WO2020230168A1

WO2020230168A1 - A self-operated device for female vaginal and uterine sampling, inspection and performing medical procedure(s) therein

Info

Publication number: WO2020230168A1
Application number: PCT/IN2020/050438
Authority: WO
Inventors: Anirban Palit
Original assignee: PRAMANIK, Sayantani
Priority date: 2019-05-16
Filing date: 2020-05-14
Publication date: 2020-11-19

Abstract

A self-operated manoeuvring device (100) for female vagina and uterine inspection, and performing medical procedure(s) therein is disclosed. The device (100) includes a hollow elongated cylindrical body (102) having a proximal end A and a distal end A'. The distal end A' has a smaller diameter as that of the proximal end A. A plunger (104) is configured to trail the body (102). The plunger 104 has a knob (110) and a shaft (106).The shaft (106) is attachable to at least one rotatable payload. The shaft (106) is configured to retract inside and extend out of the distal end A' of the body (102) as pulling and pushing the knob (110) respectively. The shaft (106) is also configured to rotate as the knob (110) rotates.

Description

1. TITLE OF THE INVENTION: A SELF-OPERATED DEVICE FOR FEMALE VAGINAL AND UTERINE SAMPLING, INSPECTION AND PERFORMING MEDICAL PROCEDURE(S) THEREIN

3. PREAMBLE OF THE DESCRIPTION: The following complete specification particularly describes the invention and the manner in which it is performed. FIELD OF INVENTION

The present embodiment generally relates to the field of medical devices, and more particularly to a self-operated device for female vaginal and uterine sample collection and/or inspection, and to method(s) for performing medical procedure(s) therein. More particularly, the device is capable of being used independently for obtaining ecto- epthelial and endo-epithelial cells from women’s cervix for the identification of pre- cancerous and cancerous conditions.

SUMMARY OF THE PRIOR ART

There are certain tests for screening of cervical cancer in females, such as Liquid Cytology (PAP), Direct Pap Smear, PCR based hrHPV detection which require cervical sample collection from the uterine lining thereof. Cervical cancer is a leading cause of cancer-related mortalities in women of developing countries and is the second most common type of cancer in women worldwide. It is estimated that in India, about 160 million women aged 30-59 years are at risk of developing cervical cancer. Approximately 96,000 new cases are diagnosed annually with 60,000 deaths, representing an appalling case fatality rate of 49 percent. The cervical cancer usually progresses slowly over an extended period from the first appearance of precancerous abnormalities like lesions in the cervix. Such lesions are also known as cervical intraepithelial neoplasia. If left untreated, these lesions can deepen over time and ultimately develop into an invasive cancer of the cervix and associated tissues. Early detection and diagnosis can save lives and reduce the burden on the national healthcare system. Therefore, it is important for sexually active women to undergo periodic screening by PAP or HPV as they are at a greater risk of Human Papilloma Virus infection. There are different manoeuvring tools which can easily collect specimens from the female vagina and uterine. However, such tools are handled by medical practitioners, leading to feeling of discomfort, embarrassment, and expense while obtaining specimens to diagnose cervical cancer of female patients. Apart from the cervical sampling, there are certain other medical procedures to be performed in female vagina and uterine such as para cervical block, hysteroscopy, curette scraping, cone biopsy, copper T implantation and removal, cervical diaphragm implantation, and so on. Currently, the available tools though can collect samples from vagina and uterine lining, however require medical practitioner’s assistance, leading to higher cost and effort. Some devices may collect ecto-cervical samples only. Some recent devices may include a brush which may be extended to collect cells, however may be incapable to rotate and may be difficult to be ejected from the device to store specimens for transportation. In addition, such brushes when extended and go to retract, may touch the walls surrounding the brush. Such disadvantages may lead to loss of specimens, making the current devices less efficient to collect the specimens. Such devices may be limited to only one purpose of sample collection, not the other purposes such as inspection, para cervical block, hysteroscopy, curette scraping, cone biopsy, copper T implantation and removal, cervical diaphragm, and so on.

Hence, there may be a need to develop handheld selmanoeuvring devices that are self- operable while collecting endo-epithelial and ecto-epithelial cells from woman’s cervix and perform other medical procedure(s). SUMMARY OF THE INVENTION

In view of the foregoing, an embodiment herein provides a portable manoeuvring device 100 for female vagina and uterine sampling and inspection, and performing medical procedure(s) therein. The device 100 includes a hollow elongated cylindrical body 102 having a proximal end A and a distal end A’. The distal end A’ has a smaller diameter as that of the proximal end A. A plunger 104 trailing the body 102 has been labelled with a curly bracket depicting the length of the plunger. The plunger 104 has a knob 110 and a shaft 106. The shaft 106 is attachable to at least one rotatable payload. The shaft 106 is configured to retract inside and extend out of the distal end A’ of the body 102 while pulling and pushing the knob 110 respectively. The shaft 106 is also configured to rotate as the knob 110 rotates. The device 100 is handheld, self- manoeuvring, and self-operable for obtaining cervical sample(s). The payload is detachably attached to the shaft 106. The payload is selected from a group consisting of a brush 108, a camera or an imaging sensor, a curette scraping tool, a telescopic arm, a scalpel and so on with or without a telescopic arm. In an aspect, a portable manoeuvring device 100 for cervical sample collection from the female vagina and uterine is disclosed. The device 100 includes a hollow elongated cylindrical body 102 having a proximal end A and a distal end A’. The distal end A’ has a smaller diameter compared to that of the proximal end A. A plunger 104 trailing the body 102 has a knob 110 and a shaft 106. The shaft 106 is configured to retract inside and extend out of the distal end A’ of the body 102, while pulling and pushing the knob 110 respectively. The shaft 106 is configured to rotate as the knob 110 rotates. A brush 108 having a plurality of bristles 112 is configured to swipe the uterine lining and collect the cervical sample therefrom. The brush 108 is configured to detachably attach to the shaft 106, and follow all the movements of the shaft 106. The device 100 is handheld, self-manoeuvring, and self-operable. Number of rotations of the shaft 106 is countable with a clear“clicking sound/ feel” ensuring adequate number of turns for the procedure(s) and the sample collection. The shaft 106 is extensible. The shaft 106 has at least one O-ring 116 and a plurality of barrel(s) 114 encompassing thereof. The payload and the brush 108 are configured to rotate axially to mount over the head 106A of the shaft 106, providing a snap fit attachment therein. The payload and/or the brush 108 are configured to extend out of the shaft 106 as the shaft extends out of the body

102, and retract inside therein as the shaft 106 retracts inside the body 102. The sample is collected for tests selected from a group consisting of HPV Detection, Liquid Cytology, Triaging, direct Pap Smear, and so on. In another aspect, a method for performing medical procedure(s) in a female vagina and uterine is disclosed. The method involves attaching a payload to a head 106 A of a shaft 106 of a maneuvering device 100. The device 100 includes a hollow elongated cylindrical body 102 having a proximal end A and a distal end A’. The distal end A’ has a smaller diameter as compared to that of the proximal end A. A plunger 104 is configured to trail the body 102, and includes a rotatable shaft 106 and a knob 110. The device 100 is handheld, and to be used by the gynecologist. The distal end A’ of the device 100 is configured to ingress into vagina of the female. The method involves pushing a knob 110 of the shaft 106, traversing the shaft 106 and the payload through the body 102 and extending out of the distal end A’ thereof. The procedure is performed in vagina and uterine, followed by pulling the knob 110 causing the shaft 106 to retract inside the body 102. The shaft 106 is configured to retract inside and extend out of the body 102 as pulling and pushing the knob 110 respectively.

In yet another aspect, a method for collecting specimens from a female vagina and uterine is disclosed. The method involves attaching a brush 108 to a head 106A of a shaft 106 of a maneuvering device 100. The device 100 further includes a hollow elongated cylindrical body 102 having a proximal end A and a distal end A’. The distal end A’ has a smaller diameter as that of the proximal end A. A plunger 104 trailing the body 102 includes a knob 110 and a rotatable shaft 106. The device 100 is handheld, and self-operable by the female. The device 100 is configured to ingress into the vagina, followed by maneuvering through the uterine lining. Thereafter, the knob 110 is caused to push to move the shaft 106, and hence the brush 108 to traverse through the body 102 until the brush 108 extends out of the distal end A’. The method further involves collecting ecto-and endo-epithelial cells from the uterine lining by rotating the shaft 106. The knob 110 is then pulled to retract the shaft 106 inside the body 102 such that the brush 108 is still out of the mouth 102A of the body 102. Finally, the collected specimens can be procured from the brush 108 for further testing. The device 100 is portable after collecting the specimens. The brush 108 retracts inside the body 102 without touching walls thereof. These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the concept thereof, and the embodiments herein include all such modifications.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, features, and advantages of the embodiment will be apparent from the following description when read with reference to the accompanying drawings. In the drawings, wherein like reference numerals denote corresponding parts throughout the several views:

Figure 1A shows a schematic view of a portable manoeuvring device (100), in accordance with an illustrative embodiment;

Figure IB shows a schematic view of the device (100) in an extended position, in accordance with the illustrative embodiment;

Figure 2A shows another schematic view of the device (100) including a brush 108 attached therewith in an extended position, in accordance with another aspect of the embodiment herein;

Figure 2B shows a transverse sectional view of the device (100) with the brush

108 in an extended out position, in accordance with the embodiment herein; Figure 2C shows a transverse sectional view of the device (100) with the brush 108 in a retracted position, creating click sound during rotation of the shaft 106, in accordance with the embodiment herein; and Figure 2D shows a transverse sectional view of the device (100) with the brush

108 in a retracted position, in accordance with the embodiment herein.

DETAILED DESCRPTION OF THE PREFERRED EMBODIMENTS

Definitions

Plunger relates to a device that works with thrusting movement applying suction to eject or withdraw fluids or specimens.

Cervix relates to a cylinder-shaped neck of tissue that connects the vagina and uterus. The upper cervix (endocervix) is lined by a simple columnar epithelium that contains mucous-secreting cells. Endo- and ecto- epithelial cervical cells are taken for sample for cancer diagnosis.

Human papillomavirus (HPV) test refers to a screening test for cervical cancer, but the test doesn’t tell whether the patient has cancer. A sample of cells is taken from the cervical area during a pelvic exam using a swab or small brush.

Pap Smear Test also called a Pap test. The test is a screening procedure for detection of precancerous and cancerous processes in the cervix or colon.

Liquid Cytology Testis a latest method of preparing cervical samples for cytological examination. It involves making a suspension of cells from the sample and this is used to produce a thin layer of cells on a slide. The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein. As the existing manoeuvring device(s) or tools are handled by medical practitioners for vaginal and uterine inspection and performing other medical procedure(s) therein, such devices may provide feeling of discomfort, embarrassment, and expense. In addition, such tools are not ergonomic, hence difficult to handle. Therefore, the present invention discloses various aspects of an embodiment of handheld manoeuvring device(s) which can be handled autonomously for ecto- and endo cells collection from cervix. The present invention also discloses method(s) for performing other medical procedure(s) therein in accordance with another embodiment. In an embodiment, a schematic view of a manoeuvring device 100 is shown in Figure 1A. The device 100 includes a hollow elongated cylindrical body 102 having a proximal end A and a distal end A’. The device 100 introduces into the vagina and/or uterine for performing procedure(s) therein from the distal end A’ to the proximal end A. The distal end A’ has a smaller diameter than the proximal end A.

The body 102 has varying diameter throughout the length thereof. The body 102 is divided into various regions basis the diameter thereof. The body 102 has regions such as a mouth portion 102A, a major portion 102B, followed by a plurality of portions 102C, 102D, 102E1, and 102E2. The portion 102A has the smallest diameter and the first portion to be introduced into the vagina. The smallest diameter enables easy insertion into the vagina and manoeuvring therethrough. The portion 102A is configured to be a hole through which a shaft 106 or a payload comes out therethrough to perform procedure(s), details thereof are discussed hereinbelow. The portion 102A is configured to be a hole through which the extended out shaft 106 or the payload traverses back to retract.

The diameter of the portion 102 A smoothly and continuously increases to form the portion 102B. The portion 102B is the major portion such that the shaft 106 and/or the payload traverse therethrough, details thereof are discussed hereinbelow. The portion 102B has the diameter thereof increases proximally throughout to reach another portion 102C which is slightly elevated as that of the portion 102B. The increased diameter of the portion 102C is configured to provide a maximum grip of holding thereon while manoeuvring the device 100 into the vagina. The portion 102C has greater diameter as that of the portion 102B and also continuously elevating therethrough. The portion 102C further elevates to a comparatively larger extent to form a disc 102D. The disc 102D appears to be a disc shaped. The disc 102D has constant diameter along the length thereof. The disc 102D is configured to provide a kind of stopper beyond which the device 100 cannot be inserted into the vagina. The diameter of the portion 102D further depreciates to form a portion 102E1, further depreciating to form another portion 102E2. The portions 102E1 and 102E2 are configured to provide a medium through which the shaft 106 just enters into the body 102. In some aspects, the body 102 is a solid body throughout but with hollowness enough to allow the shaft 106 to traverse therethrough. Therefore, as the diameter of the body 102 is varying, the diameter of the shaft 106 is also varying or tapering from the proximal end A to the distal end A’. The device 100 further includes a plunger 104 trailing the body 102. As shown in Figure 1A, the plunger 104 is divided into various portions basis on the diameter thereof. The plunger 104 is defined by a first cylindrical portion 104 A of almost half diameter than that of the disc 102D. The portion 104A has a constant diameter. Hence, the shaft 106 has smaller diameter than that of the body 104A such that the shaft 106 is able to traverse therethrough efficiently. Further, the shaft 106 has length greater than that of the body 102 throughout and is solid enough to allow the shaft 106 to traverse therethrough. The shaft 106 elongating towards the distal end A’, traverses through the portion 102E2, and the portion 102E1, then through the disc 102D, and the portions 102C, 102B, and 102A in sequence. The shaft 106 is configured to extend out of the portion 102 A. The diameter of the shaft 106 is tapering towards the distal end A’ such that the shaft 106 is able to traverse through the varying diameter portions of the body 102. Hence, the shaft 106 is extensible and substantial distal portion thereof is very thin as compared to that of the remaining portion thereof.

Looping back to the portion 104A, the portion 104A further extends to provide a barrel(s) 114 encompassing the shaft 106. The barrel(s) 114 as shown in Figure 1A may be defined as zigzag pattern of curved altitude(s) or a number of protruded layer(s) encompassing the shaft 106. In some aspects, the barrel(s) 114 may be a plurality of thin layers extending from the encompassing the shaft 106. In some aspects, the barrel(s) 114 may be a plurality of thick rings encompassing the shaft 106. Such multiple barrels 114 may be closely placed to each other when in multiple numbers. The number of such barrels 114 may be one or more than two. In some aspects, the barrel(s) 114 may be a single ring encompassing the shaft 106. The barrel(s) 114 may be a unified single equivalent to more than two discs encompassing the shaft 106. Thickness of the barrel(s) 114 may be such that the barrel(s) 114 enable the shaft 106 to rotate in one axis only. The barrel(s) 114 may be of any shape such as including but are not limited to circular, rectangular, oblong, triangular, concave, convex, pentagon, hexagon, quadron, and so on.

In some aspects, there may be at least one O-ring 116 at a distance of the barrel(s) 114, encompassing the shaft 106. The O-ring 116 may be disposed either proximal or distal to the barrel(s) 114. The O-ring 116 is configured to prevent jerk movements of the shaft 106 during extension and retraction thereof. In case of plurality of O-rings, the O-rings 116 may be spaced apart from each other. In another aspect, the O-rings may be disposed closely adjacent to one another. In an aspect, the O-rings 116 may also provide as a marker lines of number of rotation of the shaft 106. The O-rings 116 may also be configured to avoid retracting back of the shaft 106 while rotating thereof or performing the procedure(s) in the vagina.

In some aspects, the barrel(s) 114 and the O-ring(s) 116 may be made from biocompatible plastic such as including but are not limited to Polycarbonate, Polyethersulfone, Polyethylene, Polypropylene, Polysulfone, Poly etheretherke tone, Polytetrafluoroethylene, Polyurethane, Polyvinylchloride, Polyetherimide, Silicone and so on.

Proximal to the barrel(s) 114, the plunger 104 includes a disc 104B and disposed such that the shaft 106 is configured to originate from the portion trailing the portion 104A and is proximally attached thereto. The disc 104B has almost half diameter than that of the disc 102D.

Further, a second cylindrical portion 104C following the disc 104B, has a smaller diameter as that of the disc 104B. The plunger 104 also includes another disc defined by a knob 110 which is of same diameter as that of the portion 102D.

As shown in Figure IB, when the manual pressure is applied on the knob 110, the portion 104A including the barrel(s) 114, the O-ring(s) 116 along with the shaft 106 move inside the body 102 while the disc 104B, the portion 104C, and the knob 110 moves towards the distal end A’ altogether. In such a situation, the disc 104B touches the portion 102E2 ensuring the shaft 106 is extended out completely. Once the shaft 106 is extended out completely out of the portion 102 A, the knob 110 may be rotated clockwise and anti-clockwise to rotate the shaft 106. The barrel(s) 114 may be configured to provide a rigid support to the shaft 106 to avoid the deflection thereof while rotation, and supporting thereof to rotate in one axis only. The O-ring(s) 116 may be configured to avoid retract back of the shaft 106 while rotation and extending out thereof.

In an aspect, a first protrusion 118A may be introduced beneath the portion 102E2 as shown in Figures 1A and IB. In the aspect, a second protrusion 118B may be introduced over the disc 104B. As the knob 110 rotates, the portion 104C and the disc 104B may also rotate. While rotation thereof, the first protrusion 118A may be configured to rotate and touch the second protrusion 118B, producing the“clicking sound’Vfeel indicating completion of one rotation. Hence, number of rotations of the shaft 106 is countable with the clear“clicking sound” ensuring adequate number of turns for the procedure(s) and the sample collection. In some embodiments, obstructed movement of the first and second protrusions 118A and 118B cause the user to feel when one rotation is completed, thereby ensuring number of rotations for the procedure(s). However, as the shaft 106 retracts, the second protrusion 118B moves apart from the first protrusion 118 A. The first and second protrusions 118A and 118B remain outside while the shaft 106 retracts and extends out.

Further, pulling of the knob 110 causes the disc 104B and the portions trailing thereof (the portion 104C and the knob 110) to move apart from the portion 102E2 towards the proximal end A. Such a motion causes the shaft 106 to retract and move back through the body 102 towards the proximal end A.

In another aspect, the manual pressure involving pushing the knob 110 causes the portion 104C to squeeze thereby touching the knob 110 with the disc 104B. As the portion squeezes 104C, the knob 110 touches the disc 104B. Such a movement causes the portion 104C to squeeze thereby touching the knob 110 with the disc 104B. In another aspect, further manual pressure applied on the knob 110 and the disc 104B causes the disc 104B to touch the portion 102E2, thereby squeezing the portion 104A. Further, pulling of the knob 110 causes the knob 110 to move apart from the disc 104B towards the proximal end A. Further pulling of the knob 110 may cause the disc 104B to move apart from the portion 102E2, towards the proximal end A, and the knob 110 from the disc 104B and the portion 104C returns to the“unsqueezed” state. Such a motion causes the shaft 106 to retract and move back through the body 102 towards the proximal end A.

In another aspect, the knob 110 is configured to rotate clockwise and anti-clockwise. The knob 110 rotating clockwise may cause the shaft 106 to elongate and extend out of the portion 102 A while anti-clockwise rotation thereof may cause the shaft 106 to retract inside the body 102. Once the shaft 106 has reached to maximum extension, the knob 110 touches the disc 104B and rotation thereof in clockwise direction may also rotate the shaft 106 in clockwise direction, in accordance with another aspect of the invention. As the knob 110 and the shaft 106 rotate, the O-ring 116, the barrels 114 may also rotate along with.

The device 100 is handheld, self-manoeuvring, and self-operable. As the body 102 is disposable, the device 100 is single use and hygiene to use. The device 100 is a fit for all sizes of female anatomy. The device 100 is made from a biocompatible material selected from a group consisting of propylene of high or medium or low density, latex, silicone, and so on, and/or any combinations thereof. In some aspects, the device 100 is coated with a biocompatible material or anti-microbial liquids or water repellant polymers and/or combinations thereof. In another aspect, the shaft 106 is attachable to at least one payload. The payload is configured to perform the various procedure(s) inside the female vagina and uterine. The procedure(s) is selected from one or more of the group consisting of cervical sample collection, biological sample collection, curette scraping, removal of copper T, providing local anesthesia, visual inspection, uterine sampling, endo- and ecto- epithelial cervical cells collection, removal of tissue, delivery of mesh, intra-uterine insemination, mounting vaginal pessary, mounting a cervical diaphragm, cervical cauterization, radiation therapy, prostadin gel application in intracervical canal to terminate pregnancy, vaginal vault marking, Human Papillomavirus (HPV) test, Pap Smear Test, Liquid cytology test, Intra-uterine insemination during artificial insemination, Foley’s catheter placing and inflation for extra-amniotic fluid insertion during abortion for pregnancy beyond 12 weeks, insertion and removal of intrauterine radioactive probe-caesium (5mm by 3 cm) for radiation therapy, cervical cauterization of vaginal or cervical ulcer, total laparoscopic hysterectomy for vaginal vault marking, to deliver medicine or apply thereof into the vagina, and so on, and/or the combinations thereof. It is contemplated that the procedure(s) disclosed hereinabove may be exemplary for the skilled persons to have a better understanding of the present embodiment.

In some aspects, the payload defines a manoeuvring tool or device that is configured to manoeuvre through the female vagina and uterine to perform the procedure(s) therein. In an aspect, the payload is a camera or an imaging sensor for internal view and inspection. In some aspects, the payload is a curette scraping tool for uterine sampling. In some aspects, the payload has a telescopic arm and hence extensible. In some aspects, the payload is a scalpel. In some embodiments, the payload is a probe onto which the medicine can be applied to further apply thereof into the vagina. In some aspects, the payload is an applicator for applying prostadin gel in intracervical canal to terminate pregnancy. In some aspects, the payload is a sample collector such as a brush which can be configured to collect cervical or any other biological sample(s) from the uterine lining. In some aspects, the payload is a clip or a tool which can be configured to remove copper T. In some aspects, the payload is configured to provide local anesthesia. In some aspects, the payload is a tool which can be configured to remove tissue from the female vagina. In some aspects, the payload may be configured to deliver mesh implants. In some aspects, the payload may be configured to provide intra-uterine insemination during artificial insemination. In some aspects, the payload may be configured to mount vaginal pessary for uterine prolapse or mounting a cervical diaphragm or ring as a contraceptive. In some aspects, the payload may be configured to perform cervical cauterization of vaginal or cervical cancer. In some aspects, the payload may be a laser configured to provide radiation therapy therein. The laser may be configured to insert and remove intrauterine radioactive probe-caesium (5mm by 3 cm) for radiation therapy. In some aspects, the payload may be a marker which is configured to mark vaginal vault for total laparoscopic hysterectomy. In some aspects, the payload may be configured to collect a specimen that can be utilized for all female tests such as including but are not limited to Human Papillomavirus (HPV) test, Pap Smear Test, and Liquid cytology test. In some aspects, the payload may be configured to place a Foley’s catheter placing and inflation for extra-amniotic fluid insertion during abortion for pregnancy beyond 12 weeks. In some aspects, the device 100 is handheld for performing various minor procedure(s) such as gel application, medicine or drug delivery, sample collection. In some embodiments, medical supervision may be required for performing the procedure(s) using the device 100. It is contemplated that the payload (s) disclosed hereinabove may be exemplary for the skilled persons to have a better understanding of the present embodiment.

As shown in Figure 2A, a brush 108 may be detachably attached to a tip or a head 106 A of the shaft 106 for a procedure of cervical sample collection from the uterine or vagina.The brush 108 defines a plurality of bristles 112 and a holder (not shown). The bristles 112 can be arranged in any pattern such as crown-shaped, zig-zag, curved, triangular, concave, convex, or any pattern already known in the art. The bristles 112 are configured to swipe the uterine lining and collect the cervical sample therefrom. In some aspects, any type of cytobrush known in the art can be detachably attached to the shaft 106.

In some aspect, the brush 108/the payload are configured to rotate helically to mount over the head 106A of the shaft 106, providing a snap fit attachment there between. The payload and the brush 108 are configured to rotate axially to fit inside the head 106A of the shaft 106, providing a snap fit attachment therein. The payload and/or the brush 108 are configured to extend out of the shaft 106 as the shaft extends out of the body 102, and retract inside therein as the shaft 106 retracts inside the body 102. In some aspects, the brush 108/the payload may be attached to the shaft 106 through a biocompatible adhesive(s) known in the art.

The holder of the brush 108/the payload is configured to detachably attach to the shaft 106, and mimic all the movements of the shaft 106. As the knob 110 is pushed, the shaft 106 is pushed to extend out of the distal end A’ of the body 102, pushing the brush 108/the payload to extend out therefrom as shown in Figure 2B. The O-ring 116 and the barrel(s) 114 may also move inside the body 102. As the shaft 106 rotates clockwise or anti-clockwise, the O-ring 116 and the barrel(s) 114 may also rotate mimicking the shaft 106. As shown in Figure 2C, the first protrusion 118A comes into contact with the second protrusion 118B during the rotation and touch with each other producing a click sound ensuring completion of one rotation. In some embodiments, the user may feel rubbing of the first and second protrusions 118 A, and 118B.

As the knob 110 is pulled, the shaft 106 is pulled to retract inside the body 102 towards the proximal end A, pulling the brush 108/the payload to retract therein as shown in Figure 2D. As the knob 110 rotates, the shaft 106 rotates, rotating the brush 108/the payload.

In some aspects, length of the body 102 is at least 9 cm. In some aspects, diameter of the portion 102A of the body 102 is in the range of 9.7-8.3 cm while that of the portion 102B is in the range of 10-9 cm. Length of the device 100 overall is at least 16 cm. In some aspects, length of body 102 after the brush 108/the payload moves out therefrom is in the range of 10-12 cm.

In another aspect, a method for performing medical procedure(s) in a female vagina and uterine is disclosed. The method involves attaching the payload to the head 106A of the shaft 106. Further, the distal end A’ of the device 100 is ingressed into vagina of the female. The method involves pushing the knob 110 of the shaft 106, traversing the shaft 106 and the payload through the body 102 and extending out of the distal end A’ thereof. The procedure is performed in vagina and/or uterine, followed by pulling the knob 110 causing the shaft 106 to retract inside the body 102. The shaft 106 is configured to retract inside and extend out of the body 102 as pulling and pushing the knob 110 respectively. The shaft 106 can also be caused to rotate while collecting the cells. One rotation thereof is determined by clickable sound or“feel” produced by rubbing action of the first and second protrusions 118A and 118B. In yet another aspect, a method for collecting specimens from a female vagina and uterine is disclosed. The method involves attaching the brush 108 to the head 106A of the shaft 106 of the maneuvering device 100. The device 100 is configured to ingress into the vagina, followed by maneuvering through the uterine lining. Thereafter, the knob 110 is caused to push to move the shaft 106, and hence the brush 108 to traverse through the body 102 until the brush 108 extends out of the distal end A’. The method further involves collecting ecto-and endo-epithelial cells from the cervix and uterine lining. The shaft 106 can also be caused to rotate while collecting the cells. One rotation thereof is determined by clickable sound or“feel” produced by rubbing action of the first and second protrusions 118A and 118B. The knob 110 is then pulled to retract the shaft 106 inside the body 102 such that the brush 108 is still out of the mouth 102A of the body 102. Finally, the collected specimens can be procured from the brush 108 for further testing. In some aspects, the device 100 is portable after collecting the specimens. The brush 108 retracts inside the body 102 without touching walls thereof. Hence, the device 100 is self-operable or self-maneuverable for the purpose of collecting endo- and ecto- epithelial cells from female’s cervix and uterine. In some other embodiments, the device 100 is operable by medical practitioner for performing some or all of the other medical procedure(s). The device 100 can be without the shaft 106 for performing a medical procedure(s). In some embodiments, the device 100 is without the shaft 106 when the payload is other than the brush. Other benefits of the device 100 is producing a clickable sound or feel to the user due to rubbing action of the protrusions 118A, and 118B, ensuring completion of one rotation. Apart from collecting endo- and ecto- epithelial cells from the cervix and uterine, the device 100 is compatible for performing other medical procedure(s) in female’s vagina and uterine. As the body 102 is disposable, the device 100 is completely safe and hygiene.

As will be readily apparent to those skilled in the art, the present embodiment may easily be produced in other specific forms without departing from its essential characteristics. The present embodiment are, therefore, to be considered as merely illustrative and not restrictive, the scope being indicated by the claims rather than the foregoing description, and all changes which come within therefore intended to be embraced therein.

Claims

We Claim:

1. A portable maneuvering device 100 for female vagina and uterine inspection, and performing medical procedure(s) therein, the device 100 comprising:

a disposable hollow elongated cylindrical body 102 having a proximal end A and a distal end A’, the distal end A’ having smaller diameter than the proximal end A;

a plunger 104 trailing the body 102, having a knob 110 and a shaft 106, such that at least one rotatable payload detachably attached to the shaft 106retracts inside and extends out of the distal end A’ of the body 102as pulling and pushing the knob 110 respectively, and rotating as the knob 110 rotates; wherein the device 100 being handheld, and self-operable by the female undergoing the procedure.

2. The device 100 as claimed in claim 1, wherein the payload is selected from a group consisting of a brush, a camera, a curette scraping tool, a scalpel, and/or so on in combination with or without a telescopic arm.

3. A portable maneuvering device 100 for cervical sample collection from the female vagina and uterine, the device 100 comprising:

a plunger 104 trailing the body 102, having a knob 110 and a shaft 106, such that the shaft 106 retracting inside and extending out of the distal end A’ of the body 102, as pulling and pushing the knob 110 respectively, and rotating as the knob 110 rotates; and

a brush 108 having a plurality of bristles 112swiping the uterine lining and collecting the cervical sample therefrom, such that the brush 108 detachably attaching to the shaft 106 and following all the movements of the shaft 106 ; wherein the device 100 being handheld, and self-operable by the female undergoing the procedure of cervical sampling.

4. The device 100 as claimed in claims 1 and 3, wherein the shaft 106 rotates clockwise and/or anticlockwise.

5. The device 100 as claimed in claims 1 and 3, wherein number of rotations of the shaft 106 countable with a clear“clicking sound” or feel ensuring adequate number of turns for the procedure(s) and the sample collection.

6. The device 100 as claimed in claims 1 and 3, wherein the shaft 106 is extensible.

7. The device 100 as claimed in claims 1 and 3, wherein the shaft 106 has at least one O-ring 116, and a plurality of barrel(s) 114 encompassing thereof.

8. The device 100 as claimed in claims 1 and 3, wherein the payload and/or the brush

108 rotate helically to mount over the head 106A of the shaft 106, providing a snap fit attachment therein.

9. The device 100 as claimed in claims 1 and 3, wherein the payload and the brush 108 rotate helically to fit inside the head 106 A of the shaft 106, providing a snap fit attachment therein.

10. The device 100 as claimed in claim 9, wherein the sampling is collected for tests selected from a group consisting of HPV, Liquid Cytology, Triaging, Pap Smear, and so on

11. A method for performing medical procedure(s) in a female vagina and uterine, the method comprising:

attaching a payload to a head 106A of a shaft 106 of a maneuvering device 100, the device 100 further comprising: a hollow elongated cylindrical body 102 having a proximal end A and a distal end A’, the distal end A’ having smaller diameter as that of the proximal end A; and a plunger 104 trailing the body 102, comprising a rotatable shaft 106 and a knob

110; wherein the device 100 being handheld, and self-operable by the female undergoing the procedure(s); ingressing the distal end A’ of the device 100 into vagina of the female;

pushing a knob 110 of the shaft 106, traversing the shaft 106 and the payload through the body 102 and extending out of the distal end A’ thereof;

performing the procedure in vagina and/or uterine;

pulling the knob 110 causing the shaft 106 to retract inside the body 102.

12. The method as claimed in claim 11, wherein the shaft 106 retracts inside and extends out of the body 102 as pulling and pushing the knob 110 respectively.

13. The method as claimed in claim 11, wherein the shaft 106 and the payload rotate as the knob 110 rotates in clockwise or anti-clockwise direction.

14. .A method for collecting specimens from a female vagina and uterine, the method comprising:

attaching a brush 108 to a head 106A of a shaft 106 of a maneuvering device 100, the device 100 further comprising: a hollow elongated cylindrical body 102 having a proximal end A and a distal end A’, the distal end A’ having smaller diameter than the proximal end A; and a plunger 104 trailing the body 102, comprising a knob 110 and a rotatable shaft

106; wherein the device 100 being handheld, and inserting into vagina and uterine by the female undergoing the procedure by herself; ingressing the device 100 into the vagina;

maneuvering the device 100 through the uterine lining;

pushingthe knob 110, moving the shaft 106, and hence the brush 108 to traverse through the body 102 until the brush 108 extends out of the distal end A’; collecting ecto-and endo-epithelial cells from cervix and uterine lining by rotating the shaft 106 and the brush 108; pulling the knob 110, retracting the shaft 106 inside the body 102 such that the brush 108 is still out of the mouth 102A of the body 102; and

procuring the collected specimens from the brush 108 for further testing.

15. The method as claimed in claim 26, wherein the device 100 is portable after collecting the specimens.

16. The method as claimed in claim 27, wherein the brush 108 retracts inside the body

102 without touching walls thereof.