WO2023280315A1 - 一种血管内斑块切除系统及切除方法 - Google Patents

一种血管内斑块切除系统及切除方法 Download PDF

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Publication number
WO2023280315A1
WO2023280315A1 PCT/CN2022/104692 CN2022104692W WO2023280315A1 WO 2023280315 A1 WO2023280315 A1 WO 2023280315A1 CN 2022104692 W CN2022104692 W CN 2022104692W WO 2023280315 A1 WO2023280315 A1 WO 2023280315A1
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Prior art keywords
balloon
plaque
carotid artery
catheter
balloon catheter
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PCT/CN2022/104692
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English (en)
French (fr)
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张桂运
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张桂运
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Priority to CN202280048160.6A priority Critical patent/CN117651532A/zh
Priority to US18/577,475 priority patent/US20240238044A1/en
Publication of WO2023280315A1 publication Critical patent/WO2023280315A1/zh

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Definitions

  • the present invention relates to an intravascular plaque excision system and excision method, in particular to an artery plaque excision system and excision method.
  • carotid plaque formation to a certain extent can lead to carotid artery stenosis or unstable plaque detachment, leading to ischemic stroke, which seriously threatens the health of the population.
  • carotid endarterectomy CEA
  • CAS carotid artery balloon stent implantation
  • the purpose of the present invention is to provide an intravascular plaque excision system, which can not only obtain the effect of thorough plaque excision under the open visual environment of CEA, but also can completely strip off the intima and plaque of the diseased part; The characteristics of invasive surgery, while avoiding the inherent defects of CEA and CAS itself.
  • an intravascular atherectomy system comprising: a balloon catheter system suitable for being inserted into a blood vessel, including a guiding catheter and a first balloon, a second balloon and a a third balloon, the first balloon, the second balloon and the third balloon are adapted to be inflated to block blood flow in the blood vessel, the second balloon includes a blood diversion unit; an endoscopic device, It includes an endoscope connecting tube, an illumination unit and an image acquisition unit arranged at the far end of the connecting tube, suitable for being inserted into a blood vessel through the guide catheter for illumination and image acquisition; the intimal dissection device includes an operating unit arranged at the proximal end , the stripping unit at the far end and the stripping connection tube connecting the operation unit and the stripping unit, suitable for entering the blood vessel through the guiding catheter to perform the stripping operation of the plaque in the blood vessel.
  • the intravascular atherectomy system further includes: a laser device, including a laser generator and a laser transmission fiber, the laser transmission fiber is suitable for entering the blood vessel through the fiber optic channel of the endoscope device, and the laser generator generates The laser beam is transmitted to the selected location for laser ablation of the plaque in the blood vessel.
  • a laser device including a laser generator and a laser transmission fiber
  • the laser transmission fiber is suitable for entering the blood vessel through the fiber optic channel of the endoscope device
  • the laser generator generates The laser beam is transmitted to the selected location for laser ablation of the plaque in the blood vessel.
  • the intravascular atherectomy system further includes: a digital subtraction angiography machine capable of imaging blood vessels, determining the position of plaque in the blood vessel, and clarifying the filling state of the balloon and the location of the balloon.
  • a digital subtraction angiography machine capable of imaging blood vessels, determining the position of plaque in the blood vessel, and clarifying the filling state of the balloon and the location of the balloon.
  • the intravascular atherectomy system further includes: a control device, controlling the inflation of the balloon and the laser generator to generate laser light according to preset instructions.
  • the intravascular plaque excision system is suitable for excision of plaque in the carotid artery.
  • the first balloon is adapted to be placed at the opening of the external carotid artery on the affected side
  • the second balloon is adapted to be placed on the internal carotid artery on the affected side at the distal end of the plaque
  • the third balloon It is suitable to be placed in the common carotid artery on the affected side at the proximal end of the plaque, so that when the first, second and third balloons are inflated, a bloodless environment is formed in the blood vessel around the plaque.
  • the blood flow unit of the second balloon communicates with the arterial blood flow to deliver the arterial blood flow to the distal end of the second balloon in an open state.
  • the balloon catheter system comprises a first balloon catheter, a second balloon catheter and a third balloon catheter.
  • the third balloon catheter is inserted into the common carotid artery through the right femoral artery, and the first balloon catheter and the second balloon catheter are inserted into the external carotid artery and the internal carotid artery through the left femoral artery in a parallel arrangement.
  • said third balloon catheter comprises said guiding catheter.
  • the endoscopic device has a catheter, and the catheter includes a first lumen for accommodating an illumination unit and an image acquisition unit, and a second lumen for passing a laser transmission optical fiber and/or lavage fluid, and the inner lumen
  • the distal end of the mirror device is provided with a vessel wall protection device.
  • the multiple image acquisition units there are multiple image acquisition units, and the multiple image acquisition units are evenly distributed along the circumference; there are multiple illumination units, and the multiple illumination units are equally spaced between two adjacent images. between collection units.
  • the endoscopic device further includes a third channel used as a working channel.
  • an intravascular atherectomy system comprising: a balloon catheter system suitable for being inserted into a blood vessel, including a guiding catheter and a first balloon, a second balloon and a third balloon, the first balloon, the second balloon and the third balloon are adapted to be inflated to block blood flow in the blood vessel, the second balloon includes a blood diversion unit; an endoscopic device, It includes an endoscope connecting tube, an illumination unit and an image acquisition unit arranged at the far end of the connecting tube, and is suitable for being inserted into a blood vessel through an arterial sheath for illumination and image acquisition; the intima dissection device includes an operating unit arranged at the proximal end, The stripping unit at the far end and the stripping connection tube connecting the operation unit and the stripping unit are suitable for entering the blood vessel through the working channel of the endoscope device to perform the stripping operation of the plaque in the blood vessel.
  • the intravascular atherectomy system further includes: a laser device, including a laser generator and a laser transmission fiber, the laser transmission fiber is suitable for entering the blood vessel through the working channel of the endoscope device, and the laser generator generates The laser beam is transmitted to the selected location for laser ablation of the plaque in the blood vessel.
  • a laser device including a laser generator and a laser transmission fiber
  • the laser transmission fiber is suitable for entering the blood vessel through the working channel of the endoscope device
  • the laser generator generates The laser beam is transmitted to the selected location for laser ablation of the plaque in the blood vessel.
  • the intravascular atherectomy system further includes: a digital subtraction angiography machine capable of imaging blood vessels, determining the position of plaque in the blood vessel, and clarifying the filling state of the balloon and the location of the balloon.
  • a digital subtraction angiography machine capable of imaging blood vessels, determining the position of plaque in the blood vessel, and clarifying the filling state of the balloon and the location of the balloon.
  • the intravascular atherectomy system further includes: a control device, controlling the inflation of the balloon and the laser generator to generate laser light according to preset instructions.
  • the intravascular plaque excision system is suitable for excision of plaque in the carotid artery.
  • the first balloon is adapted to be placed at the opening of the external carotid artery on the affected side
  • the second balloon is adapted to be placed on the internal carotid artery on the affected side at the distal end of the plaque
  • the third balloon It is suitable to be placed on the affected common carotid artery at the proximal end of the plaque, so that when the first, second and third balloons are inflated, a bloodless environment is formed in the blood vessel around the plaque; the carotid artery sheath
  • the distal end of the target point occluded by the third balloon is set on the common carotid artery, so that the endoscopic device can enter the common carotid artery and the internal carotid artery.
  • the blood flow unit of the second balloon communicates with the arterial blood flow to deliver the arterial blood flow to the distal end of the second balloon in an open state.
  • the balloon catheter system comprises a first balloon catheter, a second balloon catheter and a third balloon catheter.
  • the third balloon catheter enters the right common carotid artery through the right femoral artery, the first balloon catheter and the second balloon catheter enter the third balloon catheter in a parallel arrangement, and exit the third balloon catheter.
  • Three balloon catheters were used to enter the external carotid artery and the internal carotid artery respectively.
  • said third balloon catheter comprises said guiding catheter.
  • the endoscopic device has a dual-chamber design, including an inner chamber and an outer chamber coaxially arranged; wherein, the inner chamber is optionally a working channel, which is suitable for sending corresponding plaque peeling, crushing, It is used for grasping and other instruments, and for washing the surgical field; the external cavity is suitable for the layout channel of the endoscopic lighting and camera system.
  • the plurality of image acquisition units are evenly distributed along the circumference of the outer cavity of the endoscope device; there are multiple illumination units, multiple illumination units, etc.
  • the spacing is distributed between two adjacent image acquisition units.
  • a method of operating the above-mentioned intravascular atherectomy system comprising: inserting the first balloon, the second balloon and the third balloon of the intravascular atherectomy system into the carotid artery , so that the first balloon is placed at the opening of the external carotid artery on the affected side, the second balloon is placed on the distal end of the internal carotid artery plaque on the affected side, and the third balloon is placed on the common carotid artery on the affected side.
  • the proximal end of the arterial plaque filling the second balloon, the first balloon and the third balloon in turn; after the second balloon catheter has blood regurgitation, open the blood transfer valve set in the second balloon flow unit.
  • the method further comprises: operating the intimal dissection device after inflating the first balloon, the second balloon and the third balloon.
  • the method further comprises: operating said laser device to direct laser light to plaque within the carotid artery.
  • the method further includes: guiding the lavage fluid into the carotid artery.
  • a method for removing common carotid artery plaque comprising: puncturing the bilateral femoral arteries through the femoral artery approach, and inserting them into arterial sheaths respectively; inserting the third balloon catheter through the right femoral artery sheath Place the common carotid artery on the affected side, then place the first balloon catheter on the external carotid artery through the left femoral artery sheath, and then place the second balloon catheter on the internal carotid artery on the affected side through the left femoral artery sheath, The first balloon is placed at the opening of the external carotid artery on the affected side, the second balloon is placed on the distal end of the internal carotid artery plaque on the affected side, and the third balloon is placed on the common carotid artery on the affected side The proximal end of the plaque; inflate the second, first, and third balloons successively, open the flanks of the Y valve at
  • the method for removing the arterial plaque further includes: continuously stripping the plaque to the distal end, followed by laser ablation and flushing, until the plaque is completely removed under the endoscopic view, and fully flushed to ensure that the surgical field is clean crumbs.
  • the method for removing arterial plaque further includes: when the resection is finished, keep the tail end of the third balloon catheter open, first deflate the second balloon and then refill it, then deflate the first balloon and withdraw it , properly suction the third balloon catheter, then deflate the third balloon, and finally deflate and withdraw the second balloon.
  • the method for removing the arterial plaque further includes: confirming the patency of the internal carotid artery and the intracranial artery by performing an angiography again through the third balloon catheter.
  • Endovascular atherectomy systems are mainly used in the field of coronary arteries as well as in the field of peripheral blood vessels.
  • the intravascular atherectomy systems used in these two fields are all performed under X-ray fluoroscopy, which cannot directly view the surgical area, which is likely to cause blood vessel penetration.
  • it can only partially ablate the plaque protruding to the vascular lumen, and cannot completely ablate the thickened intima and plaque. It is easy to cause damage to the vessel wall under visual inspection.
  • the intravascular plaque excision system realizes the operation under the visual environment of the endoscope, achieves the same immediate result of the operation as CEA, and at the same time ensures that the blood vessel wall is free from laser damage.
  • the intravascular plaque excision system of the present invention belongs to the minimally invasive interventional surgery system, without neck incision and tissue separation; it has the advantages of CEA and CAS at the same time, and successfully avoids the disadvantages of the two; it can realize no permanent implant in the body , reducing or not requiring long-term dual antiplatelet aggregation therapy. It also facilitates the implementation of salvage techniques, such as the release of carotid stents or stent grafts via balloon catheters.
  • Using the intravascular plaque excision system of the present invention to remove carotid plaque mainly includes the following steps: using the improved flexible electronic endoscope as the carotid intraluminal lighting and video acquisition system through the femoral artery approach, Depending on the environment, through the optical fiber laser transmission system, the plaque protruding to the lumen is directional removed, the intima of the lesion is peeled off by physical methods, and the separated intima tissue is further eliminated with laser under the protection device of the vessel wall, so as to completely remove the intima and Plaque, achieving the same effect as CEA, while ensuring that the vessel wall is protected from laser damage.
  • This novel intravascular atherectomy system of the present invention has unique innovations:
  • an endoscopic device can be provided in two ways.
  • the transfemoral approach is suitable.
  • a high-resolution (4K) flexible electronic endoscope was applied to endovascular ablation of carotid plaque.
  • the endoscope has the feature that the head end can turn left or right up to 90 degrees in the same plane.
  • By rotating the endoscope catheter and changing the direction of the endoscope end it can realize the full-angle observation of the carotid artery wall and plaque, which is an endoscopic Membrane plaque stripping provides detailed, ultra-high-definition imaging.
  • the instant image obtained through this endoscope is comparable to microscopic open surgery (CEA).
  • the biggest advantage is that it can obtain a full-angle view in the arterial lumen without opening the carotid artery wall.
  • the most innovative feature of this endoscope is that the distal end of the endoscope device (6F and 12F) is equipped with a vessel wall protection device, which can protect the vessel wall to the maximum extent, avoid accidental laser injury and improve work efficiency.
  • the second type of endoscopic device is suitable for the transcarotid approach, and has a coaxial double-lumen structure.
  • the lumen used as the working lumen has a larger diameter, which facilitates the entry and operation of instruments.
  • the multi-point lighting and camera system are arranged in the external cavity, and the observation of the surgical field is clearer and has a wider range.
  • Balloon occlusion and bypass unit A clear image can only be obtained by endoscopy in a bloodless water environment. By blocking the forward blood flow of the common carotid artery, external carotid artery, superior thyroid artery, and internal carotid artery with three balloons, a bloodless environment centered on plaque can be realized through the endoscopic flushing system. In the water environment, the operator performs precise laser ablation of plaques through ultra-high-definition endoscopic observation.
  • the blood bypass function of the affected side ensures the blood supply to the remote brain of the affected side, making the operation time relatively sufficient and unlimited, which is different from the bypass tube commonly used in CEA.
  • the two ends of the shunt tube commonly used in CEA include a balloon for blocking the proximal end of the common carotid artery and a balloon for blocking the proximal end of the internal carotid artery. These two balloons are inserted by cutting the common carotid artery and the internal carotid artery. Yes, it is not applicable in the system of the present invention.
  • the system of the present invention can achieve intracavitary plaque excision effect comparable to that of traditional CEA.
  • intracavitary laser ablation for cardiac coronary arteries was performed under DSA (non-direct vision), and the laser ablation catheter was advanced along the micro guide wire to partially ablate the plaque, which could only mostly eliminate the plaque and could not be achieved.
  • the plaque is completely separated from the media, and it is impossible to remove the plaque at the anatomical level.
  • the diameter of peripheral blood vessels is usually smaller than that of carotid arteries, and usually only a single balloon proximal occlusion can be achieved.
  • the first balloon catheter and the second balloon catheter are preferably sent into the third balloon catheter in a parallel arrangement to reach their respective blocking targets.
  • the placement of the first and second balloon catheters is facilitated after the third balloon catheter is in place. It further eliminates the space occupation of the catheter between the third balloon and the blood vessel wall caused by the parallel way during the transfemoral approach, so that the third balloon can directly fit the blood vessel wall better, and the occlusion is more accurate.
  • the diameter of the working channel of the endoscope device is increased to a greater extent, and the effective length of the endoscope entering the blood vessel is greatly shortened, which facilitates the entry and exit of corresponding surgical instruments and improves work efficiency. It avoids problems such as long path, tortuous blood vessels, and difficulty in passing through the femoral artery approach that the endoscopic system may face.
  • the operating steps of the system of the present invention for carotid plaque resection are as follows (taking transfemoral artery approach as an example): the patient lies supine on the DSA bed, general anesthesia, routine disinfection and draping, take bilateral femoral artery puncture points, cut The skin was opened and the bilateral femoral arteries were punctured with the modified Seldinger technique, and 15F arterial sheaths were placed respectively.
  • the third balloon (high compliance) catheter was guided by the guide wire through the right femoral artery sheath (15F) Placed in the common carotid artery of the affected side, and then through the left femoral artery sheath (15F), the first balloon (high compliance) catheter was placed in the external carotid artery of the affected side under the guidance of the guide wire, and then passed through the left femoral artery sheath (15F) 15F) A second balloon (high compliance) catheter was placed over the ipsilateral internal carotid artery over a guide wire.
  • an intima stripping device can be inserted through the working channel of the 12F endoscope, and the proximal end of the plaque is mechanically stripped to separate it from the media. Flush to make debris flow out of the working lumen of the 12F endoscope.
  • the plaque was continuously stripped to the distal end, followed by laser ablation and flushing, until the plaque was completely removed under the endoscope, and adequate flushing was performed to ensure that the surgical field was clean and free of debris.
  • keep the tail end of the third balloon catheter open first deflate the second balloon and then inflate again, then deflate the first balloon and withdraw it, properly suck the third balloon catheter, and then deflate the third balloon. balloon, and finally deflate and withdraw the second balloon.
  • the third balloon catheter re-angiography confirmed the patency of the internal carotid artery and intracranial artery, the operation ended.
  • Fig. 1 is a schematic structural diagram of an intravascular plaque excision system according to an embodiment of the present invention
  • Fig. 2 is a schematic diagram of the intravascular atherectomy system working in the human body according to an embodiment of the present invention
  • Fig. 3 is the enlarged view of place A in Fig. 2;
  • Fig. 4 is an experimental treatment effect diagram of an intravascular plaque excision system according to an embodiment of the present invention.
  • FIG. 5 is a schematic diagram of a transcatheter fiber stripper used in an intravascular atherectomy system according to an embodiment of the present invention
  • FIG. 6, Fig. 7 and Fig. 8 are schematic diagrams of a vessel wall protection device used in an intravascular plaque excision system according to an embodiment of the present invention
  • FIG 9, 10 and 11 are schematic structural diagrams of an endoscope device according to an embodiment of the present invention.
  • Fig. 1 is a schematic structural view of an intravascular atherectomy system according to an embodiment of the present invention, which is used for intravascular laser atherectomy via a femoral artery approach.
  • an intravascular atherectomy system 10 which may include an endoscope device 12, a balloon catheter system 13, an intimal dissection device 14, and may also include a laser device for laser generation and transmission 15.
  • the balloon catheter system 13 can be put into the blood vessel of the human body through the sheath tube 16, and can be used to block blood flow (131), block blood flow and bypass function (132), and can also be used to block blood flow and conduct Guide tube (133).
  • the balloon catheter system 13 may include three balloons, for example, a guide catheter and a first balloon 131 , a second balloon 132 and a third balloon 133 disposed at the distal end.
  • the first balloon, the second balloon, and the third balloon are adapted to be inflated to block blood flow in the blood vessel, and the second balloon further includes a blood bypass unit.
  • the first balloon 131 , the second balloon 132 and the third balloon 133 may respectively have corresponding guide catheters and constitute a first balloon catheter, a second balloon catheter and a third balloon catheter.
  • balloon catheter system 13 may be used to guide endoscopic device 12, endarterectomy device 14, and laser device 15 into the body.
  • the endoscopic device 12 is entered into the human body through a third balloon catheter.
  • the endoscope device 12 may be an improved flexible electronic endoscope, capable of performing illumination and video acquisition in blood vessels, such as carotid artery lumen.
  • blood vessels such as carotid artery lumen.
  • the second balloon catheter can be a double-lumen catheter, one lumen communicates with the balloon, through which the contrast medium can be filled to inflate the balloon; the other lumen is the main channel, and the inner Instruments such as microcatheters and microguidewires can be inserted, and fluid can be injected or arterial blood from the femoral artery can be diverted to ensure positive blood flow in the distal vascular bed where the balloon is blocked.
  • the inner Instruments such as microcatheters and microguidewires can be inserted, and fluid can be injected or arterial blood from the femoral artery can be diverted to ensure positive blood flow in the distal vascular bed where the balloon is blocked.
  • the second balloon catheter Because of the introduction of the second balloon catheter, it blocks the reverse blood flow of the internal carotid artery and realizes a bloodless environment in the blood vessel of the lesion together with the first and third balloon catheters, and more importantly, provides The blood circulation function of the affected side ensures the blood supply to the remote brain of the affected side, so that the operation time is relatively sufficient and unrestricted.
  • the intima stripping device 14 may be, for example, a microscopic instrument for stripping the intima under an endoscope, such as a transcatheter microdissector.
  • the transcatheter microdissection tool is made of nickel-titanium alloy wire, integrally formed, and divided into two parts, the distal and proximal ends.
  • the far end is a stripping shovel 41, and the shovel surface 42 of the stripping shovel is cut at an angle of 15-45 degrees by a nickel-titanium alloy wire with a diameter of 1 mm to 1.5 mm, such as at multiple angles of 15 degrees, 30 degrees or 45 degrees. Cut at an angle, the sharp edges around the cut surface are ground and passivated.
  • the proximal end is the joystick 43, and the stripping shovel 41 and the joystick 43 are folded into an angle of 5-45 degrees along the direction of the shovel surface 42 as required, such as being folded into an angle of 5 degrees, 15 degrees, 30 degrees or 45 degrees.
  • the distance from the shovel end to the corner point is 5mm, 10mm, 15mm, 20mm and other different lengths.
  • the intima stripping device 14 can be a transcatheter microscopic tissue capture device, which consists of a storage net, a capture ring, and a delivery rod.
  • the former is made of nylon or other membranous materials, and the mesh diameter is 50-100 microns. Both are made of Nitinol and the capture ring is angled at 135 degrees to the delivery rod.
  • the intima stripping device 14 may also be other suitable instruments capable of stripping the intima and plaque.
  • the intima stripping device 14 can strip the intima and plaque 17 at the lesion, and can completely strip the plaque 17 at the lesion.
  • Plaque stripping or intimal stripping in the present invention refers to stripping from the anatomical structure, that is, stripping from the potential gap between the subintima and the media at the plaque, which is realized by physical methods without causing damage to the vessel wall. heat damage.
  • the laser device 15 includes a laser generator and a laser transmission fiber 151 .
  • the laser generator is used to emit laser light and control the emitted laser light.
  • the laser transmission fiber 151 guides the laser to the stripped plaque area, and uses the laser to ablate the plaque.
  • the laser optical fiber 151 reaches the stripped plaque area through the optical fiber chamber (and flushing channel) of the endoscope device 12 .
  • the endoscopic device 12 has a catheter, and the catheter includes at least two chambers, one of which is provided with a laser transmission optical fiber, and can also allow lavage liquid to pass through.
  • the lavage liquid can flush the ablated plaque debris, and at the same time, it can also cool down the laser transmission optical fiber 151 and the blood vessel in the working area, so as to reduce the thermal damage to the blood vessel wall.
  • the other chamber of the endoscope device 12 is provided with a light source for illumination and a video capture device.
  • the endoscopic device 12 is a double-chamber system with a diameter of 6F (or a three-chamber system with a diameter of 12F, which has one more working channel than that of 6F, through which the stripping device can be transported, or suction or Take out the plaque debris through the capture device), one cavity is the endoscope lighting and camera system, and the other cavity is the optical fiber entry and flushing channel.
  • the 2cm of the head end is a soft structure, which can be operated outside the body to change the direction of the lens.
  • the distal end of the endoscope device 12 may also be provided with a vessel wall protection device. For example, see Figures 6-8.
  • the vessel wall protection device is a thin-walled stainless steel tube with a diameter of 1/2-2/3 inlaid on the periphery of the endoscopic segment.
  • the device can isolate the separated plaque from the vessel wall Open, provide the best protection for the fiber-transmitted laser to act on the target, and avoid the thermal damage of the laser to the blood vessel wall.
  • the optical fiber head end is located inside the protection device, 1mm away from the head end of the protection device.
  • the distal end of the laser transmission fiber 151 is located in the vessel wall protection device, so that the laser transmission fiber 151 will not cause damage to the vessel wall during ablation.
  • F is the unit related to the size of the catheter (abbreviation of French), and 1F is about 0.33mm.
  • the intravascular atherectomy system 10 may further include a digital subtraction angiography machine, and the digital subtraction angiography machine (DSA) can image blood vessels to determine lesion areas (plaques)
  • DSA digital subtraction angiography machine
  • balloon catheters of different specifications can be selected according to the diameter.
  • the third, second and first balloon catheters were introduced over the guide wire under DSA fluoroscopy. After the balloon catheter is in place, the filling degree of the balloon is monitored under fluoroscopy, and angiography is performed to judge whether the balloon completely blocks the blood flow.
  • the endoscopic device 12 is then introduced through the third balloon catheter.
  • the balloon catheter system 13 may include three balloon catheters, namely the first balloon catheter (2F), the second balloon catheter (4F) and the third balloon catheter (10F or 12F).
  • the balloon catheter system 13 can also be an integrated balloon catheter system.
  • the so-called integrated balloon catheter system refers to that the catheter part of the first balloon catheter and the second balloon catheter are fitted into the first balloon catheter through a certain process.
  • the advantage is that the third balloon has a more accurate blocking effect on the blood flow of the common carotid artery.
  • an inflatable balloon is provided at the front end of the balloon catheter, and the balloon may be a highly compliant balloon.
  • the first balloon 131 is placed at the opening of the external carotid artery on the affected side
  • the second balloon 132 is placed at the distal end of the stenosis of the internal carotid artery.
  • the third balloon 133 is placed at the common carotid artery of the affected side, that is, the proximal end of the plaque.
  • the balloon 131 at the opening of the external carotid artery can block the reverse blood flow of the external carotid artery and the superior thyroid artery
  • the balloon 132 at the distal end of the internal carotid artery stenosis can block the reverse blood flow of the internal carotid artery.
  • the balloon 133 at the common carotid artery can block the blood flow of the common carotid artery, and by filling the three balloons 131, 132, 133, a bloodless environment in the vascular lumen of the lesion can be realized.
  • the catheter of the balloon 133 at the common carotid artery can be used as a guiding catheter for guiding the endoscopic device 12, the endarterectomy device 14 and the laser device 15 into the diseased area in the body, and can also be used as a suction catheter , for suction of debris.
  • the intravascular atherectomy system 10 may also include a continuous irrigation and withdrawal device, wherein the irrigation can deliver lavage fluid to the body through one of the chambers of the endoscope device 12 (6F endoscope) , the suction can be used to aspirate the debris in the body through the third balloon catheter (or aspirate through the working channel of the 12F endoscope).
  • the irrigation can deliver lavage fluid to the body through one of the chambers of the endoscope device 12 (6F endoscope)
  • the suction can be used to aspirate the debris in the body through the third balloon catheter (or aspirate through the working channel of the 12F endoscope).
  • FIG. 2 is a schematic diagram of the operation of the intravascular atherectomy system in a human body according to an embodiment of the present invention.
  • the intravascular atherectomy system 10 when the intravascular atherectomy system 10 according to one embodiment of the present invention is in use, firstly, with the assistance of a digital subtraction angiography machine, puncture through the bilateral femoral arteries, and respectively insert into the arterial sheath 16. Introduce the first and second balloon catheters through the left femoral artery sheath under the condition of continuous pressure flushing, and place the first balloon and the second balloon at the opening of the external carotid artery and the internal carotid artery on the affected side respectively The distal end of the stenosis.
  • a third balloon catheter was introduced through the right femoral artery sheath 16, and the third balloon was placed in the affected common carotid artery, that is, the proximal end of the plaque.
  • the side tube of the left arterial sheath is connected to the Y-shaped valve flank at the tail end of the balloon catheter 132 and the three-way switch is opened, so that the blood of the left femoral artery flows through the balloon catheter 132 to the far side of the affected side.
  • Both femoral artery sheaths are 15F arterial sheaths with a length of 20cm.
  • the main channel can enter the catheter or guide wire within 15F.
  • the side tube has a three-way switch.
  • Outflow, through the flanks of the Y-shaped valve connected to the tail end of the second balloon catheter, can guide the blood flow part of the left femoral artery to the second balloon catheter, thereby realizing the inflation of the balloon at the head end of the second balloon catheter 132 blocks the reverse blood flow of the internal carotid artery while ensuring the positive blood flow of the internal carotid artery to provide effective perfusion for the brain on the surgical side. Therefore, the operation can be carried out leisurely, almost without time limit.
  • the balloon 132 is inflated to block the blood flow of the internal carotid artery, so as to ensure the effective perfusion of the affected cerebral hemisphere.
  • the intima stripping device 14 is sent into the lesion area through the third balloon catheter, and the intima and plaque in the lesion area are stripped.
  • the laser generator is turned on, and laser light is emitted through the laser transmission fiber 151 to ablate the stripped intima and plaque.
  • intracavitary laser ablation can be performed first, followed by mechanical stripping, and then the stripped tissue can be ablated, and the resulting larger tissue fragments can be removed with a transcatheter microscopic tissue trap until the lesion is completely removed intima and plaques.
  • the blood diversion unit may include the main channel of the second balloon catheter or a catheter in the main channel, appropriate control valves (such as the above-mentioned three-way valve and Y-valve, etc.), and the like.
  • the main channel or a catheter within the main channel introduces blood at the femoral artery and draws it out beyond the distal end of the second balloon, and devices such as control valves are used to control the flow of blood.
  • the direction shown by B in FIG. 2 is the blood diversion direction in an embodiment of the present invention.
  • the blood flow returns to the brain by means of diversion, so that the carotid artery plaque stripping operation can be realized under the condition that the blood vessels in the lesion area are blocked but the blood flow in the brain does not stop.
  • Fig. 3 is an in vitro experimental therapeutic effect diagram using the intravascular plaque excision system according to an embodiment of the present invention.
  • the endovascular atherectomy system 10 of the present invention can achieve the same operation result as CEA under minimally invasive conditions comparable to traditional percutaneous carotid artery stent implantation, that is, intima , Complete excision of the plaque.
  • the plaque Under the protection of the vascular wall protection device at the end of the endoscope, the plaque can be completely ablated by the laser, while the vascular wall is protected from damage.
  • Figure 3 shows the complete and undamaged state of the vessel wall after the plaque tissue is completely removed by laser ablation under the endoscope equipped with a vessel wall protection device in the simulated state of carotid plaque stenosis or occlusion in vitro (the model is a porcine aorta blood vessels, made from human carotid artery plaques obtained through chimera surgery). This trial confirmed that laser ablation of carotid plaque is safe and feasible with a vessel wall protection device.
  • Fig. 4 is an experimental therapeutic effect diagram of the intravascular atherectomy system according to an embodiment of the present invention.
  • the endoscopic device 12 enters the common carotid artery and the internal carotid artery through the arterial sheath placed in the common carotid artery, and the endoscope handle is held in hand or a fixed endoscope is placed outside the body.
  • the corresponding device is convenient for maintaining a good surgical field of view.
  • the puncture point where the arterial sheath enters the common carotid artery is at or below the level of the thyroid cartilage, and the puncture point is located at the distal end of the target point for occlusion by the third balloon.
  • the inner diameter of the arterial sheath should match the outer diameter of the endoscope.
  • the maximum design length of the part of the endoscopic device 12 entering the blood vessel is 15 cm, generally the effective length of entering the blood vessel is 5 cm, the tip 2 cm is a soft structure, and the maximum deflection angle of the soft structure is 45-60 degrees.
  • Endoscopic device 12 may include an inner lumen and an outer lumen arranged coaxially.
  • the maximum designed outer diameter of the endoscope device 12 can be selected as 12F, 14F, 16F or 18F, and the corresponding inner diameter of the lumen is 5F, 7F, 9F or 11F respectively.
  • the diameter of the working channel of the endoscope is increased to a greater extent, and the effective length of the endoscope entering the blood vessel is greatly shortened, which facilitates the entry and exit of corresponding surgical instruments and improves work efficiency. It avoids the problems of long path, tortuous blood vessels, and difficulty in passing through the femoral artery approach that the original endoscopic system may face.
  • the inner cavity can optionally be a working channel, through which corresponding plaque peeling, crushing, grasping and other instruments can be sent, and the surgical field can also be rinsed.
  • the external cavity is optionally a layout channel for the endoscopic illumination and camera system.
  • the endoscope lighting system includes multiple lighting units, and the camera system includes multiple image acquisition units. A plurality of image acquisition units are evenly distributed along the circumference of the outer cavity of the electronic endoscope, and a plurality of illumination units are equally spaced between two adjacent image acquisition units.
  • This method increases the diameter of the working channel of the endoscope to a greater extent, greatly shortens the effective length of the endoscope entering the blood vessel, facilitates the entry and exit of corresponding surgical instruments, and improves work efficiency. It avoids problems such as long path, tortuous blood vessels, and difficulty in passing through the femoral artery approach that the endoscopic system may face.
  • the external cavity is divided into 12 equal parts, and multiple image acquisition units are respectively located at 3 o'clock, 6 o'clock, 9 o'clock and 12 o'clock, and the acquired images can be synthesized into a holographic real-time image through a computer software system.
  • the images can also be imaged separately on 4 external monitors, which is convenient for the operator to observe.
  • a plurality of lighting units are respectively located at 1 o'clock, 2 o'clock, 4 o'clock, 5 o'clock, 7 o'clock, 8 o'clock, 10 o'clock, and 11 o'clock.
  • the layout of the external cavity can ensure a good surgical field of view during the intravascular operation, and avoid the possibility that a single camera system cannot see the surgical field clearly due to special angles and obstructions of corresponding tissues.
  • the endoscope device 12 includes a tubular endoscope part and a handle; a data cable extends from the bottom of the handle and can be connected to the host.
  • the handle and the tubular endoscope part form a certain angle ⁇ , and the angle ⁇ can be any suitable angle, for example, the angle ⁇ is 120 degrees.
  • Fig. 11 is a perspective view of direction A in Fig.
  • the distance between the plurality of image acquisition units and the distance between the plurality of illumination units may also be unequal, for example, they may be set in a symmetrical manner or in other suitable manners.
  • a good surgical field of view can be ensured during intravascular operation, and the possibility that a single camera system cannot see the surgical field clearly due to special angles and obstructions of corresponding tissues is avoided.
  • the first balloon catheter (2F) and the second balloon catheter (4F) are sent into the third balloon catheter (10F or 12F) in a parallel arrangement to reach their respective blocking targets. point.
  • the placement of the first and second balloon catheters is facilitated after the third balloon catheter is in place. It further eliminates the space occupied by the catheter between the third balloon 133 and the blood vessel wall in the transfemoral approach, so that the third balloon 133 can be better directly attached to the blood vessel wall, and the occlusion is more accurate.
  • a method of operating the above-mentioned intravascular atherectomy system comprising: inserting the first balloon, the second balloon and the third balloon of the intravascular atherectomy system into the carotid artery , so that the first balloon is placed at the opening of the external carotid artery on the affected side, the second balloon is placed on the distal end of the internal carotid artery plaque on the affected side, and the third balloon is placed on the common carotid artery on the affected side.
  • the proximal end of the arterial plaque filling the second balloon, the first balloon and the third balloon in turn; after the second balloon catheter has blood regurgitation, open the blood transfer valve set in the second balloon flow unit.
  • said method further comprises operating said endarterectomy device after inflating said first balloon, second balloon and third balloon.
  • the method further comprises operating said laser device to direct laser light to the plaque within the carotid artery.
  • the method further comprises directing lavage fluid into the carotid artery.
  • a method for removing common carotid artery plaque comprising: puncturing the bilateral femoral arteries through the femoral artery approach, and inserting them into the arterial sheath respectively; inserting the third balloon through the right femoral artery sheath
  • the catheter is placed in the common carotid artery of the affected side, and then the first balloon catheter is placed in the external carotid artery of the affected side through the left femoral artery sheath, and then the second balloon catheter is placed in the internal carotid artery of the affected side through the left femoral artery sheath , so that the first balloon is placed at the opening of the external carotid artery on the affected side, the second balloon is placed on the distal end of the internal carotid artery plaque on the affected side, and the third balloon is placed on the common carotid artery on the affected side.
  • the proximal end of the arterial plaque inflate the second, first, and third balloons successively, open the flanks of the Y valve at the tail end of the second balloon catheter, and connect it to the left femoral artery sheath connecting tube after seeing blood regurgitation , make the arterial blood in the left femoral artery sheath flow into the internal carotid artery of the affected side through the second balloon catheter; introduce the endoscopic device into the common carotid artery through the third balloon catheter or introduce the endoscopic device into the common carotid artery through the carotid sheath Artery, to the proximal end of the plaque; insert the intimal stripping device through the working lumen of the endoscopic device, mechanically strip the proximal end of the plaque, separate it from the media, and perform laser ablation on the plaque tissue, and Flushing is performed to allow debris to flow out of the working lumen of the endoscopic device.
  • the first, second and third balloon catheters can also be introduced: the third balloon The balloon catheter enters the right common carotid artery through the right femoral artery, the first balloon catheter and the second balloon catheter enter the third balloon catheter in a parallel arrangement, and after exiting the third balloon catheter, respectively Access to the external and internal carotid arteries.
  • the method for removing the arterial plaque further includes continuously stripping the plaque to the distal end, followed by laser ablation and flushing, until the plaque is completely removed under the endoscopic view, and fully flushed to ensure that the surgical field is clean and free of fragments crumbs.
  • the method for excision of arterial plaque further includes keeping the tail end of the third balloon catheter open when the excision is finished, first deflecting the second balloon and then refilling, then deflecting the first balloon and withdrawing it, Suction the third balloon catheter appropriately, then deflate the third balloon, and finally deflate and withdraw the second balloon.
  • the method for removing the arterial plaque further includes confirming the patency of the internal carotid artery and the intracranial artery by performing an angiography again through a third balloon catheter.
  • the intravascular atherectomy system 10 of the present invention is not limited to the resection of carotid artery plaques, and can also be used in the field of peripheral blood vessels, such as the aorta, mesenteric artery, iliac artery, lower extremity above the knee joint level Arteriosclerotic plaques in larger diameter vessels, and other suitable areas of surgery.

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Abstract

一种血管内斑块切除系统（10），包括：适于插入血管中的球囊导管系统（13），球囊导管系统（13）包括导引导管和设置在远端的第一球囊（131）、第二球囊（132）和第三球囊（133），第一球囊（131）、第二球囊（132）和第三球囊（133）适于被充盈以在血管中阻断血流，第二球囊（132）包括血液转流单元；内镜装置（12），包括内镜连接管和设置在连接管远端的照明单元和图像采集单元，适于通过导引导管插入血管中进行照明和图像采集；内膜剥离装置（14），包括设置在近端的操作单元、在远端的剥离单元和连接操作单元与剥离单元的剥离连接管，适于通过导引导管进入血管中进行血管中斑块的剥离操作。

Description

一种血管内斑块切除系统及切除方法 技术领域
本发明涉及一种血管内斑块切除系统及切除方法，具体而言涉及动脉内的斑块切除系统及切除方法。
背景技术
颈动脉斑块的发病率较高，数据表明我国颈动脉斑块的患者达到2亿人，60岁以上人群颈动脉斑块的检出率接近100％。颈动脉斑块形成达到一定程度可以导致颈动脉狭窄或不稳定斑块脱落，进而导致缺血性卒中发生，严重威胁人群的健康。
目前针对颈动脉斑块导致的颈动脉狭窄或闭塞的主要手术方式包括颈动脉内膜剥脱术(CEA)和颈动脉球囊扩张支架植入术(CAS)，前者具有斑块切除比较彻底的优势，后者具有微创，不需要开放式手术的优势。但是，二者均存在一定的问题。
CEA本身特有的主要问题：1、心肺功能较差者不能耐受全身麻醉下的这类开放性手术；2、发生心脏事件相对较高；3、血管缝合口致命性出血，导致窒息和心脏骤停；4、切口感染的可能；5、颈动脉窦神经损伤及颅神经损伤的缺陷，严重者造成术后难以控制的高血压、声音嘶哑、颈部皮肤感觉障碍等；6、手术切口较大，瘢痕形成，影响外观的缺陷。
CAS本身特有的问题：1、支架植入后需要长期口服双联抗血小板聚集药物，增加了神经系统和消化系统出血的风险；2、斑块未被清除，而是靠球囊扩张挤压出血管通道，支架植入维持狭窄部位的形态并保持通畅，但远期存在支架内再狭窄或闭塞问题；3、围术期斑块脱落、栓子栓塞事件相对较高，尤见于不稳定斑块的患者；4、对于颈动脉窦反射比较敏感的患者，支架植入术后常出现较长时间的心率减慢，血流动力学不稳定的情况；5、支架本身为金属永久性植入物。
因此，需要一种新型的血管内斑块切除系统及切除方法。
发明内容
本发明的目的在于提供一种血管内斑块切除系统，既能获得CEA开放式可视环境下彻底切除斑块的效果，可以完全剥除病变部位的内膜和斑块；又能媲美CAS微创手术的特点，同时规避CEA和CAS本身固有的缺陷。
根据本发明的一个方面，提供一种血管内斑块切除系统，包括：适于插入血管中的球囊导管系统，包括导引导管和设置在远端的第一球囊、第二球囊和第三球囊，所述第一球囊、第二球囊和第三球囊适于被充盈以在血管中阻断血流，所述第二球囊包括血液转流单元；内镜装置，包括内镜连接管和设置在连接管远端的照明单元和图像采集单元，适于通过所述导引导管插入血管中进行照明和图像采集；内膜剥离装置，包括设置在近端的操作单元、在远端的剥离单元和连接操作单元与剥离单元的剥离连接管，适于通过导引导管进入血管中进行血管中斑块的剥离操作。
优选的，所述的血管内斑块切除系统还包括：激光装置，包括激光发生器和激光传导光纤，所述激光传输光纤适于通过内镜装置的光纤通道进入血管中，将激光发生器产生的激光传导到选定位置对血管中的斑块进行激光消融。
优选的，所述的血管内斑块切除系统还包括：数字减影血管造影机，能够对血管成像，确定血管中产生斑块的位置，明确球囊充盈状态及球囊所处的位置。
优选的，所述的血管内斑块切除系统还包括：控制装置，根据预设的指令控制球囊进行充盈和激光发生器产生激光。
优选的，所述的血管内斑块切除系统适于对颈动脉内的斑块进行切除。
优选的，所述第一球囊适于放置在患侧颈外动脉开口处，所述第二球囊适于在斑块的远心端放置在患侧颈内动脉，所述第三球囊适于在斑块的近心端放置在患侧颈总动脉，使得所述第一、第二和第三球囊充盈时在斑块周围的血管内形成无血环境。
优选的，所述第二球囊的血液转流单元与动脉血流联通以在打开状态下将动脉血流输送到第二球囊的远心端。
优选的，所述球囊导管系统包括第一球囊导管、第二球囊导管和第三球囊导管。
优选的，第三球囊导管经右侧股动脉置入颈总动脉，第一球囊导管和第二球囊导管以并行排列方式经左侧股动脉置入颈外动脉和颈内动脉。
优选的，所述第三球囊导管包括所述导引导管。
优选的，所述内镜装置具有导管，所述导管包括容纳照明单元和图像采集单元的第一腔道，和适于激光传输光纤和/或灌洗液通过的第二腔道，所述内镜装置的远端设有血管壁保护装置。
优选的，所述图像采集单元有多个，多个所述图像采集单元沿周向均匀分布；所述照明单元有多个，多个所述照明单元等间距分布在相邻两个所述图像采集单元之间。
优选的，所述内镜装置还包括第三通道，用作工作通道。
根据本发明另一个方面，提供一种血管内斑块切除系统，包括：适于插入血管中的球囊导管系统，包括导引导管和设置在远端的第一球囊、第二球囊和第三球囊，所述第一球囊、第二球囊和第三球囊适于被充盈以在血管中阻断血流，所述第二球囊包括血液转流单元；内镜装置，包括内镜连接管和设置在连接管远端的照明单元和图像采集单元，适于通过动脉鞘管插入血管中进行照明和图像采集；内膜剥离装置，包括设置在近端的操作单元、在远端的剥离单元和连接操作单元与剥离单元的剥离连接管，适于通过内镜装置的工作通道进入血管中进行血管中斑块的剥离操作。
优选的，所述的血管内斑块切除系统还包括：激光装置，包括激光发生器和激光传导光纤，所述激光传输光纤适于通过内镜装置的工作通道进入血管中，将激光发生器产生的激光传导到选定位置对血管中的斑块进行激光消融。
优选的，所述的血管内斑块切除系统还包括：数字减影血管造影机，能够对血管成像，确定血管中产生斑块的位置，明确球囊充盈状态及球囊所处的位置。
优选的，所述的血管内斑块切除系统还包括：控制装置，根据预设的指令控制球囊进行充盈和激光发生器产生激光。
优选的，所述的血管内斑块切除系统适于对颈动脉内的斑块进行切除。
优选的，所述第一球囊适于放置在患侧颈外动脉开口处，所述第二球囊适于在斑块的远心端放置在患侧颈内动脉，所述第三球囊适于在斑块的近心端放置在患侧颈总动脉，使得所述第一、第二和第三球囊充盈时在斑块周围的血管内形成无血环境；所述颈动脉鞘管在第三球囊封堵的靶点远端设置于颈总动脉，使得内镜装置能够进入颈总动脉及颈内动脉。
优选的，所述第二球囊的血液转流单元与动脉血流联通以在打开状态下将动脉血流输送到第二球囊的远心端。
优选的，所述球囊导管系统包括第一球囊导管、第二球囊导管和第三球囊导管。
优选的，第三球囊导管经右侧股动脉进入右侧颈总动脉，所述第一球囊导管、所述第二球囊导管以并行排列方式进入所述第三球囊导管，出第三球囊导管后分别进入颈外动脉和颈内动脉。
优选的，所述第三球囊导管包括所述导引导管。
优选的，所述内镜装置具有双腔设计，包括同轴设置的内腔和外腔；其中，内腔可选地为工作通道，适于经过该通道送入相应的斑块剥离、粉碎、抓取等器械，及用于对手术野进行冲洗；外腔适于用作内镜照明和摄像系统的布局通道。
优选的，内镜装置的所述图像采集单元有多个，多个所述图像采集单元沿内镜装置的外腔周向均匀分布；所述照明单元有多个，多个所述照明单元等间距分布在相邻两个所述图像采集单元之间。
根据本发明另一方面，提供一种操作上述血管内斑块切除系统的方法，包括：将所述血管内斑块切除系统的第一球囊、第二球囊和第三球囊插入颈动脉，使得所述第一球囊放置在患侧颈外动脉开口处，所述第二球囊放置在患侧颈内动脉斑块的远心端，所述第三球囊放置在患侧颈总动脉斑块的近心端；依次充盈所述第二球囊、第一球囊和第三球囊；第二球囊导管有血液返流后，打开所述第二球囊中设置的血液转流单元。
优选的，所述的方法还包括：在充盈所述第一球囊、第二球囊和第三球囊后操作所述内膜剥离装置。
优选的，所述的方法还包括：操作所述激光装置以将激光引导到颈动脉内的斑块。
优选的，所述的方法还包括：将灌洗液引导到颈动脉内。
根据本发明另一方面，提供一种切除颈总动脉斑块的方法，包括：经股动脉入路穿刺双侧股动脉，分别置入动脉鞘；经右侧股动脉鞘将第三球囊导管置于患侧颈总动脉，再经左侧股动脉鞘将第一球囊导管置于患侧颈外动脉，然后经左侧股动脉鞘将第二球囊导管置于患侧颈内动脉，使得所述第一球囊放置在患侧颈外动脉开口处，所述第二球囊放置在患侧颈内动脉斑块的远心端，所述第三球囊放置在患侧颈总动脉斑块的近心端；先后充盈第二、第一、第三球囊，打开第二球囊导管尾端Y阀的侧翼，见血液返流后将其与左侧股动脉鞘连通管连接，使左侧股动脉鞘内的动脉血经第二球囊导管流入患侧颈内动脉；将内镜装置经第三球囊导管引入颈总动脉或者将内镜装置经过颈动脉鞘引入颈总动脉，至斑块的近心端；经内镜装置的工作腔道置入内膜剥离装置，机械剥离斑块近心端，使其与中膜分离，并对斑块组织进行激光消融，并进行冲洗，使碎屑从内镜装置的工作腔道流出。
优选的，所述的切除动脉斑块的方法还包括：不断向远心端剥离斑块，继之激光消融、冲洗，直至在内镜视野下斑块完全切除，充分冲洗，确保术野干净无碎屑。
优选的，所述的切除动脉斑块的方法还包括：结束切除时，保持第三球囊导管尾端开放，先泄掉第二球囊随即再次充盈，然后泄掉第一球囊并撤出，适当抽吸第三球囊导管，之后泄掉第三球囊，最后泄掉并撤出第二球囊。
优选的，所述的切除动脉斑块的方法还包括：经第三球囊导管再次造影确认颈内动脉及颅内动脉通畅。
血管内斑块切除系统主要用于冠状动脉领域以及外周血管领域。但是这两个领域使用的血管内斑块切除系统均是在X光透视下进行，无法直视手术区域，容易造成血管穿透。并且其只能对凸向血管腔的斑块进行部分消融，无法做到对增厚的内膜与斑块的完 全消融，斑块仍然会再生长，造成术后再狭窄或闭塞，而且非直视下容易造成血管壁损伤。
根据本发明一种实施方式的血管内斑块切除系统实现了血管内镜可视环境下手术，达到CEA同样的手术即期结果，同时确保血管壁免于激光损伤。本发明的血管内斑块切除系统属于微创介入手术系统，无需颈部切开皮肤和分离组织；同时具备CEA和CAS的优势，成功规避了二者的劣势；能够实现体内无永久植入物，减少或不需要长期双联抗血小板聚集治疗。另外还便于补救技术的实施，例如可以经球囊导管释放颈动脉支架或覆膜支架。
采用本发明所述的血管内斑块切除系统切除颈动脉斑块，主要包括以下步骤：经股动脉入路，将改良的软性电子内镜作为颈动脉腔内照明和录像采集系统，在可视环境下通过光纤激光传输系统，定向清除凸向管腔的斑块，采用物理方法剥离病变处内膜，在血管壁保护装置下进一步以激光消除分离的内膜组织，从而彻底清除内膜和斑块，达到与CEA相同的效果，同时确保血管壁免于激光损伤。
本发明的这种新型的血管内斑块切除系统具有独特的创新性：
1)内镜系统：根据本发明的不同实施例，能够以两种方式提供内镜装置。对于第一种内镜装置，适于经股动脉入路。首次将高分辨率(4K)的软性电子内镜应用于颈动脉斑块腔内消融术。该内镜具备头端在同一平面内向左或向右转向最大至90度的特点，通过旋转内镜导管和改变内镜头端指向，可以实现对颈动脉壁和斑块的全角度观察，为内膜斑块剥离操作提供精细、超高清的影像。通过该内镜获得的即时影像效果堪比显微镜下开放手术(CEA)。而其最大的优点就是不需要开放式切开颈动脉壁，就可以动脉腔内获得全角度视野。该内镜的最大创新之处在于内镜装置(6F和12F)的远端设有血管壁保护装置，可以最大限度保护血管壁，免受激光的误伤以及提高工作效率。对于第二种内镜装置，适于经颈动脉入路，具有内外同轴的双腔结构，作为工作腔道的内腔，直径更大，便于器械进入和操作。外腔布局多点照明及摄像系统，术野观察更清晰范围更广的特点。
2)球囊阻断及转流单元：血管内镜需要在无血的水域环境下才可获得清晰的图像。通过三球囊分体式阻断颈总动脉正向血流、颈外动脉、甲状腺上动脉及颈内动脉的返流，通过内镜的冲洗系统就可以实现以斑块为中心的无血环境。在水域环境 下，术者通过超高清内镜观察对斑块进行精准激光消融。因为第二球囊导管的引入，其在阻断颈内动脉的反向血流并与第一和第三球囊导管共同实现病变处血管内一个无血环境的同时，更重要的是提供了患侧的血液转流功能(即转流单元)，保证患侧远端的大脑血供，使得手术时间相对充足，不受限制，其不同于CEA时常用的转流管。CEA时常用的转流管两端分别包括阻断颈总近端的球囊和阻断颈内动脉近端的球囊，这两个球囊是通过切开颈总动脉和颈内动脉置入的，在本发明的系统中不适用。
3)全视野可视+解剖分离+激光消融：本发明的系统可以实现腔内斑块切除效果媲美传统CEA。以往的用于心脏冠脉的腔内激光消融术是在DSA下(非直视下)，沿微导丝推进激光消融导管，对斑块进行部分消融，仅能大部分消除斑块，无法实现斑块完整地与中膜分离，也就无法达到解剖学水平上的清除斑块。而外周血管管径通常比颈动脉小，通常只能实现单球囊近段阻断。由于远端侧枝吻合，很难实现斑块处绝对无血，这就影响了内镜观察。因此，目前临床上在下肢动脉斑块激光消融时，仍然类似于心脏冠脉斑块激光消融，很难实现内镜下完全可视，因而无法达到解剖学水平的切除斑块。而本发明的系统用于颈动脉斑块切除时，在DSA+内镜+三球囊阻断+转流+机械剥离+血管壁保护+激光消融的组合配合下，完全实现了颈动脉斑块腔内可视环境下解剖学水平切除。
4)经颈动脉入路时，第一球囊导管、第二球囊导管优选地以并行排列方式送入第三球囊导管，分别送达各自的阻断靶点。在第三球囊导管置放到位后，方便了第一和第二球囊导管到位。进一步消除了经股动脉入路时第三球囊与血管壁之间因并行方式导致的导管占位，使第三球囊更好的直接与血管壁贴合，封堵更加确切。
5)经颈动脉入路时，更大程度地增加了内镜装置的工作通道直径，极大地缩短了内镜进入血管的有效长度，便于相应手术器械的进出，提高工作效率。避免了内镜系统经股动脉入路可能面临的路径较长、血管迂曲、通过困难等问题。
本发明系统用于颈动脉斑块切除术的操作步骤如下(以经股动脉入路为例)：患者平卧于DSA床板，全身麻醉，常规消毒铺巾，取双侧股动脉穿刺点，切开皮肤并以改良Seldinger技术穿刺双侧股动脉，分别置入15F动脉鞘，在DSA透视下，经右侧股动脉鞘(15F)将第三球囊(高顺应性)导管在导丝引导下置于患侧颈总动脉，再经左侧股动脉鞘(15F)将第一球囊(高顺应性)导管在导丝引导下置于患侧颈外动脉，然后经 左侧股动脉鞘(15F)将第二球囊(高顺应性)导管在导丝引导下置于患侧颈内动脉。先后充盈第二、第一、第三球囊，经第三球囊导管注射造影剂，确认各个球囊阻断确切，最后打开第二球囊导管尾端Y阀的侧翼，见血液返流后将其与左侧股动脉鞘连通管连接，使左侧股动脉鞘内的动脉血经第二球囊导管流入患侧颈内动脉。再将内镜系统经第三球囊导管，在DSA透视下缓慢引入颈总动脉，斑块的近心端。经内镜冲洗以斑块为中心的术野，在内镜下再次确认各个球囊阻断确切。之后可经12F内镜的工作腔道置入内膜剥离装置，机械剥离斑块近心端，使其与中膜分离，对内镜头端的血管壁保护装置内的斑块组织进行激光消融，不断冲洗，使碎屑从12F内镜的工作腔道流出。不断向远心端剥离斑块，继之激光消融、冲洗，直至内镜下斑块完全切除，充分冲洗，确保术野干净无碎屑。结束手术时，保持第三球囊导管尾端开放，先泄掉第二球囊随即再次充盈，然后泄掉第一球囊并撤出，适当抽吸第三球囊导管，之后泄掉第三球囊，最后泄掉并撤出第二球囊。经第三球囊导管再次造影确认颈内动脉及颅内动脉通畅后结束手术。
附图说明
通过以下详细的描述并结合附图将更充分地理解本发明，其中相似的元件以相似的方式编号，其中：
图1是根据本发明一实施方式的血管内斑块切除系统结构示意图；
图2是根据本发明一实施方式的血管内斑块切除系统在人体内工作的示意图；
图3是图2中A处的放大图；
图4是根据本发明一种实施方式的血管内斑块切除系统的实验治疗效果图；
图5是根据本发明的一种实施方式的血管内斑块切除系统使用的经导管纤维剥离子的示意图；
图6、图7和图8是本发明的一种实施方式的血管内斑块切除系统使用的血管壁保护装置的示意图；
图9、图10和图11是根据本发明的一个实施例的内镜装置的示意性结构图。
具体实施方式
下面通过实施例，并结合附图，对本发明的技术方案作进一步详细的说明，但本发明不限于下面的实施例。
图1是根据本发明一实施方式的血管内斑块切除系统的结构示意图，用于经股动脉入路进行血管内的激光斑块切除。
如图1所示，本发明公开一种血管内斑块切除系统10，可以包括内镜装置12、球囊导管系统13、内膜剥离装置14，还可以包括用于激光发生及传输的激光装置15。
球囊导管系统13可以通过鞘管16放进人体的血管内，可以用于阻断血流(131)，阻断血流兼转流功能(132)，也可以用作阻断血流兼导引导管(133)。根据本发明的一种实施方式，球囊导管系统13可以包括三个球囊，例如包括导引导管和设置在远端的第一球囊131、第二球囊132和第三球囊133。如下所述，第一球囊、第二球囊和第三球囊适于被充盈以在血管中阻断血流，第二球囊还包括血液转流单元。第一球囊131、第二球囊132和第三球囊133可以分别具有相应的导引导管并构成第一球囊导管、第二球囊导管和第三球囊导管。
在操作时，例如，球囊导管系统13可以用于引导内镜装置12、内膜剥离装置14和激光装置15进入体内。在一种实施方式中，所述内镜装置12通过第三球囊导管进入人体内。
所述内镜装置12可以是改良的软性电子内镜，能够对血管内，如颈动脉腔内进行照明和录像采集。通过球囊131、132、133阻断血流和内镜装置的引入，实现了血管内无血可视环境下的手术，达到与CEA同样的手术即期结果。
根据本发明的优先实施方式，第二球囊导管可为双腔导管，一个腔道与球囊相通，通过该腔道充盈造影剂即可充盈球囊；另一腔道为主通道，其内可插入微导管、微导丝等器械，也可以注入液体或转流来自股动脉的动脉血，以保证球囊阻断处远端血管床内的正向血流。因为第二球囊导管的引入，其在阻断颈内动脉的反向血流并与第一和第三球囊导管共同实现病变处血管内一个无血环境的同时，更重要的是提供了患侧的血液转流功能，保证患侧远端的大脑血供，使得手术时间相对充足，不受限制。
内膜剥离装置14例如可以是一种内镜下手术剥离内膜的显微器械，如经导管显微剥离子。参见图5，该经导管显微剥离子由镍钛合金丝制成，一体化成型，分为远近端两个部分。远端为剥离铲41，所述剥离铲的铲面42由直径1mm至1.5mm的镍钛合金丝以15-45度成角切割而成，如以15度、30度或45度等多个成角切割而成，切割面周围锐利缘予以打磨钝化。近端为操纵杆43，剥离铲41与操纵杆43根据需要，沿着铲面42方向折成5-45度的成角，如折成5度、15度、30度或45度的成角，铲端至转角点的距离有5mm、10mm、15mm、20mm等不同长度。或者，内膜剥离装置14可以是经导管显微组织捕获器，由储存网、捕获环、输送杆三部分组成，前者由尼龙或其他膜性材料制成，网孔直径50-100微米，后二者由镍钛合金制成，捕获环与输送杆成角135度。内膜剥离装置14也可以是其它合适的能够剥离内膜和斑块的器械。
所述内膜剥离装置14可以剥离病变处的内膜和斑块17，能够将病变处的斑块17完全剥离下来。本发明所述的斑块剥离或内膜剥离是指从解剖结构上进行剥离，即从斑块处内膜下与中膜之间潜在间隙进行剥离，采用物理方法实现，不会对血管壁造成热损伤。
根据本发明的优选实施方式，激光装置15包括激光发生器以及激光传输光纤151。所述激光发生器用于发射激光，并对发出的激光进行控制。所述激光传输光纤151将激光引导至已剥离的斑块区域，利用激光对斑块进行消融。所述激光光纤151通过内镜装置12的光纤腔室(兼冲洗通道)到达已剥离斑块区域。
根据本发明一实施方式，所述内镜装置12具有导管，导管包括至少两个腔室，其中一个腔室内设有激光传输光纤，同时也可以供灌洗液体通过。这样灌洗液体一方面可以对消融的斑块碎屑进行冲洗，同时也可以对激光传输光纤151及工作区域血管内进行降温，减少对血管壁的热损伤。所述内镜装置12的另外一个腔室内设有用于照明的光源和录像采集装置。
优选的，所述内镜装置12为直径6F的双腔系统(或者为直径12F的三腔系统，比6F的多出一个工作通道，可以通过该工作通道进行输送剥离装置，也可抽吸或通过捕获装置取出斑块碎屑)，一个腔道为内镜照明和摄像系统，另一腔道为光纤进入兼冲洗通道。头端2cm为软性结构，可于体外操作改变镜头的指向。所述内镜装置12的远端还可以设有血管壁保护装置。例如，参见图6-8，该血管壁保护装置为镶嵌于内镜头段外围 的1/2-2/3周径的薄壁不锈钢管，工作时该装置可以将分离后斑块与血管壁隔离开来，为光纤传输激光作用于靶点提供最佳的保护，避免激光对血管壁的热损伤。光纤头端位于保护装置以内，距离保护装置头端1mm。激光传输光纤151的远端位于血管壁保护装置内，这样激光传输光纤151在进行消融的时候不会对血管壁造成损伤。其中F为导管尺寸相关的单位(French的缩写)，1F约为0.33mm。
根据本发明一实施方式，所述血管内斑块切除系统10还可以包括数字减影血管造影机，所述数字减影血管造影机(DSA)能够对血管进行成像，确定病变区(斑块)的位置和血管的管径，可根据管径选用不同规格的球囊导管。在DSA透视下经导丝引入第三、第二和第一球囊导管。球囊导管到位后，透视下监测球囊的充盈程度，造影判断球囊是否完全阻断血流。再经第三球囊导管引入内镜装置12。
根据本发明一实施方式，所述球囊导管系统13可以是包括3根球囊导管，即第一球囊导管(2F)、第二球囊导管(4F)和第三球囊导管(10F或12F)。所述球囊导管系统13也可以是整合的球囊导管系统，所谓整合的球囊导管系统是指将第一球囊导管和第二球囊导管的导管部分通过一定的工艺，嵌合于第三球囊导管的导管壁内，或完全无缝包被于第三球囊导管的球囊中，优点是第三球囊对颈总动脉血流的阻断效果更确切。
如图1、图2和图3所示，所述球囊导管前端部设置有可膨胀的球囊，所述球囊可以是高顺应性球囊。3根球囊导管通过鞘鞘管16放进人体的血管内后，第一球囊131置于患侧颈外动脉开口处，第二球囊132置于颈内动脉狭窄处的远心端，以及第三球囊133置于患侧颈总动脉处，即斑块的近心端。其中颈外动脉开口处的球囊131可以阻断颈外动脉和甲状腺上动脉的反向血流，颈内动脉狭窄处的远心端处的球囊132可以阻断颈内动脉的反向血流，颈总动脉处的球囊133可以阻断颈总动脉血流，通过充盈三个球囊131、132、133，实现病变处血管腔内无血环境。其中所述颈总动脉处的球囊133的导管可用作导引导管，用于引导内镜装置12、内膜剥离装置14和激光装置15进入体内的病变区域，也可以用作抽吸导管，用于对碎屑进行抽吸。
根据本发明一实施方式，所述血管内斑块切除系统10还可以包括持续冲洗与回抽装置，其中冲洗可以通过内镜装置12(6F内镜)的其中一个腔室向体内递送灌洗液体，回抽可以通过第三球囊导管对体内的碎屑进行抽吸(或者经过12F内镜的工作通道进行抽吸)。
图2是根据本发明一实施方式的血管内斑块切除系统在人体内工作的示意图。如图2所示，根据本发明其中一种实施方式的血管内斑块切除系统10在使用时，首先在数字减影血管造影机辅助下，经双侧股动脉穿刺，分别置入动脉鞘管16，在持续加压冲洗条件下经左侧股动脉鞘管引入第一和第二球囊导管，将第一球囊和第二球囊分别置于患侧颈外动脉开口处和颈内动脉狭窄处的远心端。经右侧股动脉鞘管16引入第三球囊导管，将第三球囊置于患侧颈总动脉，即斑块的近心端。优选的，在充盈之前将左侧动脉鞘管的侧管与球囊导管132尾端的Y型阀侧翼连结并打开三通开关，使左侧股动脉的血流经球囊导管132流向患侧远心端的颈内动脉。双侧股动脉鞘管均为15F动脉鞘，长20cm，其主通道可以进入15F以内的导管或导丝，其侧管带有三通开关，打开三通开关后，股动脉的血液可以从侧管流出，通过与连结在第二球囊导管尾端的Y型阀的侧翼，可将左侧股动脉的血流部分导向第二球囊导管，从而实现了通过充盈第二球囊导管头端的球囊132阻断颈内动脉反向血流的同时，又保证了颈内动脉的正向血流，为手术侧大脑提供有效的灌注。因而，手术操作可以从容进行，几乎不受时间限制。首先充盈球囊132以阻断颈内动脉血流，保证患侧大脑半球的有效灌注。再充盈颈外动脉的球囊131，阻断颈外动脉和甲状腺上动脉的反向血流，最后充盈置于患侧颈总动脉的球囊133，实现病变处血管腔内无血环境。
接着将内膜剥离装置14通过第三球囊导管送入病变区域，将病变区域的内膜和斑块进行剥离。剥离完以后，打开激光发生器，通过激光传输光纤151发射激光对剥离下来的内膜和斑块进行消融。对于斑块体积较大者，也可以腔内先激光消融，再机械剥离，之后再对剥离组织进行消融，产生的较大组织碎片可通过经导管显微组织捕获器予以取出，直至彻底清除病变处的内膜和斑块。在内镜装置12的持续灌洗和第三球囊导管的抽吸下，完成颈动脉内膜剥脱术，实现病变处增厚的内膜和斑块组织完全切除，达到解剖层次的清除病变的目的。
与第二球囊导管的血液转流功能相关的部件可以共同称为血液转流单元。例如，血液转流单元可以包括第二球囊导管的主通道或主通道内的导管、适当的控制阀(例如上述三通阀和Y型阀等)等。主通道或主通道内的导管在股动脉处引入血液，并在超过第二球囊的远端处将血液引出，控制阀等装置用来控制血液的转流。如图2中B所示的方向即为本发明一种实施方式的血液转流方向。
本发明通过采用转流的方式使得血流重新回到脑部，可以在病变区血管被阻断，但是脑部血流不停的情况下实现颈动脉斑块的剥离手术。
图3是采用本发明一种实施方式的血管内斑块切除系统的离体实验治疗效果图。如图3所示，采用本发明的血管内斑块切除系统10，能够在与传统经皮颈动脉支架植入术相媲美的微创条件下，实现了与CEA同样的手术结果，即内膜、斑块的完全切除。在内镜头端血管壁保护装置的保护下，斑块可以被激光彻底消融，而血管壁免受损伤。图3展示了体外模拟颈动脉斑块狭窄或闭塞状态下，在装有血管壁保护装置的内镜下进行激光消融，彻底切除斑块组织后血管壁的完整无损状态(模型是利用猪主动脉血管，嵌合手术获得的人体颈动脉斑块制成)。该试验证实了在血管壁保护装置下，激光切除颈动脉斑块是安全可行的。
图4是根据本发明一种实施方式的血管内斑块切除系统的实验治疗效果图。
根据本发明的另一个实施例(即经颈动脉入路)，内镜装置12通过置于颈总动脉的动脉鞘管进入颈总动脉及颈内动脉，手持内镜手柄或体外有固定内镜的相应装置，便于保持良好的手术视野。动脉鞘管进入颈总动脉的穿刺点平甲状软骨水平或其以下，并确保穿刺点位于第三球囊封堵的靶点远端，动脉鞘内径应与内镜外径相匹配。
内镜装置12进入血管部分的最大设计长度为15cm,一般有效进入血管长度为5cm,头端2cm为软性结构，软性结构的最大偏转角度为45-60度。内镜装置12可以包括同轴设置的内腔和外腔。内镜装置12的最大设计外径可选为12F、14F、16F或18F，其对应的内腔内径分别为5F、7F、9F或11F。更大程度地增加了内镜的工作通道直径，极大地缩短了内镜进入血管的有效长度，便于相应手术器械的进出，提高工作效率。避免了原内镜系统经股动脉入路可能面临的路径较长、血管迂曲、通过困难等问题。
其中，内腔可选地为工作通道，可以经过该通道送入相应的斑块剥离、粉碎、抓取等器械，也可以对手术野进行冲洗。外腔可选地为内镜照明和摄像系统的布局通道。内镜照明系统包括多个照明单元，摄像系统包括多个图像采集单元。多个图像采集单元沿电子内镜的外腔的周向均匀分布，多个照明单元等间距分布在相邻两个图像采集单元之间。
此方式更大程度地增加了内镜的工作通道直径，极大地缩短了内镜进入血管的有效长度，便于相应手术器械的进出，提高工作效率。避免了内镜系统经股动脉入路可能面临的路径较长、血管迂曲、通过困难等问题。
优选的，外腔均分为12等份，多个图像采集单元分别位于3点钟、6点钟、9点钟和12点钟位置，获取的影像可以通过计算机软件系统合成为一个全息的实时图像，也可以是分别成像于外置的4个显示器上，方便术者观察。多个照明单元分别位于1点钟、2点钟、4点钟、5点钟、7点钟、8点钟、10点钟、11点钟位置。该外腔布局能够确保血管腔内操作时具有良好的手术视野，避免了单一摄像系统因特殊角度和相应组织的阻挡无法看清手术野的可能。
图9、图10和图11示例性地示出了根据上述实施例的内镜装置12。如图9和10所示，内镜装置12包括管状内镜部分及手柄；手柄下方延伸出数据线，可以连接到主机。所述手柄与管状内镜部分呈一定的角度α，所述角度α可以为任何合适的角度，如角度α为120度。图11是图10中A方向的透视图，示出了内镜装置12的管状部分的外管被均分为12等份的情形，其中4个图像采集单元示例性地位于3点钟、6点钟、9点钟和12点钟位置，多个照明单元分别位于1点钟、2点钟、4点钟、5点钟、7点钟、8点钟、10点钟、11点钟位置。
所述多个图像采集单元之间的间距，以及多个照明单元之间的间距也可以不相等，如可以设置成对称的方式或其它合适的方式。
根据上述实施例的内镜照明系统和摄像系统，能够确保血管腔内操作时具有良好的手术视野，避免了单一摄像系统因特殊角度和相应组织的阻挡无法看清手术野的可能。
根据本发明的优选实施方式，第一球囊导管(2F)和第二球囊导管(4F)以并行排列方式送入第三球囊导管(10F或12F)，分别送达各自的阻断靶点。
在第三球囊导管置放到位后，方便了第一和第二球囊导管到位。进一步消除了经股动脉入路中第三球囊133与血管壁之间因并行方式导致的导管占位，使第三球囊133更好的直接与血管壁贴合，封堵更加确切。
根据本发明一个实施例，提供一种操作上述血管内斑块切除系统的方法，包括：将所述血管内斑块切除系统的第一球囊、第二球囊和第三球囊插入颈动脉，使得所述第一球囊放置在患侧颈外动脉开口处，所述第二球囊放置在患侧颈内动脉斑块的远心端，所述第三球囊放置在患侧颈总动脉斑块的近心端；依次充盈所述第二球囊、第一球囊和第三球囊；第二球囊导管有血液返流后，打开所述第二球囊中设置的血液转流单元。
优选的，所述的方法还包括在充盈所述第一球囊、第二球囊和第三球囊后操作所述内膜剥离装置。优选的，所述的方法还包括操作所述激光装置以将激光引导到颈动脉内的斑块。优选的，所述的方法还包括将灌洗液引导到颈动脉内。
根据本发明另一个实施例，提供一种切除颈总动脉斑块的方法，包括：经股动脉入路穿刺双侧股动脉，分别置入动脉鞘；经右侧股动脉鞘将第三球囊导管置于患侧颈总动脉，再经左侧股动脉鞘将第一球囊导管置于患侧颈外动脉，然后经左侧股动脉鞘将第二球囊导管置于患侧颈内动脉，使得所述第一球囊放置在患侧颈外动脉开口处，所述第二球囊放置在患侧颈内动脉斑块的远心端，所述第三球囊放置在患侧颈总动脉斑块的近心端；先后充盈第二、第一、第三球囊，打开第二球囊导管尾端Y阀的侧翼，见血液返流后将其与左侧股动脉鞘连通管连接，使左侧股动脉鞘内的动脉血经第二球囊导管流入患侧颈内动脉；将内镜装置经第三球囊导管引入颈总动脉或者将内镜装置经过颈动脉鞘引入颈总动脉，至斑块的近心端；经内镜装置的工作腔道置入内膜剥离装置，机械剥离斑块近心端，使其与中膜分离，并对斑块组织进行激光消融，并进行冲洗，使碎屑从内镜装置的工作腔道流出。
在上述方法中，当将内镜装置经过颈动脉鞘引入颈总动脉时，即经颈动脉入路方式下，第一、第二和第三球囊导管的引入方式也可以采用：第三球囊导管经右侧股动脉进入右侧颈总动脉，所述第一球囊导管、所述第二球囊导管以并行排列方式进入所述第三球囊导管，出第三球囊导管后分别进入颈外动脉和颈内动脉。
优选的，所述的切除动脉斑块的方法还包括不断向远心端剥离斑块，继之激光消融、冲洗，直至在内镜视野下斑块完全切除，充分冲洗，确保术野干净无碎屑。优选的，所述的切除动脉斑块的方法还包括结束切除时，保持第三球囊导管尾端开放，先泄掉第二球囊随即再次充盈，然后泄掉第一球囊并撤出，适当抽吸第三球囊导管，之后泄 掉第三球囊，最后泄掉并撤出第二球囊。优选的，所述的切除动脉斑块的方法还包括经第三球囊导管再次造影确认颈内动脉及颅内动脉通畅。
需要注意的是，本发明的血管内斑块切除系统10不限于用在颈动脉斑块的切除手术，也可以用于外周血管领域，例如主动脉、肠系膜动脉、髂动脉、下肢膝关节水平以上的较大管径血管内的动脉硬化斑块，以及其他适合的领域内的手术。
本发明的实施方式并不限于上述实施例所述，在不偏离本发明的精神和范围的情况下，本领域普通技术人员可以在形式和细节上对本发明做出各种改变和改进，而这些均被认为落入了本发明的保护范围。

Claims (33)

  1. 一种血管内斑块切除系统，包括：
    适于插入血管中的球囊导管系统，包括导引导管和设置在远端的第一球囊、第二球囊和第三球囊，所述第一球囊、第二球囊和第三球囊适于被充盈以在血管中阻断血流，所述第二球囊包括血液转流单元；
    内镜装置，包括内镜连接管和设置在连接管远端的照明单元和图像采集单元，适于通过所述导引导管插入血管中进行照明和图像采集；
    内膜剥离装置，包括设置在近端的操作单元、在远端的剥离单元和连接操作单元与剥离单元的剥离连接管，适于通过导引导管进入血管中进行血管中斑块的剥离操作。
  2. 根据权利要求1所述的血管内斑块切除系统，还包括：
    激光装置，包括激光发生器和激光传导光纤，所述激光传输光纤适于通过内镜装置的光纤通道进入血管中，将激光发生器产生的激光传导到选定位置对血管中的斑块进行激光消融。
  3. 根据权利要求1或2所述的血管内斑块切除系统，还包括：
    数字减影血管造影机，能够对血管成像，确定血管中产生斑块的位置，明确球囊充盈状态及球囊所处的位置。
  4. 根据权利要求1-3中任一项所述的血管内斑块切除系统，还包括：控制装置，根据预设的指令控制球囊进行充盈和激光发生器产生激光。
  5. 根据权利要求1-4中任一项所述的血管内斑块切除系统，适于对颈动脉内的斑块进行切除。
  6. 根据权利要求5所述的血管内斑块切除系统，所述第一球囊适于放置在患侧颈外动脉开口处，所述第二球囊适于在斑块的远心端放置在患侧颈内动脉，所述第三球囊 适于在斑块的近心端放置在患侧颈总动脉，使得所述第一、第二和第三球囊充盈时在斑块周围的血管内形成无血环境。
  7. 根据权利要求6所述的血管内斑块切除系统，所述第二球囊的血液转流单元与动脉血流联通以在打开状态下将动脉血流输送到第二球囊的远心端。
  8. 根据权利要求1-7中任一项所述的血管内斑块切除系统，所述球囊导管系统包括第一球囊导管、第二球囊导管和第三球囊导管。
  9. 根据权利要求8所述的血管内斑块切除系统，其特征在于，第三球囊导管经右侧股动脉置入颈总动脉，第一球囊导管和第二球囊导管以并行排列方式经左侧股动脉置入颈外动脉和颈内动脉。
  10. 根据权利要求8所述的血管内斑块切除系统，所述第三球囊导管包括所述导引导管。
  11. 根据权利要求1-10中任一项所述的血管内斑块切除系统，所述内镜装置具有导管，所述导管包括容纳照明单元和图像采集单元的第一腔道，和适于激光传输光纤和/或灌洗液通过的第二腔道，所述内镜装置的远端设有血管壁保护装置。
  12. 根据权利要求11所述的血管内斑块切除系统，所述图像采集单元有多个，多个所述图像采集单元沿周向均匀分布；所述照明单元有多个，多个所述照明单元等间距分布在相邻两个所述图像采集单元之间。
  13. 根据权利要求11所述的血管内斑块切除系统，所述内镜装置还包括第三通道，用作工作通道。
  14. 一种血管内斑块切除系统，包括：
    适于插入血管中的球囊导管系统，包括导引导管和设置在远端的第一球囊、第二球囊和第三球囊，所述第一球囊、第二球囊和第三球囊适于被充盈以在血管中阻断血流，所述第二球囊包括血液转流单元；
    内镜装置，包括内镜连接管和设置在连接管远端的照明单元和图像采集单元，适于通过动脉鞘管插入血管中进行照明和图像采集；
    内膜剥离装置，包括设置在近端的操作单元、在远端的剥离单元和连接操作单元与剥离单元的剥离连接管，适于通过内镜装置的工作通道进入血管中进行血管中斑块的剥离操作。
  15. 根据权利要求14所述的血管内斑块切除系统，还包括：
    激光装置，包括激光发生器和激光传导光纤，所述激光传输光纤适于通过内镜装置的工作通道进入血管中，将激光发生器产生的激光传导到选定位置对血管中的斑块进行激光消融。
  16. 根据权利要求14或15所述的血管内斑块切除系统，还包括：
    数字减影血管造影机，能够对血管成像，确定血管中产生斑块的位置，明确球囊充盈状态及球囊所处的位置。
  17. 根据权利要求14-16中任一项所述的血管内斑块切除系统，还包括：控制装置，根据预设的指令控制球囊进行充盈和激光发生器产生激光。
  18. 根据权利要求14-17中任一项所述的血管内斑块切除系统，适于对颈动脉内的斑块进行切除。
  19. 根据权利要求18所述的血管内斑块切除系统，所述第一球囊适于放置在患侧颈外动脉开口处，所述第二球囊适于在斑块的远心端放置在患侧颈内动脉，所述第三球囊适于在斑块的近心端放置在患侧颈总动脉，使得所述第一、第二和第三球囊充盈时在斑块周围的血管内形成无血环境；所述颈动脉鞘管在第三球囊封堵的靶点远端设置于颈总动脉，使得内镜装置能够进入颈总动脉及颈内动脉。
  20. 根据权利要求19所述的血管内斑块切除系统，所述第二球囊的血液转流单元与动脉血流联通以在打开状态下将动脉血流输送到第二球囊的远心端。
  21. 根据权利要求14-20中任一项所述的血管内斑块切除系统，所述球囊导管系统包括第一球囊导管、第二球囊导管和第三球囊导管。
  22. 根据权利要求21所述的血管内斑块切除系统，其特征在于，第三球囊导管经右侧股动脉进入右侧颈总动脉，所述第一球囊导管、所述第二球囊导管以并行排列方式进入所述第三球囊导管，出第三球囊导管后分别进入颈外动脉和颈内动脉。
  23. 根据权利要求22所述的血管内斑块切除系统，所述第三球囊导管包括所述导引导管。
  24. 根据权利要求14-23中任一项所述的血管内斑块切除系统，所述内镜装置具有双腔设计，包括同轴设置的内腔和外腔；其中，内腔可选地为工作通道，适于经过该通道送入相应的斑块剥离、粉碎、抓取等器械，及用于对手术野进行冲洗；外腔适于用作内镜照明和摄像系统的布局通道。
  25. 根据权利要求24所述的血管内斑块切除系统，其特征在于，内镜装置的所述图像采集单元有多个，多个所述图像采集单元沿内镜装置的外腔周向均匀分布；所述照明单元有多个，多个所述照明单元等间距分布在相邻两个所述图像采集单元之间。
  26. 一种操作根据权利要求1-25中任一项所述的血管内斑块切除系统的方法，包括：
    将所述血管内斑块切除系统的第一球囊、第二球囊和第三球囊插入颈动脉，使得所述第一球囊放置在患侧颈外动脉开口处，所述第二球囊放置在患侧颈内动脉斑块的远心端，所述第三球囊放置在患侧颈总动脉斑块的近心端；
    依次充盈所述第二球囊、第一球囊和第三球囊；
    第二球囊导管有血液返流后，打开所述第二球囊中设置的血液转流单元。
  27. 根据权利要求26所述的方法，还包括：在充盈所述第一球囊、第二球囊和第三球囊后操作所述内膜剥离装置。
  28. 根据权利要求25或26所述的方法，还包括：操作所述激光装置以将激光引导到颈动脉内的斑块。
  29. 根据权利要求28所述的方法，还包括：将灌洗液引导到颈动脉内。
  30. 一种切除颈总动脉斑块的方法，包括：
    经股动脉入路穿刺双侧股动脉，分别置入动脉鞘；
    经右侧股动脉鞘将第三球囊导管置于患侧颈总动脉，再经左侧股动脉鞘将第一球囊导管置于患侧颈外动脉，然后经左侧股动脉鞘将第二球囊导管置于患侧颈内动脉，使得所述第一球囊放置在患侧颈外动脉开口处，所述第二球囊放置在患侧颈内动脉斑块的远心端，所述第三球囊放置在患侧颈总动脉斑块的近心端；
    先后充盈第二、第一、第三球囊，打开第二球囊导管尾端Y阀的侧翼，见血液返流后将其与左侧股动脉鞘连通管连接，使左侧股动脉鞘内的动脉血经第二球囊导管流入患侧颈内动脉；
    将内镜装置经第三球囊导管引入颈总动脉或者将内镜装置经过颈动脉鞘引入颈总动脉，至斑块的近心端；
    经内镜装置的工作腔道置入内膜剥离装置，机械剥离斑块近心端，使其与中膜分离，并对斑块组织进行激光消融，并进行冲洗，使碎屑从内镜装置的工作腔道流出。
  31. 根据权利要求30所述的切除动脉斑块的方法，还包括：
    不断向远心端剥离斑块，继之激光消融、冲洗，直至在内镜视野下斑块完全切除，充分冲洗，确保术野干净无碎屑。
  32. 根据权利要求30所述的切除动脉斑块的方法，还包括：
    结束切除时，保持第三球囊导管尾端开放，先泄掉第二球囊随即再次充盈，然后泄掉第一球囊并撤出，适当抽吸第三球囊导管，之后泄掉第三球囊，最后泄掉并撤出第二球囊。
  33. 根据权利要求32所述的切除动脉斑块的方法，还包括：
    经第三球囊导管再次造影确认颈内动脉及颅内动脉通畅。
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