Integrated Hysteroscopy and Biopsy Device for Single-Insertion Sampling
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Solution Overview
Problem
Current medical devices for hysteroscopic examinations and endometrial sampling require multiple instrument insertions and removals, causing discomfort and prolonging procedures, while existing solutions lack integrated visualization and efficient sampling mechanisms.
Innovation Solution
A medical device with an integrated endoscopic apparatus featuring a tubular member with a distal end for insertion into the uterus, equipped with a light delivery system, electronic imaging module, and fluid coupling for distention and suction, allowing for simultaneous hysteroscopy and endometrial sampling without repeated instrument insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple separate instruments are used for hysteroscopy and endometrial biopsy, then diagnostic accuracy is improved through direct visualization, but patient discomfort increases and procedure time is prolonged due to repeated insertions and removals
Solution Approach 1:
The patent combines the hysteroscope and endometrial biopsy forceps into a single integrated instrument. The hysteroscope provides direct visualization of the uterine cavity while the biopsy forceps, positioned at the distal end, enable tissue sampling through the same instrument channel. This merging eliminates the need for separate instrument insertions, thereby maintaining diagnostic accuracy while reducing patient discomfort and procedure time.
Solution Approach 2:
The integrated instrument serves multiple functions simultaneously: visualization through the hysteroscope, tissue sampling through the biopsy forceps, and illumination. By designing a single instrument that performs hysteroscopy and endometrial biopsy functions, the device achieves multi-functionality that resolves the contradiction between diagnostic precision and operational ease.
2Measurement precision
If multiple separate instruments are used for hysteroscopy and endometrial biopsy, then diagnostic accuracy is improved through direct visualization, but procedure time is prolonged due to repeated insertions and removals
Solution Approach 1:
The integration of hysteroscope and biopsy forceps into one instrument allows both visualization and tissue sampling to be performed during a single insertion. This eliminates the time-consuming repeated insertions and removals of separate instruments, thereby maintaining diagnostic accuracy while significantly reducing overall procedure time and improving productivity.
Solution Approach 2:
The integrated instrument enables continuous useful action by maintaining visualization capability throughout the entire biopsy procedure. The hysteroscope remains in place providing continuous visual guidance while the biopsy forceps operate through the same instrument, eliminating interruptions and maintaining procedural continuity that reduces overall procedure time.
3Ease of operation
If a single integrated instrument is used for hysteroscopy and endometrial biopsy, then patient comfort is improved by eliminating repeated insertions, but device complexity increases compared to separate instruments
Solution Approach 1:
The biopsy forceps are positioned within or alongside the hysteroscope shaft, with both components working through a single insertion path. The distal end of the instrument integrates the optical components of the hysteroscope with the mechanical components of the biopsy forceps, creating a nested or integrated structure that provides multiple functions without requiring proportionally complex separate systems.
4Productivity
If a single integrated instrument is used for hysteroscopy and endometrial biopsy, then procedure time is reduced by eliminating repeated insertions, but device complexity increases compared to separate instruments
Solution Approach 1:
The integration consolidates multiple instrument systems into a single unified device with shared structural components, control mechanisms, and insertion pathways. This merging reduces the overall system complexity compared to managing multiple separate instruments, while simultaneously achieving the productivity benefit of eliminated repeated insertions and continuous procedural flow.
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 comfortable combined hysteroscopy and endometrial sampling with improved diagnostic accuracy and reduced procedure time by integrating visualization and sampling functions into a single device.
Implementation Method 1
a light delivery system adapted to illuminate the tissues being examined
Implementation Method 2
a fluid delivery system adapted to deliver a fluid under pressure into the uterus to distend the uterus
Implementation Method 3
a suction system adapted to remove excess fluid from the uterus
Data Source
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AI summary
Methods and devices are described for performing a combined hysteroscopy and endometrial sampling in a manner that requires only a single insertion of an elongate object through a cervical opening of a patient's uterus. The distal end of an elongate, hollow sampling sheath of an integrated medical device is inserted through the cervical opening and into the uterus. Fluid is infused through the hollow interior of a sampling sheath, and outward through a distal opening into the uterus. The uterus becomes distended by the positive fluid pressure, allowing visualization. The inside surface of the distended uterus is endoscopically viewed by manipulating the integrated medical device in a manner that directs an imaging module attached to the sampling sheath near the distal end to multiple viewing positions. The corresponding video images of the inside surface are viewed on an electronic display screen of the integrated medical device that is positioned near the proximal end of the sampling sheath. After the viewing, and before withdrawing the distal end of the sampling sheath from the uterus, suction is applied to the hollow interior of the sampling sheath, which causes the distending fluid in the uterus to flow back into the sampling sheath through the distal opening, which returns the uterus to a non-distended state. With the uterus in the non- distended state, suction is applied while the integrated medical device is manipulated within the uterus in a manner that causes a sample of endometrium to be sucked into the tubing. The sample of endometrium is severed by at least one sharp edge formed along the distal opening. The sample is thus trapped in the hollow interior of the sampling sheath. Methods and devices are also described for performing a combined hysteroscopy and endometrial ablation in a manner that requires only a single insertion of an elongate object through a cervical opening of a patient's uterus.