Self-expanding bracket systemTechnical 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 stentoverlap Length L of self-expanding stent in press-holding state3comp Ratio L ofoverlap /L3comp 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 stentoverlap Length L of self-expanding stent in press-holding state3comp Ratio L ofoverlap /L3comp 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 3overlap Length L of self-expanding stent in press-holding state3comp Ratio L ofoverlap /L3comp 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 3overlap Length L of self-expanding stent3comp Ratio L ofoverlap /L3comp 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.