CN1113741A - Endocervical probe for pap smear sample head - Google Patents

Abstract

The present invention relates to a Ba's smear sampling device for examining cervical carcinoma cells, including a sampling head capable of nestling up to the surface of cervix uteri and scraping it to collect sample cell and a slender handle capable of allowing the sampling head to make controlled rotation. Said sampling head includes two elastic arms which can be axially extended from said handle and outwards bent. When the elastic arms are inserted into the cervix uteri, they can be moved together to form a closed structure, and then they are elastically dilated in the cervix uteri to form an opening structure, so that the arms can form a scraping contact with endocervical cells, and can make the smapling head flexibly and elastically rotate to collect the sample cells.

Description

Endocervical probe for pap smear sample head

Employed Pap smear sampler when the present invention relates to the gynecologial examination cervical cancer cell.

Can buy many kinds of samplers so far and carry out these so-called " Pap smears " test.Such device is commonly used to be inserted in the cervix uteri, rotates then, scrapes the cervix uteri surface thereby wipe or shovel, to gather and to obtain representational cell sample.In case the taking-up sample, a part of cell that is captured on the sampler to the major general is transferred on the optics microscope slide, then conducts a survey at suitable microscopically, so that determine the cervical cancer situation.This operating process is known to this field those of ordinary skill and understands; Here no longer for a more detailed description.

But, find that in practice these known Pap smear samplers exist not enough in many importances.Statistics points out that the accuracy rate that cervical cancer is checked is lower, and the stage can not detect because the present various Pap smear sampler effects of using are bad many situations mostly in early days.

A kind of typical known sampler is made by wood, is integral the common and cervix uteri cross-sectional surface shape adaptation of this sampling head with sampling head.But such " spatula " type device is too hard, thereby should not do suitable adjusting and adapt to the daily cervix uteri that size and dimension has bigger variation that runs into.In addition, because these rigidity spatuves can not be fit to cervix uteri surface topography quite complicated and that change flexibly, the useful effect zone during the sampling operation is quite little.Then this can cause mistaken diagnosis, and can cause patient's undue pain and uncomfortable.This spatula type sampler also causes contact bleeding easily, and this just must check out that cancerous cell becomes very difficult in the erythrocyte that scatters, and accuracy is lower.

For this is made improvements, many one type of prior art syringe attachings various manes, fiber, filament or hair brush structure, they are installed on support arm or the tinsel usually.But these " brush " type devices also can cause than serious pain and hemorrhage, and are all the more so when particularly not giving enough attentions during sampling operation.Such sampler is compared with rigidity spatula type device discussed above and is helped to obtain the district of surface action preferably, and this is because therefore mane can make hairbrush more closely adapt with the cervix uteri surface configuration flexibly in to a certain degree internal strain.But these devices still can't be used for the whole zone of action, have some self inherent problem in addition, and the sample that is difficult to collect in other words is transferred to the analysis of doing next step on the microscopical microscope slide.This mainly is because sample cell is tended to be clamped in the gap between the interior zone mane of hairbrush, therefore is not easy to connect and be transferred on the microscope slide.Equally, will this cause mistaken diagnosis once more, especially at initial stage of cervical cancer key.

In addition, adopt two kinds of main known samplers discussed above, cancerous cell and dysplastic cell usually can be damaged and change shape in sampling process, be difficult to check out exactly with known diagnostic techniques like this.This will further reduce itself ability of employed Pap smear experimental evidence in the present reality the accuracy of the early stage believable cervical cancer indication that should be able to provide.

Except top consideration, a special problem relates to that part of known sampler that is specially adapted to gather cervical canal inner membrance sample cell.In order to allow to be inserted in the cervix uteri, the device of most prior art or be integral quite hardy, or from the axially extended brush type of instrument handle cervix uteri internal probe or core bar.But the same because sample discussed above of sampling core bar passes on ability and inapplicable in the brush type cervix uteri.Just there is the insufficient problem in surface action discussed above zone in the type device, and in addition, the sample cell that is collected is erased from bar being easy to when cervical canal is drawn back.Have recognized that at present become shovel to scrape contact because sampler can not open up into cervical canal in both cases, the effect of sampling is bad especially.The defective of these and other makes various prior art samplers in the poor effect that obtains representing cell sample from cervical canal.

The purpose of this invention is to provide a kind of improved Pap smear sampler, it can overcome and at least from improving the defective of some above-mentioned prior aries in essence.

Thereby, at present imagination the invention provides a kind of Pap smear sampler that is used for checking cervical cancer cell, this device comprises that is used for being adjacent to and shoveling sampling head and a control rotation of a permission sampling head do and a rotating elongate handle of scraping cervix uteri acquisition surface sample cell, above-mentioned sampling head comprises that at least two are totally extended and bandy elastic arm vertically from handle, these two arms are designed to be moved into together the structure of closing when being inserted into cervix uteri, after this elastic dilatation becomes Unclosing structure and becomes shovel to scrape to contact with cervical canal is inner in cervical canal, above-mentioned two arms are tending towards soft and flexiblely adapt with the cervical canal inner surface configuration at the Unclosing structure state, and are rotating and collected specimens cell from it during the revolution sampling head.

Best, two arms are connected at their end becomes a top away from handle, and therefore two arms form an elongated interstitial hole and clamp sample cell.

Preferably also with a flexible scraping blade part that outwards stretches from the sampling head bottom usually, the ectocervix sample cell is scraped and gathered to shovel to this device simultaneously.This scraping blade preferably can match with ectocervix surface flexible ground, and keeps an effective shovel to scrape the angle when rotating and turn round sampling head.

In a most preferred embodiment, this scraping blade is made of the lateral margin of a quite softish hyoplastron, and sampling head also further comprises a comparatively inflexible support arm, and it outwards stretches the far-end that supports hyoplastron from handle or core bar.

Best, this device also comprises a quite softish connector that allows to have slightly between handle and the sampling head axial dislocation, so that can rotate and turn round this device effectively under the situation that handle tilts with respect to sampling head.

In most preferred embodiment, flexible joint is realized by being positioned at the intermediate neck district that sampling head bottom, cross section reduce usually.

Preferably sampling head is made of these materials such as rubber, santophen (santoprene), silicon, soft poly-imines fat, polyethylene, polypropylene, epoxy resin, polyester and acrylate basically suitable elastic materials.

Handle preferably has a flat scraping blade away from the end of sampling head, scrapes so that be used for during sample ectocervix shoveled in not requiring cervix uteri.

In conjunction with the accompanying drawings most preferred embodiment of the present invention is described with way of example below.

Fig. 1 is the front view of the Pap smear sampler of first kind of embodiment of expression the present invention;

Fig. 2 is the view that is similar to Fig. 1, the another kind of embodiment of expression.

At first consult Fig. 1, the invention provides the Pap smear sampler that a kind of " Pap smear " test procedure that is used for and understanding known by this field those of ordinary skill is checked cervix uteri (not drawing among the figure) cancerous cell.This sampler comprises that one is applicable to be adjacent to and to shovel and scrapes the sampling head 5 that comes the collected specimens cell in the cervix uteri surface and one and allow sampling head to make control rotation and rotating elongate handle 6 when being adjacent to cervix uteri.

Sampling head 5 comprises a pair of extend vertically from handle, bandy elastic arm 10 opposite each other usually.This two bend arm 10 forms a core bar 11 together, and is connected at its far-end and constitutes the top 12 of sampling head.Like this, two arms form an interstitial hole that is similar to the eye of needle structure of having amplified.

A flexible scraping blade 15 stretches out from the sampling head bottom.In the embodiment of Fig. 2, a support arm 7 supports this scraping blade from the far-end that the sampling head bottom extends to scraping blade.

In each situation, the work edge of scraping blade is a sweep gradually along its length, and the core bar that forms from two arms 10 turns over the angle 90 ° to 180 °, is preferably about 140 °.In other words, the tangent line of making from scraping blade work edge far-end and the axes intersect angle of this core bar and handle are preferably about 40 ° 0 ° to 90 °.This flexibility guarantees that cervix uteri and transition region have enough zones of action.

Handle 6 has a neck regions direct and the sampling head bottom is adjacent, cross section reduces, and forms " universal " joint 25 of a flexibility.This universal joint allows to take place limited relative motion and axially dislocation between handle and sampling head, this can make sampling head do effectively to rotate under handle and angle case of its inclination.Also can dream up the flexibility joint of other form.In two embodiment, handle has an auxiliary sampling scraping blade 30 away from the end of sampling head, is used in not require in the occasion of passing cervix uteri.

The using method that makes a brief explanation now, at first that sampler is in place with traditional method, will survey core bar 11 and be inserted in the cervix uteri.In this insertion process, two elastic arms 10 draw in and motion together, therefore in fact seal this interstitial hole 13 of position.This contraction has reduced the effective cross section of core bar, thereby can insert and make the uncomfortable and extent of injury that brings to patient to reduce to minimum easily.In core bar is advanced further to cervical canal, two arms, 10 outside elastic dilatations, thus just in time be adjacent at the cervical canal inwall.Along with sampler is in place at last, scraping blade (hyoplastron) 15 touch ectocervix simultaneously.Rotate this device with hands along clockwise direction or counterclockwise by handle then.

During this rotation and revolution, the outer rim of two elastic arms 10 shovel is scraped the cervical canal inner membrance, the collected specimens cell, and these cells are kept on each faces of two arms and in the middle eyelet 13.The elasticity of crooked shovel scraping arm 10 preferably can make the soft face of core bar flexiblely adapt with the irregular surface of cervical canal in this process, keeps reliable, an outside constant contact pressure simultaneously.To make the contact area maximum like this, local pressure is concentrated minimum, guarantees to obtain a representational sample.

Simultaneously, scraping blade 15 shovels are scraped ectocervix, the collected specimens cell, and the front surface of these sample preservation at scraping blade.In this operating period, because the axial compressive force that applies of operator, scraping blade is soft and match with the whole surface (comprising any irregular surface) of cervix uteri progressively.In the situation of Fig. 2 embodiment, support bar 17 helps guarantee keep an effective shovel to scrape the angle at whole cervix uteri by providing support away from core bar one end to wiping mode scraping blade, and allows to have on scraping blade a uniform basically pressure distribution.This embodiment is specially adapted to patient nullipara, and Fig. 1 embodiment mainly is applicable to patient multipara.

In case sampling process is finished, draw back this device.When drawing back, two arms 10 flexibly stretch once more and draw in, thereby make patient's uncomfortable sensation and suffered injury reduce to minimum.

Sample cell is transferred to a suitable optics microscope slide from two arms 10, interstitial hole 13 and hyoplastron or scraping blade analyzes and test by the diagnostic method of having set up by wiping action simply then for next step.One simply wipes action and is enough to the front surface of whole sample from scraping blade 15 is transferred on the microscope slide.Therefore, the sample of whole basically collections all can be used for analyzing.

Obviously, the present invention compared with prior art can provide many significant advantages.At first, because its intrinsic " form fit " ability, the useful effect zone of cervix uteri, particularly cervical canal increases greatly during sampling process, when especially comparing with rigidity spatula type device in the prior art.

And then in fact device of the present invention can be transferred to the sample of gathering fully on the microscope slide and analyze usefulness for next step.It makes sample cell be clamped in the probability that (resembles between mane, fiber or the filament that remains in prior art brush type device) in the interstitial hole to reduce to minimum.In addition, the cell that is kept in the eyelet 13 is drawn back Shi Buhui owing to wiped because of carelessness at core bar from cervical canal.As mentioned above, according to statistical analysis, these factors have reduced the probability of mistaken diagnosis widely.

In addition, although Handle axis is bigger to the scope of dislocation, because sampling head can be near the optimum position of cervix uteri automatically, the flexible energy-saving that forms between sampling head and handle makes this device offset operator's the influence that malfunction caused to a great extent.

So the improvement structure of sampling head and flexible make this device can adapt to the cervix uteri size and dimension bigger variation to be arranged, accurate control is provided makes pain, uncomfortable, hemorrhage and cell injury reduce to minimum.Especially, the contractility of two bend arms of core bar in being inserted into cervix uteri the time makes the uncomfortable of patient and the damage of cervix uteri and sample cell reduced to minimum, make zone of action maximum and next in cervical canal, radially be expanded to Unclosing structure, and make uncomfortable and damage reduce to minimum.Reduce contact bleeding and cell injury by this method, can further reduce the probability of the incorrect diagnosis of cervical cancer situation.Because this device can provide an effectively and accurately sample, significantly reduced sample time again.

By identifying the sample in the inboard and outside of the cervix uteri taken out simultaneously, and again they are separated into if necessary on separately the microscope slide and analyze respectively, can further improve the accuracy and the specificity of diagnosis.Owing to these reasons, obviously the present invention is compared with prior art representing the coml significant improvement.

Made description though The present invention be directed to special case, for those of ordinary skills, the present invention obviously also can specialize many other forms.For example, if necessary can be with the working edge roughening of scraping blade.

Claims (10)

1, a kind of cervix uteri sampler, comprise that one is used for being inserted into part in the cervix uteri that the cervical canal interior zone operates and one is used for the ectocervix part of rotating on the ectocervix surface, it is characterized in that: above-mentioned cervix uteri is inner divide comprise at least two movably elastic arm so that it is outwardly-bent when the normal position, the arrangement of this two elastic arm makes them be tending towards inwardly compression to pass through cervix uteri when operation, closely cooperate thereby expand outwardly with intracervical shape in cervical canal inside, and when rotating said apparatus from the inner sample cell of taking out of this cervical canal.

2, according to the described device of claim 1, it is characterized in that: above-mentioned two arms are connected to each other in each end.

3, according to the described device of claim 2, it is characterized in that: above-mentioned two arms form a ring.

4, according to any described device in the claim 1 to 3, it is characterized in that: the ectocervix branch comprises slick basically, as to be used for turning over a ectocervix surface flexible hyoplastron, thereby gather the material on this ectocervix, this hyoplastron has a section that conforms to the ectocervix shape usually, thereby the hyoplastron bending fits tightly with the ectocervix surface configuration when operation.

5, according to the described device of claim 4, it is characterized in that: this hyoplastron only stretches out from a side of device.

6, according to any described device in the claim 1 to 5, it is characterized in that: said apparatus further comprises a handle and the flexibility joint between this handle and above-mentioned flexible hyoplastron.

7, according to the described device of claim 6, it is characterized in that: said apparatus further comprises a supporting construction that stretches between handle and above-mentioned flexible hyoplastron.

8, according to the described device of claim 7, it is characterized in that: above-mentioned supporting construction comprises a comparatively inflexible pole that extends to above-mentioned flexible hyoplastron rear surface from above-mentioned handle.

9, according to any described device in the claim 1 to 8, it is characterized in that: said apparatus integral body is made by plastic material.

10, according to the described device of claim 6, it is characterized in that: the part that above-mentioned flexible joint is reduced by diameter on the above-mentioned handle portion constitutes.

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