Patent Application
20160158070
The present invention relates to a method of analyzing internal sanitary protection articles in order to determine the effect of fiber density on the fluid absorbent properties of the article. It is especially helpful in understanding how absorbency of a compressed article such as a tampon can be affected by fiber density and fiber density gradients formed by compression and/or manufacturing process.
Tampons are absorbent articles and formed in order to absorb menstrual fluid before it exits the vagina. While tampons are efficient in offering protection to the wearer, tampons can fail, which results in leakage unto the users undergarment. There are three basic reasons for failure: the tampon is saturated with fluid and cannot hold any more, the user has a gush of fluid due to fluid pooling in the body and a sudden intra-abdominal pressure occurs (either due to changes in body position or stress event such as coughing, laughing, or sneezing) which the tampon cannot quickly absorb or the fluid has managed to by-pass the tampon and exit the body without contacting the absorbent material. The first mode of leakage can be mitigated by changing the tampon; the second mode of leakage can be improved by the inherent properties of the tampon and the third is the subject of structure and material improvements.
The second type of leakage is referred to as “early leakage,” where women see the tampon as “half-full” and still leaks. Early leakage can be avoided by developing tampons that quickly absorb the fluid and keeps the fluid in after uptake. O.b.® tampons were developed to have a fiber density gradient with lower fiber density on the outside to quickly move fluid in and a higher fiber density in the inside to secure the fluid within its core. Understanding and quantifying this fiber density and fiber density gradient of tampons and how it affects its ability to manage menstrual fluid is important for developing tampons with superior leakage protection.
Standard ways to calculate the fiber density of a tampon, where overall fiber density is derived from the mass and volume, are limited as they only provide the fiber density of the tampon as a whole rather than the fiber density gradient through the cross-section of the tampon. Other methodologies include single slice 2-D X-ray scanning and impregnating the tampon in epoxy and slicing the tampon to visualize its cross-section. These methods are also limited as it only provides a qualitative understanding rather than a quantitative measurement of the fiber density of the tampon at its outer and inner sections.
U.S. Pat. No. 6,839,402 purports to disclose a radiological system for analyzing an absorbent article. The system can include computed tomography (CT) and measures the liquid in an absorbent article. Examples of diapers and sanitary napkins were analyzed. A visualization of the liquid within an article can be displayed as can just the liquid alone can be displayed.
U.S. Pat. No. 7,166,085 purports to disclose an in vitro testing device to study the placement of a tampon into a receptacle representing relevant in vivo anatomical and physical characteristics. It discloses a coronal MRI image of a user having a tampon in the vagina, inserted by the user using a typical commercial tampon and applicator system.
US 20120277710 purports to disclose methods for making absorbent members having fiber density profile. A micro CT Scan procedure is described under Test Methods, which is used to quantitatively measure the fiber density profile throughout the thickness of the absorbent article non-invasively. The section of the absorbent article tested is preferably free from embossments and apertures and cut from the article in a way that doesn't disrupt the thickness or fiber density of the section. The micro-computed tomography system used in the test methods is μCT 40, ID#4286, Scanco Medical AG.
This invention relates to the use of X-ray CT (computed tomography) scanning technology and software to understand the fiber density and the fiber density gradient of tampon products in quantitative measures. This invention allows for improved analysis of a tampon, especially as it is exposed to fluid in a simulated anatomical environment.
In one aspect of the invention, an apparatus for in vitro testing of an absorbent article includes a radiolucent pressure chamber, a radiological device, and a computing device. The radiolucent pressure chamber includes a radiolucent simulated body cavity arranged and configured to accommodate the absorbent article, a test liquid port, and a pressure control system. The radiological device is disposed to collect radiological data from the absorbent article, and it includes a radiolucent test device support capable of accommodating the radiolucent pressure chamber, and at least one radio scanning element rotatable about the radiolucent test device support. The computing device is operatively connected to the radiological device and has a program for analyzing the data collected by the radiological device.
In another aspect of the invention, a method for in vitro testing of an absorbent article includes the steps of inserting the absorbent article into a radiolucent simulated body cavity, placing the radiolucent simulated body cavity into a radiolucent pressure chamber, placing the radiolucent pressure chamber into a radiological device, pressurizing the radiolucent pressure chamber to a predetermined pressure, providing test liquid through the test liquid port and to the absorbent article, acquiring data relating to the absorbent article and the test liquid via the radiological device and an associated computing device, and analyzing the acquired data. The radiological pressure chamber includes a simulated body cavity arranged and configured to accommodate the absorbent article, a test liquid port, and a pressure control system. The radiolucent test device has at least one radio scanning element rotatable about radiolucent test device support having the pressure chamber disposed thereon.
A more particular description of the invention, briefly summarized above may be had by reference to the embodiments thereof that are illustrated in the appended drawings. It is to be so noted, however, that the appended drawings illustrate only typical embodiments of the invention and, therefore, are not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments.
Understanding how fluid dynamically moves through a tampon is an important part of assessing tampon structure and function to improve the products. The main challenge with this understanding is that the fluid movement and distribution through a tampon cannot be visualized without advanced medical imaging technologies. We have devised a novel method to qualitatively understand how fluid moves through a tampon using an in vitro apparatus that simulates the vaginal environment.
This method improves on state-of-the-art scanning technology such as x-ray computed tomography (“CT”) scanning in which absorbent articles may be scanned. In one improvement, tampons can be scanned inside a plastic vial extending over the end of the scanner bed. After scanning each tampon, the tampon fiber density can be measured from the CT scan images and corrected to Hounsfield Units (“HU”) as described below.
In addition, the method takes advantage of the concepts in Hou et al., US Pat. App. Pub. No. US 2011-0200976 A1, describing a pressurized simulated testing device and method, the contents of which are herein incorporated by reference.
Thus, the inventive method employs an x-ray transparent, pressurizable container for a tampon. The container includes one or more environmental control ports and at least one liquid delivery port.
In one embodiment, shown in
In the embodiment shown in
CT Scanning for Fiber Density:
Current commercial O.b.® ProComfort tampons in Normal absorbency, 9-12 g made out of 75% GALAXY® rayon fibers (available from Kelheim Fibres GmbH, Kelheim, Germany) and 25% viscose rayon fibers (N=10) and a prototype tampon of “higher fiber density” made out of 100% GALAXY® rayon fibers in “Normal” absorbency, 9-12 g (N=10) were placed on the radiolucent test bed 104 of an Inveon CT scanner (Siemens Medical Systems, Knoxville, Tenn.), such as shown in
Tampons were scanned inside a plastic 10 ml vial extending over the end of the scanner bed. CT scan images were taken from the tip of the tampon to the base, using the following settings: X-ray source 80 kVp, 500 μA, X-ray detector magnification low, binning 2, CCD size 3072×2048, exposure 800 ms/step, 360 rotation steps over 360 degrees. Images were reconstructed using a cone-beam filtered back projection algorithm on a Cobra multiprocessor system, into images of size 1536×1536×1024, with isotropic voxels of size 53 μm.
After scanning each tampon, the tampon fiber density was measured from the CT scan images using PMOD software (PMOD Technologies Ltd, Zurich, Switzerland), and corrected to Hounsfield Units (HU) using scale factors derived from a CT scan of a small vial of water (air HU=−1000, water HU=0).
The tampon fiber density was converted from HU units to the standard density units of grams per cubic centimeter (g/cc) using CT scans of pellets of known fiber density. Fiber pellets of two different materials were compressed at various pressures (1500-2500 psi) to generate a range of fiber density values. The pellets were weighed, and scanned in the CT machine, and the size of each pellet was measured from the images. A total of 30 pellets were imaged: fifteen were made with a uniform blend of 75% Galaxy rayon fibers and 25% Viscose rayon fibers (same as the ProComfort tampon) and fifteen were made with 100% Galaxy rayon fibers (same as the High Fiber density Prototype).
The pellet fiber density data in HU and g/cc units were plotted and a linear regression line was fit to the data. The regression equation was used to convert the HU fiber density data to g/cc data for the tampon analysis.
Density (g/cc)=(HU+1008)/1224
Table 1, below, summarizes the average fiber density of the eight lobes, eight stems, and core for the O.b.® ProComfort tampon and the “high fiber density” tampon Prototype.
While the absolute fiber density values are informative, it is the fiber density gradient that impacts the flow of fluid from one region of the tampon to another. The gradients between the lobe and the stem, and the stem and the core, are shown in
CT scans of tampons demonstrated that the density of material inside the tampons could be measured accurately, using a non-invasive and non-destructive imaging methodology. Tampons exhibited X-ray densities ranging from −750 HU to −430 HU. Conversion factors were derived from standard pellets of known fiber density, to relate X-ray densities in HU to mass densities in g/cc.
Two different tampon types were tested, to compare and contrast the performance of a commercially available O.b.® ProComfort tampon, and a High Fiber density Prototype tampon. Based on CT imaging data, three main differences can be observed between the O.b.® ProComfort tampon and the Prototype tampon: (1) the O.b.® ProComfort tampon showed lower fiber density at the lobe, stem, and core; (2) O.b.® ProComfort tampon showed a higher fiber density gradient between the lobe and stem versus the Prototype tampon; (3) both tampon types exhibited a negative gradient between the stem and the core, although the O.b.® ProComfort tampon had a smaller gradient than the Prototype.
A consumer use study on the O.b.® ProComfort tampon versus the Prototype tampon with higher fiber density was conducted with results showing significantly higher leakage rates for the Prototype tampon, see Table 2, below.
The consumer use test showed that the high fiber density tampon prototype performed poorly. The higher leakage rate may be attributed to the fiber density gradient of the Prototype tampon. The fiber density gradient from the lobe to the stem was lower in the Prototype tampon than the O.b.® ProComfort tampon, which may slow fluid transfer away from the periphery. In addition, there was a negative fiber density gradient from the stem to the core, particularly in the Prototype tampon, which could prevent fluid moving into the core from the stem. In both areas, the fluid flow is sub-optimal, and the O.b.® ProComfort tampon outperformed the Prototype.
Dynamic Fluoroscope:
Tampons were imaged using dynamic fluoroscope (Siemens MicroCAT II). Acquisition parameters included a 70 kVp X-ray voltage at 500 uA current, a 100 ms exposure time, with 50 um pixels.
The tampon overwrap was carefully removed from each tampon before testing. The tampon weight was recorded in order to calculate the total fluid add-on. Each tampon was placed to the left side of the simulated vaginal model made out of a thermoplastic elastomeric polymer (Dermasol, California Medical Innovations) in an environment that instilled uniform intra-abdominal pressure shown in
5 cc of a simulated menstrual fluid was instilled into the pressurized chamber (test container 106) through port 206c over 20 seconds (similar to a gush) via a syringe by hand. Dynamic fluoroscopic data was recorded over 5 minutes as the tampon absorbed the fluid. Scans were taken during the menstrual fluid insult of the tampon at a rate of one image per 1.5 second.
Five tampons of each O.b.® Original (McNeil-PPC, Inc., Skillman, New Jersey, US) in Super Absorbency and O.b.® Flexia (J&J GmbH, Wuppertal, Germany) in Super Absorbency were imaged during the menstrual fluid insult, as described above. Fluid movement through the tampon was visualized in the sagittal view.
Five (5) women used the O.b.® Original tampon (J&J GmbH, Wuppertal, Germany) in the Normal absorbency versus the O.b.® Flexia tampon (J&J GmbH, Wuppertal, Germany) in Normal absorbency in a home use test. Each subject recorded the stain pattern of the tampon post-wear in a tampon diary sheet.
The stain pattern data from the in-vivo clinical test samples were compared against the stain patterns achieved during the in-vitro dynamic fluoroscope insults. Both in-vivo and in-vitro data sets showed similar stain patterns for the O.b.® Original tampons—the absorbed fluid (both menstrual in in-vivo testing and test fluid in in-vitro testing) remains to one side of the tampon in the sagittal view. Similarly, in-vivo and in-vitro data sets showed similar stain patterns for the O.b.® Flexia tampons—the absorbed fluid (both menstrual in in-vivo testing and test fluid in in-vitro testing) is distributed around the tampon. This movement is facilitated by the apertured film that is attached to the tampon in a wing-like design.
The specification and embodiments above are presented to aid in the complete and non-limiting understanding of the invention disclosed herein. Since many variations and embodiments of the invention can be made without departing from its spirit and scope, the invention resides in the claims hereinafter appended.
