A device for collecting cervical tissue samples

Abstract

The present invention proposes a device (100) for collecting cervical tissue samples, comprising: a sample collecting bud (10) connecting to one end of an elongated shaft (21); a holder (20) provided at the other end of the elongated shaft (21); a handle (30) enclosing the elongated shaft (21), wherein the elongated shaft (21) is slidable and rotatable within the handle (30); characterized in that: the sample collecting bud (10) is retractable into the handle (30) and extendable from the handle (30) by moving the holder (20) connected to the sample collecting bud (10) via the elongated shaft (21); wherein the sample collecting bud (10) comprises a star-shaped center cone (11) having a flat tip end, and a plurality of petal-like structures (12) surrounding the center cone (11), each of the petal-like structure (12) having an inner scraping ridge (13) and an outer scraping ridge (14).

Description

A DEVICE FOR COLLECTING CERVICAL TISSUE SAMPLES

[0001] The present invention pertains to the field of medical devices. More particularly, it relates to the cervical self-sampling devices for collecting tissue sample for early cancer detection.

[0002] Cervical cancer is a serious global health concern, with early detection and treatment crucial for improved outcomes. Self-sampling devices have emerged as a promising approach to increase screening rates. Existing devices often employ brush-based or spatula-like sampling methods, which can be less effective in collecting adequate cervical cells for accurate diagnosis. There is a need for innovative devices that enhance sample collection efficiency and reliability to improve early detection of cervical cancer.

[0003] Below are several examples of prior arts related to cervical self-sampling devices.

[0004] US6387058B1 discloses a device for self-sampling a body cavity, in particular the cervix, and a method is provided to use the device to obtain samples from the cervix for testing for the presence of human papillomavirus (HPV) DNA. The device includes elongated flexible bristles attached to a handle to form a mop-like sampling member. The sampling member is slidably disposed within an annular shield for insertion into the vaginal cavity and for positioning in contact with the cervix. After the shield is located in position, the shield is partially withdrawn to expose the elongated bristles to the cervix. The sampling member is rotated to mop the cervix and obtain a sample of cervical cells on the elongated bristles. The sampling device is then withdrawn from the vaginal cavity and the sample is sent for analysis.

[0005] Moreover, one of the existing sampling devices by Rovers Medical Devices in the Netherlands comprises a flexible bristle brush, a cap for hygienic handling before and after use, a handle that rotates easily, allowing for audible and tactile clicks to indicate the completion of five necessary rotations for correct sampling, a wing to ensure correct sample collection and maintain a predefined insertion length, and a casing to store the sample. The device is labeled with a 2D barcode or data matrix and requires a dry sample. It is also available with a unique RFID chip for rapid processing in the laboratory.

[0006] It is evident that the existing cervical self-sampling device lack features to efficiently collect adequate cervical cell samples for cytological examination accurate diagnosis.SUMMARY OF THE INVENTION

[0007] The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[0008] It is an objective of the present invention to develop a cervical self-sampling device that effectively collects adequate cervical cell samples for accurate testing, cytological examination and early detection of cervical cancer.

[0009] It is also an objective of the present invention to design a device that is user-friendly, comfortable, and easy to use for self-administration of various ages and backgrounds.

[0010] Accordingly, these objectives may be achieved by following the teachings of the present invention. The present invention proposes a device for collecting cervical tissue samples, comprising: a sample collecting bud connecting to one end of an elongated shaft; a holder provided at the other end of the elongated shaft; a handle enclosing the elongated shaft, wherein the elongated shaft is slidable and rotatable within the handle; characterized in that: the sample collecting bud is retractable into the handle and extendable from the handle by moving the holder connected to the sample collecting bud via the elongated shaft; wherein the sample collecting bud comprises a star-shaped center cone having a flat tip end, and a plurality of petal-like structures surrounding the center cone, each of the petal-like structure having an inner scraping ridge and an outer scraping ridge.

[0011] The foregoing and other objects, features, aspects, and advantages of the present invention will become better understood from a careful reading of a detailed description provided herein below with appropriate reference to the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] So that the manner in which the above recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may have been referred by embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments.

[0013] These and other features, benefits, and advantages of the present invention will become apparent by reference to the following text figures, with like reference numbers referring to like structures across the views, wherein:

[0014] illustrating a device for collecting cervical tissue samples in accordance with an embodiment of the present invention;

[0015] shows a fully retracted device before collecting cervical tissue samples in accordance with an embodiment of the present invention; and

[0016] shows a fully extended device for collecting cervical tissue samples in accordance with an embodiment of the present invention.

[0017] DETAILED DESCRIPTION OF THE INVENTION

[0018] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for claims. It should be understood that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the present invention as defined by the appended claims. As used throughout this application, the word "may" is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words "include," "including," and "includes" mean including, but not limited to. Further, the words "a" or "an" mean "at least one” and the word "plurality" means one or more, unless otherwise mentioned. Where the abbreviations or technical terms are used, these indicate the commonly accepted meanings as known in the technical field.

[0019] The present invention is described hereinafter by various embodiments with reference to the accompanying drawings, wherein reference numerals used in the accompanying drawings correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, a number of materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.

[0020] The present invention proposes a device(100)for collecting cervical tissue samples, comprising: a sample collecting bud(10)connecting to one end of an elongated shaft(21); a holder(20)provided at the other end of the elongated shaft(21); a handle(30)enclosing the elongated shaft(21), wherein the elongated shaft(21)is slidable and rotatable within the handle(30); characterized in that: the sample collecting bud(10)is retractable into the handle(30)and extendable from the handle(30)by moving the holder(20)connected to the sample collecting bud(10)via the elongated shaft(21); wherein the sample collecting bud(10)comprises a star-shaped center cone(11)having a flat tip end, and a plurality of petal-like structures(12)surrounding the center cone(11), each of the petal-like structure(12)having an inner scraping ridge(13)and an outer scraping ridge(14).

[0021] In accordance with an embodiment of the present invention, the handle(30)comprises a ridge(31)on the exterior of the handle(30)for limiting insertion of the device(100). This ridge(31)act as a visual and tactile indicator, preventing excessive insertion of the device(100)into the vagina and ensuring proper placement for optimal sample collection.

[0022] In accordance with an embodiment of the present invention, the sample collecting bud(10)is removable from the elongated shaft(21)for placing into a container. This detachable feature is achieved through a secure yet easily separable connection mechanism, such as a snap-fit or twist-lock design. Once the sample has been collected, the user can readily remove the bud and place it into a designated container for subsequent laboratory analysis.

[0023] In accordance with an embodiment of the present invention, the shaft(21)comprises a pin for limiting sliding of the shaft within the handle(30). It prevents unintentional or excessive sliding of the shaft(21), ensuring precise control and stability during sample collection. The pin is securely fastened to the shaft(21)and engages with a corresponding slot or groove within the handle(30), providing a durable locking mechanism.

[0024] In accordance with an embodiment of the present invention, the holder(30)is rotatable to facilitate the circular movement of the sample collecting bud(10)in a clockwise direction. The holder(30)can be rotated freely within the confines of the handle, enabling the user to effectively maneuver the sample collecting bud across the cervical surface for optimal sample acquisition.

[0025] In accordance with an embodiment of the present invention, the handle(30)comprises a hollow interior. This hollow space serves multiple functions, including accommodating internal components for the rotating the sample collection bud(10)provides space for extension and retraction of sample collecting bud(10), when not in use it protects internal device from external contaminants.

[0026] In accordance with an embodiment of the present invention, the star-shaped center cone(11)of the sample collecting bud(10)has a radius of about 1 to 4 millimeters. In particular, the star-shaped center cone(11)comprises a central point with five radiating arms, each arm extending outward to form a symmetrical five-pointed star pattern. The conical shape, combined with the radiating arms, facilitates efficient sample collection by creating a focused point of contact and preventing excessive pressure on the delicate cervical tissue, minimizing tissue trauma.

[0027] In accordance with an embodiment of the present invention, the plurality of petal-like structures(12)of the sample collecting bud(10)is provided with a length of about 15 to 16 millimeters. The petal-like structures(12)work in conjunction with the center cone(11)to maximize contact with the cervical cells and effectively capture cellular material.

[0028] In accordance with an embodiment of the present invention, the plurality of petal-like structures(12)comprises five petals. It is understood that the number of petals is not limited to this specific quantity. The arrangement and number of petals can be optimized to achieve optimal sample collection and device performance, considering factors such as cervical anatomy and user preferences.

[0029] Referring to the drawing as shown into 3, the present invention will now be described in more detail.

[0030] Referring to the, the device(100)consists primarily of the sampling collecting bud(10), the holder(20), the shaft(21)and the handle(30). The holder(30)is designed to be held by the user, while the shaft(21)allows for the extension and retraction of the sample collecting bud(10). The holder(20)is used to rotate the sample collecting bud(10)and the bud(10)is responsible for collecting the cervical tissue sample.

[0031] The device(100)is initially in a retracted state, as illustrated in, with the sample collecting bud(10)housed within the handle(30). To commence sample collection, the device(100), in its retracted state is inserted into the vagina. The ridge(31)on the exterior of the handle(30)acts as a depth indicator, preventing excess insertion and ensuring proper placement. Once positioned, the holder(20)is slid along the elongated shaft(21)to extend the sample collecting bud(10), as depicted in. The deployed bud(10)comprises a start-shaped center cone(11)surrounded by the plurality of petal-like structures(12), and each of the petal-like structures(12)is equipped with the inner and outer scraping ridges(13, 14)designed to optimize sample acquisition. The device(100)is then rotated in a circular motion 5 to 10 times to facilitate comprehensive coverage of the cervical surface. The combined action of the star-shaped center cone(11)and the plurality of petal-like structures(12)effectively collect cervical cells, which are subsequently retained within the bud(10). Following sample collection, the device(100)is withdrawn and the sample collecting bud(10)is detached for placement in a collecting vial. The collected sample in the vial is then ready for laboratory analysis, including Human Papillomavirus (HPV) and Liquid-based Cytology (LBC) screening for early detection of cervical cancer.

[0032] Accordingly, the present invention features a device(100)for collecting cervical tissue samples comprising a handle(30), an elongated shaft(21), a holder(20), and a unique sample collecting bud(10). The bud(10)is characterized by a star-shaped center cone(11)surrounded by a plurality of petal-like structures(12)equipped with scraping ridges(13, 14)for efficient sample collection. The device(100)allows for easy insertion, rotation, and retraction of the bud(10), ensuring optimal contact with the cervical surface. The handle(30)includes a ridge to guide insertion depth, while the holder(20)facilitates rotation and houses the retractable bud(10).

[0033] The present invention addresses the limitations of the conventional cervical self-sampling devices by introducing a sample collecting bud(10)design. Unlike traditional brush or spatula-based methods, this device(100)incorporates the petal-like structures(12)bud equipped with scraping ridges to enhance sample acquisition. This innovative design is intended to improve the collection of cervical cells, thereby increasing the accuracy of not only Human Papillomavirus (HPV) testing but also Liquid-based Cytology (LBC) testing and early detection of cervical cancer. By addressing the shortcomings of current technologies, the invention seeks to contribute to better cervical cancer prevention and management.

[0034] Various modifications to these embodiments are apparent to those skilled in the art from the description and the accompanying drawings. The principles associated with the various embodiments described herein may be applied to other embodiments. Therefore, the description is not intended to be limited to the embodiments shown along with the accompanying drawings but is to be providing broadest scope of consistent with the principles and the novel and inventive features disclosed or suggested herein. Accordingly, the invention is anticipated to hold on to all other such alternatives, modifications, and variations that fall within the scope of the present invention and appended claims.

[0035] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

A device(100)for collecting cervical tissue samples, comprising:a sample collecting bud(10)connecting to one end of an elongated shaft(21);a holder(20)provided at the other end of the elongated shaft(21);a handle(30)enclosing the elongated shaft(21), wherein the elongated shaft(21)is slidable and rotatable within the handle(30);characterized in that:the sample collecting bud(10)is retractable into the handle(30)and extendable from the handle(30)by moving the holder(20)connected to the sample collecting bud(10)via the elongated shaft(21);wherein the sample collecting bud(10)comprises a star-shaped center cone(11)having a flat tip end, and a plurality of petal-like structures(12)surrounding the center cone(11), each of the petal-like structure(12)having an inner scraping ridge(13)and an outer scraping ridge(14).The device as claimed in claim 1, the handle(30)comprises a ridge(31)on the exterior of the handle(30)for limiting insertion of the device(100).The device(100)as claimed in claim 1, wherein the sample collecting bud(10)is removable from the elongated shaft(21)for placing into a container.The device(100)as claimed in claim 1, wherein the shaft(21)comprises a pin for limiting sliding of the shaft within the handle(30).The device(100)as claimed in claim 1, wherein the holder(30)is rotatable to rotate the sample collecting bud(10).The device(100)as claimed in claim 1, wherein the handle(30)comprises a hollow interior.The device(100)as claimed in claim 1, wherein the star-shaped center cone(11)of the sample collecting bud(10)has a radius of about 1 to 4 millimeters.The device(100)as claimed in claim 1, wherein the plurality of petal-like structures(12)of the sample collecting bud(10)each have a length of about 15 to 16 millimeters.The device(100)as claimed as claim 1, wherein the plurality of petal-like structures(12)comprises five petals.

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