Totally occluded vessel recanalization device and method

Abstract

Embodiments of the present application provide a full occlusion recanalization device and method, relating to the field of medical devices, aiming to improve the problem of high difficulty of blood vessel occlusion opening operation. The full occlusion recanalization device comprises a catheter group, a cutting blade, a fixed balloon and an operating handle; the cutting blade and the fixed balloon are fixed at the distal end of the catheter group, and the operating handle is used to drive the catheter group to reciprocally move the cutting blade to repeatedly cut the blood vessel occlusion tissue; the operating handle is provided with a stamping port, the stamping port is communicated with the fixed balloon through the catheter group, and the expanded fixed balloon is supported and fixed in the blood vessel, so that the cutting blade can always be located between the inner walls of the blood vessel during cutting. The full occlusion recanalization method is implemented by using the above device, the position of the cutting blade is adjusted by the fixed balloon and the operating handle, and the blood vessel of the full occlusion blood vessel can be safely opened in a fast and simple manner without the need for active driving such as electricity or laser.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and in particular, to a full occlusion recanalization device and method. BACKGROUND

[0002] Chronic total occlusion (CTO) refers to a 100% occlusion of an artery and an occlusion lasting more than 3 months, which has the characteristics of high recurrence rate and high reocclusion rate, and is difficult to treat. The average success rate of interventional treatment is about 40%-60%, which is the biggest problem currently faced by arterial interventional treatment. CTO can occur in any blood vessel tissue periphery, and is known as the "last fortress that has not been conquered".

[0003] For any treatment of CTO vascular lesions, including drug and interventional treatment, such as balloon dilation, stent implantation, etc., the blocked blood vessels need to be opened first, which is also the difficulty of CTO lesion treatment. Because the blood vessel is completely occluded when CTO occurs, blood flow cannot pass through, resulting in the inability to clearly determine the correct blood vessel running direction. The operator cannot know the direction of the blood vessel, just like tunneling from one place to another place, but the workers do not know the specific direction. In this case, if a puncture-resistant guide wire is blindly selected, it is easy to cause complications such as "blood vessel dissection, perforation", etc.

[0004] The current CTO interventional treatment methods include balloon dilation, electric rotary grinding and laser ablation, etc. Balloon dilation treatment requires a metal guide wire to pass through the blocked lesion first, and then the balloon is placed in the narrow place through the guide wire. The method of passing through the guide wire includes forward opening or reverse opening. The so-called forward opening is to determine the general running direction of the blood vessel through some image guidance, such as contralateral angiography, microchannel, calcification shadow, etc.; while the reverse opening refers to reaching the occlusion distal end through the collateral circulation provided by other blood vessels to the occluded blood vessels, and trying to deliver the guide wire through the occluded lesion in the opposite direction of the normal blood vessel running direction. This process is like tunneling, which can be directly dug from one side to the other side, or both sides can be dug at the same time until the opening is completed.

[0005] The success rate of balloon dilation surgery depends on the experience and technology of the surgery. For the selection of the access, the selection of the guide wire with different hardness, and the direction of the head end of the guide wire, etc., the operator needs to "judge the situation and act accordingly", when to choose what kind of instrument, and when to adjust the direction of puncture, are very important. For example, for the head end of the CTO lesion, it is generally relatively hard, and a guide wire with high hardness is needed, but once the hard part of the head end is broken through, the hardness of the guide wire needs to be reduced to reduce the possibility of complications. In addition, during the process of opening the blood vessel, the direction of the head end of the guide wire needs to be observed through different body positions, so as to timely adjust the angle and path of puncture, which requires the operator to have a fast 3D thinking, etc.

[0006] Electric rotary grinding, rotary grinding head is installed at the distal end of the catheter, and the rotary grinding head is driven by the electric device at the proximal end to grind the narrow tissue. The high-speed rotary grinding head in the blood vessel is not easy to control, and is easy to cause complications such as blood vessel rupture; the depth and progress of the rotary grinding cannot be accurately controlled, which also increases the risk of operation.

[0007] Laser ablation, the calcified blocked tissue is ablated by laser, and the laser parameters and the vaporized tissue are difficult to control, and the clinical use is not convenient.

[0008] When the blood vessel is opened and a reliable track is established, different implantation strategies need to be selected according to the actual situation, and the current implantation strategies after CTO opening are often: 1) immediate drug-eluting stent implantation; 2) drug-coated balloon; 3) leaving the lesion and then performing secondary PCI; 4) hybrid use of drug-eluting stent and drug-coated balloon. SUMMARY

[0009] The purposes of the present application include, for example, providing a full occlusion blood vessel recanalization device which can improve the problem of high difficulty of blood vessel occlusion opening operation.

[0010] The purposes of the present application also include providing a full occlusion blood vessel recanalization method which can improve the problem of high difficulty of blood vessel occlusion opening operation.

[0011] The embodiments of the present application can be implemented as follows:

[0012] The embodiments of the present application provide a full occlusion blood vessel recanalization device, which comprises a catheter group, a cutting blade, a fixed balloon and an operation handle; the cutting blade and the fixed balloon are fixed at the distal end of the catheter group, the operation handle is connected with the proximal end of the catheter group, and the operation handle is used to drive the catheter group to reciprocally move the cutting blade to repeatedly cut the blood vessel occlusion tissue; the operation handle is provided with a stamping port, the stamping port is communicated with the fixed balloon through the catheter group, and the stamping port is used to inflate the inflation medium into the fixed balloon, so that the inflated fixed balloon is supported and fixed in the blood vessel, so that the cutting blade is always located between the inner walls of the blood vessel.

[0013] In addition, the full occlusion blood vessel recanalization device provided by the embodiments of the present application can also have the following additional technical features:

[0014] Optionally, the catheter set comprises an outer tube and an inner tube, the outer tube is provided with a center lumen and a balloon lumen, the inner tube is movably arranged in the center lumen; the cutting blade is fixed at the distal end of the inner tube; the fixed balloon is fixed at the distal end of the outer tube, and the fixed balloon is in communication with the distal end of the balloon lumen; the operating handle is connected with the proximal end of the inner tube and the outer tube, and the punch port is in communication with the balloon lumen; the operating handle is used to repeatedly drive the relative movement of the inner tube and the outer tube, so that the distal end of the inner tube is repeatedly extended relative to the distal end of the outer tube, thereby driving the cutting blade to repeatedly cut the blood vessel occlusion tissue.

[0015] Optionally, the inner wall of the inner tube surrounds an inner lumen, the cutting blade is provided with a blade channel in communication with the inner lumen of the inner tube, and the blade channel and the inner lumen are used together to pass a guide wire or to suck the blood vessel occlusion tissue fragments cut by the cutting blade; the operating handle is provided with a suction guide wire port in communication with the inner lumen.

[0016] Optionally, the cutting blade comprises at least two blades spaced around the center of the blade channel and capable of being closed or opened, the at least two blades are used to be in a closed state when accommodated in the center lumen, or the at least two blades are used to be released to be in an open state when extended out of the center lumen.

[0017] Optionally, the distal end of the cutting blade is cylindrical or sharp-angled.

[0018] Optionally, the outer tube comprises a first catheter and a second catheter, the first catheter is sleeved outside the inner tube, and the second catheter is sleeved outside the first catheter; the inner wall of the first catheter surrounds the center lumen, and the balloon lumen is formed between the outer wall of the first catheter and the inner wall of the second catheter.

[0019] Optionally, the inner wall of the outer tube surrounds the center lumen, and the balloon lumen is formed between the inner wall and the outer wall of the outer tube.

[0020] Optionally, a gap is arranged between the outer wall of the inner tube and the center lumen, the gap forms a suction lumen for sucking the blood vessel occlusion tissue fragments cut by the cutting blade; the operating handle is provided with a suction port in communication with the suction lumen.

[0021] Optionally, the operation handle comprises a handle housing, a handle push rod and a spring; the spring is arranged in the handle housing, the handle push rod is slidably arranged at a distal end of the handle housing, and the handle push rod is in abutment with the spring; a proximal end of the outer tube is fixed to the handle housing, and a proximal end of the inner tube is fixed to the handle push rod; the handle push rod is used to move relative to the handle housing under the action of an external force, so as to push the distal end of the inner tube to extend relative to the distal end of the outer tube, or the handle push rod is used to reset under the action of the restoring force of the spring, so as to drive the distal end of the inner tube to retract relative to the distal end of the outer tube.

[0022] Optionally, the handle push rod is provided with a push block; the operation handle further comprises a pressing module, the pressing module is slidably arranged on the handle housing, and the pressing module has a push surface; the push surface is in sliding cooperation with the push block; the pressing module is used to push the push block and the handle push rod to move through the push surface under the action of an external pressing force, so as to make the distal end of the inner tube extend relative to the distal end of the outer tube, or the pressing module is used to reset under the action of the restoring force of the spring, so as to drive the distal end of the inner tube to retract relative to the distal end of the outer tube.

[0023] Optionally, the operation handle further comprises a stress release tube; the stress release tube is sleeved on the outside of the outer tube, and the stress release tube is rotationally connected to the distal end of the handle housing; the stress release tube is used to make the proximal end of the balloon lumen communicate with the outside during rotation relative to the handle housing, so as to make the fixed balloon release pressure.

[0024] Embodiments of the present application also provide a full-occlusion blood vessel recanalization method, which is implemented by using the full-occlusion blood vessel recanalization device, and the full-occlusion blood vessel recanalization method further comprises:

[0025] The fixed balloon is expanded and supported at a first position in front of the blood vessel occlusion tissue by using the operation handle, so that the cutting blade is always located between the inner walls of the blood vessel;

[0026] The cutting blade is repeatedly cut on the blood vessel occlusion tissue by using the operation handle until the cutting at the first position is completed, the fixed balloon is expanded and released pressure by using the operation handle, and then the next position is moved to;

[0027] The above steps are repeated until the blood vessel occlusion tissue is opened.

[0028] The full-occlusion blood vessel recanalization device and method of the embodiments of the present application have the following beneficial effects, for example:

[0029] The full occlusion blood vessel recanalization device comprises a catheter group, a cutting blade, a fixed balloon and an operating handle; the cutting blade and the fixed balloon are fixed at the distal end of the catheter group, the operating handle is connected with the proximal end of the catheter group, and the operating handle is used for driving the catheter group to reciprocally move the cutting blade to repeatedly cut the blood vessel occlusion tissue; the operating handle is provided with a stamping port, the stamping port is communicated with the fixed balloon through the catheter group, and the stamping port is used for blowing inflation medium into the fixed balloon, so that the inflated fixed balloon is supported and fixed in the blood vessel, so that the cutting path of the cutting blade is always located between the inner walls of the blood vessel during the cutting process of the cutting blade.

[0030] By fixing, positioning and adjusting the position of the cutting blade by the fixed balloon, the blood vessel perforation or dissection of the cutting blade during the cutting process is avoided, thereby reducing the operation difficulty. The overall structure is simple to operate, and the blood vessel blockage can be safely and effectively unblocked.

[0031] The full occlusion blood vessel recanalization method is implemented by using the full occlusion blood vessel recanalization device, and can improve the high operation difficulty of the blood vessel occlusion opening operation. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0033] Figure 1 The first structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application is shown in the axial view of the shaft.

[0034] Figure 2 The first structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application is shown in the axial view of the shaft.

[0035] Figure 3 The first structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application is shown in the axial view of the shaft.

[0036] Figure 4 The first structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application is shown in the axial view of the shaft.

[0037] Figure 5 The first structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application is shown in the axial view of the shaft. Figure 4 The sectional view of A-A in the middle.

[0038] Figure 6 The first structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application is shown in the axial view of the shaft.

[0039] Figure 7 is Figure 6 a sectional view of B-B in FIG. 1;

[0040] Figure 8 a structure diagram of a first structure of a full occlusion blood vessel recanalization device provided by an embodiment of the present application, in which a cutting blade is not extended;

[0041] Figure 9 a shaft side view of a second structure of a full occlusion blood vessel recanalization device provided by an embodiment of the present application;

[0042] Figure 10 a partial structure diagram of the second structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application;

[0043] Figure 11 a top view of the second structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application;

[0044] Figure 12 is Figure 11 a sectional view of C-C in FIG. 2;

[0045] Figure 13 a structure diagram of a second structure of a full occlusion blood vessel recanalization device provided by an embodiment of the present application, in which a cutting blade is extended;

[0046] Figure 14 a structure diagram of the second structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application, in which the cutting blade is not extended;

[0047] Figure 15 a shaft side view of a third structure of a full occlusion blood vessel recanalization device provided by an embodiment of the present application;

[0048] Figure 16 a partial structure diagram of the third structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application;

[0049] Figure 17 a top view of the third structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application, in a first perspective;

[0050] Figure 18 is Figure 17 a sectional view of D-D in FIG. 3;

[0051] Figure 19 a top view of the third structure of the full occlusion blood vessel recanalization device provided by the embodiment of the present application, in a second perspective;

[0052] Figure 20 is Figure 19 a sectional view of E-E in FIG. 4;

[0053] Figure 21 This is a partial structural diagram of the protruding cutting blade in the third structure of the fully occluded blood vessel recanalization device provided in an embodiment of the present invention;

[0054] Figure 22 This is a schematic diagram of the vascular occlusion recanalization device provided in an embodiment of the present invention cutting vascular occlusion tissue.

[0055] Icons: 10 - Completely occluded vessel recanalization device; 100 - Catheter assembly; 110 - Outer tube; 111 - Second catheter; 112 - Balloon channel; 113 - First catheter; 114 - Central channel; 115 - Aspiration channel; 120 - Inner tube; 121 - Inner channel; 200 - Cutting blade; 210 - Blade; 300 - Fixing balloon; 400 - Operating handle; 410 - Handle housing; 411 - Three-way valve housing; 412 - Punch port; 420 - Distal housing; 421 - Aspiration port; 4 30 - Proximal outer shell; 440 - First outer shell; 450 - Second outer shell; 500 - Handle push rod; 510 - Front push rod; 511 - Push block; 520 - Rear push rod; 521 - Suction guide wire port; 600 - Spring; 700 - Pressing module; 710 - Pushing surface; 800 - Stress relief tube; 900 - Connecting buckle; 910 - Front nut; 920 - Rear nut; 930 - Stainless steel tube; 940 - O-ring chuck; 950 - O-ring; 11 - Vascular occlusion tissue; 12 - Blood vessel. Detailed Implementation

[0056] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0057] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0058] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0059] In the description of the present application, it should be noted that if the terms "upper", "lower", "inner", "outer" and the like indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the product of the present application is usually placed, which is only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0060] In addition, if the terms "first", "second" and the like appear, they are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0061] It should be noted that the features in the embodiments of the present application can be combined with each other without conflict.

[0062] The following will be described in combination with Figures 1 to 22 The full occlusion blood vessel recanalization device 10 provided in the present embodiment will be described in detail.

[0063] Please refer to Figure 1 and Figure 2 , in combination Figure 22 The embodiments of the present application provide a full occlusion blood vessel recanalization device 10, which comprises a catheter group 100, a cutting blade 200, a fixed balloon 300 and an operating handle 400; the cutting blade 200 and the fixed balloon 300 are fixed at the distal end of the catheter group 100, the operating handle 400 is connected with the proximal end of the catheter group 100, and the operating handle 400 is used to drive the catheter group 100 to reciprocally move the cutting blade 200, so as to repeatedly cut the blood vessel occlusion tissue 11; the operating handle 400 is provided with a punch port 412, the punch port 412 communicates with the fixed balloon 300 through the catheter group 100, and the punch port 412 is used to inflate the inflation medium into the fixed balloon 300, so that the inflated fixed balloon 300 is supported and fixed in the blood vessel 12, so that the cutting blade 200 is always located between the inner walls of the blood vessel 12. That is, the cutting blade 200 can always keep approximately parallel with the inner walls of the blood vessel 12 during the cutting process, and will not perforate.

[0064] It should be noted that throughout the full text, during use, the front end of the catheter group 100 is used to extend into the blood vessel 12, and the rear end of the catheter group 100 is operated by the doctor. Therefore, relatively, the part of each component close to the front end of the catheter group 100 is called the distal end of the component, and the part of the component close to the rear end of the catheter group 100 is called the proximal end of the component. Among them, the front end of the catheter group 100 is the distal end of the catheter group 100, and the rear end of the catheter group 100 is the proximal end of the catheter group 100. For example, Figure 1The relative positions in the drawings are introduced as follows: the left end of the catheter group 100 is the distal end of the catheter group 100, the right end of the catheter group 100 is the proximal end of the catheter group 100, and the left end of the operating handle 400 is the distal end of the operating handle 400, and the right end of the operating handle 400 is the proximal end of the operating handle 400. The cutting blade 200, the fixed balloon 300, the catheter group 100 and the operating handle 400 are sequentially arranged from left to right.

[0065] The cutting blade 200, the catheter group 100 and the operating handle 400 are sequentially connected, the distal end of the catheter group 100 and the cutting blade 200 are used to extend into the front of the blood vessel occlusion tissue 11 in the blood vessel 12, the operating handle 400 drives the cutting blade 200 to reciprocatingly extend and retract through the catheter group 100, and the cutting blade 200 cuts the blood vessel occlusion tissue 11. Gradually move the position of the cutting blade 200 to gradually open the blood vessel occlusion tissue 11.

[0066] The fixed balloon 300, the catheter group 100 and the stamping port 412 on the operating handle 400 are sequentially communicated, the distal end of the catheter group 100 with the cutting blade 200 and the fixed balloon 300 extends into the front of the blood vessel occlusion tissue 11, and then inflates the fixed balloon 300 through the stamping port 412 and the catheter group 100, so that the fixed balloon 300 inflates and expands, and the expanded fixed balloon 300 can be supported and fixed on the inner wall of the blood vessel 12, so that the cutting blade 200 can be approximately parallel to the blood vessel segment in front of the cutting blade 200, to ensure that the cutting blade 200 does not deviate from the outer wall of the blood vessel 12 during cutting, to avoid penetrating the blood vessel 12 or damaging the blood vessel 12. By adjusting the position of the fixed balloon 300, the cutting blade 200 can be adjusted to always be located between the inner walls of the blood vessel 12. The fixed balloon 300 has the functions of fixing, positioning and straightening the cutting blade 200. On the other hand, after the fixed balloon 300 is inflated and expanded, the blood vessel 12 is blocked, and a closed space is formed between the blood vessel occlusion tissue 11 and the fixed balloon 300. The tissue fragments cut by the cutting blade 200 are left in the closed space, and then sucked and removed, so as to avoid the tissue fragments flowing to the distal end after the blood vessel occlusion tissue 11 is opened, causing secondary blockage of the distal blood vessel 12.

[0067] The operation process is as follows, combined with Figure 22 , the fixed position is fixed after the fixed balloon 300 is inflated, then the cutting blade 200 is operated by the operating handle 400 to cut the blood vessel occlusion tissue 11, after the blood vessel occlusion tissue 11 at this position is opened, the fixed balloon 300 is depressurized, then moved to the next position, and the fixed position is fixed after the fixed balloon 300 is inflated and expanded, and then cutting is performed. Repeat the above process until the blood vessel occlusion tissue 11 is completely opened.

[0068] Referring to Figure 4 , Figure 5 ,Figure 6 and Figure 7 In this embodiment, the catheter set 100 comprises an outer tube 110 and an inner tube 120, the outer tube 110 is provided with a center lumen 114 and a balloon lumen 112, and the inner tube 120 is movably arranged in the center lumen 114; the cutting blade 200 is fixed at the distal end of the inner tube 120; the fixed balloon 300 is fixed at the distal end of the outer tube 110, and the fixed balloon 300 is in communication with the distal end of the balloon lumen 112; the operating handle 400 is connected with the proximal end of the inner tube 120 and the outer tube 110, and the punch port 412 is in communication with the balloon lumen 112; the operating handle 400 is used to repeatedly drive the relative movement of the inner tube 120 and the outer tube 110, so that the distal end of the inner tube 120 is repeatedly extended relative to the distal end of the outer tube 110, thereby driving the cutting blade 200 to repeatedly cut the blood vessel occlusion tissue 11.

[0069] The cutting blade 200, the inner tube 120 and the operating handle 400 are connected in sequence, and the operating handle 400 drives the synchronous movement of the inner tube 120 and the cutting blade 200. In the initial state, the cutting blade 200 is located between the distal end of the inner tube 120 and the distal end of the outer tube 110, that is, at the distal end of the center lumen 114, and the operating handle 400 drives the distal end of the inner tube 120 to extend beyond the distal end of the outer tube 110, so that the cutting blade 200 is released to the outside of the outer tube 110 and cuts the blood vessel occlusion tissue 11. Figure 5 The relative position of the cutting blade 200 is introduced in the left end of the outer tube 110, and the operating handle 400 drives the cutting blade 200 to move to the left, so that the cutting blade 200 is exposed to the left end of the outer tube 110. Referring to Figure 5 , the cutting blade 200 extends beyond the distal end of the outer tube 110, and referring to Figure 8 , the cutting blade 200 is retracted into the intermediate lumen.

[0070] Referring to Figure 6 and Figure 7 In this embodiment, the inner wall of the inner tube 120 surrounds the inner lumen 121, the cutting blade 200 is provided with a blade passage in communication with the inner lumen 121 of the inner tube 120, and the blade passage and the inner lumen 121 are used together to pass the guide wire or to suck the blood vessel occlusion tissue 11 fragments cut by the cutting blade 200; the operating handle 400 is provided with a suction guide wire port 521 in communication with the inner lumen 121.

[0071] Referring to Figure 6 , the blade passage and the inner lumen 121 are coaxially arranged. After the cutting blade 200 cuts the blood vessel occlusion tissue 11, it is sucked to the outside through the blade passage and the inner lumen 121. After the fixed balloon 300 is pressurized and expanded to block the blood vessel 12, a sealed space is formed between the fixed balloon 300 and the blood vessel occlusion tissue 11, and the tissue fragments cut by the cutting blade 200 are left in the sealed space, and then sucked and removed through the blade passage and the inner lumen 121.

[0072] The suction guide wire port 521 is arranged on the operation handle 400 in correspondence, and the blade channel, the inner lumen 121, and the suction guide wire port 521 are sequentially communicated. The blade channel, the inner lumen 121, and the suction guide wire port 521 can pass the guide wire, guide the moving direction of the catheter set 100, and also can be used for suctioning the fragment tissue.

[0073] With reference to Figure 3 , Figure 6 and Figure 7 In the embodiment, the outer tube 110 includes a first catheter 113 and a second catheter 111. The first catheter 113 is sleeved outside the inner tube 120, and the second catheter 111 is sleeved outside the first catheter 113. The inner wall of the first catheter 113 forms a center lumen 114, and the outer wall of the first catheter 113 and the inner wall of the second catheter 111 form a balloon lumen 112.

[0074] Specifically, the inner tube 120, the first catheter 113, and the second catheter are sequentially sleeved from inside to outside. The first catheter 113 and the second catheter form a balloon channel. The distal end of the first catheter 113 and the distal end of the second catheter are sealingly arranged, the distal end of the balloon channel is sealingly arranged, and the proximal end of the balloon channel is in communication with the punching port 412 on the operation handle 400. The distal end of the second catheter 111 is provided with a communication hole in communication with the balloon channel, the fixing balloon 300 is wrapped around the distal end of the second catheter 111, and the fixing balloon 300 is wrapped outside the communication hole and is in communication with the communication hole. Specifically, the balloon lumen 112 formed between the outer wall of the first catheter 113 and the inner wall of the second catheter 111 is in the form of a ring.

[0075] In other embodiments, the inner wall of the outer tube 110 forms the center lumen 114, and the balloon lumen 112 is arranged between the inner wall and the outer wall of the outer tube 110. The outer wall of the outer tube 110 can also be protruded to form the balloon channel. Specifically, the balloon lumen 112 arranged between the inner wall and the outer wall of the outer tube 110 can be in the form of a ring arranged around the circumference of the outer tube 110, or can be arranged only in a part of the circumference of the outer tube 110.

[0076] With reference to Figure 6 and Figure 7 In the embodiment, a gap is arranged between the outer wall of the inner tube 120 and the center lumen 114, the gap forms a suction lumen 115, the suction lumen 115 is used for suctioning the vascular occlusion tissue 11 fragments cut by the cutting blade 200, and the operation handle 400 is provided with a suction port 421 in communication with the suction lumen 115.

[0077] In addition to the blade channel, the inner channel 121 and the suction guide wire port 521 mentioned above, a suction channel 115 can also be formed between the inner tube 120 and the outer tube 110, specifically, the suction channel 115 formed between the outer wall of the inner tube 120 and the inner wall of the first guide tube 113, the suction channel 115 is in communication with the suction port 421, and the fragment tissue can also be suctioned through the suction channel 115 and the suction port 421, which can improve the efficiency of tissue fragment suction and avoid the accumulation or blockage of the cutting blade 200, thereby improving the opening efficiency of the occluded tissue 11. The operation handle 400 is provided with the suction guide wire port 521 and the suction port 421, and has two ports for suctioning tissue fragments.

[0078] With reference to Figure 3 , Figure 4 and Figure 5 , in this embodiment, the operation handle 400 includes a handle housing 410, a handle push rod 500 and a spring 600; the spring 600 is arranged in the handle housing 410, the handle push rod 500 is slidably arranged at the distal end of the handle housing 410, and the handle push rod 500 is in abutment with the spring 600; the proximal end of the outer tube 110 is fixed with the handle housing 410, and the proximal end of the inner tube 120 is fixed with the handle push rod 500; the handle push rod 500 is used to move relative to the handle housing 410 under the action of an external force, so as to push the distal end of the inner tube 120 to extend relative to the distal end of the outer tube 110, or the handle push rod 500 is used to reset under the action of the restoring force of the spring 600, so as to drive the distal end of the inner tube 120 to retract relative to the distal end of the outer tube 110.

[0079] The spring 600 and the handle push rod 500 are sequentially arranged in the handle housing 410, the cutting blade 200, the inner tube 120 and the handle push rod 500 are sequentially connected, and the outer tube 110 is connected with the handle housing 410. With reference to Figure 5 , the handle push rod 500 is manually pushed to move left, the inner tube 120 and the cutting blade 200 are pushed to move left, the cutting blade 200 is extended left out of the outer tube 110, and the spring 600 is compressed. After the pushing force is removed, the spring 600 is reset by the restoring force, the handle push rod 500 is pushed right, the inner tube 120 and the cutting blade 200 are moved right, and the cutting blade 200 is retracted into the outer tube 110.

[0080] Specifically, with reference to Figure 5The handle housing 410 comprises a tee housing 411, a distal end housing 420 and a proximal end housing 430 arranged in sequence. The tee housing 411 is provided with a punching port 412. The tee housing 411 is fixed to the distal end of the distal end housing 420. One end of the distal end housing 420 is fixed to one end of the proximal end housing 430. The spring 600 is movably arranged in the distal end housing 420 and the proximal end housing 430. The handle push rod 500 is slidably arranged at the proximal end of the proximal end housing 430. The distal end of the handle push rod 500 extends into the proximal end housing 430 and abuts against the spring 600.

[0081] With reference to Figure 5 The handle push rod 500 comprises a front push rod 510 and a rear push rod 520 connected in sequence. The front push rod 510 is located in the distal end housing 420 and the proximal end housing 430 and abuts against the spring 600. The distal end of the rear push rod 520 extends into the proximal end housing 430 and is connected to the front push rod 510. The proximal end of the inner tube 120 is fixed to the rear push rod 520. The rear push rod 520 is manually pushed to push the front push rod 510 to move forward. The front push rod 510 compresses the spring 600, and at the same time, the rear push rod 520 pushes the inner tube 120 to move forward. The rear push rod 520 is provided with an aspiration guide wire port 521 which is in communication with the catheter.

[0082] With reference to Figure 3 The handle further comprises a stainless steel tube 930 which is sleeved on the outside of the inner tube 120. The spring 600 is sleeved on the outside of the stainless steel tube 930. The stainless steel tube 930 is used as a sliding track of the spring 600 and has the effects of supporting and reducing abrasion.

[0083] With reference to Figure 9 , Figure 10 , Figure 11 and Figure 12 is a second structure of the full occlusion blood vessel recanalization device 10 provided by the embodiment. There are some differences from the operation handle 400 of the above-mentioned embodiment.

[0084] The distal end housing 420 is provided with an aspiration port 421 which is used together with the aspiration guide wire port 521 provided by the rear push rod 520 to aspirate tissue fragments. The operation handle 400 is provided with the aspiration port 421, so that there is a gap between the inner tube 120 and the outer tube 110 to form an aspiration lumen 115. If the operation handle 400 is not provided with the aspiration port 421, the inner tube 120 and the outer tube 110 can relatively move without the gap.

[0085] The operation handle 400 further comprises an O-ring chuck 940 and an O-ring 950. The O-ring chuck 940 is arranged in the distal end housing 420. The O-ring 950 is arranged between the O-ring chuck 940 and the distal end housing 420. The spring 600 is arranged between the O-ring chuck 940 and the front push rod 510.

[0086] Referring to Figure 13 and Figure 14 , the structure of setting the suction guide wire port 521 and the suction port 421 at the same time. Among them, Figure 13 In the second embodiment, the cutting blade 200 extends out of the outer tube 110 after pressing the rear push rod 520. Figure 14 In the first embodiment, the rear push rod 520 is not pressed, and the cutting blade 200 does not extend out of the outer tube 110.

[0087] Referring to Figure 15 , Figure 16 , Figure 17 , Figure 18 , Figure 19 and Figure 12 , the third structure of the full occlusion recanalization device 10 provided by the present embodiment. In the present embodiment, the handle push rod 500 is provided with a push block 511; the operating handle 400 further comprises a pressing module 700, which is slidably arranged on the handle shell 410, and the pressing module 700 has a pushing surface 710; the pushing surface 710 and the push block 511 are in sliding cooperation; the pressing module 700 is used to move the push block 511 and the handle push rod 500 by the pushing surface 710 under the action of external force pressing, so that the distal end of the inner tube 120 extends out of the distal end of the outer tube 110, or the pressing module 700 is used to reset the push block 511 under the action of the restoring force of the spring 600, so as to drive the distal end of the inner tube 120 to retract relative to the distal end of the outer tube 110.

[0088] Under the action of external force pressing, the pressing module 700 moves towards the inside of the handle shell 410, the pushing surface 710 cooperates with the push block 511, the pushing surface 710 pushes the push block 511, the handle push rod 500 and the inner tube 120 to move forward, and at the same time the spring 600 is compressed. After the external force is removed, the restoring force of the spring 600 pushes the handle push rod 500 to reset, and at the same time the pushing surface 710 is pushed to move by the push block 511, so that the pressing module 700 resets.

[0089] Without the need for active driving such as electricity or laser, and without the need for guidance such as contrast and ultrasound, the extension and retraction of the blade can be controlled by pressing the button module on the handle 400 with one hand, which greatly facilitates the clinical use.

[0090] Referring to Figure 16 and Figure 18The pushing surface 710 is an inclined surface, the pushing block 511 is located at the left side of the pushing surface 710, the pressing module 700 is arranged along the radial direction of the handle shell 410, the manual pressing of the pressing module 700 is moved along the vertical downward direction, the pushing surface 710 pushes the pushing block 511 to move left, which drives the handle push rod 500 and the inner tube 120 to move left, so that the cutting blade 200 is extended out of the outer tube 110. When the external force is removed, the handle push rod 500 and the pushing block 511 are moved right under the action of the spring 600, which drives the cutting blade 200 to retract.

[0091] In the embodiment, the handle shell 410 includes a first shell 440 and a second shell 450, one side of the first shell 440 is fixed with one side of the second shell 450. The handle shell 410 further includes a front nut 910 and a rear nut 920, the front ends of the first shell 440 and the second shell 450 are fixed together by the front nut 910, and the rear ends of the first shell 440 and the second shell 450 are fixed together by the rear nut 920, so as to fix the first shell 440 and the second shell 450. The proximal end of the three-way shell 411 is fixed with the front ends of the first shell 440 and the second shell 450.

[0092] The shape of the rear push rod 520 is different from the shape of the rear push rod 520 mentioned above. The front push rod 510 is longer. The operating handle 400 further includes a connecting buckle 900, the connecting buckle 900 is arranged between the first shell 440 and the second shell 450, the proximal end of the front push rod 510 is threadedly connected with the connecting buckle 900, and the distal end of the rear push rod 520 is clamped with the connecting buckle 900.

[0093] Referring to Figure 2 , Figure 9 and Figure 15 , the operating handle 400 further includes a stress release tube 800; the stress release tube 800 is sleeved outside the outer tube 110, and the stress release tube 800 is rotationally connected with the distal end of the handle shell 410; the stress release tube 800 is used for communicating the proximal end of the balloon lumen 112 with the outside during rotation relative to the handle shell 410, so as to release the pressure of the fixed balloon 300.

[0094] Referring to Figure 21 , in the embodiment, the cutting blade 200 includes at least two blades 210 which are arranged at intervals around the center of the blade passage and can be closed or opened, the at least two blades 210 are used for being in a closed state when being accommodated in the central lumen 114, or the at least two blades 210 are used for being released to be in an open state when being extended out of the central lumen 114. The cutting blade 200 adopts a memory metal, and the blades 210 are automatically opened after the cutting blade 200 is pushed out of the central lumen 114.

[0095] Specifically, the cutting blade 200 is funnel-shaped, the outer diameter of the distal end of the cutting blade 200 is the same as or greater than the inner diameter of the first catheter 113, and the inner diameter of the proximal end of the cutting blade 200 is the same as the inner diameter of the inner tube 120 and is fixed to the distal end of the inner tube 120.

[0096] In this embodiment, the distal end of the cutting blade 200 is cylindrical or has an acute angle shape. The acute angle shape is similar to a triangle.

[0097] In this embodiment, the distal end of the outer tube 110 is also provided with a developing mark which is formed by winding a wire.

[0098] According to the full occlusion recanalization device 10 provided in this embodiment, the working principle of the full occlusion recanalization device 10 is as follows:

[0099] The distal end of the catheter group 100 with the cutting blade 200 and the fixed balloon 300 is sent to the front of the blood vessel occlusion tissue 11 under the image, the fixed balloon 300 is pressurized and inflated, the catheter group 100 is parallel to the wall of the blood vessel 12, and the local blood flow is blocked.

[0100] The operating handle 400 is pressed, the cutting blade 200 extends out of the central lumen 114, cuts the blood vessel occlusion tissue 11 forward, and the operating handle 400 is released, the cutting blade 200 automatically retracts into the central lumen 114. The depth of each excavation is realized by controlling the cutting blade 200, and the depth of each excavation ranges from 0.1 mm to 10 mm. The cut tissue fragments are sucked through the inner lumen 121 and the suction lumen 115. The fixed balloon 300 is depressurized, and the catheter group 100 is pushed into the newly opened tunnel. The fixed balloon 300 is pressurized again, and the cutting blade 200 is fixed and straightened to always be located between the inner walls of the blood vessel 12. The above steps are repeated until the occlusion tissue is completely opened.

[0101] The full occlusion recanalization device 10 provided in this embodiment has at least the following advantages:

[0102] After the fixed balloon 300 is pressurized and inflated, it can be supported and fixed in the blood vessel 12. Through the fixed balloon 300, the position of the cutting blade 200 can be positioned, fixed and adjusted, so that the cutting blade 200 always cuts between the inner walls of the blood vessel 12 during cutting, avoids perforation, reduces the difficulty of opening the blood vessel occlusion tissue 11, and improves the opening efficiency.

[0103] The cut tissue fragments are left in the cavity between the fixed balloon 300 and the blood vessel occlusion tissue 11, and are directly sucked away through the inner tube 120 and the suction lumen 115, so as to avoid the tissue fragments entering the distal end after opening and causing secondary embolism of the blood vessel 12.

[0104] The full occlusion recanalization device 10 provided by the embodiment is suitable for all blood vessel 12 occlusions, such as complete blockage type lesions in cardiovascular 12, cerebral blood vessels 12, and peripheral blood vessels 12.

[0105] The embodiment of the present application also provides a full occlusion recanalization method, which is implemented by using the full occlusion recanalization device 10, and further includes the following steps: supporting the first position in front of the blood vessel occlusion tissue 11 after the fixed balloon 300 is inflated by operating the handle 400, so that the cutting blade 200 is always located between the inner walls of the blood vessel 12; repeatedly cutting the blood vessel occlusion tissue 11 by operating the cutting blade 200 through the handle 400 until the cutting at the first position is completed, the fixed balloon 300 is inflated and pressure is released by operating the handle 400, and then the next position is moved; repeating the above steps until the blood vessel occlusion tissue 11 is opened. For example, the catheter group 100 is inserted into the peripheral blood vessel 12 of a pig under a light machine, the fixed balloon 300 is inflated, and then the cutting blade 200 is operated through the handle 400, so that the blocked blood vessel 12 is opened. The problem that the operation difficulty of the blood vessel 12 occlusion opening is high is improved.

[0106] The above merely provides a specific embodiment of the present application, but the protection scope of the present application is not limited to this. Any changes or replacements that can be easily thought of by those skilled in the art within the technical range disclosed by the present application should be covered within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A total occlusion recanalization device, characterized in that, The device comprises a catheter group (100), a cutting blade (200), a fixed balloon (300) and an operating handle (400). The cutting blade (200) and the fixed balloon (300) are fixed at the distal end of the catheter group (100), and the operating handle (400) is connected with the proximal end of the catheter group (100), and the operating handle (400) is used to drive the catheter group (100) to reciprocally move the cutting blade (200) to repeatedly cut the blood vessel occluded tissue (11). The operating handle (400) is provided with a stamping port (412) which is communicated with the fixed balloon (300) through the catheter group (100), and the stamping port (412) is used to inflate the inflation medium into the fixed balloon (300) to make the inflated fixed balloon (300) support and fix in the blood vessel (12), so that the cutting blade (200) is always located between the inner walls of the blood vessel (12). The catheter group (100) comprises an outer tube (110) and an inner tube (120), the outer tube (110) is provided with a center channel (114) and a balloon channel (112), and the inner tube (120) is movably arranged in the center channel (114); the cutting blade (200) is fixed at the distal end of the inner tube (120); the fixed balloon (300) is fixed at the distal end of the outer tube (110), and the fixed balloon (300) is communicated with the distal end of the balloon channel (112); the operating handle (400) is connected with the proximal end of the inner tube (120) and the outer tube (110), and the stamping port (412) is communicated with the balloon channel (112); the operating handle (400) is used to repeatedly drive the inner tube (120) and the outer tube (110) to relatively move, so that the distal end of the inner tube (120) is repeatedly extended relative to the distal end of the outer tube (110), thereby driving the cutting blade (200) to repeatedly cut the blood vessel occluded tissue (11); the fixed balloon (300) is inflated and fixed at a position, and the cutting blade (200) is operated by the operating handle (400) to cut the blood vessel occluded tissue (11) at the position; after the blood vessel occluded tissue (11) at the position is opened, the fixed balloon (300) is depressurized, moved to the next position, inflated to fix the position, and the cutting blade (200) is cut again.

2. The full occlusion blood vessel recanalization device according to claim 1, wherein ​ The inner wall of the inner tube (120) surrounds an inner channel (121), the cutting blade (200) is provided with a blade channel in communication with the inner channel (121) of the inner tube (120), and the blade channel and the inner channel (121) are used together for passing a guide wire or for pumping the blood vessel occlusive tissue (11) fragments cut by the cutting blade (200); the operation handle (400) is provided with a pumping guide wire port (521) in communication with the inner channel (121).

3. The total occlusion blood vessel recanalization device according to claim 2, characterized in that: The cutting blade (200) comprises at least two blades (210) arranged at intervals around the center of the blade channel and capable of being closed or opened, and the at least two blades (210) are used to be in a closed state when accommodated in the central channel (114), or the at least two blades (210) are used to be in an open state when extended out of the central channel (114).

4. The total occlusion blood vessel recanalization device according to claim 2, characterized in that: The distal end of the cutting blade (200) is cylindrical or angular.

5. The total occlusion blood vessel recanalization device according to any one of claims 2-4, characterized in that: The outer tube (110) comprises a first catheter (113) and a second catheter (111), the first catheter (113) is sleeved outside the inner tube (120), and the second catheter (111) is sleeved outside the first catheter (113); the inner wall of the first catheter (113) surrounds the central channel (114), and the outer wall of the first catheter (113) and the inner wall of the second catheter (111) form the balloon channel (112).

6. The total occlusion blood vessel recanalization device according to any one of claims 2-4, characterized in that: The inner wall of the outer tube (110) surrounds the central channel (114), and the inner wall and the outer wall of the outer tube (110) are provided with the balloon channel (112).

7. The total occlusion blood vessel recanalization device according to any one of claims 2-4, characterized in that: The outer wall of the inner tube (120) and the central channel (114) are provided with a gap, the gap forms a pumping channel (115), and the pumping channel (115) is used for pumping the blood vessel occlusive tissue (11) fragments cut by the cutting blade (200); the operation handle (400) is provided with a pumping port (421) in communication with the pumping channel (115).

8. The total occlusion blood vessel recanalization device according to any one of claims 2-4, characterized in that: The operation handle (400) comprises a handle shell (410), a handle push rod (500) and a spring (600); the spring (600) is arranged in the handle shell (410), the handle push rod (500) is slidably arranged at a distal end of the handle shell (410), and the handle push rod (500) is in abutment with the spring (600); a proximal end of the outer tube (110) is fixed with the handle shell (410), and a proximal end of the inner tube (120) is fixed with the handle push rod (500); the handle push rod (500) is used to move relative to the handle shell (410) under the action of an external force, so as to push the distal end of the inner tube (120) to extend relative to the distal end of the outer tube (110), or the handle push rod (500) is used to reset under the action of the restoring force of the spring (600), so as to drive the distal end of the inner tube (120) to retract relative to the distal end of the outer tube (110).

9. The full occlusion vascular recanalization device according to claim 8, characterized in that: The handle push rod (500) is provided with a push block (511); the operation handle (400) further comprises a pressing module (700), the pressing module (700) is slidably arranged on the handle shell (410), and the pressing module (700) has a push surface (710); the push surface (710) is in sliding fit with the push block (511); the pressing module (700) is used to push the push block (511) and the handle push rod (500) to move through the push surface (710) under the action of external pressing, so as to make the distal end of the inner tube (120) extend relative to the distal end of the outer tube (110), or the pressing module (700) is used to reset under the action of the restoring force of the spring (600) and the reset of the push block (511), so as to drive the distal end of the inner tube (120) to retract relative to the distal end of the outer tube (110).

10. The full occlusion vascular recanalization device according to claim 9, characterized in that: The operation handle (400) further comprises a stress release tube (800); the stress release tube (800) is sleeved outside the outer tube (110), and a distal end of the stress release tube (800) is rotatably connected with the handle shell (410); the stress release tube (800) is used to make the proximal end of the balloon lumen (112) communicate with the outside during rotation relative to the handle shell (410), so as to make the fixed balloon (300) release pressure.

Images