Pressure-Sensing Implant Tool Positioning Across Tissue Layers
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Solution Overview
Problem
Clinicians face difficulty in determining when an implant tool crosses layers of diaphragmatic attachments during medical procedures, such as implanting medical leads, due to the challenge of distinguishing tactile sensations through different types of tissue, which can lead to unintended contact with non-target tissues like the pericardium or heart.
Innovation Solution
The use of pressure-sensing medical devices that monitor pressure changes within or at the leading edge of the implant tool, providing feedback to clinicians on the tool's progress by detecting drops in pressure and respiratory oscillations to determine when the tool has crossed tissue layers, thereby guiding safe advancement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If clinicians rely on tactile sensations to determine when the implant tool crosses tissue layers, then the procedure can be performed with simple equipment, but the precision of determining tool position relative to tissue layers deteriorates
Solution Approach 1:
The patent replaces the mechanical tactile sensing system with a pressure sensing system. Pressure sensors mounted on the implant tool measure pressure changes as the tool advances through tissue layers, providing objective quantitative data instead of subjective tactile sensations. This substitution enables precise determination of tool position relative to tissue layers while maintaining relatively simple device architecture.
Solution Approach 2:
The patent introduces pressure sensors as an intermediary between the implant tool and the tissue layers. These sensors act as mediators that convert mechanical contact information into measurable pressure signals, allowing clinicians to indirectly but accurately assess tool position without direct tactile interpretation. The pressure sensors bridge the gap between physical tool-tissue interaction and clinical decision-making.
2Reliability
If clinicians advance the implant tool without precise feedback, then the procedure is simpler to perform, but the risk of unintended contact with non-target tissues like pericardium or heart increases
Solution Approach 1:
The patent implements a feedback mechanism where pressure sensors continuously monitor pressure changes during tool advancement and provide real-time information to the clinician. When the tool approaches or contacts non-target tissues, characteristic pressure patterns are detected, alerting the clinician to adjust the advancement. This feedback loop enhances procedural safety by preventing unintended contact with the pericardium or heart while maintaining a relatively simple tool design.
3Measurement precision
If clinicians use pressure sensing to determine tool position, then the precision of determining when tissue layers are crossed improves, but the device complexity increases
Solution Approach 1:
The patent replaces complex mechanical indicators of tissue layer crossing with a pressure sensing system. Instead of relying on mechanical switches, tactile feedback interpretation, or complex imaging systems, the invention uses pressure sensors to detect the characteristic pressure changes that occur when the tool transitions between tissue layers. This substitution achieves high measurement precision with relatively simple device architecture.
Solution Approach 2:
The patent exploits parameter changes in pressure as the tool advances through different tissue layers. Each tissue layer presents a unique pressure signature during tool advancement, and by monitoring pressure changes, the system can precisely determine when transitions occur. This approach uses natural parameter variations in the physiological system to provide measurement information without adding complex sensing mechanisms.
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 approach allows for safer and more efficient medical procedures by accurately determining the position of the implant tool relative to tissue layers, reducing the risk of unintended punctures or abrasions and ensuring precise placement of medical devices.
Implementation Method 1
one or more pressure sensors positioned within or at a leading edge of the implant tool configured to sense a pressure
Data Source
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AI summary
In some examples, a system includes a medical device comprising an elongate body (60) configured to advance through layers of tissue of a patient, a lumen extending through the elongate body, a fluid line configured to supply fluid to the lumen, and a pressure sensor (76) positioned within the lumen or the fluid line. The system may further include processing circuitry configured to receive, from the pressure sensor, a signal corresponding to the pressure of the fluid at each of a plurality of time points, determine, for each time point: a corresponding amplitude value of the signal, a difference between two amplitude values of the signal, an amplitude oscillation status of the signal, a position of the elongate body based on the difference and the amplitude oscillation status; and provide an indication of the position of the elongate body relative to the layers of tissue.