A BIOPSY MACHINE

Abstract

The invention relates to a biopsy device comprising a body with a proximal and a distal end, an operating switch located on the body, a cable supplied at the proximal end of the body, a camera located at the distal end, at least one light source, and a cutting tip, for obtaining tissue samples from oral mucosal lesions. The biopsy device described in the invention includes a contact tip holder connected to the body at the distal end, a contact tip made of biocompatible material, attached to the aforementioned contact tip holder in a detachable manner, and structured to sit on the mucosal surface from which the tissue sample is to be taken, and a drive mechanism that allows the cutting tip to be displaced gradually to a maximum displacement distance that can penetrate the tissue.

Description

1 TARIFF A BIOPSY MACHINE TECHNICAL FIELD The invention relates specifically to a biopsy device used in dentistry and oral surgery. is related.5 More specifically, the invention targets tissue sampling from oral mucosal lesions. an imaging unit that enables the viewing and preferably illumination of the area, a contact that ensures the device is positioned stably on the mucosal surface and The targeting tip and the entry distance of the cutting tip into the mucosa are determined at a predetermined distance. a depth limiting device that mechanically restricts the value on a fuselage10 It relates to a handheld biopsy device that combines these two functions. STATE OF THE ART The process of obtaining a tissue sample from oral mucosal lesions is, in known practice, carried out by the physician. direct visual assessment of the lesion and then using a scalpel, punch biopsy instrument or similar device.15 This is performed by taking a tissue sample with cutting instruments. The boundaries of the lesion and the area to be sampled is generally assessed visually by the physician, based on this assessment and This is determined based on clinical experience. However, especially in areas where the boundaries can be unclear. In lesions, selecting the most suitable area becomes difficult, and the tissue that is most diagnostically significant. It may not be possible to obtain a sample from the lesion area. On the other hand, during the procedure, the lesion surface and20 Since a visual record is usually not created of the sampled area, the sample taken... Confirmation of the exact location on the lesion and possible follow-up examinations of previous It may not be possible to make a comparison with the situation. In such applications, the imaging unit and the cutting edge should not be on the same device. Therefore, the target area determined before the operation must be redefined at the time of cutting.25 This may be necessary. The physician uses the positional information obtained during imaging to determine the location of the cutting instrument. It may not be possible to directly confirm this during use. Also, the cutting edge should not touch the mucous membrane surface. During placement, the instrument tip is positioned against the target due to the slippery and mobile nature of the mucosa. It is possible for the area to shift. 2 In standard practice, biopsy depth depends largely on the surgeon's hand movement and the instrument used. It can vary depending on the force applied. This results in a more superficial effect than intended. or it may lead to taking a deeper tissue sample. In samples that remain superficial It may not be possible to obtain sufficient tissue for histopathological evaluation, and the procedure... It may need to be repeated. In cases of deeper than anticipated penetration, the tissues beneath the mucosa5 It can be affected, leading to undesirable situations such as bleeding and prolonged healing time. It is possible to get out. On the other hand, in some known biopsy devices, the piece that comes into contact with the mucosal surface, They can be manufactured from materials unsuitable for repeated sterilization processes. Because instruments used in oral procedures come into contact with blood and saliva, every 10 steam sterilization under high temperature and pressure after use It is necessary. Made from materials that are not resistant to sterilization conditions. In parts, surface deterioration, discoloration and Dimensional changes may occur. The part in question is also part of the device. a support surface that allows it to sit on the mucosa and limit the depth of entry15 In the structures it carries, this dimensional change directly affects the accuracy of biopsy depth. It can have an impact. Furthermore, in some known devices, the part that comes into contact with the mucosa is a single piece with the body. They can be manufactured in a way that is either indestructible or cannot be removed. In these structures, the mucosa... wear, deformation of the contacting part, or a different size for a different application. The lifespan of the device may be reduced if a replacement part is needed. In conclusion, during the oral mucosal biopsy procedure, the target area is directly examined by the device. visualization, stable placement of the device on the mucosa, insertion of the cutting tip mechanically limiting its depth to a predetermined value and its interaction with the mucosa the contacting part must be biocompatible, sterilizable and replaceable.25 A hand tool is needed to provide the necessary support within the structure. A BRIEF DESCRIPTION OF THE INVENTION The present invention is a biopsy developed to overcome the aforementioned drawbacks. It is related to the device.30 3 One aim of the invention is to ensure that the contact tip that comes into contact with the mucous membrane is biocompatible and repeatable. By ensuring that the device is manufactured from a material resistant to sterilization processes, hygiene is ensured. to meet their needs. Another aim of the invention is to adjust the depth of penetration of the cutting edge into the mucosa, according to the physician's hand. regardless of its movement and the force it applies, the mechanical value is at a pre-selected value. to limit it. Another aim of the invention is to improve imaging, illumination, and targeting in oral mucosal biopsy procedures. Stable seating on the area and controlled depth cutting functions all in a single hand tool. to provide a biopsy device (1) that offers a combination of Another aim of the invention is to enable simultaneous imaging of the target area and tissue sampling. by enabling the process to be carried out via the device and without changing the device's location Eliminates the need to redefine the previously determined target area at the moment of cutting. to remove. To achieve its objectives, the present invention enables the collection of tissue samples from oral mucosal lesions. To provide this, a body with a proximal end and a distal end, arranged on the body15 an operating button, a cable supplied at the proximal end of the body, distal A biopsy involves a camera positioned at the tip, at least one light source, and a cutting tool. It relates to the device. The biopsy device, suitable for the invention, is connected to the body at its distal end. a contact end holder, The aforementioned contact end is attached to the holder in a detachable manner, tissue sample20 a surface that is structured to sit on the mucosal surface to be removed, a contact tip made of biocompatible material, and The cutting edge is stepped to a maximum displacement distance that allows it to penetrate the tissue. It includes a drive system that provides displacement. According to some sample arrangements of the invention, the aforementioned drive arrangement is located on the fuselage25 a rotatable drive knob, a drive knob into the housing an extending drive pin, supplied on the drive pin, each with a different displacement a cam mechanism consisting of stepped cams corresponding to a certain distance, cam at one end a device that is in contact with the cutting edge mentioned at the other end It includes a follower connected to the cutting edge pin.30 4 BRIEF DESCRIPTION OF THE FIGURES Figure 1 shows a representative overview of the biopsy device that is the subject of this invention. Figure 2 shows a representative view of the distal end of the biopsy device, which is the subject of the invention, in a disassembled state. Figure 3 shows a representative view of the cutting tool drive mechanism. Figure 4a shows a representative camera view.5 Figure 4b shows a representative view of the lesion boundaries. Figure 4c shows a representative view of the target area where the cutting tool will intervene. Figure 4d shows a representative view of a biopsy sample. EXPLANATION OF REFERENCE NUMBERS10 1 Biopsy device 2 Fuselages 3. Power button 4 Cables Away indicator 15 6 Distal end 7 Contact tip holder 8 Contact points 9 Cameras Light source20 11 Cutting edge 12 Glass 13 Drive button 14 actuator pins Cam mechanism25 16 Cutting body 17 Cutting edge pins 18 Followers 19 Spring Camera view 21 Lesion images5 22 Target area images 23 Lesions 24 Proximal tip DETAILED DESCRIPTION OF THE INVENTION10 The invention is a biopsy device (1) for taking controlled depth tissue samples from oral mucosal lesions. This is to be done in accordance with the preferred structure shown in the attached figures below. It is explained. As shown in Figure 1, the biopsy device (1) preferably has a longitudinally shaped body (2) It includes. The body (2) is sized to be easily grasped by the hand of the physician / user and 15 It can be arranged in an ergonomic form. The body (2) can preferably be arranged in the form of the biopsy device (1) that is the subject of the invention. It can provide the load-bearing structure that houses or contains the other elements. One end of the body (2) is the proximal end (24) which remains close to the physician during use, The other end is the distal end (6) which is brought close to the mucosa. A cable (4) connection may be provided on the proximal end (24) side of the body (2). Cable20 (4), in addition to providing power to the biopsy device (1), the camera (9) which will be explained below It can also function to transfer image data obtained by the device to an external source. Thus Power supply and data transfer can be carried out via a single cable (4), thus, A data line connection may not be required on the trunk (2). However, It is possible to transmit camera images wirelessly from the device (1) to a processor.25 It is possible. In such a case, as is known from technology, there is a wireless transmitter inside the device (1). The unit is customizable (in which case, the processor can also be equipped with a wireless receiver unit). On the body (2) there is an operating button that enables the biopsy device (1) to be switched on and off. (3) is located. The operating button (3) is preferably near the proximal end (24) of the body (2). 6 in that area, without disrupting the physician's grasping position and accessible for example with the thumb. It may be positioned in this way. At the distal end (6) of the biopsy device (1), there is a disassembled one as shown in Figure 2. A contact end holder (7) and a contact end (8) are arranged. The contact end holder (7) can preferably be attached to the housing (2) in a detachable manner.5 The contact end (8) can be attached to the contact end holder (7) in a detachable manner. In particular, the contact end (8), thanks to the detachable connection, is the contact end that comes into contact with the mucosa. (8), the biopsy device (1) can be separated from the body (2) independently of other elements, It can be cleaned, sterilized, replaced with a new one if it wears out, or If necessary, it can be replaced with a contact tip (8) of a different size. Contact tip10 A shape-dependent arrangement for the detachable connection of the holder (7) to the housing (2), For example, as is known from the technique, there are various numbers of indentations and contacts on the connection surface (2) in the body. The end of the holder (7) is shaped to fit snugly with these indentations on the connecting surface. Given, various protrusions can be provided. Similarly, as known from the technique, a clawed arrangement, for example, various number of slots and contact points on the connection surface (2) on the body15 The shape of the retainer (7) on the connecting surface will fit snugly with these slots. Various numbers of nails are available. A shape-connection for the detachable connection of the contact end (8) to the contact end holder (7). The arrangement, for example, known from the technical field, is various on the connection surface of the contact end holder (7). a number of indentations and contact ends (8) on the connection surface, with these indentations tightly 20 Various numbers of protrusions can be provided, shaped to match. Similarly, a known technical arrangement, for example, on the contact surface of the contact end holder (7) on the connection surface of the various number of sockets and contact ends (8), these sockets are tightly connected with each other. Various numbers of nails, shaped to match, are available. The contact tip holder (7) and / or contact tip (8) are preferably circular in shape. The contact tip (8)25 The peripheral portion that remains at the outermost edge in the axial direction, in contact with the mucosal surface during use. forming the part that ensures the biopsy device (1) sits stably on the mucosa. This provides the axial contact between the distal end (6) and the mucosal surface. fixing the distance and thus providing a fixed reference for the feed movement of the cutting edge (11). It can create a reference plane. This reference plane is created by the drive mechanism described below.30 Together, these ensure that the biopsy depth remains within the predetermined value. 7 The contact tip (8) is made of a biocompatible and medical-grade material, preferably PEEK. It may be made of (polyetheretherketone) material and may be in the form of a contact ring. The material in question must withstand repeated steam sterilization cycles. thanks to which the contact end (8) maintains surface integrity and dimensional stability. This ensures that the contact end (8) maintains its dimensional stability, and this element also 5 By creating a reference plane that sits on the mucosal surface, it allows for the determination of biopsy depth. This contributes to maintaining the same accuracy over repeated uses. The edges of the surface of the contact tip (8) that contacts the mucosa, which may form on the mucosa It can be shaped with a rounded or beveled edge to reduce trauma. A camera (9) and a cutting tip (11) are arranged at the distal end (6) of the biopsy device (1).10 According to some sample arrangements of the invention, at the distal end (6), at least one light source (10) It can be arranged. The light source (10) can preferably be two and preferably of the LED type. Two Positioning the light source (10) around the camera (9) reduces shadowing of the target area. It can provide lighting in a way that will reduce its intensity. The camera (9) and light source (10) are located on the contact end (8) as shown in Figure 1. The openings are positioned in line with the camera (9) and the light. a light-transmitting glass (12) that prevents the source (10) from coming into direct contact with oral fluids. It may be closed. The glass (12), as well as the camera (9) and the light source (10) can be cleaned. This ensures that it remains hidden behind a surface. The biopsy device (1) suitable for the invention, the cutting tip (11) extends outwards from the device (1) (i.e. into the tissue20 a drive to cause displacement towards the device (1) (to penetrate) It includes the mechanism. In an example configuration of the aforementioned drive mechanism, the cutting edge (11) is on the body (2). a drive knob that allows you to gradually adjust the displacement distance it will travel. (13) is arranged. The drive button (13) will protrude from the upper surface of the body (2) and25 It is designed so that the doctor can rotate it with their finger. A displacement indicator (5) may also be found on the fuselage (2). Displacement indicator (5), Showing the physician the preferred displacement distance adjusted by the drive button (13). The design features graduated markings corresponding to values ​​of 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm. and includes indicator elements associated with these signs.30 where the actuation button (13) is located. The indicator element corresponding to the location becomes active, and the physician adjusts the settings. 8 Confirm the penetration / displacement distance directly via the biopsy device (1). is able to. As shown in Figure 3, a drive switch (13) extends from inside the body (2) There is a drive pin (14). A cam mechanism (15) is provided on the drive pin (14). The cam assembly (15) is arranged in stages around the drive pin (14). It includes cams, and each cam corresponds to a specific displacement distance. It is coming. A follower (18) is provided in contact with the cam mechanism (15). The follower (18) has one end It rests on the cam mechanism (15) on one end and on the other end with the cutting end pin (17) It is connected. The cutting edge pin (17) extending axially is on the other end of the cutting edge pin (11)10 It is located there. The cutting end pin (17) is axially positioned within a cutting body (16) arranged inside the housing (2). It is mounted in such a way that it moves in the direction of the cutting pin (17). The cutting body is around the cutting pin (17). An axially extending spring (19) is provided inside (16). The spring (19) holds the cutting end pin. (17) and therefore force the cutting edge (11) towards the retracted or forward position, the same15 This ensures that the follower (18) remains in constant contact with the cam device (15) over time. By turning the drive knob (13), the drive pin (14) and the cam assembly on it are activated. (15) when he turns, the follower (18) the cam that the cam assembly (15) is in contact with at that moment According to its profile, it is displaced in the axial direction and this movement is transmitted through the cutting end pin (17) to the cutter. It transfers to the tip (11). The maximum distance the cutting tip (11) can advance distally is the distance in contact.20 It is determined by the height of the cam. Beyond this distance, a cam mechanism (15) This is prevented by mechanical contact between the follower (18) and the biopsy. depth, regardless of the hand force applied by the physician, with a pre-selected value. It becomes mechanically restricted. If the drive button (13) is released or returned to the starting position25 The spring (19) returns the cutting tip pin (17) and the cutting tip (11) to the retracted position. The cutting edge (11) displaces outwards from the device (1) or toward the device (1). The drive mechanism providing this is different from the technically known configuration, apart from the example structure described above. It should be appreciated that it may include another drive mechanism. For example, a rotary drive knob. instead, a protruding element such as a claw that can move linearly on the body (2) is provided30 and this protruding element may be mechanically connected to the cutting edge pin. 9 During use, the biopsy device (1) is switched to the operating position using the operating button (3). The distal end (6) of the biopsy device (1) is brought close to the area where the lesion (23) is located and contact is made The tip (8) is placed on the mucosal surface. In this position, the contact tip (8) of the biopsy device (1) is placed on the mucosal surface. It ensures that it stands stably without slipping. As shown in Figure 4a, after the camera (9) takes an image, the resulting camera images5 (20), biopsy via cable (4) (or thanks to a wireless transceiver arrangement) It is transferred from the device (1) to an independent processor where it is processed as shown in figure 4b. The boundaries of the lesion (23) in the lesion image (21) are determined. The boundaries of the lesion An AI-powered application or software can preferably be used in this determination. Thus, the target area image (22) is displayed on a screen that the physician can see by the processor.10 is transferred. The processor in question is preferably located outside the software and screen biopsy device (1). can be obtained, biopsy device (1) which is the subject of the invention will be suitable for use with these. It is structured in this way. After the lesion boundaries are visualized on the screen, a cutting tool is prepared for the biopsy. (11) is displaced. The physician adjusts the trigger button according to the depth of the tissue sample to be taken.15 (13) By rotating, the displacement distance can be adjusted gradually. Preferred In this configuration, the maximum displacement distance can be, for example, 5 mm, and each displacement In this step, the distance will be in 1 mm intervals, that is, 1 mm, 2 mm, 3 mm, 4 mm. or can be selected as 5 mm. However, the mentioned displacement distances can be adjusted to any desired level. It can be selected in this way. The selected value can be confirmed via the displacement indicator (5). Drive20 By turning the knob (13), the cam assembly (15), the follower (18) and the cutting end pin (17) The cutting edge (11) is advanced distally over the reference point (8) formed by the contact edge. By penetrating the mucosa only for the selected distance from the plane, as shown in Figure 4d. As can be seen, a tissue sample can be taken. When the process is completed, the cutting edge (11) returns to the retracted position by the effect of the spring (19) and25 The biopsy device (1) is removed from the mucosal surface. After use, the contact tip (8), The contact end holder (7) can be cleaned by removing it from the housing (2), and the contact end holder (7) can be cleaned by removing it from the housing (2). It can be sterilized or replaced.

Claims

REQUESTS 1. To obtain a tissue sample from oral mucosal lesions, a proximal end is used. (24) and a body (2) with a distal end (6), arranged on the aforementioned body (2). an operating button (3) is located on the proximal end (24) side of the aforementioned body (2). a camera5 arranged on the side of the aforementioned distal end (6) with a supplied cable (4). (9) is a biopsy device (1) which includes at least one light source (10) and a cutting tip (11), feature, a contact on the mentioned distal end (6) side, connected to the mentioned body (2) end holder (7), The tissue10 is connected to the aforementioned contact end holder (7) in a detachable manner. a surface structured to sit on the mucosal surface from which the sample will be taken containing a contact tip made of a biocompatible material (8), and The cutting edge mentioned (11) has a maximum displacement that can penetrate the tissue. a drive system that provides gradual displacement up to a certain distance It includes.15 2. It is a biopsy device according to claim 1, and its feature is that the mentioned contact tip (8) is biocompatible. and a material suitable for medical applications, preferably PEEK (polyetheretherketone) It is made of a certain material.

3. A biopsy device according to any of the previous requests, and its feature is as mentioned. the drive arrangement can be rotated on the aforementioned body (2)20 a regulated drive knob (13), the mentioned drive knob (13) a drive pin (14) extending into the housing (2), on the aforementioned drive pin (14) supplied and in stages, each corresponding to a different displacement distance. a cam assembly consisting of cams (15), a cam assembly mentioned by one end (15) is in contact with the cutting edge mentioned by the other end (11)25 It includes a follower (18) connected to a cutting edge pin (17).

4. A biopsy device according to any of the previous requests, and its feature is as mentioned. the detachable connection of the contact end (8) to the aforementioned contact end holder (7) It involves a shape-based arrangement.

5. A biopsy device according to any of the previous requests, and its feature is the one mentioned30 the contact end (8) has a circular form. 11 6. A biopsy device according to any of the previous requests, and its feature is as mentioned. The edges of the surface of the contact end (8) that contact the mucosa, on the mucosa a rounded or beveled shape to reduce potential trauma It includes.

7. A biopsy device according to any of the previous requests, and its feature is as mentioned.5 prevent the camera (9) and light source (10) from coming into direct contact with oral fluids It contains a light-transmitting glass (12) which allows it to be sealed in this way.

8. A biopsy device according to any of the previous requests, and its feature is as mentioned. The maximum displacement distance is 5 mm and each displacement step The distance is 1 mm.10

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