Myocardial biopsy system

Abstract

The present application provides a myocardial biopsy system, comprising: a catheter; a handle connected to the tail end of the catheter, the handle being provided with an operating button; and a clamp claw connected to the head end of the catheter, the catheter being provided with a clamp claw control rod, one end of the clamp claw control rod being connected to the clamp claw, and the other end being connected to the operating button, the opening and closing of the clamp claw being controlled by the operating button, the clamp claw being provided with a negative pressure traction hole, the negative pressure traction hole being connected to the negative pressure control member on the handle through a negative pressure airway airway, the negative pressure airway being operated by the negative pressure control member to negatively attract the clamp claw to the target object. In this way, the clamp claw can be tightly attached to the target object tissue when clamping the target object tissue, so that deep tissue can be extracted with high safety.

Description

Technical Field

[0001] The present application relates to the field of cardiovascular intervention technology, and in particular to a myocardial biopsy system. Background Art

[0002] Percutaneous endomyocardial biopsy (EMB) is a technique that uses myocardial biopsy forceps to obtain endomyocardial tissue through peripheral blood vessels. It has been used clinically for more than 50 years, and related technologies are constantly updated. At present, endomyocardial biopsy and myocardial pathology diagnosis have become important means of diagnosing myocarditis and cardiomyopathy.

[0003] As an invasive procedure, EMB is most commonly used to monitor heart transplant (HTx) rejection. In addition, EMB plays an important complementary role in the diagnosis of a variety of cardiac diseases, including myocarditis, cardiomyopathy, drug-related cardiotoxicity, amyloidosis, other infiltrative heart diseases, and cardiac tumors. Guidelines from many countries emphasize the use of EMB in cardiovascular management. Summary of the invention

[0004] The present application provides a myocardial biopsy system, comprising:

[0005] catheter;

[0006] a handle connected to the tail end of the catheter, wherein the handle is provided with an operating button; and

[0007] A clamping jaw connected to the tip of the catheter,

[0008] A clamp jaw control rod is arranged in the catheter, one end of the clamp jaw control rod is connected to the clamp jaw, and the other end is connected to the operating button, and the opening and closing of the clamp jaw is controlled by the operating button.

[0009] The clamp claw is provided with a negative pressure traction hole, and the negative pressure traction hole is connected to the negative pressure control component on the handle through a negative pressure airway. The negative pressure airway is negatively operated by the negative pressure control component to negatively attract the clamp claw onto the target object.

[0010] Furthermore, the jaw includes at least two jaws, and the at least two jaws are rotatably connected by a rotating shaft, and the rotating shaft is a rotating ventilation shaft. The negative pressure traction hole is arranged on at least one jaw, and the negative pressure traction hole is connected to the negative pressure control component via the rotating ventilation shaft air circuit.

[0011] Furthermore, the rotary ventilation shaft includes at least a first air path through hole and a second air path through hole, the first air path through hole is air-connected to the negative pressure traction hole, and the second air path through hole is air-connected to the negative pressure control component.

[0012] Furthermore, the second air path through hole is connected to the head end of the catheter, and the tail end of the catheter is connected to the negative pressure control component.

[0013] Furthermore, an air circuit pipe is also provided in the conduit, the second air circuit through hole is air-connected to one end of the air circuit pipe, and the other end of the air circuit pipe is air-connected to the negative pressure control component.

[0014] Furthermore, the negative pressure control component is a Luer connector structure.

[0015] Furthermore, the negative pressure traction hole is also connected to a blood pressure monitoring sensor through the negative pressure airway, and the blood pressure of the target area is monitored by the blood pressure monitoring sensor. The target area is the area near the target object.

[0016] Furthermore, a curvature control line is provided in the catheter, one end of the curvature control line is connected to the head end of the catheter, and the other end is connected to the operating button, and the curvature of the catheter is controlled by the operating button.

[0017] The jaw control rod can be controlled by pushing and pulling the operating button to control the opening and closing of the jaw, and the curvature control line can be controlled by rotating the operating button to control the curvature of the catheter.

[0018] Furthermore, a first electrode lead and a second electrode lead are also provided in the catheter, and the clamp flap is a metal clamp flap, which is connected to one end of the first electrode lead as a first electrode. A ring electrode is also provided at the head end of the catheter, and the ring electrode is connected to one end of the second electrode lead as a second electrode. The other end of the first electrode lead and the other end of the second electrode lead are connected to an electrophysiological mapping device or a radiofrequency ablation device.

[0019] Furthermore, when the other end of the first electrode lead and the other end of the second electrode lead are connected to the radiofrequency ablation device, when the radiofrequency ablation device performs a discharge operation on the first electrode and the second electrode, physiological saline is infused into the negative pressure airway through the negative pressure control component.

[0020] According to the above specific implementation of the present application, a negative pressure traction hole is provided on the jaws, and the negative pressure traction hole is connected to the negative pressure control member on the handle through the negative pressure airway, and the negative pressure airway is operated by the negative pressure control member to negatively pressure the jaws to attract the target object. In this way, the jaws can be tightly attached to the target tissue when clamping the target tissue, so that deep tissue can be extracted with high safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The attached drawings below are part of the specification of the present application, which illustrate embodiments of the present application. The attached drawings together with the description of the specification are used to explain the principles of the present application.

[0022] Figure 1 A schematic diagram of a myocardial biopsy system according to an embodiment of the present application is shown.

[0023] Figure 2 A schematic diagram of a myocardial biopsy system according to an embodiment of the present application is shown.

[0024] Figure 3 A schematic diagram of the front end of a myocardial biopsy system according to an embodiment of the present application is shown.

[0025] Figure 4 A schematic diagram of a rotating ventilation shaft according to an embodiment of the present application is shown.

[0026] Figure 5 A schematic diagram of a partial negative pressure airway according to an embodiment of the present application is shown.

[0027] Figure 6 A schematic diagram of controlling the opening and closing of the jaws by pushing and pulling an operating button according to an embodiment of the present application is shown.

[0028] Figure 7 A schematic diagram of controlling the bending of a catheter by rotating an operating knob according to an embodiment of the present application is shown.

[0029] Figure 8 A schematic diagram of controlling a clamp flap by a connecting rod according to an embodiment of the present application is shown.

[0030] Fig. 9 A schematic diagram of a ring electrode according to an embodiment of the present application is shown.

[0031] Fig.10 A schematic diagram of a magnetic sensor according to an embodiment of the present application is shown. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solutions and advantages of the embodiments of the present application more clearly understood, the spirit of the contents disclosed in the present application will be clearly explained with the accompanying drawings and detailed descriptions below. After understanding the embodiments of the contents of the present application, any technician in the relevant technical field can change and modify them according to the techniques taught by the contents of the present application without departing from the spirit and scope of the contents of the present application.

[0033] The exemplary embodiments and descriptions of the present application are used to explain the present application, but are not intended to limit the present application. In addition, elements / components with the same or similar reference numerals used in the drawings and embodiments are used to represent the same or similar parts.

[0034] The terms “first”, “second”, etc. used in this document do not particularly refer to an order or sequence, nor are they used to limit this application. They are only used to distinguish elements or operations described with the same technical terms.

[0035] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0036] As used herein, "and / or" includes any or all combinations of the items described.

[0037] As used herein, “plurality” includes “two” and “more than two”; as used herein, “plurality groups” includes “two groups” and “more than two groups”.

[0038] Certain terms used to describe the present application are discussed below or elsewhere in this specification to provide additional guidance to those skilled in the art regarding the description of the present application.

[0039] The present application embodiment provides a myocardial biopsy system. Figure 1 As shown, the myocardial biopsy system includes a catheter, a handle and a clamp claw. The handle is connected to the tail end of the catheter, and the clamp claw is connected to the head end of the catheter. An operating button is provided on the handle.

[0040] A clamp jaw control rod is arranged in the catheter, one end of which is connected to the clamp jaw, and the other end of which is connected to the operating button, and the opening and closing of the clamp jaw are controlled by the operating button.

[0041] When using the myocardial biopsy system, the catheter tip of the myocardial biopsy system is first placed near the target object. The target object may be the myocardium, and the catheter can be placed near the myocardium through a peripheral blood vessel. Then, the clamp claws are opened and closed by an operating button to clamp part of the target object. After that, the catheter is withdrawn from the body, and the part of the target object removed is tested to confirm the health of the patient's myocardium.

[0042] However, in the above process, when clamping the target object such as the myocardium with the claws of the forceps, it is difficult to judge whether the claws are in close contact with the myocardium. Sometimes, in order to extract deeper myocardial tissue, greater force may be used to push the claws, which may easily lead to cardiac perforation and cardiac tamponade, and may even be fatal if not treated in time.

[0043] Therefore, the embodiment of the present application also provides a myocardial biopsy system that can extract myocardial tissue through negative pressure traction, which has strong conformability, can extract deep tissue, and has high safety.

[0044] like Figure 2As shown, in the myocardial biopsy system of an embodiment of the present application, a negative pressure traction hole is provided on the forceps claw, and the negative pressure traction hole is connected to the negative pressure control component on the handle through a negative pressure airway. The negative pressure airway is negatively operated through the negative pressure control component to negatively attract the forceps claw onto the target object.

[0045] In one embodiment, if Figure 2 As shown, the jaws include at least two jaw petals, and the negative pressure traction hole is provided on at least one jaw petal. Of course, those skilled in the art know that, according to actual conditions, negative pressure traction holes may also be provided on multiple jaw petals, or multiple negative pressure traction holes may be provided on one jaw petal, and this application does not make specific limitations.

[0046] In one embodiment, the negative pressure control member is a Luer connector structure. The Luer connector structure can be adapted to a common Luer cone syringe in an operating room to achieve negative pressure suction and sealing effects. The negative pressure airway can be suctioned to attract the clamp claw to the target object.

[0047] In one embodiment, if Figure 3 and Figure 4 As shown, the at least two clamp flaps are rotatably connected via a rotating shaft, the rotating shaft is a rotating ventilation shaft, and the negative pressure traction hole is connected to the negative pressure control component via the rotating ventilation shaft air path.

[0048] Figure 4 Schematic diagrams of rotating ventilation axes at different angles according to one embodiment are shown. Figure 4 As shown, the rotary ventilation shaft is cylindrical, and the column body has evenly arranged grooves, which realize axial and radial connection of each gas path through the grooves, ensuring that the gas path connection can be achieved during the opening and closing process of the clamp petals.

[0049] Specifically, the rotary ventilation shaft includes at least a first air path through hole and a second air path through hole. The first air path through hole is located on the clamp flap side, and the air path is connected to the negative pressure traction hole on the clamp flap. The number of the first ventilation holes can be the same as the number of the negative pressure ventilation holes. The second air path through hole is located on the catheter side, and the air path is connected to the negative pressure control member.

[0050] In one embodiment, the portion of the negative pressure airway in the catheter can be realized by the inside of the catheter itself. Because the catheter itself is airtight, the second airway through hole on the rotating ventilation shaft can be directly connected to the head end of the catheter, and the tail end of the catheter is connected to the negative pressure control member. In this way, the negative pressure airway includes a negative pressure traction hole, a rotating ventilation shaft, a catheter and a negative pressure control member, and the negative pressure control member can be used to perform negative pressure operation on the negative pressure airway so that the clamp claws are negatively attracted to the target object. Figure 5 A schematic diagram showing the partial negative pressure airway of the myocardial biopsy system.

[0051] In another embodiment, an airway tube can be separately provided in the catheter as the part of the negative pressure airway in the catheter. The second airway through hole is connected to one end of the airway tube, and the other end of the airway tube is connected to the negative pressure control member. In this way, the negative pressure airway includes a negative pressure traction hole, a rotating ventilation shaft, an airway tube and a negative pressure control member, and the negative pressure control member can be used to perform a negative pressure operation on the negative pressure airway so that the clamp claws are negatively attracted to the target object.

[0052] The material of the gas line tube can be selected from: polymer materials such as polytetrafluoroethylene PTFE, polyimide PI, polycarbonate PC, or polyetheretherketone PEEK.

[0053] By setting a separate airway tube in the catheter, more precise negative pressure suction can be achieved.

[0054] In the above embodiment, by providing a negative pressure airway and a negative pressure control member, the clamp claws can be tightly attached to the target tissue when clamping the target tissue, so that deep tissue can be extracted with high safety.

[0055] The myocardial biopsy system provided in the embodiment of the present application can not only capture myocardial tissue, but also be used as a tool for grasping foreign bodies in the cardiac cavity or a tool for removing electrode wires implanted in the cardiac cavity. In this case, the target object is a foreign body in the cardiac cavity or an electrode or wire in the cardiac cavity.

[0056] In addition, based on the above-mentioned embodiment, the embodiment of the present application also provides a myocardial biopsy system that can simultaneously monitor blood pressure. In this embodiment, the negative pressure traction hole is also connected to a blood pressure monitoring sensor through the negative pressure airway, and the blood pressure of the target object is monitored by the blood pressure monitoring sensor when the clamp claw is negatively pressured on the target object. In one implementation, the blood pressure monitoring sensor can be set on the handle. In addition, the blood pressure monitoring sensor can also be electrically connected to the electrical connection interface. In this way, the operator can monitor the blood pressure in the heart in real time, which is conducive to the evaluation of fluid balance and ventricular function.

[0057] On the basis of the above-mentioned embodiments, the embodiments of the present application also provide a myocardial biopsy system with good bending control. In the myocardial biopsy system, a curvature control line is also provided in the catheter, one end of which is connected to the head end of the catheter, and the other end is connected to the operating button, and the curvature of the catheter is controlled by the operating button. In this embodiment, the jaw control rod and the curvature control line are both connected to the operating button. For example, the jaw control rod can be controlled by pushing and pulling the operating button to control the opening and closing of the jaw, and the curvature control line can be controlled by rotating the operating button to control the curvature control line and thus control the curvature of the catheter. Figure 6 A schematic diagram showing a push-pull operating button to control the opening and closing of the clamp jaws according to an embodiment of the present application is shown. Figure 7FIG. 2 shows a schematic diagram of implementing a rotary operating knob to control catheter bending according to the present application. Figure 8 As shown, the myocardial biopsy system is provided with a connecting rod between the rotating ventilation shaft and the operating button. By pushing and pulling the operating button, the connecting rod can be driven to move forward and backward to control the opening and closing of the clamp flap. At the same time, the operating button can be rotated, and a curvature control line (for example, a steel wire) is set between the operating button and the catheter head end. When the operating button is rotated, the steel wire is tightened to achieve the purpose of controlling the bending of the head end. The bending control performance of the biopsy system is easy to improve its operability, and solves the problems in the prior art that it is difficult to quickly and accurately position and difficult to effectively fit with the tissue in the target area. In the above manner, the operator can conveniently control the opening and closing operation of the clamp jaws and the catheter bending control operation.

[0058] On the basis of the above-mentioned embodiments, the embodiments of the present application also provide a myocardial biopsy system with a physiological electrical mapping function. In this embodiment, the clamp flap is a metal clamp flap, which can be used as a mapping electrode. An electrode lead is also provided in the catheter, one end of which is connected to the metal clamp flap, and the other end can be electrically connected to an electrophysiological mapping device through, for example, an electrical connection interface, so as to perform physiological electrical mapping on the target object. In this embodiment, the two clamp flaps serve as electrodes, which are electrically connected to the handle cable and connector through a slender electrode lead when closed, and can map and display the endocardial potential after being connected to the electrophysiological mapping device.

[0059] In another embodiment, if Fig. 9 As shown, a ring electrode can also be provided at the catheter head end, and another electrode lead connected to the ring electrode can be provided in the catheter, one end of the other electrode lead can be connected to the ring electrode, and the other end can be electrically connected to the electrophysiological mapping device through, for example, an electrical connection interface, so as to achieve dual-electrode physiological electromapping of the metal clamp flap and the ring electrode. In this embodiment, the ring electrode is also electrically connected to the handle cable and connector through a slender electrode lead, and after connecting to the electrophysiological mapping device, the endocardial potential can be mapped and displayed.

[0060] In one embodiment, the ring electrode material is a platinum-iridium alloy, with the proportion of platinum being 90%-95%.

[0061] In this embodiment, physiological electrical mapping is helpful to find abnormal endocardial conduction points through abnormal potential signals, locate abnormal lesions, and then perform tissue extraction.

[0062] In one embodiment, the claws and ring electrodes of the myocardial biopsy system can be used not only as mapping electrodes, but also as ablation electrodes. In this embodiment, the claw is a metal claw, which can be used as an ablation electrode. An electrode lead is provided in the catheter, one end of which is connected to the metal claw, and the other end is electrically connected to the radiofrequency ablation device through, for example, an electrical connection interface. Another electrode lead is also provided in the catheter, one end of which is connected to the ring electrode, and the other end is electrically connected to the radiofrequency ablation device through, for example, an electrical connection interface. The discharge of the electrode by the radiofrequency ablation device can achieve the function of ablating tissue, and can also achieve ablation treatment of arrhythmia diseases while being used for biopsy.

[0063] In addition, during the ablation process, normal saline can be infused into the negative pressure airway, which can reduce the catheter electrode contact impedance and allow ablation at a higher power, thereby achieving a better ablation effect.

[0064] Based on the above embodiments, the present application also provides a myocardial biopsy system with magnetic navigation function. In this embodiment, Fig.10 As shown, a magnetic sensor can also be set at the catheter head end, and the magnetic sensor collects the curvature of the catheter and / or the position of the clamp claws, and transmits the signal to a signal receiver. Specifically, a magnetic sensor is set at the head end of the myocardial biopsy system, which is electrically connected to the handle cable and connector through a slender wire. After connecting to the electrophysiological three-dimensional mapping system, the relative position of the head end in the heart can be displayed through magnetic induction positioning, so that the movement of the biopsy system head end can be observed in real time, which is convenient for positioning, and is conducive to reducing the exposure of X-rays and reducing radiation damage to doctors and patients.

[0065] The above description is only an illustrative specific implementation manner of the present application. Without departing from the concept and principle of the present application, any equivalent changes and modifications made by any technician in the field should fall within the scope of protection of the present application.

Claims

1. A myocardial biopsy system, characterized in that: include: catheter; a handle connected to the tail end of the catheter, wherein the handle is provided with an operating button; and A clamping jaw connected to the tip of the catheter, A clamp jaw control rod is arranged in the catheter, one end of the clamp jaw control rod is connected to the clamp jaw, and the other end is connected to the operating button, and the opening and closing of the clamp jaw is controlled by the operating button. The clamp claw is provided with a negative pressure traction hole, and the negative pressure traction hole is connected to the negative pressure control member on the handle through a negative pressure airway. The negative pressure airway is operated by the negative pressure control member to negatively pressure the clamp claw onto the target object. The negative pressure traction hole is also connected to a blood pressure monitoring sensor through the negative pressure airway, and the blood pressure of the target area is monitored through the blood pressure monitoring sensor.

2. The myocardial biopsy system according to claim 1, characterized in that: The jaw includes at least two jaws, which are rotatably connected via a rotating shaft, wherein the rotating shaft is a rotating ventilation shaft, and the negative pressure traction hole is arranged on at least one jaw, and the negative pressure traction hole is connected to the negative pressure control component via the rotating ventilation shaft air circuit.

3. The myocardial biopsy system according to claim 2, characterized in that: The rotary ventilation shaft includes at least a first air path through hole and a second air path through hole, wherein the first air path through hole is air-connected to the negative pressure traction hole, and the second air path through hole is air-connected to the negative pressure control member.

4. The myocardial biopsy system according to claim 3, characterized in that: The second air path through hole is connected to the head end of the catheter, and the tail end of the catheter is connected to the negative pressure control component.

5. The myocardial biopsy system according to claim 3, characterized in that: An air circuit pipe is also provided in the conduit, the second air circuit through hole is air-connected to one end of the air circuit pipe, and the other end of the air circuit pipe is air-connected to the negative pressure control component.

6. The myocardial biopsy system according to claim 1, characterized in that: The negative pressure control component is a Luer connector structure.

7. The myocardial biopsy system according to claim 1, characterized in that: A curvature control line is also provided in the catheter, one end of the curvature control line is connected to the head end of the catheter, and the other end is connected to the operating button, and the curvature of the catheter is controlled by the operating button.

8. The myocardial biopsy system according to claim 2, characterized in that: A first electrode lead and a second electrode lead are also provided in the catheter. The clamp flap is a metal clamp flap, which is connected to one end of the first electrode lead as a first electrode. A ring electrode is also provided at the head end of the catheter, which is connected to one end of the second electrode lead as a second electrode. The other end of the first electrode lead and the other end of the second electrode lead are connected to an electrophysiological mapping device or a radiofrequency ablation device.

9. The myocardial biopsy system according to claim 8, characterized in that: When the other end of the first electrode lead and the other end of the second electrode lead are connected to the radiofrequency ablation device, when the radiofrequency ablation device performs a discharge operation on the first electrode and the second electrode, physiological saline is infused into the negative pressure airway through the negative pressure control component.

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