Surgical Stapler End Effector With Adjustable Gap and Alignment Control
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Solution Overview
Problem
Current surgical staplers used in vertical sleeve gastrectomy lack consistency and quality in creating staple lines due to tissue thickness variations and deflection issues, leading to complications such as leaks and suboptimal anatomy, which are difficult to address with existing calibration tools and surgeon techniques.
Innovation Solution
The end effector system includes an anvil and cartridge with adjustable gaps and shim configurations to accommodate varying tissue thickness, along with a flexible member and tensioning device to maintain alignment and clamping force, ensuring precise staple formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If standard surgical staplers are used with fixed gap configurations, then device simplicity is maintained, but staple line consistency deteriorates due to tissue thickness variations
Solution Approach 1:
The patent implements adjustable gap configurations between the anvil and cartridge that can be dynamically changed during the procedure. The end effector allows surgeons to adjust the gap distance to match varying tissue thicknesses, transforming a static device into a dynamic one that adapts to different anatomical conditions, thereby improving staple line consistency without requiring completely different devices for each tissue thickness.
Solution Approach 2:
The patent changes the physical parameter of gap distance between the anvil and cartridge to accommodate different tissue thicknesses. By providing multiple predetermined gap configurations (e.g., first gap configuration for thinner tissue, second gap configuration for thicker tissue), the device allows parameter adjustment that directly addresses tissue thickness variations, improving manufacturing precision of the staple line while maintaining reasonable device complexity through discrete rather than continuous adjustment options.
2Measurement precision
If rigid alignment structures are used to maintain anvil-cartridge alignment, then alignment precision is improved, but adaptability to tissue variations deteriorates
Solution Approach 1:
The patent employs a flexible member (such as a bowtie member or flexible connector) that connects the anvil and cartridge, allowing the alignment structure to be dynamic rather than rigid. This flexible connection maintains precise alignment through its inherent elastic properties while simultaneously adapting to different tissue thicknesses and anatomical variations, thus resolving the contradiction between alignment precision and adaptability.
Solution Approach 2:
The patent utilizes flexible members including bowtie members and elastic elements that provide both structural support for alignment and flexibility for adaptation. These flexible components maintain the geometric relationship between anvil and cartridge faces while accommodating variations in tissue thickness, allowing the device to adapt to different anatomical conditions without sacrificing alignment precision.
3Adaptability or versatility
If multiple calibration tools are provided for different tissue thicknesses, then adaptability is improved, but device complexity and procedural time increase
Solution Approach 1:
The patent integrates multiple gap configurations into a single end effector device, combining what would traditionally require multiple separate calibration tools or devices into one unified instrument. The anvil and cartridge assembly includes multiple predetermined gap settings that can be selected based on tissue thickness, eliminating the need for multiple separate devices and reducing procedural complexity and time.
Solution Approach 2:
The patent creates a universal end effector that performs multiple functions by incorporating adjustable gap configurations for different tissue thicknesses within a single device. This multi-functional design allows the same end effector to be used across various tissue types and thicknesses, reducing the number of devices needed and streamlining the surgical procedure.
4Manufacturing precision
If surgeon estimation and visual orientation are used for stapler alignment, then ease of operation is maintained, but manufacturing precision of staple line deteriorates
Solution Approach 1:
The patent incorporates predetermined gap configurations that are pre-calibrated for specific tissue thicknesses, allowing the surgeon to select the appropriate configuration before the procedure based on preoperative imaging or intraoperative assessment. This preliminary preparation of the device with pre-set parameters reduces the need for complex intraoperative adjustments and improves staple line quality while maintaining ease of operation.
Data Source
AI summary
An end effector for use to staple an anatomical structure of a patient during a surgical procedure includes an anvil and a cartridge. The anvil has an anvil face and a first staple pocket defined by the anvil face, where the first staple pocket comprises a first cup and a second cup for staple formation. The cartridge has a first staple and a first driver. The first staple, once deployed by the first driver and deformed by the first staple pocket, has a formed configuration in which a first portion of a first staple leg and a second portion of a second staple leg are bent relative to a crown and cross the midpoint of the crown and one of the first portion and the second portion overlaps the other of the first portion and the second portion.