Medical device and method for conducting papanicolaou (pap) test

Abstract

A medical device and method for conducting papanicolaou (pap) test is disclosed. The device comprises a protective guide, an endoscopic device, a cell extraction device, and a computing device. The protective guide has an upper chamber and a lower chamber. The endoscope has a camera and a light emitting device assembly. The endoscope is securely positioned within the upper chamber. The cell extraction device has a handle at one end and a brush affixed at another end. The cell extraction device is slidably positioned within the lower chamber. The cell extraction device slides outward for positioning the brush around the user's cervix, thereby conveniently allowing for a cervical cell sample to be collected. The computing device is in communication with the endoscope device to improve detection accuracy and visual examinations of the targeted cervical area, thereby enabling the user to collect the cervical cell sample for conducting the PAP test.

1 . A medical device for conducting a Papanicolaou (PAP) test, comprising:
 (a) a protective endoscopic catheter or protective guide having an upper chamber and a lower chamber;   (b) an endoscope device having a camera and a light emitting device assembly, wherein the endoscope device is securely positioned within the upper chamber of the disposable protective guide, and
 wherein the upper chamber comprises a lip stopper configured to stop the endoscopic camera from going forward with hollow middle to provide better visual without creating extra barrier in front of the light emitting device and lenses of the camera, and 
   (c) a cell extraction device having a handle at one end and a brush affixed at another end, wherein the cell extraction device is slidably positioned within the lower chamber of the protective guide, and
 wherein the cell extraction device is configured to enable a user to slide outward for positioning the brush around the user's cervix, thereby conveniently collecting a cervical cell sample, and 
   (d) a computing device in communication with the endoscope device configured to improve detection accuracy and visual examinations of the targeted cervical area, thereby enabling the user to accurately position the cell extraction device and comfortably collecting the cervical cell sample for conducting the PAP test without the need for assistance by a gynecologist and/or a medical practitioner,
 wherein the computing device comprises a processor and a memory having a software module executed by the processor, wherein the software module is at least one of a plugin component and/or a browser extension, wherein the processor is in communication with a server via a network; 
 wherein the computing device is in communication with the endoscope via a universal serial bus (USB) cable, and 
 a database in communication with the server configured to store data related PAP test for the user. 
   
     
     
         2 . The medical device of  claim 1 , wherein the protective guide is a disposable dual-chambered tube. 
     
     
         3 . The medical device of  claim 1 , wherein the light emitting device assembly comprises one or more light emitting diodes (LEDs) configured to produce illumination for the camera through the endoscope to acquire video and/or image data of the user's cervical area. 
     
     
         4 . The medical device of  claim 1 , wherein the database in communication with the server is configured to store data related to testing documentation for patients, medical history forms and patient file database, training videos and guideline manuals, image and video file capture and storage, specimen label and laboratory requisition form printable templates, and Health Insurance Portability and Accountability Act (HIPAA) compliant integration options for Electronic Health Record (EMR) systems. 
     
     
         5 . The medical device of  claim 1 , wherein the computing device is at least anyone of a smart phone, a tablet, a computer, a laptop, a monitor, and other suitable electronic communication device configured to provide visual reference for the medical professionals conducting the test. 
     
     
         6 . The medical device of  claim 1 , is further configured to utilize for early detection of chlamydia, gonorrhea, human papillomavirus (HPV), and other sexually transmitted viruses or infections. 
     
     
         7 . A protective guide for protecting a cell extraction device during a pap smear test, comprising:
 (a) an endoscopic device, comprising:
 i. a camera configured to determine the location of the cervix; 
 ii. a light emitting device configured to illuminate the surfaces or spaces to view the width; 
 iii. a camera cover configured to cover the camera and the light emitting device, wherein the camera cover is an endoscope cover, and 
 iv. a thin flexible transparent sheath configured to cover the camera cover, wherein the flexible transparent sheath is a condom covering the camera cover, and 
   (b) a cell extraction device cover configured to cover the cell extraction device, wherein the cell extraction device is a pap smear brush or pap smear broom, or pap smear spatula,
 wherein the cell extraction device is pushed outward from the cell extraction device cover, thereby allowing the cell extraction device brush to contact the cervix and allow for the extraction of sample cells from the cervix, wherein the cell extraction device is pulled back into the cell extraction device cover after collecting sample cells from the cervix. 
   
     
     
         8 . The protective guide of  claim 7 , wherein the thin flexible transparent sheath covers the endoscope cover, the endoscope, an endoscope cord. 
     
     
         9 . The protective guide of  claim 7 , wherein the cell extraction device cover comprises a tunnel configured to insert the cell extraction device. 
     
     
         10 . The protective guide of  claim 7 , wherein the camera cover and cell extraction device cover are press fit together. 
     
     
         11 . The protective guide of  claim 7 , further comprising at least one elastic band for holding the camera cover and the cell extraction device cover together. 
     
     
         12 . A method of collecting cervical tissue samples from a patient/user, comprising the steps of:
 a) inserting a protective guide through the introitus of a user's vagina, wherein the protective guide comprising an upper chamber configured to receive an endoscope device and a lower chamber configured to receive a cell extraction device;   b) determining the location of the cervix using the endoscope device;   c) pushing the cell extraction device outward from the lower chamber to contact the cervix;   d) collecting cervical tissue samples from the cervix using the cell extraction device;   e) pulling the cell extraction device back into the lower chamber;   f) removing the protective guide with the endoscope device and cell extraction device from the user's vagina, and   g) securing the cervix tissue samples in a collection container for submitting them to a lab for diagnosis and results.   
     
     
         13 . The method of  claim 12 , allows the user to collect the cervical tissue samples by themselves with maximum comfort and privacy at any convenience time. 
     
     
         14 . The method of  claim 12 , is utilized for early detection of chlamydia, gonorrhea, human papillomavirus (HPV), abnormal cervical cells, precancerous and cancerous lesions, vulvar cancers, cervical polyps, growths and anomalies of the vaginal canal and cervix, and other sexually transmitted viruses or infections. 
     
     
         15 . A method of collecting cervical tissue samples from a patient for conducting a PAP smear test, comprising the steps of:
 a) inserting a cell extraction device into a protective guide,
 wherein the protective guide comprising an upper chamber for receiving an endoscope device having a camera and a light emitting device assembly and a lower chamber for receiving the cell extraction device and to allow for access and movement of the cell extraction device, and 
 wherein the cell extraction device comprising a handle at one end and a brush or head fixed at another end, 
   b) inserting the protective guide through the introitus of a user's vagina until the cervix is visualized;   c) determining the location of the cervix using the endoscope device;   d) pushing the cell extraction device outward from the lower chamber to contact the cervix;   e) cleansing the cell extraction device to clear secretions from the cervix;   f) collecting cervical tissue samples from the cervix using the cell extraction device;   g) pulling the cell extraction device back into the lower chamber;   h) removing the protective guide with the endoscope device and cell extraction device from the user's vagina;   i) securing the cervix tissue samples in a collection container, and   j) submitting the sample's container to PapEasy lab for diagnosis and results.   
     
     
         16 . The method of  claim 15 , uses a small lubricant package to lubricate the vaginal introitus enough to coat the rim of the vaginal opening. 
     
     
         17 . The method of  claim 15 , wherein the endoscope device is bend slightly upwards or downwards to visualize the cervix. 
     
     
         18 . The method of  claim 15 , wherein the samples are submitted with the contact information of the user via a dedicated application software. 
     
     
         19 . A method for generating results for a PAP smear test, comprising the steps of:
 a) creating a PapEasy user account by registering into a registration portal of a dedicated PapEasy application software using one or more user credentials;   b) submitting the user's cervical tissue samples to PapEasy lab for diagnosis and results;   c) submitting the user's contact information clearly in the registration portal, and   d) receiving the PAP test result on the registered PapEasy user account.   
     
     
         20 . The method of  claim 19 , wherein the result of PAP test sent to the registered account is notified to the user as soon as the results are ready via a message or email.