Inflatable Seal Assembly for Circular Stapling Instruments
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Solution Overview
Problem
Circular stapling instruments face challenges in forming a reliable seal during procedures, leading to pressure loss during leak testing of anastomosis due to inadequate sealing between the instrument and the patient's tubular body.
Innovation Solution
A seal assembly featuring an inflatable member, such as an inflatable cuff or sleeve, is slidably disposed about the tubular body of the adapter assembly, which can be inflated to create a fluid-tight seal between the instrument and the patient's tubular body, preventing pressure loss during leak testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If no seal assembly is used, then the device structure remains simple, but pressure is lost during leak testing due to inadequate sealing
Solution Approach 1:
The seal assembly is divided into distinct functional components: an inflatable member (cuff or sleeve) that provides the sealing interface, an inflation tube for fluid delivery, and a valve system for pressure control. This segmentation allows each component to be optimized for its specific function while maintaining overall system reliability.
Solution Approach 2:
The seal assembly transitions from a static structure to a dynamic system through the inflatable member that can be selectively inflated and deflated. This dynamic capability allows the seal to be engaged during leak testing and disengaged during instrument removal, providing adaptive sealing behavior without permanent structural complexity.
2Reliability
If an inflatable seal assembly is added, then pressure retention during leak testing is improved, but the device complexity increases
Solution Approach 1:
The seal assembly utilizes pneumatic principles by employing an inflatable member that expands when fluid is introduced through the inflation tube. This pneumatic mechanism creates a reliable seal against the tubular body tissue without requiring complex mechanical compression or clamping systems.
Solution Approach 2:
The inflatable member is constructed as a flexible thin-walled structure that can conform to the irregular surface of the tubular body tissue. This flexibility allows the seal to adapt to anatomical variations while maintaining pressure retention, eliminating the need for rigid or complex adjustable sealing mechanisms.
3Reliability
If the inflatable member is made larger to improve sealing, then sealing effectiveness is improved, but the device size and insertion difficulty increase
Solution Approach 1:
The inflatable member provides a dynamic size adaptation capability: in the deflated state, it has a compact profile that facilitates easy insertion through the anus and navigation to the surgical site. Once positioned, inflation expands the sealing surface area to achieve effective sealing without requiring the device to be large in its stored configuration.
Solution Approach 2:
The inflation tube and valve mechanisms are nested within or integrated with the inflatable member structure, allowing the entire seal assembly to be collapsed into a compact form for insertion. The nested configuration enables the large sealing surface to be contained within a small insertion profile.
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 inflatable seal assembly effectively maintains pressure during leak testing, ensuring the integrity of the anastomosis by preventing leaks and facilitating the removal of the instrument without external pressure.
Implementation Method 1
an inflatable member, such as an inflatable cuff or sleeve, is slidably disposed about the tubular body of the adapter assembly, which can be inflated to create a fluid-tight seal
Data Source
Figure 1
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AI summary
A circular stapling instrument includes an adapter assembly having a tubular body, a shell assembly disposed on a distal portion of the tubular body, and a seal assembly supported on the tubular body. The seal assembly includes an inflatable member disposed proximal of the shell assembly, wherein the inflatable member includes a first diameter when in a deflated condition and a second diameter when in an inflated condition, the second diameter being larger than the first diameter.