APPARATUS FOR SIMULATING ANATOMIC STRUCTURES AND METHOD FOR FLUID FLOW SIMULATION IN A VAGINAL MODEL

专利摘要:
method and apparatus for in vitro testing of medical devices. the present invention relates to an apparatus for simulating a female vagina which includes a pressure chamber, a vaginal model arranged in a pressure chamber and means for applying liquid to the vaginal model. the pressure chamber includes an interior, a first means for supplying fluid pressure to the pressure chamber, and a second means for supplying fluid pressure located within the pressure chamber. the vaginal model includes a wall that (1) defines a vaginal lumen that extends inwardly from a vaginal opening associated with an orifice through an outer surface of the pressure chamber for vaginal fornices adjacent to the cervical port; (2) it has an outer surface comprising an anterior vaginal surface and a posterior vaginal surface; and (3) has at least one passage to supply fluid to the cervical port. methods for using this device are also presented.
公开号:BR112012020289B1
申请号:R112012020289-8
申请日:2011-02-10
公开日:2020-02-27
发明作者:Mari Hou；Joseph Junio
申请人:Mcneil-Ppc, Inc.；
IPC主号:

专利说明:

Descriptive Report of the Invention Patent for APPARATUS FOR SIMULATING ANATOMIC STRUCTURES AND METHOD FOR SIMULATING FLOW FLOW IN A VAGINAL MODEL.
FIELD OF THE INVENTION [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 increases in pressure that mimic intra-abdominal pressures in vivo. Additionally, the device can be used to test external products that collect body fluids discharged from the vagina.
BACKGROUND OF THE INVENTION [0002] The internal organs and tissues of the human body function while under normal body pressure. In general, normal body pressure is a constant pressure, which can be altered by the performance of activities such as exercise, cough, sleep, etc. The pressure change can occur gradually or suddenly.
[0003] The vagina is a flat tube-like structure that is 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 allows the vagina to deform and be displaced, specifically by the uterus during pregnancy. It is a very complex and dynamic system, which complicates the development of products intended to be inserted into the vaginal canal or used externally adjacent to the vulvar lips. For a product to work properly, it needs to be flexible for the sudden or gradual change in the vagina when the vagina and surrounding tissues experience pressure increases.
[0004] A commercial buffer can be identified to have a
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2/28 specific absorbance, which can be determined by a test developed by the FDA (37 CFR 801.430). This test is known as the Syngyna test and involves placing an un lubricated condom in a glass chamber filled with water pumped from a temperature-controlled water bath. The Syngyna fluid is then pumped through an infusion tube into a plug. During the test, the plug is under water pressure inside the glass chamber.
[0005] An in vitro device and a test method for simulating menstruation and / or incontinence should take into account the various issues discussed above. It must be robust enough to allow for real situations. For example, a woman may experience spurts of menstrual fluid when she sneezes. Another woman with weak abdominal muscles may experience stress incontinence during a coughing fit. Menstrual fluid may flow differently through the vagina from a standing or supine position.
[0006] Others have tried to address the design needs of a biomechanical model that could be used as a vaginal model, which could be used for product design to overcome some of these problems. For example, US patent No. 7166085 (Gann et al.) Aims to present an apparatus for in vitro testing of a buffer and applicator systems. In this patent, there is a target placement position that is obtained by expelling a buffer contained within an applicator into the receptacle in vitro. The in vitro receptacle can be pressurized above ambient atmospheric pressure using compressed air. This creates resistance for applying the tampon to the vagina. WO 2009002648 (Dougherty et al.) Intends to present in vitro measurement of catamenial buffer systems. In that publication, there is a test device that
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3/28 includes a pressure vessel set, a support, a pump for applying fluid, such as menstruation, and a pressure regulator. The operating range of the static pressure within the assembly chamber extends from a range of about 0 to 138 kPa (0-20 psig). The present invention solves the problems experienced by menstruating and incontinent women by providing an apparatus and method for designing products, such as tampons and incontinence devices that can deal with fluid problems resulting from dynamic intra-abdominal pressures.
SUMMARY OF THE INVENTION [0007] A method and apparatus for simulating a woman's vagina for use in in vitro tests of medical devices designed to be inserted into the vaginal cavity has been invented.
[0008] In an embodiment of the invention, an apparatus for simulating a female vagina that includes a pressure chamber, a vaginal model arranged in a pressure chamber and means for applying liquid to the vaginal model. The pressure chamber includes an interior, a first means for supplying fluid pressure to the pressure chamber, and a second means for supplying fluid pressure located within the pressure chamber. The vaginal model includes a wall that (1) defines a vaginal lumen that extends inwardly from a vaginal opening associated with an orifice through an outer surface of the pressure chamber to vaginal fornices adjacent to the cervical port; (2) has an outer surface comprising an anterior vaginal surface and a posterior vaginal surface; and (3) has at least one passageway to supply fluid to the cervical port.
[0009] Another embodiment of the invention relates to a method for simulating fluid flow in a vaginal model arranged in a
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4/28 pressure chamber. The vaginal model has a wall that (1) defines a vaginal lumen that extends inwardly from a vaginal opening associated with an orifice through an outer surface of the pressure chamber for vaginal fornices adjacent to the cervical port, (2) an outer surface comprising an anterior vaginal surface and a posterior vaginal surface, and (3) has at least one passageway to supply fluid to the cervical port. The Method includes the steps of (a) providing a first pressure in a pressure chamber; (b) applying liquid to at least one passage to supply fluid to the cervical port; and (c) providing a second pressure to the anterior vaginal surface.
BRIEF DESCRIPTION OF THE DRAWINGS [00010] Figure 1 is a cross section of a female abdomen showing the location and orientation of the vagina, uterus, bladder, urethra and related structures.
[00011] Figure 2 is a schematic drawing of a system of simulated incontinence and menstruation apparatus (SIMA), according to an embodiment of the present invention.
[00012] Figure 3 is a perspective view of a vaginal model useful for the present invention.
[00013] Figure 4 is a perspective view of a pressure chamber of the present invention fitted to a pivot.
[00014] Figure 5 is a front view of the pressure chamber of Figure 4 containing a vaginal model useful for the present invention.
[00015] Figure 6 is a side view of the pressure chamber in figure 4.
[00016] Figure 7 is a schematic diagram of the SIMA system with peripheral equipment.
[00017] Figure 8 is a schematic diagram of an air control panel modality useful to the present invention.
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5/28 [00018] Figure 9 is an extraction of a fluid delivery system useful to the present invention.
[00019] Figure 9A is an enlarged detail view of the fluid release cannula shown in figure 9.
DETAILED DESCRIPTION [00020] The present invention relates to an apparatus and method for testing and designing intravaginal products that can be more efficient in absorbing fluid in the presence of dynamic intra-abdominal pressures. The device, a SIMA incontinence and menstruation simulation device, can be used in conjunction with intravaginal tampons and their absorption of liquids, such as body fluids. In addition, the present invention can be used with devices for incontinence, such as those shown in US Patent Publication No. 20080009662, 20080033230,
20080009931, and 20080009814, whose descriptions are hereby incorporated by reference in their entirety.
[00021] There are two types of pressures that are applied in SIMA :. Body pressure and intra-abdominal pressures. For use in the present invention in the specification and in the embodiments, the term body pressure and variants thereof refer to the pressure which is the pressure of fluid applied locally to the body, even at rest. This pressure has been measured to change depending on the woman's position (sitting, standing, supine, etc.). SIMA stimulates this pressure by applying constant pressure to the chamber. This pressure can also be altered to correspond to real changes or movements, such as sitting, lying down, etc. It can also be considered as being generally static (for a given body position), bottom pressure.
[00022] In addition to general static and background body pressure, SIMA is able to provide intra-abdominal pressures. For use in
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6/28 present invention in the specification and in the embodiments, the term intra-abdominal pressures and variants thereof refer to those dynamic pressures that are applied to the pelvic system in a descending manner. Such pressures may include, but are not limited to, pressures related to normal routine activities, such as getting up, coughing, laughing, walking, taking a deep breath, sitting, sneezing, as well as the pressures intentionally generated, such as through a Valsava maneuver. The Valsalva maneuver is typically defined as a forced attempt at exhalation, holding one's breath and was originally used to clean the ears. Pressure to force bowel movement or contraction of the abdominal muscles during a cough or sneeze is included in this definition. This type of Valsalva pressure ranges from greater than 0 to more than 21.6 kPa (0-220 cm H2O, 0-3,129 psi) and causes the pelvic organs to descend (coughing generates about 9.81 kPa (100 cm H2O) pressure). SIMA simulates these movement-derived pressures by applying direct downward pressure towards the vaginal anatomy.
[00023] These movements can also be associated with stress-type events, which can result in incontinence or spurt of menstrual fluid flow already residing in the vagina. The movements can be sudden (instantaneous) or of short duration. [00024] Body pressure varies according to activity and position (sitting / standing / lying down). SIMA can simulate these variations in body pressures, from more than 0 to over 21.6 kPa (0-220 cm H2O, 0 - 3.13 psi). The body pressures for non-exercised activities are normally in the range between about 1.96 kPa (20 cm H2O) to about 4.9 kPa (50 cm H2O) ok. On average, the body pressure to sit is about 2.26 kPa (23 cm H2O), to lift is 2.65 kPa (27 cm H2O) and to lie in the
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7/28 supine, body pressure is about 0.24 kPa (2.4 cm H2O). It should be noted that several factors can affect body pressure. For example, the body mass index (BMI) can affect body pressure; as the BMI increases, the body pressure in the abdomen also increases. This is probably due to an increase in the gravitational force in the body mass above and around the abdomen supported by the pelvis and organs located in the pelvic region. [00025] Intra-abdominal pressure increases during exercise or jumping, due to increased downward pressure from the muscles and / or downward movement of body mass over the pelvic organs. This increase in intra-abdominal pressure can be exemplified by an average waltz pressure of about 8.63 kPa (88 cm H2O) (standing), and average pressures measured when climbing stairs of about 9.22 kPa (94 cm) H2O). These values for body and intra-abdominal pressures can be found in Cobb et al., Journal of Surgical Research, v. 129, pages 231-235 (2005).
[00026] As stated earlier, intra-abdominal or instantaneous pressures result from sudden stress events, such as sneezing / coughing and also from intense, slightly longer pressures, such as Valsava pressures. These types of pressures can be simulated in the SIMA system. At SIMA, coughing can be stimulated by applying pressure to the vaginal anatomy (7,35-
14.7 kPa) (75-150 cm H2O, 1.07-2.13 psi) over a short period of time, typically 1-2 seconds. However, SIMA can be programmed to apply for less time, as low as 0.5 seconds or less. The Valsava maneuver can be simulated by applying pressure to the vaginal anatomy (4.90-8.83 kPa) (50-90 cm H2O) (0.71-1.28 psi) over a longer period of time (510 seconds). Certainly, the important thing is that the pressure inside
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Abdominal 8/28 provides an increase in pressure over a relatively short period of time in relation to static or body background pressure. These pressures can also be repeated over a period of time. For example, the cough can be replicated by a series of three 1-second pressure bursts, each burst 2 seconds apart.
[00027] The simulation of these intra-abdominal or instantaneous pressures is useful to understand the flow of menstrual fluid and its interaction with anatomy and medical devices. Referring to figure 1, the flow of menstrual fluid exits cervix 1 and generally flows into the upper third of vagina 3. In most women, this portion of vagina 3 is somewhat horizontal when standing . These clustered fluids can then move downward towards the vaginal opening 4 and vulvar lips 5, when a woman exerts intra-abdominal pressures, such as when coughing, sneezing, laughing or when changing position from sitting, standing or lying down. Downward pressures squeeze the anterior and posterior vaginal walls 6, 7 together, causing the fluid to move. In addition, the condition of nearby anatomical structures, including the bladder 8 and urethra 9, can affect or be affected by the movement of fluid and devices located inside the vagina. These dynamic pressures are valuable phenomena to simulate, for example a test method, specifically for tampons and / or medical devices that involve the movement of liquids, such as body fluids.
[00028] Intra-abdominal pressure is also important to stimulate testing of intravaginal incontinence devices for urinary stress incontinence. It is useful to model stress events such as coughing, laughing, or sneezing that usually result in leakage of urine from the bladder and urethra in order to study incontinence of
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9/28 urinary stress. The simulation of downward intra-abdominal pressures exerted during these events is important to simulate on test devices, such as vaginal incontinence suppositories (for example, to determine their ability to remain in place).
[00029] The SIMA system includes the vaginal anatomy that was replicated from a 3D computer model. The 3D model was reconstructed from 2D MRI. Having the actual geometry of vaginal anatomy is an important aspect of understanding how intra-vaginal devices like vaginal suppositories for incontinence fit and stay in place in the vagina.
[00030] The location of a device for incontinence in the vagina is an important factor for the effectiveness of the device. The working section of the device should be applied to the desired portion of an adjacent urinary system. Applicators can be developed and tested on the SIMA system to determine whether they apply a desired incontinence device to a desired location within the vaginal model. Some devices are designed to be placed at the urethra-vesicle junction (UV), while others can be arranged in a mid-urethral location. Since SIMA has complete external vaginal labial anatomy in a pressurized environment similar to a real woman, SIMA is a simulation test method useful for testing various prototype applicators for its ability to apply the device in this location.
[00031] For use in the present invention, the term medical device should mean devices that can be inserted into a woman's body to perform a function. For example, vaginal plugs, suppositories, birth control devices such as IUDs and diaphragms, internal devices and vaginal suppositories for incontinence, and intimate showers, lubricant applicators
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10/28 personnel and applicators for yeast infection are all examples of medical devices that can be studied in conjunction with SIMA.
[00032] SIMA can also be used for the development of other external products, such as napkins and linings. By controlling the amount of fluid flow, the function of napkins and panties protectors can be investigated. In particular, modeling how a product such as napkins handle spurts of fluid can be useful in developing a napkin having an improved system of rapid absorption.
[00033] The SIMA system includes the anatomy of the outer lips, which is composed of a soft, transparent and extensible material. In a preferred embodiment, the anatomy of the vulvar lips was modeled after a woman and molded in the desired material. The movement of the fluid along the vulvar lips and spurts are important aspects for understanding how sanitary pads interact with anatomy. The movement and spurts of the fluid can be simulated in the SIMA system.
[00034] Examples of fluids that can be used in SIMA include, but are not limited to, adequate syngyna or artificial menstrual fluid. Syngyna fluid is prepared as described in 21 CFR §801.430. Another example of a suitable fluid can be found in North American publication No. 20070219520 (Rosenfeld et al.). In this description, test fluid was produced from the following mixture, to stimulate body fluids: 49.5% 0.9% sodium chloride solution (VWR catalog number: VW 3257-7), 49, 05% glycerin (Emery 917), 1% phenoxy ethanol (Clariant Corporation
Phenoxetoll®) and 0.45% sodium chloride (Baker sodium chloride crystal No. 9624-05).
[00035] In this invention, SIMA includes at least (1) a model
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11/28 vaginal in vitro that is subjected to an initial pressure and (2) means to apply a secondary pressure. In order to use SIMA for medical device testing, the test device can be inserted during the initial pressure. Secondary pressure will then be applied.
[00036] In another embodiment, SIMA includes 1) the pressure chamber, 2) means for applying body pressure, 3) means for applying intra-abdominal pressures, 4) the vaginal model, 5) means for applying and controlling fluid flow for the vaginal model, 6) means to regulate both pressures, 7) means to visualize the effect of the fluid, and 8) means to control and record the simulated event (s).
[00037] In an embodiment of the invention, the registration and monitoring of all simulated events can be obtained through the application of the data capture system. The requirements for a data capture system may include 1) graphical user interface (GUI) terminal, 2) a local computer, such as a personal computer (PC), 3) a programmable logic controller (PLC), 4) sensors and 5) control components. The signals from the sensor and the control components are inserted into the inputs and outputs of the PC / PLC. The data can be read and processed by the PC / PLC. The data can be displayed on the user interface (GUI) terminal automatically in real time. The data can be saved in memory by the PC on the PC. An advantage of using a system with a PC is that all data can be saved and retrieved by the user, allowing for data management, archiving, graphical representation and report generation. Data capture includes but is not limited to measurements of 1) body pressure, 2) intra-abdominal pressure, 3) fluid flow, 4) timing and pulse intervals, 5) date and time indicators, 6) tests and users, etc.
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12/28 [00038] SIMA has the potential to initially have a constant uniform body pressure to replicate normal body pressures and also to replicate sudden increases in intra-abdominal pressure, which can simulate coughing, sneezing, and any other movements, such as such as Valsava maneuvers or other changes in intra-abdominal pressure. By using the various electronic controllers, SIMA can be programmed to imitate a simple cough or repeat a series of coughs. This ability allows an investigator to analyze and study fluid flow through the vaginal model. This will be discussed in more detail in the Example section.
[00039] With reference to figure 2, a schematic of a modality of the simulation apparatus of the present invention is shown. In this modality, SIMA 10 includes a vaginal model 20 contained within a pressure chamber 30 and control elements including an air control panel 40, electrical control panel 50, personal computer (PC) 52, fluid pump 54 , and a graphical user interface (GUI) terminal 56. The air control panel 40 is connected to the pressure chamber 30 through the pressure control air line 58 and the dynamic pressure air line 60, and the dynamic pressure air 60 is monitored and / or controlled with the solenoid air valve (cough valve) 62, body pressure / intra-abdominal pressure transducer 64 and a pressure relief valve 66. The fluid can be released from of a fluid pump 54 to the pressure chamber 30 via the fluid release line 68.
[00040] The in vitro vaginal model 20 (shown in detail in figure 3) of the present invention includes the internal vaginal lumen 21, the external geometry of the vagina including the anterior surface 22 and the posterior surface 23 with the cervical port 24 at the proximal end the release of fluid in the vaginal model 20, and in the vulvar lips 25. In a preferred embodiment, the vaginal model is
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13/28 molded in a unique structure. Although the vaginal model can be produced from any color, it has been found that an optically transparent model is preferred. It allows the trajectory of any fluid or device to be observed during the test.
[00041] The vaginal anatomy of the present invention was developed from MRI data of a female subject. In particular, an MRI of a nulliparous woman (no vaginal delivery) was obtained and a supine position. Using commercially available software, the internal vaginal lumen and the external geometry of the vagina were traced from the introitus to the cervix. An example of this software program capable of analyzing the scan of image formation is the 3D-Doctor ™ program, available from Able Software (Billerica, MA, USA). 3D-Doctor ™ software provides advanced three-dimensional modeling, image processing, and dimensional analysis for various image formations, including, but not limited to, MRI, CT, PET, microscopy, scientific and industrial three-dimensional imaging. 3D-Doctor ™ software supports both grayscale and color images stored in DICOM and other image file formats and can create surface model images and volume representations from two or more two-dimensional cross-sectional images taken in time on a computer with adequate graphics functions. By means of a simple trace, specific anatomical features can be seen separately. The strokes were then stored in 3D geometry and converted to a .stl file. This 3D model was then used to develop the impression of a vaginal part. MRIs of multiparous women can also be used to form the vaginal model. When molding the actual vaginal model used on this device, care must be taken to provide a realistic model. There were difficulties in removing the model from the
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14/28 mold after healing, so that the lateral sides 26 (shown in figure 3) are thicker than the actual vagina used to create the model. However, care has been taken to provide an accurate front wall having the appropriate thickness to represent the actual vagina used in MRI images. This importance will become evident below. The lip anatomy of the present invention was developed from a real woman. The foundry was then converted into a 3D CAD file (computer aided design) in order to develop a mold using a digitized probe. The resulting information from the vulvar lips was then combined with the vaginal geometry to create a unitary mold. The unitary mold was used to create the final in vitro vaginal template 20.
[00042] As indicated above, the vaginal model 20 is installed in a pressure chamber 30. This installation is shown in more detail in figures 4-6. The in vitro vaginal model 20 is attached to the bottom floor 30a and the back wall 30b of the pressure chamber 30 by a series of flanges and / or claws. The vaginal lumen 21 is shown in the vaginal model 20. The upper portions of the in vitro vaginal model 20 are positioned at an angle α relative to the lower floor 30a of the pressure chamber 30. To accurately model the location and orientation of a woman's vagina average human being, the vaginal model is installed to provide an α angle between the vaginal lumen adjacent to the cervical port 24 and the bottom floor 30a of about 40 °.
[00043] Figure 6 shows a side view of the vaginal model 20 installed in a pressure chamber 30. The upper portion of the vaginal model 20 is attached to the back wall 30b of the pressure chamber 30 so that the fluid can be injected into the lumen vaginal 21 on top of the vaginal model 20 which corresponds to the location of the cervix by
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15/28 a cannula 31. The lower portion of the vaginal model 20 is attached to an opening in the floor 30a in such a way that the vulvar lips 25 of the vaginal model 20 extend beyond the opening. The fluid that is released from the cannula 31 can then flow through the vaginal lumen 21 and can exit the vaginal model through an opening in the vulvar lips 25. In the embodiment of figure 6, the fluid release can include a first supply of fluid for releasing a relatively constant supply of fluid through the fluid delivery line 68 and a second fluid supply 33 to release spurts of fluid.
[00044] During operation, the pressure chamber 30 is suitably sealed to maintain the background air pressure, the body pressure discussed above. This pressure is established by applying air through one or more air supply ports 34.
[00045] Body pressure varies according to activity and position (sitting / standing / lying down). SIMA can simulate these variations in body pressures, from more than 0 to over 21.6 kPa (0-220 cm H2O, 0 - 3.13 psi). The body pressures for activities not performed are normally in the range between about 1.96 kPa (20 cm H2O) to about 4.9 kPa (50 cm H2O). On average, the body pressure to sit is about 2.26 kPa (23 cm H2O), to lift is 2.65 kPa (27 cm H2O) and to lie in the supine position is about 0.24 kPa (2.4 cm H2O). Preferably, the background pressure or the first pressure in the SIMA system is maintained at more than about 0 kPa (0 cm H2O), as for a woman in the supine position, more preferably, the background pressure is maintained at more than about 1.96 kPa (20 cm H2O). Preferably, the background pressure is less than about 4.9 kPa (50 cm H2O). Thus, a preferred first pressure range would be between more than about 0 kPa (0 cm H2O) and about 4.9 kPa (50 cm H2O).
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16/28
A more preferred range would be between about 1.96 kPa (20 cm H2O) and about 4.9 kPa (50 cm H2O). The first pressure range is kept relatively constant during a test simulation. Preferably, the first pressure range or background pressure range is maintained between about 0.49 kPa (5 cm H2O), more preferably, within about 0.2 kPa (2 cm H2O) and with maximum preference, within about 0.1 kPa (1 cm H2O).
[00046] As shown in figure 6, dynamic intra-abdominal pressure is provided by air flowing through flexible hose 35 and nozzle 36 to the anterior vaginal surface 22 of a central portion of the in vitro vaginal model 20. As stated earlier , the anterior vaginal surface 22 was shaped as close as possible to the image of a nulliparous vagina.
[00047] The pressure chamber 30 is fitted with a rotating support to allow the system to model a woman in a band or orientations while standing, supine or lying on her back. This is shown in figure 4 showing the pressure chamber 30 fitted over a pivot 37 with a release pin 38 to maintain the desired orientation.
[00048] As detailed above and shown in the figures, the vagina can be characterized as a cone-shaped structure with the proximal end (upper fornices) being wider than the distal end (introitus). The anterior and posterior walls of the vagina are also flattened together, even with an intra-vaginal device in place. These walls, however, can also open and close depending on the woman's position, muscle structure and activity. Intra-vaginal pressures help the fluid to move between these walls by compressing the walls together. The vagina is also curved in the sagittal plane (side). The vagina generally extends vertically from the introitus to a
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17/28 vaginal flexure in which it begins to curve to an α angle of about 40 ° from the horizontal. This vaginal flexion 27 is about 5 cm above the introitus in the SIMA model based on the subject from which the vaginal model 20 was derived. This difference could affect the way an intra-vaginal device is placed in the vagina and, consequently, the perceived comfort when using the device. Factors affecting the vaginal flexion of the vagina can include genetics, muscle structure and strength, as well as ligaments and tendons that link the muscle structure, and the pelvic bone structure. In a preferred embodiment shown in figures 3 to 6, the vaginal model contains a casting of a nulliparous vagina, which is 9 cm long and 5 cm wide (at the widest location at the proximal end).
[00049] Other modalities may contain vagina, primiparous and / or multiparous, which differs from a nulliparous vagina mainly in the width and support structures (angle) of the vagina. IMR studies of multiparous women showed that the vaginal width at the widest part of the vagina (proximal end, close to the fornices) ranges from 3.5 to 5.7 cm. Support structures for the vagina may decrease in resistance with injury to the pelvic floor muscles due to child birth, genetics, surgery, increased weight gain and other factors. The SIMA model can simulate this change in the support structure by changing the angle of the vaginal model in vitro. In addition, the length of the vagina can vary widely from woman to woman. In other modalities, the SIMA system can simulate these anatomical differences to better understand how these factors affect the flow of menstrual fluid and its interaction with the tampon or vaginal anatomy and an incontinence device.
[00050] Any materials can be used to create the final vaginal model. Materials that can be molded but retain
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18/28 a certain flexibility are preferred. Other materials useful for making the vaginal model may include but are not limited to silicones (including vulcanized silicone rubber at room temperature), polyethylene, polyurethane sealant, plasticized polyvinyl chloride, styrene-butadiene, thermoplastic elastomers, latex rubber, and the like . Preferred materials include thermoplastic elastomeric materials, such as Santoprene ™ brand thermoplastic vulcanates (TPV) (supplier: Exxon Mobil Chemical, Houston, Texas, USA). In a preferred embodiment, the vaginal model is produced from a 30:60 blend of DS-302 and DS-303 (California Medical Innovations, Pomona, California, USA). Materials that can be molded but are clear after curing are also preferred.
[00051] The materials can be heated until liquefied and then poured into the mold. The filled mold can be placed in an oven to cure over a period of time. The vaginal model is then released from the mold. Once cooled, it is mounted on the support platform.
[00052] Molded vulvar lips provide a resistance normally seen in women when inserting a medical device. The vaginal model also provides a realistic resistance to the medical device in which the model is supplied at an angle (as in a female body) and the inner walls are in the shape of a flat cone The material chosen to manufacture the vaginal model is important since the material can affect the flexibility of the shaped vulvar lips and the shaped vagina. A doctor (urologist) performed a pelvic examination of the vagina in vitro SIMA and considered it realistic in relation to that of a typical female patient.
Examples
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19/28 [00053] The following examples will detail how the vaginal model described above is used.
Example 1 [00054] A SIMA example was built for this example using the diagram shown in figure 2. Next, there is a discussion of the details and components.
[00055] In a preferred embodiment shown schematically in figure 7, the pressure chamber 30, fluid pump 54, and user interface terminal 56 were located inside a safety canopy 70. In addition to the safety canopy 70, compartments members kept in an air control panel 40, electrical control panel 50, local computer, for example, a PC 52, and a printer 72. In this example, the pressure chamber 30 was located inside the canopy 70 for safety purposes although, for example, pressure relief valves 66 have been used.
[00056] As in Figure 2, the pressure chamber 30 provided a closed environment that allowed the in vitro vaginal model 20 to be subjected to pressure by replicating background body pressure and dynamic intra-abdominal pressure. Body pressure was provided by maintaining the interior of the pressure chamber 30 under constant pressure. Intra-abdominal pressure was introduced as air pressure directed to the anterior vaginal surface 22 in the in vitro vaginal model 20. Both procedures were provided by the air control panel 40 and associated controls discussed below. The body pressure air line 58 in figure 2 supplied air to the air supply port 34 in figures 4-6. The dynamic pressure air line 60 of figure 2 supplied air to hose 35 and flexible air supply nozzle 36 for directing dynamic intra-abdominal pressure to the anterior vaginal surface 22 of figures 4 to 6.
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20/28 [00057] As shown in figure 2, a pressure transducer 64 was connected to the air solenoid valve 62 to measure the air pressure of the intra-abdominal pressure stimulating elements. This pressure transducer measured both the air pressure inside the pressure chamber (modeling the background body pressure) and the dynamic pressure (intra-abdominal) or impulse pressure supplied to the vaginal model 20, through the pressure line. of air 60.
[00058] Figure 8 is a schematic diagram of the air control panel 40, which can be located below the rest of the SIMA device. The air control panel 40 had a supply of pressurized air 41 connected to pressure regulator 42. Downstream of pressure regulator 42, a solenoid valve 43 applied pressurized air to one of the two proportional valves. A first proportional valve 44 having an integral pressure sensor for regulating the pressure related to the body pressure system and applied body pressure to the pressure chamber 30 through the pressure air line 58 (figure 2) to the air supply port 34 (figures 4 to 6). Through a proportional valve, the pressure was regulated to provide constant body pressure and release the pressure, once the test has been completed.
[00059] A second proportional valve 45 having an integral pressure sensor for regulating pressure related to the intra-abdominal system and applied pressurized air by air line 46 to an accumulator tank 47. Again, the proportional valve regulates the pressure in the accumulator tank 47 to provide constant intra-abdominal pressure supply and to release pressure when the test is complete. The accumulator tank 47 was connected to the pressure chamber solenoid air valve (cough valve) 62 (figure 2) in the pressure chamber 30 through the dynamic pressure air line 60. The pressure chamber solenoid valve 62 can be can be
Petition 870190093150, of 09/18/2019, p. 23/40
21/28 changed from On to Off at defined time intervals to provide the intra-abdominal pressure pulses for the in vitro vaginal model 20. Pressure relief valve 48 was located at the outlet of the air accumulator tank 47 and was used as protection in case of over-pressurization of the system.
[00060] The SIMA pressurization system allows precise control of the air pressure inside the pressure chamber 30 (body pressure). After air was introduced into the pressure chamber 30 to simulate dynamic intra-abdominal pressure, the air pressure in the pressure chamber 30 (body pressure) increased momentarily. Once the intra-abdominal pressure supply ended, the body pressure was gradually adjusted automatically to the original body pressure setting. Pressure relief valve 66 (figure 2), located at the top of the pressure chamber 30 provided additional protection, in the case of pressurization of the chamber 30.
[00061] As shown in figure 9, a fluid pump 54 for releasing simulated menstrual fluid was located near the pressure chamber 30. Although any pump can be used, it is important to accurately control the fluid release. For example, the pump was able to deliver fluid at a constant rate or in spurts (to mimic spurts). The fluid from reservoir 54a was released by the fluid pump 54 through tube 68. As shown in figure 9A, junction tube 54b connected tube 68 to cannula 31, which released fluid into cervical port 24 of the in vitro vaginal model 20. Junction 54b also had a second fluid inlet port 54c to accommodate a syringe for alternative fluid injection (independently or in conjunction with fluid delivery via 68).
[00062] An example of a suitable fluid pump is made by Watson-Marlow Model 520 Di with Pump Head Model
Petition 870190093150, of 09/18/2019, p. 24/40
22/28
505L, which was used for this example. Although for medical devices, such as tampons, an artificial menstrual fluid is preferred, other fluids can be replaced.
[00063] As shown in figure 4, the pressure chamber 30 was fitted to a pivot 37. This allowed the pressure chamber 30 to rotate in such a way that the in vitro vaginal model 20 could be oriented as if it were in the standing position , sitting or lying down. In an alternative modality (not shown), a secondary articulation means can rotate the box to mimic turning on its side or sleeping. In the embodiment shown in the figures, the articulation means rotated the entire pressure chamber 30 until the desired position at the point where the release pin 38 was engaged. Upon completion of the test, the release pin 38 was disengaged to allow the pressure chamber 30 to return to its original position.
[00064] The in vitro vaginal model 20 included vaginal lumen 21, cervical port 24, and vulvar lips 25. The intra-abdominal pressure nozzle 36 was arranged adjacent to the central portion of the anterior vaginal surface 22 of the in vitro vaginal model 20 (figure 4 to 6).
[00065] Synthetic menstrual fluid was supplied through the cervical port 24 through a cannula 31, and flowed into the vaginal lumen 21, and out through the vulvar lips 25 (figures. 4 to 6). During the testing of a medical device, the device was inserted into the vaginal model 20 before introducing the synthetic menstrual fluid.
[00066] In the mode shown in the figures, the temperature was room temperature, but additional controls can be put in place to raise or lower the temperature inside the box, which includes the vaginal and fluid model.
[00067] SIMA allows two modes of operation -. Manual and automatic. These modes are further discussed in examples 2 and 3.
Petition 870190093150, of 09/18/2019, p. 25/40
23/28 [00068] Another advantage of a system like SIMA is the ability to capture data. It is also possible to control the test using video recording devices and / or to take photographs during the test since the vaginal model can be transparent.
[00069] Whenever the test starts, the data capture system can also start automatically. The data capture system is capable of, but is not limited to, recording events at specified sampling rates and recording date, time, test name, user name, body pressure, intra-abdominal pressure in the accumulation, intra-abdominal pressure applied to the vaginal model, menstrual pump flow and menstrual pump flow events. During the recording period, data is saved to the computer's hard drive under an assigned file name. The data is saved in a comma-delimited format, also called comma-separated values (CSV) and can be imported into an Excel spreadsheet. The data can be imported into an Excel spreadsheet to allow additional data visualization, data management, data archiving, graphical representation and report generation.
[00070] During the data acquisition process, the acquired data can be viewed in real time on the graphical user interface (GUI) terminal. You can move back and forth in time using the arrows on each side of the pause button. Pressing the pause button again will bring you back to the trend screen in real time monitoring. There is also the ability to run the print screen function.
Example 2 - Manual mode [00071] Step A - Before using the device, artificial menstrual fluid is prepared according to US patent publication 20070219520. The computer, monitor, and fluid pump are turned on.
Petition 870190093150, of 09/18/2019, p. 26/40
24/28
The internal vaginal cavity is cleaned of any residual menstrual fluid from previous tests using a cotton swab and the pump is rinsed with water until the hose is clean. Then, the vaginal cavity is prepared with artificial menstrual fluid before the test. The fluid pump is calibrated and the cannula is placed inside the opening of the cervix of the vaginal model. The box is then closed and configured in the desired test position (seated, standing, or supine). A tampon is weighed without the cello wrap (example: regular absorbency of the commercial o.b.® tampon manufactured by McNeill Consumer Products). A small amount (~ 0.1-0.2 grams) of KY gel® is placed on the tip of the plug (to facilitate insertion). The plug is weighed with KY and the weight recorded. The plug is inserted into the opening of the lip portion. In some cases it is preferable to place the tampon on the left side of the vagina, as the tampons are typically placed on the side wall of the vagina (left or right). The placement of the tampon is recorded, as measured from the cervix. In a preferred embodiment, the tampon is placed about 10 mm below the cervix.
[00072] Step B - In the touch screen controls, the manual operation mode is selected. The desired body pressure is selected (in cm H2O). In a preferred mode, 2.65 kPa (27 cm H2O) was selected to stimulate the standing position. The green On key (next to the designation body pressure) is pressed to set the body pressure. The cough pressure is selected (in cm H2O). In a preferred example, 14.3 kPa (146 cm H2O) was selected. In addition, the time of the cough and the time of the complete cough cycle is selected. The cough time ”represents the duration of the single cough and, in a preferred mode, 1.0 seconds was selected. The complete cycle time of the cough represents the
Petition 870190093150, of 09/18/2019, p. 27/40
25/28 period of time in which the cough will occur. In a preferred mode, 10 seconds is selected. These settings will provide a cough of 1 (one) second every 10 seconds for a cough pressure of 14.3 kPa (146 cm H2O). The green ON key (next to the name cough pressure) is pressed to identify the cough pressure. Then, the menstrual flow in mL / Min is entered. In a preferred embodiment, 1 mL / Min is entered. The On Time stream is entered, which is the duration of the stream. In a preferred mode, 10 seconds is selected. The complete cycle time of the flow ”is entered. In a preferred mode, 20 seconds is selected. The setup will provide 10 seconds of fluid flow every 20 seconds. The pump calibration value is entered and the green ON button (next to the Menstrual Flow designation) is pressed to identify the menstrual flow.
[00073] Step C - The start button is pressed to start the test. Video recording and / or digital photographs can be obtained during the test. To stop the test, the Stop button is pressed.
[00074] Step D - Upon completion of the test, the plug is carefully removed and the stain and weight pattern is recorded. The internal vaginal anatomy of the vaginal model is cleaned using a cotton swab and the fluid / hose pump washed with water. Example 3 - Automatic Mode
Repeat step A of example 2 [00075] Step B - On the touch screen controls, press the automatic operation mode button. This mode of operation allows a user to re-execute a previously created recipe or enter the parameters for a new one. As used in the present invention, the term recipe should mean the combination of pressures (body, intra-abdominal), time sequences, and flow, all
Petition 870190093150, of 09/18/2019, p. 28/40
26/28 which occur at predefined time intervals. If this is a first recipe, the user enters the information and creates a recipe name or number, which is then saved. For example, the conditions in Step B in manual mode are entered and saved as a new recipe. Parameters such as body pressure and the duration of the step (length of time you would like to perform body pressure entered in seconds) are entered. Likewise, the cough pressure recipe is selected, which includes the cough pressure in cm H2O, cough time, in seconds, the complete cycle time in seconds, the count (number of times you would like to run the cough) cycle), and the duration of the step (count x complete cycle time). The menstrual flow recipe is entered in mL / min, flow time, in seconds, the complete cycle time in seconds, count (number of times the cycle must be performed), and the duration of the step (count x time of complete cycle). The save button is connected at the top of the screen to save this recipe.
[00076] Step C - The test is started by pressing the start button. Video recording and / or digital photographs can be obtained during the test. The system completes its cycle automatically, or is manually stopped, as appropriate. [00077] Step D - Upon completion of the test, the plug is carefully removed and the stain and weight pattern is recorded. The internal vaginal anatomy of the vaginal model is cleaned using a cotton swab and the fluid / hose pump washed with water. [00078] The user can also edit or execute a previously introduced recipe, which would include other cycles, trends, etc.
[00079] For both manual and automatic SIMA execution mode, instantaneous pressure can be repeated manually or automatically programmed to repeat at intervals of time
Petition 870190093150, of 09/18/2019, p. 29/40
27/28 determined. For example, SIMA can be used to study the effects of coughing every 60 seconds, each cough being 1 second long. This means that the SIMA vaginal model can be under a body pressure of 2.94 kPa (30 cm H2O) for 60 seconds, with the intra-abdominal pressure reaching * 14.7 kPa (150 cm H2O) for 1 second. This trend seeks to replicate the body dynamics of a menstruating or incontinent woman when she coughs - a body action that is intense and brief.
Example 4 - Use with external sanitary products [00080] The SIMA system includes the external lip anatomy, which was molded from a woman, which is composed of a soft, transparent, and extensible material. The movement of the fluid along the vulvar lips and spurts are important aspects for understanding how sanitary pads interact with anatomy. The movement and spurts of the fluid can be simulated in the SIMA system.
[00081] The SIMA system is configured with the same parameters used in any of examples 1 to 3. Body pressure is applied to the system at 2.65 kPa (27 cm H2O), cough pressure is set to 14.3 kPa (146 cm H2O) (with a cough in periods of 1 second and periods of a complete cycle of 10 seconds) , and the flow of menstrual fluid is set to 1 mL / min with the flow running for 10 seconds over a 20 second cycle. Spurts (3 mL) are also introduced into the system after 3 minutes of flow using a syringe. A regular ultrafine Stayfree® napkin is manually applied against the SIMA system and the movement and interaction of the fluid with the anatomy is observed. Time to pour and addition (in grams) are recorded. Observations are produced based on how the fluid moves along the body and interacts with the napkin. These observations are important in
Petition 870190093150, of 09/18/2019, p. 30/40
28/28 developing new insights into the napkin absorbent system and how leakage can occur.
Example 5 - Use with intravaginal incontinence devices [00082] The SIMA system includes a vaginal anatomy that has been replicated from a 3D computerized vaginal model. The 3D model was reconstructed from 2D MRI. Having the actual geometry of vaginal anatomy is an important aspect of understanding how intra-vaginal devices like vaginal suppositories for incontinence fit and stay in place in the vagina.
[00083] The SIMA system is configured with the same pressure parameters used in Examples 1-3. Body pressure is applied to the system at 2.65 kPa (27 cm H2O) and cough pressure is set to 14.3 kPa (146 cm H2O) (with coughing in periods of 1 second and full cycle period of 10 seconds) . Flow of menstrual fluid is interrupted for testing the incontinence device. The incontinence device is inserted into the vagina and the device's ability to stay in place is recorded and observed.
[00084] The descriptive report and the above modalities are presented to assist the complete and non-limiting understanding of the invention presented here.

权利要求:
Claims (20)
[1]
1. Apparatus for simulating anatomical structures, characterized by the fact that it is disposed in a lower abdominal cavity of a female human being, including a female vagina (20), the apparatus comprising:
a) a pressure chamber (30) comprising:
i) an interior;
ii) first means (58) for supplying fluid pressure to the pressure chamber (30); and iii) second means (35, 36, 60) for supplying fluid pressure located within the pressure chamber (30);
b) a vaginal model (20) disposed inside the pressure chamber (30) and comprising a wall:
i) defining a vaginal lumen (21) extending into a vaginal opening (25) associated with an orifice through an outer surface of the pressure chamber (30) for vaginal fornices adjacent to a cervical port (24);
ii) having an outer surface comprising an anterior vaginal surface (22) and a posterior vaginal surface (23); and iii) having at least one passage to supply fluid to the cervical port (24); and
c) means (31, 54, 68) for applying liquid to at least one passage to supply fluid to the cervical port (24).
[2]
Apparatus according to claim 1, characterized in that the first means (58) for supplying fluid pressure comprises a first air pressurization system.
[3]
Apparatus according to claim 1, characterized in that the second means (35, 36, 60) for supplying fluid pressure located within the pressure chamber (30) comprises a
Petition 870190093150, of 09/18/2019, p. 32/40
2/4 air pressurization system.
[4]
4. Apparatus according to claim 3, characterized in that the second means (35, 36, 60) for providing localized fluid pressure comprises an air delivery nozzle close to the anterior vaginal surface (22) of the vaginal model (20).
[5]
5. Apparatus according to claim 3, characterized by the fact that the second means for providing localized fluid pressure is controlled to apply pressure to model dynamic pressures selected from the group consisting of lifting, coughing, laughing, walking, breathing deeply, sit, sneeze, as well as the intentionally generated pressures, such as through a Valsava maneuver.
[6]
6. Apparatus according to claim 1, characterized by the fact that the pressure chamber (30) is rotatable around a pivot.
[7]
7. Apparatus according to claim 1, characterized by the fact that the vaginal model (20) additionally comprises vaginal flexion.
[8]
8. Apparatus according to claim 1, characterized by the fact that it additionally comprises a programmable controller.
[9]
9. Apparatus according to claim 1, characterized by the fact that the vaginal lumen (21) is arranged and configured to accept the feminine hygiene product through the orifice.
[10]
10. Method for simulating fluid flow in a vaginal model (20) disposed in a pressure chamber (30), characterized by the fact that the vaginal model (20) has a wall that (1) defines a vaginal lumen (21 ) extending inwardly from a vaginal opening associated with an orifice through an outer surface of the pressure chamber (30) to vaginal fornices adjacent to the
Petition 870190093150, of 09/18/2019, p. 33/40
3/4 cervical port (24), (2) has an outer surface comprising an anterior vaginal surface (22) and a posterior vaginal surface (23), and (3) has at least one passage to supply fluid to the cervical port (24), the method comprising the steps of:
a) supplying a first pressure in the pressure chamber (30);
b) applying liquid to at least one passage to supply fluid to the cervical port (24); and
c) providing a second pressure to the anterior vaginal surface (22).
[11]
11. Method according to claim 10, characterized by the fact that the first pressure is substantially maintained during a simulation.
[12]
12. Method according to claim 11, characterized by the fact that the first pressure is maintained between 1.96 kPa (20 cm H2O) to 4.9 kPa (50 cm H2O).
[13]
13. Method, according to claim 12, characterized by the fact that the first pressure is maintained within 0.49 kPa (5 cm H2O) of an average pressure during the simulation.
[14]
14. Method according to claim 10, characterized by the fact that the second pressure is greater than the first pressure.
[15]
15. Method according to claim 10, characterized by the fact that the second pressure is at least 4.9 kPa (50 cm H2O).
[16]
16. Method according to claim 10, characterized in that the second pressure is supplied to a portion of a simulation.
[17]
17. Method, according to claim 16, characterized by the fact that the second pressure is supplied intermittently during the simulation.
[18]
18. Method according to claim 17, characterized
Petition 870190093150, of 09/18/2019, p. 34/40
4/4 due to the fact that the second pressure is provided for less than 10 seconds per application during the simulation, or for less than 5 seconds per application during the simulation.
[19]
19. Method, according to claim 10, characterized by the fact that the second pressure varies during the simulation.
[20]
20. Method according to claim 10, characterized by the fact that it additionally comprises the step of orienting the vaginal model (20) according to a woman standing, a woman in the supine position, or variations between them.

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-07-30| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2019-12-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-02-27| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/02/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US12/704,607|US20110200976A1|2010-02-12|2010-02-12|Method and apparatus for in vitro testing for medical devices|

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US12/704,607|2010-02-12|

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PCT/US2011/024291|WO2011100393A1|2010-02-12|2011-02-10|Method and apparatus for in vitro testing for medical devices|

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