Biopsy instruments, kits and methods

Abstract

The biopsy instrument (1) includes a base member (10) extending from a proximal end (10a) along a central geometric axis (A) to a distal end (10b), wherein at least a distal portion (10b') of the base member (10) is shaped as an elongated hollow tube (10'), the distal end (10b) being intended to be at least partially inserted into tissue (50) from which a biopsy is to be obtained, wherein the elongated hollow tube (10') is provided with a distally facing circular cutting edge (11) defining a nozzle (10c) at the distal end (10b) of the elongated hollow tube (10'), wherein the elongated hollow tube (10') has a hollow elongated tubular sample acquisition portion (10b') at the distal portion (10b') of the elongated hollow tube (10') having a smooth inner surface (12). This disclosure also relates to an assembly and a method for obtaining a biopsy.

Description

[0001] Invention Field

[0002] This invention relates to biopsy instruments.

[0003] The present invention also relates to kits of parts.

[0004] The present invention also relates to a method for obtaining biopsies. Technical Background

[0006] A biopsy is a medical examination typically performed by a physician, involving the sampling of cells or tissue for examination. Biopsies are usually obtained using biopsy instruments inserted into the patient's body via an endoscope. A wide variety of endoscopic biopsy instruments are available today, most of which are biopsy forceps that clamp tissue samples or fine needles that aspirate cells by applying negative pressure.

[0007] For some diagnostic purposes, the millimeter-sized samples retrieved using the biopsy forceps are sufficient, but for some types of lesions and tumors (such as relatively deep lesions or deep-growing tumors), such small and superficial millimeter-sized samples are insufficient for diagnosis. Fine needles can typically reach deeper tumors, but can only retrieve a small number of scattered cells, thus limiting diagnostic capabilities.

[0008] When using endoscopic biopsy instruments to collect tissue samples, the instrument is inserted into the working channel of the endoscope and advanced to the biopsy site. After obtaining the tissue sample, the endoscopic biopsy instrument is retracted from the endoscope, allowing the tissue sample to be placed in the storage unit for evaluation by a pathologist.

[0009] Biopsy is currently the primary diagnostic tool for determining the malignancy of tumor growth. As cancer treatments improve and become more sophisticated, the number of biopsies required for diagnosis is also increasing. Before the optimal treatment approach can be determined, the spread and density of malignant cells need to be assessed; for example, the diagnosis of laryngeal or esophageal cancer may require 20 to 30 biopsies. This process is time-consuming and inconvenient for both patients and physicians. Furthermore, biopsy forceps separate tissue samples from the patient's body by tearing, which carries the risk of damaging the tissue sample and makes its evaluation more difficult. Fine needles provide small amounts of cells that cannot be prepared using conventional histological methods and often require more advanced endoscopic ultrasound equipment.

[0010] In this context, one might refer to WO201166470, which discloses an endoscopic biopsy instrument having a clamp with a storage cavity for multiple biopsies. The biopsy is transported upwards into the storage cavity using suction applied during sample retrieval.

[0011] Another technique sometimes used involves providing a needle element with a closed distal end and, conversely, an opening in the circumferential surface near the distal end. In such a needle element, aspiration is used to draw a portion of tissue into the opening in the circumferential surface. A reciprocating cutting tool is positioned inside the needle element, moving back and forth across the opening and cutting the tissue portion within the circumferential surface. Examples of this technique are shown in US20100152756 and US20060074343.

[0012] WO200197702 discloses a biopsy instrument in which an external needle or cannula is inserted into tissue and contacts a lesion, thereby applying continuous suction at the proximal end of the cannula to fix the lesion to the distal end of the cannula. While maintaining the suction force that holds the lesion in place, a second medical device (e.g., a biopsy needle or cryoprobe) is inserted into the lesion through an airtight seal at the proximal end of the instrument and through the cannula. US2013 / 0223702 A1 also discloses various types of biopsy instruments that use forceps, augers, or vacuum to aspirate tissue samples into the instrument.

[0013] The problem with the aforementioned disclosed technologies is that they rely on the application of suction, which complicates the instruments.

[0014] Therefore, it would be advantageous to have a biopsy instrument that allows for a direct and robust design, and that can retrieve a sufficient amount of tissue sample for diagnostic purposes in a short time. Furthermore, it would be advantageous if the tissue sample provided by the biopsy instrument is coherent. Invention Overview

[0016] One object of the present invention is to provide a biopsy instrument that allows for a straightforward and robust design and that can retrieve a sufficient amount of tissue sample for diagnostic purposes in a short time.

[0017] This objective is achieved through a complete set of components, which includes:

[0018] Biopsy instruments, and

[0019] The control unit includes a motor.

[0020] Biopsy instruments include:

[0021] An elongated hollow tubular member, extending from the proximal end to the distal end along a central geometric axis; and

[0022] A basal member extending from a proximal end to a distal end along a central geometric axis, wherein at least the distal portion of the basal member is shaped as an elongated hollow tube, the elongated hollow tube at the distal end of the basal member being intended to be at least partially inserted into the tissue from which a biopsy is to be obtained.

[0023] The base component is arranged inside the elongated hollow tubular component and can move independently of the elongated hollow tubular component in terms of rotation and translation.

[0024] The base member can transmit force along the central geometric axis, such that movement of the proximal end of the base member along the central geometric axis is transmitted to movement of the distal end of the base member along the central geometric axis. Furthermore, the base member can transmit torque about the central geometric axis, such that rotation and torque applied by the motor at the proximal end of the base member about the central geometric axis are transmitted from the proximal end to the distal end of the base member, thereby causing the distal end of the base member to rotate about the central geometric axis.

[0025] The elongated hollow tube can be advanced beyond the distal end of the outer elongated hollow tubular member by moving the proximal end of the base member along the central geometric axis, and the elongated hollow tube can also retract into the outer elongated hollow tubular member. Simultaneously, by applying rotation and torque at the proximal end of the base member via a motor, the elongated hollow tube can rotate about the central geometric axis within and relative to the outer elongated hollow tubular member.

[0026] The elongated hollow tube is provided with a circular cutting edge facing the distal end, which defines the nozzle at the distal end of the elongated hollow tube.

[0027] The elongated hollow tube has a hollow elongated tubular sample acquisition section at its distal end, and this hollow elongated tubular sample acquisition section has a smooth inner surface.

[0028] The proximal end of the base member is configured to connect to a motor, such that rotation and torque can be applied to the proximal end of the base member by the motor and transmitted from the base member to the elongated hollow tube at the distal end of the base member.

[0029] The motor is configured to provide rotation of the elongated hollow tube, which, when advanced beyond the distal end of the outer elongated hollow tubular member and retracted into the outer elongated hollow tubular member, rotates within and relative to the outer elongated hollow tubular member about a central geometric axis by applying rotation and torque to the proximal end of the base member, at a rotational speed of at least 13,000 rpm. The base member is flexible and the outer elongated hollow tubular member is flexible.

[0030] The advantage of this kit compared to existing biopsy instruments is that it can retrieve a sufficient amount of tissue sample for diagnosis in a relatively short time. This kit can also be referred to as a biopsy instrument or device. In this case, the component mentioned above as a biopsy instrument can be, for example, referred to as a disposable component of a biopsy instrument. The kit can also be called a biopsy system. This device is capable of retrieving multiple tissue samples one after another directly, without the need to harvest the initial sample.

[0031] When a biopsy is to be obtained, the cutting edge and distal end of the elongated hollow tube are configured to advance into the tissue along the central geometric axis while being rotated at a speed of at least 13,000 rpm by a motor driven at its proximal end, thereby cutting the tissue core. The tissue core enters the sample acquisition portion of the elongated hollow tube relative to the nozzle as the elongated hollow tube is advanced, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion. Subsequently, the elongated hollow tube retracts from the tissue while being rotated at a speed of at least 13,000 rpm by a motor driven at its proximal end, thereby detaching the tissue core from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesive force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which holds the core within the sample acquisition portion having the smooth inner surface.

[0032] When the distal end is advanced into the tissue for the second time, the first sample is pushed further proximally into the hollow tube by the core of the second sample in a controlled manner. The hollow tube has a smooth inner surface, which allows the core to adhere to the inside of the hollow tube due to the smooth surface and the presence of fluid in the tissue. This allows for sample retrieval with minimal damage and still allows the cutting edge and distal end to drill into and out of the tissue, thus reducing patient discomfort. When the core adheres to the inside of the elongated tubular member, it will twist and separate from the sample site at the nozzle of the elongated tubular member due to shear or tensile forces. Compared to prior art biopsy instruments, the biopsy instrument of the present invention does not require any hooks or similar devices on the inside of the instrument (hooks have the disadvantage of being difficult to integrate with drilling into and out of the tissue) and also avoids sample damage. In fact, the biopsy instrument of the present invention is so gentle on the sample and allows for controlled sample retrieval that each sample remains uniquely identifiable and remains undamaged or coherent. This allows physicians to retain any information provided by the tomography and / or location of the corresponding sample, which can then be used to increase the amount of data provided by the biopsy, thereby improving the accuracy of the final diagnosis.

[0033] It can be noted that the phrase "the base member can rotate and translate independently relative to the elongated hollow tubular member" means that rotational movement is independent of translational movement, and vice versa.

[0034] It can be noted that the reference mentioned above is a reference sample. When defining a reference for smoothness, the concept of referencing a reference sample is used because biopsy instruments can be used in actual biopsy sampling according to a variety of different methods. The biopsy instrument can, for example, be used according to a method in which the reference is as described above and, for example, as... Figures 3a to 5 As shown, the distal end is advanced a distance into the tissue and then retracted to actually use the biopsy instrument. However, according to another method, the biopsy instrument can be used to move along the surface of the tissue from which the biopsy is to be obtained, such as... Figures 13a to 13c and Figures 14a to 14c As shown. In Figures 3a to 3b and Figure 4 In the user method shown, the distal end is fully inserted into the tissue, i.e., the distal end is inserted into the tissue with its entire circumferential portion, thereby creating an adhesion force greater than the breaking force required for the core to detach from the tissue. Figures 13a to 13c and Figures 14a to 14c In the method shown, the distal end is only partially inserted into the tissue; that is, the distal end is inserted only as a portion of the entire circumferential portion into the tissue. Surface smoothness is advantageous in both methods, but when the aforementioned reference sample is performed, this is clearly demonstrated by the detachment of the core from the remaining portion of the tissue, and the adhesion provided by smoothness can be observed. It should be noted that the reference sample refers to a sample performed in healthy tissue.

[0035] Preferably, the hollow tube has an extension, i.e. a length segment along the central geometric axis, and the hollow tube is provided with the smooth surface along the length from the distal end to the proximal end, the extension having a length that allows at least two, preferably at least three, reference samples of the above-disclosed type to be obtained one after another.

[0036] From a bending perspective, the basal component and the outer elongated hollow tubular component are flexible, allowing the biopsy instrument to extend along the central geometric axis in various shapes that change over time, typically required for biopsy instruments used in endoscopes. Such flexible biopsy instruments for endoscopes are sometimes referred to as endoscopic biopsy instruments. For a design where the basal component and the outer elongated hollow tubular component are flexible (from a bending perspective), providing a rotational speed of at least 13,000 rpm is particularly useful, as the relatively high rotational speed will allow a relatively blunt cutting edge to effectively penetrate tissue, and because the rotation of the basal component will stabilize the distal extension of the basal component beyond the outer elongated hollow tubular component. The fact that a relatively blunt cutting edge can be present is advantageous, as it reduces the risk of the cutting edge becoming stuck within the outer elongated hollow tubular component, especially when the outer elongated hollow tubular component is flexible and bent relatively sharply. Preferably, the cutting edge is a blunt cutting edge. The fact that the cutting edge can have a relatively blunt cutting edge is advantageous because it reduces the risk of the cutting edge accidentally cutting tissue before initiating rotation. According to a preferred embodiment, the rotation speed can be between 13,000 rpm and 25,000 rpm. Among other things, the upper limit depends on mechanical constraints. In some embodiments, a higher upper limit, such as 30,000 rpm, may be possible. Furthermore, in the embodiments described herein, no improvement is currently achieved through higher rotation speeds, but improvements can be achieved in other designs or embodiments of the invention. According to a more preferred embodiment, the rotation speed is between 13,000 rpm and 20,000 rpm. It can be noted that in order to achieve the desired cutting effect, the rotation speed relative to the tissue is at least 13,000 rpm. However, from a practical point of view, since the outer elongated hollow tubular member is connected to the housing of the operating unit and the base member is connected to the motor, the rotation speed of the base member relative to the outer elongated hollow tubular member is also at least 13,000 rpm.

[0037] It can be noted that, according to the alternative, from a bending perspective, the basal member and the outer elongated hollow tubular member can be rigid and extend along a central geometric axis that runs in a straight line. Such a rigid instrument is typically used as a standalone biopsy instrument. Therefore, it is typically not used in conjunction with an endoscope. Figures 23 to 25 and Figures 26a to 26b An example of such a device is shown. In this context, it can be noted that for such a device, a lower rotational speed compared to that used for flexible devices is conceivable. Therefore, the base member and the outer elongated hollow tubular member can be rigid, and the motor is designed to provide a rotational speed of at least 3000 rpm.

[0038] It can be noted that the elongated hollow tubular member is connected to the operating unit's components other than the motor, allowing the base member to rotate relative to the elongated hollow tubular member via the motor. The elongated hollow tubular member can be connected to the housing, for example, or via a telescopic mechanism. The telescopic mechanism allows the elongated hollow tubular member to translate relative to the housing within the boundaries defined by the telescopic mechanism. It can be noted that the telescopic mechanism allows the elongated hollow tubular member to rotate relative to the housing, for example, by hand, allowing adjustment of the angular orientation of the elongated hollow tubular member. For example, such adjustment might be necessary if the distal end of the elongated hollow tubular member has a stop with a variable shape when viewed circumferentially along its length. However, the proximal end of the elongated hollow tubular member is connected to the operating unit such that it is at least semi-stationary relative to the housing, i.e., it is not rotated relative to the housing by any motor. Advantageously, the elongated hollow tubular component is stationary relative to the tissue, preventing accidental damage that could easily occur if it were rotating at high speed relative to the tissue. In this context, it is advantageous that the instrument allows the elongated hollow tube of the base component to rotate at high speeds before it is advanced beyond the outer elongated hollow tubular component, during its advancement into the tissue, and also during its retraction into the outer elongated hollow tubular component. It is also conceivable to provide a removable internal component configured to be positioned inside the base component and to close the opening at the distal end of the hollow tube in the base component during insertion of the biopsy instrument, thereby preventing unnecessary tissue filling into the hollow tube. The removable internal component can also be configured to close the distal opening of the outer elongated hollow component during insertion of the biopsy instrument, thereby preventing unnecessary tissue filling into the outer elongated hollow component.

[0039] It can be noted that the rotational directions during advance and retraction can be the same, but do not necessarily have to be the same. For example, having the same rotational direction is advantageous, such as when the base member has a stronger ability to transmit torque in one rotational direction than in the opposite direction. This difference in torque transmission capability may occur, for example, when the base member is designed as a wire such as a cord or hollow cord. In one rotational direction, the winding of the wire tends to tighten, and typically the wire is relatively strong when the transmitted torque has a tendency to tighten the winding. From the user's perspective, it is advantageous if the rotation remains in the same rotational direction and preferably also at the same or at least similar rotational speed during the advance of the elongated hollow tube of the base member into the tissue and during the retraction of the elongated hollow tube of the base member out of the tissue, because any tactile feedback from the tissue to the user via the instrument is typically caused by the tissue and is not affected by differences in the specific interactions between the tissue and the elongated hollow tube with respect to different rotational directions and / or rotational speeds.

[0040] The inner or outer surface of the sample acquisition section is preferably impermeable to liquids. This impermeability is advantageous when adhesion is involved between the outer envelope surfaces of the tissue core during the retraction of the elongated hollow tube outside the tissue. When subjected to tension, the change in tissue geometry will, in a sense, locally result in localized negative pressure, thereby enhancing adhesion. This localized negative pressure is particularly pronounced if the elongated hollow tube is closed at its proximal end or subjected to negative pressure at its proximal end. Preferably, the inner or outer surface of the sample acquisition section is also impermeable to gases. It can be noted that the preferred property of the inner or outer surface being impermeable to liquids, and more preferably impermeable to gases, does not necessarily mean that the inner or outer surface needs to be both impermeable to liquids and gases when long-term performance is involved. The preferred property of the inner or outer surface being impermeable to liquids actually means that the surface is preferably impermeable to liquids for at least a period of time sufficient for retrieving the biopsy sample, and preferably also sufficient for allowing the sample to be harvested. That is, the inner or outer surface should preferably be impermeable to liquids for at least several seconds. Similarly, preferably, the inner or outer surface is also gas-impermeable for at least the time period sufficient for retrieving the biopsy sample, and preferably also sufficient for allowing the sample to be harvested.

[0041] In a preferred embodiment, the inner surface is impermeable to liquids, and more preferably impermeable to gases. It can be noted that a smooth inner surface is preferably impermeable to liquids, and more preferably impermeable to gases.

[0042] According to a preferred embodiment, a circular cutting edge facing distally is formed, and a smooth inner surface (preferably a liquid-impermeable smooth inner surface) is connected to the cutting edge such that the smooth inner surface (preferably a liquid-impermeable smooth inner surface), viewed along the central geometric axis, extends to the distal portion of the cutting edge. This connection of the smooth inner surface to the cutting edge, such that the smooth inner surface extends to the distal portion of the cutting edge, provides adhesion between the smooth inner surface and the circumferential outer surface of the core, viewed along the central geometric axis, up to the incision in the tissue. This is advantageous when it involves achieving a clear and effective separation between the core, which is trapped inside the elongated hollow tube, and the remaining portion of the tissue just outside the nozzle of the sample acquisition portion of the elongated hollow tube. This is further enhanced if the smooth inner surface is a liquid-impermeable smooth inner surface connected to the cutting edge such that, viewed along the central geometric axis, the liquid-impermeable smooth inner surface extends to the distal portion of the cutting edge.

[0043] Preferably, the smoothness of the inner surface is such that, when a reference biopsy is to be obtained, the cutting edge and distal end of the elongated hollow tube are configured to be advanced into the tissue along the central geometric axis while being rotated at a speed of at least 13,000 rpm by a motor driven at its proximal end, thereby cutting the tissue core. The tissue core enters the sample acquisition portion of the elongated hollow tube relative to the mouthpiece of the elongated hollow tube as it is advanced, wherein the circumferential outer surface of the core is at least partially adjacent to the smooth inner surface of the sample acquisition portion. Subsequently, the elongated hollow tube is retracted from the tissue while being rotated at a speed of at least 13,000 rpm by a motor driven at its proximal end, thereby detaching the tissue core from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by an adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which holds the core inside the sample acquisition portion having the smooth inner surface.

[0044] Preferably, the surface smoothness is such that, when using the biopsy instrument of the type described above to perform a reference sample procedure, the core detaches from the tissue during the retraction of the elongated hollow tube when the distal end has been inserted into the tissue at a distance equal to or greater than the inner diameter of the nozzle. However, in many cases, it is preferred that the surface smoothness is such that, when using the biopsy instrument of the type described above to perform a reference sample procedure, the core detaches from the tissue during the retraction of the hollow tube when the distal end has been inserted into the tissue at a distance 1.3 times or greater than the inner diameter of the nozzle. More preferably, the surface smoothness is such that, when using the biopsy instrument of the type described above to perform a reference sample procedure, the core detaches from the tissue during the retraction of the hollow tube when the distal end has been inserted into the tissue at a distance at least 1.7 times or greater than the inner diameter of the nozzle. The above applies at least to those with an inner diameter between 1 mm and 5 mm.

[0045] When the smooth inner surface is formed of steel such as medical-grade stainless steel, the surface roughness Ra value of the smooth inner surface is preferably less than 1.5 µm, more preferably less than 1 µm, and when the smooth inner surface is formed of a polymer-based material, the Ra value is less than 6 µm, such as between 1 µm and 6 µm. When the smooth inner surface is formed of steel such as medical-grade stainless steel, the surface roughness Ra value of the smooth inner surface is preferably between 0.05 µm and 1.5 µm, more preferably between 0.05 µm and 1 µm. The surface roughness value Ra is preferably determined according to the standard ISO 4287:1997. Preferably, the surface has low friction. Currently, this is considered one reason why a higher Ra value can be achieved when the smooth inner surface is formed of a polymer-based material compared to when the smooth inner surface is formed of steel. Therefore, it is believed that a suitable Ra value increases as the coefficient of friction decreases. Therefore, a suitable combination is found to be materials with a coefficient of friction of about 0.6 to 1.0, such as for steel to steel, with a combined Ra value between 0.05 µm and 1.5 µm, preferably between 0.05 µm and 1 µm, and another suitable combination is materials with a coefficient of friction of about 0.02 to 0.3, such as for polymer-based materials mentioned below, with a combined Ra value between 1 µm and 6 µm.

[0046] A smooth surface is disposed inside a tubular member, such as an elongated hollow tube, having parallel and straight generatrices and a circular cross-section. The smooth surface is disposed without any protrusions. The smooth surface is disposed to cover the entire inner circumference of the tubular member. The smooth surface is disposed at least at the distal end of the tubular member.

[0047] The tubular member may also have an outer surface, at least on the distal portion of the tubular member, having a predetermined smoothness.

[0048] The smooth surface can be the inner surface of a tubular component. The inner surface of the tubular component can be machined to a predetermined smoothness. The inner surface can be made of medical-grade stainless steel.

[0049] A smooth surface can be a layer or film arranged on the inner surface of a tubular member.

[0050] A smooth surface is arranged along the tubular member, the length of which corresponds at least to the sample to be obtained. The sample length can range from a few millimeters to about 50 millimeters. The smooth surface can be arranged along the tubular member, the length of which corresponds to a number of consecutive samples to be obtained sequentially. The smooth surface can extend to the cutting edge, or terminate at a short distance from the cutting edge, such as 0.5 mm from the cutting edge.

[0051] For example, it is conceivable to form a base member such that the base member includes an end tube (such as a rigid end tube) at its distal end, the end tube being machined from steel such that the inner side of the end tube is formed from steel, and the smoothness of the inner side of the end tube is as described above, so as to enable sample acquisition, wherein the end tube is relatively short to allow the instrument to follow the curvature of the endoscope. Proximal to this end tube, the base member is formed from a hollow wire, which is provided with a polymer-based inner layer, such as by coating the inner side of a metal hollow wire with a polymer. This provides a smooth surface to allow the sample to slide further into the base member as more sample is acquired. It can be noted that this portion of the end tube formed by coating the inner side of the hollow wire can result in a portion with a smooth surface, i.e., it has low friction, but due to the weaving, the inner surface of the hollow wire is not a flat surface, and the Ra value of this portion will be higher than discussed above. However, in such a design, the end tube will be smooth, preferably having the Ra value as described above, to provide the desired adhesion during sample acquisition. This coating can be provided, for example, by a so-called dip coating.

[0052] Preferably, the smooth inner surface is formed of a polymer-based material. The polymer-based material can be of a grade generally referred to as non-sticky polymer. Using a non-sticky polymer is advantageous because it reduces friction between the first tissue sample and the smooth surface and facilitates further transport of the first tissue sample into the elongated tubular member. Furthermore, surfaces typically considered non-sticky are generally smooth enough to provide the desired smoothness. The polymer-based material can be, for example, ethylene tetrafluoroethylene (TFE). Other plastic materials, such as other fluoropolymers, are also conceivable. Such fluoropolymers can be, for example, polytetrafluoroethylene (PTFE), perfluoroalkoxy, PFA, fluorinated ethylene propylene, FEP, and ETFE, ethylene tetrafluoroethylene.

[0053] It can be noted that polymer-based materials can be provided in a variety of different physical designs. Polymer-based materials can be provided in the form of elongated tubular components. Polymer-based materials can be attached to the inside of external components. Polymer-based materials can be disposed within external components and can move and rotate relative to the external components. Polymer-based materials can be provided as a coating within external components. These various physical designs will be discussed in more detail below.

[0054] The base component preferably comprises an elongated hollow tubular member extending from the proximal end to the distal end of the base component. This extension of the base component from proximal to distal facilitates manufacturing, as the entire length of the base component can be designed in the same manner. Furthermore, this extension of the base component from proximal to distal facilitates the harvesting of biopsy samples, as it allows for the safe ejection of the sample using a mechanical tool (e.g., a flexible metal stylet) extending from the proximal end of the biopsy instrument through the entire biopsy instrument to its distal end. The elongated hollow tube also allows for the ejection of the sample at the distal end for harvesting using air jets or fluid injections at the proximal end. These methods require the elongated tube to be sufficiently impermeable to gas or liquid to allow for a sufficient volume of air or liquid to be ejected to actually expel the sample. Preferably, the elongated hollow tube is designed to have a uniform cross-section extending from the proximal end to the distal end; in addition, the elongated hollow tube also has local irregularities in the form of specific design features at the proximal end and / or the distal end. These local irregularities may, for example, be a connector at the proximal end of the hollow tube, and / or the hollow tube being specifically designed at the distal end to provide a cutting edge or to receive a separate component that provides the cutting edge.

[0055] Preferably, the elongated hollow tubular member is formed of a polymer-based material that provides the smooth inner surface. This is a convenient way to provide a smooth inner surface.

[0056] The polymer-based material forming the smooth inner surface is preferably provided in the form of a film, preferably a tubular film, which is inserted into and attached to the inner surface of the elongated hollow tubular member. The tubular film of polymer-based material can be attached to the inner surface of the elongated hollow tubular member, for example, by directly or indirectly heating the polymer-based material, such that it adheres to the inner surface of the elongated hollow tubular member.

[0057] Alternatively, a polymer-based material forming a smooth inner surface can be provided as a coating.

[0058] Preferably, the elongated hollow tubular member includes a hollow metal cord capable of transmitting force along a central geometric axis, such that movement of the proximal end along the central geometric axis is transmitted to movement of the distal end along the central geometric axis, and the hollow metal cord capable of transmitting torque about the central geometric axis, such that rotation and torque about the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate about the central geometric axis.

[0059] Preferably, the elongated hollow tubular member has a circular cutting edge facing the distal side at its distal end.

[0060] Preferably, the elongated hollow tubular component also includes hollow metal cord.

[0061] An inner elongated hollow tubular component is arranged within an outer elongated hollow tubular component and is rotatably and translationally movable relative to the outer elongated hollow tubular component. One advantage of this design is that the outer elongated hollow tubular component can remain stationary relative to the endoscope during sample acquisition. It is designed to advance the inner elongated hollow tubular component into the tissue while the outer elongated hollow tubular component remains outside the tissue. By positioning the distal end of the outer elongated hollow tubular component outside the tissue and advancing the distal end of the inner elongated hollow tubular component into the tissue, it facilitates good control of the insertion depth. The fact that the outer elongated hollow tubular component can remain stationary relative to the endoscope during sample acquisition also makes it possible to provide a stop for the distal end of the outer elongated hollow tubular component, preventing the distal end from being unintentionally advanced into the tissue. Furthermore, by allowing the outer elongated hollow tubular component to remain stationary relative to the endoscope during sample acquisition, combined with the rotatable and translational movement of the inner elongated hollow tubular component relative to the outer elongated hollow tubular component, the outer elongated hollow tubular component can be designed to fit relatively tightly with the working channel of the endoscope. Moreover, due to the provision of relative movement between the two interacting components in the instrument's specialized design and manufacture, a relatively tight fit can be provided between the inner and outer elongated hollow tubular components while still ensuring sufficient play. Furthermore, by enabling a tight fit, the inner and outer elongated hollow tubular components will, in a sense, support each other and prevent collapse, which in turn allows for the use of relatively thin material thicknesses in both components. For a given working channel with a given internal diameter, this will further allow the distal end of the inner elongated hollow tubular component to have a relatively large internal diameter. Other advantages and specific design features of the second embodiment will be discussed in more detail in conjunction with the accompanying drawings.

[0062] Preferably, the rotatable mobility of the inner elongated hollow tubular member is independent of its translational mobility, so that the inner elongated hollow tubular member can be rotated by a motor and move back and forth relative to the outer elongated hollow tubular member independently of rotational movement.

[0063] It can also be noted that in this embodiment (where the inner elongated hollow tubular member is arranged within the outer elongated hollow tubular member and is rotatably and translationally movable relative to the outer elongated hollow tubular member), the base member, viewed from a bending perspective, can be rigid according to one embodiment and flexible according to another. In the rigid embodiment, the base member extends along a central geometric axis extending in a straight line. Such a rigid biopsy instrument is typically used as a standalone biopsy instrument. In such an embodiment, the base member can be formed as a needle with a removable internal probe. Rigid biopsy instruments allow percutaneous access to the tumor. Typically, in such an embodiment, the outer elongated hollow tubular member is fixed, and the inner elongated hollow tubular member is rotated by a motorized handle and advanced into the tissue after the probe is withdrawn. Once the rigid internal probe has been completely removed, the inner hollow tube can be drilled into a hollow space, such as the abdomen, chest, sinuses, or joints, and used for inserting other instruments, such as cameras, injection devices for fluids or gases, or guide wires / rods. According to another embodiment of this example (in which an inner elongated hollow tubular member is arranged within an outer elongated hollow tubular member and is rotatably and translationally movable relative to the outer elongated hollow tubular member), the base member is flexible from a bending perspective, thereby enabling the base member to extend along a central geometric axis in various shapes, which is typically required for biopsy instruments used in endoscopes. Such flexible biopsy instruments for endoscopes are sometimes referred to as endoscopic biopsy instruments.

[0064] The flexible inner tube can be used to insert a flexible guide wire, and then the flexible inner tube can be removed to put the guide wire in place for insertion of other devices such as stents and dilating balloons.

[0065] Preferably, the elongated hollow tubular member is capable of transmitting force along the central geometric axis, such that movement of the proximal end along the central geometric axis is transmitted to movement of the distal end along the central geometric axis, and the elongated hollow tubular member is capable of transmitting torque about the central geometric axis, such that rotation and torque about the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate about the central geometric axis.

[0066] Preferably, the elongated hollow tubular member has a connector at its proximal end for connection (preferably a releasable connection) to a motor, which is capable of transmitting the movement, rotation, and torque along the central geometric axis.

[0067] The above objective is also achieved by a biopsy device comprising:

[0068] An elongated hollow tubular member extending from the proximal end to the distal end along the central geometric axis, and

[0069] A basal member extending from a proximal end along a central geometric axis to a distal end, wherein at least a distal portion of the basal member is shaped as an elongated hollow tube, the elongated hollow tube at the distal end of the basal member being intended to be at least partially inserted into the tissue from which a biopsy is to be obtained.

[0070] The base component is arranged inside the elongated hollow tubular component and can move independently of the elongated hollow tubular component in terms of rotation and translation.

[0071] The base member can transmit force along the central geometric axis, such that movement of the proximal end of the base member along the central geometric axis is transmitted to movement of the distal end of the base member along the central geometric axis. Furthermore, the base member can transmit torque about the central geometric axis, such that rotation and torque applied by the motor at the proximal end of the base member about the central geometric axis are transmitted from the proximal end to the distal end of the base member, thereby causing the distal end of the base member to rotate about the central geometric axis.

[0072] The elongated hollow tube can be advanced beyond the distal end of the outer elongated hollow tubular member by moving the proximal end of the base member along the central geometric axis, and the elongated hollow tube can also retract into the outer elongated hollow tubular member. Simultaneously, by applying rotation and torque to the proximal end of the base member by a motor, the elongated hollow tube can rotate about the central geometric axis within the outer elongated hollow tubular member and relative to the outer elongated hollow tubular member.

[0073] The elongated hollow tube is provided with a circular cutting edge facing the distal end, which defines the nozzle at the distal end of the elongated hollow tube.

[0074] The elongated hollow tube has an elongated hollow tubular sample acquisition section at its distal end, and this elongated hollow tubular sample acquisition section has a smooth inner surface.

[0075] The proximal end of the base member is configured to connect to a motor, such that rotation and torque can be applied to the proximal end of the base member by the motor and transmitted from the base member to the elongated hollow tube at the distal end of the base member.

[0076] The motor is configured to, when the elongated hollow tube is advanced beyond the distal end of the outer elongated hollow tubular member and when the elongated hollow tube retracts into the outer elongated hollow tubular member, apply rotation and torque to the proximal end of the base member, causing the elongated hollow tube to rotate about its central geometric axis within and relative to the outer elongated hollow tubular member.

[0077] The smooth inner surface has a surface roughness, which is less than 1.5 µm when formed of steel (such as medical grade stainless steel), preferably less than 1 µm, and less than 6 µm when formed of polymer-based materials, such as between 1 µm and 6 µm.

[0078] The above objective is also achieved by a method for obtaining a biopsy, the method comprising:

[0079] A biopsy instrument is provided, the biopsy instrument comprising:

[0080] An elongated hollow tubular member extending from the proximal end to the distal end along the central geometric axis, and

[0081] A basal member extending proximally along a central geometric axis from a central end to a distal end, wherein at least the distal portion of the basal member is shaped as an elongated hollow tube having a distally facing circular cutting edge defining a nozzle at the distal end of the hollow tube, the cutting edge being designed to be at least partially inserted into tissue from which a biopsy is to be obtained.

[0082] The base component is arranged inside the elongated hollow tubular component and can move independently of the elongated hollow tubular component in terms of rotation and translation.

[0083] Provides a control unit with a motor.

[0084] Connect the proximal end of the base component to the motor.

[0085] Connect the proximal end of the elongated hollow tubular component to the operating unit.

[0086] The distal end of the biopsy instrument is moved to the location where a tissue sample is to be obtained. Preferably, the distal end of the base component is located inside the elongated hollow tubular component.

[0087] Start the motor so that rotation at a speed of at least 13,000 rpm is transmitted to the distal end of the biopsy instrument.

[0088] A long, hollow tube with a distally facing circular cutting edge is pushed into the tissue from which a tissue sample is to be obtained, while a motor rotates the distal end at a speed of at least 13,000 rpm to cut the tissue core. The tissue core enters the sample acquisition section of the long, hollow tube relative to the nozzle as the long, hollow tube is advanced.

[0089] While the distal end of the base component is rotated by a motor, the distal end of the base component is retracted outside the tissue, wherein the circumferential outer surface of the core is at least partially adjacent to the smooth inner surface of the hollow elongated tubular sample acquisition portion, which is located at the distal portion of the elongated hollow tube.

[0090] The core of the tissue is thus detached from the tissue by a pulling force caused by the retraction of the elongated hollow tube and by the adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which holds the core within the sample acquisition portion having a smooth inner surface.

[0091] The above objective is also achieved by a set of components, which includes:

[0092] Biopsy instruments, biopsy instruments being the type of biopsy instrument disclosed in its basic construction or any preferred embodiment, and

[0093] The control unit includes a motor.

[0094] The biopsy instrument can be connected to a motor at its proximal end, so that rotation and torque can be applied to the proximal end of the base member and transmitted to the distal end of the base member.

[0095] The above objective is also achieved by a method for obtaining a biopsy, the method comprising:

[0096] Connect the proximal end of the biopsy instrument to a motorized control unit.

[0097] Move the distal end of the biopsy instrument to the location where you want to obtain the tissue sample.

[0098] Start the motor to transmit rotation to the distal end of the biopsy instrument.

[0099] While the distal end is rotated by a motor, it is advanced into the tissue from which a tissue sample is to be obtained. The distal end is shaped into an elongated hollow tube at least at the distal portion of the base member. This elongated hollow tube has a circular cutting edge facing distally, which defines a nozzle at the distal end of the hollow tube, thereby cutting the tissue core. The tissue core enters the sample acquisition portion of the hollow tube relative to the hollow tube passing through the nozzle as the hollow tube is advanced.

[0100] When the distal end is rotated by the motor, it is retracted outside the tissue, and the circumferential outer surface of the core is at least partially adjacent to the smooth inner surface of the hollow elongated tubular sample acquisition portion located at the distal part of the hollow tube.

[0101] The core of the tissue is thus detached from the tissue by a pulling force caused by the retraction of the hollow tube and by the adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which keeps the core within the sample acquisition portion having a smooth inner surface.

[0102] The above objective is also achieved by a biopsy device comprising:

[0103] A basal member extending from a proximal end to a distal end along a central geometric axis, wherein at least a distal portion of the basal member is shaped as an elongated hollow tube, the distal end being intended to be at least partially inserted into the tissue from which a biopsy is to be obtained.

[0104] The base component may be able to transmit force along the central geometric axis, such that movement of the proximal end along the central geometric axis is transmitted to movement of the distal end along the central geometric axis, and the base component may be able to transmit torque about the central geometric axis, such that rotation and torque about the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate about the central geometric axis.

[0105] The hollow tube may be provided with a circular cutting edge facing the distal end, which defines the nozzle at the distal end of the hollow tube.

[0106] The hollow tube may have a hollow, elongated tubular sample acquisition section at its distal end, and this section has a smooth inner surface.

[0107] Preferably, the smoothness of the inner surface is such that, when a reference biopsy is to be obtained, the cutting edge and distal end of the hollow tube are configured to be advanced into the tissue along the central geometric axis while being rotated by a motor at its proximal end, thereby cutting the tissue core. The tissue core, due to the advancement of the hollow tube relative to the passage of the hollow tube through the nozzle, enters the sample acquisition portion of the hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion. Subsequently, the hollow tube retracts from the tissue while being rotated by the motor at its proximal end, thereby detaching the tissue core from the tissue by a pulling force caused by the retraction of the hollow tube and by the adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which holds the core within the sample acquisition portion having the smooth inner surface. As the sample is pulled back, the adhesion force, combined with rotation, causes the sample at its distal end to rotate, thereby releasing the sample from the tissue through a gradually thinning and twisting thread generated by the rotation of the biopsy.

[0108] The above objective is also achieved by a biopsy device comprising a base member extending from a proximal end along a central geometric axis to a distal end, wherein at least a distal portion of the base member is shaped as an elongated hollow tube, the distal end being intended to be at least partially inserted into tissue from which a biopsy is to be obtained, wherein the hollow tube is provided with a distally facing circular cutting edge defining a nozzle at the distal end of the hollow tube, wherein the hollow tube has a hollow elongated tubular sample acquisition portion at the distal portion of the hollow tube having a smooth inner surface.

[0109] It can be noted, and can be imagined, that for some user scenarios, an elongated hollow tubular component (rigid or flexible) can be manually rotated at the proximal end, resulting in the rotation of the circular cutting edge facing the distal side. Brief description of the attached diagram

[0111] The invention will be described in more detail by way of example with reference to the accompanying illustrative drawings, which illustrate presently preferred embodiments of the invention.

[0112] Figure 1a The illustration depicts a physician obtaining tissue samples from a patient using a biopsy instrument and endoscope according to one embodiment.

[0113] Figure 1b The illustration depicts a physician obtaining tissue samples from a patient using a biopsy instrument and endoscope according to another embodiment.

[0114] Figure 2a More details were disclosed. Figure 1a The proximal end of the endoscope and the proximal end of the biopsy instrument.

[0115] Figure 2b More details were disclosed. Figure 1b The proximal end of the endoscope and the proximal end of the biopsy instrument.

[0116] Figure 3a The distal end of the outer sheath and the distal end of the biopsy instrument are disclosed, with the distal end of the biopsy instrument being advanced into the tissue from which a sample will be obtained.

[0117] Figure 3a The distal end of the endoscope and the distal end of the base component are disclosed, with the distal end of the base component extending from the elongated hollow component and entering the tissue from which the sample will be obtained.

[0118] Figure 3b The distal end of the endoscope and the distal end of the base component are disclosed, with the distal end of the base component being advanced into the tissue from which a sample will be obtained.

[0119] Figure 4 It was made public. Figure 3b The endoscopes and instruments shown are in several samples.

[0120] Figure 5 The tissues after several samples were obtained are shown.

[0121] Figure 6 The process of harvesting samples from biopsy instruments was made public.

[0122] Figure 7 The method of harvesting using overpressure provided by a syringe was disclosed.

[0123] Figure 8The interior of the manipulation member configured to be attached to the proximal end of a biopsy instrument is disclosed.

[0124] Figure 9 It was made public. Figure 8 The external control components and control buttons.

[0125] Figure 10 The manipulation component attached to the proximal end of the biopsy instrument has been disclosed.

[0126] Figure 11 Flexible biopsy instruments have been disclosed.

[0127] Figure 12 The elongated flexible hollow component is disclosed in more detail with cross-sections and exploded views.

[0128] Figures 13a to 13b The first and second positions of the distal end of the biopsy instrument when obtaining tissue samples along the surface of the tissue are disclosed.

[0129] Figure 13c It discloses how the telescoping function can be manipulated to obtain tissue samples along the surface of the tissue.

[0130] Figure 14a It was made public as follows Figures 13a to 13b The cross-sectional view shows the distal end of the biopsy instrument when obtaining tissue samples along the surface of the tissue.

[0131] Figure 14b A microstructure having recesses in its surface is disclosed, such as... Figures 13a to 13b and Figure 14a The image shows a biopsy device.

[0132] Figure 14c yes Figure 14b A top view of the tissue and concave areas.

[0133] Figure 15 This is a cross-sectional view of the biopsy instrument according to the second embodiment.

[0134] Figure 16 yes Figure 15 Another cross-sectional view of the biopsy instrument.

[0135] Figure 17 It discloses the use of endoscopes Figure 15 and Figure 16 A schematic diagram of a biopsy instrument.

[0136] Figure 18 It was made public with Figures 15 to 17 A schematic diagram of a biopsy instrument of the same type, connected to a variant of a telescope mechanism located between the motor and the biopsy instrument.

[0137] Figure 19 More details were disclosed. Figure 18 The telescopic mechanism shown.

[0138] Figure 20 yes Figure 18 and Figure 19 Cross-sectional view of the telescopic mechanism.

[0139] Figure 21 yes Figures 18 to 20 An exploded view of the telescopic mechanism.

[0140] Figure 22 A motor, a telescopic mechanism, and a biopsy instrument are disclosed, and an example of a biopsy instrument interface is schematically disclosed, the interface being configured to connect to the telescopic mechanism.

[0141] Figure 23 A rigid outer hollow needle component and a rigid inner hollow needle component are disclosed, the rigid inner hollow needle component being configured to be positioned within the rigid outer hollow needle component.

[0142] Figure 24 A rigid inner hollow needle element that is inserted into a rigid outer hollow needle element is disclosed.

[0143] Figure 25 A rigid inner hollow needle and a rigid outer hollow needle are disclosed in the retracted position, wherein the needles are configured to be operated and inserted into a handle for operation in a sample acquisition method.

[0144] Figure 26a The needle is disclosed as being positioned in the handle and in a state ready to obtain a biopsy sample.

[0145] Figure 26b The operation of the handle to obtain biopsy samples is illustrated.

[0146] Figure 27 It is a schematic diagram of a system including a motor, a telescopic mechanism, and biopsy instruments.

[0147] Figure 28 It shows the connection to the endoscope. Figure 27 The telescopic mechanism.

[0148] Figures 29 to 30 More details were disclosed. Figures 27 to 28 The telescopic mechanism shown.

[0149] Figures 31 to 32 It was made public. Figures 27 to 30 The variant of the telescopic mechanism shown.

[0150] Detailed Description of Preferred Embodiments

[0151] exist Figures 1a to 1b The document generally discloses how a user U (such as a physician) uses an endoscope 40 to guide a biopsy instrument 1 through the body cavity of a patient P to a sample site 50. By inserting the endoscope 40 through the patient's body cavity and, as the biopsy instrument 1 is inserted into the working channel 41 of the endoscope 40, the biopsy instrument 1 is inserted into the patient's body to reach the intended sample site 50. Figures 1a to 1b As shown and in Figures 2a to 2b As shown in more detail, the endoscope has an access opening 41a at the proximal end of the remaining portion outside the patient's body, through which the biopsy instrument 1 is intended to be inserted. The endoscope 40 is typically equipped with a camera and / or an ultrasound probe, and is typically connected to a screen 44 via a processing unit 45 capable of converting data from the camera or ultrasound probe into images on the screen 44.

[0152] The biopsy instrument 1 includes a base component 10, which extends from the proximal end 10a to the distal end 10b along a central geometric axis A.

[0153] Figure 11 An embodiment of the complete biopsy instrument 1 is shown. Figure 11 In the illustrated embodiment, the base member 10 is flexible when viewed from a bending perspective. Therefore, this base member can extend along the central geometric axis A, thus having various shapes, which is typically required for the biopsy instrument 1 used in the endoscope 40. This flexible biopsy instrument 1 used in the endoscope 40 is sometimes referred to as an endoscopic biopsy instrument 1. However, it can be noted that the biopsy instrument 1 is also useful for applications not used in an endoscope. In this case, the biopsy instrument can be rigid when viewed from a bending perspective and extends along the central geometric axis A, which extends in a straight line. This rigid biopsy instrument is typically used as a standalone biopsy instrument 1.

[0154] The near-end 10a is used in various environments. Figures 1a to 1b and Figures 2a to 2b As shown, the remote 10b, with its application environment, for example in... Figures 3a to 3b and Figure 4 As shown in the image.

[0155] It can be noted that, Figure 1a In this configuration, the operating unit 30, equipped with a motor 31, is a separate housing positioned on a shelf or similar object. The biopsy instrument includes a telescopic mechanism 101 and is connected to the motor 31 via a drive line 39. For further details, see, for example... Figures 27 to 32 To provide.

[0156] It can be noted that, Figure 1b In this design, the control unit 30 with motor 31 is designed as a handheld component.

[0157] It can be noted that in descriptions relating to the manipulation of the distal end of biopsy instruments, in most cases, the use of... Figure 1a or Figure 1b Any one of the control units 30.

[0158] For example Figures 3a-3b and Figure 4 As shown, at least the distal portion 10b' of the base member 10 is formed as an elongated hollow tube 10'. Specifically in... Figure 12 and Figures 15 to 16 In the preferred embodiment shown in detail, the base member 10 is shaped as a hollow tube 10' extending from the proximal end 10a to the distal end 10b of the base member 10.

[0159] like Figures 3a to 3b and Figure 4 As shown, the distal end 10b, shaped as an elongated hollow tube 10', is intended to be at least partially inserted into the tissue 50 from which a biopsy is to be obtained. Figures 3a to 3b and Figure 4 In the user scenario shown, the distal end 10b is completely inserted into the tissue; that is, the distal end 10b is inserted such that the entire circumferential portion C is inserted into the tissue 50. Figures 13a to 13b and Figures 14a to 14c In the user case shown, the distal end 10b is only partially inserted into the tissue, that is, the distal end 10b is inserted into the tissue 50 only as a part of the entire circumferential portion C.

[0160] The base member 10 is capable of transmitting force along the central geometric axis A, thereby transmitting the movement LF, LB of the proximal end 10a along the central geometric axis A to the distal end 10b. The base member 10 is also capable of transmitting torque about the central geometric axis A, thereby transmitting the rotation ω and torque T applied by the motor 31 at the proximal end 10a about the central geometric axis A from the proximal end 10a to the distal end 10b, causing the distal end 10b to rotate about the central geometric axis A. Therefore, the distal end 10b of the base member 10 can be manipulated by advancing and retracting the proximal end 10a and by applying rotation ω and torque T at the proximal end 10a.

[0161] Biopsy instrument 1 is designed to be used in accordance with the above reference. Figures 1a to 1b The brief public information presented is used. See below for reference. Figures 1a to 1b and Figures 2a to 2bThe intended method of use is disclosed in more detail. User U connects the proximal end 10a of biopsy instrument 1 to the manipulation unit 30, which has a motor 31. By moving the endoscope 40 and subsequently by moving the distal end 10b of biopsy instrument 1 relative to the endoscope 40, the distal end 10b of biopsy instrument 1 is moved to the position where a tissue sample is to be obtained. During this movement, user U is guided by an image on screen 44. Thereafter, user U activates motor 31, causing rotation to be transmitted to the distal end 10b of biopsy instrument 1. Subsequently, while the distal end 10b rotates via the motor 31, the user U advances the distal end 10b into the tissue 50 from which a tissue sample is to be obtained. The distal end 10b is shaped as an elongated hollow tube 10' at least the distal portion 10b' of the base member 10. This hollow tube 10' has a distally facing circular cutting edge 11 that defines a nozzle 10c at the distal end 10b of the hollow tube 10', thereby cutting a core 51 of the tissue 50. This core 51, due to the advancement of the hollow tube 10', passes through the nozzle 10c and enters the sample acquisition portion 10b' of the hollow tube 10'. This advancement can be described as the movement of the biopsy instrument 1 relative to the endoscope 40 in a direction extending from the proximal end 10a to the distal end 10b.

[0162] exist Figure 2a In one embodiment, the propulsion is performed by manipulating the telescopic mechanism 101. For example... Figure 2a As shown in the four smaller figures, the telescopic mechanism 101 is manipulated to move the outer elongated hollow tubular member 14, initially preferably located within the working channel 41 of the endoscope 40, relative to the tissue to the desired position. Subsequently, the motor 31 is activated, causing the inner elongated hollow tube 10' to begin rotating. Then, the telescopic mechanism 101 is manipulated to advance the base member with the inner elongated hollow tube 10' beyond the outer elongated hollow tubular member 14 and into the tissue. Subsequently, the telescopic mechanism 101 is manipulated to partially or completely retract the base member with the inner elongated hollow tube 10' back into the outer elongated hollow tubular member 14. The advancement and retraction of the inner elongated hollow tube 10' can be repeated until the desired number of samples are retrieved.

[0163] exist Figure 2b In this embodiment, this advancement is performed by moving the manipulator 30 forward along arrow LF relative to the endoscope 40 and the access opening 41a, thereby reducing the free distance I of the biopsy instrument 1. Once the distal end 10b has been inserted into the tissue 50 to the desired depth d, the user U then retracts the distal end 10b out of the tissue 50 while the distal end 10b is rotated by the motor 31, at least partially abutting the smooth inner surface 12 of the hollow elongated tubular sample acquisition portion 10b' located at the distal portion 10b' of the hollow tube 10'.

[0164] The core 51 of the tissue 50 is detached from the tissue 50 by a pulling force caused by the retraction LB of the hollow tube 10' and by the adhesion force formed at the interface between the smooth inner surface 12 and the circumferential outer surface of the core 51, which holds the core 51 within the sample acquisition portion 10b' having the smooth inner surface 12.

[0165] Furthermore, the core 51 can be separated from the tissue 50 by shear and / or tensile forces. Without being limited by the following description, it can be assumed that the sample acquisition portion rotates relative to the tissue at a high rotational speed, thereby forming a liquid film between the inner surface of the sample acquisition portion and the tissue core, which reduces friction between the tissue core and the sample acquisition portion. The formation of this film is enhanced by the high rotational speed.

[0166] Similarly, a liquid film can be formed on the outer surface of the sample acquisition section. If the inner surface is smooth, for example, with a surface roughness of less than 0.5 micrometers, the formation of the liquid film is enhanced. The tissue core does not rotate as long as the sample acquisition section is pushed further into the tissue. When the sample acquisition section is no longer pushed into the tissue but is retracted, the tissue core within the sample acquisition section will adhere to the inner surface of the sample acquisition section and begin to rotate, thereby separating the sample core from the surrounding tissue through shear and tearing or tensile forces. The sample core will now rotate with the sample acquisition section. When the next sample core is to be obtained, the previous sample core will be pushed further into the sample acquisition section against the friction exerted on the inner surface. The coefficient of friction should be as small as possible, such as less than 0.10 or less than 0.06.

[0167] When the smooth inner surface is formed of steel (such as medical-grade stainless steel), the surface roughness Ra value of the smooth inner surface is preferably less than 1.5 µm, preferably less than 1 µm, while when it is formed of a polymer-based material, the surface roughness is preferably less than 6 µm, such as between 1 µm and 6 µm.

[0168] For example, such as Figures 3a to 3b and Figure 4 The schematic diagram and Figure 12 and Figure 16 As shown in more detail, the hollow tube 10' is provided with a distally facing circular cutting edge 11 that defines a nozzle 10c at the distal end 10b of the hollow tube 10'. In all preferred embodiments, for both flexible and rigid variants, the distally facing circular cutting edge 11 has a straight configuration when viewed along the circumferential direction C of the nozzle 10c. It is also preferred that the nozzle 10c defines a plane whose normal is parallel to the extension of the central geometric axis A when the central geometric axis passes through the plane of the nozzle 10c. That is, in the embodiment, the hollow tube 10' is cut at the nozzle 10c by a plane orthogonal to the longitudinal extension of the hollow tube 10'.

[0169] The hollow tube 10' has a hollow elongated tubular sample acquisition portion 10b' at its distal portion 10b', the hollow elongated tubular sample acquisition portion 10b' having a smooth inner surface 12. The tubular sample acquisition portion 10b' has a length along a central geometric axis A, which is preferably sufficient to allow multiple samples 51, 52, 53, 54, 55 to be collected and positioned one after another along the central geometric axis A in the tubular sample acquisition portion 10b'. This length is preferably at least 10 times the inner diameter of the hollow tube 10', and more preferably at least 20 times. However, as mentioned above, the base member 10 is preferably formed by an elongated hollow tube 10' extending from the proximal end 10a to the distal end 10b of the base member 10. Thus, it can be said that the hollow elongated tubular sample acquisition portion 10b' is formed substantially from the distal end 10b to the proximal end 10a.

[0170] The elongated hollow tube 10' can be designed to have a uniform cross-section extending from the proximal end 10a to the distal end 10b; in addition, the hollow tube has local irregularities in the form of specific design features at the proximal end 10a itself and / or at the distal end 10b itself. These local irregularities may, for example, be that the hollow tube 10' has a connector 15 at the proximal end 10a, and / or the hollow tube 10' is specifically designed at the distal end 10b to provide a cutting edge 11 or to receive a separate component that provides the cutting edge 11.

[0171] The smoothness of the smooth inner surface 12 makes it possible to achieve the desired effect based on... Figures 3a to 3b and Figure 4When obtaining a reference biopsy using the method shown, the cutting edge 11 and distal end 10b of the hollow tube 10' are configured to rotate ω and T under the drive of a motor at its proximal end 10a, while advancing along the central geometric axis A into the tissue 50, thereby cutting the core 51 of the tissue 50. The core 51 of the tissue 50 enters the sample acquisition portion 10b' of the hollow tube 10' through the nozzle 10c due to the advancement LF of the hollow tube 10', wherein the circumferential outer surface of the core 51 is at least partially adjacent to... The smooth inner surface 12 of the sample acquisition portion 10b' is then used to retract the hollow tube 10' from the tissue 50 while it is rotated ω, T by a motor driven at its proximal end 10a. This causes the core 51 of the tissue 50 to detach from the tissue 50 by a pulling force resulting from the retraction LB of the hollow tube 10' and from the adhesion force formed at the interface between the smooth inner surface 12 and the circumferential outer surface of the core 51. This adhesion force holds the core 51 within the sample acquisition portion 10b' having the smooth inner surface 12. Preferably, the smoothness of the surface 12 is such that when performing a reference sample procedure using the biopsy instrument 1 of the type described above, the core 51 detaches from the tissue 50 during the retraction of the hollow tube 10', provided that the distal end 10b has been inserted into the tissue 50 at a distance equal to or greater than the inner diameter D10ci of the nozzle 10c. However, in many cases, it is acceptable that the smoothness of surface 12 allows the core 51 to detach from the tissue 50 during retraction of the hollow tube 10' when a reference sample is being processed using the biopsy instrument 1 of the type described above, provided that the distance from which the distal end 10b has been inserted into the tissue 50 is 1.3 times or greater than the inner diameter D10ci of the nozzle 10c. Furthermore, in many cases, it is acceptable that the smoothness of surface 12 allows the core 51 to detach from the tissue 50 during retraction of the hollow tube 10' when a reference sample is being processed using the biopsy instrument 1 of the type described above, provided that the distance from which the distal end 10b has been inserted into the tissue 50 is 1.7 times or greater, or even 2 times or greater than the inner diameter D10ci of the nozzle 10c. The above applies at least to cases where the inner diameter D10ci is between 1 mm and 5 mm.

[0172] It can be noted that the smallest or most superficial sample typically obtainable depends on the type of tissue and tumor sampled. Generally, firmer tissues and tumors are easier to sample, and biopsies as small as 1 mm can typically be obtained. In mucosa, it also depends on which organ from which the biopsy was taken, due to differences in consistency, such as the relatively soft gastrointestinal tract versus the relatively firm respiratory tract. In most types of tissues and tumors, biopsies between 1 mm and 3 mm are typically obtainable with high reproducibility.

[0173] like Figure 4As shown, the biopsy instrument 1 can retrieve multiple tissue samples one after another directly without needing to retrieve the first sample. As the distal end 10b is advanced into the tissue 50, the first sample 51 is pushed further into the hollow tube 10' in a controlled manner by the core 52 of the second sample towards the proximal end 10a. The hollow tube 10' is provided with a smooth inner surface 12, the smoothness of which allows the core 51 to adhere to the inside of the hollow tube 10' by its own adhesiveness. This fact allows for sample retrieval with minimal damage to the sample 51, while still allowing the cutting edge 11 and the distal end 10b to drill into and out of the tissue 50, thereby reducing patient discomfort. Figure 4 The image depicts a variant without the elongated hollow tubular component. It can be noted that biopsy instruments including the elongated hollow tubular component 14, such as... Figure 2a and Figure 3a The disclosed method can also be used to retrieve multiple samples by advancing and retracting the hollow tube 10' relative to the elongated hollow tubular member 14, or optionally by advancing and retracting the hollow tube 10' and the elongated hollow tubular member 14 together relative to the endoscope 40.

[0174] The hollow tube 10' is impermeable to liquids and air or gas. However, it should be noted that impermeability to liquids and air or gas is not intended to solve any long-term problems related to impermeability to liquids and air or gas, as is typically discussed when long-term storage of liquids or gases is involved. The hollow tube 10' should be impermeable to liquids and air or gas such that when the hollow tube 10' is retracted, suction is provided at the interface between the inner wall of the hollow tube 10' and the core 51 of the tissue sample. The hollow tube 10' is impermeable to liquids and air or gas at least along the length of the tubular sample acquisition portion 10b' along the central geometric axis A. The tubular sample acquisition portion 10b' preferably has an extension and a smooth surface 12 is provided along the length 10b' from the distal end 10b toward the proximal end 10a. The extension 10b' has a length that allows for the acquisition of at least two, preferably at least three, reference samples of the disclosed type one after another, each reference sample having an insertion depth at least equal to the inner diameter D10ci, or the insertion depth is at least 1.3 times, at least 1.7 times, or even 2 times the inner diameter D10ci. In a preferred embodiment, the hollow tube 10' is airtight along its entire length from the proximal end 10a to the distal end 10b.

[0175] like Figure 6As shown, samples 51, 52, 53, 54, and 55 can be harvested in a controlled manner, ensuring that each sample remains uniquely identifiable and undamaged. This allows physicians to retain any information provided by the tomography and / or location of the respective samples 51, 52, 53, 54, and 55, which can then be used to increase the amount of data provided by the biopsy, thereby improving the accuracy of the final diagnosis.

[0176] Harvesting can, for example, be achieved by using... Figure 6 The middle arrow 71 schematically indicates the mechanical tool used to perform the procedure, which is inserted and extends from the proximal end 10a through the entire biopsy instrument to the distal end 10b, allowing samples 51, 52, 53, 54, and 55 to be safely withdrawn. Figure 7 As shown, the elongated hollow tube 10' also allows for the use of air jets at the proximal end 10a to expel samples 51, 52, 53, 54, and 55 at the distal end 10b for harvesting. The latter requires the elongated tube 10' to be sufficiently airtight so that a sufficient amount of air or other gaseous or liquid fluid jet can effectively expel samples 51, 52, 53, 54, and 55. The air jet can be provided, for example, by a syringe 70 connected to the proximal end 10a of the hollow tube 10'.

[0177] Preferably, the smooth inner surface 12 is formed of a polymer-based material 12. The polymer-based material may be, for example, ethylene tetrafluoroethylene (ETFE). Other plastic materials, such as other fluoropolymers, such as polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA), and fluorinated ethylene propylene (FEP), are also conceivable. The inner surface may also be at least partially made of medical-grade stainless steel, polished to the desired smoothness.

[0178] It can be noted that the polymer-based material 12 can be provided in various different physical designs. The polymer-based material 12 can be provided in the form of an elongated tubular component. The polymer-based material 12 can be attached to the inside of an external component. The polymer-based material 12 can be disposed within an external component and is movable and rotatable relative to the external component. The polymer-based material 12 can be provided as a coating within an external component. Various physical designs will be discussed in more detail below.

[0179] It can be noted that the design of the hollow tube 10' and the movement of the hollow tube 10' relative to the tissue 50 have already been discussed in the detailed description above. Other parts of the biopsy instrument 1 can be designed in several different ways to achieve the desired movement of the hollow tube 10' in a suitable manner for different use scenarios. Different embodiments indicating representative choices of some of these different approaches will be disclosed in detail below.

[0180] exist Figure 11and Figure 12 In the embodiment shown in detail, the elongated hollow tubular member 13 includes a smooth inner surface 12 formed of a polymer-based material, which is rotatably and translationally fixed relative to the inside of the supporting portion of the elongated hollow tubular member 13.

[0181] like Figure 12 As shown, the supporting portion of the elongated hollow tubular member 13 includes a hollow metal rope 13'. The hollow metal rope 13' can transmit force along the central geometric axis A, such that the movement LF, LB of the proximal end 10a along the central geometric axis A is transmitted to the movement LF, LB of the distal end 10b along the central geometric axis A. The hollow metal rope 13' can also transmit torque around the central geometric axis A, such that the rotation ω and torque T around the central geometric axis A applied by the motor 31 at the proximal end 10a are transmitted from the proximal end 10a to the distal end 10b, thereby causing the distal end 10b to rotate around the central geometric axis A.

[0182] For example, such as Figure 11 and Figure 12 As shown, the hollow tube 10' has a connector 15 at its proximal end 13a for connection to the motor 31. The connector 15 is capable of transmitting the movement LF and LB along the central geometric axis A and of transmitting the rotation ω and torque T.

[0183] The hollow tube 10' also includes an outer layer 13", which is disposed on the outside of the elongated hollow tubular member 13. The outer layer 13" may be, for example, a polymer-based shrink film.

[0184] like Figure 12 As shown, the hollow tube 10' is designed according to the first embodiment and optionally also manufactured according to the following.

[0185] End tube 16 is attached to the distal end 10b of the hollow metal wire rope 13'. The distal end 10b has been ground. End tube 16 is provided with a cutting edge 11. The cutting edge 11 can be sharp. End tube 16 also has an opening 16b used during laser welding to secure end tube 16 to the outside of the hollow metal wire rope 13'. The distal end of the end tube can be laser welded to the surface of the hollow metal wire rope around its entire circumference. Base connector 17 is crimped or retracted onto the proximal end 10a of the hollow metal wire rope 13'. Base connector 17 is further designed to connect to connector 15, which is designed to connect to actuating unit 30. In a sense, base connector 17 can be said to form part of connector 15. Connectors 15 and 17 are manufactured as two main components 15 and 17 because it is advantageous for the component 17 actually attached to the hollow metal wire rope 13' to have a small and straightforward design. Then, connector 15 provides the desired functionality for the user-friendly connection between connector 15 and operating unit 30. The connection between base connector 17 and connector 15 enables the transmission of the force along the central geometric axis A and the transmission of the torque about the central geometric axis A, so that the rotation ω and the torque T can be transmitted.

[0186] The smooth inner surface 12 is provided by an internal material located inside the hollow metal cord 13'. In the disclosed embodiment, the internal material is in the form of a polymer-based film, preferably a tubular polymer-based film. The internal material 13 is welded to the hollow metal cord 13'. When the internal material is positioned inside the hollow metal cord 13', the internal material preferably has a length excessively long compared to the length of the hollow metal cord 13', and is welded and fixed in place before being cut flush. It may also be mentioned that, preferably, the cutting edge 11c is also flush with the distal end 10a of the hollow tube 10'. Thus, the smooth surface 12 extends all the way to the distal end 10a.

[0187] The outer shrink tube retracts to the outside of the hollow metal wire rope 13'.

[0188] It can be noticed, and it can also be thought of Figure 12The internal material 13 shown is rotatable and translatable relative to the support portion 13'. The internal material 13 can be, for example, a hollow polymer-based elongated tube 13 forming the base member 10 and having sufficient rigidity to transmit force along the central geometric axis A, thereby transmitting the movement LF, LB of the proximal end 10a along the central geometric axis A to the movement LF, LB of the distal end 10b along the central geometric axis A, and being able to transmit torque about the central geometric axis A, thereby transmitting the rotation ω and torque T applied by the motor 31 at the proximal end 10a about the central geometric axis A from the proximal end 10a to the distal end 10b, which in turn causes the distal end 10b to rotate about the central geometric axis A. In this design, the hollow metal wire 13' will form a stationary outer elongated hollow tubular member 14. In this design, the distal end 10b of the internal material 13 can form a cutting blade 11.

[0189] exist Figure 27 The document discloses an embodiment, wherein reference is made to... Figure 12 The disclosed elongated member 10 has an inner polymer base tube 13 fixed inside the hollow metal cord 13'. The elongated member 10 is arranged inside the outer elongated hollow tubular member 14, so that it can be rotated and translated independently relative to the outer elongated hollow tubular member 14.

[0190] Regardless of the specific design of the base member 10, the elongated hollow tubular member 14 can be a hollow metal cord. Preferably, the inner tubular member 13 is formed of a hollow metal cord, and the elongated hollow tubular member 14 is also formed of a hollow metal cord. Alternatively, the elongated hollow tubular member 14 may be provided with an inner tube, such as a polymer-based tube.

[0191] Alternatively, refer to Figure 12 The disclosed base member 10 has an inner polymer base tube 13 fixed inside a hollow metal cord 13'. The base member 10 can be arranged within the working channel 41 of the endoscope 40, allowing it to rotate and translate independently relative to the working channel 41. In this design, the working channel 41 of the endoscope 40 can be described in a sense as an elongated hollow tubular member 14.

[0192] However, preferably, the elongated hollow tubular member 14 forms part of the biopsy instrument 1. For use with the endoscope 40, preferably, the biopsy instrument 1 is provided with the elongated hollow tubular member 14 and a base member 10, the base member 10 being independently rotatable and translationally movable relative to the elongated hollow tubular member 14, and the biopsy instrument 1 being inserted into the working channel 41 of the endoscope 40. With this design, the elongated hollow tubular member 14 can be translated within the working channel 41 and preferably also rotated within the working channel 41. However, this mobility and rotatability are intended for positioning the elongated hollow tubular member 14 relative to the endoscope 40 and relative to the tissue 50, while the rotation intended for the cutting blade 11 to cut the tissue 50 is provided by rotating the base member 10 relative to the elongated hollow tubular member 14.

[0193] refer to Figure 15 and Figure 16 The following embodiments will be described in more detail, in which an inner elongated hollow tubular member 13 is arranged inside an outer elongated hollow tubular member 14 and is rotatably and translationally movable relative to the outer elongated hollow tubular member 14. The inner elongated hollow tubular member 13 may, for example, be referenced to... Figure 12 In the disclosed configuration, the internal material is secured to a hollow metal cord 13'. During sample acquisition, the outer elongated hollow tubular member 14 is designed to remain stationary relative to the endoscope. The inner elongated hollow tubular member 13 is designed to be rotated and advanced into the tissue 50, while the outer elongated hollow tubular member 14 remains outside the tissue 50. Figure 16As shown, a stop 19 is provided at the distal end 14b of the elongated hollow tubular member 14. The stop 19 prevents the distal end 14b from being unintentionally pushed into the tissue 50. The stop 19 is designed to increase the abutment surface between the distal end 14b of the elongated hollow tubular member 14 and the tissue 50. The stop 19 provides this increased abutment surface by being positioned at the distal end 14b and designed to provide one or more circumferential portions of the body that increase the distal end 14b. The stop 19 may be an expandable ring 19 attached to the elongated hollow tubular member 14. The stop 19 may be one or more arms 19' that are pivotally connected to the elongated hollow tubular member 14. When the inner elongated hollow tubular member 13 retracts, the increased abutment surface provided by the stop portion 19 provides stability and acts as a reaction force, thereby making it easier to remove the sample without exerting too much strain on the tissue surrounding the sample site. Furthermore, by keeping the outer elongated hollow tubular member 14 stationary relative to the endoscope during the sample acquisition process, combined with the rotatable and translational movement of the inner elongated hollow tubular member 13 relative to the outer elongated hollow tubular member 14, the outer elongated hollow tubular member 14 can be designed to fit relatively tightly with the working channel 41 of the endoscope. Moreover, since relative movement is provided between the two components of the instrument (which are specifically designed and manufactured for interaction), a relatively tight fit can be provided between the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14, while still ensuring sufficient clearance. Furthermore, due to the ability to use a tight fit, the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14 will, in a sense, support each other and prevent them from collapsing. This, in turn, makes it possible to use relatively thin material thicknesses in both the outer elongated hollow tubular member 14 and the inner elongated hollow tubular member 13. For a given working channel 41 with a given inner diameter, this will further allow the distal end 13b of the inner elongated hollow tubular member 13 to have a relatively large inner diameter D10ci.

[0194] The elongated hollow tubular member 13 is capable of transmitting force along the central geometric axis A, such that the movement LF, LB of the proximal end 10a along the central geometric axis A is transmitted to the distal end 10b along the central geometric axis A. Furthermore, the elongated hollow tubular member is capable of transmitting torque about the central geometric axis A, such that the rotation ω and torque T about the central geometric axis A applied by the motor 31 at the proximal end 10a are transmitted from the proximal end 10a to the distal end 10b, thereby causing the distal end 10b to rotate about the central geometric axis A.

[0195] The elongated hollow tubular member 13 has a connector 15 at its proximal end 13a for connection to the motor 31. The connector 15 is capable of transmitting the movement LF, LB and the rotation ω and torque T along the central geometric axis A.

[0196] The outer elongated hollow tubular member 14 has a connector 18 at its proximal end 14a for connection to the manipulation unit 30, so that the outer elongated hollow tubular member 14 can be moved to the intended sample location and remain stationary during sample acquisition by advancing the inner elongated hollow tubular member 13 and retracting it LB when the inner elongated hollow tubular member 13 is rotated by the motor 31.

[0197] The elongated hollow tubular member 13 has a distally facing circular cutting edge 11 at its distal end. (See reference...) Figure 12 The cutting edge 11 discussed can be located on a separate component such as the end tube 16. However, since the inner elongated hollow tubular component 13 and the outer elongated hollow tubular component 14 support each other and can therefore be designed to have a thin material thickness, it is conceivable to use the cutting distal end of the inner elongated hollow tubular component 13, such as the cutting edge 11.

[0198] If the diameter of the cutting edge's nozzle is 1 mm and the rotational speed is 15,000 rpm, the circumferential speed of the cutting edge will be 0.75 m / s. It is currently believed that the cutting edge will effectively cut tissue if the circumferential speed exceeds approximately 0.40 m / s. Such a circumferential speed gives the cutting edge a cutting radius of approximately 0.02 mm, corresponding to a relatively blunt cutting edge. The cutting radius can be smaller. A blunt cutting edge with a cutting radius of 0.01 mm to 0.02 mm is convenient from a treatment perspective because a blunt cutting edge is less likely to injure the user if accidentally struck during treatment, and it remains effective for biopsy procedures. In biopsy procedures, a cutting edge with a cutting radius of 0.001 mm to 0.01 mm will be more effective at cutting tissue. Larger cutting edge diameters, such as 2 mm (or 4 mm), will result in a higher circumferential speed of approximately 1.5 m / s (3 m / s), which is still preferable from the perspective of efficient biopsy procedures.

[0199] The control unit 30 briefly includes a housing 32, an electric motor 31 within the housing 32, and a connector 33. The connector 33 is configured to interconnect with and connect to the motor 31 via a connector 15, such that torque T and rotation ω can be transmitted from the motor 31 to the connector 15. The control unit 30 also includes one or more batteries 34a to 34b. The control unit 30 may be provided with one or more buttons 35a to 35b. Buttons 35a to 35b can be used, for example, to turn the motor 31 on and off. As exemplarily shown with a connection 36, the control unit 30 may be provided with one or more electrical connections. The connection 36 may, for example, provide an interface to a pedal 37, as shown in FIG. 1, whereby the pedal 37 can be used to turn the motor 31 on and off. The user U may, for example, be given the option to change the rotation speed by pressing / releasing the pedal 37. The connection 36 may also be used to charge the batteries 34a to 34b in the control unit 30. The connecting portion 36 and the housing 32 can be configured to receive a connector 80 extending from the connecting portion 36, the connector 80 being, for example... Figure 8 The diagram shows a typical connector 80 located at one end of the wire 81. The connection portion 36 and the housing 32 can be configured to receive a sub-housing 82 having the shape and dimensions of an extension 32' forming the housing 32. This sub-housing can, for example, have the same circumferential shape and dimensions, and as... Figure 9 and Figure 10 The wire 81 is attached to the end of the housing 32. This extension 32' of the housing 32 can accommodate batteries 34a to 34b. Therefore, the batteries 34a to 34b can be quick-replaceable, can be charged separately from the housing portion including the motor 31 and connector 33, and can be used with a single operating unit 30 having the motor 31, connector 33, and more than one extension 32', each extension 32' having its own set of one or more batteries 34a to 34b.

[0200] exist Figure 10 The diagram shows how the manipulation unit 30 is connected to the biopsy instrument 1 via connector 15, which is connected to connector 33.

[0201] exist Figure 17The telescopic mechanism 90 is shown in the diagram. The telescopic mechanism can also be referred to as a telescopic functional component. The telescopic mechanism 90 may include a cover 91 that at least partially, but preferably completely, covers the portion of the biopsy instrument 1 located between the access opening 41a and the operating unit 30. The telescopic mechanism 90 may have an adjustable length along axis A, such that a biopsy instrument 1 of a certain length can be used in different types of endoscopes 40 having a working channel 41 of slightly different lengths (e.g., measured between the access opening 41a and the distal opening 41b). The telescopic mechanism 90 may also provide limits on the maximum extension of the distal end 10b of the elongated hollow tubular member 10 and / or the maximum extension of the distal end 14b of the outer elongated hollow tubular member 14. The telescopic mechanism 90 may also be provided with a locking member 92, which secures the outer elongated hollow tubular member 14 relative to the endoscope 40 once the biopsy instrument 1 has been moved to the intended sample site. The telescopic mechanism 90 may also be equipped with a locking member or an adjacent member 93, which allows the maximum relative movement between the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14 to be set, thereby providing a clearly defined maximum sample depth. It can be noted that in... Figure 17 In the image, for clarity, the distal ends of the endoscope 40 and biopsy instrument 1 are shown magnified. However, in practice, the biopsy instrument 1 typically has the same diameter at its distal portion 10b' as the other portions along the length of the biopsy instrument, for example, as shown in the image. Figure 19 As shown.

[0202] Figures 18 to 22 The telescopic mechanism 100 shown is specifically configured for use with Figures 15 to 16 The biopsy instrument disclosed herein is of the type that has a non-rotating outer elongated hollow tubular member 14 and an inner elongated hollow tubular member 13 rotatably arranged within the outer elongated hollow tubular member 14. The proximal end of the telescopic mechanism 100 is connected to a motor 30, while the distal end of the telescopic mechanism 100 is connected to an endoscope 40. Different parts of the telescopic mechanism 100 are connected to different parts of the biopsy instrument 1, which will be disclosed in more detail below.

[0203] The telescopic mechanism 100 includes a base sleeve 110. A connector 111 is provided at its distal end of the base sleeve 110, and the base sleeve 110 is configured to connect via the connector 111 to the insertion opening 41a of the endoscope 40. A motor 30 is configured to connect to the proximal end of the base sleeve 110. The base sleeve 110 has a fixed length.

[0204] The telescopic mechanism 100 also includes an inner sleeve 120 slidably disposed within the base sleeve 110. The inner sleeve 120 is connected to the outer elongated hollow tubular member 14 such that sliding motion of the inner sleeve 120 relative to the base sleeve 110 in the distal direction causes distal movement of the outer elongated hollow tubular member 14 relative to the endoscope. The telescopic mechanism 100 also includes a first annular member 115 movably disposed about the base sleeve 110. The first annular member 115 can slide back and forth along the base sleeve 110. Essentially, it controls the length of the outer elongated hollow tubular member 14 at the distal end of the endoscope 40. The first annular member 115 is provided with a connector 116, which in the disclosed embodiment is a screw and wedge, through which the first annular member 115 can be connected to the inner sleeve 120. In the disclosed embodiment, a screw is positioned in a threaded hole in the first annular member 115, and when the screw is screwed into the threaded hole of the first annular member 115, the screw pushes a wedge into contact with the inner sleeve 120, which can be described as adjusting the length of the outer elongated hollow tubular member 14 distally beyond the endoscope. A connector 116 extends through a through-hole 112 formed in the wall of the base sleeve 110. By moving the first annular member 115 relative to the inner sleeve 120 to a desired position, and connecting the first annular member 115 to the inner sleeve 120 at the desired position by activating the connector 116, combined with the fact that the connector 116 extends through the through-hole 112, the extent to which the outer elongated hollow tubular member 14 can be moved beyond the distal opening 41b of the endoscope 40 can be defined. When the connector 116, which is connected to the inner sleeve 120 and extends through the elongated hole 112, reaches the distal end of the elongated hole 112, the connector 116, and therefore the first annular member 115 and the inner sleeve 120, are prevented from any further movement in the distal direction relative to the base sleeve 110.

[0205] The telescopic mechanism 100 also includes a central sleeve 130 slidably disposed within the inner sleeve 120. The central sleeve 130 is connected to the inner elongated hollow tubular member 13 such that sliding motion of the central sleeve 130 relative to the inner sleeve 120 in the distal direction causes the inner elongated hollow tubular member 13 to move relative to the outer elongated hollow tubular member 14 in the distal direction. The inner elongated hollow tubular member 13 is rotatable within the central sleeve 130. In a preferred embodiment, the inner elongated hollow tubular member 13 extends through the central sleeve 130 in a channel 131, the diameter of which creates a gap between the inner side of the channel 131 and the inner elongated hollow tubular member 13.

[0206] The telescopic mechanism 100 also includes a second annular member 125 movably arranged around the base sleeve 110. The second annular member 125 is slidable back and forth along the base sleeve 110. The second annular member 125 is provided with a connector 126, which in the disclosed embodiment is a screw and a wedge, through which the second annular member 125 can be connected to the central sleeve 130. In the disclosed embodiment, the screw is positioned in a threaded hole in the second annular member 125, and when the screw is screwed into the threaded hole, the screw pushes the wedge into contact with the central sleeve 130. The connector 126 extends through a through-hole 113 formed in the wall of the base sleeve 110 and through a through-hole 121 in the inner sleeve 120. By moving the second annular member 125 relative to the central sleeve 130 to a desired position, and connecting the second annular member 125 to the central sleeve 130 at the desired position via the activation connector 126, combined with the fact that the connector 126 extends through the elongated hole 121 in the inner sleeve 120, the extent to which the inner elongated hollow tubular member 13 can move beyond the outer elongated hollow tubular member 14 can be limited. When the connector 126, connected to the central sleeve 130 and extending through the elongated hole 121, reaches the distal end of the elongated hole 121, the connector 126, and therefore the second annular member 125 and the central sleeve 120, are prevented from any further movement in the distal direction relative to the inner sleeve 120.

[0207] The telescopic mechanism 100 also includes a connector 135 configured to interconnect the central sleeve 130 and the inner sleeve 120 in a desired relative position, as seen along a slidable direction of the central sleeve 130 relative to the inner sleeve 120. In the disclosed embodiment, the connector 135 is connected to the central sleeve 130 at a fixed position along the sliding direction. The connector 135 extends through a through-hole 122 formed in the wall of the inner sleeve 120, allowing the connector 135 to be accessed by a user and allowing the central sleeve 130 to slide relative to the inner sleeve 120 without the connector 135 impeding such sliding movement. A connector 136 is configured to be activated and interconnect the inner sleeve 120 with the central sleeve 130. In the disclosed embodiment, the connector 136 is further screwed into a threaded hole in the central sleeve 130 such that the head of the screw interacts with the wall of the inner sleeve 120 on the side of the through-hole 122.

[0208] It can be noted that it is conceivable that the telescopic mechanism 100 may include those disclosed above and, for example, Figures 18 to 21 The full set of functions is shown. However, it is conceivable that some applications would prefer to present only one or two of the functions mentioned above.

[0209] For example, it is conceivable that, for some applications, it is preferable to combine the inner elongated hollow tubular member 13 with an adjustable maximum length that can be moved beyond the outer elongated hollow tubular member 14, adjusting the maximum length by which the outer elongated hollow tubular member 14 extends beyond the distal opening 41b of the endoscope 40. For example... Figures 3a to 3b and Figure 4 As shown, this setup is typically useful when a biopsy needs to be performed.

[0210] In alternative embodiments, only one configuration is available: the possibility of interconnecting the inner sleeve 120 and the central sleeve 130. This is necessary when performing actions such as... Figures 13a to 13b This setup is typically useful during biopsies. The user sets a fixed distance, which is the distance the inner elongated hollow tubular member 13 extends beyond the outer elongated hollow tubular member 14. Thereafter, the inner and outer elongated hollow tubular members 13 and 14 move together relative to the distal opening 41b of the endoscope 40 to obtain superficial samples from the surface of the organ wall, such as… Figures 13a to 13b and Figures 14a to 14c As shown.

[0211] In this context, it can also be noted that the telescopic mechanisms 90 and 100 can be separate components, i.e., independent of the endoscope 40, biopsy instrument 1, and motor 31, and can be connected to the endoscope 40, biopsy instrument 1, and motor 30. Alternatively, the telescopic mechanism can, for example, be part of the biopsy instrument 1, and thus have an interface for connecting to the motor 31, and optionally also have an interface for connecting to the endoscope 40. Figure 18 The diagram schematically illustrates how the operating unit 30, including the motor 31, is connected to the telescopic mechanism. Optionally, the telescopic mechanisms 90 and 110 can be connected via, for example... Figure 27 The disclosed drive line 39 is connected to the operating unit 30, which includes the motor 31.

[0212] exist Figure 22 The diagram schematically illustrates a telescopic mechanism 100 designed independently of the biopsy instrument 1. The telescopic mechanism 100 may be an integral part of the manipulation unit 30, but alternatively, it may be a separate component connectable to the manipulation unit 30. The biopsy instrument 1 includes an interface for connection to the telescopic mechanism. The interface includes a first connecting member 13e connected to an inner elongated hollow tubular member 13 and configured to connect to the central sleeve 130 of the telescopic mechanism 100. The interface includes a second connecting member 14e connected to an outer elongated hollow tubular member 14 and configured to connect to the inner sleeve 120.

[0213] In actual biopsy sampling, biopsy instrument 1 can be used according to a variety of different methods. For example, the biopsy instrument can be used according to a method in which the biopsy instrument, such as... Figures 3a to 5 As shown, in this method, the distal end 10b is advanced a distance into the tissue 50 and then retracted. However, according to another method, the biopsy instrument 1 can be used to move along the surface of the tissue 50 to obtain a biopsy from the tissue 50, such as, for example... Figures 13a to 13c and Figures 14a to 14c As shown. In Figures 3a to 3b and Figure 4 In the user method shown, the distal end 10b is fully inserted into the tissue 50, that is, when the distal end 10b is inserted, the entire circumferential portion C is inserted into the tissue 50, thereby forming an adhesion force greater than the breaking force required for the core to detach from the tissue. Figures 13a to 13c and Figures 14a to 14c In the method shown, the distal end 10b is only partially inserted into the tissue 50; that is, the distal end 10b is inserted into the tissue 50 only as a portion of the entire circumferential portion C. Figure 14a As shown. In Figure 14a In the middle, about half of the circumferential part C (in Figure 14a The lower half (the middle section) is inserted into tissue 50. For example... Figures 13a to 13b As shown, in this method, the biopsy instrument 1 moves along the surface of the tissue 50 and cuts out a substantially continuous or at least semi-continuous recess 57 in the surface of the tissue 50.

[0214] The distal end of the basal component rotates at high speed (13,000 rpm or higher). This means that the distal end of the basal component, extending beyond the elongated tubular component, will be stabilized, thus offsetting any deviation from the straight path. This is an advantage if the tissue is softer / harder in different locations, as is often the case with cancerous tumors. The sample will be taken along a substantially straight path, without any deviation in terms of tissue softness / hardness. This specifically involves... Figures 3a to 5 Implementation examples and according to Figures 13a to 14c Examples of implementations.

[0215] exist Figures 3a to 3b and Figure 4In the illustrated user method, the telescopic mechanism, such as telescopic mechanism 100, can be configured such that the inner elongated hollow tubular member 13 is rotatable relative to the outer elongated hollow tubular member 14, and that the inner elongated hollow tubular member 13 is translatable relative to the outer elongated hollow tubular member 14 between a proximal position and a distal position. In the proximal position, the inner elongated hollow tubular member 13 is completely concealed within the outer elongated hollow tubular member 14; in the distal position, the inner elongated hollow tubular member 13 extends beyond the outer elongated hollow tubular member 14 by a predetermined maximum distance. The telescopic mechanism (e.g., telescopic mechanism 100) can be configured such that the outer elongated hollow tubular member 14 is initially movable relative to the working channel 41 of the endoscope 40, and that once the desired position of the distal end 14b of the outer elongated hollow tubular member 14 has been reached, the position of the outer elongated hollow tubular member 14 can be fixed relative to the endoscope 40.

[0216] exist Figures 13a to 13c and Figures 14a to 14c In the illustrated user method, the telescopic mechanism, such as telescopic mechanism 100, can be configured such that the inner elongated hollow tubular member 13 is rotatable relative to the outer elongated hollow tubular member 14, and that the inner elongated hollow tubular member 13 is initially translatable relative to the outer elongated hollow tubular member 14 between a closest position and a farthest position, wherein in the closest position the inner elongated hollow tubular member 13 is completely concealed within the outer elongated hollow tubular member 14, and in the farthest position the inner elongated hollow tubular member 13 extends beyond the outer elongated hollow tubular member 14 by a predetermined maximum distance, thereby... When the biopsy instrument is inserted into the working channel 41 and positioned relative to the tissue 50, the inner elongated hollow tubular member 13 is concealed within the outer elongated hollow tubular member 14. Subsequently, the inner elongated hollow tubular member 13 moves to its furthest position and is fixed therein, allowing the outer elongated hollow tubular member 14 to move along the tissue 50. The distal end 13b of the inner elongated hollow tubular member 13 extends a predetermined distance beyond the outer elongated hollow tubular member 14 (preferably fixed at this predetermined distance), and the inner elongated hollow tubular member 13 rotates relative to the outer elongated hollow tubular member 14. Figure 13c The diagram illustrates how a user can move the telescopic mechanism 101 relative to the endoscope 40, causing the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14 to move together along the surface of the tissue.

[0217] In these cases, the base member 10 is flexible, and the elongated hollow tubular member 14 is also flexible. The base member 10 preferably rotates at a rotational speed of at least 13,000 rpm. Preferably, the rotational speed is between 13,000 rpm and 25,000 rpm, and more preferably between 13,000 rpm and 20,000 rpm.

[0218] exist Figure 23and Figure 24 The present invention discloses a variant of the biopsy instrument 1, wherein the outer elongated hollow tubular member 14 is a rigid hollow needle member 214. The inner elongated hollow tubular member 13 is also a rigid hollow needle member 213. For example... Figure 23 As shown, the rigid inner hollow needle 213 is configured to be positioned within the rigid outer hollow needle 214. Figure 24 As shown, the rigid inner hollow needle 213 has a length sufficient to extend beyond the distal opening of the rigid outer hollow needle 214. When operating the rigid inner hollow needle 213 and the rigid outer hollow needle 214, as... Figure 25 As shown, the rigid inner hollow needle 213 is preferably retracted so that it does not extend beyond the distal opening of the rigid outer hollow needle 214. Figure 25 In this process, a rigid inner hollow needle 213 and a rigid outer hollow needle 214 are positioned in a manipulation unit 200 for manipulating the rigid inner hollow needle 213 and the rigid outer hollow needle 214 to obtain a biopsy. The rigid outer hollow needle 214 may have an angled end, which facilitates insertion of the rigid outer hollow needle 214 into the tissue to be sampled.

[0219] Furthermore, it is conceivable to provide an internal probe within a rigid inner hollow needle 213. The internal probe may, for example, be provided with an angled solid tip corresponding to the tip of the rigid outer hollow needle 214. When the biopsy instrument 1 is inserted into the tissue to be sampled, the internal probe can be used to cover the nozzle of the rigid inner hollow needle 213, and the internal probe can be partially or completely removed before the rigid inner hollow needle 213 is rotated and / or inserted into the tissue.

[0220] This design with an internal probe can be used to move a biopsy instrument 1 to a sample site, for example, by inserting the biopsy instrument 1 through the skin or via a body cavity into tissue, wherein the internal probe is positioned such that it closes the mouth of a rigid inner hollow needle during this movement of the biopsy instrument 1. Subsequently, the internal probe moves in a proximal direction, causing the mouth of the rigid inner hollow needle 213 to open. The internal probe moves in the proximal direction at least a distance sufficient to open the distal portion of the rigid inner hollow needle 213, wherein the distal portion has sufficient length to allow a sufficient amount of tissue to be retrieved back into the rigid inner hollow needle 213. Subsequently, the rigid inner hollow needle 213 is advanced (and simultaneously rotated) relative to the rigid outer hollow needle 214 in a distal direction to acquire the sample. The rigid inner hollow needle 213 preferably rotates at a rotational speed of at least 3000 rpm. Subsequently, the rigid inner hollow needle 213 retracts into the rigid outer hollow needle 214, and the biopsy instrument 1 retracts from the sample site, preferably while still rotating during retraction. It can be noted that it is preferable to move the internal probe in the proximal direction before the rigid inner hollow needle 213 is advanced, but it is sufficient to move the internal probe in the proximal direction at the latest simultaneously with the retraction of the rigid inner hollow needle 213 into the rigid outer hollow needle 214, so that the internal probe does not push the sample out of the rigid inner hollow needle 213. After the biopsy instrument 1 has been removed from the sample site, the internal probe can be used to harvest the sample from the rigid inner hollow needle 213 by moving the internal probe in the distal direction, such that the internal probe pushes the sample out of the rigid inner hollow needle 213. The internal probe can be rigid. The internal probe can be flexible and guided by the rigid inner hollow needle. Figures 4 to 6 As shown, this embodiment can also be used to collect several consecutive samples, whereby the probe is completely removed or at least retracted to allow the sample to accumulate in a position within the rigid hollow needle 213.

[0221] It can be noted that the use of an internal probe can also be applied to a flexible biopsy instrument 1, which is configured for use with an endoscope 40. In this case, the internal probe is also flexible and is guided by an elongated hollow tubular member 13.

[0222] like Figure 23 As shown, the rigid inner hollow needle member 213 includes an interface section 213e, and the rigid outer hollow needle member 214 also includes an interface section 214e.

[0223] exist Figures 26a to 26b An example of an operating unit 200 is schematically shown, which is adapted for use Figure 23 and Figure 24The basic types of biopsy instruments disclosed in the document 1.

[0224] Figure 26a A needle positioned in the manipulation unit 200 is disclosed, and the needle is in a state ready to acquire a biopsy sample.

[0225] Figure 26b The handle 210 of the operating unit 200 is schematically disclosed for obtaining biopsy samples.

[0226] More specifically, the operating unit 200 includes a base member 201 that supports the various components of the operating unit 200. The operating unit 200 includes a support member 202 configured to interact with the interface section 214e of the rigid outer hollow needle member 214 and hold the rigid outer hollow needle member 214 in place. Preferably, the rigid outer hollow needle member 214 is fixed relative to the operating unit 200, i.e., the rigid outer hollow needle member 214 is immovable in the longitudinal direction and non-rotatable relative to the operating unit 200.

[0227] The actuation unit 200 also includes a sliding member or sled 203 configured to interact with the interface section 213e of the rigid inner hollow needle 213. The sled 203 further includes a motor 30 configured to rotate the rigid inner hollow needle 213 relative to the actuation unit 200 and also to rotate the rigid inner hollow needle 213 relative to the rigid outer hollow needle 214. The sled 203 is configured to move back and forth relative to the support 201 such that the distal end of the rigid inner hollow needle 213 can extend beyond the distal end of the rigid outer hollow needle 214, similar to... Figure 24 As shown, this allows the rigid inner hollow needle member to retract again, so that the distal end of the rigid inner hollow needle member 213 retracts into the rigid outer hollow needle member 214, preventing the distal end of the rigid inner hollow needle member 213 from extending beyond the distal end of the rigid outer hollow needle member 214. These insertion and / or retraction operations can be manual, or they can be automatic and electrically controlled by one or more buttons on the operating unit 200.

[0228] The skid 203 can be manipulated, for example, by a link 204 connected to the handle 205 in a reciprocating manner. By manipulating the handle 205 relative to the support 201, the skid 203 will be affected by the link 204. In a preferred embodiment, the manipulation unit 200 may include a second handle that is fixed relative to the support 201, and Figures 26a to 26b The handle 205 shown can move toward such a fixed handle. For clarity, this fixed handle is omitted.

[0229] Figures 23 to 24 The biopsy instrument 1 is designed to be positioned within the manipulation unit 200 such that the interface 214e of the rigid outer hollow needle 214 interacts with the support member 202, and the interface 213e of the rigid inner needle 213 interacts with the skid 203 and the motor 30 on the skid 203. The manipulation unit 200 is configured to be subsequently closed by either closing a cover 206 over the interface sections 213e and 214e of the rigid inner hollow needle 213 and the rigid outer hollow needle 214, as well as the associated components 202 and 203 of the manipulation unit 200, or placing the cover 206 over the interface sections 213e and 214e of the rigid inner hollow needle 213 and the rigid outer hollow needle 214, as well as the associated components 202 and 203 of the manipulation unit 200. The cover 206 may be hinged relative to the base member 201. The cover can be attached to the base member 201 in other suitable ways, such as slidably to the base member 201, using snap-fit ​​connections or the like for a fully detachable connection.

[0230] The control unit 200 is equipped with a motor controller, which may be, for example, a switch or button operated by the user, or an automatic controller connected to the manipulator of the skid 203, such that when the user begins to move the skid 203, the motor controller turns on the motor 30, thereby causing the rigid hollow needle 213 to begin to rotate, so that the rigid hollow needle 213 rotates throughout the sample acquisition process.

[0231] After the sample has been acquired, the rigid inner hollow needle 213 retracts into the rigid outer hollow needle 214, and the manipulation unit 200 moves such that the rigid inner hollow needle 213 and the rigid outer hollow needle 214 move outside the sampled tissue.

[0232] The interface section 213e of the rigid hollow needle 213 may be provided with a plunger or similar element capable of sealing the proximal end of the rigid hollow needle 213. By providing such a plunger, air within the rigid hollow needle 213 is trapped between the plunger at the proximal end and the tissue at the distal end, forming an air cushion that prevents excessive tissue accumulation within the rigid hollow needle 213. Alternatively, such a plunger may be replaced by a mechanical blocking member positioned within the rigid hollow needle 213. This mechanical blocking member is preferably inserted from the proximal end of the rigid hollow needle 213. The mechanical blocking member may, but is not required to, provide an airtight or partially airtight connection to the inside of the rigid hollow needle 213. It can be noted that this provision of an air plunger or mechanical blocking member is not limited to... Figures 23 to 26a to Figure 26b The design of the biopsy instrument shown. The concept of having an air plunger or mechanical blocking component applies to all biopsy instruments disclosed.

[0233] During insertion, the blocking member can be positioned to block or close the mouth of the rigid inner hollow needle 213 or the mouth of the inner elongated hollow tubular member 213.

[0234] exist Figure 27 The present invention discloses a variant of biopsy instrument 1, which is configured to, for example, in... Figure 1a The endoscope 40 disclosed herein is used in conjunction with the above. Unless clearly contradicted by the disclosure below, the biopsy instrument 1 and the assembly are as discussed above, especially with reference to Figures 1a to 22 The type.

[0235] The biopsy instrument 1 includes an operating unit 30 containing a motor 31. Figure 27 In the disclosed embodiments, the control unit 30 is a separate housing configured to be positioned on a shelf or the like. The control unit 30 may house a power source and / or be connectable to a power source. The control unit 30 may, for example, include a battery and / or be connectable to a power source (mains) 38.

[0236] The biopsy instrument 1 includes a telescopic mechanism. In this embodiment, the telescopic mechanism is connected to the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14, such that from the user's perspective, they are a single component, used as a single component, and typically also arranged as a single component. Alternatively, the telescopic mechanism may be a separate component that can be connected to the inner elongated hollow tubular member 13 and the outer elongated hollow tubular member 14.

[0237] The telescopic mechanism can be, for example, referenced... Figures 18 to 22 The detailed telescopic mechanism 100 is disclosed. Figure 27 In the middle, the telescopic mechanism is Figures 28 to 30 The telescopic mechanism 101 is disclosed in more detail below. The telescopic mechanism 101 has a connector 111 at its distal end, and the telescopic mechanism 101 is configured to be connected to the insertion opening 41a of the endoscope through the connector 111.

[0238] The telescopic mechanism 101 has a connector 15 at its proximal end, which is configured to connect the base member 10 to the motor 31. Figure 27 In the illustrated embodiment, the motor 31 is connected to the connector 15 via a drive line 39. The drive line 39 is preferably flexible. The drive line 39 includes an inner drive line 39i and a housing 39c. The inner drive line 39i transmits rotation and torque from the motor 31 to the base member 10. The housing 39c is stationary relative to the operating unit 30 and relative to the handle 102 of the telescopic mechanism 101.

[0239] refer to Figures 28 to 30The telescopic mechanism 101 includes a handle 102. The handle 102 is connected to the base member 10 such that the base member 10 is rotatable relative to the handle 102. The handle 102 is connected to the base member 10 such that when the handle 102 translates along geometric axis A, the base member 10 also translates along geometric axis A. Preferably, the base member 10 is translationally coupled to the handle 102 such that translational movement of the handle 102 relative to the connector 111 along geometric axis A provides a corresponding translational movement of the base member 10 relative to the connector 111, and more preferably, the same translational movement.

[0240] The handle 102 also includes a connection to the drive line 39, which allows the internal drive line 39i to transmit rotation and torque from the motor 31 to the base member 10, and to keep the housing 39c stationary relative to the handle 102.

[0241] The telescopic mechanism 101 also includes an intermediate component 103. The intermediate component 103 may also be referred to as a base component adjuster. The handle 102 is translatably movable relative to the intermediate component 103. Figure 29 As shown, the handle 102 is hollow and capable of receiving the intermediate component 103. The intermediate component 103 is slidably received within the handle 102. Figures 27 to 29 In the diagram, the intermediate component 103 and the handle 102 are shown in the extended position; the intermediate component 103 extends to the maximum distance beyond the handle 102.

[0242] exist Figure 30 In this configuration, the intermediate component 103 is received within the handle 102. Because the intermediate component 103 is received within the handle 102, the handle 102 has moved closer to the connector 111, thus the base component 10 connected to the handle 102 has moved relative to the connector 111 in a distal or forward direction. Therefore, the movement of the handle 102 relative to the intermediate component 103 toward the connector 111 causes the base component 10 to move, advancing relative to the endoscope 40 and optionally also relative to the outer sheath 14.

[0243] The telescopic mechanism 101 also includes an adjusting member 104. The adjusting member 104 is slidably received on the intermediate member 103 such that the adjusting member 104 can slide relative to the intermediate member 103 along a central geometric axis A. The adjusting member 104 is provided with a locking member 104a, which is configured to lock the adjusting member 104 relative to the intermediate member 103 at different positions along the central geometric axis A. A handle 102 is configured to receive the intermediate member 103 until the handle 102 abuts the adjusting member 104. Thus, a mechanism is provided that allows an operator to move the base member 10 while still controlling the maximum distance the base member 10 can be advanced.

[0244] exist Figure 28 In the middle, the adjusting member 104 is in its foremost position, that is, the position where the handle 102 can move the maximum distance relative to the middle member 103 until the handle 102 is adjacent to the adjusting member 104.

[0245] The telescopic mechanism 101 also includes an end component 105. The end component 105 may also be referred to as an elongated hollow tubular member adjuster.

[0246] The end member 105 is translatably movable relative to the intermediate member 103. For example... Figure 29 As shown, the intermediate component 103 is hollow and capable of receiving the end component 105. The end component 105 is slidably received within the intermediate component 103. Figures 27 to 29 In the diagram, the intermediate component 103 and the end component 105 are shown in the extended position; the end component 105 extends to the maximum distance beyond the intermediate component 103.

[0247] exist Figure 30 In the middle, the end part 105 is received in the intermediate part 103, which causes the intermediate part 103 to move closer to the connector 111.

[0248] The intermediate component 103 is connected to the elongated hollow tubular member 14 such that when the intermediate component 103 translates along geometric axis A, the elongated hollow tubular member 14 also translates along geometric axis A. Preferably, the elongated hollow tubular member 14 is translationally coupled to the intermediate component 103 such that translational movement of the intermediate component 103 relative to the connector 111 along geometric axis A provides a corresponding translational movement of the elongated hollow tubular member 14 relative to the connector 111, and more preferably, provides the same translational movement of the elongated hollow tubular member 14 relative to the connector 111. The end component 105 is provided with a channel 107 extending through the end component 105 along the central geometric axis A, the channel 107 allowing the elongated hollow member 14 to slide through the end component 105.

[0249] Therefore, when the end member 105 is received in the intermediate member 103, the elongated hollow tubular member 14 has already moved relative to the connector 111 in a distal or forward direction. Thus, the movement of the intermediate member 103 relative to the end member 105 toward the connector 111 causes the elongated hollow tubular member 14 to move, thereby advancing the elongated hollow tubular member 14 relative to the endoscope 40.

[0250] The telescopic mechanism 101 also includes an adjusting member 106.

[0251] The adjusting member 106 can be slidably received on the end member 105, such that the adjusting member 106 can slide relative to the end member 105 along the central geometric axis A. The adjusting member 106 is provided with a locking member 106a, which is configured to lock the adjusting member 106 relative to the intermediate member 103 at different positions along the central geometric axis A.

[0252] In one variant, the intermediate component 103 is configured to receive the end component 105, wherein the adjusting member 106 is fixedly connected to the intermediate component 103, such as Figure 30 As optimally shown. Therefore, a mechanism is provided for locking the intermediate part 103 and the end part 105 in different relative positions, thereby also locking the elongated hollow tubular member 14 relative to the connector 111, and subsequently also locking the elongated hollow tubular member 14 relative to the endoscope 40.

[0253] In one variant, the intermediate member 103 is configured to receive the end member 105 until the intermediate member 103 abuts the adjusting member 106. Thus, a mechanism is provided that allows an operator to move the elongated hollow tubular member 14 while still controlling the maximum distance the elongated hollow tubular member 14 can be advanced. In this variant, the adjusting member 106 is separated from the intermediate member 103.

[0254] exist Figures 17 to 22 and Figures 27 to 30 In an embodiment of the telescopic mechanism disclosed herein, the actuator (such as a drive line) is aligned with the base member 10.

[0255] However, in Figures 31 to 32 One variant is disclosed in which the actuator (such as drive line 39) is offsetly connected to the base member 10. This allows the base member 10 to extend through the telescopic mechanism, making it accessible at the proximal end of the telescopic mechanism. This could be useful, for example, for applications requiring negative pressure. In this case, the base member 10 preferably includes an internally hollow elongated tubular member 13, which is preferably impermeable to liquids or gases, so that negative pressure can be applied through the connector 108 at the proximal end of the telescopic mechanism.

[0256] The handle 102 is connected to the base member 10 such that the base member 10 is rotatable relative to the handle 102. The handle 102 is connected to the base member 10 such that when the handle 102 translates along geometric axis A, the base member 10 also translates along geometric axis A. Preferably, the base member 10 is translationally coupled to the handle 102 such that translational movement of the handle 102 along geometric axis A relative to the connector 111 provides a corresponding translational movement of the base member 10 relative to the connector 111, and more preferably provides the same translational movement of the base member 10 relative to the connector 111.

[0257] The handle 102 also includes a connection to the drive line 39, such that the inner drive line 39i can transmit rotation and torque from the motor 31 to the base member 10, and that the housing 39c is stationary relative to the handle 102. In this variant, the handle 102 also includes a gear mechanism 109 connected between the connection to the drive line 39 and the base member 10, such that the drive line 39 is offset relative to the central geometric axis A.

[0258] It can also be noted that different variations of the biopsy instrument 1 can be used for other purposes. Whether the inner hollow elongated tubular member 13 is rigid or flexible, it can be used as an introduction channel for introducing a guide wire. Whether the outer hollow elongated tubular member 14 is rigid or flexible, it can be used as an introduction channel for introducing a guide wire. The guide wire can be used, for example, to insert a stent, balloon, camera, syringe, or the like. The guide wire can also be used to insert markers, such as those visible on X-ray images. In this scenario, the biopsy instrument 1 is typically used as follows: First, the instrument is inserted into the tissue, and optionally a sample is also obtained; thereafter, one of the elongated hollow tubular members 13, 14 is optionally completely removed (if a sample has been obtained, the inner hollow elongated tubular member 13 is removed so that the sample can be harvested); thereafter, a guide wire is inserted via a component of the biopsy instrument 1 still inserted in the intended position; thereafter, all components of the biopsy instrument are retracted while the guide wire continues to extend to the intended position; thereafter, a stent, balloon, or marker is inserted or activated; and finally, the guide wire is also retracted.

Claims

1. A complete set of components, comprising: Biopsy instruments, and The control unit includes a motor. The biopsy instrument includes: - An elongated hollow tubular member, extending along its central geometric axis from the proximal end to the distal end, and - A base member extending from a proximal end to a distal end along the central geometric axis, wherein the distal portion of the base member is shaped as an elongated hollow tube located at the distal end of the base member, the elongated hollow tube being intended to be at least partially inserted into the tissue from which a biopsy is to be obtained. -The base member is arranged within the elongated hollow tubular member and is capable of independent rotational and translational movement relative to the elongated hollow tubular member. - wherein the base member is capable of transmitting force along the central geometric axis, such that movement of the proximal end of the base member along the central geometric axis is transmitted as movement of the distal end of the base member along the central geometric axis, and the base member is capable of transmitting torque about the central geometric axis, such that rotation and torque about the central geometric axis applied by the motor at the proximal end of the base member are transmitted from the proximal end of the base member to the distal end of the base member, thereby causing the distal end of the base member to rotate about the central geometric axis. - Wherein, by moving the proximal end of the base member along the central geometric axis, the elongated hollow tube can be advanced beyond the distal end of the outer elongated hollow tubular member and the elongated hollow tube can be retracted into the outer elongated hollow tubular member. Simultaneously, by applying rotation and torque at the proximal end of the base member by the motor, the elongated hollow tube can rotate within and relative to the outer elongated hollow tubular member about the central geometric axis. -The elongated hollow tube is provided with a distally facing circular cutting edge, the distally facing circular cutting edge defining a nozzle at the distal end of the elongated hollow tube, wherein, viewed circumferentially along the nozzle, the distally facing circular cutting edge has a straight line configuration and defines a plane, wherein when the central geometric axis passes through the plane of the nozzle, the plane has a normal parallel to the extension of the central geometric axis, and -The elongated hollow tube has a hollow elongated tubular sample acquisition portion on its distal portion, the sample acquisition portion having a smooth inner surface. The proximal end of the base member is configured to connect to the motor, such that rotation and torque can be applied by the motor to the proximal end of the base member and transmitted from the base member to the elongated hollow tube at the distal end of the base member. The motor is configured to, when the elongated hollow tube is advanced beyond the distal end of the outer elongated hollow tubular member and when the elongated hollow tube retracts into the outer elongated hollow tubular member, provide rotation and torque to the proximal end of the base member, allowing the elongated hollow tube to rotate at a speed between 13,000 rpm and 25,000 rpm about the central geometric axis within and relative to the outer elongated hollow tubular member, wherein the base member is flexible and the outer elongated hollow tubular member is flexible, and The sample acquisition section is impermeable to liquids, and is also impermeable to air or gas.

2. The kit-of-parts according to claim 1, wherein, The rotational speed is between 13,000 rpm and 20,000 rpm.

3. The complete set of components according to claim 1, wherein, The circular cutting edge facing the distal side is shaped, and the smooth inner surface is connected to the cutting edge such that, when viewed along the central geometric axis, the smooth inner surface extends to the distal portion of the cutting edge.

4. The complete set of components according to claim 1, wherein, The smoothness of the inner surface is such that, when obtaining a reference biopsy, the cutting edge and distal end of the elongated hollow tube are configured to be advanced into the tissue along the central geometric axis while being driven by a motor at its proximal end to rotate at a speed of at least 13,000 rpm, and thus cutting the core of the tissue. The core, due to the advancement of the elongated hollow tube relative to the nozzle, enters the sample acquisition portion of the elongated hollow tube, wherein the circumferential outer surface of the core at least partially abuts the smooth inner surface of the sample acquisition portion, thereafter being driven by a motor at its proximal end to rotate at a speed of at least 13,000 rpm. As the tube rotates at a speed of rpm, the elongated hollow tube retracts from the tissue, thereby causing the core of the tissue to detach from the tissue by a pulling force. This pulling force is caused by the retraction of the elongated hollow tube and by the adhesion force formed at the interface between the smooth inner surface and the circumferential outer surface of the core, which holds the core within the sample acquisition portion having the smooth inner surface.

5. The complete set of components according to claim 1, wherein, When the smooth inner surface is formed of steel, the surface roughness Ra value of the smooth inner surface is less than 1.5 µm.

6. The complete set of components according to claim 1, wherein, The smooth inner surface is formed of a polymer-based material.

7. The complete set of components according to claim 6, wherein, The base member includes an elongated hollow tubular member extending from the proximal end of the base member to the distal end of the base member.

8. The complete set of components according to claim 7, wherein, The polymer-based material forming the smooth inner surface is configured as a film, the polymer-based material being inserted into the elongated hollow tubular member and attached to the inner surface of the elongated hollow tubular member.

9. The complete set of components according to claim 7, wherein, The inner elongated hollow tubular component includes a hollow metal cord capable of transmitting force along the central geometric axis, such that movement of the proximal end along the central geometric axis is transmitted as movement of the distal end along the central geometric axis, and the hollow metal cord capable of transmitting torque about the central geometric axis, such that rotation and torque about the central geometric axis applied by the motor at the proximal end are transmitted from the proximal end to the distal end, thereby causing the distal end to rotate about the central geometric axis.

10. The complete set of components according to claim 7, wherein, The elongated hollow tubular member has a circular cutting edge facing the distal side at its distal end.

11. The complete set of components according to claim 1, wherein, The elongated hollow tubular component includes a hollow metal cord.

12. The complete set of components according to claim 1, wherein, The base member includes an inner elongated hollow tubular member, the base member having a connector at its proximal end for connection to a motor, the connector being capable of transmitting the movement, rotation, and torque along the central geometric axis.

13. The complete set of components according to claim 4, wherein, The core is separated from the tissue by shearing and / or tensile forces.

14. The complete set of components according to claim 1, wherein, The smooth inner surface is an impermeable smooth inner surface.

15. The complete set of components according to claim 1, wherein, When the smooth inner surface is formed of steel, the surface roughness Ra value of the smooth inner surface is less than 1 µm.

16. The complete set of components according to claim 5 or 15, wherein, The steel is medical-grade stainless steel.

17. The complete set of components according to claim 1, wherein, When the smooth inner surface is formed of a polymer-based material, the surface roughness Ra value of the smooth inner surface is less than 6 µm.

18. The complete set of components according to claim 1, wherein, When the smooth inner surface is formed of a polymer-based material, the surface roughness Ra value of the smooth inner surface is between 1 µm and 6 µm.

19. The complete set of components according to claim 8, wherein, The membrane is a tubular membrane.

20. The complete set of components according to claim 12, wherein, The connector is used for releasable connection to the motor.

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