CN110811735A - Locally-enhanced nickel-titanium alloy intracranial support - Google Patents
Locally-enhanced nickel-titanium alloy intracranial support Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—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
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
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Abstract
The invention relates to a local enhanced nickel-titanium alloy intracranial stent which can be used for assisting a spring ring embolism to treat intracranial aneurysm and belongs to the field of medical instruments. The intracranial stent main body is a tubular structure consisting of a single rhombus unit consisting of a sine wave structure and a connecting rod and a double rhombus unit formed by combining the two single rhombus units. The flexibility of support can be improved to two rhombus units, and the stability support performance of support can be guaranteed to a certain extent to single rhombus structure. In addition, various support structures can be designed and changed by adjusting the positions and the number of the units with different shapes, so that different mechanical properties are realized. The design of the local enhanced nickel-titanium alloy intracranial support based on the mixed unit structure can design an optimized unit proportion aiming at different use environments, realizes the support enhancement of a specific position (such as a tumor diameter opening) on the premise of ensuring the support compliance, and can be used for assisting the spring ring embolism.
Description
Technical Field
The invention relates to a local enhanced nickel-titanium alloy intracranial stent which can be used for assisting a spring ring embolism to treat intracranial aneurysm and belongs to the field of medical instruments.
Background
Intracranial aneurysm is abnormal expansion of cerebral vessels caused by the causes of hypertension, atherosclerosis, potential vascular diseases, trauma, infection, tumor and the like, and is also the primary cause of hemorrhagic cerebrovascular diseases. With the continuous innovation of endovascular interventional materials and the continuous development of related technologies, the treatment of intracranial aneurysms is made simpler and safer, and more intracranial aneurysms can be completely embolized by interventional means. But for intracranial complex aneurysms, such as: the interventional therapy difficulty is still very high under the conditions of huge size, wide neck, fusiform shape, interlayer, blood vessel puncture and branch, and the like; the existing product is difficult to coordinate flexibility and supporting performance, the whole stent with high rigidity is hard, the adherence is poor after implantation, and the excessive hyperplasia of endothelium is easily caused. The support performance of the stent with good compliance is often not enough, and complications such as stent displacement, poor stent expansion, collapse and the like exist at the position where the stent is placed into a complex lesion.
Disclosure of Invention
The invention aims to provide a local enhanced nickel-titanium alloy intracranial support which can be used for assisting in the embolism of a spring ring. The intracranial stent comprises a flexible double-diamond unit and a single-diamond unit with stronger support. Various support structures can be designed and changed by adjusting the positions, shapes and quantity ratios of different units, so that different mechanical properties are realized; the support enhancement of a specific position (such as a tumor diameter opening) is realized on the premise of ensuring the compliance of the bracket.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a local reinforced nickel-titanium alloy intracranial stent is characterized in that an intracranial stent main body is a tubular structure consisting of a single rhombus unit formed by a sine wave structure and a connecting rod and a double rhombus unit formed by combining two single rhombus units.
The arrangement mode of the single diamond unit and the double diamond unit of the local reinforced nickel-titanium alloy intracranial support adopts a middle reinforcing mode, namely, a single diamond unit structure is added in the middle of the intracranial support; the span of the single diamond-shaped unit is larger than 4mm, and the single diamond-shaped unit accounts for 12.5-50% of the surface area of the whole intracranial support.
The local enhancement type nickel-titanium alloy intracranial support adopts a uniform enhancement mode in the arrangement mode of the single diamond units and the double diamond units, namely, a single diamond unit structure is uniformly added on the surface of the whole intracranial support, and the single diamond units account for 0-33.3% of the surface area of the whole intracranial support.
In the process of combining the single diamond units into the double diamond units, the local enhanced nickel-titanium alloy intracranial support keeps the connecting rod with the original structure, and performs fillet treatment on the connecting rod, wherein the radius of the fillet is 0.02-0.05 mm.
The ratio of the height dimension to the width dimension of a single diamond-shaped unit formed by the sine wave structure and the connecting rod of the locally enhanced nickel-titanium alloy intracranial support is 1-1.5.
The local reinforced nickel-titanium alloy intracranial support has a sine wave structure wire width of 0.03-0.07 mm, a connecting rod height of 0.05-0.1 mm and a width of 0.05-0.1 mm.
The locally enhanced nickel-titanium alloy intracranial support is of a semicircular arc structure at the vertex of the unit at two ends of the intracranial support, and the diameter of the circular arc is 0.15-0.25 mm.
The wall thickness of the locally enhanced nickel-titanium alloy intracranial support is 0.05-0.085 mm, the length of the intracranial support is 15-40 mm, and the nominal diameter of the intracranial support is 2-7 mm.
The locally enhanced nickel-titanium alloy intracranial stent is made of superelastic nickel-titanium alloy materials, and the elasticity range of the intracranial stent is 10% -15%.
The design idea of the invention is as follows:
the invention designs the integral structure of the intracranial artery stent based on a mixed unit method, firstly designs a rhombic unit and a double-rhombic unit which are composed of a sine wave structure and a connecting rod, and can obtain different mechanical support strengths by adjusting the filament width and the height-width ratio of the units. The double-diamond-shaped unit endows the support with better flexibility, the single-diamond-shaped unit improves the stability and the supporting strength of the support to a certain extent, and the mechanical enhancement of a specific position can be realized. The present invention contemplates two typical mixed cell arrangements: a central enhancement and a uniform enhancement. The design mode of middle part reinforcing, add the single rhombus structure of a certain amount in intracranial support middle part promptly, through the span and the density of adjusting middle part single rhombus unit, can realize the different mechanical properties of support. The middle-reinforced intracranial stent can provide stronger supporting force at the neck of a giant artery, a wide-neck aneurysm and other complex aneurysms, and effectively support the part needing to be excessively filled with a spring ring so as to prevent the stent from poor expansion or collapse. The mode of uniform reinforcement is that the single diamond-shaped unit is uniformly added on the whole surface of the intracranial support. The uniformly reinforced intracranial stent can realize the enhancement of radial supporting force on the basis of keeping the flexibility of the stent, strengthen the attaching degree of the released stent and a blood vessel, and reduce the possibility that the stent displaces in the blood vessel with larger diameter size.
The advantages and the beneficial effects of the invention are embodied in that:
1. the design method of the mixing unit can realize the intracranial support with various unit structure combinations, and can adjust the position and the number of the mixing unit according to different use conditions to realize different mechanical properties of the intracranial support.
2. The double-diamond-shaped unit increases the softness of the bracket, and the single-diamond-shaped unit improves the stability of the bracket to a certain extent; therefore, the design method based on the merging unit can enable the support to have flexibility and supporting performance.
3. The intracranial stent with the reinforced middle part can provide stronger supporting force at the neck of a large artery, a wide-neck aneurysm and other complex aneurysms, and effectively support the part needing to be excessively filled with the spring ring so as to prevent the stent from poor expansion or collapse. The uniformly reinforced intracranial stent can realize the enhancement of radial supporting force on the basis of keeping the flexibility of the stent, strengthen the attaching degree of the released stent and a blood vessel, and reduce the possibility that the stent displaces in the blood vessel with larger diameter size. The design of the mixing unit can expand the adaptation diseases of a single bracket and reduce the operation difficulty and the complication rate.
Drawings
Fig. 1(a) is a schematic structural diagram of intracranial stent units, fig. 1(b) is a detailed enlarged view of a stent connecting rod part, and fig. 1(c) is a detailed enlarged view of a connecting rod part after the units are combined. In the figure, 1 sine wave structure, 2 connecting rods, 3 single diamond units, 4 double diamond units, 5 connecting rod heights and 6 connecting rod widths.
Fig. 2(a) -2 (d) are planar development views of the intracranial stent designed in example 1. Wherein fig. 2(a) is a pure double diamond unit stent, fig. 2(b) is an 8.3% single diamond unit middle reinforced stent, fig. 2(c) is a 16.7% single diamond unit middle reinforced stent, and fig. 2(d) is a 33.3% single diamond unit middle reinforced stent.
FIG. 3 is a diagram of finite element simulation results of the stent design in example 1. Wherein, fig. 3(a) is a contact force cloud chart of a pressure head in a three-point simulation bending process of four brackets (a simple double-diamond unit, 8.3% single-diamond unit, 16.7% single-diamond unit, 33.3% single-diamond unit structure), and fig. 3(b) is a contact force cloud chart of a pressure head in a simulation extrusion process of four brackets (a simple double-diamond unit, 8.3% single-diamond unit, 16.7% single-diamond unit, 33.3% single-diamond unit structure).
Fig. 4(a) is a plan development view of the uniformly reinforced stent (20% single diamond unit structure) designed in example 2, and fig. 4(b) is an actual view of the uniformly reinforced stent designed in example 2.
Fig. 5 is a stress cloud of the blood vessel after implantation simulated by designing the stent in example 2. Wherein, fig. 5(a) is a blood vessel with 20% single diamond unit evenly reinforced stent function, and fig. 5(b) is a blood vessel with single double diamond unit stent function.
FIG. 6 is a graph of the results of finite element simulation radial compression of the stent designed in example 3.
FIG. 7 is a graph of the results of finite element simulation radial compression of the stent designed in example 4.
Detailed Description
As shown in figures 1(a) -1 (c), the local reinforced nickel-titanium alloy intracranial stent of the invention firstly designs a single diamond unit 3 consisting of a sine wave structure 1 and a connecting rod 2, and different mechanical support strengths can be obtained by adjusting the wire width and the height-width ratio of the sine wave structure 1. The thread width of the sine wave structure 1 is preferably 0.03-0.07 mm, and the ratio of the height dimension to the width dimension of the single diamond-shaped unit 3 is preferably 1-1.5; the width 6 of the connecting rod is preferably 0.05-0.1 mm, and the height 5 of the connecting rod is preferably 0.05-0.1 mm. Merge two adjacent single rhombus units 3 and form two rhombus units 4, remain the connecting rod of original structure in the merging process to carry out the fillet to connecting rod 2 and handle, the fillet radius is preferred 0.02 ~ 0.05 mm.
The single diamond-shaped unit 3 and the double diamond-shaped unit 4 have various combination modes, and the invention designs two typical unit arrangement modes: 1. the design mode that the middle part is strengthened, add the single rhombus unit 3 structure of a certain amount in the middle part of intracranial support promptly, form the intracranial support of middle part enhancement mode, through the span and the density of adjusting middle part single rhombus unit 3, can realize the different mechanical properties of support. The middle-reinforced intracranial stent can provide stronger supporting force at the neck of a giant artery, a wide-neck aneurysm and other complex aneurysms so as to prevent the stent from poor expansion or collapse. In the middle enhanced intracranial stent, the span of a single diamond-shaped unit is more than 4mm, and the single diamond-shaped unit accounts for 12.5-50% of the surface area of the whole intracranial stent. 2. The design mode of uniform reinforcement is that a single diamond-shaped unit is uniformly added on the whole surface of the intracranial support. The uniformly reinforced intracranial stent can realize the enhancement of radial supporting force on the basis of keeping the flexibility of the stent, strengthen the attaching degree of the released stent and a blood vessel, and reduce the possibility that the stent displaces in the blood vessel with larger diameter size. The single diamond unit accounts for 0-33.3% (excluding 0) of the whole intracranial stent surface area, and preferably 12.5-25%.
In order to prevent the blood vessel from being damaged by the excessively sharp top end of the bracket in the releasing process of the bracket, the vertexes of the units at the two ends of the intracranial bracket are designed to be of a semi-circular arc structure, and the preferred diameter of the circular arc is 0.15-0.25 mm.
And carrying out laser cutting on the nickel-titanium tube according to a set drawing, and then cleaning, heat treatment setting, polishing and cleaning again to obtain the final intracranial stent. According to the size characteristics of intracranial blood vessels, the wall thickness of the intracranial stent is preferably 0.5-0.85 mm, the length of the intracranial stent is preferably 15-40 mm, and the nominal diameter of the intracranial stent is preferably 2-7 mm.
In the present invention, the definition of the related terms is as follows:
the height of a single diamond-shaped unit refers to the height value of the single diamond-shaped unit along the axial direction of the stent in a planar development view of the stent.
The width of the single diamond-shaped unit refers to the width value of the single diamond-shaped unit along the direction vertical to the axial direction of the stent in a planar development view of the stent.
The span of the single diamond-shaped unit refers to the projection distance along the axial direction of the stent between the geometric center of the single diamond-shaped unit closest to the proximal end of the stent and the geometric center of the single diamond-shaped unit closest to the distal end of the stent.
The height of the connecting rod refers to the height value of the connecting rod along the axial direction of the bracket in a planar development view of the bracket.
The width of the connecting rod refers to the width value of the connecting rod along the direction vertical to the axial direction of the bracket in a planar development view of the bracket.
The thread width of the sine wave structure refers to the minimum value of the length of a connecting line of any two points on the two side edges of the sine wave structure.
The technical solution of the present invention is further explained below with reference to the embodiments and the accompanying drawings.
Example 1
As shown in fig. 2(a) -2 (d), three kinds of middle enhanced intracranial stents were designed in this embodiment, the span of the single diamond unit was designed to be 8mm, and the proportion of the single diamond unit to the surface area of the whole intracranial stent was adjusted to 8.3%, 16.7% and 33.3%, respectively, and the stent designed by the single double diamond unit was used as a control. The length of the intracranial support is 22.5mm, the outer diameter is 4.43mm, and the wall thickness of the intracranial support is 0.8 mm. The sine wave structure wire width of the intracranial support is 0.05mm, the width of the connecting rod is 0.05mm, and the height of the connecting rod is 0.045 mm. The ratio of the height dimension to the width dimension of the single diamond shaped cell was 1.03. And simulating a three-point bending process and an extrusion process of the bracket by using a finite element.
As shown in FIG. 3, the finite element results show that the bending moments of the four structures in the three-point bending test are 0.93N · mm (single double-diamond unit), 1.07N · mm (8.3% single-diamond unit), 1.23N · mm (16.7% single-diamond unit) and 1.42N · mm (33.3% single-diamond unit), and the compliance performance of the stent is reduced along with the increase of the density of the single-diamond unit, as shown in the four cases from top to bottom in FIG. 3 (a). Meanwhile, the extrusion experiment result shows that the supporting force of the bracket on the pressure head is respectively 0.15N (a pure double-rhomboid unit), 0.17N (8.3% single-rhomboid unit), 0.19N (16.7% single-rhomboid unit) and 0.25N (33.3% single-rhomboid unit), and the supporting force of the bracket is enhanced along with the increase of the density of the single-rhomboid unit, which is shown in four conditions from top to bottom in fig. 3 (b).
Example 2
Example 2 a stent length of 22.5mm, an outer diameter of 4.43mm and an intracranial stent wall thickness of 0.8mm were designed. The intracranial stents are uniformly reinforced. According to the simulation result in the embodiment 1, when the proportion of the single diamond-shaped unit is between 16.7% and 33.3%, the stent has better flexibility and supporting performance. Therefore, the present embodiment uses a design mode in which the area of the single diamond-shaped unit occupies 20% of the entire surface area of the stent to verify the effect of the uniform enhancement design. The sine wave structure wire width of the intracranial support is 0.05mm, the connecting rod width is 0.05mm, and the connecting rod height is 0.05 mm. The ratio of the height dimension to the width dimension of the single diamond shaped cell was 1.03.
As shown in fig. 4(a) -4 (b), after laser cutting is performed on the nickel titanium tube according to the set drawing, the final intracranial stent can be obtained after cleaning, heat treatment setting, polishing and cleaning again.
As shown in fig. 5(a) -5 (b), the finite element model is used to simulate the interaction process with the blood vessel after the stent is implanted. The results show that the applied stress to the tissue after implantation is significantly enhanced compared to non-reinforced scaffolds.
Example 3
Example 3 intracranial stents of different wire widths were designed, the sinusoidal wave structure of the intracranial stents having wire widths of 0.025mm, 0.05mm and 0.075mm, the intracranial stent wall thickness of 0.85mm, the connecting rod width of 0.05mm, the connecting rod height of 0.05 mm. The ratio of the height dimension to the width dimension of the single diamond shaped cells was 1.5.
A part of the stent is selected to carry out radial compression simulation to explore the influence of different filament widths on the support performance of the stent. The results show that the radial forces of the four stents are respectively: 0.009 N.mm-1(0.025mm filament width), 0.015 N.mm-1(0.05mm filament width), 0.021 N.mm-1(0.075mm filament width). The radial support force increases with increasing filament width, see fig. 6.
Example 4
Example 4 the fillet sizes of the bracket joints are respectively set as non-fillet treatment, 0.02mm and 0.05mm, the sine wave structure wire width of the intracranial bracket is 0.05mm, and the other parameters are the same as those of example 3. The results of selecting a part of the stent to perform radial compression simulation to explore the influence of different wire widths on the local stress distribution of the stent show that the bracket without fillet treatment has more serious stress concentration, which is shown in fig. 7.
The embodiment result shows that the invention provides a locally enhanced nickel-titanium alloy intracranial stent which is made of superelastic nickel-titanium alloy, wherein the intracranial stent main body is formed by mixing a single rhombus unit consisting of a sine wave structure and a connecting rod and a double rhombus unit formed by combining two single rhombus units. The flexibility of support can be improved to two rhombus units, and the stability support performance of support can be guaranteed to a certain extent to single rhombus structure. In addition, various support structures can be designed and changed by adjusting the positions and the number of the units with different shapes, so that different mechanical properties are realized. The design of the local enhanced nickel-titanium alloy intracranial support based on the mixed unit structure can design an optimized unit proportion aiming at different use environments, realizes the support enhancement of a specific position (such as a tumor diameter opening) on the premise of ensuring the compliance of the support, and can be used for assisting the embolism of a spring ring.
Claims (9)
1. A local reinforced nickel-titanium alloy intracranial stent is characterized in that an intracranial stent main body is of a tubular structure consisting of a single rhombus unit formed by a sine wave structure and a connecting rod and a double rhombus unit formed by combining two single rhombus units.
2. The locally enhanced nickel-titanium alloy intracranial support according to claim 1, wherein the single diamond-shaped unit and the double diamond-shaped unit are arranged in a middle reinforcing mode, namely a single diamond-shaped unit structure is added to the middle of the intracranial support; the span of the single diamond-shaped unit is larger than 4mm, and the single diamond-shaped unit accounts for 12.5-50% of the surface area of the whole intracranial support.
3. The locally enhanced nickel-titanium alloy intracranial stent as defined in claim 1, wherein the single diamond units and the double diamond units are uniformly arranged in a reinforcing manner, that is, the single diamond units are uniformly added on the surface of the whole intracranial stent, and the single diamond units account for 0-33.3% of the surface area of the whole intracranial stent.
4. The locally enhanced nickel-titanium alloy intracranial support according to claim 1, wherein in the process of combining the single diamond-shaped units into the double diamond-shaped units, the connecting rods of the original structure are retained, and the connecting rods are subjected to fillet treatment, and the fillet radius is 0.02-0.05 mm.
5. The locally enhanced nitinol intracranial stent of claim 1, wherein the ratio of the height dimension to the width dimension of the single diamond-shaped unit of the sinusoidal structure and the connecting rod is 1-1.5.
6. The locally reinforced Ni-Ti alloy intracranial stent as defined in claim 1, wherein the sinusoidal wave structure of the intracranial stent has a wire width of 0.03-0.07 mm, a connecting rod height of 0.05-0.1 mm, and a width of 0.05-0.1 mm.
7. The locally enhanced nickel-titanium alloy intracranial support according to claim 1, wherein the vertex of the unit at both ends of the intracranial support is in a semi-circular arc structure, and the diameter of the circular arc is 0.15-0.25 mm.
8. The locally enhanced nickel-titanium alloy intracranial support according to claim 1, wherein the intracranial support has a wall thickness of 0.05-0.085 mm, a length of 15-40 mm, and a nominal diameter of 2-7 mm.
9. The locally enhanced nitinol intracranial stent of claim 1, wherein the intracranial stent is a superelastic nitinol material with an elasticity in the range of 10% to 15%.
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| CN113545898A (en) * | 2021-08-31 | 2021-10-26 | 西北有色金属研究院 | Vascular stent structure with uniform stress |
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