CN109199658B - Self-expanding type lumen stent and manufacturing method thereof - Google Patents
Self-expanding type lumen stent and manufacturing method thereof Download PDFInfo
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- CN109199658B CN109199658B CN201810705885.3A CN201810705885A CN109199658B CN 109199658 B CN109199658 B CN 109199658B CN 201810705885 A CN201810705885 A CN 201810705885A CN 109199658 B CN109199658 B CN 109199658B
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- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
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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
- A61F2/82—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
-
- 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
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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)
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- Veterinary Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention provides a self-expanding type lumen stent and a manufacturing method thereof, wherein the stent comprises the following components: more than two circulators (1), more than one connecting rod (2) and more than one first connecting sleeve (3), at least two circulators (1) are connected with the both ends of connecting rod (2) respectively, and connecting rod (2) at least one end and circulators (1) are cup jointed with first connecting sleeve (3) to form the support. The stent not only can be compressed into a smaller delivery sheath, but also has excellent flexibility and fatigue resistance, ensures that the stent can not be broken when being compressed into a tiny sheath, and also ensures that the stent is stable in the lumen of a human body for a long time.
Description
Technical Field
The invention relates to the technical field of medical equipment for supporting or repairing a human body lumen, in particular to a self-expanding type lumen stent used in an intervention way in the lumen and a manufacturing method thereof.
Background
The human body has large and small lumens, such as blood vessels, trachea, esophagus, biliary tract, intestinal tract, urethra, etc., and the diameters vary from several millimeters to tens of millimeters. When such natural lumens of the human body are subject to lesions such as stenoses, leaks, or tumor-like distensions, surgical treatments have been commonly employed. But surgical methods are not only traumatic but also have long recovery periods. More and more human body lumen diseases can be prevented and/or treated by minimally invasive interventional methods.
For example, the lumen stent is implanted to expand and prop up a narrow lumen, or the covered stent is implanted to repair a lumen tumor and a leakage breaking part, so that the lumen of a human body is restored to be a smooth pipeline. The stent is typically loaded into a small delivery sheath, delivered along a lumen path to the lesion in the body lumen, and withdrawn from the sheath and released into the lumen. Such treatment generally requires: 1) The stent should be compressed into a smaller sheath tube as much as possible so as to reduce the damage to the lumen in the conveying process and reduce the conveying difficulty; 2) The bracket has relatively fatigue resistance; 3) The support should have good flexibility.
At present, the lumen stent is mainly manufactured by adopting a laser cutting and braiding mode. Laser cut stents are self-expanding stents made from a novel laser cut nitinol tube as described in patent CN 103784222B. The stent struts consist of helical bands which run continuously in the axial and longitudinal direction of the stent. After the stent is cut by laser according to the designed patterns, the stent is formed by heat treatment, expansion and shaping, and although the flexibility of the stent can be improved and the fatigue resistance of the stent can be improved by the design of various patterns, the inherent flexibility of the stent cut by the laser is poor, the stent is easy to break due to fatigue, and the stent is not suitable for comparing the positions of the human body lumen which are bent and have certain mobility. Another type of lumen stent is a braided stent, such as a wavy ring formed by bending nickel titanium wires according to a waveform as described in patent CN103598929B, which effectively solves the problem of flexibility of the stent, but if the curvature radius of the waveform is too small, the stent is liable to break, and if the curvature radius of the waveform is too large, the stent cannot be compressed into a small sheath. Thus, the delivery sheath currently used for this type of stent is generally larger than that used for laser cut stents. A wound-type braided stent as described in patent CN102973341B also overcomes only the problem of compliance. Because the wound nickel titanium wire cannot be too large and can only be manufactured by using a thinner nickel titanium wire, the support force of the bracket is smaller and the bracket can only be used in a small lumen. The woven stent described in the patent application CN105769383A adopts wave weaving and winding weaving mixed weaving at the same time, so that the support performance of the stent is further improved. However, the fracture resistance of the stent caused by bending of the nickel titanium wires in the braiding process is low and the large performance of the delivery sheath is not effectively improved.
The currently accepted ideal luminal stent should possess the following characteristics: (1) compressible into a smaller delivery sheath; (2) the flexibility is good; (3) has higher fatigue resistance. It is therefore an object of the present invention to develop a novel stent and a method of making the same, whereby the above three features are met simultaneously.
Disclosure of Invention
In view of the defects of the prior art, the invention aims to develop a novel stent and a manufacturing method thereof, so that the stent can be compressed into a smaller delivery sheath, has excellent flexibility and fatigue resistance, ensures that the stent can not be broken when being compressed into a tiny sheath, and also ensures that the stent is stable in a human body lumen for a long time.
In order to achieve the above object, a first technical solution of the present invention is: a self-expanding luminal stent comprising: more than two circulators (1), more than one connecting rod (2) and more than one first connecting sleeve (3), at least two circulators (1) are connected with the both ends of connecting rod (2) respectively, and connecting rod (2) at least one end and circulators (1) are cup jointed with first connecting sleeve (3) to form the support.
The ring-shaped objects (1) are sleeved by one or more connecting rods (2) and the connecting sleeve (3), so that the support is not easy to break when being bent, the ring-shaped objects can adapt to various forms of human body lumens, the clinical treatment effect is remarkably improved, and meanwhile, the connection between the ring-shaped objects is more stable, and the support rods are prevented from being twisted when the support enters and exits the sheath.
Preferably, the ring (1) is composed of a plurality of support rods (4), and one end of each of at least two support rods (4) is sleeved by a second connecting sleeve (5).
Wherein the first connection sleeve (3) and the second connection sleeve (5) may be the same or different connection sleeves.
The ring (1) of the support is not limited by the curvature of the bending part of the woven support, the two support rods (4) of the ring (1) can be well compressed and attached together, the diameter of the compressed support can be effectively reduced, the support can be compressed into a smaller delivery sheath without breaking, and meanwhile, the deformation of the support rods caused by attaching the support rods (4) in an adopted splicing mode is much smaller than the deformation of the bending part of the woven support, so that the support has good compression performance and fatigue resistance.
The support is formed by splicing nickel titanium wires preferably, so that the support inherits the flexibility of the woven support, and the defect of poor flexibility of the cut support is avoided.
The connecting rod (2) and the supporting rod (4) are preferably respectively in a circular column shape, partial materials are removed from opposite sides of two ends of the connecting rod (2) and the supporting rod (4), the ends of the two supporting rods (4) and the ends of the connecting rod (2) are assembled to form a column shape, and the column shape is sleeved into the first connecting sleeve (3). Preferably, the two support rods (4) connected with the connecting rod (2) and the opposite sides of the end parts of the connecting rod are respectively used for removing part of materials by taking a sector of 120 degrees as the center.
The two ends of the connecting rod (2) and the two ends of the supporting rod (4) are spliced together to form a cylinder, and are connected through sleeved sleeves, so that the whole process is simple and convenient, the operability is strong, and meanwhile, the connection is firmer through welding.
In addition, the ends of the other two support rods (4) which are not connected with the connecting rod (2) are arranged side by side to form a cylinder, and are sleeved into the second connecting sleeve (5). Preferably by means of a fixed connection such as welding. Preferably, a plurality of support rods (4) are connected end to end through sleeves (5) in sequence to form an annular object (1). Preferably, the opposite sides of the end parts of the other two support rods (4) which are not connected with the connecting rod (2) are respectively provided with a semicircle as the center for removing part of materials.
The peaks and valleys of the ring waveform are connected by the sleeve, and cannot be bent by a nickel titanium wire to form a wave shape as in the prior art, the peaks and valleys are limited by bending curvature, and even if the bent angles are subjected to various treatments at the peaks and valleys, such as arc forming, the stent is inevitably broken when being compressed into the sheath. According to the invention, the sleeve is spliced with the supporting rod to form the wave crest and the wave trough, so that bending limitation is avoided, and the problems can be effectively solved.
Partial materials are removed from opposite sides of two ends of the support rod (4) which are not connected with the connecting rod (2) by taking a semicircle as a center, so that after the ends of the two support rods (4) are arranged side by side, the stress after being connected by a sleeve is more uniform, and the firmness is better; and the opposite sides of the two ends of the supporting rod (4) connected with the connecting rod (2) are used for removing part of materials by taking a sector of 120 degrees as the center; therefore, after the end parts of the two support rods (4) and the end parts of the connecting rods (2) are arranged side by side, the stress after being connected through the sleeve is more uniform, and the firmness is better.
Wherein, when partial materials are removed by the support rod (4) and the connecting rod (2), the materials can be removed vertically along the cylinder, or removed in a certain radian, and the optimal radian is 3-15 degrees (namely, the angle between the cutting plane (408) and the axis of the cylinder is cut, when two rods are spliced, namely, the cutting radian is changed to 165-177 degrees and 183-195 degrees to match, and when three rods or four rods are spliced, the angle is adjusted according to the above angle).
Through the scheme, the connecting end parts (401) and (402) of the supporting rods (4) and the surface of the connecting part (403) can form an angle of 15-90 degrees, so that the end parts of the two supporting rods (4) are spliced into a cylinder shape, the shape of the connecting end parts is consistent with that of the connecting part (403), and the connecting end parts of the supporting rods are spliced more easily, so that the end parts of the supporting rods are connected more firmly.
The ring (1) of the invention is composed of 8-32 support rods (4) to form 4-16 waves. The annular wave-shaped support formed by 8-32 support rods can adapt to various sizes of tube cavities, and good support force of the support is ensured from the geometric angle. The number, diameter and shape of the rings (1) can be properly adjusted according to the length and structure of the lesion of the lumen.
The support rod (4) of the present invention has a diameter of 0.1-1.2 mm and a length of preferably 4-40 mm.
The wave crest and wave trough included angles of the wave form of the ring (1) formed by the plurality of support rods (4) are respectively 10-120 degrees.
The design can avoid too small or too large curvature radius of the waveform, so that the stent is easier to compress into the sheath tube without bending and breaking, meanwhile, the pipe diameter of the used conveying device can be reduced to about 9F, the damage to the lumen in the conveying process is reduced, the conveying difficulty is reduced, and the setting of the diameter of the supporting rod and the setting of the angle and the height of the waveform can lead the stent to have good supporting force after being implanted into a large blood vessel, thereby remarkably improving the clinical treatment effect. The stent described above is preferably suitable for arterial vessels, in particular the aorta and aortic branches.
Another object of the present invention is to provide a method for manufacturing the self-expandable luminal stent, which specifically includes: the supporting rod (4) is sleeved with a sleeve (5). After sleeving, the sleeve is fixedly connected, and hot welding modes such as laser welding, argon arc welding, resistance welding and the like can be adopted. A stamped connection may also be used.
The rings (1) at the two ends of the bracket are connected through the end connecting rod (6) to form a spiral line shape or a straight line shape.
Preferably, the end connecting rod (6) is sleeved in a mode of adopting the connecting rod (2).
The self-expanding type lumen stent also comprises a film (7) which is made into a covered stent, wherein the stent can be partially or completely covered with the film, and the film can be a PET film or an ePTFE film. Preferably, the film may be accompanied by a drug to enhance therapeutic effect.
Compared with the prior art, the invention has the following advantages:
the self-expanding type lumen stent can be compressed into a smaller delivery sheath, and the diameter of the sheath can be reduced to about 9F, so that the stent can reduce the damage to the lumen in the delivery process and reduce the delivery difficulty.
The self-expanding type lumen stent has excellent flexibility and fatigue resistance, and ensures that the stent can be compressed into a small sheath tube without breaking.
The self-expanding type lumen stent has excellent supporting force, can be suitable for lumens in various forms, and ensures that the stent is stable in the human body lumen for a long time.
The self-expanding type lumen stent provided by the invention has a better treatment effect by covering the surface of the self-expanding type lumen stent with the PET or ePTFE film.
The self-expanding type lumen stent support rods are firmly connected, the manufacturing method is simple, and the cost is saved.
Description of the drawings:
FIG. 1 is a diagram showing the overall structure of a self-expanding type lumen stent according to the present invention
FIG. 2 is a view showing the construction of a ring for a self-expanding lumen stent according to the present invention
FIG. 3 is a schematic illustration showing the connection of support rods of a self-expanding type lumen stent according to the present invention
FIG. 4 is an enlarged view of a splicing portion of a support rod of a self-expanding type lumen stent according to the present invention
FIG. 5 is a schematic illustration of a self-expanding luminal stent wrapped with a membrane
Wherein, ring (1), connecting rod (2), first connection sleeve (3), bracing piece (4), second connection sleeve (5), tip connecting rod (6).
The specific embodiment is as follows:
the present invention will be described in further detail with reference to specific examples and drawings, but the content of the present invention is not limited to the examples.
Example 1
As shown in fig. 1, the self-expanding type lumen stent is formed by splicing nickel titanium wires, so that the stent inherits the flexibility of a braided stent and the defect of poor flexibility of a cut stent is avoided.
The bracket comprises: more than two circulators (1), more than one connecting rod (2) and more than one first connecting sleeve (3), at least two circulators (1) are connected with the both ends of connecting rod (2) respectively, and connecting rod (2) at least one end and circulators (1) are cup jointed with first connecting sleeve (3) to form the support.
The novel self-expanding type lumen stent implementation mode is provided, and the yield force born by the connecting rod and the peaks and the troughs of the stent in the pressing and holding process is greatly reduced.
Example 2
As shown in fig. 1, the self-expanding type lumen stent is formed by splicing nickel titanium wires, so that the stent inherits the flexibility of a braided stent and the defect of poor flexibility of a cut stent is avoided.
The bracket comprises: more than two circulators (1), more than one connecting rod (2) and more than one first connecting sleeve (3), at least two circulators (1) are connected with the both ends of connecting rod (2) respectively, and connecting rod (2) at least one end and circulators (1) are cup jointed with first connecting sleeve (3) to form the support.
Wherein the ring (1) is composed of a plurality of support rods (4), and one end of each of at least two support rods (4) is sleeved by a second connecting sleeve (5). The first connection sleeve (3) and the second connection sleeve (5) may be the same or different connection sleeves. The number of the rings (1) in the bracket depends on the actual clinical requirement, and the number of the supporting rods (4) is determined according to the space size of the treatment part and the overall structural stability of the bracket.
The ring-shaped objects (1) are sleeved by one or more connecting rods (2) and the connecting sleeve (3), so that the support is not easy to break when being bent, the ring-shaped objects can adapt to various forms of human body lumens, the clinical treatment effect is remarkably improved, and meanwhile, the connection between the ring-shaped objects is more stable, and the support rods are prevented from being twisted when the support enters and exits the sheath. The support and the ring (1) are not limited by the curvature of the bending part of the woven support, the two support rods (4) of the ring (1) can be well compressed and attached together, the diameter after compression is effectively reduced, the support can be compressed into a smaller delivery sheath without breaking, and meanwhile, the deformation of the support rods caused by attaching the support rods (4) in a splicing mode is much smaller than that of the bending part of the woven support, so that the support has good compression performance and fatigue resistance.
Example 3
As shown in fig. 1 and 2, the self-expanding type lumen stent of the embodiment is formed by splicing nickel titanium wires, so that the stent inherits the flexibility of a woven stent and the defect of poor flexibility of a cut stent is avoided.
The bracket comprises: more than two circulators (1), more than one connecting rod (2) and more than one first connecting sleeve (3), at least two circulators (1) are connected with the both ends of connecting rod (2) respectively, and connecting rod (2) at least one end and circulators (1) are cup jointed with first connecting sleeve (3) to form the support. As further shown in fig. 2, the ring (1) is formed by splicing a plurality of support rods (4) through a second connecting sleeve (5).
The connecting rod (2) and the supporting rod (4) are preferably in a round column shape, partial materials are removed from opposite sides of two ends of the connecting rod (2) and the supporting rod (4), the ends of the two supporting rods (4) and the ends of the connecting rod (2) are assembled to form a column shape, and the column shape is sleeved in the first connecting sleeve (3) and fixedly connected through welding and the like. The three splice parts are spliced together to form cylindrical sleeved sleeve connection, the whole process is simple and convenient, the operability is strong, and meanwhile, the connection is firmer through welding.
The ends of the other two support rods (4) which are not connected with the connecting rod (2) are arranged side by side to form a cylinder, sleeved into the second connecting sleeve (5) and fixedly connected through welding and the like. Preferably, the support rods (4) are connected end to end through the sleeves (5) in sequence to form the ring (1). The wave crest and the wave trough of the ring-shaped wave form are connected by the sleeve, the wave form can not be formed by bending a nickel titanium metal wire like the prior art, the wave crest and the wave trough can be limited by bending curvature, even if the bent angle is processed at the wave crest and the wave trough, such as forming a circular arc shape, the like, the wave crest and the wave trough are inevitably broken when the bracket is compressed into the sheath, the wave form is formed by splicing the sleeve and the supporting rod, and the bending limitation does not exist, so that the problems can be effectively solved.
Example 4
Based on the embodiment 1, the embodiment 2 or the embodiment 3, partial materials are removed from opposite sides of two ends of the supporting rod (4) which are not connected with the connecting rod (2) by taking a semicircle as a center, so that after the ends of the two supporting rods (4) are arranged side by side, the stress after being connected by a sleeve is more uniform, and the firmness is better; and the opposite sides of the two ends of the supporting rod (4) connected with the connecting rod (2) are used for removing part of materials by taking a sector of 120 degrees as the center; therefore, after the end parts of the two support rods (4) and the end parts of the connecting rods (2) are arranged side by side, the stress after being connected through the sleeve is more uniform, and the firmness is better.
Preferably, as shown in fig. 4, when part of the material is removed, the material can be removed vertically along the cylinder, or removed in a certain radian, and the optimal radian is 3-15 degrees.
As shown in fig. 3, the ends (401, 402) of the support rods (4) of the invention can form an angle with the surface of the connecting part (403) respectively, and the angle is 15-90 degrees, so that the ends of the two support rods (4) can be spliced into a cylinder shape, which is consistent with the cylindrical shape of the connecting part (403), and the ends of the support rods can be spliced more easily, so that the connection of the ends of the support rods is firmer.
Example 5
Based on the embodiment 1, the embodiment 2, the embodiment 3 or the embodiment 4, the ring (1) of the embodiment is composed of 8-32 support rods (4) to form 4-16 waves. The annular wave-shaped support formed by 8-32 support rods can adapt to various sizes of tube cavities, and good support force of the support is ensured from the geometric angle. The number, diameter and shape of the rings (1) can be properly adjusted according to the length and structure of the lesion of the lumen. Meanwhile, the diameter of the supporting rod (4) of the embodiment is 0.1-1.2 mm,
the wave crest and wave trough included angle of the wave form of the ring (1) formed by the supporting rods (4) is 10-120 degrees, the wave crest and wave trough height difference of the wave form of the ring (1) formed by the supporting rods (4) is 4-40 mm, and the rest is the same as that of the embodiment 3. Therefore, the waveform curvature radius can be prevented from being too small or too large, the stent is easier to compress into the sheath tube and cannot be bent and broken, the pipe diameter of the used conveying device can be reduced to about 9F, the damage to the lumen in the conveying process is reduced, the conveying difficulty is reduced, and the setting of the diameter of the supporting rod and the setting of the waveform angle and the height can enable the stent to have good supporting force after being implanted into a large blood vessel, so that the clinical treatment effect is remarkably improved.
Example 6
Based on embodiment 5, ring (1) is formed the wave by 8-32 spinal branch vaulting pole (4) head and tail through second adapter sleeve (5) concatenation in proper order, and the ring that adopts this quantity bracing piece to form can adapt to the human lumen of different form sizes, forms 4-16 wave that crest trough angle is 90 degrees, and the difference in height of crest trough is 25 millimeters, and crest trough angle is the right angle and can makes the support possess better holding power, and it can make the support whole obtain more firm structure to inject crest trough difference in height, has also consequently limited ring quantity simultaneously, prevents that ring quantity from too little influence treatment, and too many is unfavorable for saving cost of manufacture. The supporting rod (4) is generally in a circular column shape, the diameter is 0.5 millimeter, and the problem that the whole supporting force of the bracket is reduced due to too thin supporting rod (4) is avoided.
Example 7
The embodiment provides a method for manufacturing the self-expanding type lumen stent, which specifically comprises the following steps: the connecting rod or the supporting rod is sleeved with a sleeve.
Further fixing means include: the method can adopt the hot welding modes such as laser welding, argon arc welding, resistance welding and the like. A stamped connection may also be used. The remainder was the same as in example 4. Compared with the prior art adopting a mechanical method for fixing, the fixing device is firmer, and the service life of the bracket is greatly prolonged.
Example 8
As shown in FIG. 5, in the self-expanding type lumen stent of the present embodiment, the rings (1) at both ends of the stent can be connected with the first connecting sleeve (3) by using one or more end connecting rods (6), so that the connection between the rings is more stable, and the twisting between the supporting rods when the stent enters and exits the sheath can be avoided, and at the same time, the connecting rings of the present embodiment can form a spiral or linear stent after being connected by the connecting rods.
Through the number and the form setting of the connecting rods of the embodiment, the whole bracket obtains stability, and is beneficial to clinical treatment effect.
Example 9
As shown in fig. 5, the self-expanding type lumen stent of the present embodiment further comprises a film (7) which can be made into a covered stent.
The stent of the invention can be partially or completely covered with a plastic film, the film can be a PET or ePTFE film, and the film can be attached with medicines to improve the treatment effect.
Compared with the prior art, the invention has the following beneficial effects:
the self-expanding type lumen stent can be compressed into a smaller delivery sheath, and the diameter of the sheath can be reduced to about 9F, so that the stent can reduce the damage to the lumen in the delivery process and reduce the delivery difficulty.
The self-expanding type lumen stent has excellent flexibility and fatigue resistance, and ensures that the stent can be compressed into a small sheath tube without breaking.
The self-expanding type lumen stent has excellent supporting force, can be suitable for lumens in various forms, and ensures that the stent is stable in the human body lumen for a long time.
The self-expanding type lumen stent provided by the invention has a better treatment effect by covering the surface of the self-expanding type lumen stent with the PET or ePTFE film.
The self-expanding type lumen stent support rods are firmly connected, the manufacturing method is simple, and the cost is saved.
The embodiments 1 to 9 are embodiments of the present invention, but the embodiments of the present invention are not limited to the embodiments described above, and any other changes, modifications, substitutions, combinations, and simplifications that do not depart from the spirit and principle of the present invention should be equivalent to the embodiments described above, and are included in the scope of the present invention.
Claims (15)
1. A self-expanding luminal stent comprising: the device comprises more than two circulators (1), more than one connecting rod (2) and more than one first connecting sleeve (3), wherein at least two circulators (1) are respectively connected with two ends of the connecting rod (2), the circulators (1) are provided with wave crests and wave troughs, and at least one end of the connecting rod (2) is sleeved with the wave crests or the wave troughs of the circulators (1) through the first connecting sleeve (3) to form a bracket;
the ring (1) is formed by a plurality of support rods (4) and is in a wave shape, and one end of each of the two support rods (4) is sleeved with a second connecting sleeve (5) to form a wave crest or a wave trough of the wave shape.
2. A self-expanding luminal stent according to claim 1, wherein the first connection sleeve (3) and the second connection sleeve (5) are the same or different connection sleeves.
3. A self-expanding luminal stent according to claim 1, wherein the opposite sides of the two ends of the connecting rod (2) and the supporting rod (4) are partially removed, and the ends of the two supporting rods (4) and the ends of the connecting rod (2) are assembled to form a cylinder shape and are sleeved in the first connecting sleeve (3).
4. A self-expanding lumen stent according to claim 3, wherein the connecting rod (2) and the supporting rod (4) are respectively in a circular column shape, and two supporting rods (4) connected with the connecting rod (2) and opposite sides of the end of the connecting rod are respectively used for removing part of materials by taking a sector of 120 degrees as a center.
5. A self-expanding lumen stent according to claim 3 or 4, characterized in that the ends of the other two support rods (4) which are not connected with the connecting rod (2) are arranged side by side to form a cylinder shape and are sleeved into the second connecting sleeve (5); the support rods (4) are connected end to end through the second connecting sleeve (5) in sequence to form a ring (1).
6. A self-expanding luminal stent according to claim 3 wherein the support bars (4) are circular columns and the opposite sides of the ends of the other two support bars (4) not connected to the connecting bars (2) are each partially removed with a semicircle as the center.
7. A self-expanding luminal stent according to claim 3 wherein the material at the ends of the support bar (4) and the connecting bar (2) is removed vertically along a cylinder or in a curvature of 3-15 degrees.
8. A self-expanding luminal stent according to claim 1, wherein the support bar (4) has a first end (401) and a second end (402) opposite thereto, and a connecting portion (403) extending between the first end (401) and the second end (402), the first end (401) and the second end (402) respectively forming an angle with the surface of the connecting portion (403) of 15-90 degrees.
9. A self-expanding luminal stent according to claim 1, wherein the ring (1) consists of 8-32 struts (4) forming 4-16 waves; the diameter of the supporting rod (4) is 0.1-1.2 mm, and the length is 4-40 mm; the wave crest and wave trough included angles of the wave form of the ring (1) formed by the plurality of support rods (4) are respectively 10-120 degrees.
10. A self-expanding luminal stent according to claim 1, wherein the first connecting sleeve (3) is fixedly connected by heat welding or stamping after being sleeved.
11. A self-expanding luminal stent according to claim 2, wherein the second connecting sleeve (5) is fixedly connected by heat welding or punching after being sleeved.
12. A self-expanding luminal stent according to claim 1, wherein the rings (1) constituting the ends of the stent are connected by end connecting bars (6) to form a spiral or straight line.
13. A self-expanding luminal stent according to claim 1, further comprising a membrane (7) partially or totally covering the luminal stent.
14. The self-expanding luminal stent of claim 13 wherein the membrane is a PET or ePTFE membrane having a drug affixed thereto.
15. A method of making a self-expanding luminal stent according to any of claims 1 to 14 comprising: one end part of each supporting rod and one end part of the other supporting rod are sleeved and fixed by a sleeve, and the two supporting rods sleeved and fixed by the sleeve are positioned on the same side of the sleeve and are distributed outwards from the sleeve in an included angle manner so as to form peaks or troughs of a ring-shaped object of the bracket;
or, one end part of the supporting rod, the end part of the other supporting rod and one end part of the connecting rod are sleeved and fixed together by a sleeve, and the two supporting rods sleeved and fixed by the sleeve are positioned on the same side of the sleeve and are distributed outwards from the sleeve in an included angle mode so as to form peaks or troughs of the ring-shaped object of the bracket.
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| CN201810705885.3A Active CN109199658B (en) | 2017-07-03 | 2018-07-02 | Self-expanding type lumen stent and manufacturing method thereof |
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| CN209107691U (en) * | 2017-07-03 | 2019-07-16 | 深圳市科奕顿生物医疗科技有限公司 | A kind of self-inflated intraluminal stent |
| CN112972083B (en) * | 2019-12-17 | 2022-11-11 | 北京迈迪顶峰医疗科技股份有限公司 | Pulmonary artery stent for children |
| CN116115286B (en) * | 2022-03-14 | 2024-06-07 | 杭州亿科医疗科技有限公司 | Vascular stent with good adherence |
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| CN109199658A (en) | 2019-01-15 |
| CN209107691U (en) | 2019-07-16 |
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