Implantable Tissue Validation Circuit for Safe Energy Delivery
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Solution Overview
Problem
There is an unmet need for automatic tissue site validation in implantable medical devices to prevent damage from delivering electrical energy to incorrect tissue types, such as cardiac pacing or shocking energy to non-cardiac tissues, and neural stimulation energy to cardiac tissues, which can cause impairment or pro-arrhythmic conditions.
Innovation Solution
An implantable medical device system with an electrical energy delivery circuit and an intrinsic electrical signal sensing circuit, coupled with a validation module that determines tissue type by sensing intrinsic signals and enables or inhibits energy delivery, using test energies and user confirmation or override mechanisms to ensure safe and effective energy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrical energy is delivered to tissue without validation, then treatment effectiveness is improved, but tissue damage risk increases
Solution Approach 1:
The system performs preliminary tissue validation by sensing intrinsic electrical signals and delivering test energies before committing to full treatment energy delivery. This advance verification ensures the electrode is properly positioned on the target tissue (cardiac or neural) before therapeutic energy is applied, preventing both ineffective treatment and tissue damage.
Solution Approach 2:
The validation module acts as an intermediary between the energy delivery circuit and the tissue. It senses intrinsic electrical signals and responds by delivering appropriate test energies to confirm tissue type, serving as a safety buffer that prevents direct harmful interaction between unvalidated energy delivery and sensitive tissue.
2Measurement precision
If tissue validation is performed using test energies, then tissue type identification accuracy is improved, but energy consumption increases
Solution Approach 1:
The system applies partial action by using low-level test energies sufficient only for tissue identification rather than full therapeutic energies. The test energies are calibrated to elicit measurable responses from tissue without delivering excessive energy, achieving the minimum necessary action for validation while conserving overall energy consumption.
Solution Approach 2:
Validation is performed as a periodic preliminary step before treatment delivery. The system intermittently performs validation sequences (sensing intrinsic signals, delivering test energies, determining tissue type) rather than continuously consuming energy, allowing treatment to proceed efficiently once validation is complete.
3Reliability
If automatic validation is implemented, then safety is improved, but device complexity increases
Solution Approach 1:
The validation module combines multiple functions into a single integrated component: it senses intrinsic electrical signals, delivers test energies, determines tissue type, and controls energy delivery authorization. This merging reduces overall system complexity compared to having separate systems for validation and treatment.
Solution Approach 2:
The validation system is self-contained and automatically performs tissue identification and validation without requiring external intervention. The implantable device independently senses signals, delivers test energies, determines tissue type, and makes delivery decisions autonomously, reducing the need for complex external validation infrastructure.
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 ensures accurate tissue type identification and safe electrical energy delivery, preventing tissue damage and ensuring the intended therapeutic benefits by automatically enabling or inhibiting energy delivery based on validated tissue types, thereby enhancing the safety and efficacy of cardiac and neural stimulation.
Implementation Method 1
an intrinsic electrical signal sensing circuit, configured to sense at least one intrinsic electrical signal at a corresponding at least one tissue site
Implementation Method 2
delivering a test electrical energy to the at least one tissue site; detecting a response energy in response to the delivered test electrical energy
Data Source
AI summary
Electrical energy delivery tissue site validation systems and methods can determine an indication of a tissue type at a tissue site. This information can be used to enable or inhibit electrical energy delivery to the tissue site. The tissue type at the tissue site can be determined such as by delivering a test electrical energy and sensing a responsive electrical energy. An electrical connectivity to the tissue site can also be determined, such as by using a sensed intrinsic electrical signal at the tissue site. Tissue type information may be communicated externally, such as to allow user confirmation or override of the determined indication of tissue type at the tissue site, such as by a physician, user, or other operator.