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Method and apparatus for in vitro testing for medical devices

A device, fluid technology, used in the field of in vitro testing of medical devices and devices

Inactive Publication Date: 2012-10-24
MCNEIL PPC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This creates resistance to delivering the tampon into the vagina

Method used

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  • Method and apparatus for in vitro testing for medical devices
  • Method and apparatus for in vitro testing for medical devices
  • Method and apparatus for in vitro testing for medical devices

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0057] use figure 2 The diagram shown in builds an instance of SIMA for use with this example. Details and components are discussed below.

[0058] exist Figure 7 In a preferred embodiment shown schematically, the pressure chamber 30 , fluid pump 54 and GUI terminal 56 are located within a safety enclosure 70 . In addition to the safety enclosure 70 , associated compartments hold an air control panel 40 , an electrical control panel 50 , a local computer (eg PC) 52 and a printer 72 . In this example, the pressure chamber 30 is located within the enclosure 70 for safety purposes even when a safety relief valve such as 66 is used.

[0059] Such as figure 2 As shown in , the closed environment provided by the pressure chamber 30 enables the in vitro vaginal model 20 to withstand pressures that reproduce background body pressure and dynamic intra-abdominal pressure. The body pressure is provided by maintaining the inside of the pressure chamber 30 at a constant pressure. ...

example 2

[0074] Example 2: Manual Mode

[0075] Step A: Prepare artificial menstrual fluid according to patent publication US 20070219520 before using the device. Turn on the computer, monitor and fluid pump. Use a cotton swab to remove any menstrual fluid left in the vaginal cavity from the previous test and flush the pump with water until the hose is clean. Next, the vaginal cavity is filled with artificial menstrual fluid before the test. Calibrate the fluid pump and place the cannula in the cervical opening of the vaginal model. The box is then closed and set to the desired testing position (sitting, standing or supine). Weigh tampons in cellophane-free packaging (example: commercial tampons manufactured by McNeill Consumer Products regular absorbent tampons). Put a small amount (about 0.1 to 0.2 grams) Place on top of tampon (to facilitate insertion). Weigh the tampon with the KY gel and record the weight. Insert the tampon into the opening of the labia. In some cases...

example 3

[0079] Example 3: Automatic Mode

[0080] Repeat step A in Example 2

[0081] Step B: On the touch screen control element, press the "automatic mode" of operation. This mode of operation enables the user to re-run a previously established "recipe" or enter parameters for a new recipe. As used herein, the term "prescription" shall refer to a combination of pressure (body pressure, intra-abdominal pressure), time sequence, and flow characteristics (these all occur at preset time intervals). If this is a first time prescription, the user enters the relevant information and creates a prescription name or number, then saves. For example, enter the conditions of step B in manual mode and save as a new recipe. Enter parameters such as body pressure and step length (how long in seconds you want to run the entered body pressure). Similarly, select the cough pressure prescription, which includes the cough pressure (in cm H 2 O), cough time (in seconds), full cycle time (in seco...

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PUM

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Abstract

An apparatus for simulating a female vagina includes a pressure chamber, a vaginal model disposed in a pressure chamber and means to deliver liquid into the vaginal model. The pressure chamber includes an interior, first means to provide fluid pressure to the pressure chamber, and second means to provide localized fluid pressure within the pressure chamber. The vaginal model includes a wall that (1) defines a vaginal lumen extending inwardly from a vaginal opening associated with a bore through an exterior surface of the pressure chamber to vaginal fornices adjacent a cervical port; (2) has an outer surface comprising an anterior vaginal surface and a posterior vaginal surface; and (3) has at least one passage for providing a fluid to the cervical port. Methods for using this apparatus are also disclosed.

Description

technical field [0001] The present invention relates to a method and apparatus for in vitro testing of medical devices designed to be inserted into the vaginal cavity. The device is capable of constant pressure and sudden boosts, which mimic intra-abdominal pressure in the body. Alternatively, the device could be used to test topical products that collect bodily fluids expelled from the vagina. Background technique [0002] The internal organs and tissues of the human body function under normal body pressure. In general, normal body pressure is a constant pressure, which can be changed by performing activities (eg, exercising, coughing, sleeping, etc.). Changes in pressure may occur gradually or suddenly. [0003] The vagina is a collapsed, tube-like structure surrounded by other organs such as the uterus, bladder, and rectum. The vagina is also held in place by connective tissue, muscles, and ligaments. The interaction of this suspension system enables the vagina to de...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G09B23/32
CPCG09B23/32
Inventor M·霍J·朱尼奥
Owner MCNEIL PPC INC
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