CN105662532A - Blood-vessel embolectomy device with semi-closed structure and thrombus treating apparatus with the same - Google Patents

Abstract

The invention relates to a blood-vessel embolectomy device with a semi-closed structure and a thrombus treating apparatus with the same. The blood-vessel embolectomy device comprises an embolectomy device body, a developing loop located at the near end of the embolectomy device body and developing rings located at the far end of the embolectomy device body. The embolectomy device body is of a web-tubular or cage-shaped structure composed of a plurality of connected unit grids; the near end of the embolectomy device body is of the closed conical structure; a longitudinal gap is formed in the side face of the far end of the embolectomy device body. The thrombus treating apparatus comprises the blood-vessel embolectomy device with the semi-closed structure, a protecting sheath tube, a conveying wire, a micro guide tube, a guiding guide tube and a rotating bleeding stopping valve. The micro guide tube is pushed to a thrombus embolism in the guiding guide tube along the guiding guide tube, the protecting sheath tube is communicated with the micro guide tube through the rotating bleeding stopping valve, and the embolectomy device body is placed in the protecting sheath tube, pushed into the micro guide tube through the conveying wire and pushed to the thrombus embolism. According to the blood-vessel embolectomy device with the semi-closed structure and the thrombus treating apparatus, flexibility is good, the embolectomy device body can pass through the bent blood vessel or reach the blood vessel with the thin far end, and harm to the blood vessel wall is small.

Description

A kind of taking thrombus device with semi-closed structure and thrombus treating apparatus thereof

Technical field

The present invention relates to a kind of taking thrombus device with semi-closed structure and thrombus treating apparatus thereof, specifically, particularly to a kind of medical apparatus and instruments getting involved blood vessel, for when acute ischemic stroke occurs, eliminating mechanically and be blocked in endovascular thrombosis to reach the Therapeutic Method of instant recovery blood flow, what be particularly suited for intracranial vessel takes bolt.

Background technology

Cerebral infarction is once occur, it is necessary within the shortest time, (effective time window) makes revascularization. At present, the Therapeutic Method of Intracranial thrombus mainly has two kinds: medicine thrombolytic and machinery take bolt.

Medicine thrombolytic is with thrombus by intravenous injection rt-PA (tissue-type plasminogen activator) or urokinase, it is possible to by intra-arterial contact thrombolysis, antiplatelet aggregation and anticoagulant treatment etc. Although thromboembolism treatment has been shown to improve preferably neurological outcome, but, according to US National sacred disease and apoplexy institute (TheNationalInstituteNeurologicalDisordersandStrokert-PAS trokeStudyGroup, NINDS) research is thought, intravenous thrombolysis should carry out within falling ill 3 hours, Arterial thrombolysis time window should within 6 hours, and the patient that so short thrombolytic time window causes only 4.5%-6.3% can accept thromboembolism treatment; Secondly, thromboembolism treatment is suitable only for the thrombosis of small volume, and the therapeutic effect of large volume thromboembolism is unsatisfactory; And, thrombolytic drug is had anaphylaxis by some patients, is not suitable for thromboembolism treatment.

In order to solve the problem of said medicine thrombolytic, for exceeding thrombolytic time window and not tolerating the patient of thromboembolism treatment, adopt machinery to take bolt and remove the thrombosis of blocking. In the prior art, it has been disclosed that machinery as described below takes pin device:

In the patent of invention that the patent No. is CN104000635A " take bolt device and take pin device " that China announces, have and multiple stretch into the cancellated intraluminal interior female rod with three-D profile, tube chamber is fixed at its two ends, in removal process after catching thrombosis, it is possible to by interior female rod fix blood bolt.

The patent of invention " for removing the device of thrombosis from blood vessel " that the patent No. disclosed in China is CN101340849A, by a caged or tubular structure, one distal member with the fiber extended radially out is taken in wherein, and safely eliminate thrombosis from Ink vessel transfusing under the help of fiber.

In the patent of invention " Intravascular Thrombus and embolus resectoscope " that the patent No. disclosed in China is CN101396295A; there is the thrombectomy device of a thrombectomby spring and the basket in contraction or release conditions; basket is positioned at the far-end of thrombectomy device; arrest thrombosis by the winding of thrombectomby spring, and take out to protect the far-end of blood vessel with basket together with thrombosis fragment by taking the clot of generation in bolt process.

In the patent of invention that the patent No. is CN102316809A " endovascular thrombosis grabber " that China announces, having the line main body haunted freely and be located at the thrombosis capture portion of its front end, the motion of the elastica circle body by being erected between fixed part and movable part removes, to catch, the thrombosis being attached to blood vessel wall.

In the patent of invention " device for removal of thromboses " that the patent No. disclosed in China is CN101035474A, there is the guide wire that a far-end is equipped with the fiber component of an orthohormbic structure, from body cavity and blood vessel, take out foreign body and thrombosis by the motion before and after it.

In the patent of invention that the patent No. is CN102014772A " method and apparatus for restoration of blood flow " that China announces, have a self expandable taper overlay structure by the cancellated parts of interconnective line or filament or pillar, by microtubular with push after wire is introduced into inaccessible blood vessel self expandable to recover blood flow.

In the patent of invention " for treating the system and method for cerebral infarction " that the patent No. disclosed in China is CN101027004A, there is guiding and occlusion catheter, conveying and draw catheter, lift suction pump, thromboembolic receiver and thromboembolic separator, lift suction pump passes through draw catheter by Biochemical analyzer to thromboembolic receiver, thus withdrawing from external.

In the utility model that the patent No. is ZL200620164685.4 " taking bolt device " of China's bulletin, there is the umbrella of the three-jaw short by two length one of elastic memory function, with periphery have net formed a circular configuration take pin device, by drawing push-pull bar to make three-jaw close up outward, thrombosis pocket is recovered in trocar sheath in umbrella portion, thrombosis is taken out.

In the patent of invention that the patent No. is US7931659B2 " SystemandMethodforTreatingIschemicStroke " of U.S. Publication, there is a receptor being surrounded into hollow tubular by many filaments being fixed on an elongated extension tube end, by extension tube, receptor is placed in blood vessel embolism position, and thrombosis taken in the intracavity of receptor hollow and takes out external.

In the patent of invention that the patent No. is US2006/0047286A1 " ClotRetrieverDevice " of U.S. Publication, there is one and be fixed on the expansible of pusher end and the recovery basket shunk, it has a tinsel that can pass through to be fixed on basket end control the uncovered in order to be caught in basket by thrombosis of opening and closing.

In the patent of invention that the patent No. is US2002/0049452A1 " ClotRetrieverDevice " of U.S. Publication, have one or more be fixed on slender conduit can in compression element movable have a shape memory take latch, after being transported to thromboembolism position by slender conduit, take in latch is flared out thrombosis is caught and is wrapped in.

In the patent of invention that the patent No. is US2009/0240238A1 " ClotRetrievalMechanism " of U.S. Publication, have one be fixed on a slender axles end can the snare of self-expanding and an attached to it folding sack being made up of flexible non-porous material, by slender axles, device is placed in thromboembolism position along internal passage, opens sack by thrombosis bag in the inner.

Various machineries described above take pin device, all there is open defect: when thrombosis cannot be looked at straight, the catching device of basket or web form tends not to entangle blood clot and causes taking bolt failure, and its volume is often excessive, cannot use in the cerebral arterieies such as thinner middle cerebral artery M1, M2 section of blood vessel diameter, when catching recovery after thrombosis, thrombosis is fixed insecure, it is easy to come off; Although although the pin device that takes having solves the problem of thrombus breaks loose, but its structure is complicated, the interior female rod structure for fixing thrombosis of increase makes the compliance taking pin device overall greatly reduce, so as to tortuous intracranial vessel can not be passed through.

On the other hand, although it is safe that the mode of existing negative pressure absorbing takes bolt, but only that relatively soft thromboembolism is effective by drawing removal; In order to strengthen drawing effect, adopt rotating blade or resectoscope fragmentation thrombosis, although this rotating blade feature improves the effect of this aspiration technique, but considerably increased the risk that blood vessel wall is caused damage; Although laser and ultrasound wave are cleaning and the effective energy, but such as misoperation, very easily peripheral vessels are caused damage, and energy is too low then invalid, too high then injured blood vessel, therefore it is difficult to determine that giving how high-octane laser intensity can be only achieved optimum curative effect.

Accordingly, it would be desirable to prior art is further improved, it is desirable to the intracranial vessel designing a kind of improvement takes bolt device, one, and volume should be sufficiently small, compliance should be enough good, so that device can enter the distal vessels that intracranial is thinner; Its two, capture rate is high, and thrombosis is grip good, fixation in taking bolt removal process, difficult drop-off; Its three, radially support force is little, and blood vessel wall and Peripheral Vascular Injuries is little.

Summary of the invention

The technical problem to be solved is in that, a kind of taking thrombus device with semi-closed structure and thrombus treating apparatus thereof are provided, take bolt device and be provided with half-open semi-enclosed structure, not only there is good pulling property but also there is overall compliance better, take during bolt the chucking power of thrombosis is sufficiently large, take thrombosis in bolt process and do not slip; Compliance is good, takes bolt device and can pass through curved blood vessel or arrive the blood vessel that far-end is thinner; Radially support force is little, takes in bolt process and causes damage to be preferably minimized blood vessel wall and peripheral vessels.

The present invention is realized in, a kind of taking thrombus device with semi-closed structure is provided, can be used for intracranial, cervical region, including taking bolt device, it is positioned at the developing ring taking bolt device near-end and is positioned at the development circle taking bolt device far-end, described take webmaster shape or the cage structure that bolt device includes being made up of multiple unit grids being coupled to each other, each described unit grid by interconnective muscle around forming, this webmaster shape or cage structure can be collapsed folding under pressure and have self-expanding recovery capability in a free state, and, this webmaster shape or collapsing of cage structure fold and expand and can mutually change without difficulty, the proximal end taking bolt device described under self-expanding state is arranged to pyramidal structure, its proximate expand gradually, the described near-end pyramidal structure taking bolt device is to close, and is provided with axial clearance on the side of its far-end. this device can be used for human vas, and other adapts to position.

Further, described in take bolt device there is oblong shape or oblong shape under self-expanding state, its length range is between 5 millimeters to 60 millimeters, and its diameter range is between 2 millimeters to 6 millimeters.

Further, the ratio of the length of described unit grid and height is more than 1 and less than 2.

Further, the surface-coated taking bolt device described in has the coating containing anticoagulant or antiplatelet drug.

Further, described developing ring and development circle all by can be visual under X ray material make.

Further, described developing ring and development circle are connected with taking bolt device by modes such as welding or crimp or be cementing.

Further, take bolt device described in be made up of shape-memory material.

The invention also discloses a kind of thrombus treating apparatus; employ the aforesaid taking thrombus device with semi-closed structure; this therapeutic instrument also includes protection sheath pipe, conveying silk, microtubular, guiding catheter and rotates haemostatic valve; the external diameter of described microtubular is less than the internal diameter of guiding catheter; described microtubular is pushed to blood embolization place along guiding catheter in guiding catheter; described protection sheath pipe is interconnected with microtubular by rotating haemostatic valve; the described bolt device that takes is placed in protection sheath pipe; it is pushed in microtubular by described conveying silk, and is pushed to blood embolization place.

Further, described conveying silk is made up of the soft tinsel with certain rigidity.

Further, described protection sheath pipe is made up of polymeric material.

Compared with prior art, taking thrombus device with semi-closed structure and the thrombus treating apparatus thereof of the present invention provide the benefit that: by taking the pyramidal structure of bolt device near-end closing and the design with axial clearance that far-end is open, make to take the advantage that bolt device has opening and sealing concurrently simultaneously, maintain the advantage that open cell grid compliance is good, add simultaneously and close the feature that tapered portion propelling movement property is good. Meanwhile, far-end semi-open, semi-enclosed can limitedly fold, and makes thrombosis be less susceptible to come off. On the other hand, structurally do not increase extra parts, just can reach this purpose only by changing shape, it is easy to processing.

Accompanying drawing explanation

Fig. 1 is the structural representation of the thrombus treating apparatus of the blood vessel with semi-closed structure of the present invention;

The bolt device that takes that Fig. 2 is in Fig. 1 is accommodated in the viewgraph of cross-section protected in sheath pipe;

Fig. 3 is the schematic perspective view taking bolt device of the present invention;

Fig. 4 is the expansion schematic diagram taking bolt device first embodiment of Fig. 3;

Fig. 5 be Fig. 4 take the schematic perspective view that bolt device is under free state;

Fig. 6 is the expansion schematic diagram taking bolt device the second embodiment of Fig. 3;

Fig. 7 be Fig. 6 take the schematic perspective view that bolt device is under free state;

Fig. 8 is the size relationship schematic diagram of the unit grid of Fig. 4.

Detailed description of the invention

In order to make the technical problem to be solved, technical scheme and beneficial effect clearly understand, below in conjunction with drawings and Examples, the present invention is further elaborated. Should be appreciated that specific embodiment described herein is only in order to explain the present invention, is not intended to limit the present invention.

In the terms of the present invention, " far-end " and " near-end " is appreciated that and observes from the direction of the doctor in charge. Far-end is remote from the side of the doctor in charge, and it relates to the parts of the apparatus of the present invention being advanced in vascular system further, and near-end represents towards the doctor in charge, i.e. it is not far that the nearside arrangement component of this device is introduced in blood vessel.

In the present invention, if phrase " longitudinal direction " is with in this document, it is to be understood as the direction representing that apparatus of the present invention are pushed into, and the longitudinal axis of this device also overlaps along the longitudinal axis of its blood vessel moved forward with this device.It is defined as axially with longitudinally perpendicular direction.

Shown in Fig. 1 and Fig. 3, a kind of taking thrombus device with semi-closed structure of the present invention, including taking bolt device 100, being positioned at the developing ring 300 taking bolt device 100 near-end and be positioned at the development circle 200 taking bolt device 100 far-end. Take webmaster shape or cage structure that bolt device 100 includes being made up of multiple unit grids 170 being coupled to each other, each unit grid 170 by interconnective muscle 120 around forming. This webmaster shape or cage structure can be collapsed folding under pressure and have self-expanding recovery capability in a free state, and, this webmaster shape or collapsing of cage structure fold and expand and can mutually change without difficulty.

The proximal end taking bolt device 100 described under self-expanding state is arranged to pyramidal structure 130, its proximate expand gradually. In the present invention, the tapering of pyramidal structure 130 is 30 ° to 60 °. The near-end pyramidal structure 130 taking bolt device 100 is to close, and is provided with axial clearance 160 on the side of its far-end. Open be interpreted as unit grid 170 be interconnected to do not close, there are webmaster shape or the cage structure of open axial clearance 160 in its side, this axial clearance 160 has at least a place, it is possible to design has many places. The axial clearance 160 embodiment design of the present invention is a place, as shown in figure 5 and figure 7. Utilizing this structure, the pyramidal structure 130 taking bolt device 100 closing can fold easily, and when taking bolt device 100 and moving, can play good supporting role; Open unit grid 170 can make to take bolt device 100 entirety and become submissiveer, tortuous blood vessel can be easily passed through, and open far-end can fold more by a small margin, strengthen and take the bolt device 100 grasping ability to thrombosis, make thrombosis be less susceptible to come off, effectively prevent thrombus breaks loose from flowing to the blood vessel that far-end is more tiny.

The open architecture of the axial clearance 160 taking bolt device 100 has numerous embodiments, The present invention gives following several embodiment:

Embodiment one, as shown in Figures 3 to 5: the pyramidal structure 130 taking bolt device 100 is to close, and remainder is wide-open, and axial clearance 160 is the longest. With this structure, the pyramidal structure 130 of closing can keep good pulling property, makes to take bolt device 100 and can draw in microtubular easily, also can for taking the bolt device 100 support advancing offer good in microtubular. Open unit grid 170 makes to take bolt device 100 entirety and becomes submissiveer, can be easier to by tortuous blood vessel, and can slightly fold at far-end, make thrombosis be less susceptible to come off.

Embodiment two, as shown in Fig. 6 and Fig. 7: it is one semi-open, one semiclosed for taking the unit grid 170 of bolt device 100, and the length of axial clearance 160 occupies about the half of bolt device 100. So can so that take the advantage that bolt device 100 has opening and sealing concurrently simultaneously, the advantage that open cell grid 170 easily folds can be had, also can have the advantage that closed cell lattice 170 propelling movement property is good, further, the quantity (being equivalent to adjust the length of axial clearance 160) of the unit grid 170 closed by adjustment regulates the overall compliance taking bolt device and propelling movement property.

The near-end taking bolt device 100 is arranged to pyramidal structure 130, proximate expand gradually, and its tapering is 30 ° to 60 °. The advantage of this design is can greatly to reduce propelling resistance when taking bolt device 100 and reclaiming into guiding catheter.

Taking bolt device 100 and have oblong shape or oblong shape under self-expanding state, its length range is between 5 millimeters to 60 millimeters, and its diameter range is between 2 millimeters to 6 millimeters, to adapt to the anatomical structure of patient's intracranial vessel.

Refer to shown in Fig. 8, the ratio of the length L1 of unit grid 170 and height H1, more than 1 and less than 2, is similar to diamond structure, and the advantage of this structure is easy to deformation, taking bolt device self-expanding expansion and retraction can be readily accomplished when subsiding folding.

The surface-coated taking bolt device 100 has the coating containing anticoagulant or antiplatelet drug, to strengthen the mobility of blood, it is simple to take pushing of bolt device.

Developing ring 300 and development circle 200 all by can be visual under X ray material make, it is preferable that for platinum, platinoiridita, platinum-tungsten alloys, gold, silver etc. The not transmission X-ray label of the type adds to be located at and takes bolt device 100 proximally and distally so that the doctor in charge can monitor by imaging device location relative to each other and therapeutic advance thus improve the accuracy taking bolt. Being connected to the label developing ring with not transmission X-ray taking bolt device two ends and development circle, making to take bolt device can operate visually under the support of digital subtraction angiography system, and makes to take bolt accurately and reliably. Doctor only advances and withdraws this device and just can complete to take bolt operation, with traditional take bolt operation compared with, operation process is greatly simplified, and has both alleviated the workload of doctor, get again the treatment time of preciousness for patient, strive for the more time for reversible ischemic tissue of brain.

Developing ring 300 and development circle 200 are connected with taking bolt device 100 by modes such as welding or crimp or be cementing. This connection should reach certain intensity, it is prevented that takes bolt device 100 and comes off in taking bolt process.

Take bolt device 100 to be made up of shape-memory material. The shape-memory material of indication of the present invention refer in particular to generation be NiTi evanohm. Taking bolt device 100 is adopt NiTi evanohm to make via cut.

Shown in Fig. 1 and Fig. 2; the invention also discloses a kind of thrombus treating apparatus; employ the above-mentioned taking thrombus device with semi-closed structure; this therapeutic instrument also includes protection sheath pipe 400, conveying silk 500, microtubular 600, guiding catheter (not shown) and rotates haemostatic valve (not shown), and the external diameter of microtubular 600 is less than the internal diameter of guiding catheter. Microtubular 600 is pushed to blood embolization place along guiding catheter in guiding catheter; protection sheath pipe 400 is interconnected with microtubular 600 by rotating haemostatic valve; take bolt device 100 and be placed in protection sheath pipe 400, conveying silk 500 be pushed in microtubular 600, and be pushed to blood embolization place. Guiding catheter has ratio for placing protection sheath pipe 400 and the bigger internal diameter of microtubular 600. So, whole thrombosis and be in the bolt device 100 that takes of its swelling state and can move and be placed in guiding catheter. During treating, microtubular 600 is also advanced to usually by guiding catheter, although guiding catheter can be pushed ahead until blood embolization position, but in the blood vessel that inner chamber is little especially, especially in intracranial area, only with the microtubular 600 that diameter is only small, take bolt device 100 and be placed in microtubular 600 and be transported to the enforcement of blood embolization position take bolt operation.

Conveying silk 500 is made up of the soft tinsel with certain rigidity. Should be appreciated that to expect purpose, the far-end of conveying silk 500; especially into intracranial vessel section, it is necessary to have enough rigidity, but simultaneously must be sufficiently flexible or flexible; make them can pass protection sheath pipe 400 or guiding catheter, and be damaged from blood vessel wall. Its length dimension should ensure that and will take pin device and be delivered to the position of thromboembolism.Protection sheath pipe 400 is made up of polymeric material. This polymeric material is politef. The internal diameter of protection sheath pipe 400 and length dimension should ensure that and the soft taking bolt device 100 and conveying silk 500 far-end is held protection wherein.

The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all any amendment, equivalent replacement and improvement etc. made within the spirit and principles in the present invention, should be included within protection scope of the present invention.

Claims (10)

1. the taking thrombus device with semi-closed structure, including taking bolt device (100), it is positioned at the developing ring (300) taking bolt device (100) near-end and is positioned at the development circle (200) taking bolt device (100) far-end, it is characterized in that, described take webmaster shape or the cage structure that bolt device (100) includes being made up of multiple unit grids (170) being coupled to each other, one or more described unit grids (170) and other adjacent cells grid (170) are formed by connecting, this webmaster shape or cage structure can be collapsed folding under pressure and have self-expanding recovery capability in a free state, and, this webmaster shape or collapsing of cage structure fold and expand and can mutually change, the proximal end taking bolt device (100) described under self-expanding state is arranged to pyramidal structure (130), its proximate expand gradually, the described near-end pyramidal structure (130) taking bolt device (100) is to close, and is provided with axial clearance (160) on the side of its far-end.

2. the taking thrombus device with semi-closed structure as claimed in claim 1, it is characterized in that, the described bolt device (100) that takes has oblong shape or oblong shape under self-expanding state, its length range is between 5 millimeters to 60 millimeters, and its diameter range is between 2 millimeters to 6 millimeters.

3. the taking thrombus device with semi-closed structure as claimed in claim 2, it is characterised in that the length (L1) of described unit grid (170) and the ratio of height (H1) are more than 1 and less than 2.

4. the taking thrombus device with semi-closed structure as claimed in claim 1, it is characterised in that described in take the surface-coated of bolt device (100) and have the coating containing anticoagulant or antiplatelet drug.

5. the taking thrombus device with semi-closed structure as claimed in claim 1, it is characterised in that described developing ring (300) and development enclose (200) all by can be visual under X ray material make.

6. the taking thrombus device with semi-closed structure as claimed in claim 5, it is characterised in that described developing ring (300) and development circle (200) are connected with taking bolt device (100) by modes such as welding or crimp or be cementing.

7. the taking thrombus device with semi-closed structure as claimed in claim 1, it is characterised in that described in take bolt device (100) and be made up of shape-memory material.

8. a thrombus treating apparatus, it is characterized in that, employ the taking thrombus device with semi-closed structure as described in any one in Claims 1-4, this therapeutic instrument also includes protection sheath pipe (400), conveying silk (500), microtubular (600), guiding catheter and rotation haemostatic valve, the external diameter of described microtubular (600) is less than the internal diameter of guiding catheter, described microtubular (600) is pushed to blood embolization place along guiding catheter in guiding catheter, described protection sheath pipe (400) is interconnected with microtubular (600) by rotating haemostatic valve, the described bolt device (100) that takes is placed in protection sheath pipe (400), it is pushed in microtubular (600) by described conveying silk (500), and it is pushed to blood embolization place.

9. thrombus treating apparatus as claimed in claim 8, it is characterised in that described conveying silk (500) is made up of the soft tinsel with certain rigidity.

10. thrombus treating apparatus as claimed in claim 8, it is characterised in that described protection sheath pipe (400) is made up of polymeric material.