CN109700581B - Stent and stent system - Google Patents
Stent and stent system Download PDFInfo
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- CN109700581B CN109700581B CN201811640973.6A CN201811640973A CN109700581B CN 109700581 B CN109700581 B CN 109700581B CN 201811640973 A CN201811640973 A CN 201811640973A CN 109700581 B CN109700581 B CN 109700581B
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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
- A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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Abstract
The invention relates to a stent, which comprises at least one degradable segment region and at least one non-degradable segment region, wherein the degradable segment region and the non-degradable segment region are connected with each other, the axial length of at least one degradable segment region is not less than 3mm, at least one end part of the stent is provided with the non-degradable segment region with the axial length of not less than 3mm, the stent can be used for closing an arterial catheter without being taken out after being implanted into the arterial catheter, and therefore, the injury and other complication probability to a child patient are reduced. The invention also provides a bracket system.
Description
Technical Field
The invention relates to the field of interventional medical devices, in particular to a stent and a stent system.
Background
However, in patients with complicated congenital heart disease such as tricuspid valve occlusion, right ventricular outflow obstruction (pulmonary valve occlusion or pulmonary artery stenosis), pulmonary hypertension, etc., blood shunts from right to left through abnormal passages (such as atrial septal defect, ventricular septal defect, etc.) between the right and left heart, and then a large amount of venous blood with low oxygen content flows to systemic circulation, so that the patients have persistent cyanosis and reduced pulmonary blood flow. Therefore, the infant patients rely on the opening of the arterial duct to maintain the effective pulmonary circulation or systemic circulation of the infant patients so as to improve the symptoms of low pulmonary blood flow, low blood oxygen saturation, cyanosis and the like, and the self-closing or artificial closing of the arterial duct can cause serious hemodynamic disorders.
For the complicated congenital heart disease patient with ductus arteriosus dependence, the prior art does not have a completely symptomatic stent, but uses a permanent stent with other indications for treatment, and has the problem that the permanent stent growing in the tissue needs to be taken out again through surgical operation when the patient is treated radically in the follow-up process, and then the ductus arteriosus is ligated or an occluder is placed to close the ductus arteriosus. Surgical trauma is extreme and removal is difficult due to the stent already growing in the ductal artery tissue, which can easily cause injury or other complications.
Disclosure of Invention
In view of the above, there is a need for a stent that allows for subsequent closure of an arterial catheter after implantation without removal, thereby reducing the risk of injury and other complications to the child patient.
A scaffold comprising at least one degradable segment region and at least one non-degradable segment region, said degradable segment regions and said non-degradable segment regions being interconnected, at least one of said degradable segment regions having an axial length of not less than 3mm, at least one end of said scaffold being provided with said non-degradable segment region having an axial length of not less than 3 mm.
Further, the material of the degradable segment region is degradable polymer material or degradable metal material, and the material of the non-degradable segment region is metal material.
Further, the stent is a ball-expanded stent, the material of the non-degradable segment region is at least one selected from gold, silver, platinum, rhodium, iridium, tantalum, tungsten, cobalt, chromium, molybdenum and niobium, and the material of the degradable segment region is selected from magnesium, iron, zinc, magnesium-based alloy, iron-based alloy, zinc-based alloy, polylactic acid or polycarbonate.
Further, the stent is a self-expanding stent, the non-degradable segment region is made of nickel-based alloy or titanium-based alloy, the degradable segment region is made of iron-based alloy, and the iron-based alloy is selected from iron-manganese alloy, iron-nickel alloy, iron-platinum alloy or iron-palladium alloy.
Further, the stent is a self-expanding stent, and at least part of the sections in the non-degradable section area are outward turning or outward rolling parts.
Further, the inside-out or outside-rolling part forms an annular region approximately like a brim in the circumferential direction of the end of the self-expandable stent, the annular region being in a continuous state or a discontinuous state.
Further, the axial profile of the stent under unconstrained after release is rectangular, conical, toroids, or dumbbell shaped.
Further, a visualization structure is provided on the non-degradable segment region or on the degradable segment region at the end of the scaffold.
Further, at least a portion of a surface region of the degradable segment region is provided with at least one of surface pores, blind grooves, through holes, hollow holes or coatings on which a corrosion-promoting or absorption substance is carried.
Further, at least part of the surface area of the stent is provided with at least one of surface micropores, blind grooves, through holes, hollow holes and coatings, and the surface micropores, the blind grooves, the through holes, the hollow holes and the coatings carry anti-proliferative, anti-tumor, anti-inflammatory, anti-thrombotic or anti-allergic medicines.
A bracket system comprises the bracket.
The stent ensures that a doctor has enough operable space when ligating the arterial catheter corresponding to the corresponding degradable segment region along with the degradation of the degradable segment region after the stent is implanted for a certain time by arranging the degradable segment region with the axial length not less than 3 mm; at least one end of the support is provided with an undegradable section area with the axial length not less than 3mm, after the support is released, the area extends out of the arterial catheter by at least 1mm, the whole arterial catheter is supported by the support, at least 1mm is positioned in the arterial catheter, and the support part extending out of the arterial catheter can be coated and fixed by neovascular intima subsequently, so that vascular embolism caused by falling-off of the support part is prevented, a doctor judges the length of lesion and selects the length of the support to have certain deviation, in order to ensure that the above functions of the support can still be realized, and a certain margin is required to be left for the minimum length of the undegradable section area. Meanwhile, the stent is allowed to be implanted into the arterial catheter and then can be subsequently closed without being taken out, so that the probability of injury and other complications to the sick child is reduced.
Drawings
Fig. 1 is a schematic view of an arterial catheter.
Fig. 2 is a schematic view of a bracket 100 provided in an embodiment.
Fig. 3 is a schematic view of a stand 200 according to an embodiment.
Fig. 4 is a schematic view of a bracket 300 provided by an embodiment.
Fig. 5 is a schematic view of a stent system 1000 according to an exemplary embodiment.
FIG. 6 is a schematic view of the stent provided in example 1 applied to an arterial catheter.
FIG. 7 is a schematic view of the stent provided in example 6 applied to an arterial catheter.
Fig. 8 is a top view of the stent provided in example 6.
FIG. 9 is a schematic view of the stent provided in example 7 applied to an arterial catheter.
FIG. 10 is a top view of the stent provided in example 7.
FIG. 11 is a schematic view of the stent provided in example 8 applied to an arterial catheter.
FIG. 12 is a top view of the stent provided in example 8.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
"axial" refers to a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the stent, and "radial" refers to a direction perpendicular to the above-mentioned axial direction. "proximal" refers to the end into which blood flows; "distal" refers to the end from which blood flows.
It should be noted that, in the drawings mentioned in the examples, in order to be able to distinguish degradable segment regions from non-degradable segment regions in the drawings, lines of the non-degradable segment regions are thicker, lines of the degradable segment regions are thinner, and the thickness of the lines in the drawings is only used for distinguishing the non-degradable segment regions from the degradable segment regions.
This embodiment provides a stent comprising at least one degradable segment region and at least one non-degradable segment region, the degradable segment region and the non-degradable segment region being connected to each other, the axial length of at least one of the degradable segment regions being not less than 3mm, at least one end of the stent being provided with a non-degradable segment region having an axial length of not less than 3 mm.
The degradable segment region is arranged to ensure that after the stent is implanted for a certain time, the degradable segment region can be gradually degraded to be completely deconstructed after the stent is implanted for a certain time, so that the arterial catheter can be directly ligated without taking out the stent after the stent is implanted for a certain time. With the degradation of the degradable segment region, the physician has enough space to operate when ligating the arterial catheter corresponding to the corresponding degradable segment region, so that at least one degradable segment region with a length not less than 3mm is defined. The end part of the stent is provided with the non-degradable section area, so that after the stent is released, the area extends out of the arterial catheter by about 1mm, at least 1mm is positioned in the arterial catheter under the condition that the whole arterial catheter is supported by the stent, and the area can be coated and fixed by neovascular intima subsequently, so that vascular embolism caused by falling off of the stent area extending out of the arterial catheter is prevented; in order to ensure that the functions above the stent can still be realized, a certain margin needs to be left for the minimum length of the nondegradable segment region, so that the length of the nondegradable segment region at the end part is limited to be not less than 3 mm.
In this embodiment, the degradable segment region and the non-degradable segment region are connected with each other at intervals, and the degradable segment region and the non-degradable segment region can be connected together by riveting, crimping, welding, bonding, alloying with autologous materials, and the like.
In one embodiment, the stent is provided with non-degradable segment regions at both ends. For example, referring to fig. 2, the scaffold 100 includes one degradable segment region 11 and two non-degradable segment regions 121, 122, the degradable segment region 11 being located between the non-degradable segment regions 121, 122. The axial lengths of the two non-degradable segment regions 121, 122 may or may not be equal. In other embodiments, the stent may further include a plurality of degradable segment regions and a plurality of non-degradable segment regions, where the degradable segment regions and the non-degradable segment regions are connected at intervals, and it is a protection scope of this embodiment as long as it is ensured that both ends of the stent are provided with the non-degradable segment regions, and at least one end of the stent is provided with the non-degradable segment regions with an axial length of not less than 3 mm.
In another embodiment, one end of the scaffold is provided with a non-degradable segment region and the other end of the scaffold is provided with a degradable segment region. Referring to fig. 3, the stent 200 includes a degradable segment region 11 and a non-degradable segment region 12 connected in sequence. In other embodiments, the stent may further include a plurality of degradable segment regions and a plurality of non-degradable segment regions, and the degradable segment regions and the non-degradable segment regions are connected at intervals, so long as it is ensured that one end of the stent is provided with the non-degradable segment regions, and the axial length of the non-degradable segment regions provided at the ends of the stent is not less than 3mm, which is the protection scope of this embodiment.
In one embodiment, the material of the degradable segment region is a degradable polymer material or a degradable metal material, and the material of the non-degradable segment region is a corrosion-resistant metal material. When the material of the degradable segment region is degradable metal material, oxygen concentration corrosion is formed between the degradable segment region in the arterial catheter and the part extending out of the non-degradable segment region of the arterial catheter, and corrosion of the degradable segment region is promoted.
In the embodiment, the non-degradable segment region can realize self-development by selecting a material with development property, and can also assist development by arranging a development structure. It is understood that the degradable segment region can also be self-developed by selecting a material with developing properties, and can also be provided with a developing structure to assist in development. The metallic material is self-developable, and the developability of the stent section made of the metallic material can be improved or reduced by increasing or decreasing the thickness of the stent mesh rod made of the metallic material. The polymer can be developed through special treatment, for example, polycarbonate can realize self development through grafting iodine groups.
When the scaffold is a spherical expansion type scaffold, the degradable polymer material is selected from degradable polylactic acid and degradable polycarbonate; the degradable metal material is selected from degradable magnesium, magnesium-based alloy, degradable iron, iron-based alloy, degradable zinc or zinc-based alloy; the corrosion-resistant metal material is a high developability metal selected from gold, silver, platinum, rhodium, iridium, tantalum, tungsten, cobalt, chromium, molybdenum, niobium or an alloy of at least two of gold, silver, platinum, rhodium, iridium, tantalum, tungsten, cobalt, chromium, molybdenum and niobium. When the material of the degradable segment region is a degradable metal material and the material of the non-degradable segment region is a high-developability metal, the high-developability metal is a cathode with corrected potential, and the degradable metal material can form a corrosive couple pair, so that the degradation of the degradable segment region is greatly promoted, and the high-developability metal can play a role in enhancing visibility. In other embodiments, the non-degradable segment region of the balloon expandable stent may also be provided with a visualization structure to aid in visualization.
When the stent is a self-expanding stent, the material of the degradable segment region and the material of the non-degradable segment region are both super-elastic materials, and the corrosion-resistant metal material is selected from super-elastic nickel-based alloy or titanium-based alloy. The degradable metal material is selected from super-elastic iron-based alloy, and the super-elastic iron-based alloy is selected from iron-manganese (Fe-Mn) alloy, iron-nickel (Fe-Ni) alloy, iron-platinum (Fe-Pt) alloy and iron-palladium (Fe-Pd) alloy.
When the stent is a self-expanding stent, at least part of segments in the nondegradable segment area at the end part of the self-expanding stent can be outwards turned or rolled, and an annular area similar to a brim is formed on the circumferential direction of the end part of the self-expanding stent, so that the stent can be placed in a percutaneous intervention mode to close an arterial duct or/and directly ligate the arterial duct without taking out the stent after being implanted into the arterial duct, meanwhile, the outwards turned/rolled annular area of the stent can be embedded by neovascular tissues in the aorta or/and the pulmonary artery due to the fact that the annular area is attached to the wall of the aorta or/and the wall of the pulmonary artery, the stent is not easy to displace after being implanted, and is not easy to fall off to cause embolism.
Referring to fig. 4, fig. 4 shows the self-expanding stent 300 in its expanded, i.e., released, state, with the stent 300 out of the constraint of the delivery device, at least some of the non-degradable segment regions at the ends of the self-expanding stent 300 will evert or roll over to form everted portions 2, forming an annular region that approximates a brim in the circumferential direction at the ends of the stent. It should be noted that when the turning part 2 is a thin and short whisker-like filament or flexible segment, an outward rolling design can be adopted, and when the turning part 2 is a rigid plane or curved surface with a large area, an outward rolling design can be adopted, the specific shape of at least part of the non-degradable segment region at the end of the self-expandable stent 300 is not limited, and the outward rolling or outward rolling is used for better adherence, so as to be embedded by the neovascular intima tissue and reduce the risk of desquamation, embolism and thrombus. In addition, the annular region may be asymmetrically designed or irregularly designed for different arterial catheter anatomies.
Due to the anatomical structure of the vessel wall, i.e. the arterial catheter does not perpendicularly access the pulmonary artery or the aorta, but may access at an angle, the self-expandable stent 300 actually shows an eversion angle of between 30 and 150 degrees when released in vivo. Therefore, when the self-expandable stent 300 is manufactured, the eversion inclination angle a after heat setting is selected to be more than 90 degrees, preferably more than 150 degrees, so as to adapt to various vascular anatomical structures and ensure that the eversion sections of the stent adhere well after eversion. It should be noted that the self-expandable stent 300 includes a main body part 1 and a turning part 2, and the eversion inclination angle a is an angle between an axially extending line of the main body part 1 and the turning part 2 of the self-expandable stent 300. In this embodiment, the self-expandable stent 300 includes a degradable segment region 11 and a non-degradable segment region 12 connected in sequence from the distal end to the proximal end, the non-degradable segment region 12 includes the turn-over portion 2, and the body portion 1 includes the non-degradable segment region 12 and the degradable segment region 11 excluding the turn-over portion 2.
The annular region that approximates the brim may be continuous or discontinuous circumferentially at the end of the holder. In this embodiment, when the approximately hat brim annular region is discontinuous in the stent end circumference direction, the turning part 2 may be provided with a plurality of whisker-like structures or/and pattern structures radiating outward from the circumference of the end face of the self-expandable stent 300, and the planes or curved surfaces of the plurality of whisker-like structures or/and pattern structures form an annular shape around the end face of the main body part 1 of the stent. It should be noted that the shape, size or length of each whisker-like structure or pattern structure may be the same or different, and the number is not limited. The shape of the whisker-shaped structure can be a straight line shape, a broken line shape, a curved line shape or a combination of at least two shapes, and the shape of the pattern structure can be a circle, an ellipse, a V-shaped shape, a polygon, a Y-shaped shape, a saw-tooth shape or a combination of a plurality of shapes. Any whisker-shaped structures, any pattern structures, or whisker-shaped structures and pattern structures which form a ring can be mutually overlapped or not. In one bracket, if both ends of the bracket are provided with the turning parts, the shapes of the turning parts at both ends can be the same or different.
Preferably, the everting portion 2 of the self-expanding stent 300 is designed to be discontinuous, less material can be used for the everting portion 2, the stent can be constrained to a smaller profile outer diameter, so that a smaller sheath can be fitted, less trauma is brought to the infant, and the target vessel with a more complex anatomical structure can be accessed.
When the non-degradable segment regions are arranged at two ends of the bracket, the two ends of the bracket are turned outwards or outwards, the turning parts 2 are respectively arranged at two ends of the main body part, and the lengths of the turning parts 2 at the two ends of the main body part can be the same or different.
In another embodiment, the stent is a self-expanding stent that may not be configured to evert or roll over in the area of the non-degradable segments at the ends of the self-expanding stent.
The axial profile of the main body portion of the stent, which is unconstrained after release, may be rectangular, tapered, toroids, or dumbbell shaped to conform to the anatomy of the arterial catheter, reducing the risk of displacement of the stent after implantation.
In an embodiment, at least part of the surface region of the degradable segment region is provided with at least one of surface pores, blind grooves, through holes, hollow holes, coatings on which a corrosion-promoting or absorption substance is carried.
In one embodiment, at least a portion of the surface area of the stent is provided with at least one of surface pores, blind grooves, through holes, hollow holes, and coatings on which an antiproliferative, antineoplastic, anti-inflammatory, antithrombotic, or anti-allergic drug is carried.
As shown in fig. 5, the present embodiment provides a stent system 1000 comprising a stent 200 and a delivery device 3, the delivery device 3 being used to deliver the stent 200 to a target site. In this embodiment, the bracket is any one of the brackets in the above embodiments.
The stents described above may also be used in the treatment of restenosis in a bridge vessel such as a surgical coronary artery bypass graft or in the treatment of restenosis in a complicated precordial surgical palliative treatment of the Blalock-Taussig bypass.
The absorbable metal stent described above is further illustrated by the following specific examples.
Example 1
A ball-expandable stent, as shown in fig. 6, comprises a degradable segment region 11 with a length of 5mm and a non-degradable segment region 12 with a length of 3mm arranged at the distal end of the stent. The degradable segment area 11 can be made of degradable nitriding iron pipe through laser engraving and polishing, can develop by self body, but has weaker developing property than the non-degradable segment, and can be coated with a polylactic acid coating containing rapamycin. The non-degradable segment area 12 can be made of a platinum-chromium alloy tube with high developability through laser engraving and polishing, and can be developed by self. The degradable segment region 11 and the non-degradable segment region 12 can be connected together by welding and then pressed onto the balloon catheter.
The axial outline of the unconstrained stent main body of the stent is rectangular after the stent is expanded and released through the balloon catheter in vitro, and the stent is suitable for the arterial catheter with the external diameter not changed much along with the length. The high visualization of the non-degradable segment region 12 may help to accurately position the stent when implanted in an arterial catheter, such that after an 8mm long stent is released in a 6mm long arterial catheter 82, a 1mm long portion of the non-degradable segment region 12 remains in the arterial catheter 82, leaving the arterial catheter 82 and extending into the pulmonary artery 83. Degradation of the degradable segment region 11 can be greatly promoted because the potential of the non-degradable segment region 12 of the scaffold is more positive relative to the potential of the degradable segment region 11 to serve as a cathode and a corrosive couple is formed between the degradable segment region 11 and the scaffold.
After the arterial catheter 82 is implanted for a period of time, the section area of the stent contacted with the inner wall of the arterial catheter 82 is embedded by the neovascular tissue, at least part of the non-degradable section area 12 at the end part of the stent is also embedded in the neovascular tissue of the arterial catheter 82, and even if the degradable section area 11 of the stent is completely degraded, the non-degradable section 12 at the end part of the stent can not be degraded and fall off to cause embolism. The erosion of the degradable segment region 11 is further promoted by the oxygen concentration erosion between the degradable segment region 11 embedded in the neovascular tissue and the portion of the end non-degradable segment region 12 exiting the arterial catheter 82 exposed to the blood flow of the pulmonary artery 83.
After the stent is implanted into the arterial catheter 82, the arterial catheter 82 can be kept open for a certain period of time. As the degradable segment region 11 of the stent, 5mm in length, gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 1 year of stent implantation.
Example 2
A ball-expanded stent comprises a degradable segment area with the length of 10mm and non-degradable segment areas with the length of 5mm which are arranged at two ends of the stent respectively. The degradable segment area can be made of degradable polylactic acid tubes through laser engraving and polishing, and is not developable by self body, and no developing structure is arranged. The non-degradable segment area can be made of a tantalum-niobium alloy tube with high developability through laser engraving and polishing, and can be developed by self. The degradable segment region and the non-degradable segment region can be connected together by means of crimping and then crimped on the balloon catheter.
The axial profile of the unconstrained stent main body of the stent after the stent is expanded and released through the balloon catheter in vitro is waist drum-shaped, and the stent is suitable for the artery catheter with obviously large middle outer diameter and small outer diameters at two ends. The high visualization of the non-degradable segment regions can help the stent to be accurately positioned when being implanted into the arterial catheter, so that after the 20mm long stent is released in the 15mm long arterial catheter, 2.5mm long parts of the non-degradable segment regions at two ends of the stent are still in the arterial catheter, and the rest of the non-degradable segment regions extend out of the arterial catheter and respectively extend into the pulmonary artery and the aorta.
After the arterial catheter is implanted for a period of time, the section area of the stent contacted with the wall of the arterial catheter is embedded by the neovascular tissue, and the non-degradable section area at the end part of the stent is at least partially embedded in the neovascular tissue of the arterial catheter, so that even if the degradable section area of the stent is completely degraded, the non-degradable section at the end part of the stent can not be degraded and shed to cause embolism.
After the stent is implanted into an arterial duct, the opening of the arterial duct can be maintained for a certain time. As the degradable segment region of the stent, 10mm in length, gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 1.5 years of stent implantation.
Example 3
A ball expanded stent comprises a degradable segment area with the length of 16mm and a non-degradable segment area with the length of 4mm arranged at one end of the stent. The degradable segment area can be made of degradable pure zinc tubes through laser engraving and polishing, and can develop by itself, but the segment with lower developability is weaker than the segment with lower degradability. The non-degradable segment area can be made of a platinum-chromium alloy tube with high developability through laser engraving and polishing, and can be developed by self. The degradable segment region and the non-degradable segment region can be connected together by riveting and then pressed on the balloon catheter.
The axial outline of the unconstrained stent main body of the stent after the stent is expanded and released through the balloon catheter in vitro is dumbbell-shaped, and the stent is suitable for the artery catheter with small outer diameter in the middle and large outer diameters at two ends. The high visualization of the non-degradable segment regions can help to accurately position the stent when implanted in an arterial catheter, so that after a 20mm long stent is released in an 18mm long arterial catheter, a 2mm long portion of the non-degradable segment regions remains in the arterial catheter, and the remainder extend out of the arterial catheter and into the aorta. Because the potential correction of the non-degradable segment region of the stent relative to the degradable segment region is used as a cathode, and a corrosive couple pair is formed between the degradable segment region, the degradation of the degradable segment region can be greatly promoted.
After the arterial catheter is implanted for a period of time, the section area of the stent contacted with the wall of the arterial catheter is embedded by the neovascular tissue, and the non-degradable section area at the end part of the stent is at least partially embedded in the neovascular tissue of the arterial catheter, so that even if the degradable section area of the stent is completely degraded, the non-degradable section at the end part of the stent can not be degraded and shed to cause embolism. The degradable segment region embedded in the neovascular tissue and the part of the end non-degradable segment region extending out of the arterial catheter exposed to the aortic blood flow form oxygen concentration differential corrosion, further promoting corrosion of the degradable segment region.
After the stent is implanted into an arterial duct, the opening of the arterial duct can be maintained for a certain time. As the degradable segment region of the stent 16mm in length gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 9 months of stent implantation.
Example 4
A ball-expanded stent comprises a degradable segment area with the length of 20mm and a non-degradable segment area with the length of 6mm arranged at one end of the stent. The degradable segment area can be made of a degradable magnesium iron alloy pipe through laser engraving and polishing, and a developing structure is arranged on the degradable magnesium iron alloy pipe. The non-degradable segment area can be made of a high-developability pure tantalum tube through laser engraving and polishing, and can be developed by self. The degradable segment region and the non-degradable segment region can be connected together by means of adhesion and then pressed onto the balloon catheter.
The axial profile of the stent main body under the unconstrained condition is conical after the stent is expanded and released through the balloon catheter in vitro, and the stent is suitable for arterial catheters with conical profiles (such as conical arterial catheters with smaller outer diameter obviously close to the pulmonary artery side and larger outer diameter close to the aorta side). The high visualization of the non-degradable segment regions can help to accurately position the stent when implanted in an arterial catheter, so that after a 26mm long stent is released in a 24mm long arterial catheter, a 4mm long portion of the non-degradable segment regions remains in the arterial catheter, and the rest extends out of the arterial catheter and into the pulmonary artery. Because the potential of the nondegradable segment region of the scaffold is corrected relative to the potential of the degradable segment region, as a corrosive couple is formed between the cathode and the degradable segment region, the degradation of the degradable segment region can be greatly promoted.
After the arterial catheter is implanted for a period of time, the section area of the stent contacted with the wall of the arterial catheter is embedded by the neovascular tissue, at least part of the non-degradable section area at the end part of the stent is also embedded in the neovascular tissue of the arterial catheter, and even if the degradable section area of the stent is completely degraded, the non-degradable section at the end part of the stent can not be degraded and shed to cause embolism. The degradable segment region embedded in the neovascular tissue and the portion of the end non-degradable segment region extending out of the arterial catheter exposed to the pulmonary arterial blood flow form an oxygen concentration corrosion that further promotes corrosion of the degradable segment region.
After the stent is implanted into the arterial duct, the opening of the arterial duct can be maintained for a certain time. As the degradable segment region of the stent 20mm in length gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 6 months of stent implantation.
Example 5
A self-expanding stent comprising a degradable segment region of 3mm length and a non-degradable segment region of 7mm length disposed at one end of the stent. The degradable segment area can be made of degradable iron-palladium alloy tubes through laser engraving and polishing, and can be developed by self. The non-degradable section area can be made of a nickel-titanium alloy tube through laser engraving and polishing, and a gold developing structure is arranged on the non-degradable section area. The degradable segment region and the non-degradable segment region can be connected together by welding, and the whole stent surface carries paclitaxel through the micropores and then is assembled in the delivery sheath.
The axial outline of the unconstrained stent main body of the stent after the sheath is released outside the body is rectangular, and the stent is suitable for the arterial catheter with the external diameter not changing much along with the length. The visualization structure of the non-degradable segment area can help the stent to be accurately positioned when the stent is implanted into the arterial catheter, so that after the stent with the length of 10mm is released in the arterial catheter with the length of 8mm, the 5mm long part of the non-degradable segment area is still in the arterial catheter, and the rest of the non-degradable segment area extends out of the arterial catheter and into the pulmonary artery. Because the potential of the nondegradable segment region of the scaffold is corrected relative to the potential of the degradable segment region, as a corrosive couple is formed between the cathode and the degradable segment region, the degradation of the degradable segment region can be greatly promoted.
After the arterial catheter is implanted for a period of time, the section area of the stent contacted with the wall of the arterial catheter is embedded by the neovascular tissue, at least part of the non-degradable section area at the end part of the stent is also embedded in the neovascular tissue of the arterial catheter, and even if the degradable section area of the stent is completely degraded, the non-degradable section at the end part of the stent can not be degraded and shed to cause embolism. The degradable segment region embedded in the neovascular tissue and the portion of the end non-degradable segment region extending out of the arterial catheter exposed to the pulmonary arterial blood flow form an oxygen concentration corrosion that further promotes corrosion of the degradable segment region.
After the stent is implanted into an arterial duct, the opening of the arterial duct can be maintained for a certain time. As the degradable segment region of the stent, 3mm in length, gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 1 year of stent implantation.
Example 6
A self-expanding stent, as shown in fig. 7, comprises a degradable segment region 11 of 6mm length and non-degradable segment regions 121, 122 of 5mm length disposed at both ends of the stent. The degradable segment region 11 can be made of a degradable ferro-manganese alloy pipe through laser engraving and polishing, and is weak in self-development and not provided with a development structure. The non-degradable section areas 121 and 122 can be made of nickel-titanium alloy tubes through laser engraving and polishing, a tantalum developing structure is arranged on the portion, located at the proximal port of the arterial catheter, in the non-degradable section area 121, and a tantalum developing structure is also arranged on the portion, located at the distal port of the arterial catheter, in the non-degradable section area 122. The degradable segment region 11 and the non-degradable segment regions 121 and 122 are connected together by crimping and then assembled into the delivery sheath.
The axial outline of the unconstrained stent main body of the stent after the sheath is released outside the body is rectangular, and the stent is suitable for the arterial catheter with the external diameter not changing much along with the length. The visualization of the non-degradable segment regions can help to accurately position the stent when it is implanted in the arterial catheter, so that after the 16mm long stent is released in the 10mm long arterial catheter 82, the two non-degradable segment regions 121 and 122 at the two ends of the stent each have a 2mm long portion still in the arterial catheter 82, and the rest extend out of the arterial catheter 82 and into the aorta 81 and the pulmonary artery 83, respectively. The 3mm length of the non-degradable segments 121, 122 extending into the aorta 81 and pulmonary artery 83, respectively, will each curl outward to form circumferentially near the ends of the stent discrete annular regions 21 and 22 approximating the brim. In this embodiment, referring to fig. 8, the portions of the non-degradable segments 121 and 122 where the outward rolling occurs are arranged as whiskers radiating outward from the circumference of the two end faces of the stent, respectively, the planes or curved surfaces where the whiskers lie form annular regions 21 and 22 around the end faces of the stent. Therefore, the patent ductus arteriosus plugging device can be placed in an interventional mode immediately after the stent is implanted into the ductus arteriosus. Degradation of the degradable segment region 11 can be greatly promoted because the potential of the non-degradable segment regions 121 and 122 of the scaffold is more positive relative to the potential of the degradable segment region 11 to serve as a cathode and a corrosive couple is formed between the degradable segment region 11.
After the arterial catheter is implanted for a period of time, the section area of the stent contacted with the wall of the arterial catheter is embedded by the neovascular tissue, and the non-degradable section area at the end part of the stent is at least partially embedded in the neovascular tissue of the arterial catheter 82, so that even if the degradable section area 11 of the stent is completely degraded, the non-degradable section at the end part of the stent can not be degraded and fall off to cause embolism. The degradable segment region 11 embedded in the neovascular tissue and the portion of the end non-degradable segment region exiting the arterial catheter 82 exposed to the blood flow of the pulmonary artery 83 and aorta 81 create an oxygen concentration differential erosion that further promotes erosion of the degradable segment region 11.
After the stent is implanted into the arterial catheter, the opening of the arterial catheter can be maintained for a certain time. As the degradable segment region 11 of the stent, 6mm in length, gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 1.5 years of stent implantation.
Example 7
A self-expanding stent, as shown in fig. 9, comprises a degradable segment region 11 of 10mm length and a non-degradable segment region 12 of 8mm length disposed at one end of the stent. The degradable segment region 11 can be made of degradable polycarbonate tube by laser engraving and polishing, and the polycarbonate is grafted with iodine groups to realize that self-body can be developed, but the developing property is weak. The nondegradable section area can be made of a titanium-zirconium-niobium alloy tube through laser engraving and polishing, and a platinum developing structure is arranged on the nondegradable section area 12 at the opening of the proximal end of the arterial catheter 82. The degradable segment region 11 and the non-degradable segment region 12 are connected together by means of adhesion and then assembled in the delivery sheath.
The axial profile of the stent body under the unconstrained condition is conical after the stent releases the sheath in vitro, and the stent is suitable for arterial catheters with conical profiles (such as conical arterial catheters with smaller external diameter obviously close to the pulmonary artery side and larger external diameter close to the aorta side). The visualization of the non-degradable segment region and the visualization of the degradable segment region may help to accurately position the stent when implanted in the arterial catheter such that after the 18mm long stent is released in the 15mm long arterial catheter 82, a 5mm long portion of the non-degradable segment region remains in the arterial catheter 82 and the remaining 3mm extends out of the arterial catheter 82 and into the aorta 81. A non-degradable segment extending 3mm long out of arterial catheter 82 and into aorta 81 will tend to evert 150 degrees, but the net effect is that the everted region conforms to the inner wall of the aorta, forming a continuous annular region 21 (shown in fig. 10) approximating a brim in the circumference of the stent end. Therefore, the patent ductus arteriosus plugging device can be placed in an interventional mode immediately after the stent is implanted into the ductus arteriosus.
After the arterial catheter is implanted for a period of time, the section area of the stent contacted with the wall of the arterial catheter is embedded by the neovascular tissue, at least part of the non-degradable section area at the end part of the stent is also embedded in the neovascular tissue of the arterial catheter, and even if the degradable section area 11 of the stent is completely degraded, the non-degradable section at the end part of the stent can not be degraded and shed to cause embolism.
After the stent is implanted into the arterial duct, the opening of the arterial duct can be maintained for a certain time. As the degradable segment region 11 of the stent, 10mm in length, gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 9 months of stent implantation.
Example 8
A self-expanding stent, as shown in fig. 11, comprises a 6mm long non-degradable segment region 121, a 2mm long degradable segment region 111, a 4mm long non-degradable segment region 122, a 6mm long degradable segment region 112 and a 6mm long non-degradable segment region 123 which are connected in sequence from the distal end to the proximal end. The degradable segment regions 111 and 112 can be made of degradable ferro-manganese alloy tubes through laser engraving and polishing, autodeveloping is weak, and developing structures are not arranged. The non-degradable section areas 121, 122 and 123 can be made of nickel-titanium alloy tubes through laser engraving and polishing, and platinum developing structures are respectively arranged on the non-degradable section areas 123 and 121 of the openings at the proximal end and the distal end of the arterial catheter. The degradable segment region and the non-degradable segment region are connected together by riveting and then assembled in the delivery sheath.
The axial outline of the unconstrained stent main body of the stent after the sheath is released outside the body is rectangular, and the stent is suitable for the arterial catheter with the external diameter not changing much along with the length. The visualization of the non-degradable segment regions helps to accurately position the stent when it is implanted in the arterial catheter 82 so that after a 24mm long stent is released in a 20mm long arterial catheter, a 4mm long portion of each of the two non-degradable segment regions remains in the arterial catheter 82 and the remaining portions extend out of the arterial catheter 82 and into the aorta 81 and pulmonary artery 83. The 2mm length of the non-degradable segment extending into the aorta 81 and the pulmonary artery 83 respectively will tend to evert 150 and 120 degrees respectively, but the net effect is that the everted regions conform to the inner wall of the aorta and the inner wall of the pulmonary artery respectively, forming discrete annular regions 21 and 22 approximating a brim in the circumferential direction at the ends of the stent. In this embodiment, in fig. 12, the everted portions of the non-degradable segments 123 are arranged in a pattern like a "V" that radiates outward from the circumference of the two end faces of the stent, respectively, and the plane or curved surface on which the pattern lies forms an annular region 21 around the end faces of the stent. The everted portions of the non-degradable segments 121 are arranged in a pattern like a "V" that radiates outward from the circumference of the two end faces of the stent, respectively, and the plane or curved surface on which the pattern lies forms an annular region 22 around the end faces of the stent. Therefore, the patent ductus arteriosus blocking device can be placed by means of intervention immediately after the stent is implanted into the arterial duct 82. Degradation of the degradable segment regions 111 and 112 can be greatly promoted by the formation of a corroding couple between the cathode and the degradable segment region due to the potential correction of the non-degradable segment region of the scaffold relative to the degradable segment region.
After the arterial catheter 82 is implanted for a period of time, the section areas of the stent contacted with the wall of the arterial catheter are embedded by the neovascular tissue, at least parts of the nondegradable section areas 121 and 123 at the ends of the stent are also embedded in the neovascular tissue of the arterial catheter, and even if the degradable section areas 111 and 112 of the stent are completely degraded, the nondegradable sections 121 and 123 at the ends of the stent can not be degraded and fall off to cause embolism. The degradable segment region embedded in the neovascular tissue and the non-degradable segment region at the end extending out of the arterial catheter form an oxygen concentration corrosion between the pulmonary artery and the portion of the aortic blood flow, further promoting corrosion of the degradable segment regions 111 and 112.
After the stent is implanted into an arterial duct, the opening of the arterial duct can be maintained for a certain time. As the degradable segment region 112 of the stent 6mm in length gradually degrades to lose structural integrity, the segment of the arterial catheter that it contacts can be surgically ligated directly after 1.5 years of stent implantation.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (6)
1. An arterial catheter stent, characterized in that the stent comprises at least one degradable segment region and at least one non-degradable segment region, the degradable segment region and the non-degradable segment region are connected with each other, the axial length of at least one degradable segment region is not less than 3mm, at least one end of the stent is provided with the non-degradable segment region with the axial length not less than 3mm, wherein the stent is a self-expanding stent, after the stent is released, at least part of segments of the non-degradable segment region at the end of the stent are outwards turned or outwards rolled to form an overturning part for better adherence, and the outwards turned inclination angle of the overturning part after heat setting is more than 90 degrees when the self-expanding stent is manufactured; the material of the non-degradable section area is nickel-based alloy or titanium-based alloy, the material of the degradable section area is iron-based alloy, and the iron-based alloy is selected from iron-manganese alloy, iron-nickel alloy, iron-platinum alloy or iron-palladium alloy; wherein the potential of the non-degradable segment region is more positive than the potential of the degradable segment region, and a corrosive couple pair is formed between the cathode and the degradable segment region; a visualization structure is disposed on the non-degradable segment region or on the degradable segment region at an end of the scaffold.
2. An arterial catheter stent according to claim 1, wherein said everted or rolled out portions form an annular region approximating a brim circumferentially at the ends of said self-expandable stent, said annular region being in a continuous or discontinuous state.
3. The ductal arterial stent of claim 1, wherein the axial profile of said stent in its unconstrained condition after release is rectangular, conical, toroids or dumbbell shaped.
4. The arterial catheter stent according to claim 1, wherein at least a portion of the surface region of said degradable segment region is provided with at least one of surface pores, blind grooves, through holes, hollow holes or a coating on which a corrosion or absorption promoting substance is carried.
5. The ductal arterial stent according to claim 1, wherein at least a portion of the surface area of said stent is provided with at least one of surface micropores, blind grooves, through holes, hollow holes, coatings carrying an antiproliferative, antineoplastic, anti-inflammatory, antithrombotic or anti-allergic drug thereon.
6. A stent system comprising an arterial catheter stent according to any one of claims 1 to 5.
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| CN201811640973.6A CN109700581B (en) | 2018-12-29 | 2018-12-29 | Stent and stent system |
| PCT/CN2019/114687 WO2020134540A1 (en) | 2018-12-29 | 2019-10-31 | Stent and stent system |
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| CN109700581B (en) * | 2018-12-29 | 2021-12-03 | 元心科技(深圳)有限公司 | Stent and stent system |
| CN109964846A (en) * | 2019-05-14 | 2019-07-05 | 江苏农牧科技职业学院 | A kind of implantable animal movement monitoring device, system and method |
| CN112656460B (en) * | 2020-12-21 | 2022-01-28 | 中国医学科学院阜外医院 | Main pulmonary artery shunting device |
| CN113397762B (en) * | 2021-05-31 | 2022-02-08 | 上海心瑞医疗科技有限公司 | Atrium shunting implantation device |
| CN218684866U (en) * | 2021-07-28 | 2023-03-24 | 陈绍良 | Biodegradable drug eluting stent |
| CN116212124B (en) * | 2023-05-09 | 2023-08-18 | 杭州糖吉医疗科技有限公司 | Intragastric balloon degradable self-closing valve and preparation method and application thereof |
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