Transvaginal Occluder Multi-Durometer Sealing
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Solution Overview
Problem
Current transvaginal occluders fail to effectively seal the vaginal canal during laparoscopic surgery, leading to gas leaks due to improper fit and lack of safety features, which can cause abdominal wall collapse and disrupt surgical operations.
Innovation Solution
A transvaginal occluder with an elongated housing made of materials with varying durometers, featuring compression regions, bulbous sections, and tapered geometries to securely engage vaginal tissue and surgical instruments, ensuring a fluid-tight seal and preventing gas leaks, printed using Liquid Additive Manufacturing (LAM) technology.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a single-material occluder is used, then the device is simple to manufacture, but it cannot provide both structural support and tissue engagement
Solution Approach 1:
The occluder employs a three-material composite construction: a high-durometer material for structural support, a medium-durometer material for tissue engagement, and a low-durometer material for instrument sealing. This composite approach allows each material to perform its specific function optimally while being manufactured as an integrated single-piece structure through selective laser melting, resolving the contradiction between manufacturing simplicity and functional adaptability.
2Strength
If a rigid occluder is used, then structural integrity is maintained, but tissue engagement and comfort are compromised
Solution Approach 1:
Different regions of the occluder are assigned different durometer values tailored to their specific functions. The proximal portion uses high-durometer material for structural integrity, the middle portion uses medium-durometer material for tissue engagement, and the distal portion uses low-durometer material for instrument sealing. This local differentiation allows the rigid structure to remain strong where needed while providing soft tissue engagement where required.
3Ease of manufacture
If a standardized occluder size is used, then manufacturing is simplified, but it cannot accommodate varying vaginal canal dimensions
Solution Approach 1:
The occluder incorporates a compression region that dynamically adapts to the vaginal canal's dimensions. Upon insertion, the compression region compresses to accommodate smaller canals and then expands to engage the vaginal tissue, providing a self-adjusting mechanism that accommodates varying anatomic sizes without requiring multiple standardized sizes. This dynamic adaptation maintains manufacturing standardization while achieving anatomic versatility.
4Reliability
If safety features are added to prevent device displacement, then patient safety is improved, but device complexity increases
Solution Approach 1:
The occluder incorporates self-retaining features including a compression region that automatically expands to engage vaginal tissue and a tapered distal portion that guides insertion and ensures proper positioning. These features provide safety against device displacement without requiring additional mechanical locking mechanisms or complex control systems, maintaining structural simplicity while enhancing reliability.
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 occluder effectively seals the vaginal canal, preventing gas leaks and maintaining insufflation pressure, while its ergonomic design ensures secure placement and comfort, facilitating successful surgical procedures by maintaining abdominal pressure and reducing trauma to vaginal tissues.
Implementation Method 1
the compression region configured to compress during insertion of the transvaginal occluder within a vaginal canal and expand beyond the pelvic floor once inserted therein to fix the transvaginal occluder in vivo
Implementation Method 2
The third material includes a bulbous section configured to frictionally engage the shaft of the surgical instrument upon insertion thereof
Data Source
AI summary
A transvaginal occluder includes an elongated housing having proximal and distal portions and an internal cavity defined therebetween configured for selective receipt of a surgical instrument therethrough. The elongated housing includes a first material having a first durometer extending between the proximal and distal portions and defining the internal cavity, the first material including one or more recesses defined therein along the internal cavity. The elongated housing also includes a second material having a second, lower durometer and that extends between the proximal and distal portions, the second material encapsulating a portion of the first material and configured to engage vaginal tissue. The elongated housing also includes a third material having a third, lowest durometer disposed within the one or more recesses that is configured to engage a shaft of the surgical instrument in a fluid tight manner.