Abstract:
A sample collection apparatus or device, various abrasive devices or components, and methods for their use, are provided for collecting samples from within a mammalian body. Tissue collection and sample preparation is the gold standard in cytology. Many cell scrapers and abrasives and their respective methods of collection destroy cellular tissue, decreasing the quality of the sample. Devices for obtaining cell and tissue samples, can comprise a collection device which is inserted into a cavity, a finger worn collection device, a glove based collection device and respective abrasive instruments or components.

Description:
PRIORITY CLAIM 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 62/162,309 which was filed on May 15, 2015, the entire contents of which are incorporated herein by reference and relied upon. 
     
    
     STATEMENT REGARDING FEDERAL FUNDING 
       [0002]    This invention was made with government support under R44CA168185, R42CA168055, U01CA111257, and R01CA165309 awarded by the National Institutes of Health. The government has certain rights in the invention. 
     
    
     FIELD 
       [0003]    The present technology relates generally to sample collection devices, and more specifically, to cytology devices for the collection of mammalian tissue, and associated systems and methods. 
       BACKGROUND 
       [0004]    Existing cytology techniques such as Pap Smear tests have been the state of art for decades. The development of minimally invasive methods and devices in recent years has revolutionized the practice of medicine. The ability to quickly obtain high quality samples with little discomfort has generally made such procedures more acceptable. However, obtaining proper samples for diagnostic testing can be a challenge because certain collection areas are difficult to access and may require more intensive collection and biopsy procedures. 
         [0005]    Certain sample collection devices in the market may have limitations or drawbacks that prevent adequate sample collection. For example, some devices lack proper protection against contaminates. Additionally, certain devices are complex and difficult to navigate, which can lead to even more poor tissue collection. Further, devices with limited or no tactile feedback often prevent sufficient or adequate collection. Moreover, the length of many devices is not ideal and also leads to unsatisfactory collection. Accessing the proper collection site is also more difficult with some devices since they are too long, rigid, inconsistent, or difficult to control. Some devices may even cause added discomfort to a patient from contact between the device and tissue of the patient. Several collection methods require that a specific area is sampled making the configuration or design of the device a critical feature. Therefore, there remains a need for improved collection devices that can provide high quality samples. 
       SUMMARY 
       [0006]    Methods and materials are provided for the collection of biological samples from a patient. 
         [0007]    The present disclosure provides sample collection devices comprising an outer shield assembly comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end comprises a flexible tip portion; and an inner component comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end of the inner component is configured to be inserted into the lumen of the outer shield assembly at its proximal end and to protrude past the distal end of the outer shield assembly thereby penetrating the flexible tip portion when the outer shield assembly and the inner component are in an assembled configuration. In one embodiment, the sample collection device further comprises a sample component having an abrasive head portion at a distal end, wherein the sample component is configured to be inserted into the lumen of the inner component at its proximal end and to protrude past the distal ends of the inner component and outer shield assembly when the outer shield assembly and the inner component are in an assembled configuration. In another embodiment, the sample collection device further comprises at least one of a vacuum tube, an irrigation conduit, an optical sensor, or a camera. In one embodiment, the inner component comprises a stopper secured or attached to the proximal end for contacting the proximal end of the outer shield assembly and thereby limiting a distance the distal end of the inner component can protrude past the distal end of the outer shield assembly when the outer shield assembly and the inner component are in an assembled configuration. In one embodiment, the flexible tip portion is configured to open when the distal end of the inner component protrudes past the distal end of the outer shield assembly. In another embodiment, the flexible tip portion is unitarily or monolithically formed with the outer shield assembly. In yet another embodiment, the flexible tip portion is rounded and outwardly spreadable relative to the distal end of the outer shield assembly. In one embodiment, the sample collection device further comprises a handle comprising a distal end and proximal end coupled the outer shield assembly. In one embodiment, the sample collection device further comprises a protective barrier secured or coupled to the distal end of the handle. In one embodiment, the abrasive head portion comprises one or more bristles. In another embodiment, the sample component is configured to be inserted into a cavity of a patient to a desired sample collection site in the patient through the lumen of the inner component. In another embodiment, the sample component comprises a threaded portion at a proximal end. In yet another embodiment, the threaded portion of the sample component is configured to securably attach to a threaded fitting. In still another embodiment, when the threaded portion of the sample component is securably attached to a threaded fitting, rotational force applied to the threaded fitting imparts a rotational motion on the sample component. In still another embodiment, the inner component is configured to be releasably secured to the outer shield assembly. 
         [0008]    In another aspect, the present disclosure provides sample collection devices comprising an outer shell configured to conform to a finger of a human subject, the outer shell comprising a proximal end and a distal end, wherein the proximal end comprises an opening to receive said finger; and a channel on an interior dorsal surface of the device having a first channel opening in proximity to the proximal end of the device and a second channel opening in proximity to the distal end of the device. In one embodiment, the channel shares a wall or surface with an interior portion of the shell. In one embodiment, the channel is configured to receive a sample component, pretreatment component, or a vacuum tube. In one embodiment, the outer shell is configured to include a molded groove in a bottom or lower portion of the distal end of the outer shell. In another embodiment, the distal end of the outer shell is covered by a moveable flap or cover. In yet another embodiment, the sample collection device further comprises a tab on a top or upper portion of the proximal end of the shell. 
         [0009]    In another aspect, the present disclosure provides glove-based sample collection devices configured to be worn on at least a finger portion of a hand of a human subject comprising an inner layer that is protected by at least one outer layer; and wherein the inner layer comprises a sample component positioned in proximity to a distal tip of a finger portion of the inner layer, and wherein the sample component is configured for collecting a sample. In one embodiment, the sample component comprises at least one of plastic, silicone, multiple bristles, abrasive, foam, or an adhesive. In one embodiment, the sample component is configured to be expandable. In one embodiment, sample component is configured to be protected and/or covered by the outer layer during insertion and/or retraction of the collection device into and out of a patient cavity. In one embodiment, the sample component is attached to a string. In another embodiment, the glove-based sample collection device further comprises a stopper component positioned on the outer and/or inner layer, wherein the stopper is configured to prevent the sample component from being inserted farther into a patient cavity. In yet another embodiment, a distal tip of the at least one outer layer is configured to open or release once the sample component is inserted. 
         [0010]    In another aspect, the present disclosure provides glove-based sample collection devices configured to be worn on at least a finger portion of a hand of a human subject comprising an inner layer that is protected by at least one outer layer; and a channel on an interior dorsal surface of the outer layer having a first channel opening in proximity to the proximal end of the glove-based sample collection device, a second channel opening in proximity to the distal end of the glove-based sample collection device, and a lumen extending therebetween. In one embodiment, the second channel opening comprises a protective covering. In one embodiment, the channel is configured to receive a sample component, pretreatment component, or a vacuum tube. In another embodiment, the channel is unitarily or monolithically formed with the outer layer. In yet another embodiment, the sample component is configured to be protected and/or covered by the channel during insertion and/or retraction of the collection device into and out of a patient cavity. 
         [0011]    In another aspect, the present disclosure provides sample collection devices comprising a flexible sample component configured to conform to a finger of a human subject, the flexible sample component comprising a distal end, a proximal end and a lumen therebetween, wherein an inside surface of the distal end and the lumen are configured to receive said finger; an abrasive head portion on an outside surface of the distal end of the sample component; and a removal component securably attached to the inside surface of the distal end of the flexible sample component. In another embodiment, the sample collection device further comprises a positioning component coupled to the proximal end of the flexible sample component. 
         [0012]    In another aspect, the present disclosure provides sample collection devices comprising an outer shield assembly comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end comprises a flexible tip portion; an inner component comprising a distal end, a proximal end and a lumen extending therebetween, wherein the proximal end comprises an opening to receive a finger of a human subject, and further wherein the distal end comprises an abrasive head; and an adaptor configured to be inserted into the lumen of the outer shield assembly at its proximal end and guide the inner component to protrude past the distal end of the outer shield assembly thereby penetrating the flexible tip portion. In one embodiment, the inner component is configured to be releasably secured to the adaptor. 
         [0013]    In another aspect, the present disclosure provides sample collection devices comprising an outer shield assembly comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end comprises at least one aperture; and an inner component comprising a distal end, a proximal end and a lumen extending therebetween, wherein the proximal end comprises at least one opening to receive a finger of a human subject, and further wherein the distal end comprises at least one abrasive head and at least a portion of the abrasive head is configured to protrude past the aperture of the outer shield assembly. In one embodiment, the sample collection device further comprises a locking mechanism to secure the inner component in the outer shield assembly. In one embodiment, the locking mechanism is at or near the proximal end of the outer shield assembly. In one embodiment, the inner component further comprises a tab that is configured to engage the locking mechanism. In another embodiment, the sample collection device further comprises a release mechanism configured to protrude the abrasive head past the aperture of the outer shield assembly. In yet another embodiment, the abrasive head comprises at least one of bristles, foam, abrasive polymer, or adhesive. In still yet another embodiment, the abrasive head is flexible. 
         [0014]    In another aspect, the present disclosure provides sample components comprising a flexible member and an abrasive head having a plurality of abrasive surfaces comprising two or more wires wherein the wires comprise abrasive surfaces. In one embodiment, at least one of the wires is a flexible wire. In one embodiment, the abrasive surfaces comprise the sample component comprises at least one of plastic, silicone, multiple bristles, foam, or adhesive. In one embodiment, the abrasive surfaces comprise multiple bristle portions or sections. In one embodiment, at least one or a portion of the flexible wires comprise bristle portions or sections. In another embodiment, at least one of the wires are configured to expand once inserted into a patient cavity. 
         [0015]    In another aspect, the present disclosure provides methods of collecting a biological sample using a sample collection device disclosed herein comprising inserting the outer shield assembly and the flexible tip portion into a patient cavity; pushing the inner component through the lumen of the outer shield assembly to protrude the inner component past the distal end of the outer shield assembly thereby opening the flexible tip portion; inserting a sample component through the lumen of the inner component and outer shield assembly until an abrasive head at a distal end of the sample component extends past the distal end of the inner component; and collecting a biological sample from the patient cavity on the sample component. 
         [0016]    In another aspect, the present disclosure provides methods of collecting a biological sample comprising inserting a finger of a human subject comprising a sample collection device disclosed herein into a patient cavity; inserting a sample component through the channel on the inner dorsal surface of the device until an abrasive head at a distal end of the sample component extends past the distal end of the device; and collecting a biological sample from the patient cavity on the sample component. 
         [0017]    In another aspect, the present disclosure provides methods of collecting a biological sample comprising inserting at least one finger of a human subject comprising a glove-based sample collection device disclosed herein; pushing the inner layer through the outer layer thereby exposing the sample component on the distal tip of the finger portion; and collecting a biological sample from the patient cavity on the sample component. 
         [0018]    In another aspect, the present disclosure provides methods of collecting a biological sample comprising inserting at least one finger of a human subject comprising a glove-based sample collection device disclosed herein into a patient cavity; pushing the sample component through the lumen of the channel until an abrasive head at a distal end of the sample component extends past the second channel opening; and collecting a biological sample from the patient cavity on the sample component. 
         [0019]    In another aspect, the present disclosure provides methods of collecting a biological sample comprising positioning a sample collection device disclosed herein into or near a patient cavity with the flexible sample component configured away from the patient cavity such that the abrasive head portion is not exposed; pushing the inside surface of the distal end of the flexible sample component into the patient cavity to expose the abrasive head portion; collecting a biological sample from the patient cavity on the abrasive head portion; pulling on the removal component to retract the abrasive head portion so that the abrasive head portion is not exposed; and removing the sample collection device from the patient cavity. 
         [0020]    In yet another aspect, the present disclosure provides methods of collecting a biological sample using a sample collection device disclosed herein, comprising inserting the outer shield assembly into a patient cavity; inserting the inner component through the lumen of the outer shield assembly; engaging the inner component with the adapter to guide the inner component; twisting the inner component until an abrasive head at a distal end of the inner component extends past the distal end of the outer shield assembly component; and collecting a biological sample from the patient cavity on the sample component. 
         [0021]    In yet another aspect, the present disclosure provides methods of collecting a biological sample using a sample collection device disclosed herein comprising inserting the outer shield assembly into a patient cavity; positioning the aperture of the outer shield assembly on or near a sample for collection; twisting the inner component to expose the at least one abrasive head portion past the aperture of the outer shield assembly; and collecting the biological sample from the patient cavity on the abrasive head portion. 
         [0022]    In one embodiment, at least a portion of a sample collection device is pre-lubricated prior to insertion into a patient cavity. 
         [0023]    In one embodiment, the methods of collecting a biological sample further comprise imparting a rotational motion on the sample component and/or abrasive head to collect the biological sample from the patient cavity. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]      FIG. 1  is a front isometric view of outer and inner assemblies of a sample device configured in accordance with an embodiment of the present technology. 
           [0025]      FIG. 2  is a front isometric view of the sample collection device of  FIG. 1  in an assembled configuration with a sample component inserted therethrough in accordance with an embodiment of the present technology. 
           [0026]      FIG. 3  is a side view of the assembled sample collection device of  FIG. 2  illustrating example dimensions in accordance with an embodiment of the present technology. 
           [0027]      FIG. 4A  is an isometric view of a finger worn sample collection device configured in accordance with another embodiment of the present technology. 
           [0028]      FIG. 4B  is an isometric view of a finger worn sample collection device configured in accordance with another embodiment of the present technology. 
           [0029]      FIG. 4C  is an isometric view of a finger worn sample collection device configured in accordance with another embodiment of the present technology. 
           [0030]      FIG. 4D  is an end view of a finger worn sample collection device configured in accordance with another embodiment of the present technology. 
           [0031]      FIG. 5A  is a top view of the finger worn sample collection device of  FIG. 4 . 
           [0032]      FIG. 5B  is a bottom view of the finger worn sample collection device of  FIG. 4 . 
           [0033]      FIG. 6A  is a bottom view of the finger worn sample collection device of  FIG. 4  with a sample component inserted therethrough. 
           [0034]      FIG. 6B  is a side view of the finger worn sample collection device of  FIG. 4  with the sample component and a user finger inserted therethrough. 
           [0035]      FIG. 7A  is a side view of the finger worn sample collection device of  FIG. 4  with a sample component inserted therethrough illustrating example dimensions of the device and component. 
           [0036]      FIG. 7B  is a side view of the finger worn sample collection device of  FIG. 4  with the sample component inserted past a distal end of the device illustrating example dimensions of the device and component. 
           [0037]      FIG. 7C  is a side view of the finger worn sample collection device of  FIG. 7B  with a user finger inserted therethrough. 
           [0038]      FIG. 8  is a side view of a portion of a sample component configured in accordance with an embodiment of the present technology. 
           [0039]      FIG. 9  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0040]      FIG. 10  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0041]      FIG. 11  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0042]      FIG. 12  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0043]      FIG. 13  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0044]      FIG. 14  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0045]      FIG. 15  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0046]      FIG. 16  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0047]      FIG. 17  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0048]      FIG. 18  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0049]      FIG. 19  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0050]      FIG. 20A  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0051]      FIG. 20B  is a side view of the sample component of  FIG. 20A  with the multiple abrasive surfaces expanded. 
           [0052]      FIG. 20C  is a side view of the distal end of the inner component of the sample collection device of  FIG. 1  with the sample component of  FIG. 20A  collapsed within the lumen of the inner component. 
           [0053]      FIG. 20D  is a side view of the distal end of the inner component of the sample collection device of  FIG. 1  with the sample component of  FIG. 20A  protruding past the distal end of the inner component having bristles of the abrasive head portion of the sample component expanded outwardly. 
           [0054]      FIG. 21  is a side view of a portion of a sample component configured in accordance with another embodiment of the present technology. 
           [0055]      FIG. 22A  is a side view of a glove-based sample collection device configured in accordance with another embodiment of the present technology. 
           [0056]      FIG. 22B  is a side view of the glove-based sample collection device of  FIG. 22A  with a sample component exposed. 
           [0057]      FIG. 23  is a bottom view of the glove-based sample collection device illustrating certain features of the device configured in accordance with an embodiment of the present technology. 
           [0058]      FIG. 24  is a bottom view of the glove-based sample collection device illustrating certain features of the device configured in accordance with an embodiment of the present technology. 
           [0059]      FIG. 25  is a side view of a glove-based sample collection device configured in accordance with another embodiment of the present technology. 
           [0060]      FIG. 26  is a bottom view of the glove-based sample collection device of  FIG. 25  illustrating certain features of the device configured in accordance with an embodiment of the present technology. 
           [0061]      FIG. 27A  is a side view of a glove-based sample collection device illustrating certain outer features of the device configured in accordance with an embodiment of the present technology. 
           [0062]      FIG. 27B  is a side view of a glove-based sample collection device illustrating certain features of the outer and inner layers of the device configured in accordance with an embodiment of the present technology. 
           [0063]      FIG. 27C  is a side view of a glove-based sample collection device illustrating certain features of the inner layer and sample component protruding past the outer layer of the device configured in accordance with an embodiment of the present technology. 
           [0064]      FIG. 28A  is a side view of a sample component in accordance with an embodiment of the present technology in accordance with an embodiment of the present technology. 
           [0065]      FIG. 28B  is a side view of an expanded sample component in accordance with an embodiment of the present technology. 
           [0066]      FIG. 29A  is a side view of the outside of an assembled sample collection device configured in accordance with an embodiment of the present technology. 
           [0067]      FIG. 29B  is a cut away view of the assembled sample collection device of  FIG. 29A  in accordance with an embodiment of the present technology. 
           [0068]      FIG. 30A  is a side view of a sample collection device having a threaded component and push button activator configured in accordance with an embodiment of the present technology. 
           [0069]      FIG. 30B  is a side view of the assembled sample collection device of  FIG. 30A  in an activated configuration in accordance with an embodiment of the present technology. 
           [0070]      FIG. 31A  is a side view of a sample collection device having a threaded component and push button activator configured in accordance with an embodiment of the present technology. 
           [0071]      FIG. 31B  is a cut away view of the assembled sample collection device of  FIG. 31A  in accordance with an embodiment of the present technology. 
           [0072]      FIG. 32A  is a side view of a sample collection device having a threaded component and push button activator configured in accordance with an embodiment of the present technology. 
           [0073]      FIG. 32B  is a cut away view of the assembled sample collection device of  FIG. 32A  in accordance with an embodiment of the present technology. 
           [0074]      FIG. 33A  is a side view of a flexible finger worn sample collective device in accordance with an embodiment of the present technology. 
           [0075]      FIG. 33B  is a side view of the flexible finger worn sample collection device of  FIG. 33A  configured with an exposed abrasive head in accordance with an embodiment of the present technology. 
           [0076]      FIG. 34A  is a rear isometric view of outer shield assembly and inner component of a sample collection device configured in accordance with an embodiment of the present technology. 
           [0077]      FIG. 34B  is a rear isometric view of the finger worn sample collection device of  FIG. 34A  in an assembled configuration with the inner component inserted therethrough in accordance with an embodiment of the present technology. 
           [0078]      FIG. 35A  is a side view of a push-and-twist finger worn sample collection device in accordance with an embodiment of the present technology. 
           [0079]      FIG. 35B  is a side view of a push-to-expand finger worn sample collection device in accordance with an embodiment of the present technology. 
       
    
    
     DETAILED DESCRIPTION 
       [0080]    The present technology describes various embodiments of sampling collection devices and associated systems and methods for collecting samples (e.g., tissue samples) of mammals or other animals in the diagnostic or other contexts. For example, various sampling (e.g., cytology) collection devices, features, and methods for their use are described herein. The various devices and methods generally employ reduced or minimally invasive technologies in order to collect cytology samples from, for example, the gastrointestinal body of a patient. In several embodiments, for example, a sampling collection device can be inserted into a cavity, e.g., through an anal canal and into a rectum, and introduced to a nearby site (e.g., the cervix, colon, etc. of a patient) that may be investigated for cellular inconsistencies. The present technology also describes systems and methods for collecting samples using rapid collection procedures. 
         [0081]    Many diagnostic procedures have been developed over the years which have diminished the need for more severe procedures. Particularly, the Pap Smear screening has paved the way for cervical cancer prevention. Studies have shown that the risk of developing invasive cervical cancer is three to ten times greater in women who have not been screened, demonstrating the importance of these tests and accurate sample collection. 
         [0082]    Similarly, for colon cancer screening, a colonoscopy is the state of the art procedure. However, the technique is costly, requires sedation and is lengthy which increases the cost and burden on the healthcare system. Novel procedures such as virtual colonoscopy done via a CT or MRI scan has gained traction but is usually not as widely available or covered by healthcare providers (e.g., health insurance). Additionally, if a virtual procedure detects any abnormalities, generally a conventional colonoscopy must be performed. 
         [0083]    Certain details are set forth in the following description and in  FIGS. 1-35  to provide a thorough understanding of various embodiments of the present technology. Other details describing well-known structures and systems often associated with sample collection devices however, are not set forth below to avoid unnecessarily obscuring the description of the various embodiments of the present technology. 
         [0084]    Many of the details, dimensions, angles and other features shown in  FIGS. 1-35  are merely illustrative of particular embodiments of the present technology. Accordingly, other embodiments can include other details, dimensions, angles and features without departing from the spirit or scope of the present invention. In addition, those of ordinary skill in the art will appreciate that further embodiments of collection devices described herein can be practiced without several of the details described below. Various embodiments of the present technology can also include structures other than those illustrated in the Figures and are expressly not limited to the structures shown in the Figures. Moreover, the various elements and features illustrated in the Figures may not be drawn to scale. 
         [0085]    In the Figures, identical reference numbers identify identical or at least generally similar elements. To facilitate the discussion of any particular element, the most significant digit or digits of any reference number refers to the Figure in which that element is first introduced. For example, element  110  is first introduced and discussed with reference to  FIG. 1  and element  2110  is first introduced and discussed with reference to  FIG. 21 . 
       Sample Collection Device 
       [0086]      FIG. 1  is a front isometric view of a sample collection device  100  configured in accordance with an embodiment of the present technology. The sample collection device  100  (e.g., an insertion device) is configured to protect or shield a sample component  108  (e.g., an abrasive component) and can include an outer component or assembly (also referred to as an outer shield assembly)  104  and an inner component or assembly  106 . The outer and inner assemblies  104 , 106  can be separate components configured to be removably secured or attached together as described in more detail below. In other embodiments, various components of the sample collection device  100  can be monolithically or integrally formed together as a single component. Both the outer and inner assemblies  104 , 106  can be formed from suitable flexible or rigid materials. 
         [0087]    The sample collection device  100  includes a proximal end and a distal end, for guiding the sample component  108  into and through a cavity (e.g., an orifice or lumen) of a patient. The outer shield assembly  104  includes a distal end  110  opposite a proximal end  112 . In certain embodiments, the sample collection device  100  can be configured to be small enough to held with one hand of a user (e.g., by a doctor, physician, surgeon, or other medical or clinical practitioner). The proximal end  112  of the outer shield assembly  104  includes an opening  114  for receiving a distal end  116  of the inner component  106  to be inserted therethrough. A first body portion (i.e., lumen)  118  of the inner component  106  is configured to travel or extend through a second body portion (i.e., lumen)  120  of the outer shield assembly  104 . For example, the second body portion  120  can be an outer tube (e.g., conduit, sheath, etc.) and the first body portion  118  can be an inner tube (e.g., conduit, sheath, etc.) configured to be inserted into and extend at least partially through the outer tube as illustrated and described in more detail with respect to  FIG. 2 . 
         [0088]    The distal end  110  of the outer shield assembly  104  includes a movable (e.g., deformable or resilient) tip portion  122 . For example, the tip portion  122  can be made from a flexible or other suitable material which can aid in inserting or maneuvering the sample collection device  100  into or through variously shaped anatomical cavities, openings, and conduits. The tip portion  122  can open (e.g., by deforming) when the inner component  106  is inserted though the outer shield assembly  104  until the distal end  116  of the inner component  106  protrudes from the distal end  110  of the outer shield assembly. By opening the tip portion  122 , another component (e.g., the sample component  108 ) may be inserted through the sample collection device  100 . The tip portion  122  may be unitarily or monolithically formed with the rest of the outer shield assembly  104  as a single component. In other embodiments, the tip portion  122  and the outer shield assembly  104  can be two separate components. 
         [0089]    The second body portion  120  of the outer shield assembly  104  can be connected or coupled to a handle  124 . The handle  124  can have a spool-shaped body or other suitable configuration with the opening  114  or channel extending therethrough between first and second ends of the handle  124 . The handle  124  may be formed from a flexible or rigid material. The handle  124  may be a single, unitary (e.g., monolithically formed) piece or composed of several pieces assembled together. 
         [0090]    A protective barrier  126  can be secured or coupled to a distal end of the handle  124  between the distal and proximal ends  110 , 112  of the outer shield assembly  104 . The protective barrier  126  can prevent the sample collection device  100  from being inserted too deep into a cavity or orifice (e.g., the protective barrier  126  can be greater in diameter than the cavity or orifice to prevent further insertion of the outer shield assembly  104 ). The protective barrier  126  can also provide protection (e.g., contamination protection) against fluids that may escape or leak out of the cavity or orifice and flow around the circumference of second body portion  120 . As illustrated, in some embodiments, the protective barrier  126  can have a rectangular cross-sectional shape. In other embodiments, the protective barrier  126  can have a circular or other suitable cross-sectional shape. The protective barrier  126  can be formed from a flexible (e.g., silicone) or rigid material. 
         [0091]    As described above, the first body portion  118  of the inner assembly  106  can be an inner tube (e.g., conduit, sheath, etc.) having proximal and distal ends. The first body portion  118  can be made from a flexible or rigid material. In some embodiments, the first body portion  118  can include one or more slots or grooves  130  to increase flexibility of the first body portion  118 . The first body portion  118  can also include a stopper component  128  configured to be secured or attached to a proximal end of the first body portion  118 . The stopper component  128  can be configured such that it cannot be inserted into the opening  114 . For example, the stopper component  128  can have a diameter greater than the diameter of the opening  114 . This can prevent the inner component  106  from being inserted further into the outer shield assembly  104  when the stopper component  128  contacts a proximal end of the handle  124 . 
         [0092]      FIG. 2  illustrates an assembled configuration of the sample collection device  100 . During assembly, the inner component  106  is inserted into the opening  114  at the proximal end  112  of the outer shield assembly  104 . The stopper component  128  can prevent the first body portion  118  of the inner component  106  from being inserted too deep or far into the cavity of the patient. For example, the stopper component  128  provides a physical and visual signal to a user that the inner component  106  is fully inserted into the outer shield assembly  104  when a distal end of the stopper component  128  reaches and contacts the proximal end  112  of the outer shield assembly  104  (e.g., the handle  124 ) and cannot be moved farther toward the distal end  110  of the outer shield assembly  104 . The stopper component  128  can also serve to signal to the user when the sample component  108  can be inserted through the inner component  106  (e.g., when the inner component  106  has been fully inserted into the outer shield assembly  104 ). 
         [0093]    During assembly, as the inner component  106  is inserted through the handle  124  and toward the distal end  110  of the outer shield assembly  104 , the tip portion  122  of the outer shield assembly  104  will begin to open as the distal end  116  of the inner component  106  is pushed through the tip portion  122 . Once the inner component is fully inserted, whereby the stopper component  128  contacts the handle  124 , the tip portion  122  is fully opened (e.g., spread or deformed outward). Such features prevent the sample component  108  from directly touching or contacting the tip portion  122  when inserted through the inner and outer assemblies  106 , 104 . The tip portion  122  may be contaminated with fluids or other tissue when the outer shield assembly  104  was first inserted into the cavity or other orifice of the patient. Further, the tip portion  122  may be covered with a lubricant to aid inserting the outer shield assembly  104  that may potentially contaminate any potential sample collected with the sample component  108 . The shape or contour of the distal end  116  of the inner component  106  can be rounded, smooth, and/or curved to minimize any sharp edges to facilitate insertion of the inner component  106  through the outer shield assembly  104 . 
         [0094]    The outer shield assembly  104  (e.g., the tip portion  122 ) aids in moving tissue away from a potential sample site prior to inserting the inner component  106 . Once the inner component  106  is fully inserted into the outer shield assembly  104  (e.g., the stopper component  128  makes contact with the handle  124 ), the sample component  108  may be inserted into and through the inner component  106 . The sample component  108  is inserted until it exits the distal end  110  of the outer shield assembly  104  near the tip portion  122  and into the patient sample site. 
         [0095]    In some embodiments, the sample component  108  can be an abrasive sample component configured to be inserted into a cavity of a patient to a desired sample collection site in the patient through the inner and outer assemblies  106 , 104  to collect a tissue sample. Example sample components or abrasive head portions that can be used with the sample collection devices described herein are described in more detail below with respect to  FIGS. 8-21B  and  FIG. 28 . However, the sample collection devices are not limited to using such sample components. The sample component  108 , as shown in  FIG. 2 , is inserted into the sample collection device  100  through the inner and outer assemblies  106 , 104 . The conduits, tubes, or sheaths of the inner and outer assemblies  106 , 104  are sized such that the sample component and/or abrasive head portion can move or rotate in a circular or radial direction (e.g., to collect or swab a tissue sample). The sample component  108  can include an abrasive head portion (e.g., a brush or bristles) for collecting a sample. 
         [0096]    The interior spaces (e.g., body portions, conduits, sheaths, tubes, the handle  124 , the stopper component  128 , the protective barrier  126 , the tip portion  122 , etc.) of the sample collection device  100  can sized to permit passage of other structures and components to be inserted through or along the sample collection device  100 . For example, a vacuum tube may be inserted through the sample collection device  100 . The vacuum tube may be used to remove liquid, fluid, or other debris (e.g., from the collection site). An irrigation conduit (e.g., for providing liquid, fluid, etc.) to the sample collection site can also be inserted through or along the sample collection device  100  in certain embodiments. In some embodiments, an optical sensor can be used with the sampling device  100  (e.g., with the tip portion  122  or sample component  108 ) to signal to a user a location of the sample collection device  100  within the patient. In other embodiments, a camera can be used, for example, to provide video of the insertion site. All materials forming the sample collection device  100 , sample component  108 , and/or other components used with the sample collection device  100  can be biocompatible and approved for use in humans. 
         [0097]    Further in some embodiments, the tip portion  122 , second body portion  120 , protective barrier  126 , and/or handle  124  can form a first distinct assembly (e.g., the outer shield assembly  104 ) and the first body portion  118  and the stopper component  128  can form a second distinct assembly (e.g., the inner component  106 ). The first and second distinct assemblies can function together and be assembled to form the sample collection device  100  for receiving the sample component  108  or other components. 
         [0098]    In other embodiments, the sample collection device  100  includes an integrated hand piece whereby the first body portion  118 , the stopper component  128  of the inner component  106  and the sample component  108  (e.g., an abrasive component) are integrated with the tip portion  122 , second body portion  120 , the protective barrier  126  and the handle  124 . This embodiment can control how far the first body portion  118  and/or the integrated sample component  108  are inserted or retracted relative to the outer shield assembly or cavity (e.g., the distance of insertion and retraction). The distance can be controlled by, for example, a slide feature whereby a user can push the slide feature forward to enable insertion and pulls the feature back to enable retraction. The feature can enable the position of the first body portion  118  and/or the integrated sample component  108  to be locked before and/or during sample collection. The sliding feature may reach a point along the handle  124  that restricts the sliding features motion and prevents its return without additional force. For example, it can include an extruded feature that can interfere with or lock the free motion of the sliding feature. In an alternative embodiment, the device can include a mechanism (e.g., a knob that is twisted or turned) which will move the first body portion  118  and/or the integrated sample component  108  forward or backward. The stopper component  128  can have a threaded component which is inserted into the handle  124 . By twisting, the threaded component, the stopper component  128  can be moved forward or backward. Other suitable twisting mechanisms can also be used. Another embodiment, includes integrating the sample component  108  with the device  100  such that it may be push fit into the stopper component  128  to temporarily secure the two structures together. However, the sample component  108  can be removed by pulling it away from the stopper component  128 . In certain embodiments, the first body portion  118  can be locked in position after the first body portion  118  is inserted to a proper or desired location. Then after the first body portion  118  is secured or locked in position, the sample component  108  can be inserted through the opening  114  and extend through and exit the distal end  110  of the device  100 . 
         [0099]      FIG. 3  illustrates example dimensions of various components of the sample collection device  100 . In some embodiments, a length of the sample device  100  can be defined as the distance between the proximal end and the distal end (e.g., between the proximal end of the stopper component  128  and the distal end of the tip portion  122  or between the proximal and distal ends of the sample component  108 ). For example, in some embodiments, the length can be in the range of about 10 cm to about 16 cm and/or any value therebetween. In other embodiments, the length can be in the range of about 6 cm to about 18 cm and/or any value therebetween. In further embodiments, the length can be in the range of about 4 cm to about 20 cm and/or any value therebetween. The length of the sample collection device  100  may vary depending on the required or desired area of sample (e.g., tissue) collection and/or the distance a desired sample collection area is away from a cavity, opening, or orifice the sample collection device  100  can enter through to access the sample collection area. In some embodiments, a length of the outer shield assembly  104  (e.g., between the protective barrier and distal end of the tip portion  122 ) that is actually inserted into the patient can be about 2 inches, 3 inches, 4 inches, 5 inches, and/or any value therebetween. 
         [0100]      FIG. 29  illustrates one embodiment of a sample collection device  2900  configured to have an activator  2912  and threaded fitting  2910  that function to impart rotational motion on the sample component  2906 . The sample collection device can comprise an outer shield assembly  2901  with a flexible tip portion  2902 , an inner component  2903 , a threaded fitting  2910 , and an activator  2912 . In some embodiments, the activator can be a push button, a switch, or the like. In some embodiments, the sample component  2904  comprises an abrasive head portion  2906 , and optionally a removal component  2908 . The sample component  2904  can further comprise a threaded portion at a proximal end wherein the threaded portion of the sample component is configured to securably attach to a threaded fitting  2910 . Example sample components or abrasive head portions that can be used with the sample collection devices described herein are described in more detail below with respect to  FIGS. 8-21B  and  FIG. 28 . However, the sample collection devices are not limited to using such sample components. 
         [0101]      FIG. 30  illustrates another embodiment of a sample collection device  3000  configured to have an activator  3016  and threaded fitting  3014  that function to impart rotational motion on the sample component  3008  and the abrasive head portion  3018 . The sample component  3008  can comprises a threaded portion at a proximal end of the sample collection device  3000  which is configured to securably attach to a threaded fitting  3014 . In one embodiment, the inner component  3006  securably attaches to the outer shield assembly  3004 . In some embodiments, the proximal end  3012  of the outer shield assembly  3004  comprises a handle  3020  and/or a protective barrier  3022 . The protective barrier  3022  can be secured or coupled to a distal end of the handle  3020 , for example, near the proximal end  3012  of the outer shield assembly  3004 . The protective barrier  3022  can prevent the sample collection device  3000  from being inserted too deep into a cavity or orifice (e.g., the protective barrier  3022  can be greater in diameter than the cavity or orifice to prevent further insertion of the outer shield assembly  3004 ). The sample collection device  3000  can also have an activator  3016  which engages with the handle  3020 . 
         [0102]      FIG. 31  illustrates yet another embodiment of a sample collection device  3100  configured to have a threaded fitting  3102  and a cap  3104  that function to impart rotational motion on the abrasive head portion  3122  of the sample component. In some embodiments, the cap  3104  is threaded or snapped onto the threaded fitting  3102 . In some embodiments, the threaded fitting  3102  is securably attached to the sample collection device  3100  by a housing component  3106 . In some embodiments, the inner component  3117  and/or sample component can be releasably secured to the housing component  3106  by a lever  3108 . In some embodiments, the proximal end of the sample component or the inner component  3117  comprises a threaded portion that is securably attached to the threaded fitting  3102 . The sample collection device  3100  can have a handle  3112  and a protective barrier  3114 . In some embodiments, the sample collection device  3100  can have a flexible adaptor  3116  which can conform to the anatomy of a patient. The flexible adaptor  3116  can be attached to the handle  3112  and/or outer shield assembly  3118 . The outer shield assembly  3118  can have a flexible tip portion  3120  on the distal end. The flexible tip portion  3120  can be greater in diameter than the outer shield assembly  3118 . The flexible tip portion  3120  can be unitarily or monolithically formed with the outer shield assembly  3118 . The abrasive head portion  3122  of the sample collection device  3100  can rest inside the flexible tube portion  3122  prior to use such that the abrasive head portion  3122  does not extend out of the sample collection device  3100 . 
         [0103]      FIG. 32  illustrates yet another embodiment of a sample collection device  3200  configured to have a threaded fitting  3204  and a cap  3201  that function to impart rotational motion on the abrasive head portion  3220  of the sample component  3218 . In some embodiments, the cap  3201  is threaded or snapped onto the threaded fitting  3204 . The sample collection device  3200  can further comprise an activator  3202 , which can be a push button, a switch, or the like. In some embodiments the sample collection device  3200  comprises a lever  3206  that functions to securably attach or release the attachment component  3208  which attaches the threaded fitting  3204  to the outer shield assembly  3218 . The sample collection device  3200  can have a handle  3210  and a protective barrier  3212 . The outer shield assembly  3216  can have a flexible tip portion  3214  on the distal end. The flexible tip portion  3214  can be unitarily or monolithically formed with the outer shield assembly  3218 . The abrasive head portion  3220  and the inner component  3218  of the sample collection device  3200  can rest inside the flexible tube portion  3214  prior to use such that the abrasive head portion  3220  and the inner component  3218  do not extend out of the sample collection device  3200  until the sample collection device  3200  is positioned appropriately for collecting a sample. 
         [0000]    Method of Collection with Sample Collection Device 
         [0104]    An example method of collecting a sample (e.g., a tissue sample) with the sample collection device  100  can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device  100  can be removed from a packaging or other wrapping that it is stored in. The sample collection device  100  can be pre-lubricated or a physician or other user can lubricate the outer shield assembly  104  (e.g., the second body portion  120  and/or the tip portion  122 ) before inserting the outer shield assembly  104  into the patient. 
         [0105]    The sample collection device  100  (e.g., the outer assembly  104 ) can be inserted into the patient cavity or orifice until the protective barrier  126  is touching or contacting the patient&#39;s body. Next, the inner component  106  is inserted into the outer assembly  104  through the opening  114  until the stopper component  128  contacts the handle  124  and pushes the tip portion  122  (e.g., end flaps) outward. The first body portion  118  of the inner component  106  is sized such that when the stopper component  128  contacts the handle  124 , the distal end of the first body portion  118  pushes open or otherwise spreads outwardly the tip portion  122 . 
         [0106]    The sample component  108  (e.g., brush or other abrasive head portion) is then inserted into a proximal opening of the stopper component  128  and inserted through the inner and outer assemblies  106 , 104  until a head portion (e.g., abrasive part) of the sample component  108  extends past a distal end of the tip portion  122 . The sample component  108  can be pre-marked with dashes or other marks along its body or shaft portion. The marks can indicate the location or distance of the sample component  108  (e.g., how far it extends into the patient or past the distal end of the tip portion  122 ). For example, a user can insert the sample component  108  a desired length into the patient and/or past the distal end of the tip portion  122  based on the location of the marks and/or which marks are still visible. 
         [0107]    If any resistance is met while inserting the assemblies or components, the sample collection device  100  (the outer shield assembly  104 , inner component  106 , and/or sample component  108 ) may be repositioned (e.g., removed, re-inserted, moved, etc.) accordingly as human and other animal anatomy may vary (e.g., cavity shape may change). The sample component  108  can then be rotated to collect the sample from the desired sample site within the patient. Once the sample is collected, the sample component  108  can be removed from device  100  (e.g., pulled out). After the sample component  108  is removed, the sample collection device  100  (e.g., the inner and outer assemblies  106 , 104 ) may be removed and discarded. In some embodiments, the sample collection device  100  (e.g., the inner and outer assemblies  106 , 104 ) can be washed or decontaminated for reuse. 
       Finger Worn Sample Collection Device 
       [0108]      FIGS. 4A-4D  illustrate various isometric views and an end view, respectively, of a sample collection device  400  configured in accordance with another embodiment of the present technology. The sample collection device  400  is configured to be worn or placed onto a finger (e.g., the index finger) of a user. Referring to  FIGS. 4A-4D  together, the sample collection device  400  includes an outer shell  402  (e.g., body, case, mount, etc.) shaped and sized to conform to a user&#39;s finger. The shell  402  includes a proximal end  404  and a distal end  406 . The proximal end  404  has an opening  414  configured to receive the user&#39;s finger  418  ( FIGS. 6A and 6B ). The device  400  has a channel  410  (e.g., a hollow channel, conduit, or tube) that extends from the proximal end  404  to the distal end  406  along a lower or bottom portion of the shell  402  within an interior or cavity of the shell  402 . In some embodiments, the channel  410  can share a wall or surface with an interior portion of the shell  402  (e.g., a bottom or lower surface). The channel  410  can be completely enclosed within the interior of the shell  402 . In other embodiments, the channel  410  can be open to the interior (e.g., cavity) of the shell  402 . 
         [0109]    The channel  410  may house and receive a sample component  408  (e.g., an abrasive head portion) configured to extend therethrough and be inserted through a proximal opening (e.g., the opening  414  and/or a proximal opening of the channel  410 ) and past (e.g., exit) a distal opening  412  of the shell  402 . In some embodiments, the sample component  408  can also extend past the distal end  406  of the shell  402  to reach deeper or farther into the cavity of a mammal or other animal ( FIGS. 7A-7C ). The channel  410  can have a cylindrical, cuboid, prismatic, or other suitable cross-sectional shape. 
         [0110]    A bottom or lower portion of the distal end  406  of the shell  402  includes a molded groove  416  (e.g., slot, channel, valley, etc.) that a head or distal portion (e.g., brush) of the sample component  408  can sit or reside in to collect a sample as the shell  402  is moved or rotated in a radial direction by the user&#39;s finger. The groove  416  allows the distal end (e.g., head or brush portion) of the sample component  408  to reside in a specific location at the distal end of the shell  402 . Such a location is near or proximate a distal tip of the user&#39;s finger when inserted into the shell  402  ( FIGS. 6A and 6B ). This can provide greater tactile contact or feedback between the user&#39;s finger, the sample component  408 , and patient cavity for more accurate sample collection. For example, the groove  416  enables the user&#39;s finger to press on the distal end of the sample component  408  and ensure contact between the wall of a patient cavity and the sample component  408 . The groove  416  can also prevent the distal end of the sample component  408  from shifting or moving side to side when residing in the groove  416 . 
         [0111]    The channel  410  also provides a space where the sample component  408  can be protected from contamination (e.g., mammalian tissue) prior to the sample component  408  being used to collect a sample at a desired sample site as described in more detail below. In some embodiments, the channel  410  may be used to insert other types of components to the sample collection site or otherwise into the patient. For example, a pretreatment component such as a foam brush can be inserted therethrough. In other embodiments, the channel  410  can be used to insert a vacuum tube in order to clean out the collection site or area (e.g., a cavity). Once the area is clean, the vacuum tube may be retracted and the sample component  408  can be inserted to collect a sample. Any components inserted into the proximal opening  414  will be positioned outside of the patient cavity. The component  408  can then be inserted through the channel  410  (e.g., beginning at a proximal opening  411 ) until a distal end of the component  408  exits through the distal opening  412  which will be inside the patient cavity. 
         [0112]    In some embodiments, the distal opening  412  is protected and/or covered by a movable flap or cover. The flap or cover can prevent contaminants from entering the interior of the shell  402  through the opening  412  as the device  400  is inserted through the patient cavity. The flap or cover can be pushed or moved open by the sample component  408  or other components as described above when inserted through the opening  412 . In other embodiments, a distal end  406  of the device  400  can include a stopper component  413 . The stopper component  413  can prevent a component (e.g., the sample component  408 ) from extending past the distal tip or end  406  of the device  400 . The stopper component  413  can also ensure that contact between the finger, device  400 , and inserted component (e.g., the head or distal portion of the sample component  408 ) is maintained throughout the collection process. 
         [0113]    In certain embodiments, as illustrated in  FIGS. 4-7C , the device  400  can include a tab  420  (e.g., a projection portion) on the top or upper portion of the device  400  at the proximal end  404  to assist or help the user place the device  400  on a finger. The tab  420  may have one or more ridges  422  to provide increased gripping portions on the tab  420 . 
         [0114]    The device  400  can include curved or rounded edges to decrease resistance during insertion and increase maneuverability. In some embodiments, the distal end  406  of the device  400  may be designed with extruded geometry to help with removing debris during insertion. The device  400  can be composed of a flexible biocompatible material which may be stretched over the user&#39;s finger when being worn or mounted. 
         [0115]    The device  400  can include one or more openings in the walls or surfaces of the device  400  (e.g., around the top or upper portion of the device  400 ) to minimize the surface area contact between the device  400  and the finger. This can simplify placing the device  400  on the finger. In certain embodiments, the device  400  can include an additional activation component  424  (e.g., a thumb rest) for activating the sample component  408  for collection once the finger worn device  400  is inserted into a patient cavity. The activation component  424  can be press fit or otherwise suitably secured onto the sample component  408 . In some embodiments, the activation component  424  can be molded onto the sample component  408 . For example, the activation component  424  can include a projection or tab at the proximal end of the sample component  408  for providing an additional traction or contact surface to activate the sample component  408  for collection. 
         [0116]    In some embodiments, the sample collection device  400  can have a molded feature at the distal end to enable the sample component  408  to slide into a proper or desired location along the device  400  and/or in the patient cavity. The feature can also stop or prevent the sample component  408  from further or deeper insertion. 
         [0117]      FIGS. 33A-B  illustrate various side views of a flexible finger worn sample collection device  3300  (e.g., push in adaptor) configured in accordance with another embodiment of the present technology. The sample collection device  3300  is configured to be worn or placed onto a finger (e.g., the index finger) of a human subject. Referring to  FIGS. 33A-B  together, the sample collection device  3300  includes a flexible sample component  3302 , having an inside surface (shown in  FIG. 33A ) and an outer surface (shown in  FIG. 33B ) shaped and sized to conform to a human subject&#39;s finger. The sample component  3302  includes a proximal end  3306  and a distal end  3304 . The distal end  3304  of the sample component  3302  comprises at least one abrasive portion  3308 . The sample component  3302  is configured to receive the user&#39;s finger at an inside surface of the distal end  3304 . The sample collection device  3300  has a removal component  3310  (e.g., a string) securably attached to an inside surface of the distal end  3304  of the sample component  3302 . 
         [0118]    In certain embodiments, as illustrated in  FIGS. 33A-B , the sample collection device  3300  can include a positioning component  3312  at the proximal end  3306  of the sample component  3302 . The positioning component  3312  can contain one or more tabs  3314  (e.g., a projection portion) to assist or help the user place the device  3300  in a cavity of a patient as well as to manipulate the device to collect a sample. Both the sample component  3302  and positioning component  3312  can be formed from suitable flexible or rigid materials. In a preferred embodiment, the sample component  3302  is formed from a suitable flexible material such that the subject&#39;s finger can push against the inside surface of the distal end  3304  of the sample component  3302  to force the sample component  3302  extends into a cavity of a patient and to configure the abrasive head portion  3308  to be on an exposed surface of the sample component  3302 . The abrasive head portion  3308  can be made of any suitable material and geometry. 
         [0119]      FIGS. 34A-B  illustrate various side views of a finger worn sample collection device  3400  (e.g., push-and-twist) configured in accordance with an alternative embodiment of the present technology. The sample collection device  3400  is configured to be worn or placed onto a finger (e.g., the index finger) of a human subject. Referring to  FIGS. 34A-B  together, the sample collection device  3400  includes a proximal end and a distal end, for guiding the abrasive head portion  3410  into and through a cavity (e.g., an orifice or lumen) of a patient. The outer shield assembly  3402  includes a distal end  3416  opposite a proximal end  3414 , wherein the distal end  3416  may comprise a flexible tip portion  3418 . The proximal end  3416  of the outer shield assembly  3402  is configured for receiving a distal end  3408  of the inner component  3404  to be inserted therethrough. The inner component  3404  comprises a distal end  3406 , a proximal end  3408 , with a lumen extending therebetween. The proximal end  3408  of the inner component  3404  is configured to receive a finger of a human subject. The distal end  3408  of the inner component  3404  comprises an abrasive head portion  3410 . The adapter  3412  is configured to be inserted into the lumen of the outer shield assembly at its proximal end  3414 . The adapter  3412  is further configured to guide the abrasive head portion  3410  of the inner component  3404  to protrude past the distal end  3416  of the outer shield assembly  3402  thereby penetrating the flexible tip portion  3418 . In some embodiments, the inner component has a twisting mechanism  3420  that is configured to allow the inner component to be released and/or locked. In some embodiments, by twisting the inner component  3404  within the adapter  3412 , the inner component  3404  moves through the outer shield assembly and the abrasive head portion  3410  protrudes past the flexible tip portion  3418 . The adapter  3412  can be formed from a suitable rigid material, semi-rigid material, and/or semi-flexible material. In some embodiments, the adapter  3412  is positioned in the outer shield assembly  3402  and held in place by cutouts in the outer shield assembly  3402  or extrusions  3424  in the adapter  3412  and extrusions  3426  in the outer shield assembly  3402 . The extrusions  3424  in the adapter  3412  can be positioned symmetrically to allow the twisting mechanism  3420  to move. The twisting mechanism  3420  can also have extrusions that securably attach to the extrusions  3424  of the adapter  3412  which allows the abrasive head portion  3410  of the inner component  3404  to protrude past the distal end  3416  of the outer shield assembly  3402  and to lock the inner component in place during use. 
         [0120]      FIGS. 35A-B  illustrate a finger worn sample collection device  3500  (e.g., push-and-twist and push-to-expand) configured in accordance with alternative embodiments of the present technology. The sample collection device  3500  is configured to be worn or placed onto a finger (e.g., the index finger) of a human subject. Referring to  FIGS. 35A-B  together, the sample collection device  3500  includes an outer shield assembly  3502  having a proximal end and a distal end and an inner component  3504  having a distal end and a proximal end. The outer shield assembly  3502  can be flexible or rigid. The inner component  3504  can be flexible or rigid. In some embodiments, the inner component  3504  is rotatable. The distal end of the inner component  3504  comprises at least one abrasive head portion  3508  and the proximal end is configured to receive a finger (e.g., index finger) of a human subject. The outer shield assembly  3502  is configured to have at least one aperture  3510 . The abrasive head portion(s)  3508  protrudes past the at least one aperture  3510  when the inner component  3504  is twisted inside the outer shield component  3502  (as shown in  FIG. 35A ) or when the inner component is pushed through the outer shield component  3502  (as shown in  FIG. 35B ). In some embodiments, the outer shield assembly  3502  can be configured to have a covering over the aperture  3510  that can be opened to expose the abrasive head portion  3508  when needed. In some embodiments, the sample collection device  3500  can also comprise a locking mechanism to secure the inner component  3504  in the outer shield assembly  3502 . The locking mechanism can be positioned anywhere on the sample collection device  3500 , but in a preferred embodiment it is positioned at or near the proximal end of the outer shield assembly  3502 . When the inner component  3504  is twisted it can lock into position with the outer shield assembly  3502 . In other embodiments, the inner component  3504  locks into position with the outer shield assembly  3502  when the inner component  3504  is pressed into the outer shield assembly  3502 . In another embodiment, the sample collection device  3500  includes a release mechanism configured to protrude the abrasive head  3508  past the aperture  3510  of the outer shield assembly  3502 . The abrasive head  3508  can be bristles, foam (e.g., expandable), abrasive polymer, or adhesive, plastic, silicone, or other suitable materials. In some embodiments, the abrasive head  3508  is flexible and/or bendable such that by compressing the ends it may bend and protrude through the aperture  3510  of the outer shield assembly  3502 . 
         [0121]    A protective barrier  3512  can be secured or coupled to a distal end of the outer shield assembly  3500 . In some embodiments, the inner component  3504  can be configured to have a tab  3506  on the proximal end of the inner component  3504  which functions to lock or releasably secure the inner component  3504  into the outer shield assembly  3502  when the at least one abrasive head portion  3508  aligns with the  3510  at least one aperture. 
         [0000]    Method of Collection with Sample Collection Device 
         [0122]    An example method of collecting a sample (e.g., a tissue sample) with the sample collection device  400  can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device  400  can be removed from a packaging or other wrapping that it is stored in. The sample collection device  400  can be pre-lubricated or a physician or other user can lubricate an outer surface of the device  400  before inserting the device  400  into the patient. The device  400  is then placed on the user&#39;s finger  418  and inserted into the patient cavity. Once the device  400  is located at the desired tissue sample site, the sample component  408  is inserted through proximal opening  414  of the device  400  and/or the channel  410 . The sample component  408  is inserted until it exits the distal opening  412  and reaches the distal end  406  of the device  400  and/or finger. In some embodiments, as described above, the sample component  408  can be inserted past the distal end  406  of the device  400 . 
         [0123]    For collection, the user moves its finger  418  in a radial or circular motion to collect a sample (e.g., a tissue sample). Once the sample is collected, the sample component  408  can be removed from device  400 . After the sample component  408  is removed, the device  400  can be removed from the cavity and the user&#39;s finger and discarded. In some embodiments, the device  400  can be decontaminated and reused for another sample collection. 
         [0124]    An example method of collecting a sample (e.g., a tissue sample) with the sample collection device  3300  can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device  3300  can be removed from a packaging or other wrapping that it is stored in. The sample collection device  3300  can be pre-lubricated or a physician or other user can lubricate an outer surface of the device  3300  before inserting the device  3300  into the patient. The device  3300  is then positioned into or near a patient cavity with the flexible sample component  3302  configured away from the patient cavity such that the abrasive head portion is not exposed, as depicted in  FIG. 33A . The positioning component  3312  can be held by the user&#39;s hand and may be used to twist or otherwise configure the device  3300  into position. Once the device  3300  is located at the desired tissue sample site, the sample component  3302  is inserted into the patient cavity by the user pushing the inside surface of the distal end  3304  of the sample component  3302  into the patient cavity, as depicted in  FIG. 33B . This exposes the abrasive head portion  3308  to the sample site. 
         [0125]    For collection, the user moves its finger in a radial or circular motion to collect a sample (e.g., a tissue sample). Once the sample is collected, the user holds that device  3300  in position with one hand on the positioning component  3312  and/or tabs  3314  and pulls the removal component  3310  with its other hand to retract the abrasive head portion  3308  so that the abrasive head portion is not exposed, as in  FIG. 33A . After the abrasive head portion is retracted within the sample component  3302 , the device  3300  can be removed from the cavity. In some embodiments, the device  3300  can be decontaminated and reused for another sample collection. 
         [0126]    Another example method of collecting a sample (e.g., a tissue sample) with the sample collection device  3400  can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device  3400  can be removed from a packaging or other wrapping that it is stored in. The sample collection device  3400  can be pre-lubricated or a physician or other user can lubricate an outer surface of the device  3400  before inserting the device  3400  into the patient. The device  3400  is then placed on the user&#39;s finger and inserted into the patient cavity. Once the device  3400  is located at the desired tissue sample site, the inner component  3404  is inserted through the lumen of the outer shield assembly  3402  until it engages with the adapter  3412 . The protrusions  3424  on the adapter  3412  can guide the abrasive head portion  3410  of the inner component  3404  to protrude past the distal end  3416  of the outer shield assembly  3402  thereby penetrating the flexible tip portion  3418 . 
         [0127]    Once the sample is collected, the inner component  3404  can be withdrawn back into the outer shield assembly  3402  and the sample collection device  3400  can be removed from the cavity and the user&#39;s finger and the outer shield assembly discarded. In some embodiments, the device  3400  can be decontaminated and reused for another sample collection. 
         [0128]    An example method of collecting a sample (e.g., a tissue sample) with the sample collection device  3500  can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device  3500  can be removed from a packaging or other wrapping that it is stored in. The sample collection device  3500  can be pre-lubricated or a physician or other user can lubricate an outer surface of the device  3500  before inserting the device  3500  into the patient. The device  3500  is then placed on the user&#39;s finger and inserted into the patient cavity. Once the device  3500  is located at the desired tissue sample site, the inner component  3504  can be twisted to expose the abrasive head portion  3508  past the aperture  3510  of the outer shield component  3502 . The user may move its finger in a radial or circular motion to collect a sample (e.g., a tissue sample). Once the sample is collected, the inner component  3504  may be rotated to retract the abrasive head  3508  back through the aperture  3510 . The device  3500  can then be removed from the cavity and the user&#39;s finger and discarded. In some embodiments, the device  3500  can be decontaminated and reused for another sample collection. 
       Abrasive Sample Component 
       [0129]      FIGS. 8-21B  illustrate side views of various sample components  808 ,  908 ,  1008 ,  1108 , etc. (e.g., a cytobrush, brush, abrasive head, etc.) configured in accordance with embodiments of the present technology that can be used with the sample collection devices (e.g.,  100 ,  400 , etc.) as described herein or other types of sample collection devices. The sample components  808 ,  908 , etc. can include an abrasive head, distal, or end portion  810  (e.g., one or more bristle sections as described in more detail below) for collecting samples. For example, referring to  FIG. 8 , the sample components  808 , etc. can include a flexible metal wire  812  with strands twisted together. The flexible twisted metal wire  812  can support the multiple bristles  814  positioned at the head portion  810 . The bristles  814  can have any suitable shape, size, rigidity, and density. Diameters (e.g., radial distance from the wire  812 ) of the bristles  814  along the axis of the wire  812  may be generally constant (as illustrated in  FIG. 8 ) or may have varying diameters ( FIGS. 9 and 10 ). 
         [0130]    The bristles  814  can contact the lumen walls of a patient cavity or lumen (e.g., a rectum) to collect a sample. The bristle density may vary along the length of the wire as can the bristle thickness. The diameter and shape of the bristles  814  can be suitably sized and shaped to ensure sufficient contact with the lumen walls for accurate sample collection. During collection, the force exerted by the bristles  814  must be sufficient to ensure abrasion against the lumen walls. Such force can be varied or changed by using a variety of bristle types (e.g., hardness, stiffness, rigidity, diameter), varying geometry or shape, and/or changing flexibility of the twisted wire  812 . 
         [0131]    Because the shape of a patient cavity (e.g., orifice or lumen) can vary or be irregular, the sample component  808 ,  908 , etc. is flexible enough to bend and make contact with the lumen walls during twisting of the brush and/or movement in the radial and back and forth directions. In some embodiments, a distal end of the sample component  808 ,  908 , etc. may require a smaller diameter bristle  814  length to ease insertion, gently open the lumen, fit into a nook, and/or for brushing to collect a sample ( FIG. 9 ). However, some collection protocols may require the distal end of the bristles  814  sample component having a greater diameter as compared to the proximal end ( FIG. 10 ). In certain embodiments, as illustrated in  FIG. 9 , the proximal and distal ends of the bristles  814  can have generally equal diameters that increase in size toward a middle portion of the abrasive head portion  810   
         [0132]    During insertion, the distal end of the head portion  810  (e.g., bristles  814 ) will be inserted through the sample devices and initially contact the lumen walls and abrade the surface of the lumen walls. By having smaller diameter bristles  814  at the distal end, the contact with the inner walls of the sample device as the sample component is inserted therethrough is minimized or reduced. This can minimize or reduce any cross contamination between the bristles  814  and device  100 ,  400 , etc. 
         [0133]    As illustrated in the various embodiments, the bristles  814  may be arranged in multiple configurations such that there can be sections with varying bristle density ( FIGS. 8-15 ). For example, individual bristles  814  or bristle sections can be spaced apart at varying gaps and distances ( FIGS. 11 and 12 ). In some embodiments, the bristle sections (e.g., abrasive portions) include more or less bristles  814  along the length of the wire  812 . Further, the bristle sections can be positioned at varying locations along the length of the wire  812  (e.g., more proximate the distal end, more proximate the proximal end, etc.). The bristles  814  or bristle sections can have varying sizes and stiffnesses in sections along the length of the wire as illustrated by the varying distances between the bristles  814  and line weights of the bristles  814  ( FIG. 13 ). 
         [0134]    In certain embodiments, additional materials  1316  can be placed or coupled onto the front or distal end  810  of the sample components. The additional materials can be used to clean or prepare the collection area, protect the channel from contamination, move contaminants or take in contamination ( FIGS. 13-16 ). The additional material may be plastic, foam, rubber, metal or other alternative materials that are biocompatible and safe. The material may be expandable, such as foam. As the sample component is inserted, the material can expand inside the cavity and/or sample collection device ( FIG. 17 ). The expandable material may be used to clean the area or device before collection, make room in the cavity, and take in fluid so that the fluid does not reach the brush or flow through the channel (e.g., of the cavity and/or sample collection device). 
         [0135]    In some embodiments, sample component  808 ,  908 , etc. can have a generally thin protective cover  1718  that protects the bristles  814 , the tip portion  810 , and/or any other material along the length of the sample component ( FIG. 17 ). The protective cover  1718  can move (e.g., expand and retract) as the sample component is inserted and retracted to help expose and cover the sample component ( FIGS. 18A-18C and 19A-19C ). In some embodiments, multiple protective barriers or covers can be used to isolate the materials on the distal front or tip of the sample component  808 ,  908 , etc. from the collection bristles  814  ( FIGS. 18A-18C and 19A-19C ). 
         [0136]    The distal tip of the sample component  808 ,  908 , etc. can be blunt or round as illustrated in the various embodiments ( FIG. 8 ). The distal tip may be any suitable size ( FIGS. 8, 13 and 15 ). The blunt distal tip can serve multiple purposes. For example, it can prevent or reduce patient discomfort during insertion of the sample component. Additionally, the greater the bluntness, the greater the surface area, and the greater distribution of force during contact between the sample component and the tissue. This can ensure generally quick, easy and/or painless insertion. Minimizing any rigid and sharp edges can also diminish the potential of puncturing tissue. 
         [0137]    The sample components can have multiple independent abrasive surfaces. For example, as illustrated in  FIGS. 20A-20B , the sample component  2008  can include one or more flexible wires  2012  (e.g., identified individually as a first wire  2012 A, second wire  2012 B, and third wire  2012 C). All the wires  2012 A- 2012 C can include one or more abrasive surfaces (e.g., multiple bristle portions or sections). In some embodiments, only certain wires include abrasive surfaces (e.g., wires  2012 A and  2012 C). As illustrated, the wires  2012 A and  2012 C can include multiple abrasive surfaces which are contracted inside a sample collection device ( FIG. 20A ) and expand and spring out ( FIG. 20B ) once inserted into, for example, a mammalian cavity. 
         [0138]    In some embodiments, The sample component  808 ,  908 , etc. can include a balloon  2120  with multiple extruded fingers  2122  on the outside of the balloon  2120 . Once inserted past the distal end of a sample collection device, the balloon  2120  can be inflated. This allows the fingers  2122  to make contact with the lumen walls, whereby when twisted, will abrade the surface ( FIGS. 21A-21B ) to collect a sample. The abrasive balloon  2120  will expand to achieve maximum contact with the lumen walls. 
       Glove-Based Abrasive Sample Collection Device 
       [0139]      FIGS. 22A-24  illustrate various side views and bottom views of a glove-based sample collection device  2200  configured in accordance with another embodiment of the present technology. Referring to  FIGS. 22A-24  together, the sample collection device  2200  is configured to be worn over the hand of a user (e.g., a glove). In some embodiments, the sample collection device  2200  can be worn on only a portion of the hand of a user (e.g., one or more fingers). The sample collection device  2200  includes an inner layer  2202  (e.g., liner) that is protected (e.g., covered or shielded) by an outer layer  2204  (e.g., liner). The inner layer  2202  can include an abrasive pad  2206  (e.g., an abrasive material, portion, or section) positioned on a bottom of a distal tip of a finger portion  2208  of the inner layer  2202  for collecting a sample. The abrasive pad  2206  can be composed of a variety of materials. For example, the abrasive pad  2206  can be composed of silicone. The abrasive pad  2206  can include multiple bristles  2214 . The height, density, spacing, stiffness, rigidity, and/or diameter of the bristles  2214  may vary. The bristles  2214  may be made from plastic, silicone, or other suitable materials. 
         [0140]    In some embodiments, the inner layer  2202  can include another material on the distal tip of the finger portion  2208 . For example, the inner layer  2202  can be overmolded with a silicone feature or have a silicone feature secured onto the layer with an adhesive. This silicone feature may have ribs, bristles, or other extrusions. One alternative to silicone would be a plastic component which may be fixed to the inner layer  2202  with adhesive. This layer may enable material from being moved away to provide access to a surface (for example, the rectal lining). 
         [0141]    The outer layer  2204  is configured to protect and/or cover the abrasive pad  2206  during insertion and retraction of the collection device  2200  into and out of the patient cavity. The collection device  2200  can include a stopper component  2224  (e.g., over-molded ring element) positioned (e.g., extending radially about) on the outer layer  2204  to prevent the collection device  2200  from being inserted farther into patient cavity. In some embodiments, the outer layer  2204  can include multiple layers. For example, the outer layer  2204  can include two or more layers to increase thickness, while still providing flexibility. In other embodiments, the distal tip of the outer layer  2204  may also have an additional layer of material to enable clearing of the sample collection area of fluid or other debris. 
         [0142]    In operation, the distal tip or end of the outer layer  2204  distal tip will open during insertion exposing the abrasive pad  2206  ( FIG. 22B ) underneath the outer layer  2204 . For example, the outer layer distal tip can be perforated  2220  (e.g., include one or more flaps) configured to open (e.g., spread outwardly or roll away from the tip) once the device  2200  is inserted ( FIGS. 22B and 24 ). The outer layer  2204  distal tip may be cut to allow the inner layer  2202  to be exposed to the cavity or lumen wall ( FIG. 24 ). The outer layer  2202  may be removed, folded, rolled or moved by pulling an additional piece (e.g., string, tab, etc.) to expose the inner layer  2202  or abrasive pad  2206 . In some embodiments, the outer layer  2204  may be opened or released by pushing on another piece or portion which is attached to the distal end of the device  2200  (e.g., the abrasive pad  2206  or stopper component  2224 ). For example, in some embodiments, a molded lever can extend between the distal end to some area proximal to the distal end. When the device  2200  is inserted into a cavity, once the outer area of the cavity makes contact with the lever arm, it opens the distal end (e.g., of the outer layer  2204 ). As the distal end opens, the inner layer  2202  may be exposed and is inserted into the cavity. 
         [0143]    In some embodiments, the inner layer  2202  may be inserted through a side opening in the outer layer  2204 . The outer layer  2204  may have a slit on either side which may be collapsed (e.g., resiliently deforms) when nothing is being forced through. However, if the inner layer  2202 , which will have a finger inside, slides through the slit, the outer layer  2204  can expand and open, allowing said inner layer  2202  to extend through the outer layer  2204 . The abrasive pad  2206  may then contact the collection area or site to collect a sample. 
         [0144]      FIG. 27  illustrates various side views of a glove-based sample collection device  2700  configured in accordance with another embodiment of the present technology. The sample collection device  2700  is configured to be worn over the hand of a user (e.g., a glove). In some embodiments, the sample collection device  2700  can be worn on only a portion of the hand of a user (e.g., one or more fingers). The sample collection device  2700  includes an inner layer  2702  (e.g., liner) that is protected (e.g., covered or shielded) by an outer layer  2704  (e.g., liner). The inner layer  2702  can include a sample component  2706  (e.g., an abrasive material, expandable foam, etc.) positioned on a distal tip of a finger portion  2708  of the inner layer  2702  for collecting a sample. The sample component  2706  can be composed of a variety of materials. For example, the sample component  2706  can be composed of an expandable foam, plastic, silicone, or other suitable materials (shown in  FIG. 27C  in expanded an configuration). 
         [0145]    In some embodiments, the inner layer  2702  can include another material on the distal tip of the finger portion  2708 . For example, the inner layer  2702  can be overmolded with a silicone feature or have a silicone feature secured onto the layer with an adhesive. This silicone feature may have ribs, bristles, or other extrusions. One alternative to silicone would be a plastic component which may be fixed to the inner layer  2702  with adhesive. This layer may enable material from being moved away to provide access to a surface (for example, the rectal lining). 
         [0146]    The outer layer  2704  is configured to protect and/or cover the sample component  2706  during insertion and retraction of the collection device  2700  into and out of the patient cavity. The collection device  2700  can include a stopper component  2724  (e.g., over-molded ring element) positioned (e.g., extending radially about) on the outer layer  2704  to prevent the collection device  2700  from being inserted farther into patient cavity. In some embodiments, the outer layer  2704  can include multiple layers. For example, the outer layer  2704  can include two or more layers to increase thickness, while still providing flexibility. In other embodiments, the distal tip of the outer layer  2704  may also have an additional layer of material to enable clearing of the sample collection area of fluid or other debris. In operation, the distal tip or end of the outer layer  2704  distal tip will open during insertion exposing the sample component  2706  ( FIG. 27C ) underneath the outer layer  2704 . For example, the outer layer distal tip can be perforated  2720  (e.g., include one or more flaps) configured to open (e.g., spread outwardly or roll away from the tip) once the device  2700  is inserted ( FIGS. 27B-C ). The outer layer  2702  may be removed, folded, rolled or moved by pulling an additional piece (e.g., string, tab, etc.) to expose the inner layer  2702  or sample component  2706 . In some embodiments, the outer layer  2704  may be opened or released by pushing on another piece or portion which is attached to the distal end of the device  2700  (e.g., the sample portion  2706 ). For example, in some embodiments, a molded lever can extend between the distal end to some area proximal to the distal end. When the device  2700  is inserted into a cavity, once the outer area of the cavity makes contact with the lever arm, it opens the distal end (e.g., of the outer layer  2704 ). As the distal end opens, the inner layer  2702  may be exposed and is inserted into the cavity. 
       Glove-Based Conduit Sample Collection Device 
       [0147]      FIGS. 25 and 26  illustrate side and bottom views, respectively of a glove-based sample collection device  2500  configured in accordance with another embodiment of the present technology. Referring to  FIGS. 25 and 26  together, the embodiment consists of a glove-based configuration having an outer layer in the shape of a hand that is generally similar to the configuration in  FIGS. 22A-24 . However, the embodiment of  FIGS. 25 and 26  includes a channel  2502  (e.g., conduit, sheath, tube, lumen, etc.) that extends from the proximal end  2504  to the distal end  2506  (e.g., from the wrist portion to the distal end of a finger portion) of the sample collection device  2500  ( FIG. 25 ). The channel  2502  is open on the proximal end or side ( FIGS. 25 and 26 ) to receive a sample component therethrough as described in more detail below. 
         [0148]    The distal end of the channel  2502  may be open. In some embodiments, the distal end of the channel  2502  may include a protective flap or cover to shield the channel  2502  from contaminants or debris as the device  2500  is inserted into a patient cavity. The channel  2502  is sized to support various components (e.g., a sample component, cytobrush, vacuum conduit, irrigation conduit, cleaner component, etc.) to be inserted through the channel  2502  and into the patient cavity. 
         [0149]    The channel  2502  can be comprised of a flexible material. In other embodiments, the channel  2502  can be formed from a suitable rigid material, semi-rigid material, and/or semi-flexible material. The channel  2502  can be a separately formed component that is fixed or secured to the device  2500  by an adhesive or other suitable fastener. In other embodiments, the channel  2502  can be molded as one piece with the device  2500  or cut or formed through a layer of the device  2500 . 
         [0150]    The distal tip of the finger of the device  2500  has space for the sample component  2508  or other component to rest or reside at the tip whereby a user can provide a force on the sample component  2508 . The distal tip of the device  2500  could have a molded end or stopping component to stop or prevent any component from being inserted beyond the distal tip. 
         [0151]    From the foregoing, it will be appreciated that specific embodiments of the present technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the scope of the present technology. Specific elements of any of the foregoing embodiments can also be combined or substituted for elements in other embodiments. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the present technology is not limited, except as by the appended claims.