Surgical Stapler Incomplete Firing Indicator
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Solution Overview
Problem
Current surgical stapling instruments face challenges in ensuring a secure and leak-proof end-to-end anastomosis between anatomical lumens, particularly in maintaining the appropriate gap distance between the anvil and stapling head to prevent leakage or tissue damage during the stapling process.
Innovation Solution
The development of a circular stapling instrument with a handle assembly that includes a rotatable knob for precise clamping and a mechanism to adjust the gap distance between the anvil and stapling head, featuring a safety trigger and firing trigger system, along with a motor-activated stapling head assembly that drives staples through tissue while cutting excess tissue, ensuring secure sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the gap distance between anvil and stapling head is not precisely controlled, then the operation is simpler, but the anastomosis may leak or tissue may be damaged
Solution Approach 1:
The instrument pre-sets the gap distance between the anvil and stapling head using a adjustable collar and depth stop mechanism before the stapling operation begins. This preliminary configuration ensures that when the stapling head engages the anvil, the correct gap is already established, eliminating the need for real-time adjustment during the critical stapling moment and ensuring consistent reliable results.
Solution Approach 2:
The instrument incorporates visual indicators (such as colored zones or markings on the collar) that provide real-time feedback to the operator about the current gap distance setting. This feedback mechanism allows the operator to verify that the correct gap is established before firing, ensuring reliable anastomosis formation without requiring complex automated sensing systems.
2Measurement precision
If manual clamping control is used, then the device is simpler, but precise gap distance adjustment is difficult
Solution Approach 1:
The instrument employs a dynamic adjustment mechanism where the collar can be rotated to different positions during the setup phase to establish the desired gap distance. Once set, the depth stop provides a mechanical limit that maintains this precise gap throughout the stapling operation. This dynamic setup followed by static maintenance allows precise adjustment without requiring complex continuous control systems during operation.
Solution Approach 2:
The collar acts as an intermediary element between the operator's manual control and the final gap distance between anvil and stapling head. By adjusting the collar position, the operator indirectly controls the gap distance with precision, as the collar translates small rotational movements into precise linear positioning of the stapling head relative to the anvil.
3Manufacturing precision
If the stapling head travels the full distance without stop, then the mechanism is simpler, but the anvil may not be properly positioned relative to the stapling head
Solution Approach 1:
The depth stop mechanism is pre-configured on the drive shaft at a specific location that corresponds to the correct firing position. Before the stapling operation, this stop is positioned to ensure that when the firing trigger is activated, the stapling head will travel exactly the required distance and stop at the precise point where the anvil should be positioned relative to the stapling head, ensuring accurate anastomosis formation.
Solution Approach 2:
The drive shaft with its integrated depth stop provides self-limiting motion for the stapling head. The mechanical stop automatically prevents the stapling head from traveling beyond the correct position, eliminating the need for external sensors, motors, or complex control systems to detect and stop the motion. The mechanism serves itself by using its own structural features to ensure precise positioning.
Data Source
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AI summary
A surgical instrument includes a stapling head assembly, an anvil, a firing assembly, a load sensor, and an indicator. The firing assembly actuates the stapling head assembly to drive an annular array of staples through tissue toward the anvil. The load sensor is operable to sense a load in the firing assembly while the firing assembly actuates the stapling head assembly. The indicator is operable to provide feedback based on the load sensed by the load sensor. The firing assembly may include a longitudinally translatable member. The instrument may further include a position sensor that is operable to sense a longitudinal position of the translatable member while the firing assembly actuates the stapling head assembly. The indicator may be activated based on data from at least one of the sensors indicating completion or failure of a full actuation stroke of the firing assembly.