CN109303587A - A kind of encephalic takes pin device and its manufacturing method - Google Patents

A kind of encephalic takes pin device and its manufacturing method Download PDF

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Publication number
CN109303587A
CN109303587A CN201810970867.8A CN201810970867A CN109303587A CN 109303587 A CN109303587 A CN 109303587A CN 201810970867 A CN201810970867 A CN 201810970867A CN 109303587 A CN109303587 A CN 109303587A
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China
Prior art keywords
encephalic
pin device
takes
shape
seal wire
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Inventor
刘恒全
缪中荣
邓双
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Butler Biotechnology Suzhou Co ltd
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Suzhou Ruifan Medical Technology Co Ltd
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Priority to CN201810970867.8A priority Critical patent/CN109303587A/en
Publication of CN109303587A publication Critical patent/CN109303587A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2217Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions single wire changing shape to a gripping configuration

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The present invention relates to a kind of encephalics to take pin device and its manufacturing method, the device include push seal wire and self-expanding take bolt bracket, the push seal wire and described bolt bracket is taken to be made of a shape-memory alloy wire, the push seal wire is the proximal part of the shape-memory alloy wire, the distal end for taking bolt bracket to be arranged on the push seal wire, is cut by laser by the distal portions of the shape-memory alloy wire.Encephalic of the invention take the Unique physical design of pin device i.e. and can guarantee the entrance of bracket and withdraw during good compliance, the damage to vascular wall and peripheral vessels is reduced, and can guarantee the good supportive of bracket upon discharge to enhance the removal effect to thrombus.

Description

A kind of encephalic takes pin device and its manufacturing method
Technical field
The present invention relates to a kind of medical instruments, relate in particular to one kind for patient in acute ischemic cerebral apoplexy (Cerebral Ischemic Stroke, CIS) fall ill when, by way of intervention machinery eliminate thrombus, with reach it is quick or The encephalic for responding immediately to occlusion cerebral artery blood flow takes pin device and its manufacturing method.
Background technique
Stroke Death occupies world death rate the 2nd.In China, cerebral apoplexy, which has become, causes death and deformity The 1st reason.It is shown according to the stroke epidemiological report of Chinese stroke association publication in 2015, at present the annual new hair brain blood of China Pipe disease 270, about the 1300000 of cranial vascular disease are died of every year, just have within every 12 seconds the raw cerebral apoplexy of 1 human hair, every 21 seconds with regard to someone Die of cerebral apoplexy.Cerebral apoplexy is given every year loses about 40,000,000,000 caused by China's economic, and is in rise year by year trend.Further accordance with " China Acute ischemic cerebral apoplexy diagnosis and treatment guide 2014 ", acute ischemic cerebral apoplexy (acute cerebral infarction) is the most common stroke type, Account for about the 60%~80% of whole cerebral apoplexies.Research in recent years show China be hospitalized acute cerebral infarction patients fall ill the latter moon when disease Dead rate is about 3.3%~5.2%, and case fatality rate is about 9%~9.6% within 3 months, and death/disability rate is about 34.5%~37.1%, Case fatality rate is about 11.4%~15.4% within 1 year, and death/disability rate is about 33.4%~44.6%.
The processing of acute ischemic cerebral apoplexy is it should be emphasized that early diagnosis, early treatment, early rehabilitation and early prevention are sent out again. The therapeutic modality being currently known has drug thrombolysis, intravascular Mechanical recanalization, angioplasty etc..Recombinant tissue-type plasminogen swashs Agent (rtPA) living and urokinase are China's mainline thrombolytic drugs used at present, now think effectively to rescue Penumbra zone tissue Time window is in 4.5 hours or in 6 hours, and drug thrombolytic treatment time window is narrow, recanalization rate is low, bleeding risk is high.Drug simultaneously The time logical again of thrombolysis is long, either intravenous thrombolysis or Arterial thrombolysis, then the logical time at least needs 1~2 hour.And it is some Patient's discomfort composite medicine thromboembolism treatment.To solve the problems, such as above-mentioned drug thrombolysis, mechanical technology of leading to again becomes nearest hot spot.
Mechanical to lead to technology again, i.e., mechanical thrombus removal/device for excising can accelerate the process led to again, increase recanalization rate, very Or window of opportunity can be increased.The some mechanical technologies of leading to again used at this stage have: thrombectomy, the method take bolt thorough, but It is larger to vascular damaged, easily cause various complication;Laser or ultrasound take bolt, and the method operation difficulty is larger, laser energy It is more difficult to control, it is relatively low, it not can be removed thrombus, it is higher, it is easy to damage blood vessel, and easily cause vascular inflammation;Helical form thrombus is grabbed Device for catching is made of the Ultimum Ti with superlastic, is distally in five gradually smaller spiral shells of diameter if Merci takes bolt device Rotation is cyclic annular, and shape is similar to corkscrew, with the announcement of clinical study results, Merci with it is other take pin device compared with, due to its phase To the complication such as low recanalization rate and vascular puncture height, have the tendency that gradually being eliminated;Thrombus is sucked by vacuum by proximal end approach Device such as Penumbra system, but faces equipment, complicated for operation, additional complication occurrence risk and true recanalization rate Problem;Bracket takes pin device, and such as Solitaire bracket, Trevo takes bolt device etc..American Heart Association/American Stroke association (AHA/ASA) in the new edition Treatment of Stroke guide of joint publication in 2015, recommend in existing standard IV thromboembolism treatment (IV- TPA taking bolt technology using Solitaire on the basis of) is the preferred therapeutic scheme of patients with acute ischemic stroke.Solitaire is It is most widely used in global clinical and experimental study to take bolt bracket.But have no similar products at present at home and enter clinic, make It is with external product higher cost and unfavorable to patient and Technique Popularizing.
Summary of the invention
In view of the drawbacks of the prior art, the object of the present invention is to provide a kind of encephalics to take pin device and its manufacturing method, should Device can restore regional flow in the vascular site for having embolic occlusion, effectively improve the effect of cerebrovascular thrombi reconstructing blood vessel And speed.
It is an object of the invention to what is be achieved through the following technical solutions:
A kind of encephalic takes pin device, takes bolt bracket, the push seal wire and institute including push seal wire and self-expanding It states and bolt bracket is taken to be made of a shape-memory alloy wire, the push seal wire is the close end of the shape-memory alloy wire Point, the distal end for taking bolt bracket to be arranged on the push seal wire is passed through by the distal portions of the shape-memory alloy wire It is cut by laser.
The purpose of the present invention is also further realized by following preferred technical solution:
In some embodiments, the distal portions of the push seal wire are that proximally distally diameter gradually becomes smaller Vertebra shape structure.
In some preferred embodiments, spring ring is provided in the vertebra shape structure.
In some embodiments, the distal portions for pushing seal wire have the dumbbell being gradually reduced from both ends to mid diameter Shape structure.
In some embodiments, described that bolt bracket is taken to be treated as that there is the hollow vertical of shape-memory properties by thermal finalization Body reticular structure, the proximal part of the hollow three-dimensional reticular structure are vertebra shape.
In some preferred embodiments, the distal end for taking bolt bracket is open or closed.
In some preferred embodiments, described to take bolt bracket that be radially compressed in the inner cavity of microtubular, when After the microtubular is transported to target site, the push seal wire is operated, then withdraws the microtubular and described to take bolt branch Frame expands outside the distal end of the microtubular expands into the hollow three-dimensional reticular structure.
In some preferred embodiments, coating is coated on bolt bracket in described take.
In some preferred embodiments, the coating is anticoagulant or antiplatelet drug or the coating For the biodegradable bioavailable polymer for being loaded with anticoagulant or antiplatelet drug.
In some preferred embodiments, holding tank is provided on bolt bracket in described taking.
In some embodiments, the both ends for taking bolt bracket are provided with Marking ring.
In some embodiments, shape-memory alloy wire is Ultimum Ti silk.
In some embodiments, it further includes transportation system that the encephalic, which takes pin device, and the transportation system includes one The tube body of elongated hollow, and the handle being fixedly connected with the proximal end of the tube body, the push seal wire and described take bolt bracket It is arranged in the lumen of the tube body, the proximal end of the push seal wire is fixedly connected with the handle.
Another object of the present invention is achieved through the following technical solutions:
A kind of encephalic takes the manufacturing method of pin device, includes the following steps:
1) prepare shape-memory alloy wire of the diameter between 0.1~3.0mm;
2) mode being cut by laser carves the distal portions of the shape-memory alloy wire, obtains an end seal The space network closed;
3) space network is shaped to hollow three-dimensional reticular structure, the hollow three-dimensional using heat treatment process The proximal part of reticular structure is vertebra shape.
Another object of the present invention is also further realized by following preferred technical solution:
In some embodiments, the hollow three-dimensional reticular structure is the structural unit repeated arrangement shape by multiple diamond shapes At the structural unit is made of the filament or pillar interconnected.
In some embodiments, the distal portions of the push seal wire are to be cut into proximally distally diameter Gradually smaller vertebra shape is provided with spring ring in the vertebra shape structure.
In some embodiments, the distal portions for pushing seal wire have the dumbbell being gradually reduced from both ends to mid diameter Shape structure is provided with platinum taenidium in the dumbbell-shaped structure.
In some embodiments, the shape-memory alloy wire is nitinol alloy wire.
Compared with prior art, device provided by the invention has the advantage that
1, encephalic of the invention takes pin device to be manufactured by single shape-memory alloy wire through laser cutting, domestic at present temporary Without this technology.Manufacturing and designing product using individual thread can enter thinner embolism firstly, the bracket of smaller outer diameter can be produced Intracranial vessel increases the adaptability and application range of product;Secondly, pin device and push seal wire integrated design are taken, it can be by In compression arrangement to microtubular, and it is recycled to microtubular again after releasing crawl thrombus, and crawl thrombus from microtubular All it is easy compared with existing product;Third, the shape-memory alloy wire that encephalic of the invention takes pin device that minor diameter can be used manufacture, Diameter is small, and framework size is small, compresses assembling, product allocation adaptability, flexibility, be unfolded the supportive of after-poppet all compared with The bracket of existing tubing cutting is excellent;4th, take bolt bracket to be structure as a whole with push seal wire, connectionless structure, product machinery The product structure of connection (welding, bonding etc.) is strong after performance is relatively assembled, and entrance or recession compliance are good, product structure intensity compared with It is good;5th, the outer diameter of matched conduit can be accordingly reduced, the damage to blood vessel, product passability, better adaptability are reduced.
2, good during encephalic of the present invention takes the unique structure design of pin device to can guarantee the entrance of bracket and withdraw Good compliance reduces the damage to vascular wall and peripheral vessels, but can guarantee the good supportive of bracket upon discharge with Enhance the removal effect to thrombus.
Detailed description of the invention
Fig. 1 is the overall structure diagram that encephalic of the invention takes pin device, wherein described take bolt bracket for self-expanding shape State.
Fig. 2 is the overall structure diagram that encephalic of the invention takes pin device, wherein described take bolt bracket for compressive state.
Fig. 3 is the partially expanded configuration schematic diagram for taking bolt bracket that encephalic of the invention takes pin device.
Fig. 4 be encephalic of the invention take pin device take bolt bracket and the structural schematic diagram with matched microtubular.
Fig. 5 takes bolt stent deployment to the structural schematic diagram of thrombus position (compressive state) for of the invention.
Fig. 6 takes bolt stent deployment to the structural schematic diagram of thrombus position (release expansion state) for of the invention.
Fig. 7 is the schematic diagram for taking bolt bracket to remove loosening thrombus of the invention.
Fig. 8 is the structural schematic diagram of the distal end for taking bolt bracket of the invention.
Fig. 9 is the structural schematic diagram of one embodiment for taking bolt bracket of the invention.
Figure 10 a and Figure 10 b are the structural schematic diagram of the changeover portion of push wire distal part of the invention.
Figure 11 is the structural schematic diagram of another embodiment for taking bolt bracket of the invention.
Figure 12 a and 12b are the structural schematic diagram for taking setting holding tank on bolt bracket of the invention.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, below in conjunction with attached drawing and specific implementation Example, the present invention is described in detail.It should be appreciated that specific embodiment described herein is used only for explaining the present invention, and It is not used in the restriction present invention.
In order to clearly describe the structure that encephalic provided by the invention takes pin device, herein limit term " distal end " and " proximal end ", above-mentioned term are the common terminology in interventional medical device field.Specifically, " proximal end " indicates close in surgical procedure One end of operator, " distal end " indicate one end in surgical procedure far from operator.
The present invention is described in further details below in conjunction with attached drawing and multiple specific embodiments.
The present invention relates to the devices for restoring regional flow to occluded blood vessel.Vascular site is by embolic occlusion.Apparatus of the present invention It can be positioned at vascular site 2 with microtubular 1 and optional guiding catheter.The device of the invention is wholly recyclable device, It, can be to avoid the lifelong anticoagulant therapy of patient without Permanent implantation.
As shown in Figures 1 to 4, encephalic of the invention takes pin device that can restore the blood flow in cerebral artery by embolic occlusion, Bolt bracket 3 is taken comprising push seal wire 9 and self-expanding, the push seal wire 9 and described bolt bracket 3 is taken to be remembered by a shape Recall alloy wire to be made, the push seal wire 9 is the proximal part of the shape-memory alloy wire, described that bolt bracket 3 is taken to be set In the distal end of the push seal wire 9, it is cut by laser by the distal portions of the shape-memory alloy wire.The present apparatus Take bolt bracket 3 can precommpression, self expandable, recyclable, as shown in figure 4, taking spigot 6 comprising distal end 4, proximal end 5 and centre, can make It is pushed with the push seal wire 9 for being integrated with structure into cerebral artery, as figure 12 a shows, the distal portions of the push seal wire 9 The distal portions 10 of 10 transition integrated with the proximal end 5 of bolt bracket 3 is taken, the push seal wire 9 have proximally to far end party To the gradually smaller pyramidal structure of diameter, spring ring 12 is provided in the pyramidal structure, described takes bolt bracket 3 using vertical To closure or the tubulose or branch portion that open, and it is treated as having the hollow three-dimensional of shape-memory properties netted by thermal finalization Structure, the proximal part of the hollow three-dimensional reticular structure are vertebra shape, one embodiment of the hollow three-dimensional reticular structure Expanded view is as shown in Figure 3.It is in further embodiments, described that take bolt bracket 3 that can also be cut into commonly used in the prior art Structure, details are not described herein.It is described to take bolt bracket 3 in the state of non-stress for self-expanding state, as shown in Figure 1, when described It is compressive state when bolt bracket 3 being taken to be placed in microtubular, as shown in Figure 2.
Above-mentioned encephalic takes pin device to be manufactured using following steps:
1) prepare shape-memory alloy wire of the diameter between 0.1~3.0mm;
2) mode being cut by laser carves the distal portions of the shape-memory alloy wire, obtains an end seal The space network closed;
3) space network is shaped to hollow three-dimensional reticular structure, the hollow three-dimensional using heat treatment process The proximal part of reticular structure is vertebra shape.
Laser cutting means have become the common processing method of medical instruments field at present, due to the laser of different model The equipment difference of cutting machine, specific cutting parameter can be also slightly different, the type of laser of the laser cutting machine that our company uses for Femtosecond laser, laser energy 1000mW-16000mW, laser pulse frequency 100-500KHZ, those skilled in the art can Parameter by adjusting laser cutting machine realizes that the encephalic takes pin device, it can according to the depth and width of cutting come Adjust the intensity of laser.Therefore specific parameters of laser cutting and detailed processing method, those skilled in the art can be according to existing There is technology to be selected, the present invention repeats no more.
As shown in figure 5, in operation, encephalic of the invention takes pin device to be radially compressed in the inner cavity of microtubular 1 In, by encephalic take pin device can self-expanding take the bolt bracket 3 to be placed on the remote of the microtubular 1 in the form of compressive state 8 The device is transported to the target site in blood vessel by microtubular 1 by end part, and then operation push seal wire 9 will take bolt bracket 3 It is located at the blood vessel by embolic occlusion, its distal end 4 is made to be arranged in the distal side of thrombus, proximal end 5 is arranged in the proximal end of thrombus Side makes to take all covering thrombus 15 of spigot 6 among it.Taking bolt bracket 3 to push by manipulation, seal wire 9 is static to be located in target position It sets, so that it is expanded expansion outside the distal end of the microtubular 1 and withdrawing microtubular 1, revert back to self-expanding from compressive state 8 The hollow three-dimensional reticular structure of state 8 ' (as shown in Figure 6).It takes the centre of bolt bracket 3 that spigot 6 is taken to contact and penetrates thrombus 15, it is right The radial force that thrombus applies reduces cross-sectional area of the thrombus 15 at occluded blood vessel 2, and rebuilds the blood flow across thrombus 15 immediately 16。
In a preferred embodiment, restoring the blood flow 16 in occluded blood vessel 2 includes placement microtubular 1, so that The distal end 17 of microtubular 1 is more than 3~10mm of distal end of thrombus 15.Bolt bracket 3 is taken, in compressive state 8, to lead when micro- in microtubular 1 After pipe 1 is transported to target position, takes bolt bracket 3 to be pushed seal wire 9 and be pushed to distal end more than thrombus 15 and without departing from micro- The distal end 17 of conduit 1.For the ease of positioning, the both ends for taking bolt bracket 3 are provided with Marking ring, in the distal end of microtubular 1 17 setting flags 19.The distal end 17 of the radiopaque Marking ring 18 being arranged on the distal end 4 for taking bolt bracket 3 and microtubular 1 is arranged Radiopaque label 19 be aligned, typical imaging method be X-ray examination inspection or contrast agent injection.As shown in fig. 6, then passing through It keeps push seal wire 9 motionless, while microtubular 1 proximally being withdrawn from, the self-expanding at thrombus 15 of bolt bracket 3 is taken to be unfolded, until Bolt bracket 3 is taken to restore preset shape.So that the clinician that is identified as taking that bolt bracket 3 discharges completely sees and is taking bolt bracket 3 The radiopaque Marking ring 20 that is arranged of proximal end 5 and the distal end 17 of microtubular 1 on the radiopaque label 19 that is arranged be aligned or position In the distal end of label 19.When take bolt bracket 3 expand when, can recover immediately across thrombus 15 blood flow and can by injection contrast agent Visual confirmation.
Encephalic of the present invention takes pin device that can be removed thrombus operation after the appearance of following any situation: taking After bolt bracket 3 expands a period of time, it can be about 0 minute~120 minutes;Have already passed through maximum flowing time amount;It observes The blood flow for flowing through thrombus 15 stops, no matter it is above which kind of can be carried out removing thrombus first and operate.Known in medical domain The case where be to remove the thrombus of apoplexy in time or embolus is key factor that patient can survive.The difference of following discloses Illustrative embodiments, the encephalic blood of description takes pin device to may include transportation system part, so that expandable take bolt bracket 3 On position required for capable of being selectively deployed to, to allow to remove or recycle thrombus or embolus.
It further includes transportation system that the encephalic, which takes pin device, and the transportation system includes the tube body of an elongated hollow, with And the handle being fixedly connected with the proximal end of the tube body, the push seal wire 9 and described bolt bracket 3 is taken to be arranged on the tube body Lumen in, it is described push seal wire 9 proximal end be fixedly connected with the handle.
Embodiment 1
In this exemplary embodiment, it discloses the encephalic for removing Intracranial thrombus or embolus and takes pin device and its system Method is made, to provide the ability for the blood flow for repairing Acute Ischemic Stroke Patients.
As shown in figure 4, it is the distal portions of simple solid memory alloy wire that encephalic of the present invention, which takes the bolt bracket 3 that takes of pin device, Through being cut by laser, surface structure is tubbiness or tubular structure closed at one end, and expanded form is knot shown in Fig. 3 Structure, the method for using laser processing is manufactured to be arranged at the duplicate diamond-shaped element of filament or pillar-shaped, takes the proximal end of bolt bracket 3 5 seamlessly transit with the distal portions of the simple solid memory alloy wire, form integrated junction 7, take the proximal end of bolt bracket 3 Part is taper, which, which is conducive to lead, drags the distal portions 6 for taking bolt bracket 3 of recycling insertion embolus and withdraw microtubular 1. The distal end 4 for taking bolt bracket 3 is open cylindrical structure shown in Fig. 8, and the distal end 4 for taking bolt bracket 3 has multiple free ends Portion 20.As shown in figure 8, the free end 20, which has, is horizontally arranged at its internal radiopaque marker 23, it is more The distal face 24 of a free end 20 is concordant.The marker 23 can be the substances such as platinum or platinumiridio, can lead to It crosses known laser welding technology or machinery pressure holds and connect it with free end 20, in order to position.
As shown in figure 9, hollow three-dimensional reticular structure 21 is formed by 22 repeated arrangement of structural unit of multiple diamond shapes, the knot Structure unit 22 is made of the filament or pillar 23 interconnected.Duplicate number can be structural unit 22 in a circumferential direction, but It is not limited to, 2 to 12, may be, but not limited to, in axially upper duplicate number, 1 to 30.It will be appreciated that Circumference or the duplicate number of axial direction can be selected according to practical situations, function or other considerations.
In one embodiment, during the cross-sectional diameter of the distal end 4 of hollow three-dimensional reticular structure 21 can be equal to or more than The cross-sectional diameter at empty 21 middle part of space network.The end diameter of biggish distal end 4 can contribute to capture blood vessel embolism Object, the hollow three-dimensional reticular structure 21 may be configured so that arterial blood tube wall because a possibility that contact leads to damage is minimum Change.Preferably, the filament of hollow three-dimensional reticular structure 21 or pillar 23 are smooth or taper, to reduce when encephalic takes bolt A possibility that tearing blood vessel when bolt bracket 3 being taken to move in the blood vessel of device.
Described takes bolt bracket 3 to take spigot 6 and distal end 4 comprising proximal end 5, centre, can be accommodated in such as microtubular Conveying device in, when it is released from conveying device can self-expanding expansion, to be deployed to thrombus or embolism Object location.This takes bolt bracket 3 to can be compressed to minimum volume (or diameter dimension), so that it can be smoothly arranged in for example In the conveying device of microtubular.
In the present embodiment, the size of structural unit 22 is uniform, hollow three-dimensional netted 21 entirely taking in bolt bracket 3 When being laser machined, the size of structural unit 22 is identical.
As shown in fig. lob, in the present embodiment, the distal portions 10 of push seal wire 9 have from both ends to mid diameter gradually The outside of reduced dumbbell-shaped structure, the push seal wire 9 at minor diameter is provided with platinum taenidium 27, the platinum taenidium 27 with push away The distal portions 10 of seal wire 9 are sent to connect using the mode of laser welding.Dumbbell-shaped structure can to push seal wire 9 and take bolt branch The transition of frame 3 is more soft, makes its compliance more preferably will pass through narrow or wide-angle blood vessel, radiopaque platinum taenidium It can provide the proximally-located for taking bolt bracket 3, and can effectively reinforce pushing the push performance of the distal portions 10 of seal wire 9.
It can be used for the encephalic to take the suitable material of pin device including the alloy with shape memory characteristic, preferably For Nitinol, especially there is hyperelastic Ultimum Ti silk.By the semi-finished product after laser processing, pass through electrochemistry The processing method of polishing, to eliminate burr and other irregularities, so that smooth surface is obtained, smooth edge and preset ruler It is very little.By semi-finished product pre-expansion at preset shape, the commonly used material at a temperature of carry out tempering, thus permanent Form preset shape and structure.
Embodiment 2
In the present embodiment, the size, shape of structural unit 22 as described above can change.As shown in figure 11, it is located at The vestibule of the structural unit 22 of the proximal part for taking bolt bracket can be greater than the structure that centre takes 4 parts of spigot 6 and distal end The vestibule of unit 22.The biggish hole chamber size of structural unit 22 and structure of conical section, thicker filament or pillar, so as to When introducing by distal portions 3 and arranging in place, the seal wire thrust or drawing that will preferably apply from integrated junction 7 Power is transmitted to centre and takes spigot 6 and distal end 4.In 5 part of tapered proximal end, it is not usually required to the support and tube wall covering of tube wall, but On the other hand such as tensile strength and push-and-pull intensity requirement are increased.Take the filament of the structural unit 22 of 3 distal portions of bolt bracket thick Degree size is 0.01~0.1mm, and the filament thickness of the structural unit 11 of the conical section of proximal end is typically larger than 0.05mm。
Embodiment 3
In the present embodiment, composition encephalic takes the filament of the hollow three-dimensional reticular structure 21 of pin device or the surface of pillar 23 Anticoagulant and/or anti-platelet agents coating can be coated, also can be used alone or the combination of several drugs.Anticoagulant To prevent blood clotting from being formed, anti-platelet agents and preventing platelet aggregation to prevent blood clotting from being formed.
Coating can control rate of release, so that a certain amount of, such as 50% drug can be defeated within about 2 hours time It send to thrombus or embolus.This controlled conveying can by it is following it is one or more of in the form of realize.Can by drug with The mixture of polymer is coated on the surface of hollow three-dimensional reticular structure 21;As shown in figures 12 a and 12b, it can be in pillar 23 Surface by laser processing, continuous groove is made in electrochemical polish, the forms such as machining, or interrupted recessed one by one Slot, as holding tank 28,28 ' to accommodate above-mentioned anticoagulant and/or anti-platelet agents.
In scheme described above, polymer is bio-compatible and biodegradable.The polymerization that the coating uses Object, medicament be all it is known in the art generally using and be proved to be safe and effective.The coating can be with known in this field Method such as impregnate, be sprayed, coat and brush to implement.
Finally it should be noted that the foregoing is merely preferred embodiments of the invention, not to limit this Invention, any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in this hair Within bright protection scope.

Claims (15)

1. a kind of encephalic takes pin device, it is characterised in that: it includes push seal wire and a self-expanding that the encephalic, which takes pin device, Take bolt bracket, the push seal wire and it is described take bolt bracket to be made of a shape-memory alloy wire, the push seal wire is institute State the proximal part of shape-memory alloy wire, the distal end for taking bolt bracket to be arranged on the push seal wire, by the shape The distal portions of memory alloy wire are cut by laser.
2. a kind of encephalic according to claim 1 takes pin device, it is characterised in that: it is described push seal wire distal portions be The proximally distally gradually smaller vertebra shape structure of diameter.
3. a kind of encephalic according to claim 2 takes pin device, it is characterised in that: be provided with bullet in the vertebra shape structure Spring coil.
4. a kind of encephalic according to claim 1 takes pin device, it is characterised in that: the distal portions tool of the push seal wire There is the dumbbell-shaped structure being gradually reduced from both ends to mid diameter.
5. a kind of encephalic according to claim 1 takes pin device, it is characterised in that: described that bolt bracket is taken to be handled by thermal finalization As the hollow three-dimensional reticular structure with shape-memory properties, the proximal part of the hollow three-dimensional reticular structure is vertebra shape.
6. a kind of encephalic according to claim 5 takes pin device, it is characterised in that: the distal end for taking bolt bracket is open Or closing.
7. a kind of encephalic according to claim 5 takes pin device, it is characterised in that: be coated with painting on bolt bracket in described take Layer.
8. a kind of encephalic according to claim 7 takes pin device, it is characterised in that: the coating is anticoagulant or anti-blood Platelet drug or the coating are the biodegradable bio-compatible polymerization for being loaded with anticoagulant or antiplatelet drug Object.
9. a kind of encephalic according to claim 5 takes pin device, it is characterised in that: be provided on bolt bracket in described taking Holding tank.
10. a kind of encephalic according to claim 1 takes pin device, it is characterised in that: shape-memory alloy wire is NiTi note Recall alloy wire.
11. a kind of encephalic according to claim 1 takes pin device, it is characterised in that: the encephalic takes the pin device to further include Transportation system, the transportation system include the tube body of an elongated hollow, and the hand being fixedly connected with the proximal end of the tube body Handle, in the push seal wire and the lumen for taking bolt bracket to be arranged on the tube body, the proximal end of the push seal wire and institute Handle is stated to be fixedly connected.
12. a kind of encephalic as described in any one of claims 1 to 11 takes the manufacturing method of pin device, include the following steps:
1) prepare shape-memory alloy wire of the diameter between 0.1~3.0mm;
2) mode being cut by laser carves the distal portions of the shape-memory alloy wire, obtains closed at one end Space network;
3) space network is shaped to hollow three-dimensional reticular structure using heat treatment process, the hollow three-dimensional is netted The proximal part of structure is vertebra shape.
13. a kind of encephalic according to claim 12 takes the manufacturing method of pin device, it is characterised in that: the hollow three-dimensional Reticular structure is formed by the structural unit repeated arrangement of multiple diamond shapes, and the structural unit is the filament or pillar group by interconnecting At.
14. the manufacturing method that a kind of encephalic according to claim 12 takes pin device, it is characterised in that: the push seal wire Distal portions be cut into proximally the gradually smaller vertebra shape of distally diameter, be provided in the vertebra shape structure Spring ring.
15. the manufacturing method that a kind of encephalic according to claim 12 takes pin device, it is characterised in that: push the remote of seal wire End part has the dumbbell-shaped structure being gradually reduced from both ends to mid diameter, and platinum spiral is provided in the dumbbell-shaped structure Silk.
CN201810970867.8A 2018-08-24 2018-08-24 A kind of encephalic takes pin device and its manufacturing method Pending CN109303587A (en)

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