This invention relates generally to means and methods for collecting cell tissue for analysis and relates, more particularly, to means and methods for collecting cervical cells for laboratory purposes.
The class of devices with which this invention is to be compared includes brush-including devices for collecting cervical cells for laboratory (e.g. pap smear) testing purposes. Such devices can include a long-handled device whose bristles extend longitudinally of the handle. One example of such a brush device is currently available from Wallach Surgical Devices of Trumbull, Conn. under the trade designation Papette.
It would be desirable to provide a sample-collecting device which possesses an improved capacity for collecting cervical cell samples for laboratory testing purposes.
Accordingly, it is an object of the present invention to provide a new and improved device for collecting cervical cells for laboratory purposes.
Another object of the present invention is to provide such a device which reduces the likelihood of user discomfort when used to collect cell samples.
Yet another object of the present invention is to provide such a device enabling the collection of cell samples by a patient (i.e. in a self-administered operation) or by a physician in a clinical setting.
Still another object of the present invention is to provide such a device which is uncomplicated in structure, yet effective in operation.
This invention resides in a device for collecting cervical cells for analysis.
The device include a thin base portion having two opposite side faces and having an outer edge which is rounded in shape. In addition, the base portion is insertable into the vaginal canal of a female for cell-collecting purposes and includes a leading end which first enters the vaginal canal when the device is directed therein and an opposite trailing end. Furthermore, a plurality of bristles are joined to and extend away from one of the side faces of the base portion and substantially normal to the longitudinal axis of the base portion so that upon insertion of the base portion for cell-collecting purposes, the bristles of the device move across and collect cervical cells from the surface of the cervix.
Turning now to the drawings in greater detail and considering first
In addition, the base portion 22 is shaped and sized to facilitate the insertion of the device 20 along the vaginal canal and to facilitate the subsequent removal of the device 20 from the vaginal canal following collection of the sample cells. The device 20 can be utilized by a patient for collection of cell samples in a self-administered process or, in the alternative, from a patient by a physician in a clinical setting.
With reference to
To provide the base portion 22 with a desired degree of inflexibility, the base portion 22 can be constructed of any of a number of elastomeric materials, such as a relatively hard plastic (which can include silicon), or other classes of materials, such as a coated paper. However, it may be preferable to avoid latex as a choice of material for the base portion 22 due to the allergic reaction that some individuals have to that material.
It is a feature of the device 20 that its base portion 22 has a rounded, or oval-shaped, outer edge 26 (defining an inwardly-directed lip 27 which encircles the concave side face 28. In this connection, the outer edge 26 of the base portion 22 of the depicted device 20 (as best shown in
While an oval, by definition, is symmetrical about at least one of its major or minor axes, the oval shape of the base portion 22 could be symmetrical about each of its major and minor axes 36, 38. However, the shape of the depicted base portion 22 somewhat resembles that of a teardrop having one (i.e. a leading) end 40 which is smaller, or more pointed in form, than the opposite (i.e. trailing) end 42 thereof.
Moreover and as used herein, the phrase “oval shape of markedly elongate form” is intended to connote that the outer edge 26 of the base portion 22 has an appearance which is distinctively elongate, and such a distinctively elongate appearance is described herein in structural terms by way of the stated requirement that the maximum diameter of the base portion 22 as measured along its major axis 36 is at least 1.5 times the size of the minimum dimension of the base portion 22 as measured along its minor axis 38.
The device 20, and more specifically, the base portion 22, is intended to be inserted endwise, or lengthwise, through the vaginal canal as the base portion 22 is directed and moved lengthwise (i.e. in a direction parallel to the major axis 36) through the canal. Moreover and for present purposes, the opposite sides of the base portion 22 which extend between the leading and trailing ends 40 and 42 are indicated 44 and 46 in
With reference again to
It is also a feature of the device 20 that it is provided with a tension member, generally indicated 100 in
With reference again to
The tension member 100 of the depicted device 20 is in the form of a cord, or string, 72 which is comprised of a material (e.g. cotton) which is flexible in nature and has two opposite end portions 92, 94 (
During assembly of the device 20, the looped mid-portion 99 of the cord 100 can be secured, as with a stitch 102 (
It is another feature of the device 20 that the major portion 78 of the length of the tension member 100 remains positioned against the concave side face 28 of the base portion 22 and within the interior 106 until such time as it is desired to remove the device 20 following a sample collecting procedure. Preferably, the major portion 78 of the tension member 100 remains positioned in a gathered condition adjacent the concave side face 28, as depicted in
Because the trailing end 42 of the base portion 22 has been described above as being the end of the base portion 22 which follows the leading end 40 of the base portion 22 into the vaginal canal during a sample-collecting operation, the trailing edge 42 is the first end of the base portion 22 which exits the vaginal canal when withdrawn from the user. This being the case, the knot 112 provides a visual indication to the user as to which end of the base portion 22 corresponds with the trailing end 42 thereof.
During a sample collecting procedure, the device 20 is inserted along the vaginal canal as the base portion 22 is directed endwise (i.e. leading end 40-first) into and through the vaginal canal. The relatively small size of the smallest dimension (i.e. as measured across the minor axis 38) of the oval-shaped base portion 22 in comparison to the size of the largest, or lengthwise, dimension (i.e. as measured across the major axis 36) of the base portion 22 facilitates the lengthwise movement of the device 20 along the canal without requiring that the base portion 22 be compressed across the smallest dimension during insertion of the device 20 during insertion or removal of the device 20. Moreover, the oval shape of the base member 22 reduces the likelihood of discomfort to the female from whom cervix cells are being collected.
As suggested earlier, the removal of the device 20 from the vaginal canal is facilitated by the tension member 100 which can be pulled upon by the user. In particular and as the knot 112 is pulled upon by a user, the major portion 78 of the tension member 100 is withdrawn from the interior of the base portion 22 by way of the through-openings 90, 91 so that the tension member 100 begins to lengthen, or extend, as it is pulled, or withdrawn, from the base portion 22 before the base portion 22 begins to move along the vaginal canal toward the opening thereof. When the tension member 100 has been pulled from the interior of the concave side face 106 by a sufficient distance, the looped mid-portion 99 of the tension member cord 72 engages the region 70 of the base portion 22 and is prevented from exiting the interior 106 of the concave side face 28 by the region 70 so that any continued pull upon the knot 112 effects the withdrawn of the device 20 along the vaginal canal.
It follows from the foregoing that until the device 20 is desired to be removed following a sample collecting procedure, the major portion 78 of the tension member 100 remains in a gathered condition within the interior 106 of the concave side face 28 of the base portion 22. Furthermore, the base portion 22 does not have to be squeezed or compressed from side-to-side in order to remove the device 20 from the canal.
As mentioned earlier and upon insertion of the device 20 through the vaginal canal and across the opening of the cervix, the tips of the bristles 25 collect cells from the surface of the cervix. If desired, a long-handled clamp (not shown) can be used to grasp the trailing end 42 of the base portion 22 and gently manipulate the device 20 (by, for example, alternately rotating the device 20 rightwardly and leftwardly about the longitudinal axis 38 of the base portion 22) in somewhat of a scrubbing action to increase the amount of cells collected by the tips of the bristles 25. Moreover and because the bristles 25 of the brush-including portion 24 are shaped to bend less easily from side-to-side rather than from front-to-back, the aforedescribed rightward and leftward movement of the device 20 about the longitudinal axis 38 of the device 20 renders the bristles 25 more abrasive, and thus more effective, for cell-collecting purposes than would be the case if the device 20 were simply moved longitudinally across the surface of the cervix.
Upon retraction, or removal, of the device 20 from the vaginal canal following a cell-collecting process, the cells which are collected upon the tips of the bristles 25 of the brush-including portion 24 can be rinsed from the device 20 in a suitable solution (and in a known manner) for laboratory (e.g. pap smear) testing purposes.
The device 20 can be constructed in any of a number of sizes to accommodate a range of vaginal sizes. For example, the base portion 22 can be sized so that it measures about 65 mm, 75 mm or 85 mm along its major axis 38 to accommodate vaginal canals of different sizes.
As mentioned earlier, the device 20 can be used by a patient upon herself to collect cell samples in a self-administered process or alternatively, by a physician who collects cell samples from a female patient in a clinical setting. It has been found that by simply leaving the device 20 in place across the cervix for a predetermined amount of time (e.g. about four hours) before removal effects the collection of sufficient cervical cell samples by the tips of the bristles 25 for analysis purposes.
It will be understood that numerous modifications and substitutions can be had to the aforedescribed embodiment 20 without departing from the spirit of the invention. Accordingly, the aforedescribed embodiment 20 is intended for the purpose of illustration and not as limitation.