Patent Abstract:
A non-invasive endometrial sample collector has an outer body of absorbent material configured for insertion into a vaginal cavity of a patient such that a distal end of the body is positioned proximate a uterine cervix of the patient. The collector has an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly includes a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, and a reservoir in fluid communication with the funnel. During a menstruation cycle of the patient when endometrial tissue cells are shed within menstrual fluid that passes through the uterine cervix, or during any type of normal or abnormal bleeding episode, at least a portion of said fluid is directed to the reservoir via the funnel under the force of gravity.

Full Description:
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
       [0001]    Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. 
         [0002]    This application claims priority to Ecuadorean Patent Application No. SP2013-12745 filed on Jun. 28, 2013, the entire contents of which are hereby incorporated by reference and should be considered a part of this specification. 
       BACKGROUND 
       [0003]    1. Field 
         [0004]    The present application is directed to a system for collecting an endometrial tissue sample, and more particularly to a non-invasive endometrial sample collector. 
         [0005]    2. Description of the Related Art 
         [0006]    There are several existing procedures for obtaining samples of endometrial tissue. One such procedure involves the sampling of the endometrium with a small plastic device that is introduced in the uterine cavity and through the uterine cervix in order to obtain the tissue sample. This procedure is usually performed in a doctor&#39;s office, without anesthesia. 
         [0007]    Another existing procedure for obtaining an endometrial tissue sample involves cervical dilation and curettage (D&amp;C). The D&amp;C procedure requires insertion of instruments (e.g., curette or sharp curettage, suction curettage, electric vacuum aspiration) in the uterine cavity and through the uterine cervix to remove endometrial tissue samples, such as by scraping and scooping the endometrial tissue sample. This procedure is performed in a hospital, under anesthesia. The procedure is often performed blindly by the doctor (e.g., without the use of any imaging technique such as ultrasound or hysteroscopy) 
         [0008]    Still another existing procedure for obtaining an endometrial tissue sample involves a hysteroscopy. This procedure involves introducing an optical system (e.g., endoscope) within the uterine cavity and through the uterine cervix to directly observe the endometrium. The endoscope can have operative channels through which instruments (e.g., biopsy instruments, resectoscope) can be deployed to obtain a sample of the endometrial tissue under the visual guidance provided by the optical system. Such a procedure can be performed at a hospital or surgical centers, or a clinic, and can be performed under local anesthesia. Hysteroscopies are more expensive procedures (from the patient&#39;s and doctor&#39;s point of view) since they require expensive equipment and trained specialists. 
         [0009]    All of the above described existing procedures for obtaining endometrial tissue samples have numerous disadvantages and potential risks to the patient, including: the risk of infection (e.g., due to the introduction of instruments into the vaginal cavity); the risk of perforating the endometrium and uterine wall (e.g., and possibly damage other organs, such as the intestines); severe bleeding (even in the absence of perforation of the endometrium); endometrial lesions by scarring, leading to infertility (i.e., Asherman&#39;s Syndrome); the risk of interrupting an existing but undiagnosed pregnancy; the risk of side effects from antibiotics or pain medication; the risks associated with anesthesia; pain and/or discomfort to the patient; interruption of sexual activity following the procedure; interruption of work and/or social activity for the patient following the procedure; and the risk of allergic reactions to drugs (e.g., antibiotics, analgesic, anesthesia, etc.), iodine (used for cleaning the uterine cervix and vagina during the procedure), latex (e.g., surgical gloves). Other drawbacks of existing procedures include the amount of time the procedures take, the elevated cost of the procedures and the complications they cause in the patient&#39;s lives (e.g., anxiety, interruption of work, family interactions and sexual activity). 
       SUMMARY 
       [0010]    Accordingly, there is a need for an improved system and method for obtaining an endometrial tissue sample that does not suffer from the drawbacks associated with existing procedures, such as those described above. 
         [0011]    In accordance with an aspect of the invention, an endometrial sample collector is provided. The collector comprises an outer body of absorbent material configured for insertion into a vaginal cavity of a patient such that a distal end of the body is positioned proximate a uterine cervix of the patient. The collector also comprises an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly comprises a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, and a reservoir in fluid communication with the funnel. During a menstruation cycle of the patient when endometrial tissue cells are shed within menstrual fluid that passes through the uterine cervix, at least a portion of said menstrual fluid is directed to the reservoir via the funnel under the force of gravity. 
         [0012]    In accordance with an aspect of the invention, an endometrial sample collector is provided. The collector comprises an outer body of absorbent material configured for insertion into a vaginal cavity of a patient such that a distal end of the body is positioned proximate a uterine cervix of the patient. The collector also comprises an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly comprises a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, a conduit in fluid communication with the funnel, and a reservoir in fluid communication with the conduit. During a menstruation cycle of the patient when endometrial tissue cells are shed within menstrual fluid that passes through the uterine cervix, at least a portion of said menstrual fluid is directed to the reservoir via the funnel and the conduit under the force of gravity. 
         [0013]    In accordance with an aspect of the invention, a method for passively collecting an endometrial tissue sample is provided. The method comprises inserting a sample collector into a vaginal cavity of a patient so that a distal end of the collector is positioned proximate a uterine cervix of the patient. The method also comprises collecting an endometrial sample in the sample collector during a menstrual cycle of the patient or during any type of normal or abnormal bleeding solely under the force of gravity. The method also comprises sending the sample collector with the collected sample to a laboratory for evaluation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is a schematic perspective top view of an endometrial sample collector. 
           [0015]      FIG. 2  is a schematic perspective top view of the endometrial sample collector of  FIG. 1 , showing internal components of the collector in phantom. 
           [0016]      FIG. 3  is a schematic bottom view of the endometrial sample collector of  FIG. 1 . 
           [0017]      FIG. 4  is a schematic front view of the endometrial sample collector. 
           [0018]      FIG. 5  is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. 
           [0019]      FIG. 6A  is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. 
           [0020]      FIG. 6B  is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. 
           [0021]      FIG. 6C  is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. 
           [0022]      FIG. 6D  is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. 
           [0023]      FIG. 7A  is a schematic top view of the collection assembly of  FIG. 6A . 
           [0024]      FIG. 7B  is a schematic top view of the collection assembly of  FIGS. 6B ,  6 C and  6 D. 
           [0025]      FIG. 8  is a block diagram illustrating a method of collecting an endometrial tissue sample. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]      FIGS. 1-4  show and endometrial sample collector  100  that extends between a proximal end  2  and a distal end  3  and includes and outer body  10  and an internal collection assembly  50 . The outer body  10  is of an absorbent material (e.g., cotton, rayon, sponge material, absorbent polymer), such as the material used in typical tampons, and has absorption channels  11  through which fluid passes toward the internal collection assembly  50 . The outer body  10  of absorbent material advantageously facilitates patient comfort during collection of an endometrial sample in the manner discussed further below. The sample collector  100  can have a thread or cord  20  attached to it to aid in the removal of the collector  100 . As shown in  FIG. 1 , the thread or cord  20  is in the form of a loop. However, the thread or cord  20  can optionally be a single string that extends to a free end (e.g., not a loop). 
         [0027]    The endometrial sample collector  100  has a length L between the proximal end  2  to the distal end  3  of between about 4 cm and about 6 cm, and has a width W of between about 1 cm and about 3 cm. However, the endometrial sample collector can have other suitable dimensions. 
         [0028]    The inner collection assembly  50  can be wrapped by the outer body  10 . The collection assembly has a cup or funnel  52  with an open end at the distal end  3  of the collector  100  that receives the sample therein. The funnel  52  is in fluid communication with a conduit  54 , which is itself in communication with a reservoir  56 , such that the conduit  54  is interposed between the funnel  52  and the reservoir  56 . The reservoir  56  can be at least partially filled with a fluid  4  that preserves the endometrial sample once received. The funnel  52 , conduit  54  and reservoir  56  can be separate components that are coupled together to form the collection assembly  50 . Optionally, the funnel  52 , conduit  54  and reservoir  56  can be made as a single monolithic piece (e.g., via an injection molding process). In other variations, the funnel can be augmented to have, or can be replaced with, a mesh or screen or permeable layer (e.g., foam layer) through which the sample fluid can pass to the reservoir  56 . The funnel  52 , conduit  54  and reservoir  56  can be made of a bio-compatible material, such as a plastic material, or other suitable material. The conduit  54  can optionally be excluded and the funnel  52  be in fluid communication with the reservoir  56 . 
         [0029]    As discussed above, the fluid  4  in the reservoir  56  facilitates preservation of the collected endometrial sample. In one embodiment, the fluid  4  can be sterile saline. In another embodiment, the fluid  4  can be a solution made from a 1 L amount of distilled water in combination with the following composition: 0.9 gm/L Sodium Thioglycollate, 10.0 gm/L Sodium Glycerophosphate, 0.1 gm/L Calcium Chloride, and 3.0 gm/L Agar. The solution has a pH of 7.4±0.2. In some embodiments, the composition can optionally include 0.002 gm/L of methylene blue. 
         [0030]    As shown in  FIG. 5 , the collection assembly  50  can have a length L 2  that is substantially equal to the length L of the collector  100 . In one embodiment, the length L 2  is about 6 cm. The funnel  52  has a width W 1  (e.g., a diameter), and the reservoir  56  has a width W 2 , with the conduit  54  having a width smaller than the widths W 1 , W 2  of the funnel  52  and reservoir  56 . Optionally, the width of the conduit  54  can be generally equal to the widths W 1 , W 2  of the funnel  52  and reservoir  56 . The width W 1  of the funnel  52  can optionally be substantially equal to the width W 2  of the reservoir  56 . Optionally, the widths W 1 , W 2  (e.g., diameters) of the funnel  52  and reservoir  56  can be about 2 cm. As shown in  FIG. 5 , the reservoir  56  has a generally spherical shape. However, the reservoir  56  can have other suitable shapes (e.g., oval). 
         [0031]      FIGS. 6A-6D  show various embodiments of the collection assembly  50 , in which the funnel  52  and reservoir  56  are the same, but where the conduit  54  is different for each embodiment. 
         [0032]    In  FIG. 6A , the conduit  54 A has a cross-shaped cross-section (see  FIG. 7A ) that defines channels  54 A 2  between adjacent fins  54 A 2  of the conduit  54 A. The channels  54 A 2  can extend along the length of the conduit  54 A and can receive fluid axially from the funnel  52  as well as radially through the outer body  10  of absorbent material. The channels  54 A 2  can direct the sample fluid to the reservoir  56 . 
         [0033]    In  FIG. 6B , the conduit  54 B has a plurality of openings  54 B 1  distributed on a surface of the conduit  54 B (e.g., in spiral form) that are in fluid communication with an inner flow channel  54 B 2  of the conduit  54 B. Fluid can pass axially through the flow channel  54 B 2  from the funnel  52  to the reservoir  56  (see  FIG. 7B ). Fluid can also pass transversely from the outer body  10  of absorbent material, through the openings  54 B 1  and into the flow channel  54 B 2 , which then directs the fluid to the reservoir  56 . 
         [0034]    In  FIG. 6C , the conduit  54 C has a plurality of openings  54 C 1  distributed on a surface of the conduit  54 C (e.g., in linear form) that are in fluid communication with an inner flow channel  54 C 2  of the conduit  54 C. Fluid can pass axially through the flow channel  54 C 2  from the funnel  52  to the reservoir  56  (see  FIG. 7B ). Fluid can also pass transversely from the outer body  10  of absorbent material, through the openings  54 C 1  and into the flow channel  54 C 2 , which then directs the fluid to the reservoir  56 . 
         [0035]    In  FIG. 6D , the conduit  54 D is a tube that without any openings on its outer surface and has an internal flow channel  54 D 2  that directs fluid from the funnel  52  to the reservoir  56 , as shown in  FIG. 7B . 
         [0036]      FIG. 8  is a block diagram illustrating a method  200  of collecting an endometrial tissue sample using the sample collector  100 . The sample collector  200  is first inserted  210  (e.g., by the patient) into the vaginal cavity, in a similar manner as a tampon, so that the distal end  3  of the collector is proximate the uterine cervix and so that the funnel  52  faces the uterine cervix. Optionally, the distal end  3  is placed in contact with the uterine cervix. During menstruation, menstrual fluid, which will include endometrial tissue that is shed during the menstrual cycle and passes through the uterine cervix, is collected  220  by the collector  100  in the manner discussed above. For example, menstrual fluid can be collected in the funnel  52  and directed via the conduit  54 A,  54 B,  54 C,  54 D to the reservoir  56 , where the endometrial cells in the sample can be preserved in the preservation liquid  4 . Additionally, menstrual fluid absorbed by the outer body  10  of absorbent material can be directed transversely through channels (e.g.,  54 A 1 ) or openings (e.g.,  54 B 1 ,  54 C 1 ) in a surface of the conduit  54 A,  54 B,  54 C, which can then also be directed to the reservoir  56 . Advantageously, the endometrial sample collector  100  passively collects the endometrial tissue sample using gravity and without the use of an external actuation force (e.g., without an aspiration or vacuum force, without a mechanical force such as scraping, etc.). Once the sample has been collected, the collector  100  can be can packaged in a container (e.g., plastic receptacle) and be sent  230  to a laboratory for evaluation. For example, the sample collector  100  can include user instructions directing the user on how to collect the sample, and how to package the sample for shipping to the laboratory, and optionally instructions on where to ship the collected sample. 
         [0037]    Advantageously, the endometrial sample collector  100  and its use allows the patient to collect the sample without having to visit a doctor&#39;s office, clinic or hospital, and therefore without disruption to their normal daily activities. Additionally, the use of the collector  100  is non-invasive and does note expose the patient to the potential risks noted above with existing procedures (e.g., risk of infection, risk of perforation of the endometrium, pain and discomfort, bleeding, allergic reaction to medication, risks associated with anesthesia). Further, the sample collector  100  is as easy to use for patients as existing tampons. Additionally, the sample collector  100  can be used in patients with intact hymens (e.g., virgin women), patients that refuse gynecological exams or who live in remote areas far away from healthcare facilities, or patients who have problems adopting the correct gynecological position due to problems in their pelvic articulations, which is often the case following menopause. Further, the sample collector  100  allows the collection of endometrial tissue samples at much lower cost than existing procedures because, for example, doctor&#39;s fees (e.g., gynecologist, anesthesiologist), hospital fees, and disposable instruments and devices are avoided. 
         [0038]    While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the systems and methods described herein may be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure. Accordingly, the scope of the present inventions is defined only by reference to the appended claims. 
         [0039]    Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. 
         [0040]    Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a sub combination. 
         [0041]    Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. 
         [0042]    For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. 
         [0043]    Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment. 
         [0044]    Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z. 
         [0045]    Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree. 
         [0046]    The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

Technology Classification (CPC): 0