Tissue Removal Device High Reciprocation Rate
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Solution Overview
Problem
Current methods for removing uterine fibroids, such as hysterectomy and hysteroscopic resection, come with significant drawbacks including loss of fertility, surgical complications, and the need for anesthesia and hospital-based procedures due to the size of conventional resectoscopes and hysteroscopes.
Innovation Solution
A novel tissue removal device with a morcellator system that includes a flexible hysteroscope, a fluid supply, a vacuum assembly, and a motor drive assembly, allowing for minimally invasive procedures with a smaller diameter to reduce discomfort and eliminate the need for general anesthesia, featuring a cutting mechanism with a rotating and oscillating inner tubular member to efficiently remove tissue through a smaller uterine access point.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional resectoscopes and hysteroscopes are used for tissue removal, then tissue resection can be achieved, but the device diameter is large requiring general anesthesia and hospital-based procedures
Solution Approach 1:
The cutting mechanism is divided into separate components: an outer tubular member and an inner tubular member that can move independently. The inner member reciprocates within the outer member to perform cutting, allowing the overall device diameter to be reduced while maintaining cutting functionality. This segmentation enables the device to pass through smaller cervical openings without requiring general anesthesia.
Solution Approach 2:
The inner tubular member is designed to reciprocate dynamically within the outer tubular member during the cutting process. This dynamic movement allows the cutting edges to engage and disengage, enabling tissue removal through a small-bore device. The reciprocating action provides the necessary cutting force despite the reduced device diameter, eliminating the need for large-bore hysteroscopes that require general anesthesia.
2Ease of operation
If smaller diameter devices are used to reduce discomfort, then patient comfort improves, but tissue resection rate decreases
Solution Approach 1:
The inner tubular member reciprocates at high frequency within the outer tubular member, creating a rapid cutting action. This mechanical vibration/reciprocation enables efficient tissue cutting despite the small device diameter. The high-speed reciprocating motion of the inner member's cutting edge against the outer member's cutting surface allows rapid tissue removal, maintaining high productivity while using a small-bore device that improves patient comfort.
3Reliability
If hysterectomy is performed to remove uterine fibroids, then complete removal is achieved, but fertility is lost and surgical complications occur
Solution Approach 1:
The device extracts and removes only the fibroid tissue through hysteroscopic resection, leaving the uterus intact. The reciprocating cutting mechanism efficiently cuts and removes fibroid tissue through the cervical opening, allowing complete fibroid removal while preserving the uterus and maintaining patient fertility. This extraction approach eliminates the need for hysterectomy and its associated harmful effects.
4Ease of operation
If fluid is administered under pressure to distend the uterus, then working space is created, but intravasation risk increases
Solution Approach 1:
The system monitors fluid uptake and provides feedback to control the distension process. By tracking the amount of fluid administered and the patient's response, the system can adjust distension pressure to maintain adequate working space while minimizing the risk of intravasation. This feedback mechanism allows safe creation of working space without excessive pressure that could cause harmful fluid uptake by blood vessels.
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
Enables efficient and minimally invasive uterine fibroid removal with reduced patient discomfort and avoidance of general anesthesia, achieving higher tissue resection rates through a smaller access point while managing fluid flow and minimizing intravasation risks.
Implementation Method 1
a vacuum assembly, the distal end of a vacuum tube of the vacuum assembly being inserted through a second port of the introducer device
Implementation Method 2
prior to fibroid removal, the uterus is typically distended to create a working space within the uterus. (Such a working space typically does not exist naturally in the uterus because the uterus is a flaccid organ.)
Data Source
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AI summary
Disclosed is a tissue removal device. The device includes an outer tubular body, an inner tubular body and a cutting edge on the inner tubular body. The outer tubular body includes a window, which may be opened or closed by moving the cutting edge. The cutting edge has a hardness that exceeds the hardness of the material of the inner tube. The cutting edge may have a Rockwell C hardness of at least about 50, while the inner tube has a Rockwell C hardness of no more than about 40. The cutting edge may be formed by a milling step, and the inner tube may be formed by a drawing step. Tissue severed by the cutting edge may be removed at a rate of at least about 1.8 grams per minute through the inner tube, and the outer tubular body may have an outside diameter of no more than about 3.5 mm.