Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. application Ser. No. 11/588,120, filed Oct. 26, 2006, entitled “Method and Apparatus for Simultaneously Collecting Exocervical and Endocervical Samples”, which claims the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 60/810,055, filed Jun. 1, 2006, entitled “Method and Apparatus for Simultaneously Collecting Exocervical And Endocervical Samples”; all of which are incorporated herein by reference 
     
    
     BACKGROUND 
       [0002]    The Papanicolaou test (“Pap test” or Pap smear) has proven to be highly valuable in the early detection of cervical pre-cancerous and cancerous growths. The Pap test refers to the collection of cells from the cervical face, the endocervical canal, and occasionally from the vaginal wall. The collected cells are subsequently “smeared” onto a microscope plate or deposited and mixed into a broth and analyzed for evidence of pre-cancerous or cancerous growth. A periodic Pap test permits the early detection of malignant cells, which enables early palliative care in treating cervical pre-cancerous and cancerous growths. 
         [0003]    One device that has been useful in collecting cells during a Pap test includes a wooden or plastic spatula. Such spatulas are inexpensive and can be effective at collecting cells from the cervical face. However, spatulas have proven to be less than effective in collecting adequate cell samples from the endocervical canal. This is a potentially serious short-coming, because any sample that does not include endocervical cells is deemed to be an inadequate Pap smear sample. That is to say, the proper interpretation and diagnosis of the state of the cells is inconclusive unless a sufficient number of cells are collected from the endocervical canal. 
         [0004]    Other devices that are useful in collecting cells during Pap tests include cotton swabs and the like. In general, cell samples are collected by swabbing the exocervical wall and the endocervical canal with the swab. Although cotton swabs are associated with a somewhat improved collection/yield of cells, cotton swabs are not abrasive enough to scrap the endocervical canal and consistently retrieve an adequate, representative sample. 
         [0005]    Certain bristle brushes have also proven useful in collecting cells during a Pap test. In this regard, the bristle brushes are capable of obtaining endocervical cells during sampling, however bristle brushes are abrasive, and their use can be uncomfortable and increase the incidence of patient bleeding. 
         [0006]    Pap tests have proven to be useful in the early detection of malignant cells and are related to a reduction in the incidence and death rate due to cervical cancers. Improvements to sampling devices useful in collecting cells during Pap tests will be welcomed by the medical community and patients alike. 
       SUMMARY 
       [0007]    One embodiment provides a combination exo-endocervical sampling device that includes a shaft, a sampler, and a combination exo-endocervical sampler. The shaft defines a first end opposite a second end, a transverse break line between the first and second ends, and a textured surface adjacent to the break line. The sampler is coupled to the first end, and the combination exo-endocervical sampler is coupled to the second end. The combination exo-endocervical sampler includes a pair of opposing wings disposed transverse to the shaft, and a brush that extends from the wings along a central axis of the shaft. In this regard, each of the opposing wings includes a sampling surface having a staggered array of beads, and the brush includes a multiplicity of looped fibers, where each looped fiber includes a first closed end opposite a second closed end such that the closed ends extend transverse from the central axis of the shaft. 
         [0008]    Another embodiment of the present invention provides a combination exo-endocervical sampling device that includes a shaft, and a combination exo-endocervical sampler coupled to the shaft. The combination exo-endocervical sampler includes a pair of opposing wings disposed transverse to the shaft and a prominence extending from the wings along a central axis of the shaft. In this regard, the opposing wings define a first sampling surface and the prominence includes a second sampling surface, at least one of the first and second sampling surfaces characterized by an absence of bristles and defining a void space configured to capture exo-endocervical cells. 
         [0009]    Another embodiment of the present invention provides a combination exo-endocervical sampling device. The device includes a shaft, a sampler coupled to an end of the shaft, and a combination exo-endocervical sampler coupled to another end of the shaft. The shaft defines a transverse break line between the ends, and a textured surface adjacent to the break line. The sampler includes one of a swab or a spatula. The combination exo-endocervical sampler includes a pair of opposing wings disposed transverse to the shaft and a prominence extending from the wings along a central axis of the shaft. In this regard, the opposing wings define a first sampling surface and the prominence includes a second sampling surface, at least one of the first and second sampling surfaces including a multiplicity of endless fibrils defining a void space therebetween configured to capture exo-endocervical cells. 
         [0010]    Another embodiment of the present invention provides a method of simultaneously collecting exocervical and endocervical cells from a female patient. The method includes providing a combination exo-endocervical sampling device including a sampler having a pair of opposing wings and a prominence extending from the wings, at least one of the opposing wings and the prominence including a multiplicity of looped fibers defining a void space therebetween configured to capture exo-endocervical cells. The method additionally includes placing the sampling device in contact with a cervix of the female patient. The method further includes collecting exocervical cells with the opposing wings of the sampling device, and simultaneously collecting endocervical cells with the prominence. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    Embodiments of the invention are better understood with reference to the following drawings. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
           [0012]      FIG. 1A  illustrates a front view of a combination exo-endocervical sampling device according to one embodiment of the present invention. 
           [0013]      FIG. 1B  illustrates a side view of the combination exo-endocervical sampling device illustrated in  FIG. 1A . 
           [0014]      FIG. 1C  illustrates a top view of a combination exo-endocervical sampler according to one embodiment of the present invention. 
           [0015]      FIG. 2  illustrates a perspective view of a brush portion of a combination exo-endocervical sampler according to one embodiment of the present invention. 
           [0016]      FIG. 3A  illustrates a cross-sectional view of a fiber of the brush portion illustrated in  FIG. 2 . 
           [0017]      FIG. 3B  illustrates a cross-sectional view of another fiber for the brush portion illustrated in  FIG. 2  according to one embodiment of the present invention. 
           [0018]      FIG. 4  illustrates a front view of another combination exo-endocervical sampling device according to one embodiment of the present invention. 
           [0019]      FIG. 5A  illustrates a front view of an exocervical sampling device according to one embodiment of the present invention. 
           [0020]      FIG. 5B  illustrates a top view of one end of the exocervical sampling device illustrated in  FIG. 5A . 
           [0021]      FIG. 6  illustrates a front view of another combination exo-endocervical sampler according to one embodiment of the present invention. 
           [0022]      FIG. 7  illustrates a front view of another combination exo-endocervical sampler according to one embodiment of the present invention. 
           [0023]      FIG. 8  illustrates a perspective view of another brush portion of a combination exo-endocervical sampler according to one embodiment of the present invention. 
           [0024]      FIG. 9A  illustrates a perspective view of another combination exo-endocervical sampling device according to one embodiment of the present invention. 
           [0025]      FIG. 9B  illustrates a cross-sectional view of a combination exo-endocervical sampler of the device illustrated in  FIG. 9A . 
           [0026]      FIG. 10  illustrates a cross-sectional view of a combination exo-endocervical sampling device employed to simultaneously collect exocervical and endocervical cells. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    In the following Detailed Description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of the embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. 
         [0028]      FIG. 1A  illustrates a front view of a combination exo-endocervical sampling device  20  according to one embodiment of the present invention. Combination exo-endocervical sampling device  20  includes a shaft  22 , a sampler  24 , and a combination exo-endocervical sampler  26 . As a point of reference, shaft  22  and sampling device  20  are aligned along a central axis A. Central axis A is a major, or longitudinal, axis of sampling device  20 . 
         [0029]    Although combination exo-endocervical sampling device  20  is not typically employed in a sterile field when cell samples are collected, one embodiment provides for combination exo-endocervical sampling device  20  to be sterilized or sterilizable. In any regard, combination exo-endocervical sampling device  20  is provided with a reduced bio-load that does not disrupt cell sampling or analysis. 
         [0030]    Shaft  22  defines a first end  30  opposite a second end  32 , a transverse break line  34  between the first end  30  and the second  32 , and a textured surface  36  adjacent to break line  34 . In one embodiment, shaft  22  is integrally formed of molded plastic. Suitable molded plastics for shaft  22  include thermoplastic materials in general, and medical grade polyolefins including polypropylene and polyethylene in particular. 
         [0031]    In one embodiment, shaft  22  defines a first portion  37  that extends from break line  34  to sampler  24 , and a second portion  39  that extends from break line  34  to combination exo-endocervical sampler  26 . In one embodiment, textured surface  36  is disposed on second portion  39  adjacent to break line  34 . In this regard, when shaft  22  is severed at break line  34 , sampler  24  defines a distal end of first portion  37 . In a similar manner, when shaft  22  is severed at break line  34 , combination exo-endocervical sampler  26  defines a distal end of second portion  39 . In one embodiment, break line  34  is approximately centered within textured surface  36 . 
         [0032]    In one embodiment, first portion  37  defines a length L 1  between about 5 to 7 cm, and preferably the length L 1  of first portion  37  is about 6.5 cm. In one embodiment, second portion  39  defines a length L 2  that is between about 16 to 20 cm, preferably about 18 cm. 
         [0033]    Sampler  24  is coupled to first end  30 . In one embodiment, sampler  24  includes a cotton-tipped swab. In another embodiment, sampler  24  is a rigid spatula (as best illustrated in  FIG. 4 ). 
         [0034]    Combination exo-endocervical sampler  26  is coupled to second end  32  of shaft  22 . Combination exo-endocervical sampler  26  includes a pair of opposing wings  40 ,  42  that are disposed transverse to shaft  22  (i.e., transverse to central axis A), and a brush  46  that extends away from the wings  40 ,  42  along the central axis A of shaft  22 . The wings  40 ,  42  combine to define a generally curved sampling surface  44  separate from a sampling surface area provided by brush  46 . 
         [0035]    In one embodiment, brush  46  defines a height H between about 1 to 3 cm, and preferably the height H of brush  46  is about 1.5 cm when sampling device  20  is employed in a Pap test on a non-parous patient, and height H of brush  46  is about 2 cm when sampling device  20  is employed in a Pap test for a parous patient. 
         [0036]    The sampler  24  and the combination exo-endocervical sampler  26  of the combination exo-endocervical sampling device  20  enable the simultaneous collection of cells during Pap test procedures and wet prep procedures through the use of a single device  20 . 
         [0037]    As employed herein, parous means a patient who has given birth vaginally one or more times. The terms non-parous and nulli-parous mean a woman who has never given birth vaginally. Pregnant means a patient carrying developing offspring within the body, and in particular within the uterus. Stenotic means a constriction or narrowing of a canal and in particular, a constriction or narrowing of the cervical canal. 
         [0038]      FIG. 1B  illustrates a right side view of combination exo-endocervical sampling device  20  according to one embodiment of the present invention. In one embodiment, at least a portion of brush  46  defines a diameter that is wider than a thickness of wing  42 . In other words, portions of brush  46  extend transverse to the central axis A and are wider than the wings  40 ,  42  are thick. 
         [0039]      FIG. 1C  illustrates a top view of exo-endocervical sampler  26  according to one embodiment of the present invention. In one embodiment, exo-endocervical sampler  26  includes rigid, molded wings  40 ,  42  and a flexible brush  46  formed from looped fibers (as best illustrated in  FIG. 2 ). Wings  40 ,  42  define a thickness T that is between about 1.5 to 5 mm, and preferably thickness T is between about 2 to 4 mm. In one embodiment, wings  40 ,  42  extend transverse to the central axis A ( FIG. 1A ) and combine to define sampling surface  44 . Wings  40 ,  42  are molded from a plastic, such as thermoplastic polyolefin including polyethylene, polypropylene, polyester, nylon, or “soft” polymers including block co-polymers such as block co-polyesters. In general, wings  40 ,  42  are molded from plastics that are FDA approved for medical devices. 
         [0040]    Sampling surface  44  is provided to atraumatically scrape a face portion of a cervix to collect exocervical cells. In one embodiment, sampling surface  44  includes an array of beads  60   a,    60   b,    60   c,    60   d,    60   e,    60   f  that project from sampling surface  44  by between about 1-2 mm. In one embodiment, the array of beads  60   a,    60   b,    60   c,    60   d,    60   e,    60   f  is a staggered array of alternating beads, as illustrated. As shown in the illustrated embodiment, the sampling surface  44  has a first row of first projections (e.g., beads in the top row in  FIG. 1C  including beads  60   b  and  60   d ) with each of the first projections spaced one from a next by a gap and a second row of second projections (e.g., beads in the bottom row in  FIG. 1C  including beads  60   a,    60   c,    60   e,  and  60   f ) with each of the second projections spaced apart and disposed in one of the gaps formed by the first row of first projections. It is to be understood that other patterns of arranging  60   a,    60   b,    60   c,    60   d,    60   e,    60   f  are also acceptable, and other suitable arrangements of beads is contemplated. In addition, although beads  60   a,    60   b,    60   c,    60   d,    60   e,    60   f  are illustrated as circular, other shapes and conformations of beads  60   a,    60   b,    60   c,    60   d,    60   e,    60   f  are contemplated. Sampling surface  44  and beads  60   a,    60   b,    60   c,    60   d,    60   e,    60   f  combine to atraumatically collect, or sample, exocervical cells during a Pap test procedure. 
         [0041]      FIG. 2  illustrates a perspective, simplified view of brush  46  according to one embodiment of the present invention. In general, brush  46  is provided to atraumatically collect endocervical cell samples. Brush  46  includes multiple loops of fibers  70 , only three of which are illustrated in the simplified view. It is to be understood that brush  46  includes many multiples of loops of fibers  70 . In this regard, in one embodiment the multiple loops of fibers  70  are wound in a helical fashion. In another embodiment, the multiple loops of fibers  70  are wound and uniformly spaced in a symmetric “Christmas tree” configuration. In any regard, the loops of fibers  70  do not terminate in an end, as is commonly associated with a bristle of a bristle-styled brush. Bristles of a bristle brush have the potential to damage cells as they are collected. In contrast, the endless loops of fibers  70  atraumatically collect exo-endocervical and retain the cells in a void space defined between the loops of fibers  70 . 
         [0042]    Brush  46  includes a semi-rigid or rigid strand  68 , and looped fibers  70   a,    70   b,  and  70   c  that are coupled to strand  68 . Strand  68  is generally oriented along central axis A, and looped fibers  70   a,    70   b,  and  70   c  generally extend transverse to strand  68  and central axis A. In one embodiment, strand  68  includes two twined or twisted strands wrapped to capture looped fibers  70   a,    70   b,  and  70   c.  Strand  68  includes corrosion resistant metal, such as stainless steel. Alternatively, strand  68  is formed from plastic materials, such as nylon or polyester. In one embodiment, each looped fiber includes a first closed end  72  opposite a second closed end  74 , and the closed ends  72 ,  74  extend transverse from the central axis A. 
         [0043]    The open spaces between the closed loop ends  72 ,  74  provide a first means to atraumatically collect endocervical cell samples. Looped fibers  70   a,    70   b,  and  70   c  capture and retain cervical cell samples between loop ends  72 ,  74 . In contrast to the known bristle brushes that have bristle ends (i.e. end-on bristles), looped fibers  70   a,    70   b,  and  70   c  do not have bristle ends that can potentially puncture or otherwise damage tissue. Significantly, looped fibers  70   a,    70   b,  and  70   c  are provided with closed loop ends  72 ,  74  that present a lower puncture/trauma risk to tissue when compared to end-on bristles of the known cervical brushes. 
         [0044]      FIG. 3A  illustrates a cross-sectional view of looped fiber  70   a  according to one embodiment of the present invention. In one embodiment, looped fiber  70   a  defines a transverse cross-section that is tri-lobal. For example, looped fiber  70   a  includes a first lobe  80   a,  a second lobe  80   b,  and a third lobe  80   c.    
         [0045]    In one embodiment, looped fiber  70   a  defines an effective diameter D 1  of between about 50 micrometers (microns) to about 1,000 microns. Diameter and effective diameter are terms that are used broadly in this Specification to define the outermost planform (or perimeter) of an object viewed in cross-section. Diameter, as used herein, is not limited to circular objects. In particular, shaped looped fibers, such as fiber  70   a,  define a perimeter that is non-circular. 
         [0046]    The open area between each lobe  80   a,    80   b,    80   c  defines a trough that is suitable for the atraumatic collection of cervical cells. Looped fiber  70   a  defines a non-circular perimeter in transverse cross-section that is configured for atraumatic collection of cervical cells in a Pap test procedure. In this regard, the surfaces of looped fiber  70   a  are suited to abrade portions of the endocervical canal to remove cervical cells for sampling without traumatizing the surface from which the cells are removed, and without damaging the collected cells. The cross-sectional non-circular shape of looped fibers  70  provide a second means for atraumatically collecting endocervical cell samples. 
         [0047]    Suitable fibers and equipment to produce suitable fibers are available from, for example, Hills, Inc., W. Melbourne, Fla. Other suitable fibers are shaped fibers available from Du Pont, Wilmington, Del. One such suitable fiber is a mushroom-shaped bicomponent fiber identified as a 3GT fiber available from Du Pont-Torray Co., as marketed by Du Pont-Torray Co., Ltd., and available through Du Pont in Wilmington, Del. 
         [0048]      FIG. 3B  illustrates a cross-sectional view of another looped fiber  70   a.  In one embodiment, looped fiber  70   a  is X-shaped in transverse cross-section. In another embodiment, looped fiber  70   a  is cross-shaped in transverse cross-section. In this regard, X-shaped looped fiber  70   a  defines an effective diameter D 2  that is between about 50 to 1,000 microns. The open areas illustrated between legs of the X-shaped fiber  70   a  form troughs that are suitable for atraumatic collection of cervical cells in a Pap test procedure, as described above. 
         [0049]    Suitable materials for forming/extruding shaped looped fibers  70  include polyolefins in general and thermoplastic polymers such as nylon, or polyester in particular. 
         [0050]      FIG. 4  illustrates a front view of another combination exo-endocervical sampling device  100  according to one embodiment of the present invention. Combination exo-endocervical sampling device includes a shaft  102 , a sampler  104 , and a combination exo-endocervical sampler  106 . In general, shaft  102  and exo-endocervical sampler  106  are similar to shaft  22  and exo-endocervical sampler  26 , respectively, illustrated in  FIG. 1A  above. 
         [0051]    In one embodiment, sampler  104  includes a molded plastic spatula that defines a width S of between about 0.5 to 2 cm, and preferably width S is about 0.75 cm. In one embodiment, molded plastic spatula sampler  104  is integrally formed with shaft  102  of a molded plastic, such as, for example, polyethylene. Sampler  104  is suitable for atraumatic collection of cervical cells from a face of a cervix and/or cells from a vaginal wall, for example, during a Pap test procedure. 
         [0052]      FIG. 5A  illustrates a front view of an exocervical sampling device  220  according to one embodiment of the present invention. In one embodiment, exocervical sampling device  220  is configured for cervical cell sampling of a pregnant patient and includes a shaft  222 , a sampler  224 , and an exocervical sampler  226 . In one embodiment, exocervical sampling device  220  is sterilized or sterilizable, similar to device  20  above. 
         [0053]    Shaft  222  defines a first end  230  opposite a second end  232 , a transverse break line  234  between the first end  230  and the second  232 , and a textured surface  236  adjacent to break line  234 . In one embodiment, shaft  222  is integrally formed of molded plastic. Suitable molded plastics for shaft  222  include thermoplastic materials in general, and medical grade plastics including polypropylene and polyethylene in particular. 
         [0054]    In one embodiment, shaft  222  defines a first portion  237  that extends from break line  234  to sampler  224 , and a second portion  239  that extends from break line  234  to combination exo-endocervical sampler  226 . In one embodiment, textured surface  236  is disposed on second portion  239  adjacent to break line  234 . In this regard, when shaft  222  is severed at break line  234 , sampler  224  defines a distal end of first portion  237 . In a similar manner, when shaft  222  is severed at break line  234 , combination exo-endocervical sampler  226  defines a distal end of second portion  239 . In another embodiment, textured surface  236  spans either side of break line  234 . 
         [0055]    In one embodiment, first portion  237  defines a length LL 1  between about 5 to 7 cm, and preferably the length LL 1  of first portion  237  is about 6.5 cm. In one embodiment, second portion  239  defines a length LL 2  that is between about 16 to 20 cm, preferably about 16.5 cm. 
         [0056]    Sampler  224  is coupled to first end  230 . In one embodiment, sampler  224  is a mat of fibers, such as are provided in a cotton-tipped swab. In another embodiment, sampler  224  is a rigid spatula (similar to spatula  104  illustrated in  FIG. 4 ). 
         [0057]    Exocervical sampler  226  is coupled to second end  232  of shaft  222 . Exocervical sampler  226  includes a pair of opposing wings  240 ,  242  that are disposed transverse to shaft  222  (i.e., transverse to central axis A) and are curved to correspond to a shape compatible with an exterior surface of the cervix. The wings  240 ,  242  combine to define a sampling surface  244 . 
         [0058]      FIG. 5B  illustrates a top view of exocervical sampler  226  according to one embodiment of the present invention. Wings  240 ,  242  define a thickness T 2  that is between about 1.5 to 5 mm, and preferably thickness T 2  is between about 2 to 4 mm. In one embodiment, wings  240 ,  242  extend transverse to the central axis A ( FIG. 1A ) and combine to define sampling surface  244 . 
         [0059]    Sampling surface  244  is provided to atraumatically scrape a face portion of a cervix of a pregnant patient to collect exocervical cells. In one embodiment, sampling surface  244  includes an array of beads  260   a,    260   b,    260   c,    260   d  that project above sampling surface  244 . In one embodiment, array of beads  260   a,    260   b,    260   c,    260   d  is a staggered array, although other arrangements for beads  260   a,    260   b,    260   c,    260   d  are also acceptable. Beads  260   a,    260   b,    260   c,    260   d  are illustrated as cylinders, although other shapes are also acceptable. Sampling surface  244  and beads  260   a,    260   b,    260   c,    260   d  combine to atraumatically collect, or sample, exocervical cells from a face of a cervix of a pregnant patient during a Pap test procedure. 
         [0060]    In one embodiment, wings  240 ,  242  are molded from a plastic, such as thermoplastic polymers including polyethylene, polypropylene, polyester, nylon, or “soft” polymers including block co-polymers such as block co-polyesters. In general, wings  240 ,  242  are molded from plastics that are FDA approved for medical devices. 
         [0061]    In another embodiment, wings  240 ,  242  include a lofted intertwined mat of endless fibers that form a surface that is characterized by a random collection of interconnecting fibrils, as more fully described below in  FIG. 9A . 
         [0062]      FIG. 6  illustrates a front view of another combination exo-endocervical sampler  326  according to one embodiment of the present invention. Combination exo-endocervical sampler  326  includes a pair of opposing wings  340 ,  342  that are disposed transverse to shaft  322  (i.e., transverse to central axis A), and a brush  346  that extends away from the wings  340 ,  342  along the central axis A of shaft  322 . The wings  340 ,  342  combine to define a sampling surface  344  separate from a sampling surface area provided by brush  346 . 
         [0063]    In one embodiment, brush  346  is substantially cylindrical in shape and defines a height H 2  between about 1 to 3 cm, and preferably the height H 2  of brush  346  is about 1.5 cm when sampler  326  is employed in a Pap test on a non-parous patient, and height H 2  of brush  346  is about 2 cm when sampler  326  is employed in a Pap test for a parous patient. 
         [0064]    Brush  346  includes multiple loops of fibers  370 . Brush  346  includes a semi-rigid or rigid strand  368 , and looped fibers  370  that are coupled to strand  368 . Strand  368  is generally oriented along central axis A, and looped fibers  370  generally extend transverse to strand  368  and central axis A. In one embodiment, strand  368  includes two twined or twisted strands wrapped to capture looped fibers  370 . 
         [0065]    Strand  368  includes corrosion resistant metal, such as stainless steel. Alternatively, strand  368  is formed from plastic materials, such as nylon. In one embodiment, each looped fiber includes a first closed end opposite a second closed end, and the closed ends extend transverse from the central axis A, in a manner similar to that illustrated in  FIG. 2 . 
         [0066]    Fibers  370  are similar to the fibers illustrated in  FIGS. 2 and 3A  and  3 B. In this regard, fibers  370  are looped and can include a non-circular perimeter in transverse cross-section that is configured for atraumatic collection of cervical cells in a Pap test procedure. Looped fibers  370  are suited to abrade portions of the endocervical canal to remove cervical cells for sampling without traumatizing the surface from which the cells are removed. 
         [0067]      FIG. 7  illustrates a front view of another embodiment of a combination exo-endocervical sampler  426  according to one embodiment of the present invention. Combination exo-endocervical sampler  426  includes a pair of opposing wings  440 ,  442  that are disposed transverse to shaft  422  (i.e., transverse to central axis A), and a brush  446  that extends away from the wings  440 ,  442  along the central axis A of shaft  422 . The wings  440 ,  442  combine to define a sampling surface  444  separate from a sampling surface area provided by brush  446 . 
         [0068]    In one embodiment, brush  446  is substantially conical in shape and defines a height H 3  between about 1 to 3 cm, and preferably the height H 3  of brush  446  is about 1.5 cm when sampler  426  is employed in a Pap test on a non-parous patient, and height H 3  of brush  446  is about 2 cm when sampler  426  is employed in a Pap test for a parous patient. 
         [0069]    Brush  446  includes multiple loops of fibers  470  wound conically in a helical fashion about a semi-rigid or rigid strand  468 . Strand  468  is generally oriented along central axis A, and looped fibers  470  generally extend transverse to strand  468  and central axis A. In one embodiment, strand  468  includes two twined or twisted strands wrapped to capture looped fibers  470 . 
         [0070]    Strand  468  includes corrosion resistant metal, such as stainless steel. Alternatively, strand  468  is formed from plastic materials, such as nylon. In one embodiment, each looped fiber includes a first closed end opposite a second closed end, and the closed ends extend transverse from the central axis A, in a manner similar to that illustrated in  FIG. 2 . 
         [0071]    Fibers  470  are similar to the fibers illustrated in  FIGS. 2 and 3A  and  3 B. In this regard, fibers  470  are looped and can include a non-circular perimeter in transverse cross-section that is configured for atraumatic collection of cervical cells in a Pap test procedure. Looped fibers  470  are suited to abrade portions of the endocervical canal to remove cervical cells for sampling without traumatizing the surface from which the cells are removed. 
         [0072]      FIG. 8  illustrates a perspective view of a brush  546  according to one embodiment of the present invention. Brush  546  is usefully employed on any one of the combination exo-endocervical samplers  26 ,  106 ,  326 , and  426  illustrated above. 
         [0073]    In one embodiment, brush  546  is substantially conical in shape and defines a height H 4  between about 1 to 3 cm, and preferably the height H 4  of brush  546  is about 1.5 cm when employed in a Pap test on a non-parous patient, and height H 4  of brush  546  is about 2 cm when employed in a Pap test for a parous patient. 
         [0074]    Brush  546  includes a sponge  550  that defines a helical surface  552  wound about a semi-rigid or rigid strand  568 . In one embodiment, sponge  550  is an open celled absorbent sponge formed of natural or synthetic cellulose or its derivatives, or of polymers. In another embodiment, sponge  550  is a closed cell sponge form of polyurethane or the like. Strand  568  is generally oriented along central axis A, and includes corrosion resistant metal, such as stainless steel. Alternatively, strand  568  is formed from plastic materials, such as nylon. 
         [0075]    Helical surface  552  includes helically spaced ledges  554   a,    554   b,  and  554   c.  Helical surface  552  is suited to abrade portions of the endocervical canal to remove cervical cells for sampling without traumatizing the surface from which the cells are removed. 
         [0076]    In one embodiment, brush  546  includes a pair of opposing wings defined by helical surfaces  552  that are disposed transverse to the strand  568 , and a prominence defined by top  550  of sponge. Prominence, or top  550  of sponge, extends from the wings  552  along a central axis A of the strand  568 . In this regard, the opposing wings  552  define a first sampling surface and the prominence  550  defines a second sampling surface. The sponge  550  is characterized by an absence of bristles and defines pores or a void space within the sponge  550  that is configured to capture exo-endocervical cells. 
         [0077]      FIG. 9A  illustrates a perspective view of another combination exo-endocervical sampling device  620  according to one embodiment of the present invention. Combination exo-endocervical sampling device  620  includes a shaft  622 , and a combination exo-endocervical sampler  626  extending from shaft  622  and aligned along a central longitudinal axis A. In one embodiment, a separate sampler such as a swab or a spatula is coupled to shaft  622  opposite sampler  626  in a manner similar to that illustrated in Figure lA (swab) or  FIG. 4  (spatula). 
         [0078]    Combination exo-endocervical sampler  626  includes a pair of opposing wings  640 ,  642  that are disposed transverse to shaft  622  (i.e., transverse to central axis A), and a prominence  646  that extends away from the wings  640 ,  642  along the central axis A of shaft  622 . The prominence  646  and wings  640 ,  642  combine to define a sampling surface  644 . In one embodiment, sampling surface  644  is covered at least partially by a lofted intertwined mat  648  of looped fibers that is suitable for the collection of cells from the cervical face and/or the endocervical canal. 
         [0079]    In one embodiment, prominence  646  is substantially conical in shape and defines a height H 5  between about 1 to 3 cm, and preferably the height H 5  of prominence  646  is about 1.5 cm when sampler  626  is employed in a Pap test on a non-parous patient, and height H 5  of prominence  646  is about 2 cm when sampler  626  is employed in a Pap test for a parous patient. 
         [0080]    Lofted intertwined mat  648  of fibers forms a surface that is characterized by a random collection of interconnecting fibrils. The interconnecting fibrils define open spaces between the fibrils. The fibrils and the opens spaces combine to create a “lofty” structure that is useful in the atraumatic collection of cervical cells in a Pap test procedure. The looped fibrils may be referred to as “endless” fibers or fibrils, as individual fibrils forming the lofted intertwined mat  648  are formed to have no distinct “beginning” or “end” (i.e., the fibrils are not bristles). The lofted intertwined mat  648  is suited to abrade portions of the endocervical canal to remove cervical cells for sampling, and the open spaces between fibrils gather/retain the cells and minimize trauma to the cells as the cells are removed from the patient. 
         [0081]      FIG. 9B  illustrates a cross-sectional view of combination exo-endocervical sampler  626 . Wings  640 ,  642  and prominence  646  are covered by lofted intertwined mat  648  of fibers. In one embodiment, lofted intertwined mat  648  of fibers includes a base  650  and intertwined fibers  652  extending from base  650 . In one embodiment, lofted intertwined mat  648  of fibers is formed by extruding fibers  652  from a strand die onto a carrier web, or base  650 . In an alternative embodiment, lofted intertwined mat  648  of fibers is formed by extruding fibers  652  from a strand die onto a moving conveyor belt, where the speed of the conveyor belt is selected to enable a portion of fibers  652  to cool into a continuous polymeric base  650 , and another portion of fibers  652  becomes randomly tangled and intertwined as they cool on top of base  650 . In this manner, a single process is employed to form base  650  and intertwine fibers  652 . By an appropriate selection of fiber extrusion rate and collection speed, the mat of randomly intertwined fibers  652  will extend a distance from base  650  to provide a lofty structure. Between each of the randomly intertwined fibers  652 , a void or space  653  is defined that is suited for the collection of cervical cell samples. 
         [0082]    In one embodiment, base  650  and intertwined fibers  652  are formed from a thermoplastic polymeric material. Preferably, thermoplastic polymeric material is flexible, soft, and suited for medical applications. Examples of suitable thermoplastic materials include polyurethane, polyolefins, and polyolefins including a soft fraction of another polymer, for example, polybutylene. In one embodiment, after forming base  650  and intertwined fiber  652 , lofted intertwined mat  648  of “endless” fibers is thermo-formed onto sampler  626  to cover wings  640 ,  642  and prominence  646 . 
         [0083]      FIG. 10  illustrates a cross-sectional view of combination exo-endocervical sampling device  20  employed to collect cervical cells from a cervix during a Pap test according to one embodiment of the present invention. 
         [0084]    With reference to  FIG. 1A , second portion  39  of combination exo-endocervical sampling device  20  has been severed from first portion  37 . First portion  37  including sampler  24  ( FIG. 1A ) is provided to permit the clinician to collect a sample of cells from a wall of vagina V. Generally, sampler  24  is swabbed along walls of the vagina V to capture cells for analysis. First portion  37  having the cells collected on sampler  24  is removed from the vagina V, deposited inside a standard sized test tube, the test tube is capped, and the collected sample is sent to a laboratory for analysis. 
         [0085]    Thereafter, second portion  39  is inserted into the vagina V to collect cervical cells. For example, exo-endocervical sampler  26  is placed in contact with the cervix C such that sampling surface  44  contacts exocervical surface EX and brush  46  enters the cervical os to contact endocervical surface EN. 
         [0086]    Textured surface  36  on shaft  22  is available to provide a gripping surface that enables a clinician, for example a clinician wearing gloves, to rotate shaft  22 . Rotation of shaft  22  rotates exo-endocervical sampler  26  such that sampling surface  44  sweeps across the exocervical surface EX and brush  46  rotates within and around the endocervical surface EN. In this manner, sampling surface  44  collects cells from exocervical surface EX and looped fibers  70  atraumatically abrades and collects cells from the endocervical surface EN of cervix C. The exo-endocervical cells that are collected are appropriately “smeared” across one or more microscope plates and readied for subsequent laboratory analysis, or alternatively, deposited in a standard wet prep broth container. 
         [0087]    In one embodiment, combination exo-endocervical sampling devices described above are selected based upon a status of the patient. For example, one algorithm of use provides that the clinician determines whether the patient is pregnant, and if so selects exocervical sampling device  200  ( FIG. 5A ). If the patient is not pregnant, the clinician determines if the patient is nulli-parous and/or likely stenotic, and if so employs combination exo-endocervical sampling device  20  ( FIG. 1A ). In this regard, in the case where the patient is nulli-parous, height H of brush  46  is selected to have a height of about 1.5 cm. If the clinician determines that the patient is parous, the clinician selects combination exo-endocervical sampling device  20  provided with brush  46  having a height H of about 2.0 cm. 
         [0088]    Embodiments described above permit the clinician to use one tool to collect both endocervical and exocervical cell samples during a Pap test procedure. This reduces the duration of the office visit, which translates to improved clinic efficiency, and reduces the cost of the instruments used to collect the samples. The looped fibers effectively collect endocervical cell samples without traumatizing the endocervical tissue or the cells. The combination exo-endocervical sampling devices described above permit the clinician to match the device to a given cervix type and sample tissue, which after analysis and diagnosis provides vitally important information useful to the clinician in the early diagnosis of cytopathologic abnormalities and common vaginoses. 
         [0089]    Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof

Technology Category: 1