Coronary artery thrombectomy device and use method thereof

Abstract

The invention discloses a coronary artery thrombectomy device and a use method thereof. The invention relates to an embolectomy device comprising an embolectomy head which is particularly designed to be deployable in a complex coronary artery system in order to optimally treat coronary artery diseases. The thrombector head may include a deployable framework having a plurality of branches that are in a closed state in a first position and an expanded state in a second position from which the framework expands radially away from the longitudinal axis, thereby enabling mechanical opening of an intravascular embolism pathway, and the operation can be repeated for multiple times in the folded state and the expanded state. The framework may include a capture protection net surrounding a distal end of the framework for capturing thrombus and fragments thereof. The thrombectomy device can be used for working in a straight and bent vascular system. In the thrombus removal process, the head of the thrombus extraction device can be inserted into the thrombus by using a proper guide wire; and then framework expansion is carried out to take out thrombus.

Description

Technical Field

[0001] The invention relates to a mechanically deployed and mechanically controlled coronary artery thrombectomy device and a use method thereof, and belongs to the technical field of medical devices. Background Art

[0002] Acute myocardial infarction is a common emergency in cardiovascular medicine, with a high morbidity and mortality rate, which seriously threatens the health of residents. Coronary thrombosis is a pathological blood clot formed at the site of coronary intimal lesions, mainly composed of blood components such as fibrin, platelets, white blood cells and red blood cells. Intracoronary thrombosis can cause a decrease in coronary blood flow or interruption of blood supply, leading to ischemia, hypoxia and necrosis of myocardial tissue in the supply area, which is one of the core pathological bases of acute myocardial infarction.

[0003] Coronary revascularization represented by percutaneous coronary intervention is a direct method and effective means to treat patients with acute myocardial infarction. Its main purpose is to open the infarction-related artery, remove the thrombus, and relieve the stenosis. In the actual operation process, how to efficiently remove the thrombus in the coronary artery is an important technical problem that clinicians often face. Although the thrombus aspiration catheter commonly used in clinical practice can remove the thrombus in the coronary artery of some patients, it has the constraints of slow thrombus removal, incomplete thrombus removal, easy blockage of the catheter head, and large blood loss during the operation, which makes it difficult to meet the clinical needs of most patients. At the same time, this type of catheter usually adopts a negative pressure needle aspiration method, with a short wedge-shaped structure at the head end, poor passability, and most of them need to be imported from abroad and are expensive, which limits their widespread use. Therefore, it is urgent to propose a new solution to improve the existing thrombus aspiration device so that more patients can benefit. Summary of the invention

[0004] The purpose of the present invention is to provide a coronary artery thrombectomy device and a method of using the same in view of the deficiencies of the existing coronary artery thrombectomy devices.

[0005] In order to achieve the above-mentioned purpose, the present invention provides a coronary artery thrombus removal device, which comprises an expandable thrombus removal device head and an operating component for operating the thrombus removal device head to expand or contract and adjust its expansion or contraction size, the thrombus removal device head comprises a coaxially arranged proximal rod and a distal rod, and an expandable frame composed of a plurality of elastic wires, and a capture protection net wrapped around the distal end of the elastic wire, the elastic wire is connected between the proximal rod and the distal rod; the proximal rod and the distal rod are respectively provided with a proximal developing ring and a distal developing ring; the elastic wire is made of a shape memory material;

[0006] The proximal and distal rods are comprised of a hollow tube or rod having a wall with an inner surface and an outer surface, and a lumen extending from a proximal end to a distal end thereof and defining a longitudinal axis;

[0007] The elastic wire extends longitudinally from one end to the other end along a portion of the length of the rod, and the ends of the elastic wire are not connected to each other; the frame has an expanded state and a contracted state. In the expanded state, the frame is a spindle-shaped structure with small ends and a large middle, and its shape is symmetrical about the cross section where the midpoint of the frame is located; when the longitudinal length of the frame is reduced, the frame expands radially away from the longitudinal axis, so that the frame expands from the contracted state to the expanded state;

[0008] The capture protection net surrounds the distal end of the elastic wire, starts at the midpoint of the framework, and ends at the proximal end of the distal rod.

[0009] Preferably, the number of the elastic threads is 6 to 12, and in a fully contracted (closed) state, the elastic threads are evenly distributed along the central axis of the tube or rod and are arranged in straight lines that do not cross each other.

[0010] Preferably, the number of the elastic threads is 6 to 12. In the fully contracted (closed) state, the elastic threads are evenly distributed along the central axis of the tube or rod of the head of the thrombus remover and are arranged in a spiral curve that does not cross each other.

[0011] Preferably, it also includes an internal rod, which includes a wall having an inner surface and an outer surface, and a cavity extending between its distal end and proximal end, and the internal rod is coaxially arranged in the cavity of the frame of the thrombus remover head; one end of the internal rod is fixedly connected to the distal end of the frame, and the other end is arranged at the proximal end of the frame but not fixedly connected thereto, so that the internal rod can move freely in the longitudinal direction relative to the proximal end of the thrombus remover head and remain stationary relative to the distal end.

[0012] Preferably, the operating component comprises a sliding operating portion provided with a dial, the sliding operating portion is connected to the proximal end of the inner rod and is configured to drive the thrombus remover head from any state of closed to expanded when moving axially along the proximal rod.

[0013] Preferably, the sliding operation part is provided with a sliding member and a sliding groove, the sliding member is installed in the sliding groove and can slide horizontally in the sliding groove; the scale plate is provided with 8 evenly distributed scales for indicating the relative position of the sliding member, so that the sliding member can accurately locate its position when sliding along the longitudinal direction, and then determine the degree of opening and closing of the head component of the thrombus remover through the positioning, so that the diameter of the head of the thrombus remover is in the range of 0.6mm-5mm. It is also convenient to adjust the degree of opening and closing of the head component of the thrombus remover according to the size of the thrombus.

[0014] Preferably, an internal pressure sensor and an external pressure sensor are provided on the elastic wire at the midpoint of the frame, the internal pressure sensor is located on the inner side of the frame, and the external pressure sensor is located on the outer side of the frame; the number of the internal pressure sensor or the external pressure sensor is one or more, and they are fixedly installed on different elastic wires.

[0015] Preferably, it also includes a pressure identification and display device arranged outside the human body, and the pressure identification and display device is respectively communicated with the internal pressure sensor and the external pressure sensor, and the connection method is wireless connection; the operating component is provided with a sliding member, a sliding groove and a dial, the sliding member is installed in the sliding groove and can slide horizontally in the sliding groove, and the dial is provided with 8 evenly distributed scales for indicating the relative position of the sliding member, so that the sliding member can accurately locate its position when sliding along the longitudinal direction, and then determine the degree of opening and closing of the head component of the thrombus remover through the positioning, so that the diameter of the head of the thrombus remover is in the range of 0.6mm-5mm.

[0016] Preferably, it also includes a host computer control system disposed outside the human body and a driving motor for driving the head component of the thrombus remover to expand or contract; the host computer control system includes a pressure identification module, a pressure display module and a control module for identifying pressure sensor signals, and the host computer control system is respectively connected to the operating component, the internal / external pressure sensor and the driving motor for communication;

[0017] The inner rod of the head part of the thrombus remover is connected to the driving motor through a transmission mechanism;

[0018] The operating component is an electronic operator provided with an expansion button and a contraction button;

[0019] The host computer control system is configured to control the working state of the drive motor according to the pressure signal recognized by the pressure recognition module, or the host computer control system is configured to control the working state of the drive motor according to the input instruction of the operating component.

[0020] Preferably, the transmission mechanism includes a gear transmission mechanism and a gear slider mechanism; the gear transmission mechanism is used to convert the faster rotation of the motor into the slower rotation of the gear, and the gear transmission mechanism includes a meshing first gear, a second gear, a third gear and a fourth gear; the first gear is connected to the driving motor through a rotating shaft, and the diameters of the first gear, the second gear, the third gear and the fourth gear increase successively.

[0021] Preferably, the gear slider mechanism comprises a fourth gear, a connecting rod, a slider and a base, wherein:

[0022] The fourth gear is the main transmission component, which meshes with the third gear and is connected to the slider through a connecting rod, and transmits the rotational motion of the gear to the slider through the connecting rod, so that the slider performs linear reciprocating motion in a specific guide rail or slide groove;

[0023] The connecting rod is an intermediate rod connecting the fourth gear and the slider, one end of which is fixedly connected to the fourth gear and the other end is hinged to the slider;

[0024] The slider is a component that performs linear reciprocating motion in the guide rail or the slide groove, one end of which is connected to the other end of the connecting rod, and the reciprocating motion is achieved by the driving of the connecting rod, and the other end of the slider is fixedly connected to the internal rod of the head of the thrombus remover;

[0025] The base is used to support and fix the gear, the connecting rod and the sliding block.

[0026] Preferably, the diameter of the frame in the closed state is 0.6-1.0 mm, and the diameter in the expanded state is between 2.0 and 5.0 mm; the length of the frame in the closed state is 20.0-30.0 mm, and the length in the expanded state is 15.0-25.0 mm.

[0027] The present invention also provides a method for using the above-mentioned thrombus removal device, comprising the following steps:

[0028] S1. Insert the catheter with the thrombus removal device head into the coronary artery to the proximal end of the thrombus blocking the blood vessel. At this time, the thrombus removal device head will be accurately positioned under the action of the distal imaging ring. Then, the closed thrombus removal device head is passed over the thrombus until the proximal imaging ring of the thrombus removal device head passes over the distal end of the thrombus.

[0029] S2. Withdraw the catheter and the head of the thrombectomy device will expand from the closed state to the expanded state;

[0030] S3. Next, the head of the thrombus remover is retracted, and the capture protection net in the frame will wrap the thrombus. The capture protection net will prevent small thrombus fragments from escaping from the frame, thereby pulling the entire thrombus back toward the proximal end. Finally, the frame and the thrombus are retracted into the catheter to achieve the overall removal of the thrombus.

[0031] Preferably, steps S2-S3 are to operate the internal rod to move axially through the sliding operation part on the operating component to drive the head of the thrombus remover to expand or contract, and the expansion or contraction size is adjusted by the sliding operation part of the operating component and the indication of the dial.

[0032] Preferably, the steps S1-S3 are performed under pressure monitoring, and the expansion or contraction size (degree) of the thrombus remover head is manually or electrically adjusted according to the pressure signal indication monitored by the pressure sensor.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] 1. The thrombus removal device provided by the present invention has an operating component that can slide, and the expansion degree of the head of the thrombus removal device can be adjusted to 8 sizes through the sliding member, and the specific opening value can be determined, or the operating component can adjust its expansion or contraction size according to the pressure indication; therefore, it can be applied to blood vessels with different inner diameters and thrombi of different sizes;

[0035] 2. The design of the head of the thrombectomy device can be used for thrombus removal without damaging the inner wall of the blood vessel; the appropriate type of thrombectomy head can also be selected according to the characteristics of the thrombus and the patient's characteristics;

[0036] 3. Different schemes can be selected for thrombus removal according to different types (size, hardness, shape, etc.); thus, the thrombus can be removed more thoroughly; the thrombus removal speed is fast, the effect is good, and it can be adjusted; the thrombus removal speed is faster than the current negative pressure thrombectomy device; and the degree of completeness of thrombus removal is more thorough than the current negative pressure thrombectomy device;

[0037] 4. The capture protection net at the distal end of the thrombus remover head can effectively prevent thrombus fragments from moving to the distal end of the blood vessel, thereby removing the thrombus thoroughly, safely and reliably; and because it is a mechanical thrombectomy, the amount of blood loss is less than that of the current negative pressure thrombectomy device, and the mechanical thrombectomy will not bring too much blood out of the body, reducing damage to the patient's body;

[0038] 5. During the thrombus removal process, the thrombus will not block the head of the thrombus remover; low cost and good economy;

[0039] 6. The spindle-shaped frame of the device is designed, and the frame is composed of elastic wire made of shape memory material, so that the head of the thrombus remover can easily pass through blood vessels of various shapes and sizes. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1A : Shows the front view of the thrombectomy device head according to Scheme 1 of the present disclosure.

[0041] Figure 1B : Shows a right side view of the unfolded head of the thrombectomy device according to Scheme 1 of the present disclosure.

[0042] Figure 2 : Shows the front view of the expanded head of the thrombectomy device according to Scheme 2 of the present disclosure.

[0043] Figure 3 : Shows the front view of the expanded head of the thrombectomy device according to Scheme 3 of the present disclosure.

[0044] Figure 4 : Shows the front view of the expanded head of the thrombectomy device according to scheme 4 of the present disclosure.

[0045] Figure 5 : shows the complete structure of the thrombus remover device according to the present disclosure.

[0046] Figure 6 : shows the complete structure of the electrically controlled thrombectomy device according to the optimized solution disclosed in the present invention.

[0047] Figure 7 : Shows the complete structure of the manually controlled thrombectomy device according to the optimized solution of the present disclosure. DETAILED DESCRIPTION

[0048] In order to make the present invention more clearly understood, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0049] Many improved embodiments and other embodiments of the present invention described herein will be appreciated by those skilled in the art to which the present invention belongs. Therefore, it is to be understood that the present invention is not limited to the specific embodiments disclosed, and improved embodiments and other embodiments are also included within the scope of the appended claims.

[0050] The features, advantages, or similar language mentioned throughout this specification does not mean that all features and advantages that can be achieved by the present disclosure should be or fall into any single embodiment of the present disclosure. On the contrary, the language referring to features and advantages is understood to mean that the specific features, advantages, or distinguishing features described in conjunction with the embodiment are included in at least one embodiment of the present disclosure. Therefore, the discussion of features, advantages, or similar language throughout the specification can, but not necessarily, refer to the same embodiment.

[0051] In addition, the features, advantages and distinguishing features described in the present disclosure may be combined in any suitable manner into one or more embodiments. According to the description herein, those skilled in the relevant art will recognize that the present disclosure can be implemented in the absence of one or more specific features and advantages of a specific embodiment.

[0052] References throughout this specification to "one embodiment," "an embodiment," or similar language expressions mean that a particular feature, structure, or distinguishing feature described in conjunction with the indicated embodiment is included in at least one embodiment of the present disclosure. Thus, the phrases "in one embodiment," "in some embodiments," and similar language expressions throughout this specification may, but need not, all refer to the same embodiment.

[0053] The present invention relates to a coronary artery thrombus removal device and a thrombus removal method thereof. The thrombus removal device comprises a thrombus removal head, and the thrombus removal head component of the present invention is specially designed to be deployed in a complex coronary artery system so as to optimally treat coronary artery diseases, such as acute or chronic coronary artery embolism.

[0054] In some embodiments, the thrombus remover head includes an expandable frame, and the branches of the expandable frame are in a closed state at a first position and in an expanded state at a second position. From the first position to the second position, the frame expands radially away from the longitudinal axis. In this way, the present disclosure provides a thrombus remover device for mechanically opening an intravascular embolic passage. In some embodiments, the mechanical expansion of the frame can be repeated multiple times in the closed state and the expanded state.

[0055] The method disclosed herein can be used in coronary arteries of the heart. The expandable thrombus remover disclosed herein can be designed to work in straight or curved vascular systems. In some embodiments, the process of removing a thrombus can start with using an appropriate guide wire to pass the head of the thrombus remover of the present invention over the thrombus in a closed state, and expand until the thrombus is wrapped by the thrombus remover head, and then withdrawn into the catheter to remove the thrombus.

[0056] However, it is understood that the framework can be made of any suitable material understood by a person of ordinary skill in the art, and can include, for example, nickel-titanium alloys. The heat setting of the framework provides the ability for it to deform after being subjected to a force, and when the external force is removed, it can automatically restore its original shape. In some embodiments, the framework can be heat-set to a closed shape, in which the elastic wire remains flat against the longitudinal axis and is generally formed into a rod shape. As described above, such a heat-set framework can be deployed to an expanded state by applying a force to reduce the longitudinal length of the framework, and once this force is removed, the framework will return to the closed state. In other embodiments, the framework can be heat-set to an expanded shape, in which the elastic wire is bent and multiple elastic wires together form a spindle shape. As described above, such a heat-set framework can be contracted to a straightened state by applying a force to increase the longitudinal length of the framework, and once this force is removed, the framework will return to the expanded state.

[0057] The singular forms "a", "an" and "the" used herein include plural forms unless the context clearly indicates otherwise. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0058] As used herein, the terms "about" and "approximately" are used interchangeably and are meant to encompass variations of ±20%, ±10%, ±5%, ±1%, ±0.1%, etc. of the particular value.

[0059] The term "connectable" or "connect" as used herein means capable of being joined together. The term "connectable" may mean capable of being joined together temporarily or permanently.

[0060] As used herein, the terms verb "retrieve" and noun "retrieve" interchangeably refer to the removal of a thrombus from a coronary artery.

[0061] The term "Luer connector" as used herein refers to a connector that complies with the International Standards Organization (ISO).

[0062] As used herein, the term "patient" or "subject" refers to a member of any animal species, preferably a mammal, and most preferably a human. A subject can be an apparently healthy individual, a diseased individual, or an individual being treated for a disease.

[0063] The term "shape memory material" used herein may include shape memory alloys or shape memory polymers. The characteristic of these materials is that they allow the material to return to its original state from a temporarily deformed state after the force is removed. Exemplary shape memory alloys include, but are not limited to, nickel-titanium alloys.

[0064] As used herein, the terms verb "treat" and noun "treat" refer to the management and care of a patient who is ill or suffering from a condition by administering one or more of the treatments contemplated by the present disclosure. The verb treat also includes administering one or more of the methods of the present disclosure, or using any system, device, or composition of the present disclosure, in the treatment of a patient. As used herein, "treat" or "treatment" refers to both therapeutic treatment and preventive measures. The verb "treat" and noun "treat" do not require complete relief of symptoms, do not require a cure, and include treatment regimens that have little or incomplete effect on the patient.

[0065] Figure 1A , Figure 1B A scheme 1 of the thrombus remover head of the present disclosure is provided. Figure 1A , which is a front view of the thrombus remover head when it is unfolded. The thrombus remover head that can be unfolded includes a proximal rod 103, a distal rod 104, a cap 105, a proximal developing ring 106, and a distal developing ring 107. The proximal rod 103 and the distal rod 104 are composed of a hollow tube or rod, which has a wall with an inner surface and an outer surface, and a cavity extending from its proximal end 101 to the left end seam 108 of the elastic wire and defining a longitudinal axis. The distal rod 104 includes a hollow tube or rod that is exactly the same as the proximal rod 103 and extends from its symmetrical seam position to the distal end 102. The elastic wire 109 extends longitudinally from one end (such as the distal end) along a portion of the length of the rod to the other end (such as the proximal end), and the ends of these elastic wires are free and not connected to each other, and the shape of the elastic wire is symmetrical about the plane where the fixed point 110 is located.

[0066] Figure 1AA structure with a plurality of elastic wires 109 is shown. The ends of the elastic wires 109 can be permanently and evenly overlapped near the ends of the proximal rod 103 to prevent the free ends from moving, especially moving away from the longitudinal axis in the radial direction. The cap 105 is wrapped around the ends of the elastic wires 109 symmetrically. The elastic wires 109 are thereby fixed to the proximal rod 103 and the distal rod 104. Since the ends of the elastic wires 109 are fixed, the thrombus remover head can be expanded from a closed state to an expanded state by reducing its longitudinal length. When the longitudinal length of the thrombus remover head is reduced, the elastic wires 109 expand radially away from the longitudinal axis.

[0067] The fully assembled thrombectomy head is Figure 1A As shown in the figure, 6-12 elastic wires 109 and a capture protection net 111 constitute the main body of the thrombus remover head. By fixing the elastic wire 109, the two ends of the elastic wire 109 can be permanently connected to the proximal rod 103 and the distal rod 104. The cap 105 can be placed near the position of the proximal rod 103 and the distal rod 104 close to the elastic wire 109. As described above, once the thrombus remover head is released from the tube, the thrombus remover head is unfolded to an expanded state by reducing its longitudinal length. The structural shape of the elastic wire 109 determines the style of the thrombus remover head. The thrombus remover head expands radially away from the longitudinal axis when its longitudinal length is reduced. In this way, when the thrombus remover head is placed in a blood vessel containing a thrombus, the thrombus remover disclosed in the present invention can mechanically open a passage through the blocked blood vessel by expanding the diameter of the head.

[0068] The length and diameter of the thrombectomy head can be adjusted to provide the desired treatment effect for the intended target location. In some embodiments, the diameter of the thrombectomy head in the closed state can be between 0.6 mm and 1.0 mm, and the diameter in the expanded state can be between 2.0 mm and 5.0 mm. The length of the thrombectomy head in the closed state is between 20.0 mm and 30.0 mm, and the length of the thrombectomy head in the expanded state is between 15.0 mm and 25.0 mm.

[0069] The thrombectomy head may also include a capture protection net 111 surrounding the distal end of the elastic wire 109. The capture protection net 111 can be used as a safety net by preventing large embolic fragments from embolizing the distal end of the blood vessel. This may be particularly dangerous when the thrombectomy head is placed in the coronary vessels of the heart. A thin flexible polymer film will be attached to the outside of the elastic wire 109 to provide a covering mesh when the elastic wire 109 expands. Once expanded, the mesh forms a parachute-shaped capture device that can capture thrombus fragments that may drift downstream. The capture protection net 111 has holes 112 of uniform pore size and uniform arrangement. The size of the holes 112 is made to allow blood to flow through while still allowing the capture protection net 111 to wrap any thrombus fragments that may be generated during the thrombectomy process. The size of the hole is: 0.2mm-0.4mm range. Once the thrombectomy is completed, the thrombectomy head can be retracted and removed from the patient's body, and any emboli will be captured in the capture protection net 111 and will be safely removed from the body. The capture protection mesh 111 can be made of any suitable material, including but not limited to several different polymers. The exact hardness and thickness of the mesh of the capture protection mesh 111, as well as the arrangement of the mesh's holes 112, can be optimized for a particular size of thrombus remover head and desired application. The capture protection mesh 111 can be made by any standard method known to those of ordinary skill in the art to fit the elastic wire 109, and then attached or can be directly fixed to the distal end of the thrombus remover head.

[0070] The capture protection net 111 starts at the midpoint of the head of the thrombus remover and ends at the proximal end of the distal rod. The capture protection net 111 at the midpoint of the head of the thrombus remover is permanently and firmly fixed to the position of the fixing point 110 with the elastic wire 109 by means of gluing or welding. The number of fixing points 110 is the same as the number of elastic wires 109, and the fixing points are evenly arranged at the outer ends of the elastic wires 109 in a manner of surrounding the central axis where the axes of the proximal rod and the distal rod are located. The capture protection net 111 is closed at the distal end and is permanently fixed to the proximal position of the distal rod 104 by means of gluing or welding, and a cap 105 is provided on the outside to permanently wrap and fix it. The diameter of the cap 105 on the distal rod 104 is slightly larger than the size of the cap 105 on the proximal rod 103, so that the closing of the end of the capture protection net 111 can be well placed between the cap 105 and the distal rod 104. The net at the end of the capture protection net 111 is placed outside the multiple elastic wires 109 evenly arranged outside the distal rod. Figure 1A The leftmost position of the middle elastic wire 109 is a schematic diagram showing the overlap with the proximal rod 103. In fact, there is a cap 105 ( Figure 1A The PCB is wrapped with a plastic bag (not shown) to fix its position and prevent it from moving.

[0071] A distal developing ring 107 is provided at the proximal end of the distal rod 104; a proximal developing ring 106 is provided at the proximal rod 103 near the cap 105, so as to facilitate development under X-rays, thereby being able to well determine the position range of the thrombus remover head, and then effectively remove the thrombus. The developing ring provided in the present disclosure can be formed by coating a developing substance.

[0072] The elastic wire 109 is made of a shape memory material, for example, a nickel-titanium alloy. The elastic wire 109 is heat set in a fully expanded state, and the elastic wire 109 can be brought back to a closed state by applying a force to stretch the longitudinal length of the framework. Once the force is removed, the longitudinal length will be shortened and the elastic wire 109 will return to the original expanded state. A catheter cover can be arranged on the heat set expanded deployable thrombus remover head to maintain the closed position when the thrombus remover head is manipulated through the vascular system into place. The catheter cover can then be removed at the thrombus site to allow expansion, and then the catheter cover can be re-covered after enveloping the thrombus to maintain the closed state for removal.

[0073] The process and principle of thrombus removal in Scheme 1 are as follows: The thrombus remover head is in a catheter of appropriate size, and the thrombus remover head is in a closed state. The catheter with the thrombus remover head is inserted into the coronary artery to the proximal end of the thrombus blocking the blood vessel. At this time, the thrombus remover head will be accurately positioned under the action of the distal imaging ring 107, and then the closed thrombus remover head will pass over the thrombus until the proximal imaging ring 106 of the thrombus remover head passes over the distal end of the thrombus. At this time, the catheter is withdrawn, and the thrombus remover head will expand from the closed state to Figure 1A Next, the thrombus remover head is withdrawn, and the capture protection net 111 will wrap the thrombus. The fine capture protection net 111 will prevent tiny thrombus fragments from escaping from the distal end of the thrombus remover head, thereby pulling the entire thrombus back toward the proximal end. Finally, the thrombus remover head and the thrombus are withdrawn into the catheter to achieve the overall removal of the thrombus.

[0074] Figure 2 A second embodiment of the thrombus remover head of the present disclosure is provided. Figure 2 , which is an expanded front view of the thrombus remover head. The expandable thrombus remover head includes a frame 200, a proximal rod 203, a distal rod 204, a proximal developing ring 205, and a distal developing ring 206. The proximal rod 203 and the distal rod 204 include a hollow tube or rod having a wall with an inner surface and an outer surface, and a cavity extending from its proximal end 201 to the frame 200 and from its distal end 202 to the frame 200, and defining a longitudinal axis. The frame 200 extends longitudinally from one end along the length of the rod, thereby providing a plurality of elastic wires 208, the ends of which are fixed and converge at the distal end of the proximal rod 203 and the proximal end of the distal rod 204.

[0075] Figure 2 The frame 200 with a plurality of elastic wires 208 is shown. The elastic wires 208 are formed by cutting the tube or rod of the thrombus remover head uniformly into 6-12 equal parts along the axial direction by laser cutting. Since the ends of the elastic wires 208 are fixed, the frame 200 of the thrombus remover head can be expanded from the closed state to the expanded state by reducing the longitudinal length of the frame 200. When the longitudinal length of the frame 200 is reduced, the elastic wires 208 of the frame 200 expand radially away from the longitudinal axis.

[0076] A plurality of elastic wires 208 form the main body of the framework 200. Once the thrombus remover head is released from the tube, the framework 200 can be deployed to an expanded state by reducing its longitudinal length. The structure of the framework 200 determines the style of the thrombus remover head. The framework 200 expands radially away from the longitudinal axis when its longitudinal length is reduced. In this way, when the thrombus remover head is placed in a blood vessel containing a thrombus, the thrombus remover of the present disclosure can mechanically open a passage through the blocked blood vessel through the branches of the framework 200.

[0077] The length and diameter of the thrombus remover head can be adjusted to provide an ideal treatment effect for the intended target location. In some embodiments, the diameter of the frame 200 in the closed state can be between 0.6 mm and 1.0 mm, and the diameter of the frame 200 in the expanded state can be between 2.0 mm and 5.0 mm. The length of the frame 200 in the closed state is between 20.0 mm and 30.0 mm, and the length of the frame 200 in the expanded state is between 15.0 mm and 25.0 mm.

[0078] The thrombectomy head 200 may also include a capture protection net 210 surrounding the distal end of the framework 200. The capture protection net 210 can be used as a safety net by preventing large embolic fragments from embolizing the distal part of the coronary artery. This may be particularly dangerous when the thrombectomy head is placed in the coronary vessels of the heart. A thin flexible polymer film will be attached to the outside of the framework 200 to provide a mesh when the framework 200 is expanded. Once expanded, the capture protection net 210 forms a parachute-shaped capture device that can capture thrombus fragments that may drift downstream. The capture protection net 210 has evenly arranged holes 211, and the size of the holes 211 is made to allow blood to flow through while still allowing the capture protection net 210 to capture any fragments that may be generated during the thrombectomy process. The size of the holes 211 is in the range of 0.2mm-0.4mm. Once the thrombectomy is completed, the framework 200 can be retracted and removed from the patient's body, and any emboli will be captured in the capture protection net 210 and will be safely removed from the body. The capture protection mesh 210 can be made of any suitable material, including but not limited to several different polymers. The exact hardness and thickness of the mesh of the capture protection mesh 210, as well as the arrangement of the mesh's holes 211, can be optimized for a particular size of thrombus remover head and desired application. The capture protection mesh 210 can be made by any standard method known to those of ordinary skill in the art to fit the frame and then attached or can be directly fixed to the distal end of the frame.

[0079] The capture protection net 210 starts at the midpoint of the frame 200 and ends at the proximal end of the distal rod 204. The capture protection net 210 at the midpoint of the frame 200 and the elastic wire 208 are permanently and firmly fixed at the fixed point 209 by gluing or welding. There are 6 to 12 fixed points 209, which are evenly arranged at the outer end of the elastic wire 208 in a manner of surrounding the central axis where the proximal rod and the distal rod axis are located. The capture protection net 210 is closed at the distal end and is permanently fixed to the proximal position of the distal rod 204 by gluing or welding.

[0080] A distal developing ring 206 is provided at the proximal end of the distal rod 204. A proximal developing ring 205 is provided at the proximal rod 203 near the elastic wire 208 to facilitate development under X-rays, so as to well judge the position range of the thrombus remover head and effectively remove the thrombus.

[0081] The frame 200, the distal rod 204 and the proximal rod 203 are formed from the same rod or tube, and the frame 200 and the proximal rod 203 intersect at the left seam 207, and the frame 200 and the distal rod 204 intersect at the right seam (not marked in the figure). The frame 200 is made of a shape memory material, for example, it can be made of a nickel-titanium alloy. The frame 200 is heat-set in a fully expanded state, and the frame 200 can be brought back to a closed state by applying a force to stretch the longitudinal length of the frame. Once the force is removed, the longitudinal length will be shortened and the frame 200 will return to the expanded state. A catheter cover can be arranged on the heat-set expanded and expandable frame 200 to maintain the closed position when the thrombus remover head is manipulated through the vascular system into place. The catheter cover can then be removed at the thrombus site to allow expansion, and then the cover can be re-covered after enveloping the thrombus to maintain the closed state for removal.

[0082] The process and principle of thrombus removal in Scheme 2 are as follows: the head of the thrombus remover is in a catheter of suitable size, and the frame 200 is in a closed state. The catheter with the head of the thrombus remover is sent along the coronary artery to the proximal end of the thrombus position blocking the blood vessel. At this time, the head of the thrombus remover will be accurately positioned under the action of the distal developing ring 206, and then the closed head of the thrombus remover will pass over the thrombus until the proximal developing ring 205 of the head of the thrombus remover passes over the distal end of the thrombus. At this time, the catheter is withdrawn, and the head of the thrombus remover will expand from the closed state to the expanded state. Next, the head of the thrombus remover is withdrawn, and the capture protection net 210 in the frame 200 will wrap the thrombus. The fine capture protection net 210 will prevent small thrombus fragments from detaching from the frame 200, thereby pulling the entire thrombus proximally and withdrawing it. Finally, the frame 200 and the thrombus are withdrawn into the catheter to achieve the overall removal of the thrombus.

[0083] Figure 3 A third embodiment of the thrombus remover head of the present disclosure is provided. Figure 3 , which is a front view of the thrombus remover head. The thrombus remover head that can be expanded includes a frame 300, a proximal rod 303, a distal rod 304, a proximal developing ring 305, and a distal developing ring 306. The proximal rod 303 includes a hollow tube or rod, which has a wall with an inner surface and an outer surface, and a cavity extending from its proximal end 301 to the frame 300 and defining a longitudinal axis. The distal rod 304 includes a hollow tube or rod that is completely identical to the proximal rod 303, which has a wall with an inner surface and an outer surface, and extends from its distal end 302 to the frame 300. The frame 300 extends longitudinally from one end along a portion of the length of the rod, thereby providing a plurality of elastic wires 308, the ends of which are fixed and converge at the distal end of the proximal rod 303 and the proximal end of the distal rod 304.

[0084] Figure 3A frame 300 with a plurality of elastic wires 308 is shown. The elastic wires are fed by the tool moving horizontally, the turntable fixing the tube or rod is rotated, and the head of the thrombus remover cuts the tube or rod by laser cutting, and the circumference of the tube or rod is divided into 6-12 equal parts at 360 degrees. The above laser cutting steps are repeated at each equal part, for a total of 6-12 times. Then, the main elastic wire 308 part of the frame 300 is formed. Since the ends of the elastic wires 308 are not cut and fixed, the frame 300 of the thrombus remover head can be expanded from the closed state to the expanded state by reducing the longitudinal length of the frame 300. When the longitudinal length of the frame 300 is reduced, the elastic wires 308 of the frame 300 expand radially and away from the longitudinal axis.

[0085] 6-12 elastic wires 308 are arranged in a spiral curve to form the main body of the frame 300. The two ends of the elastic wire 308 are permanently connected to the proximal rod 303 and the distal rod 304. As described above, once the thrombus remover head is released from the tube, the frame 300 can be deployed to an expanded state by reducing its longitudinal length. The structure of the frame 300 determines the structural style of the thrombus remover head. The frame 300 expands radially away from the longitudinal axis when its longitudinal length is reduced. In this way, when the thrombus remover head is placed in a blood vessel containing a thrombus, the thrombus remover of the present disclosure can mechanically open a passage through the blocked blood vessel through the branches of the frame 300.

[0086] The length and diameter of the thrombus remover head can be adjusted to provide the desired treatment effect for the intended target location. In some embodiments, the diameter of the frame 300 in the closed state can be between 0.6 mm and 1.0 mm, and the diameter of the frame 300 in the expanded state can be between 2.0 mm and 5.0 mm. The length of the frame 300 in the closed state is between 20.0 mm and 30.0 mm, and the length of the frame 300 in the expanded state is between 15.0 mm and 25.0 mm.

[0087] The thrombectomy head may also include a capture protection net 310 surrounding the distal end of the framework 300. The capture protection net 310 can be used as a safety net by preventing large embolic fragments from embolizing the distal end of the blood vessel. This may be particularly dangerous when the thrombectomy head is placed in the coronary vessels of the heart. A thin flexible polymer film will be attached to the outside of the elastic wire 308 to provide a mesh when the framework 300 is expanded. Once expanded, the capture protection net 310 forms a parachute-shaped capture device that can capture thrombus particles that may drift downstream. The capture protection net 310 has evenly arranged holes 311, and the size of the holes 311 is made to allow blood to flow through while still allowing the capture protection net 310 to capture any debris that may be generated during use. The size of the holes is: 0.2mm-0.4mm range. Once the thrombectomy is completed, the framework 300 can be retracted and removed from the patient's body, and any emboli will be captured in the capture protection net 310 and will be safely removed from the body. The capture protection mesh 310 can be made of any suitable material, including but not limited to several different polymers. The exact hardness and thickness of the mesh of the capture protection mesh 310, as well as the arrangement of the mesh's holes 311, can be optimized for a particular size of thrombus remover head and desired application. The capture protection mesh 310 can be made by any standard method known to those of ordinary skill in the art to fit the frame and then attached or can be directly fixed to the distal end of the frame.

[0088] The capture protection net 310 starts at the midpoint of the frame 300 and ends at the proximal end of the distal rod. The capture protection net 310 at the midpoint of the frame 300 and the elastic wire 308 are permanently and firmly fixed at the fixed point 309 by gluing or welding. There are 6 to 12 fixed points 309, which are evenly arranged at the outer ends of 6 to 12 elastic wires 308 in a manner of surrounding the central axis where the proximal rod and the distal rod axis are located. The capture protection net 310 is closed at the distal end and is permanently fixed to the proximal position of the distal rod 304 by gluing or welding.

[0089] A distal developing ring 306 is provided at the proximal end of the distal rod 304. A proximal developing ring 305 is provided at the proximal rod 303 near the elastic wire 308 to facilitate development under X-rays, so as to well judge the position range of the thrombus remover head and effectively remove the thrombus.

[0090] The frame 300 and the distal rod 304 and the proximal rod 303 are all made of shape memory material, for example, nickel titanium alloy. The frame 300 and the proximal rod 303 intersect at the left seam 307, and the frame 300 and the distal rod 304 intersect at the right seam (not marked in the figure). The frame 300 is heat set in a fully expanded state, and the frame 300 can be brought back to a closed state by applying a force to stretch the longitudinal length of the frame, and once the force is removed, the longitudinal length will be shortened and the frame 300 will return to the expanded state. A catheter can be arranged on the heat set expanded and expandable frame 300 as a cover to maintain the closed position while the thrombus remover head is manipulated through the vascular system into place. The cover can then be removed at the thrombus site to allow expansion, and then the cover can be re-covered after enveloping the thrombus to maintain the closed state for removal.

[0091] The process and principle of thrombus removal in Scheme 3 are as follows: the head of the thrombus remover is in a catheter of suitable size, and the frame 300 is in a closed state. The catheter with the head of the thrombus remover is sent along the coronary artery to the proximal end of the thrombus position blocking the blood vessel. At this time, the head of the thrombus remover will be accurately positioned under the action of the distal developing ring 306, and then the closed head of the thrombus remover will pass over the thrombus until the proximal developing ring 305 of the head of the thrombus remover passes over the distal end of the thrombus. At this time, the catheter is withdrawn, and the head of the thrombus remover will expand from the closed state to the expanded state. Next, the head of the thrombus remover is withdrawn, and the capture protection net in the frame 300 will wrap the thrombus, and the fine capture protection net 310 will prevent small thrombus fragments from falling to the distal end of the blood vessel, thereby pulling the entire thrombus to the proximal end and withdrawing it. Finally, the frame 300 and the thrombus are withdrawn into the catheter to achieve the overall removal of the thrombus.

[0092] Figure 4One of the embodiments with an internal rod 412 is shown. Based on the third solution, the thrombus remover head with a proximal rod 403 and a distal rod 404 includes a frame 400 as described above, and the frame 400 includes a plurality of elastic wires 408 arranged in the thrombus remover head. The thrombus remover head also includes an internal rod 412, which includes a wall with an inner surface and an outer surface, and a cavity extending between a distal end and a proximal end, and the internal rod 412 is coaxially arranged in the cavity of the frame of the thrombus remover head. The internal rod 412 can be permanently connected and fixed to the distal end of the frame 400 at its distal end, for example, by gluing or fusing the internal rod 412 to the distal end 402 of the elastic wire 408 of the frame 400, while the internal rod 412 is not fixed at the proximal end 401. The internal rod 412 is free to move in the longitudinal direction relative to the proximal end 401 of the thrombus remover head and is stationary relative to the distal end 402. The diameter of the lumen of the inner rod 412 can be made to match the size of commercially available tubes or rods. Therefore, the thrombus remover head of the present disclosure can be threaded on a guide wire through the lumen of the inner rod 412 to deploy the thrombus remover head in place within the blood vessel. The diameter of the lumen of the inner rod 412 is between 0.05 mm and 0.2 mm.

[0093] The frame 400 and the distal rod 404 and the proximal rod 403 are all made of shape memory material, for example, nickel titanium alloy. The frame 400 and the proximal rod 403 intersect at the left seam 407, and the frame 400 and the distal rod 404 intersect at the right seam (not marked in the figure). The frame 400 is heat set in a fully expanded state, and the frame 400 can be brought back to a closed state by applying a force to stretch the longitudinal length of the frame, and once the force is removed, the longitudinal length will be shortened and the frame 400 will return to the expanded state. A catheter can be arranged on the heat set expanded and expandable frame 400 as a cover to maintain the closed position while the thrombus remover head is manipulated through the vascular system into place. The cover can then be removed at the thrombus site to allow expansion, and then the cover can be re-covered after enveloping the thrombus to maintain the closed state for removal.

[0094] The thrombectomy head may also include a capture protection net 410 surrounding the distal end of the framework 400. The capture protection net 410 can be used as a safety net by preventing large embolic fragments from embolizing the distal end of the blood vessel. This may be particularly dangerous when the thrombectomy head is placed in the coronary vessels of the heart. A thin flexible polymer film will be attached to the outside of the elastic wire 408 to provide a mesh when the framework 400 is expanded. Once expanded, the capture protection net 410 forms a parachute-shaped capture device that can capture thrombus particles that may drift downstream. The capture protection net 410 has evenly arranged holes 411, and the size of the holes 411 is made to allow blood to flow through while still allowing the capture protection net 410 to capture any debris that may be generated during use. The size of the holes is: 0.2mm-0.4mm range. Once the thrombectomy is completed, the framework 400 can be retracted and removed from the patient's body, and any emboli will be captured in the capture protection net 410 and will be safely removed from the body. The capture protection mesh 410 can be made of any suitable material, including but not limited to several different polymers. The exact hardness and thickness of the mesh of the capture protection mesh 410, as well as the arrangement of the mesh's holes 411, can be optimized for a particular size of thrombus remover head and desired application. The capture protection mesh 410 can be made by any standard method known to those of ordinary skill in the art to fit the frame and then attached or can be directly fixed to the distal end of the frame.

[0095] The capture protection net 410 starts at the midpoint of the frame 400 and ends at the proximal end of the distal rod. The capture protection net 410 at the midpoint of the frame 400 is permanently and firmly fixed to the fixing point 409 with the elastic wire 408 by gluing or welding. There are 6 to 12 fixing points 409, which are evenly arranged at the outer ends of 6 to 12 elastic wires 408 in a manner of surrounding the central axis where the proximal rod and the distal rod axis are located. The capture protection net 410 is closed at the distal end and is permanently fixed to the proximal position of the distal rod 404 by gluing or welding.

[0096] A distal developing ring 406 is provided at the proximal end of the distal rod 404. A proximal developing ring 405 is provided at the proximal rod 403 near the elastic wire 408 to facilitate development under X-rays, so as to well judge the position range of the thrombus remover head and effectively remove the thrombus.

[0097] The process and principle of thrombus removal in Scheme 4 are as follows: In the first position (closed position), the elastic wire 408 of the frame 400 is flat against the inner rod 412 in a closed manner. In this state, the outer diameter of the frame 400 is not much different from the outer diameters of the inner rod 412 and the distal end rod 404. The frame 400 can be expanded to the second open position (open position), such as Figure 4As shown. From the first position (closed position) to the second position (open position), by moving the inner rod 412 in the proximal direction, the longitudinal length of the frame 400 is reduced and the elastic wire 408 of the frame 400 expands outward and away from the inner rod 412. Then, the inner rod 412 is moved, and the frame 400 can return to the first position. Therefore, the head of the thrombus remover disclosed in the present invention can be transported to the vicinity of the thrombus position and pass over the thrombus in the closed first position, and then expand to the open second position, capture the inside of the protective net 410 by contacting the thrombus, thereby mechanically removing the thrombus, and then return to the closed first position for removal. The frame 400 is initially in a closed state, and the frame 400 can be adjusted by the inner rod 412 to be in any position from fully open to closed, so as to better contact with the thrombus and facilitate the removal of the thrombus. The distal ends of the elastic wires 408 are permanently joined together to ensure that the frame 400 remains firm during the opening and closing process. The inner rod 412 is coaxially disposed within the inner cavity of the frame 400 .

[0098] While maintaining the internal rod 412 as a part of the thrombus remover head, a series of solutions can be derived, and all are within the scope of protection of the present disclosure. The specific solutions are as follows:

[0099] An internal rod is provided on the basis of Scheme 1, and the expansion and contraction degree of the head of the thrombectomy device is realized by the internal rod.

[0100] An internal rod is provided on the basis of Scheme 2, and the expansion and contraction degree of the thrombectomy device head is realized by the internal rod.

[0101] On the basis of Scheme 3, an internal rod is provided, and the expansion and contraction degree of the head of the thrombus remover is realized by the internal rod (ie, the above-mentioned Scheme 4).

[0102] In a series of schemes with internal rods, the elastic wires in schemes 1, 2, and 3 can also be heat-set into a closed state, in which the elastic wires remain flat against the longitudinal axis. As described above, the heat-set frame can be expanded to an expanded state and any state between the expanded and closed state by applying a force along the axial direction to reduce the longitudinal length of the frame. Similarly, the elastic wire can also be heat-set into any state from the closed state to the fully expanded state according to the situation, so as to be suitable for different thrombosis situations and different demand situations.

[0103] The various tubes and rods disclosed herein may be made of any suitable material known to those skilled in the art, including but not limited to 304 stainless steel, 316L stainless steel, shape memory alloys, or braided polymer fibers.

[0104] Scheme 1, Scheme 2, Scheme 3, and their corresponding derivative schemes of inserting an internal rod (eg, Scheme 4) are all applicable to thrombectomy at different locations in the coronary artery.

[0105] In some embodiments, after the thrombus remover head is introduced into the area of ​​interest, the thrombus remover head itself is deployed to a suitable position within the coronary artery, and the elastic wires of the framework expand outward to the straight area of ​​interest or the curved area of ​​interest, thereby capturing the thrombus against the inner wall of the vessel. Therefore, the device can immediately restore blood flow to the affected area. In certain embodiments, the thrombus remover head assembly can be deployed multiple times to capture the thrombus for removal.

[0106] Figure 5 The complete structure of the thrombus remover device according to the present disclosure is shown. The complete structure of the thrombus remover device is mainly composed of an operating component 501 and a thrombus remover head component 502, and the operating component 501 is a handle-type operating component. The thrombus remover head component can be any of the forms of the internal rod set in scheme 4 or schemes 1-3. At the same time, the elastic wire of the thrombus remover head can be heat-set into a closed state or heat-set into an expanded state in the above four schemes containing an internal rod, and any state between the two. The external part of the thrombus remover device includes an operating component 501. The operating component 501 includes a sliding member 505, a dial 506, and a slide groove 507. The sliding member 505 is connected to the proximal end of the internal rod 509. The sliding member 505 moves axially along the proximal rod 508 to enable the thrombus remover head component 502 to be in any state from closed to expanded. There are 8 scales evenly distributed on the dial 506, and the frame can be adjusted so that the diameter of the thrombus remover head is in the range of 0.6mm-5mm. This allows the sliding member 505 to be accurately located at a certain position when sliding along the longitudinal direction, and the degree of opening and closing of the thrombus remover head component 502 is determined by the positioning, and it is also convenient to adjust the opening and closing of the thrombus remover head component 502 according to the size of the thrombus.

[0107] The Luer connector 504 is inserted into the nearest end of the operating component 501 and is coaxially arranged with the proximal rod 508 and the internal rod 509. Before thrombus removal, the guide wire 503 can be inserted into the Luer connector 504 for positioning, and then the thrombus removal device determines the direction of the thrombus removal head component in the coronary artery under the guidance of the guide wire.

[0108] The components of the thrombus remover head component 502 have been described above and will not be described in detail here. The length of the proximal rod 508 is limited to a range of 1.3m-1.8m, preferably 1.5m.

[0109] Figure 6 and Figure 7Two optimization schemes of the thrombus remover device according to the present disclosure are shown. A pressure sensing control system is introduced in the scheme, and the pressure sensing control system is introduced to control the expansion and contraction degree of the thrombus remover head according to the pressure condition of the physiological position of the thrombus remover head, and the control mode can be divided into electric control and manual control.

[0110] For electric control solutions, such as Figure 6 As shown, the complete structure of the thrombus remover device is mainly composed of an operating component 601, a thrombus remover head component 602, a pressure sensor control system 613, a drive motor 617 and a transmission mechanism 618; in this optimized solution, the operating component is replaced by an electronic operator from the handle-type operating component in Solution 5. The pressure sensing control system 613 includes a sensor which is arranged on the head part 602 of the thrombus remover and can monitor the internal and external pressures of the head frame 600 of the thrombus remover, and a host computer control system 616. The host computer control system 616 includes a pressure identification module, a pressure display module and a control module. The host computer control system 616 is respectively connected to the pressure sensor, the drive motor 617 and the operating part 601 for communication. The pressure signal monitored by the pressure sensor is fed back to the pressure identification module, and the pressure signal identified by the pressure identification module is displayed via the pressure display module. The head part 602 of the thrombus remover can be any one of the forms in which the internal rod is arranged in schemes 1 to 4, which includes a frame 600 and an internal rod 609, and an external pressure sensor 614 and an internal pressure sensor 615 are respectively arranged on two elastic wires 621 and 626 on opposite sides of the frame 600. The operating part 601 is an electronic operator provided with operating buttons, and the operating buttons include an expansion button 623 and a contraction button 624. The inner rod 609 of the thrombus remover head component 602 is connected to the driving motor 617 via a transmission mechanism 618 .

[0111] The external pressure sensor 614 is installed on the outside of the elastic wire in the middle of the head of the thrombus remover, that is, on the side close to the inner surface of the blood vessel. In order to facilitate the fixing of the pressure sensor, the nickel-titanium alloy wire used to install the pressure sensor can be set to a thicker nickel-titanium alloy wire (for example, the diameter can be set to 0.15mm-0.40mm) and solid, which is convenient for fixing the pressure sensor. When the external pressure sensor 614 contacts the inner wall of the blood vessel, the pressure signal monitored by the external pressure sensor 614 is fed back to the host computer control system for pressure identification and display.

[0112] The internal pressure sensor 615 is installed on the inner side of the elastic wire in the middle of the head of the thrombus remover, that is, on the side away from the inner surface of the blood vessel. The purpose of such installation is that when the head of the thrombus remover wraps around the thrombus, the internal pressure sensor can sense the pressure between the nickel-titanium alloy wire frame of the head of the thrombus remover and the thrombus wrapping, thereby controlling the contraction diameter of the head of the thrombus remover. The pressure signal monitored by the internal pressure sensor 615 is fed back to the host computer control system for pressure identification and display.

[0113] The external pressure sensor 614 and the internal pressure sensor 615 are installed on different elastic threads, for example, they can be installed on two elastic threads on opposite sides.

[0114] Among them, the transmission mechanism 618 includes a first transmission mechanism and a second transmission mechanism, the first transmission mechanism is a gear transmission mechanism 619, and the second transmission mechanism is a gear slider mechanism 620; after the pressure identification module of the host computer control system 616 receives the signals from the internal pressure sensor 615 and the external pressure sensor 614, the control module will control the rotation of the motor according to the set program, and the drive motor 617 transmits its rotation to the gear transmission mechanism 619 through the motor shaft. The gear transmission mechanism 619 includes 4 meshing gears: a first gear 619a, a second gear 619b, a third gear 619c and a fourth gear 620a. The size of the gear gradually increases from the first gear 619a to the fourth gear 620a, the purpose is to convert the faster rotation of the motor into the slower rotation of the gear. The rotation of the gear is transmitted to the internal rod 609 of the thrombus remover head through the gear slider mechanism 620, so that the internal rod 609 of the thrombus remover head can be accurately controlled to move slowly and accurately.

[0115] The gear slider mechanism 620 specifically comprises a fourth gear 620a, a connecting rod 620b, a slider 620c and a base 620d, and its specific structure is as follows:

[0116] The fourth gear 620a, as the main transmission component, meshes with the third gear 619c and is connected to the slider 620c through the connecting rod 620b, transmitting the rotational motion of the fourth gear 620a to the slider 620c through the connecting rod 620b, so that the slider 620c performs linear reciprocating motion in a specific guide rail or slide groove.

[0117] The connecting rod 620b is an intermediate rod connecting the fourth gear 620a and the slider 620c. One end of the connecting rod is fixedly connected to the fourth gear and the other end is hinged to the slider. It can transmit the rotational motion of the fourth gear to the slider while ensuring the motion coordination between the two.

[0118] The slider 620c is a component that performs linear reciprocating motion in the guide rail or the slide groove. One end of the slider 620c is connected to the other end of the connecting rod 620b, and the reciprocating motion is achieved by the drive of the connecting rod. The other end of the slider 620c is fixedly connected to the internal rod 609 of the head of the thrombus remover.

[0119] Base 620d: A frame or structure used to support and fix components such as gears, connecting rods and sliders.

[0120] The host computer control system 616 includes a pressure identification module, a pressure display module and a control module. The pressure display module displays the pressure value and whether it has contacted the inner wall of the blood vessel and can also display whether it has contacted the thrombus.

[0121] The driving motor 617 is used to drive the head component 602 of the thrombus remover to expand or contract, and its characteristics are as follows:

[0122] The drive motor 617 rotates forward or reverse after receiving the instruction from the pressure sensing control system 613. When the head of the thrombus remover needs to be expanded, the drive motor rotates forward until it expands to a suitable size, and then the drive motor stops rotating forward. When the head of the thrombus remover needs to be contracted, the drive motor rotates reversely until it contracts to a suitable size, and then the drive motor stops reversing.

[0123] The driving motor 617 rotates at a relatively slow speed in order to reduce the expansion and contraction speed of the frame 600 to prevent the frame from hitting the inner wall of the blood vessel or a thrombus due to excessive expansion or contraction, thereby damaging the blood vessel or crushing the thrombus.

[0124] The driving motor 617 has a self-locking function after stopping rotation, and will not rotate under any external interference (such as when the doctor's hand accidentally touches the motor shaft).

[0125] In this electric control scheme, the working principle and process of the pressure sensor control system are as follows: when the head of the thrombectomy device is released from the catheter, the doctor needs to press the expansion button on the operating component 601. After receiving the expansion command, the host computer control system 616 controls the drive motor to rotate forward, and the head of the thrombectomy device expands under the rotation of the drive motor until the external pressure sensor senses that the nickel-titanium alloy wire in the middle of the head of the thrombectomy device contacts the inner wall of the blood vessel, and the motor stops rotating, and the head of the thrombectomy device stops expanding; then the doctor manually withdraws the head of the thrombectomy device, and under X-ray development, it is determined that the capture protection net of the head of the thrombectomy device has completely covered the thrombus. At this time, the doctor presses the contraction button on the operating component 601. After receiving the contraction command, the host computer control system 616 controls the drive motor to reverse, and the head of the thrombectomy device contracts under the rotation of the drive motor until the internal pressure sensor senses a certain pressure, and the drive motor stops rotating, and the head of the thrombectomy device stops contracting. Next, the doctor manually withdraws the head of the thrombectomy device, thereby completing the thrombectomy process.

[0126] In this solution, the operating component 601 can also be replaced by an operating module built into the host computer.

[0127] In this scheme, the expansion and contraction degree of the thrombectomy head is controlled by a pressure sensing control system, which has the following advantages:

[0128] 1) The external pressure sensor can accurately monitor the pressure between the outside of the thrombectomy head and the inner wall of the blood vessel, preventing the thrombectomy head from contacting the inner wall of the blood vessel during expansion and causing damage to the inner wall of the blood vessel due to excessive pressure.

[0129] 2) The internal pressure sensor can accurately monitor the pressure between the inner side of the thrombus retriever head and the thrombus, to prevent the thrombus from not being wrapped up due to insufficient contraction of the thrombus retriever head, and to prevent the thrombus from being crushed due to excessive contraction of the thrombus retriever head, causing the broken thrombus to flow into the distal end of the blood vessel.

[0130] 3) Since the operating component is provided with expansion and contraction buttons, the doctor can manually press the expansion and contraction buttons, making the operation precise, convenient and controllable.

[0131] 4) The setting of the pressure display module makes the pressure visible, and when the expansion and contraction of the thrombectomy head stop, the pressure status can be displayed on the display screen, which is convenient for doctors to operate.

[0132] For the manually controlled solution, the complete structure of the thrombus remover device is mainly composed of an operating component 701, a thrombus remover head component 702 and a pressure sensing control system 713; the operating component 701 in this solution is also a handle-type operating component, which is the same as the operating component 501 in Solution 5. The pressure sensing control system 713 includes an internal and external pressure sensor disposed on the head component 702 of the thrombus remover and capable of monitoring the pressure at the middle position of the frame 700, and a pressure identification and display device 712 disposed outside the human body. The pressure sensor and the pressure identification and display device are in communication connection, and the pressure signal monitored by the pressure sensor is fed back to the pressure identification and display device, and the pressure identification and display device identifies the pressure signal and displays the pressure state; the head component 702 of the thrombus remover can be any one of the forms of internal rods in schemes 1 to 4, and includes a frame 700 and an internal rod 709, and two elastic wires 716 and 717 on opposite sides of the frame 700 are respectively provided with an external pressure sensor 714 and an internal pressure sensor 715; the operating component 701 includes a sliding member 705, a dial 706, and a slide groove 707. The sliding member 705 is connected to the proximal end of the internal rod 709. The sliding member 705 moves axially along the proximal rod 708 to adjust the frame 700 from any state between a closed state and an expanded state.

[0133] The external pressure sensor 714 is installed on the outside of the elastic wire in the middle of the head of the thrombus remover, that is, on the side close to the inner surface of the blood vessel. In order to facilitate the fixing of the pressure sensor, the nickel-titanium alloy wire used to install the pressure sensor can be set to a thicker nickel-titanium alloy wire (for example, the diameter can be set to 0.15mm-0.40mm) and solid. When the external pressure sensor 714 contacts the inner wall of the blood vessel, the pressure signal monitored by the external pressure sensor 714 is fed back to the pressure identification and display device 712 for pressure identification and display.

[0134] The internal pressure sensor 715 is installed on the inner side of the elastic wire in the middle of the thrombus remover head, that is, on the side away from the inner surface of the blood vessel. The purpose of such installation is that when the thrombus remover head wraps around the thrombus, the internal pressure sensor can sense the pressure of the nickel-titanium alloy wire frame of the thrombus remover head and the thrombus wrapping, thereby controlling the contraction diameter of the thrombus remover head. The pressure signal monitored by the internal pressure sensor 715 is fed back to the pressure identification and display device 712 for pressure identification and display.

[0135] The external pressure sensor 714 and the internal pressure sensor 715 are installed on different elastic threads, for example, they can be installed on two elastic threads on opposite sides.

[0136] The pressure sensor in the present disclosure is a micro pressure sensor, which can generally be a pressure sensing element made of pressure sensing fiber.

[0137] In the manual control scheme, the working principle and process of the pressure sensing control system are as follows: when the head of the thrombectomy device is initially released from the catheter, the pressure identification and display module will display that the head of the thrombectomy device is not in contact with the inner wall of the blood vessel. The doctor needs to manually push the sliding member 705 on the operating component 701, so that the head of the thrombectomy device is expanded under manual operation and its expansion size is indicated by the dial 706, until the external pressure sensor senses that the nickel-titanium alloy wire in the middle of the head of the thrombectomy device is in contact with the inner wall of the blood vessel, and the display screen will display that it has been in contact with the inner wall of the blood vessel. Next, the doctor manually withdraws the head of the thrombectomy device and the head of the thrombectomy device shrinks until the head of the thrombectomy device wraps the thrombus. At the beginning of the withdrawal, the pressure identification and display module will display that the head of the thrombectomy device is not tightly wrapped with the thrombus. At this time, the doctor needs to manually push the sliding member 705 in the operating component 701 until the internal pressure sensor senses a certain pressure, and the pressure identification and display module shows that the head of the thrombectomy device has tightly wrapped the thrombus, and the doctor will stop pushing the sliding member 705. Next, the doctor manually withdraws the head of the thrombectomy device, thereby completing the thrombectomy process.

[0138] This manual control method has the following advantages:

[0139] 1) The external pressure sensor can accurately monitor the pressure state between the outermost end of the thrombectomy head and the inner wall of the blood vessel, preventing the thrombectomy head from contacting the inner wall of the blood vessel during expansion and causing damage to the inner wall of the blood vessel due to excessive pressure.

[0140] 2) The internal pressure sensor can accurately monitor the pressure status between the inner side of the thrombus retriever head and the thrombus, to prevent the thrombus from not being wrapped up due to insufficient contraction of the thrombus retriever head, and to prevent the thrombus from being crushed too tightly due to the thrombus being large and causing the broken thrombus to flow into the distal end of the blood vessel.

[0141] 3) Due to the external pressure identification and display device, the pressure can be visualized, and the pressure state of the thrombectomy device head during the expansion and contraction process can be displayed on the display screen, which is convenient for doctors to operate.

[0142] 4) The doctor can manually push the sliding member 705 on the operating component 701 according to the displayed pressure status, and if the appropriate pressure is reached, the display screen will show it, so that the doctor can stop manually pushing the sliding member 705 on the operating component 701 in time.

[0143] For the thrombectomy device schemes in Scheme 1 to Scheme 4 and their derivative schemes, as well as a thrombectomy device scheme (manual control scheme) in the optimized scheme of the present invention, a negative pressure suction device with adjustable negative pressure can be adapted at the nearest end of the operating component 501 or 701, that is, the left opening of the Luer connector 504 or the left opening of the Luer connector 703, to cooperate with the thrombectomy head to remove the thrombus, so as to achieve a dual effect of thrombectomy, thereby making the thrombectomy more thorough.

[0144] The suction process and principle after adding the negative pressure suction device with adjustable negative pressure are as follows: after the thrombus remover reaches the location of the thrombus under the accurate positioning of the guide wire 503 or 704, the guide wire is withdrawn from the body. After the head of the thrombus remover expands to the appropriate position and the capture protection net has wrapped the thrombus, the negative pressure suction device with adjustable negative pressure is connected to the left opening of the Luer connector 504 or the left opening of the Luer connector 703, and the switch of the negative pressure suction device with adjustable negative pressure is turned on and the negative pressure is adjusted to a suitable value. At this time, the negative pressure value can not only suck the thrombus to the proximal end but also does not damage the inner wall of the blood vessel. Next, the thrombus is continuously or intermittently sucked with negative pressure while the head of the thrombus remover is withdrawn. Until the thrombus is completely removed from the blocked position and stored in the distal catheter.

[0145] The beneficial effects of increasing the negative pressure adjustable negative pressure suction device are:

[0146] 1. Since the suction device has a certain suction force, it can prevent the occasional tiny thrombus particles from not being wrapped by the capture protection net of the thrombus remover head when the head of the thrombus remover contacts the thrombus for the first time, and flowing to the distal end of the blood vessel, causing distal blockage;

[0147] 2. It can aspirate and remove blood clots on the inner wall of the blood vessel that are difficult to be removed by the head of the thrombus remover;

[0148] 3. Avoid small thrombi from scattering and drifting to the distal end of the blood vessel during the withdrawal of the thrombectomy head of the single thrombectomy device.

[0149] The above-mentioned implementation cases are only preferred implementation cases of the present invention and are not any formal and substantial limitations of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A coronary artery thrombectomy device, characterized in that: The thrombus remover comprises an expandable thrombus remover head and an operating component for operating the thrombus remover head to expand or contract and adjust the expansion or contraction size thereof, the thrombus remover head comprises a coaxially arranged proximal rod and a distal rod, and an expandable frame composed of a plurality of elastic wires, and a capture protection net wrapped around the distal end of the elastic wires, the elastic wires are connected between the proximal rod and the distal rod; the proximal rod and the distal rod are respectively provided with a proximal developing ring and a distal developing ring; the elastic wires are made of a shape memory material; The proximal and distal rods are comprised of a hollow tube or rod having a wall with an inner surface and an outer surface, and a lumen extending from a proximal end to a distal end thereof and defining a longitudinal axis; The elastic wire extends longitudinally from one end to the other end along a portion of the length of the rod, and the ends of the elastic wire are not connected to each other; the frame has an expanded state and a contracted state. In the expanded state, the frame is a spindle-shaped structure with small ends and a large middle, and its shape is symmetrical about the cross section where the midpoint of the frame is located; when the longitudinal length of the frame is reduced, the frame expands radially away from the longitudinal axis, so that the frame expands from the contracted state to the expanded state; The capture protection net surrounds the distal end of the elastic wire, starts at the midpoint of the framework, and ends at the proximal end of the distal rod.

2. The coronary artery thrombectomy device according to claim 1, characterized in that: The number of the elastic threads is 6 to 12, and the elastic threads are evenly distributed along the central axis of the tube or rod and arranged in straight lines that do not cross each other.

3. The coronary artery thrombectomy device according to claim 1, characterized in that: The elastic wires are arranged in a spiral curve along the central axis direction of the tube or rod of the head of the thrombus remover.

4. The coronary artery thrombectomy device according to any one of claims 1 to 3, characterized in that: It also includes an internal rod, which includes a wall with an inner surface and an outer surface, and a cavity extending between its distal end and proximal end, and the internal rod is coaxially arranged in the cavity of the frame of the thrombus remover head; one end of the internal rod is fixedly connected to the distal end of the frame, and the other end is arranged at the proximal end of the frame but not fixedly connected thereto, so that the internal rod can move freely in the longitudinal direction relative to the proximal end of the thrombus remover head and remain stationary relative to the distal end.

5. The thrombus removal device according to claim 4, characterized in that: The operating component includes a sliding operating part with a dial, which is connected to the proximal end of the inner rod and is configured to drive the thrombus remover head from any state of closing to expansion when moving axially along the proximal rod.

6. The thrombus removal device according to claim 5, characterized in that: The sliding operation part is provided with a sliding member and a sliding groove, wherein the sliding member is installed in the sliding groove and can slide horizontally in the sliding groove; the scale plate is provided with 8 evenly distributed scales for indicating the relative position of the sliding member, so that the sliding member can accurately locate its position when sliding along the longitudinal direction, and then determine the degree of opening and closing of the head component of the thrombus remover through the positioning, so that the diameter of the head of the thrombus remover is in the range of 0.6mm-5mm. It is also convenient to adjust the degree of opening and closing of the head component of the thrombus remover according to the size of the thrombus.

7. The thrombus removal device according to claim 4, characterized in that: An internal pressure sensor and an external pressure sensor are provided at the midpoint of the elastic wire on the frame, the internal pressure sensor is located on the inner side of the frame, and the external pressure sensor is located on the outer side of the frame; the number of the internal pressure sensor or the external pressure sensor is one or more, and they are fixedly installed on different elastic wires.

8. The thrombus removal device according to claim 7, characterized in that: It also includes a pressure identification and display device arranged outside the human body, and the pressure identification and display device is respectively communicated with the internal pressure sensor and the external pressure sensor, and the connection method is wireless connection; the operating component is provided with a sliding member, a dial and a slide groove, the sliding member is installed in the slide groove and can slide horizontally in the slide groove, and the dial is provided with 8 evenly distributed scales for indicating the relative position of the sliding member, so that the sliding member can accurately locate its position when sliding along the longitudinal direction, and then determine the degree of opening and closing of the head component of the thrombus remover through the positioning, so that the diameter of the head of the thrombus remover is in the range of 0.6mm-5mm.

9. The thrombus removal device according to claim 7, characterized in that: It also includes a host computer control system arranged outside the human body and a driving motor for driving the head component of the thrombus remover to expand or contract; the host computer control system includes a pressure identification module, a pressure display module and a control module for identifying pressure sensor signals, and the host computer control system is respectively connected to the operating component, the internal / external pressure sensor and the driving motor for communication; The inner rod of the head part of the thrombus remover is connected to the driving motor through a transmission mechanism; The operating component is an electronic operator provided with an expansion button and a contraction button; The host computer control system is configured to control the working state of the drive motor according to the pressure signal recognized by the pressure recognition module, or the host computer control system is configured to control the working state of the drive motor according to the input instruction of the operating component.

10. The thrombus removal device according to claim 9, characterized in that: The transmission mechanism includes a gear transmission mechanism and a gear slider mechanism; the gear transmission mechanism is used to convert the faster rotation of the motor into the slower rotation of the gear, and the gear transmission mechanism includes a meshing first gear, a second gear, a third gear and a fourth gear; the first gear is connected to the driving motor through a rotating shaft, and the diameters of the first gear, the second gear, the third gear and the fourth gear increase successively.

11. The thrombus removal device according to claim 10, characterized in that: The gear slider mechanism comprises a fourth gear, a connecting rod, a slider and a base, wherein: The fourth gear is the main transmission component, which meshes with the third gear and is connected to the slider through a connecting rod, and transmits the rotational motion of the gear to the slider through the connecting rod, so that the slider performs linear reciprocating motion in a specific guide rail or slide groove; The connecting rod is an intermediate rod connecting the fourth gear and the slider, one end of which is fixedly connected to the fourth gear and the other end is hinged to the slider; The slider is a component that performs linear reciprocating motion in the guide rail or the slide groove, one end of which is connected to the other end of the connecting rod, and the reciprocating motion is achieved by the driving of the connecting rod, and the other end of the slider is fixedly connected to the internal rod of the head of the thrombus remover; The base is used to support and fix the gear, the connecting rod and the sliding block.

12. The thrombus removal device according to claim 1, characterized in that: The diameter of the frame in the closed state is 0.6-1.0 mm, and the diameter in the expanded state is between 2.0-5.0 mm; the length of the frame in the closed state is 20.0-30.0 mm, and the length in the expanded state is 15.0-25.0 mm.

13. The method for using the thrombus removal device according to any one of claims 1 to 12, characterized in that: The following steps are involved: S1. Insert the catheter with the thrombus removal device head into the coronary artery to the proximal end of the thrombus blocking the blood vessel. At this time, the thrombus removal device head will be accurately positioned under the action of the distal imaging ring. Then, the closed thrombus removal device head is passed over the thrombus until the proximal imaging ring of the thrombus removal device head passes over the distal end of the thrombus. S2. Withdraw the catheter and the head of the thrombectomy device will expand from the closed state to the expanded state; S3. Next, the head of the thrombus remover is retracted, and the capture protection net in the frame will wrap the thrombus. The capture protection net will prevent small thrombus fragments from escaping from the frame, thereby pulling the entire thrombus back toward the proximal end. Finally, the frame and the thrombus are retracted into the catheter to achieve the overall removal of the thrombus.

14. The method according to claim 13, characterized in that The steps S2-S3 are to operate the internal rod to move axially through the sliding operation part on the operation component, thereby driving the head of the thrombus remover to expand or contract, and the expansion or contraction size is adjusted by the sliding operation part of the operation component and the indication of the dial.

15. The method according to claim 13, characterized in that The steps S1-S3 are performed under pressure monitoring, and the expansion or contraction size (degree) of the thrombus remover head is manually or electrically adjusted according to the pressure signal indication monitored by the pressure sensor.

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