Biopsy device for sampling tissue probes and application of substances in one operation

The invention relates to a biopsy device for obtaining tissue samples with a two- or multi-lumen biopsy cannula including a biopsy channel having over its entire length a constant cross section and at least one application channel and at at its proximal end with connections for a suction and at least one applicator device and provided its front end with a cutting edge, wherein at least one application channel is formed by an eccentric on the biopsy channel wall supposititious pipe.

It is known that various biopsy techniques on the principle of Einkanalnadel with suction and / or cutting apparatus exist for the removal of tissue samples from animal and human organs with and without a trocar. furthermore are known multi-lumen cannulas and needles (DE-C - 818 246 and DE-A - 26 43 594), which are not suitable for a biopsy and drug application in a single operation, however.

For suction biopsy should be noted: The most famous Saugbiopsietechnik based on the principle stated by Menghini (Menghini, G. 1957: Un effettivo progresso nella tecnica della puntura biopsia del fegato Rass Fisiopat clin Ter 29 756.....). It is a holding on average 1.4 mm in diameter hollow needle with an approach possible for a syringe with which to pierce the skin and before the actual organ puncture a negative pressure (suction) is applied. The organ puncture (liver) is then carried out with sustained suction in a split second.

For cutting biopsy should be noted: The core needle biopsy is done in principle with a zugeschliffenen at the front end cannula. Cutter and lumen of the cannula are protected during the puncture operation by an inserted into the cannula lumen stylet is removed after the puncture. Only then is from the punctured organ under suction with rotating, forward facing movement, a cylindrical piece of tissue excised (eg: Tru-Cut needle, Fa Travenol®.).

In all currently available biopsy techniques must be expected complications, depending on the type of puncture (such as to be punctured organ and technique) and the general condition of the patient. The main complications of suction biopsy of the liver primarily provide excessive bleeding, biliary peritonitis and the pneumothorax is (Lindner, H. 1967: limits and dangers of percutaneous liver biopsy with the Menghini needle Dtsch med Wschr 39, 1751; Piccinino.... , F., E. Sagnelli, Pasquale, G., G. Giusti 1986. Complications Following percutaneous liver biopsy J. Hepatology 2, 165). Cutting biopsies from lung tissue have a relatively high rate of complications by bleeding events and pneumothorax on (McEvoy, RD, Begley, MD, Antic, R. 1983: Percutaneous Biopsy of Intrapulmonary Mass Lesions Cancer 51 2321.). severe bleeding also for kidney biopsies and biopsies of other organs in the first place is considered most important complication.

To address these complications, the subsequent sealing of the puncture channel was recommended with absorbable material, in particular disregard keep bleeding complications (Riley, SA, Irving, HC, Axon, ATR, Ellis, WR, Lintott, DJ, Losowsky MS 1984: Percutaneous liver biopsy with plugging the needle track: a. safe method for use in patients with impaired coagulation Lancet, August 25, 1984, 436). However, such techniques require a long residence time of the puncture needle in the body, which in particular in liver punctures a renewed cause for complications represents (Thaler, H. 1982: liver biopsy, Springer-Verlag, Heidelberg-New York).

a doppellumige puncture needle for oocyte retrieval in the context of in vitro fertilization is described with a größerlumigen suction channel for sucking the follicle contents and a kleinerlumigen irrigation channel for supplying drilling fluid in the Follikelinnere 35 22 782 - From the earlier priority subsequently published document DE-A. The puncture needle is designed as a double-walled pipe, which consists of two coaxial and firmly mated tubes. The puncture needle has a sharpened pointed tip with hollow ground, the cutting edge is formed by the outer tube.

The invention has as its object to provide a biopsy device of the type described above, with both the extraction of tissue samples and the application of substances in a single operation in a very short time (less than 1 s) is possible.

This object is achieved in that the cutting alone is formed by an acute angle formed end of the biopsy channel wall and projecting the biopsy channel wall with their cutting from the tube and the tube end with the Biopspiekanalwand an obtuse angle.

Preferably, the biopsy channel wall ends at right angles to the longitudinal axis of the biopsy channel.

the biopsy channel wall in the cross section advantageously is partially flattened so that between the flattened side of the biopsy channel and the tube wall, an application channel is formed and there is a surface contact between the non-flattened side of the biopsy channel and the tube wall.

A preferred embodiment is characterized in that on the needle in a known manner a two-part contacting mechanism is fastened, wherein the proximal portion is fixedly connected to the cannula and the distal movable part is held by a spring in the initial position, so that after reaching a predetermined penetration depth of this part is moved through the body surface so that one or more contacts between the proximal rigid and the distal moving part to be closed, allowing the control of an application system depends on the penetration depth and puncture speed, and further by reaching the stop of the distal the movable part to the proximal part of the puncture depth is limited.

An embodiment of the Biospieeinrichtung is shown in the drawing. Fig. 1 shows a longitudinal section and Fig. 2 a cross section according to the line II-II of FIG. 1 of the cutting end of a two-channel needle. It further demonstrate the Fig. 3 a longitudinal section through a contact mechanism, and Fig. 4 is a view of the same for the illustrated in FIGS. 1 and 2 two-channel needle.

The puncture needle includes a biopsy channel 1, which also detected the largest needle transverse diameter, on. As shown in FIG. 1, the separation with respect to the application channel 2 is made such that the biopsy channel 1 no rough edges occur, which could cause deterioration in quality of the tissue samples. As an application channel acts a separated from the main channel of smaller area of ​​the puncture needle. The separation of the channels is effected by two mutually adapted, eccentric, one into thin-walled tubes.

The cutting end is formed solely from the perpendicular to the longitudinal axis ending biopsy channel 1, the wall of which is cut at an acute angle. The resultant by an eccentrically about the biopsy needle wall supposititious pipe application channel 2 does not reach the cutting end. Its wall is honed obtuse at the end, so that a smooth transition of the outer wall of the biopsy channel 1 in the outer wall of the application channel 2 is in the section, in which touch both channels causes.

On approach the end of the needle (Fig. 3, 4) there is a lumen of the needle is not completely occlusive bolt 7 which in the case 3 connectable vacuum system (eg syringe with lock) prevents aspiration of the tissue sample. 4 illustrates the approach way for an application system whose arrangement and design (eg, cone, thread, etc.) to the respective requirements (eg pressurized system) can be adjusted. Limiting the puncture depth and the control of the application system is performed by a needle seated mechanism, consisting of a fixed to the cannula and one or more contact points having part 6 and one or more contact points having movable part 5, which is held by a spring 8 in the starting position becomes. After reaching a certain puncture depth part 5 after contact with the body surface moves towards part 6 until the stop is reached and the contact is closed. The number of array of contact points can be adapted to the requirements for the control of the application system. Instead of the outlined electrical control system, a mechanical system is conceivable, without affecting the essence of the invention undergoes a change.

The puncture is made after the Menghini technique in which, after piercing the skin, a vacuum is generated by means of an attached at the position 3, lockable syringe. Then the needle is further inserted into the to be punctured tissue (organ). After reaching the stop 5, the needle is immediately withdrawn. The injection of substances (eg, blood clotting agents, vasoactive drugs, cytostatics, antibiotics, etc.) is automatically triggered by the triggering mechanism upon reaching a predeterminable penetration depth.

The design allows for tissue removal and coordinated with the puncture procedure application of substances in a single operation. Thereby, the engagement time is significantly reduced as compared to previously known methods. The arrangement of the channels ensured despite the presence of additional channels have a minimum overall diameter cannula while maintaining quality of taken for histological evaluation tissue sample. This needle allows among others the simple sealing of the puncture channel with coagulation-active substances. The indications for punctures can be substantially expanded, which means an improved diagnosis and treatment.