WO2010081000A1

WO2010081000A1 - Collection device for biological specimens

Info

Publication number: WO2010081000A1
Application number: PCT/US2010/020499
Authority: WO
Inventors: Philip Castle; Jerome L. Belinson
Original assignee: The United States Of America, As Represented By The Secretary, Department Of Health And Human Services; Preventive Oncology International Inc.
Priority date: 2009-01-09
Filing date: 2010-01-08
Publication date: 2010-07-15

Abstract

A device for self-collecting a cervicovaginal specimen consisting of a collection component (3) and an applicator component (9), wherein the collection component comprises a shaft (4), a handle disposed (5) at a distal end of the shaft, and a specimen collection element (7) disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft; and the applicator component comprises a hollow cylinder having a proximal end and a distal end and defining a distal opening have a peripheral edge, wherein the collection component is disposed inside the hollow cylinder, the distal handle being configured so that when the distal handle is in contact with the distal end of the hollow cylinder the distal handle does not encompass the entire circumference of the distal peripheral edge of the hollow cylinder.

Description

COLLECTION DEVICE FOR BIOLOGICAL SPECIMENS

This application claims the benefit of U.S. Provisional Application No. 61/204,725, filed January 9, 2009, which is incorporated herein by reference.

FIELD

The disclosure herein relates to self-collection devices for biological specimens, particularly cervical specimens.

SUMMARY

According to one embodiment disclosed herein, there is provided a device for self-collecting a cervicovaginal specimen consisting of a collection component and an applicator component, wherein:

(a) the collection component comprises a shaft, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft; and

(b) the applicator component comprises a hollow cylinder having a proximal end and a distal end and defining a distal opening have a peripheral edge, wherein the collection component is disposed inside the hollow cylinder, the distal handle being configured so that when the distal handle is in contact with the distal end of the hollow cylinder the distal handle does not encompass the entire circumference of the distal peripheral edge of the hollow cylinder. According to another embodiment disclosed herein, there is provided a device for self-collecting a cervicovaginal specimen consisting of a collection component and an applicator component, wherein:

(a) the collection component comprises a shaft having an exterior surface, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft; and (b) the applicator component comprises a hollow cylinder having a proximal end, a distal end, and an inner surface, wherein the collection component is configured to fit inside the hollow cylinder and the exterior surface of the shaft does not contact the inner surface of the hollow cylinder. Also disclosed herein is a package for self-collecting a cervicovaginal specimen that comprises:

(a) a collection component comprising a shaft having an exterior surface, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft;

(b) an applicator component comprising a hollow cylinder having a proximal end, a distal end, and an inner surface, wherein the collection component is configured to fit inside the hollow cylinder and the exterior surface of the shaft does not contact the inner surface of the hollow cylinder; and (c) a container containing a biological specimen storage media.

Further disclosed herein is a method for self-collecting a cervicovaginal specimen, comprising: inserting into a vagina a self-collection device that includes an applicator component comprising a hollow cylinder having a proximal end and a distal end, wherein a collection component is disposed inside the hollow cylinder, the collection component comprising a shaft, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft, and the specimen collection element is sheathed inside the hollow cylinder during insertion of the applicator component into the vagina; moving the collection component relative to the applicator component, thus exposing the specimen collection element to the vagina or cervical cavity; rotating the specimen collection element to collect a specimen; pulling the distal handle outward to retract the specimen collection element into the hollow cylinder; removing the self-collection device from the vagina; and

- ? - contacting the specimen collection element with a storage media to release at least a portion of the specimen into the storage media, wherein no component of the device remains in the storage media for transportation of the specimen-containing storage media.

The foregoing will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a collection component of the self-collection device.

FIG. 2 is a perspective view of one embodiment of an applicator component of the self-collection device. FIG. 3 is a perspective view of the assembled device.

FIG. 4 is a cross-sectional view of inserting the assembled device into a vagina.

FIG. 5 is a cross-sectional view of extending the collection component into the cervical cavity. FIG. 6 is a cross-sectional view of removing the assembled device from a vagina.

FIG. 7 is a view of a container holding a biological specimen storage media. FIG. 8 is a perspective view of one embodiment of a collection component of the self-collection device. FIG. 9 is a perspective view of another embodiment of an applicator component of the self-collection device.

FIG. 10 is a perspective view of the assembled device. FIG. 11 is a perspective view of another embodiment of a specimen collection element. DETAILED DESCRIPTION

The devices disclosed herein may be used for self-collection of cervicovaginal specimens that can be tested for markers related to cervical cancer risk such as HPV as well as other sexually transmitted diseases. In certain embodiments, the device consists of only two physically separate (i.e., not structurally integral) components - a collection component and an applicator component. The collection component includes a shaft, a distal handle, and a proximal specimen collection element. The specimen collection element may comprise a flocked fibrous material since such a material is soft to the touch and offers a higher cellular collection yield. The applicator component comprises a simple hollow cylinder. The overall dimension of the device, especially the applicator component, is smaller compared to the dimensions of conventional cervicovaginal specimen self-collection devices (e.g., a commercially-available "Fournier" device).

The collection component is located within the hollow opening of the cylinder such that the cylinder and the collection component can slide in an axial longitudinal direction relative to each other. The collection component also is free to radially rotate relative to the cylinder. In certain embodiments, the cylinder does not include any structural or shape elements other than the cylinder itself. For example, the hollow cylinder does not include any raised or recessed elements that serve as a guide or stop for the collection component.

The design of the device, particularly the ease-of-use, the collection element material (e.g., flocked nylon) and the reduced size, is intended to achieve a greater efficacy for collecting and releasing cells compared to conventional cervicovaginal specimen self-collection devices (e.g., a commercially-available "Fournier" device). Moreover, a low-cost self-collection device paired with molecular testing could improve cervical cancer screening coverage by providing women who do not participate in clinic-based cytology screening an alternative method. In resource- limited populations, such self-collection could reduce the need for clinic -based exams by understaffed clinics. FIGS. 1-3 depict a first embodiment of a collection device 1. The collection device includes an applicator component 2 and a collection component 3. The assembled device 1 with the collection component 3 sheathed within the applicator component 2 is shown in FIG. 3. The applicator component 2 and collection component 3 may be provided as separate articles in a single package, as separate articles in separate packages, or as a pre-assembled device in a single package. The shaft 4 and the handle 5 can be composed of any material appropriate for human contact such as certain plastics (e.g., nylon 66 or biodegradable polystyrene).

The collection component 3 includes a shaft 4, which may have an elongate shape, a handle 5 disposed at a distal end 6 of the shaft 4, and a specimen collection element 7 disposed at a proximal end 8 of the shaft 4. The specimen collection element 7 is not detachable from the shaft 4.

The applicator component 2 includes a hollow cylinder 9 having a distal end 10, a proximal end 11, an inner surface 12, and an outer surface 13. The cylinder 9 includes a distal opening 14 and a proximal opening 15, each of which defines a peripheral edge 16 or circumference. The hollow cylinder 9 may be dimensioned so as to fit comfortably within the vagina. For example, the hollow cylinder 9 may be 10 to 14 cm, more particularly 11 to 13 cm, in length. The outer diameter of the hollow cylinder may be 1.2 to 2.0 cm, more particularly 1.4 to 1.6 cm. The cross- sectional shape of the cylinder 9 may be any round shape such as a circle or oval. The cylinder 9 may be made from any material appropriate for human contact such as certain plastics (e.g., reticulated polyurethane or biodegradable polystyrene) or wax-coated cardboard.

As shown in FIG. 2, the hollow cylinder 9 is a simple cylinder that does not include any does not include any structural or shape elements other than the cylinder itself. In other words, the entire inner surface 12 and the entire outer surface 13 of the cylinder 9 are both substantially smooth curved surfaces. Moreover, neither the distal end 10 nor the proximal end 11 is tapered. In other words, the hollow cylinder has the same diameter along its entire axial length. The hollow cylinder 9, specimen collection element 7, and shaft 4 are dimensioned such that the specimen collection element 7 and shaft 4 can fit inside the hollow cylinder 9 (see FIG. 3). The collection component 3 can slide in a longitudinal direction relative to the longitudinal axis of the hollow cylinder 9. In addition, the collection component 3 can rotate radially within the hollow cylinder 9. In certain embodiments, the largest cross-section dimension of the specimen collection element 7 is such that it contacts the inner surface 11 of the cylinder 9 but it still slidable within the hollow cylinder 9. However, contact between the specimen collection element 2 and the inner surface 11 is not necessary. For example, there may be a clearance of up to about 1.0 cm between the inner surface 11 and the outer surface of the specimen collection element 7. In one example, the outer diameter of the shaft 4 is sufficiently small so that the external surface 19 of the shaft 4 does not contact the inner surface 12 of the cylinder 9. In another example, the entire external circumferential surface 19 does not contact the inner surface 12 of the cylinder 9 (i.e., only a portion of the external surface 19 may incidentally contact the inner surface 12). In another example, the external surface 19 does not contact the inner surface 12 of the cylinder 9 when the specimen collection element 7 is sheathed inside the cylinder 9 (however, in this embodiment a portion of the external surface 19 contacts the inner surface 12 when the specimen collection element 7 is not sheathed inside the cylinder 9).

The specimen collection element 7 may be made from any material suitable for collecting a biological sample from a cervix or vagina. For example, the material may have a high capacity for cellular uptake, excellent cellular release and yields, non-toxicity to users and biospecimens, compatibility with specimen storage buffers, and acceptance by women. Illustrative materials include flocked poly amide polymer and polyurethane foam (e.g., "Zapped Cy to", Puritan). According to certain embodiments, the specimen collection element 7 comprises a flocked fibrous material (e.g., flocked polyamide polymer, polyester polymer or polypropylene polymer).

The specimen collection element 7 may have any shape suitable for insertion into the vagina. For example, the shape of element 7 may be elliptical (as shown in FIG. 1-3), spherical, ovoid, conical or tubular. In another embodiment shown in FIG. 11, the specimen collection element 7 has a teardrop shape with the thicker portion nearest the proximal end 9. The largest diameter cross-section of the specimen collection element may have a dimension of 1.3 to 1.7 cm, more particularly 1.4 to 1.6 cm.

The handle 5 may have any shape enabling grasping by the user. In addition, in certain embodiments, the handle 5 may have a cross-section dimension that is greater than the diameter of the cylinder 9. For example, the cross-section dimension of the handle 5 may be from 0.2 to 0.7 cm, more particularly from 0.3 to 0.5 cm. In such embodiments, the handle 5 is a stop that can prevent further longitudinal movement of the applicator component 2/cylinder 9 in the direction of the longitudinal axis of the cylinder 9. For example, in the embodiment shown in FIGS. 1-3 the handle 5 is in the shape of a paddle. However, the handle 5 could be in the shape of a rectangle or oval. In certain embodiments, the handle 5 is shaped such that it does not encompass the entire peripheral edge 16 of the distal opening 14. For example, the handle is not a cap or lid that covers the distal opening 14. In other words, the handle 5 only contacts a portion of the peripheral edge 16 as opposed to the entire peripheral edge 16. In the embodiment shown in FIGS. 1-3 the handle may contact the peripheral edge at only two points.

The collection component 3 may be fabricated in any suitable manner. For example, the shaft 4, specimen collection element 7, and/or handle 5 may be molded or formed as a single, integral article of manufacture. Alternatively, the specimen collection element 7 and/or handle 5 may be permanently fastened to the shaft 4 via an adhesive or mechanical attachment. The handle 5 may be made from the same material as the shaft 4 or from a different material. The collection component 3 should be sufficiently long for insertion into the cervix. For example, the collection component may be may be 17 to 23 cm, more particularly 19 to 21 cm, in length.

Another embodiment is shown in FIGS. 8-10. The collection component 3 shown in FIG. 8 is the same as that shown in FIG. 1. A different applicator component 30 is shown in FIGS. 9 and 10. In contrast to the hollow cylinder 9 shown in FIG. 2, the applicator component 30 shown in FIG. 9 includes at least two additional shape elements. The applicator component 30 is tapered at a proximal end 31. The tapered end includes an opening defined by at least one slit 32. In the example shown in FIG. 9, there are four slits arranged in a cross pattern that form flaps 33. The flaps 33 formed by the slits are flexible so that the specimen collection element 7 can be inserted through the opening.

The applicator component 30 at its distal end 34 may be the same as the distal end 10 of the applicator cylinder 9 as shown in FIG. 2. However, in the embodiment shown in FIG. 9, the distal end 34 includes a cylindrical section 35 that has a smaller diameter compared to the diameter of a central cylindrical section 36.

The use of the devices is depicted in FIGS. 4-7. The assembled device 1 with the specimen collection element 7 sheathed inside the applicator component 2 is gently inserted in the vagina 20 until it stops (-10-12 cm) or the applicator component 2 is completely inserted (see FIG. 4). A speculum is not needed to open the vagina for insertion of the device 1 , but a speculum may be used if desired. In one approach, the applicator component 2 is pulled back (possibly until it is stopped by the handle 5 of the collection component 3), exposing the specimen collection element 7 to the cervix or vaginal wall. The distal handle 5 has at least one dimension that is greater than the diameter of the cylinder 9 so that the distal handle 5 acts as a stop preventing further extension into the cervical cavity. According to another approach, the collection component 3 is advanced through the cylinder 9 and gently pushed into the cervicovaginal cavity, exposing the specimen collection element 7 to the cervix or vaginal wall (see FIG. 5).

Using the handle 5, the specimen collection element 7 is rotated at least one time, preferably a plurality of times, to collect cells from the cervix. The specimen collection element 7 may reside in the cervix from 15 to 120 seconds. The specimen collection element 7 is retracted into the applicator component 2 by holding the applicator component 2 in place while pulling (by the handle 5) the collection element outward (see FIG. 6). The entire collection device 1 then is removed from the vagina. The collection of cells from the vagina is minimized (if undesired) and the collection of cells from the cervix is maximized, since the specimen collection element 7 is shielded by the hollow cylinder 9 during insertion and removal of the device 1 from the vagina. The specimen collection element 7 then is exposed and vigorously swirled in a specimen transport container 17 that contains a biological specimen storage media 18 (see FIG. 7). The storage media 18 may be a buffered preservative solution such as PreservCyt (Hologics), specimen transport medium (Qiagen), dem (Qiagen), RN Alater (Ambion), saline, or phosphate-buffered saline. It may also be stored and/or sealed without a buffer, dried, or stored on a solid transport carrier (GE Health Care). Cells collected on the specimen collection element 7 are released into the storage media 18. Neither the specimen collection element 7 nor the whole device 1 is transported to a lab; only the specimen transport container 17 that includes the storage buffer 18 and the collected cells is transported to a lab. After use, the whole device 1 is disposed of.

RESULTS

5043 women from 3 sites in rural Guangdong Province as well as "inner city" Shenzhen were eligible if non-pregnant, 25-59 yrs of age, no screening for at least 3 years, no hysterectomy, and no prior pelvic radiation. The self-sampling was randomized between the inventive device shown in FIG. 3 and a brush commercially available from Qiagen and tested with the Cervista HPV assay and MALDI-TOF spectroscopy. Direct cervical samples were placed in PreservCyt and the Cervista assay and MALDI-TOF assays were processed from the same specimen. All women with >=ASCUS ThinPrep cytology and/or a positive self and/or direct Cervista or Direct HC-II test were asked to return for colposcopy and biopsy using the POI biopsy protocol (minimum of 5 directed and "random" biopsies including ECC). Results and Conclusions: Mean age was 38.8 years (25-59); McNemars test for the comparisons of self vs direct test for both Maldi and Cervista p=<0.01.

In view of the many possible embodiments to which the principles of the disclosed devices and methods may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the invention.

Claims

What is claimed is:

1. A device for self-collecting a cervicovaginal specimen consisting of a collection component and an applicator component, wherein: the collection component comprises a shaft, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft; and the applicator component comprises a hollow cylinder having a proximal end and a distal end and defining a distal opening having a peripheral edge, wherein the collection component is disposed inside the hollow cylinder, the distal handle being configured so that when the distal handle is in contact with the distal end of the hollow cylinder the distal handle does not encompass the entire circumference of the distal peripheral edge of the hollow cylinder.

2. The device of claim 1, wherein the specimen collection element comprises a flocked fibrous material.

3. The device of claim 1 or 2, wherein the distal handle is in the shape of an elongated paddle.

4. The device of any one of claims 1 to 3, wherein the collection component does not include a cap that encompasses the entire circumference of the distal end of the hollow cylinder.

5. The device of any one of claims 1 to 4, wherein the hollow cylinder does not include any structural or shape elements other than the cylinder itself.

6. The device of any one of claims 1 to 5, wherein the hollow cylinder does not include any internal or external protrusions or recesses.

7. The device of any one of claims 1 to 4, wherein the proximal end of the hollow cylinder is tapered.

8. The device of any one of claims 1 to 6, wherein the hollow cylinder has the same diameter along its entire axial length.

9. A device for self-collecting a cervicovaginal specimen consisting of a collection component and an applicator component, wherein:

(a) the collection component comprises a shaft having an exterior surface, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft; and

(b) the applicator component comprises a hollow cylinder having a proximal end, a distal end, and an inner surface, wherein the collection component is configured to fit inside the hollow cylinder and the exterior surface of the shaft does not contact the inner surface of the hollow cylinder.

10. The device of claim 9, wherein the specimen collection element comprises a flocked fibrous material.

11. The device of claim 9 or 10, wherein the distal handle is in the shape of an elongated paddle.

12. The device of any one of claims 9 to 11, wherein the collection component does not include a cap that encompasses the entire circumference of the distal end of the hollow cylinder.

13. The device of any one of claims 9 to 12, wherein the hollow cylinder does not include any structural or shape elements other than the cylinder itself.

14. The device of any one of claims 9 to 13, wherein the hollow cylinder does not include any internal or external protrusions or recesses.

15. The device of any one of claims 9 to 14, wherein the exterior surface of the shaft does not contact the inner surface of the hollow cylinder when the specimen collection element is sheathed inside the hollow cylinder.

16. A package for self-collecting a cervicovaginal specimen that comprises:

(a) a collection component comprising a shaft, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft;

(b) an applicator component comprising a hollow cylinder having a proximal end and a distal end and defining a distal opening having a peripheral edge, wherein the collection component is disposed inside the hollow cylinder, the distal handle being configured so that when the distal handle is in contact with the distal end of the hollow cylinder the distal handle does not encompass the entire circumference of the distal peripheral edge of the hollow cylinder; and

(c) a container containing a biological specimen storage media.

17. A package for self-collecting a cervicovaginal specimen that comprises:

(a) a collection component comprising a shaft having an exterior surface, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft; (b) an applicator component comprising a hollow cylinder having a proximal end, a distal end, and an inner surface, wherein the collection component is configured to fit inside the hollow cylinder and the exterior surface of the shaft does not contact the inner surface of the hollow cylinder; and

(c) a container containing a biological specimen storage media.

18. A method for self-collecting a cervicovaginal specimen, comprising: inserting into a vagina a self-collection device that includes an applicator component comprising a hollow cylinder having a proximal end and a distal end, wherein a collection component is disposed inside the hollow cylinder, the collection component comprising a shaft, a handle disposed at a distal end of the shaft, and a specimen collection element disposed at a proximal end of the shaft, wherein the specimen collection element is not detachable from the shaft, and the specimen collection element is sheathed inside the hollow cylinder during insertion of the applicator component into the vagina; moving the collection component relative to the applicator component, thus exposing the specimen collection element to the vagina or cervical cavity; rotating the specimen collection element to collect a specimen; pulling the distal handle outward to retract the specimen collection element into the hollow cylinder; removing the self-collection device from the vagina; and contacting the specimen collection element with a storage media to release at least a portion of the specimen into the storage media, wherein no component of the device remains in the storage media for transportation of the specimen-containing storage media.

19. The method of claim 18, wherein the specimen collection element remains in the vagina or cervical cavity for 15 to 120 seconds.

20. The method of claim 18 or 19, wherein the specimen collection element is exposed only to the cervical cavity.