Summary of the invention
Technical problem to be solved by this invention provides.
For solving the problems of the technologies described above, the present invention provides a kind of Wicresoft to get involved the thrombosis extraction system, comprises delivery guidewire, it is characterized in that, the thrombosis trap setting that also comprises microtubular, guiding catheter, links together with the delivery guidewire far-end,
Said thrombosis trap setting is that the far-end of support becomes closing structure or throat structure by network single or that the braiding of multi-filament material forms, and the vertebra angle that cancellated near-end is open tapered and axis forms is got involved 0 and spent to 75 degree;
The inside diameter ranges of microtubular is 0.2 millimeter to 3 millimeters; The external diameter scope is 0.5 millimeter to 4 millimeters, and length range is 20 centimetres to 300 centimetres;
The guiding catheter inside diameter ranges is 1 millimeter to 10 millimeters; The external diameter scope is 2 millimeters to 15 millimeters.Length range is 20 centimetres to 300 centimetres.
Said RF is shaped as semi-closed support shape, netted, basket or open stent shape.
The silk material diameter range that weaves said thrombosis trap setting is 10 microns to 1 millimeter;
The cancellated diameter range that the braiding back forms is 1 millimeter to 30 millimeters;
It is 1 millimeter to 100 millimeters that said netted (or basket shape or support) structure is opened the back length range
The delivery guidewire length that links together with the thrombosis trap setting is 20 centimetres to 200 centimetres.
Said braided support with the material of the silk material of fastening rack far end is:
Tweezer titanium alloy, cochrome, rustless steel, pure platinum or its alloy, true yellow gold or its alloy, pure tungsten or its alloy, pure tantalum or its alloy, pure titanium or its alloy, degradable metal material, Biodegradable material (for example polylactic acid PLLA).
The material of the delivery guidewire that said and thrombosis trap setting is connected is:
Tweezer titanium alloy or cochrome or rustless steel.
Said guiding catheter can be the former guiding catheter of ball.
It is former that said guiding catheter far-end has ball,
The former wall thickness range of said ball is 10 microns to 1 millimeter;
The former hardness range of ball is that Shore hardness 25A is to 55D;
The former material of ball is polyurethane, silicone rubber or natural rubber.
Said guiding catheter head end has axial otch.
Said guiding catheter far-end has one than the softish soft head of catheter main body.
The wall thickness range of said soft head is 100 microns to 2 millimeters;
Soft material is polyurethane, silicone rubber or Pebax;
Soft hardness range is that Shore hardness 50A is to 72D.
Said thrombosis trap setting is that sidewall is closed or for having opening, deployable one-tenth one planar network.
Said network structure can be separated with said delivery guidewire through electrolysis, thereby support is released in the narrow blood vessel, plays the effect of mediation blood flow.
The beneficial effect that the present invention reached:
1) Wicresoft of the present invention gets involved the thrombosis trap setting that is provided with special protection distal vessels in the thrombosis extraction system; The RF that its far-end is closed both can entangle bigger main body thrombosis; Can cause the [of peeling off out and other foreign body of thromboembolism to catch again; Thereby can avoid [to flow to the more blood vessel of far-end, reduce the probability of second stroke greatly.
2) the guiding catheter head end has carried out improving design, because this softness head end can be big by the thrombosis support, can successfully fix the thrombosis of diameter up to 4 millimeters.And under the same experiment condition, the 8F guiding catheter with same external diameter that uses on the market now all can't be fixed the thrombosis that diameter surpasses 3.5 millimeters.Native system is potential to obtain bigger thrombosis thereby make.
3) the guiding catheter far-end of native system improves than the fracture resistance and the compliance of the guiding catheter far-end that uses on the market greatly, thereby can be transported to the more blood vessel of far-end.Based on this, use native system approximately can save operating time 10 to 15 minutes, for the acute cerebral stroke patient wins 10 minute very valuable treatment time, increase substantially the logical again success rate of patient vessel.
4) thrombosis trap setting of the present invention has the braided support structure; If patient's section angiostenosis is serious; Thrombosis trap setting with network structure can also be retained in the narrow section blood vessel as support, thereby plays the adjection of blood vessel dilating, mediation blood flow alleviation disease.Use native system can save operating time, the patient wins treatment time for acute cerebral stroke, improves the logical again success rate of patient vessel.
The specific embodiment
Below in conjunction with accompanying drawing the present invention is further described.Following examples only are used for technical scheme of the present invention more clearly is described, and can not limit protection scope of the present invention with this.
Embodiment 1
Wicresoft of the present invention gets involved the thrombosis extraction system and comprises delivery guidewire 1, is welded in the thrombosis trap setting 2 on the delivery guidewire, a microtubular, a guiding catheter 3.
Wherein, the inside diameter ranges of microtubular is 0.2 millimeter to 3 millimeters; The external diameter scope is 0.5 millimeter to 4 millimeters, and length range is 20 centimetres to 300 centimetres;
The guiding catheter inside diameter ranges is 1 millimeter to 10 millimeters; The external diameter scope is 2 millimeters to 15 millimeters.Length range is 20 centimetres to 300 centimetres.
Thrombosis trap setting 2 is arranged on the far-end of delivery guidewire 1; Be the RF that forms by the braiding of silk material, cancellated far-end closed (perhaps reducing), the open design of near-end; Can entangle bigger main body thrombosis; Can catch the [that breaks away from the main body thrombosis and other foreign bodies that causes thromboembolism live again, thereby can avoid [to flow to the more blood vessel of far-end, reduce the probability of second stroke greatly.This thrombosis trap setting can also be squeezed into a plurality of less thrombosis by the thrombosis that size is bigger and hard, is beneficial to very much whole thrombosis are pulled in the former guiding catheter of ball.
Several kinds of schemes below the RF specific constructive form of thrombosis trap setting can adopt in the present embodiment, those of ordinary skills can recognize, also can adopt other forms of RF in other embodiments.
1, as shown in Figure 1, its shape and structure can be the semi-closed supportingstructure 210 of braiding, and far-end 213 is woven together, and forms closed reducing.Perhaps rack farend 213 grids are fastened into closing structure by a more tiny silk 215.Mountproximal end 211 is open and tapered.Preferable scheme is that rack far end grid nearer end and other positions are closeer.
Mountproximal end 211 and far-end 213 all have one or moreX lines ring 212 that well develops.Delivery guidewire 1 surface is provided with insulating coating (overlay film is materials such as Parylene, polyurethane Polyurethane, silicone rubber or Pebax), and the pad place that only welds together with the support most proximal end is the segment 214 (this segment length is the 0.2-5 millimeter) that does not have insulating coating.Mainly contain under two kinds of situation, need and separate with delivery guidewire and stay in the patient's blood vessel as the thrombosis trap setting: 1) patient's section angiostenosis be serious, needs to have this narrow blood vessel of support expansion of certain radial support power; 2) thrombosis is in the guiding catheter course of conveying of near-end; Run into very crooked blood vessel, make the thrombosis trap setting that has thrombosis be stuck in the curved blood vessel section, if brute force is outwards removed delivery guidewire and thrombosis trap setting; Can damage patient's blood vessel, cause great risk.Run into above arbitrary situation; The doctor is with electrolysis unit in most proximal end (outside the patient body) connection of delivery guidewire 1 or the equipment of high-frequency pulse current can be provided; There is not thesegment 214 of insulating coating generally can in one minute, be melted by electrolysis; Like this can be so that support separate with delivery guidewire 1 from pad, thus entire bracket is stayed in the patient's blood vessel.
2, as shown in Figure 2, its shape can be the fishing net shape of braiding or the structure of string bag shape, and far-end forms closure, and near-end is an opening.
3, as shown in Figure 3, its shape and structure can be the basket structure of braiding, and far-end is woven together and forms closure, proximal openings.Compare the RF trap setting, basket structure can't capture very little thrombosis, but basket simple in structure, with low cost, the more important thing is can manufacture more tiny, thereby can place the more tiny microtubular of entering.More tiny microtubular (such as 1.5F) can get into the blood vessel of more tiny more far-end.And more the blood vessel diameter of far-end is generally less than 2 millimeters, and this place's thrombosis is also very little, even thrombosis is divided into more tiny a plurality of thrombosis in operation, the size of finally going out from basket shape fabric drain is very little, patient is endangered less.That is to say that the thrombosis trap setting of basket shape structure is more suitable for being positioned in taking-up the thrombosis of the blood vessel of more tiny more far-end
4, as shown in Figure 4, its shape and structure can be openshape supporting structure 220, and near-end one side of this support is wedge shape (analysing and observe), and such structure is beneficial to the thrombosis that captures.Mountproximal end 221 and far-end 223 all have one or moreX lines ring 222 that well develops, and the development ring material can be a platinum, or gold, or tantalum, or tungsten, perhaps multiple alloy.Delivery guidewire 1 surface is provided with insulating coating (overlay film is materials such as Parylene, polyurethane Polyurethane, silicone rubber or Pebax), and the pad place that only welds together with the support most proximal end is the segment 24 (this segment length is the 0.2-5 millimeter) that does not have insulating coating.If clinical needs are arranged; Electrolysis unit in the most proximal end of delivery guidewire 1 (outside the patient body) connection; The segment 24 that does not have an insulating coating generally can be by the electrolysis fusing in one minute, like this can be so that support separate with delivery guidewire 1 from pad, thus entire bracket is stayed in the patient's blood vessel.Openshape supporting structure 220 far-ends 223 parts are conventional stent designses, and have suitable radial support power.The far-end semi-closed supporting structure of Fig. 1 design also can be used for above-mentioned occasion; Because with the rack far end grid fasten together fasten the silk more tiny than rack body silk; In case whole system connects electrolysis unit; The tiny silk of fastening can be dissolved by electrolysis very soon and holds, thereby the rack far end grid is no longer in bond, and rack far end becomes traditional tube-shaped structure at this moment.And after-poppet is also melted by electrolysis from pad and delivery guidewire naked section, and support separates with delivery guidewire and stays the narrow blood vessel place, plays the effect of mediation blood flow.
The thrombosis trap setting of Fig. 1 and Fig. 4 design is fit to the treatment distal vessels very much has serious narrow patient.Run into similar case; The doctor takes out the thrombosis of artery-clogging at first rapidly; Need not withdraw from the thrombosis trap setting of this supporting structure then, but this support is shunk the entering microtubular earlier, then microtubular is pushed to narrow blood vessel place; Pin delivery guidewire and return simultaneously and remove microtubular, can support be discharged like this.If the doctor is dissatisfied to backing positions, can take in microtubular to support once more, behind the adjustment microtubular position, it is desirable until its position to discharge support once more.Most proximal end with delivery guidewire connects upward electrolysis unit at last, and inner support separated with delivery guidewire from pad in about one minute, withdraws from delivery guidewire and other equipment, thereby entire bracket is stayed in the narrow blood vessel, and narrow blood vessel is played dilating effect.Perhaps delivery guidewire most proximal end 211,221 is connected the equipment that high-frequency pulse current can be provided, operable clinically electric current is between 0.2 ampere to 2 amperes, and voltage is 15 to 25 volts, and frequency is 150 roads, 350 KHzs.General connection about one minute; Disconnection will be fused in support most proximal end 211,221 and position, delivery guidewire 1 boundary; Thereby supporting structure 210,220 separates with delivery guidewire 1; Withdraw from delivery guidewire and other equipment, thereby entire bracket is stayed in the narrow blood vessel, narrow blood vessel is played dilating effect.
The silk material diameter range that the thrombosis trap setting uses is 10 microns to 1 millimeter; Diameter range after RF is opened is 1 millimeter to 30 millimeters; Opening the back length range is 1 millimeter to 100 millimeters.
The material of the silk material of braided support includes, but are not limited to following material, and multiple different materials mixed weaving comes out in the perhaps following material:
Tweezer titanium alloy, cochrome, rustless steel, pure platinum or its alloy, true yellow gold or its alloy, pure tungsten or its alloy, pure tantalum or its alloy, pure titanium or its alloy, degradable metal material, Biodegradable material (for example polylactic acid PLLA).
The material of the delivery guidewire that said and thrombosis trap setting is connected is:
Tweezer titanium alloy or cochrome or rustless steel.
5, the thrombosis trap setting can be for the pipe shape support of routine, like Fig. 1, shown in Figure 4; Also can haveopening 230, deployable one-tenth one planar network forsidewall 23; As shown in Figure 6;Sidewall 23 forms open structure, and near-end 231 1 sides of this support are wedge shape (analysing and observe), and such structure is beneficial in the less microtubular of support income diameter.Near-end 231 and far-end 233 all have one or more X lines ring 232 that well develops.Delivery guidewire 1 far-end is connected with the near-end 231 of support, and its surface is provided with insulating coating equally, and the pad place that only welds together with the support most proximal end is thesegment 234 that does not have insulating coating.
Embodiment 2
Microtubular can be selected standard type number in the present embodiment, and guiding catheter has been done further improvement, and all the other are identical with embodiment 1.
The guiding catheter head end has been carried out improving design, as shown in Figure 5, have theotch 311 of about 2 mm lengths at guiding catheter 3 head ends 31.
The guiding catheter far-end of this structure is not dribbled former among the present invention; Thereby need not specially to the fluidic passage of the former injection of ball; So do not dribble former 8F guiding catheter its when keeping same external diameter; Internal diameter than the former 8F guiding catheter of dribbling is big by 15%, and native system is potential to obtain bigger thrombosis thereby make.
8F guiding catheter of the present invention is placed in the simulated blood vessel, can be big owing to have the soft head end of otch by the thrombosis support, can successfully fix the hard thrombosis of diameter up to 4 millimeters.And under the same experiment condition, the 8F guiding catheter that uses on the market all can't be fixed the hard thrombosis that diameter surpasses 3.5 millimeters.
As shown in Figure 5, guidingcatheter head end 31 is selected for use than the more softish material of catheter main body among the present invention, is called soft head:
1) wall thickness range of soft head is 100 microns to 2 millimeters.
2) soft material includes, but are not limited to following material, and be multiple in the perhaps following material: polyurethane (Polyurethane), silicone rubber, Pebax.
3) soft hardness range is that Shore hardness 25A is to 72D.
The operating procedure of conventional intervention thrombosis extraction system is following:
1) at first the 6F guiding catheter is placed into patient's common carotid artery (Common Carotid Artery).
2) seal wire gets into intracranial vessel through the 6F guiding catheter, and crosses thrombosis.
3) withdraw from the 6F guiding catheter, along seal wire a very softish 5F angiography catheter of far-end is placed and got into internal carotid artery.
4) place the entering internal carotid artery along the 5F angiography catheter 8F guiding catheter that internal diameter is bigger.
5) withdraw from the 5F angiography catheter, microtubular is got into intracranial vessel along seal wire, until near thrombosis.
6) withdraw from seal wire.Slowly push the delivery guidewire have the thrombosis trap setting and get into microtubular,, and cross thrombosis the thrombosis trap setting intracranial vessel of slowly making a gift to someone.
7) the thrombosis trap setting is released microtubular, thrombosis is just encased by the thrombosis trap setting like this.
8) slowly return and remove delivery guidewire, thereby thrombosis is dragged the guiding catheter to 8F.
9) if the thrombosis size is less; Only need to surpass 20 milliliter injection devices this moment and be connected 8F guiding catheter near-end connection wye place with one; Firmly aspirate the former guiding catheter of ball, thrombosis will suck the 8F guiding catheter, finally along with the 8F guiding catheter is withdrawn from outside the patient body together.If the thrombosis size is big and quality is harder, just be difficult to successful removal of thromboses.
Compare conventional system, simple and fast is wanted in the operation of intervention thrombosis extraction system of the present invention, and concrete steps are following:
1) the direct common carotid artery (Common Carotid Artery) that the softish guiding catheter of far-end is placed into patient.
2) seal wire is pierced into guiding catheter, and push seal wire entering intracranial vessel, and cross thrombosis.
3) microtubular is got into intracranial vessel along seal wire, until crossing thrombosis.
4) withdraw from seal wire.Slowly push the delivery guidewire that has the thrombosis trap setting and get into microtubular, the thrombosis trap setting is slowly sent into intracranial vessel, and cross thrombosis.
5) pin the delivery guidewire that welds together with the thrombosis trap setting, and slowly return and remove microtubular and discharge the thrombosis trap setting, thrombosis is just encased by the thrombosis trap setting like this.
6) slowly return and remove delivery guidewire, thereby thrombosis is dragged to guiding catheter.
7) if the thrombosis size is less, only need to surpass 20 milliliter injection devices this moment and be connected guiding catheter near-end connection wye place with one, firmly aspirate guiding catheter, thrombosis will suck guiding catheter, finally along with guiding catheter is withdrawn from outside the patient body together.If the thrombosis size is bigger and hard, pin guiding catheter, slowly return and remove the delivery guidewire that welds together with the thrombosis trap setting, because about the shearing of trap setting outer rim, thrombosis will be cut into a plurality of less thrombosis.Surpass 20 milliliter injection devices with one this moment and firmly aspirate guiding catheter, a plurality of less thrombosis will suck guiding catheter, finally along with guiding catheter is withdrawn from outside the patient body together.
Under the simulation test condition, use system of the present invention to get thrombosis and approximately can save operating time 10 to 15 minutes.Each minute all is of great value for the acute cerebral stroke patient, shortens 10 minutes and just can increase substantially the logical again success rate of patient vessel.
The processing method of thrombosis trap setting-1
Network like Fig. 4 can be designed to plurality of specifications (different-diameter and length) according to clinical needs.According to a certain particular design, at first a metal cylinder is processed into the mould very approaching with stent diameter, and on mould, processes many parallel helical grooves according to design.Get one or multi-filament with the staggered mode of passing through of positive and negative helix, twine along groove that to be woven into near-end tapered and far-end is columnar network.Support and mould thereof are put into baking oven carry out thermal finalization.The different materials heat setting process has than big-difference.With the memorial alloy is example, and heat setting temperature is between 450 degree ~ 550 degree Celsius, and the time is 2 to 30 minutes.Silk material diameter and stent diameter are more little, and shaping time is short more.After the support thermal finalization, get the relevant position that one or more development rings are fixed to mount proximal end and far-end.Perhaps the silk compact winding that it is good that the X line develops is become to the relevant position of mount proximal end and far-end, be used for showing the near-end and the remote location of support.At last the grid of support most proximal end and delivery guidewire are welded together and be made into thrombosis trap setting finished product.
For the support of Fig. 1, at first make the open shape network of Fig. 4 according to above method.Get the silk more tiny than braided support again, with its all grids that pass this support distal-most end successively, appropriateness is tightened up this and is fastened silk, thereby rack far end is made complete closure or throat structure.Using laser-beam welding machine will fasten a two ends welds together.Finally produce the thrombosis trap setting finished product of the semi-closed supporting structure of Fig. 1.The reducing of Fig. 1 far-end or closing structure can realize that also the mould far-end of i.e. thermal finalization is not cylindrical through thermal finalization, but taper or Semen Jujubae shape.
The processing method of thrombosis trap setting-2
Network like Fig. 4 can be designed to plurality of specifications (different-diameter and length) according to clinical needs.According to a certain particular design, at first a metal cylinder is processed into the mould very approaching with stent diameter, and on mould, processes many parallel helical grooves according to design.Get one or multi-filament with the staggered mode of passing through of positive and negative helix, twine along groove that to be woven into near-end tapered and far-end is columnar network.Support and mould thereof are put into baking oven carry out thermal finalization.The different materials heat setting process has than big-difference.With the memorial alloy is example, and heat setting temperature is between 450 degree ~ 550 degree Celsius, and the time is 2 to 30 minutes.Silk material diameter and stent diameter are more little, and shaping time is short more.After the support thermal finalization, use very sharp cutter according to designing with the mount proximal end bevel cut.Adopt laser-beam welding machine that a plurality of wire bonds that scatter are received on the silk of outer most edge again.Get one or more development rings and be fixed to the relevant position of mount proximal end and far-end.Perhaps the silk compact winding that it is good that the X line develops is become to the relevant position of mount proximal end and far-end, be used for showing the near-end and the remote location of support.At last the grid of support most proximal end and delivery guidewire are welded together and be made into thrombosis trap setting finished product.
During the support of construction drawing 1; At first produce open shape network structure as shown in Figure 4 earlier according to above method; Get the silk more tiny again than braided support; With its all grids that pass the support distal-most end successively, appropriateness is tightened up this and is fastened silk, thereby rack far end is made complete closure or throat structure.Using laser-beam welding machine will fasten a two ends welds together.Finally produce the thrombosis trap setting finished product of the semi-closed supporting structure of Fig. 1.The reducing of Fig. 1 far-end or closing structure can realize that also the mould far-end of i.e. thermal finalization is not cylindrical through thermal finalization, but taper or Semen Jujubae shape.
The above only is a preferred implementation of the present invention; Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from know-why of the present invention; Can also make some improvement and distortion, these improvement and distortion also should be regarded as protection scope of the present invention.