BIOPSIESYSTEM

Description

[0001] The present disclosure relates to a biopsy system for taking tissue samples from an organic, preferably human or animal, body, in particular for cytological examination. In particular, the present disclosure relates to a system for fine needle biopsy (FNB) or fine needle aspiration biopsy (FNAB).

[0002] Often, an abnormality is diagnosed during cancer screening or follow-up, or in cases of suspected cancer, using an X-ray, CT scan, ultrasound, or other non-invasive imaging procedure. There are various reasons for performing such an examination, including screening (e.g., screening of the lungs of smokers), follow-up care (e.g., examination of the lungs in follow-up care for colorectal cancer), or an examination for another reason (e.g., examination of a potentially injured lung after an accident with the incidental finding of a nodular lesion).

[0003] The detection of an abnormality often requires treatment (therapy). However, a prerequisite for a targeted and effective therapeutic intervention, or the decision as to whether such a therapeutic intervention is even necessary, is the clarification of the exact cause of the abnormality in the examination image. The cause of the shadowing can be of completely different types, e.g., tumor, infection, granuloma, etc. Different causes, however, sometimes require completely different therapeutic approaches (surgical removal, chemotherapy, radiation therapy, hormonal treatment, drug treatment, etc.).

[0004] Such clarification (i.e., the search for the cause of the abnormal appearance, i.e., the shadowing) is achieved through an ex situ histopathological or cytological examination of the suspicious tissue. Such an examination requires a piece of tissue or individual cells from the area of ​​the detected abnormality.

[0005] Such a piece of tissue or tissue cells are obtained via a tissue sample or a sample of tissue fluid, a so-called biopsy. There are basically different options for performing the tissue sample. If the procedure is to be as minimally stressful for the patient as possible, the biopsy can be performed percutaneously (e.g., using CT or ultrasound guidance to visualize the suspicious area where the sample is to be taken). A thin, long, rigid biopsy needle is pushed from the outside through the skin and the underlying tissue into the affected organ to the abnormality in order to take a tissue sample from there, at or within the abnormality. Hollow needles of various shapes and designs are usually used for the percutaneous procedure.

[0006] While images obtained with conventional imaging techniques (CT, ultrasound, etc.) allow for the visualization of suspicious tissue, the degree of tissue differentiation is limited, meaning the specificity is restricted.

[0007] An abnormality as such stands out relatively clearly from the surrounding healthy tissue—for example, by a different color tone (a different shade of gray in CT and US images). This allows it to be relatively well detected, and the desired tissue sampling can be performed relatively easily, for example, by guiding the distal end of the biopsy needle into the center of the lesion.

[0008] However, conventional imaging techniques (CT, ultrasound, etc.) cannot determine how or in what form the shadowed tissue has been altered, for example, whether it is benign or malignant. For example, a lesion that has already been treated in the past may continue to appear as a shadow in follow-up CT images, even though it is only fibrous, i.e., non-malignant tissue. A biopsy from the center of the shadow and subsequent pathological or cytological examination would confirm this diagnosis.

[0009] Any residual tumor that may still be present (due to, for example, inadequate initial treatment) or even a new tumor formation (recurrence, newly formed after the initial treatment) could not be differentiated in the CT or US image from the surrounding fibrous tissue that is displayed as shadowing and would therefore remain unremarkable.

[0010] A single biopsy from the center of the apparently homogeneous abnormality - there would initially be no reason to biopsy at another location based on the CT or US image - would therefore lead to a serious misassessment because it would not include the residual tumor or the new tumor formation that cannot be differentiated in the CT or US image and, accordingly, the actually required therapy would not be available.

[0011] Furthermore, conventional imaging techniques (CT, US, etc.) cannot guarantee that all of the suspicious tissue will actually be visualized. In addition to specificity, sensitivity is also limited. This means that an abnormality that is sufficiently large and whose tissue is sufficiently altered will stand out relatively clearly as a shadow from the surrounding healthy tissue. In this case, tissue can be removed relatively easily from this area and sent for further pathological examination. However, early malignant changes or small malignant changes often cannot be visualized, or at least not well enough, using conventional imaging techniques (CT, US, etc.). Any additional early malignant changes and small malignant changes that may be located, for example, at the edge of the abnormality or even outside the abnormality would remain invisible in the CT or US image.

[0012] Therapy (based on the histopathological or cytological results from the biopsy taken from the central area of ​​the shadow) would therefore be limited to the area of ​​the shadow and a "safety zone" around it. Any early-stage and small malignant changes in the peripheral area or outside the shadow (invisible on CT or ultrasound images) would be treated inadequately or not at all.

[0013] To solve this problem, it is known to take a large number of biopsies from the entire area of ​​the abnormality and also from the tissue surrounding the abnormality in order to reduce the risk of missing pathologically relevant tissue that must be submitted for pathological or cytological examination.

[0014] For example, US 2017 / 319186 A1 describes a biopsy device with a shaft guided in a hollow needle, which has a lateral recess for receiving a biopsy sample and a light guide. US 2005 / 203419 A1 describes a biopsy needle with a lateral sample window and a light guide. US 2010 / 168610 A1 discloses an endoscopic biopsy procedure in which an optical guide is embedded in a biopsy forceps. US 2009 / 326384 A1 describes a biopsy instrument with an integrated multi-fiber optic bundle.

[0015] However, multiple biopsies have many disadvantages and place a considerable burden on the patient. Further complicating matters, i.e., further burdening the patient, is the fact that a good (in the sense of a meaningful) tissue sample must be sufficiently large, and therefore the biopsy needle and, directly related to this, the puncture channel must be sufficiently large in diameter.

[0016] Furthermore, taking numerous tissue samples is time-consuming, which, in addition to the strain on the operator and the treatment costs, also places additional strain on the patient, such as longer anesthesia. In addition, radiation exposure increases over time during CT-guided tissue sampling. Since all tissue samples must be evaluated histopathologically or cytologically, this procedure is also costly.

[0017] In certain cases, it is not necessary to perform a comprehensive histopathological examination of the tissue. For a comprehensive histopathological examination, typically an entire cylinder of tissue is punched out (core needle biopsy) or a relatively large piece of tissue is cut out (cutting biopsy) in order to have enough tissue material available for ex situ examination. However, this is not necessary for some medical diagnoses. For example, sometimes it is only necessary to determine whether a suspicious area, such as an opacification in CT or US, contains exclusively benign tissue or also malignant tissue. In this case, a histological cytological examination of just a few individual cells may be sufficient. For such examinations, a less traumatic fine needle biopsy (FNB) or fine needle aspiration biopsy (FNAB) is typically used. Compared to a cutting or core biopsy, FNB orFNAB is more gentle, painless, and has fewer complications (including less bleeding). Sedation or even anesthesia is usually not required. Furthermore, because it is more gentle, it can cover larger areas, effectively "scanning" the organ.

[0018] To ensure a more gentle, painless, and less complication-prone procedure, a fine needle, typically less than 1 mm in diameter and thus thinner than the coarse needle used for core biopsy, is inserted percutaneously into the shadowed area. However, larger needle diameters are also used for highly viscous fluids such as pus and blood.

[0019] In FNB or FNAB, after reaching the puncture target (in the case of FNAB under suction), the puncture is ideally performed in a fan-shaped pattern to obtain tissue material from different regions. As the fine needle is moved back and forth, cells are exfoliated with a sharp distal edge of the cannula and pushed or aspirated into the cannula.

[0020] By using a fan-shaped puncture and a series of puncture fans (made possible by the use of a gentle fine needle), i.e. by obtaining cell material from many different areas within a comparatively large volume, the suspicious tissue area (i.e. the area appearing as shadowing on CT or US) can be examined more completely. More complete means that, compared to a punch or cutting biopsy, there is a lower probability that smaller and initially inconspicuous malignant areas within an otherwise benign shadow will not be detected, biopsied, or examined pathologically. Furthermore, additional tissue material can be obtained from the peripheral area and from areas outside the suspicious area (shadowing) relatively easily, quickly, gently, and with few complications.

[0021] FNB or FNAB becomes particularly difficult when only small amounts of malignant tissue are present within a larger shadow. Cells must always be exfoliated and sampled from all areas of the shadow. This means that the suspicious area (the shadow) must be examined closely, i.e., within a relatively narrow puncture cone (slightly altered needle orientation when moving the needle back and forth per puncture), and completely, i.e., with multiple puncture cones (many punctures at different positions).

[0022] This procedure (if a truly reliable statement about the presence of malignant areas in the area of ​​the shadow and its edges is to be made) is associated with a relatively high time expenditure, which is all the greater the larger the volume of the shadow.

[0023] A meaningful pathological evaluation and assessment of the tissue (benign or malignant) can only be carried out ex situ after the entire tissue sample has been taken. This, in turn, means that local classification is no longer possible, i.e. a statement as to which area (and possibly peripheral area) of the shadowing any malignant cells originate from. This would, however, be advantageous if, for example, an additional cutting or punch biopsy is to be taken specifically from the malignant area in order to achieve a more precise, i.e. comprehensive histological evaluation in order to find out exactly what type of malignant tissue is involved. Furthermore, one could specifically treat only the malignant area of ​​the shadowing (and not necessarily the entire area of ​​the shadowing).

[0024] Another difficulty with FNB or FNAB is that a large amount of material is often taken from irrelevant tissue areas (i.e., too many benign cells) and too little—possibly even no—tissue is taken from relevant areas (i.e., too few or no malignant cells). The result can therefore be "diluted" beyond recognition by a high proportion of irrelevant tissue, i.e., have insufficient specificity. Statistically, a repeat FNB or FNAB (re-puncture) is required in one-third of patients when tumors are suspected. This is time-consuming and expensive, placing additional strain on the patient.

[0025] It is therefore an object of the present disclosure to provide a biopsy system which allows a diagnosis to be made with fewer biopsies in a faster, more cost-effective and more patient-friendly manner with higher specificity and higher sensitivity.

[0026] According to the present disclosure, to achieve this object, a biopsy system according to claim 1 is provided.

[0027] With such a biopsy system, the tissue can be pre-selected for cytological examination in situ before it is actually taken. This means that tissue that appears undifferentiated and suspicious with conventional non-invasive imaging techniques (CT, US, etc.) can be assessed in situ in a more differentiated manner (e.g. with regard to malignancy), thereby increasing specificity. The fluorescence endoscopy element can stimulate tissue to fluoresce in situ using excitation light. The pathological tissue itself stimulated by the excitation light, or a bacterial accumulation indicative of pathological tissue, can specifically fluoresce and thus be clearly localized compared to the surrounding healthy tissue. Fluorescence endoscopy can be performed, for example, using a photosensitizer or marker substance (e.g. chlorin e6), which selectively accumulates on pathological tissue and fluoresces.

[0028] The fluorescence endoscopy element can therefore be used to very precisely localize pathological tissue. Once the fluorescence endoscopy element has localized tissue relevant for biopsy based on fluorescence, the fluorescence endoscopy element can be withdrawn from the introducer sleeve, leaving the introducer sleeve in the body. The biopsy needle can then be guided through the introducer sleeve to the exact location where the fluorescence endoscopy element identified the tissue to be examined. This biopsy system can therefore be used to localize more—ideally all—relevant areas in the organ in question, e.g., early malignant and malignant lesions, in situ, without having to take random biopsies of irrelevant tissue, which is stressful for the patient. This results in significantly higher sensitivity.

[0029] This biopsy system significantly reduces the number of repeat punctures, making diagnosis significantly faster, more patient-friendly, and more cost-effective. This is because the specificity of the tissue sample can be tested in situ, thus preventing "diluted" samples with an excessive amount of irrelevant tissue from being taken in the first place.

[0030] A further advantage of this biopsy system is that it reduces the risk that the tissue sample taken, which is examined pathologically or cytologically as a relevant piece of tissue and determines the subsequent therapeutic approach, comes from a benign, pathologically irrelevant tissue area.

[0031] Preferably, the biopsy system is a system for fine needle biopsy or fine needle aspiration biopsy, wherein the biopsy element is a fine biopsy needle. According to the invention, the distal portion of the fluorescence endoscopy element serves as a suction piston in the biopsy element to suck tissue material into the receiving space when the distal portion of the fluorescence endoscopy element is moved from the distal position to the proximal position. However, it is also possible to use the biopsy system disclosed here for punch or cutting biopsy. Ultimately, FNB or FNAB differs from the coarser punch or cutting biopsy only in the thinner biopsy needle and, if necessary, in the suction of tissue into the biopsy needle.

[0032] Optionally, the distal section of the fluorescence endoscopy element can completely fill the receiving space when in the distal position. This allows the distal section of the fluorescence endoscopy element to easily serve as a suction piston, allowing the biopsy element to be designed very thinly.

[0033] Optionally, the fluorescence endoscopy element can be configured to selectively couple out excitation light and couple in fluorescence light at the distal position of the distal section of the fluorescence endoscopy element, the proximal position of the distal section of the fluorescence endoscopy element, and / or any intermediate position of the distal section of the fluorescence endoscopy element. This is particularly advantageous for immediately checking in situ whether malignant tissue is actually present in the acquisition space. For example, when the distal section of the fluorescence endoscopy element is in the distal position, a high fluorescence signal is detected by the fluorescence endoscopy element, and the distal section of the fluorescence endoscopy element is then pulled into the proximal position to aspirate tissue.If the fluorescence signal weakens, this means that the fluorescent tissue was not drawn into the recording chamber. If, on the other hand, the fluorescence signal does not weaken, or only slightly, up to the proximal position, this is a sure sign that fluorescent tissue is present in the recording chamber. This can be assessed not only qualitatively but also quantitatively by the intensity of the fluorescence signal. Thus, a specific lower limit for the fluorescence signal can ensure that the tissue sample has a certain specificity.

[0034] According to the invention, the distal portion of the fluorescence endoscopy element is guided radially and sealingly within the biopsy element, so that a suction effect is created in the receiving space during proximal retraction of the distal portion of the fluorescence endoscopy element in the biopsy element. The distal portion of the fluorescence endoscopy element can thus function as a suction piston.

[0035] Optionally, a distal end of the distal section of the fluorescence endoscopy element can be positioned in the distal position, flush with a distal tip of the biopsy element, or protrude distally from the distal tip of the biopsy element. This allows for gentle insertion and forward movement of the biopsy element in areas not currently being biopsied. The distal section of the fluorescence endoscopy element can remain in the distal position until a sufficiently strong fluorescence signal is detected. This protects all the benign and healthy tissue that must be penetrated to reach the relevant malignant tissue.

[0036] Optionally, the distal section of the fluorescence endoscopy element can be locked in the distal position and / or in the proximal position relative to the biopsy element. A lock is advisable, at least in the distal position, to prevent the distal section of the fluorescence endoscopy element from being accidentally pushed in during insertion or having to be manually held. The proximal position can also be fixed by a lock, but can also be any axial position manually selected by the operator. The length of the recording chamber can be selected by the operator via the proximal position or fixed by a stop or lock.

[0037] Optionally, the distal section of the fluorescence endoscopy element can be mounted in a defined rotational position in the biopsy element, at least in the distal position, so as to prevent rotation about its longitudinal axis. Preferably, the rotational position is defined by a longitudinal web in a corresponding longitudinal groove. Between the distal position and the proximal position, the angular position of the longitudinal web and / or longitudinal groove can be different than in the distal or proximal position. This allows axial locking in the distal or proximal position to be achieved, whereby the locking can be released by rotating the distal section of the fluorescence endoscopy element to the other angular position.

[0038] Optionally, a distal end of the distal portion of the fluorescence endoscopy element and a distal tip of the biopsy element may be beveled at the same angle. Preferably, the angle may be acute and preferably 45° or less.

[0039] Optionally, the distal section of the fluorescence endoscopy element and / or the biopsy element can be designed as a single-use disposable item. This allows the distal section of the fluorescence endoscopy element and / or the biopsy element to be manufactured particularly thinly and inexpensively.

[0040] Optionally, the fluorescence endoscopy element can have a light guide with a proximal coupling of excitation light and / or a proximal coupling of fluorescent light, with a distal end of the light guide acting as the distal coupling of the excitation light and / or the distal coupling of the fluorescent light. This is the preferred embodiment for particularly thin biopsy elements. The light guide itself acts as a suction piston and is guided in a very thin channel of the biopsy element in a radially sealed manner, so that when the light guide is retracted, a distal section of the channel forms the receiving space, which is completely filled by the light guide in the distal position. The light guide can form both an illumination path for the excitation light and an image path for the fluorescent light. "Image path" here is not limited to the generation of an image from the coupled fluorescent light.Only a coupled fluorescence signal can be transmitted in the image path, the properties of which are determined.

[0041] Optionally, the distal section of the fluorescence endoscopy element can have an LED for coupling out excitation light and / or an image sensor, a photodiode or similar for coupling in fluorescent light. In combination with a light guide or alternatively, the illumination path and / or the image path can be electrically connected to the distal section of the fluorescence endoscopy element. An LED at the distal end can be used to emit the excitation light and the fluorescent light can either be guided via a light guide to a proximal image sensor, a photodiode or similar or be recorded by a distal-side image sensor, a photodiode or similar. Likewise, a light guide can guide excitation light from a proximal LED to the distal section of the fluorescence endoscopy element and couple it out there. It should be noted at this point that coupling in fluorescent light using an image sensor, a photodiode or similar is also possible.does not necessarily have to be used for image generation. To decide whether the fluorescence signal is abnormal or not, i.e., whether a biopsy should be taken or not, it is often sufficient to determine only one property of a fluorescence signal, such as its amplitude or intensity. For example, the abnormality can be indicated by an increased or decreased fluorescence intensity compared to the surrounding tissue or a reference value.

[0042] Optionally, the fluorescence endoscopy element can be configured to selectively couple a first excitation light and a second excitation light proximally, wherein the first excitation light is, on average, shorter-wavelength than the second excitation light, and wherein the fluorescence endoscopy element is configured to selectively generate a first image or a first fluorescence signal from a first tissue region from first fluorescence light excited by the first excitation light and to record a second image or a second fluorescence signal from a second tissue region from second fluorescence light excited by the second excitation light. Since the penetration depth of the short-wavelength first excitation light can be less than the penetration depth of the longer-wavelength second excitation light, the first tissue region is preferably smaller than the second tissue region.The localization of pathological tissue is thus achieved with a higher spatial resolution using the first excitation light. Since the penetration depth of the longer-wavelength second excitation light can be greater, the detected fluorescence signal can also originate from a correspondingly larger second tissue region. The localization of pathological tissue using the second excitation light is thus achieved with a lower spatial resolution, but a larger volume is captured. Thus, a larger second tissue region can first be preselected more coarsely using the longer-wavelength second excitation light, and then a smaller first tissue region, which is preferably part of the second tissue region, can be examined more closely using the shorter-wavelength first excitation light.

[0043] Optionally, the fluorescence endoscopy element can have an optical component on the proximal side that is detachably coupled or permanently coupled to the distal section of the fluorescence endoscopy element. The optical component has a beam splitter with an image path side and an illumination path side. An image sensor, a photodiode, or the like is detachably coupled or permanently coupled to the image path side for coupling out the fluorescence light. A light source is detachably coupled or permanently coupled to the illumination path side for coupling in the excitation light. The light source is preferably at least one LED or at least one laser output. The beam splitter can, for example, have a pair of prisms that together form a beam splitter block and at least largely separate the excitation light and the fluorescence light from one another, so that the fluorescence light is transmitted or reflected to the image path side.Conversely, the prism pair can reflect or transmit the excitation light to the illumination path side. Preferably, the image path side and the illumination path side of the beam splitter are located on sides of the beam splitter arranged at an angle, preferably of approximately 90°, to each other. Preferably, the image path side is located on the proximal side, so that fluorescent light is essentially transmitted from the distal entrance side of the beam splitter to the image path side. The illumination path side is preferably located on the lateral side, so that excitation light is essentially reflected from the lateral entrance side to the distal exit side.

[0044] Optionally, the optical component can comprise an optical long-pass filter that transmits the fluorescent light more strongly toward the image path side than the excitation light, and / or an optical short-pass filter that reflects the fluorescent light more strongly toward the image path side than the excitation light. For example, the long-pass filter or the short-pass filter can be arranged between a pair of prisms acting as a beam splitter and / or implemented as a layer on one or both of the mutually facing sides of the prisms. This is particularly useful when the excitation light has a shorter wavelength than the fluorescent light.

[0045] Optionally, the fluorescence endoscopy element can have an operating unit that is signal-connected or connectable to the image sensor, photodiode, or similar device and / or the light source. The operating unit has an optical and / or acoustic display component, a control and supply component, and an operating component. Optionally, the optical component can be arranged in a handpiece of the fluorescence endoscopy element, to which the distal section of the fluorescence endoscopy element and the biopsy element can be coupled. The handpiece is preferably designed for multiple use. This is useful because the optical component, possibly with an LED and / or image sensor or photodiode, or similar device, can be relatively expensive and the handpiece does not have direct patient contact.The distal section of the fluorescence endoscopy element and the biopsy element, which are preferably disposable items for single use, can then be removed from a sterile package and coupled to the handpiece for the biopsy.

[0046] The terms "distal" and "proximal" are used herein to mean a relative position that is distal or proximal, respectively, from an operator of the system as a reference position. The terms "distal" and "proximal" are used herein to mean positions on a distal or proximal side of an object, respectively. The terms "distal" and "proximal" are used herein to mean directions that extend distally or proximally, respectively.

[0047] The disclosure is explained in more detail below with reference to exemplary embodiments illustrated in the drawings. They show: Fig. 1 schematically an exemplary embodiment of a biopsy system disclosed herein; Fig. 2-7a-c schematically the exemplary embodiment of Fig. 1 in different phases of use; Fig. 8 schematic sectional views of a first exemplary embodiment of a locking mechanism of a biopsy system disclosed herein; and Fig. 9 schematic sectional views of a second exemplary embodiment of a locking mechanism of a biopsy system disclosed herein.

[0048] Fig. 1 shows a biopsy system 1 with a biopsy element 3 in the form of a fine biopsy needle, which is designed as a very thin cannula with a distal tip 4 beveled at an acute angle γ on the distal side. The biopsy system 1 also has a fluorescence endoscopy element 5. The fluorescence endoscopy element 5 itself has a distal section 7 in the form of a light guide, which is precisely guided through the cannula of the biopsy element 3, a handpiece 9, and an operating unit 11. An optical component 13 is arranged in the handpiece 9, to which the light guide 7 can be detachably coupled or permanently coupled. The biopsy element 3 can be mechanically detachably coupled or permanently coupled to the handpiece 9 for handling by means of the handpiece 9. Preferably, the handpiece 9 is designed for multiple use, whereas the biopsy element 3 and the light guide 7 are designed as a pre-assembled unit as disposable items for single use and for coupling to the handpiece 9.

[0049] By coupling the light guide 7 to the optical component 13, a proximal coupling of fluorescent light from the light guide 7 into the optical component 13 and a proximal coupling of excitation light from the optical component 13 into the light guide 7 are achieved. A distal end 14 of the light guide is beveled at the same acute angle γ as the distal tip 4 of the biopsy element 3 and can terminate the cannula of the biopsy element 3 flush on the distal side.

[0050] The optical component 13 has a beam splitter 15 in the form of a beam splitter block formed by a pair of prisms. The prisms each lie adjacent to one another with optical interfaces extending at an angle of approximately 45° to the optical axis. A long-pass filter 17 is arranged between, or at least at, or on one of the optical interfaces. This filter essentially transmits longer-wavelength fluorescent light and reflects short-wavelength excitation light. Essentially coaxial with the optical axis, the beam splitter 15 therefore has an image path side on which an image sensor 19, a photodiode, or the like is arranged. Laterally, the beam splitter 15 has an illumination path side on which a light source 21, for example, in the form of an LED or a laser output, is arranged. The long-pass filter 17 reflects the excitation light distally toward the light guide 7.

[0051] The operating unit 11 is signal-connected or connectable to the image sensor 19, the photodiode, or the like, and the light source 21 via a cable connection 23. The light source 21 can be controlled via the operating unit 11, and the signals from the image sensor 19, the photodiode, or the like can be received, processed, and, if necessary, visualized by the operating unit 11. For this purpose, the operating unit 11 has an optical and / or acoustic display component 25, a control and supply component 27, and an operating component 29.

[0052] The Fig. 1 shows the biopsy element 3 and the light guide as the distal section 7 of the fluorescence endoscopy element 5 in various axial positions of the light guide 7 relative to the biopsy element 3. At the top, the light guide 7 is in a distal position and at the bottom in any proximal position. In the proximal position shown below, the light guide 7 is retracted proximally, creating a receiving space 31 for receiving tissue samples 33 in the cannula of the biopsy element 3 distal to the light guide 7. As an alternative to the light guide, the distal section 7 of the fluorescence endoscopy element 5 could have a distal-side LED and / or a distal-side image sensor, a photodiode, or the like, and the image path and / or illumination path could be implemented electrically without the optical component 13.

[0053] Fig. 2 shows the biopsy element 3 and the light guide 7 schematically in their distal position shortly before penetrating the skin 35 of a patient. An organ 37 is located in the patient's body, which, in the CT image and / or US image, displays a conspicuous shadow 39 in a relatively large volume. In fact, in this example, the majority of the shadow 39 is benign tissue, and only a small portion of it is malignant tissue 41.

[0054] In Fig. 3 is shown how the biopsy element 3 with the light guide 7 in a locked distal position was inserted into the shadow 39 of the organ 37. The puncture is relatively minor trauma because the recording space 31 is closed off on the distal side by the light guide 7. In this case, excitation light is preferably continuously coupled out via the distal end 14 of the light guide 7. It is also preferably constantly checked whether a fluorescence signal is being received. Since the patient has preferably been administered a photosensitizer or marker substance (e.g. chlorin e6) before the biopsy, malignant tissue in front of the distal end 14 of the light guide 7 should fluoresce noticeably. Since the benign tissue in the shadow 39 does not fluoresce or fluoresces inconspicuously, the operator can decide that a biopsy at this point is not advisable and withdraw the biopsy element 3 and the light guide 7.

[0055] In Fig. 4 It is shown how the biopsy element 3 with the light guide 7 in a locked distal position was inserted at a different angle into the shadow 39 of the organ 37. The biopsy element 3 may not have to be completely withdrawn from the skin 35, but perhaps only from the organ 37 or the shadow 39. There, too, the fluorescence endoscopy element 5 does not detect a fluorescence signal, since only benign tissue is present in front of the distal end 14 of the light guide 7.

[0056] In Fig. 5 The operator has decided to insert the biopsy element 3 with the light guide 7 locked in its distal position at a completely different location through the skin 35 into a peripheral area of ​​the shadow 39. This is where the malignant tissue 41 is located, which fluoresces conspicuously due to the excitation light. If the fluorescence signal is conspicuous enough in the operator's opinion, the malignant tissue 41 can be exfoliated by moving it back and forth (see Fig. 6 ). The operator then releases the lock of the light guide 7 and pulls it back proximally into a proximal position. The proximal position can be arbitrary or fixed by a stop or a second lock. By pulling back the light guide 7, the receiving chamber 31 opens, creating a suction effect with which an exfoliated tissue sample 33 of the malignant tissue 41 lying in front of the distal end 14 of the light guide 7 is sucked into the receiving chamber 31. Particular care is taken to ensure that the fluorescence signal remains conspicuous. If it becomes very inconspicuous, this is a clear sign that no malignant tissue 41 was sucked into the receiving chamber 31 or too little of it.

[0057] Even during the final withdrawal of the biopsy element 3 from the patient’s body, as shown in Fig. 7 As shown, care must be taken to ensure that the fluorescence signal remains sufficiently conspicuous. This can, for example, prevent tissue that has not been completely exfoliated from being pulled out of the receiving space 31 unnoticed.

[0058] In Fig. 8 A first embodiment for axially locking the distal section 7 of the fluorescence endoscopy element 5 in the distal position relative to the biopsy element 3 is shown. For this purpose, the biopsy element 3 has a locking flange 43 on the proximal side. In cross-sectional view A, it is clear that the locking flange 43 is not uniformly circumferential, but is formed here from two longitudinal webs 45. The distal section 7 of the fluorescence endoscopy element 5 has a female receiving part 47 complementary to the locking flange 43, the axial position of which is matched to the length of the biopsy element 3. In the two cross-sectional views B, C, the female receiving part 43 has a different cross-sectional contour, each with longitudinal grooves 49 positioned differently in the circumferential direction, through which the longitudinal webs 45 of the biopsy element 3 fit.By appropriately rotating the locking flange 43, it can be inserted into the receiving part 47 and locked therein by rotation. For secure, tight, and stable mechanical coupling, the locking flange 43 and the receiving part 47 are preferably combined with a Luer system having an inner cone 51 (shown here in simplified form as a cylinder) and a corresponding outer cone (of another component not shown here). The Luer system is preferably standardized and allows the use of readily available biopsy elements. The axial position of the receiving part 47 relative to the distal section 7 of the fluorescence endoscopy element 5 is determined such that, when the locking flange 43 is received and locked, the distal end 14 of the distal section 7 of the fluorescence endoscopy element 5 is flush with the distal tip 4 of the biopsy element 3.Radial stops 55 are provided in the cross-sectional contour C so that the rotational position of the beveled distal tip 4 of the biopsy element 3 and the similarly beveled distal end 14 of the distal section 7 of the fluorescence endoscopy element 5 are coordinated with one another. An additional locking function, e.g., by locking lugs 57 on an inner side of the receiving part 47, can prevent the biopsy element 3 and the distal section 7 of the fluorescence endoscopy element 5 from rotating against each other about their common longitudinal axis during use. The longitudinal webs 45 are namely locked between the locking lugs 57 and the radial stops 55. The distal section 7 of the fluorescence endoscopy element 5 is thus mounted in the distal position in a defined rotational position in the biopsy element 3, fixed against rotation about its longitudinal axis.

[0059] In Fig. 9 a second embodiment is shown with axial locking of the distal portion 7 of the fluorescence endoscopy element 5 both in the distal position and in the proximal position relative to the biopsy element 3. In contrast to the first embodiment according to Fig. 8 In the second embodiment, the proximal position is not arbitrarily selectable, but structurally fixed. The biopsy element 3 does not differ from the biopsy element 3 according to Fig. 8 , ie it also has the locking flange 43 on the proximal side. The female receiving part 47 of the fluorescence endoscopy element 5, which is complementary to the locking flange 43, has cross-sectional contours B 1 , B 2 and C 1 , C 2 at axially different positions. The cross-sectional contour C 1 defines the distal position and the cross-sectional contour C 2 defines the proximal position. The cross-sectional contours B 1 , B 2 serve to lock the locking flange 43 in the respective axial positions C 1 and C 2 . Analogous to Fig. 8 The locking flange 43 can be moved axially through the cross-sectional contours B 1 , B 2 by a corresponding rotational position in the receiving part 47 and locked in the axial positions C 1 and C 2 by rotation. The axial position of the cross-sectional contour C 2 with respect to the distal section 7 of the fluorescence endoscopy element 5 is set such that when the locking flange 43 is received and locked in the cross-sectional contour C 2 , the distal end 14 of the distal section 7 of the fluorescence endoscopy element 5 is flush with the distal tip 4 of the biopsy element 3. The distal section 7 of the fluorescence endoscopy element 5 is analogous to in Fig. 8 by means of locking lugs 57 and radial stops 55, it is mounted in a defined rotational position in the biopsy element 3 in a rotationally fixed manner around its longitudinal axis both in the distal position C 2 and in the proximal position C 1.

[0060] The numbered designations of the components or directions of movement as "first," "second," "third," etc., are chosen purely arbitrarily to distinguish the components or directions of movement from one another and can be used in any way. This does not imply any significance. The designation of a component or technical feature as "first" should not be misunderstood to imply that there must be a second component or technical feature of this type. Furthermore, any process steps can be performed in any order and / or partially or completely overlapping in time, unless explicitly stated otherwise or absolutely necessary.

[0061] Equivalent embodiments of the parameters, components, or functions described herein that would appear obvious to a person skilled in the art in light of this description are intended to be included herein as if explicitly described. Accordingly, the scope of the invention is intended to include such equivalent embodiments, provided they fall within the scope of the claims. Features designated as optional, advantageous, preferred, desirable, or similar are to be understood as optional and not as limiting the scope of protection.

[0062] The described embodiments are to be understood as illustrative examples and do not represent an exhaustive list of possible embodiments. Each feature disclosed in an embodiment can be used alone or in combination with one or more other features, regardless of the embodiment in which the features were described, provided that the resulting combination of features falls within the scope of the claims. While at least one embodiment has been described and shown herein, modifications and alternative embodiments that would be obvious to a person skilled in the art in view of this description are intended to be within the scope of this disclosure, provided that these modifications and alternative embodiments fall within the scope of the claims.Furthermore, the term "comprising" is not intended to exclude additional other features or process steps, nor is "a" or "an" intended to exclude a plurality. List of reference symbols:

[0063] 1 Biopsy system 3 Biopsy element 4 Distal tip of the biopsy element 5 Fluorescence endoscopy element 7 Light guide or distal section of the fluorescence endoscopy element 9 Handpiece 11 Operating unit 13 Optical component 14 Distal end of the distal section of the fluorescence endoscopy element or light guide 15 Beam splitter 17 Long-pass filter 19 Image sensor, photodiode, or similar 21 Light source 23 Cable connection 25 Display component 27 Control and supply component 29 Operating component 31 Recording chamber 33 Tissue sample 35 Patient's skin 37 Patient's organ 39 Shadowing 41 Malignant tissue 43 Locking flange 45 Longitudinal webs 47 Mounting part 49 Longitudinal grooves 51 Inner cone 55 Radial stops 57 locking lugs

Claims

1. A biopsy system (1) comprising: - a biopsy element (3) for taking a sample (33) of tissue (41) to be examined from an organic body, - a fluorescence endoscopy element (5), wherein the fluorescence endoscopy element (5) has a distal portion (7) with a decoupling of stimulation light and coupling of fluorescence light, wherein the distal portion (7) of the fluorescence endoscopy element (5) in the biopsy element (3) is axially positionable in a distal position and in a proximal position, wherein for receiving the sample (33) of the tissue (41) to be examined, the biopsy element (3) has a receiving space (31) which in the distal position of the distal portion (7) of the fluorescence endoscopy element (5) is distally closed and in the proximal position of the distal portion (7) of the fluorescence endoscopy element (5) is distally open, characterised in that the distal portion (7) of the fluorescence endoscopy element (5) is guided in a radially sealed manner in the biopsy element (3), so that in the receiving space (31), during the pulling back of the distal portion (7) of the fluorescence endoscopy element (5) proximally in the biopsy element (3), a sucking-in effect is produced in the receiving space (31).

2. The biopsy element (1) according to claim 1, wherein the distal portion (7) of the fluorescence endoscopy element (5) completely fills the receiving space (31) in the distal position.

3. The biopsy system (1) according to claim 1 or 2, wherein the fluorescence endoscopy element (5) is configured to optionally distally decouple stimulation light and couple in fluorescence light in the distal position of the distal portion (7) of the fluorescence endoscopy element (5), the proximal position of the distal portion (7) of the fluorescence endoscopy element (5) and / or any intermediate position of the distal portion (7) of the fluorescence endoscopy element (27).

4. The biopsy system (1) according to any one of the preceding claims, wherein a distal end (14) of the distal portion (7) of the fluorescence endoscopy element (5) in the distal position closes the receiving space (31) in a flush manner with a distal tip (4) of the biopsy element (3) or distally projects from the distal tip (4) of the biopsy element (15).

5. The biopsy system (1) according to any one of the preceding claims, wherein the distal portion (7) of the fluorescence endoscopy element (5) is lockable in the distal position and / or the proximal position relative to the biopsy element (3).

6. The biopsy system (1) according to any one of the preceding claims, wherein the distal portion (7) of the fluorescence endoscopy element (5) at least in the distal position is mounted in a rotationally fixed manner in a defined rotational position about its longitudinal axis in the biopsy element (3).

7. The biopsy system (1) according to any one of the preceding claims, wherein a distal end (14) of the distal portion (7) of the fluorescence endoscopy element (5) and a distal tip (4) of the biopsy element (3) are bevelled at a same angle (γ).

8. The biopsy system (1) according to claim 7, wherein the angle (γ) is acute and preferably is 45° or less.

9. The biopsy system (1) according to any one of the preceding claims, wherein the distal portion (7) of the fluorescence endoscopy element (5) and / or the biopsy element (3) are configured as a disposable article for single use.

10. The biopsy system (1) according to any one of the preceding claims, wherein the fluorescence endoscopy element (5) comprises a light guide (7) with proximal coupling in of stimulation light and / or proximal decoupling of fluorescence light, wherein a distal end (14) of the light guide (7) distally decouples the stimulation light and / or distally couples in the fluorescence light.

11. The biopsy system (1) according to any one of the preceding claims, wherein the distal portion (7) of the fluorescence endoscopy element (5) has an LED for decoupling stimulation light and / or an image sensor or a photodiode for coupling in fluorescence light.

12. The biopsy system (1) according to any one of the preceding claims, wherein the fluorescence endoscopy element (5) is configured to selectively proximally couple in a first stimulation light and a second stimulation light, wherein the first stimulation light is on average shorter wave than the second stimulation light, and wherein the fluorescence endoscopy element (5) is configured to optionally produce a first image or a first fluorescence signal of a first tissue region from first fluorescence light stimulated with the first stimulation light and a second image or a second fluorescence signal from a second tissue region from second fluorescence light stimulated with the second stimulation light.

13. The biopsy system (19) according to any one of the preceding claims, wherein proximally, the fluorescence endoscopy element (5) comprises an optical component (13) which is detachably coupleable or fixedly coupled to the distal portion (7) of the fluorescence endoscopy element (5), wherein the optical component (13) comprises a beam splitter (15) with an image path side and an illumination path side, wherein to decouple the fluorescence light an image sensor (19) or a photodiode is detachably coupleable or fixedly coupled to the image path side, and wherein to couple in the stimulation light, a light source (21) is detachably coupleable or fixedly coupled to the illumination path side.

14. The biopsy system (1) according to claim 13, wherein the optical component (13) has an optical longpass filter (17) which transmits the fluorescence light more strongly to the image path side than the stimulation light, and / or has an optical shortpass filter which reflects the fluorescence light more strongly to the image path side than the stimulation light.

15. The biopsy system (1) according to any one of claims 13 or 14, wherein the fluorescence endoscopy element (5) has an operating unit (11) signal-connected or connectable to the image sensor (19) or the photodiode and / or the light source (21), wherein the operating unit (11) has an optical or acoustic display component (25), a control and supply component (27) and an operating component (29).

16. The biopsy system according to any one of claims 13 to 15, wherein the optical component (13) is arranged in a handpiece (9) of the fluorescence endoscopy element (5), to which the distal portion (7) of the fluorescence endoscopy element (5) and the biopsy element (3) can be coupled, wherein the handpiece (9) is preferably designed for repeated use.

17. The biopsy system (1) according to any one of the preceding claims, wherein the biopsy system is a system for fine-needle biopsy or fine-needle aspiration biopsy.