GB1566004A - Cervicalvaginal spatula - Google Patents

Description

(54) CERVICAL-VAGINAL SPATULA (71) I, RICHARD NEIL FREDERICKS, of 201 East 28th Street, New York, New York 10016, United States of America; a citizen of the United States of America do hereby declare the invention, for which I pray that a patent may be granted to me, and the method by which it is to be performed, to be particularly described in and by the following statement: The invention relates generally to cervical specimen collecting devices and more particularly to a cytological specimen scraper or spatula.

Cytological specimen samplers have been employed to obtain cervical-vaginal specimens by scraping the cervical region with a bladed spatula. Among the commonly used samplers was the cervical scraper described in United States Letters Patent No.

2,471,088, issued to Dr. James Ernest Ayre.

This scraper was designed with a heart shaped tip which comprises a pair of divergent peaks, both offset from the axis of a stem in opposite directions. In use, one of the peaks was positioned against the cervical orifice, and the scraper was rotated while held in such position allowing the other peak to lightly scrape the circumference of the cervical lip.

A substantial number of cytological specimens obtained with scrapers such as the Ayre scraper did not indicate cells of endocervical origin and a swab was often conjunctively employed to obtain an endocervical sampling. Utilization of the scraperswab technique, however, stilt did not achieve adequate endocervical samplings and an average of 50% of the specimens ex mined at processing laboratories did not contain endocervical cells. This fact is of major significance because it has been meters mined that a majority d early cervical carcinomas begin in the canal above the upper limits of the squamous epithelium, and for this reason a satisfactory specimen for cytological analysis must contain cells of endocervical origin.

Studies have revealed that the area of transition or transition zone between the histologic portio and the endoceirvix provides endocervical cells anel is therefore of particular pathological importance. Thus, the transition zone has become the target area for obtaining an adequate cytological specimen.

The broad pivotal tip of the Ayre spatula did not function to permit adequate penetration into the transition zone dfle to both its relatively short length and its broad span.

Furthermore, manipulation of the spatula itself was awkward since the stem or rotating axis was offset with respect to the pivotal tip. When attempts were made to rotate the spatula about a fixed axis of rotation, the offset tip generated a broad circular path displacing the cervix and often produced haemorrhaging and trauma.

Returning to the recognition of the transition zone as the target area for specimen samplings, it has been determined that the zone varies in length and position and generally ascends the canal as the patient's age increases. This presented even further diffi- culties with respect to the use of the Ayre spatula because penetration of its broad tip was hampered due to the decreased elasticity of atrophic cervixes.

After some of the foregoing problems were appreciated attempts were made at providing modified scraper designs which would permit penetration deeper into the canal. An example of such attempts was illustrated in United States Patent No. 3,352,299 wherein an elongate slender semi-elliptical scraper tip was designed for insertion into the canal.

The use of scrapers of such configuration has not been widespread due to the increased incidence of haemorrhaging associated with the relatively pointed tip and the trauma inherent with deep penetration particularly when sharp implements were employed.

Further, when such an implement was; inserted and inward pressure exerted against the face of the cervical portio, deflection of the cervix became a significant problem and adequate specimens could not be obtained without the exercise of a high degree of skill.

A further problem with regard to such scrapers was that since the protuberance was slender and long the scraper could not be fabricated of wood without the danger of possible tip fracture during manipulation within the canal and such scrapers were therefore restricted to plastics which resulted in higher costs and presented a sampling surface to which specimens did not readily adhere.

It is an object of the present invention to provide a cervical-vaginal sampling spatula of the general character described which Is not subject to the disadvantages aforementioned.

A further object of the present invention is to provide a cervical-vaginal sampling spatula of the general character described which is simple in construction, low in cost, reliable in use, and well adapted for mass production fabrication techniques.

According to the present invention there is provided a cervical sampling scraper for human females comprising a planar body including a stem and means for scraping the wall of the cervical canal in the region of the transition zone to obtain a sampling of cells of endocervical origin said scraping means including a wedge shaped protuberance at one end of the stem, which protuberance in plan has a base portion of from 6 to 9 millimeters in width and a projection axially away from the end of the stem a distance of at least one centimeter measured along a first straight lateral edge which is coincident with an edge of the stem and terminates at a rounded tip, a second scraping edge extending toward the stem from the rounded tip at an angle of approximately 12" from the first scraping edge and terminating at the base portion of the protuberance, a supportive web for controlling depth of penetration of the protuberance into the cervical canal, the supportive web in plan, projecting laterally from the stem adjacent the protuberance and having a squamous sampling edge extending substantially transverse to the axis of the stem and coterminous with the second scraping edge at the base portion of the protuberance whereby the protuberance may be fully inserted into and effectively distend a cervical canal with the exertion of a minimal wedge pressure to scrape a deposit of endocervical cell material from the cervical wall with a sampling edge cradling the cervical lip to simultaneously remove a deposit of the squamous material upon rotative manipulation of the stem.

Preferably, the squamous sampling edge has a curved contour extending from the second scraping edge at the base portion of the protuberance to a rounded squamous tip.

Desirably, the supportive web is approx- imately 1.5 centimeters in width as measured from the first scraping edge to the squamous tip, whereby the rotative manipulation of the stem permits the deposit of a sample of squamous cell material on the web without interference between the web and the walls of the vaginal cavity.

In a preferred embodiment of the invention, the stem includes two substantially parallel lateral edges, one of the iateral edges being coincident with one of the scraping edges.

Desirably, the angle of divergence between the two scraping edges lie & within a range between 12" to 22".

In a particularly desired embodiment, the scraper is formed of a one-piece wood construction whereby a low cost yet highly efficient cytological sampler is provided.

In the accompanying drawings in which are shown some of the various possible exemplary embodiments of the invention; FIG. 1 is a frontal sectional view through the vagina and uterus and illustrating a cervicalwaiginal specimen spatula constructed in accordance with and embodying the invention in situ and positioned with a wedge protuberance seated in the cervical canal and with a direction arrow indicating the typical manipulation of the spatula for cytological specimen sampling; FIG. 2 is an elevational view of the spatula illustrated in FIG. 1 after removal from the sampling position and indicating, in schematized fashion, the cytological specimens which have been deposited; FIG. 3 is a fragmentary side view of the spatula; FIG. 4 is a greatly enlarged fragmentary elevational view of the endocervical sampling head of the spatulas and more clearly illustrating the anatomic surfaces of the wedge protuberance and a transverse squamous cell sampling web; and FIG. 5 is a fragmentary view of an alternative embodiment of the invention, the same having a modified endocervical head wherein the protuberance is extended in length for deeper penetration into the canal.

Referring now in detail to the drawings wherein the reference numeral 10 denotes an endocervical scraper constructed in accordance with and embodying the invention, the scraper 10 generally comprises a flat planar body incorporating a stem 12 having at one end an endocervical head 14 and at the other end a broad vaginal sampling head 16.

The vaginal head 16 is of conventional configuration having a width approximately twice the width of the stem and including a generally rounded tip. The head 16 is utilized to obtain a vaginal cell cytology specimen by manipulation thereof in the vaginal pool area and subsequent transfer of the specimen deposited on the head 16 to a suitable slide for analysis, all in a manner well known to skilled medical personnel.

A principal feature of the present invention resides in the configuration of the endocervical head 14 designed with anatomic criteria such that in routine use a sampling of cells of endocervical origin will be deposited thereon as a result of simple manipulation and while minimizing trauma and haemorrhaging normally attendant such samplings when prior art devices were utilized.

With reference to FIGS. 1 and 4, it will be seen that the endocervical head 14 includes a generally wedge shaped forward protuberance 18 having a rounded distal tip 20. A first straight scraping edge 22 of the protuberance is coincident with a straight lateral edge of the stem 12 and leads tangentially to the rounded distal tip 20 while a second straight scraping edge 24 slopes tangentially from the tip 20 toward the stem at an angle of the order of 18" from the edge 22. The second edge 24 extends along a straight line to the base of the wedge protuberance 18 which is of a transverse dimension of from 6 to 9 millimeters. Commencing at approximately the wedge base, the second edge 24 leads to an undulated concave-convex squamous sampling edge 26 which extends generally transverse to the axis of the stem.

The squamous sampling edge 26 is the upper edge of a generally triangular web 32 forming a supportive base for the endocervical head 14, all of which is formed of a one-piece construction with the scraper body.

In order to permit free rotative manipulation of the scraper within the vaginal cavity, the maximum width of the head 14 at the web 32 is approximately 1.5 centimeters.

It will be appreciated that for both safety and ease in insertion into the cervical canal the distal tip 20 of the endocervical head 14 is generally of a diameter not appreciably exceeding the normal diameter of an average cervical canal. Thus, it has been determined that the optimum diameter of the tip 20 is within a range of 3 to 5 millimeters.

To assure adequate distension of the cervical canal and therefore the deposit of an adequate endocervical specimen on the edges 22, 24 of the protuberance 18, the transverse base dimension of the protuberance 18 is of from 6 to 9 millimeters.

To insure penetration of the wedge protuberance 18 at least into the transition zone, the distance between the distal tip 20 and the squamous sampling edge 26 is at least one centimeter as illustrated in FIG. 4.

The angular orientation between the scraping edges 22, 24 of the wedge protuberance 18 conforms with the anatomical transverse base and tip dimensions of the protuberance and is approximately 18", however it will be appreciated that variations are possible without departing from the invention and it is believed that satisfactory results are obtainable with wedge angles from 12" to 22".

With reference now to FIG. 1 wherein the scraper 10 is shown; in situ within a vaginal cavity 34 with the endocervicai head 14 prepared for rotative scraping of the cervix for the removal of suitable cytologicai specimens, it will be observed that the reference numeral 36 denotes the uterus, the numeral 38 the cervix, and the numeral 40 the endocervical canal. In operation, the scraper 10 is inserted into the vaginal cavity 34 with the endocervical head 14 leading and the wedge protuberance 18 initially positioned at the cervical portio. Since the rounded distal tip 20 of the protuberance 18 is of a diameter approximately that of the cervical canal, the protuberance 18 may be easily introduced into the canal without the utilization of lubricants which might interfere with laboratory analysis of the specimens.

Further penetration is accomplished while minimizing trauma because of the gradual distension of the endocervical canal while the edge 24 gently exerts lateral pressure on the cervical mucosa.

With the protuberance 18 fully inserted, the concave portion of the squamous sampling edge 26 is seated against the cervical lip which provides an abutment stop limiting further penetration of the protuberance. In this position the protuberance 18 extends a distance of at least one centimeter into the canal, well within the transition zone of the canal, so that upon manipulative rotation of the scraper 10 about the axis of the stem 12, as diagramatically illustrated by the arrow in FIG. 1, the edges 22 and 24 of the protuberance 18 will scrape the walls of the endocervical canal in the transition zone thus depositing a suitable specimen of cells of endocervical origin on the flat, front and rear faces of the endocervical head 14 adjacent the scraping edges 22, 24.

Simultaneously with the deposit of cells of endocervical origin, i.e. endocervical and/ or metaplastic cells, on the fiat parallel faces of the protuberance 18, the squamous sampling edge 26, cradling the cervical lip and circumscribing the same during rotation of the scraper 10, scrapes the cervical lip and deposits a sampling of squamous cells on the flat parallel faces of the web support 32 adjacent the squamous sampling edge 26.

In FIG. 2 the scraper 10 illustrated in FIG. 1 is shown removed from the vaginal cavity and prior to the transfer of the specimens onto suitable slides which is done in the conventional manner. In diagramatic fashion, a typical deposit of endocervical material 42 is shown in a zone denoted for the purpose of illustration only by a plurality of parallel horizontal markings and a deposit of squamous material 44 is shown in a zone denoted for the purpose of illustration only by a series of vertical parallel markings. It should be appreciated that said markings have no bearing with respect to the actual appearance of the respective specimens deposited.

A further embodiment of the invention is illustrated in mG. 5 wherein like numerals designate like components of the previous embodiment however bearing the suffix "a" after respective numerical designations. In this embodiment a scraper lOa is identical to the scraper 10 previously described except for the dimension of the endocervical head l4a.

The wedge protuberance 18a of the head 14a extends from its base to its distal tip 20a a length of approximately 1.5 centimeters while the distal tip 20a is a diameter approximating 3 mm., and the angular orientation between the edges 22a and; 24a is of the order of 13 to 22".

It should be appreciated that the protuberance 18a base dimension will therefore be from 6 to 9 millimeters and the endocervical head 14a of this embodiment is adapted for utilization in instances wherein the transition zone is not readily accessible utilizing the wedge protuberance 18 of the prior embodiment.

The scraper of the present invention is adapted for a one-piece construction of wood having a thickness in the order of 2 millimeters or less, and due to the width of the protuberance at the base and the configura- tion of the web support 32, fracture of the protuberance and or web during manipulation is minimized. Thus, the scraper need not be fabricated of plastic which necessitates increased costs as well as difficulties with specimen adhesion. Furthermore, the utilization of wood construction facilitates economical mass fabrication with relatively low tooling costs.

Thus, it will be seen that there is provided a cervical scraper which achieves the various objects of the invention and which is well adapted ta meet ithe conditionsl of practical use.

WHAT I CLAIM IS: 1. A cervical sampling scraper for human females comprising a planar body including a stem and means for scraping the wall of the cervical canal in the region of the transition zone to obtain a sampling of cells of endocervical origin, said scraping means including a wedge shaped protuberance at one end of the stem, which protuberance in plan has a base portion of from 6 to 9 millimeters in width and a projection axially away from the end of the stem a distance of at least one centimeter measured along a first straight lateral edge which is coincident with an edge of the stem and terminates at a rounded tip, a second scraping edge extend ing toward the stem from the rounded tip at an angle of approximately 12" from the first scraping edge and terminating at the base portion of the protuberance, a supportive web for controlling depth of penetration of the protuberance into the cervical canal, the supportive web in plan, projecting laterally from the stem adjacent the protuber ance and having a squamous sampling edge extending substantially transverse to the axis of the stem and coterminous with the second scraping edge at the base portion of the protuberance whereby the protuberance may be fully inserted into and effectively distend a cervical canal with the exertion of a minimal wedge pressure to scrape a deposit of endocervical cell material from the cervical wall with a sampling edge cradling the cervical lip to simultaneously remove a deposit of the squamous material upon rotative manipu lation of the stem.

2. A cervical sampling scraper as claimed in claim 1, wherein the squamous sampling edge has a curved contour extending from the second scraping edge at the base portion of the protuberance to a rounded squamous tip.

3. A cervical sampling scraper as claimed in claim 2, wherein the supportive web is approximately 1.5 centimeters in width as measured from the first scraping edge to the squamous tip, whereby the rotative manipulation of the stem permits the deposit of a sample d squamous cell material on the web without interference between the web and the walls of the vaginal cavity.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (7)

**WARNING** start of CLMS field may overlap end of DESC **. specimens onto suitable slides which is done in the conventional manner. In diagramatic fashion, a typical deposit of endocervical material 42 is shown in a zone denoted for the purpose of illustration only by a plurality of parallel horizontal markings and a deposit of squamous material 44 is shown in a zone denoted for the purpose of illustration only by a series of vertical parallel markings. It should be appreciated that said markings have no bearing with respect to the actual appearance of the respective specimens deposited. A further embodiment of the invention is illustrated in mG. 5 wherein like numerals designate like components of the previous embodiment however bearing the suffix "a" after respective numerical designations. In this embodiment a scraper lOa is identical to the scraper 10 previously described except for the dimension of the endocervical head l4a. The wedge protuberance 18a of the head 14a extends from its base to its distal tip 20a a length of approximately 1.5 centimeters while the distal tip 20a is a diameter approximating 3 mm., and the angular orientation between the edges 22a and; 24a is of the order of 13 to 22". It should be appreciated that the protuberance 18a base dimension will therefore be from 6 to 9 millimeters and the endocervical head 14a of this embodiment is adapted for utilization in instances wherein the transition zone is not readily accessible utilizing the wedge protuberance 18 of the prior embodiment. The scraper of the present invention is adapted for a one-piece construction of wood having a thickness in the order of 2 millimeters or less, and due to the width of the protuberance at the base and the configura- tion of the web support 32, fracture of the protuberance and or web during manipulation is minimized. Thus, the scraper need not be fabricated of plastic which necessitates increased costs as well as difficulties with specimen adhesion. Furthermore, the utilization of wood construction facilitates economical mass fabrication with relatively low tooling costs. Thus, it will be seen that there is provided a cervical scraper which achieves the various objects of the invention and which is well adapted ta meet ithe conditionsl of practical use. WHAT I CLAIM IS:

1. A cervical sampling scraper for human females comprising a planar body including a stem and means for scraping the wall of the cervical canal in the region of the transition zone to obtain a sampling of cells of endocervical origin, said scraping means including a wedge shaped protuberance at one end of the stem, which protuberance in plan has a base portion of from 6 to 9 millimeters in width and a projection axially away from the end of the stem a distance of at least one centimeter measured along a first straight lateral edge which is coincident with an edge of the stem and terminates at a rounded tip, a second scraping edge extend ing toward the stem from the rounded tip at an angle of approximately 12" from the first scraping edge and terminating at the base portion of the protuberance, a supportive web for controlling depth of penetration of the protuberance into the cervical canal, the supportive web in plan, projecting laterally from the stem adjacent the protuber ance and having a squamous sampling edge extending substantially transverse to the axis of the stem and coterminous with the second scraping edge at the base portion of the protuberance whereby the protuberance may be fully inserted into and effectively distend a cervical canal with the exertion of a minimal wedge pressure to scrape a deposit of endocervical cell material from the cervical wall with a sampling edge cradling the cervical lip to simultaneously remove a deposit of the squamous material upon rotative manipu lation of the stem.

2. A cervical sampling scraper as claimed in claim 1, wherein the squamous sampling edge has a curved contour extending from the second scraping edge at the base portion of the protuberance to a rounded squamous tip.

3. A cervical sampling scraper as claimed in claim 2, wherein the supportive web is approximately 1.5 centimeters in width as measured from the first scraping edge to the squamous tip, whereby the rotative manipulation of the stem permits the deposit of a sample d squamous cell material on the web without interference between the web and the walls of the vaginal cavity.

4. A cervical sampling scraper as claimed

in claim 1, 2 or 3, wherein the stem includes two substantially parallel lateral edges, one of the lateral edges being coincident with one of the scraping edges.

5. A cervical sampling scraper as claimed in any one of claims 1 to 4, wherein the angle of divergence between the two scraping edges lies within a range between 12" and 22".

6. A cervical sampling scraper as claimed in any preceding claim, wherein the scraper is formed of a one-piece wood construction whereby a low cost yet highly efficient cytological sampler is provided.

7. A cervical sampling scraper constructed and arranged to operate substantially as hereinbefore described with reference to and as illustrated in the accompanying drawings.