CN117045409A - Coronary vessel stent - Google Patents
Coronary vessel stent Download PDFInfo
- Publication number
- CN117045409A CN117045409A CN202311250405.6A CN202311250405A CN117045409A CN 117045409 A CN117045409 A CN 117045409A CN 202311250405 A CN202311250405 A CN 202311250405A CN 117045409 A CN117045409 A CN 117045409A
- Authority
- CN
- China
- Prior art keywords
- main supporting
- connecting piece
- blood vessel
- supporting rod
- stent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Physics & Mathematics (AREA)
- Vascular Medicine (AREA)
- Optics & Photonics (AREA)
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Manufacturing & Machinery (AREA)
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Abstract
The invention provides a coronary vessel stent. The stent comprises a main supporting rod which is continuously arranged in the axial direction of a blood vessel, and a connecting piece which is arranged in the radial direction, wherein the connecting piece is made of a shape memory alloy material, when in a first state, the connecting piece can be deformed into a spiral shape or a curve shape, the volume of the connecting piece is reduced so as to be convenient to convey, when in a second state, the connecting piece can be deformed into an arc shape which is attached to the inner wall of the blood vessel, the connecting piece is matched with the main supporting rod to finish the supporting of the inner wall of the blood vessel, the opening effect of the stenosis of the blood vessel is realized, the smoothness of the inner wall of the blood vessel in the axial direction is maintained, and the problem that the inner wall of the blood vessel is fluctuant after the stent is installed is avoided. The support can realize continuous support of the inner wall of the blood vessel in the axial direction, and overcomes the defect that the annular support piece of the blood vessel support in the prior art is arranged in the radial direction.
Description
Technical Field
The invention relates to the technical field of vascular stents, in particular to a vascular stent for heart coronary artery stenosis.
Background
The vascular stent is a tubular stent made of metal materials or polymer materials, and is characterized in that on the basis of balloon dilatation and shaping, an inner stent is arranged on a blood vessel at a narrow occlusion section so as to support the blood vessel at the narrow occlusion section, and the elastic retraction and reshaping of the blood vessel are reduced, so that the blood flow of a lumen is kept smooth. Belongs to a vascular interventional instrument. Vascular stents are widely used in the treatment of vascular diseases such as coronary artery, intracranial artery, carotid artery, renal artery and femoral artery, and have remarkable therapeutic effects.
Vascular stents have undergone four generations of development processes:
first generation of support: balloon expandable stent
The balloon expandable stent is a stent which is made of medical stainless steel, cobalt-chromium alloy and the like and is pre-arranged on a balloon catheter.
Second generation: bare metal bracket
Bare metal stents act as self-expanding stents, widely used in cardiology to maintain coronary patency. After insertion, the lumen of the stent is epithelialized and integrated into the endothelium over time. The treatment of the metal bare stent becomes safer than the expansion of the balloon, and when the blood vessel is blocked, the stent is immediately used for expanding the blood vessel, so that the danger can be relieved, and the restenosis rate is about 10-20%.
Third generation: tectorial membrane support
The stent graft is composed of a fabric or graft material, such as Polytetrafluoroethylene (PTFE), coated on a metal stent. They have a variety of clinical applications in peripheral arterial disease management.
Fourth generation: drug coated stent
Drug-coated stents: the medicine for inhibiting cell proliferation is coated on the stent, so that the medicine can be slowly released about 3 months after the stent is implanted, the smoothness of the stent is kept, and restenosis is avoided. The restenosis rate of the drug-coated stent is only 5% -10%, and the long-term prognosis of patients with coronary heart disease is obviously improved. Drug eluting stents are typically composed of three parts-a stent platform, a polymer coating that binds the drug to the stent and releases the drug, and the drug.
Fifth generation: biodegradable and bioabsorbable stent
The degradable stent can be absorbed after being implanted into a body for a period of time, no foreign matters exist in blood vessels, and the degradable stent is mainly made of magnesium alloy, iron alloy or polymer materials, wherein the polymer materials are selected from polymer materials such as polylactic acid and the like.
In a fourth generation of stent, patent document CN101732114a discloses a coronary vessel stent with a drug-loading groove, the stent comprises a plurality of main supporting unit rings and connecting rods, the main supporting unit rings are composed of a plurality of unit waves, and the outer surface of a wave rod of each unit wave is provided with the drug-loading groove.
In a fifth generation of stent, patent document CN102525701a discloses an absorbable vascular stent, the stent is made of an iron-based alloy material, the stent has a proximal end and a distal end, an expandable pattern structure is arranged between the proximal end and the distal end, four connected bands are combined, each band is formed by connecting eight arch-shaped supporting pieces end to form a circle of circumference, and each band is connected through a linear connecting rod.
After studying the stent, the pen finds that in order to achieve the effect of supporting the inner wall of the blood vessel, radial supporting rings or supporting rings are arranged, connecting rods are arranged between adjacent unit rings or supporting rings, and the whole stent is connected into a whole. The inner wall of the blood vessel is expanded by utilizing radial elasticity, and the effect of radially supporting the inner wall of the blood vessel is achieved after the expansion;
however, the support arranged in the mode causes small supporting force of the position of the connecting rod on the inner wall of the blood vessel and small opening size of the blood vessel; the radial support ring has large support force at the position where the radial support ring is positioned, and the blood vessel is large in opening size; the inner wall of the blood vessel is rugged after the stent is implanted, which is not beneficial to blood flow, the impact force of the blood flow at the raised place is large, and the inner wall of the blood vessel is easy to break; the impact force of the place with the groove is small, and thrombus is easy to form. Therefore, there is a need for improvements in the existing vascular stents to overcome the technical problem of uneven vessel wall after stent implantation.
Disclosure of Invention
Aiming at the technical problem that the inner wall of a blood vessel is easy to undulate after implantation due to the radial arrangement of the support rings of the blood vessel stent in the prior art, the scheme adopts the following technical scheme:
a vascular stent comprising main struts arranged in the axial direction of a vessel, the main struts being arranged consecutively in the axial direction; and a plurality of connecting pieces arranged in the radial direction, wherein the connecting pieces are made of shape memory alloy materials;
the main supporting rods are uniformly arranged in the circumferential direction, and N main supporting rods can be arranged; one end of the connecting piece is fixedly connected with the main supporting rod on one side, and the other end of the connecting piece is fixedly connected with the main supporting rod on the other side;
in the first state, the connecting piece can be deformed into a spiral shape or a curve shape to reduce the volume so as to facilitate transportation; in the second state, the connecting piece can be deformed into an arc shape attached to the inner wall of the blood vessel, the arc length is pi D/N-L1, the central angle is 360 degrees/N, the connecting pieces are arranged in a staggered mode in the radial direction, D is the diameter of the blood vessel with stenosis, a plurality of arc-shaped connecting pieces form a circular shape, the inner wall of the blood vessel is supported, and L1 is the arc length occupied by the main support rod in the circumferential direction.
As a further development of the invention, the arc length taken up by the main support rod in the circumferential direction is taken as the diameter of the main support rod;
as a further improvement of the present invention, the number of the main supporting bars is 5, 6, 8, or 10.
As a further improvement of the invention, the surface of the main supporting rod is provided with a medicine carrying groove for containing medicine.
As a further improvement of the present invention, the medicine carrying grooves of the main support bar are distributed on the outer surface which is in direct contact with the inner wall of the blood vessel, and the medicine is for preventing endothelial hyperplasia.
As a further improvement of the present invention, the medicine carrying grooves of the main support bar are distributed on the side surface parallel to the inner wall of the blood vessel, and the medicine is for preventing thrombosis.
As a further improvement of the present invention, the main supporting rod may be provided in a continuously variable U-shaped structure or S-shaped structure or W-shaped structure, preventing the migration of the stent.
As a further improvement of the invention, two ends of the connecting piece are respectively connected with the wave crest and the wave crest of the U-shaped structure or the S-shaped structure or the W-shaped structure or the wave crest or the wave trough.
As a further improvement of the present invention, the intermediate position of the main supporting bar is provided with a developing mark.
As a further improvement of the invention, the main supporting rod is made of shape memory aggregate materials, and the main supporting rod and the connecting piece are cut by adopting laser cutting tubular structural materials.
As a further improvement of the invention, the main supporting rod is made of non-memory aggregate materials, and the main supporting rod and the connecting piece are fixed in a welding mode.
According to the invention, the main supporting rod is continuously arranged in the axial direction of the blood vessel and is supported by the connecting piece after being implanted into the blood vessel, so that the main supporting rod can be deformed into a structure with a circular cross section.
In order to ensure that the main supporting rod has enough radial supporting strength after being unfolded, the connecting piece is made of a memory alloy material, and is converted into an arc-shaped structure in a second form after being implanted into a blood vessel, the arc length is pi D/N-L1, the central angle is 360 degrees/N, and a plurality of connecting pieces form a supporting structure with a circular cross section in the circumferential direction, so that the radial supporting effect is ensured.
Drawings
Fig. 1 is a schematic diagram of a prior art vascular stent.
Fig. 2 is a schematic view of a stent deployment configuration of the present invention.
Fig. 3 is a schematic cross-sectional view of a stent of the present invention.
FIG. 4 is a schematic view of the position of a drug loading slot on a main support bar according to the present invention.
FIG. 5 is a schematic view of the main support of the present invention in a U-shaped configuration.
FIG. 6 is a schematic cross-sectional view of the primary support rod and connector of the present invention in a second state when the primary support rod is in a U-shaped configuration.
Detailed Description
The invention is further illustrated below with reference to examples.
Example 1:
as shown in fig. 1, in the prior art, a stent comprises a plurality of support rings 10 in a radial direction, 7 radial support rings 10 are shown in fig. 1, and adjacent support rings 10 are connected by a connecting member 20; when the stent is expanded, the radial support ring 10 is positioned at a position with large support force on the inner wall of the blood vessel, and the connecting piece 20 is positioned at a position with small support force on the inner wall of the blood vessel, so that the condition that the inner wall of the blood vessel is fluctuant is easy to occur.
In order to solve the problem that when the support ring is radially arranged, the support force on the inner wall of the blood vessel is uneven, the axial main support rod 1 is arranged, the support on the main support rod 1 is completed by adopting the connecting pieces 2 which are radially arranged, the support ring is deformed into a circular cross section, and the smooth transition of the inner wall of the blood vessel after the support is realized. The connecting piece 2 is made of a shape memory alloy material.
As shown in fig. 2, a stent for a blood vessel comprises a main support bar 1 arranged in the axial direction of the blood vessel, the main support bars being arranged in succession in the axial direction; and a plurality of connecting pieces 2 arranged in the radial direction, the connecting pieces being made of a shape memory alloy material;
in fig. 2-3, the arrangement of 5 main struts 1 is shown; the main supporting rods are uniformly arranged in the circumferential direction, the connecting pieces 2 are staggered in the radial direction, one end of each connecting piece is fixedly connected with one side of the main supporting rod 1, and the other end of each connecting piece 2 is fixedly connected with the other side of the main supporting rod 1;
in the first state, the connector can be deformed into a spiral shape or a curve shape to reduce the volume for convenient transportation; in the second state (as shown in fig. 3), the connecting pieces can be deformed into an arc shape attached to the inner wall of the blood vessel, the arc length is pi D/5-L1, the central angle is 360 °/5, the connecting pieces are arranged in a staggered manner in the radial direction, D is the diameter of the blood vessel with stenosis, and a plurality of arc-shaped connecting pieces 2 form a circular shape to support the inner wall of the blood vessel.
As a preferred embodiment, the number of main struts 1 can also be N, for example 6, 8 or 10. When the number is N, the arc length of the connecting piece after being unfolded is pi x D/N-L1, and the central angle is 360 degrees/N, so that the total body is ensured to form a circular structure, and stable support is provided for the inner wall of the blood vessel. When the radial support strength is insufficient, the diameter of the connection may be increased to provide higher radial support. D is the diameter of a blood vessel where stenosis occurs, N is the number of main support rods, and L1 is the arc length occupied by the main support rods in the circumferential direction.
As shown in fig. 4, a medicine carrying groove I3 and a medicine carrying groove II 4 are arranged on the surface of the main supporting rod 1; the medicine carrying groove I3 is positioned on two side surfaces of the main supporting rod 1 and avoids the joint of the connecting piece 1, and is used for containing medicines for preventing thrombosis, such as warfarin sodium tablets, aspirin tablets, low molecular weight heparin sodium injection and the like. The medicine carrying groove II 4 is positioned on the outer surface of the main supporting rod 1 and is in direct contact with the inner wall of the blood vessel, and is used for containing medicines for preventing cell endothelial proliferation, such as rapamycin, paclitaxel and derivatives thereof, or antiplatelet medicines, lipid-lowering medicines, blood pressure-lowering medicines, and the like. 1. Antiplatelet agents: clopidogrel bisulfate, aspirin and other medicaments. 2. Lipid-lowering medicine: comprises statin lipid-lowering drugs, 3, antihypertensive drugs: including hydrochlorothiazide, triamterene, amiloride, furosemide, and the like.
As shown in fig. 5, the main supporting pole 1 may be provided in a continuously variable U-shaped structure, preventing migration of the stent inside the blood vessel. The U-shaped structure is shown in the figure as being unfolded into a plane, but in the three-dimensional structure thereof, the cross section of the main supporting rod 1 is still in an arc-shaped structure so as to match with the connecting piece in the second state to form a circular unfolding structure which is attached to the inner wall of the blood vessel, and the connecting piece is connected at the wave crest and the wave crest, the wave crest or the wave trough, or the wave trough of the U-shaped structure. Since the main supporting rod 1 has a U-shaped structure, it has a width L1 in the circumferential direction, and the sum of the arc lengths of the main supporting rods and the arc lengths of the connecting pieces of the widths L1 satisfies the formula pi.
As shown in fig. 6, when the main supporting rod 1 has a U-shaped structure, it occupies a certain circumferential circumference in the circumferential direction, and the sum of the total width of the N main supporting rods 1 and the total arc length of the connecting piece 2 in the N second forms satisfies the formula pi×d, where D is the diameter of the blood vessel at the stenotic lesion.
The shape of the main support bar 1 in the axial direction may also be designed as an S-shaped structure or a W-shaped structure.
In order to facilitate the transportation of the support, a developing mark is arranged on the main support rod at the middle position of the support, or a developing mark is arranged on the connecting piece at the middle position, or the connecting piece at the middle position is marked by adopting an X-ray developable material.
Through above-mentioned structural design, utilize the connecting piece of shape memory alloy material preparation, can radially support the main tributary vaulting pole, guaranteed to have smooth surface all the time in the axis direction when whole vessel support carries the second state, avoided the wave form supporting ring or the uneven problem that causes of the vascular inner wall fluctuation of supporting ring struts vascular dynamics among the prior art.
Embodiment two:
the preparation method of the bracket comprises the following steps:
the preparation method comprises the following steps: the main supporting rod is made of conventional metal materials, the connecting piece is made of shape memory aggregate materials such as nickel-titanium alloy, titanium alloy and the like, and the main supporting rod and the connecting piece are welded and fixed together by adopting a welding method after the main supporting rod and the connecting piece are respectively made of nickel-titanium alloy, titanium alloy and the like. After welding, the memory alloy material is processed, so that the memory alloy material can be converted between a first state and a second state, and after verification is qualified, the whole bracket is converted into the first state and stored.
The preparation method II comprises the following steps:
the main supporting rod and the connecting piece are made of shape memory alloy materials. Firstly, manufacturing a shape memory alloy metal tube, manufacturing the shape of the vascular stent by adopting a laser engraving method, performing shape memory treatment on the manufactured stent, converting the stent from a first state to a second state, and converting the whole stent into the first state for storage after verification is passed.
The preparation method comprises the following steps:
and simultaneously manufacturing the main support rod and the connecting piece by adopting a 3D printing method, and 3D printing the vascular stent with a specific shape. The main supporting rod can be made of conventional metal materials or shape memory alloy materials, and the connecting piece is made of shape memory alloy materials.
The main supporting rod can be made of cobalt-chromium alloy, stainless steel, nickel-titanium alloy and the like, and the connecting piece can be made of nickel-titanium alloy, titanium alloy and other shape memory alloy materials.
It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
Claims (9)
1. A vascular stent characterized by comprising the following features: the stent comprises a main supporting rod (1) arranged in the axial direction of the blood vessel and a plurality of connecting pieces (2) arranged in the radial direction, wherein the connecting pieces (2) are made of shape memory alloy materials;
the main supporting rods (1) are uniformly arranged in the circumferential direction, and N main supporting rods can be arranged; one end of the connecting piece (2) is fixedly connected with the main supporting rod on one side, and the other end of the connecting piece is fixedly connected with the main supporting rod on the other side;
in the first state, the connecting piece can be deformed into a spiral shape or a curve shape to reduce the volume so as to facilitate transportation; in the second state, the connecting piece can be deformed into an arc shape attached to the inner wall of the blood vessel, the arc length of the connecting piece (2) is pi-D/N-L1, the central angle is 360 degrees/N, the connecting pieces (2) are arranged in a staggered manner in the radial direction, a plurality of arc-shaped connecting pieces form a circular shape, the support D on the inner wall of the blood vessel is realized, the diameter of the blood vessel is narrow, and L1 is the arc length occupied by the main support rod in the circumferential direction;
and the surface of the main supporting rod is provided with a medicine carrying groove I (3) and a medicine carrying groove II (4) for containing medicines.
2. The vascular stent of claim 1, wherein the number of main struts is 5, 6, 8, or 10.
3. The stent of claim 1, wherein when the main struts are in a straight configuration, the arc length L1 of the main struts in the circumferential direction is equal to the diameter of the main struts.
4. A vascular stent according to claim 1, wherein the drug-carrying grooves (3) of the main supporting rod are distributed on the side surface parallel to the inner wall of the blood vessel, and the drug is a thrombus formation preventing agent; the medicine carrying grooves II (4) of the main supporting rod are distributed on the outer surface which is in direct contact with the inner wall of the blood vessel, and medicines are used for preventing endothelial hyperplasia.
5. Vessel stent according to claim 1, characterized in that the main struts (1) can be arranged in a continuously varying U-shaped or S-shaped or W-shaped configuration, preventing stent migration; the two ends of the connecting piece (2) are respectively connected with the wave crest and the wave crest of the U-shaped structure or the S-shaped structure or the W-shaped structure or the wave crest or the wave trough.
6. A vascular stent according to claim 1, wherein the main supporting rod (1) is made of a shape memory aggregate material, and the main supporting rod (1) and the connecting piece (2) are cut by adopting a laser cutting tubular structure material.
7. The vascular stent according to claim 1, wherein the main supporting rod (1) is made of non-memory aggregate materials, and the main supporting rod (1) and the connecting piece (2) are fixed in a welding mode.
8. A vascular stent characterized by comprising the following features: the stent comprises a main supporting rod (1) arranged in the axial direction of the blood vessel and a plurality of connecting pieces (2) arranged in the radial direction, wherein the connecting pieces (2) are made of shape memory alloy materials;
the main supporting rods (1) are uniformly arranged in the circumferential direction, N main supporting rods can be arranged, the main supporting rods 1 are of continuously-changed U-shaped structures, and the cross sections of the main supporting rods are of arc-shaped structures; one end of the connecting piece (2) is fixedly connected with the main supporting rod on one side, and the other end of the connecting piece is fixedly connected with the main supporting rod on the other side; the two ends of the connecting piece are respectively connected with the wave crest or the wave trough of the U-shaped structure;
in the first state, the connecting piece can be deformed into a spiral shape or a curve shape to reduce the volume so as to facilitate transportation; in the second state, the connecting piece can be deformed into an arc shape attached to the inner wall of the blood vessel, the arc length of the connecting piece is pi D/N-L1, the central angle is 360 degrees/N, the connecting pieces are arranged in a staggered manner in the radial direction, a plurality of arc-shaped connecting pieces form a circular shape, the inner wall of the blood vessel is supported, D is the diameter of the blood vessel with a narrow shape, N is the number of main supporting rods, and L1 is the arc length occupied by the main supporting rods in the circumferential direction.
9. The vascular stent according to claim 8, wherein the U-shaped structure of the main supporting rod (1) can be further provided in an S-shaped structure or a W-shaped structure.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311250405.6A CN117045409A (en) | 2023-09-26 | 2023-09-26 | Coronary vessel stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311250405.6A CN117045409A (en) | 2023-09-26 | 2023-09-26 | Coronary vessel stent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117045409A true CN117045409A (en) | 2023-11-14 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311250405.6A Pending CN117045409A (en) | 2023-09-26 | 2023-09-26 | Coronary vessel stent |
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| Country | Link |
|---|---|
| CN (1) | CN117045409A (en) |
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2023
- 2023-09-26 CN CN202311250405.6A patent/CN117045409A/en active Pending
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