enables pre-evaluation and selection of optimal programs, eliminating the need for time-consuming trial and error during clinical programming sessions.
Solution Approach 2:
The patent creates a computational model that replicates the physical effects of electrical stimulation on tissue. This virtual model allows clinicians to evaluate multiple therapy programs in silico by calculating VTA based on stimulation parameters, electrode configurations, and tissue properties, thereby avoiding repeated physical trials with the actual patient and significantly reducing programming time.
3Object-generated harmful factors
If electrical stimulation parameters are increased to maximize tissue activation, then therapeutic benefit increases, but side effects also increase
Solution Approach 1:
The patent implements a feedback mechanism where the calculated VTA for each therapy program is compared against target activation volumes or clinical criteria. This feedback allows clinicians to evaluate the relationship between stimulation intensity and tissue activation volume, enabling selection of therapy programs that achieve sufficient therapeutic activation while avoiding excessive stimulation that would cause side effects. The VTA metric provides quantitative feedback for optimizing the balance between efficacy and safety.
Data Source
AI summary
In some examples, a processor of a system evaluates a therapy program based on a score determined based on a volume of tissue expected to be activated (“VTA”) by therapy delivery according to the therapy program. The score may be determined using an efficacy map comprising a plurality of voxels that are each assigned a value. In some examples, the efficacy map is selected from a plurality of stored efficacy maps based on a patient condition, one or more patient symptoms, or both the patient condition and one or more patient symptoms. In addition, in some examples, voxels of the efficacy map are assigned respective values that are associated with a clinical rating scale.