CN115500895A

CN115500895A - Thrombectomy device

Info

Publication number: CN115500895A
Application number: CN202211131442.0A
Authority: CN
Inventors: 颜世平; 李维; 黄贤才; 向俊; 郭聪; 尹豪
Original assignee: APT MEDICAL Inc
Current assignee: APT MEDICAL Inc
Priority date: 2022-09-16
Filing date: 2022-09-16
Publication date: 2022-12-23

Abstract

The embodiment of the disclosure provides a thrombus plaque cutting device, which comprises a catheter, a rotor pair and a driving device, wherein the catheter is arranged between the rotor pair and the driving device, the rotor pair comprises an outer rotor and an inner rotor for cutting, the outer rotor is fixedly connected with the distal end part of the catheter, the inner rotor is arranged on the inner side of the outer end part of the outer rotor, a connecting part is arranged in the catheter and the outer rotor, the near end of the connecting part is connected with the driving device, and the far end of the connecting part is fixedly connected with the inner rotor. The thrombus plaque excision device can be used for excision of thrombus plaques aiming at severe diseases of peripheral blood vessels, has the advantages of short action time, high rotation speed, high excision efficiency, small side effect and the like, has excellent thrombus removal and biocompatibility, is favorable for solving ischemic diseases clinically, and obviously improves the success rate of operations.

Description

Thrombectomy device

Technical Field

The disclosure relates to the technical field of vascular surgery, in particular to a thrombus plaque cutting device.

Background

At present, cardiovascular disease death accounts for the first cause of total death of urban and rural residents, 45.91% in rural areas and 43.56% in cities. Among patients with severe heart blood disease, 75% or more of patients are accompanied by peripheral arterial obstruction, in the population over 60 years old, the incidence rate of chronic lower limb arterial ischemia caused by peripheral arterial obstruction is 17% -20%, the amputation rate is up to 5% or more, the prevalence rate of smoking especially combined with diabetes is more than 20%, and the incidence rate of veins is 10 times of that of arterial disease. Peripheral vascular related diseases can be classified into lower limb arteriosclerosis obliterans (ASO), thromboangiitis obliterans (TAO), acute arterial embolism, diabetic foot, and the like.

For example, lower limb arteriosclerotic occlusive disease (ASO), treatment of lower limb arteriosclerotic occlusive disease ASO) includes non-surgical treatment, and endovascular treatment. Wherein the non-operative treatment comprises general treatment, chinese traditional medicine treatment and western medicine treatment. Surgical treatments include endarterectomy and arterial bypass. According to the TASC 2 nd edition of the guidelines (TASC II): the C grade lesion can be selected by intervention or artery bypass operation according to the condition, and the D grade advocates artery bypass operation. Endovascular therapies include Percutaneous Transluminal Angioplasty (PTA), stent implantation, catheter thrombolysis, directed atherectomy, thrombectomy, laser debulking, and ultrasound ablation. Among them, percutaneous Transluminal Angioplasty (PTA) and stent implantation are the first-line treatment methods of ASO at present.

Disclosure of Invention

An object of the disclosed embodiments is to provide a cutting device for a thrombus plaque, so as to solve the problems of cutting and transporting plaque in peripheral blood vessels in the prior art.

The embodiment of the disclosure provides a thrombus plaque cutting device, which comprises a catheter, a rotor pair and a driving device, wherein the catheter is arranged between the rotor pair and the driving device, the rotor pair comprises an outer rotor and an inner rotor for cutting, the outer rotor is fixedly connected with the distal end part of the catheter, the inner rotor is arranged on the inner side of the outer end part of the outer rotor, a connecting part is arranged in the catheter and the outer rotor, the near end of the connecting part is connected with the driving device, and the far end of the connecting part is fixedly connected with the inner rotor.

In some embodiments, a cutting edge for cutting a thrombus plaque in a blood vessel by rotation is provided on an end face of an outer end of the inner rotor.

In some embodiments, the cutting edge is provided with a plurality of chamfer structures.

In some embodiments, a turbine head is disposed within the inner rotor, the turbine head being co-rotatable with the inner rotor, an impeller being disposed on the turbine head, rotation of the turbine head rotating the impeller to generate suction to draw the minced thrombus plaque into the outer rotor and the interior of the catheter.

In some embodiments, the turbine head is connected to an inner surface of the inner rotor by a bracket.

In some embodiments, the impeller comprises a plurality of blades.

In some embodiments, the connection between the inner rotor and the outer end of the outer rotor is a clearance fit.

In some embodiments, the connection portion is a clearance fit with the conduit and the outer rotor.

In some embodiments, the outer rotor is tubular, having an inner diameter the same as the conduit and an outer diameter different from the conduit.

In some embodiments, the connecting portion is a connecting straight rod or a screw rod, and the body of the screw rod is provided with the blade.

The thrombus plaque excision can be performed on the serious disease of the peripheral blood vessel, has the advantages of short action time, high rotating speed, high excision efficiency, small side effect and the like, has excellent thrombus removal and biocompatibility performances, is favorable for clinically solving ischemic diseases, and remarkably improves the success rate of surgery.

The short action time means that the medicine can directly act on the position of the vascular embolism; the high rotating speed and the high efficiency mean that the embolus can be directly conveyed out of the body; the small side effect means that the mechanical thrombectomy system does not need to place a bracket, dissolve thrombus and have no hemolytic reaction, the risk of a patient can be reduced, and the operation cost can be saved.

Drawings

In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings used in the embodiments or the description of the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments described in the present disclosure, and for those skilled in the art, other drawings may be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic structural view of a thrombectomy apparatus according to an embodiment of the present disclosure;

fig. 2 is a schematic structural view of an inner rotor in the thrombectomy device according to the embodiment of the present disclosure.

Reference numerals:

1-a catheter; 2-an outer rotor; 3-an inner rotor; 4-a connecting part; 5-cutting edge; 6-impeller; 7-turbine head.

Detailed Description

Various aspects and features of the disclosure are described herein with reference to the drawings.

It will be understood that various modifications may be made to the embodiments of the present application. Accordingly, the foregoing description should not be construed as limiting, but merely as exemplifications of embodiments. Other modifications will occur to those skilled in the art within the scope and spirit of the disclosure.

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the disclosure.

These and other characteristics of the present disclosure will become apparent from the following description of preferred forms of embodiment, given as non-limiting examples, with reference to the attached drawings.

It should also be understood that, although the present disclosure has been described with reference to some specific examples, a person of skill in the art shall certainly be able to achieve many other equivalent forms of the disclosure, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

The above and other aspects, features and advantages of the present disclosure will become more apparent in view of the following detailed description when taken in conjunction with the accompanying drawings.

Specific embodiments of the present disclosure are described hereinafter with reference to the drawings; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure that may be embodied in various forms. Well-known and/or repeated functions and structures have not been described in detail so as not to obscure the present disclosure with unnecessary or unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

The specification may use the phrases "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may each refer to one or more of the same or different embodiments in accordance with the disclosure.

The disclosed embodiment relates to an excision device for thrombus plaque, which is inserted into human body, and the key point is how to safely, accurately and efficiently excise various thrombus plaques in blood vessels, wherein the excised thrombus plaque is transported to the outside of the body completely, and peripheral blood vessels are prevented from being injured in the excision process.

To this end, the disclosed embodiment provides a cutting device for cutting a thrombus plaque, as shown in fig. 1, the cutting device comprises a catheter 1, a rotor pair and a driving device (not shown), wherein the rotor pair is arranged at the distal end of the catheter 1, the proximal end of the catheter 1 is connected with the driving device, the driving device is used for driving the rotor pair to rotate, and the driving device can be a motor or other suitable driving device. The distal portion herein refers to the end portion away from the operator and close to the patient, and the proximal portion herein refers to the end portion close to the operator and away from the patient.

The rotor pair and the distal end portion of the catheter 1 may be fixedly connected to each other by various means such as a snap connection, a screw connection, and an adhesive, which are not limited herein.

Further, a detachable connection between the pair of rotors and the distal end of the catheter 1 may be achieved to facilitate the installation and use of differently sized pairs of rotors with the catheter 1, for example different sizes and lengths of catheters and corresponding pairs of rotors may be selected depending on the location of the operation in the patient.

Further, the rotor pair can perform a cutting operation on thrombus plaque in a blood vessel by rotating, specifically, the rotor pair comprises an outer rotor 2 and an inner rotor 3, wherein the outer rotor 2 is a tubular structure and is fixedly connected with the distal end part of the catheter 1, and the inner diameter of the catheter 1 and the outer rotor 2 can be kept the same while the outer diameter is kept different, so as to facilitate the clamping installation between the two. The inner rotor 3 is arranged at the inner side of the outer end part of the outer rotor 2, wherein the inner rotor 3 is connected with the outer end part of the outer rotor 2 in a clearance fit mode, so that the outer rotor 2 is kept still relative to the guide pipe 1 during rotation, and the inner rotor 3 realizes high-speed rotation.

A connecting part 4 is arranged in the catheter 1 and the outer rotor 2, the proximal end of the connecting part 4 is connected with the driving device, so that the connecting part 4 can be driven by the driving device to rotate, and the distal end of the connecting part 4 is fixedly connected with the inner rotor 3, for example, the inner surface of the inner rotor 3, so that the inner rotor 3 can rotate together with the connecting part 4. The connecting part can be a connecting straight rod or a spiral rod, blades are arranged on the rod body of the spiral rod, and the spiral rod can also be used for sucking minced thrombus plaques in a blood vessel of a patient when rotating. In order to facilitate the aspiration of the minced thrombus plaque into the outer rotor 2 and the catheter 1 by the screw rod, a clearance fit is achieved between the screw rod and the catheter 1 and the outer rotor 2. In another embodiment, the connection 4 may be a coil spring, which, in addition to the above-mentioned advantages of the screw rod, can also adjust the position of the inner rotor 3 in the outer rotor 2 for a better cutting effect.

Further, the cutting edge 5 for cutting the thrombus plaque in the blood vessel by high-speed rotation is provided on the end surface of the outer end of the inner rotor 3, where the cutting edge 5 is provided protruding from the end surface of the inner rotor, so that the cutting efficiency and the cutting accuracy can be made higher. The shape of the cutting edge 5 can here take any shape that facilitates cutting. In this way, the driving device drives the connecting portion 4 to rotate, and further drives the cutting blade 5 on the inner rotor 3 to rotate, so as to realize the operation of rotary cutting.

In addition, consider that the thrombus plaque in the blood vessel can be on the vascular wall, cutting edge 5 adopts the blunt sword structure of many places chamfer, specifically, set up many places chamfer structure on cutting edge 5, make wholly cutting edge 5 forms blunt sword structure, makes like this the part that contacts with the vascular wall on cutting edge 5 is the slick and sly surface, and the part that contacts with the bellied thrombus plaque of vascular inner wall is sharp surface, can cut the thrombus plaque that the softness and hardness degree is different on the vascular wall like this, can not harm the vascular wall again, has higher commonality and security.

Further, after the thrombus plaque in the blood vessel is cut by the cutting edge 5, in order to realize that the cut thrombus plaque can be recovered without being blocked in the blood vessel, a turbine head 7 is arranged in the inner rotor 3, the turbine head 7 can be connected with the inner surface of the inner rotor 3 through a bracket for example, the turbine head 7 can rotate together with the inner rotor 3, an impeller 6 is arranged on the turbine head 7, the impeller 6 comprises a plurality of blades, and the number and the shape of the blades can be set according to requirements; the rotation of the turbine head 7 rotates the impeller 6, where the impeller 6, by rotation, can create suction to draw the minced thrombus plaque from the distal end of the inner rotor 3 to the proximal end and into the outer rotor 2 and the interior of the catheter 1.

Specifically, the impeller 6 is located the rear side of the cutting edge 5, from the cutting edge 5 to be the fretwork state between the pipe 1, the outer waste liquid collection bag of the proximal end portion external body of pipe 1, when the inner rotor 3 rotates, retrieve the thrombus plaque that is cut up through the way of the suction that the impeller 6 produced at high-speed rotation, certainly can also with connecting portion 4 and impeller 6 mutually combine and produce stronger suction in order to retrieve the thrombus plaque, here for example the helical structure of spiral portion can promote the suction after combining, like this, be favorable to the thrombus plaque after being cut up to be transported to the external body, transportation reliability and efficiency are higher.

After the cutting device of the embodiment of the present disclosure is inserted into a human blood vessel and reaches a designated position, the driving device, such as a motor, drives the connecting portion 4 to rotate at high speed inside the outer rotor and the catheter 1, the connecting portion 4 drives the inner rotor 3 to rotate at high speed inside the outer rotor 2, the cutting blades 5 on the inner rotor 3 are driven by the connecting portion 4 to cut thrombus plaque in the blood vessel, specifically, cut thrombus and atherosclerotic plaque in the blood vessel or on the blood vessel wall, generate suction through the impeller 6 and the connecting portion 4, and transport the thrombus plaque into an extracorporeal collection bag through the outer rotor 3 and the catheter 1, thereby achieving a blood vessel dredging effect.

The thrombus plaque removal device can be used for removing thrombus plaques in blood vessels aiming at serious diseases of peripheral blood vessels, has the advantages of short action time, high rotating speed, high removal efficiency, small side effect and the like, has excellent thrombus removal and biocompatibility performances, is favorable for clinically solving ischemic diseases, and remarkably improves the success rate of operations. The short action time means that the medicine can directly act on the position of the vascular embolism; the high rotating speed and the high efficiency mean that emboli can be directly conveyed to the outside of the body; the small side effect means that the mechanical thrombectomy device does not need to be provided with a bracket, thrombolysis and hemolytic reaction, can reduce the risk of patients and can save the operation cost.

Further, while operations are depicted in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order. Under certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while several specific implementation details are included in the above discussion, these should not be construed as limitations on the scope of the disclosure. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

While the present disclosure has been described in detail with reference to the embodiments, the present disclosure is not limited to the specific embodiments, and those skilled in the art can make various modifications and alterations based on the concept of the present disclosure, and the modifications and alterations should fall within the scope of the present disclosure as claimed.

Claims

1. An excision device of thrombus plaque, it includes pipe, rotor pair and drive arrangement, the pipe sets up between the rotor pair and the drive arrangement, its characterized in that, the rotor pair includes outer rotor and the inner rotor that is used for cutting, outer rotor and the distal end portion mutual fixed connection of pipe, inner rotor sets up the inboard of the outer tip of outer rotor, set up connecting portion in the pipe and the outer rotor, the near-end of connecting portion with drive arrangement is connected, the distal end of connecting portion with inner rotor fixed connection.

2. The resection device of claim 1, wherein a cutting edge for cutting thrombus plaque within a blood vessel by rotation is provided on an end face of the outer end of the inner rotor.

3. The resection device of claim 2 wherein the cutting edge is provided with a plurality of chamfer configurations.

4. The resection device of claim 1, wherein a turbine head is disposed within the inner rotor, the turbine head being co-rotatable with the inner rotor, an impeller being disposed on the turbine head, rotation of the turbine head rotating the impeller to create suction to draw the minced thrombus plaque into the outer rotor and the interior of the catheter.

5. The resection device of claim 4, wherein the turbine head is connected to an inner surface of the inner rotor by a bracket.

6. The resection device of claim 4, wherein the impeller includes a plurality of blades.

7. The cutting device of claim 1, wherein the connection between the outer ends of the inner and outer rotors is a clearance fit.

8. The resection device of claim 1, wherein the connection portion is clearance fit with the catheter and the outer rotor.

9. The resection device of claim 1, wherein the outer rotor is tubular, having an inner diameter that is the same as the catheter, and an outer diameter that is different from the catheter.

10. The resection device of claim 1, wherein the connection portion is a connecting straight rod or a screw rod, and a blade is provided on a rod body of the screw rod.