Biopsy forceps

Abstract

The invention relates to biopsy forceps for excision of a tissue sample, comprising at least two forceps jaws which are mounted so as to be reversibly pivotable between an open and a closed position by means of pivot kinematics, of which at least one forceps jaw has a concave contour which, in the closed position, encloses a resection volume in cooperation with the at least one other forceps jaw. The invention is characterised in that a cutting device is provided which is connected or can be operatively connected to at least one of the forceps jaws in such a way that the cutting device divides the resection volume into two resection partial volumes in the closed position of the at least two forceps jaws and separates a tissue sample located in the resection volume into two tissue sample parts by mechanical cutting.

Description

[0001] Biopsy forceps

[0002] Technical field

[0003] The invention relates to a biopsy forceps for excising a tissue sample with at least two forceps jaws which are reversibly pivotable between an open and a closed position via a pivoting kinematic mechanism, at least one of which forceps jaws has a concave contour which, in the closed position, in conjunction with the at least one other forceps jaw, encloses a resection volume.

[0004] State of the art

[0005] Biopsy forceps for excising tissue samples are known in a wide variety of designs. Typical characteristics of all biopsy forceps include at least two jaws pivotally mounted around an axis, which can be reversibly moved from a closed to an open position via a hinge mechanism. This movement is achieved by control elements connected to and extending proximally from the hinge mechanism, for example, in the form of cables or control rods, which are connected to a manual actuating device, such as a scissor handle.

[0006] The vast majority of known biopsy forceps have two hemispherical jaws which, in the closed position, enclose a capsule- or pill-shaped resection volume. Both jaws feature blade-like cutting edges to ensure minimal tissue damage during resection. These edges preferably completely surround the hemispherical jaws and come into direct contact when the jaws are closed.

[0007] A known biopsy forceps is disclosed in US patent 4,817,630, which has two semi-circular jaws pivotally connected by a hinge mechanism. Additionally, the known jaw has a spear-like projection located centrally between the two jaws, which, when the jaws are open, penetrates the area of ​​tissue to be sampled and fixes it relative to the closing jaws within the resection volume formed by the closing jaws.

[0008] Comparable biopsy forceps can be found in the following publications: EP 1 221 896 B1 , EP 2 083699 B1 , EP 3 967 243 A1 .

[0009] All known biopsy forceps are based on the resection goal that the tissue sample taken from a specific tissue area ideally corresponds in shape and size to the resection volume enclosed by the forceps jaws.

[0010] The tissue sample, taken extracorporeally using biopsy forceps, undergoes histological examination to identify malignant or otherwise diseased tissue areas or structures. For this purpose, the tissue sample is usually prepared for optical microscopic examination and stained with high contrast using appropriate staining techniques to visually distinguish different tissue structures. Among the numerous staining methods, hematoxylin and eosin (H&E) staining has become the widely used standard histological examination.

[0011] Histological screening methods based on the aforementioned hematoxylin and eosin (H&E) staining are all subject to the visual judgment of the person performing the screening and thus represent subjectively qualified statements. As an alternative or supplement to conventional screening methods based on H&E staining, Raman spectroscopy, including stimulated Raman histology (SRH), offers a safe, objective, and reliable tissue analysis. Raman spectroscopy enables tissue examination for the purpose of tissue identification based on the interaction of monochromatic light and the molecules contained in the material or tissue, which are capable of scattering the incident light in a molecule-specific manner. In particular, stimulated Raman histology (SRH), a laser-based optical imaging technique, offers the possibility of obtaining an intraoperative diagnosis within minutes.

[0012] To significantly improve the reliability of histological analysis results on a tissue sample, it is possible to perform both the visually supported analysis method based on the HE staining technique and a tissue examination based on Raman spectroscopy.

[0013] A particular challenge when applying both examination methods to a tissue sample lies in the ideal requirement that the tissue area to be analyzed using both methods should be as identical as possible. This requirement could be met by first subjecting a specific tissue sample to Raman spectroscopy and subsequently to a standardized visual tissue examination based on hematoxylin and eosin (H&E) staining. However, this presupposes that the tissue sample does not undergo any degradation as a result of the Raman spectroscopy. Furthermore, when performing histological examinations of tissue samples, there is often a desire to carry out the analyses as quickly as possible, especially in cases where the analysis result is needed during a surgical procedure in which a tissue sample was taken. Description of the invention

[0014] The invention is based on the objective of providing a medical instrument with which it is possible to obtain a tissue sample from a tissue area by means of excision and to prepare it with as little crushing as possible, so that two tissue sample surfaces that are as identical as possible and can be handled separately are obtained. Both tissue sample surfaces can subsequently be examined histologically at the same time, so that one can be analyzed by visual tissue examination based on hematoxylin and eosin (H&E) staining and the other by Raman spectroscopy using identical tissue sections.

[0015] The solution to the problem underlying the invention is specified in claim 1. Advantageously developing features of the invention are described in the dependent claims and the further description.

[0016] The invention is based on the idea of ​​giving a further, novel function to a biopsy forceps known per se, which is able to separate a tissue sample enclosed by the at least two jaws of the biopsy forceps and separated from a surrounding tissue area by means of excision into two parts, each forming a tissue sample surface.

[0017] A solution-type biopsy forceps for excising a tissue sample, comprising at least two forceps jaws reversibly pivotable between an open and a closed position via a pivoting kinematic mechanism, at least one of which has a concave contour which, in the closed position, in conjunction with the at least one other forceps jaw, encloses a resection volume, is characterized by the provision of a cutting device which is connected or can be brought into operative connection with at least one of the forceps jaws such that the cutting device divides the resection volume into two resection part volumes in the closed position of the at least two forceps jaws and separates a tissue sample located in the resection volume into two tissue sample parts by mechanical cutting.With the biopsy forceps designed for this purpose, it is possible to separate a tissue sample from a preferably intracorporeal tissue environment in a manner known per se and to fully enclose it within the resection volume within the closed jaws of the forceps. Using the additional cutting device, which is designed either as an integral component of the biopsy forceps or as a separate component, the tissue sample enclosed by the jaws of the biopsy forceps is separated into two tissue sample parts by cutting, forming two mirror-image, but otherwise identical, tissue sample surfaces.Since the separated tissue sample is located within the closing or already closed jaws of the forceps while being cut into two parts, any crushing effects caused by the cutting process are largely minimized. This is especially true because any pressure and shear forces generated by the cutting process and directed at the tissue sample are immediately and completely absorbed and supported by the inner wall of the jaws encompassing the resection volume. In this way, the tissue sample retains its shape and structure even after being cut.

[0018] After opening the biopsy forceps, both separated tissue sample parts can be removed. This allows the mirror-image, but otherwise identical, tissue sample surfaces of the two parts to be simultaneously subjected to visual examination using hematoxylin and eosin (H&E) staining and Raman spectroscopy. Raman spectroscopy / SRH, in particular, enables diagnosis within 3 to 4 minutes, significantly accelerating treatment and increasing certainty in the selection of therapeutic options. Furthermore, the concurrently obtained diagnostic result from the standard H&E staining method offers a second, independent diagnostic option for the same tissue sample surface, which differs from the surface examined by Raman spectroscopy only in that it is a mirror image.In a first preferred embodiment, the cutting device is inseparably connected to at least one jaw of the biopsy forceps.

[0019] The cutting device has at least one planar separating element with a cutting blade which is firmly attached to one of the jaws of the pliers such that the planar separating element separates the resection volume into the two resection partial volumes in the closed position of the at least two jaws of the pliers, wherein the cutting blade rests flush against a surface contour of the other jaw of the pliers oriented towards the resection volume.

[0020] Preferably, the cutting device is mounted centrally along one jaw of the pliers, so that when the jaws of the biopsy forceps are closed, the cutting device divides the resection volume into two equal halves, so that the tissue sample separated by the biopsy forceps by excision is cut by the cutting device into two equal, symmetrical halves of the tissue sample.

[0021] Of course, different divisions of the resection volume using the cutting device are also conceivable or desirable, e.g., such that the tissue sample intended for Raman spectroscopy should be smaller, e.g., have a thickness of about 250 pm, than the tissue sample intended for HE examination, e.g., with a thickness greater than 1 mm.

[0022] Preferably, the flat separating agent is bonded to one of the at least two jaws of the forceps, preferably monolithically, with its cutting blade oriented towards the opposite jaw. The shape and size of the flat separating agent are adapted to the inner contour of the jaws that completely encompass the resection volume when the biopsy forceps are closed. The flat separating agent extends beyond the resection volume bounded by the jaw to which the cutting device is attached. The portion of the flat separating agent projecting beyond the jaw has a cutting blade oriented towards the opposite jaw, which, when the biopsy forceps are closed, rests flush against the inner surface contour of the opposite jaw.This ensures that the tissue sample enclosed within the jaws of the pliers is completely cut into two tissue sample parts, e.g. two tissue sample halves, by the closing movement of the jaws and the associated penetration of the cutting device by the tissue sample.

[0023] Alternative designs regarding the shape and size of the flat separating element permanently attached to one of the at least two jaws of the pliers are conceivable. For example, one possible design features a flat separating element with a cutting blade on each side of both jaws, permanently bonded to the concave inner wall of the respective jaw, with the cutting blades of these elements touching each other along a line when the jaws are closed. Both flat separating elements can be identical in shape and size or have different, coordinated shapes and surface areas.

[0024] Another alternative involves a groove-shaped recess on the otherwise smooth, concave inner wall of the jaw of the pliers that faces the jaw connected to the flat release agent. This allows the cutting blade of the release agent to engage flush with the groove when the jaws are closed. The groove provides mechanical support for the cutting blade and also facilitates the complete severing of the tissue sample.

[0025] In contrast to a cutting device fixed to at least one jaw of the forceps, another preferred embodiment of a solution-oriented biopsy forceps provides a cutting device that is movable relative to the jaws of the forceps and, in the closed position of the pivotably mounted jaws of the forceps, can be moved from an initial position in which the planar separating agent is located outside the resection volume enclosed by the jaws or only slightly protrudes into the resection volume, to a final position in which the planar separating agent separates the resection volume into two resection sub-volumes.By allowing the flat cutting agent to be inserted into the resection volume completely enclosed by the at least two jaws after the forceps jaws have been fully closed, tissue sample separation using the biopsy forceps is completely unaffected by the cutting device. Only after the forceps jaws have been fully closed and the tissue sample has been taken, i.e., the removed tissue sample is located within the resection volume enclosed by the at least two jaws, does the flat cutting agent of the cutting device penetrate the resection volume and cut through the tissue sample contained therein.

[0026] In a preferred embodiment, the flat separating agent is designed as a component separate from the jaws of the pliers. It can be manually inserted into the resection volume enclosed by the jaws from outside the closed jaws through a slot-shaped recess within at least one of the jaws. For this purpose, the flat separating agent has a thickness corresponding to the width of the slot-shaped recess, plus an additional thickness that allows for largely gap-free and unimpeded insertion of the separating agent into the slot-shaped recess.

[0027] The shape and dimensions of the planar release agent as well as the slot-shaped recess are coordinated in such a way that the planar release agent can be introduced into the resection volume along a movement trajectory that is as linear as possible.

[0028] As an alternative to a separate design of the flat separating element, another design of the biopsy forceps provides for a flat separating element that is inseparably formed and arranged with and relative to at least one jaw of the forceps. Because the flat separating element is inseparably attached to the jaw of the forceps, there is no risk of potential loss of the separating element. Furthermore, handling the flat separating element is considerably simplified, especially since threading a separate flat separating element into the slot-shaped recess is avoided or made easier.

[0029] One possibility for an inseparable, yet relatively movable mounting is to arrange the flat separating agent on the jaw of the pliers which has a slot-shaped recess, via a linear guide, such that the flat separating agent is located outside the resection volume, which is limited on one side by the jaw of the pliers, when the jaws are open, and can be fully inserted into the interior of the resection volume by means of the linear guide when the jaws are closed.

[0030] Another possibility involves an integral arrangement of the flat separating agent within a biopsy forceps designed according to the solution, in which the flat separating agent is mounted so that it can be deflected relative to the forceps jaws. The pivotally mounted forceps jaws, in their closed position, have a longitudinal extension that is oriented from a proximal end of the forceps jaw towards a distal end. The flat separating agent, designed as an integral component of the biopsy forceps, is initially positioned proximal to the resection volume enclosed by the forceps jaws. The flat separating agent remains in this position until a tissue sample is taken with the biopsy forceps and enclosed by the forceps jaws.With the aid of a suitably designed actuating device, which is in operative connection with the flat separating element, the flat separating element can be moved distally into its final position, in which it separates the resection volume into two resection subvolumes. For this purpose, the flat separating element has a cutting blade at least on its end face, oriented towards the distal end of the forceps jaws, by means of which the tissue sample enclosed by the forceps jaws is cut into two tissue sample parts with as little crushing as possible. The flat separating element is also adapted to the geometry of the resection volume enclosed by the forceps jaws in such a way that, in its final position, it lies flush against a surface contour oriented towards the resection volume or against the inner wall of the forceps jaws.

[0031] Another training method for the solution-based biopsy forceps additionally utilizes cryobiopsy techniques, in which a tissue sample is usually taken from an intracorporeally locally shock-frozen tissue area using a cryobiopsy probe by means of a sudden tissue separation, see Böckeler M., Implementation of transbronchial cryobiopsy, Pneumologie 2020; 74: 456-466, but avoids the tissue disruption that occurs when separating the tissue sample from the surrounding tissue.

[0032] For this purpose, at least one of the two forceps jaws has an access opening into the resection volume, or both forceps jaws together define an access opening into the resection volume. Furthermore, a cryobiopsy probe is provided, which is arranged relative to at least one of the two forceps jaws such that the cryobiopsy probe projects into the resection volume through the access opening or is mounted so that it can be passed through the access opening bidirectionally. Preferably, the cryobiopsy probe is mounted so that it can be deflected bidirectionally along a linear axis relative to both forceps jaws and through the access opening.

[0033] For the purpose of tissue sampling, the biopsy forceps are positioned intracorporeally with the jaws closed, such that the jaws are located at or within a target tissue area. After opening the jaws, the cryobiopsy probe is advanced distally into the target tissue relative to both jaws. The probe is advanced manually by actuating an instrument shaft to which the probe is attached distally. The shaft is linearly movable to or within the biopsy forceps and forms a structurally integrated handling unit. Preferably, the shaft and the cryobiopsy probe are linearly movable as an integral component of the forceps within a channel that at least partially traverses the forceps.

[0034] A fluid channel also runs through the instrument shaft, connected proximally to a pressurized gas source, such as a compressed air source or a CO2 or N2 reservoir, and distally via a throttling element within an expansion chamber enclosed by the cryobiopsy probe. The gas source can be controlled via an on / off valve.

[0035] Once the cryobiopsy probe is placed within and surrounded by the target tissue with the forceps jaws open, the cryobiopsy probe is cooled by opening the control valve, causing increasingly frozen target tissue to adhere to and around the cryobiopsy probe as the freezing process continues.

[0036] The size or volume of the frozen target tissue adhering to the cryobiopsy probe depends primarily on the freezing time and should not significantly exceed the resection volume encompassed by both jaws of the forceps. Furthermore, it is desirable that the shape of the frozen target tissue area corresponds as closely as possible to the shape of the resection volume encompassed by both jaws. Additionally, the frozen target tissue should represent a tissue sample that is as homogeneous and uninterrupted as possible. This means that the shape of the cryobiopsy probe should be chosen so that a frozen "tissue bead" forms at its distal tip, preferably in the form of a solid sphere or a solid ellipsoid. A probe shape that tapers distally, e.g., a conical shape, has proven particularly suitable.After the freezing process is complete, the jaws of the biopsy forceps are closed. This occurs either after the jaws are moved distally toward the advanced cryobiopsy probe and / or while the cryobiopsy probe and the frozen tissue sample are fully retracted proximally into the resection volume. The cryobiopsy probe is preferably withdrawn completely proximally through the access opening from the resection volume, which is increasingly enclosed by both jaws, to avoid potential collisions with a cutting device integrated into the jaws. If the cutting device is separate from the jaws, there is no risk of collision.

[0037] By closing the forceps jaws, the frozen biopsy sample is gently separated from the surrounding tissue by means of a cutting process, so that only minimal irritation occurs in the tissue environment, leading to significantly less post-bleeding than in the case of disruptive tissue separation.

[0038] In a preferred embodiment, the cryobiopsy probe can be moved distally relative to both forceps jaws in such a limited manner that the probe achieves a maximum penetration depth into the resection volume encompassed by both jaws. This ensures that, when both jaws are closed, the probe lies within the resection volume without contact with either jaw. In this way, damage to the sharp, blade-like circumferential edges of the concave jaws is avoided. A mechanical stop, for example, located proximally on the instrument shaft, serves as a movement limiter, preventing further distal advancement through the channel that at least partially traverses the biopsy forceps.An alternative preferred application of the solution-shaped biopsy forceps with integrated cryobiopsy probe involves advancing the cryobiopsy probe distally relative to both jaws without any limiting stop. This allows the probe to penetrate and shock-freeze a target tissue area located distal to the jaws. Once a frozen tissue sample bead has formed on or around the cryobiopsy probe, the jaws are closed. Simultaneously, the cryobiopsy probe is pulled proximally along the instrument shaft until it is completely outside the resection volume enclosed by the jaws.

[0039] To ensure that the frozen tissue sample completely separates from the cryobiopsy probe as it is withdrawn from the resection volume through the access port, the access port has a diameter equal to the maximum diameter of the cryobiopsy probe, plus an excess that is solely tolerable for movement; that is, the excess ensures longitudinal displacement of the cryobiopsy probe within or through the access port, which otherwise largely encloses the cryobiopsy probe in a fluid-tight manner.

[0040] Typically, cryobiopsy probes have a maximum diameter of 1.5 mm to 5 mm, so the solution-compatible access opening is dimensioned with an oversize of 5% to 10%.

[0041] A design concept that differs from the contact avoidance described above between the cryobiopsy probe and the cutting device utilizes the cryobiopsy probe as a component of the cutting device, which serves as a kind of counter-support during tissue sample sectioning. One such implementation is illustrated below.

[0042] There is often a desire to mark the intracorporeal tissue sampling site in order to perform control biopsies at a later time after the initial tissue sample collection, or to facilitate subsequent diagnostic and therapeutic steps at the same site. For this purpose, another embodiment provides an opening for an applicator on at least one of the two forceps jaws, or on the biopsy forceps directly adjacent to both jaws, through which a liquid or mechanical marker can be released. A marker known per se is used for this purpose, e.g., in liquid form, as a gel, or in the form of a mechanical biomarker, which usually consists of a biocompatible metal wire. The biomarker preferably comprises radiopaque material, e.g., iodine for X-ray and CT imaging, or nanoparticles with magnetic properties for MRI imaging.

[0043] For intracorporeal marker release at the site of tissue sampling, a hollow channel is formed longitudinally to the biopsy forceps with a distal hollow channel opening that corresponds to the opening of the applicator and is preferably located on the distal side of one of the two forceps jaws.

[0044] The hollow channel also has a proximal opening that is fluid-tightly connected to a reservoir containing a marker fluid or marker gel, or through which a propellant, e.g. in the form of a stylet or similar, can be guided distally into the hollow channel, by means of which a biomarker stored in the hollow channel, e.g. in the form of a three-dimensionally shaped nitinol wire piece, can be released.

[0045] Before the biopsy forceps are removed from the body after tissue sampling, the applicator marks the sampling site by releasing the biomarker. Following marker release, a hemostatic agent, i.e., a hemostasis material, can be applied locally through the applicator, which is designed as a hollow channel. This solution-based biopsy forceps, with all its advantageous configurations, is used for intracorporeal tissue sampling in humans and animals, preferably in brain regions, but not limited to these areas. Ex vivo applications on human or veterinary tissue, or biological tissue from the field of botany, are also conceivable.

[0046] Brief description of the invention

[0047] The invention is described below by way of example, without limiting the general concept of the invention, with reference to the drawings. The drawings show:

[0048] Fig. 1a, b, c Illustrations of a biopsy forceps known per se,

[0049] Fig. 2a Cross-sectional view through a pair of pliers jaws designed according to the solution,

[0050] Fig. 2b Longitudinal view of the pliers jaw designed according to the solution, similar to Fig. 2a.

[0051] Fig. 2c Cross-sectional view of another pair of pliers jaws designed according to the solution,

[0052] Fig. 2d perspective view of the pliers jaw designed according to the solution, similar to Fig. 2c.

[0053] Fig. 3a-c Multi-view drawings of a solution-designed pliers jaw with separate release agent,

[0054] Figs. 3d-f Multi-view drawings of an alternative embodiment of a pliers jaw designed according to the solution with a separate release agent, Figs. 4a-c Schematic sequence image representations of pliers jaws designed according to the solution with an integral release agent,

[0055] Fig. 5 ac. Illustrations of a solution-shaped biopsy forceps with cryobiopsy probe,

[0056] Fig. 6a, b Illustrations of an advantageous embodiment of the biopsy forceps with marking device and

[0057] Fig. 7 Cross-sectional view of another pair of forceps jaws designed according to the solution with cryobiopsy probe as cutting counter-support.

[0058] Ways to implement the invention, industrial applicability

[0059] Figures 1a and 1b schematically depict a biopsy forceps, known per se, for excising a tissue sample in the open position (a) and the closed position (b). The biopsy forceps have two jaws 1 and 2, each shaped like a half-shell, which can be reversibly moved from the open position (see Fig. 1a) to the closed position (see Fig. 1b) by means of a manually operated pivoting mechanism 3. The pivoting mechanism 3 is connected via a force-transmitting element 4 to a proximally arranged manual actuating unit 5, preferably in the form of a scissor handle.

[0060] The jaws of the forceps 1, 2 each have a blade-like cutting contour 6 at their open edge, which, when the jaws 1, 2 are closed, is capable of separating tissue material (not shown) projecting between the jaws 1, 2 from the surrounding tissue by means of a shearing and cutting action. See also the perspective view of one of the two jaws 1, 2 illustrated in Figure 1c, which is preferably designed as a half-shell and whose concave shape limits, for example, half of the resection volume to be enclosed by both jaws 1, 2. While not necessarily required, both jaws 1, 2 are preferably identical in shape and size.

[0061] Starting from a biopsy forceps shown in Figures 1a to c, which are known per se, the biopsy forceps according to the solution differs in that, in addition to the blade-like cutting edges 6 for separating a tissue sample from a tissue environment, a further cutting device 7 is connected to or can be brought into operative connection with at least one of the forceps jaws 1, 2, so that, firstly, the resection volume R formed by closing the forceps jaws 1, 2 and enclosed by the forceps jaws is divided into two resection partial volumes 10, 11 by the cutting device 7, and secondly, the cutting device is able to separate a tissue sample located in the resection volume R into two tissue sample parts by mechanical cutting.

[0062] Figure 2a illustrates a cross-section through two plier jaws 1, 2 joined together in the closed position. In the closed position, the blade-like cutting edges 6 of both plier jaws 1, 2 meet flush and in a form-fitting manner. Additionally, in the case of Figure 2a, the upper plier jaw 2a is fixedly, preferably integrally, connected to the cutting device 7, which in turn consists of a flat separating element 8 and a cutting blade 9 that surrounds the end face of the separating element 8. To illustrate the shape and size of the flat separating element 8 and the cutting blade 9 surrounding its end face, the upper plier jaw 1 is shown in a longitudinal side view in Figure 2b, similar to the representation of the upper plier jaw as shown in Figure 1a.Unlike the known jaw 1, this jaw extends beyond the planar separating element 8 with the cutting blade 9 attached to it, such that the cutting blade 9, when both jaws 1, 2 are closed, makes line contact with the inner wall of the lower jaw 2. In this way, the resection volume R enclosed by both jaws 1, 2 is divided into two partial resection volumes 10, 11, as can be seen in Figure 2a. In a preferred embodiment of the jaw arrangement shown in Figure 2a, the lower jaw 2 has a surface contour in the form of a groove-shaped recess 12 in the area where the cutting blade 9 makes contact with the inner wall of the jaw 2, which enhances the shearing action of the cutting blade 9.

[0063] Figure 2c shows an alternative embodiment of a pliers jaw arrangement 1, 2 designed according to the solution, with a cutting device 7'. Each pliers jaw has a flat separating element 8' with a cutting blade 9', wherein the cutting blade 9' of the flat separating element 8' lies in a plane defined by the blade-like cutting contour 6 of the respective pliers jaws 1, 2. Figure 2d shows a perspective view of one of the pliers jaws 1, 2 for illustration. Naturally, the dimensions and shapes of both cutting devices 7' can be variably selected to be coordinated with each other, provided that the cutting blades 9' contact each other in the closed pliers jaw position and ensure the shearing effect.

[0064] The effect of the solution-based cutting device 7 is that a tissue sample, which can be grasped with the biopsy forceps in the open position, is separated from the surrounding tissue by closing the forceps jaws and is then cut within the forceps jaws 1, 2 into two, for example, equally sized tissue sample parts or halves by means of the solution-based cutting device 7, whereby the tissue sample surfaces of both cut tissue sample parts, formed by the shearing or cutting action of the cutting device 7, are mirror images and otherwise identical. After the biopsy forceps are completely closed, the tissue sample surfaces thus lie directly against the flat separating agent 8 or 8' on both sides and are additionally stabilized by it.

[0065] Another embodiment of the biopsy forceps according to the solution provides a cutting device 7 spatially separate from the jaws 1, 2 of the biopsy forceps, which, after the jaws 1, 2 have been moved into the closed position, is inserted through a slot-shaped recess in one of the two jaws into the resection volume completely enclosed by both jaws.

[0066] Figure 3a shows a top view of an upper jaw 1 of the pliers, which has a longitudinal slot 13. The longitudinal slot 13 preferably extends over the entire length of the resection volume enclosed by both jaws 1 and 2. Figure 3b shows a side view of the jaws 1 and 2 in the closed position, as well as the separately designed cutting device 7', which consists of a flat separating element 8' and a cutting blade 9' circumferentially surrounding its end face. The length and thickness of the flat separating element 8' correspond to the length and width of the slot-shaped recess 13 such that the cutting device 7' can be inserted as flush as possible and with free sliding action into the resection volume R enclosed by both jaws 1 and 2.The wall thickness of the jaw of the pliers 1, at least in the area of ​​the longitudinal slot 13, is preferably chosen to be so large that the slot walls delimiting the longitudinal slot 13 exert a guiding effect centering the planar release agent 8', which supports the most precise possible linear guidance of the planar release agent 8' during its insertion into the resection volume.

[0067] Figure 3c illustrates a longitudinal section through both forceps jaws 1, 2 in the closed position with a cutting device 7' fully inserted into the resection volume, the cutting blade 9' of which lies flush against the inner wall of the lower forceps jaw 2. This ensures that the tissue sample within the forceps jaws 1, 2 is completely separated into two tissue sample parts.

[0068] Figures 3d to f illustrate a cutting device 7” similarly designed separately from the pliers jaws 1, 2; however, in contrast to the embodiment described above according to Figures 3a to c, the slot-shaped recess 13' is arranged transversely to the longitudinal extent of the upper pliers jaw 1, as can be seen in Figure 3d. Figures 3e and f are functionally equivalent illustrations comparable to Figures 3b and c.

[0069] The advantage of a cutting device 7', 7" designed and operated separately from the jaws 1, 2 is that the tissue separation process can be carried out with the aid of the biopsy forceps completely unaffected by the cutting device as provided for in the solution, as is also the case with biopsy forceps known per se.

[0070] If a tissue sample is located within the closed jaws of the forceps, the appropriate cutting device allows the sample to be divided into two separate parts. The complete enclosure of the tissue sample by both jaws ensures that the pressure and shear forces exerted on the sample by the cutting device are evenly absorbed by the inner walls of the jaws. This minimizes or even eliminates any crushing effects on the tissue sample, thus preventing or negligibly irritating delicate tissue structures.

[0071] Another optional embodiment of the separately handled cutting device 7', 7" concerns the formation of the planar separating agent 8', 8" in the form of a light-transparent, thin glass plate, which, in addition to its cutting effect by means of its cutting blade 9', 9", can also serve as a tissue substrate support plate for the subsequent Raman and / or HE examination.

[0072] Figures 4a to c illustrate a cutting device 7'" designed according to the solution in combination with two plier jaws 1, 2, which is arranged to be movable relative to the plier jaws 1, 2 and is designed as a single unit inseparable from the plier jaws 1, 2. Figure 4a shows the open position of the plier jaws 1, 2. The cutting device 7'" is arranged proximal to the plier jaws 1, 2 and does not extend, or only extends slightly, into the area of ​​the resection volume, which is not completely enclosed by both plier jaws 1, 2. The arrows 14 indicated between the cutting device 7'" and the jaws 1 , 2 are intended to illustrate that the cutting device 7'" is linearly movable to and inseparably connected to the jaws 1 , 2 via a kinematic mechanism not shown.In the open position shown in Figure 4a, a tissue sample is taken between the two forceps jaws 1, 2, which is then moved to the closed position, as shown in Figure 4b, to separate the tissue sample from the surrounding tissue. At this stage, the cutting device 7'" is still located proximally outside the closed forceps jaws 1, 2 or extends only slightly into the resection volume enclosed by both forceps jaws 1, 2.

[0073] Figure 4c illustrates a cross-sectional view through the forceps jaws 1, 2 in the closed position. It also shows that the cutting device 7'" is inserted into the resection volume R enclosed by both forceps jaws 1, 2 by a complete distal advance relative to the forceps jaws 1, 2. During the distal advance, the cutting device 7'" with its cutting blade 9'", located at its end face on the flat separating element 8'", cuts through the tissue sample within the resection volume.

[0074] To enable linear guidance of the cutting device both distally and proximally relative to the forceps jaws 1, 2, a separate, preferably manual, operating unit 15 is used. This unit is designed and arranged separately from the manual actuation unit 5 described above on the proximal side of the biopsy forceps. The manual operating unit 15 is capable of transmitting push and / or pull forces to the cutting device 7'", by means of which the cutting device 7'" can be moved distally and proximally relative to the forceps jaws 1, 2 in a controlled manner using the linear kinematics 14. Naturally, a slot-shaped recess 16 extending over both proximal end regions of the forceps jaws 1, 2 and adapted to the cutting device 7'" is required for the insertion of the cutting device 7'" into the resection volume enclosed by both forceps jaws 1, 2.Figures 5a to c show a biopsy forceps of the solution as explained, for example, in Figures 3a to f above, in which at least one of the two forceps jaws 1, 2 has a slot-shaped recess 13 for inserting the cutting device which is designed separately for the biopsy forceps.

[0075] Additionally, the biopsy forceps feature a channel K1 traversing its longitudinal extension, through which a cryomedical instrument is guided. This instrument has a shaft K2 and a cryobiopsy probe K3 attached distally to the shaft. The probe extends through an access opening K4, bounded by both jaws 1 and 2, into the resection volume R enclosed by both jaws 1 and 2. The metal cryobiopsy probe K3 includes an internal expansion chamber. Gas from a gas reservoir K5 expands into this chamber under pressure via a throttling element, cooling the cryobiopsy probe to temperatures below -40°C.

[0076] The cryobiopsy probe K3 is mounted so that it can move longitudinally relative to both forceps jaws 1, 2. This allows the penetration depth I, with which the cryobiopsy probe K3 is inserted into the area of ​​the resection volume R and, if necessary, beyond, to be manually set or regulated by advancing it along the instrument shaft K2, which protrudes proximally beyond the biopsy forceps.

[0077] For the purpose of tissue sampling, the biopsy forceps with the internally arranged cryomedical instrument are positioned intracorporeally at the site of the target tissue to be examined via biopsy. Both forceps jaws 1, 2 are opened, and the cryobiopsy probe is advanced distally until it penetrates the target tissue area. The freezing process then begins, during which frozen tissue adheres to and around the cryobiopsy probe K3, forming a frozen tissue sample K6, which remains connected to the surrounding tissue at this stage. The tissue sample is separated by closing both forceps jaws 1, 2, thereby creating a cut with the blade-like cutting contours 6 of both forceps jaws 1, 2. During or after the closing process, the cryobiopsy probe K3 is withdrawn proximally from the resection volume 6.To ensure that the frozen tissue sample K6 is completely separated from the cryobiopsy probe K3, the diameter of the access opening K4 is chosen to correspond to the diameter of the cryobiopsy probe K3, so that on the one hand a gliding movement of the cryobiopsy probe K3 through the access opening K4 is possible and on the other hand no tissue material adheres along the cryobiopsy probe K3 as it is pulled proximally through the access opening K4.

[0078] The tissue sample K6, enclosed by both jaws of the forceps 1 , 2, see figure 5b, is deep-frozen and solid and can be taken extracorporeally in this form without risk of cross-contamination to surrounding body areas.

[0079] The frozen tissue sample K6, thus contained in the biopsy forceps and enclosed by both jaws 1, 2, can be separated into two parts by inserting the cutting device through the slot-shaped recess 13, which are then available for subsequent histological examination.

[0080] The cryomedical instrument can also be used in a biopsy forceps designed according to the solution, with a cutting device permanently integrated into the jaws, as illustrated in Figures 2a to 2d. Similarly, as explained in the preceding embodiment relating to Figures 5a and 5b, the cryomedical instrument is longitudinally displaceable within a channel K1 traversing the biopsy forceps along its length and extends through an access opening K4, which is partially enclosed by both jaws. In a starting position, the cryobiopsy probe is located in a proximally retracted position outside the resection volume enclosed by both jaws 1 and 2. In this starting position, the biopsy forceps can be placed intracorporeally.After opening the forceps jaws 1, 2, the cryobiopsy probe is guided distally, penetrating a target tissue area and freezing it to the probe. With the forceps jaws open, the cryobiopsy probe is withdrawn proximally and preferably completely removed from the jaw area through the access opening. This causes the tissue sample adhering to the cryobiopsy probe to detach from the probe by scraping at the access opening. The forceps jaws 1, 2 are then closed after the cryobiopsy probe has been completely removed from the resection volume R enclosed by both jaws. This eliminates any risk of collision between the cutting device, which is firmly integrated into the jaws, and the cryobiopsy probe.

[0081] However, it is also conceivable that the movement sequence between the closing of both jaws of the pliers and the proximal withdrawal of the cryobiopsy probe is coordinated in such a way that the cryobiopsy probe and the cutting device do not touch.

[0082] In another embodiment shown in Figure 7, the cryobiopsy probe is used as a functional element that comes into contact with the cutting device and serves as a kind of counter-bearing for the cutting device during tissue sample sectioning. The forceps jaw assembly has a cutting device 7"", each of which has a flat separating element 8" with a cutting blade 9"" per forceps jaw 1, 2. In the closed forceps jaw state, the cutting blades 9"" of both separating elements 8"" do not touch in the center, as in Figure 2c, but rather maintain a distance d from each other that corresponds to the diameter of the cryobiopsy probe K3. In this case, the cryobiopsy probe K3 serves, in addition to its main function as a freezing medium, as a kind of cutting surface.The cutting surface, onto which both cutting blades 9"" come into contact, helps to separate the tissue sample located between the two forceps jaws 1, 2 into two tissue sample halves. The cryobiopsy probe K3 assumes an arrangement comparable to that shown in Figures 5 a, b. While not necessarily required, it is advantageous in this case as well that the cryobiopsy probe K3, together with the instrument shaft K2, is arranged to be longitudinally movable within the channel K1 traversing the biopsy forceps.

[0083] There is often a desire to mark the tissue sampling site for later localization. In an advantageous further development of the biopsy forceps, see Figures 6a, b, an applicator M1 in the form of a hollow channel is attached to the biopsy forceps either removably or permanently. The hollow channel applicator M1 has an opening M2 located at the distal end of one of the two forceps jaws 1, which opens openly outside the jaw. The hollow channel applicator M1 has a proximal opening M3 that is fluid-tightly connected to a reservoir M4 containing a marker fluid or marker gel, or through which a thrusting device M5, e.g., a stylet, can be advanced distally into the hollow channel, by means of which a biomarker M6 stored in the hollow channel, e.g., in the form of a three-dimensional NiTi wire, can be released at the tissue sampling site.

[0084] Only after the release of the biomarker M6 can the biopsy forceps be completely removed extracorporeally.

[0085] Reference symbol list

[0086] 1 jaw of a pair of pliers

[0087] 2 jaws

[0088] 3 Swivel kinematics

[0089] 4. Tension and / or thrust transmitting means

[0090] 5 Manual operating unit

[0091] 6 blade-like cutting contour

[0092] 7, 7', 7", 7"',7"" cutting device

[0093] 8, 8', 8", 8"',8"" Surface release agent

[0094] 9, 9', 9", 9"',9"" cutting blade

[0095] 10 resection partial volumes

[0096] 11 Resection partial volumes

[0097] 12 Grooved recesses

[0098] 13 Slit-shaped recess

[0099] 14 Linear kinematics

[0100] 15 Manual control unit

[0101] 16 slotted recesses

[0102] K1 channel, hollow channel

[0103] K2 Instrument Set

[0104] K3 cryobiopsy probe

[0105] K4 access opening

[0106] K5 Reservoir

[0107] K6 Tissue sample M1 Applicator

[0108] M2 opening

[0109] M3 Proximal Opening

[0110] M4 Reservoir

[0111] M5 thrust device

[0112] M6 Biomarker

[0113] I Penetration depth

[0114] R Resection volume

Claims

Patent claims 1. Biopsy forceps for excising a tissue sample, comprising at least two forceps jaws (1, 2) reversibly pivotable between an open and a closed position via a pivoting kinematic mechanism (3), at least one of which has a concave contour which, in the closed position, in conjunction with the at least one other forceps jaw (1, 2), encloses a resection volume, characterized in that a cutting device (7) is provided which is connected or can be brought into operative connection with at least one of the forceps jaws (1, 2) such that the cutting device (7) divides the resection volume (R) in the closed position of the at least two forceps jaws (1, 2) into two resection part volumes (10, 11) and separates a tissue sample located in the resection volume into two tissue sample parts by mechanical cutting.

2. Biopsy forceps according to claim 1, characterized in that the cutting device (7) has at least one planar separating means (8) with a cutting blade (9) which is firmly attached to one of the forceps jaws (1 , 2) such that the separating means (7) separates the resection volume (R) in the closed position of the at least two forceps jaws (1 , 2) into the two resection partial volumes (10, 11) and the cutting blade (9) lies flush against an inner wall or surface contour of the other forceps jaw (1 , 2) oriented towards the resection volume.

3. Biopsy forceps according to claim 2, characterized in that the surface contour of the other forceps jaw (1 , 2) is designed as a cutting blade (9') against which the cutting blade (9) of the separating agent (8) rests flush in the closed position, or that the surface contour of the other forceps jaw (1 , 2) is designed in the form of a groove-shaped recess (12) into which the cutting blade (9) of the separating agent (8) engages flush in the closed position.

4. Biopsy forceps according to claim 1, characterized in that the cutting device (7) has at least one planar separating element (8) with a cutting blade (9) which is mounted to be movable relative to the forceps jaws (1, 2) and, in the closed position of the pivotably mounted forceps jaws (1, 2), can be moved from an initial position in which the separating element (8) is located outside the resection volume (R) enclosed by the forceps jaws (1, 2) or only slightly protrudes into the resection volume (R) to a final position in which the separating element (8) separates the resection volume into the two resection partial volumes (10, 11).

5. Biopsy forceps according to claim 4, characterized in that at least one of the forceps jaws (1 , 2) has a slot-shaped recess (13) into which the separating agent (8) can be inserted from the initial to the final position.

6. Biopsy forceps according to claim 5, characterized in that the planar separating agent (8) has a thickness dimension corresponding to a slot width of the slot-shaped recess (13) plus an excess that enables the otherwise gap-free insertion of the separating agent (8) into the slot-shaped recess (13).

7. Biopsy forceps according to claim 5 or 6, characterized in that the pivotably mounted forceps jaws (1 , 2) in the closed position can be assigned a longitudinal extension which is oriented from a proximal to a distal forceps jaw end region, and that the slot-shaped recess (13) is oriented longitudinally or transversely.

8. Biopsy forceps according to one of claims 4 to 7, characterized in that the planar separating agent (8) is designed as a component separate from the forceps jaws (1 , 2) or is inseparably connected with one of the forceps jaws (1 , 2).

9. Biopsy forceps according to claim 4, characterized in that the pivotably mounted forceps jaws (1, 2) in the closed position have a longitudinal extension which is oriented from a proximal to a distal forceps jaw end region, that the planar separating element (8) is designed as an integral component of the biopsy forceps and is attached in the initial position proximal to the resection volume (R) enclosed by the forceps jaws (1, 2), and that the separating element (8) is in operative connection with an actuating means by which the separating element (8) can be transferred distally to assume the final position.

10. Biopsy forceps according to claim 9, characterized in that the separating agent (8) is adapted to the geometry of the resection volume (R) enclosed by the forceps jaws (1 , 2) such that the separating agent (8) in the final position is flush against a surface contour of the forceps jaws (1 , 2) oriented towards the resection volume (R).

11. Biopsy forceps according to one of claims 1 to 10, characterized in that the concave contour of the at least one jaw of the forceps (1 , 2) is surrounded by a blade-like contour.

12. Biopsy forceps according to one of claims 1 to 11, characterized in that the cutting device (7) divides the resection volume (R) in the closed position of the at least two forceps jaws (1 , 2) into two equally sized resection volume halves (10, 11) and separates a tissue sample located in the resection volume by mechanical cutting into two tissue sample halves, forming two mirror-image identical tissue sample surfaces.

13. Biopsy forceps according to one of claims 1 to 12, characterized in that at least one of the two forceps jaws (1 , 2) encloses an access opening (K4) into the resection volume (R) or both The jaws of the forceps (1, 2) define an access opening (K4) into the resection volume (R), and a cryobiopsy probe (K3) is provided which is arranged relative to at least one of the two jaws of the forceps (1, 2) such that the cryobiopsy probe (K3) extends through the access opening (K4) into the resection volume (R) or is mounted in a manner that allows passage through the access opening (K4) in both directions.

14. Biopsy forceps according to claim 13, characterized in that the cryobiopsy probe (K3) is attached distally at the end of an instrument shaft (K2) within which a gas supply line leading to the cryobiopsy probe (K3) is arranged, which opens within the cryobiopsy probe (K3) via a throttling element.

15. Biopsy forceps according to claim 14, characterized in that the instrument shaft (K2) is formed and arranged as an integral component of the biopsy forceps within a channel (K1) that at least partially traverses the biopsy forceps.

16. Biopsy forceps according to one of claims 13 to 15, characterized in that the cryobiopsy probe (K3) has a maximum penetration depth (I) extending into the resection volume (R), so that the cryobiopsy probe (K3) is positioned within the resection volume (R) without contact with both jaws (1 , 2) when both jaws (1 , 2) are closed.

17. Biopsy forceps according to one of claims 13 to 17, characterized in that the cryobiopsy probe (K3) is mounted so as to be movable relative to the access opening (K4) and can be reversibly moved from a first position in which the cryobiopsy probe (K3) is advanced distally relative to both open jaws (1, 2) to a second position in which the cryobiopsy probe (K3) is in a retracted position relative to both jaws (1, 2). the cryobiopsy probe (K3) partially or not at all protrudes through the access opening (K4) into the resection volume (R).

18. Biopsy forceps according to one of claims 13 to 17, characterized in that the access opening (K4) has an opening width corresponding to a maximum diameter attributable to the cryobiopsy probe (K3) with an excess that is tolerable only for movement.

19. Biopsy forceps according to one of claims 13 to 18, characterized in that the cryobiopsy probe (K3) is cylindrical or tapered distally.

20. Biopsy forceps according to one of claims 1 to 19, characterized in that an opening (M2) of an applicator (M1) is provided on at least one of the two forceps jaws (1 , 2) or on the biopsy forceps immediately adjacent to both forceps jaws (1 , 2), through which a liquid or mechanical marker (M6) can be released.

21. Biopsy forceps according to claim 20, characterized in that the applicator (M1) is designed in the form of a hollow channel extending longitudinally to and along the biopsy forceps with a distal hollow channel opening that corresponds to the opening (M2) of the applicator (M1).

22. Biopsy forceps according to claim 21, characterized in that the hollow channel has a proximal opening (M3) which is fluid-tightly connected to a reservoir (M4) containing a marker fluid or marker gel, or through which a thrusting means (M5) can be guided distally into the hollow channel, by means of which a biomarker (M6) stored in the hollow channel.

23. Biopsy forceps according to claim 22, characterized in that the biomarker (M6) is a mechanical biomarker.

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