Biopsy device.

(42) Date of commencement of the patent: 15. 2.1993 (45) Date of issue: 25.10.1993

<td>(56) Documents:</td><td>(73) Patent owner:</td>

<td>EP-A2 243341 GB-PS1569150 US-PS4850373 US-PS 4693257 US-P54096860 US-PS3477423</td><td>IMMUNO AKTIENGESELLSCHAFT A-1221 VIENNA (AT).</td>

<td></td><td>(72) Inventor:</td>

<td></td><td>THINGS HANS PETER DR. GRAZ, STYRIA (AT). ZATLOUKAL KURT DR. GRAZ, STYRIA (AT). HABISON GEORG DIPL.ING. DR. VIENNA (AT).</td>

(54) BIOPSY DEVICE (57) A biopsy device for obtaining a tissue sample and applying at least one substance in a single operation has a biopsy cannula (1) forming a biopsy channel and is provided with a tissue-severing cutting edge (3) and an application channel (9).

In order to be able to equip conventional biopsy instruments of various designs in a simple manner with an application channel, the application channel (9) is formed as a gap surrounding the biopsy cannula (1), which is delimited by an application tube (6) pushed over the biopsy cannula 1, whose front end (7) is set back relative to the cutting edge (3) of the biopsy cannula (1) and at the opposite end of which a connecting piece (11) is provided for connecting at least one line conveying the substance (s) to the application channel (9), which fitting

QQ (11) is tightly connected to the application tube (6) and is penetrated by the biopsy cannula (1) and sealed against the biopsy cannula (1).

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AT 396 548 itsems

The invention relates to a biopsy device for obtaining a tissue sample and application of at least one substance in one operation, with a biopsy channel forming and a tissue-severing cutting having biopsy cannula and with an application channel for application of a blood clotting substance.

A biopsy device of this kind is known from EP-A 0 243 341.

This known biopsy device for suction biopsy is formed according to a special embodiment of two nested pushed tubes, wherein the outer tube has a circular cross-section and the inner tube is spaced from the outer tube over a partial circumference of its cross section over its entire length. The inner tube serves to receive the tissue sample with the aid of a suction device, and the space formed between the inner tube and the outer tube serves to apply a substance, preferably a blood coagulation substance, for sealing the defect formed by the biopsy device in the tissue.

The invention aims a further development of this known biopsy device to the effect that the production of the biopsy device is substantially simplified; In particular, conventional biopsy needles of different »design should be able to be equipped in a simple manner with an application channel, without structural changes and special training on conventional biopsy needles are required. Thus it should be possible with the biopsy device according to the invention not only to equip biopsy needles for suction biopsy (with or without stiletto) with an application channel, but also to provide cutting biopsy needles (with or a stiletto), for example cutting biopsy needles according to US Pat. No. 3,477 423rd

This object is achieved according to the invention that the application channel is designed as an annular gap surrounding the biopsy cannula, which is delimited by an application tube pushed over the circular cross-section biopsy cannula, whose front end is set back in a known manner with respect to the cutting edge of the biopsy cannula and at the opposite end of which a connecting piece is provided for connecting at least one line conveying the substances to the application channel, which fitting is tightly connected to the application tube, and that the biopsy cannula pierces the Anschluß25 piece and is sealed against this

This biopsy device according to the invention allows the placement of an application tube on conventional biopsy needles regardless of their mode of operation (suction or cutting biopsy, with or without stiletto or systems with a trocar) and regardless of their length. The fact that the biopsy channel forming biopsy cannula passes through the fitting, can be easily a seal between them

Arrange the biopsy cannula and the connector for sealing and fixing the application channel, without structural changes must be made to the biopsy cannula. The annular gap formed between the biopsy cannula and the application tube can be dimensioned very narrow, so that there is an only slightly larger than conventional biopsy cannulas enlarged outer diameter of the biopsy device according to the invention. Nevertheless, the substance to be administered can be properly supplied to the body tissue. A particular »advantage of the biopsy device according to the invention is the fact that biopsy needles arranged in the interior of the biopsy cannula cutter such. B.Tru-cut biopsy needles can be provided with an application channel, so that even in this type of biopsy needles, the advantage of applying a blood clotting substance, fully comes into play.

From GB-PS 1 589 150, US-PS 4,096,860 and US-PS 4,224,943 double-lumen catheters are known, which are formed by two concentrically arranged needles. However, these double lumen catheters have only a very short length, since they are used near the skin surface. The tube ends of the two mutually concentrically arranged tubes are as far away from each other as possible to ensure a proper blood circulation, which is formed by blood flowing out through a cannula and the second cannula returned blood. Tissue-separating blades must be avoided in such dual-lumen catheters so as not to cause obstruction of any of the cannulas. In addition, there are certain requirements for the size of the cross sections in the case of double-lumen catheters for the purpose of ensuring blood circulation.

According to a »preferred embodiment, the connecting piece according to the invention T- or Y-shaped and has a straight tube part through which the biopsy cannula protrudes, at one end of the

Application tube is sealingly fixed and its opposite end is sealed against the »biopsy cannula and opens into the straight pipe part of a straight pipe part projecting pipe part to which at least one substance (s) to the application pipe conveying line can be connected.

Hiebei is expedient to seal the fitting relative to the biopsy cannula at a concentric with the biopsy cannula end of the fitting a nut having a central passage for the biopsy cannula and one between the nut and the fitting and by tightening the

Mutt »deformable seal provided, wherein advantageously the mother is designed as a union nut.

Advantageously, the deformable seal made of elastic plastic, such as silicone od »polyurethane formed. According to a preferred embodiment, the connecting piece with the application tube by a

Adhesive connection connected or poured directly into the connector.

A further preferred embodiment is characterized in that the connecting piece is connected to the application tube by a mechanical connection, such as a screw, plug or lockable connector

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This has the advantage that the diameter and the length of the application tube for one and the same connector are freely selectable and can be selected according to the biopsy needle to be provided with an application tube.

Advantageously, the projecting tubular part of the connecting piece is provided with a Luerkonus.

As already mentioned, special advantages arise when the biopsy cannula and the application tube have a circular cross-section, wherein expediently the inner diameter of the application tube to the outer diameter of the biopsy cannula is in a ratio of 1.05 to 1.5.

The biopsy device according to the invention is suitable for suction biopsy when the biopsy cannula can be connected to a suction device.

For the purposes of cutting biopsy advantageously within the biopsy cannula longitudinally displaceable with a cutting or tissue penetrating tip needle is provided, which is provided at its front end with a recess for receiving a tissue sample, the recess of aa position within the biopsy cannula in a outside the biopsy cannula lying position and back is displaceable.

A particularly easy penetration of the biopsy device is made possible when the front end of the application tube is formed inclined to the longitudinal axis.

The invention is explained in more detail below with reference to an embodiment shown in the drawing, wherein Fig. 1 shows a longitudinal section through the biopsy device shown enlarged and Fig. 2 shows a detail (I) of FIG. 1 on an enlarged scale. FIG. 3 shows a modified embodiment analogous to FIG. 2.

The biopsy device according to the invention has a biopsy cannula (1) with advantageously circular cross-section. The front end (2) of this biopsy cannula (1) is formed as a cutting edge (3), which is arranged to the longitudinal axis (4) of the biopsy cannula (1) either at right angles or obliquely or curved.

The rear end (5) of the biopsy cannula (1) can be connected in a known manner to a suction device, which is not shown in detail.

This rear end (5) could also be equipped with a contact mechanism for limiting the puncture depth, similar to α shown in EP-A 243 341.

About the biopsy cannula (1) is also a suitably circular cross-section exhibiting application tube (6) pushed, whose length is shorter than that of the biopsy cannula (1), d. H. the front end (7) of the application tube (6) ends at a small distance (8) behind the cutting edge (3) of the biopsy cannula (1). This end (7) is (according to embodiment Fig. 2) at right angles to the longitudinal axis (4) and obliquely ground, wherein the front end is rounded, so that the tissue from the application tube (6) is urged outwards and not in between the biopsy cannula (1) and application tube (6) formed annular Application channel (9) can penetrate.

The rear slightly flared end (10) of the application tube (6) is cast in a connecting piece (11) - it could also be glued -, which fitting (11) a rectilinear, in the direction of the longitudinal axis (4) extending tubular member (12) with a central through-channel (13) for the biopsy cannula (1) has at the rear end of the tube part (12) a union nut (14) is screwed. Between the union nut (14) and the rear end face (15) of this tube part (12) is an elastically deformable seal (16) made of plastic, preferably made of silicone or polyurethane, arranged tightening the nut against the pipe part (12) causes a deformation of the elastic seal (16) and thus a dense concern and a fixation on the outside of the biopsy cannula (1).

On the straight, provided with the central passage channel (13) tube part (12) of the connecting piece (11) has a laterally projecting pipe part (17) is formed, the inner channel (18) opens into the central passageway (13) At the outer end of this pipe part (17) expediently provided with a Luerkonus (19) for applying an application device. The application device can also be fastened to the pipe part (17) with a screw-on, plug-in or lockable plug connection.

According to the embodiment shown in FIG. 3, the front end (7 *) of the application tube (6) is bevelled. It extends approximately parallel to the cutting edge (3) of the biopsy cannula (1). As can be seen in FIGS. 2 and 3, the polished section of the end (2) of the biopsy cannula (1) is struck at an angle (α) which is sharper than the angle between the end face of the application tube (6) and its longitudinal axis (4) ).

The invention is not limited to the embodiments shown in the drawing, but can be modified. For example, it is possible, instead of the illustrated connection between the application tube (6) and connector (11) to provide a mechanical connection, such as a screw, plug or lockable connector so that in one and the same connector (11) different application tubes (6) can be used, the inner diameter optimally to the outer diameter of the biopsy cannula or whose length is adapted to the length of the biopsy cannula Instead of the suction biopsy cannula (1) shown in the drawing, a cutting biopsy cannula can be provided, as described for. B. in US-A-3 477 423

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