Camera-based visualization device

Abstract

In alternative embodiments, provided are medical devices for cervical cancer screening including a flexible endoscopic stalk which includes a camera disposed at a camera end of the flexible endoscopic stalk and a control device disposed within the flexible endoscopic stalk upstream of the camera, and a cell extraction device removably affixed to the camera end of the flexible endoscopic stalk, such that the cell extraction device surrounds the camera.

Description

CAMERA-BASED VISUALIZATION DEVICERELATED APPLICATIONSThis Patent Convention Treaty (PCT) International Application claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63 / 551,660 filed February 9, 2024. The aforementioned application is expressly incorporated herein by reference in its entirety and for all purposes. All publications, patents, patent applications cited herein are hereby expressly incorporated by reference for all purposes.TECHNICAL FIELDThe present invention relates to medical devices and procedures, and in particular, to camera-based visualization devices. In alternative embodiments, provided are medical devices for cervical cancer screening comprising a flexible endoscopic stalk which comprises a camera disposed at a camera end of the flexible endoscopic stalk and a control device disposed within the flexible endoscopic stalk upstream of the camera, and a cell or tissue extraction device affixed to the camera end of the flexible endoscopic stalk, such that the cell or tissue extraction device surrounds the camera.BACKGROUND

[0001] Cervical cancer screenings are done by taking a sample of cervical cells from a female patient and sending the samples to a laboratory for a Papanicolaou test, also referred to as a Pap test, which can detect abnormal cells. In the laboratory, the samples are either preserved in a fixative liquid (liquid-based Pap test) or are transferred onto a glass slide where they are examined under a microscope to look for characteristics in the cells that indicate cancer or a precancerous condition.

[0002] The American College of Gynecology recommends cervical cancer screening every three years for women who are between the ages of twenty five and twenty nine and every three to five years for women between the ages of forty and sixty five. However, the decision for women to undergo cervical cancer screenings like the Pap test comes with a host of challenges and discomforts, both physical and emotional.

[0003] Common complaints for women include discomfort due to the stirrup positioning, the cold sensation caused by metal and plastic speculums used during cervical cancer screenings, pain at the vaginal opening which remains open for the entire procedure, and anxiety caused by hearing clicking from the speculum. Additionally, women have oftenreported feeling vulnerable because of the intimate proximity of a healthcare provider to their private area which is often unsettling.

[0004] Medical providers share similar concerns, highlighting the ergonomic challenges and physical strain involved in maneuvering into a position to visualize the cervix. They expressed concerns about the time consumed in getting the patient properly positioned, the difficulty in locating the cervix due to anatomical variations, and the risk of having to redo tests if samples were contaminated by lubricant. Cervical cancer screenings performed by a male medical provider can add an extra layer of discomfort for female patients, often leading to hurried exams. There is also the possibility that a Pap test needs to be repeated because the cervical cells are tainted by lubricant.

[0005] Moreover, the procedure can be especially traumatic for women with histories of sexual assault, resulting in emotional distress that can lead to skipping crucial screenings altogether.

[0006] Accordingly, there is the need for a camera-based visualization devices which addresses the above-listed drawbacks.SUMMARY

[0007] In alternative embodiments, the above-listed need is met or exceeded by the present camera-based visualization device, which comprises a cell or tissue extraction device that is smaller and more comfortable than speculums used with traditional cervical visualization devices. In alternative embodiments a cell or tissue extraction device as provided herein is designed to be suitable for patients of different anatomical variations, including those who are obese, reducing the need for multiple sizes of speculums; and in alternative embodiments is compatible with lubrication, helping reduce the longstanding issue of sample contamination.

[0008] Moreover, the present camera-based visualization device is easily inserted and removed by patients themselves, which eliminates the need for stirrups and allows for female patients to sit or lay in a more comfortable position and remain covered while conducting cervical cancer screenings. This also mitigates ergonomic issues associated with traditional cervical cancer screenings by allowing providers to operate either sitting or standing, without having to position themselves uncomfortably between the patient's legs.

[0009] In an alternative embodiment, provided are camera-based visualization devices comprising a high-fidelity flexible endoscopic type camera stalk which is maneuvered with an upstream control system. This type of maneuvering is familiar togynecologists who use flexible cameras in bladder visualization. The cell or tissue extraction device is removably affixed to an end of the camera stock, and in alternative embodiments is approximately the size of a small tampon and in alternative embodiments is disposable. After inserting the cell or tissue extraction device through the patient’s vaginal opening, a great mechanism such as a quiet gear mechanism is used to open petals of the cell or tissue extraction device without the annoying clicking sounds of a speculum. In alternative embodiments the petals have a strong core which withstands forces applied to the petals by the patient, allowing the cell or tissue extraction device to open tissues for improved cervical visualization, including in obese patients. In alternative embodiments the outside of the petals is made of (or the petals comprise) a polysiloxane such as a medical grade silicone which provides a soft touch and is not cold as with traditional speculum.

[0010] In alternative embodiments the inside surface of each petal comprises a plurality of nodes which fit over and scrape the exterior of the patient’s cervix to collect cells or a tissue sample such as a biopsy. In alternative embodiments, a center of the cell or tissue extraction device comprises a stamen like brush which samples the inside of the patient’s cervix at the same time as the nodes collect cells from the outside of the patient’s cervix, helping to reduce the time to complete cervical cancer screenings. In alternative embodiments once the cells or a tissue (for example, a biopsy) from the patient’s cervix have been collected, the petals are closed securely to protect the cells or tissue sample, which helps reduce the number of repeat tests needed.

[0011] In alternative embodiments these petals are then immersed in a liquid medium, allowing for lab tests to be performed in the conventional manner. With its patient-centric and provider-friendly features, the present camera-based visualization device makes cervical cancer screenings more comfortable, efficient, and reliable.

[0012] In alternative embodiments, a camera-based visualization device as provided herein is optionally used for different medical screening such as colorectal cancer screenings, diagnosing infertility issues or for intrauterine insemination procedures, prostate cancer screening, testicular cancer screening, and sexually transmitted infection (STI) testing.

[0013] In an alternative embodiment, provided are medical devices for cervical cancer screening which include a flexible endoscopic stalk with a camera disposed at a camera end of the flexible endoscopic stalk and a control device disposed within the flexible endoscopic stalk upstream of the camera, and a cell or tissue extraction device removablyaffixed to the camera end of the flexible endoscopic stalk, such that the cell or tissue extraction device surrounds the camera.

[0014] In alternative embodiments, the camera is a high-fidelity camera, the cell or tissue extraction device is disposable, and the extraction device has a diameter less than 0.5 inches, or between about 0.1 inches and 1 inch, or between about 0.2 inches and 0.8 inches, or between about 0.3 inches and 0.7 inches, or between about 0.4 inches and 0.6 inches. In alternative embodiments, the cell or tissue extraction device has a plurality of petals which are operable between an open position and a closed position, such that in the open position the camera is exposed and in the closed position the petals securely encapsulate or substantially encapsulate the camera and a sample collected from a patient. In an additional alternative embodiment, each of the petals has a gear mechanism which causes each of the petals to move from the open position to the closed position. Optionally, the gear mechanism includes a gear which is rotated by a rotary motor that is optionally operated by control signals received from the controller. Alternatively, the rotary motor receives control signals from a hand-held trigger on the flexible endoscopic stalk.

[0015] each of the petals is constructed with a stiff core material coated with silicone, and the plurality of the petals open to a diameter of at least about 12 inches, or between about 1 to 12 inches, or about 1, 2, 3, 4, 5,6 ,7, 8, 9 or 10 inches.

[0016] In alternative embodiments, each of the petals is equipped with a plurality of nodes designed or configured to scrape a tissue surface or take a cell or tissue sample of a tissue, such that the tissue is optionally an exterior of a cervix of a patient, and the cell or tissue extraction device has a brush which samples a tissue, where the tissue optionally includes an interior of a cervix of a patient. In alternative embodiments, a lubricant is applied to an exterior of the cell or tissue extraction device.

[0017] In an alternative embodiment, the control device includes a processing unit with memory including non-transitory computer readable storage medium which receives and processes real-time data from the camera, such that the non-transitory computer readable storage medium utilizes machine learning algorithms to identify potential abnormalities in the cervix during the screening process. In alternative embodiments, the control device has a reporting system capable of automatically generating reports detailing the findings of the cervical screening. In alternative embodiments, the control device has a machine learning algorithm within the memory which is trained on a diverse set of cervical cell or tissue images and medical histories, such that the algorithm is capable of continuously updating itspredictive model for improved accuracy and reliability in detecting abnormal cells, based on new data collected through the device.

[0018] In alternative embodiments, the flexible endoscopic stalk has a rotation device and an inflation pump.

[0019] In alternative embodiments, provided are medical devices or products of manufacture for taking vaginal tissue or biopsy samples or for cervical cancer screening, comprising: a flexible endoscopic stalk 12 comprising a camera 14 disposed at a camera end 16 of said flexible endoscopic stalk and a control device 18 disposed within said flexible endoscopic stalk upstream of said camera; and a cell or tissue extraction device 24 removably affixed to said camera end of said flexible endoscopic stalk, said cell or tissue extraction device surrounding said camera.

[0020] In alternative embodiments, of medical devices or products of manufacture as provided herein:

[0021] - the camera 14 is a high-fidelity camera;

[0022] - the cell or tissue extraction device 24 is disposable;

[0023] - the cell or tissue extraction device 24 has a diameter less than about 0.5 inches, or said cell or tissue extraction device has a diameter of between about 0.2 inches to about 1 inch;

[0024] - the cell or tissue extraction device 24 comprises or has operatively disposed on its distal end a plurality of petals 26 which are operable between an open position and a closed position (or are capable of being manipulated to have an open and closed position), wherein in the open position said camera 14 is exposed and in the closed position said petals securely encapsulate or substantially encapsulate said camera and a sample or biopsy collected from a patient or individual in need thereof;

[0025] - the each of said petals 26 has a gear mechanism 28 operatively connected to the petal which causes each of said petals to move from the open position to the closed position, wherein optionally each of said petals has its own gear mechanism, or optionally all of said petals is operatively connected to one gear mechanism;

[0026] - the gear mechanism 28 includes a gear 28a which is rotated by a rotary motor 28b that is optionally operated by control signals received from said controller 18;

[0027] - the gear mechanism 28 includes a gear 28a which is rotated by a rotary motor 28b that receives control signals from a hand-held trigger on said flexible endoscopic stalk 12;

[0028] - the petal 26 is constructed with a stiff core material coated with, or comprising, a silicone;

[0029] - the plurality of said petals 26 open to a diameter of at least about 12 inches, or between about 1 to 12 inches, or about 0.5 to 16 inches, or about 1, 2, 3, 4, 5, 6 ,7, 8, 9 or 10 inches;

[0030] - wherein each said petal 26 is equipped with (or configured with) or comprises a plurality of nodes 30 designed or configured to scrape a tissue surface or take a cell sample of a tissue, wherein optionally the tissue comprises an exterior of a cervix of a patient;

[0031] - the cell or tissue extraction device 24 comprises (or further comprises) a brush 32 which samples a tissue or is capable of adsorbing or taking up a plurality of cells as a cell or tissue sample, wherein optionally the tissue or plurality of cells comprise or are located in or on an interior of a cervix of a patient;

[0032] - the further comprising a lubricant 34 applied to (all or substantially all of) an exterior of said cell or tissue extraction device 24;

[0033] - the control device 18 comprises (or further comprises), or is operably linked to, a processing unit with memory including (or comprising) a non-transitory computer readable storage medium which receives and processes real-time data from said camera 14, wherein said optionally non-transitory computer readable storage medium utilizes a machine learning algorithm to identify potential abnormalities in the cervix during the screening process;

[0034] - the control device 18 further comprises a reporting system capable of automatically generating, or upon prompting, reports detailing the findings of the cervical screening;

[0035] - the machine learning algorithm within said memory is trained on a diverse set of, or plurality of, cervical cell images and medical histories, wherein said algorithm is capable of continuously updating its predictive model for improved accuracy and reliability in detecting abnormal cells, based on new data collected through the medical device 10; and / or

[0036] - the flexible endoscopic stalk 12 comprises or further comprises, or is operably attached or linked to, a rotation device 20 and an inflation pump 22.

[0037] In alternative embodiments, provides are methods for taking a tissue or a biopsy sample comprising use of a medical device as provided herein or product of manufacture as provided herein.

[0038] In alternative embodiments, provided are methods for taking a tissue or a biopsy sample from an individual in need thereof, comprising:

[0039] (a) providing a medical device as provided herein or product of manufacture as provided herein;

[0040] (b) inserting the distal end of the medical device or product of manufacture into a vaginal opening of the individual in need thereof;

[0041] (c) closing the plurality of petals 26 over a desired tissue or biopsy sample, wherein optionally the tissue or biopsy sample is located in an interior of a cervix of the individual in need thereof;

[0042] (d) removing the medical device or product of manufacture and retrieving the tissue or biopsy sample.

[0043] In alternative embodiments, provided are medical devices or product of manufacture for use in taking a tissue or a biopsy sample from an individual in need thereof, wherein the medical device or product of manufacture comprises a medical device or product of manufacture as provided herein.

[0044] In alternative embodiments, provided are use of a medical device or product of manufacture for taking a tissue or a biopsy sample from an individual in need thereof, wherein the medical device or product of manufacture comprises a medical device or product of manufacture as provided herein.

[0045] The details of one or more exemplary embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

[0046] All publications, patents, patent applications cited herein are hereby expressly incorporated by reference in their entireties for all purposes.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] FIG. l is a front perspective view of the present camera-based visualization device with a cell or tissue extraction device in an open position;

[0048] FIG. 2 is a front perspective view of the camera-based visualization device of FIG. 1 where the cell or tissue extraction device is in a closed position; and

[0049] FIG. 3 is an alternate embodiment of the present disclosure.

[0050] Like reference symbols in the various drawings indicate like elements.DETAILED DESCRIPTION

[0051] Referring now to FIGs. 1-2, in which the components are shown schematically and not to scale, the present camera-based visualization device is generally designated 10, and includes a flexible endoscopic stalk 12 with a camera 14, optionally a high-fidelity camera, disposed at a camera end 16 of the flexible endoscopic stalk. A control device 18 is disposed within the flexible endoscopic stalk 14, upstream of the camera 16, and optionally includes a rotation device 20 which rotates the flexible endoscopic stalk 12 and an inflation pump 22.

[0052] In alternative embodiments, removably attached to the camera end 16 of the flexible endoscopic stalk 12 is a cell or tissue extraction device 24 which includes a plurality of petals 26 disposed around the camera 14. While FIG. 1 depicts the cell or tissue extraction device 24 which includes five of the petals 26, it is contemplated that greater or fewer petals are optionally provided. Each of the petals 26 includes a stiff core and a silicone coating.The stiff core is optionally made of metal or hard plastic which provides sufficient strength for the petals to withstand forces applied to the petals 26 by the patient, and the silicone coating is optionally made with medical grade silicone.

[0053] In alternative embodiments, the cell or tissue extraction device 24 is disposable, such that the cell or tissue extraction device 24 is removable from the flexible endoscopic stalk 12 and may be disposed after the extracted cells or tissue have been tested; optionally the cell or tissue extraction device 24 has a diameter less than about 0.5 inches, about 1 inch or between about 0.5 and 2 inches.

[0054] FIG. 1 depicts the cell or tissue extraction device 24 where each of the petals 26 are in an open position, and the camera 16 is exposed, while FIG. 2 depicts each of the petals in a closed position where the petals securely encapsulate or substantially encapsulate the camera and a sample collected within the or tissue extraction device 24. The plurality of the petals 26 open to a diameter of at least about 12 inches, or between about 1 to 12 inches, or about 1, 2, 3, 4, 5,6 ,7, 8, 9 or 10 inches, in an open position, or in the completely open position.

[0055] Gear mechanisms 28 are attached to each of the petals 26 and the camera end 16 of the flexible endoscopic stalk 12, such that each of the gear mechanisms moves the petals between the open position and the closed position. Each gear mechanism 28 is compact and quiet, so that the petals 26 open and close without producing an annoyingclicking sound which is made by traditional speculum. In an embodiment, the gear mechanism 28 includes a gear 28a which is rotated by a rotary motor 28b that is optionally operated by control signals received from the controller 18. Alternatively, or additionally, the rotary motor 28b receives control signals from a hand held trigger (not shown) on the flexible endoscopic stalk 12 or a handle (not shown) of the camera-based visualization device 10.

[0056] In alternative embodiments, each of the petals 26 is equipped with (or comprise) a plurality of nodes 30 designed to scrape an exterior of a cervix of a patient when the camera-based visualization device 10 is performing cervical cancer screenings. The nodes 30 fit over and scrape the outside of the cervix, thereby collecting cervical cells which are tested. Additionally, the center of the or tissue extraction device 24 includes a brush 32, which optionally is in the form of a stamen, and which samples an interior of the cervix. In an embodiment, the brush 32 is attached to the petals 26, and extends above the camera 14. Thus, the cells or tissue are extracted from the interior and the exterior of the cervix at the same time, thereby reducing the time required to conduct cervical cancer screenings. In alternative embodiments, a lubricant 34 is applied to an exterior of the or tissue extraction device 24, and specifically the exterior of each petal 26, which reduces patient discomfort while conducting the cervical cancer screening.

[0057] In alternative embodiments the control device 18 comprises a processing unit with a memory which receives and processes real-time data from the camera 16, such that the memory includes non-transitory computer readable storage medium which utilizes machine learning algorithms to identify potential abnormalities in the cervix during the screening process. In alternative embodiments, the control device 18 includes a reporting system capable of automatically generating reports detailing the findings of the cervical screening.

[0058] The machine learning algorithm within the memory is optionally trained on a diverse set of cervical cell images and medical histories, such that the algorithm is capable of continuously updating its predictive model for improved accuracy and reliability in detecting abnormal cells, based on new data collected through the device.

[0059] Referring now to FIG. 3, in which the components are shown schematically and not to scale, a second embodiment of the present disclosure includes a medical examination device which is generally designated 100. Components shared with the camerabased visualization device 10 are designated with identical reference numbers.

[0060] In alternative embodiments a medical examination device 100 comprises a cell or tissue extraction device 102 which includes the plurality of the petals 26, the gear mechanisms 28, and the nodes 30. However, in alternative embodiments the cell or tissue extraction device 102 does not include the brush 32. In alternative embodiments, an opening 104 replaces the camera 14, such that other medical devices, such as a speculum, are optionally inserted through the opening 104 within the cell or tissue extraction device 102. In this way, other types of medical testing are optionally performed with the medical examination device 100.

[0061] In alternative embodiments the processing unit comprises, for example, any type of general-purpose microprocessor or microcontroller, a digital signal processing (DSP) processor, a central processing unit (CPU), an integrated circuit, a field programmable gate array (FPGA), a reconfigurable processor, other suitably programmed or programmable logic circuits, or any combination thereof.

[0062] The memory may be any suitable known or other machine-readable storage medium. The memory may comprise non-transitory computer readable storage medium such as, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. The memory may include a suitable combination of any type of computer memory that is located either internally or externally to the device such as, for example, random-access memory (RAM), read-only memory (ROM), compact disc read-only memory (CDROM), electro-optical memory, magneto-optical memory, erasable programmable read-only memory (EPROM), and electrically-erasable programmable read-only memory (EEPROM), Ferroelectric RAM (FRAM) or the like. The memory may comprise any storage means (e.g., devices) suitable for retrievably storing the computer-executable instructions executable by processing unit.

[0063] While a particular embodiment of the present camera-based visualization device has been described herein, it will be appreciated by those skilled in the art that changes and modifications may be made thereto without departing from the invention in its broader aspects and as set forth in the following claims.

[0064] Any of the above aspects and embodiments can be combined with any other aspect or embodiment as disclosed here in the Summary, Figures and / or Detailed Description sections.

[0065] As used in this specification and the claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise.

[0066] Unless specifically stated or obvious from context, as used herein, the term “or” is understood to be inclusive and covers both “or” and “and”.

[0067] Unless specifically stated or obvious from context, as used herein, the term “about” is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. About (use of the term “about”) can be understood as within 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12% 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from the context, all numerical values provided herein are modified by the term “about.”

[0068] Unless specifically stated or obvious from context, as used herein, the terms “substantially all”, “substantially most of’, “substantially all of’ or “majority of’ encompass at least about 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 99.5%, or more of a referenced amount of a composition.

[0069] The entirety of each patent, patent application, publication and document referenced herein hereby is incorporated by reference. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or date of these publications or documents. Incorporation by reference of these documents, standing alone, should not be construed as an assertion or admission that any portion of the contents of any document is considered to be essential material for satisfying any national or regional statutory disclosure requirement for patent applications. Notwithstanding, the right is reserved for relying upon any of such documents, where appropriate, for providing material deemed essential to the claimed subject matter by an examining authority or court.

[0070] Modifications may be made to the foregoing without departing from the basic aspects of the invention. Although the invention has been described in substantial detail with reference to one or more specific embodiments, those of ordinary skill in the art will recognize that changes may be made to the embodiments specifically disclosed in this application, and yet these modifications and improvements are within the scope and spirit of the invention. The invention illustratively described herein suitably may be practiced in the absence of any element(s) not specifically disclosed herein. Thus, for example, in each instance herein any of the terms "comprising", "consisting essentially of', and "consisting of' may be replaced with either of the other two terms. Thus, the terms and expressions whichhave been employed are used as terms of description and not of limitation, equivalents of the features shown and described, or portions thereof, are not excluded, and it is recognized that various modifications are possible within the scope of the invention. Embodiments of the invention are set forth in the following claims.

Claims

WHAT IS CLAIMED IS:

1. A medical device or product of manufacture for taking vaginal tissue or biopsy samples or for cervical cancer screening, comprising: a flexible endoscopic stalk 12 comprising a camera 14 disposed at a camera end 16 of said flexible endoscopic stalk and a control device 18 disposed within said flexible endoscopic stalk upstream of said camera; and a cell or tissue extraction device 24 removably affixed to said camera end of said flexible endoscopic stalk, said cell or tissue extraction device surrounding said camera.

2. The medical device or product of manufacture of claim 1, wherein said camera 14 is a high-fidelity camera.

3. The medical device or product of manufacture of claim 1, wherein said cell or tissue extraction device 24 is disposable.

4. The medical device or product of manufacture of claim 1, wherein said cell or tissue extraction device 24 has a diameter less than about 0.5 inches, or said cell or tissue extraction device has a diameter of between about 0.2 inches to about 1 inch.

5. The medical device or product of manufacture of claim 1, wherein said cell or tissue extraction device 24 comprises or has operatively disposed on its distal end a plurality of petals 26 which are operable between an open position and a closed position (or are capable of being manipulated to have an open and closed position), wherein in the open position said camera 14 is exposed and in the closed position said petals securely encapsulate or substantially encapsulate said camera and a sample or biopsy collected from a patient or individual in need thereof.

6. The medical device or product of manufacture of claim 5, wherein said each of said petals 26 has a gear mechanism 28 operatively connected to the petal which causes each of said petals to move from the open position to the closed position, wherein optionally each of said petals has its own gear mechanism, or optionally all of said petals is operatively connected to one gear mechanism.

7. The medical device or product of manufacture of claim 6, wherein said gear mechanism 28 includes a gear 28a which is rotated by a rotary motor 28b that is optionally operated by control signals received from said controller 18.

8. The medical device or product of manufacture of claim 6, wherein said gear mechanism 28 includes a gear 28a which is rotated by a rotary motor 28b that receives control signals from a hand held trigger on said flexible endoscopic stalk 12.

9. The medical device or product of manufacture of claim 5, wherein each said petal 26 is constructed with a stiff core material coated with silicone.

10. The medical device or product of manufacture of claim 5, wherein said plurality of said petals 26 open to a diameter of at least about 12 inches, or between about 1 to 12 inches, or about 1, 2, 3, 4, 5,6 ,7, 8, 9 or 10 inches.

11. The medical device or product of manufacture of claim 5, wherein each said petal 26 is equipped with or comprises a plurality of nodes 30 designed or configured to scrape a tissue surface or take a cell sample of a tissue, wherein optionally the tissue comprises an exterior of a cervix of a patient.

12. The medical device or product of manufacture of claim 5, wherein said cell or tissue extraction device 24 comprises a brush 32 which samples a tissue, wherein optionally the tissue comprises an interior of a cervix of a patient.

13. The medical device or product of manufacture of claim 1, further comprising a lubricant 34 applied to an exterior of said cell or tissue extraction device 24.

14. The medical device or product of manufacture of claim 1, wherein said control device 18 comprises a processing unit with memory including non-transitory computer readable storage medium which receives and processes real-time data from said camera 14, wherein said non-transitory computer readable storage medium utilizes a machine learning algorithm to identify potential abnormalities in the cervix during the screening process.

15. The medical device or product of manufacture of claim 14, wherein said control device 18 further comprises a reporting system capable of automatically generating reports detailing the findings of the cervical screening.

16. The medical device or product of manufacture of claim 14, wherein said machine learning algorithm within said memory is trained on a diverse set of, or plurality of, cervical cell images and medical histories, wherein said algorithm is capable of continuously updating its predictive model for improved accuracy and reliability in detecting abnormal cells, based on new data collected through the medical device 10.

17. The medical device or product of manufacture of claim 1, wherein said flexible endoscopic stalk 12 comprises a rotation device 20 and an inflation pump 22.

18. A method for taking a tissue or a biopsy sample comprising use of a medical device 10 or product of manufacture of any of claims 1 to 17.

19. A method for taking a tissue or a biopsy sample from an individual in need thereof, comprising:(a) providing a medical device 10 or product of manufacture of any of claims 1 to 17;(b) inserting the distal end of the medical device or product of manufacture into a vaginal opening of the individual in need thereof;(c) closing the plurality of petals 26 over a desired tissue or biopsy sample, wherein optionally the tissue or biopsy sample is located in an interior of a cervix of the individual in need thereof;(d) removing the medical device or product of manufacture and retrieving the tissue or biopsy sample.

20. A medical device or product of manufacture for use in taking a tissue or a biopsy sample from an individual in need thereof, wherein the medical device or product of manufacture comprises a medical device or product of manufacture of any of claims 1 to 17.

21. Use of a medical device or product of manufacture for taking a tissue or a biopsy sample from an individual in need thereof, wherein the medical device or product of manufacture comprises a medical device or product of manufacture of any of claims 1 to 17.

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