# Patent

## Title
PAP smear sampling device and system

## Abstract

A PAP smear sampling device includes a PAP smear brush having a base with peripheral bristles and a central brush for sampling both cervical and endo cervical areas. A break away handle is provided for supporting the brush from enabling depositing of the brush into a specimen capsule.

## Background
The present application is a continuation-in-part of U.S. Ser. No. 11/848,877 filed Aug. 31, 2007 which claims priority from U.S. Ser. No. 60/842,838 filed Sep. 6, 2006. These applications are to be incorporated herein in their entirety.


The present invention is generally related to devices for the safe collection of specimens, for example, oral fluids, urine, microbiological specimens, genome DNA, cervical PAP smear samples, or the like, and safe transportation thereof for diagnostic testing including time sensitive testing. More particularly, the present invention provides for a system having a specific brush configuration for cervical PAP smears and a specimen capsule for enabling closed system transfer of the sample from the absorbent via docking with the capsule with the aid of a docking connector.
Heretofore, bio-molecular sampling and assay for analysis of fluids have typically required at least two different actions. Specifically, the sample, for example urine, saliva, bacteriological, genome DNA, cervical or pap smear sample, is collected and thereafter the collected sample is either stored for later transfer into an appropriate reagent for assay in a laboratory in a capsule other than the collection device. Thus, these procedures require multiple steps and components which are often expensive to manufacture and cumbersome for patient use.
With regard to oral fluids and urine, when prior art collection containers are utilized, they are time consuming, multi-action and cumbersome involving transferring of samples. Such additional manipulation necessary for obtaining the required sample often results in contamination either of the sample or medical persons handling the samples.
The bio-molecular sampling and transportation system in accordance with the present invention is closed, i.e. self-contained, compact, leak-proof, tamper resistant, reliable and bar-codeable for insuring integrity of the sample. The system is also simple and easy to use by patients as well as being ergonomically designed and hygienic. In addition, its simplicity leads to an economically produced system.
SUMMARY OF THE INVENTION
A safe and retractable bio-molecular sampling and transportation system in accordance with the present invention utilizes a unique docking mechanism. The system includes an elongate enclosure having open ends with a collection sponge which can be slideably disposed within the elongated closure.
For use in collecting urine, the collection sponge may have a cylindrical shape for direct sampling by soaking from a stream or indirect sampling by soaking from a collection cup. However, for the collection of oral fluids, i.e. saliva, or genome DNA the collection sponge may include a swab with a stem attached thereto. The collection sponge is slidably disposed within the elongate structure and a sponge moving piston is disposed within the elongate structure and has an engageable end disposed proximate one end of the elongate enclosure.
A plunger handle is removably attached to the piston engageable end for enabling manual sliding of the collection sponge between a position inside of the elongate enclosure and a position exterior another end of the elongate enclosure. That is, the sponge is extended from the enclosure for specimen collection and then retracted within the enclosure following collection.
A specimen capsule containing time sensitive diagnostic preservative or reagent, or bacteriological culture medium is provided and removably dockable to another end of the enclosure by using the docking connector thereby enabling leak-proof transfer of the specimen from the sponge into the specimen capsule. In that regard, the specimen capsule may include a perforated baffle with the baffle perforation enabling passage of the specimen therepast into the specimen capsule upon compressing of the collection sponge against the baffle by the piston via the plunger handle. A removable enclosure cap may be provided for sealing the elongate enclosure and a removable specimen capsule cap may be provided for sealing the specimen capsule. In this embodiment, only the specimen capsule is transported to the laboratory.
In one embodiment of the present invention, the plunger handle is stored separate from the elongate enclosure while in another embodiment of the present invention, the plunger handle comprises a tube which is storable within the elongate enclosure between the collection sponge and an inside of the enclosure. This embodiment provides for compact storage.
Preferably, the capsule cap includes a nozzle and the specimen capsule is squeezable, thus enabling dispensing of specimen directly from the capsule through the nozzle. A nozzle cap is also provided.
The system in accordance with the present invention may also include pre-filled active agent or culture medium such as a time sensitive preservative when a time sensitive analysis is to be performed disposed in the specimen capsule for reacting with the specimen when introduce thereinto.
More specifically, in one embodiment of the present invention a PAP smear sampling device includes a PAP smear brush having a base with peripheral bristles and a central brush for sampling both cervical and endo-cervical areas. A break away handle is provided for supporting the brush and enabling depositing of the brush into a specimen capsule.



BRIEF DESCRIPTION OF THE DRAWINGS
The advantages and features of the present invention will be better understood by the following description when considered in conjunction with the accompanying drawings, in which:
FIG. 1 illustrates elements of a bio-molecular sampling and transportation system in accordance with the present invention generally showing an elongate enclosure with capped ends and a separately stored plunger handle having a piston engagable end;
FIG. 2 is a cross sectional view of the elongate enclosure illustrated in FIG. 1 showing a collection sponge slidably disposed within the enclosure along with a sponge moving piston which is disposed within the enclosure and including an engagable end disposed proximate one end of the enclosure and another end attached to the collection sponge;
FIG. 3 is a cross sectional view illustrating the extension of the collection sponge from the enclosure in order to directly or indirectly receive a sample;
FIG. 4 is a cross sectional view illustrating the withdrawal of the collection sponge into the enclosure and the attachment of a specimen capsule attached to the enclosure by a docking connector including a baffle with a perforation therethrough for enabling passage of the specimen into the capsule;
FIG. 5 is a cross sectional view similar to that shown in FIG. 4 illustrating the compression of the collection sponge by the piston via a plunger handle in order to transfer specimen from the sponge through the perforation and into the capsule;
FIG. 6 is a cross sectional view of the capsule along with a capsule cap including a nozzle and a nozzle cap;
FIG. 7 illustrates the specimen capsule shown in FIG. 6 with the cap removed;
FIG. 8 illustrates the dispensing of specimen from the capsule by squeezing of the specimen capsule;
FIG. 9 illustrates another embodiment of the present invention in which the plunger handle includes a tube storable within the elongate enclosure between the collection sponge and an inside of the elongate enclosure;
FIG. 10 illustrates the embodiment shown in FIG. 9 with the plunger handle removed from the elongate enclosure and attached to a piston for extending and retracting the collection sponge from and into the elongate enclosure;
FIG. 11 is a cross sectional view of another embodiment of the present invention in which the collection sponge includes a swab suitable for collection of the saliva from a buccal cavity, genome DNA for crime scene or sexual assault investigation, throat swab for bacterial, viral culture and sensitivity studies, and endocervical specimens such as gonorrhea and Clamydia Trichomatis infection and PAP smear examination for cervical cancer;
FIGS. 11A-11C illustrate a brush specifically designed for PAP smear sampling with a break-away handle enabling separation of a brush head into a sealable container;
FIG. 12 is a view similar to FIG. 11 with a cap removed from the enclosure enabling extension of the swab from the enclosure;
FIG. 13 illustrates an extended swab for collection of saliva, buccal epithelial cells for DNA analysis, or bacterial, viral throat specimen from a patient's mouth (not shown);
FIG. 14 illustrates the transfer of collected liquid specimen such as saliva into a specimen capsule with the aid of a docking connector which includes a pre-filled active agent for reacting with the specimen;
FIG. 14A illustrates the transfer of the capsule and enclosure with the aid of the docking connector together to a laboratory as may be desired when the pre-filled preservative or reagent is in the form of a gel, paste or semisolid colloid reagent used to inter-react with the specimen on the swab;
FIG. 15 illustrates the soft compressible capsule along with a capsule cap with nozzle and a nozzle cap;
FIG. 16 illustrates dispensing of the specimen treated by the active agent through the nozzle by squeezing of the capsule after agitation to dissolve or react with the active agent.



DETAILED DESCRIPTION
With reference to FIGS. 1-16, there is shown a safe self-contained bio-molecular sampling and transportation and dispensing system in accordance with the present invention which generally includes an elongate enclosure 12 having open ends 14, 16, as shown in FIGS. 1 and 2, and a specimen capsule 20 shown in FIGS. 6-8.
With reference again to FIG. 2, a collection sponge 24, which may be formed from any suitable absorbent material, is slidably disposed within the elongate enclosure 12 and fixed to a piston 26, also disposed within the enclosure 12, for extending and retracting the sponge 24, as hereinafter described in greater detail. The piston 26 includes an engagable end 28 having threads 30.
Removable enclosure caps 34, 36 threadably 38, 40 engage the enclosure 12 proximate the open ends 14, 16 for sealing the enclosure 12 with the sponge 24 therein before and after use. A separate plunger handle 44, see FIGS. 1, and 3-5 includes a handle end 48 having threads 50 for engaging the piston threads 30 for enabling manual sliding of the collection sponge 24 between a position inside the elongate enclosure 12 as shown in FIGS. 2 and 3 and a position exterior the enclosure end 16 as shown in FIG. 3 for the collection of a specimen. That is, the sponge 24 may be extended and retracted out of and into the enclosure 12.
For illustration purposes only, in FIG. 3 the sponge is shown absorbing a sample from a cup 54, i.e. indirect sample collection. However, it is also well suited for direct collection by receiving a urine stream or insertion into a buccal cavity (not shown) for the collection of oral fluids.
Buccal saliva specimens may be used for DNA testing, HIV testing, substance of abuse testing, etc., whereas urine specimens may be utilized for clinical urinalysis, bacterial culture, pregnancy, ovulation, HIV and substance of abuse tests. Throat swab specimens in children are important for strep throat infection diagnosis. Endo-cervical swabs are for the diagnosis of women uro-genital pathologies.
With reference to FIGS. 4-8, the specimen capsule 20 is removably dockable to the enclosure proximate the open end 16 by means of a docking connector 58 threadably engaging the enclosure 12 and specimen capsule 20 as shown in FIGS. 4 and 5. The connector 58 may have standard threads for engaging various capsules, even commercially available capsules (not shown). A baffle 60 is provided with at least one perforation, or opening 62, for enabling passage of specimen through the opening 62 and into the capsule 20 upon compressing of the collection sponge 24 against the baffle 60 by the piston 26 via the plunger handle 44 as illustrated in FIG. 5. It should be appreciated that the opening 62 may be of varying size to accommodate various anticipated viscosities of the specimen preservatives and also the size and shape of the collector tips.
Following the receipt of the urine specimen 66, as shown in FIG. 5, the docking connector 58 is removed and the capsule 20 sealed with a capsule cap 70, (see FIG. 6) which preferably includes a nozzle 72 which may, in turn, be sealed with a cap 74, the capsule 20, the capsule cap being shown in FIG. 7 sans the nozzle cap 74.
The specimen capsule 20 may be safely transported with the capsule cap 70 and nozzle cap 74 in place and the enclosure 12 sealed again with the caps 34, 36 for disposal thus enabling sample collection and transport with total security from contamination or spillage. Alternatively, the entire enclosure 12 may be transported to a laboratory with the capsule 20 attached thereto with the docking connector 58, see FIG. 14A. This is important if a gel, colloid, or semi-solid preservative 110 is used. In this case, the swab may be immersed into this preservative 110 until removed for analysis at the lab. If the specimen requires drying, vents 12A in the enclosure 12 may be provided. (See FIG. 2).
Preferably, the capsule is formed from a resilient material enabling squeezing thereof, as shown in FIG. 8, for dispensing of specimen on an assay sheet 76 or a test tube for diagnostic analysis. It should be appreciate that the specimen 66 may be dispensed into any suitable diagnostic device (not shown). A bar code 78 may be provided on the capsule 20 for identification and security tracking purposes.
Another alternative embodiment of the present invention is shown in FIGS. 9 and 10 with common reference characters representing identical or similar components as shown in FIGS. 1 and 2. In this arrangement, a plunger handle 44A includes a tube 45A storable within the elongate enclosure 12 between the sponge 24 and an inside 46A of the elongate enclosure 12. The handle 44A is removably secured to the enclosure 12 by way of a cap 47A. The arrangement provides for compact storage of the enclosure 12 with the tube 45A stored within.
As shown in FIG. 10, when the tube 45A is removed from the enclosure 12 it may be attached by a screw thread 48A to the piston 26 for extending and retracting the sponge 24 from and into the enclosure 12, the sponge 24 being shown inside the enclosure 12 in FIG. 10.
Yet another alternative embodiment of the present invention is shown in FIGS. 11-16. In these embodiment, an absorbent swab 80 is provided which is interconnected with a piston 82 by a stem 84 while initially disposed in the elongate enclosure 12.
In the embodiment shown in FIG. 11, a plunger handle 88 includes a tube 90 storable within the enclosure 12 between the swab 80 and an inside 92 of the enclosure 12. A handle cap 96 sealably engages the tube at the open end 16 thereof.
As hereinabove noted, this arrangement enables even more compact storage and shipment of the system since the handle 88 does not need separate handling and storage. On the other hand, in the system shown in FIG. 1, a single handle 44 may be used with any number of enclosures 12.
In operation, as illustrated in FIGS. 12 and 13, the handle 88 is removed from within the enclosure 12 and coupled to the piston 82 by threads 98, or the like. It should also be appreciated that any means of coupling the handle to the 90 to piston 82 may be utilized and be within the scope of the present invention.
As earlier described, the handle tube 90 may be used to manually extend the swab 80 for collection of specimen 66, as illustrated in FIG. 13. Again, the cup 54 shown is merely demonstrative of one way for enabling the swab 80 to absorb the specimen 66 and as indicated earlier, any means for wetting of the swab, i.e. direct or indirect, is to be considered within the scope of the present invention.
Following collection of the specimen 66, the swab 80 is again extended into a specimen capsule 102 through a connector 104 with larger aperture 106. In this embodiment, the capsule 102 may include a liquid, solid, or gel active agent preservative 110 for treating, fixing, or chemically interacting with the specimen 66, as may be desirable for certain diagnostic tests or to preserve the sample during the transportation. The specimen can easily be agitated, by shaking, within the capsule 102 for promoting specimen extraction or eluting mechanism or dissolving the specimen by the agent 110.
Following introduction of the specimen 66 into the capsule 102, the capsule is sealed by a capsule cap 114 having a nozzle 116 with a nozzle cap 118. At this point, the capsule and contents may be further agitated to be either mixed or activate the agent 110 and the specimen 66. Thereafter, sample may be dispensed on the nozzle 116 by squeezing of the capsule 102 as hereinbefore described in connection with FIG. 8.
As illustrated in FIGS. 11A-11C, a PAP smear sampling device 120 includes a PAP smear brush 124 to facilitate gathering of a specimen from tissue. The PAP smear brush 124 includes a base 128 with peripheral bristles 130 and a central brush 134 to sample both cervical and endo-cervical areas simultaneously.
The brush 124 is supported by a break away handle 140 which includes a separable junction 142 to releasably attach to a brush stub 144.
An outer release tube, or sleeve, 150 when slid along the handle 140 causes separation of the brush stub 144 from the handle and into a container 154 containing PAP smear preservation and stabilizer 156, the container is thereafter sealed by a cap not shown for transport.
Although there has been hereinabove described a specific PAP smear sampling and transporting system and method in accordance with the present invention for the purpose of illustrating the manner in which the invention may be used to advantage, it should be appreciated that the invention is not limited thereto. That is, the present invention may suitably comprise, consist of, or consist essentially of the recited elements. Further, the invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically disclosed herein. Accordingly, any and all modifications, variations or equivalent arrangements which may occur to those skilled in the art, should be considered to be within the scope of the present invention as defined in the appended claims.

## Claims

1. A PAP smear sampling device comprising: an elongate enclosure having open ends; a PAP smear brush disposed within said elongate enclosure, the brush having a base with peripheral bristles and a central brush for sampling both cervical and endo-cervical areas; a handle having a distal end for supporting the brush, said handle being severable to enable separation of the brush from the handle distal end; a piston attached to a proximal end of said handle and having an engagable end disposed proximate one end of said elongate enclosure; and a tubular handle, storable within said elongate enclosure between said PAP smear brush and an inside of said elongate enclosure and removably engagable with said piston, for enabling manual sliding of said PAP smear brush between a piston inside of said elongate enclosure and a position exterior another end of said elongate enclosure.

2. The device according to claim 1 further comprising a brush separating sleeve disposed over said handle and slidable toward said handle distal end for forcing said brush to separate from said handle.

3. The device according to claim 2 further comprising a specimen capsule for receiving the separated brush and receiving specimen therefrom.

4. The device according to claim 3 further comprising a removable enclosure cap for sealing of said specimen capsule.

5. The system according to claim 4 wherein the enclosed cap includes a nozzle and a nozzle cap.

6. The system according to claim 5 wherein said specimen capsule is squeezable for enabling dispensing of specimen through said nozzle.

7. The system according to claim 6 wherein said specimen capsule further comprises an active agent for reacting with said specimen.