CN114053008A - Stent expansion device - Google Patents
Stent expansion device Download PDFInfo
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- CN114053008A CN114053008A CN202111420101.0A CN202111420101A CN114053008A CN 114053008 A CN114053008 A CN 114053008A CN 202111420101 A CN202111420101 A CN 202111420101A CN 114053008 A CN114053008 A CN 114053008A
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- mandrel
- core wire
- expansion
- stent
- core
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- 239000000956 alloy Substances 0.000 claims abstract description 7
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims abstract description 7
- 230000001681 protective effect Effects 0.000 claims description 6
- 210000004204 blood vessel Anatomy 0.000 description 53
- 238000007917 intracranial administration Methods 0.000 description 14
- 208000007536 Thrombosis Diseases 0.000 description 10
- 210000001367 artery Anatomy 0.000 description 10
- 201000008450 Intracranial aneurysm Diseases 0.000 description 6
- 208000016988 Hemorrhagic Stroke Diseases 0.000 description 5
- 238000005452 bending Methods 0.000 description 5
- 208000020658 intracerebral hemorrhage Diseases 0.000 description 5
- 206010002329 Aneurysm Diseases 0.000 description 4
- 208000006011 Stroke Diseases 0.000 description 4
- 230000017531 blood circulation Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 230000002792 vascular Effects 0.000 description 4
- 208000005189 Embolism Diseases 0.000 description 3
- 238000006073 displacement reaction Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000013151 thrombectomy Methods 0.000 description 3
- 230000001154 acute effect Effects 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- 230000008602 contraction Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 229910001000 nickel titanium Inorganic materials 0.000 description 2
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 208000022211 Arteriovenous Malformations Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 208000028698 Cognitive impairment Diseases 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 208000012661 Dyskinesia Diseases 0.000 description 1
- 208000032382 Ischaemic stroke Diseases 0.000 description 1
- 208000032376 Lung infection Diseases 0.000 description 1
- 230000005744 arteriovenous malformation Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 208000010877 cognitive disease Diseases 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000013156 embolectomy Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000009916 joint effect Effects 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 208000037803 restenosis Diseases 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
- A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
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- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
- A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
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- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0057—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0066—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof shrinkable
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- Health & Medical Sciences (AREA)
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- Transplantation (AREA)
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- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention discloses a stent expansion device, which comprises an expansion assembly, an adjusting core wire and an adjusting sleeve, wherein the adjusting sleeve is sleeved at the near end of the adjusting core wire, the adjusting core wire is in sliding fit with the adjusting sleeve, the expansion assembly comprises a mandrel A, the mandrel A is made of memory alloy materials, the memory shape of the mandrel A is spiral, the mandrel A is arranged in a surrounding mode along the axial direction of the adjusting core wire, the far end of the mandrel A is fixedly connected with the far end of the adjusting core wire, and the near end of the mandrel A is fixedly connected with the far end of the adjusting sleeve.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a stent expansion device.
Background
The cerebral apoplexy is an acute cerebrovascular disease with high morbidity, high mortality and high disability rate, and comprises ischemic stroke and hemorrhagic stroke, about 1700 thousands of people are ill every year in the world, nearly 600 thousands of people die from the stroke, the mortality rate is about 30%, the condition of China is shown by the research of Ministry of health in 2012, the population of the stroke over 40 years old in China exceeds 1000 thousands and shows the trend of youthfulness, about 30-40% of the stroke is hemorrhagic stroke, and the cause of the hemorrhagic stroke is as follows: intracranial aneurysm rupture bleeding and arteriovenous malformation, the highest death rate can reach 68 percent, the death rate in the acute stage is 30-40 percent, and the subsequent death is mostly caused by complications such as lung infection and the like. Many of the survivors remain with varying degrees of dyskinesia, cognitive impairment, speech dysphagia.
The hemorrhagic stroke treatment modes mainly include a mode of treating aneurysm by using a pure spring coil embolism, a mode of treating aneurysm by using a stent auxiliary spring coil embolism, a mode of treating intracranial aneurysm by using a blood flow guiding device and the like. Because intracranial blood vessels are too tortuous and have small inner diameter (2-4 mm), and the like, the bracket assists the spring ring embolism to treat intracranial aneurysm and the blood flow guide device to treat the intracranial aneurysm, the bracket and the blood flow guide device are self-expandable brackets, when a parent artery of the intracranial aneurysm is positioned at a blood vessel bending part, the self-expandable bracket cannot be attached to a blood vessel wall after being unfolded at the bending part, the self-expandable bracket is often bent and collapsed in the bracket, the blood vessel smoothness of the bending part is influenced, and the bracket cannot adhere well to the wall, so that serious sequelae such as early thrombosis of bracket implantation, restenosis in the later bracket and the like can be caused.
CN2021104789609, by its research, discloses an adjustable stent type embolectomy device, comprising an expandable stent, a sleeve and a first operation wire, wherein the expandable stent can be radially expanded or radially collapsed when the distance between the proximal end and the distal end is compressed or stretched, the distal end of the sleeve is connected with the proximal end of the expandable stent, the proximal end of the sleeve is provided with a connecting piece, the connecting piece is provided with a fixing point and a perforation, the first operation wire passes through the perforation and can slide in the sleeve, and the first operation wire is fixedly connected with the distal end of the expandable stent.
CN202011438406X discloses a thrombectomy support, including handle, pusher and thrombectomy support, pusher includes seal wire and hypotube, and thrombectomy support's near-end is fixed on the distal end of hypotube, and the distal end is fixed on the seal wire to expand and contract under the effect of handle.
CN201811331717.9 discloses a get and tie device, including getting a tie support, conveying system and propelling movement handle, conveying system includes the dabber and supplies the outer tube that the dabber marched, and the dabber runs through whole outer tube and gets a tie support, gets a tie support distal end and is connected with the dabber, and the near-end is connected with the outer tube, through the removal of dabber in the outer tube, makes to get a tie support and can adjust according to the diameter of lesion site blood vessel, improves and gets the tie support and the matching nature of lesion blood vessel.
Assuming that the structure of the thrombus taking support is used for assisting in treating hemorrhagic stroke, after the self-expandable support is expanded at a parent artery part, the thrombus taking support capable of radially expanding and contracting is extended into the self-expandable support, and the self-expandable support is tightly attached to the vessel wall through the radial expansion and contraction of the thrombus taking support.
The method has the following disadvantages: even if the structure of the thrombus taking support is in a contraction state in a catheter, the whole external diameter is large, and the thrombus taking support cannot be pushed in a slender and tortuous blood vessel in the cranium; and the thrombus taking support is required to be stretched into the self-expanding support, the whole outer diameter of the thrombus taking support needs to be further reduced, and the processing difficulty is high.
Clinical experiments prove that the structure is not suitable for intracranial, and the thrombus removal support cannot be used for support-assisted thrombus of intracranial aneurysm and cannot be used for support expansion.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides the stent expansion device which has simple process and convenient operation, can assist in further expanding the stent, ensures good joint effect of the stent and the inner wall of the blood vessel and is suitable for intracranial expansion stents and blood flow guiding devices.
The technical scheme adopted by the invention for solving the technical problems is as follows:
a stent expansion device characterized by: the expansion assembly comprises a mandrel A, the mandrel A is made of memory alloy materials, the mandrel A is spiral in memory shape and is arranged in a surrounding mode along the axial direction of the adjustment core wire, the far end of the mandrel A is fixedly connected with the far end of the adjustment core wire, the near end of the mandrel A is fixedly connected with the far end of the adjustment core wire, the expansion assembly is transferred into a stent after the stent reaches a position of a parent artery to be released, the mandrel A is radially expanded by axially moving the adjustment sleeve or the adjustment core wire to enable the stent to be attached to the inner wall of a blood vessel in an auxiliary mode, the mandrel A is matched with the adjustment core wire in the conveying process by using the mandrel A, the overall outer diameter is small, and the expansion assembly can be pushed in a small, long and tortuous blood vessel in the cranium, the expansion assembly reaches the parent artery, the mandrel A expands spirally to open the stent, the structure is simple, the manufacturing cost is low, the position and the force of the mandrel A expansion are accurate and controllable, the vessel wall cannot be expanded or damaged when the stent is attached to the inner wall of the vessel, and the controllability is high; the whole design size of the stent expansion device is small, the stent can be directly conveyed through the conveying catheter of the conveying stent, the stent is conveyed to the position of the parent artery through the conveying catheter and released, the stent conveying guide wire is retracted, the conveying catheter does not need to be withdrawn, the expansion assembly is transferred into the stent through the conveying catheter, the operation time is greatly saved, and the operation safety is improved.
The expansion assembly also comprises a mandrel B, wherein the mandrel B is made of a memory alloy material, the memory shape of the mandrel B is a spiral shape opposite to the rotation direction of the mandrel A, the mandrel B is arranged in a surrounding mode along the axial direction of the adjusting core wire and is intersected with the mandrel A in a mirror image mode, the far end of the mandrel B is fixedly connected with the far end of the adjusting core wire, the near end of the mandrel B is fixedly connected with the far end of the adjusting sleeve, the mandrel A and the mandrel B are arranged in a matched mode, the overall outer diameter is small, circumferential expansion of the stent can be achieved, the expansion effect of the stent is further guaranteed to be good, and the operation time is short.
The mandrel A is composed of an expansion core wire A and a spring ring A, the spring ring A is wound and fixed on the expansion core wire A, the mandrel B is composed of an expansion core wire B and a spring ring B, the spring ring B is wound and fixed on the expansion core wire B, and the arrangement of the expansion core wire and the spring ring enables the flexibility and the support of the mandrel A and the mandrel B to be good, so that the mandrel A can be pushed in intracranial blood vessels conveniently, and the stent can be opened effectively.
The inner ring of the spring ring A is a passage A for an expansion core wire A to pass through, the inner ring of the spring ring B is a passage B for an expansion core wire B to pass through, the spring ring A and the spring ring B are contacted with each other at the intersection to form a communicating passage which enables the passage A to be communicated with the passage B, the expansion core wire A and the expansion core wire B both pass through the communicating passage, the mandrel A is in sliding fit with the mandrel B, so that the mandrel A and the mandrel B cannot be separated when the mandrel A and the mandrel B expand and contract, and the controllability of an expansion assembly is high.
According to the invention, the mandrel A and the mandrel B are arranged at the intersection, the mandrel B passes through the space between the expansion core wire A and the spring ring A or the mandrel A passes through the space between the expansion core wire B and the spring ring B, and the mandrel A and the mandrel B are in sliding fit, so that when the mandrel A and the mandrel B expand and contract, the mandrel A and the mandrel B cannot be separated, and the controllability of the expansion assembly is high.
The outer diameters of the mandrel A and the mandrel B are between 0.1mm and 0.5 mm.
The outer diameter of the adjusting core wire is 0.05 mm-0.3 mm.
The push handle comprises a handle outer shell and a handle inner core, a slide way is arranged on the handle inner core, a slide block matched with the slide way is arranged on the inner wall of the handle outer shell, the handle outer shell is sleeved on the handle inner core and is in sliding fit with the handle inner core, the near end of the adjusting core wire is fixedly connected with the handle inner core or the handle outer shell, the near end of the adjusting sleeve is fixedly connected with the handle outer shell or the handle inner core, the handle outer shell is pushed to axially slide along the handle inner core, and the adjusting sleeve moves to drive the expansion assembly to radially expand or radially contract or the adjusting core wire moves to drive the expansion assembly to radially expand or radially contract.
The graduated scale is arranged on the inner core of the handle.
The adjusting mandrel is fixedly wound with a protective core wire between the head and the far end of the expansion component.
The invention has the beneficial effects that: the support is after the release inflation of blood vessel bending part, the expansion subassembly is transferred to in the support, adjust the sleeve pipe or adjust the core silk so that the expansion subassembly radially expands through axial displacement, the supplementary support that makes can paste tight blood vessel inner wall, the whole external diameter of support expanding unit is little, the expansion subassembly of being convenient for can be in intracranial thin again long and crooked blood vessel smooth removal, reach the parent artery position, the expansion subassembly expansion, when making support and the laminating of blood vessel inner wall, can not prop big or damage the vascular wall with the blood vessel inner wall, moreover, the steam generator is simple in structure, low in manufacturing cost, high controllability, clinical use is convenient.
Drawings
Fig. 1 is a schematic view showing the overall structure of the stent expansion device of the present invention.
Fig. 2 is another overall structure diagram of the stent expanding device of the present invention.
Fig. 3 is a schematic view showing the overall structure of the stent expansion device (contracted within the delivery catheter) of the present invention.
Fig. 4 is a structural schematic diagram of the stent of the invention in a stretched state at a bent blood vessel.
Fig. 5 is a structural view showing a stent of the present invention in a spread state by a stent expansion means.
Fig. 6 is an enlarged schematic view at a in fig. 1.
Fig. 7 is an enlarged schematic view at B in fig. 2.
Fig. 8 is an enlarged view of another structure at B in fig. 2.
Fig. 9 is an enlarged schematic view at C in fig. 2.
Fig. 10 is an enlarged schematic view at D in fig. 3.
Fig. 11 is an enlarged schematic view at E in fig. 3.
Fig. 12 is an enlarged schematic view at F in fig. 3.
Fig. 13 is an enlarged schematic view at G in fig. 5.
Reference numerals: the stent comprises a stent expansion device-1, an expansion assembly-101, a mandrel A-1011, a spring ring A-10111, an expansion core wire A-10112, a mandrel B-1012, a spring ring B-10121, an expansion core wire B-10122, an adjustment core wire-102, a protection core wire-1021, an adjustment sleeve-103, a pushing handle-104, a handle inner core-1041, a handle outer shell-1042, a graduated scale-1043, a conveying catheter-2, a stent-3, a blood vessel inner wall-4 and a space region-5 between the stent and the blood vessel inner wall.
Detailed Description
The invention is described below with reference to the accompanying drawings and examples.
Example 1: (radial expansion by mandrel A)
As shown in fig. 1, a stent expansion device comprises an expansion assembly 101, an adjustment core wire 102 and an adjustment sleeve 103, wherein the adjustment sleeve 103 is sleeved at the proximal end of the adjustment core wire 102, the adjustment core wire 102 is in sliding fit with the adjustment sleeve 103, the expansion assembly 101 comprises a core shaft a1011, the core shaft a1011 is made of a memory alloy material, the memory shape of the core shaft a1011 is spiral, the core shaft a1011 is arranged around the adjustment core wire 102 in the axial direction, the distal end of the core shaft a1011 is fixedly connected with the distal end of the adjustment core wire 102, the proximal end is fixedly connected with the distal end of the adjustment sleeve 103, after the stent is released and expanded at a bending part of a blood vessel, the expansion assembly 101 is transferred into the stent, the adjustment sleeve 103 or the adjustment core wire 102 is moved in the axial direction to radially expand the core shaft a1011 to assist in making the stent to be attached to the inner wall of the blood vessel, one core shaft a1011 is used, and the core shaft a1011 is matched with the adjustment core wire during the delivery process, the stent has the advantages that the overall outer diameter is small, the stent can be pushed in a slender, long and tortuous blood vessel in a cranium, the expansion assembly reaches the position of a parent artery, the mandrel A expands in a spiral shape to open the stent, the structure is simple, the manufacturing cost is low, the position and the force of the mandrel A expansion are accurate and controllable, the vascular wall cannot be expanded or damaged when the stent is attached to the inner wall of the blood vessel, and the controllability is high; the whole design size of the stent expansion device is small, the stent expansion device can be directly conveyed through a conveying catheter of a conveying stent, the stent 3 is conveyed to a position of a parent artery through the conveying catheter and released, the stent conveying guide wire is retracted, the conveying catheter does not need to be withdrawn, the expansion assembly is transferred into the stent through the conveying catheter, the operation time is greatly saved, and the operation safety is improved.
In this embodiment, when the mandrel A1011 is contracted in the delivery catheter, the mandrel A1011 is placed in tension and against the adjusting core wire to ensure that the outer diameter of the stent expansion device in the vessel is minimized.
As shown in fig. 6, the mandrel a1011 is composed of an expansion core wire a10112 and a spring ring a10111, the spring ring a10111 is wound and fixed on the expansion core wire a10112, and the arrangement of the expansion core wire and the spring ring enables the mandrel a to have good flexibility and support, so that the mandrel a can be pushed in an intracranial blood vessel conveniently and has good stent-expanding effect.
In this embodiment, the expansion core wire a10112 may be made of nitinol, which has memory, and the material of the expansion core wire a is not limited thereto, but may be made of stainless steel.
The outer diameter of the mandrel A1011 is between 0.1mm and 0.5 mm.
The outer diameter of the adjusting core wire 102 is 0.05 mm-0.3 mm.
The outer diameter of the mandrel A1011 in this embodiment is set to 0.1mm and the outer diameter of the adjustment core wire 102 is set to 0.05mm, so that the mandrel A1011 is contracted in the delivery catheter to have the smallest overall outer diameter to fit the adjustment core wire 102, and to be moved in the intracranial blood vessel. The outer diameter of the mandrel a1011 in this embodiment refers to the outer diameter of the coil a and does not represent the overall outer diameter of the spiral in the expanded state of the mandrel a.
The pushing handle 104 of this embodiment further includes a handle housing 1042 and a handle inner core 1041, the handle inner core 1041 is provided with a slide, the inner wall of the handle housing 1042 is provided with a slide block matched with the slide, the handle housing 1042 is sleeved on the handle inner core 1041 and is in sliding fit, the proximal end of the adjusting core wire 102 is fixedly connected with the handle inner core 1041 or the handle housing 1042, the proximal end of the adjusting sleeve 103 is fixedly connected with the handle housing 1042 or the handle inner core 1041, the handle housing 1042 is pushed to slide axially along the handle inner core 1041, the adjusting sleeve 103 moves to drive the expansion assembly to expand radially or contract radially, or the adjusting core wire 102 moves to drive the expansion assembly to expand radially or contract radially.
A graduated scale 1043 is arranged on the handle inner core 1041.
In this embodiment, the adjusting sleeve 103 is fixedly connected to the handle housing 1042, and the adjusting sleeve 103 is driven to move axially by the axial movement of the handle housing 1042, so that the friction between the sliding block and the sliding track causes the handle housing 1042 to move axially only when the sliding block is pushed by a human force, thereby radially expanding or contracting the expanding assembly.
The structure of the pushing handle is various, and the relative displacement between the core wire and the adjusting sleeve can be adjusted, which is the prior art and is not described in detail herein.
The adjusting core wire 102 is fixedly wound with a protective core wire 1021 between the head and the distal end of the expansion component, and the protective core wire 1021 is arranged to improve the control force of the head end of the adjusting core wire 102.
After the expansion assembly is expanded at the bent part of the blood vessel once, if the stent is not completely attached to the inner wall of the blood vessel, the expansion assembly can be expanded again after moving the position of the expansion assembly back and forth, so that the stent can be completely attached to the inner wall of the blood vessel in the circumferential direction.
When the invention is used:
step S1: when the aneurysm is positioned at the intracranial vascular curve, an operator sends the stent 3 to the parent artery through the stent delivery guide wire and the delivery catheter 2, and the stent 3 is sent out from the delivery catheter 2 and self-expands;
step S2: the operator withdraws the stent delivery guide wire, and the delivery catheter 2 is still left in the intracranial blood vessel;
step S3: the stent expanding device is pushed in the conveying catheter 2 and transferred into the stent;
step S4: the delivery catheter 2 is withdrawn for a certain distance, so that the expansion assembly is moved out of the delivery catheter 2, an operator holds the push handle 104, pushes the handle shell 1042 towards the far end, the distance between the far end of the adjusting core wire 102 and the far end of the adjusting sleeve 103 is shortened, the mandrel A1011 expands radially to be spiral, and the stent is expanded to be attached to the inner wall of the blood vessel;
step S5: an operator holds the push handle 104, pulls the handle shell 1042 towards the proximal end to reduce the radial diameter of the stent 101, and then moves the stent integrally back and forth along the axial direction of the blood vessel to adjust the position of the stent;
step S6: the handle housing 1042 is pushed distally again to expand the stent to ensure the stent can be completely attached to the inner wall of the blood vessel;
step S7: after the stent is tightly attached to the inner wall of the blood vessel, an operator holds the pushing handle 104 and pulls the handle shell 1042 towards the proximal end, so that the radial diameter of the expansion assembly 101 is reduced;
step S8, the operator pushes the delivery catheter to the distal end, so that the expansion assembly 101 is retracted into the delivery catheter, and the delivery catheter and the stent expansion device are withdrawn out of the body.
Example 2 (radial expansion achieved by mandrel a, mandrel B cooperation):
as shown in fig. 2-13, a stent expanding device 1 comprises an expanding component 101, an adjusting core wire 102 and an adjusting sleeve 103, wherein the adjusting sleeve 103 is sleeved on a proximal end of the adjusting core wire 102, the adjusting core wire 102 is in sliding fit with the adjusting sleeve 103, the expanding component 101 comprises a core shaft a1011 and a core shaft B1012, the core shaft a1011 and the core shaft B1012 are made of memory alloy materials, the memory shapes of the core shaft a1011 and the core shaft B1012 are spiral, the rotation direction of the core shaft B1012 is opposite to that of the core shaft a1011, the core shaft a1011 and the core shaft B1012 are arranged around along the axial direction of the adjusting core wire 102, the core shaft B1012 is arranged to intersect with the core shaft a1011 in a mirror image manner, the distal ends of the core shaft a1011 and the core shaft B1012 are fixedly connected with the distal end of the adjusting core wire 102, the proximal end is fixedly connected with the distal end of the adjusting sleeve 103, and the core shafts a1011 and B1012 are radially expanded by axially moving the adjusting core wire 103 or the adjusting core wire 102, the auxiliary support 3 can be attached to the inner wall 4 of the blood vessel, the mandrel A1011 and the mandrel B1012 are arranged, the overall outer diameter is small, the support can adapt to the slender and long blood vessel in the cranium, the expansion assembly 101 can be conveniently and smoothly transferred in the intracranial blood vessel, the support 3 can be circumferentially expanded during expansion, the operation time is shortened, and the controllability is high, so that the blood vessel wall cannot be damaged.
In this embodiment, when the mandrels a1011 and B1012 are contracted in the delivery catheter, the mandrels a1011 and B1012 are in tension and tightly fit the core wire to ensure that the outer diameter of the stent expansion device in the blood vessel is minimized.
The mandrel A1011 consists of an expansion core wire A10112 and a spring ring A10111, the spring ring A10111 is wound and fixed on the expansion core wire A10112, the mandrel B1012 consists of an expansion core wire B10122 and a spring ring B10121, the spring ring B10121 is wound and fixed on the expansion core wire B10122, the arrangement of the expansion core wire and the spring ring enables the flexibility and the support of the mandrel A1011 and the mandrel B1012 to be good, and the effect of pushing and opening the stent in intracranial blood vessels is good.
As shown in fig. 7, the inner ring of the spring ring a10111 is a passage a through which the expansion core wire a10112 passes, the inner ring of the spring ring B10121 is a passage B through which the expansion core wire B10122 passes, the spring ring a10111 and the spring ring B10121 contact with each other at the intersection to form a communication passage communicating the passage a with the passage B, the expansion core wire a10112 and the expansion core wire B10122 both pass through the communication passage, the core shaft a1011 and the core shaft B1012 are in sliding fit, so that when the core shaft a1011 and the core shaft B1012 expand and contract, the core shaft a1011 and the core shaft B1012 cannot be separated, and the controllability of the expansion assembly is high.
As shown in fig. 8, the core shaft a1011 and the core shaft B1012 are at the intersection, the core shaft B1012 passes through between the expansion core wire a10112 and the spring ring a10111 or the core shaft a1011 passes through between the expansion core wire B10122 and the spring ring B10121, the core shaft a1011 and the core shaft B1012 are in sliding fit, so that when the core shaft a1011 and the core shaft B1012 expand and contract, the core shaft a1011 and the core shaft B1012 cannot be separated, and the controllability of the expansion assembly is high.
In this embodiment, the expansion core wire a10112 and the expansion core wire B10122 are made of nitinol, but the memory expansion core wire may be made of stainless steel, or the like.
The outer diameters of the mandrel A1011 and the mandrel B1012 are between 0.1mm and 0.5 mm.
The outer diameter of the adjusting core wire 102 is 0.05 mm-0.3 mm.
In this embodiment, the outer diameters of the core shaft A1011 and the core shaft B1012 are both set to be 0.1mm, and the outer diameter of the adjusting core wire 102 is set to be 0.05mm, so that the overall outer diameters of the core shaft A1011, the core shaft B1012 and the adjusting core wire 102 are minimized, and the movement in the intracranial blood vessel is facilitated.
The pushing handle 104 of this embodiment further includes a handle housing 1042 and a handle inner core 1041, the handle inner core 1041 is provided with a slide, the inner wall of the handle housing 1042 is provided with a slide block matched with the slide, the handle housing 1042 is sleeved on the handle inner core 1041 and is in sliding fit, the proximal end of the adjusting core wire 102 is fixedly connected with the handle inner core 1041 or the handle housing 1042, the proximal end of the adjusting sleeve 103 is fixedly connected with the handle housing 1042 or the handle inner core 1041, the handle housing 1042 is pushed to slide axially along the handle inner core 1041, the adjusting sleeve 103 moves to drive the expansion assembly to expand radially or contract radially, or the adjusting core wire 102 moves to drive the expansion assembly to expand radially or contract radially.
A graduated scale 1043 is arranged on the handle inner core 1041.
In this embodiment, the adjusting sleeve 103 is fixedly connected to the handle housing 1042, and the adjusting sleeve 103 is driven to move axially by the axial movement of the handle housing 1042, so that the friction between the sliding block and the sliding track causes the handle housing 1042 to move axially only when the sliding block is pushed by a human force, thereby radially expanding or contracting the expanding assembly.
The structure of the pushing handle is various, and the relative displacement between the core wire and the adjusting sleeve can be adjusted, which is the prior art and is not described in detail herein.
The adjusting core wire 102 is fixedly wound with a protective core wire 1021 between the head and the distal end of the expansion component, and the protective core wire 1021 is arranged to improve the control force of the head end of the adjusting core wire 102.
In this embodiment, as shown in fig. 4, after the stent 3 is released in the blood vessel, the stent 3 is not attached to the inner wall 4 of the blood vessel at the bend of the blood vessel, so as to form a space region 5 between the stent and the inner wall of the blood vessel.
As shown in FIG. 5, after the expansion member 101 is expanded, the stent 3 can be completely attached to the inner wall 4 of the blood vessel.
The lengths of the core wire, the sleeve and the delivery catheter are only shown in the drawing of the embodiment, and the actual length is far longer than the length.
After the expansion assembly is expanded at the bent part of the blood vessel once, if the stent is not completely attached to the inner wall of the blood vessel, the expansion assembly can be expanded again after moving the position of the expansion assembly back and forth, so that the stent can be completely attached to the inner wall of the blood vessel in the circumferential direction.
When the invention is used:
step S1: when the aneurysm is positioned at the intracranial vascular curve, an operator sends the stent 3 to the parent artery through the stent delivery guide wire and the delivery catheter 2, and the stent 3 is sent out from the delivery catheter 2 and self-expands;
step S2: the operator withdraws the stent delivery guide wire, and the delivery catheter 2 is still left in the intracranial blood vessel;
step S3: the stent expanding device is pushed in the conveying catheter 2 and transferred into the stent;
step S4: the conveying catheter 2 is withdrawn for a certain distance, so that the expansion assembly is moved out of the conveying catheter 2, an operator holds the pushing handle 104 and pushes the handle shell 1042 towards the far end, the distance between the far end of the adjusting core wire 102 and the far end of the adjusting sleeve 103 is shortened, the mandrel A1011 and the mandrel B1012 radially expand to form a spiral shape, the stent 3 is expanded, and the stent 3 is attached to the inner wall 4 of the blood vessel;
step S5: an operator holds the push handle 104, pulls the handle shell 1042 towards the proximal end to reduce the radial diameter of the stent expansion assembly 101, and then integrally moves the stent expansion device back and forth along the axial direction of the blood vessel;
step S6: the handle housing 1042 is pushed distally again to expand the stent to ensure the stent can be completely attached to the inner wall of the blood vessel;
step S7: after the stent 3 is tightly attached to the inner wall of the blood vessel, an operator holds the pushing handle 104 and pulls the handle shell 1042 towards the proximal end, so that the radial diameter of the expansion assembly 101 is reduced;
step S8, the operator pushes the delivery catheter 2 to the distal end, so that the expansion assembly 101 retracts into the delivery catheter, and the delivery catheter 2 and the stent expansion device 1 are withdrawn out of the body.
Claims (10)
1. A stent expansion device characterized by: including expansion element, adjustment core silk and adjustment sleeve pipe, the near-end cover of adjustment core silk is equipped with the adjustment sleeve pipe, adjustment core silk and adjustment sleeve pipe sliding fit, expansion element includes dabber A, dabber A adopts the memory alloy material to make, dabber A's memory shape is the spiral, dabber A encircles the setting along the axial of adjustment core silk, dabber A's distal end and the distal end fixed connection of adjustment core silk, near-end and adjustment sleeve pipe's distal end fixed connection.
2. A stent expansion device according to claim 1, wherein: the expansion assembly further comprises a mandrel B, the mandrel B is made of memory alloy materials, the memory shape of the mandrel B is spiral opposite to the rotation direction of the mandrel A, the mandrel B is arranged in a surrounding mode along the axial direction of the adjusting core wire and is intersected with the mandrel A in a mirror image mode, the far end of the mandrel B is fixedly connected with the far end of the adjusting core wire, and the near end of the mandrel B is fixedly connected with the far end of the adjusting sleeve.
3. A stent expansion device according to claim 2, wherein: the mandrel A is composed of an expansion core wire A and a spring ring A, the spring ring A is wound and fixed on the expansion core wire A, the mandrel B is composed of an expansion core wire B and a spring ring B, and the spring ring B is wound and fixed on the expansion core wire B.
4. A stent expansion device according to claim 3, wherein: the inner ring of the spring ring A is a passage A for the expansion core wire A to pass through, the inner ring of the spring ring B is a passage B for the expansion core wire B to pass through, the spring ring A and the spring ring B are contacted with each other at the intersection to form a communicating passage which enables the passage A to be communicated with the passage B, the expansion core wire A and the expansion core wire B both pass through the communicating passage, and the mandrel A is in sliding fit with the mandrel B.
5. A stent expansion device according to claim 3, wherein: the mandrel A and the mandrel B are arranged at the intersection, the mandrel B passes through the space between the expansion core wire A and the spring ring A or the mandrel A passes through the space between the expansion core wire B and the spring ring B, and the mandrel A and the mandrel B are in sliding fit.
6. A stent expansion device according to claim 2 or 3 or 4 or 5, wherein: the outer diameters of the mandrel A and the mandrel B are between 0.1mm and 0.5 mm.
7. A stent expansion device according to claim 6, wherein: the outer diameter of the adjusting core wire is 0.05 mm-0.3 mm.
8. A stent expansion device according to claim 1, 2, 3, 4, 5 or 7, wherein: still include the propelling movement handle, the propelling movement handle includes handle shell and handle inner core, be equipped with the slide on the handle inner core, be equipped with on the inner wall of handle shell with slide matched with slider, handle shell cover is on the handle inner core and sliding fit, the near-end and the handle inner core of adjustment core silk or handle shell fixed connection, the near-end and the handle shell of adjustment sleeve pipe or handle inner core fixed connection.
9. A stent expansion device according to claim 8, wherein: and a graduated scale is arranged on the inner core of the handle.
10. A stent expansion device according to claim 1, 2, 3, 4, 5, 7 or 9, wherein: and a protective core wire is fixedly wound between the head part of the adjusting mandrel and the far end of the expansion component.
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