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

p0001The invention relates to a biopsy device for obtaining tissue samples and application of substances in a single operation. 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 Pat. No. 818 246 and DE-OS 2,643,594), which are not suitable for a biopsy and drug application in a single operation, however.

p0002For 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.

p0003For 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, which is removed after the puncture. Only then is from the punctured organ under suction with rotating, forward facing movement, a cylindrical piece of tissue cut out (for example: Tru-Cut needle, Travenol).

p0004In 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 filters primarily represents (Lindner excessive bleeding, biliary peritonitis and pneumothorax, H. 1967: limits and dangers of percutaneous liver biopsy with the Menghini needle Dtsch.med.Wschr 39, 1751; Piccinino.. , F., E. Sagnelli, Pasguale, 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 employ a long residence time of the puncture needle in the body ahead of what particular liver punctures a renewed cause for complications represents (Thaler, H. 1982: Liver biopsy Springer-Verlag Heidelberg-New York..).

p0005To avoid the above complications has been found that with a biopsy device mehrkanäligen both the removal of tissue samples and the application of substances in a single operation in a very short time (less than one second) is possible. The biopsy device according to the invention characterized in that a biopsy needle is provided, the second over its longitudinal extension for forming a biopsy channel and one or more rer application channels or is executed mehrlumig, wherein at least the transverse diameter of the biopsy channel is maintained over the entire length of the cannula, and further moved into a cross-section on a longitudinal plane of the full cannula diameter, wherein the inner boundary of the Kanülenlumina carried by a continuously merging into the cannula outer wall partition, so that the biopsy channel not having the quality of the tissue sample interfering corners or edges, and further biopsy and application channel or application channels in area of ​​the cannula tip to communicate, and also at the proximal end of the cannula connections for suction and application devices exist.

p0006Three embodiments of the biopsy device illustrated in the following drawings. Shown are FIG. 1 a longitudinal section through a two-channel puncture needle, Fig. 3 shows a cross section in the area of ​​dual-channel needle along the line B in Fig. 1 and Fig. 2 shows a cross section of the two-channel needle in the region of the lug means for generating a positive and / or negative pressure along the line a of Fig. 1, Fig. 4 is a front view of the two-channel version, Fig. 5 shows a longitudinal section of a three-channel puncture needle, Fig. 7 shows a cross section in the area of ​​three-channel needle along the line B of FIG. 5, FIG. 6 shows a cross section the three-channel needle in the region of the lug means along the line a of Fig. 5, Fig. 8 is a front view of the three-channel version. FIG. 9 is a longitudinal section, FIG. 10 illustrates the cross-section on the line BB of the cutting end of a two-channel needle.

p0007The puncture needle consists of a biopsy channel -1- which also detected the largest needle transverse diameter. As shown in Figures 3 and 7, the separation is carried out with respect to the application channel -2- or against the application channels -2 a, 2 b by -an partition -9 such that the biopsy channel -1- no rough edges occur, that could cause quality deterioration 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, for example, by two mutually adapted, eccentric telescoped walled tubes (Figure 9, Figure 10) can be effected. In the examples shown in Figures 1 to Figure 8, the partition wall between -9 biopsy channel -1- -2- and application channel or application channels ranges - 2 a, 2 b is not right up to the cut end of the cannula zoom, so biopsy channel -1- and application channel (channels) -2, 2 a, 2 b in the region of the needle tip with each other. The outer wall of the application channel -2- or application channels -2 a, 2 b directed in the area of ​​the tip inward, so that the cutting end extends to the course of the biopsy channel -1-. The cut of the needle according to the usual for suction or cutting biopsy guidelines.

p0008The embodiment of the biopsy apparatus corresponding to the section shown in Figure 9 and in longitudinal -.. In cross section line BB shown Fig 10 of _Fig. 9 shows that the cutting end is formed solely from the perpendicular ending to the longitudinal axis biopsy channel -1- whose wall is cut at an acute angle, and that the resultant by an eccentric on the biopsy needle wall supposititious pipe application channel -2- does not reach the cutting end and its wall is honed obtuse at the end, so that a smooth transition of the outer wall of the biopsy channel is -1 in the outer wall of the application channel in the section in which touch both channels, causing -2-.

p0009On approach the end of the needle (Fig. 1,2,4,5,6,8) is a lumen of the needle is not completely occlusive bolt -7-, the aspiration of the tissue sample in the case - 3- connectable vacuum system (for example, syringe with lock) prevents. -4- Represents the approach way for an application system whose arrangement and design to the respective requirements (eg pressurized system) can be adjusted (for example, cone, thread, etc.). 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, by a spring -8- is held in the starting position. After reaching a certain puncture depth is 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.

p0010The puncture is made after the Menghini technique in which, after piercing the skin, a vacuum is generated by means of an attached at the location -3-, lockable syringe. Then the needle is further inserted into the to be punctured tissue (organ). After reaching the stop -5- the needle is withdrawn immediately. The injection of substances (for example, blood clotting agents, vasoactive drugs, cytostatics, antibiotics, etc.) is automatically triggered by the triggering mechanism upon reaching a predeterminable penetration depth.

p0011The design allows for tissue removal and coordinated with the puncture procedure application of substances in a single operation. Thus the procedure time is shortened strongly ver 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 usually permits easy sealing of the puncture channel with coagulation-active substances. The indications for punctures can be substantially expanded, which means an improved diagnosis and treatment.