CN101912289B - Thrombus excider and preparation method - Google Patents
Thrombus excider and preparation method Download PDFInfo
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- CN101912289B CN101912289B CN2010102624957A CN201010262495A CN101912289B CN 101912289 B CN101912289 B CN 101912289B CN 2010102624957 A CN2010102624957 A CN 2010102624957A CN 201010262495 A CN201010262495 A CN 201010262495A CN 101912289 B CN101912289 B CN 101912289B
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Abstract
In order to solve the technical problem of taking out thrombus in veins and ensuring unobstruction of blood stream at the far end of veins, the invention discloses a thrombus excider and a preparation method and a use method thereof. In the invention, the thrombus excider is provided with a wire guiding head, a far-end beacon, a weaving basket, a near-end beacon and wire guiding rods which are sequentially arranged from the far end to the near end, wherein the wire guiding rods are arranged in the far-end beacon, the weaving basket and the near-end beacon. The preparation method is as follows: manufacturing each part, performing heat treatment, welding and assembling. The use method is as follows: putting a delivery conduit into a thrombus collecting conduit, sending to a lesion location,delivering the thrombus excider to the delivery conduit, propelling the thrombus excider to the far end, observing that the basket releases under the X-ray, flushing blood clots to the weaving basketby blood flow, and recovering the thrombus excider and the delivery conduit to the thrombus collecting conduit. Compared with the prior art, during the processes of exciding and capturing thrombus, the invention can ensure the continuity of blood flow in far-end veins to prevent the broken blood clots from flowing to the far end, thus enabling the operation process to be safer and more effective.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments and preparation method thereof, particularly a kind of resection instrument that is used for thrombosis in the interventional therapy blood vessel and preparation method thereof.
Background information
Thrombotic disease is meant thrombotic disease, mainly by thrombosis and two kinds of caused diseases of pathological process of thromboembolism.Clinical very common, serious harm public life and health, thromboembolism has the advantages that sickness rate height, disability rate are high, mortality rate is high and relapse rate is high, is the principal disease that middle age causes death and disables.Thrombosis is in case formation often causes irreversible serious consequence.In recent years, the thromboembolism preventing treatment has obtained developing rapidly.Because the size of population of aging constantly increases and the raising of people's living standard, the sickness rate of thromboembolism is still in continuous rising in the blood vessel.Thrombotic disease mainly comprises: cerebral vessels embolism, heart built-in wall thrombosis, venous thrombosis, pulmonary infarction box peripheral artery embolization.
Antithrombotic therapy utilization thrombolytic drug, antiplatelet drug and anticoagulant.Heparin is the main medicine of anticoagulant medicine in the treatment of thrombotic disease, can effectively prevent and treat deep venous thrombosis of lower limbs, is widely used in unstable angina pectoris in recent years, acute myocardial infarction and the brain treatment of diseases of finally waiting indefinitely.But heparin has many shortcomings, and is hemorrhage as being prone to, and the chamber clotting mechanism monitoring that must experimentize is used inconvenience, and can be brought out thrombocytopenia and aleucia etc.
The thrombosis that produces in the blood vessel being taken out, make inaccessible revascularization, is the key of recovering the thrombosis artery-clogging, also is the frontier of present international blood vessel research.What can be applicable to the interior thrombectomby of blood vessel at present only has just by the Concentric Retriever of the U.S. Merci Concentric Inc of drugs approved by FDA production.The smooth rate of the revascularization of this utensil after clinical use is 55.6%～60%, is the thrombectomby utensil that is applied to treat at present blood vessel embolism in the world.The principle that this utensil uses is: at the lesion vessels near-end; Utilize the blood supply of interim filling air bag blocking-up blood vessel, utilize seal wire snare thrombosis thing, use the negative pressure-pumping lumen of vessels; Then withdraw from seal wire; Snare is drawn in thrombosis in the conduit in blood vessel, and eliminate blood vessel filling air bag this moment, withdraws from conduit then.This utensil is prone to cause thrombosis to be broken into the thrombosis fragment soon owing to be that nearly segment protect is only arranged in its spiral helicine snare excision thrombosis process, and no distal embolic protection is prone to cause distal embolization.In clinical extremity vascular intervention procedure, in speckle on the blood vessel and the interventional procedure process, broken clot all can flow to distal vessels, forms the new thromboembolism of distal site.
Summary of the invention
The purpose of this invention is to provide a kind of thrombectomy device and preparation method thereof, the technical problem that solve is the unobstructed property that guarantees blood vessel far-end blood flow when taking out interior thrombosis of blood vessel and embolus.
The present invention adopts following technical scheme: a kind of thrombectomy device, be provided with conductive filament head, far-end indicating, braiding basket, near-end indicating from far-end to proximal sequential, and be arranged on the conducting wire pole in far-end indicating, braiding basket and the near-end indicating; Said braiding basket is shaped as oval netted; One end opening; Oval-shaped major axis is coaxial with conducting wire pole, and opening is towards near-end, and it is 0.020mm to 0.060mm that the braiding basket adopts diameter; Quantity is that composite silk or nitinol alloy wire and the composite silk braiding of gold of 8 to 288 nitinol alloy wire, titanium silk, tungsten filament, tantalum wire, platinum wire, platinumiridio silk, stainless steel silk, stainless steel silk and platinum forms; Every foot node number that has of braiding basket is 20 to 250, and the diameter of braiding basket free state is 2mm to 6mm, and long is 10mm to 100mm.
Near-end indicating of the present invention is nested with on conducting wire pole, can slide along conducting wire pole, forms with conducting wire pole to be slidingly connected.
Be wound with the development spring on the conducting wire pole of the present invention, the development spring adopts the tungsten billon silk of diameter 0.2mm to 0.5mm, and development spring shaft line length is 0.2mm to 5mm, its two ends and conducting wire pole welding; The far-end of said development spring is positioned at the opening part of braiding basket free state.
Conductive filament head of the present invention is to form softish helical spring with the platinum wire of diameter 0.2mm to 0.5mm, tungsten alloy filament or billon filament winding system, and spring outside coil diameter is 0.2mm to 0.5mm, and long is 50mm to 150mm.
Far-end indicating external diameter of the present invention is 0.20mm～0.40mm, and thick is 0.001mm to 0.01mm, and long is 5mm to 50mm; Said near-end indicating external diameter is 0.30mm to 0.70mm, and thick is 0.001mm to 0.01mm, and long is 5mm to 50mm; Platinum alloy, Nitinol or billon are adopted in far-end indicating and near-end indicating.
Conducting wire pole of the present invention is rustless steel or nitinol alloy wire, and its external diameter is 0.25mm to 0.8mm, and length is 1500mm to 3000mm.
Form in the joint of the delivery conduit that thrombectomy device of the present invention is used by conduit insertion near-end, joint adopts high density polyethylene (HDPE), and conduit adopts inner polytetrafluoroethyllayer layer, PEBAX is outer and intermediary stainless steel cloth and spring layer composition; Bed thickness 0.001mm to 0.10mm in said, outer bed thickness 0.005mm to 0.01mm; Said distal end of catheter is the less relatively pipe of interior external diameter, and the relative near-end of material is softer, and near-end is the relatively large pipe of interior external diameter, and material is harder; In near distal end the pipe, the delivery catheter distal end indicating is housed, the delivery catheter distal end indicating is a ring-type, and its internal diameter is consistent with the delivery catheter distal end internal diameter; Said distal end of catheter internal diameter is 0.25mm～0.60mm, and external diameter is 0.40mm～0.90mm, long 100mm to 500mm, and proximal inner diameter is 0.40mm～0.80mm, external diameter is 0.60mm～1.00mm, long 1500mm to 2500mm.
The thrombosis collecting duct that thrombectomy device of the present invention uses is tubulose, near the pipe the distal end, the indicating of thrombosis collecting duct far-end is housed, and the indicating of thrombosis collecting duct far-end is a ring-type, and its internal diameter is consistent with thrombosis collecting duct internal diameter; The thrombosis collecting duct is collected in the joint by the near-end insertion of collecting duct and is formed; Said collection joint material is a high density polyethylene (HDPE), and collecting duct is made up of inner polytetrafluoroethyllayer layer, PEBAX skin and intermediary stainless steel cloth and spring layer; Bed thickness 0.001mm to 0.10mm in said, outer bed thickness 0.005mm to 0.01mm, collecting duct (11) external diameter is 0.60mm to 1.80mm, internal diameter is 0.35mm to 1.20mm, long 1500mm to 3000mm.
A kind of method for preparing of thrombectomy device; May further comprise the steps: one, use 8 to 288 diameters to be the composite silk of nitinol alloy wire, titanium silk, tungsten filament, tantalum wire, platinum wire, platinumiridio silk, stainless steel silk, stainless steel silk and the platinum of 0.020mm to 0.060mm or the composite silk braiding webmaster of nitinol alloy wire and gold, every foot node number that has of braiding webmaster is 20-250; Use rustless steel or the nitinol alloy wire of diameter as 0.25mm to 0.8mm, be 1500mm to 3000mm blanking by length after, be ground to conical by its shape on the end with seal wire; Platinum wire, tungsten alloy filament or billon filament winding with diameter 0.2mm to 0.5mm are processed the coil spring shape conductive filament head, and the conductive filament head external diameter is 0.2mm to 0.5mm, and long is 50mm to 150mm; The employing external diameter is 0.20mm～0.40mm, thick for after the platinum alloy of 0.001mm to 0.01mm, Nitinol or the blanking of billon pipe the polishing light obtain the far-end indicating; The employing external diameter is 0.30mm to 0.70mm, thick for after the platinum alloy of 0.001mm to 0.01mm, Nitinol or the blanking of billon pipe the polishing light obtain the near-end indicating; Two, the webmaster of braiding is loaded onto thrombectomy device basket mould core, the fine copper wire tighten is used at two ends then, heat treatment typing in the fixed outside mould vacuum heat treatment furnace, vacuum 1.33 * 10
-2～1.33 * 10
-4Pa is warmed up to 200 ℃ to 600 ℃ with 3 seconds to 30 seconds programming rates from room temperature, is incubated 10 minutes to 60 minutes, is cooled to room temperature in the stove naturally; Basket is taken off from mould, and the far-end indicating of packing into of basket one end is with the braided wires and the near-end indicating welding of the basket other end; Three, the conducting wire pole far-end is passed through the indicating of basket near-end, its far-end milled portion is inserted in the indicating of thrombectomy device far-end welding conductive filament head, far-end indicating, basket far-end and conducting wire pole; Tungsten billon silk helical form with diameter 0.2mm to 0.5mm is wrapped on the conducting wire pole, and the welding two ends are made into the development spring, and the external diameter of development spring is 0.15mm to 0.25mm, and long is 0.2mm to 5mm.
The present invention compared with prior art; Thrombectomy device adopts the basket structure, thrombectomby, arrest and the removal process in can guarantee that the blood flow of distal vessels is able to continue, and does not disturb the blood of normal cardiovascular and cerebrovascular vessel to supply; In removal of thromboses and embolus, the lumen of vessels far-end is protected; Avoid in thrombectomby and interventional procedure process broken clot to flow to the blood vessel far-end, form the new thrombosis of distal site, make in the whole surgery process more safe and effective.
Description of drawings
Fig. 1 is a thrombectomy device structure chart of the present invention.
Fig. 2 is a delivery conduit structure chart of the present invention.
Fig. 3 is a thrombosis collecting duct structure chart of the present invention.
Fig. 4 is a sketch map before the thrombectomy device excision thrombosis.
Fig. 5 is a thrombectomy device course of conveying sketch map of the present invention.
Fig. 6 is a thrombectomy device dispose procedure sketch map of the present invention.
Fig. 7 is a thrombectomy device excision thrombosis process sketch map of the present invention.
Fig. 8 is that thrombectomy device embodiment of the present invention weaves the webmaster sketch map.
Fig. 9 is a sketch map after the invention thrombectomy device basket of the present invention molding.
Figure 10 is a thrombectomy device embodiment basket mould sketch map of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing and embodiment the present invention is explained further details.As shown in Figure 1, thrombectomy device of the present invention is provided with conductive filament head 1, far-end indicating 2, braiding basket 3, development spring 4, near-end indicating 5 from far-end to proximal sequential, runs through the conducting wire pole 6 that is arranged in far-end indicating 2, braiding basket 3 and the near-end indicating 5.
Braiding basket 3 is shaped as oval netted, and an end opening of oval major axis is assemblied on the conducting wire pole 6, oval-shaped major axis and conducting wire pole 6 coaxial settings, and opening is towards near-end.Braiding basket 3 can be along its minor axis radial contraction; The basket material adopts the composite silk of nitinol alloy wire, titanium silk, tungsten filament, tantalum wire, platinum wire, platinumiridio silk, stainless steel silk, stainless steel silk and platinum or the composite silk braiding of nitinol alloy wire and gold to form; Diameter is 0.020mm to 0.060mm, and quantity is 8 to 288.Braiding basket 3 every foot nodes that have are counted PPI (Point per inch) and are 20-250.After braiding basket 3 discharged fully, promptly the diameter of the braiding basket 3 of free state was 2mm to 6mm, and long is 10mm to 100mm.
Far-end and far-end indicating 2, conductive filament head 1, conducting wire pole 6 far-ends of braiding basket 3 are welded to connect; The near-end braided wires and the near-end indicating 5 of braiding basket 3 link together; Near-end indicating 5 is nested with on conducting wire pole 6, and near-end indicating 5 can be slided along conducting wire pole 6, forms with conducting wire pole 6 to be slidingly connected.Be welded with a development spring 4 on the conducting wire pole 6, the tungsten billon silk of development spring 4 usefulness diameter 0.2mm to 0.5mm, compact winding is on conducting wire pole 6, and outer appearnce springy, spring shaft line length are 0.2mm to 5mm.Development spring 4 two ends are connected as one through laser weld or TIG welding manner and conducting wire pole 6.Opening part when the far-end of development spring 4 is positioned at braiding basket 3 free states and opens is judged the position that weaves basket 3 openings down in order to keep watch at X ray.The near-end restriction near-end indicating 5 of development spring 4 is slided to far-end.
Platinum wire, tungsten alloy filament or the billon filament winding system of conductive filament head 1 usefulness diameter 0.2mm to 0.5mm form softish helical spring, and spring outside coil diameter is 0.2mm to 0.5mm, and long is 50mm to 150mm.
Far-end indicating 2 external diameters are 0.20mm～0.40mm, and thick is 0.001mm to 0.01mm, and long is 5mm to 50mm.Near-end indicating 5 external diameters are 0.30mm to 0.70mm, and thick is 0.001mm to 0.01mm, and long is 5mm to 50mm.Far-end indicating 2 is a ring-type with near-end indicating 5, adopts platinum alloy, Nitinol or billon.
Conducting wire pole 6 is rustless steel or nitinol alloy wire, and its external diameter is 0.25mm to 0.8mm, and length is 1500mm to 3000mm, and conducting wire pole 6 far-ends have the tapering transition section, is used to insert in the ring-type far-end indicating 2.
As shown in Figure 2, the delivery conduit that thrombectomy device is used adopts bioabsorbable polymer material to process, and its pliability is good, can in the cardiovascular and cerebrovascular vessel of complicacy, freely be transferred.Delivery conduit is made up of with conduit 8 joint 9 of near-end, and the near-end of conduit 8 inserts to form in the joint 9 and connects.The material of joint 9 is high density polyethylene (High Density Polyethylene); 8 in conduit is by polytetrafluoroethylene PTFE internal layer and PEBAX (Polyether block amide; The block polyetheramides resin of commodity PEBAX by name; Being embedded with softish polyether segment by the linear polyamidoamine segment of rule constitutes) the outer composition, there are stainless steel cloth and spring reinforcement in the centre, and catheter proximal end has far-end indicating 7.Interior bed thickness 0.001mm to 0.10mm, outer bed thickness 0.005mm to 0.01mm.Conduit 8 is a tubulose, is connected and composed by external diameter, the inconsistent conduit of material hardness in two sections, and far-end is the less relatively pipe of interior external diameter; The relative near-end of material is softer; Make that enough softnesses of far-end and size are less, can in cerebrovascular, freely carry that near-end is the relatively large pipe of interior external diameter; Material is harder, when pushing, can guarantee enough propelling movement power.In near distal end the pipe, the delivery catheter distal end indicating 7 that can under X ray, develop is housed, delivery catheter distal end indicating 7 is a ring-type, and its internal diameter is consistent with the delivery catheter distal end internal diameter.The delivery catheter distal end internal diameter is 0.25mm～0.60mm, and external diameter is 0.40mm～0.90mm, long 100mm to 500mm.Proximal inner diameter is 0.40mm～0.80mm, and external diameter is 0.60mm～1.00mm, long 1500mm to 2500mm.
As shown in Figure 3; The thrombosis collecting duct that thrombectomy device uses is tubulose, near the pipe the distal end, and the thrombosis collecting duct far-end indicating 10 that observability under X ray is housed; Thrombosis collecting duct far-end indicating 10 is a ring-type, and its internal diameter is consistent with thrombosis collecting duct internal diameter.The effect of thrombosis collecting duct is delivery conduit and the thrombectomy device that is used for collecting behind the excision thrombosis, and the relative near-end of far-end material is softer, can in blood vessel, freely carry.The relative far-end of near-end material is harder, when pushing, can guarantee enough propelling movement power.The thrombosis collecting duct also adopts bioabsorbable polymer material to process, and the thrombosis collecting duct is made up of the collection joint 12 of collecting duct 11 and near-end, and the near-end of collecting duct 11 inserts to collect to form in the joint 12 and connects.Collecting joint 12 materials is HDPE, and 11 of collecting ducts are made up of with PEBAX is outer the PTFE internal layer, and there are stainless steel cloth and spring reinforcement in the centre.Interior bed thickness 0.001mm to 0.10mm, outer bed thickness 0.005mm to 0.01mm.Collecting duct 11 external diameters are 0.60mm to 1.80mm, and internal diameter is 0.35mm to 1.20mm, long 1500mm to 3000mm.
The method for preparing of thrombectomy device of the present invention may further comprise the steps:
One, each part is made; Braiding webmaster: use 8 to 288 diameters to be the composite silk of nitinol alloy wire, titanium silk, tungsten filament, tantalum wire, platinum wire, platinumiridio silk, stainless steel silk, stainless steel silk and the platinum of 0.020mm to 0.060mm or the composite silk of nitinol alloy wire and gold; Braiding webmaster as shown in Figure 8 on the HTBZ-40 type braider of Shenzhen Huitai Medical Instrument Co., Ltd manufacturing, every foot node that has of webmaster are counted PPI (Point per inch) and are 20-250.
Grinding conducting wire pole: use rustless steel or the nitinol alloy wire of diameter as 0.25mm to 0.8mm; After being 1500mm to 3000mm blanking by length, an end of seal wire is ground to conical by its shape on the TG12X4 type cylindrical grinder that U.S. ROYAL MASTER GEINDERS.INC makes.
Conductive filament head is processed coil spring shape with platinum wire, tungsten alloy filament or the billon filament winding of diameter 0.2mm to 0.5mm, and spring outside coil diameter is 0.2mm to 0.5mm, and long is 50mm to 150mm.
It is 0.20mm～0.40mm that external diameter is adopted in the far-end indicating, thickly obtains for the light of polishing after the platinum alloy of 0.001mm to 0.01mm, Nitinol or the blanking of billon pipe.It is 0.30mm to 0.70mm that external diameter is adopted in the near-end indicating, thickly obtains for the light of polishing after the platinum alloy of 0.001mm to 0.01mm, Nitinol or the blanking of billon pipe.
The joint of delivery conduit adopts machining to obtain with HDPE, and conduit adopts polyurethane material, utilizes the injection moulding extrusion molding and gets.
The collection joint of thrombosis collecting duct adopts machining to obtain with HDPE, collecting duct, and conduit adopts polyurethane material, utilizes the injection moulding extrusion molding and gets.
Two, the resectoscope basket is made, and the webmaster of braiding is loaded onto thrombectomy device basket mould core shown in figure 10, and the fine copper wire tighten is used at two ends then, the fixed outside mould.Braiding webmaster behind the dress mould is put into the ZSK2-12-6 type vacuum heat treatment furnace heat treatment typing that Wuhan industrial furnace head factory is made, vacuum 1.33 * 10
-2～1.33 * 10
-4Pa is preferably 1.33 * 10
-3Pa is warmed up to 200 ℃ to 600 ℃ with 3 seconds to 30 seconds programming rates from room temperature, is preferably 450 ℃, is incubated 10 minutes to 60 minutes, is preferably 30 minutes, is cooled to room temperature in the stove naturally.After the thermoforming basket is taken off the far-end indicating of packing into of basket one end, LCT-W1 type laser-beam welding machine or the welding of TIG welding manner that the braided wires and the near-end indicating of the basket other end are made with pool, Beijing photoelectricity technology corporation, Ltd. from mould.
Three, the assembling of thrombectomy device; With the indicating ring of conducting wire pole 7 far-ends through the basket near-end; Its far-end milled portion is inserted in the thrombectomy device far-end indicating ring, used the mode of welding that conductive filament head, far-end indicating, basket far-end are connected with conducting wire pole and be fixed up.The near-end indicating is nested with and is assembled on the conducting wire pole, makes it free movable on conducting wire pole.Tungsten billon silk with diameter 0.2mm to 0.5mm is wrapped on the conducting wire pole, forms coil spring shape, and laser weld or soldering two ends are made into the development spring again.The external diameter of development spring is 0.15mm to 0.25mm, and long is 0.2mm to 5mm.
The method for using of thrombectomy device of the present invention may further comprise the steps:
One, as shown in Figure 4, radiography finds that there is thrombi 13 at cerebrovascular disease position 14.
Two, as shown in Figure 5, delivery conduit is inserted in the thrombosis collecting duct.Guiding through seal wire is transported to cerebrovascular disease position 14 with thrombosis collecting duct 11 and delivery conduit 8.Fixedly the invariant position of thrombosis collecting duct 11 continues seal wire and delivery conduit 8 to push forward, under X ray is kept watch on, observes seal wire and delivery conduit 8 and passes thrombi 13 arrival diseased region far-ends.
Three, as shown in Figure 6, fixedly delivery conduit 8, return and remove seal wire; Through loading bin thrombectomy device is sent in the delivery conduit 8; Push conducting wire pole forward, push thrombectomy device to far-end, through the observability of development spring 4 under X ray on far-end indicating 2, the conducting wire pole; Adjustment braiding basket 3 positions make the basket opening part be positioned at the blood vessel far-end from thrombi 13 nearby; Return and remove delivery conduit 8, under X ray, observe the thrombectomy device basket and discharge fully and position suitable, accomplished the conveying and the release of thrombectomy device.
Four, as shown in Figure 7, through breeches joint injection of contrast medium in blood vessel of thrombosis collecting duct 11, under X ray was kept watch on, the thrombi of observing in the lesion vessels 13 was poured in the braiding basket 3 by blood flow.
Five, delivery conduit 8 is pushed away a bit toward far-end slightly, make braiding basket 3 openings shrink few part, avoid back that thrombi 13 discharges in the process of removing from weave basket 3.
Six, the fixing relative position of thrombectomy device and delivery conduit 8; Thrombectomy device and delivery conduit 8 are back removed simultaneously; Under X ray is kept watch on, thrombectomy device and delivery conduit 8 are recovered in the thrombosis collecting duct 11, promptly accomplish the excision process of pathological changes thrombi 13.
Seven, through shadowgraph technique observe the unobstructed property of blood flow at cerebrovascular disease position 14 good after, external with withdrawing operator simultaneously in delivery conduit 8, thrombectomy device and the thrombosis collecting duct 11.
Embodiment 1: select one of 20 kilograms of dog of body weight for use, in this dog cerebral artery vessel tangible thromboembolism is arranged, the thromboembolism size is 0.5mm; Thrombectomy device of the present invention and accessory one cover thereof, it is 3.5mm that thrombectomy device discharges back basket maximum outside diameter, the PPI of thrombectomy device webmaster braiding is 55; The conducting wire pole external diameter is 0.36mm, and the delivery catheter distal end external diameter is 0.82mm, and internal diameter is 0.50mm; Thrombosis collecting duct far-end external diameter is 1.38, and internal diameter is 1.04mm.Puncture through femoral artery, under angiography, confirm cerebral artery thrombosis thromboembolism position after, under X ray is kept watch on, at first send into seal wire, the guiding function through seal wire is pushed to preset position with delivery conduit and thrombosis collecting duct.Whether the position of judging conduit through the far-end indicating of delivery conduit and thrombosis collecting duct is suitable; Fixing thrombosis collecting duct; Seal wire and delivery conduit are passed the pathological change of thrombus position simultaneously, under X ray, observe the delivery catheter distal end indicating and crossed thrombosis arrival blood vessel far-end.Fixing delivery conduit is withdrawn from seal wire external, through reprinting device thrombectomy device is packed in the delivery conduit.Push conducting wire pole forward; Through the observability of development spring under X ray on far-end indicating, the conducting wire pole, adjustment braiding basket position makes the basket opening part be positioned at the blood vessel far-end from thrombi nearby, returns and removes delivery conduit; Under X ray, observing the thrombectomy device basket discharges and position suitable fully; Breeches joint through collecting duct is observed thrombosis and is poured in the basket by the impulsive force of blood flow to the intravascular injection contrast agent under X ray, shrink the opening that few part weaves basket; Delivery conduit and thrombectomy device are back removed simultaneously, be recovered in the thrombosis collecting duct; Through shadowgraph technique observe the unobstructed property of blood flow at this place good after, delivery conduit and collecting duct are withdrawn simultaneously external, accomplish this thrombectomby process.This operation process required time is short, and success rate of operation is high, requires relatively low to doctor's operating technology.
Claims (8)
1. thrombectomy device; It is characterized in that: said thrombectomy device is provided with conductive filament head (1), far-end indicating (2), braiding basket (3), near-end indicating (5) from far-end to proximal sequential, is arranged on the conducting wire pole (6) in far-end indicating (2), braiding basket (3) and the near-end indicating (5); Said braiding basket (3) is shaped as oval netted; One end opening; Oval-shaped major axis is coaxial with conducting wire pole (6), and opening is towards near-end, and it is 0.020mm to 0.060mm that the braiding basket adopts diameter; Quantity is that composite silk or nitinol alloy wire and the composite silk braiding of gold of 8 to 288 nitinol alloy wire, titanium silk, tungsten filament, tantalum wire, platinum wire, platinumiridio silk, stainless steel silk, stainless steel silk and platinum forms; The node number that braiding basket (3) every foot have is 20 to 250, and the diameter of braiding basket (3) free state is 2mm to 6mm, and long is 10mm to 100mm;
The interior composition of joint (9) that the delivery conduit that said thrombectomy device is used inserts near-end by conduit (8), joint (9) adopts high density polyethylene (HDPE), and conduit (8) adopts inner polytetrafluoroethyllayer layer, PEBAX skin and intermediary stainless steel cloth and spring layer to form; Bed thickness 0.001mm to 0.10mm in said, outer bed thickness 0.005mm to 0.01mm; Said conduit (8) far-end is the less relatively pipe of interior external diameter, and the relative near-end of material is softer, and near-end is the relatively large pipe of interior external diameter, and material is harder; In near distal end the pipe, delivery catheter distal end indicating (7) is housed, delivery catheter distal end indicating (7) is a ring-type, and its internal diameter is consistent with the delivery catheter distal end internal diameter; The distal inner diameter of said conduit (8) is 0.25mm～0.60mm, and external diameter is 0.40mm～0.90mm, long 100mm to 500mm, and proximal inner diameter is 0.40mm～0.80mm, external diameter is 0.60mm～1.00mm, long 1500mm to 2500mm.
2. thrombectomy device according to claim 1 is characterized in that: said near-end indicating (5) is nested with on conducting wire pole (6), can slide along conducting wire pole (6), forms with conducting wire pole (6) to be slidingly connected.
3. thrombectomy device according to claim 2; It is characterized in that: be wound with development spring (4) on the said conducting wire pole (6); Development spring (4) adopts the tungsten billon silk of diameter 0.2mm to 0.5mm, and development spring (4) axis is long to be 0.2mm to 5mm, its two ends and conducting wire pole (6) welding; The far-end of said development spring (4) is positioned at the opening part of braiding basket (3) free state.
4. thrombectomy device according to claim 3; It is characterized in that: said conductive filament head (1) is that platinum wire, tungsten alloy filament or the billon filament winding system with diameter 0.2mm to 0.5mm forms softish helical spring; Spring outside coil diameter is 0.2mm to 0.5mm, and long is 50mm to 150mm.
5. thrombectomy device according to claim 4 is characterized in that: said far-end indicating (2) external diameter is 0.20mm～0.40mm, and thick is 0.001mm to 0.01mm, and long is 5mm to 50mm; Said near-end indicating (5) external diameter is 0.30mm to 0.70mm, and thick is 0.001mm to 0.01mm, and long is 5mm to 50mm; Platinum alloy, Nitinol or billon are adopted in far-end indicating (2) and near-end indicating (5).
6. thrombectomy device according to claim 5 is characterized in that: said conducting wire pole (6) is rustless steel or nitinol alloy wire, and its external diameter is 0.25mm to 0.8mm, and length is 1500mm to 3000mm.
7. thrombectomy device according to claim 6; It is characterized in that: the thrombosis collecting duct that said thrombectomy device uses is tubulose; In near the distal end the pipe; Thrombosis collecting duct far-end indicating (10) is housed, and thrombosis collecting duct far-end indicating (10) is a ring-type, and its internal diameter is consistent with thrombosis collecting duct internal diameter; The thrombosis collecting duct is collected in the joint (12) by the near-end insertion of collecting duct (11) and is formed; Said collection joint (12) material is a high density polyethylene (HDPE), and collecting duct (11) is made up of inner polytetrafluoroethyllayer layer, PEBAX skin and intermediary stainless steel cloth and spring layer; Bed thickness 0.001mm to 0.10mm in said, outer bed thickness 0.005mm to 0.01mm, collecting duct (11) external diameter is 0.60mm to 1.80mm, internal diameter is 0.35mm to 1.20mm, long 1500mm to 3000mm.
8. the method for preparing of a thrombectomy device; May further comprise the steps: one, use 8 to 288 diameters to be the composite silk of nitinol alloy wire, titanium silk, tungsten filament, tantalum wire, platinum wire, platinumiridio silk, stainless steel silk, stainless steel silk and the platinum of 0.020mm to 0.060mm or the composite silk braiding webmaster of nitinol alloy wire and gold, every foot node number that has of braiding webmaster is 20-250; Use rustless steel or the nitinol alloy wire of diameter as 0.25mm to 0.8mm, be 1500mm to 3000mm blanking by length after, be ground to conical by its shape on the end with seal wire; Platinum wire, tungsten alloy filament or billon filament winding with diameter 0.2mm to 0.5mm are processed the coil spring shape conductive filament head, and the conductive filament head external diameter is 0.2mm to 0.5mm, and long is 50mm to 150mm; The employing external diameter is 0.20mm～0.40mm, thick for after the platinum alloy of 0.001mm to 0.01mm, Nitinol or the blanking of billon pipe the polishing light obtain the far-end indicating; The employing external diameter is 0.30mm to 0.70mm, thick for after the platinum alloy of 0.001mm to 0.01mm, Nitinol or the blanking of billon pipe the polishing light obtain the near-end indicating; Two, the webmaster of braiding is loaded onto thrombectomy device basket mould core, the fine copper wire tighten is used at two ends then, heat treatment typing in the fixed outside mould vacuum heat treatment furnace, vacuum 1.33 * 10
-2～1.33 * 10
-4Pa is warmed up to 200 ℃ to 600 ℃ with 3 seconds to 30 seconds programming rates from room temperature, is incubated 10 minutes to 60 minutes, is cooled to room temperature in the stove naturally; Basket is taken off from mould, and the far-end indicating of packing into of basket one end is with the braided wires and the near-end indicating welding of the basket other end; Three, the conducting wire pole far-end is passed through the indicating of basket near-end, its far-end milled portion is inserted in the indicating of thrombectomy device far-end welding conductive filament head, far-end indicating, basket far-end and conducting wire pole; Tungsten billon silk helical form with diameter 0.2mm to 0.5mm is wrapped on the conducting wire pole, and the welding two ends are made into the development spring, and the external diameter of development spring is 0.15mm to 0.25mm, and long is 0.2mm to 5mm.
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| CN2010102624957A CN101912289B (en) | 2010-08-25 | 2010-08-25 | Thrombus excider and preparation method |
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| CN2010102624957A CN101912289B (en) | 2010-08-25 | 2010-08-25 | Thrombus excider and preparation method |
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| CN101912289B true CN101912289B (en) | 2012-05-30 |
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Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102670282A (en) * | 2012-05-14 | 2012-09-19 | 湖南依微迪医疗器械有限公司 | Cerebral thrombosis exsector |
| CN102670277A (en) * | 2012-05-17 | 2012-09-19 | 湖南埃普特医疗器械有限公司 | Cerebral apoplexy embolus protecting system and preparation method thereof |
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| CN104068952B (en) * | 2014-07-14 | 2015-09-16 | 业聚医疗器械(深圳)有限公司 | The subsidiary conduit carried for guiding endovascular stent |
| CN104739486B (en) * | 2015-03-12 | 2017-11-07 | 湖南瑞康通科技发展有限公司 | A kind of thrombectomby system |
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| CN109998635B (en) * | 2019-05-19 | 2024-03-26 | 常州市三润医疗器械科技有限公司 | Unidirectional thrombus removing device |
| CN113827369A (en) * | 2021-04-12 | 2021-12-24 | 聚辉医疗科技(深圳)有限公司 | Conveying device |
| WO2023087459A1 (en) * | 2021-11-17 | 2023-05-25 | 上海腾复医疗科技有限公司 | Vascular recanalization device |
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