WO1994008512A1

WO1994008512A1 - Instrument for taking biopsies

Info

Publication number: WO1994008512A1
Application number: PCT/SE1993/000828
Authority: WO
Inventors: Kjell Thor
Original assignee: Ab Tesi; Kjell Thor Lk Ab
Priority date: 1992-10-12
Filing date: 1993-10-11
Publication date: 1994-04-28
Also published as: AU5289793A; SE470005B; SE9202997L; SE9202997D0

Abstract

A biopsy device intended for endoscopy instruments, which comprise a housing and a tubing-like device attached therein, which tubing comprises means for lighting and viewing and a channel for supply of air and/or water to the free end of the tubing, as well as a channel intended for a so-called biopsy forceps, where the biopsy device comprises a tubing with an outer diameter less than the inner diameter of the channel (10) intended for the biopsy forceps, which tubing comprises a channel for transportation up of biopsies, where an opening is present in the tubing near or at the lower end thereof, at which opening a detachment means is present arranged for detachment of biopsies, and where means are present arranged for providing reduced pressure in said channel, for transportation up of biopsies. The invention is distinguished in that the opening (24) in the tubing (20) is located in the envelope surface of the tubing above said lower end (22) of the tubing (20), which end (22) is closed; in that at least the portion (25, 26) of the boundary of the opening (24) closest to said end (22) is designed as a cutting edge; and in that the tubing (20) is displaceable in the longitudinal direction by manipulation at the housing (2) of the endoscopy instrument (1).

Description

Instrument for taking biopsies

The present invention is related to a biopsy device, in particula an instrument for taking biopsies in connection with endoscopy.

Different parts of the gaεtro-intestinal channel may be made available for examination by endoscopy. Endoscopy is carried out with an instrument named an endoscope, which comprises an elongated tubing-like device, which contains fibre-optical cables, both for lighting and for viewing.

Endoscopy is primarily carried out with regard to the oesophagus, stomach, duodenum, colon and urinary bladder.

In addition to these, a number of less usual endoscopic examinations occur, which however are carried out in the same general manner as those referred to above,

In connection with the endoscopic examinations tissue samples are taken for microscopical analysis. Sampling is done with a forceps, a so called biopsy forceps, with which a piece of tissue is taken out from the interior of the body. The tissue sample obtained is named a biopsy. The biopsy is placed in a test tube with transportation and preservation substrate, usually formaldehyde, for microscopical examination.

The endoscopes employed have an approximate length of 1,5-2 m and comprise a channel through which the biopsy forceps can be brought down to the end of the endoscope by means of an operation wire for taking the tissue samples there under the sight of the eye. The operation wire is about 2 m in length and flexible, and has to be removed out of the endoscope after each sampling for enabling collection of the tissue pieces, since the actual biopsy forceps is at the lower end of the operation wire. Thereafter, the forceps is again introduced through the channel and fed all the way to the end of the endoscope for renewed sampling. Regularly, repeated samples are taken from suspected organ portions. Each operation causes a substantial time consumption, in part for removing the forceps and collecting the material and for again introducing the forceps the often 2 m long route through the instrument. During the interval between two biopsies an occluding bleeding can occur and make adequate sampling more difficult.

A substantial time saving could be achieved if the biopsy forceps could remain in its lower position during taking of several biopsies.

Taking tissue samples is a routine measure which, on the average, is done in 50-80% of endoscopies carried out. In Sweden its is a matter of between 10,000 - 20,000 examinations with taking of biopsies/million inhabitants/year.

For endoscopy, several instruments have been developed which function as described above. In addition to what is said above, the outer part of the tubing-like device may be moved by means of knobs at a housing at the other end of the endoscope. Further, there is often an air and water channel and a suction channel running from valves in the housing to the free end of the endoscope.

As an example, it may be mentioned that the company Olympus Optical Co, Ltd., Tokyo, Japan manufactures endoscopy instruments denoted CF Type l TL and GIF Type Q, inter alia.

A sampling instrument which permits taking of several successive biopsies, where the biopsies can be transported up through the tubing one after the other, is previously known, but this instrument does not enable viewing of the sampling area. Sampling is then carried out quite blindly. E.g., a tumour may be of millimetre size, thus disabling adequate sampling without the control of the eye and guiding of the instrument to the suspected area. Further, an endoscopy instrument is previously known from US 4,998,527, which additionally permits taking of several successive samples, where the sampling area can be viewed. This instrument has a mechanically complicated construction, where detachment of a sample is carried out by the lower end of the instrument comprising two concentric tubes, which are provided with openings in the envelope surface of the respective tube, which openings coincide when a sample is brought into the openings, and where the tubes are rotated relative to each other, thus that the openings no longer coincide, whereby detachment of the sample occurs.

These instruments thus have a complicated construction. This renders the parts exposed to the samples difficult to make in disposable design.

Due to the variety of endoscopes, there is a very great number of endoscopy instruments in hospitals around the world which are of the type mentioned initially. These are provided with a channel for bringing down the biopsy forceps, which typically has an inner diameter of 2,3 to 3,2 mm, while the tubing-like device through which the channel runs typically has an outer diameter of 13-15 mm.

The present invention does away with the drawbacks mentioned initially and provides a very simple device with which successive biopsies may be taken and transported up. Further, the device according to the invention may be used together with the multitude of existing endoscopy instruments of the type manufactured e.g. by Olympus Optical Co, Ltd., whereby the sampling area may be viewed and sampling can take place under the control of the eye.

Further, the device according to the invention is substantially simpler and less expensive to manufacture than the biopsy instruments described. The present invention thus relates to a biopsy device intende for endoscopy instruments, which comprise a housing and a tubing like device attached therein, which tubing comprises means fo lighting and viewing and a channel for supply of air and/or wate to the free end of the tubing, as well as a channel intended fo a so-called biopsy forceps, where the biopsy device comprise a tubing with an outer diameter less than the inner diameter o the channel intended for the biopsy forceps, which tubing comprise a channel for transportation up of biopsies, where an openin is present in the tubing near or at the lower end thereof, a which opening a detachmentmeans is present arranged for detachmen of biopsies, and where means are present arranged for providin reduced pressure in said channel for transportation up of biopsies, and is distinguished in that the opening in the tubing is located in the envelope surface of the tubing above said lower end of the tubing, which end is closed; in that at least a portion of the boundary of the opening is designed as a cutting edge; and in that the tubing is displaceable in the longitudinal direction by manipulation at the housing of the endoscopy instrument.

Below, the invention is described more closely in connection with an embodiment of the invention shown on the attached drawings, wherein

Fig. 1 schematically shows a known endoscopy instrument,

Fig. 2 shows a detail view of a part of the device in Fig. 1,

Fig. 3 shows an axial section through a tubing belonging to the invention.

Fig. 4 shows a section along the line A-A in Fig. 3, Fig. 5 shows a section along the line B-B in Fig. 3,

Fig. 6 shows a collection vessel.

In Fig. 1 is shown an endoscopy instrument 1 of a previously mentioned, usually occurring kind. The instrument 1 comprises a housing 2 and a tubing-like device 3 attached therein, which may have a length of 1,5-2 m. Fig. 2 shows a plan view of the lower free end 4 of the tubing. The tubing comprises fibre optical light conductors 5,6 for lighting, and a lens 7 connected to a fibre optical light conductor for viewing. The viewing takes place through an eyepiece 8. Further, the tubing comprises a channel for supply of air and/or water to a mouthpiece 9 at the free end of the tubing. The mouthpiece is arranged to spray air and/or water in a circle sector which may extend as hinted by the dashed lines in Fig. 8.

Further there is a channel 10 for introducing a so called biopsy forceps, which channel as mentioned above typically has a diameter of 2,3 to 3,2 mm. This channel 10 may be connected with a source for reduced pressure by a valve 11. Air and/or water supply to the mouthpiece is controlled by means of a valve 12. The channel 10 opens in a tubular collar 13 in the housing 2.

Air, water and suction connection to the instrument is generally denoted with the number 14.

It is channel 10 in known instruments that is used for introducing the biopsy device according to the present invention in such manner that the lower, free end of the biopsy device projects a portion out of the lower end 4 of the tubing-like device 3, whereby biopsies may be taken.

According to the present invention the biopsy device comprises a tubing 20, the upper end 21 of which projects out of the endoscopy instrument and the lower end 22 of which is shown in Fig. 2. The tubing thus has a length exceeding the length of the channel 10 in the endoscopy instrument 1.

The outer diameter of the tubing 20 is less then the inner diameter of the channel 10 intended for the biopsy forceps. The lower end

22 of the tubing 20 is closed. The tubing comprises a channel

23 for transportation up of biopsies.

An opening 24 is present in the tubing at or close to the lower end 22 thereof, at which opening there is arranged a detachment means for detachment of biopsies. Further, there aremeans arranged for providing reduced pressure in said channel 23 for transportation up of biopsies.

According to the invention the opening 24 in the tubing 20 is located in the envelope surface of the tubing, above said lower end of the tubing which end is closed, where at least a portion of the boundary of the opening is designed as a cutting edge. Preferably, at least the part 25 of the boundary of the opening 24 closest to said end 22 is designed as a cutting edge. Of course, another part of the boundary of the opening, or the entire boundary running around the opening, may be designed as a cutting edge.

The tubing 20 is displaceable in the longitudinal direction by manipulation at the housing of the endoscopy instrument. This manipulation is most suitably carried out manually, simply by the surgeon who is to take a sample pulling the portion 21 of the tubing 20 projecting out of the instrument.

According to a preferred embodiment, said cutting edge 25 is designed with an apex 26 projecting in the direction away from the lower end of the tubing.

According to a preferred embodiment, said opening 24 viewed in a cross-section through the tubing, see Fig.5, occupies a circular arch less than 180° but more then 60°, preferably about 90°. Further, the opening 24 has a length in the axial direction of the tubing 20 which at least corresponds to the diameter of the tubing. The opening may be e.g. 2-6 mm wide and have an axial extension of 4-6 mm.

The edge or knife 25 is of thin material and is curved to a shape corresponding to the envelope surface of the tubing.

According to one embodiment, the tubing 20 is in disposable design in a plastic or similar material. Herby, the tubing, including the opening and the edge or knife 25 may be made of the same material, such as a plastic material. Such plasticmaterial howeve should have the ability of being moulded or sharpened to sufficient sharpness to obtain a sufficiently sharp edge.

According to another embodiment, the lower part of the biops device is made up of a unit comprising the opening and bein releasable from the remainder of the tubing, which unit is mad in re-usable design. This is illustrated with dashed lines i Fig. 3, where the lower part corresponds to the part shown wit continuous lines and where the tubing is illustrated with dashe lines. For example, the lower part may be provided with a round going elevation 27 intended for cooperation with a correspondin groove 29 in the lower part 28 of the tubing, thus that the lowe part is snapped into the lower end 28 of the tubing. Also a scre joint or a bayonet joint is contemplated for joining the lowe part with the tubing. In this design, the tubing may be of flexible plastic material, while the lower part with the edg is made of a metal material.

According to an important embodiment of the invention, the tubing, from the cutting edge of the opening towards the lower end of the tubing, has a greater diameter than the remainder of th tubing, thus that the edge is radially outside the envelope surface of the remainder of the tubing. In Fig. 3, the tip of the edge is at a distance C outside the envelope surface. This implies that it is easy to detach samples from soft tissues and that it is easy to scrape off a sample from a hard tissue such as a tumour.

The upper end 21 of the tubing is connected in use to a source for reduced pressure of suitable known kind, not shown, to obtain an air current from the lower end of the tubing 20 towards the source for reducedpressure. Hereby, reducedpressure is produced at the opening 24, which causes a part of the tissue to be sucked in through the opening 24. After this having taken place, the surgeon pulls the tubing in the part thereof located at the instrument, whereby the edge cuts off the tissue. The detached part is transported up thereafter, by action of the air curren in the channel.

If a biopsy is difficult to transport due to too small air curren in the channel 23, the surgeon may use valve 12 to spray throug the mouthpiece 9 air or water, which is sucked in through th opening 24.

According to a preferred embodiment, the tubing 20 is however internally treated in such way that its inner surface shows lo frictions to biopsies. Such a treatment is disclosed in European Patent EP 0,217,771. This treatment renders biopsies more easily transported up in channel 23.

The reduced pressure in the tubing is operated by the surgeon by a suitable known valve or the like, not shown. It is apparent that one skilled in the art may provide several different designs of source for reduced pressure and operation means for producing a desired reduced pressure in the channel.

Between the upper end of said tubing 20 and said source for reduced pressure there is a separation and collection vessel 30, see Fig. 6, for biopsies transported up through the channel 23.

The lid 31 of the collection vessel is provided with two through- going tubes, where one 32 is connected to the upper end of the tubing 20 and one 33 is connected to the source for reduced pressure. A jar 34 is threaded into the lid. The jar contains a liquid of the kind mentioned initially. A net 35 may be present for facilitating location of biopsies collected.

When it is necessary to separate different biopsies taken, the jar 34 is exchanged between each taking of biopsies.

The function of the biopsy device is described in the following in connection with the first embodiment. An endoscopy instrument of known kind is used where the presen biopsy device is introduced through the channel 10 until the lowe end of the tubing projects a portion out of the lower openin of the channel 10.

Thereupon, the endoscope is directed towards a point where a tissu sample is to be taken, thus that the opening 24 faces the tissue

Thereupon reduced pressure is applied in the channel 23 thus tha a tissue sample is sucked into the opening and detached in th manner mentioned. In the case where the tissue is hard, as ma be the case with tumours, the present device allows the surgeo to move the edge back and forth against the tissue from whic the sample is to be taken by moving the upper part of the tubin back and forth. Hereby, the edge will thus make a scraping move ment, where the pieces scraped off are transported up by th reduced pressure prevailing in the channel 23, and is collecte in the collection vessel 30.

It is thus apparent that by the present invention several biopsie may be taken while the biopsy device remains in its position i the endoscope. This advantage is achieved while using existin endoscopes.

It is further apparent, that the present device is extraordinar simple in its construction, compared with the known devices. I is in fact so simple that, it may be made in disposable design, as mentioned above. In spite of said simplicity, one obtains th additional technical effect, as compared with known devices, o facilitating taking of samples from hard tissues.

The present invention is not to be considered as limited to th embodiments given above, but may be varied within the scope se out by the appended claims.

Claims

1. A biopsy device intended for endoscopy instruments, whic comprise a housing and a tubing-like device attached therein, which tubing comprises means for lighting and viewing and a channe for supply of air and/or water to the free end of the tubing, as well as a channel intended for a so-called biopsy forceps, where the biopsy device comprises a tubing with an outer diamete less than the inner diameter of the channel (10) intended fo the biopsy forceps, which tubing comprises a channel fo transportation up of biopsies, where an opening is present i the tubing near or at the lower end thereof, at which openin a detachment means is present arranged for detachment of biopsies, and wheremeans are present arranged for providing reducedpressur in said channel for transportation up of biopsies, characterize in that the opening (24) in the tubing (20) is located in th envelope surface of the tubing above said lower end (22) of th tubing (20) , which end (22) is closed; in that at least a portion (25,26) of the boundary of the opening (24) is designed as a cutting edge; and in that the tubing (20) is displaceable in the longitudinal direction by manipulation at the housing (2) of the endoscopy instrument (1) .

2. A biopsy device according to claim 1, characterized in that said cutting edge (25) is designed with an apex (26) projecting in the direction away from the lower end (22) of the tubing (20) .

3. A biopsy device according to claim 1 or 2, characterized in that the tubing (20) is in disposable design in a plastic or similar material.

4. A biopsy device according to claim 1, 2 or 3, characterized in that the lower end of the device is made up of a unit (20') releasable from the rest of the tubing (20) , said unit comprising the opening (24) , which unit is in re-usable design.

5. A biopsy device according to claim 1, 2, 3 or 4, characterize in that the tubing (20) has been made subject to internal treatmen causing the inner surface thereof to have a low friction t biopsies.

6. A biopsy device according to claim 1, 2, 3, 4 or 5 characterized in that the tubing (20) , from the cutting edg (25,26) of the opening (24) towards the lower end (22) of th tubing, has a greater diameter than the remainder of the tubing thus that the edge (26) is radially outside the envelope surfac of the remainder of the tubing.

7. A biopsy device according to claim 1, 2, 3, 4, 5 or 6 characterized in that said opening (24) viewed in a cross-sectio through the tubing occupies a circular arch less than 180° bu more then 60°, preferably about 90°, and that the opening ha a length in the axial direction of the tubing which at leas corresponds to the diameter of the tubing.

8. A biopsy device according to any of the preceding claims characterized in that between the upper end (21) of said tubin (20) and said source for reduced pressure there is a separatio and collection vessel (30) for biopsies transported up throug the channel (23) of the tubing.