IMAGE ANALYSIS PROCESSES AND METHODS FOR THE EVALUATION OF TAMPON PERFORMANCE

• US 20080294378A1
• Filed: 05/05/2008
• Published: 11/27/2008
• Est. Priority Date: 05/10/2007
• Status: Active Grant

• Current Assignee: Eveready Battery Company Incorporated (Energizer Holdings, Inc.)
• Original Assignee: Playtex Products Incorporated (Edgewell Personal Care Company)
• Inventors: Dougherty, Eugene P. JR., McCarthy, Shirley, Minkin, Mary Jane, Ebert, Phil
• Granted Patent: US 8,571,883 B2
• Time in Patent Office: Days
• US Class Current: 702/182
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: G01R 33/285 Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR
• CPC Class Codes: G01R 33/5608 Data processing and visualization specially adapted for MR, e.g. for feature analysis and pattern recognition on the basis of measured MR data, segmentation of measured MR data, edge contour detection on the basis of measured MR data, for enhancing measured MR data in terms of signal-to-noise ratio by means of noise filtering or apodization, for enhancing measured MR data in terms of resolution by means for deblurring, windowing, zero filling, or generation of gray-scaled images, colour-coded images or images displaying vectors instead of pixels image data processing or generation, in general G06T
• CPC Class Codes: G06Q 10/00 Administration; Management

Abstract

A method for the study and evaluation of the performance of medical devices in vivo is disclosed. The medical devices are preferably tampons that are observed and evaluated in the vaginal cavities of women during their menstrual cycles in order to obtain data relative to tampon performance for the improvement of tampon technology. The method preferably uses magnetic resonance imaging (MRI), although other types of imaging techniques may be used. The present invention also resides in a method of MRI analysis in which a three-dimensional surface model image of a medical device such as a tampon or similar feminine hygiene product in vivo is created from two or more two-dimensional cross section images and combined with a second surface model image to produce a single image.

Claims

1. A method for evaluating the behavior and performance of medical devices in vivo, said method comprising the steps of:

establishing a database populable with information relevant to a study of the performance of medical devices;

qualifying one or more candidates as participants in said study for evaluating the performance of said medical devices in vivo by subjecting said candidates to an evaluation process that at least determines the ability of said candidates to safely participate in said study and obtains consent from said candidates regarding said participation;

entering information relevant to said candidates and the qualification thereof into said database;

determining detailed protocols and MRI parameter settings relevant to said candidates and said study;

providing an MRI operable in accordance with said protocols and MRI parameter settings and using said MRI to conduct one or more scans of each candidate;

qualitatively analyzing said MRI scans;

quantitatively analyzing at least a portion of said MRI scans by determining physical characteristics of at least one of said anatomical structures and said medical device using image analysis software and data analysis and statistical software packages; and

populating said database with information indicative of said quantitative and qualitative analyses.

2. The method of claim 1, wherein said medical device is a tampon.

3. The method of claim 2, wherein said step of qualifying one or more candidates includes collecting information selected from said one or more candidates, said information including at least one of age, height, weight, current state of well-being, number of children delivered, hygiene practices, medical histories, birth control histories, characterizations of typical menstrual flows, handedness, and combinations of the foregoing.

4. The method of claim 2, wherein said one or more candidates for said study include at least three teenagers, at least two multiparous women of any age, and at least three perimenopausal women.

5. The method of claim 2, wherein said step of determining detailed protocols and MRI parameter settings includes at least one of sequencing imaging scans to define appropriate anatomical features, timing imaging scans, determining pulse times, and determining spin echo parameters.

6. The method of claim 2, wherein said step of determining detailed MRI protocols and parameter settings includes determining time intervals relative to the placement of said tampon.

7. The method of claim 6, wherein the time intervals relative to the placement of said tampon include planning scans prior to the insertion of said tampon and after insertion of said tampon.

8. The method of claim 2, wherein said one or more scans includes a plurality of sagittal scans, a plurality of transaxial scans, and a plurality of coronal scans.

9. The method of claim 2, wherein said step of providing an MRI operable in accordance with said protocols and MRI parameter settings and using said MRI to conduct one or more scans of each candidate includes providing a plurality of scans, each scan consisting of a localizer gradient echo sequence followed by three orthogonal planes of fast spin echo T2-weighted scans through said tampon.

10. The method of claim 9, further comprising providing a plurality of axial T1-weighted imaging scans.

11. The method of claim 2, wherein said step of qualitatively analyzing said MRI scans comprises at least one of a step of identifying anatomical structures proximate said tampon in said participant;

observing said tampon over time;

observing said tampon'"'"'s influence on a vaginal wall of said participant;

determining movement of said tampon within said participant;

determining how a specific disease state influences tampon performance; and

determining an indication of fluid absorption of said tampon.

12. The method of claim 2, wherein said step of quantitatively analyzing at least a portion of said MRI scans comprises segmenting at least two images of said scanned participant.

13. The method of claim 2, further comprising using data from said step of quantitatively analyzing at least a portion of said MRI scans by determining physical characteristics to produce at least one of a vaginal cavity mold and a tampon using rapid prototyping.

14. A method of MRI analysis, said method comprising the steps of:

creating a surface model image of a medical device in vivo from two or more two-dimensional cross section images of said medical device in vivo; and

combining said surface model image of said medical device in vivo with a second surface model image to produce a single image;

wherein said second surface model image is at least one of said medical device in vivo and an anatomical structure proximate said medical device in vivo.

15. The method of claim 14, wherein said medical device is a tampon.

16. The method of claim 15, further comprising using software to export said surface model image to a computer-readable format.

17. The method of claim 15, further comprising making a quantitative analysis of a measurement of at least one of said medical device in vivo and said anatomical structure.

18. The method of claim 15, further comprising making a qualitative analysis regarding said medical device in vivo.

19. The method of claim 15, further comprising using rapid prototyping to produce at least one of a vaginal cavity mold and a tampon for use in a study of the performance of tampons.