The sampler finds particular application as a sampler for exfoliative cytology and it will be described with reference to a cervical spatula by way of example.

The so-called PAP test, named after the Greek-American physician George Papanicolaou who developed the cervical smear test in 1928 to diagnose cervical cancer, is probably the most widely used example of exfoliative cytology. PAP tests are normally performed using a hand held scraper or spatula that is used to scrape off the outer cells of the cervix prior to a transfer of the cells to a glass slide for microscopic evaluation.

There are many sampling devices in common use. These devices can however give less than satisfactory results in obtaining adequate endocervical and ectocervical cell samples due to the rigidity of both the sampling head and the stem.

To address these problems, spatula devices that are more flexible have been developed, one of which is the well-known CYTOBRUSH spatula ; others are the Medscand Accelor Combi and the Cervitula produced by Harwill Medical.

Medical samplers are known which comprise a grip and a substantially planar blade including a loop of a resiliently deformable material extending about the outer periphery of the blade and a lattice of spaced apart bars of a resiliently deformable material that arise from the peripheral loop and transect the body of the blade.

This spatula is adapted for use as a cervical spatula in that the periphery of the blade is shaped to conform to the shape of the average cervical os.

Samplers have also been developed with sleeves on the stem of the spatula, which can be slid along the stem to collapse the flexible head to enhance the transfer of samples from the head to a slide. An example of such a spatula is the Accellor Combi Cervical Biosampler marketed by Medscand. In this spatula the head is a flexible quadrangle mounted on the stem by means of a polypropylene hinge so the head can move in a direction perpendicular to the axis of the stem.

Samplers have also been developed with a head readily removable from the stem. In this way the head with the sample thereon may be broken from the stem into a bottle of sterile liquid which may then be analysed. This provides an alternate method to the tradition analysis of samples on microscope slides.

It is appreciated that the shape of the cervical os varies widely from woman to woman and that the shape and consistency of the tissue of the cervical os tends to vary, within the same woman. Various shapes and designs of spatula heads have been proposed for improving the taking of samples. Examples of such heads are described in European Patent 106461, and PCT publications 93/01749; 94/09704 and 99/25251.

One of the difficulties faced by the practitioner in conducting PAP tests is to be found in the fact that the cervical passage, in most women, enters the vaginal passage at an angle. However, the practitioner is obliged to insert and manipulate the cervical spatula coaxially with the vaginal passage and to make the best of keeping the insertion end of the spatula in constant engagement with the cervical os.

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

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

In an attempt to overcome this difficulty, the CYTOBRUSH was developed. It includes a 360° circular brush head. However this does not adjust angularity with the cervical os during the conduct of the PAP test.

It is with these difficulties in mind that the stem/handle cervical spatula of the invention was developed, the intention being to provide a spatula with sufficient deformability in or parallel to the principal axis of the spatula to permit total conformity with the shape of the cervical os during rotation of the spatula head of any type, but yet sufficient rigidity in the blade plane to perform an adequate scraping operation without hurting or injuring the patient.

In the sampler of the present invention the sampling head is linked to the stem by means of a universal joint whereby the head may be freely rotated with variable angular disposition to the stem. In this way through rotation of the stem the head can be brought into contact with all, or substantially all, of the external os surface area thus reducing the likelihood of missing abnormal cells.

Accordingly the present invention provides a medical sampler comprising a sampling head linked to a stem or grip by a universal joint whereby the head may be rotated with variable angular disposition in relation to the stem.

The invention is applicable to samplers using any type of sampling head such as those described in European Patent 106461 and PCT publications 93/01749; 94/09704 and 99/25251 or the head employed in the Accellor Combi Cervical Biosampler marketed by Medscand AB or the sampler described in United Kingdom Patent Application 9928842.5. We prefer however that the head be flexible so that in use it can conform to the size and shape of the cervix being sampled. In addition we prefer that the head be provided with sampling protrusions. We also prefer that the head can be readily removed from the stem either by cutting or bending to break so that once samples have been taken the head can be quickly removed and placed in a transport solution within a container for subsequent analysis.

To enable the head to be rotated in relation to the stem the universal joint may be formed in any suitable way. For example if the product is formed in moulded plastic the joint may be formed in the moulding process. Alternatively the joint may be formed by crimping as in the production of drinking straws. We have found that a product such as the bendy drinking straw as is an excellent stem for the samplers of the present invention.

In a preferred embodiment of the present invention the sampler comprises a flexible head, which will conform to the cervix being sampled, the head being provided with sampling protrusions. The universal joint is provided by a crimped region in a hollow stem similar to a bendy drinking straw with the head being very near to the crimp. The stem also is so constructed that the head can be removed from the stem either by cutting or bending so that if can be readily placed in a sample jar once the sample have been taken. This may be achieved by making the stem from materials that are readily cut or by providing a weakness in the stem. Where a weakness is provided in the stem it is preferred that the weakness be close to the universal joint and on the side of the joint nearer to the sampler head.

The present invention is illustrated but in no way limited by reference to the accompanying drawing Figure 1 which shows an assembled sampler, consisting of a flexible head 1) which is a loop 2) of flexible plastic preferably nylon provided with sampling protrusions 3) and 4). The loop is such that it can be compressed against the os during sampling. The loop is provided with a stem 5) which is preferably provided with ribs 6). The head then fits into the top 7) of a tube such as a bendy straw provided with a concertinaed ribbed section 8) to allow angular rotation of the head in relation to the stem of the tube 9). The stem may be provided with a weakened section 10) to allow ready removal of the head.

As can be seen, the sampler has great flexibility in operation due to the combination of the compressibility of the sampler loop and the ability to rotate the sampler head relative to the stem.