CN110192941B - Self-expanding bracket system - Google Patents

Self-expanding bracket system Download PDF

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Publication number
CN110192941B
CN110192941B CN201910584701.7A CN201910584701A CN110192941B CN 110192941 B CN110192941 B CN 110192941B CN 201910584701 A CN201910584701 A CN 201910584701A CN 110192941 B CN110192941 B CN 110192941B
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self
expanding
valve
stent
constraint
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CN201910584701.7A
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CN110192941A (en
Inventor
王媛媛
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Jiangsu Nuanyang Medical Instruments Co ltd
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Jiangsu Nuanyang Medical Instruments Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention discloses a self-expanding stent system, which comprises a micro-catheter, a push rod, a self-expanding constraint valve and a self-expanding stent, wherein the micro-catheter can slide along a longitudinal axis to completely cover the self-expanding stent and the self-expanding constraint valve in a pressure holding state at the far end of the micro-catheter; the proximal end part of the self-expanding stent is wrapped by a self-expanding binding valve, and the proximal end head and the distal end head of the self-expanding stent are respectively provided with a developing element; the proximal end part of the self-expanding constraint valve is fixed on the push rod; the pushing rod is positioned at the distal end head of the self-expanding binding valve and is provided with a developing element A and a developing element B. The self-expanding stent system, self-expanding constraining flaps and self-expanding stents have a first state and a second state; in the second state, the leaflets of the self-expanding restraining valve automatically open, and the proximal end of the self-expanding stent is disengaged and released from the positioning module on the push rod. The conveying system ensures that the stent is extruded and deformed in the pushing process, ensures that the released stent completely covers the lesion position, effectively prevents falling or blockage and shortens the operation time.

Description

Self-expanding bracket system
Technical Field
The invention relates to the technical field of medical instruments, in particular to a self-expanding bracket system.
Background
Intracranial aneurysms are a common and high mortality and disability rate cerebrovascular disease that forms as a result of local vascular abnormalities that are thought to result in tumor-like projections under the impact of blood flow, which is also the origin of the name of an aneurysm and is not itself a tumor. The mortality rate of the ruptured intracranial aneurysm is very high and almost reaches 50%, even if the ruptured intracranial aneurysm survives, the disability rate is also high to 50%, the traditional treatment means adopts the intracranial aneurysm clamping operation, but the operation difficulty is high, the operation risk is high, and years of operation experience support is needed, so that the treatment means is limited by a large bottleneck, and along with the rapid development of interventional treatment technology, the intracranial aneurysm interventional treatment has obvious advantages of micro-trauma, safety, effectiveness and the like compared with the traditional treatment, and the intracranial aneurysm interventional treatment is widely accepted and accepted by doctors and patients.
The blood flow guiding device is an emerging intracranial aneurysm treatment method in recent years, the principle is to reconstruct the correct path of a blood vessel at the aneurysm, restore the blood flow direction, once the blood flow guiding device is brought out, the attention of a plurality of doctors and patients at home and abroad is obtained, the advanced treatment mechanism and the product idea can remodel the blood flow direction of the intracranial blood vessel, gradually shrink the aneurysm until the aneurysm disappears, and compared with spring coil thrombus race treatment, the blood flow guiding device has obvious advantages and reduces the long-term problem, and belongs to a terminal treatment method. And for large-scale and huge aneurysms, the blood flow guiding device is generally used by matching a self-expanding stent with a conveying device, and the self-expanding stent is conveyed to the position of the intracranial aneurysms through a microcatheter and released, however, the current blood flow guiding device has the advantages that the stent is dragged to a target position through friction components on a conveying system, and the mode leads to larger stress in the pushing process due to smaller inner diameter of the microcatheter, so that the resistance of a plurality of doctors in the feedback pushing process is larger and unacceptable. If the design is improper or the sizes are not matched, the stent is likely to be extruded and deformed in the pushing process, so that the lesion position can not be completely covered after the stent is released, the stent is separated or blocked, the operation time is prolonged, the operation content is complex, and even the life safety of a patient is endangered.
Disclosure of Invention
1. Technical problem to be solved
The technical problem solved by the invention is that the defects that the stent is dragged to the target position through friction construction on a conveying system, the force applied in the pushing process is larger due to the smaller inner diameter of the microcatheter, the resistance of a plurality of doctors in the feedback pushing process is larger and unacceptable, the stent is likely to be extruded and deformed in the pushing process, the lesion position cannot be completely covered after release, the stent falls off or is blocked, the operation time is prolonged, the operation content is complex, and even the life safety of a patient is endangered are overcome.
2. Technical method
In order to achieve the above purpose, the present invention provides the following technical solutions: the self-expanding stent system comprises a micro-catheter, a push rod, a self-expanding constraint valve and a self-expanding stent, wherein the micro-catheter can slide along a longitudinal axis to completely cover the self-expanding stent and the self-expanding constraint valve in a far-end press-holding state of the micro-catheter; the proximal end head of the self-expanding bracket is clung to a positioning module at the distal end of the pushing rod, and the positioning module is fixed on the pushing rod; the proximal end part of the self-expanding stent is wrapped by a self-expanding binding valve, and the length L of the overlapping part of the self-expanding binding valve and the self-expanding stent overlap Length L of self-expanding stent in press-holding state 3comp Ratio L of overlap /L 3comp The range is 5% -30%;
the proximal end head and the distal end head of the self-expanding bracket are respectively provided with a developing element A and a developing element B; the self-expanding binding valve proximal end part is fixed on the push rod, and the distal end part of the fixed area is wrapped by the developing element A; the pushing rod is provided with a developing element B at the distal end head of the self-expanding binding valve.
The self-expansion bracket system is characterized in that the front end of the self-expansion constraint valve is fixedly connected with the rear end of the push rod through welding, glue bonding or mechanical connection, and the positioning module connected with the front end of the push rod is wrapped inside the self-expansion constraint valve.
The self-expanding constraint valve material is a polymer material, and comprises one or more of PTFE, FEP, fluorine-containing material, POM, nylon, pebax, polyimide, polyurethane, polyester, polyethylene, polyvinyl chloride and polyvinylpyrrolidone, wherein the self-expanding constraint valve material is a multi-group valve leaf structure capable of being opened by self, and the number of the valve leaf groups is 2-24, preferably 6.
In the self-expanding stent system, the valve leaves of the self-expanding constraint valve are rectangular or are combined by rectangular and circular arc.
The self-expanding stent system, wherein the self-expanding constraint valve is in a first state, the plurality of groups of valve leaves are closed to tightly wrap the proximal end part of the self-expanding stent, and the length L of the overlapping part of the self-expanding constraint valve and the self-expanding stent overlap Length L of self-expanding stent in press-holding state 3comp Ratio L of overlap /L 3comp In the range of 3% to 50%, preferably 10%.
In the self-expanding stent system, the self-expanding constraint valve is in the second state, a plurality of groups of valve leaves are automatically opened, and the self-expanding stent is automatically unfolded.
In the self-expanding stent system, the proximal end of the self-expanding constraint valve is fixed at the distal end of the push rod by welding, glue bonding or mechanical connection.
3. Advantageous effects
In summary, the beneficial effects of the invention are as follows:
(1) The self-expanding constraining flap has a first state and a second state; in the first state, a portion of the proximal end of the self-expanding stent or the entirety of the self-expanding stent is wrapped with a self-expanding constraining flap; in the second state, the leaflets of the self-expanding restraining valve automatically open, and the proximal end of the self-expanding stent is disengaged from the positioning module on the push rod and released. The conveying system ensures that the deformation bracket is extruded in the pushing process, ensures that the released bracket completely covers the lesion position, effectively prevents falling or blockage and shortens the operation time;
(2) The self-expanding stent adopted has two states; in the first state, the proximal end of the self-expanding stent or the stent as a whole is constrained by the self-expanding constraining petals, assuming a contracted state; in the second state, the self-expanding stent is released from the constraint valve, presents a stretched cylindrical shape, completely covers the lesion position and is convenient to use.
Drawings
FIG. 1 is a schematic cross-sectional view of a first state of the self-expanding, constraining valve in a delivery configuration of the present invention;
FIG. 2 is a simplified cross-sectional view of a self-expanding constraint lobe in a first state;
FIG. 3 is a simplified cross-sectional view of a self-expanding stent release process;
FIG. 4 is a simplified cross-sectional view of the self-expanding stent in a second state with the self-expanding constraining petals fully released;
FIG. 5 is a side view of a second state of the self-expanding, constraining valve in accordance with the present invention, showing expansion of the distal portion of the self-expanding, constraining valve;
FIG. 6 is a side view of a second state of the self-expanding, constraining valve in accordance with the present invention, showing expansion of the distal portion of the self-expanding, constraining valve;
fig. 7 is a schematic top view of a second state of the self-expanding constraint flap of the present invention.
In the figure: 1. a microcatheter; 2. self-expanding binding petals; 3. a self-expanding stent; 4. a developing member A; 5. a positioning module; 6. a developing member B; 7. a push rod; 8. self-expanding constraint valve leaflets.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Referring to fig. 1-7, the present invention provides a technical solution: a self-expanding stent system, which comprises a micro-catheter 1, a push rod 7, a self-expanding constraint valve 2 and a self-expanding stent 3, wherein when the self-expanding stent system is in a conveying configuration, the micro-catheter 1 can slide along a longitudinal axis to completely cover the self-expanding stent 3 and the self-expanding constraint valve 2 in a state of being pressed and held at the far end of the micro-catheter 1; the proximal end head of the self-expanding bracket 3 is tightly attached to the positioning module 5 at the distal end of the push rod 7, and the positioning module 5 is permanently fixed on the push rod 2; the proximal end part of the self-expanding stent 3 is wrapped by the self-expanding constraint valve 2, and the length L of the overlapping part of the self-expanding constraint valve 2 and the self-expanding stent 3 overlap Length L of self-expanding stent in press-holding state 3comp Ratio L of overlap /L 3comp At least 5%, at most 30%; the proximal end head and the distal end head of the self-expanding bracket 3 are respectively provided with a developing element A and a developing element B; the proximal end part of the self-expanding binding valve 2 is permanently fixed on the push rod 7, and the distal end part of the fixed area is wrapped by the developing element A4; the pushing rod 7 is provided with a developing element B6 at the distal end head of the self-expanding binding valve 2.
The self-expanding constraint valve 2 is made of a high polymer material, and comprises one or more of PTFE, FEP, fluorinated ethylene propylene copolymer and other fluorine-containing materials, POM, nylon, pebax, polyimide, polyurethane, polyester, polyethylene, polyvinyl chloride, polyvinylpyrrolidone-coated and the like, and the self-expanding constraint valve is in a multi-group valve leaf 8 structure capable of being opened by self, wherein the structure is at least 2 groups, at most 24 groups and preferably 6 groups. The valve leaves 8 of the self-expanding constraint valve 2 are rectangular or are combined by rectangular and circular arc shapes.
When the self-expanding stent system is in a delivery configuration, the self-expanding constraint valve 2 is in a first state, the multiple groups of valve leaves 8 are closed, the proximal end part of the self-expanding stent 3 or the whole self-expanding stent 3 is tightly wrapped, the self-expanding stent 3 is in a pressing and holding state, and the length L of the overlapped part of the self-expanding constraint valve 2 and the self-expanding stent 3 overlap Length L of self-expanding stent 3comp Ratio L of overlap /L 3comp At least 3%, up to 50%, preferably 10%.
When the self-expanding stent system is in a release configuration, the self-expanding constraint valve 2 is in a second state, a plurality of groups of valve leaves 8 are automatically opened, the proximal end of the self-expanding stent 3 is separated from and released from the positioning module 5 on the push rod 7, and the self-expanding stent is automatically unfolded.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (4)

1. A self-expanding stent system, comprising a microcatheter (1), a push rod (7), a self-expanding binding flap (2) and a self-expanding stent (3), characterized in that: the micro-catheter (1) can slide along the longitudinal axis, so that the distal end of the micro-catheter (1) can completely cover the self-expanding bracket (3) and the self-expanding constraint valve (2) in the press-holding state; the proximal end head of the self-expanding bracket (3) is tightly attached to a positioning module (5) at the distal end of the pushing rod (7), and the positioning module (5) is fixed on the pushing rod (7); the self-expanding constraint valve (2) is of a multi-group valve leaf (8) structure capable of being opened automatically, the number of the valve leaf groups is 2-24, when the self-expanding constraint valve (2) is in a first state, the multi-group valve leaf (8) is closed, the proximal end part of the self-expanding bracket (3) is wrapped by the self-expanding constraint valve (2), and the length L of the overlapped part of the self-expanding constraint valve (2) and the self-expanding bracket (3) overlap Length L of self-expanding stent in press-holding state 3comp Ratio L of overlap /L 3comp The range is 5% -30%; when the self-expanding constraint valve (2) is in a second state, a plurality of groups of valve leaves (8) are automatically opened, and the self-expanding bracket (3) is automatically expanded;
the proximal end head and the distal end head of the self-expanding bracket (3) are respectively provided with a developing element A (4) and a developing element B (6); the proximal end part of the self-expanding binding valve (2) is fixed on the pushing rod (7), and the distal end part of the fixed area is wrapped by the developing element A (4); the pushing rod (7) is positioned at the distal end head of the self-expanding constraint valve (2) and is provided with a developing element B (6).
2. A self-expanding stent system according to claim 1, wherein: the self-expanding binding flap (2) is made of a high polymer material, and comprises one or more of PTFE, FEP, fluorine-containing material, POM, nylon, pebax, polyimide, polyurethane, polyester, polyethylene, polyvinyl chloride and polyvinylpyrrolidone.
3. A self-expanding stent system according to claim 1, wherein: the valve leaves (8) of the self-expanding constraint valve (2) are rectangular.
4. A self-expanding stent system according to claim 1, wherein: the proximal end of the self-expansion binding valve (2) is fixed at the distal end of the pushing rod (7) through welding, glue bonding or a mechanical connection method.
CN201910584701.7A 2019-07-01 2019-07-01 Self-expanding bracket system Active CN110192941B (en)

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CN110192941B true CN110192941B (en) 2024-04-05

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111467102A (en) * 2020-05-25 2020-07-31 李立 Blood flow guider's conveyor

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CN107496057A (en) * 2017-09-20 2017-12-22 金仕生物科技(常熟)有限公司 Self-inflated intervenes valve and its application method
CN210811784U (en) * 2019-07-01 2020-06-23 江苏暖阳医疗器械有限公司 Self-expanding stent system

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US7731741B2 (en) * 2005-09-08 2010-06-08 Boston Scientific Scimed, Inc. Inflatable bifurcation stent
US7712606B2 (en) * 2005-09-13 2010-05-11 Sadra Medical, Inc. Two-part package for medical implant
US8764820B2 (en) * 2005-11-16 2014-07-01 Edwards Lifesciences Corporation Transapical heart valve delivery system and method
US8696698B2 (en) * 2009-12-02 2014-04-15 Surefire Medical, Inc. Microvalve protection device and method of use for protection against embolization agent reflux
WO2012118508A1 (en) * 2011-03-03 2012-09-07 Empire Technology Development Llc Temporary perfusion channel percutaneous delivery of balloon-expandable stents

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Publication number Priority date Publication date Assignee Title
CN107496057A (en) * 2017-09-20 2017-12-22 金仕生物科技(常熟)有限公司 Self-inflated intervenes valve and its application method
CN210811784U (en) * 2019-07-01 2020-06-23 江苏暖阳医疗器械有限公司 Self-expanding stent system

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