Accessory Tissue Sensor for Stapler Force and Thickness Sensing
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Solution Overview
Problem
Existing surgical staplers lack the capability to provide accurate information for selecting the appropriate staple cartridge and staple height based on tissue characteristics such as compressibility, thickness, and property variability, which can lead to suboptimal sealing outcomes during transection procedures.
Innovation Solution
An accessory tissue sensor system is integrated with surgical stapling instruments to sense and wirelessly communicate tissue force, thickness, and position measurements, enhancing preoperative planning and intraoperative decision-making by providing real-time feedback.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional surgical staplers are used without tissue sensing capabilities, then the device complexity remains low, but the measurement precision of tissue characteristics is insufficient
Solution Approach 1:
The surgical system is divided into separate functional modules: the surgical stapler for tissue sealing, the accessory tissue sensor for measurement, and the processor for data analysis. This segmentation allows the measurement function to be added without redesigning the entire stapler system, thus improving measurement precision while controlling overall device complexity.
Solution Approach 2:
An accessory tissue sensor is introduced as an intermediary device between the surgical stapler and the tissue. This sensor includes force sensors and proximity sensors that measure tissue characteristics independently, then communicate the data to the processor. The intermediary sensor provides precise measurement capability without requiring the stapler itself to be complex.
2Measurement precision
If accessory tissue sensor is integrated with surgical stapler, then the measurement precision of tissue force and thickness is improved, but the device complexity increases
Solution Approach 1:
The accessory tissue sensor is integrated with the surgical stapler by positioning the sensor between the stapler jaws and the tissue. The force sensors are incorporated into the jaw structure, and the proximity sensors are aligned with the cutting element. This merging allows simultaneous measurement of multiple tissue parameters (force, thickness, compressibility) using a single integrated accessory device, improving measurement precision while consolidating complexity into one modular component.
3Reliability
If real-time tissue measurement is implemented, then the reliability of staple cartridge selection is improved, but the loss of time for measurement and communication occurs
Solution Approach 1:
The tissue sensor performs measurements of tissue characteristics (force, thickness, compressibility) before the surgical stapler is activated or during the clamping phase. This preliminary measurement allows the processor to determine the appropriate staple cartridge and staple height in advance, ensuring reliable staple cartridge selection without delaying the surgical procedure. The measurement occurs as part of the pre-firing assessment.
Solution Approach 2:
The system implements real-time feedback by having the tissue sensor continuously measure tissue characteristics and communicate the data to the processor during the surgical procedure. The processor analyzes the tissue properties and provides feedback recommendations for staple cartridge selection. This feedback loop ensures reliable staple cartridge selection based on actual tissue conditions while minimizing time loss through automated real-time analysis.
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 tissue sensor system allows for precise selection of staple cartridges and staple height, improving surgical performance and patient outcomes by ensuring optimal sealing and transection of tissues.
Implementation Method 1
a force sensor configured to sense a mechanical force as input in response to the clamping of the tissue and the tissue sensor by the surgical stapler and convert the sensed force into an electrical output signal that can be measured
Data Source
AI summary
A tissue sensor is used with a surgical stapling instrument to sense tissue characteristics and to provide accurate tissue measurements. The tissue sensor includes a flexible substrate, a sensor array, and a controller. The flexible substrate is disposed between the tissue and the surgical stapler. The sensor array comprises sensors disposed on the flexible substrate, senses a parameter, and generates a signal indicative thereof in response to a clamping force that is applied by the surgical stapler to clamp the tissue and the tissue sensor together. The controller is disposed in or on the flexible substrate and is configured to receive the signal from the sensor array, process the signal to determine a measurement of the parameter based on the processed signal, and provide an indication of the measurement of the parameter to a user of the surgical stapler.