Colpotomy Device Rotating Cutting Element
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Solution Overview
Problem
Current hysterectomy procedures, particularly less invasive methods like TLH and LAVH, face challenges such as difficulty in securing uterine arteries and ligaments, limited visibility, and longer procedure times due to poor anatomical identification and manipulation of organs, leading to increased surgical complexity and recovery times.
Innovation Solution
A colpotomy device with a flexible shaft assembly and a cutting element that can be rotated and translated to circumferentially incise the vaginal-cervical junction, featuring a pneumo-occlusion assembly for sealing and an inflatable intrauterine balloon for uterine manipulation, allowing precise and efficient removal of the uterus and cervix through the vagina.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If less invasive hysterectomy procedures (TLH, LAVH) are used, then recovery time and scarring are improved, but surgical complexity and difficulty increase due to limited visibility and anatomical identification
Solution Approach 1:
The surgical procedure is divided into distinct phases: laparoscopic phase for securing arteries and ligaments, and vaginal phase for colpotomy and uterus removal. The colpotomy device itself is segmented with separate functional components (cutting element, occlusion assembly, illumination) that can be independently operated.
Solution Approach 2:
A colpotomy cup assembly is introduced as an intermediary tool that facilitates the separation between the vaginal and abdominal cavities. The cup provides a stable platform for cutting while the occlusion assembly seals the vaginal cavity, mediating the transition between surgical approaches.
2Loss of time
If less invasive hysterectomy procedures are used, then hospital stay is reduced, but procedure time increases due to difficulty in manipulating organs
Solution Approach 1:
Uterine arteries and ligaments are secured during the laparoscopic phase before the vaginal colpotomy procedure begins. This preliminary action simplifies the subsequent vaginal phase by eliminating the need for complex vascular control during the colpotomy itself.
Solution Approach 2:
The colpotomy device incorporates dynamic elements including a rotatable cutting element that can circumferentially incise tissue, and an inflatable occlusion assembly that dynamically seals the vaginal cavity. The flexible shaft assembly allows dynamic positioning and adaptation to anatomical variations.
3Manufacturing precision
If a colpotomy device with rotatable cutting element is used, then cutting precision is improved, but device complexity increases
Solution Approach 1:
Multiple functions are merged into a single integrated device: the flexible shaft assembly, colpotomy cup assembly, cutting element, and occlusion assembly work together as one unified tool. The cutting element is integrated with the cup assembly, eliminating the need for separate cutting instruments.
Solution Approach 2:
The colpotomy device serves multiple functions: it provides circumferential incision through the rotatable cutting element, seals the vaginal cavity through the occlusion assembly, and provides structural support through the flexible shaft. The device can be used for both cutting and occlusion simultaneously.
4Illumination intensity
If an inflatable occlusion assembly is used to seal the vaginal cavity, then visibility and access are improved, but device complexity increases
Solution Approach 1:
The occlusion assembly uses pneumatic inflation to seal the vaginal cavity. Inflatable balloons or cuffs are expanded with gas or fluid to create an effective seal, providing visibility and access while maintaining a simple mechanical principle.
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 colpotomy device simplifies the hysterectomy procedure by improving visibility and access, reducing surgical complexity and time, and facilitating quicker recovery by enabling precise and efficient uterine and cervical removal with reduced blood loss and scarring.
Implementation Method 1
an inflatable intrauterine balloon for uterine manipulation
Implementation Method 2
a pneumo-occlusion assembly for sealing
Data Source
AI summary
A colpotomy device includes a shaft assembly having a hollow outer shaft and an inner shaft disposed within, and rotatable and translatable relative to, the outer shaft, a handle assembly operably coupled to a proximal end of the shaft assembly, and configured to selectively rotate the inner shaft relative to the outer shaft, a colpotomy cup assembly including an outer cup and an inner cup disposed within the outer cup, wherein the inner cup is fixedly coupled to a distal end of the inner shaft, and the outer cup is fixedly coupled to a distal end of the outer shaft, and a cutting element coupled to the inner cup, such that the inner shaft the shaft assembly, inner cup, and cutting element rotate together relative to the outer shaft.