Myocardial biopsy device

Abstract

The application provides a myocardial biopsy device, which comprises a sampling assembly and a detection assembly; the detection assembly comprises an inner catheter and a detection head fixed at the distal end of the inner catheter, and is used for detecting the electrical signal of normal and pathological myocardium and positioning pathological tissue. The sampling assembly comprises an outer catheter and a sampling forceps, the inner catheter is arranged in the inner part of the outer catheter and extends to the distal end, the distal end of the sampling forceps is formed with a special channel for the inner catheter to pass through, so that the detection head is located in front of the sampling forceps when the sampling forceps is not sampling; a forceps control mechanism is connected with the sampling forceps; after the pathological tissue is positioned, the sampling forceps is controlled to open and move forward to be approximately flush with the detection head, and then is closed to grab the pathological myocardial tissue positioned by the detection head, so that the grabbed tissue and the detection head are located in the covering range of the sampling forceps. The device is integrated by positioning first and sampling later, the detection head locks the pathological target point, the sampling forceps covers the detection head and the grabbed tissue after being closed, precise sampling is realized, and the risk of cardiac perforation caused by blind sampling is reduced.

Description

Technical Field

[0001] This invention relates to the field of interventional cardiology diagnostic and therapeutic devices, and in particular to a myocardial biopsy device. Background Technology

[0002] With the increasing incidence of cardiovascular diseases year by year, accurate diagnosis of diseases such as cardiomyopathy, myocarditis, and post-heart transplant rejection is of great significance for patients' treatment decisions and prognostic assessments. Among various diagnostic methods, percutaneous endocardial biopsy is a technique that uses a catheter-based biopsy forceps to reach the right or left ventricle through peripheral blood vessels to obtain endocardial myocardial tissue for pathological analysis. Because it can directly obtain myocardial tissue specimens, it is considered the "gold standard" for diagnosing a variety of myocardial diseases.

[0003] However, myocardial lesions are often focal and unevenly distributed, making it difficult to accurately determine the location of the lesion solely based on imaging or laboratory tests. This leads to a high risk of missed diagnoses in percutaneous endocardial myocardial biopsy. In clinical practice, close collaboration with multiple disciplines such as echocardiography, cardiac magnetic resonance imaging, and cardiovascular pathology is often necessary to reduce the rate of missed and misdiagnosed diagnoses. Furthermore, this procedure is an invasive interventional treatment, with reported complication rates of approximately 0-3.3%, including vasovagal syncope, cardiac perforation, cardiac tamponade, cardiogenic shock, supraventricular and ventricular arrhythmias, and rarer complications such as atrial perforation, pneumothorax, vascular injury, nerve injury, pulmonary embolism, coronary artery cisternaechionephrosis, hemorrhage, and tricuspid valve injury. While rare, cardiac perforation can be life-threatening. Therefore, the development of a convenient, precise, and complication-reducing myocardial biopsy device is urgently needed in clinical practice.

[0004] Previously, the myocardial biopsy devices widely used in clinical practice were mainly single-function biopsy forceps. The typical surgical procedure was as follows: vascular access was established via the right internal jugular vein and the surface of the biopsy forceps was rinsed with heparinized saline; under X-ray fluoroscopy, the biopsy forceps were inserted into the right atrium, crossed the tricuspid valve, and then the direction was adjusted counterclockwise and continued to be pushed. After contacting the right ventricular surface of the interventricular septum, the heartbeat was felt by touch, and the forceps valve was strictly prohibited from being opened during the pushing process to avoid cardiac perforation; after confirming that it was against the interventricular septum, it was withdrawn 1-2 cm, and the forceps valve was opened under fluoroscopy so that the forceps valve and the push rod formed a typical "Y" shape to confirm the position. The forceps were continued to be pushed forward until resistance was encountered, and then the handle was pressed to close the forceps valve. The forceps were gently pulled away from the interventricular septum and withdrawn to obtain myocardial tissue; finally, the area was rinsed with heparinized saline and the clamping was repeated 3-6 times.

[0005] The aforementioned devices can only perform mechanical clamping actions. Although the operator can sometimes delineate the approximate area of ​​the lesion under the guidance of X-ray fluoroscopy with the help of a special mapping catheter, it is still impossible to confirm the contact position, contact force, and angle between the forceps and the myocardial tissue in real time. There is a possibility of taking non-disease myocardium. Moreover, if the forceps are advanced too far forward, it may cause cardiac perforation. In addition, due to the limited bending angle of the sheath pre-shaping and the fact that the biopsy forceps themselves cannot actively control the bending, it is difficult to reach some lesion sites.

[0006] The existing technologies described above have three main drawbacks. First, insufficient safety and accuracy: the operator cannot know the contact status between the forceps and the endocardium in real time before the biopsy, making it difficult to guarantee that the tissue taken is the diseased myocardium, leading to both missed and incorrect biopsies. Furthermore, the risk of cardiac perforation is high due to blind advancement. Limited by sheath curvature and passive instrument movement, some lesions are inaccessible. Second, limited functionality: traditional biopsy forceps only have a grasping function; the operator cannot assess the electrophysiological characteristics of suspicious areas before the biopsy, thus failing to scientifically target the most pathologically potential sites. Third, low efficiency and significant trauma: due to the inability to accurately locate the tissue, it is often necessary to repeatedly grasp the tissue 3-6 times to obtain a satisfactory specimen. Multiple entry and exit and repeated grasping significantly increase the probability of mechanical damage and complications for the patient, delaying recovery.

[0007] In summary, the core problem with existing myocardial biopsy devices lies in the disconnect between the "clamping" and "localization" functions. Without real-time, precise electrophysiological localization methods, blindly clamping not only fails to guarantee the pathological value of the sampling target but also amplifies the fatal risks such as cardiac perforation, and reduces efficiency due to repeated operations. Therefore, there is an urgent need for a myocardial biopsy device capable of real-time localization of diseased myocardium before biopsy and precise and safe sampling after localization. Summary of the Invention

[0008] In view of this, embodiments of the present invention provide a myocardial biopsy device to eliminate or improve one or more defects present in the prior art.

[0009] A myocardial biopsy device includes a sampling component and a detection component; wherein the detection component includes an inner catheter and a detection head, the detection head being fixedly disposed at the distal end of the inner catheter; the sampling component includes an outer catheter, a sampling forceps, and a forceps control mechanism; the sampling forceps are disposed at the distal end of the outer catheter, and the forceps control mechanism is disposed at the proximal end of the outer catheter or at a segment of the outer catheter outside the operator's body; the inner catheter passes through the interior of the outer catheter, and the distal end of the inner catheter extends from the distal end of the outer catheter; the distal end of the sampling forceps has a specific passage for the inner catheter to pass through. The sampling forceps are positioned such that the detection head is located in front of the sampling forceps in a non-sampling state. The detection head is used to detect the electrical signals of normal myocardial tissue and diseased myocardial tissue, thereby locating the diseased myocardial tissue. The forceps control mechanism is connected to the sampling forceps and is configured to: after locating the diseased myocardial tissue, control the sampling forceps to open and move forward to approximately level with the detection head; and control the sampling forceps to close and grasp the diseased myocardial tissue located and pressed by the detection head, so that the grasped diseased myocardial tissue and the detection head are both within the coverage area of ​​the sampling forceps.

[0010] In some embodiments, a pressure sensor is provided at the distal or proximal end of the detection head for monitoring the pressure between the device and the endocardial tissue.

[0011] In some embodiments, the outer wall of the detection head is provided with at least a first calibration electrode and a second calibration electrode, and the first calibration electrode and the second calibration electrode are isolated from each other by an insulating layer.

[0012] In some embodiments, the myocardial biopsy device further includes a three-dimensional positioning system, the three-dimensional positioning system including a position sensor disposed at the distal peripheral portion of the external catheter.

[0013] In some embodiments, the detection head is a spherical structure.

[0014] In some embodiments, the sampling forceps includes two jaws and a scissor-link drive mechanism. The distal ends of the jaws are formed with biting blades. The scissor-link drive mechanism includes a first link and a second link, and two sets of the first link and the second link are provided. The proximal end of one jaw is fixedly connected to the distal end of one of the first links, and the proximal end of the first link is rotatably connected to the distal end of the second link. The proximal end of the second link is connected to the forceps control mechanism through an intermediate conductor. The middle portions of the two first links are rotatably connected by a first pin, so that the two jaws can rotate around the first pin as the center, thereby driving the opening and closing of the sampling forceps. The proximal ends of the two second links are rotatably connected by a second pin.

[0015] In some embodiments, the clamp control mechanism includes a first control button and a second control button, and the intermediate transmission section includes a first intermediate transmission element and a second intermediate transmission element. The length of the intermediate transmission section in the axial direction of the external conduit remains fixed and cannot be compressed or extended. The first control button is connected to the proximal end of the first intermediate transmission element, and the distal end of the first intermediate transmission element is connected to the first pin. The second control button is connected to the proximal end of the second intermediate transmission element, and the distal end of the second intermediate transmission element is connected to the second pin. The clamp control mechanism and the scissor-link drive mechanism are configured such that when the second control button is pushed forward and the first control button remains stationary, the second pin also moves forward while the first pin remains stationary, thereby opening the clamp jaws. When both the first and second control buttons are pushed forward simultaneously, the first and second pins move forward simultaneously, thereby moving the sampling clamp as a whole forward.

[0016] In some embodiments, the scissor linkage drive mechanism further includes a seat with a displacement limiting groove, or the inner wall of the outer guide tube has a displacement limiting groove; the first pin is inserted into the displacement limiting groove, the displacement limiting groove having a set length and including an opening section, a displacement section, and a closing section; the clamp control mechanism includes a third control button, the third control button being connected to the proximal end of the intermediate conductor, and the distal end of the intermediate conductor being connected to the first pin; the displacement section includes a stop block, and the stop block, the clamp control mechanism, and the scissor linkage drive mechanism are configured such that the clamp jaws are in a closed state. When the third control button is pushed forward, the first pin is located in the opening section and abuts against the near end of the stop, forcing the second pin forward to open the jaws. When the jaws are open, as the third control button continues to be pushed forward, the first pin can pass the stop and reach the closing section, causing the sampling clamp to move forward as a whole. When the jaws are open, as the third control button is pushed backward, the first pin is located in the closing section and abuts against the far end of the stop, forcing the second pin backward to close the jaws.

[0017] In some embodiments, the position and set length of the displacement limiting groove are configured such that when the first pin reaches the farthest end of the displacement limiting groove, the far end of the jaws is positioned approximately flush with the detection head.

[0018] In some embodiments, the proximal and / or distal ends of the stop block, and the ends of the first pins, are formed with guide ramps or guide surfaces.

[0019] Compared to the limitations of traditional myocardial biopsy forceps, which can only mechanically grasp the tissue, prevent the operator from locating the lesion area before biopsy, and require repeated grasping 3 to 6 times, this invention, through an integrated architecture of "first positioning, then sampling," allows the detection head to be positioned in front of the sampling forceps in a non-sampling state and to detect the electrical signals of normal and diseased myocardium in real time to lock the lesion target. This breaks through the core bottleneck of blind clamping leading to missed detection, erroneous sampling, and cardiac perforation. Specifically: First, the detection head extends forward in front of the sampling forceps and completes electrical signal positioning, allowing the operator to locate the diseased myocardial area before grasping, eliminating the accidental removal of non-disease tissue from the source and significantly improving the pathological value of the sampling target. Second, after positioning, the forceps control mechanism first controls the sampling forceps to open and move forward to approximately level with the detection head, and then controls its closure to grasp the diseased myocardial tissue positioned and compressed by the detection head. Both the grasped diseased tissue and the detection head are included within the coverage of the sampling forceps, ensuring "what you see is what you get," obtaining the target specimen in one operation, significantly reducing the number of grasps and minimizing trauma caused by repeated entry and exit. Third, because the sampling action is based on the real-time positioning of the detection head rather than blindly advancing it, the risk of cardiac perforation caused by excessive advance of the forceps head is reduced from the source.

[0020] Additional advantages, objects, and features of the invention will be set forth in part in the description which follows, and will also become apparent in part to those skilled in the art upon studying the description, or may be learned by practice of the invention. The objects and other advantages of the invention can be realized and obtained by means of the structures specifically pointed out in the description and drawings.

[0021] Those skilled in the art will understand that the objectives and advantages achievable with the present invention are not limited to those specifically described above, and that the above and other objectives achievable with the present invention will become clearer from the following detailed description. Attached Figure Description

[0022] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, are not intended to limit the scope of the invention. The components in the drawings are not drawn to scale but are merely illustrative of the principles of the invention. For ease of illustration and description of certain parts of the invention, corresponding portions in the drawings may be enlarged, i.e., may appear larger relative to other components in an exemplary device actually manufactured according to the invention. In the drawings: Figure 1 This is a schematic diagram of the distal structure of a myocardial biopsy device according to an embodiment of the present invention.

[0023] Figure 2 This is a schematic diagram of the displacement limiting groove and the first pin in one embodiment of the present invention.

[0024] Figure 3This is a schematic diagram of the proximal end structure of a myocardial biopsy device according to an embodiment of the present invention.

[0025] Figure 4 This is a schematic diagram of the sampling process of a myocardial biopsy device in one embodiment of the present invention. In the figure, (a) is a schematic diagram of the state of the device intervention process, (c) is a schematic diagram of the opening state after locating the lesion tissue, (d) is a schematic diagram of the state of the sampling forceps moving forward to the located lesion tissue, and (d) is a schematic diagram of the state of the device withdrawing after sampling.

[0026] Figure label: 100. Detection Components; 110. Detection Head; 111. First Calibration Electrode; 112. Second Calibration Electrode; 113. First Lead Wire; 114. Second Lead Wire; 120. Inner Tube; 131. Pressure Sensor; 132. Third Lead Wire; 141. Position Sensor; 150. Wiring Port; 200. Sampling assembly; 210. Sampling clamps; 211. Clamping jaws; 211-1. Specific channel; 212-1. First connecting rod; 212-2. Second connecting rod; 212-3. First pin; 212-4. Second pin; 220. Outer guide tube; 230. Clamping control mechanism; 231. Third control button; 232. First mark; 233. Second mark; 234. Third mark; 240. Displacement limiting groove; 241. Clamping opening section; 242. Stop; 243. Clamping closing section; 300. Bending control component; 310. Bending control knob. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the embodiments and accompanying drawings. Here, the illustrative embodiments and descriptions of this invention are used to explain the invention, but are not intended to limit the invention.

[0028] It should also be noted that, in order to avoid obscuring the invention with unnecessary details, only the structures and / or processing steps closely related to the solution according to the invention are shown in the accompanying drawings, while other details that are not closely related to the invention are omitted.

[0029] It should be emphasized that the term "including / comprises" as used herein refers to the presence of a feature, element, step, or component, but does not exclude the presence or addition of one or more other features, elements, steps, or components.

[0030] It should also be noted that, unless otherwise specified, the term "connection" in this article can refer not only to a direct connection, but also to an indirect connection involving an intermediary.

[0031] In the following description, embodiments of the invention will be illustrated with reference to the accompanying drawings. In the drawings, the same reference numerals represent the same or similar parts, or the same or similar steps.

[0032] The myocardial biopsy device in this embodiment of the invention includes two main parts: a sampling component and a detection component. The coaxial arrangement of the two components and the core working logic of "electrophysiological positioning first, followed by mechanical sampling" fundamentally change the traditional blind grasping operation method of biopsy forceps.

[0033] For ease of description, the directional terms used in this article are defined as follows: In this specification, "distal" refers to the end of the device that enters the human body, faces the heart and penetrates deep into the body, that is, the end away from the operator's operating end; "proximal" refers to the end of the device that is located outside the operator's body and is held and operated by the operator; "forward" refers to movement along the axial direction of the catheter toward the distal end, that is, deeper into the body, while "backward" refers to the direction of withdrawal toward the proximal end, that is, back out of the body.

[0034] like Figure 1 As shown, the detection component 100 may include an inner catheter 120 and a detection head 110. The inner catheter 120 is a long and slender tube, with the detection head 110 fixedly disposed at its distal end. It should be noted that in this embodiment of the invention, the detection head 110 can remain fixed relative to the distal end of the outer catheter 220. This fixing can be achieved by the inner catheter 120 itself, or by a connecting rod disposed inside or outside the inner catheter 120, thereby ensuring a fixed connection between the detection head and the outer catheter 220. This allows the detection head 110 to maintain a constant spatial position relative to the outer catheter 220 throughout the entire sampling process (opening the clamp, moving forward, closing), serving as a stable positioning reference. The detection head 110 is used to detect the electrical signals of normal myocardial tissue and diseased myocardial tissue, thereby achieving the localization of diseased myocardial tissue.

[0035] like Figure 1 As shown, the sampling assembly 200 includes an external catheter 220, sampling forceps 210, and a forceps control mechanism 230. The external catheter 220 is a flexible, slender catheter. The sampling forceps 210 is located at the distal end of the external catheter 220. The forceps control mechanism 230 is located at the proximal end of the external catheter 220 or at the section of the external catheter 220 outside the operator's body, and is held and operated by the operator.

[0036] Furthermore, the inner catheter 120 is axially inserted through the interior of the outer catheter 220, and the distal end of the inner catheter 120 extends from the distal end of the outer catheter 220; the distal end of the sampling forceps 210 forms a specific channel 211-1 that allows the inner catheter 120 to pass through, the specific channel 211-1 axially penetrates the distal region of the sampling forceps 210, allowing the inner catheter 120 to pass through unobstructed, so that in the non-sampling state, the detection head 110 is located in front of the sampling forceps 210, that is, closer to the distal end and contacting the myocardium first.

[0037] Since the detection head 110 is fixed relative to the distal end of the outer conduit 220 via the inner conduit 120 or connecting rod, the spatial position of the detection head 110 in the axial direction does not change with the movement of the clamp control mechanism 230. The sampling clamp 210 moves back and forth in the axial direction relative to the detection head 110 via the clamp control mechanism 230. This coaxial sleeve and through-channel design allows the detection component and the sampling component 200 to be highly integrated in the radial direction and to have separate functions in the axial direction: the detection head 110 extends and positions itself first as a fixed reference, and the sampling clamp 210 then follows and samples relative to the detection head 110, working together without interfering with each other. The specific channel 211-1 formed at the distal end of the sampling clamp 210 to allow the inner conduit 120 to pass through is the structural prerequisite for the detection head 110 to be located in front of the sampling clamp 210, and it also ensures that the subsequent movement of the sampling clamp 210 to cover the detection head 110 does not interfere with it.

[0038] The clamp control mechanism 230 is connected to the sampling clamp 210 and configured to perform a "first open the clamp and move it forward, then close it and grasp" action sequence. Its working process is as follows: In the non-sampling state, the sampling clamp 210 is closed or slightly open, with the detection head positioned in front of it and against the endocardium to complete electrical signal localization and identify the diseased myocardial tissue; thereafter, the detection head 110 remains fixed relative to the distal end of the external catheter 220, and the clamp control mechanism 230 only drives the sampling clamp 210 to move relative to the detection head 110, first controlling the sampling clamp 210 to open, and... The sampling forceps 210 is moved forward to a position roughly level with the detection head 110, so that the distal opening of the forceps 210 is directly aligned with the lesion tissue pressed by the detection head. Then, the forceps control mechanism 230 controls the sampling forceps 210 to close, and the cutting edge formed at the distal end engages to grasp the lesion myocardial tissue located and pressed by the detection head 110. Because the distal coverage area of ​​the closed sampling forceps 210 simultaneously accommodates both the grasped lesion tissue and the detection head 110, it ensures that what is taken is the target located by the detection head 110, achieving "what you see is what you get." After grasping, the operator withdraws the entire device from the body, and the myocardial specimen can be retrieved by opening the sampling forceps 210 from outside the body. This sequence of actions—"positioning—opening and moving the forceps forward—closing and grasping"—strictly limits the sampling target to the lesion area identified by the detection head 110, avoiding the accidental removal of non-lesion tissue and cardiac perforation caused by blind forward movement.

[0039] In some embodiments, to monitor the adhesion force between the device and the endocardial tissue in real time and to avoid excessive pressure causing cardiac perforation, refer to Figure 1A pressure sensor 131 is provided at the distal or proximal end of the detection head 110. The pressure sensor 131 can sense the normal pressure generated when the detection head 110 contacts the endocardium and transmit the pressure signal to an external display, allowing the operator to adjust the advance force accordingly and maintain the contact pressure within a safe range. Specifically, the pressure sensor 131 can be located on the distal surface of the detection head 110 or at the connection point between the inner catheter 120 and the detection head 110 (i.e., the proximal end of the detection head); both locations can effectively monitor the contact pressure. The pressure sensor 131 can be connected to the wiring port 150 at the proximal end of the catheter via a third lead 132, which can be placed inside the inner catheter 120 for integrated placement.

[0040] In some embodiments, in order to perform in-situ mapping of the electrophysiological properties of myocardial tissue and thereby locate the lesion area before biopsy, reference is made to... Figure 1 The outer wall of the detection head 110 is provided with at least a first mapping electrode 111 and a second mapping electrode 112, which are isolated from each other by an insulating layer. Normal myocardium and diseased myocardium differ in electrical signal characteristics such as depolarization sequence, local activation time, and voltage amplitude. The first mapping electrode 111 and the second mapping electrode 112 respectively collect myocardial electrical signals at their respective locations. After being insulated to prevent short circuits, the signals are transmitted to an external processing system for comparison and analysis by the surgeon to determine the lesion extent and target point. The arrangement of at least two mapping electrodes allows the detection head 110 to continuously collect signals along the contact trajectory as it is pushed forward to adhere to the endocardium, improving the comprehensiveness of localization. The arrangement of the first mapping electrode 111 and the second mapping electrode 112 on the outer wall of the detection head 110 can be circumferentially spaced, axially spaced, or a combination of both, as long as they are reliably isolated from each other by the insulating layer.

[0041] Optionally, the first mapping electrode 111 can be connected to the connection port 150 at the proximal end of the catheter via the first lead 113, and the second mapping electrode 112 can be connected to the connection port 150 at the proximal end of the catheter via the second lead 114. The two leads are independent and led out separately, so that the electrical signals collected by the first mapping electrode 111 and the second mapping electrode 112 can be transmitted to the external processing system without crosstalk; the operator can connect to the signal acquisition device through the connection port 150 to independently compare and analyze the two signals to determine the lesion range and target point.

[0042] In some embodiments, to obtain real-time information about the spatial position of the instrument within the cardiac cavity and overcome the limitation of traditional biopsy forceps, which are difficult to reach certain lesions due to the passive bending of the sheath, the myocardial biopsy device also includes a three-dimensional positioning system, referencing... Figure 1The three-dimensional positioning system includes a position sensor 141 located at the distal peripheral portion of the external catheter 220. The position sensor 141 enters the heart along with the distal end of the external catheter 220, transmitting or reflecting positioning signals to the external positioning system. This allows for real-time reconstruction and display of the position of the distal end of the external catheter 220 and even the detection head 110 on a three-dimensional electroanatomical mapping map. This assists the operator in navigating the instrument to lesion sites that are difficult to reach via traditional methods and can be corroborated with the electrical signal positioning of the mapping electrodes, further improving the spatial accuracy of the target.

[0043] In some embodiments, the detection head 110 has a spherical structure, and its spherical outer contour can form a stable contact with the endocardium, applying moderate pressure to the target area while mapping electrical signals, providing a contact reference for subsequent sampling. The spherical structure can also minimize damage to the myocardial tissue.

[0044] In some embodiments, to achieve reliable opening and closing of the jaws 211 of the sampling clamp 210 and stable force transmission, the sampling clamp 210 includes two jaws 211 and a scissor-type linkage drive mechanism, with a biting blade formed at the distal end of the jaws 211. For example... Figure 3 As shown, the scissor-type linkage drive mechanism includes a first link 212-1 and a second link 212-2. Two sets of the first link 212-1 and the second link 212-2 are arranged symmetrically from left to right. Specifically, the proximal end of one jaw 211 is fixedly connected to the distal end of one set of the first link 212-1, and the proximal end of the other jaw 211 is fixedly connected to the distal end of the other set of the first link 212-1. The proximal end of each set of the first link 212-1 is rotatably connected to the distal end of its corresponding second link 212-2. The proximal end of the second link 212-2 is connected to the clamp control mechanism 230 via an intermediate transmission member. The middle parts of the two sets of first connecting rods 212-1 are rotatably connected together by the first pin 212-3, so that the two jaws 211 can rotate relative to each other around the axis centered on the first pin 212-3, thereby driving the opening and closing of the sampling clamp 210; the proximal ends of the two sets of second connecting rods 212-2 are rotatably connected by the second pin 212-4.

[0045] Therefore, when the axial relative positions of the first pin 212-3 and the second pin 212-4 change, the two sets of connecting rods of the scissor linkage change their opening angle, converting the axial thrust transmitted by the clamp control mechanism 230 through the intermediate conductor into the rotational motion of the jaws 211 around the first pin 212-3, thus achieving opening and closing. The aforementioned intermediate conductor can refer to a built-in push-pull steel wire that connects the proximal end of the second connecting rod 212-2 to the clamp control mechanism 230 and transmits axial motion. It can convert the control force of the clamp control mechanism 230 into axial push-pull action, driving the scissor blades to complete opening and closing. The biting and cutting edges formed at the distal ends of the jaws 211 bite each other when closed, completing the biting and grasping of diseased myocardial tissue.

[0046] In some embodiments, to enable independent control buttons for opening the clamps and overall forward movement, making the operation intuitive and controllable, the clamp control mechanism 230 includes a first control button and a second control button (not shown in the figure). The intermediate transmission section includes a first intermediate conductor and a second intermediate conductor. The length of the intermediate transmission section along the axial direction of the outer conduit 220 remains fixed and cannot be compressed or extended. The first control button is connected to the proximal end of the first intermediate conductor, and the distal end of the first intermediate conductor is connected to a first pin 212-3; the second control button is connected to the proximal end of the second intermediate conductor, and the distal end of the second intermediate conductor is connected to a second pin 212-4. Because the intermediate transmission section has a fixed length and cannot be compressed or extended, the axial displacement of the control button is transmitted losslessly as the axial displacement of the corresponding pin.

[0047] The clamp control mechanism 230 and the scissor-link drive mechanism are configured with two operating modes. The first mode is the opening mode: when the second control button is pushed forward while the first control button remains stationary, the second intermediate conductor pushes the second pin 212-4 forward while the first pin 212-3 remains stationary. The proximal ends of the two sets of second links 212-2 move forward, while the middle of the first link 212-1 rotates around the stationary first pin 212-3, causing the distal ends of the two jaws 211 to move away from each other and open. Similarly, when the second control button is pushed backward while the first control button remains stationary, the second intermediate conductor pushes the second pin 212-4 backward while the first pin 212-3 remains stationary. The proximal ends of the two sets of second links 212-2 move backward, while the middle of the first link 212-1 rotates around the stationary first pin 212-3, causing the distal ends of the two jaws 211 to move closer together and close.

[0048] The second mode is the overall forward movement mode: When the first and second control buttons are pushed forward simultaneously, the first pin 212-3 and the second pin 212-4 move forward synchronously. Because the two pins move synchronously and the scissor linkage angle remains unchanged, the sampling forceps 210, along with the jaws 211, moves forward at a predetermined opening until the distal end of the jaws 211 is approximately flush with the detection head 110. Thus, the operator can complete the two independent yet sequentially connected actions of "opening the forceps" and "overall forward movement" by pressing the two control buttons separately or simultaneously. The operation is intuitive and controllable. This dual-control button scheme has a clear structure and decoupled actions, making it suitable for scenarios requiring precise step-by-step control and operation by the operator using both hands or one hand with fingers spread apart.

[0049] As another possible approach, see reference Figure 2 and Figure 3The scissor-type linkage drive mechanism also includes a seat with a displacement limiting groove, or the inner wall of the outer guide tube 220 itself has a displacement limiting groove. The first pin 212-3 is inserted into the displacement limiting groove, which has a set length and is divided into an opening section, a displacement section, and a closing section 243 along its axial direction. The clamp control mechanism 230 includes a third control button 231, which is connected to the proximal end of an intermediate conductor, the distal end of which is connected to the first pin 212-3. Thus, the axial movement of the third control button 231 directly drives the first pin 212-3 to slide within the displacement limiting groove. A stop block 242 is provided in the displacement section. The stop block 242 separates the opening section and the closing section 243 within the groove length, and at the same time defines a displacement area within the displacement section where the first pin 212-3 can move a short distance.

[0050] The working process of this solution is as follows: 1. With jaws 211 in the closed state (refer to...) Figure 4 (a) When the third control button 231 is removed from the first mark 232 (refer to (a)), Figure 3 When the position is pushed forward, the first pin 212-3 is located in the clamping section and abuts against the proximal end of the stop 242 (e.g., Figure 2 (As shown in the image) Because the stop 242 restricts the first pin 212-3 from moving forward, while the second pin 212-4 is not restricted, the reaction force exerted by the first pin 212-3 on the proximal end of the stop 242 is transmitted through the scissor linkage, forcing the second pin 212-4 to move forward. The angle between the two sets of linkages changes, causing the jaws 211 to open. At this time, the third control button 231 reaches the second mark 233 (see reference). Figure 3 ); Reference for the open state of the pincers 211 Figure 4 (b)

[0051] 2. With the jaws 211 open, when the third control button 231 is pushed forward from the second mark 233 position, the first pin 212-3 overcomes the constraint of the stop 242, passes the stop 242, and reaches the clamping function section 243. During this process, the jaws 211 remain open, and the entire sampling clamp 210 moves forward with the first pin 212-3, achieving forward feeding, until the first pin 212-3 reaches the far end of the displacement limiting groove. At this time, the third control button 231 reaches the third mark 234 (see reference). Figure 3 At this point, the jaws 211 are approximately flush with the detection head 110; this state is referenced. Figure 4 (c)

[0052] Third, with the clamping jaws 211 open, when the third control button 231 is pushed backward, the first pin 212-3 is located in the clamping function section 243 and abuts against the distal end of the stop block 242. The stop block 242 restricts the backward movement of the first pin 212-3, forcing the second pin 212-4 to advance backward. The two sets of connecting rods retract, thereby closing the clamping jaws 211, thus completing the grasping of the diseased myocardial tissue located by the detection head 110. After the grasping is completed, keep the third control button 231 stationary, and adjust the bend to withdraw the catheter from the body.

[0053] By using a single control button in conjunction with a displacement limiting slot with a stop 242, the three functions of "opening the clamps - moving forward - closing the clamps" can be realized sequentially, resulting in a compact structure and reliable operation. This single-control button displacement limiting slot solution completes the entire process with the fewest possible operating components, making it suitable for scenarios where the outer diameter of the adapter is limited, the operating components need to be simplified, and operation can be completed with one hand and one control button.

[0054] In some embodiments, to ensure that the sampling forceps 210 moves forward into position while preventing excessive forward movement that could cause cardiac perforation, the position and set length of the displacement limiting groove are configured such that when the first pin 212-3 reaches the farthest end of the displacement limiting groove, the distal end of the claw 211 is approximately flush with the detection head 110. That is, the farthest end of the displacement limiting groove constitutes the mechanical stop point for forward movement; the claw 211 is limited by the groove wall and cannot continue to move forward. At this point, the distal end of the claw 211 is approximately flush with the detection head 110, ensuring that the grasping area covers the diseased tissue positioned and pressed by the detection head 110 after closure, and mechanically eliminating the risk of the claw 211 overshooting the detection head 110 and damaging the myocardium or perforating the heart wall.

[0055] Understandably, although the jaws 211 rotate around the first pin 212-3 when closed, causing their distal ends to retract inward, they can still reliably grasp the diseased myocardial tissue pressed by the detection head 110. The principle is that when the jaws 211 are open, their distal ends move away from each other, and the width of the jaw opening formed is greater than the radial dimension of the detection head. When the sampling forceps 210 moves forward to be roughly level with the detection head, the detection head is located in the cavity between the two jaws 211. The diseased myocardial tissue pressed by the detection head is located on the side of the detection head facing the endocardium (i.e., in front of the detection head). During closure, the jaws 211 rotate inward around the first pin 212-3, with their distal cutting edges converging towards the center. Since the radial dimension of the detection head is smaller than the inner diameter of the area covered by the jaws 211, the inner wall of the jaws 211 is confined when it comes into contact with the outer surface of the detection head. The lesion tissue in front of the detection head (on the endocardial side) is precisely within the biting area of ​​the two jaws 211, and is bitten and clamped as the jaws 211 close. Thus, the detection head serves both as a fixed positioning reference and as a centering limiter for the jaws during sampling. The jaws 211 covering the detection head means that the center of the jaws is strictly aligned with the lesion target point pressed by the detection head, and the inward retraction of the jaws 211 is precisely constrained by the outer diameter of the detection head, ensuring that the biting position accurately falls on the target tissue. Because the detection head itself is fixed relative to the external catheter 220, it is neither pushed nor injured during the closure of the jaws 211, only playing a positioning and centering role.

[0056] Furthermore, the gripping depth can be controlled through real-time feedback from the detection components: the working current of the mapping electrode when it contacts the myocardium, and the actual contact pressure monitored by the pressure sensor 131, both reflect the contact state and degree of indentation between the detection head and the myocardial tissue 110. The operator or control system can adjust the closing stroke of the clamping mechanism 230 and the deformation of the clamp jaws 211 in real time, ensuring that the cutting blade enters the diseased myocardium at an appropriate depth, guaranteeing sufficient sampling while avoiding excessive indentation that could damage deep structures or perforate the heart wall. Thus, the current signal from the mapping electrode and the pressure signal from the pressure sensor 131 provide a quantitative basis for gripping depth control, further ensuring that "what you see is what you get" is implemented as appropriate, safe, and controllable sampling.

[0057] In some embodiments, to ensure that the first pin 212-3 switches smoothly and without jamming when switching between the opening and closing clamping functional sections 243, i.e., when passing over the stop 242 and entering the shifting functional section, refer to Figure 2 The proximal and / or distal ends of the stop block 242 and the end of the first pin 212-3 are formed with guide ramps or guide curved surfaces. The guide ramps or guide curved surfaces play a guiding and transitioning role during the pushing and pulling of the third control button 231, allowing the first pin 212-3 to smoothly slide along the ramp over the stop block 242, avoiding operational jerking or mechanism jamming caused by hard collisions, and improving the continuity of action and the feel of operation.

[0058] In some embodiments, reference Figure 1 and Figure 3 The device can also be equipped with a bending control assembly 300, which includes a bending control wire and a bending control knob 310 located at the proximal end of the external catheter 220. This assembly controls the bidirectional bending of the catheter, facilitating adjustment of the catheter tip direction and covering a wider lesion area. Specifically, the bending control wire is arranged axially along the external catheter 220 and connected to its distal end. By rotating or turning the bending control knob 310, the operator can selectively pull one side of the bending control wire, causing the distal end of the external catheter 220 to bend in the corresponding direction, thereby achieving active adjustment of the catheter tip direction. The introduction of bidirectional bending capability allows the device to actively control its bending, reaching lesion sites that are difficult to reach with traditional passively guided devices, further expanding the sampling area, and facilitating stable contact of the probe with the target endocardial site after mapping and positioning.

[0059] In specific implementation, the aforementioned "fixed connections" and "rotatable connections" are as follows: the fixed connection between the proximal end of the jaws 211 and the distal end of the first connecting rod 212-1 can be achieved through welding, integral molding, or fastener locking, ensuring that there is no relative rotation between the two; the rotatable connection between the proximal end of the first connecting rod 212-1 and the distal end of the second connecting rod 212-2, as well as the rotatable connection at the first pin 212-3 and the second pin 212-4, can all be achieved by opening hinge holes at the ends of the corresponding rods, allowing pins to pass through and achieve circumferential relative rotation; the connection between the intermediate transmission component and the control button of the jaw control mechanism 230, and the pins, can be a snap-fit, threaded connection, or integral molding, etc., which are detachable or fixed connections, facilitating assembly and maintenance. Unless otherwise specified in this document, the term "connection" can refer to either a direct connection or an indirect connection with an intermediate component.

[0060] The myocardial biopsy device in this embodiment of the invention, through an integrated collaborative architecture of "detection and positioning—forceps advancement—closure and grasping," combined with configurable means such as mapping electrodes, three-dimensional positioning, and bending control, has the following advantages compared to traditional blind-grabbing biopsy forceps: (i) Faster surgery. The three-dimensional positioning system reconstructs and displays the spatial position of the catheter in the heart cavity in real time, making catheter placement faster; the mapping electrode of the detection head can accurately identify diseased myocardial tissue and achieve precise sampling without relying on blind repeated clamping, thus significantly shortening the operation time.

[0061] (ii) Simpler operation. The bending control component 300 gives the catheter bidirectional bending capability, allowing the operator to easily adjust the direction of the catheter tip to cover more lesion areas, reducing reliance on passive instrument movement and operator feel.

[0062] (III) Safer. The sampling forceps 210 head remains closed until the lesion tissue is located, preventing the head from scratching the cardiac structure during the movement and probing process; even after the forceps are opened, the head only moves forward (to a position roughly level with the detection head) without making any other large movements, minimizing the risk of damaging normal myocardium and chordae tendineae; precise sampling guided by the mapping electrode replaces multiple blind clamping, causing less damage to the patient's heart and helping to reduce the occurrence of complications.

[0063] These effects work synergistically to achieve accurate, safe, and minimally invasive myocardial biopsy.

[0064] In this invention, features described and / or illustrated for one embodiment may be used in the same or similar manner in one or more other embodiments, and / or combined with or in place of features of other embodiments.

[0065] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, various modifications and variations of the embodiments of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A myocardial biopsy device, characterized in that, The device includes a sampling component (200) and a detection component (100); The detection component (100) includes an inner catheter (120) and a detection head (110), wherein the detection head (110) is fixedly disposed at the distal end of the inner catheter (120); The sampling assembly (200) includes an external catheter (220), sampling forceps (210), and a forceps control mechanism (230); the sampling forceps (210) is disposed at the distal end of the external catheter (220), and the forceps control mechanism (230) is disposed at the proximal end of the external catheter (220) or at a section of the external catheter (220) located outside the operator's body; The inner catheter (120) passes through the interior of the outer catheter (220), and the distal end of the inner catheter (120) extends from the distal end of the outer catheter (220). The distal end of the sampling forceps (210) forms a specific channel (211-1) that allows the inner catheter (120) to pass through, so that the detection head (110) is located in front of the sampling forceps (210) in the non-sampling state. The detection head (110) is used to detect the electrical signals of normal myocardial tissue and diseased myocardial tissue, thereby locating the diseased myocardial tissue. The clamp control mechanism (230) is connected to the sampling clamp (210). The clamp control mechanism (230) is configured to: after locating the diseased myocardial tissue, control the sampling clamp (210) to open and move forward to be approximately flush with the detection head (110); and control the sampling clamp (210) to close and grasp the diseased myocardial tissue located and pressed by the detection head (110), so that the grasped diseased myocardial tissue and the detection head (110) are both within the coverage area of ​​the sampling clamp (210).

2. The myocardial biopsy device according to claim 1, characterized in that, A pressure sensor (131) is provided at the distal or proximal end of the detection head (110) for monitoring the pressure between the device and the endocardial tissue.

3. The myocardial biopsy device according to claim 1, characterized in that, The outer wall of the detection head (110) is provided with at least a first calibration electrode (111) and a second calibration electrode (112), and the first calibration electrode (111) and the second calibration electrode (112) are isolated from each other by an insulating layer.

4. The myocardial biopsy device according to claim 1, characterized in that, The myocardial biopsy device also includes a three-dimensional positioning system, which includes a position sensor (141) disposed at the distal peripheral portion of the external catheter (220).

5. The myocardial biopsy device according to claim 1, characterized in that, The detection head (110) has a spherical structure.

6. The myocardial biopsy device according to claim 1, characterized in that, The sampling clamp (210) includes two jaws (211) and a scissor linkage drive mechanism, wherein the distal end of the jaws (211) is formed with a biting blade; The scissor linkage drive mechanism includes a first link (212-1) and a second link (212-2), with two sets of the first link (212-1) and the second link (212-2); the proximal end of one of the jaws (211) is fixedly connected to the distal end of one of the first links (212-1), the proximal end of the first link (212-1) is rotatably connected to the distal end of the second link (212-2), and the proximal end of the second link (212-2) is connected to the jaw control mechanism (230) through an intermediate conductor; The two first connecting rods (212-1) are rotatably connected at the middle by a first pin (212-3), so that the two jaws (211) can rotate around the first pin (212-3) as the center, thereby driving the opening and closing of the sampling clamp (210); The proximal ends of the two second connecting rods (212-2) are rotatably connected by a second pin (212-4).

7. The myocardial biopsy device according to claim 6, characterized in that, The clamp control mechanism (230) includes a first control button and a second control button. The intermediate transmission section includes a first intermediate transmission element and a second intermediate transmission element. The length of the intermediate transmission section in the axial direction of the outer conduit (220) remains fixed and cannot be compressed or stretched. Wherein, the first control button is connected to the proximal end of the first intermediate conductor, and the distal end of the first intermediate conductor is connected to the first pin (212-3); the second control button is connected to the proximal end of the second intermediate conductor, and the distal end of the second intermediate conductor is connected to the second pin (212-4); The clamp control mechanism (230) and the scissor linkage drive mechanism are configured such that when the second control button is pushed forward and the first control button remains fixed, the second pin (212-4) also moves forward while the first pin (212-3) remains fixed, thereby opening the clamp (211). When the first control button and the second control button are pushed forward at the same time, the first pin (212-3) and the second pin (212-4) move forward at the same time, thereby moving the sampling clamp (210) forward as a whole.

8. The myocardial biopsy device according to claim 6, characterized in that, The scissor linkage drive mechanism also includes a seat with a displacement limiting groove, or the inner wall of the outer guide tube (220) has a displacement limiting groove. The first pin (212-3) is inserted into the displacement limiting groove, which has a set length and includes an opening clamping section, a displacement clamping section and a closing clamping section (243). The clamp control mechanism (230) includes a third control button (231), which is connected to the proximal end of the intermediate conductor and the distal end of the intermediate conductor is connected to the first pin (212-3). The shifting function section includes a stop (242). The stop (242), the clamp control mechanism (230), and the scissor linkage drive mechanism are configured such that: when the clamp jaws (211) are closed, and the third control button (231) is pushed forward, the first pin (212-3) is located in the opening function section and abuts against the proximal end of the stop (242), forcing the second pin (212-4) to move forward, thereby opening the clamp jaws (211); When the jaws (211) are open, and the third control button (231) is pushed forward, the first pin (212-3) can pass the stop (242) and reach the clamping function section (243), so that the sampling clamp (210) moves forward as a whole; When the jaws (211) are open, and the third control button (231) is pushed backward, the first pin (212-3) is located in the clamping function section (243) and abuts against the far end of the stop block (242), forcing the second pin (212-4) to push backward, thereby closing the jaws (211).

9. The myocardial biopsy device according to claim 8, characterized in that, The position and set length of the displacement limiting groove are configured such that when the first pin (212-3) reaches the farthest end of the displacement limiting groove, the far end of the jaw (211) is in a position approximately flush with the detection head (110).

10. The myocardial biopsy device according to claim 8 or 9, characterized in that, The proximal and / or distal ends of the stop (242) and the end of the first pin (212-3) are formed with guide slopes or guide surfaces.

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