Summary of the invention
The purpose of this invention is to provide a kind of distal protector and preparation method thereof, the technical problem that solve is can collect solid particle in operation process, allows the blood flow mistake, keeps blood flow, reduces the overall dimensions of protector again, makes it can pass through stenotic lesion.
The present invention is by the following technical solutions: a kind of distal protector, have filter, and described filter is to be provided with conducting wire pole along axis in the basket along the basket of its radial contraction, and the basket lower limb of basket near-end connects with conducting wire pole, and the basket far-end is connected with conductive filament head.
Basket of the present invention forms with the braiding of alloy silk, and the far-end of basket is netted, and near-end opens and is macropore.
The mesh aperture of basket of the present invention progressively diminishes from the circumference to the center.
The mesh aperture of basket of the present invention is 300 to 400 μ m near the circumference place of blood vessel wall, and the aperture, center is 0.
The NiTi alloy silk that alloy silk of the present invention is diameter 0.0254mm to 0.20mm, its quantity are 24 to 96.
Alloy silk quantity of the present invention is 48,60,72 or 96.
The present invention is along 1 to 8 the basket lower limb that is circumferentially with in basket aperture.
Basket lower limb of the present invention is 3 or 4.
Conducting wire pole of the present invention is stainless steel silk, NiTi silk or alloy silk, and its external diameter is 0.254mm to 0.965mm, and its length is 180cm to 300cm.
Conducting wire pole external diameter of the present invention is 0.36mm or 0.46mm.
The distal end of conducting wire pole of the present invention is tapered.
The basket lower limb of basket near-end of the present invention and conducting wire pole connection place periphery are provided with joint sleeve, and basket far-end and conductive filament head connection place periphery are provided with joint sleeve.
The near-end of filter of the present invention is connected with delivery cannula.
The internal diameter of delivery catheter distal end of the present invention is greater than the internal diameter at its middle part, and the internal diameter of delivery conduit near-end is less than the internal diameter at its middle part.
Conductive filament head of the present invention is rustless steel or NiTi silk, and its distal portion is tapered, and tapered end is connected with rustless steel, platinum or golden pogo barrel.
The length of conductive filament head of the present invention is 1cm to 5cm.
Basket of the present invention is composed of the composite silk of platinum wire, spun gold, tungsten filament, tantalum wire, NiTi and platinum or the composite silk of NiTi and gold.
Basket lower limb of the present invention is 4, and the composite silk of the composite silk of NiTi and platinum or NiTi and gold is 4,8 or 12; The basket lower limb is 3, and the composite silk of the composite silk of NiTi and platinum or NiTi and gold is 3,6 or 9.
A kind of preparation method of distal protector, may further comprise the steps: one, be woven into netted pipe with NiTi alloy silk and platinum wire, platinum wire is uniformly distributed on the netted pipe, one end of netted pipe is divided into 1 to 8 strand is the basket lower limb, the other end is enclosed within outside the core, the core that will be with netted pipe is again packed in the external mold, external mold loam cake upper mould cover, the mould that netted pipe is housed is put into heat-treatment furnace, insulation is 10 minutes under 450 to 550 ℃ of conditions, to become the two ends of basket shape to pack in the sleeve pipe after the taking-up, basket is made in welding; One end of stainless steel silk or NiTi silk is made taper, put platinum, gold or the tungsten pogo barrel of same outer diameter as, and conductive filament head is made in welding; Two, the tail end of conductive filament head is inserted in the sleeve pipe of basket far-end, sleeve pipe and conductive filament head is welded together, again stainless steel silk or NiTi silk conducting wire pole are inserted in the sleeve pipe of basket lower limb one end of basket, conducting wire pole and sleeve pipe is welded together.
The present invention compared with prior art; the filter of distal protector is for advancing basket in the delivery conduit along its radial contraction; after opening, release can catch solid particle; can keep blood flow constant substantially again; reduced the overall dimensions of distal protector; can be used for little blood vessel and serious stenotic lesion, make operation safer and effective, be particularly suitable for being transported to the far-end of target vessel by conduit.
The specific embodiment
Below in conjunction with drawings and Examples the present invention is described in further detail.As shown in Figure 1, distal protector of the present invention comprises the filter 1 and the delivery conduit 2 that is connected with filter 1 of far-end.As shown in Figure 2, filter 1 is made of conducting wire pole 3, joint sleeve 4, basket 5 and conductive filament head 6, basket 5 can be along its radial contraction, conducting wire pole 3 is arranged on wherein along basket 5 axis, the basket lower limb 7 of basket 5 near-ends connects through joint sleeve 4 with conducting wire pole 3, basket 5 far-ends connect through joint sleeve 4 with conductive filament head 6, and conductive filament head 6 connects with conducting wire pole 3 far-ends (whether PLSCONFM).
Conducting wire pole 3 is stainless steel silk, NiTi silk or other alloy silk, and external diameter is 0.254mm to 0.965mm, and is conventional with 0.36mm or 0.46mm; The external diameter of conducting wire pole 3 is identical, also its head end can be finely ground to taper, so that the front end of distal protector has better pliability and enters the more curved blood vessel of far-end; The length of conducting wire pole 3 is 180cm to 300cm.
As shown in Figure 3, delivery conduit 2 usefulness macromolecular materials are made, the distal inner diameter of delivery conduit 2 is greater than the internal diameter at its middle part, conveniently joint sleeve 4 and basket 5 are shunk in the delivery conduit 2, the near-end of delivery conduit 2 has less internal diameter, less than the internal diameter at its middle part, so that delivery conduit 2 has better propelling movement strength.When distal end filter 1 is shunk delivery conduit 2; basket 5 is compressed in line; distal protector can be taken in the delivery conduit 2 fully, and when distal protector was emitted in delivery conduit, super-elastic NiTi alloy basket can the original basket shape of automatic expansion flare up.
As shown in Figure 4 and Figure 5, the aperture of basket 5 is from changing from the circumference to the center, and the aperture, circumference place of close blood vessel wall is 300 μ m to 400 μ m, and the aperture, center is 0, can catch solid particle like this, can keep blood flow constant substantially again.
The braiding of many NiTi alloys of basket 5 usefulness silk forms, and NiTi alloy filament diameter is 0.0254mm to 0.20mm, and the quantity of NiTi silk is 24 to 96, and routine is 48,60,72 and 96.As shown in Figure 7, the far-end of basket 5 is netted, is used to catch solid particle, allows the blood flow mistake simultaneously, and near-end NiTi silk is divided into 1 to 8 basket lower limb 7, and routine is 4 lower limbs or 3 lower limbs, and the near-end flare up macropore of basket 5 enters basket 5 with convenient big granule.
For ease of under X-ray, seeing open basket 5, can be on basket 5 gold-plated or platinum film layer, also can when braiding, enroll several platinum wires, spun gold, tungsten filament, tantalum wire, the composite silk of the composite silk of NiTi and platinum or NiTi and gold, basket 5 for 4 lower limbs, routine is put into 4, or the composite silk of the composite silk of 12 NiTi and platinum or NiTi and gold article 8,, to with the basket of 3 lower limbs, routine is put into 3, article 6, or the composite silk of the composite silk of 9 NiTi and platinum or NiTi and gold, all be distributed with composite silk or the NiTi and the golden composite silk of NiTi and platinum on every lower limb.
As shown in Figure 8, the very soft so that injured blood vessel not of conductive filament head 6 puts rustless steel, platinum or golden pogo barrel 9 and makes in the rustless steel of wearing into tapering or NiTi silk 8 distal portion, and the length of conductive filament head 6 is 1cm to 5cm.
The using method of distal protector of the present invention may further comprise the steps: one, the filter of distal protector is shunk in the delivery conduit, outside conductive filament head is exposed to; Two, after the intervene operation radiography is found stenotic lesion, the filter in delivery conduit and the delivery conduit is delivered in the lesion vessels through guiding catheter together; Three, confirm that by the indicating of radiography and basket the filter near-end of distal protector has passed through diseased region; Four, begin to discharge the filter of distal protector, fixing conducting wire pole with the carrier recession, discharges the basket of filter in position and opens; Whether five, observe basket by X-ray opens fully, after confirming that basket opens fully, delivery conduit is withdrawn from external, distal protector was laid and was finished this moment, can carry out interventional treatment operation such as balloon expandable, implant frame, intravascular ultrasound inspection etc. along the distal protector conducting wire pole; Six, after operation finishes, again delivery conduit is sent into along the distal protector conducting wire pole, fixing conducting wire pole, the preceding delivery conduit that pushes away is taken in distal protector in the delivery conduit, withdraws from distal protector and delivery conduit external together through guiding catheter again.
The preparation method of distal protector of the present invention may further comprise the steps: one, preparation basket and conductive filament head; Two, preparation distal protector.
Embodiment 1
Preparation basket with netting on top: with NiTi alloy silk and 4 diameter 0.08mm platinum wires of 68 diameter 0.08mm, be woven into netted pipe as shown in Figure 6 on the HTBZ-40 type braider of Shenzhen Huitai Medical Instrument Co., Ltd manufacturing, platinum wire is uniformly distributed on the netted pipe; One end of netted pipe is divided into four basket lower limbs, and then outside the core that is enclosed within profile such as Fig. 9, the core that will be with netted pipe is again packed in the external mold of shape such as Figure 10, covers the die cap of shape such as Figure 11 on the external mold; As shown in figure 12, the mould that netted pipe is housed is put into the ZSK2-12-6 type vacuum heat treatment furnace that Wuhan industrial furnace head factory is made, insulation is 10 minutes under 450 ℃ condition; To become the two ends of basket shape to pack in the sleeve pipe after the taking-up, complete basket is promptly made in welding on the LCT-W1 type laser-beam welding machine that basket and the effective Beijing of cover Lai Ze photoelectricity technology corporation, Ltd. are made.
The preparation conductive filament head: with an end of the stainless steel silk of diameter 0.36mm at U.S. ROYAL MASTERGEINDERS, make taper on the TG12X4 type cylindrical grinder that INC makes, the external diameter that puts suitable length is the platinum pogo barrel of 0.36mm, and an end of pogo barrel and stainless steel silk are reached the conductive filament head of making welded together on the WS-120 type tungsten argon arc welding machine that source welding equipment company makes in the Shenzhen.
The preparation distal protector: the tail end of conductive filament head is inserted in the sleeve pipe of basket far-end, sleeve pipe and conductive filament head is welded together on the LCT-W1 type laser-beam welding machine with the manufacturing of Beijing Lai Ze photoelectricity technology corporation, Ltd.; Stainless steel silk conducting wire pole with diameter 0.36mm inserts in the sleeve pipe of basket lower limb one end again, and conducting wire pole and sleeve pipe is welded together on the LCT-W1 type laser-beam welding machine that Lai Ze photoelectricity technology corporation, Ltd. in Beijing makes, and promptly makes a complete distal protector.
Embodiment 2
Preparation basket with netting on top: with NiTi alloy silk and 4 diameter 0.08mm platinum wires of 68 diameter 0.08mm, be woven into netted pipe as shown in Figure 6 on the HTBZ-40 type braider of Shenzhen Huitai Medical Instrument Co., Ltd manufacturing, platinum wire is uniformly distributed on the netted pipe; One end of netted pipe is divided into four basket lower limbs, is enclosed within then outside the core of profile such as Fig. 9, the core that will be with netted pipe is again packed in the external mold of shape such as Figure 10, covers the die cap of shape such as Figure 11 on the external mold; As shown in figure 12, the mould that netted pipe is housed is put into the ZSK2-12-6 type vacuum heat treatment furnace that Wuhan industrial furnace head factory is made, insulation is 10 minutes under 550 ℃ condition; To become the two ends of basket shape to pack in the sleeve pipe after the taking-up, complete basket is promptly made in welding on the LCT-W1 type laser-beam welding machine that Lai Ze photoelectricity technology corporation, Ltd. in Beijing makes with basket and sleeve pipe.
The preparation conductive filament head: with an end of the NiTi silk of diameter 0.36mm at U.S. ROYAL MASTERGEINDERS, make taper on the TG12X4 type cylindrical grinder that INC makes, the external diameter that puts suitable length is the gold pogo barrel of 0.36mm, and an end of pogo barrel and NiTi silk are reached the conductive filament head of making welded together on the WS-120 type tungsten argon arc welding machine that source welding equipment company makes in the Shenzhen.
The preparation distal protector: the tail end of conductive filament head is inserted in the sleeve pipe of basket far-end, sleeve pipe and conductive filament head is welded together on the LCT-W1 type laser-beam welding machine that Lai Ze photoelectricity technology corporation, Ltd. in Beijing makes; NiTi silk conducting wire pole with diameter 0.36mm inserts in the sleeve pipe of basket lower limb one end again, and conducting wire pole and sleeve pipe is welded together on the LCT-W1 type laser-beam welding machine that Lai Ze photoelectricity technology corporation, Ltd. in Beijing makes, and promptly makes a complete distal protector.
Embodiment 3
Preparation basket with netting on top: with NiTi alloy silk and 4 diameter 0.08mm platinum wires of 68 diameter 0.08mm, be woven into netted pipe as shown in Figure 6 on the HTBZ-40 type braider of Shenzhen Huitai Medical Instrument Co., Ltd manufacturing, platinum wire is uniformly distributed on the netted pipe; One end of netted pipe is divided into four basket lower limbs, is enclosed within then outside the core of profile such as Fig. 9, the core that will be with netted pipe is again packed in the external mold of shape such as Figure 10, covers the die cap of shape such as Figure 11 on the external mold; As shown in figure 12, the mould that netted pipe is housed is put into the ZSK2-12-6 type vacuum heat treatment furnace that Wuhan industrial furnace head factory is made, insulation is 10 minutes under 530 ℃ condition; To become the two ends of basket shape to pack in the sleeve pipe after the taking-up, complete basket is promptly made in welding on the LCT-W1 type laser-beam welding machine that Lai Ze photoelectricity technology corporation, Ltd. in Beijing makes with basket and sleeve pipe.
The preparation conductive filament head: with an end of the NiTi silk of diameter 0.36mm at U.S. ROYAL MASTERGEINDERS, make taper on the TG12X4 type cylindrical grinder that INC makes, the external diameter that puts suitable length is the tungsten pogo barrel of 0.36mm, and an end of pogo barrel and NiTi silk are reached the conductive filament head of making welded together on the WS-120 type tungsten argon arc welding machine that source welding equipment company makes in the Shenzhen.
Preparation distal protector: the tail end of conductive filament head is inserted in the sleeve pipe of basket far-end, reach WS-120 type tungsten argon arc welding machine that source welding equipment company make on welded together in the Shenzhen sleeve pipe and conductive filament head; NiTi silk conducting wire pole with diameter 0.36mm inserts in the sleeve pipe of basket lower limb one end again, and conducting wire pole and sleeve pipe is welded together on the LCT-W1 type laser-beam welding machine that Lai Ze photoelectricity technology corporation, Ltd. in Beijing makes, and promptly makes a complete distal protector.
The present invention uses tens of meticulous NiTi silk braiding baskets, does not use filter membrane, and the overall dimensions of distal protector is little, and the thinnest delivery conduit that can arrive warp in the use 0.61mm for a short time can be used for little blood vessel and serious stenotic lesion.The basket aperture is from changing from the circumference to the center, and the circumference place of close blood vessel wall is 300 μ m to 400 μ m, and the aperture, center is 0, can catch solid particle, can keep blood flow constant substantially again.The 8mm distal protector that experiment showed, the braiding of 72 silks can be caught 99.9% 100 μ m PVA granules in the pipeline of 5mm.The present invention can see the situation of opening of whole basket by enrolling opacity material particularly NiTi and platinum or golden composite silk in operation process, make operation safer and effective.For the distal protector that uses filter membrane, can only see indicating in the operation, can not see filter membrane, if discharge or operation process in filter membrane break, displacement or basket deform, and will cause protection to be failed.