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

VSEngineering 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

Engineering Contradiction:
Improvepatient comfort and anesthesia requirementVSAvoiddevice diameter
Core Design Contradiction:
Ease of operationVSLength of moving object

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If smaller diameter devices are used to reduce discomfort, then patient comfort improves, but tissue resection rate decreases

Engineering Contradiction:
Improvepatient comfortVSAvoidtissue resection rate
Core Design Contradiction:
Ease of operationVSProductivity

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.

Inventive Principle:
Principle #18Mechanical vibration

3Reliability

If hysterectomy is performed to remove uterine fibroids, then complete removal is achieved, but fertility is lost and surgical complications occur

Engineering Contradiction:
Improvefibroid removal effectivenessVSAvoidfertility loss and surgical complications
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

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.

Inventive Principle:
Principle #2Taking out (Extraction)

4Ease of operation

If fluid is administered under pressure to distend the uterus, then working space is created, but intravasation risk increases

Engineering Contradiction:
Improveworking space creationVSAvoidintravasation risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

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.

Inventive Principle:
Principle #23Feedback

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

Methodology Applied
Scientific EffectVacuum suction: Suction

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.)

Methodology Applied
Scientific EffectFluid pressure distension: Pressure Increase

Data Source

PatentEP3132760B1Tissue removal device with high reciprocation rate
Publication Date: 2018.06.13 HOLOGIC INC
  • EP3132760B1 patent drawingFigure 1
  • EP3132760B1 patent drawingFigure 2A
  • EP3132760B1 patent drawingFigure 2B

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.