A calcification elimination system for calcified lesions of blood vessels

Abstract

The application discloses a calcification elimination system for vascular calcification lesions, and relates to the technical field of medical calcification elimination devices, which comprises a multi-cavity catheter, an ultrasonic conducting wire and a filter screen. A broken balloon is arranged on the outer wall of the multi-cavity catheter. The multi-cavity catheter comprises a suction cavity, a first filling cavity, a conducting wire cavity and a wire-retracting cavity, which all extend along the length direction. A suction hole is arranged on the distal end side wall of the suction cavity. The ultrasonic conducting wire is partially arranged in the conducting wire cavity. The proximal end of the ultrasonic conducting wire is connected with an ultrasonic energy source. The ultrasonic conducting wire has a spiral section, which is sleeved on the outside of the broken balloon. The filter screen is located on the distal end side of the broken balloon. The filter screen is connected with the distal end wall of the suction cavity. The outer edge of the filter screen is connected with a wire-retracting wire. The proximal end of the wire-retracting wire extends to the proximal end of the multi-cavity catheter through the wire-retracting cavity. The application can completely break the plaque, ensures complete breaking of the plaque and improves the breaking efficiency. In addition, the application avoids the problem of vascular thermal damage caused by the local concentration of ultrasonic energy.

Description

Technical Field

[0001] This invention relates to the field of medical calcification removal equipment technology, and more particularly to a calcification removal system for vascular calcification lesions. Background Technology

[0002] Currently, the clinical treatment of vascular calcification mainly employs single techniques such as conventional balloon dilation, high-pressure balloon dilation, rotational atherectomy, and laser ablation. These techniques generally have significant drawbacks: they cause high levels of damage to the vessel wall, easily leading to vascular dissection and perforation; the calcified plaques are broken unevenly, and residual lesions can easily cause restenosis; the fragmented plaques are easily dislodged, causing distal vascular embolism; and the various instruments have limited functions, requiring multiple instrument changes to complete the treatment process, resulting in long operation times, high operational complexity, and increased intraoperative risks for patients.

[0003] Existing patents related to ultrasound balloons mostly employ a single-layer catheter structure, with ultrasound transmission components often being straight wires embedded or energy elements wrapped in a ring. This results in problems such as low energy utilization, incomplete fragmentation of calcified plaques, and low integration between the balloon and the ultrasound transmission structure. Furthermore, ultrasound energy is prone to concentration, generating thermal effects that can easily cause thermal damage to the blood vessel wall. Moreover, it does not integrate functions such as thrombus aspiration and embolus filtration, making it impossible to achieve systematic and integrated treatment of calcified lesions and failing to meet the needs of precise clinical treatment. Summary of the Invention

[0004] The purpose of this invention is to provide a calcification removal system for vascular calcification lesions, in order to solve the problems existing in the prior art. It can comprehensively fragment plaques, ensure thorough fragmentation and improve fragmentation efficiency, and also avoid the problem of vascular thermal damage caused by the local concentration of ultrasound energy.

[0005] To achieve the above objectives, the present invention provides the following solution: A calcification removal system for vascular calcification lesions includes a multi-lumen catheter, an ultrasound transmission wire, and a filter. A fragmentation balloon is disposed on the outer wall of the multi-lumen catheter. The multi-lumen catheter includes at least a suction chamber, a first filling chamber, a transmission wire chamber, and a wire take-up / deployment chamber, all extending along its length. The proximal end of the suction chamber is connected to a negative pressure suction device, and a suction port is disposed on the distal sidewall of the suction chamber. The first filling chamber communicates with the fragmentation balloon to inflate it. A portion of the ultrasound transmission wire passes through the transmission wire chamber, and the proximal end of the ultrasound transmission wire is connected to an ultrasound energy source. The ultrasound transmission wire has a helical segment made of shape memory alloy wire. The segment is sleeved on the outside of the fragmentation balloon and can expand in diameter as the fragmentation balloon is inflated; the filter screen is located on the distal side of the fragmentation balloon and is connected to the distal wall of the suction chamber. The filter screen has filter holes that can intercept particles and allow blood flow. The outer edge of the filter screen is connected to a take-up and release wire, and the proximal end of the take-up and release wire extends through the take-up and release wire cavity to the proximal end of the multi-lumen catheter; the filter screen is configured such that: when the take-up and release wire is tightened, the filter screen contracts, and when the take-up and release wire is relaxed, the filter screen unfolds, and the opening of the filter screen faces the proximal side; at least a portion of the suction holes are located within the mesh pocket cavity formed after the filter screen unfolds.

[0006] In one embodiment, the distal ends of the suction chambers are all located on the distal sides of the first filling chamber, the conduction filament chamber, and the take-up and release filament chamber.

[0007] In one embodiment, the distal end of the ultrasonic conduction wire extends from the distal port of the aspiration cavity and is connected to a pre-expanding ball head, the diameter of which is larger than the diameter of the distal port of the aspiration cavity.

[0008] As one embodiment, a first through hole is provided on the side wall of the aspiration cavity, and a second through hole is provided on the side wall of the conduction wire cavity. The first through hole and the second through hole are located on the proximal and distal sides of the rupture balloon, respectively, for the ultrasonic conduction wire to pass through the second through hole to form the helical segment and then pass through the first through hole into the aspiration cavity.

[0009] In one embodiment, the filter screen includes a frame and a filter membrane disposed on the frame. The frame is made of shape memory alloy wire. The distal end of the frame is connected to the distal wall of the suction chamber, and the proximal end is connected to the distal end of the take-up and release wire.

[0010] As one embodiment, multiple take-up and release wires are provided along the circumference of the filter screen, and the proximal portions of the multiple take-up and release wires form an integrated wire that passes through the take-up and release wire cavity.

[0011] As one embodiment, the outer wall of the multi-lumen catheter is further provided with a stent balloon and a balloon-expanding stent sleeved on the stent balloon, the stent balloon being located on the proximal side of the fragmentation balloon; the multi-lumen catheter is further provided with a second filling cavity communicating with the stent balloon for filling it.

[0012] As one embodiment, the catheter seat is provided at the proximal end of the multi-lumen catheter. The catheter seat has multiple channels, which are respectively connected to the aspiration chamber, the first filling chamber, the second filling chamber, the conduction wire chamber, and the take-up and release wire chamber.

[0013] As one embodiment, it also includes an outer tube assembly, which includes an outer tube body and an outer tube seat fixed to the proximal end of the outer tube body, through which the multi-lumen catheter is inserted into the body.

[0014] In one embodiment, a sealing ring is provided inside the outer tube seat, and the multi-lumen catheter is inserted into the body through the sealing ring, with the inner ring of the sealing ring fitting against the outer wall of the multi-lumen catheter.

[0015] Compared with the prior art, the present invention has the following technical effects: This invention involves attaching a helical segment of an ultrasound conduction wire made of shape memory alloy to the outside of a fragmentation balloon. When the balloon inflates, the helical segment expands in diameter and eventually adheres to the surface of the plaque on the inner wall of the affected area. Ultrasonic vibration is then used to fragment the plaque, enabling 360° comprehensive fragmentation, ensuring thorough fragmentation and improving efficiency. This also avoids the problem of vascular thermal damage caused by localized concentration of ultrasound energy, significantly improving safety. Furthermore, the filter in this invention collects detached plaque and removes it through a suction chamber and suction port, preventing distal vascular embolism caused by detached plaque.

[0016] Compared with the prior art, other technical solutions in this invention have the following technical effects: The calcification removal system of this invention has five major functions: "pre-expansion-fracture-filtration-suction-stent release". After the pre-expansion ball head breaks the hard shell of calcification, the fragmentation balloon precisely breaks the residual calcification, the filter screen intercepts the debris at the same time, and the debris is discharged through the suction hole and suction chamber. The stent balloon provides support as needed. The entire process does not require changing instruments, which solves the pain points of existing technologies such as "multiple instrument changes and long operation time". Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the structure of a calcification elimination system in one embodiment of the present invention; Figure 2 for Figure 1 A schematic diagram of the structure before implantation; Figure 3 This is a schematic diagram of the connection between the filter screen and the take-up / outlet yarn in one embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of the pre-expanded ball head and the ultrasonic conduction wire in one embodiment of the present invention; Figure 5 This is a schematic diagram of the structure of a multi-lumen catheter in one embodiment of the present invention; Figure 6 for Figure 5 Enlarged view of the structure of region A in the middle; Figure 7 This is a schematic diagram of the radial cross-section of a multi-lumen catheter in one embodiment of the present invention; Figure 8 This is a schematic diagram of the structure of the outer tube assembly in one embodiment of the present invention; Figure 9 for Figure 8 A schematic diagram of the side section structure; Figure 10 This is a three-dimensional structural diagram of the outer tube seat in one embodiment of the present invention; Figure 11 This is a schematic diagram of the structure of the catheter seat in one embodiment of the present invention; Figure 12 This is a schematic diagram of the calcification removal system after the multi-lumen catheter and the outer tube assembly are combined in one embodiment of the present invention; Figure 13 for Figure 12 A schematic diagram of the structure before it is implanted in the human body.

[0019] Figure label: 1. Multi-lumen catheter; 11. Aspiration chamber; 110. Aspiration port; 12. Conductor wire chamber; 13. Wire take-up and release chamber; 14. First filling chamber; 15. Second filling chamber; 16. First through hole; 17. Second through hole; 2. Ultrasonic conductor wire; 21. Helical segment; 3. Filter screen; 31. Wire take-up and release; 4. Fracture balloon; 5. Pre-expanding balloon head; 6. Stent balloon; 7. Balloon expansion stent; 8. Catheter seat; 9. Outer tube body; 91. Braided mesh tube; 92. Stress protection tube; 93. Imaging ring; 10. Outer tube seat; 101. Fixing seat; 102. Compression seat; 103. Connecting seat; 104. Sealing ring. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] The purpose of this invention is to provide a calcification removal system for vascular calcification lesions, in order to solve the problems existing in the prior art. It can comprehensively fragment plaques, ensure thorough fragmentation and improve fragmentation efficiency, and also avoid the problem of vascular thermal damage caused by the local concentration of ultrasound energy.

[0022] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0023] like Figures 1-13As shown, this embodiment provides a calcification removal system for vascular calcification lesions, including a multi-lumen catheter 1, an ultrasonic conduction wire 2, and a filter screen 3. A fragmentation balloon 4 is disposed on the outer wall of the multi-lumen catheter 1. The multi-lumen catheter 1 includes at least an aspiration chamber 11, a first filling chamber 14, a conduction wire chamber 12, and a wire take-up and release chamber 13, all extending along the length direction. The proximal end of the aspiration chamber 11 is used to connect to a negative pressure aspiration device, and an aspiration hole 110 is disposed on the distal side wall of the aspiration chamber 11. After the negative pressure aspiration device is turned on, emboli, plaques, and other particles near the aspiration hole 110 can be discharged from the body through the aspiration chamber 11. The proximal end of the first filling chamber 14 is connected to an injection device, and the distal end is connected to the fragmentation balloon 4 to inflate the fragmentation balloon 4. A portion of the ultrasonic conduction wire 2 is inserted within the conduction wire cavity 12. The proximal end of the ultrasonic conduction wire 2 is connected to an ultrasonic energy source. The ultrasonic conduction wire 2 has a helical segment 21 made of shape memory alloy wire (e.g., nickel-titanium alloy). The helical segment 21 is sleeved on the outside of the rupture balloon 4, and the axial length of the helical segment 21 is greater than the axial length of the rupture balloon 4. When the rupture balloon 4 is not inflated, the helical segment 21 has a small diameter and a small pitch (closely arranged) helical structure. After the rupture balloon 4 is inflated (the inflating medium can be a mixture of contrast agent and physiological saline), the diameter of the helical segment 21 increases under the expansion force of the rupture balloon 4, and the small-pitch helical structure unwinds to a certain extent, forming a large-diameter helical structure with a larger pitch (sparsely arranged).

[0024] In this embodiment, the filter screen 3 is located at the distal end of the fragmentation balloon 4. The filter screen 3 is connected to the distal wall of the suction chamber 11. The filter screen 3 has filter holes that can intercept particles and allow blood flow. A take-up and release wire 31 is connected to the outer edge of the filter screen 3. The proximal end of the take-up and release wire 31 extends through the take-up and release wire cavity 13 to the proximal end of the multi-lumen catheter 1. By pulling the take-up and release wire 31, the contracted and unfolded states of the filter screen 3 can be switched. After the filter screen 3 is unfolded, the mesh opening faces the proximal end. Moreover, in this embodiment, at least some of the suction holes 110 are located in the mesh pocket cavity formed after the filter screen 3 is unfolded. When the negative pressure suction device is working, particles such as emboli and plaques in the filter screen 3 can be suctioned out of the body through the suction holes 110.

[0025] In this embodiment, "proximal end" refers to the end closer to the surgeon, and "distal end" refers to the end farther away from the surgeon.

[0026] During use, the retractable wire 31 tightens, causing the filter screen 3 to be in a contracted state, tightly adhering to the outer wall of the suction chamber 11, preventing the crushing sac 4 from filling. Figure 2As shown; the multi-lumen catheter 1 is inserted into the calcified lesion area of ​​the human blood vessel. When the filter 3 is located on the distal side of the lesion area, the retractable wire 31 is released, and the filter 3 unfolds; then the fragmentation balloon 4 is inflated with fluid. During the inflation of the fragmentation balloon 4, the diameter and pitch of the helical segment 21 of the ultrasound conduction wire 2 on the outside of the fragmentation balloon 4 increase, and it eventually abuts against the inner wall of the lesion area; in this embodiment, the fragmentation balloon 4 is a compliant balloon, which completely conforms to the surface of the calcified plaque after inflation, and makes the helical segment 21 of the ultrasound conduction wire 2 conform to the surface of the calcified plaque, as shown. Figure 1 As shown. After the ultrasonic energy source is turned on, the ultrasonic transmission wire 2 conducts ultrasonic energy, and the helical segment 21 generates high-frequency vibration under ultrasonic energy, which breaks up the calcified plaques. The detached plaques are collected by the filter screen 3; after the breaking is completed, the negative pressure suction device is turned on, and the detached plaques are discharged from the body using the suction chamber 11 and suction port 110.

[0027] Therefore, in this embodiment, by fitting the helical segment 21 of the ultrasonic conduction wire 2 made of shape memory alloy onto the outside of the fragmentation balloon 4, the helical segment 21 expands in diameter and eventually adheres to the surface of the plaque on the inner wall of the affected area when the fragmentation balloon 4 is inflated. This utilizes ultrasonic vibration for thrombus fragmentation, enabling 360° comprehensive fragmentation of the plaque, ensuring thorough fragmentation and improving efficiency. It also avoids the problem of vascular thermal damage caused by localized concentration of ultrasonic energy, significantly improving safety. Furthermore, the filter 3 in this embodiment can collect detached plaque and discharge it through the suction chamber 11 and suction port 110, preventing distal vascular embolism caused by detached plaque.

[0028] In this embodiment, the distal ends of the aspiration chamber 11 are all located on the distal sides of the first filling chamber 14, the conduction wire chamber 12, and the take-up / deployment wire chamber 13. Specifically, in this embodiment, the aspiration chamber 11 can be located at the center of the multi-lumen catheter 1, with the first filling chamber 14, the conduction wire chamber 12, and the take-up / deployment wire chamber 13 surrounding the aspiration chamber 11. Furthermore, the aspiration chamber 11 has the largest diameter, approximately 60% of the total diameter of the multi-lumen catheter 1, ensuring that plaques, emboli, and other particles can be aspirated and discharged. Figure 7 As shown. Moreover, in this embodiment, the proximal end faces of the suction chamber 11, the first filling chamber 14, the conduction wire chamber 12, and the take-up and release wire chamber 13 are flush, and the total length of the suction chamber 11 is longer than the other three, so that a part of the multi-lumen catheter 1 at the distal position has only the suction chamber 11 and no other lumens, which makes it easier to set suction holes 110 on the outer wall of the suction chamber 11 to directly suction emboli, plaques and other particles.

[0029] Calcified lesions typically develop a harder calcified cap on their outer surface, increasing the difficulty of fragmentation. In this embodiment, the distal end of the ultrasound transmission wire 2 extends from the distal port of the aspiration cavity 11 and connects to the pre-dilation bulb 5, which is a metal ball structure with a diameter of 0.35mm-0.4mm. After the pre-dilation bulb 5 reaches the location of the calcified lesion, the ultrasound energy source is activated, and the pre-dilation bulb 5 generates high-frequency vibrations, striking the hard calcified cap and breaking the calcified shell, thus creating conditions for the subsequent precise fragmentation of the fragmentation balloon 4.

[0030] It should be noted that the calcified hard shell is usually thin. In the experiment, it was found that even if the calcified cap produces fragments during the pre-expansion and fragmentation process of the pre-expansion ball head 5, the diameter of the fragments is very small and will not cause distal vascular embolism.

[0031] In this embodiment, the diameter of the pre-expanding ball head 5 is larger than the diameter of the distal port of the suction chamber 11. When it is necessary to suction the particles in the filter screen 3, first pull the pre-expanding ball head 5 so that it tightly seals the distal port of the suction chamber 11, and then perform negative pressure suction.

[0032] In this embodiment, the pre-expanded ball head 5 is made of nickel-titanium alloy or stainless steel.

[0033] like Figure 6 As shown, in this embodiment, a first through hole 16 is provided on the side wall of the aspiration cavity 11, and a second through hole 17 is provided on the side wall of the conduction wire cavity 12. The first through hole 16 and the second through hole 17 are located on the proximal side and the distal side of the rupture balloon 4, respectively. The ultrasonic conduction wire 2 extends along the conduction wire cavity 12, then passes through the second through hole 17 to form a spiral segment 21, and then passes through the first through hole 16 into the aspiration cavity 11. Finally, it extends out from the distal port of the aspiration cavity 11 and connects to the pre-expanding head 5.

[0034] In this embodiment, the filter 3 includes a frame and a filter membrane disposed on the frame. The frame is made of shape memory alloy wire. The distal end of the frame is connected to the distal wall of the suction chamber 11, and the proximal end is connected to the distal end of the take-up and release wire 31. The filter membrane can be a polymer biomembrane with a filter pore diameter of 60μm-80μm, allowing normal blood components (red blood cells, plasma, etc.) to pass through while effectively intercepting large calcified debris and thrombi with a diameter ≥80μm, realizing "filtration-suction" linkage to thoroughly eliminate the risk of emboli.

[0035] In this embodiment, multiple take-up and release wires 31 are provided along the circumference of the filter screen 3, and the proximal side portions of the multiple take-up and release wires 31 form an integrated wire that passes through the take-up and release wire cavity 13.

[0036] In this embodiment, a stent balloon 6 and a balloon-expanding stent 7 are also disposed on the outer wall of the multilumen catheter 1. The stent balloon 6 is located on the proximal side of the fragmentation balloon 4. A second filling chamber 15 is also disposed inside the multilumen catheter 1, which communicates with the stent balloon 6 for inflation. In this embodiment, the stent balloon 6 is a non-compliant balloon made of polymer material, and the balloon-expanding stent 7 is a metal cutting stent used for vascular support after calcification removal to prevent vascular restenosis.

[0037] The metal-cut stent is pre-loaded onto the surface of the non-compliant balloon, which has good expansion stability and can precisely control the diameter of the stent after deployment, adapting to different sizes of vascular lesions.

[0038] Once the calcified plaque is completely broken up and the thrombus and debris are aspirated and removed, the decision is made on whether to implant the balloon-expandable stent 7 based on the patient's vascular lesion condition. If necessary, a filling medium is injected into the stent balloon 6 through the second filling chamber 15, the stent balloon 6 expands, and the balloon-expandable stent 7 is precisely released into the diseased vascular segment to provide vascular support and complete the integrated repair.

[0039] Therefore, the calcification removal system in this embodiment has five major functions: "pre-expansion-fracture-filtration-suction-stent release". After the pre-expansion head 5 breaks the hard shell of calcification, the fragmentation balloon 4 precisely breaks the residual calcification, the filter screen 3 intercepts the debris at the same time, and the debris is discharged through the suction hole 110 and the suction chamber 11. The stent balloon 6 provides support as needed. The entire process does not require changing instruments, which solves the pain points of "multiple instrument changes and long operation time" in the existing technology.

[0040] like Figure 11 As shown, this embodiment also includes a catheter seat 8 disposed at the proximal end of the multi-lumen catheter 1. The catheter seat 8 has multiple channels, which are respectively connected to the suction chamber 11, the first filling chamber 14, the second filling chamber 15, the conduction wire chamber 12, and the take-up and release wire chamber 13. The catheter seat 8 is made of polymer material through extrusion molding and has at least five channels that are connected to each of the above-mentioned working chambers. The ends of the five channels are all provided with Luer connectors to facilitate rapid connection with other devices (such as negative pressure suction devices, filling devices, ultrasonic transducers, etc.).

[0041] like Figures 8-10 As shown, this embodiment also includes an outer tube assembly, which includes an outer tube body 9 and an outer tube seat 10 fixed to the proximal end of the outer tube body 9. The multi-lumen catheter 1 is inserted into the body through the outer tube body 9 and the outer tube seat 10. In this embodiment, the outer tube body 9 includes a braided mesh tube 91 and a stress protection tube 92. The braided mesh tube 91 is made of a composite of a polymer tube extruded from PEBAX (polyether block polyamide) and a metal braided mesh, possessing excellent support, torsional resistance, and flexibility. It can smoothly pass through curved and narrow blood vessel segments, preventing catheter breakage or deformation during delivery. Furthermore, the distal sidewall of the braided mesh tube 91 has a radiopaque ring 93, facilitating user observation of the distal position of the outer tube body 9. In this embodiment, radiopaque markers can also be placed at appropriate locations on the multi-lumen catheter 1 to facilitate observation of its position.

[0042] The stress protection tube 92 is sleeved on the proximal side of the braided mesh tube 91. The stress protection tube 92 is a single-lumen polymer tube extruded from PEBAX material and is used to protect the connection between the braided mesh tube and the catheter seat 8, reducing stress damage caused by intraoperative operations.

[0043] In this embodiment, a sealing ring 104 is provided inside the outer tube seat 10. The multi-lumen catheter 1 is inserted into the body through the sealing ring 104, and the inner ring of the sealing ring 104 fits against the outer wall of the multi-lumen catheter 1. The sealing ring 104 is injection molded from silicone material. Under pressure, the inner ring contracts, further improving the sealing effect and preventing leakage of blood, contrast agents, and other media during the operation.

[0044] Specifically, in this embodiment, the outer tube seat 10 includes a fixing seat 101, a pressing seat 102, and a connecting seat 103. The fixing seat 101 is fixedly connected to the proximal end of the outer tube body 9. The fixing seat 101 has an internal cavity, one end face of which is tapered, and the other end is open. The outer wall surface of the fixing seat 101 has a first thread. The sealing ring 104 is disposed in the cavity of the fixing seat 101 and has a tapered structure adapted to the tapered surface. The pressing seat 102 is located at the open end of the fixing seat 101 and abuts against the fixing seat 101. At the same time, the proximal end of the pressing seat 102 extends into the cavity of the fixing seat 101 and abuts against the sealing ring 104, pressing the sealing ring 104 tightly against the tapered surface of the fixing seat 101. The side wall of the pressing seat 102 has a second thread, which has the opposite direction of rotation to the first thread. The distal inner wall and proximal inner wall of the connecting seat 103 are respectively provided with a third thread and a fourth thread with opposite directions of rotation. The third thread cooperates with the first thread, and the fourth thread cooperates with the second thread to fix the fixing seat 101, the pressing seat 102 and the connecting seat 103.

[0045] In this embodiment, the fixing seat 101, the squeezing seat 102 and the connecting seat 103 are all provided with through holes in the middle for the insertion of the multi-lumen catheter 1.

[0046] Example 1: The clinical operating procedures for the calcification removal system are as follows: Step 1: Instrument delivery and positioning: Establish an interventional channel through percutaneous puncture, and push the outer tube 9 in this embodiment along the guidewire to the area of ​​moderate to severe coronary calcification lesion. Observe the imaging ring 93 on the outer tube 9 and the imaging mark on the multi-lumen catheter 1 through X-ray to confirm that the instrument has accurately reached the lesion location, and fix the outer tube 9 to avoid displacement.

[0047] Step 2: Pre-expansion and fragmentation of calcification: Start the ultrasonic energy source. The ultrasonic energy is transmitted to the pre-expansion head 5 through the ultrasonic transmission wire 2. The pre-expansion head 5 generates high-frequency vibration to pre-expand and initially fragment the hard calcification cap, breaking the hard calcification shell. This process lasts for 3-5 minutes. During this period, the pre-expansion effect is observed through imaging to avoid excessive damage to blood vessels.

[0048] Step 3: Release of filter 3: Slowly push the take-up and release wire 31 through the channel on the catheter seat 8 that is connected to the take-up and release wire cavity 13 to release the filter 3. The nickel-titanium metal skeleton automatically unfolds, and the filter membrane forms a net-like structure that fits against the blood vessel wall, thus activating the filtration function to intercept debris generated by subsequent breakage.

[0049] Step 4: Precise fragmentation of calcification: After pre-expansion, filler medium (contrast agent + saline) is injected into fragmentation balloon 4 to inflate the fragmentation balloon 4 and conform to the surface of the calcified plaque. At this time, the helical segment 21 of the ultrasonic conduction wire 2 wound with nickel-titanium memory wire expands with fragmentation balloon 4, the coil diameter increases, and ultrasonic energy is continuously transmitted to achieve uniform fragmentation of calcified plaque 360°. The fragmentation time is 5-8 minutes until the calcified plaque is basically cleared as observed by imaging.

[0050] Step 5: Thrombus and debris aspiration: After fragmentation, connect the external negative pressure aspiration device to the channel corresponding to the aspiration chamber 11 on the multi-catheter hub 8, turn on the negative pressure, and large calcified debris and thrombus in the blood vessel enter the aspiration chamber 11 through the aspiration port 110 and are drawn out of the body. During the aspiration process, the multi-lumen catheter 1 can be moved slowly to ensure that the debris is completely removed. The aspiration time is 2-3 minutes.

[0051] Step 6: Implantation of the balloon-expanded stent 7 (as needed): Observe the patency of the blood vessel through angiography. If there is residual stenosis in the blood vessel, inject filling medium into the stent balloon 6. The stent balloon 6 expands and the balloon-expanded stent 7 is precisely released into the diseased blood vessel segment to support the blood vessel wall. If the patency of the blood vessel is good, this step can be omitted.

[0052] Step 7: Instrument retrieval: After the balloon dilatation stent 7 is released (or after omitting the balloon dilatation stent 7 step), all balloons are deflated, the filter screen 3 is retrieved through the retraction wire 31, and the multi-lumen catheter 1 and the external tube assembly are slowly withdrawn together, exiting the interventional channel to complete the operation.

[0053] Example 2, Integrated treatment of severe peripheral vascular calcification: This example, tailored to the characteristics of calcified lesions in peripheral blood vessels (such as lower extremity arteries), makes the following adaptations to further demonstrate the clinical suitability of this device: Catheter adaptation: The diameter of the outer tube body 9 and the multi-lumen catheter 1 is adapted to the size of the peripheral blood vessels, increasing the length of the outer tube body 9 and the multi-lumen catheter 1 and improving the distal pushing force; the braiding density of the braided mesh tube 91 in the outer tube body 9 is increased to enhance the torsional resistance and adapt to the bending angle of the peripheral blood vessels.

[0054] Pre-expansion head 5 adjustment: The pre-expansion head 5 is made of stainless steel and has a diameter slightly larger than that of the pre-expansion head 5 used in Example 1, which improves the pre-expansion force and is suitable for more rigid calcified plaques in peripheral blood vessels.

[0055] Ultrasonic parameter adjustment: The ultrasonic energy frequency is slightly higher than that in Example 1, and the inflation pressure of the fragmentation balloon 4 is appropriately increased to ensure that the severely calcified plaques are completely broken up; the winding density of the threaded section in the ultrasonic transmission wire 2 is increased to improve the energy transfer efficiency.

[0056] Operational adjustments: After the filter 3 is released, it is necessary to confirm that the filter membrane is completely attached to the peripheral blood vessel wall (the peripheral blood vessel diameter is large). During aspiration, the aspiration time is extended to 3-4 minutes to ensure that the debris is completely removed. For the bulbar expansion stent 7, select a large-diameter metal cutting stent that is suitable for the peripheral blood vessel. After release, it is necessary to confirm that the bulbar expansion stent 7 is tightly attached.

[0057] Example 3: This example is used to verify the core performance of the present invention and ensure the feasibility and superiority of the technical solution: Ultrasonic energy uniformity verification: The fragmented balloon 4 was inflated to the commonly used clinical pressure, the ultrasonic energy source was turned on, and the ultrasonic energy was detected by an energy detector. The ultrasonic energy was uniformly distributed in 360° on the surface of the fragmented balloon 4, with an energy deviation of ≤5%, which is better than the existing straight wire in-wall ultrasonic balloon (energy deviation ≥15%).

[0058] Anti-embolism verification: Simulating a calcification and fragmentation scenario, generating debris with a diameter of 50μm-100μm, the filter screen 3 can effectively intercept debris ≥80μm with an interception rate of ≥98%; after the pre-expanded ball head 5 blocks the suction chamber 11, the debris escape rate is 0, demonstrating a significant dual protection effect.

[0059] Passability verification: The device was pushed into a simulated curved blood vessel (bending angle of 90°), and the push was smooth without jamming or catheter deformation; after repeated pushing and pulling 10 times, the device structure was intact, and the torsional resistance and flexibility met clinical requirements.

[0060] Sealing performance verification: Simulating intraoperative pressure (10-15 atm), the sealing ring 104 in catheter seat 8 showed no media leakage, indicating good sealing performance; the multi-lumen catheter 1 ensures that each lumen does not cross-contaminate with other lumens, ensuring that each function operates independently.

[0061] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0062] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A calcification removal system for vascular calcification lesions, characterized in that, include: A multi-lumen catheter, wherein a fragmentation balloon is disposed on the outer wall of the multi-lumen catheter, and the multi-lumen catheter includes at least an aspiration chamber, a first filling chamber, a conduction wire chamber, and a take-up and release wire chamber, all extending along the length direction; the proximal end of the aspiration chamber is used to connect to a negative pressure aspiration device, and an aspiration port is disposed on the distal sidewall of the aspiration chamber; the first filling chamber communicates with the fragmentation balloon to inflate the fragmentation balloon; An ultrasonic conduction wire, a portion of which is inserted into the conduction wire cavity, the proximal end of which is connected to an ultrasonic energy source, and the ultrasonic conduction wire having a helical segment made of shape memory alloy wire, the helical segment being sleeved on the outside of the rupture balloon and capable of expanding in diameter as the rupture balloon is inflated; The filter screen is located at the distal end of the fragmentation balloon and is connected to the distal wall of the suction chamber. The filter screen has filter holes capable of intercepting particles and allowing blood flow. A take-up / delivery wire is connected to the outer edge of the filter screen, and the proximal end of the take-up / delivery wire extends through the take-up / delivery wire cavity to the proximal end of the multi-lumen catheter. The filter screen is configured such that it contracts when the take-up / delivery wire is tightened and expands when the take-up / delivery wire is relaxed, with the opening of the filter screen facing the proximal end. At least a portion of the suction holes are located within the mesh pocket cavity formed after the filter screen is unfolded.

2. The calcification removal system for vascular calcification lesions according to claim 1, characterized in that, The distal ends of the suction chambers are all located on the distal sides of the first filling chamber, the conduction wire chamber, and the take-up and release wire chamber.

3. The calcification removal system for vascular calcification lesions according to claim 2, characterized in that, The distal end of the ultrasonic conduction wire extends from the distal port of the aspiration cavity and is connected to a pre-expanding ball head, the diameter of which is larger than the diameter of the distal port of the aspiration cavity.

4. The calcification removal system for vascular calcification lesions according to claim 3, characterized in that, A first through hole is provided on the side wall of the aspiration chamber, and a second through hole is provided on the side wall of the conduction wire chamber. The first through hole and the second through hole are located on the proximal and distal sides of the rupture balloon, respectively, for the ultrasonic conduction wire to pass through the second through hole to form the helical segment and then pass through the first through hole into the aspiration chamber.

5. The calcification removal system for vascular calcification lesions according to claim 1, characterized in that, The filter screen includes a frame and a filter membrane disposed on the frame. The frame is made of shape memory alloy wire. The distal end of the frame is connected to the distal wall of the suction chamber, and the proximal end is connected to the distal end of the take-up and release wire.

6. The calcification removal system for vascular calcification lesions according to claim 5, characterized in that, Along the circumference of the filter screen, there are multiple take-up and release wires, and the proximal portions of the multiple take-up and release wires form an integrated wire that passes through the take-up and release wire cavity.

7. The calcification removal system for vascular calcification lesions according to claim 1, characterized in that, The outer wall of the multi-lumen catheter is also provided with a stent balloon and a balloon-expanding stent sleeved on the stent balloon, the stent balloon being located on the proximal side of the fragmentation balloon; the multi-lumen catheter is also provided with a second filling cavity communicating with the stent balloon for filling it.

8. The calcification removal system for vascular calcification lesions according to claim 7, characterized in that, It also includes a catheter seat disposed at the proximal end of the multi-lumen catheter, the catheter seat having multiple channels, the multiple channels being respectively connected to the aspiration chamber, the first filling chamber, the second filling chamber, the conduction wire chamber and the take-up and release wire chamber.

9. The calcification removal system for vascular calcification lesions according to claim 1, characterized in that, It also includes an outer tube assembly, which includes an outer tube body and an outer tube seat fixed to the proximal end of the outer tube body, through which the multi-lumen catheter is inserted into the body.

10. The calcification removal system for vascular calcification lesions according to claim 9, characterized in that, A sealing ring is provided inside the outer tube seat, and the multi-lumen catheter is inserted into the body through the sealing ring, with the inner ring of the sealing ring fitting against the outer wall of the multi-lumen catheter.

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