Patent Application
20200383698
This application claims priority to Chinese Patent Application No. 201910490706.3, filed in the Chinese Intellectual Property Office on Jun. 6, 2019, which application is hereby incorporated herein by reference.
The invention relates to the field of medical devices, particularly to an apparatus for breaking thrombus and aspirating the thrombus.
Stroke is one of the main causes of human disability and death. Acute ischemic stroke (AIS) accounts for about 80% of all stroke. The key point of AIS treatment is to dredge the occluded blood vessel and restore the blood flow as early as possible to save the ischemic penumbra. At present, the typical treatment includes intravenous thrombolysis and mechanical thrombectomy.
Intravenous thrombolysis method is to inject thrombolytic agent into the vein, the main component of which is tissue plasminogen activator (rt-PA). The principle is that rt-PA can dissolve the thrombus in the diseased blood vessel, so as to achieve the purpose of recanalization of blood flow in the diseased blood vessel, such that the cerebral tissue in the vascular perfusion area can get the blood oxygen supply again, and thus reduce the area of cerebral infarction. However, the treatment of intravenous thrombolysis has strict time limit, generally within 4.5 hours of stroke onset; and some drugs are usually delivered through systemic drug release, which will increase the risk of systemic hemorrhage including cerebral hemorrhage, such that the intravenous thrombolysis is only applicable to the treatment of limited individuals.
Another option is to use instruments for thrombectomy. There are two kinds of interventional thrombectomy instruments available on the market at present. One is a suction catheter, which is designed as a structure similar to that of a micro catheter: after arriving at the lesion, the distal end of the suction catheter is applied with a negative pressure, and the free thrombus blocking the blood vessel is inhaled into the catheter or is suctioned to the catheter port and then is pulled out of the body, so as to restore the blood flow at the lesion. The other is thrombectomy stent, and the principle of stent thrombectomy is to use a micro catheter technology, the stent thrombectomy device reaches the intracranial artery along the lower limb artery through the internal artery channel, then thrombectomy means at the anterior segment of the catheter actively “catches” the thrombus which blocks the blood vessel, and a negative pressure is applied at the proximal end of the micro catheter, so that the thrombus is extracted out of the human body. The main advantage of mechanical thrombectomy is that it expands the time window of treatment to 4.5-10 hours after the onset of the disease. However, at present, there are some shortcomings in mechanical thrombectomy, such as when the device takes thrombus out of the human body, some blood clots or particles may fall during the process of retrieval or the device cannot completely remove thrombus due to the complexity of thrombus.
Therefore, it is necessary to develop a thrombus removal device which can not only expand the time window, but also take thrombus out of human body completely, so as to solve the existing problems of thrombus removal with instruments.
The information disclosed in the background part of the invention is only intended to strengthen the understanding of the general background technology of the invention, and shall not be deemed to recognize or imply in any form that the information constitutes the prior art known to those skilled in the art.
The object of the invention is to provide an apparatus for breaking thrombus and aspirating the thrombus. The aspirating action is carried out synchronously with mechanical thrombus breaking, with a high dredging rate (>98%) and significant reduction of complications.
Another object of the invention is to provide an apparatus for breaking thrombus and aspirating the thrombus. The mechanical rotary cutting is integrated in the micro catheter, which can effectively reduce the iatrogenic damage to the blood vessel wall in the process of extracting thrombus.
Another object of the invention is to provide an apparatus for breaking thrombus and aspirating the thrombus, whose distal end and sides are all provided with thrombus breaking and aspirating ports, so as to significantly improve the efficiency of extracting thrombus.
The object of the invention is realized by the following technical solutions:
An apparatus for breaking thrombus and aspirating the thrombus, characterized in that the apparatus comprises:
an aspirating rotary grinding hand-held system which integrates with a rotary grinding head driving device, an aspirating device, a power supply device and a control device;
a micro catheter device comprising a micro catheter, which is communicated with the aspirating device and the rotary grinding head driving device, respectively;
a waste liquid collecting device which is connected to the aspirating device, wherein the aspirating device and the waste liquid collecting device form an airtight passage; and
a distal end rotary grinding head device which is connected to the rotary grinding head driving device through a connection mandrel, wherein the power supply device provides power for the rotary grinding head driving device;
wherein the distal end rotary grinding head driving device and the connection mandrel are accommodated in an inner cavity of the micro catheter device; and
wherein the control device controls the aspirating device and the rotary grinding head driving device, such that the aspirating device and the rotary grinding head driving device run simultaneously.
Preferably, the rotary grinding head driving device and the aspirating device are mechanically or electrically connected to realize simultaneous operation and can stop operation at the same time.
Preferably, the distal end rotary grinding head device is made of polymer material or metal material having good biocompatibility.
Preferably, the distal end rotary grinding head device can slide finitely within the micro catheter, and the sliding distance of the finitely end rotary grinding head device is between 1 mm and 50 mm.
Preferably, the distal end rotary grinding head device can exceed the length range of the micro catheter device, and the length beyond the micro catheter device is 0.5 mm to 5 mm.
Preferably, the surface or the interior of the distal end rotary grinding head device is provided with a developing ring.
Preferably, the distal end rotary grinding head device is cylindrical or shuttle shaped, with a length of 0.5 mm to 15 mm.
Preferably, the distal end rotary grinding head device is integrally formed or formed by connecting a plurality of components.
Preferably, the side surface of the distal end rotary grinding head device is provided with rotary grinding head openings.
Preferably, the number of the rotary grinding head openings of the distal end rotary grinding head device is 1 to 15.
Preferably, the rotary grinding head opening of the distal end rotary grinding head device is a rectangular hole or a hole with a serrated edge or an elliptical hole.
Preferably, the micro catheter device is made of a polymer material having good biocompatibility, or a composite material of a polymer material and a metal material, or made by sleeve of a polymer pipe and a metal material.
Preferably, the metal material of the micro catheter device is hard alloy material and/or super elastic alloy material.
Preferably, the distal end of the micro catheter device which enters the human blood vessel is non occluded, or is provided with a semi occluded limit structure, or is provided with a fully occluded limit structure.
Preferably, the semi occluded limit structure and the fully occluded limit structure are of polymer materials, or hard alloy materials, or composite materials composed of polymer materials and hard alloy materials.
Preferably, the number of openings of the semi occluded limit structure is 1 to 15.
Preferably, the side surface of the micro catheter device is provided with micro catheter openings close to the distal end.
Preferably, the number of the micro catheter openings of the micro catheter device is 1 to 15.
Preferably, the distance from the distal end of the micro catheter openings of the micro catheter device to the distal end of the micro catheter device is 0.1 mm to 15 mm.
Preferably, the micro catheter opening of the micro catheter device is a rectangular hole or a hole having a serrated edge or an elliptical hole.
Preferably, the periphery of the connection mandrel is provided with 2 to 15 stabilizers.
Preferably, the width of the stabilizer is from 1 mm to 3 mm.
Preferably, the connection mandrel is composed of a core wire, or a core wire and a protective sheath tube sheathed on its periphery.
Preferably, the materials of the core wire and the protective sheath tube are hard metal alloy material, super elastic alloy material or polymer material.
Preferably, when the connection mandrel is composed of a core wire and a protective sheath tube sheathed on its periphery, the core wire rotates at the same speed with the protective sheath tube; or, the core wire rotates while the protective sheath tube remains stationary.
Preferably, the surface of the protective sheath tube is provided with a spiral cutting pattern.
Preferably, when the connection mandrel is composed of a core wire and a protective sheath tube sheathed on its periphery, the core wire is longer than the protective sheath tube, and the length difference between them is 2 mm to 150 mm.
Preferably, the core wire is composed of a single thread or a plurality of threads, and the core wire composed of a plurality of silk threads is formed by spiraling a plurality of threads or by spiraling a plurality of threads around a thread.
Preferably, the core wire is composed of 2 to 12 wires.
Preferably, when the rotary grinding head opening of the far-end rotary grinding head device is a hole with a serrated edge and the micro catheter opening of the micro catheter device is also a hole with a serrated edge, during the rotation process, the top point of the serrated edge of the micro catheter opening coincides with the bottom point of the serrated edge of the rotary grinding head opening at a certain position, or the top point of the serrated edge of the micro catheter opening coincides with the top point of the serrated edge of the rotary grinding head opening at a certain position.
The beneficial effects of the invention are as follows:
1. The aspirating action is carried out synchronously with the mechanical thrombus breaking, with a high dredging rate (>98%) and significant reduction of complications.
2. Syringe is connected directly for aspiration without configuration of aspirating equipment, and the doctor can complete the thrombus aspiration and mechanical extracting actions (both are carried out synchronously) with one hand operation.
3. Integrated battery supplies power, which needs no external power supply and is convenient for operation.
4. Mechanical rotary cutting is integrated into a micro catheter, which can effectively reduce the iatrogenic damage to the blood vessel wall in the process of thrombectomy.
5. The distal end and the sides are all equipped with thrombus breaking ports and aspirating ports and thus significantly improve the efficiency of thrombus extraction.
6. Thrombus has been smashed at the same time of aspiration, so it will not block the aspirating catheter, and the efficiency of thrombus extraction is high.
7. Mechanical rotary cutting is helpful to capture thrombus which has been formed for a long time and thus expand the window period of thrombus extraction.
8. There is a blood flow seal at the proximal end to prevent the embolus from rushing to the distal end by blood flow.
9. This technology can be extended to the fields of coronary artery thrombectomy, peripheral thrombectomy and pulmonary embolism.
It should be understood that the appended drawings are not drawn to scale, but merely to illustrate a properly simplified representation of the various features of the basic principles of the present invention. The specific design features of the present invention disclosed herein include, for example, specific dimensions, directions, positions and shapes to be determined in part by the specific application and use environment. In the attached drawings, the same or equivalent parts (elements) are marked with the same reference numerals.
The invention will be further described in combination with embodiments and corresponding figures.
The invention relates to an apparatus for breaking and aspirating thrombus and a manufacturing method thereof.
For the invention, any mechanical thrombus extraction apparatus which can be purchased on the market can be used to manufacture the apparatus of the invention. For example, such apparatuses include but are not limited to the following:
1) Penumbra System® is manufactured by Penumbra, Inc. A detailed description of its apparatus is provided in the patent (Patent No.: US20180353194A1, US20180263646A1), wherein some relevant content are incorporated herein by reference.
2) ROTABLATOR™ and ROTAPRO™ Rotational Atherectomy Systems, are manufactured by Boston Scientific Corporation. The detailed specification of its apparatus is provided in the patent (Patent No.: U.S. Pat. No. 6,077,282A), wherein some relevant content are incorporated herein by reference.
The aspirating device 3 generates enough negative air pressure through manual pressure gripping or electric energy drive, which is used to aspirate the broken thrombus or the blood clots or particles falling or broken in the process of breaking the thrombus into the external liquid waste collecting device 7, so as to prevent them from moving to farther region of the blood vessels in the body; at the same time, a check device 10 is arranged at the connection between the aspirating device 3 and the liquid waste collecting device 7, which can ensure that the broken thrombus always flows in the direction of the waste liquid collecting device 7 from the micro catheter device 2 to the aspirating device 3, without counter-flow. The aspirating device 3 and the rotary grinding head driving device 4 are integrated in the aspirating rotary grinding hand-held system 6, and the aspirating device 3 and the rotary grinding head driving device 4 are connected together through a control device 9, and the connection way can be circuit connection or mechanical connection, so as to realize the function that the rotary grinding process and the aspirating process conduct simultaneously, and facilitate the single hand operation of the operator.
A stabilizer 44 can be installed on the outer surface of the connection mandrel 5, as shown in
In addition, the connection mandrel 5 also can be, as shown in
The rotary grinding head openings 23 shown in
The structure of the distal end of the micro catheter device 2 is shown in
The opening shape of the micro catheter opening 31 of the micro catheter device 2 shown in
The micro catheter openings 31 of the micro catheter device 2 shown in
In actual use of the present apparatus, the operator chooses the vascular access to the affected area and sends a guide wire along the vascular access to the affected area; the micro catheter passes through the guide wire, and under the guidance of the guide wire, the distal end of the micro catheter reaches the position of the vascular obstruction, and then withdraw the guide wire. Put the distal end rotary grinding head device integrated in the handle into the micro catheter, grip the connection mandrel and push it to the distal end of the vascular access until the micro catheter and the handle form a whole through quick connection of interfaces. The operator can adjust the position of the distal end rotary grinding head device, such that the distal end rotary grinding head device cooperates with the micro catheter opening of the micro catheter device, so as to achieve better rotary cutting effect. At this time, the operator can operate the handle for aspiration, at the same time, the motor drives the head of the distal end rotary grinding head device to rotate rapidly via the connection mandrel, at the same time, it can continue to adjust the position of the distal end rotary grinding head device, which can exceed the length range of the micro catheter device to directly rotary grinding the thrombus. The thrombus in the blood vessels is broken and aspirated inside and collected outside the human body. This equipment is suitable for rapid removal of embolization in intracranial, coronary and peripheral vessels.
The foregoing description of the specific exemplary embodiments of the invention is for the purpose of explanation and description. The foregoing description does not want to be exhaustive, nor to limit the invention to the precise form disclosed. Obviously, many changes and variations are possible according to the above teaching. The purpose of selecting and describing exemplary embodiments is to explain the specific principles and practical applications of the invention, so that other skilled persons in the art can realize and utilize various exemplary embodiments of the invention and various selection forms and modification forms. The scope of the invention is intended to be defined by the appended claims and their equivalent forms.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2019-10490706.3 | Jun 2019 | CN | national |
