MXPA00004645A - Medical spatula - Google Patents

Abstract

This invention relates to a medical spatula that finds particular application as a spatula for exfoliative cytology, such as cervical or vaginal smear tests (PAP tests). The spatula of the invention comprises a grip, made up of a hand grip (12) and an insertion rod (14), and a substantially planar blade (20). The blade (20) consists of an open loop that defines the rim (24) of the blade (20) and a lattice of spaced apart bars (22) that arise from the peripheral rim (24) and transect the body of the blade (20). When adapted for use as a cervical spatula (10), the periphery of the blade is shaped to conform to the shape of the average cervix. The spatula (10) is integrally formed from a resiliently deformable material such as injection moulded plastics, preferably low density polyethylene.

Description

MEDICAL SPATULA FIELD OF THE INVENTION This invention relates to a medical spatula.

BACKGROUND OF THE INVENTION The spatula finds particular application as a spatula for exfoliative cytology and will be described with reference to a cervical spatula by way of example.

The so-called PAP tests, later called by the Greek-American physician George Papanicolao, who developed the vaginal spot test in 1928, to diagnose cervical cancer, is probably the most widely used example of exfoliative cytology. PAP assays are usually performed using a rasp or spatula with a handle that is used to scrape cervical outer cells before a transfer of the cells to a sliding glass for microscopic evaluation.

REF .: 120341 The most commonly used spatula device is the wooden AYRE spatula, as described and claimed in the specification of US Patent No. 2,471,088. These devices exist not without their disadvantages, the AYRE spatula is difficult to handle without causing discomfort or damage to the patient and giving less satisfactory results in the adequate obtaining of endocervical cell samples.

To address these problems, spatula devices have been developed that are more flexible, one of which is the well known CYTOBRUSH spatula, described in the specification of US Patent Nos. 3,881,464 and 4,759,376. 'The CITOBRUSH is significantly better than the wooden spatula for the collection of endocervical cells, but not significantly better for the collection and detection of metaplastic cells. These deficiencies in the SYTBRUSH spatula may rise due to excessive flexibility.

In addition, while the CITOBRUSH as described in the North American Patents No. 4,759,376 and 3,881,464 tend to give better coverage of the surface than the rigid spatula and CERVIZ BRUSH, still can not provide complete coverage and also suffer from the problem of poor or poor transferability of the sample collected to the microscope slide. CITOBRUSH can also cause pain and substantial bleeding. Particularly, if not enough care is exercised in the sampling procedure.

The Lonsten spatula, described in International Publication Document No. WO 94/09704, was introduced in an attempt to obtain better surface coverage and improved sample transfer. This spatula incorporates a cervical probe or sampling head with a pair of resiliently deformable arms that are adapted to open out slightly within the endocervical area of the present cervix, between the arms, a sampling aperture formed approximately similar to the eye of a needle. The cells of the endocervical sample are collected and retained on several sides of the arms, also as in the opening or eye. In addition, the cleaning arms, adapted to shape and remove the ectocervical area during the rotation of the spatula when in place, extend outwardly from the base of the sampling head. Once obtained, the different endocervical and ectocervical samples are then isolated by a withdrawal action on the separate lamellae for analysis.

It is an object of this invention to address these apparent deficiencies.

Brief Description of the Invention This invention provides a medical spatula comprising a handle and a substantially flat blade that includes a surrounding clamp of a resiliently deformable material that extends approximately the outer periphery of the blade and a grid of spaced apart rods of a material resiliently deformable which rises from the peripheral clamp and cuts transversely the body of the blade.

The spatula in the preferred form of the invention is adapted to be used as a cervical spatula so that the periphery of the blade is formed to conform to the average cervical shape.

It will be appreciated that the cervical shape varies widely from woman to woman and that the shape and consistency of the cervical tissue tends to vary, within the same woman, depending on her age, condition or pregnancy (if any) and the phase of her menstrual cycle .

"The blade of the spatula is therefore essentially formed to form an idealized cervix, however, the flexibility of the blade is proposed to assist in shaping the shape of the blade and any derivation from the shape idealized cervical that can be presented by a current cervix when using the spatula.

At this point, the blade is essentially triangular in a profiled plane, the end of the blade is constituted by the apex or tip of the triangular blade and the sides of the triangular blade are raised from the tip being concave in a profiled plane. The whole profiled plane of the triangular blade is rounded, the base concerned is rounded more at the tip, to avoid possible discomfort or damage in use.

The bars that make up the body of the blade can conveniently be constituted by a plurality of non-discrete spaces apart spaced one from the other by interposed slots. Some or all of the slots may be formed by grooves formed to extend through the plane of the blade.

In the preferred form of the invention, all slots are formed by grooves.

The blade and preferably the entire spatula, being the handle and the blade, are integrally formed of a resiliently deformable material such as a preferably injection molded plastic, low density polyethylene.

To assist in accordance with the shape of the cervix and also to maximize the scraping action of the blade, without thereby increasing the risk of damage, the blade is adapted to flex in the plane of the blade.

This can be done by staggering the blade either longitudinally and transversely or both.

To further maximize the scraping action of the blade, the peripheral edges of the blade may be relatively sharp in cross section.

The handle can be longitudinally staggered from the end of the manual handle and therefore, at the point of attachment of the handle to the blade, the narrow portion of the stepped handle is progressively more flexible to the point of attachment of the handle to the blade. . This is particularly appropriate for a spatula proposed to be used as a cervical spatula.

Brief description of the drawings. In the drawings Figure 1 is a diagrammatic isometric view of a cervical spatula according to the invention; Figure 2 is a plan view of the spatula of Figure 1; Figure 3 is a side elevation of the spatula of Figure 1; Figure 4 is a cross section through the blade on line 4-4 in Figure 3; Figure 5 is an enlarged view of one half of the section of Figure 4 (the circulated area); Figure 6 is a transverse section on line 6-6 in Figure 3; Figure 7 is an isometric view of an alternate cervical spatula in accordance with the invention; Figure 8 is a diagrammatic isometric view of still, an additional alternate cervical spatula, in accordance with the invention; Figure 9 is a side elevation (partially in section) of line 9-9 in Figure 8; Figure 10 is an enlarged view of the area circulated in Figure 9; Figure 11 is a cross section through a half of the blade of the spatula of Figure 8 taken on a line 11-11 in Figure 8; Figure 12 is a diagrammatic representation of the cervical spatula of the invention in use; Figure 13 is a diagrammatic representation illustrating the placement of the blade of the spatula on the cervix; and Figure 14 is a diagrammatic representation of the manner in which a cervical cytology sample collected with the spatula of the invention is deposited on a glass slide.

Description of the embodiments of the invention The spatula for exfoliative cytology illustrated in the drawings is a 1-0 cervical spatula that is proposed to conduct PAP tests.

One of the difficulties faced by medical specialists in the conduct of PAP tests is found in the fact that the cervical passage in most women enters the vaginal passage at an angle as illustrated in Figure 12. However, the practitioner is obliged to insert and manipulate the cervical spatula coaxially with the vaginal passage and do the best to maintain the insertion end of the spatula in constant cervical coupling.

This is very difficult to achieve during the sampling process, since spatula rotation is required.

As a result, the angular deviation of the vaginal and cervical passage makes it difficult to obtain endocervical cells when conducting PAP tests with rigid spatulas such as the AYRE spatula.

To overcome this difficulty, the CYTOBRUSH spatula was developed. It includes a pair of flexible vanes that extend on either side of a nose adapted for cervical insertion during the PAP test driving. Unfortunately, the flexibility of the blades makes it difficult to obtain metaplastic cells.

It is with these difficulties in mind, that the cervical spatula of the invention was developed, the intention being to provide a spatula with sufficient deformability at or parallel to the main axis of the spatula to allow substantial compliance with the cervical shape during the rotation of the spatula , but still sufficient rigidity in the plane of the blade to perform a proper scraping operation without cutting or damaging the patient.

The cervical spatula 10 of the invention includes a handle comprising a round manual handle 12 at the end of a thin insertion rod 14. The handle 12 is provided with slits 16 which serve as formations of the handle. The insertion rod 14 is grooved by means of longitudinally extending slits 18 which serve to increase the rotational stiffness of the insertion rod 14 without sacrificing the longitudinal flexibility that is required for the proper conduction of the PAP tests.

At this opposite end, the spatula 10 is formed with a flat flat blade 20.

The spatula is integrally molded of low density polyethylene.

The blade 20 is constituted by a separate separate bar grating 22 attached by a surrounding clamp 24 of the material defining the outer periphery of the blade 20. The spaces 23 between the bars 22 are formed to open the grooves extending to through the body of the blade 20, as can be seen more clearly from the cross sections in Figures 4 and 5.

The blade 20 is symmetrical about a central axis (which is coaxial with the main axis of the handle 14) and the blade 20 is essentially triangular in the profiled plane. The insertion end 26 of the spatula is constituted by the tip of the triangular blade and the sides of the triangle are raised from the tip to provide a heart shape or an arrowhead shape of the blade of the spatula 20.

The insertion end of the blade 20 is rounded in a plane to define a nose 28 which is designed to enter the cervical during sampling.

The peripheral edge 24 of the blade 24 curves symmetrically away from the nose 28 on either side thereof. The concave curved areas 29 of the edge 24 are formed to be complementary to the entrance and ectocervical area of the cervix.

All surfaces of the blade 20 are rounded to minimize the risk of damage, pain and discomfort.

However, along the line of intersection between the surfaces of the main plane of the blade 20 and the periphery 24, the angle of intersection is sharp and the point of intersection is relatively sharp. This is to provide relatively sharp edge edges 25 that are designed to minimize cell accumulation during sampling. For the same reason, the same design is used along the lines of intersection between the main plane of the blade 20 and the edges of the bars 22 to provide sharp edges 27 also in all those areas.

The cervical spatula 10.1 illustrated in Figure 7 is similar to the cervical spatula 10 described above with the exception of a smooth insertion rod 14.1 and a manual handle 12. 1 The cervical spatula 10.2 illustrated in FIGS. 8, 9, 10 and 11, differs from the cervical spatula 10 and 10.1 described above in several aspects. Not only the insert rod 14.2 and the manual handle 12.2 are different in the spatula 10.2, but the blades 20.2 differ markedly. Instead of being grooved, the blade 20.2 is merely grooved, such that the bars are constituted by a number of face-to-face spaces 22.2 that are apart one from the other by the grooves 23.2 interposed between the spaces 22.2.

In Figures 9, 10, 11, this aspect is more clearly illustrated. In these drawings, it can be seen that the grooves 23.2 do not extend completely through the body of the blade 20.2. The grooves 23.2 are, however, formed on either side of the blade 20.2.

~~ The spatula 10.2 will be stiffer than the spatulas 10 and 10.2 described above and similarly sized and made from similar materials.

The biconcave triangular shape of the blade 20 is designed to allow selective acquisition of cells from the endocervical and ectocervical areas of the cervix. The peripheral edge 24 of the blade 20 is constituted essentially by a clamp of resiliently deformable material, is sufficiently aggravated to accommodate most variations in the shape of the cervix.

The blade 20 is substantially planar, but can be observed from the lifting face of Figure 2 and the cross sections of Figures 4 and 5, the blade being stepped in two directions in cross section.

In the longitudinal cross section, the blade 20 is staggered towards the nose 28. The surfaces of the opposite upper and lower plane of the blade converge from the thick part of the blade 20, which is at the end and which is attached to the blade. insertion rod 14, towards the nose of 28.

In transverse cross section, the blade 20 is inversely staggered, such that, in cross section, it is thinner in half than on its sides, the areas of the blade 20 are retracted 30 defining the base of the blade 20.

In addition, the handle of the spatula which is stepped from the manual spatula 12, through the insert rod 14 to the point of attachment of the blade 20, becomes progressively more flexible to the point of attachment of the handle to the blade 20. This allows the insertion rod 14 to flex progressively more along its length to accommodate the angular misalignment of the cervix with the vaginal passage, even during the rotation of the spatula. This aspect is illustrated diagrammatically in Figure 12, which illustrates the cervical spatula 10 of the invention in use. In this drawing, the spatula 10 of the invention is inserted into the vagina of a patient through a mirror 32 that allows an unobstructed view of the cervix 34 of the patient.

The medical specialist has the blade 20 inserted through the mirror 32 to the point where the blade 20 correctly placed on the cervix 34, rotates the spatula 10 between his thumb and the index finger to collect a sample of the cervical cells.

During the rotation of the spatula 10, the insertion rod 14 is flexed to accommodate misalignment of the cervix and vaginal passage. In addition, the peripheral edge 24 of the blade 20 flexes during rotation to accommodate any of the variations in the shape of the cervix 34 that derives from the shape of the blade 20.

The edge 24 is flexed mainly in the plane of the blade 20 with the rods 22, providing relatively little resistance to such bending. The bars 22 do not detract significantly from the docility of the peripheral edge 24, still contributing to the collection of the cells.

During the rotation of the spatula 10, in the cervix 34, the blade 20 also flexes in the plane of the blade 20. The degree of flexibility is not greater and the blade 20 is proposed to rotate all slightly around the main axis of the blade. spatula 10 in the helical form.

The blade 20, in bent form, slightly performs a more aggressive scraping action within the neck 34, since the fold of the blade represents the edges 25 of the peripheral edge 24 of the blade 20 at a slightly sharper angle of the attack during the rotation of the blade 20 within the cervix 34. The bend of the blade 20 also misaligns the bars 22 slightly and presents the edges 27 of the bars to the cervical tissue to a greater extent.

The diagram of Figure 13 illustrates the location of the blade 21 within the cervix 34 in more detail. In this drawing, it can be observed how the tip of the blade 20 penetrates deep within the cervix 34 to collect the endo-cervical cells. The concave sides 29 of the blade 20 extend into the cervix to the area adjacent to the cervical inlet, to progressively collect fewer endocervical cells and progressively more ectocervical cells from the central regions of the blade 20 to the blade 30 to the blade. blade base 20 The blade 20 is docile enough to accommodate the cervix without and without tigestations.

The spatula 10 of the invention has the additional advantages. Not only do they allow the selective acquisition of the cells from the endocervical and ectocervical areas, but it allows the placement of the cells in a glass slide, for example, in a similar way.

This aspect is illustrated in Figure 14.

The smooth knife spatulas suffer from the disadvantage that the collected samples adhere preferentially to the smooth surface of the spatula. Consequently, a considerable amount of manipulation is required to force the sample to adhere to the foil preferably to the spatula to deposit the cells collected during the PAP test on the glass slide. This often results in the specialist doctor staining the cells around the glass slide and losing the original location of the cells in the eventual sample.

The spatula 10 of the invention intends to overcome this deficiency by allowing the most effective placement of the cells in a glass slide 36 without the need for excess handling.

This is done using capillarity to assist in the placement of the sample in the foil. When the blade 20 is placed smooth in a glass slide, a hole tends to be left between the lamella and the stepped nose 28 of the blade 20. This hole is in communication with and cooperates with the grooves 23 between the bars 22 in the grid defining the surface of the blade 20. The capillarity of these co-operating capillary spaces assist in the extraction of the sample from the blade 20 when, in the placement of the cells collected in a glass slide, the specialist doctor removes the blade 20. longitudinally along the glass slide (in the direction of the arrows).

In the process, the specialist does not require staining the sample. This means that the blade can be extracted straight down from the glass slide, placing the endocervical cells in the center (40) of the sample and the ectocervical cells on either side thereof (42). This will allow the pathologist to examine the lamella, knowing that the cells can be distinguished as of their origin.

The spatula 10 of the invention therefore has the disadvantage that it allows the selective acquisition of the cells from the endocervical and ecto-cervical areas. In addition, it allows the placement of the cells in a similar way.

It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention is that which is clear from the present description of the invention. Having described the invention as above, the content of the following is claimed as property.

Claims (13)

1. A medical spatula comprising a handle and a substantially flat blade, characterized by the provision of a surrounding clamp of a resiliently deformable material extending approximately the outer periphery of the blade and a grid of separate bars separated from a resiliently deformable material that is elevates the peripheral clamp and cuts the body of the blade.

2. A spatula according to claim 1, characterized in that it is adapted to be used as a cervical spatula on the periphery of the blade formed to conform to the average cervical shape, the blade is triangular in a profiled plane, the end of the spatula is constituted by the tip of the triangular blade, and the sides of the triangular blade that rise from the tip are concave in the profiled plane.

3. A spatula according to any of the preceding claims, characterized in that the bars are constituted by a plurality of non-discrete spaces, separated one from the other by interposed slots.

4. A spatula according to claim 3, characterized in that at least some of the slots are constituted by grooves, formed to extend through the plane of the blade.

5. A spatula according to claim 4, characterized in that all the grooves are constituted by grooves.

6. A spatula according to any one of the preceding claims, characterized in that the blade is integrally formed of a resiliently deformable material.

7. A spatula according to claim 6, characterized in that the blade and the handle are integrally formed from a resiliently deformable material.

8. A spatula according to any one of the preceding claims, characterized in that the blade is adapted to flex in the plane of the blade, the blade is stepped in longitudinal cross section, the surfaces of the opposite plane of the blade cover from a part thick of the blade the point of attachment of the handle to the blade towards a thinner part of the blade to the end of the blade opposite the point of attachment of the handle to the blade.

9. A spatula according to any one of the preceding claims, characterized in that the blade is adapted to flex in the plane of the blade, the blade is stepped double in longitudinal cross section, in which the surfaces of the opposite plane of the blade converge to starting from the longitudinally extending edges of the blade towards the longitudinally extending center line of the blade.

10. A spatula according to any one of the preceding claims, characterized in that the peripheral edges of the blade are relatively sharp in cross section.

11. A spatula according to any one of the preceding claims, characterized in that the handle is stepped longitudinally from one end of the manual handle thereof, to the point of attachment of the handle to the blade, the narrower portion of the stepped handle is progressively more flexible to the point of attachment of the handle to the blade.

12. A cervical spatula according to any one of the preceding claims.

13. A spatula substantially as described in this specification with reference to the accompanying drawings.