CN109223107B - Bolt taking device - Google Patents
Bolt taking device Download PDFInfo
- Publication number
- CN109223107B CN109223107B CN201811331717.9A CN201811331717A CN109223107B CN 109223107 B CN109223107 B CN 109223107B CN 201811331717 A CN201811331717 A CN 201811331717A CN 109223107 B CN109223107 B CN 109223107B
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- bracket
- super elastic
- stent
- reticular
- thrombus
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- 208000007536 Thrombosis Diseases 0.000 claims abstract description 112
- 238000007493 shaping process Methods 0.000 claims description 35
- 230000002537 thrombolytic effect Effects 0.000 claims description 22
- 238000010438 heat treatment Methods 0.000 claims description 17
- 239000000463 material Substances 0.000 claims description 10
- 239000003146 anticoagulant agent Substances 0.000 claims description 9
- 238000009941 weaving Methods 0.000 claims description 9
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- 239000007769 metal material Substances 0.000 claims description 5
- 238000009998 heat setting Methods 0.000 claims description 4
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- 238000007917 intracranial administration Methods 0.000 description 5
- 206010008190 Cerebrovascular accident Diseases 0.000 description 4
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- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
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- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
Abstract
The invention provides a thrombus taking device, which comprises: the device comprises a thrombus taking bracket, a conveying system and a pushing handle. Compared with the prior art, the invention ensures that the reticular stent can be adjusted according to the diameter of the blood vessel at the lesion part by the movement of the mandrel in the outer tube, thereby improving the matching property of the thrombus taking stent and the lesion blood vessel; meanwhile, the grid gaps of the reticular stent are gradually reduced from the near end to the far end, and the grid design of the combination of the compactness and the compactness ensures that the stent can be quickly embedded into a blood vessel and simultaneously increases the combination and catching capability of the stent and thrombus; moreover, the density of the far-end stent grid is increased, so that the broken small thrombus emboli can be effectively prevented from falling off the stent, and the damage of the stent to the vessel wall when the stent passes through the vessel can be reduced; finally, the spring is arranged at the distal end of the bracket, so that the flexibility of the thrombus taking bracket is improved; finally, through the cooperation of the pushing handle shell and the pushing handle, the operability of the thrombus taking support is improved.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a thrombus taking device.
Background
For the treatment of ischemic cerebral apoplexy patients, the speed of clearing thrombus is a key index. If the rescue is not timely and the treatment is slow, the effect after the recovery is likely to be affected. However, the traditional chemical medicines have slower thrombolytic effect, and can not meet the treatment speed requirement of patients suffering from acute ischemic stroke, which is why many patients suffering from cerebral stroke are not dead or disabled.
The current methods for treating intracranial thrombosis mainly comprise two methods: thrombolysis and mechanical thrombolysis.
The thrombolytic medicine is injected near the lesion in the blood vessel where the lesion is located, and a very high thrombolytic medicine concentration is formed at the local part of the lesion instantly, so that the thrombolysis speed is accelerated, the chance of vascular recanalization is further increased, and the operation is monitored in real time through a unique developing technology. According to the clinical study results, venous thrombolysis should be performed within 3 hours of onset, and arterial thrombolysis time window is within 6 hours. Because the time window of the thrombolytic therapy is shorter, and the thrombolytic therapy is only applicable to thrombi with smaller volume, the therapeutic effect on the thromboembolism with large volume is not ideal, so that only 3 to 5 percent of patients are suitable for the thrombolytic therapy as the medicine.
Mechanical embolectomy is the removal of an embolus that has blocked a blood vessel from the body using an embolectomy. At present, domestic products are marketed by domestic companies, and the mechanical thrombus removing device market is mainly based on products of foreign companies such as Mei Dun Li, qiang Sheng and the like. According to investigation, 300 thousands of new cerebral thrombosis groups are increased in China every year, and the proportion of acute cerebral thrombosis to cerebral apoplexy is increased from 55.8% to 81.6%, so that the cerebral thrombosis is the first major disease of the brain. Vascular recanalization is critical in the treatment of acute ischemic stroke, and mechanical thrombolysis involves several methods: capturing and taking the thrombus, sucking and taking the thrombus, rotary cutting and taking the thrombus and the like. The capturing and thrombus taking effects are best when taking large thrombus, but the plaque on the vessel wall and broken thrombus block are easy to fall off and flow to a far-end vessel to cause new embolism, once important branch vessels are blocked, serious medical accidents can be caused, and the problems of incomplete thrombus taking and residual exist frequently when taking thrombus, so that secondary acute thrombus is easy to form. The effect of the suction plug is better when taking small emboli, and in order to prevent blockage when taking large thromboses, the suction tube needs to be repeatedly smashed to suck after the thromboses, the process is troublesome and the blood vessel is easily damaged. The damage to the vessel wall caused by rotary cut thrombus removal is large, and complications are easy to cause.
The plaque and broken thrombus on the wall of the blood vessel of the current thrombus removing device are easy to fall off in the thrombus removing process, and flow to the far-end blood vessel to cause new embolism. It has been reported that about 70% of vascular interventional thrombolysis procedures observe thrombotic debris and fragments flowing to the distal blood vessel, which increases the risk of reocclusion of the patient's blood vessel.
Chinese patent publication No. CN105476689a discloses a thrombus taking stent device, which comprises a thrombus taking stent, a conveying guide wire, a guiding guide wire and a marking ring, wherein the proximal thrombus taking stent and the distal protecting stent are in a net structure with two sealed ends; chinese patent publication No. CN104000635a discloses a thrombus removing device and a thrombus removing apparatus thereof, the thrombus removing apparatus includes a guide wire, a push rod, an outer sheath tube and an inner tube moving relative to the outer sheath tube; U.S. patent No. US9,510,855B also discloses a thrombus removal device for blood vessels that includes a skeleton which may be woven from shape memory alloy wires to capture thrombus. However, these thrombus removal devices must pass through the lesion with the cooperation of the microcatheter, and the diameter of the stent opening after release at the target vessel site cannot be adjusted, especially when passing through a local stenosis, the captured thrombus is easily detached due to weak fixation.
Chinese patent publication No. CN204337002U discloses a regulatable intracranial vessel thrombus taking device, which comprises an adjustable guide wire, a thrombus taking device and an outer fixing sheath, wherein one end of the thrombus taking device is fixedly connected with the outer fixing sheath through a fixer, and the other end of the thrombus taking device is fixedly connected with a head end development through the fixer. However, the thrombus taking stent is single braided, the blood vessel is easily scratched due to larger radial force, the far-end gap is larger, small thrombus is easily dropped off, the developing material coated on the surface of the stent is easily dropped off, and the contact area between the conical stent design and the blood vessel is limited.
The intracranial acute thrombus taking system accepted by European and American doctors at present is Solitaire FR system of EV3 company in the United states, which adopts a mode of capturing and taking thrombus by a cylindrical stent, the thrombus is sleeved after the instrument is released at a lesion position by a microcatheter, and then the instrument and the thrombus are taken into a guide catheter with larger inner diameter together and then withdrawn from the body. However, according to clinical manifestations, when the apparatus is used for thrombus extraction, as the capturing force of the distal stent for thrombus is weak due to the open design, the thrombus is very easy to fall off from the thrombus extractor in the recovery process, repeated capturing is needed, the pain of patients is increased, the operation time is prolonged, and the risk of the blockage of the distal blood vessel is increased,
disclosure of Invention
In view of the above, the technical problem to be solved by the invention is to provide a thrombus taking device which has good flexibility, adjustable diameter and stronger catching power.
The invention provides a thrombus taking device, which comprises:
a thrombus taking bracket, a conveying system and a pushing handle;
the thrombus taking support comprises a reticular support and a spring, wherein the grid gap at one end of the reticular support is smaller than the grid gap at the other end of the reticular support; a spring is arranged at the top of one end of the reticular bracket with a small gap;
the conveying system comprises a mandrel and an outer tube for the mandrel to travel;
the mandrel penetrates through the whole outer tube and the reticular bracket;
the top of the end of the reticular bracket with the larger grid gap is fixedly converged at one end of the outer tube;
the pushing handle comprises a shell and a pushing handle;
a slideway is arranged on the shell; the pushing handle is arranged in the slideway and can slide along the slideway;
the shell is connected with the other end of the outer tube, and the pushing handle is connected with the other end of the mandrel;
or the shell is connected with the other end of the mandrel, and the pushing handle is connected with the other end of the outer tube.
Preferably, the device further comprises a first developing ring and a second developing ring; the first developing ring is arranged between the net-shaped bracket and the outer tube; the second developing ring is arranged between the net-shaped bracket and the spring.
Preferably, the transverse spacing of the small part of the mesh gap of the mesh-shaped bracket is 1-5 mm; the transverse distance of the part with the large mesh gap of the mesh support is 1.2-3 times of the transverse distance of the part with the small mesh gap of the mesh support.
Preferably, one end of the spring, which is not in contact with the mesh support, is closed by adopting smooth materials, and the top of the smooth materials is arc-shaped.
Preferably, the reticular stent is a positively and negatively spiral staggered stent structure woven by super elastic yarns.
Preferably, the superelastic wire comprises a metallic material visible under X-rays.
Preferably, the mesh stent is prepared according to the following steps:
a cylindrical or cylindrical fixture for shaping the bracket is adopted; the surface of the bracket shaping tool is provided with a plurality of locating points which are distributed in a spiral manner;
one end of the super elastic wire is fixed at one end of a fixture for shaping the bracket, and then the super elastic wire runs along a positioning point and is woven to obtain a net-shaped bracket structure; the grid gap at one end of the net-shaped support structure is smaller than the grid gap at the other end;
and heating and shaping the reticular bracket structure, and cooling to obtain the reticular bracket.
Preferably, the mesh stent is prepared according to the following steps:
cutting the pipe by laser to obtain a net-shaped bracket structure;
the grid gap at one end of the net-shaped support structure is smaller than the grid gap at the other end;
and heating and shaping the reticular bracket structure, and cooling to obtain the reticular bracket.
Preferably, the temperature of the heating and shaping is 400-510 ℃; the heating and shaping time is 1-15 min.
Preferably, scales are arranged on the upper edge of the shell along the slide way.
The invention provides a thrombus taking device, which comprises: a thrombus taking bracket, a conveying system and a pushing handle; the thrombus taking support comprises a reticular support and a spring, wherein the grid gap at one end of the reticular support is smaller than the grid gap at the other end of the reticular support; a spring is arranged at the top of one end of the reticular bracket with a small gap; the conveying system comprises a mandrel and an outer tube for the mandrel to travel; the mandrel penetrates through the whole outer tube and the reticular bracket; the top of the end of the reticular bracket with the larger grid gap is fixedly converged at one end of the outer tube; the pushing handle comprises a shell and a pushing handle; a slideway is arranged on the shell; the pushing handle is arranged in the slideway and can slide along the slideway; the shell is connected with the other end of the outer tube, and the pushing handle is connected with the other end of the mandrel; or the shell is connected with the other end of the mandrel, and the pushing handle is connected with the other end of the outer tube. Compared with the prior art, the invention ensures that the reticular stent can be adjusted according to the diameter of the blood vessel at the lesion part by the movement of the mandrel in the outer tube, thereby improving the matching property of the thrombus taking stent and the lesion blood vessel; meanwhile, the grid gaps of the reticular stent are gradually reduced from the near end to the far end, and the grid design of the combination of the compactness and the compactness ensures that the stent can be quickly embedded into a blood vessel and simultaneously increases the combination and catching capability of the stent and thrombus; moreover, the density of the far-end stent grid is increased, so that the broken small thrombus emboli can be effectively prevented from falling off the stent, and the damage of the stent to the vessel wall when the stent passes through the vessel can be reduced; finally, the spring is arranged at the distal end of the bracket, so that the flexibility of the thrombus taking bracket is improved; finally, through the cooperation of the pushing handle shell and the pushing handle, the operability of the thrombus taking support is improved.
Drawings
FIG. 1 is a schematic diagram of a thrombus removal device according to the present invention;
FIG. 2 is a schematic diagram of the structure of the super elastic yarn at the positioning point provided by the invention;
FIG. 3 is a schematic view of the structure of the woven mesh stent of the present invention;
FIG. 4 is a schematic diagram of a thrombus removal process of the thrombus removal device according to the present invention;
fig. 5 is a schematic structural view of a pushing handle of the thrombus removing device provided by the invention;
fig. 6 is a schematic structural view of a push sliding thrombolysis stent.
Detailed Description
The technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The invention provides a thrombus taking device, which comprises:
a thrombus taking bracket, a conveying system and a pushing handle;
the thrombus taking support comprises a reticular support and a spring, wherein the grid gap at one end of the reticular support is smaller than the grid gap at the other end of the reticular support; a spring is arranged at the top of one end of the reticular bracket with a small gap;
the conveying system comprises a mandrel and an outer tube for the mandrel to travel;
the mandrel penetrates through the whole outer tube and the reticular bracket;
the top of the end of the reticular bracket with the larger grid gap is fixedly converged at one end of the outer tube;
the pushing handle comprises a shell and a pushing handle;
a slideway is arranged on the shell; the pushing handle is arranged in the slideway and can slide along the slideway;
the shell is connected with the other end of the outer tube, and the pushing handle is connected with the other end of the mandrel;
or the shell is connected with the other end of the mandrel, and the pushing handle is connected with the other end of the outer tube.
Referring to fig. 1, fig. 1 is a schematic structural diagram of a thrombus taking support provided by the present invention, wherein 1 is a mesh support, 2 is a mandrel, 3 is an outer tube, 4 is a developing ring, 5 is a spring, 6 is a housing, and 7 is a push handle.
According to the invention, the thrombus taking support comprises a net-shaped support and a spring; the mesh stent is a mesh stent well known to those skilled in the art, and is not particularly limited, and the mesh unit of the mesh stent in the present invention is surrounded by mesh wires, and the mesh wires are preferably formed by winding 1 strand or more of monofilaments, and more preferably formed by winding 2 strands or more of monofilaments; the mesh is preferably formed by winding monofilaments to form mesh lattice units with alternate densities; the mesh-shaped bracket is preferably formed by an alloy material and/or a high polymer material with memory capability and elasticity; in order to improve the overall developability of the mesh-like support, the mesh-like support preferably comprises a metallic material visible under X-rays, more preferably one or more of gold, platinum, tantalum, platinum iridium alloy, and barium sulfate; the reticular stent can be obtained by cutting a pipe or braided by super elastic wires, and is preferably a positive and negative spiral staggered stent structure braided by the super elastic wires; the net-shaped stent is integrally designed by adopting a spiral structure, so that the flexibility of the stent is improved, the scratch to the wall of a blood vessel when the blood vessel passes through the bending is reduced, in addition, the net-shaped stent is obtained by cross braiding, and the proximal end control effect is better; the reticular bracket can be formed by weaving a single super elastic yarn back and forth, and can also be formed by weaving a plurality of super elastic yarns; when the net-shaped bracket is formed by weaving a single super elastic wire back and forth, the number of the back and forth times is preferably a multiple of 4; when the super elastic yarns are woven by a plurality of super elastic yarns, the number of the super elastic yarns is preferably a multiple of 3, and each grid intersection point is enabled to be crossed and encircled by 4 super elastic yarns without restriction to free movement; the super elastic yarn is well known to those skilled in the art, and is not particularly limited, in the present invention, at least one metal material with an inner part visible under X-ray is preferable, and the outer part is wrapped with a super elastic material, which may be a super elastic alloy material such as nickel-titanium alloy, or a high polymer material with memory capability and elasticity, so that the whole mesh-shaped stent has developability.
The grid gap at one end of the net-shaped support is smaller than the grid gap at the other end of the net-shaped support; in the medical instrument, during normal operation, one end, which is close to a doctor, is a near end, and the end, which is far away from the doctor, is a far end which is contacted with a patient at first; in a loose state, the transverse spacing of the small part of the netlike bracket is 1-5 mm; the transverse spacing of the part with large grid gaps of the reticular bracket is preferably 1.2 to 3 times, more preferably 1.2 to 2.5 times, and even more preferably 1.2 to 2 times of the transverse spacing of the part with small gaps; the ratio of the length of the small part of the grid gaps to the length of the large part of the grid gaps is preferably 1: (0.5 to 5), more preferably 1: (1 to 5), and more preferably 1: (2-4), most preferably 1: (2.5-3); the length of the reticular bracket is preferably 10-200 mm; the diameter of the mesh stent is preferably 0.5 to 40mm, more preferably 0.5 to 30mm, still more preferably 0.5 to 20mm, still more preferably 2 to 10mm, still more preferably 2 to 8mm, and most preferably 2 to 5.5mm.
According to the invention, a second developing ring is preferably arranged between the net-shaped bracket and the spring; the second developing ring may be a developing ring well known to those skilled in the art, and is not particularly limited. The working area of the mesh support can be displayed under X-rays through the first developing ring and the second developing ring which are arranged at the two ends of the mesh support.
One end of the reticular support with small grid gaps can be fixedly converged in the second developing ring or in the spring; the length of the fixing and converging in the second developing ring or the spring is preferably 2-20 mm, more preferably 5-15 mm, and still more preferably 8-10 mm; the spring is a spring well known to those skilled in the art, and is not particularly limited; one end of the spring, which is not contacted with the net-shaped bracket, is preferably closed by adopting a smooth material; the top of the smooth material is preferably arc-shaped; the length of the spring is preferably 5-20 mm, more preferably 10-20 mm, and still more preferably 15mm; the outer diameter of the spring is preferably 0.01 to 0.02 inch, more preferably 0.012 to 0.019 inch; the inner diameter of the spring is preferably 0.005 to 0.02 inches, more preferably 0.01 to 0.016 inches.
The thrombus taking device provided by the invention comprises a conveying system; the conveying system comprises a mandrel and an outer tube for the mandrel to travel; one end of the reticular bracket with a large grid gap is fixed in the outer tube; the outer tube may be any one known to those skilled in the art, and is not particularly limited, but a woven tube or a polymer tube is preferable in the present invention. The diameter of the outer tube is preferably 0.1 to 2.5mm, more preferably 0.5 to 2mm, still more preferably 0.5 to 1mm; the length of the outer tube is preferably 20 to 300cm, more preferably 50 to 250cm, still more preferably 100 to 250cm, still more preferably 150 to 200cm, and most preferably 180cm.
According to the invention, the thrombolytic stent preferably further comprises a first developing ring; the first developing ring is arranged between the reticular bracket and the outer tube and is preferably fixed on the outer tube; the first developing ring is a developing ring well known to those skilled in the art, and is not particularly limited.
A mandrel is arranged in the outer tube and can freely move in the outer tube; the mandrel penetrates through the whole outer tube and the reticular bracket, and one end of the mandrel, which is small in grid clearance with the reticular bracket, namely the far end of the reticular bracket is fixedly converged in the second developing ring or the spring; the reticular bracket can be pushed and pulled to deform by the movement of the mandrel in the outer tube, so that the diameter of the reticular bracket is changed; the mandrel is preferably a nickel titanium alloy, stainless steel or other suitably stiff wire or tube.
The thrombus taking device provided by the invention comprises a pushing handle; the pushing handle comprises a shell and a pushing handle; in the invention, the shell and the pushing handle are preferably formed by injection molding of high polymer materials. A slideway is arranged on the shell; the pushing handle is arranged in the slideway and can slide along the slideway; the shell is connected with the other end of the outer tube, namely the end which is not contacted with the reticular bracket, and the pushing handle is connected with the other end of the mandrel, namely the end which is not contacted with the reticular bracket; or the shell is connected with the other end of the mandrel, and the pushing handle is connected with the other end of the outer tube; therefore, the mesh bracket can be driven to shrink or expand by the relative sliding of the push handle and the shell and the advancing and retreating of the push handle, so that the aim of controllable bracket diameter is fulfilled.
The relative movement distance of the pushing hand and the shell is also the difference value of the length of the reticular bracket when expanding and contracting, the difference value has a corresponding linear relation with the diameter of the reticular bracket, the opening condition of the bracket can be intuitively judged for the convenience of operators, and the shell is preferably provided with scales along the slideway, namely, the stroke of the pushing hand is provided with the scales, and the scales correspond to the variable numerical value of the reticular bracket.
The housing is preferably ergonomically designed to facilitate handling by the operator and minimize handling difficulties.
According to the invention, the thrombus taking support can be adjusted according to the diameter of a lesion blood vessel by moving the mandrel in the outer tube, so that the matching property of the thrombus taking support and the lesion blood vessel is improved; meanwhile, the grid gaps of the reticular stent are gradually reduced from the near end to the far end, and the grid design of the combination of the compactness and the compactness ensures that the stent can be quickly embedded into a blood vessel and simultaneously increases the combination and catching capability of the stent and thrombus; moreover, the density of the far-end bracket grid is increased, so that the broken small thrombus emboli can be effectively prevented from falling off the bracket; finally, the distal end of the bracket is converged in the spring, so that the flexibility of the thrombus taking bracket is improved; finally, through the cooperation of the pushing handle shell and the pushing handle, the operability of the thrombus taking support is improved. In summary, the thrombus taking device provided by the invention is an adjustable blood vessel thrombus taking device which has good structural setting passing capability, strong bracket operation, difficult displacement, wide thrombus catching range and difficult falling off after thrombus taking.
The invention also provides a preparation method of the reticular stent in the thrombus taking device, which comprises the following steps:
a cylindrical or cylindrical fixture for shaping the bracket is adopted; the surface of the bracket shaping tool is provided with a plurality of locating points which are distributed in a spiral manner;
one end of the super elastic wire is fixed at one end of a fixture for shaping the bracket, and then the super elastic wire runs along a positioning point and is woven to obtain a net-shaped bracket structure; the grid gap at one end of the net-shaped support structure is smaller than the grid gap at the other end;
and heating and shaping the reticular bracket structure, and cooling to obtain the reticular bracket.
The invention adopts a tool for braiding super elastic yarns for shaping a cylindrical or columnar bracket; the fixture for stent sizing is preferably formed of a high melting point material, more preferably one or more of copper, stainless steel and ceramic; the surface of the bracket shaping tool is provided with a plurality of locating points which are distributed in a spiral manner; the positioning points are preferably distributed in a positive spiral and/or a reverse spiral mode; the number of the locating points in spiral distribution is preferably 3-6, more preferably 3-4, and still more preferably 3; and the gap size of the knitted mesh stent can be adjusted by adjusting the distribution density of positioning points in any area.
One end of the super elastic yarn is fixed at one end of a fixture for shaping the bracket, and then the super elastic yarn advances along a positioning point to be woven; the super elastic yarn can be a single super elastic yarn or a plurality of super elastic yarns, when the single super elastic yarn is adopted, one end of the super elastic yarn is fixed at one end of a fixture for shaping the bracket, then the super elastic yarn advances along positioning points, preferably advances according to a sine path, and after the super elastic yarn is positioned at two sides of the positioning points and can not be positioned at the same side and advances to the last positioning point, the super elastic yarn advances back along the opposite path by taking the positioning point as a starting point, namely advances along the cosine path direction, and the super elastic yarn of the adjacent positioning points is positioned at two sides of the positioning point on the path, and is woven in a reciprocating manner, so that a positive and negative spiral staggered net-shaped bracket structure is formed on the fixture for shaping the bracket; each positioning point is preferably provided with 4 super elastic yarns which are crossed and encircled, and four mutually staggered super elastic yarns can freely slide at the positioning point without restriction. The structural schematic diagram of the super elastic yarn at the positioning point is shown in fig. 2a, wherein the black round point is the positioning point; fig. 3 is a schematic structural view of a woven mesh stent, which is woven by adjusting the density of positioning points in any area.
When the super elastic yarns are a plurality of super elastic yarns, the number of the super elastic yarns is preferably a multiple of the number of spiral strips formed by the positioning points, and more preferably is 4 times of the number of spiral strips formed; the knitting method comprises the following steps: the method comprises the steps that super elastic wires with the same number as that of spiral strips are taken and fixed at one end of a fixture for shaping a bracket, the other end of the fixture spirally advances along a sine path of a positioning point, the super elastic wires at adjacent positioning points on the path are positioned at two sides of the positioning point, and the super elastic wires advance to the other end of the fixture and are fixed; then the super elastic wires with the same number as the spiral strips are taken and fixed at the same starting point, the other end of the super elastic wires spirally advances along the cosine path of the positioning point, and adjacent positioning points on the path enable the super elastic wires to be positioned at two sides of the positioning point, and the super elastic wires are fixed after advancing to the other end of the super elastic wires; after the steps are repeated to spiral along the sine path, the super elastic wires are then spiral along the cosine path, so that 4 super elastic wires are arranged at each positioning point in a crossed and encircling mode, and the net-shaped support structure is obtained.
The invention also provides a preparation method of the mesh stent, which comprises the following steps:
and winding and braiding the two super elastic filaments by a braiding machine or a tooling, and performing heat setting treatment to obtain the net filaments.
Weaving the mesh by a braiding machine to obtain a mesh-shaped bracket structure;
the superelastic yarn is the same as that described above, and is not repeated here; the superelastic filaments are preferably woven with tightness and form a structure with wire units with tightness and tightness as shown in fig. 2 b.
Performing heat setting treatment after braiding to obtain a net wire; the heat setting conditions are the same as those described above, and will not be described again here.
Braiding the mesh by a braiding machine to obtain a mesh stent structure, as shown in fig. 2 c; the mesh gaps, lengths and diameters of the mesh support structure are the same as those described above, and are not described in detail herein.
Heating and shaping the reticular bracket structure, and cooling to obtain a reticular bracket; the temperature of the heating and shaping is preferably 400-510 ℃; the heating and shaping time is preferably 1-15 min.
In the invention, the reticular bracket structure can also be obtained by cutting the tubular product by laser; the pipe is a pipe well known to those skilled in the art, and is not particularly limited; if the diameter of the tube is smaller than the diameter of the net-shaped support structure to be obtained, the net-shaped support structure is obtained by expanding the diameter through a die after cutting.
The mesh gaps, lengths and diameters of the mesh support structure are the same as those described above, and are not described in detail herein.
Heating and shaping the reticular bracket structure, and cooling to obtain a reticular bracket; the temperature of the heating and shaping is preferably 400-510 ℃; the heating and shaping time is preferably 1-15 min.
In order to further illustrate the present invention, a thrombus removing device provided by the present invention is described in detail below with reference to the embodiments.
The reagents used in the examples below are all commercially available.
Example 1
The length of the reticular stent is 30mm, and the diameter of the stent is 5.5mm; the length of the outer tube is 180cm; the diameter of the outer tube is 0.60mm.
This example matches the size of a microcatheter with an inner diameter of 0.021 inch, a stent working area length of 30mm and a diameter of 5.5mm.
Specifically, the superelastic wire used to weave the thrombus-removing stent is selected from nickel-titanium alloy wires with a diameter of 0.004 inch (0.0102 mm) and 30% platinum content, which can be developed integrally. By adopting a multi-wire braiding preparation method, sparse parts of braiding tool positioning points are transversely spaced by 7mm, dense parts are transversely spaced by 5mm, and the length ratio of the sparse parts to the dense parts is 3:1, weaving 12 wires into a net-shaped bracket (1) with the working area length of 30mm and the working diameter of 5.5mm, and performing heat treatment for shaping for later use. The mandrel (2) is made of nickel-titanium alloy wires with the diameter of 0.007 inch, and the outer tube (3) is made of nylon tubes with the outer diameter of 0.02 inch and the inner diameter of 0.015 inch. A developing ring (4) having an outer diameter of 0.023 inch and an inner diameter of 0.02 inch and a length of 1mm was fixed to the outside of the distal end of the outer tube. And taking down the net-shaped bracket (1) after heat treatment and shaping, and converging the straight wire parts of the 12 super elastic wires at the near end of the net-shaped bracket (1) on the inner cavity of one end of the outer tube (3) connected with the developing ring (4) for fixation. The distal end of the bracket (1) is connected with the developing ring (4), and the mandrel (2) penetrates through the inside of the bracket (1) and is penetrated out from the distal developing ring (4). The super elastic wire and the mandrel (2) beyond the distal developing ring (4) remain 10mm long. A spring (5) with the outer diameter of 0.019 inch, the inner diameter of 0.016 inch and the length of 15mm is selected, the 10 mm-length superelastic wire and the mandrel are bundled in an inner cavity of the spring (5) to be fixed, a smooth material is used for closing a spring opening at the far end of the spring (5) and the top of the spring is formed into an arc shape, the far end of the whole thrombus taking support is formed, the flexibility of the far end of the thrombus taking support can be increased through the combined design of the arc-shaped smooth top end and the spring, the thrombus taking support has better compliance with a blood vessel, the stimulation to the blood vessel wall is reduced in the releasing process of the thrombus taking device, and especially, the accident caused by the blood vessel puncture of the thrombus taking device can be prevented.
The pushing handle shell (6) is of an ergonomic design, is convenient for an operator to hold, minimizes the difficulty in operation, and is used for connecting the proximal end of the outer tube (3) of the conveying system with the shell (6) and connecting the mandrel (2) of the conveying system with the pushing handle (7) respectively. The distance of the pushing hand (7) and the shell (6) moving relatively is the difference of the length of the bracket when the thrombus taking bracket expands and contracts, the difference and the diameter of the bracket have corresponding linear relation, further, as shown in fig. 5, the stroke of the pushing hand of the handle shell is marked with a numerical value corresponding to the diameter change of the bracket, so that a doctor can intuitively judge the opening condition of the bracket, and fig. 5 is a schematic structural diagram of the pushing handle, wherein 1 is the shell, 2 is the pushing hand and 3 is a slideway; fig. 6 is a schematic structural view of a push sliding thrombolysis stent.
Example 2
The scope of application of the invention is further supplemented by matching the microcatheter with 0.013 inch inside diameter, 20.5mm length of the working area of the stent, 2mm diameter, and 0.5 mm-2.5 mm diameter of the applicable blood vessel.
Specifically, the superelastic wire used to weave the thrombus-removing stent is selected from nickel-titanium alloy wires with a diameter of 0.004 inch (0.0102 mm) and 30% platinum content, which can be developed integrally. By adopting a multi-wire braiding preparation method, sparse parts of braiding tool positioning points are transversely spaced by 2mm, dense parts are transversely spaced by 1mm, and the length ratio of the sparse parts to the dense parts is 2.5:1, weaving 12 wires into a net-shaped bracket (1) with the working area length of 20.5mm and the diameter of 2mm, and performing heat treatment for shaping for later use. The mandrel (2) is made of nickel-titanium alloy wires with the diameter of 0.005 inch, and the outer tube (3) is made of nylon tubes with the outer diameter of 0.012 inch and the inner diameter of 0.010 inch. A developing ring (4) having an outer diameter of 0.014 inch and an inner diameter of 0.012 inch and a length of 1mm was fixed to the outside of the distal end of the outer tube. And taking down the net-shaped bracket (1) after heat treatment shaping, and converging the straight wire parts of the 12 super elastic wires at the proximal end of the bracket (1) on the inner cavity of one end of the outer tube (3) connected with the developing ring (4) for fixation. The distal end of the bracket (1) is connected with the developing ring (4), and the mandrel (2) penetrates through the inside of the bracket (1) and is penetrated out from the distal developing ring (4). The super elastic wire and the mandrel (2) beyond the distal developing ring (4) remain 10mm long. A spring (5) with the outer diameter of 0.012 inch, the inner diameter of 0.010 inch and the length of 15mm is selected, the 10 mm-length superelastic wire and the mandrel are bundled in the inner cavity of the spring (5) to be fixed, a smooth material is used for closing a spring opening at the far end of the spring (5) and the top of the spring is arc-shaped, so that the far end of the whole thrombus taking device is formed, the flexibility of the far end of the thrombus taking device can be increased through the combination design of the arc-shaped smooth top end and the spring, the thrombus taking device has better compliance with a blood vessel, the stimulation to the blood vessel wall in the releasing process of the thrombus taking device is reduced, and especially, the accident caused by the thrombus taking device puncturing the blood vessel can be prevented. The handle shell (6) is designed to simulate human engineering, which is convenient for an operator to hold, and reduces the difficulty in operation to the greatest extent. The pushing system and the handle can be connected by adopting different methods from the embodiment 1, the proximal end of the outer tube (3) of the conveying system is connected with the pushing handle (7), the mandrel (2) of the conveying system is connected with the shell (6), the distance of the relative movement of the pushing handle (7) and the shell (6) is the difference value of the length of the bracket when the thrombus taking bracket expands and contracts, the difference value and the diameter of the bracket have corresponding linear relation, and further, as shown in fig. 5, the numerical value corresponding to the diameter change of the bracket is marked on the stroke of the pushing handle of the handle shell, so that a doctor can intuitively judge the opening condition of the bracket conveniently.
The embodiment is 80% smaller than the similar devices on the market, and is fed through a flexible neurovascular microcatheter with the distal outer diameter of 1.3Fr to perform the thrombus extraction operation on the intracranial blood vessel with the diameter of 0.5-2.5 mm. The vascular occlusion of the tube diameter accounts for 30% of cerebral apoplexy patients, and other machines on the market cannot treat the cerebral apoplexy.
The embodiment of the using method of the thrombus taking device is as follows:
during interventional therapy, the intracranial vascular lesion position is firstly determined through angiography, then a vascular sheath is punctured from femoral artery or brachial artery and placed, a guide wire and a microcatheter are alternately pushed and placed at the front end of a lesion part, the guide wire is withdrawn, a thrombus taking stent is placed at the lesion part along the microcatheter, the distal end of the thrombus taking stent completely passes through thrombus as shown in fig. 4a, and the thrombus taking stent is always positioned in the microcatheter and is in a contracted state. Stretching the mandrel or pushing the outer tube opens the mesh stent, as shown in fig. 4b, into the thrombus and against the vessel wall. As shown in fig. 4c, the thrombus-fused vascular thrombus-removing stent and the microcatheter are slowly pulled out as a whole, and the whole thrombus-removing stent is withdrawn from the human body, so that the thrombus-removing process is completed.
The above description of the method embodiments is directed to intracranial vascular thrombolysis, and is exemplary only, and the thrombolysis device may be adapted for other intravascular thrombolysis at suitable sizes.
Claims (7)
1. A thrombolytic device, comprising:
a thrombus taking bracket, a conveying system and a pushing handle;
the thrombus taking support comprises a reticular support and a spring, wherein the grid gap at one end of the reticular support is smaller than the grid gap at the other end of the reticular support; a spring is arranged at the top of one end of the reticular bracket with small grid gaps;
the conveying system comprises a mandrel and an outer tube for the mandrel to travel;
the mandrel penetrates through the whole outer tube and the reticular bracket;
the top of the end of the reticular bracket with the larger grid gap is fixedly converged at one end of the outer tube;
the pushing handle comprises a shell and a pushing handle;
a slideway is arranged on the shell; the pushing handle is arranged in the slideway and can slide along the slideway;
the shell is connected with the other end of the outer tube, and the pushing handle is connected with the other end of the mandrel;
or the shell is connected with the other end of the mandrel, and the pushing handle is connected with the other end of the outer tube;
in a loose state, the transverse spacing of the part with small grid gaps of the reticular bracket is 1-5 mm; the transverse distance of the part with the large mesh gaps of the mesh-shaped support is 1.2-3 times of the transverse distance of the part with the small mesh gaps of the mesh-shaped support; the ratio of the length of the small part of the grid gaps to the length of the large part of the grid gaps is 1: (0.5-5);
the reticular stent is a positive and negative spiral staggered stent structure woven by super elastic yarns;
the reticular bracket is formed by weaving single super elastic yarn back and forth or weaving a plurality of super elastic yarns; when the reticular stent is formed by weaving a single super elastic wire back and forth, the number of back and forth times is a multiple of 4; when the super elastic yarns are woven by a plurality of super elastic yarns, the number of the super elastic yarns is a multiple of 3, and each grid intersection point is crossed and surrounded by 4 super elastic yarns without restriction to free movement; at least one of the super elastic wires is internally made of a metal material visible under X-ray, and the outer part of the super elastic wire is wrapped by a super elastic material;
one end of the spring, which is not contacted with the reticular bracket, is closed by adopting smooth material, and the top of the smooth material is arc-shaped.
2. The thrombolytic device of claim 1, further comprising a first developing ring and a second developing ring; the first developing ring is arranged between the net-shaped bracket and the outer tube; the second developing ring is arranged between the net-shaped bracket and the spring.
3. The thrombectomy device of claim 1, wherein the superelastic wire comprises a metallic material visible under X-rays.
4. The thrombectomy device of claim 1, wherein the mesh stent is prepared by the steps of:
a cylindrical or cylindrical fixture for shaping the bracket is adopted; the surface of the bracket shaping tool is provided with a plurality of locating points which are distributed in a spiral manner;
one end of the super elastic wire is fixed at one end of a fixture for shaping the bracket, and then the super elastic wire runs along a positioning point and is woven to obtain a net-shaped bracket structure; the grid gap at one end of the net-shaped support structure is smaller than the grid gap at the other end;
and heating and shaping the reticular bracket structure, and cooling to obtain the reticular bracket.
5. The thrombolytic device of claim 4, wherein the temperature of said heat setting is 400 ℃ to 510 ℃; and the heating and shaping time is 1-15 min.
6. The thrombectomy device of claim 1, wherein the housing is provided with graduations along the slideway.
7. The thrombus removing device as in claim 4 wherein one end of the superelastic wire is fixed to one end of the fixture for shaping the stent and then is woven by running along the positioning point;
the super elastic yarn can be single or multiple super elastic yarns, when the single super elastic yarn is adopted, one end of the super elastic yarn is fixed at one end of a fixture for shaping a bracket, then the super elastic yarn advances along positioning points, advances according to a sine path, and after the super elastic yarn advances to the last positioning point, the super elastic yarn is positioned at two sides of the positioning points and can not be positioned at the same side, and returns to the opposite path by taking the positioning point as a starting point to advance along the cosine path direction, and the super elastic yarn is positioned at two sides of the positioning point on the path, and is woven in a reciprocating manner in such a way, so that a positive and negative spiral staggered net-shaped bracket structure is formed on the fixture for shaping the bracket;
each positioning point is provided with 4 super elastic yarns which are crossed and encircled, and four mutually staggered super elastic yarns can freely slide at the positioning point without restriction.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109771097A (en) * | 2019-03-11 | 2019-05-21 | 北京航空航天大学 | Manpower intervention type aortic valve stent with the variation of radial support power |
| CN112294394B (en) * | 2019-07-24 | 2021-09-03 | 西安交通大学医学院第一附属医院 | Adjustable peripheral blood vessel thrombus taking support assembly |
| CN113520519A (en) * | 2021-04-30 | 2021-10-22 | 常州凯尼特医疗科技有限公司 | Adjustable bracket type bolt taking device |
| CN113855159B (en) * | 2021-09-29 | 2024-04-09 | 北京泰杰伟业科技股份有限公司 | Combined type regulation and control thrombus taking device |
| CN116942255B (en) * | 2023-09-18 | 2023-12-12 | 北京华脉泰科医疗器械股份有限公司 | Thrombus removing device |
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