Mechanical thrombus removal system

Abstract

This invention relates to a mechanical thrombus removal system, comprising a catheter mechanism, a nozzle mechanism, and a fluid power source. The catheter mechanism includes an outer catheter and a high-pressure tube disposed within the outer catheter, forming a catheter lumen between the high-pressure tube and the outer catheter. The nozzle mechanism is connected to the high-pressure tube and has several fluid jet holes arranged circumferentially thereafter. By configuring the catheter and nozzle mechanisms, high-pressure fluid is injected into the catheter lumen through the several fluid jet holes, creating a negative pressure near the thrombus aspiration holes to draw thrombi outside the outer catheter into the catheter lumen. The high-pressure fluid breaks up the thrombi entering the catheter lumen. Multiple streams of high-pressure fluid converge on the central axis of the outer catheter and flow proximally, creating a positive pressure distribution near the jet holes. This causes the converging jet to be ejected from the jet holes, agitating the thrombus and promoting aspiration.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a mechanical thrombus removal system. Background Art

[0002] A thrombus is generally a solid mass that is abnormally coagulated due to the activation of platelets and coagulation factors during the flow of blood. It is mainly composed of insoluble fibrin, deposited platelets, accumulated white blood cells and trapped red blood cells. In the acute or subacute stage of thrombosis, the thrombus is generally soft and spongy. Over time, the thrombus will become hard and fibrotic. Thrombus can block blood vessels, affect blood flow, and cause pathological changes in tissues and organs. In addition, the whole or part of the thrombus falls off to become an embolus, which forms an embolism as the blood flows. If the embolism contains bacteria, it will cause septic infarction or abscess in the embolic tissue.

[0003] The existing mechanical thrombectomy (PMT) or mechanical embolectomy is increasingly favored by doctors and patients. This technology is based on the principles of mechanics or fluid mechanics, and achieves the purpose of recanalizing blood vessels by mechanically crushing and aspirating emboli through a catheter mechanism. PMT not only greatly shortens the treatment time, but also eliminates or reduces the use of thrombolytic drugs, thereby reducing the incidence of bleeding complications. However, the thrombolytic and embolectomy effects of the catheter mechanism in the prior art are relatively poor, and the thrombus removal efficiency is relatively low. In addition, in the prior art, the power source for the mechanical crushing and aspiration of emboli by the catheter mechanism mostly adopts a high-pressure fluid source and a suction source, and a one-way steel ball and a ball seat are arranged in the high-pressure chamber of the high-pressure fluid source. However, when the ball seat is subjected to high pressure, the one-way steel ball is likely to be pressed too deep into the ball seat, and there is a risk of the one-way steel ball sticking and getting stuck. Summary of the invention

[0004] Based on this, it is necessary to provide a mechanical thrombus removal system that can promote thrombus suction, enhance the suction capacity, and thus improve the efficiency of thrombus removal.

[0005] A mechanical thrombus removal system, comprising:

[0006] A catheter mechanism, the catheter mechanism comprising an outer catheter and a high-pressure tube disposed in the outer catheter, a catheter cavity is formed between the high-pressure tube and the outer catheter, and the outer catheter has a proximal end and a distal end;

[0007] A fluid power source, the fluid power source comprising a high-pressure fluid source and a suction source, the high-pressure fluid source being connected to the high-pressure tube for inputting high-pressure fluid into the high-pressure tube, and the suction source being connected to the catheter cavity;

[0008] A nozzle mechanism, the nozzle mechanism is arranged at one end of the high-pressure tube away from the proximal end of the outer catheter and is in communication with the high-pressure tube, the nozzle mechanism is provided with a plurality of fluid jet holes along its circumference, the jet holes jet high-pressure fluid toward the proximal end, the high-pressure fluid is jetted into the catheter cavity at a certain angle to the central axis of the outer catheter and converges on the central axis;

[0009] Wherein, a plurality of bolt suction holes and a plurality of injection holes are arranged on the outer wall of the outer catheter along the circumference of the outer catheter, the bolt suction holes are arranged close to the injection holes, and the injection holes are arranged close to the proximal end;

[0010] The high-pressure fluid source comprises a high-pressure pump body, the high-pressure pump body has a high-pressure chamber, the high-pressure chamber is connected to the high-pressure pipe; a ball seat is arranged at the bottom of the high-pressure pump body, a hole is arranged at the bottom of the ball seat, a one-way steel ball is accommodated in the ball seat, a spherical annular groove matching the shape of the one-way steel ball is formed on the ball seat, and when the one-way steel ball is subjected to downward pressure, a sealing area is formed between the one-way steel ball and the ball seat;

[0011] The diameter of the one-way steel ball is larger than the diameter of the hole, the volume of the one-way steel ball falling into the ball seat is less than half of the volume of the one-way steel ball, and a second groove is formed between the inner wall of the high-pressure pump body and the ball seat. When the ball seat is under pressure, the ball seat can deform into the inside of the second groove.

[0012] By setting a high-pressure fluid source, high-pressure fluid can be input into the high-pressure tube; by setting a catheter mechanism and a nozzle mechanism, the high-pressure fluid is sprayed into the catheter cavity through a plurality of fluid jet holes, so that negative pressure is generated near the embolus suction hole, so that the thrombus outside the outer catheter is sucked into the catheter cavity through the embolus suction hole. When the thrombus enters the catheter cavity, the high-pressure fluid will break up the thrombus entering the catheter cavity; at the same time, multiple streams of high-pressure fluid converge on the central axis of the outer catheter and flow toward the proximal end, so that a positive pressure distribution is present near the injection hole, so that the convergent jet is ejected from the injection hole, and the convergent jet ejected from the injection hole can It can stir the inside of the thrombus, promote thrombus suction, and effectively extend the distance that the high-pressure fluid is pushed toward the proximal end, enhance the suction capacity, and thus improve the thrombus removal efficiency; by setting a suction source, the thrombus broken in the catheter cavity can be sucked out of the patient's body in time; by setting the diameter of the one-way steel ball to be larger than the diameter of the spherical ring groove or the volume of the one-way steel ball falling into the ball seat to be smaller than half of the volume of the one-way steel ball, a second groove is formed between the inner wall of the high-pressure pump body and the ball seat, and when the ball seat is pressurized, the ball seat can deform toward the inside of the second groove, which can prevent the one-way steel ball from sticking and getting stuck.

[0013] In one embodiment, the catheter mechanism further comprises a hemostatic valve, wherein the hemostatic valve is disposed between the suction source and the catheter cavity.

[0014] In one embodiment, the catheter mechanism further includes a developing ring, and the high-pressure tube is connected to the outer catheter via the developing ring.

[0015] In one embodiment, the distal end of the outer catheter is formed with a tip for easy insertion into a blood vessel.

[0016] In one embodiment, the fluid power source comprises:

[0017] A double-chamber pump, the double-chamber pump comprises a piston rod, a piston drive mechanism, a high-pressure pump body, and a low-pressure pump body, the low-pressure pump body comprises a low-pressure chamber, the high-pressure chamber and the low-pressure chamber are coaxially arranged, one end of the piston rod is passed through the high-pressure chamber and the low-pressure chamber, the other end of the piston rod is transmission-connected to the piston drive mechanism, the piston drive mechanism is used to drive the piston rod to move up and down, and the high-pressure chamber is connected to the high-pressure pipe through a first connecting pipe;

[0018] a fluid storage mechanism, the fluid storage mechanism being in communication with the high-pressure chamber via a second connecting pipe, and a first one-way valve being connected between the fluid storage mechanism and the high-pressure chamber;

[0019] The piston rod, the piston driving mechanism, the high-pressure chamber, the first connecting pipe, the fluid storage mechanism, and the second connecting pipe cooperate with each other to form the high-pressure fluid source.

[0020] In one embodiment, the fluid power source further comprises:

[0021] A waste liquid collection mechanism, the waste liquid collection mechanism is connected to the low-pressure chamber through a third connecting pipe, the low-pressure chamber is connected to the catheter cavity through a fourth connecting pipe, and a one-way valve is connected between the waste liquid collection mechanism and the low-pressure chamber, and between the low-pressure chamber and the catheter cavity;

[0022] The piston rod, the piston driving mechanism, the low-pressure chamber, the waste liquid collecting mechanism, the third connecting pipe, and the fourth connecting pipe cooperate with each other to form the suction source.

[0023] In one embodiment, the piston rod includes a lower piston portion that forms a seal with the high-pressure chamber and an upper piston portion that forms a seal with the low-pressure chamber;

[0024] A first groove is provided at an opening of one end of the high-pressure pump body close to the low-pressure pump body, and a high-pressure sealing member is provided in the first groove;

[0025] The openings at both ends of the low-pressure pump body are both provided with grooves, and low-pressure sealing elements are both provided in the grooves. The low-pressure sealing elements are sealed with the piston rod.

[0026] In one embodiment, the mechanical thrombus removal system further comprises a driving base, the piston driving mechanism is arranged on the driving base, a capture component is arranged on the driving base, and the capture component is used for automatically docking and grabbing the piston rod.

[0027] In one of the embodiments, an exhaust mechanism is further included, and the exhaust mechanism is arranged at the connection between the high-pressure pump body and the low-pressure pump body. The exhaust mechanism includes a plurality of exhaust holes arranged on one end of the low-pressure pump body close to the high-pressure pump body and an air bag arranged at the connection, the air bag is connected to the exhaust hole, and the exhaust hole is connected to the low-pressure chamber.

[0028] In one embodiment, the ball seat is made of elastic material.

[0029] In the above scheme, by setting a high-pressure fluid source, high-pressure fluid can be input into the high-pressure tube; by setting a catheter mechanism and a nozzle mechanism, the high-pressure fluid is sprayed into the catheter cavity through a plurality of fluid jet holes, so that a negative pressure is generated near the thrombus suction hole, so that the thrombus outside the outer catheter is rolled into the catheter cavity through the thrombus suction hole. When the thrombus enters the catheter cavity, the high-pressure fluid will break up the thrombus entering the catheter cavity; at the same time, multiple streams of high-pressure fluid converge on the central axis of the outer catheter and flow toward the proximal end, so that a positive pressure distribution is present near the injection hole, so that the convergent jet is ejected from the injection hole, and the convergent jet ejected from the injection hole can stir inside the thrombus, which can promote thrombus suction and can effectively extend the distance that the high-pressure fluid is pushed toward the proximal end. The suction capacity is improved, thereby improving the thrombus removal efficiency; by setting up a suction source, the broken thrombus in the catheter cavity can be sucked out of the patient's body in time; by setting up a double-chamber pump, the function of high-pressure fluid spraying on the thrombus to break up the thrombus can be realized, and the broken thrombus can be extracted and discharged into the waste liquid collection mechanism, which greatly simplifies the complexity of the system and improves the thrombus removal efficiency; by setting the diameter of the one-way steel ball to be larger than the diameter of the hole at the bottom of the ball seat, the volume of the one-way steel ball falling into the ball seat is less than half of the volume of the one-way steel ball, and a second groove is formed between the inner wall of the high-pressure pump body and the ball seat. When the ball seat is under pressure, the elastic ball seat can deform toward the inside of the second groove, which can prevent the one-way steel ball from sticking and getting stuck. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic structural diagram of a mechanical thrombus removal system according to an embodiment of the present invention;

[0031] Figure 2 It is a principle block diagram of a mechanical thrombus removal system shown in one embodiment of the present invention;

[0032] Figure 3A liquid inlet route diagram of a mechanical thrombus removal system shown in an embodiment of the present invention;

[0033] Figure 4 A liquid discharge route diagram of a mechanical thrombus removal system shown in an embodiment of the present invention;

[0034] Figure 5 It is a structural schematic diagram of a catheter mechanism shown in an embodiment of the present invention;

[0035] Figure 6 for Figure 5 Enlarged view of point A in the middle;

[0036] Figure 7 It is a partial structural schematic diagram of a catheter mechanism according to an embodiment of the present invention, showing a suction hole and an injection hole;

[0037] Figure 8 It is a schematic diagram of the connection structure of the high-pressure pipe, the nozzle mechanism and the outer conduit shown in one embodiment of the present invention;

[0038] Fig. 9 It is a schematic diagram of the connection structure of the high-pressure pipe and the nozzle mechanism shown in one embodiment of the present invention;

[0039] Fig.10 It is a partial structural schematic diagram of a catheter mechanism shown in an embodiment of the present invention, showing the flow path of the high-pressure fluid and the converging jet;

[0040] Fig.11 It is a schematic diagram of the connection structure of the high-pressure pipe and the nozzle mechanism shown in one embodiment of the present invention;

[0041] Fig.12 A cross-sectional view of a double-chamber pump shown in one embodiment of the present invention;

[0042] Fig.13 is a cross-sectional view of a high pressure chamber shown in one embodiment of the present invention;

[0043] Fig.14 A partial structural cross-sectional view of a high-pressure chamber according to an embodiment of the present invention;

[0044] Fig.15 A partial structural cross-sectional view of a high-pressure chamber according to an embodiment of the present invention;

[0045] Fig.16 is a cross-sectional view of a low-pressure chamber shown in one embodiment of the present invention;

[0046] Fig.17 A partial structural cross-sectional view of a low-pressure chamber shown in one embodiment of the present invention;

[0047] Fig.18A partial structural cross-sectional view of a low-pressure chamber shown in one embodiment of the present invention;

[0048] Fig.19 This is a partial structural diagram of a double-chamber pump according to an embodiment of the present invention, showing the structure of the exhaust mechanism and the flow path of the bubbles.

[0049] Fig. 20 This is a partial structural schematic diagram of a double-chamber pump shown in an embodiment of the present invention, showing the structure of a driving base.

[0050] Description of Reference Numerals

[0051] 10. Mechanical thrombus removal system; 100. Catheter mechanism; 110. External catheter; 111. Suction hole; 112. Injection hole; 113. Catheter cavity; 114. Tip; 120. High-pressure tube; 130. Hemostatic valve; 140. Developing ring; 200. Nozzle mechanism; 210. Fluid jet hole; 220. Fixing ring; 300. Fluid power source; 310. Double-chamber pump; 311. Piston rod; 3111. Lower piston part; 3112. Upper piston part; 312. High-pressure chamber; 3121. High-pressure seal; 3122. First groove; 3123. High-pressure sealing ring; 3124. High-pressure locking nut; 3125. One-way steel ball; 3126. Ball seat; 3127. Second groove; 313. Low-pressure chamber; 3131. a first low-pressure seal; 3132, a second low-pressure seal; 3133, a third groove; 3134, an upper low-pressure locking nut; 3135, a fourth groove; 3136, a lower low-pressure locking nut; 314, a piston drive mechanism; 315, a high-pressure pump body; 316, a low-pressure pump body; 320, a fluid storage mechanism; 321, a first connecting tube; 322, a second connecting tube; 323, a first one-way valve; 324, a puncture device; 325, a fluid filter; 330, a waste liquid collection mechanism; 331, a third connecting tube; 332, a fourth connecting tube; 333, a second one-way valve; 334, a three-way valve; 400, an exhaust mechanism; 410, an exhaust hole; 420, an air bag; 500, a driving base; 510, a capture assembly; 520, a clamping valve; DETAILED DESCRIPTION

[0052] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

[0053] For ease of description and understanding, the terms "distal end" and "proximal end" should be understood as viewed from the direction of the handheld end of the attending physician or medical interventionist. The distal end is the side away from the handheld end of the attending physician or medical interventionist, while the proximal end refers to the side toward the handheld end of the attending physician or medical interventionist.

[0054] See also Figure 1 , Figure 8 , Fig. 9 and Fig.10 As shown, an embodiment of the present invention provides a mechanical thrombus removal system 10, comprising a catheter mechanism 100, a nozzle mechanism 200, and a fluid power source 300, wherein the nozzle mechanism 200 is disposed inside the catheter mechanism 100. The catheter mechanism 100 is used to be inserted into a blood vessel so as to collect thrombi inside the catheter mechanism 100. The fluid power source 300 is used to provide power for collecting thrombi.

[0055] See also Figure 5 , Figure 6 , Figure 7 and Figure 8 As shown, the catheter mechanism 100 includes an outer catheter 110 and a high-pressure tube 120 disposed in the outer catheter 110. A plurality of embolus suction holes 111 and a plurality of injection holes 112 are disposed on the outer wall of the outer catheter 110 along the circumference of the outer catheter 110. A catheter cavity 113 is formed between the high-pressure tube 120 and the outer catheter 110. The outer catheter 110 has a proximal end and a distal end. Specifically, the outer catheter 110 is used to be inserted into a blood vessel, and its size is determined by the size of the inserted blood vessel, which is not limited here. The outer catheter 110 has a high degree of folding resistance, and the outer catheter 110 can be selected from a sea wave tube, a pebax tube with braided wire, a peek tube, etc. The high-pressure tube 120 is made of stainless steel, and the high-pressure tube 120 can be 304L or 316L.

[0056] The distal end of the outer catheter 110 is formed with a tip 114 for easy insertion into a blood vessel. The diameter of the tip 114 gradually decreases from the proximal end to the distal end, and the tip 114 is conical. The catheter mechanism 100 also includes a hemostatic valve 130 and a developing ring 140. The hemostatic valve 130 is connected to the proximal end of the outer catheter 110. The high-pressure tube 120 is connected to the outer catheter 110 through the developing ring 140. Specifically, the hemostatic valve 130 is bonded to the proximal end of the outer catheter 110, and UV glue or two-component epoxy glue is generally selected for curing. The high-pressure tube 120 is crimped onto the outer catheter 110 through the developing ring 140.

[0057] See also Fig. 9 , Fig.10 and Fig.11As shown, the nozzle mechanism 200 is disposed at one end of the high-pressure tube 120 away from the proximal end of the outer conduit 110, and is connected to the high-pressure tube 120. The nozzle mechanism 200 is provided with a plurality of fluid jet holes 210 along its circumference, and the central axis of each fluid jet hole 210 intersects with the central axis of the outer conduit 110. The angle between the central axis of each fluid jet hole 210 and the central axis of the outer conduit 110 is an acute angle. In this embodiment, the structure of the nozzle mechanism 200 is an annular structure, for example: a circular ring. Specifically, the nozzle mechanism 200 is connected to the outer conduit 110 through a fixing ring 220, and the high-pressure tube 120 is crimped to the fixing ring 220 through a developing ring 140.

[0058] See also Figure 1 , Figure 6 , Fig. 9 and Fig.10 As shown, the fluid power source 300 includes a high-pressure fluid source and a suction source. The high-pressure fluid source is connected to the high-pressure tube 120 for inputting high-pressure fluid into the high-pressure tube 120. The high-pressure fluid ejected from the jet hole 210 is ejected into the catheter cavity 133 at a certain angle to the central axis of the outer catheter 110, and converges on the central axis of the outer catheter 110 and flows toward the proximal end. The suction hole 111 is arranged close to the fluid jet hole 210, and the injection hole 112 is arranged close to the proximal end. The suction source is connected to the catheter cavity 113. It should be understood that convergence means that multiple high-pressure fluids converge on the central axis of the outer catheter 110 to form a jet.

[0059] When the high-pressure fluid is ejected into the catheter cavity 113 through the plurality of fluid jet holes 210, negative pressure is generated near the fluid jet holes 210. Since the embolus suction hole 111 is arranged close to the fluid jet holes 210, negative pressure is generated near the embolus suction hole 111, so that the thrombus outside the outer catheter 110 can be sucked into the catheter cavity 113 through the embolus suction hole 111. When the thrombus enters the catheter cavity 113, the high-pressure fluid will break the thrombus entering the catheter cavity 113. At the same time, multiple streams of high-pressure fluid converge on the central axis of the outer catheter 110 and flow toward the proximal end, so that the end of the catheter cavity 113 close to the proximal end is distributed with positive pressure. Since the injection hole 112 is arranged close to the proximal end, a positive pressure is generated near the injection hole 112, and the positive pressure near the injection hole 112 is higher than the blood vessel pressure, so that the converging jet is ejected from the injection hole 112. The converging jet ejected from the injection hole 112 stirs inside the thrombus, which can promote the suction of the thrombus. The converging jet can effectively extend the distance that the high-pressure fluid is pushed toward the proximal end and improve the suction capacity. The suction source is connected to the catheter cavity 113, and the thrombus broken in the catheter cavity 113 can be sucked out of the patient's body in time. It should be understood that the hemostatic valve 130 is arranged between the catheter cavity 113 and the suction source.

[0060] See also Figure 1 , 2As shown in , 12, 13, 16, and 20, the fluid power source 300 includes a dual-chamber pump 310 and a fluid storage mechanism 320. The dual-chamber pump 310 includes a piston rod 311, a piston drive mechanism 314, a high-pressure pump body 315, and a low-pressure pump body 316. The high-pressure pump body 315 includes a high-pressure chamber 312, and the low-pressure pump body 316 includes a low-pressure chamber 313. The high-pressure chamber 312 and the low-pressure chamber 313 are coaxially arranged, and the high-pressure pump body 315 is fixedly connected to the low-pressure pump body 316 via a flange or a sleeve. One end of the piston rod 311 is inserted into the high-pressure chamber 312 and the low-pressure chamber 313, and the other end of the piston rod 311 is transmission-connected to the piston drive mechanism 314. The piston drive mechanism 314 is used to drive the piston rod 311 to reciprocate along the axial direction of the high-pressure chamber 312. Figure 2 Specifically, it moves up and down reciprocatingly. Specifically, the high-pressure pump body 315 and the low-pressure pump body 316 are both pressure-bearing cylinder structures, and the material can be selected from high-strength alloy steel, such as 17-4PH stainless steel. Because the interior of the pump body is a high-frequency motion area, the interior is preferably plastic-coated to reduce the risk of accidental wall wear of the piston rod 311. The exterior can also be plastic-coated into various structures that match the interface of the pump drive unit. The commonly used injection molding process is the insert molding process, which can achieve plastic coating inside and outside the pressure-bearing cylinder, which is reliable and economical. Of course, the pump body can also be machined in the form of an all-metal cylinder to achieve the above effect. The piston drive mechanism 314 can be a cam mechanism, a connecting rod mechanism, a ball screw nut mechanism, a rack and pinion mechanism, and a cylinder, etc., which is not limited here and can be adjusted according to specific circumstances.

[0061] It should be understood that the piston drive mechanism 314 drives the piston rod 311 to move reciprocatingly up and down, so that the high-pressure chamber 312 and the low-pressure chamber 313 both have a reciprocating cycle of suction stroke and discharge stroke, and there is no phase difference between the reciprocating of the high-pressure chamber 312 and the low-pressure chamber 313, that is, the suction stroke of the high-pressure chamber 312 and the suction stroke of the low-pressure chamber 313 occur simultaneously, and the discharge stroke of the high-pressure chamber 312 and the discharge stroke of the low-pressure chamber 313 occur simultaneously.

[0062] The high-pressure chamber 312 is connected to the high-pressure pipe 120 through the first connecting pipe 321. The fluid storage mechanism 320 is connected to the high-pressure chamber 312 through the second connecting pipe 322, and a first one-way valve 323 is connected between the fluid storage mechanism 320 and the high-pressure chamber 312. The piston drive mechanism 314, the piston rod 311, the high-pressure chamber 312, the first connecting pipe 321, the fluid storage mechanism 320, and the second connecting pipe 322 cooperate with each other to form a high-pressure fluid source. Among them, the liquid in the fluid storage mechanism 320 can be specifically physiological saline or heparin medicine required for the surgical axis, which is not limited here and can be adjusted according to specific circumstances. The fluid storage mechanism 320 includes a puncture device 324 connected to the second connecting pipe 322 and an external saline bag (not shown). A fluid filter 325 is provided between the fluid storage mechanism 320 and the high-pressure chamber 312, and the fluid filter 325 is used to filter out impurities and some fine bubbles, and the filtered fluid enters the high-pressure chamber 312 through the second connecting pipe 322. The first one-way valve 323 is connected to the second connecting pipe 322. The first connecting pipe 321 is a high-pressure pipe, and the second connecting pipe 322 is a PVC pipe. Specifically, the high-pressure pipe is made of stainless steel.

[0063] See also Figure 1 , Figure 2 , Figure 6 and Fig.12 As shown, the fluid power source 300 also includes a waste liquid collection mechanism 330, which is connected to the low pressure chamber 313 through a third connecting pipe 331. The low pressure chamber 313 is connected to the catheter cavity 113 through a fourth connecting pipe 332. A second one-way valve 333 is connected between the waste liquid collection mechanism 330 and the low pressure chamber 313, and between the low pressure chamber 313 and the catheter cavity 113. The piston drive mechanism 314, the piston rod 311, the low pressure chamber 313, the waste liquid collection mechanism 330, the third connecting pipe 331, and the fourth connecting pipe 332 cooperate with each other to form a suction source.

[0064] It should be understood that the high-pressure chamber 312 is connected to the high-pressure tube 120 through the first connecting tube 321, and the low-pressure chamber 313 is connected to the catheter cavity 113 through the fourth connecting tube 332. Since the high-pressure tube 120 is disposed in the outer catheter 110, and the catheter cavity 113 is formed between the high-pressure tube 120 and the outer catheter 110, the fourth connecting tube 332 and the first connecting tube 321 have an overlapping area, and a three-way valve 334 is provided at the bifurcation position of the fourth connecting tube 332 and the first connecting tube 321.

[0065] Combination Figure 3 and Figure 4As shown, when the piston driving mechanism 314 drives the piston rod 311 to move upward, the high-pressure chamber 312 is in the suction stroke period, a negative pressure is formed in the high-pressure chamber 312, and the fluid in the fluid storage mechanism 320 enters the high-pressure chamber 312 along the first connecting pipe 321. When the piston driving mechanism 314 drives the piston rod 311 to move downward, the high-pressure chamber 312 is in the extrusion stroke period, and the first one-way valve 323 plays a reverse sealing role, so that the fluid in the high-pressure chamber 312 cannot return to the fluid storage mechanism 320, so that the fluid forms a high-pressure fluid in the high-pressure chamber 312, and the high-pressure fluid in the high-pressure chamber 312 is transported to the nozzle mechanism 200 along the high-pressure pipe 120, and a suction phenomenon is generated in the catheter cavity 113, so that the thrombus outside the outer catheter 110 is sucked into the catheter cavity 113, and the thrombus entering the catheter cavity 113 is crushed.

[0066] When the piston driving mechanism 314 drives the piston rod 311 to move upward, the low-pressure chamber 313 is in the suction stroke period, and negative pressure is formed in the low-pressure chamber 313. The thrombus is sucked into the catheter cavity 113 and moves along the flow direction of the high-speed fluid ejected by the nozzle mechanism 200. Since the inside of the catheter cavity 113 is positive pressure, after the pressure difference between the low-pressure chamber 313 and the second one-way valve 333 between the low-pressure chamber 313 and the catheter cavity 113 reaches the opening pressure, the second one-way valve 333 between the low-pressure chamber 313 and the catheter cavity 113 opens, allowing the waste liquid and thrombus fragments to enter the low-pressure chamber 313 along the fourth connecting pipe 332. When the piston driving mechanism 314 drives the piston rod 311 to move downward, after the pressure difference between the front and rear of the second one-way valve 333 between the waste liquid collection mechanism 330 and the low-pressure chamber 313 reaches the opening pressure, the second one-way valve 333 between the waste liquid collection mechanism 330 and the low-pressure chamber 313 opens, allowing the waste liquid and thrombus fragments in the low-pressure chamber 313 to enter the waste liquid collection mechanism 330 along the third connecting pipe 331. At this time, the second one-way valve 333 between the low-pressure chamber 313 and the catheter cavity 113 plays a reverse sealing role, and the waste liquid and thrombus fragments will not flow back.

[0067] The suction stroke of the high-pressure chamber 312 and the suction stroke of the low-pressure chamber 313 occur simultaneously, and the extrusion stroke of the high-pressure chamber 312 and the extrusion stroke of the low-pressure chamber 313 occur simultaneously without any phase difference. By setting up a dual-chamber pump 310, the function of spraying high-pressure fluid on the thrombus to break up the thrombus and the function of extracting the broken thrombus and discharging it into the waste liquid collection mechanism 330 can be achieved simultaneously, which greatly simplifies the complexity of the system and improves the efficiency of thrombus removal.

[0068] See also Figure 1 , Figure 2 and Fig. 20As shown, the mechanical thrombus removal system 10 further includes a driving base 500, on which the piston driving mechanism 314 is disposed, and a capture assembly 510 is disposed on the driving base 500, and the capture assembly 510 is used to automatically dock and grab the piston rod 311. A clamping valve 520 is also disposed on the driving base 500, and the clamping valve 520 has a clamping groove for accommodating the fourth connecting tube 332, and a contact switch is disposed in the clamping groove, and the contact switch is used to determine whether the fourth connecting tube 332 is installed in place.

[0069] See also Figure 1 and Fig.12 As shown, the mechanical thrombus removal system 10 also includes a control module, a pressure detection mechanism and an alarm device, and the pressure detection mechanism is used to detect the pressure in the high-pressure chamber 312. The pressure detection mechanism is connected to the control module in communication, and the control module is connected to control the alarm mechanism. When the pressure detection mechanism detects that the pressure in the high-pressure chamber 312 is lower than the set value, the control module controls the alarm mechanism to trigger the alarm to remind the staff. Among them, the alarm mechanism uses sound and light alarm. The pressure detection mechanism can use a pressure sensor, a varistor, etc., which is not limited here, as long as it can achieve the function of detecting the pressure in the high-pressure chamber 312.

[0070] See also Figure 1 , Figures 12 to 15 As shown, the piston rod 311 includes a lower piston portion 3111 that forms a seal with the high-pressure chamber 312 and an upper piston portion 3112 that forms a seal with the low-pressure chamber 313. The high-pressure seal 3122 can be made of wear-resistant sealing materials such as HDPE or PTFE, and can be formed by injection molding or machining.

[0071] A first groove 3122 is provided at the opening of one end of the high-pressure pump body 315 close to the low-pressure pump body 316, and a high-pressure seal 3121 is provided in the first groove 3122. A high-pressure sealing ring 3123 is sleeved on the bottom of the high-pressure seal 3121, and the high-pressure sealing ring 3123 is installed on the bottom surface of the first groove 3122. The high-pressure seal 3121 is fixed to the first opening of the high-pressure pump body 315 by a high-pressure locking nut 3124. The high-pressure locking nut 3124 can abut against the high-pressure seal 3121. By tightening the high-pressure locking nut 3124, the high-pressure lock nut 3124 can be tightened. The locking nut 3124 moves downward to abut against the high-pressure seal 3121, the conical surface of the high-pressure seal 3121 is tightly attached to the conical surface of the high-pressure locking nut 3124, the lower piston part 3111 and the center hole of the high-pressure seal 3121 are interference-fitted to form a first sealing area, the high-pressure sealing ring 3123 is pressed by the high-pressure seal 3121, and the high-pressure sealing ring 3123 is attached to the bottom of the first groove 3122 to form a second sealing area, and the outer circumferential surface of the high-pressure seal 3121 and the side wall of the first groove 3122 are interference-fitted to form a third sealing area. The first sealing area, the second sealing area, and the third sealing area ensure that the top of the high-pressure pump body 315 can withstand high pressure without leakage to ensure the sealing effect.

[0072] A ball seat 3126 for accommodating a one-way steel ball 3125 is provided at the bottom of the high-pressure pump body 315. A hole is provided at the bottom of the ball seat, which is the liquid inlet of the high-pressure pump body 315. The ball seat 3126 is formed with a spherical annular groove matching the shape of the one-way steel ball 3125. During the operation of the high-pressure pump body 315, the one-way steel ball 3125 is subjected to downward pressure along the axis, and the one-way steel ball 3125 and the ball seat 3126 form a sealing area under pressure extrusion, and the greater the pressure, the better the sealing effect.

[0073] The inventor found that when the ball seat 3126 is under high pressure, the one-way steel ball 3125 is likely to be pressed too deep into the ball seat 3126, resulting in the risk of the one-way steel ball 3125 sticking and getting stuck. In order to effectively reduce the problem of the one-way steel ball 3125 sticking and getting stuck when it is under pressure, the inventor made the following settings: the diameter of the one-way steel ball 3125 is larger than the diameter of the hole at the bottom of the ball seat, and the volume of the one-way steel ball 3125 falling into the ball seat 3126 is less than half of the volume of the one-way steel ball 3125. The above settings can solve the risk of the one-way steel ball getting stuck. In addition, in order to achieve a better anti-stuck effect, a second groove is formed between the inner wall of the high-pressure pump body 315 and the ball seat 3126. When the ball seat 3126 is pressurized, the ball seat 3126 can deform toward the inside of the second groove 3127, which can prevent the ball seat 3126 from warping toward the spherical ring groove to jam the one-way steel ball 3125, which can effectively reduce the problem of one-way steel ball 3125 being stuck and stuck due to pressure, and can extend the service life of the high-pressure chamber 312, ensure the stability of the high-pressure chamber 312 during operation, and thus improve the efficiency of thrombus removal. In this embodiment, the ball seat 3126 is made of high-strength, elastic particle material, such as nylon elastomer containing glass fiber.

[0074] See also Figure 1 , Fig.12 , Fig.16 and Fig.18 As shown, the two opposite ends of the low-pressure pump 316 are respectively provided with a first low-pressure seal 3131 and a second low-pressure seal 3132, the first low-pressure seal 3131 and the upper piston part 3112 form a fourth sealing area, and the second low-pressure seal 3132 and the lower piston part 3111 form a fifth sealing area. The first low-pressure seal 3131 and the second low-pressure seal 3132 can be made of wear-resistant sealing materials such as HDPE or PTFE, and can be formed by injection molding or machining.

[0075] The end of the low-pressure pump 316 away from the high-pressure chamber 312 is provided with a third groove 3133 and an upper low-pressure locking nut 3134. The first low-pressure seal 3131 is provided in the third groove 3133 and can abut against the bottom of the third groove 3133. The upper low-pressure locking nut 3134 can abut against the first low-pressure seal 3131. By tightening the upper low-pressure locking nut 3134, the upper low-pressure locking nut 3134 moves downward to abut against the first low-pressure seal 3131. The first low-pressure seal 3131 is pressed, so that a sixth sealing area is formed between the bottom of the third groove 3133 and the first low-pressure seal 3131. A seventh sealing area is formed between the first low-pressure seal 3131 and the side wall of the third groove 3133. The fourth sealing area, the sixth sealing area and the seventh sealing area can ensure that the end of the low-pressure chamber 313 away from the high-pressure chamber 312 can withstand the inside without leakage, thereby ensuring the sealing effect.

[0076] The end of the low-pressure pump 316 close to the high-pressure pump 315 is provided with a fourth groove 3135 and a lower low-pressure locking nut 3136. The second low-pressure seal 3132 is provided in the fourth groove 3135 and can abut against the bottom of the fourth groove 3135. The lower low-pressure locking nut 3136 can abut against the second low-pressure seal 3132. By tightening the lower low-pressure locking nut 3136, the lower low-pressure locking nut 3136 moves downward to abut against the second low-pressure seal 3132. The second low-pressure seal 3132 is pressed, so that an eighth sealing area is formed between the bottom of the fourth groove 3135 and the second low-pressure seal 3132. The fifth sealing area and the eighth sealing area can ensure that the end of the low-pressure chamber 313 close to the high-pressure chamber 312 can withstand pressure without leakage, thereby ensuring the sealing effect.

[0077] See also Figure 1 and Fig.19 As shown, the mechanical thrombus removal system 10 also includes an exhaust mechanism 400, which is arranged at the connection between the high-pressure pump body 315 and the low-pressure pump body 316. The exhaust mechanism 400 includes a plurality of exhaust holes 410 arranged on one end of the low-pressure pump body 316 close to the high-pressure pump body 315 and an air bag 420 arranged at the connection. The air bag 420 is connected to the exhaust hole 410, and the exhaust hole 410 can be connected to the low-pressure chamber 313.

[0078] See also Figure 1 , Figure 2 and Fig.19 As shown, the mechanical thrombus removal system 10 also includes a bubble detection mechanism, a control module, a pressure detection mechanism and an alarm device. The bubble detection mechanism is used to detect whether there are bubbles in the high-pressure chamber 312. The bubble detection mechanism is connected to the control module in communication, and the control module is connected to control the piston drive mechanism 314. Among them, the bubble detection mechanism uses an ultrasonic sensor. It should be understood that: before starting to suck the thrombus, the high-pressure chamber 312 needs to be vented. First, the distal end of the catheter mechanism 100 is set in a container containing physiological saline, and then the piston drive mechanism 314 is operated to allow the physiological saline to perfuse the entire mechanical thrombus removal system 10. When the physiological saline flows to the set position in the waste liquid collection mechanism 330 or the piston drive mechanism 314 is operated to the set value, the venting is completed.

[0079] During the process of sucking out the plug, if there are bubbles in the high-pressure chamber 312, the bubbles may be injected into the patient's body, causing harm to the patient. When the high-pressure chamber 312 is in the extrusion stroke period, the bubble detection mechanism needs to detect whether there are bubbles in the high-pressure chamber 312. When the bubble detection mechanism detects that there are bubbles in the high-pressure chamber 312, the control module controls the piston drive mechanism 314 to operate to drive the piston rod 311 to move upward, so as to move the end of the lower piston part 3111 to the exhaust hole 410 position. At this time, there is a gap between the lower piston part 3111 and the high-pressure seal 3121.

[0080] When the piston rod 311 moves upward, the high-pressure chamber 312 is in the suction stroke period, and negative pressure is formed in the high-pressure chamber 312. The fluid in the fluid storage mechanism 320 enters the high-pressure chamber 312 along the first connecting pipe 321, so as to discharge the bubbles in the upper layer of the high-pressure chamber 312 from the exhaust hole 410 to the inside of the airbag 420, thereby completing the discharge of the bubbles. Accordingly, the fluid will also flow into the inside of the airbag 420, and will not flow into other components of the dual-chamber pump 310 (for example, the piston drive mechanism 314), increasing the risk of corrosion of the components. The amount of fluid that flows in is controlled by controlling the waiting time of the piston rod 311 to achieve a state of completely discharging the bubbles. The airbag 420 is fixedly installed between the high-pressure pump body 315 and the low-pressure pump body 316, which is a static connection. Compared with other similar products on the market (the airbag 420 is installed between the piston rod 311 and the high-pressure pump body 315), there is no risk of the airbag 420 exploding when it is filled with water due to the high-frequency reciprocating motion of the piston rod 311.

[0081] When the mechanical thrombus removal system 10 of the present invention is used, the position of the thrombus in the blood vessel is first determined by DSA (digital subtraction angiography), and then the catheter mechanism 100 is inserted into the position of the thrombus in the blood vessel.

[0082] The piston driving mechanism 314 drives the piston rod 311 to move upward, and the high-pressure chamber 312 is in the suction stroke period. Negative pressure is formed in the high-pressure chamber 312, and the fluid in the fluid storage mechanism 320 enters the high-pressure chamber 312 along the first connecting pipe 321.

[0083] The piston drive mechanism 314 drives the piston rod 311 to move downward, and the high-pressure chamber 312 is in the extrusion stroke period. The first one-way valve 323 plays a reverse sealing role, so that the fluid in the high-pressure chamber 312 cannot return to the fluid storage mechanism 320, so that the fluid forms a high-pressure fluid in the high-pressure chamber 312. The high-pressure fluid in the high-pressure chamber 312 is transported to the nozzle mechanism 200 along the high-pressure pipe 120, and a suction phenomenon is generated in the catheter cavity 113, so that the thrombus outside the outer catheter 110 is sucked into the catheter cavity 113, and the thrombus entering the catheter cavity 113 is broken.

[0084] When the high-pressure fluid is sprayed into the catheter cavity 113 through the plurality of fluid jet holes 210, a negative pressure is generated near the thrombus suction hole 111, so that the thrombus outside the outer catheter 110 is sucked into the catheter cavity 113 through the thrombus suction hole 111. When the thrombus enters the catheter cavity 113, the high-pressure fluid will break up the thrombus entering the catheter cavity 113. At the same time, after the multiple high-pressure fluids form a converging jet, a positive pressure is generated near the injection hole 112, and the positive pressure near the injection hole 112 is higher than the blood vessel pressure, so that the converging jet is ejected from the injection hole 112, and the converging jet ejected from the injection hole 112 stirs inside the thrombus to form a circulating flow, which can promote thrombus suction. The converging jet can effectively extend the distance that the high-pressure fluid is pushed to the proximal end and improve the suction capacity. The suction source is connected to the catheter cavity 113, and the crushed thrombus in the catheter cavity 113 can be sucked out of the patient's body in time.

[0085] The piston driving mechanism 314 drives the piston rod 311 to move upward, and the low-pressure chamber 313 is in the suction stroke period. A negative pressure is formed in the low-pressure chamber 313, and the thrombus is sucked into the catheter cavity 113 and moves along the flow direction of the high-speed fluid ejected by the nozzle mechanism 200. Since the inside of the catheter cavity 113 is positive pressure, after the pressure difference between the low-pressure chamber 313 and the second one-way valve 333 between the low-pressure chamber 313 and the catheter cavity 113 reaches the opening pressure, the second one-way valve 333 between the low-pressure chamber 313 and the catheter cavity 113 opens, allowing the waste liquid and thrombus fragments to enter the low-pressure chamber 313 along the fourth connecting pipe 332.

[0086] The piston driving mechanism 314 drives the piston rod 311 to move downward, and after the pressure difference between the front and rear of the second one-way valve 333 between the waste liquid collection mechanism 330 and the low-pressure chamber 313 reaches the opening pressure, the second one-way valve 333 between the waste liquid collection mechanism 330 and the low-pressure chamber 313 opens, allowing the waste liquid and thrombus fragments in the low-pressure chamber 313 to enter the waste liquid collection mechanism 330 along the third connecting pipe 331. At this time, the second one-way valve 333 between the low-pressure chamber 313 and the catheter cavity 113 plays a reverse sealing role, and the waste liquid and thrombus fragments will not flow back.

[0087] Among them, the suction stroke of the high-pressure chamber 312 and the suction stroke of the low-pressure chamber 313 occur simultaneously, and the extrusion stroke of the high-pressure chamber 312 and the extrusion stroke of the low-pressure chamber 313 occur simultaneously without any phase difference. By setting up a dual-chamber pump 310, it is possible to simultaneously realize the function of spraying high-pressure fluid on the thrombus to break up the thrombus, and to extract the broken thrombus and discharge it into the waste liquid collection mechanism 330, which greatly simplifies the complexity of the system and improves the efficiency of thrombus removal.

[0088] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0089] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A mechanical thrombus removal system, characterized in that: include: A catheter mechanism, the catheter mechanism comprising an outer catheter and a high-pressure tube disposed in the outer catheter, a catheter cavity is formed between the high-pressure tube and the outer catheter, and the outer catheter has a proximal end and a distal end; A fluid power source, the fluid power source comprising a high-pressure fluid source and a suction source, the high-pressure fluid source being connected to the high-pressure tube for inputting high-pressure fluid into the high-pressure tube, and the suction source being connected to the catheter cavity; A nozzle mechanism, the nozzle mechanism is arranged at one end of the high-pressure tube away from the proximal end of the outer catheter and is in communication with the high-pressure tube, the nozzle mechanism is provided with a plurality of fluid jet holes along its circumference, the jet holes jet high-pressure fluid toward the proximal end, the high-pressure fluid is jetted into the catheter cavity at a certain angle to the central axis of the outer catheter and converges on the central axis; Wherein, a plurality of bolt suction holes and a plurality of injection holes are arranged on the outer wall of the outer catheter along the circumference of the outer catheter, the bolt suction holes are arranged close to the injection holes, and the injection holes are arranged close to the proximal end; The high-pressure fluid source comprises a high-pressure pump body, the high-pressure pump body has a high-pressure chamber, the high-pressure chamber is connected to the high-pressure pipe; a ball seat is arranged at the bottom of the high-pressure pump body, a hole is arranged at the bottom of the ball seat, a one-way steel ball is accommodated in the ball seat, a spherical annular groove matching the shape of the one-way steel ball is formed on the ball seat, and when the one-way steel ball is subjected to downward pressure, a sealing area is formed between the one-way steel ball and the ball seat; The diameter of the one-way steel ball is larger than the diameter of the hole, the volume of the one-way steel ball falling into the ball seat is less than half of the volume of the one-way steel ball, a second groove is formed between the inner wall of the high-pressure pump body and the ball seat, and when the ball seat is pressurized, the ball seat can be deformed toward the inside of the second groove; The fluid power source further comprises a double-chamber pump, the double-chamber pump comprises a low-pressure pump body, the high-pressure pump body, a piston rod and a piston drive mechanism, and the low-pressure pump body comprises a low-pressure chamber; An exhaust mechanism is arranged at the connection between the high-pressure pump body and the low-pressure pump body, and the exhaust mechanism includes a plurality of exhaust holes arranged on one end of the low-pressure pump body close to the high-pressure pump body and an air bag arranged at the connection, the air bag is connected to the exhaust holes, and the exhaust holes are connected to the low-pressure chamber.

2. The mechanical thrombus removal system according to claim 1, characterized in that: The catheter mechanism further comprises a hemostatic valve, which is disposed between the suction source and the catheter cavity.

3. The mechanical thrombus removal system according to claim 1, characterized in that: The conduit mechanism further comprises a developing ring, and the high-pressure tube is connected to the outer conduit via the developing ring.

4. The mechanical thrombus removal system according to claim 1, characterized in that: The distal end of the outer catheter is formed with a tip for easy insertion into a blood vessel.

5. The mechanical thrombus removal system according to claim 1, characterized in that: The high-pressure chamber is coaxially arranged with the low-pressure chamber, one end of the piston rod is passed through the high-pressure chamber and the low-pressure chamber, the other end of the piston rod is drivingly connected with the piston driving mechanism, the piston driving mechanism is used to drive the piston rod to move up and down, and the high-pressure chamber is connected with the high-pressure pipe through a first connecting pipe; The high-pressure fluid source further includes a fluid storage mechanism, the fluid storage mechanism is connected to the high-pressure chamber through a second connecting pipe, and a first one-way valve is connected between the fluid storage mechanism and the high-pressure chamber; The piston rod, the piston driving mechanism, the high-pressure chamber, the first connecting pipe, the fluid storage mechanism, and the second connecting pipe cooperate with each other to form the high-pressure fluid source.

6. The mechanical thrombus removal system according to claim 5, characterized in that: The fluid power source also includes: A waste liquid collection mechanism, the waste liquid collection mechanism is connected to the low-pressure chamber through a third connecting pipe, the low-pressure chamber is connected to the catheter cavity through a fourth connecting pipe, and a one-way valve is connected between the waste liquid collection mechanism and the low-pressure chamber, and between the low-pressure chamber and the catheter cavity; The piston rod, the piston driving mechanism, the low-pressure chamber, the waste liquid collecting mechanism, the third connecting pipe, and the fourth connecting pipe cooperate with each other to form the suction source.

7. The mechanical thrombus removal system according to claim 5, characterized in that: The piston rod comprises a lower piston portion forming a seal with the high-pressure chamber and an upper piston portion forming a seal with the low-pressure chamber; A first groove is provided at an opening of one end of the high-pressure pump body close to the low-pressure pump body, and a high-pressure sealing member is provided in the first groove; The openings at both ends of the low-pressure pump body are both provided with grooves, and low-pressure sealing elements are both provided in the grooves. The low-pressure sealing elements are sealed with the piston rod.

8. The mechanical thrombus removal system according to claim 5, characterized in that: It also includes a driving base, the piston driving mechanism is arranged on the driving base, and a capture component is arranged on the driving base, and the capture component is used for automatically docking and grabbing the piston rod.

9. The mechanical thrombus removal system according to claim 1, characterized in that: It also includes a bubble detection mechanism, which is used to detect whether there are bubbles in the high-pressure chamber.

10. The mechanical thrombus removal system according to claim 1, characterized in that: The ball seat is made of elastic material.

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