Apparatus and method for obtaining a specimen from a bodily orifice

An apparatus and method permit a general practitioner to obtain specimens from a bodily orifice of an animal, such as, for example, a sinus specimen from a nasal area of a human. The apparatus includes a specimen access tube fixedly or removably connected to a speculum, which may be a standard nasal speculum attachment. Anti-contamination structures, either inside or outside the specimen access tube protect against contamination of the specimen due to contact with other matter in the bodily orifice. In accordance with the method, a practitioner advances the specimen access tube into the bodily orifice, and advances the speculum toward the orifice to visualize the advancement of the specimen access tube. When the tip of the specimen access tube is proximate the specimen to be collected, the practitioner advances an applicator into the end of the specimen access tube such that a head of the applicator contacts and holds the specimen. The practitioner withdraws the applicator and the specimen access tube, and places the applicator in a standard culture medium.

BACKGROUND OF THE INVENTION
 1. Field of the Invention
 This invention relates to the field of medical testing, and, more
 particularly, relates to an apparatus and method for obtaining a specimen
 from a bodily orifice of an animal, such as a human, which, for example,
 may then be analyzed or cultured to determine the presence of various
 organisms.
 2. Description of the Related Art
 Obtaining and culturing an infection provides invaluable information in the
 form of precise microorganism identification. That information typically
 enables a physician to choose and administer a form of treatment, such as
 a particular antibiotic, closely matched to the identified microorganism
 and known to be effective in treating the microorganism. Without an
 identification of the responsible microorganism, a physician is left with
 little choice but to treat an infection empirically, that is, to choose an
 antibiotic or other treatment that has proven effective in treating the
 most common organisms that cause infections. But such treatments are often
 suboptimal.
 Before an infection may be cultured, a specimen must be obtained. Because
 current methods for obtaining specimens, particularly sinus-related
 specimens, are generally difficult and often painful and require the
 skills of a specialist, the benefits of a culture are, in practice, not
 readily available to general practitioners. Thus, infections are generally
 treated empirically, and, as a result, patients often receive less than
 optimal treatment for their infections. This is particularly true for
 sinus infections.
 One existing technique for obtaining a sinus specimen is known as an antral
 tap, sometimes referred to as a canine puncture and maxillary tap. This
 procedure is the most common technique for obtaining a sinus culture. The
 antral tap procedure involves placing an instrument, such as a sturdy
 needle (18 gauge or thicker), or a special needle or trocar, through the
 face of the maxillary sinus, above the canine tooth, under the lip. The
 bone in this area--the canine fossa--is quite thin. The instrument is
 placed through the mucosa bone and the underlying sinus mucosa. Special
 instruments have been designed to allow rapid puncture of the bone. One
 such instrument, resembling a small but powerful stiletto, is designated
 the "sino-ject."
 The antral tap procedure is an extremely painful procedure, especially in
 the many cases when the patient has an inflamed infected sinus. Thus, the
 procedure often requires general anesthesia, but, at a minimum, requires
 local anesthesia and sedation. As is well known, both local and general
 anesthesia procedures carry inherent risks. Besides pain, potential
 complications of the antral tap include bleeding, maxillary fracture, and
 even orbital or eye injuries. The antral tap procedure is limited in that
 it can provide a sinus specimen from the maxillary sinus only.
 Another form of the antral tap procedure is similar to that described
 above, but is performed along the floor of the nose with penetration of
 the lateral nasal wall below the inferior turbinate. This form of the
 antral tap is just as painful, and requires a special curved needle and
 trocar, or other sturdy instrument, for puncture of the thin bone below
 the inferior turbinate. This procedure often results in severe epistaxis,
 with possible complications including intranasal injury, such as a
 persistent opening with possible chronic sinusitis, intranasal scarring,
 injury to the nasolacrimal duct possibly leading to epiphora or chronic
 tearing, or some combination of these. Both forms of antral tap must be
 performed by a specialist.
 Another existing technique for obtaining a sinus specimen is to draw the
 specimen from the middle meatus (between the middle turbinate and the
 lateral nasal wall). The middle meatus is where the maxillary sinuses
 drain naturally, as do the frontal and ethmoid sinuses. While simple nasal
 cultures have a very low correlation with those of the maxillary sinus,
 cultures from the middle meatus correlate 100% with maxillary sinus
 cultures. This technique is useful to treat cases of maxillary sinusitis,
 ethmoid sinusitis and frontal sinusitis.
 One primary difficulty with obtaining middle meatus specimens is
 contamination of the culture swab when approaching the middle meatus or
 when removing the swab from the middle meatus. Because of the high
 incidence of contaminated specimens, only skilled otolaryngologists,
 frequently with the aid of an endoscope, can perform the procedure with a
 reasonable chance for success. Moreover, with existing instruments and
 techniques, there is a serious risk of injury to the skull base, the brain
 and the orbit if the procedure is not done very carefully by a specialist.
 Because of the complexity of current techniques, the serious associated
 risks, and the high level of skill required to obtain sinus specimens,
 most patients presenting with sinusitis are treated empirically. However,
 many studies have concluded that microorganisms are rapidly developing
 resistance to the most effective general antibiotics. Thus, the efficacy
 and availability of good empiric antibiotics is decreasing. When empiric
 treatments fail to stop a sinus infection, a sinus culture must be
 obtained. Therefore, as the effectiveness of empirical antibiotics
 decreases, the need for sinus cultures will increase. Moreover, many argue
 that all sinus infections should be cultured in the first instance.
 What is needed is a technique for obtaining a specimen, and particularly a
 sinus specimen, that can be performed with consistent success by a general
 practitioner, without contamination, without substantial pain, and with
 minimal risk of injury to the patient.
 SUMMARY OF THE INVENTION
 The present invention advantageously provides an apparatus and method for
 obtaining a specimen, which can be performed routinely by a general
 practitioner, with little risk of contamination of the specimen, and with
 minimal pain and minimal risk of injury to the patient.
 One embodiment of the present invention is an apparatus for obtaining a
 specimen through a bodily orifice of an animal. The apparatus comprises:
 (1) a speculum having an insertion end and a viewing end, said speculum
 defining a visualization path from said viewing end and through said
 insertion end, said speculum permitting visualization at said viewing end
 and along said visualization path of matter within said orifice when said
 insertion end is positioned in an opening of said orifice; and (2) a
 specimen access tube having an insertion end and a collection end, said
 specimen access tube operably connected to said speculum in an arrangement
 wherein said insertion end of said specimen access tube enters said
 orifice during said visualization, said specimen access tube defining a
 collection path from said collection end and through said insertion end of
 said specimen access tube, said specimen access tube providing access from
 said collection end through said collection path to a specimen within said
 orifice proximate to said insertion end of said specimen access tube. An
 aspect of the invention is one wherein said collection end of said
 specimen access tube remains outside said bodily orifice during said
 visualization and while said access to said specimen is provided. A
 further aspect of the invention is one wherein said collection path
 provides access to said specimen in a manner substantially avoiding
 contact with matter along bodily surfaces inside said orifice during said
 access. Still another aspect of the invention is one wherein at least a
 portion of said specimen access tube is substantially viewable from said
 viewing end of said speculum via said visualization path. Yet another
 aspect of the invention is one wherein a portion of said specimen access
 tube is located within a space defined by said speculum. Another aspect of
 the invention is one wherein said speculum is a standard speculum
 attachment. An additional aspect of the invention is one wherein said
 specimen access tube is fixedly attached to said speculum. A still further
 aspect of the invention is one wherein said specimen access tube is
 integrally formed with said speculum. Yet another aspect of the present
 invention is one wherein said specimen access tube is removably attached
 to said speculum. A further desirable aspect of the invention further
 comprises means for removably attaching said specimen access tube to said
 speculum. Another embodiment of the invention further comprises a speculum
 attachment ring fitting substantially securely around said speculum, said
 speculum attachment ring holding said specimen access tube in a first
 position relative to said speculum permitting said access to said
 specimen, and said speculum attachment ring manipulable to allow said
 specimen access tube to be located in a second position relative to said
 speculum permitting said speculum attachment ring to be fit around said
 speculum. A still further embodiment of the present invention further
 comprises anti-contamination means substantially separating matter in said
 orifice from said collection path during said entry of said specimen
 access tube into said orifice. An aspect of this embodiment is one wherein
 said anti-contamination means is an approximately olive-shaped structure
 connected at a tip of the specimen access tube at said insertion end. An
 alternative aspect of this embodiment is one wherein said
 anti-contamination means includes a thin film covering an opening in said
 specimen access tube at said insertion end. A further aspect of the
 present invention is one wherein said animal is human. Another aspect of
 the present invention is one wherein said orifice is proximate to a human
 nose. One more aspect of the present invention is one wherein said
 specimen is located in a middle meatus region of a human.
 A method in accordance with the present invention obtains a specimen from a
 bodily orifice of an animal. The method comprises the steps of: (1)
 advancing an insertion end of a specimen access tube into said bodily
 orifice such that a tip of said specimen access tube at said insertion end
 comes to rest proximate to a specimen in said bodily orifice; (2) viewing
 through a speculum at least a portion of said advancing of said insertion
 end into said bodily orifice, said speculum operably connected to said
 specimen access tube; and (3) advancing a head of an applicator into a
 collection end of said specimen access tube and through said tip such that
 said head contacts and holds said specimen. In another embodiment, the
 method comprises the further step of withdrawing said specimen access tube
 from said bodily orifice. In still another embodiment, the method
 comprises the still further step of withdrawing said applicator head from
 said specimen access tube. In another embodiment, the method comprises the
 yet still further step of placing said applicator head in a standard
 culture medium. One aspect of the method is one wherein said speculum is
 removably connected to said specimen access tube. Another aspect of the
 method is one wherein said advancing of said applicator head pierces a
 thin film stretched across said tip, said thin film substantially
 preventing matter in said bodily orifice from entering said specimen
 access tube during said advancing of said insertion end of said specimen
 access tube. A still further aspect of the method is one wherein a thin
 film specimen access jacket envelopes a substantial portion of said
 insertion end of said specimen access tube, said specimen access jacket
 having at least one activation tab which operates when pulled to tear open
 a tip of said specimen access jacket covering said tip of said specimen
 access tube, said specimen access jacket substantially preventing matter
 in said bodily orifice from entering said specimen access tube during said
 advancing of said insertion end of said specimen access tube, and the
 method comprises the further step of pulling said activation tab of said
 specimen access jacket before said step of advancing said head of said
 applicator. One more aspect of the method is one wherein a blade portion
 of a slidable shield slides to a closed position to substantially close a
 hole at said tip of said insertion end of said specimen access tube and
 slides to an open position to substantially open said hole, wherein said
 slidable shield has a shaft portion extending out of the collection end of
 said specimen access tube, said shaft portion manipulable to cause said
 blade portion to open or close said hole, and the method comprises the
 further step of manipulating said shaft to substantially open said hole
 before said step of advancing said head of said applicator.
 In another embodiment, the present invention is a specimen access device
 comprising (1) collection means for providing a specimen collection path
 extending from outside a bodily orifice to a position proximate to a
 specimen in said bodily orifice; (2) a speculum attachment operably
 connected to said collection means to provide visualization of a portion
 of said collection means in said bodily orifice; and (3)
 anti-contamination means substantially separating said collection means
 from matter in said bodily orifice other than said specimen.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
 FIG. 1 is an illustration of a human skull. Bilateral orbits 102 are formed
 in part by the frontal bone 104 and the malar bones 106. A nasal area 108
 is defined in part by the nasal bone 110 and an anterior nasal spine 112.
 Frontal sinuses 114 are defined by tissues and bones of the skull, the
 frontal sinuses 114 positioned generally behind and upward of the orbits
 102. Maxillary sinuses 116 are defined by the bone and tissue of the skull
 on either side of the nasal area 108 and below the orbits 102.
 Additionally, the tissues and bones of the skull define ethmoid sinuses
 118 positioned generally between the orbits 102 and the nasal area 108.
 FIG. 2 illustrates an expanded view of regions in the skull proximate to
 the orbit 102 and nasal area 108. A superior turbinate bone structure 202,
 a middle turbinate bone structure 204, and an inferior turbinate bone
 structure 206 are shown by FIG. 2 in approximated form to be situated
 generally between the orbit 102 and the nasal area 108. The middle
 turbinate 204 partially defines a middle meatus region 208.
 As is generally known, the frontal sinuses 114, the ethmoid sinuses 118,
 and the maxillary sinuses 116 drain into the middle meatus 208. As such,
 specimens obtained from the middle meatus 208 have a high correspondence
 to the state of the frontal 114, ethmoid 118, and maxillary sinuses 116.
 Thus, cultures performed on specimens from the middle meatus 208 can
 predict with high accuracy the cause of infections in the frontal 114,
 ethmoid 118, and maxillary sinuses 116. The present invention
 advantageously permits easy, sterile access to the middle meatus 208
 without contamination.
 Also, advantageously, the present invention works with existing equipment
 for examining bodily orifices. FIG. 3 illustrates a standard otoscope 302.
 The otoscope comprises a handle 304, which may include a source of power
 such as batteries, a neck 306 and a head 308. The head 308 may include
 magnification means (not shown) such as ground lenses and/or illumination
 means (not shown) such as a high intensity light bulb.
 As will be appreciated by those of ordinary skill in the art, the otoscope
 302 may be used by a medical practitioner to look into bodily orifices,
 including the inside of a human nose. When used to look into a nose, the
 practitioner generally places a nasal speculum attachment 310 into an
 access end 312 of the head 308, and then inserts the nasal speculum
 attachment 310 some distance into a nostril while viewing an area inside
 the nostril through a viewing end 314 of the head 308.
 FIG. 4 illustrates a nasal speculum attachment 310 that may be used in
 accordance with one embodiment of the present invention. The nasal
 speculum attachment 310 comprises an approximately conical insertion
 surface 402 at an insertion end 404 of the nasal speculum attachment 310
 and an approximately cylindrical fit cylinder 406 at a fit end 408 of the
 nasal speculum attachment 310. An approximately cylindrical fit limiting
 ring 410 joins the insertion surface 402 at one end and the fit cylinder
 406 at another end.
 In operation, a practitioner inserts the fit cylinder 406 of the nasal
 speculum attachment 310 into the viewing end 312 of the head 308 of the
 otoscope 302. The outer diameter of the fit cylinder 406 is substantially
 the same as the inner diameter of the cylinder of the head 308 such that
 the fit cylinder 406 fits snugly within the head 308. The fit limiting
 ring 410, having a diameter larger than the inner diameter of the head 308
 and the fit cylinder 406, limits the distance that the nasal speculum
 attachment 310 may be inserted into the head 308. Some nasal speculum
 attachments 310 may have threaded fit cylinders 406 which threadingly
 engage threads in some otoscope head 308 cylinders. The present invention
 is not limited by the presence of threads on a fit cylinder 406.
 The insertion surface 402, fit limiting ring 410, and fit cylinder 406
 define a roughly conical hollow chamber inside the nasal speculum
 attachment 310, with a hole 412 at the viewing end 404 and a second hole
 414 at the insertion end 408. A visualization path is formed generally
 along an axis running from the hole 412 at the viewing end 404 and through
 the second hole 414 at the insertion end 408. When the nasal speculum
 attachment 310 is inserted in the head 308, a practitioner inserts the
 insertion surface into a nostril of a patient and looks through the
 viewing end 314 of the otoscope 302 and through the visualization path
 defined by the speculum attachment 310 to examine structures inside the
 patient's nostril. That viewing may be enhanced by magnifying means (not
 shown) or illumination means (not shown) located in the otoscope head 308.
 The nasal speculum attachment 310 may be constructed of plastic, stainless
 steel, or any other rigid material appropriate for insertion into a bodily
 orifice. Many such nasal specula exist in the art, and the present
 invention is not limited by differences from one nasal speculum attachment
 to another.
 FIG. 5 illustrates one embodiment of a specimen access tube 502 in
 accordance with one embodiment of the present invention. The specimen
 access tube is generally tubular, such that cross sections of the specimen
 access tube 502 are roughly circular. However, it is contemplated that
 alternative embodiments of the specimen access tube 502 have cross
 sections which are oval, triangular, rectangular, or other shapes which do
 not impede the obtaining of a specimen. The specimen access tube 502 could
 be made of a flexible, resilient or rigid material such as, for example, a
 rubber, silicone, plastic or metal appropriate for insertion into a bodily
 orifice, and appropriate for one-time disposable use or reuse with washing
 and sterilization. The specimen access tube 502 could also be made from a
 malleable material, such as a relatively soft metal or plastic, which a
 practitioner could form into an advantageous configuration suitable for a
 particular patient's anatomy.
 The specimen access tube 502 defines a passageway or collection path
 running from a hole 504 at an insertion end 506 to another hole 508 at a
 collection end 510. A bend 512 in the specimen access tube 502 is
 positioned between a substantially straight shaft portion 514 and the
 collection end 510, and conforms generally to a non-linear slope of the
 insertion surface 402 of the nasal speculum attachment 310. The specimen
 access tube 502, in alternative embodiments, could also be straight or
 substantially straight.
 FIG. 6 illustrates a representation of a specimen access tube 502 operably
 attached to the nasal speculum attachment 310. In that attachment, the
 insertion end 506 of the specimen access tube 502 is arranged to point
 away from the insertion end 404 of the nasal speculum attachment 310. The
 shaft portion 514 of the specimen access tube 502 is arranged to be
 substantially parallel to a central axis 602 defined by a straight line
 intersecting the centers of the hole 414 and the hole 412 of the nasal
 speculum attachment 310. In a preferred embodiment of the present
 invention, the tip of the shaft portion shaft 514 at the insertion end 506
 of the specimen access tube 502 is arranged proximate to or intersecting
 the central axis 602.
 FIG. 7 illustrates a representation of the nasal speculum attachment 310
 attached to the specimen access tube 502, the arrangement viewed from the
 fit end 408 of the nasal speculum attachment 310. The tip of the shaft
 portion 514 of the specimen access tube 502 is visible through the hole
 412 at the insertion end 404 of the nasal speculum attachment 310, the
 hole 412 being visible when looking substantially directly into the hole
 414 of the nasal speculum attachment 310. Thus, the arrangement
 advantageously permits a practitioner to view the tip of the specimen
 access tube 502 in relation to bodily anatomy viewed contemporaneously
 through the nasal speculum attachment 310.
 FIG. 8 illustrates another embodiment of the present invention wherein the
 specimen access tube 502 is partially integrally attached to the nasal
 speculum attachment 310. In the configuration shown in FIG. 8, a portion
 of the specimen access tube 502 proximate to the bend 512 is located
 within the substantially conical space defined by the nasal speculum
 attachment 310. This embodiment advantageously works in orifices having
 smaller openings, and may result in less stretching or distortion of
 bodily tissue to permit introduction of the specimen access tube 502.
 FIG. 9 illustrates a representation of another embodiment of the present
 invention. In this embodiment, a portion of the specimen access tube 502
 proximate to the bend 512 is located completely within the approximately
 conical space of the nasal speculum attachment 310. In this embodiment,
 the insertion surface 402 of the nasal speculum attachment 310 is
 interrupted by the hole 508. It will be appreciated that the hole 508
 could also interrupt a portion of the fit limiting ring 410. The
 embodiment advantageously works in orifices with small openings and may
 further reduce any stretching, distortion or displacement of tissue during
 insertion of the specimen access tube 502.
 In a preferred embodiment, the invention is used to obtain a specimen from
 the middle meatus 208 (FIG. 2) region of a human and potentially other
 areas of the nose, specifically the sphenoethmoid recess, the sphenoid
 sinus, the maxillary sinus, the superior and inferior meati and the
 frontal recess. It is contemplated, however, that the present invention is
 useful for obtaining any specimen from a bodily orifice of a human or
 other animal, and the present invention is not limited to the particular
 embodiments disclosed herein.
 Method of Operation
 In accordance with the system and method of the present invention, a
 patient prepares by gently blowing to clear the nose. A practitioner then
 decongests the patient's nose, preferably by applying two (2) puffs of
 oxymetazoline. It will be appreciated that other decongestants may be
 used. The practitioner then anesthetizes the patient's nose, preferably
 using a few drops of four percent (4%) lidocaine. Again, other anesthetics
 of substantially equivalent effect may be used.
 A practitioner then inserts a flexible sterile cotton-tipped applicator in
 the collection end of the specimen access tube 502, and pushes the
 applicator therethrough so that the cotton tip rests just short of
 extension through the hole 504 at the insertion end 506 of the specimen
 access tube 502. Preferably, the applicator is a sterile urethrogenital
 calcium alginate tipped applicator, having a soft aluminum shaft. It will
 be appreciated however that other applicators suitable for collecting a
 specimen may be used.
 FIG. 10 illustrates a representation of the device of the present invention
 positioned for use in a patient. In such position, the nasal speculum
 attachment 310 and the attached specimen access tube 502 are inserted
 through a nostril 1002 of the patient. The practitioner manipulates the
 tip of the specimen access tube 502 at the insertion end 506 into a
 position near or in the middle meatus 208.
 Having previously been inserted partially within the specimen access tube
 502, a portion of a sterile cotton-tipped applicator 1004 is located
 outside the hole 508 at the collection end 510 of the specimen access
 tube. The remainder of the applicator 1004 is positioned inside the
 specimen access tube 502 with the tip of the applicator 1006 resting
 substantially at and within the tip at the insertion end 506 of the
 specimen access tube 502.
 FIG. 11 illustrates a representation of the system and method of the
 present invention in use. To collect a specimen, the practitioner advances
 the applicator 1004 by gently and slowly pushing the applicator into the
 specimen access tube 502 so that the tip 1006 of the applicator emerges
 from the hole 504 of the specimen access tube to contact the surface of
 the middle meatus 208. The practitioner then withdraws the applicator 1004
 so that the tip 1006 of the applicator again comes to rest substantially
 at and within the tip of the specimen access tube 502 at the insertion end
 506.
 With the applicator 1004 withdrawn into the specimen access tube 502, the
 practitioner removes the nasal speculum attachment 310 and the attached
 specimen access tube 502 from the nose of the patient. The practitioner
 then removes the applicator from the specimen access tube 502, and places
 it in a standard culture medium. It will be appreciated that any culture
 medium effective to culture a specimen may be used.
 It is specifically contemplated that the specimen access tube 502 could be
 embodied in various configurations and sizes permitting, on the one hand
 insertion into the anterior nares area and allowing passage of the
 flexible applicator or swab, preferably providing some resistance so the
 applicator does not fall out of the specimen access tube 502 unsupported,
 and on the other hand, permitting operable connection of the specimen
 access tube to a nasal speculum attachment 310. In some embodiments, the
 entire specimen access tube 502 may be substantially straight or arced to
 varying degrees.
 In some embodiments of the present invention, such as, for example, those
 illustrated in FIGS. 6, 8 and 9, the specimen access tube 502 is fixedly
 attached to the nasal speculum attachment 310. Such attachment may be
 accomplished using a welding or soldering technique, by epoxy or cement,
 or by integral or molded formation, or by other substantially permanent
 means of attachment known in the art.
 In additional embodiments, the specimen access tube 502 may be removeably
 connected to the nasal speculum attachment 310.
 FIG. 12 illustrates one embodiment for an adapter for connecting the
 specimen access tube 502 to the nasal speculum attachment 310. The adapter
 1202 comprises a speculum attachment ring 1204 having an inner diameter
 substantially the same as the outer diameter of the fit cylinder 406 of
 the nasal speculum attachment 310.
 The speculum attachment ring 1204 is connected to a tube housing 1206. The
 tube housing is substantially cylindrical having a bore 1208 there
 through. In a preferred embodiment, the bore is substantially conical, the
 bore 1208 having a larger diameter at a speculum end 1210 of the housing
 1206 and a smaller diameter at a collection end 1212 of the housing 1206.
 The diameter of the bore 1208 at the collection end 1212 is substantially
 the same as the outer diameter of the collection end of the specimen
 access tube 502. The housing 1206 includes a transverse threaded bore 1214
 which threadingly receives a set screw 1216.
 A practitioner uses the adapter 1202 by fitting the speculum attachment
 ring 1204 over the fit cylinder 406 of the nasal speculum attachment 310,
 and advancing the speculum attachment ring 1204 into contact with the fit
 limiting ring 410 of the nasal speculum attachment 310. It will be
 appreciated that the internal walls of the speculum attachment ring 1204
 could be threaded to threadingly engage threaded fit cylinders 406 of
 certain nasal speculum attachments 310.
 The practitioner then inserts the collection end of the specimen access
 tube 502 into the speculum end 1210 of the housing 1206 and advances the
 collection end of the specimen access tube 502 through the bore 1208 until
 it extends out of the collection end of the housing 1206, and until the
 bend 512 in the specimen access tube 502 is in substantial conformance
 with the slope of the insertion surface 402 of the nasal speculum
 attachment 310. The practitioner then rotates the set screw 1216 to
 threadingly engage the bore 1214 and to advance through said bore into
 contact with and to firmly position the specimen access tube 502.
 FIG. 13 illustrates a representation of the adapter 1202 operably connected
 to the nasal speculum attachment 310 and operably connected to the
 specimen access tube 502. It will be appreciated that the thickness of the
 speculum attachment ring 1204 is sufficient to substantially prohibit
 movement of the adapter relative to the nasal speculum attachment 310. It
 will further be appreciated that the set screw 1216 is rotationally
 advanced into contact with the specimen access tube with a force
 sufficient to substantially prohibit movement of the specimen access tube
 502 relative to the nasal speculum attachment 310. It will be noted that,
 even with the speculum attachment ring 1204 fitted over it, a sufficient
 height of the fit cylinder 406 extends from the speculum attachment ring
 1204 to fit securely within the cylinder of the head 308 of the otoscope
 302.
 FIG. 14 illustrates a representation of another embodiment of a speculum
 adapter 1402 operably connected to a specimen access tube 502. In this
 embodiment, a speculum attachment ring 1404 having a dimension and
 configuration similar to that of the speculum attachment ring 1204, is
 integrally formed with, or otherwise attached to a swivel plate 1406. A
 pivot bore 1408 runs through the swivel plate 1406 and receives pivot pin
 1410 having a diameter substantially the same as the pivot bore 1408. A
 pivot pin cap 1412 is fixedly attached to the pivot pin 1410, the pivot
 pin cap having a diameter larger than the pivot pin 1410 to engage a
 surface of the swivel plate 1406.
 A set bore 1414 runs through the swivel plate 1406, preferably at a
 position between the pivot bore 1408 and the speculum attachment ring
 1404. The set bore 1414 is threaded to threadingly engage a set screw
 1416.
 A second swivel plate 1418 is fixedly attached to the specimen access tube
 502, preferably at a position between the bend 512 and the collection end
 510 of the specimen access tube. The pivot pin 1410 is fixedly attached to
 the second swivel plate 1418 to substantially align sides of the swivel
 plates 1406 and 1418. A set bore 1420 runs through the second swivel plate
 1418. The set bore 1420 is positioned to align with the set bore 1414 and
 to threadingly receive the set screw 1416 in that alignment.
 In operation, a practitioner loosens the set screw 1416 by rotating it
 counterclockwise, such that it is no longer engaged by the set bore 1420,
 but remains engaged by the set bore 1414. The practitioner then pivots the
 specimen access tube 502 with respect to the speculum attachment ring 1404
 about the pivot pin 1410 in an amount sufficient to permit fitting the
 speculum attachment ring 1404 onto the fit cylinder 406 (FIG. 4).
 FIG. 15 illustrates the pivoting of the specimen access tube 502 with
 respect to the speculum attachment ring 1404 about the pivot pin 1410 in
 accordance with one embodiment of the present invention.
 Once the speculum attachment ring 1404 is fit onto the fit cylinder 406,
 the practitioner pivots the specimen access tube 502 with respect to the
 speculum attachment ring 1404 about the pivot pin 1410 to bring the set
 bore 1420 into alignment with the set bore 1414. The practitioner then
 rotates the set screw 1416 in a clockwise manner to threadingly engage the
 set bore 1420 and thereby fix the position of the specimen access tube 502
 with respect to the speculum attachment ring 1404. The practitioner may
 then place the fit cylinder 406 into the otoscope head 308 and use the
 specimen access tube 502 as connected to the nasal speculum attachment 310
 to collect a sinus specimen in the manner described herein.
 FIG. 16 illustrates another embodiment of a speculum adapter 1602 operably
 connected to a specimen access tube 502. The speculum adapter 1602
 includes a speculum attachment ring 1603 integrally formed with or
 otherwise connected to a hinge plate 1604. A set bore 1606 runs through
 the hinge plate 1604, and is threaded to threadingly engage a set screw
 1608.
 A second hinge plate 1610 is fixedly, or otherwise attached to the specimen
 access tube 502, preferably at a position between the bend 512 and the
 collection end 510 of the specimen access tube 502. A hinge 1612 attaches
 the hinge plates 1604 and 1610 at ends of the hinge plates 1604 and 1610
 proximate to the collection end 510 of the specimen access tube 502. A
 second set bore 1614 runs through the second hinge plate 1610 and is
 positioned to align with the set bore 1606 to threadingly receive the set
 screw 1608.
 A practitioner uses the speculum adapter 1602 by loosening the set screw
 1608 (i.e., rotating it counterclockwise), to a position wherein it is no
 longer engaged by the set bore 1614, but remains threadingly engaged by
 the set bore 1606. The practitioner then pivots the specimen access tube
 502 with respect to the speculum attachment ring 1603 about the hinge 1612
 in an amount sufficient to permit fitting the speculum attachment ring
 1603 onto the fit cylinder 406 (FIG. 4).
 FIG. 17 illustrates the pivoting of the specimen access tube 502 with
 respect to the speculum attachment ring 1603 about the hinge in accordance
 with one embodiment of the present invention.
 Once the speculum attachment ring 1603 is fit onto the fit cylinder 406,
 the practitioner pivots the specimen access tube 502 with respect to the
 speculum attachment ring 1603 about the hinge 1612 to bring the set bore
 1614 into alignment with the set bore 1606. The practitioner then rotates
 the set screw 1608 in a clockwise direction to threadingly engage the set
 bore 1614 to thereby fix the position of the specimen access tube 502 with
 respect to the speculum attachment ring 1603. The practitioner may then
 position the fit cylinder 406 within the otoscope head 308 and use the
 nasal speculum attachment 310 as combined with the specimen access tube
 502 to collect a sinus specimen in the manner described herein.
 FIG. 18 illustrates another embodiment of a nasal speculum adapter 1802 in
 accordance with the present invention. A speculum attachment ring 1804 is
 integrally formed with or otherwise attached to a slide member 1806. A set
 bore 1808 runs through the slide member 1806 and is threaded to
 threadingly engage a set screw 1810. The set bore 1808 is positioned
 approximately midway along the length of the slide member 1806.
 A slide housing 1812 is fixedly or otherwise attached to the specimen
 access tube 502, preferably at a position between the bend 512 and the
 collection end 510. The slide housing 1812 defines an internal passage
 having a rectangular cross-section of substantially the same height and
 width of a cross-section of the slide member 1806, thus permitting
 insertion of the slide member 1806 into slide housing 1812 and slidable
 movement of the slide member 1806 within the slide housing 1812. It will
 be appreciated that the cross sections of both the slide member 1806 and
 the internal passage of the slide housing 1812 could be of a different
 shape, such as, for example, circular, triangular, etc., and it is
 contemplated that different cross-section shapes are within the scope of
 the present invention.
 A slot 1814 interrupts an outer surface of the slide housing 1812 on a side
 away from the specimen access tube 502. The slot 1814 permits access into
 the internal passage of the slide housing 1812.
 The shaft of the set screw 1810 extends through the slot 1814 to
 threadingly engage the set bore 1808 in the slide member 1806. The
 diameter of the head of the set screw 1810 is greater than the width of
 the slot, and thus, when tightened, engages the outer surface of the slide
 housing 1812 and thereby prevents slidable movement of the slide member
 1806 within the slide housing 1812.
 A practitioner uses the speculum adapter 1802 by loosening the set screw
 1810, preferably without removing it from the set bore 1808. The
 practitioner may then slide the specimen access tube 502 and slide housing
 1812 attached thereto, in a direction away from the speculum attachment
 ring 1804 for a distance sufficient to permit the speculum attachment ring
 1804 to be fit over the fit cylinder 406.
 FIG. 19 illustrates the specimen access tube 502 and slide housing 1812
 positioned away from the speculum attachment ring 1804 in accordance with
 an embodiment of the present invention.
 Once the practitioner has fit the speculum attachment ring 1804 over the
 fit cylinder 406, the practitioner slides the specimen access tube 502
 toward the speculum attachment ring 1804 into an operable position. The
 practitioner then tightens the set screw 1810 to substantially fix the
 specimen access tube 502 in an operable position relative to the speculum
 attachment ring 1804. The practitioner then positions the fit cylinder 406
 within the head 308 of the otoscope 302. The practitioner may then collect
 a sinus sample as described herein.
 FIG. 20 illustrates another embodiment of a nasal speculum adapter 2002 in
 accordance with the present invention. A speculum attachment ring 2004 is
 integrally formed with or otherwise attached to an adapter neck 2006. The
 adapter neck 2006 is fixedly or otherwise attached to the specimen access
 tube 502. The adapter neck 2006 is made from a material, such as a
 resilient or rubberized plastic, or a hardened metal, having resiliency or
 memory sufficient to hold the specimen access tube 502 substantially fixed
 relative to the speculum attachment ring 2004 in the absence of a force
 tending to drive the tip of the specimen access tube 502 at the insertion
 end 506 away from the speculum attachment ring 2004.
 A practitioner uses the speculum adapter 2002 by applying force to the
 specimen access tube 502 generally along its shaft portion 514 in a
 direction away from the speculum attachment ring 2004. This force causes
 the adapter neck 2006 to flex, thereby permitting the specimen access tube
 502 to separate from the speculum attachment ring 2004. The adapter neck
 2006 may flex primarily in a direction wherein the specimen access tube
 502 moves either away from or toward the speculum attachment ring 2004, or
 primarily in a twisting manner about an axis substantially perpendicular
 to a plane defined by the circular surface of the speculum attachment ring
 2004, or may flex substantially in both of those directions.
 FIG. 21 illustrates the specimen access tube 502 separated from the
 speculum attachment ring 2004 by way of flexing of the adapter neck 2006,
 in accordance with an embodiment of the present invention. When the
 specimen access tube 502 is sufficiently separated from the speculum
 attachment ring 2004, the practitioner fits the speculum attachment ring
 over the fit cylinder 406 of the nasal speculum attachment 310. The
 practitioner may then remove the force applied to the shaft portion 514 of
 the specimen access tube 502, causing the specimen access tube 502 to
 spring back into an operable position relative to the speculum attachment
 ring 2004. The practitioner may then place the fit cylinder 406 within the
 head 308 of the otoscope 302, and use the combined specimen access tube
 502 and nasal speculum attachment 310 to collect a sinus specimen as
 described herein.
 Additional embodiments of the present invention include embodiments wherein
 a modified nasal speculum attachment removably attaches to the specimen
 access tube 502. For example, FIG. 22 illustrates an embodiment of the
 present invention wherein a modified nasal speculum attachment 2202
 connects to the specimen access tube 502.
 The insertion surface 402 is formed to create a channel 2204 running along
 the inside of the insertion surface 402 in a direction substantially
 parallel to a central axis intersecting the holes 412 and 414 (FIG. 4).
 The channel 2204 slidably engages an attachment rod 2206 fixedly or
 otherwise attached to the specimen access tube 502.
 Cross sections of the channel 2204 are preferably triangular, to securely
 engage the attachment rod 2206, which preferably also has triangular cross
 sections. Cross sections of the channel 2204 and the attachment rod 2206
 may vary in shape so long as they are sufficiently similar to
 substantially fix the position of the specimen access tube 502 with
 respect to the nasal speculum attachment 2202.
 The practitioner fits the attachment rod 2206 into the channel 2204,
 sliding a length of the attachment rod 2206 into the channel 2204. The
 attachment rod 2206 is made from a material sufficiently rigid to prevent
 substantial movement of the specimen access tube relative to the nasal
 speculum attachment 2202. The practitioner may then fit the nasal speculum
 attachment 2202 into the otoscope 302 and obtain a sinus specimen as
 described herein.
 FIG. 23 illustrates another embodiment of the present invention wherein a
 modified nasal speculum attachment 2302 connects to the specimen access
 tube 502. The insertion surface 402 of the nasal speculum attachment 2302
 is formed to create a channel 2304 running along the outside of the
 insertion surface 402 in a direction substantially parallel to a central
 axis intersecting the holes 412 and 414 (FIG. 4).
 The channel 2304 comprises a substantially cylindrical space within the
 material of the insertion surface 402 and a slot. The slot runs the
 distance of the channel 2304 and has a width substantially smaller than
 the diameter of the circular cross section of the cylindrical space, and
 permits access to the cylindrical space from the outer surface of the
 insertion surface 402.
 The channel 2304 slidably engages an attachment rod 2306 fixedly or
 otherwise attached to the specimen access tube 502. The attachment rod
 comprises a cylindrical rod having substantially circular cross-sections
 of the substantially the same dimension as the cross sections of the
 channel 2304, and a ridge member running the length of the cylindrical rod
 and connecting the cylindrical rod to the specimen access tube 502. Cross
 sections of the channel 2304 and the attachment rod 2306 may vary in shape
 so long as they are sufficiently similar to substantially fix the position
 of the specimen access tube 502 with respect to the nasal speculum
 attachment 2302.
 The practitioner fits the attachment rod 2306 into the channel 2304,
 sliding a length of the attachment rod 2306 into the channel 2304. The
 attachment rod 2306 is made from a material sufficiently rigid to prevent
 substantial movement of the specimen access tube 502 relative to the nasal
 speculum attachment 2302. The practitioner may then fit the nasal speculum
 attachment 2302 into the otoscope 302 and obtain a sinus specimen as
 described herein.
 Many other techniques exist for connecting a specimen access tube 502 to a
 modified nasal speculum adapter, such as many configurations involving
 holes, slots or channels in the nasal speculum adapter and conforming and
 engaging pins, rods or tabs on the specimen access tube 502. These
 techniques and others which clamp or grip the nasal speculum attachment to
 the specimen access tube 502 are specifically contemplated to be within
 the scope of the present invention.
 Structures Avoiding Contamination
 FIG. 24 illustrates a representation of a specimen access tube having an
 anti-contamination structure in accordance with an embodiment of the
 present invention. In this embodiment, the tip of the specimen access tube
 502 at the insertion end 506 is flared to form an approximately
 olive-shaped tip 2402. The olive-shaped tip 2402 may be integrally formed
 onto or molded at the tip of the specimen access tube 502. Alternatively,
 the olive-shaped tip 2402 may be a separate structure having a
 substantially cylindrical internal passage of substantially the same
 diameter as the outer tubular diameter of the insertion end 506 tip of the
 specimen access tube 502, which may then be fixedly attached over the tip
 of specimen access tube 502.
 The olive-shaped tip, being rounded in shape, does not substantially impede
 the introduction of the specimen access tube 502 into the middle meatus
 208 area.
 Moreover, the olive-shaped tip tends to spread apart tissues during that
 introduction, and advantageously directs material that could contaminate
 the specimen away from the hole 504 (FIG. 5) at the insertion end 506,
 thus increasing the chances of obtaining an uncontaminated specimen.
 FIG. 25 illustrates another representation of a specimen access tube having
 an anti-contamination structure in accordance with an embodiment of the
 present invention. In this embodiment, the insertion end 506 tip of the
 specimen access tube is formed to have an approximately olive-shaped
 collection tip 2502, which may be integrally formed with or molded to the
 tubular insertion end 506 tip of the specimen access tube 502.
 Alternatively, the olive-shaped collection tip 2502 could be a separate
 structure defining an internal cylindrical joining ring 2504 at a joining
 end 2506 having a diameter substantially the same as the outer tubular
 diameter of the insertion end 506 tip of the specimen access tube 502,
 which may then be positioned over the tip of specimen access tube 502 and
 fixedly attached thereon. The attachment may be accomplished by
 positioning the cylindrical joining ring 2504 over the tip of the specimen
 access tube 502 at a position along the shaft portion 514 whereat a rim
 2508 at an insertion end 25010 of the olive-shaped collection tip 2502 is
 approximately coextensive with or extends just slightly beyond the tip of
 the specimen access tube 502. In that position, the cylindrical joining
 ring 2504 may be glued, cemented, welded, or friction fit to the shaft
 portion 514 of the specimen access tube. Alternatively, the cylindrical
 joining ring 2504 may be threaded to threadingly engage threads running
 from the tip of the specimen access tube 502 some distance along the shaft
 portion 514.
 When the olive-shaped collection tip 2502 is attached to the specimen
 access tube 502 and introduced into a patient's nasal area toward the
 middle meatus 208 (FIG. 2), the olive-shaped collection tip 2502, being
 rounded, tends to separate tissues and direct potentially contaminating
 matter away from the tip of the specimen access tube 502. Moreover, the
 rim 2508 conducts some of the potentially contaminating matter along inner
 walls of a roughly spherical recess 2512 within the olive-shaped
 collection tip 2502 and between the inner walls of the olive-shaped
 collection tip 2502 and the outer walls of the specimen access tube 502.
 Thus, potentially contaminating matter may not contact the hole 504 or the
 tip of the specimen access tube 502 during insertion, advantageously
 reducing the possible that an obtained specimen would be contaminated.
 FIG. 26 illustrates still another representation of a specimen access tube
 having an anti-contamination structure in accordance with an embodiment of
 the present invention. In this embodiment, the insertion end 506 tip of
 the specimen access tube is formed to have an approximately olive-shaped
 cage 2602, which may be integrally formed with or molded to the tubular
 insertion end 506 tip of the specimen access tube 502.
 Alternatively, the olive-shaped cage 2602 could be a separate structure
 defining a cylindrical joining ring 2604 at a joining end 2606 having a
 diameter substantially the same as the outer tubular diameter of the
 insertion end 506 tip of the specimen access tube 502, which may then be
 positioned over the tip of specimen access tube 502 and fixedly attached
 thereon. The attachment may be accomplished by positioning the cylindrical
 joining ring 2604 over the tip of the specimen access tube 502 at a
 position along the shaft portion 514 whereat rounded prong tips 2608
 attached via prongs 2610 to the cylindrical joining ring 2604 at an
 insertion end 2612 of the olive-shaped cage 2602 are approximately
 coextensive with or extend just slightly beyond the tip of the specimen
 access tube 502. In that position, the cylindrical joining ring 2604 may
 be glued, cemented, welded, or friction fit to the shaft portion 514 of
 the specimen access tube. Alternatively, the cylindrical joining ring 2604
 may be threaded to threadingly engage threads running from the tip of the
 specimen access tube 502 some distance along the shaft portion 514.
 A number of prongs 2610, preferably six (6), extend outwardly and upwardly
 from the cylindrical joining ring 2604 to define an approximately
 olive-shaped space within the prongs 2610. Each of the prongs 2610
 terminates in an enlarged and rounded prong tip 2608.
 When the olive-shaped cage 2602 is attached to the specimen access tube 502
 and introduced into a patient's nostril toward the middle meatus 208 (FIG.
 2), the prong tips 2608, being rounded, and the prongs 2610, being curved,
 tend to separate tissues and direct potentially contaminating matter away
 from the tip of the specimen access tube 502. Moreover, the prong tips
 2608 conduct some of the potentially contaminating matter along the
 adjoining prongs 2610 away from the hole 504 and the tip of the specimen
 access tube. Therefore, potentially contaminating matter may not contact
 the hole 504 or the tip of the specimen access tube 502 during insertion,
 advantageously reducing the possible of contaminating a specimen with
 encountered during insertion.
 FIG. 27 illustrates another embodiment of an anti-contamination structure
 in accordance with the present invention. An olive-shaped cage 2702
 includes the six prongs 2610 connected to the cylindrical joining ring
 2604 as described in relation to FIG. 26. The six prongs 2610 of the
 olive-shaped cage 2702 are, however, connected at their tips 2608 to the
 tip of the specimen access tube 502 at the insertion end 506.
 It will be appreciated that other anti-contamination structures may be
 attached or formed with or to the specimen access tube 502 to reduce or
 eliminate the possibility of contamination. Anti-contamination structures
 may also assist in closing off the inside of the specimen access tube 502
 during its insertion into a bodily orifice.
 FIG. 28 illustrates an anti-contamination lid structure in accordance with
 an embodiment of the present invention. A lid 2802 is connected to the tip
 of the specimen access tube 502 at a hinge 2804. The hinge 2804 permits at
 least 90 degrees of rotational movement about its pin, allowing the lid
 2802 to lay flat along the rim of the tip of the specimen access tube 502,
 and also allowing the lid to open an amount at least sufficient to allow
 an applicator to emerge directly from the tip with the lid having no
 effect on the direction of travel of the applicator. Such hinges are known
 in the art.
 In use, the practitioner positions the specimen access tube 502 in place as
 described above. As the practitioner inserts the specimen access tube 502,
 the lid 2802 advantageously prevents entry of any contaminant into the
 specimen access tube. Once the tube 502 is positioned, the practitioner
 then slowly advances the applicator. As the applicator is advanced, it
 contacts the lid 2802 and pushes it open. When the applicator moves past
 the lid and contacts the specimen, the practitioner withdraws the
 applicator into the specimen access tube 502 and removes the specimen
 access tube 502 from the bodily orifice.
 FIG. 29A illustrates another embodiment of an anti-contamination structure
 in accordance with the present invention. A thin sterile film 2902,
 circular in shape and having substantially the same diameter as the tip of
 the specimen access tube 502, is stretched taught and sealingly attached
 across the opening at the tip of the specimen access tube 502. That
 attachment is preferably performed by using a glue or cement presenting
 insubstantial medical risk to a patient when set.
 Advantageously, the circular film 2902 is preferably formed to have scores
 2904 (i.e., thin-walled or weakened crease lines) across its surface. When
 a force is applied against the surface of the film 2902, it tears first at
 the scores 2904. In a preferred embodiment, two score lines 2904 intersect
 the circular film 2902 at its center to form a cross.
 FIG. 29B illustrates the use of an embodiment of the circular film
 anti-contamination structure. A practitioner advances the specimen access
 tube 502 into place. During that insertion, the circular film 2902 remains
 in place and advantageously prevents any contaminant from entering the
 specimen access tube 502.
 Once the tube 502 is in place, the practitioner advances the applicator
 2906 with a force sufficient to tear the circular film 2902 at the scores
 2904. In a preferred embodiment, the force required to tear the film 2902
 is sufficiently slight that the applicator can easily pierce the film.
 Thus, the practitioner need not force the applicator to a degree that
 tissue injury would occur when the applicator suddenly bursts through the
 film. The practitioner advances the applicator 2906 carefully to contact
 the specimen, and then withdraws the applicator 2906 into the tube. The
 specimen access tube 502 is then withdrawn.
 FIG. 30A illustrates another anti-contamination structure in accordance
 with an embodiment of the present invention. A specimen access jacket
 3002, made from a sterile thin film material, has an insertion end 3004
 and an activation end 3006. The tip of the specimen access jacket 3002
 includes a score 3008 as discussed above. The specimen access jacket 3002
 is configured to form an elongated cylindrical space within the insertion
 of substantially the same dimension as the cylindrical form of specimen
 access tube 502 along the shaft portion 514.
 The specimen access jacket 3002 is further configured to have a slit 3010
 approximately midway down its length. The slit forms two activation tabs
 3012 at the activation end 3006 of the specimen access jacket 3002.
 FIG. 30B illustrates a representation of a specimen access jacket 3002 fit
 over a speculum access tube in an embodiment of the present invention. The
 shaft portion 514 of the specimen access tube 502 is substantially within
 and covered by the insertion end 3004 of the specimen access jacket 3002.
 The opening 508 at the collection end 510 of the specimen access tube 502
 is accessible and not covered by the specimen access jacket 3002.
 Activation tabs 3012 extend down below the opening 508. The hole 412 at
 the insertion end 404 of the speculum attachment is not substantially
 obstructed by the specimen access jacket 3002, and, thus, the
 practitioner's visualization of matter within a bodily orifice is not
 hindered or impeded.
 The practitioner inserts the specimen access tube 502 into the bodily
 orifice. During the insertion, the specimen access jacket 3002
 advantageously prevents any contaminants from entering the specimen access
 tube 502. Once the tube 502 is in place, the practitioner grasps the
 activation tabs 3012 and tugs in a direction away from the insertion end
 3004. Advantageously, the specimen access jacket 3002 tears at the score
 308, recedes some distance down the shaft portion 514, and thus exposes
 the tip of the specimen access tube 502 to the specimen. The practitioner
 then advances the applicator carefully into contact with the specimen and
 then withdraws the applicator into the tube 502. Finally, the practitioner
 withdraws the specimen access tube 502. The specimen access jacket 3002
 may be discarded.
 FIG. 31 illustrates a representation of the insertion end of a specimen
 access tube having contamination shield guides in accordance with an
 embodiment of the present invention. First and second shield guide side
 walls 3102, 3104 have respective shield guide channels 3106, 3108 formed
 therein.
 The first and second shield guide side walls 3102, 3104 are positioned
 across from each other within the inner cylindrical space defined within
 the tip of the specimen access tube 502.
 FIG. 32 illustrates a perspective view of the first shield guide side wall
 3102. The first shield guide wall is preferably a solid body, made of a
 rigid material such as plastic, forming generally a lengthwise portion of
 a cylinder. A curved surface 3202 fits snugly against the inner
 cylindrical wall of the specimen access tube 502. A flat surface 3204 is
 interrupted by the guide channel 3106. The guide channel 3106 runs from
 one side 3206 substantially near a top end 3208, in a curved pattern, down
 to a point substantially near a bottom end 3210. It will be appreciated
 that the second shield guide wall is constructed substantially the same,
 but having a guide channel 3108 formed in a mirror image manner to the
 guide channel 3106 to thereby match the curve of the same in location
 across from it.
 FIG. 33 illustrates a side view of the shield guide side wall 3102. The
 bottom end 3210 defines a sloped surface 3302 rising from the bottom most
 point of the bottom end along the curved surface 3202 to a point defining
 the bottom edge of the flat surface 3204. The second side wall has a
 similar sloped surface (not shown). The sloped surface 3302 advantageously
 guides an applicator between the two shield guide side walls 3102, 3104 as
 it is begin advanced into the specimen access tube.
 FIG. 34 illustrates a cross-sectional view through the shield guide side
 wall 3102. The curved surface 3202 represents an arc approximately one
 quarter of the circumference of the circle defined by a cross section of
 the specimen access tube 502.
 FIG. 35 illustrates a representation of an anti-contamination shield. The
 anti-contamination shield 3502 has a shield blade 3504 and a shaft 3506.
 The shield 3502 is made from a flexible material that can bend
 substantially without deformation.
 The shield blade 3504 is of a width spanning the distance between the guide
 channels 3106, 3108 when the side walls 3102, 3104 are positioned within
 the specimen access tube 502. The shield blade 3504 has a uniform
 thickness slightly less than the thickness of the guide channels 3106,
 3108 so that the blade 3504 fits slidably within the channels 3106, 3108.
 The shield blade 3504 has a top edge 3508 curved to match the curvature of
 the inner wall of the specimen access tube 502 and to thereby
 substantially sealingly engage that inner wall.
 The shield blade 3504 tapers into the shaft 3506. The shaft 3506 may be of
 the same thickness as the blade 3504, but is substantially narrower to
 advantageously occupy less room within the inner space of the specimen
 access tube 502, thereby permitting easier introduction and advancement of
 the applicator therein.
 FIG. 36 illustrates the specimen access tube 502 having the shield 3502
 installed therein. As depicted and in a closed position, the shield 3502
 substantially extends across a cross section of the tip of the specimen
 access tube. The shaft 3506 extends out of the specimen access tube 502 at
 the collection end 510.
 FIG. 37 represents a view looking into the tip of the specimen access tube
 502 with the shield blade 3504 substantially extending across a cross
 section at the tip of the tube 502, the top edge 3508 of the blade 3504
 engaging the inner wall of the specimen access tube. FIG. 38 illustrates a
 perspective view of the shield blade 3504 and shaft 3506 installed within
 the specimen access tube 502 in the closed position.
 FIG. 39 illustrates a representation of the specimen access tube 502 having
 a shield 3502 installed therein in an open position. The shaft 3506, when
 pulled out of the specimen access tube 502 a small distance, causes the
 blade 3504 to slide along the guide channels 3106, 3108 to a position
 leaving the tip of the specimen access tube 502 substantially open.
 FIG. 40 illustrates a view looking into the specimen access tube 502 when
 the blade 3504 is in an open position. The blade 3504 occupies little of
 the cross section at the tip of the specimen access tube 502 when it is in
 the open position.
 In using this embodiment, a practitioner advances the shaft 3506 of the
 blade 3502 into the specimen access tube 502 to ensure that the blade is
 in a closed position. The practitioner then advances an applicator into
 the specimen access tube 502 to a point just behind the blade 3504 at the
 tip of the specimen access tube 502. Next, the practitioner inserts the
 tube 502 into the bodily orifice. Advantageously, the blade prevents any
 matter from contaminating the applicator during the insertion.
 When the specimen access tube 502 is in place, the practitioner pulls the
 shaft 3506 a small distance out of the tube 502 to slide the blade 3504
 down and into an open position. It will be appreciated that the shaft 3506
 could be color coded such that when only a red portion of the shaft
 extends out of the specimen access tube, the blade is in a closed
 position. When a yellow portion also extends out, then the blade is
 partially open. When a red portion appears outside the tube 502, the blade
 3504 is fully open.
 With the blade 3504 in an open position, the practitioner advances the
 applicator to contact a specimen and then withdraws the applicator back
 into the specimen access tube 502. The practitioner may then push the
 shaft 3506 to put the blade 3504 in a closed position and then withdraw
 the specimen access tube 502.
 This invention may be embodied in other specific forms without departing
 form the essential characteristics as described herein. The embodiments
 described above are to be considered in all respects as illustrative only
 and not restrictive in any manner. The scope of the invention is indicated
 by the following claims rather than by the foregoing description. Any and
 all changes which come within the meaning and range of equivalency of the
 claims are to be considered within their scope.