CN113116594B - Blood flow guiding device and treatment device comprising same - Google Patents
Blood flow guiding device and treatment device comprising same Download PDFInfo
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- CN113116594B CN113116594B CN201911390539.1A CN201911390539A CN113116594B CN 113116594 B CN113116594 B CN 113116594B CN 201911390539 A CN201911390539 A CN 201911390539A CN 113116594 B CN113116594 B CN 113116594B
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Classifications
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Physics & Mathematics (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
Abstract
The present invention relates to a blood flow guiding device and a therapeutic device comprising the same, the blood flow guiding device comprising: the device comprises a bracket and a tectorial membrane, wherein the proximal end of the tectorial membrane is arranged on the bracket, and the distal end of the tectorial membrane is a free end. The stent is shorter, the covering film is longer, and the far end of the covering film is in a free state. Compared with the traditional covered stent, the flexibility of the stent is improved, the pushing resistance of the stent is reduced, the capability of the stent for passing through tortuous vessels is improved, and the size of a covered stent conveying system is reduced. The blood flow guiding device of the present invention can be delivered via a microcatheter to a finer vascular lesion site further distal intracranially.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a blood flow guiding device and a treatment device comprising the same.
Background
With the rapid development of national economy in China, the factors such as bad living habit, continuous acceleration of population aging process and the like cause cardiovascular and cerebrovascular diseases to become common diseases seriously threatening the life health of people while the living standard of people is increasingly improved, and the trend of low aging is already presented. According to world health organization statistics, the death number of the heart and cerebral vascular diseases in China is up to 300 ten thousand people each year, and the death number accounts for 51% of the total death etiology in China each year. The number of people dying from cardiovascular and cerebrovascular diseases every year is up to 1500 ten thousand people worldwide, and various causes of death are the first place.
Intracranial aneurysms (INTRACRANIAL ANEURYSM, IAN) are common hemorrhagic cerebrovascular diseases, most frequently found on the wall of intracranial arterial blood vessels, are the most common cause of subarachnoid hemorrhage (Subarachnoid hemorrhage, SAH), and have a second only incidence of cerebral thrombosis and hypertensive cerebral hemorrhage. Currently intracranial aneurysms (INTRACRANIAL ANEURYSM, IAN) are commonly treated by endovascular interventions, mainly spring coil embolic, dense-mesh stent, and covered stent therapies.
The spring coil embolism is an intravascular intervention technology widely applied, but for large and wide-necked cystic aneurysms, vesicular aneurysms, micro aneurysms, spindle aneurysms and interlayer aneurysms of intracranial arteries, the problems of low postoperative total occlusion rate, high long-term follow-up recurrence rate, rupture and hemorrhage of the aneurysm in operation and the like still exist in the spring coil embolism and the stent auxiliary spring coil embolism, and ideal treatment effect is difficult to obtain.
The reason for this is that the dense filling of the spring ring of the intracranial giant aneurysm is easy to generate a space occupying effect, and partial aneurysms cannot be densely filled; tumor neck residue after filling of wide carotid aneurysm; the wall of the blood bubble-like aneurysm is thin, the three-layer arterial vascular structure is not complete, and the micro-guide wire, the micro-guide tube and the spring ring touch the fragile aneurysm wall in the operation, so that the bleeding in the operation is easy to cause, and the disability rate and the death rate are high; the miniature aneurysm coil is difficult to stay in the tumor cavity, and partial coil is easy to protrude into the parent artery; the fusiform aneurysms and the dissection aneurysms have irregular tumor cavity morphology, no obvious limit exists between the tumor cavity and the normal blood vessel cavity, and the stent auxiliary spring ring cannot effectively remodel the lumen in the fusiform aneurysms.
The dense net stent therapy promotes blood retention and slow thrombosis in aneurysms by changing blood flow direction, promotes endothelial cells and neointimal tissue proliferation in the stent, and plays a role in repairing tumor-bearing arteries after a certain period by virtue of gradual intimalization of tumor necks, thereby achieving the aim of curing lesions. However, the dense mesh stent treatment method has the following problems: (1) After the stent is released, the displacement easily occurs, and the shrinkage condition of the stent is difficult to predict; (2) The delayed rupture of the aneurysm is easy to cause, and the exact reason of the delayed rupture is not completely clear, which is related to the fact that the effective blocking of the neck opening can not be realized immediately; (3) There is a risk of rupture of the aneurysm or recurrence of the aneurysm after surgery.
The dense net stent is used for treating the blood bubble-like aneurysms and spindle-shaped aneurysms, and a multi-stent overlapping technology is widely used. However, the treatment effect of the multi-stent overlapping technology has uncertainty, the number of the used stents is 2-5, the economic burden of patients is large, the operation time is long, the operation process is complex, and a certain recurrence rate is still realized after the operation.
The treatment concept of the covered stent for treating the intracranial aneurysm is changed from 'intratumoral filling' of a spring ring to 'intracavity isolation', and the treatment strategy is that the covered stent is arranged in a blood vessel under the condition that the spring ring is not used, a biological-physical barrier is arranged in a carrying aneurysm artery, the carrying aneurysm artery at the neck of the aneurysm is remodelled in the blood vessel and kept unobstructed, so that the intracranial aneurysm is isolated from the body circulation, thrombus is formed in the tumor cavity, and the purpose of curing pathological changes is achieved.
The tectorial membrane stent has more prominent advantages in the treatment of wide neck, huge, bleb-like, tiny, fusiform and interlayer aneurysms without important branch vessels, can isolate a tumor cavity from a blood vessel cavity, can immediately seal the neck of the aneurysm and change the blood flow dynamics in the carrying aneurysm, and realizes the true vascular reconstruction, thereby avoiding the risk of rupture and bleeding of the aneurysm in operation caused by touching a micro-wire, a micro-catheter and a spring coil in operation with the fragile tumor wall, strengthening the repair of the carrying aneurysm, avoiding the neck residue of the aneurysm, avoiding and relieving the occupation effect of the spring coil after the filling operation, and avoiding the recurrence, recanalization and rupture bleeding of the aneurysm after the operation.
The typical intracranial tectorial membrane stent in the existing market is a balloon-expanded laser engraving type stent, generally consists of a cobalt-based alloy stent and a polytetrafluoroethylene membrane sewn on the outer side of the stent, and the stent is arranged on a quick-exchange balloon catheter in advance and is conveyed and released by the balloon catheter. Such a stent has the following problems: (1) failure of the stent graft in place: the laser sculptured cobalt-based alloy stent has poor flexibility, is difficult to conform to intracranial tortuous vessels, and cannot ensure that the stent reaches a lesion part smoothly; (2) balloon vulnerable vessel: placing a stent on a blood vessel segment with obvious tortuosity, and straightening the tortuosity blood vessel when the saccule is expanded, so that the wall of the blood vessel is torn or branch arteries of the part to which the stent belongs are torn and damaged, and fatal hemorrhage is caused; in addition, the expansion of the balloon also causes damage to cells in the inner wall of the blood vessel, thereby leading to the formation of neointima tissue and the stenosis in the stent; (3) poor flexibility: after the stent is opened, the stent cannot be recovered again, and is difficult to move back and forth in the blood vessel, and if the stent is in place inaccurately, the stent is difficult to readjust.
Therefore, there is an urgent need to improve the intracranial stent graft so that it has better flexibility, and can be applied to the lesions of the intracranial distal blood vessels without using balloon dilation release, so as to reduce the damage to arterial blood vessels and endothelial cells in the stent release process.
Disclosure of Invention
In view of the above-described drawbacks of the prior art, an object of the present invention is to provide a blood flow guiding device which can be delivered and expanded without a balloon, which can reduce damage to arterial blood vessels and endothelial cells, which is more flexible, which has less push resistance, which has less compression volume, which has a greater ability to pass through tortuous vessels, and which can reach a lesion site further in the cranium, and a therapeutic device comprising the blood flow guiding device.
The present invention provides a blood flow guiding device comprising: the device comprises a bracket and a tectorial membrane, wherein the proximal end of the tectorial membrane is arranged on the bracket, and the distal end of the tectorial membrane is a free end.
Further, in the blood flow guiding device, the material of the cover film is at least one selected from degradable polymers and non-degradable polymers.
Further, in the blood flow guiding device, the surface of the covering film is provided with a plurality of micropores with diameters of 10 mu m-200 mu m.
Further, the blood flow guiding device further comprises a first developing element, and the first developing element is arranged at the distal end of the covering film.
Further, in the blood flow guiding device, the first developing element includes a developing sheet and/or a sprayed developing material.
Further, the blood flow guiding device further comprises a second developing element, and the second developing element is arranged at the proximal end of the bracket.
Further, in the blood flow guiding device, the stent comprises a plurality of interconnected waverods, and distal ends of the waverods at the most distal end are intersected two by two and form at least 2 closed ends.
Further, in the blood flow guiding device, a plurality of the wave rods are formed with at least 2 connection points, the wave rods form a continuous XX-shaped structure in a circumferential direction of the blood flow guiding device, and at least 2 connection points are offset from each other in an axial direction of the blood flow guiding device.
Further, in the blood flow guiding device, at least 2 of the closed ends are at different axial distances from the proximal end of the stent.
Further, in the blood flow guiding device, the stent is in a closed loop structure.
Further, in the blood flow guiding device, the proximal end of the bracket is a bevel, and an angle between the bevel and the axial direction of the blood flow guiding device is 20-60 degrees.
Further, in the blood flow guiding device, the length of the stent is 5mm to 20mm, and the length of the coating is 5mm to 60mm.
Further, in the blood flow guiding device, the material of the stent comprises super-elastic material.
Further, the blood flow guiding device further comprises a supporting wire arranged at the distal end of the bracket, and the supporting wire extends along the axial direction of the blood flow guiding device.
Further, in the blood flow guiding device, a through hole is formed in the top end of the wave rod at the most distal end in the bracket, and the supporting wire passes through the through hole and then is twisted to form a strip-shaped structure;
Or alternatively
The support wires are wound at the most distal end of the support and then are twisted together to form a strip-shaped structure;
Or alternatively
At least two supporting wires respectively penetrate through the bottom end of the wave rod at the farthest end in the bracket, are wound to the top end of the wave rod at the farthest end along the wave rod at the farthest end, and are twisted at the top end of the wave rod at the farthest end in a doubling way to form a strip-shaped structure;
Or alternatively
The wave rod is characterized in that a connecting rod is arranged at the bottom end of the wave rod at the farthest end, a spring structure is wound on the connecting rod, at least two supporting wires are inserted into a gap between the spring structure and the connecting rod, the supporting wires, the connecting rod and the spring structure are connected with each other through welding or bonding, and each supporting wire arranged on the connecting rod and one supporting wire arranged on the other connecting rod are twisted together to form a strip-shaped structure.
Further, in the blood flow guiding device, the covering film is disposed on an inner wall or an outer wall of the stent, or disposed on all or part of the waver rod.
Further, in the blood flow guiding device, the proximal end of the stent is a bevel, the covering film is arranged on the inner wall of the stent, the proximal end of the covering film covers the bevel and part of the outer wall of the stent from inside to outside, and the closed tail end is exposed out of the covering film;
Or alternatively
The proximal end of the bracket is an inclined groove, the covering film is arranged on the outer wall of the bracket and covers the closed tail end, and the inclined groove and part of the inner wall of the bracket are coated by the proximal end of the covering film from outside to inside.
Further, in the blood flow guiding device, the distal end of the supporting wire is provided with the first and third developing elements, and the first and third developing elements and the distal end of the covering film are flush at the same axial position of the blood flow guiding device.
Further, in the blood flow guiding device, the elastic modulus of the supporting wire is larger than the elastic modulus of the covering film;
And/or the number of the groups of groups,
The supporting wire is at least one selected from nickel-titanium alloy wires, nickel-titanium wires with developing core materials inside, cobalt-chromium alloy wires and polylactic acid wires.
The invention provides a therapeutic device comprising a delivery tube and a blood flow guiding device according to any one of the preceding claims; the delivery tube has an axially through lumen for receiving the blood flow guiding device and a wall of the lumen compresses the blood flow guiding device to bring the blood flow guiding device into a compressed state; the radial dimension of the lumen is from 0.017 inch to 0.029 inch.
The blood flow guiding device of the present invention comprises: the stent is characterized by comprising a stent and a tectorial membrane, wherein the proximal end of the tectorial membrane is arranged on the stent, the stent is shorter, the tectorial membrane is longer, and the distal end of the tectorial membrane is a free end and is in a free state. Compared with the traditional covered stent, the flexibility of the stent is improved, the pushing resistance of the stent is reduced, the capability of the stent for passing through tortuous vessels is improved, and the size of a covered stent conveying system is reduced.
Drawings
FIG. 1 is a schematic view showing the constitution of a blood flow guiding device according to an embodiment of the present invention;
FIG. 2 shows a schematic view of a stent structure comprising 2 closed ends according to an embodiment of the present invention;
FIG. 3 shows a schematic view of a stent structure comprising 3 closed ends according to an embodiment of the present invention;
FIG. 4 is a schematic view showing a support wire of an embodiment of the present invention twisted and formed into a strip-like structure after passing through a top end through hole of a distal-most wave rod in a stent;
FIG. 5 shows a schematic diagram of a support wire twisted and formed into a strip-like structure after the support wire is wrapped around the top end of the distal-most beam of the stent in accordance with an embodiment of the present invention;
FIG. 6 is a schematic diagram showing two support wires wound around the distal-most waverods in the support at the connection of the bottom ends of the waverods and extending to the top ends of the distal-most waverods, and twisted to form a strip structure;
FIG. 7 is a schematic view showing that a connecting rod is arranged at the bottom end of the furthest wave rod and a spring structure is wound on the connecting rod;
Fig. 8 shows a schematic view of a film attached to the inner wall of a stent according to an embodiment of the present invention.
Detailed Description
The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
In the description of the present invention, it should be understood that the terms "center," "lateral," "upper," "lower," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc. indicate orientations or positional relationships based on the orientation or positional relationships shown in the drawings, are merely for convenience in describing the present invention and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.
The following describes the blood flow guiding device according to the embodiments of the present application in detail with reference to the accompanying drawings. In the present application, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to one another from the perspective of a physician using the product, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to the end of the product that is proximal to the physician during normal operation, and "distal" generally refers to the end that first enters the patient.
A blood flow guiding device as shown in fig. 1, comprising: the stent comprises a stent 3 and a tectorial membrane 2, wherein the proximal end of the tectorial membrane 2 is arranged on the stent 3, the stent 3 is shorter, the tectorial membrane 2 is longer, the distal end of the tectorial membrane 2 is a free end, and the free end is not connected with or overlapped with the stent 3 and is in a free state. Compared with the traditional covered stent, the flexibility of the stent 3 is increased, the pushing resistance of the stent 3 is reduced, the capability of the stent 3 for passing through tortuous vessels is increased, and the size of a covered stent conveying system is reduced. The material of the cover film 2 of this embodiment is selected from at least one of a degradable polymer and a non-degradable polymer, such as polyester, polytetrafluoroethylene, polyurethane (PU) or polyethylene terephthalate (PET). The length of the coating film 2 of the embodiment ranges from 5 mm mm to 60 mm. The surface of the coating film 2 is provided with a plurality of micropores with diameters of 10 mu m-200 mu m. The shape of the micropores on the film 2 is not limited, and may be circular, quadrilateral, triangular, or other regular or irregular shapes, and the arrangement mode of the micropores on the film 2 is not limited, and may be uniformly distributed, unevenly distributed, or the like.
The present embodiment further includes a first developing element 5, where the first developing element 5 is disposed at a distal end of the covering film 2, and is used for displaying a distal boundary of the covering film 2. Preferably, the first developing member 5 includes a developing sheet and/or a sprayed developing material.
The present embodiment further comprises a second developing element 6, wherein the second developing element 6 is disposed at the proximal end of the bracket 3, and is used for displaying the opening condition of the bracket 3.
The stent 3 comprises a plurality of interconnected struts 302, the distal ends of the struts 302 at the distal most end intersecting one another and forming at least 2 closed ends 303. The closed end 303 may take on a V-shape, U-shape, sinusoidal shape, parabolic shape, etc.
In this embodiment, the plurality of wave rods 302 are formed with at least 2 connection points, and the plurality of wave rods 302 form a continuous XX-shaped structure in the circumferential direction of the blood flow guiding device, and at least 2 connection points are offset from each other in the axial direction of the blood flow guiding device, that is, the projections of the at least 2 connection points on a plane parallel to the axial direction of the blood flow guiding device are not on the same straight line perpendicular to the axial direction of the blood flow guiding device. The design makes the profile of the bracket 3 after compression smaller, and can play a role in reducing the pushing and recycling resistance of the bracket 3.
The axial distance between at least 2 of the closed ends 303 of this embodiment and the proximal end of the stent 3 is different so that the compressed end closed regions are axially offset, reducing the compression volume at the distal end, enabling adaptation to smaller delivery systems.
In one embodiment of the present invention, as shown in fig. 2, the left side of the stent 3 is a proximal connecting rod 301, and the right side is 2 closed ends 303, and this embodiment reduces the number of closed ends 303, reduces the metal amount, and makes the profile of the compressed stent 3 smaller by the connecting point (at A, B in the drawing) of the wave rod which is axially offset, so as to reduce the pushing and recovering resistance of the stent 3.
In another embodiment, as shown in fig. 3, the right side of the bracket 3 is provided with 3 closed ends 303, which are uniformly arranged in the circumferential direction, so as to provide uniform radial force in the circumferential direction for the covering film 2, and ensure that the covering film 2 is opened to adhere to the wall. The embodiment 3 has different lengths of the closed ends 303 in the axial direction of the blood flow guiding device, and the closed ends 303 are staggered in the axial direction after being compressed into a delivery system, so that the compression volume of the distal end is reduced, and the smaller delivery system can be adapted.
One of at least 2 connection points of the present invention may be provided as a separate structure, where separation of connection points means that a plurality of said waverods 302 abut or are close to each other, but do not connect or only partially connect waverods 302. For example, the stent 3 may be separated along the broken line in fig. 3, and in this case, the stent 3 has an open ring shape, so that the volume of the compressed stent 3 can be further reduced.
The material of the stent 3 in this embodiment includes super elastic material, and the stent is preferably a cut stent, which is knitted or cut. The super-elastic material refers to a material with nonlinear stress-strain relationship, and strain can be automatically recovered when the material is unloaded, such as nickel-titanium alloy material. Specifically, the bracket 3 can be formed by cutting nickel-titanium alloy pipes through laser, is in a super-elastic state at body temperature after heat treatment, and has large radial supporting force. The nickel-titanium alloy self-elastic material is used in the embodiment, the stent 3 can be automatically bounced to open the wall, and balloon delivery is not used any more, so that the problem that when the balloon is expanded, a tortuous vessel is straightened, and the vessel wall is torn or branch arteries of the part are torn and damaged, so that fatal hemorrhage is caused is avoided.
The stent 3 of the embodiment is of a closed-loop structure, and can be completely recovered to the micro-catheter or released. Preferably, the proximal end of the bracket 3 is an inclined groove, i.e. the bracket 3 adopts a single-point electrolytic detachment design, thereby being more convenient for detachment and recovery. The design of the inclined groove at the proximal end of the bracket 3 is not limited by the shape of a blood vessel, and the bracket is not folded and bent, has good adherence, and ensures adherence of the head end of a film. And the single-point release recovery bracket 3 has little influence on the blood flow in the lumen, and can judge whether the bracket 3 has an inner leak after release before release. The embodiment has good flexibility and can be repeatedly recycled and released so as to adjust the position of the device in the blood vessel. The angle between the slope opening and the axial direction of the blood flow guiding device is 20-60 degrees. The length d of the bracket 3 is 5 mm-20 mm.
As shown in fig. 1, the present invention further comprises a support wire 4 disposed at the distal end of the stent 3, the support wire 4 extending in the axial direction of the blood flow guiding device. The elastic modulus of the supporting wire 4 is larger than that of the covering film 2, and the supporting wire has certain deformability. The supporting wire 4 in this embodiment is at least one selected from a nickel-titanium alloy wire, a nickel-titanium wire with a developing core material (tantalum core or platinum core) inside, a cobalt-chromium alloy wire and a polylactic acid wire, and mainly plays roles of stress transition, supporting the coating film 2 and developing.
In order to enhance the supporting and developing effects, the supporting wire 4 may be twisted together, and a third developing element 7 is additionally disposed at the distal end of the supporting wire, where the third developing element 7 and the distal end of the covering film 2 are located at the same axial position of the blood flow guiding device, so as to display the boundary of the distal end of the covering film 2, thereby achieving the purpose of displaying the length of the covering film 2.
The supporting wire 4 of the present embodiment may be a woven wire or a monofilament, and the present invention is not limited thereto. The support wire 4 has a diameter of 0.001 inch to 0.002 inch.
In one embodiment of the present invention, as shown in fig. 4, a through hole is provided at the distal end of the wave beam 302 in the support 3, and the support wire 4 is twisted by a parallel wire after passing through the through hole and forms a strip structure, and the strip structure is parallel to the axial direction of the blood flow guiding device.
In another embodiment, as shown in fig. 5, the supporting wire 4 is twisted and formed into a strip structure after being wound around the distal-most end of the stent 3 and the top end of the wave beam 302.
In still another embodiment, as shown in fig. 6, at least two supporting wires 4 respectively pass through the bottom end of the wave beam 302 at the most distal end in the bracket 3, are wound around the wave beam 302 at the most distal end to the top end of the wave beam 302, and are twisted together at the top end of the wave beam 302 at the most distal end to form a strip structure. The two supporting wires 4 may be formed by folding and separating one supporting wire 4.
It should be noted that, in this embodiment, the two supporting wires 4 are respectively located at the inner side and the outer side of the distal-most end of the top end of the wave beam 302, and may not be the same side, and if the two supporting wires 4 are located at the same side of the distal-most end of the top end of the wave beam 302, the starting point of the kink of the supporting wire 4 may not be fixed, and the supporting or stress releasing effect may not be enhanced.
Preferably, the developing coil can be welded at the far end of the strip-shaped structure, so that the bracket 3 presents continuous YY/YYY developing patterns in the circumferential direction of the blood flow guiding device under the radioscopy, and the developing effect is good.
In still another embodiment, as shown in fig. 7, a connecting rod 305 is disposed at the bottom end of the wave rod 302 at the most distal end, a spring structure 306 is wound around the connecting rod 305, at least two supporting wires 4 are inserted into a gap between the spring structure 306 and the connecting rod 305, the supporting wires 4, the connecting rod 305 and the spring structure 306 are connected to each other by welding or bonding, and one supporting wire 4 disposed on each connecting rod 305 is twisted with one supporting wire 4 disposed on the other connecting rod 305 in parallel to form a strip structure, and the strip structures are spaced apart in the circumferential direction.
The spring structure 306 in this embodiment is a developing spring, and is used to fix the opening condition of the supporting wire 4 and the display bracket 3. In other embodiments, the spring structure 306 may not be developed, but merely serve as a fixation.
The coating 2 of the present invention is disposed on the inner wall or the outer wall of the stent 3, or on all or part of the wave beam 302. The fixing mode of the covering film 2 and the bracket 3 or the wave beam 302 is stitching, hot melting, hot pressing, electrostatic spinning or a combination of one or more of the above modes.
In one embodiment of the present invention, as shown in fig. 8, the proximal end of the stent 3 is a bevel, the covering film 2 is disposed on the inner wall of the stent 3, the proximal end of the covering film 2 is coated with the bevel and a part of the outer wall of the stent 3 from inside to outside through a hot melting process, and the closed end 303 is exposed outside the covering film 2.
In another embodiment provided by the invention, the covering film 2 may also be disposed on the outer wall of the stent 3 and cover the closed end 303, and the proximal end of the covering film 2 covers the bevel and a part of the inner wall of the stent 3 from outside to inside through a hot melting process.
Preferably, the coating 2 of the present invention may not be completely coated on the bevel groove, but coated on all or part of the waveguide 302, and this coating method obviously reduces the coating area of the bevel groove, and avoids the occlusion of the branched blood vessel caused by the coating of the bevel opening.
The invention also provides a treatment device, which comprises a conveying pipe and the blood flow guiding device; the delivery tube has an axially through lumen for receiving the blood flow guiding device and walls of the lumen squeeze the blood flow guiding device to cause the blood flow guiding device to assume a compressed state. The radial dimension of the lumen is from 0.017 inch to 0.029 inch. The blood flow guiding device can be conveyed through a micro-catheter to reach a lesion position with finer blood vessels at a far end in the cranium.
In summary, according to the blood flow guiding device provided by the invention, the stent 3 can be automatically flicked to open the wall without using the balloon for conveying, so that the problem of fatal hemorrhage caused by tearing of the vessel wall or tearing and damage of branch arteries at the part of the vessel wall caused by straightening a tortuous vessel when the balloon is inflated is avoided. Meanwhile, the blood flow guiding device has smaller compression volume and better flexibility, and can reduce the damage to arterial blood vessels and endothelial cells and reduce the pushing resistance in the release process. Compared with the prior art, the invention has stronger capability of passing through tortuous vessels, can reach the lesion position at the more distant end in the cranium, and further optimizes the current treatment method for intracranial aneurysm.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (18)
1. A blood flow guiding device, comprising: the device comprises a bracket (3) and a covering film (2), wherein the proximal end of the covering film (2) is arranged on the bracket (3), and the distal end of the covering film (2) is a free end; the free end is not connected with or overlapped with the bracket and is in a free state; the bracket (3) comprises a plurality of wave rods (302) which are connected with each other, and the distal ends of the wave rods (302) at the most distal end are connected with each other in pairs to form at least 2 closed ends (303); -at least 2 of said closed ends (303) are at different axial distances from the proximal end of said stent (3); the blood flow guiding device further comprises at least two supporting wires (4), wherein the proximal ends of the supporting wires (4) are respectively arranged at least 2 closed tail ends (303), and the supporting wires (4) extend along the axial direction of the blood flow guiding device; the distal end of the support wire (4) is provided with a third developing element (7), and the third developing element (7) and the distal end of the covering film (2) are positioned on the same axial position of the blood flow guiding device.
2. The blood flow guiding device according to claim 1, wherein the material of the cover film (2) is selected from at least one of degradable polymers and non-degradable polymers.
3. The blood flow guiding device according to claim 1 or 2, wherein the surface of the cover film (2) has a plurality of micropores with a diameter of 10 μm to 200 μm.
4. The blood flow guiding device according to claim 1 or 2, further comprising a first visualization element (5), the first visualization element (5) being arranged at the distal end of the covering film (2).
5. The blood flow guiding device according to claim 4, wherein the first visualization element (5) comprises a visualization sheet and/or a spray visualization material.
6. The blood flow guiding device according to claim 1 or 2, further comprising a second visualization element (6), the second visualization element (6) being arranged at the proximal end of the stent (3).
7. The blood flow guiding device according to claim 1, wherein a plurality of the wave bars (302) are formed with at least 2 connection points, the plurality of wave bars (302) form a continuous XX-type structure in a circumferential direction of the blood flow guiding device, and at least 2 connection points are offset from each other in an axial direction of the blood flow guiding device.
8. The blood flow guiding device according to claim 1, characterized in that the stent (3) is of closed loop construction.
9. The blood flow guiding device according to claim 8, characterized in that the proximal end of the stent (3) is a ramp mouth, the angle between the ramp mouth and the axis of the blood flow guiding device being 20-60 degrees.
10. The blood flow guiding device according to claim 1, characterized in that the stent (3) has a length of 5-20 mm and the cover (2) has a length of 5-60 mm.
11. The blood flow guiding device according to claim 1, characterized in that the material of the stent (3) comprises a superelastic material.
12. The blood flow guiding device according to claim 1, wherein a through hole is arranged at the top end of the wave rod (302) at the most distal end in the bracket (3), and the supporting wire (4) is twisted and formed into a strip-shaped structure after passing through the through hole;
Or alternatively
The supporting wire (4) is wound at the top end of the wave rod (302) at the most far end of the bracket (3) and then twisted to form a strip-shaped structure;
Or alternatively
At least two supporting wires (4) respectively penetrate through the bottom end of the wave rod (302) at the farthest end in the bracket (3), are wound to the top end of the wave rod (302) at the farthest end along the wave rod (302) at the farthest end, and are twisted at the top end of the wave rod (302) at the farthest end in a doubling mode to form a strip-shaped structure;
Or alternatively
The wave rod is characterized in that a connecting rod (305) is arranged at the bottom end of the wave rod (302) at the farthest end, a spring structure (306) is wound on the connecting rod (305), at least two supporting wires (4) are inserted into gaps between the spring structure (306) and the connecting rod (305), the supporting wires (4), the connecting rod (305) and the spring structure (306) are connected with each other through welding or bonding, and each connecting rod (305) is provided with one supporting wire (4) and the other supporting wire (4) which are arranged on the connecting rod (305) and twisted to form a strip-shaped structure.
13. The blood flow guiding device according to claim 1, characterized in that the cover (2) is arranged on an inner or outer wall of the stent (3).
14. The blood flow guiding device according to claim 1, wherein the cover film (2) is arranged on all or part of the wave beam (302).
15. The blood flow guiding device according to claim 13 or 14, wherein the proximal end of the stent (3) is a ramp mouth, the covering film (2) is arranged on the inner wall of the stent (3), the proximal end of the covering film (2) covers the ramp groove and part of the outer wall of the stent (3) from inside to outside, and the closed end (303) is exposed outside the covering film (2);
Or alternatively
The proximal end of the bracket (3) is a slope opening, the covering film (2) is arranged on the outer wall of the bracket (3) and covers the closed tail end (303), and the proximal end of the covering film (2) is coated with the slope groove and part of the inner wall of the bracket (3) from outside to inside.
16. The blood flow guiding device according to claim 1, characterized in that the elastic modulus of the support wire (4) is greater than the elastic modulus of the covering film (2);
And/or the number of the groups of groups,
The supporting wire (4) is at least one selected from nickel-titanium alloy wires, cobalt-chromium alloy wires and polylactic acid wires.
17. The blood flow guiding device of claim 16, wherein the nitinol wire has a visualization core material inside.
18. A therapeutic device comprising a delivery tube and the blood flow guiding device of any one of claims 1-17; the delivery tube has an axially through lumen for receiving the blood flow guiding device and a wall of the lumen compresses the blood flow guiding device to bring the blood flow guiding device into a compressed state; the radial dimension of the lumen is from 0.017 inch to 0.029 inch.
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| CN1409622A (en) * | 1999-09-23 | 2003-04-09 | 先进扩张技术公司 | Bifurcation stent system and method |
| CN110381855A (en) * | 2017-01-06 | 2019-10-25 | 因赛普特有限责任公司 | Anti-thrombogenic coatings for aneurysm treatment device |
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| DE102010035543A1 (en) * | 2010-08-26 | 2012-03-01 | Acandis Gmbh & Co. Kg | Medical device and system with such a device |
| CN103379882B (en) * | 2010-12-20 | 2015-12-16 | 哥德堡移植技术公司 | Removable stent and method of production |
| DE102011012501A1 (en) * | 2011-02-25 | 2012-08-30 | Phenox Gmbh | Implant with fiber fleece |
| CN110236734B (en) * | 2019-07-17 | 2024-06-04 | 通桥医疗科技有限公司 | Completely recyclable braided stent |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1409622A (en) * | 1999-09-23 | 2003-04-09 | 先进扩张技术公司 | Bifurcation stent system and method |
| CN110381855A (en) * | 2017-01-06 | 2019-10-25 | 因赛普特有限责任公司 | Anti-thrombogenic coatings for aneurysm treatment device |
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