WO2020134540A1 - 支架及支架系统 - Google Patents

支架及支架系统 Download PDF

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Publication number
WO2020134540A1
WO2020134540A1 PCT/CN2019/114687 CN2019114687W WO2020134540A1 WO 2020134540 A1 WO2020134540 A1 WO 2020134540A1 CN 2019114687 W CN2019114687 W CN 2019114687W WO 2020134540 A1 WO2020134540 A1 WO 2020134540A1
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Prior art keywords
stent
degradable
degradable segment
area
segment area
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PCT/CN2019/114687
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English (en)
French (fr)
Inventor
林文娇
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Publication of WO2020134540A1 publication Critical patent/WO2020134540A1/zh
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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 sheets 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 sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other

Definitions

  • the invention relates to the field of interventional medical devices, in particular to a stent and a stent system.
  • the arterial catheter 82 is a normal blood flow channel between the aorta 81 and the pulmonary artery 83 during fetal period (as shown in FIG. 1). Because the fetal lungs have inadequate respiratory function and no pulmonary blood circulation, the pulmonary artery blood from the right ventricle does not flow into the lungs like a normal adult, but directly enters the aorta through an arterial catheter and then flows to all parts of the body. The blood normally enters the ascending aorta, so the patency of the arterial catheter is necessary for the blood circulation in the embryonic period. After birth, the lungs expand and assume the function of gas exchange. Pulmonary circulation and systemic circulation are responsible for their duties. Arterial catheters are generally closed by themselves about 4 months after birth. If the arterial catheter is not closed after the baby is 1 year old, the arterial catheter is not closed, which is a more common congenital cardiovascular malformation. Surgery should be performed to close the arterial catheter and interrupt its blood flow.
  • the prior art does not yet have a completely symptomatic stent, but uses a permanent stent for other indications for treatment.
  • the problem is that subsequent radical treatment of the child
  • Surgical surgery is extremely invasive and because the stent has grown in the arterial catheter tissue, it is very difficult to remove, and it is easy to cause injury or other complications.
  • 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 are connected to each other, at least one of the degradable segments
  • the axial length of the area is not less than 3 mm, and at least one end of the stent is provided with the non-degradable segment area with an axial length not less than 3 mm.
  • the material of the degradable segment area is a degradable polymer material or a degradable metal material
  • the material of the non-degradable segment area is a metal material
  • the stent is a ball-expanded stent
  • the material of the non-degradable segment region is selected from at least one of gold, silver, platinum, rhodium, iridium, tantalum, tungsten, cobalt, chromium, molybdenum, and niobium.
  • 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.
  • the stent is a self-expanding stent
  • the material of the non-degradable segment area is a nickel-based alloy or a titanium-based alloy
  • the material of the degradable segment area is an iron-based alloy
  • the iron-based alloy is selected From iron manganese alloy, iron nickel alloy, iron platinum alloy or iron palladium alloy.
  • the stent is a self-expanding stent, and at least part of the segments in the non-degradable segment region are valgus or rolled parts.
  • the eversion or roll-out portion forms a ring-shaped region near the brim in the circumferential direction of the end of the self-expanding stent, and the ring-shaped region is in a continuous state or a discontinuous state.
  • the axial profile of the stent after being released without restraint is rectangular, tapered, waist-drum-shaped or dumbbell-shaped.
  • a developing structure is provided on the non-degradable segment area or the degradable segment area at the end of the bracket.
  • At least part of the surface area of the degradable segment area is provided with at least one of surface micropores, blind grooves, through holes, hollow holes or coatings.
  • the through hole, the hollow hole, and the coating layer carry substances that promote corrosion or absorption.
  • At least part of the surface area of the bracket is provided with at least one of surface micropores, blind grooves, through holes, hollow holes, and coatings, the surface micropores, the blind grooves, the through holes,
  • the hollow hole and the coating layer carry anti-proliferative, anti-tumor, anti-inflammatory, anti-thrombotic or anti-allergic drugs.
  • a bracket system includes the above bracket.
  • the above stent is provided with a degradable segment area with an axial length of not less than 3 mm to ensure that after the stent is implanted for a certain period of time, as the degradable segment area degrades, the doctor ligates the corresponding arterial catheter in the corresponding degradable segment area There is enough maneuverable space; by providing a non-degradable segment area with an axial length of not less than 3 mm at at least one end of the stent, it is ensured that at least 1 mm of the area extends out of the arterial catheter after the stent is released, ensuring that the entire arterial catheter has
  • the stent is supported, at least 1mm is in the arterial catheter, which can be covered and fixed by the neovascular endometrium to prevent the partial extension of the stent extending from the arterial catheter to cause vascular embolism, and the doctor's judgment on the length of the lesion and the choice of stent length will be certain In order to ensure that the above functions of the stent can still be
  • Figure 1 is a schematic diagram of an arterial catheter.
  • FIG. 2 is a schematic diagram of the bracket 100 provided by the embodiment.
  • FIG. 3 is a schematic diagram of the bracket 200 provided by the embodiment.
  • FIG. 4 is a schematic diagram of the bracket 300 provided by the embodiment.
  • FIG. 5 is a schematic diagram of the stent system 1000 provided by the embodiment.
  • Example 6 is a schematic diagram of applying the stent provided in Example 1 to an arterial catheter.
  • Example 7 is a schematic diagram of applying the stent provided in Example 6 to an arterial catheter.
  • FIG. 8 is a top view of the bracket provided in Example 6.
  • Example 9 is a schematic diagram of applying the stent provided in Example 7 to an arterial catheter.
  • FIG. 10 is a top view of the bracket provided in Example 7.
  • FIG. 10 is a top view of the bracket provided in Example 7.
  • FIG. 11 is a schematic diagram of applying the stent provided in Example 8 to an arterial catheter.
  • FIG. 12 is a top view of the bracket provided in Example 8.
  • FIG. 12 is a top view of the bracket provided in Example 8.
  • Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the stent, and “radial” refers to the direction perpendicular to the above axial direction.
  • Proximal refers to the end of blood flow; “distal” refers to the end of blood flow.
  • the line of the non-degradable segment area is thicker, and the degradable segment area The thickness of the line is thin, and the thickness of the line in the drawing is only used to distinguish the non-degradable segment area and the degradable segment area.
  • This embodiment provides a stent including 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 interconnected, and at least one of the degradable segment regions
  • the axial length is not less than 3 mm, and at least one end of the stent is provided with a non-degradable segment area with an axial length not less than 3 mm.
  • the degradable segment area is set to ensure that after the stent is implanted for a certain period of time, the degradable segment area can gradually degrade to a complete deconstruction after a certain time of implantation of the arterial catheter, thereby allowing direct ligation without removing the stent after a certain period of time.
  • Arterial catheter With the degradation of the degradable segment area, the doctor has enough maneuverable space when ligating the arterial catheter corresponding to the corresponding degradable segment area, so at least one degradable segment area with a length of not less than 3 mm is defined.
  • the end of the stent is provided with a non-degradable segment area to ensure that after the stent is released, about 1 mm of the arterial catheter extends out of this area.
  • the stent To ensure that the entire arterial catheter is supported by the stent, at least 1 mm is still in the arterial catheter. Afterwards, it can be covered and fixed by the neovascular endometrium to prevent the stent area of the extended arterial catheter from falling off and leading to vascular embolism; and there will be certain deviations in the judgment of the lesion length and the stent length selection by the doctor, in order to ensure that the above functions of the stent can still be achieved
  • the minimum length of the non-degradable segment area needs to be left to a certain extent, so the length of the non-degradable segment area at the end is limited to not less than 3 mm.
  • the degradable segment area and the non-degradable segment area are connected to each other at intervals, and the degradable segment area and the non-degradable segment area can be alloyed by riveting, crimping, welding, bonding, and self-material Etc. connected together.
  • both end portions of the stent are provided with non-degradable segment areas.
  • the stent 100 includes one degradable segment region 11 and two non-degradable segment regions 121 and 122, and the degradable segment region 11 is located between the non-degradable segment regions 121 and 122.
  • the axial lengths of the two non-degradable segment regions 121 and 122 may be equal or different.
  • the stent may further include a plurality of degradable segment regions and a plurality of non-degradable segment regions, the degradable segment regions and the non-degradable segment regions are connected to each other at intervals, as long as the two ends of the stent are guaranteed Both are provided with non-degradable segment areas, and at least one end of the stent is provided with non-degradable segment areas with an axial length of not less than 3 mm, which are all within the protection scope of this embodiment.
  • one end of the stent is provided with a non-degradable segment area, and the other end of the stent is provided with a degradable segment area.
  • the stent 200 includes a degradable segment region 11 and a non-degradable segment region 12 connected in sequence.
  • the stent may further include a plurality of degradable segment regions and a plurality of non-degradable segment regions, the degradable segment regions and the non-degradable segment regions are connected to each other at intervals, as long as both ends of the stent are ensured
  • the non-degradable segment area is provided, and the axial length of the non-degradable segment area provided at the end of the bracket is not less than 3 mm, which is the protection scope of this embodiment.
  • the material of the degradable segment area is a degradable polymer material or a degradable metal material
  • the material of the non-degradable segment area is a corrosion-resistant metal material.
  • oxygen concentration corrosion is formed between the degradable segment region located in the arterial catheter and the non-degradable segment region extending out of the arterial catheter, which promotes the degradation Degradation of corrosion in the segment area.
  • the non-degradable segment area can realize self-development by selecting a material with developability, and can also assist development by providing a development structure.
  • the degradable segment area can also realize self-development by selecting a material with developability, and can also assist development by providing a development structure.
  • the metallic material has self-developability, and the developability of the stent segment composed of the metal material can be increased or decreased by increasing or decreasing the thickness of the stent mesh composed of the metallic material.
  • the polymer can be developed by some special treatments, for example, polycarbonate can be self-developed by grafting iodine groups.
  • 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, and degradable Zinc or zinc-based alloy;
  • the corrosion-resistant metal material is a highly developable metal, the highly developable metal is selected from gold, silver, platinum, rhodium, iridium, tantalum, tungsten, cobalt, chromium, molybdenum, niobium or gold, silver, platinum, An alloy of at least two of rhodium, iridium, tantalum, tungsten, cobalt, chromium, molybdenum, and niobium.
  • the non-degradable segment area of the ball-expandable stent may also be provided with a development structure to assist development.
  • the material in the degradable segment area and the material in the non-degradable segment area are both super-elastic materials
  • the corrosion-resistant metal material is selected from a super-elastic nickel-based alloy or a titanium-based alloy.
  • Degradable metal materials are selected from superelastic iron-based alloys
  • superelastic iron-based alloys are selected from iron-manganese (Fe-Mn) alloys, iron-nickel (Fe-Ni) alloys, iron-platinum (Fe-Pt) alloys, and iron-palladium (Fe -Pd) alloy.
  • the stent When the stent is a self-expanding stent, at least some of the non-degradable segments located at the ends of the self-expanding stent will be everted or rolled out, forming a hat-like edge around the end of the self-expanding stent
  • the annular area allows the stent to be inserted into the arterial catheter without removing the stent.
  • the occluder can be placed through the percutaneous intervention to close the arterial catheter or/and directly ligate the arterial catheter. Closing the aortic wall or/and the pulmonary artery wall will also be embedded in the aorta or/and the new blood vessel tissue in the pulmonary artery. After the stent is implanted, it is not easy to move, and it is not easy to fall off and cause embolism.
  • FIG. 4 is the expanded state of the self-expanding stent 300, that is, the released state.
  • the stent 300 is free from the delivery device and is located at least part of the non-degradable segment region at the end of the self-expanding stent 300.
  • the segments will be turned or rolled outwards to form a turn-over portion 2, forming an annular region approximately capped in the circumferential direction of the end of the stent.
  • the inverting part 2 when the inverting part 2 is a thinner and shorter whisker or a flexible segment, an out-wrap design can be used, and when the inverting part 2 is a rigid plane or curved surface with a larger area, the following can be used: Eversion design, which does not limit the specific shape of at least part of the non-degradable segment region located at the end of the self-expanding stent 300, and roll-out or valgus is for better adherence to the vessel Embedding neointimal tissue reduces the risk of shedding, embolism and thrombosis.
  • the annular area may be asymmetrical or irregular.
  • the valgus angle a after heat setting is selected to be greater than 90 degrees, preferably greater than 150 degrees, to adapt to various vascular anatomical structures, and ensure that the valgus segments after the valgus of the stent are well adhered.
  • the self-expanding stent 300 includes a main body portion 1 and a reversing portion 2, and the valgus angle a is an angle between the axial extension line of the main body portion 1 of the self-expanding stent 300 and the reversing portion 2.
  • the self-expandable stent 300 includes a degradable segment region 11 and a non-degradable segment region 12 connected in this order from the distal end to the proximal end.
  • the non-degradable segment region 12 includes a turning part 2 and a body part 1 includes the non-degradable segment area 12 and the degradable segment area 11 with the inverted portion 2 removed.
  • the annular region of the approximate brim is continuous or discontinuous in the circumferential direction of the end of the stent.
  • the turning part 2 may be provided as a plurality of whiskers radiating outward from the circumference of the end surface of the self-expanding stent 300
  • a plurality of whisker-like structures or/and graphic structures, the plane or curved surface where the plurality of whisker-like structures or/and graphic structures are located forms a ring around the end surface of the main body portion 1 of the bracket.
  • each whisker-like structure or graphic structure may be the same or different, and the number is not limited.
  • the shape of the whisker-like structure can be linear, polyline or curved or a combination of at least two of them.
  • the shape of the graphic structure can be round, oval, "V-shaped", polygonal, "Y"-shaped, zigzag Shape or a combination of multiple shapes.
  • the arbitrary whisker-like structures or any graphic structures or the whisker-like structures and the graphic structures forming a ring may overlap each other, or may not overlap each other.
  • the shapes of the flip parts at the two ends may be the same or different.
  • the turning part 2 of the self-expanding stent 300 is designed to be discontinuous, the turning part 2 can use less material, the stent can be constrained to a smaller profile outer diameter, so that it can fit a smaller sheath tube, It brings less trauma to children and can enter into target vessels with more complicated anatomy.
  • the turning part 2 is located at both ends of the body part, and the length of the turning part 2 at both ends of the body part can be The same or different.
  • the stent is a self-expanding stent, and the non-degradable segment region at the end of the self-expanding stent may not be set to be everted or rolled.
  • the axial contour of the main body portion of the stent after being released without restraint may be rectangular, tapered, lumbar, or dumbbell-shaped to fit the anatomy of the arterial catheter, reducing the risk of displacement after stent implantation.
  • At least part of the surface area of the degradable segment area is provided with at least one of surface micropores, blind grooves, through holes, hollow holes, and coatings, the surface micropores, blind grooves, through holes, hollow
  • the holes and coatings carry substances that promote corrosion or absorption.
  • At least part of the surface area of the support is provided with at least one of surface micropores, blind grooves, through holes, hollow holes, and coatings.
  • the coating carries anti-proliferative, anti-tumor, anti-inflammatory, anti-thrombotic or anti-allergic drugs.
  • this embodiment provides a stent system 1000, which includes a stent 200 and a delivery device 3.
  • the delivery device 3 is used to deliver the stent 200 to a target location.
  • the bracket is any one of the brackets in the above embodiments.
  • the above-mentioned stent can also be used for the treatment of bridge vessel restenosis such as surgical coronary artery bypass grafting or the palliative treatment of complex congenital heart disease by Blalock-Taussig shunt.
  • a ball-expandable stent as shown in FIG. 6, includes a 5 mm long degradable segment region 11 and a 3 mm long non-degradable segment region 12 disposed at the distal end of the stent.
  • the degradable segment area 11 can be made of degradable nitriding iron tube by laser engraving and polishing, and can be developed by itself, but the developability is weaker than the non-degradable segment, which can be coated with rapamycin Polylactic acid coating.
  • 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 itself.
  • 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 contour of the stent body under the constraint is rectangular, and it is suitable for arterial catheters whose outer diameter does not change much with length.
  • the high developability of the non-degradable segment area 12 can help the stent to be accurately positioned when the arterial catheter is implanted, so that after the 8mm long stent is released in the 6mm long arterial catheter 82, the non-degradable segment area 12 has a 1mm long portion Still inside the arterial catheter 82, the rest extends out of the arterial catheter 82 and into the pulmonary artery 83.
  • the potential of the non-degradable segment region 12 of the stent is corrected relative to the degradable segment region 11 as a cathode, and a corrosion couple pair is formed between the degradable segment region 11, the degradation of the degradable segment region 11 can be greatly promoted.
  • the segment area where the stent contacts the inner wall of the arterial catheter 82 will be embedded with neovascular tissue, and at least part of the non-degradable segment area 12 at the end of the stent will also be embedded in In the neovascular tissue of the arterial catheter 82, even if the degradable segment region 11 of the stent is completely degraded, the non-degradable segment 12 at the end of the stent will not degrade and fall off, leading to embolism.
  • Oxygen concentration corrosion is formed between the degradable segment region 11 embedded in the neovascular tissue and the non-degradable segment region 12 at the end of the arterial catheter 82 exposed to the blood flow of the pulmonary artery 83, further promoting Degradation of the corrosion of the segment area 11.
  • the opening of the arterial catheter 82 can be maintained for a certain period of time.
  • the degradable segment region 11 with a length of 5 mm of the stent gradually degrades to lose its structural integrity, the arterial catheter segment it contacts can be directly ligated by surgery after the stent is implanted for 1 year.
  • a ball-expanded stent includes a 10mm long degradable segment area and 5mm long non-degradable segment areas arranged at both ends of the stent.
  • the degradable section area can be made of degradable polylactic acid tube by laser engraving and polishing, and the self-developing structure is not provided.
  • the non-degradable segment area can be made of high-developability tantalum-niobium alloy tube by laser engraving and polishing, and the self-developable can be developed.
  • the degradable segment area and the non-degradable segment area can be connected together by crimping, and then pressed onto the balloon catheter.
  • the axial contour of the stent body without restraint is a lumbar drum shape, which is suitable for an arterial catheter with a large middle outer diameter and small outer diameters at both ends.
  • the high visualization of the non-degradable segment area can help the stent to be accurately positioned when implanting the arterial catheter, so that after the 20mm long stent is released in the 15mm long arterial catheter, the non-degradable segment regions at each end have 2.5mm long Some are still in the arterial catheter, and the rest extend out of the arterial catheter and into the pulmonary artery and aorta, respectively.
  • the segment area where the stent and the artery catheter wall contact will be embedded by neovascular tissue, and at least part of the non-degradable segment area at the end of the stent will also be embedded in the neonatal catheter In the vascular tissue, even if the degradable segment area of the stent is completely degraded, the non-degradable segment at the end of the stent will not degrade and cause embolism.
  • the opening of the arterial catheter can be maintained for a certain period of time.
  • the arterial catheter segments it contacted could be directly ligated surgically 1.5 years after the stent was implanted.
  • a ball-expanded stent includes a 16mm long degradable segment area and a 4mm long non-degradable segment area provided at one end of the stent.
  • the degradable segment area can be made of degradable pure zinc tube through laser engraving and polishing, and the self-developable can be developed, but the developability is weaker than the non-degradable segment.
  • the non-degradable segment area can be made of high-developability platinum-chromium alloy tube by laser engraving and polishing, and can be developed by itself.
  • the degradable segment area and the non-degradable segment area can be connected together by riveting, and then pressed onto the balloon catheter.
  • the axial contour of the stent body under unconstrained shape is a dumbbell shape, which is suitable for an arterial catheter with a small middle outer diameter and large outer diameters at both ends.
  • the high visibility of the non-degradable segment area can help the stent to be accurately positioned when implanting the arterial catheter, so that after the 20mm long stent is released in the 18mm long arterial catheter, the 2mm long part of the non-degradable segment area is still in the arterial catheter Inside, the rest extends out of the arterial catheter and into the aorta.
  • the potential of the non-degradable segment area of the stent is corrected relative to the degradable segment area as a cathode, and a corrosion couple pair is formed between the degradable segment area, the degradation of the degradable segment area can be greatly promoted.
  • the segment area where the stent and the artery catheter wall contact will be embedded by neovascular tissue, and at least part of the non-degradable segment area at the end of the stent will also be embedded in the neonatal catheter In the vascular tissue, even if the degradable segment area of the stent is completely degraded, the non-degradable segment at the end of the stent will not degrade and cause embolism.
  • the degradable segment area embedded in the neovascular tissue and the non-degradable segment area at the end protrude from the artery catheter and are exposed to the aortic blood flow to form oxygen concentration corrosion, which further promotes degradable Corrosion of the segment area.
  • the opening of the arterial catheter can be maintained for a certain period of time.
  • the 16 mm length of the degradable segment of the stent gradually degraded to the point of loss of structural integrity, the arterial catheter segment it was in contact with could be directly ligated surgically 9 months after the stent was implanted.
  • a ball-expanded stent includes a 20mm long degradable segment area and a 6mm long non-degradable segment area provided at one end of the stent.
  • the degradable segment area can be made of degradable magnesium-iron alloy tube by laser engraving and polishing, and a developing structure is arranged on it.
  • the non-degradable segment area can be made of pure tantalum tube with high developability through laser engraving and polishing, which can be developed by itself.
  • the degradable segment area and the non-degradable segment area can be connected together by means of bonding, and then pressed onto the balloon catheter.
  • the axial contour of the stent body without restriction is tapered, which is suitable for the arterial catheter with a tapered contour (such as the outer diameter on the side of the pulmonary artery is significantly smaller and the side of the aorta is obviously The larger diameter of the conical artery catheter).
  • the high visibility of the non-degradable segment area can help the stent to be accurately positioned when implanting the arterial catheter, so that after the 26mm long stent is released in the 24mm long arterial catheter, the 4mm long part of the non-degradable segment area is still in the arterial catheter Inside, the rest extends out of the arterial catheter and into the pulmonary artery. Because the potential of the non-degradable segment area of the stent is corrected relative to the degradable segment area, the formation of a corrosion couple between the cathode and the degradable segment area can greatly promote the degradation of the degradable segment area.
  • the segment area where the stent and the artery catheter wall contact will be embedded by neovascular tissue, and at least part of the non-degradable segment area at the end of the stent will also be embedded in the neonatal catheter In the vascular tissue, even if the degradable segment area of the stent is completely degraded, the non-degradable segment at the end of the stent will not degrade and fall off resulting in embolism.
  • the opening of the arterial catheter can be maintained for a certain period of time.
  • the 20 mm length of the degradable segment of the stent gradually degraded to the point of loss of structural integrity, the arterial catheter segment it was in contact with could be directly ligated surgically 6 months after the stent was implanted.
  • a self-expanding stent includes a 3mm long degradable segment area and a 7mm long non-degradable segment area provided at one end of the stent.
  • the degradable segment area can be made of degradable iron-palladium alloy tube by laser engraving and polishing, and the self-developing can be carried out.
  • the non-degradable segment area can be made of nickel-titanium alloy tube by laser engraving and polishing, and a gold developing structure is provided on it.
  • the degradable segment area and the non-degradable segment area can be connected together by welding.
  • the entire stent surface carries paclitaxel through micropores, and then is assembled into the delivery sheath.
  • the axial profile of the stent body without restriction after the sheath is released in vitro from the stent is rectangular, and is suitable for arterial catheters whose outer diameter does not change much with length.
  • the development structure of the non-degradable segment area can help the stent to be accurately positioned when implanting the arterial catheter, so that after the 10mm long stent is released in the 8mm long arterial catheter, the 5mm long part of the non-degradable segment area is still in the arterial catheter , The rest extends out of the arterial catheter and into the pulmonary artery. Because the potential of the non-degradable segment area of the stent is corrected relative to the degradable segment area, the formation of a corrosion couple between the cathode and the degradable segment area can greatly promote the degradation of the degradable segment area.
  • the segment area where the stent and the artery catheter wall contact will be embedded by neovascular tissue, and at least part of the non-degradable segment area at the end of the stent will also be embedded in the neonatal catheter In the vascular tissue, even if the degradable segment area of the stent is completely degraded, the non-degradable segment at the end of the stent will not degrade and fall off resulting in embolism.
  • the opening of the arterial catheter can be maintained for a certain period of time.
  • the degradable segment of the stent with a length of 3 mm gradually degraded to the point of loss of structural integrity, the arterial catheter segment it was in contact with could be directly ligated surgically 1 year after the stent was implanted.
  • a self-expanding stent as shown in FIG. 7, includes a 6 mm long degradable segment region 11 and 5 mm long non-degradable segment regions 121 and 122 provided at both ends of the stent.
  • the degradable segment area 11 can be made of degradable iron-manganese alloy tube by laser engraving and polishing, and the self-developing is weak, and no developing structure is provided.
  • the non-degradable segment regions 121 and 122 can be made of nickel-titanium alloy tubes by laser engraving and polishing.
  • the non-degradable segment region 121 is provided with a tantalum developing structure at the proximal port of the arterial catheter, and the non-degradable segment The portion of the region 122 at the distal port of the arterial catheter is also provided with a tantalum visualization structure.
  • 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 profile of the stent body without restriction after the sheath is released in vitro from the stent is rectangular, and is suitable for arterial catheters whose outer diameter does not change much with length.
  • the development structure of the non-degradable segment area can help the stent to be accurately positioned when implanting the arterial catheter, so that after the 16mm long stent is released in the 10mm long arterial catheter 82, the non-degradable segment regions 121 and 122 at each end have 2mm The long part is still inside the arterial catheter 82, and the rest extends out of the arterial catheter 82 and into the aorta 81 and pulmonary artery 83, respectively.
  • the 3 mm long non-degradable segments 121, 122 that extend into the aorta 81 and the pulmonary artery 83, respectively, will roll out, forming discontinuous annular regions 21 and 22 that approximate the brim of the stent.
  • the portions of the non-degradable segments 121 and 122 that are rolled out are provided as whisker-like structures that radiate outward from the circumferences of the two end faces of the bracket, respectively.
  • the curved surface forms annular regions 21 and 22 around the end face of the stent. Therefore, immediately after the stent is implanted into the arterial catheter, the occlusion device of the arterial catheter can be placed by intervention.
  • the segment area where the stent and the artery catheter wall contact will be embedded by neovascular tissue, and at least part of the non-degradable segment area at the end of the stent is also embedded in the arterial catheter 82 In the neovascularization tissue, even if the degradable segment region 11 of the stent is completely degraded, the non-degradable segment at the end of the stent will not degrade and fall off to cause embolism.
  • the degradable segment region 11 embedded in the neovascular tissue and the non-degradable segment region at the end protrude from the arterial catheter 82 and form an oxygen concentration between the portions of the pulmonary artery 83 and the aorta 81 that are exposed to the blood flow Poor corrosion further promotes corrosion of the degradable segment area 11.
  • the opening of the arterial catheter can be maintained for a certain period of time.
  • the degradable segment region 11 with a length of 6 mm of the stent gradually degrades to lose its structural integrity, the arterial catheter segments it contacts can be directly ligated surgically 1.5 years after the stent is implanted.
  • a self-expanding stent as shown in FIG. 9, includes a 10 mm long degradable segment region 11 and an 8 mm long non-degradable segment region 12 provided at one end of the stent.
  • the degradable segment area 11 can be made of degradable polycarbonate tube through laser engraving and polishing, and the polycarbonate is grafted with iodine groups to realize self-developable, but the developability is weak.
  • the non-degradable segment area can be made of titanium zirconium-niobium alloy tube by laser engraving and polishing.
  • a platinum development structure is also provided on the non-degradable segment area 12.
  • the degradable segment region 11 and the non-degradable segment region 12 are connected together by means of bonding, and then assembled into the delivery sheath.
  • the axial contour of the stent body without restriction after the sheath is released from the body in vitro is tapered, which is suitable for the arterial catheter with a tapered contour (such as the outer diameter on the side of the pulmonary artery is significantly smaller and the outer side on the side of the aorta is obviously A larger diameter conical artery catheter).
  • the development structure of the non-degradable segment area and the development structure of the degradable segment area can help the stent to be accurately positioned when implanting the arterial catheter, so that after the 18mm long stent is released in the 15mm long arterial catheter 82, its non-degradable segment The 5 mm long part of the area is still in the arterial catheter 82, and the remaining 3 mm extends out of the arterial catheter 82 and into the aorta 81.
  • the non-degradable segment of the 3mm long extending arterial catheter 82 and extending into the aorta 81 will tend to valgus 150 degrees, but the actual effect is that the valgus area fits the inner wall of the aorta, forming an approximate cap edge around the end of the stent A continuous annular area 21 (as shown in FIG. 10). Therefore, immediately after the stent is implanted into the arterial catheter, the occlusion device of the arterial catheter can be placed by intervention.
  • the segment area where the stent and the artery catheter wall contact will be embedded by neovascular tissue, and at least part of the non-degradable segment area at the end of the stent will also be embedded in the neonatal catheter In the vascular tissue, even if the degradable segment region 11 of the stent is completely degraded, the non-degradable segment at the end of the stent will not degrade and fall off to cause embolism.
  • the opening of the arterial catheter can be maintained for a certain period of time.
  • the degradable segment area 11 with a length of 10 mm of the stent gradually degrades to lose its structural integrity, the arterial catheter segments it contacts can be directly ligated surgically 9 months after the stent is implanted.
  • a self-expanding stent as shown in FIG. 11, includes a 6mm long non-degradable segment area 121, a 2mm long degradable segment area 111, and a 4mm long non-degradable segment sequentially connected from the distal end to the proximal end Region 122, 6mm long degradable segment region 112 and 6mm long non-degradable segment region 123.
  • the degradable segment regions 111 and 112 can be made of degradable iron-manganese alloy tubes by laser engraving and polishing, and the self-developing is weak, and no developing structure is provided.
  • the non-degradable segment areas 121, 122, and 123 can be made of nickel-titanium alloy tubes by laser engraving and polishing, and are set on the non-degradable segment areas 123 and 121 at the openings of the proximal and distal ends of the arterial catheter, respectively Platinum development structure.
  • the degradable segment area and the non-degradable segment area are connected together by riveting, and then assembled into the delivery sheath.
  • the axial profile of the stent body without restriction after the sheath is released in vitro from the stent is rectangular, and is suitable for arterial catheters whose outer diameter does not change much with length.
  • the development structure of the non-degradable segment area can help the stent to be accurately positioned when implanting the arterial catheter 82, so that after the 24mm long stent is released in the 20mm long arterial catheter, the non-degradable segment regions at each end have 4mm long parts Still inside the arterial catheter 82, the rest extends out of the arterial catheter 82 and into the aorta 81 and pulmonary artery 83.
  • the 2mm long non-degradable segments that extend into the aorta 81 and the pulmonary artery 83, respectively, will tend to valgus 150 degrees and 120 degrees, but the actual effect is that the valgus area fits the inner wall of the aorta and the inner wall of the pulmonary artery, respectively, at the end of the stent
  • the discontinuous annular regions 21 and 22 approximately forming a brim are formed in the circumferential direction. In this embodiment, in FIG.
  • the portions where the non-degradable segment 123 is everted are arranged as a “V”-shaped graphic structure radiating outward from the circumferences of the two end surfaces of the bracket, and the graphic structure is located
  • a flat or curved surface forms an annular area 21 around the end face of the stent.
  • the portion of the non-degradable segment 121 that is everted is set as a "V"-shaped graphic structure that radiates outward from the circumferences of the two end surfaces of the bracket, and the plane or curved surface where the graphic structure is located forms a ring around the end surface of the bracket Region 22. Therefore, immediately after the stent is implanted into the arterial catheter 82, the occlusion device of the arterial catheter can be placed by intervention.
  • the formation of a corrosion couple between the cathode and the degradable segment region can greatly promote the degradation of the degradable segment regions 111 and 112.
  • the segment area where the stent and the arterial catheter wall contact will be embedded with neovascular tissue, and at least part of the non-degradable segment areas 121 and 123 at the end of the stent will also be embedded In the neovascular tissue of the arterial catheter, even if the degradable segment regions 111 and 112 of the stent are completely degraded, the non-degradable segments 121 and 123 at the end of the stent will not degrade and fall off resulting in embolism.
  • the degradable segment area embedded in the neovascular tissue and the non-degradable segment area at the end extend out of the arterial catheter and form an oxygen concentration corrosion between the portions exposed to the pulmonary artery and the aortic blood flow, further promoting The corrosion of the segment regions 111 and 112 can be degraded.
  • the opening of the arterial catheter can be maintained for a certain period of time.
  • the degradable segment area 112 of the stent length of 6 mm gradually degrades to lose structural integrity, the arterial catheter segments it contacts can be directly ligated surgically 1.5 years after the stent is implanted.

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Abstract

一种支架（100，200，300）和支架系统（1000），该支架（100，200，300）包括至少一可降解节段区域（11，111，112）和至少一不可降解节段区域（12，121，122，123），该可降解节段区域（11，111，112）和该不可降解节段区域（12，121，122，123）相互连接，至少一个该可降解节段区域（11，111，112）中的轴向长度不低于3mm，该支架（100，200，300）的至少一端部设置有轴向长度不低于3mm的该不可降解节段区域（12，121，122，123），允许支架（100，200，300）植入动脉导管（82）后不用取出就可以进行后续关闭动脉导管（82），从降低了对患儿的伤害和其它并发症概率。

Description

支架及支架系统 技术领域
本发明涉及介入式医疗器械领域，特别是涉及一种支架及支架系统。
背景技术
动脉导管82是胎儿时期主动脉81与肺动脉83间的正常血流通道(如图1所示)。由于此时胎儿的肺呼吸功能不全，没有肺血流循环，来自右心室的肺动脉血不像正常成人那样流入肺部，而是经动脉导管直接进入主动脉再流向全身各处，而左心室的血液则是正常进入升主动脉，故动脉导管的通畅为胚胎时期血流循环方式所必需。出生后，肺膨胀并承担气体交换功能，肺循环和体循环各司其职，动脉导管因废用一般会在婴儿出生后4个月左右自行闭合。如动脉导管在婴儿出生1岁后持续不闭合则形成动脉导管未闭，是一种较常见的先天性心血管畸形，应施行手术，闭合动脉导管，中断其血流。
但伴有三尖瓣闭锁、右室流出道梗阻(肺动脉瓣闭锁或肺动脉狭窄)、肺动脉高压等复杂性先心病患儿，其血液通过左、右心之间的异常通道(如房间隔缺损、室间隔缺损等)出现右向左的分流，继而大量低氧含量的静脉血流向体循环，患儿出现持续性的紫绀，同时肺血流减少。因此该类患儿早期有赖于动脉导管的开放维持其有效的肺循环或体循环的血流，以改善肺血流量低、血氧饱和度低及紫绀等症状，动脉导管的自行关闭或人为关闭都可导致严重的血流动力学障碍。
对动脉导管依赖型的复杂性先心病患儿而言，现有技术尚无完全对症的支架，而是使用其它适应症的永久性支架进行治疗，存在的问题是后续对患儿进行根治治疗的时候还需要再次外科手术取出已经长在组织中的永久性支架，再对动脉导管进行结扎或者放置封堵器以闭合动脉导管。外科手术创伤极大且因支架已经长在动脉导管组织中，取出十分困难，容易造成损伤或者其它并发症。
发明内容
基于此，有必要提供一种支架，该支架允许植入动脉导管后不用取出就可以进行后续关闭动脉导管，从而降低了对患儿的伤害和其它并发症概率。
一种支架，所述支架包括至少一可降解节段区域和至少一不可降解节段区域，所述可降解节段区域和所述不可降解节段区域相互连接，至少一个所述可降解节段区域的轴向长度不低于3mm，所述支架的至少一端部设置有轴向长度不低于3mm的所述不可降解节段区域。
进一步地，所述可降解节段区域的材料为可降解聚合物材料或可降解金属材料，所述不可降解节段区域的材料为金属材料。
进一步地，所述支架为球扩式支架，所述不可降解节段区域的材料选自金、银、铂、铑、铱、钽、钨、钴、铬、钼、铌中至少一种，所述可降解节段区域的材料选自镁、铁、锌、镁基合金、铁基合金、锌基合金、聚乳酸或者聚碳酸酯。
进一步地，所述支架为自膨式支架，所述不可降解节段区域的材料为镍基合金或钛基合金，所述可降解节段区域的材料为铁基合金，所述铁基合金选自铁锰合金，铁镍合金，铁铂合金或铁钯合金。
进一步地，所述支架为自膨式支架，所述不可降解节段区域中至少有部分节段为外翻或外卷部分。
进一步地，所述外翻或外卷部分在所述自膨式支架的端部周向上形成近似帽沿的环形区域，所述环形区域呈连续状态或不连续状态。
进一步地，所述支架在释放后无约束下的轴向轮廓是矩形、锥形、腰鼓形或者哑铃形。
进一步地，位于所述支架的端部的所述不可降解节段区域上或者所述可降解节段区域上设置有显影结构。
进一步地，所述可降解节段区域的至少部分表面区域设置有表面微孔、盲槽、通孔、中空孔或涂层中的至少一种，所述表面微孔、所述盲槽、所述通孔、所述中空孔、所述涂层上携载促进腐蚀或者吸收的物质。
进一步地，所述支架的至少部分表面区域设置有表面微孔、盲槽、通孔、中空孔、涂层中的至少一种，所述表面微孔、所述盲槽、所述通孔、所述中空孔、所述涂层上携载抗增生、抗肿瘤、抗炎、抗栓或抗敏的药物。
一种支架系统，包括上述的支架。
上述支架通过设置轴向长度不低于3mm的可降解节段区域，确保支架植入一定时间后，随着可降解节段区域的降解，医生在结扎相应可降解节段区域对应的动脉导管时有足够的可操作空间；通过在支架的至少一端部设置轴向长度不低于3mm的不可降解节段区域，保证支架释放后，该区域至少有1mm伸出动脉导管，确保整个动脉导管都有支架支撑，至少有1mm处于动脉导管内，后续可被新生血管内膜包覆固定，防止伸出动脉导管的支架部分脱落导致血管栓塞，而医生对病变长度的判定和支架长度选型会存在一定的偏差，为了保证支架以上功能依然能实现，不可降解节段区域的最小长度需留有一定余地。同时，允许支架植入动脉导管后不用取出就可以进行后续关闭动脉导管，从而降低了对患儿的伤害和其它并发症概率。
附图说明
图1为动脉导管示意图。
图2为实施例提供的支架100的示意图。
图3为实施例提供的支架200的示意图。
图4为实施例提供的支架300的示意图。
图5为实施例提供的支架系统1000的示意图。
图6为实施例1提供的支架运用到动脉导管的示意图。
图7为实施例6提供的支架运用到动脉导管的示意图。
图8为实施例6提供的支架的俯视图。
图9为实施例7提供的支架运用到动脉导管的示意图。
图10为实施例7提供的支架的俯视图。
图11为实施例8提供的支架运用到动脉导管的示意图。
图12为实施例8提供的支架的俯视图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
“轴向”指平行于支架远端中心和近端中心连线的方向，“径向”指垂直于上述轴向的方向。“近端”指血流流入的一端；“远端”指血流流出的一端。
需要说明的是，在实施例中提到的附图中，为了能够在图中能够区分可降解节段区域和不可降解节段区域，不可降解节段区域的线条较粗，可降解节段区域的线条较细，在附图中线条的粗细仅用于区分不可降解节段区域和可降解节段区域。
本实施例提供一种支架，该支架包括至少一可降解节段区域和至少一不可降解节段区域，可降解节段区域和不可降解节段区域相互连接，可降解节段区域中至少一个的轴向长度不低于3mm，支架的至少一端部设置有轴向长度不低于3mm的不可降解节段区域。
设置可降解节段区域是为了确保支架植入一定时间后，可降解节段区域能在植入动脉导管一定时间后逐渐降解至完全解构，从而允许植入一定时间后不用取出支架就可以直接结扎动脉导管。随着可降解节段区域的降解，医生在结扎相应可降解节段区域对应的动脉导管时有足够的可操作空间，故限定至少有一个长度不低于3mm的可降解节段区域。该支架的端部设置不可降解节段区域是为了保证支架释放后，该区域有1mm左右伸出动脉导管，为确保整个动脉导管都有支架支撑的情况下，至少还有1mm处于动脉导管内，后续可被新生血管内膜包覆固定，防止伸出动脉导管的支架区域脱落导致血管栓塞；而医生对病变长度的判定和支架长度选型会存在一定的偏差，为了保证支架以上功能依然能实现，不可降解节段区域的最小长度需留有一定余地，故端部的不可降解节段区域的长度限定为不低于3mm。
在本实施例中，可降解节段区域和不可降解节段区域相互间隔连接，可降解节段区域和不可降解节段区域间可以通过铆合、压接、焊接、粘接、自体材料合金化等方式连接到一起。
在一实施例中，支架的两个端部均设置的是不可降解节段区域。例如，请参看图2，该支架100包括一个可降解节段区域11和两个不可降解节段区域121、122，该可降解节段区域11位于不可降解节段区域121、122之间。两个不可降解节段区域121、122的轴向长度可以相等，也可以不相等。在其他实施例中， 该支架还可以包括多个可降解节段区域和多个不可降解节段区域，可降解节段区域和不可降解节段区域相互间隔连接，只要保证支架的两个端部均设置的是不可降解节段区域，并且支架的至少一端部设置有轴向长度不低于3mm的不可降解节段区域，均是本实施例的保护范围。
在另一实施例中，支架的一端部设置的是不可降解节段区域，支架的另一端部设置的是可降解节段区域。请参看图3，该支架200包括依次连接的一个可降解节段区域11和一个不可降解节段区域12。在其他实施例中，该支架还可以包括多个可降解节段区域和多个不可降解节段区域，可降解节段区域和不可降解节段区域相互间隔连接，只要保证支架的一个端部均设置的是不可降解节段区域，并且该支架端部设置的不可降解节段区域的轴向长度不低于3mm，均是本实施例的保护范围。
在一实施例中，可降解节段区域的材料为可降解聚合物材料或可降解金属材料，不可降解节段区域的材料为耐腐蚀金属材料。其中，当可降解节段区域的材料为可降解金属材料时，位于动脉导管内的可降解节段区域和伸出动脉导管的不可降解节段区域的部分之间形成了氧浓差腐蚀，促进可降解节段区域的腐蚀。
在本实施例中，不可降解节段区域可以通过选择具有显影性的材料实现自体显影，还可以通过设置显影结构来辅助显影。可以理解的，可降解节段区域也可以通过选择具有显影性的材料实现自体显影，还可以通过设置显影结构来辅助显影。需要说明的是，金属材料是具有自体显影性的，可以通过增加或减少该金属材料所构成的支架网杆厚度，来提高或降低该金属材料所构成的支架段的显影性。聚合物可以通过一些特殊的处理，可以具有显影性，例如聚碳酸酯通过接枝碘基团，可以实现自体显影。
当支架为球扩式支架，可降解聚合物材料选自可降解聚乳酸、可降解聚碳酸酯；可降解金属材料选自可降解镁、镁基合金、可降解铁、铁基合金、可降解锌或锌基合金；耐腐蚀金属材料为高显影性金属，高显影性金属选自金、银、铂、铑、铱、钽、钨、钴、铬、钼、铌或者金、银、铂、铑、铱、钽、钨、钴、铬、钼、铌中至少两个的合金。其中，当可降解节段区域的材料为可降解金属材料，不可降解节段区域的材料为高显影性金属时，高显影性金属为电位更正的阴极，和可降解金属材料可以形成腐蚀电偶对，大大促进可降解节段区域的降解，同时高显影性金属能起到增强可视性的作用。在其他实施例中，球扩式支架的不可降解节段区域也可以设置显影结构来辅助显影。
当支架为自膨式支架，可降解节段区域的材料和不可降解节段区域的材料均为超弹性材料，耐腐蚀金属材料选自超弹性的镍基合金或钛基合金。可降解金属材料选自超弹性铁基合金，超弹性铁基合金选自铁锰(Fe-Mn)合金，铁镍(Fe-Ni)合金，铁铂(Fe-Pt)合金和铁钯(Fe-Pd)合金。
当支架为自膨式支架，位于自膨式支架的端部的不可降解节段区域中至少有部分节段会外翻或外卷，在自膨式支架的端部周向上形成近似帽沿的环形区域，使该支架植入动脉导管后不用取出支架就可以通过经皮介入方式放置封堵 器闭合动脉导管或/和直接结扎动脉导管，同时该支架的外翻/外卷的环形区域因贴合主动脉壁或者/和肺动脉壁，也会被主动脉或者/和肺动脉内的新生血管组织包埋起来，支架植入后不容易移位，也不容易脱落导致栓塞。
参看图4，图4为自膨式支架300的膨胀状态，也就是释放后状态，该支架300脱离输送装置的束缚，位于自膨式支架300的端部的不可降解节段区域的至少有部分节段会外翻或外卷，形成翻转部分2，在支架的端部周向上形成近似帽沿的环形区域。需要说明的是，当该翻转部分2为较细较短的须状丝或者柔性段，可以采用的是外卷设计，当翻转部分2为面积较大的刚性的平面或曲面，可以采用的是外翻设计，在此不限定位于自膨式支架300的端部的不可降解节段区域的至少部分节段的具体形状，外卷或外翻都是为了更好地贴壁，以利于被血管新生内膜组织包埋，降低脱落、栓塞和血栓的风险。另外，针对不同的动脉导管的解剖结构，该环形区域可以为不对称设计或者不规则设计。
受血管壁解剖结构的影响，即动脉导管并不是垂直接入肺动脉或者主动脉，而是可能呈一定角度接入，因此该自膨式支架300在体内释放时，真实表现出的外翻角度一般在30-150度之间。故制作该自膨式支架300时，选择热定型后的外翻倾角a大于90度，优选大于150度，以适应各种血管解剖结构，确保支架外翻后的外翻节段贴壁良好。需要说明的是，该自膨式支架300包括主体部分1和翻转部分2，该外翻倾角a为自膨式支架300的主体部分1的轴向延伸线与翻转部分2之间的夹角。在本实施例中，该自膨式支架300包括自远端至近端依次连接的可降解节段区域11和不可降解节段区域12，该不可降解节段区域12包括翻转部分2，主体部分1包括除去翻转部分2的不可降解节段区域12和可降解节段区域11。
该近似帽沿的环形区域在支架端部周向上是连续或不连续的。在本实施例中，当该近似帽沿的环形区域在支架端部周向上是不连续的，该翻转部分2可以设置成从该自膨式支架300的端面的圆周向外辐射的多个须状结构或者/和图形结构，该多个须状结构或者/和图形结构所在的平面或曲面形成围绕该支架的主体部分1的端面的环形。需要说明的是，每一须状结构或者图形结构的形状和大小或长度可以相同或不同，并且数量不限定。其中须状结构的形状可以为直线形或折线形或曲线形或者至少其中两种形状的组合，图形结构的形状可以为圆形、椭圆形、“V字形”、多边形、“Y”字形、锯齿形或者多种形状的组合。构成一环形的任意须状结构之间或者任意图形结构之间或者须状结构与图形结构之间可以相互重叠，可以不相互重叠。在一个支架中，若支架的两端均设置有翻转部分，该两端的翻转部分的形状可以相同，也可以不同。
优选地，自膨式支架300的翻转部分2设计成不连续的，翻转部分2可以使用更少的材料，支架能被约束到更小的轮廓外径，从而可以适配更小的鞘管，给患儿带来更小的创伤，可进入解剖结构更复杂的靶血管中。
当不可降解节段区域设置在支架的两端，同时两端均发生外翻或外卷，此时翻转部分2分别位于主体部分的两端，该位于主体部分的两端的翻转部分2的长度可以相同，也可以不相同。
在另一实施例中，该支架为自膨式支架，该自膨式支架的端部的不可降解节段区域中可以不设置成外翻或外卷。
在释放后无约束下的支架的主体部分的轴向轮廓可以是矩形、锥形、腰鼓形或者哑铃形，以贴合动脉导管的解剖结构，降低支架植入后移位的风险。
在一实施例中，可降解节段区域的至少部分表面区域设置有表面微孔、盲槽、通孔、中空孔、涂层中至少一种，该表面微孔、盲槽、通孔、中空孔、涂层上携载促进腐蚀或者吸收的物质。
在一实施例中，所述支架的至少部分表面区域设置有表面微孔、盲槽、通孔、中空孔、涂层中至少一种，该表面微孔、盲槽、通孔、中空孔、涂层上携载抗增生、抗肿瘤、抗炎、抗栓或抗敏的药物。
如图5所示，本实施例提供一种支架系统1000，包括支架200和输送装置3，该输送装置3用于输送支架200至靶位置。在本实施例中，该支架为上述实施例中任意一种支架。
上述支架还可以用于如外科冠状动脉旁路移植术的桥血管再狭窄治疗或者复杂先心病外科姑息治疗Blalock-Taussig分流术的桥血管再狭窄治疗。
以下通过具体实施例对上述可吸收金属支架进一步阐述。
实施例1
一种球扩式支架，如图6所示，包括一个5mm长的可降解节段区域11和设置于支架远端的3mm长的不可降解节段区域12。其中的可降解节段区域11可采用可降解的渗氮铁管经激光雕刻和抛光制成，自体可以显影，但显影性较不可降解节段更弱，其上可涂覆含雷帕霉素的聚乳酸涂层。其中的不可降解节段区域12可采用高显影性的铂铬合金管经激光雕刻和抛光制成，自体可以显影。可降解节段区域11和不可降解节段区域12之间可通过焊接的方式连接在一起，再压握到球囊导管上。
该支架在体外通过球囊导管扩张释放后无约束下的支架主体的轴向轮廓是矩形，适用于外径随长度变化不大的动脉导管。不可降解节段区域12的高显影性可以帮助支架在植入动脉导管时准确定位，使得8mm长的支架在6mm长的动脉导管82内释放后，其不可降解节段区域12有1mm长的部分仍在动脉导管82内，其余伸出动脉导管82并伸入肺动脉83内。因支架的不可降解节段区域12相对可降解节段区域11的电位更正作为阴极，和可降解节段区域11间形成腐蚀电偶对，可以大大促进可降解节段区域11的降解。
在植入动脉导管82一段时间后，该支架和动脉导管82的内壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域12至少有部分也被包埋在动脉导管82的新生血管组织中，即使支架的可降解节段区域11完全降解了，支架端部的不可降解节段12也不会降解脱落导致栓塞。被包埋在新生血管组织中的可降解节段区域11和端部的不可降解节段区域12伸出动脉导管82暴露在肺动脉83血流中的部分之间形成了氧浓差腐蚀，进一步促进可降解节段区域11的腐蚀。
该支架植入动脉导管82后，在一定时间内可以维持动脉导管82的开通。随着支架的长度5mm的可降解节段区域11逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入1年后可以通过外科手术直接结扎。
实施例2
一种球扩式支架，包括一个10mm长的可降解节段区域和设置于支架两端的各5mm长的不可降解节段区域。其中的可降解节段区域可采用可降解的聚乳酸管经激光雕刻和抛光制成，自体不可显影，未设置显影结构。其中不可降解节段区域可采用高显影性的钽铌合金管经激光雕刻和抛光制成，自体可以显影。可降解节段区域和不可降解节段区域之间可通过压接的方式连接在一起，再压握到球囊导管上。
该支架在体外通过球囊导管扩张释放后无约束下的支架主体的轴向轮廓是腰鼓形，适用于明显中间外径大、两端外径小的动脉导管。不可降解节段区域的高显影性可以帮助支架在植入动脉导管时准确定位，使得20mm长的支架在15mm长的动脉导管内释放后，其两端的不可降解节段区域各有2.5mm长的部分仍在动脉导管内，其余伸出动脉导管并分别伸入肺动脉和主动脉内。
在植入动脉导管一段时间后，该支架和动脉导管壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域至少有部分也被包埋在动脉导管的新生血管组织中，即使支架的可降解节段区域完全降解了，该支架端部的不可降解节段也不会降解脱落导致栓塞。
该支架植入动脉导管后，在一定时间内可以维持动脉导管的开通。随着支架的长度10mm的可降解节段区域逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入1.5年后可以通过外科手术直接结扎。
实施例3
一种球扩式支架，包括一个16mm长的可降解节段区域和设置于支架一端的4mm长的不可降解节段区域。其中的可降解节段区域可采用可降解的纯锌管经激光雕刻和抛光制成，自体可以显影，但显影性较不可降解节段更弱。其中的不可降解节段区域可采用高显影性的铂铬合金管经激光雕刻和抛光制成，自体可以显影。可降解节段区域和不可降解节段区域之间可通过铆接的方式连接在一起，再压握到球囊导管上。
该支架在体外通过球囊导管扩张释放后无约束下的支架主体的轴向轮廓是哑铃形，适用于明显中间外径小、两端外径大的动脉导管。不可降解节段区域的高显影性可以帮助支架在植入动脉导管时准确定位，使得20mm长的支架在18mm长的动脉导管内释放后，其不可降解节段区域2mm长的部分仍在动脉导管内，其余伸出动脉导管并伸入主动脉内。因支架的不可降解节段区域相对可降解节段区域的电位更正作为阴极，和可降解节段区域间形成腐蚀电偶对，可以大大促进可降解节段区域的降解。
在植入动脉导管一段时间后，该支架和动脉导管壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域至少有部分也被包埋在动脉导管的新生血管组织中，即使支架的可降解节段区域完全降解了，该支架端 部的不可降解节段也不会降解脱落导致栓塞。其被包埋在新生血管组织中的可降解节段区域和端部的不可降解节段区域伸出动脉导管暴露在主动脉血流中的部分之间形成了氧浓差腐蚀，进一步促进可降解节段区域的腐蚀。
该支架植入动脉导管后，在一定时间内可以维持动脉导管的开通。随着支架的长度16mm的可降解节段区域逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入9个月后可以通过外科手术直接结扎。
实施例4
一种球扩式支架，包括一个20mm长的可降解节段区域和设置于支架一端的6mm长的不可降解节段区域。其中的可降解节段区域可采用可降解的镁铁合金管经激光雕刻和抛光制成，其上设置显影结构。其中的不可降解节段区域可采用高显影性的纯钽管经激光雕刻和抛光制成，自体可以显影。可降解节段区域和不可降解节段区域之间可通过粘接的方式连接在一起，再压握到球囊导管上。
该支架在体外通过球囊导管扩张释放后无约束下的支架主体的轴向轮廓是锥形，适用于轮廓呈锥形的动脉导管(如明显靠肺动脉侧的外径更小、靠主动脉侧的外径更大的锥形动脉导管)。不可降解节段区域的高显影性可以帮助支架在植入动脉导管时准确定位，使得26mm长的支架在24mm长的动脉导管内释放后，其不可降解节段区域4mm长的部分仍在动脉导管内，其余伸出动脉导管并伸入肺动脉内。因支架的不可降解节段区域相对可降解节段区域的电位更正，作为阴极和可降解节段区域间形成腐蚀电偶对，可以大大促进可降解节段区域的降解。
在植入动脉导管一段时间后，该支架和动脉导管壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域至少有部分也被包埋在动脉导管的新生血管组织中，即使支架的可降解节段区域完全降解了，支架端部的不可降解节段也不会降解脱落导致栓塞。其被包埋在新生血管组织中的可降解节段区域和端部的不可降解节段区域伸出动脉导管暴露在肺动脉血流中的部分之间形成了氧浓差腐蚀，进一步促进可降解节段区域的腐蚀。
所述支架植入动脉导管后，在一定时间内可以维持动脉导管的开通。随着支架的长度20mm的可降解节段区域逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入6个月后可以通过外科手术直接结扎。
实施例5
一种自膨式支架，包括一个3mm长的可降解节段区域和设置于支架一端的7mm长的不可降解节段区域。其中的可降解节段区域可采用可降解的铁钯合金管经激光雕刻和抛光制成，自体可以显影。其中的不可降解节段区域可采用镍钛合金管经激光雕刻和抛光制成，并在其上设置了黄金显影结构。可降解节段区域和不可降解节段区域之间可通过焊接的方式连接在一起，整个支架表面通过微孔携载紫杉醇，再装配到输送鞘管中。
该支架在体外释放出鞘管后无约束下的支架主体的轴向轮廓是矩形，适用于外径随长度变化不大的动脉导管。不可降解节段区域的显影结构可以帮助支 架在植入动脉导管时准确定位，使得10mm长的支架在8mm长的动脉导管内释放后，其不可降解节段区域5mm长的部分仍在动脉导管内，其余伸出动脉导管并伸入肺动脉内。因支架的不可降解节段区域相对可降解节段区域的电位更正，作为阴极和可降解节段区域间形成腐蚀电偶对，可以大大促进可降解节段区域的降解。
在植入动脉导管一段时间后，该支架和动脉导管壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域至少有部分也被包埋在动脉导管的新生血管组织中，即使支架的可降解节段区域完全降解了，支架端部的不可降解节段也不会降解脱落导致栓塞。其被包埋在新生血管组织中的可降解节段区域和端部的不可降解节段区域伸出动脉导管暴露在肺动脉血流中的部分之间形成了氧浓差腐蚀，进一步促进可降解节段区域的腐蚀。
该支架植入动脉导管后，在一定时间内可以维持动脉导管的开通。随着支架的长度3mm的可降解节段区域逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入1年后可以通过外科手术直接结扎。
实施例6
一种自膨式支架，如图7所示，包括一个6mm长的可降解节段区域11和设置于支架两端的各5mm长的不可降解节段区域121、122。其中的可降解节段区域11可采用可降解的铁锰合金管经激光雕刻和抛光制成，自体显影较弱，也未设置显影结构。其中的不可降解节段区域121、122可采用镍钛合金管经激光雕刻和抛光制成，不可降解节段区域121中位于动脉导管近端端口处的部分设置了钽显影结构，不可降解节段区域122中位于动脉导管远端端口处的部分也设置了钽显影结构。可降解节段区域11和不可降解节段区域121、122之间通过压接的方式连接在一起，再装配到输送鞘管中。
该支架在体外释放出鞘管后无约束下的支架主体的轴向轮廓是矩形，适用于外径随长度变化不大的动脉导管。不可降解节段区域的显影结构可以帮助支架在植入动脉导管时准确定位，使得16mm长的支架在10mm长的动脉导管82内释放后，其两端的不可降解节段区域121、122各有2mm长的部分仍在动脉导管82内，其余伸出动脉导管82并分别伸入主动脉81和肺动脉83内。分别伸入主动脉81和肺动脉83内的3mm长的不可降解节段121、122会各自发生外卷，在支架端部周向上形成近似帽沿的不连续的环形区域21和22。在本实施例中，参看图8，不可降解节段121和122中发生外卷的部分设置成分别从该支架的两端面的圆周向外辐射的须状结构，该须状结构所在的平面或曲面形成围绕该支架的端面的环形区域21和22。故支架植入动脉导管后即刻，可以通过介入的方式放置动脉导管未闭封堵装置。因支架的不可降解节段区域121、122相对可降解节段区域11的电位更正作为阴极，和可降解节段区域11间形成腐蚀电偶对，可以大大促进可降解节段区域11的降解。
在植入动脉导管一段时间后，该支架和动脉导管壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域至少有部分也被包埋在动脉导管82的新生血管组织中，即使支架的可降解节段区域11完全降解了，支 架端部的不可降解节段也不会降解脱落导致栓塞。其被包埋在新生血管组织中的可降解节段区域11和端部的不可降解节段区域伸出动脉导管82暴露在肺动脉83和主动脉81的血流中的部分之间形成了氧浓差腐蚀，进一步促进可降解节段区域11的腐蚀。
支架植入动脉导管后，在一定时间内可以维持动脉导管的开通。随着支架的长度6mm的可降解节段区域11逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入1.5年后可以通过外科手术直接结扎。
实施例7
一种自膨式支架，如图9所示，包括一个10mm长的可降解节段区域11和设置于支架一端的8mm长的不可降解节段区域12。其中的可降解节段区域11可采用可降解的聚碳酸酯管经激光雕刻和抛光制成，聚碳酸酯接枝碘基团，实现自体可以显影，但显影性较弱。其中的不可降解节段区域可采用钛锆铌合金管经激光雕刻和抛光制成，在动脉导管82近端开口处，不可降解节段区域12上也设置了铂金显影结构。可降解节段区域11和不可降解节段区域12之间通过粘接的方式连接在一起，再装配到输送鞘管中。
该支架在体外释放出鞘管后无约束下的支架主体的轴向轮廓是锥形，适用于轮廓呈锥形的动脉导管(如明显靠肺动脉侧的外径更小、靠主动脉侧的外径更大的锥形动脉导管)。不可降解节段区域的显影结构和可降解节段区域的显影结构可以帮助支架在植入动脉导管时准确定位，使得18mm长的支架在15mm长的动脉导管82内释放后，其不可降解节段区域有5mm长的部分仍在动脉导管82内，其余3mm伸出动脉导管82并伸入主动脉81内。3mm长伸出动脉导管82并伸入主动脉81内的不可降解节段会倾向外翻150度，但实际效果为外翻区域贴合主动脉内壁，在支架端部周向上形成近似帽沿的连续的环形区域21(如图10所示)。故支架植入动脉导管后即刻，可以通过介入的方式放置动脉导管未闭封堵装置。
在植入动脉导管一段时间后，该支架和动脉导管壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域至少有部分也被包埋在动脉导管的新生血管组织中，即使支架的可降解节段区域11完全降解了，支架端部的不可降解节段也不会降解脱落导致栓塞。
所述支架植入动脉导管后，在一定时间内可以维持动脉导管的开通。随着支架的长度10mm的可降解节段区域11逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入9个月后可以通过外科手术直接结扎。
实施例8
一种自膨式支架，如图11所示，包括从远端至近端依次连接的6mm长的不可降解节段区域121、2mm长的可降解节段区域111、4mm长的不可降解节段区域122、6mm长的可降解节段区域112和6mm长的不可降解节段区域123。其中的可降解节段区域111和112可采用可降解的铁锰合金管经激光雕刻和抛光制成，自体显影较弱，也未设置显影结构。其中的不可降解节段区域121、122、123可采用镍钛合金管经激光雕刻和抛光制成，并在位于动脉导管近端和远端的 开口的不可降解节段区域123、121上分别设置了铂金显影结构。可降解节段区域和不可降解节段区域之间通过铆接的方式连接在一起，再装配到输送鞘管中。
该支架在体外释放出鞘管后无约束下的支架主体的轴向轮廓是矩形，适用于外径随长度变化不大的动脉导管。不可降解节段区域的显影结构可以帮助支架在植入动脉导管82时准确定位，使得24mm长的支架在20mm长的动脉导管内释放后，其两端的不可降解节段区域各有4mm长的部分仍在动脉导管82内，其余伸出动脉导管82并伸入主动脉81和肺动脉83内。分别伸入主动脉81和肺动脉83内的2mm长的不可降解节段会各自倾向外翻150度和120度，但实际效果为外翻区域各自贴合主动脉内壁和肺动脉内壁，在支架端部周向上形成近似帽沿的不连续的环形区域21和22。在本实施例中，在图12中，不可降解节段123发生外翻的部分设置成分别从该支架的两端面的圆周向外辐射的类似“V”字形的图形结构，该图形结构所在的平面或曲面形成围绕该支架的端面的环形区域21。不可降解节段121发生外翻的部分设置成分别从该支架的两端面的圆周向外辐射的类似“V”字形的图形结构，该图形结构所在的平面或曲面形成围绕该支架的端面的环形区域22。故支架植入动脉导管82后即刻，可以通过介入的方式放置动脉导管未闭封堵装置。因支架的不可降解节段区域相对可降解节段区域的电位更正，作为阴极和可降解节段区域间形成腐蚀电偶对，可以大大促进可降解节段区域111和112的降解。
在植入动脉导管82一段时间后，该支架和动脉导管壁接触的节段区域会被新生血管组织包埋起来，支架端部的不可降解节段区域121、123中至少有部分也被包埋在动脉导管的新生血管组织中，即使支架的可降解节段区域111和112完全降解了，支架端部的不可降解节段121、123也不会降解脱落导致栓塞。其被包埋在新生血管组织中的可降解节段区域和端部的不可降解节段区域伸出动脉导管暴露在肺动脉和主动脉血流中的部分之间形成了氧浓差腐蚀，进一步促进可降解节段区域111和112的腐蚀。
该支架植入动脉导管后，在一定时间内可以维持动脉导管的开通。随着支架的长度6mm的可降解节段区域112逐渐降解至丧失结构完整性，其接触的动脉导管段在支架植入1.5年后均可以通过外科手术直接结扎。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (11)

  1. 一种支架，其特征在于，所述支架包括至少一可降解节段区域和至少一不可降解节段区域，所述可降解节段区域和所述不可降解节段区域相互连接，至少一个所述可降解节段区域的轴向长度不低于3mm，所述支架的至少一端部设置有轴向长度不低于3mm的所述不可降解节段区域。
  2. 如权利要求1所述的支架，其特征在于，所述可降解节段区域的材料为可降解聚合物材料或可降解金属材料，所述不可降解节段区域的材料为金属材料。
  3. 如权利要求1所述的支架，其特征在于，所述支架为球扩式支架，所述不可降解节段区域的材料选自金、银、铂、铑、铱、钽、钨、钴、铬、钼、铌中至少一种，所述可降解节段区域的材料选自镁、铁、锌、镁基合金、铁基合金、锌基合金、聚乳酸或者聚碳酸酯。
  4. 如权利要求1所述的支架，其特征在于，所述支架为自膨式支架，所述不可降解节段区域的材料为镍基合金或钛基合金，所述可降解节段区域的材料为铁基合金，所述铁基合金选自铁锰合金，铁镍合金，铁铂合金或铁钯合金。
  5. 如权利要求1所述的支架，其特征在于，所述支架为自膨式支架，所述不可降解节段区域中至少有部分节段为外翻或外卷部分。
  6. 如权利要求5所述的支架，其特征在于，所述外翻或外卷部分在所述自膨式支架的端部周向上形成近似帽沿的环形区域，所述环形区域呈连续状态或不连续状态。
  7. 如权利要求1所述的支架，其特征在于，所述支架在释放后无约束下的轴向轮廓是矩形、锥形、腰鼓形或者哑铃形。
  8. 如权利要求1所述的支架，其特征在于，位于所述支架的端部的所述不可降解节段区域上或者所述可降解节段区域上设置有显影结构。
  9. 如权利要求1所述的支架，其特征在于，所述可降解节段区域的至少部分表面区域设置有表面微孔、盲槽、通孔、中空孔或涂层中的至少一种，所述表面微孔、所述盲槽、所述通孔、所述中空孔、所述涂层上携载促进腐蚀或者吸收的物质。
  10. 如权利要求1所述的支架，其特征在于，所述支架的至少部分表面区域设置有表面微孔、盲槽、通孔、中空孔、涂层中的至少一种，所述表面微孔、所述盲槽、所述通孔、所述中空孔、所述涂层上携载抗增生、抗肿瘤、抗炎、抗栓或抗敏的药物。
  11. 一种支架系统，包括如权利要求1～10中任一所述的支架。
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116212124A (zh) * 2023-05-09 2023-06-06 杭州糖吉医疗科技有限公司 一种胃内球囊可降解自封闭阀及其制备方法和应用

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109700581B (zh) * 2018-12-29 2021-12-03 元心科技(深圳)有限公司 支架及支架系统
CN109964846A (zh) * 2019-05-14 2019-07-05 江苏农牧科技职业学院 一种可植入式动物运动监测设备、系统和方法
CN111358605A (zh) * 2020-03-20 2020-07-03 贾伟 一种髂静脉支架
CN112656460B (zh) * 2020-12-21 2022-01-28 中国医学科学院阜外医院 一种主肺动脉分流装置
CN113397762B (zh) * 2021-05-31 2022-02-08 上海心瑞医疗科技有限公司 一种心房分流植入装置
CN218684866U (zh) * 2021-07-28 2023-03-24 陈绍良 生物可降解的药物洗脱支架
CN119214841A (zh) * 2023-06-28 2024-12-31 上海鸿脉医疗科技有限公司 血管支架

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101496754A (zh) * 2008-01-29 2009-08-05 太雄医疗器株式会社 可生物降解的双支架
US7704276B2 (en) * 2002-11-15 2010-04-27 Synecor, Llc Endoprostheses and methods of manufacture
CN102858280A (zh) * 2010-04-23 2013-01-02 美敦力瓦斯科尔勒公司 具有生物不可降解端部和用于增大的支架环绕强度的机构的生物可降解支架
CN105530895A (zh) * 2013-09-13 2016-04-27 雅培心血管系统有限公司 编制支撑架
CN106456309A (zh) * 2014-04-08 2017-02-22 波士顿科学国际有限公司 部分涂覆支架
CN109700581A (zh) * 2018-12-29 2019-05-03 先健科技(深圳)有限公司 支架及支架系统

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002524196A (ja) * 1998-09-10 2002-08-06 パーカーディア，インコーポレイティド 左心室血管再生用の経心筋シャントおよびその取付機構
US20060069424A1 (en) * 2004-09-27 2006-03-30 Xtent, Inc. Self-constrained segmented stents and methods for their deployment
CN100400115C (zh) * 2005-05-24 2008-07-09 北京奥精医药科技有限公司 复合支架材料、复合支架及其生产方法
CN201042472Y (zh) * 2007-04-28 2008-04-02 北京乐普医疗器械有限公司 分叉血管开口支架
WO2012170591A2 (en) * 2011-06-07 2012-12-13 Qing Liu Hybrid polymer stent fabricated by a non-laser cut fabrication method
GB2499211B (en) * 2012-02-08 2016-03-02 Cook Medical Technologies Llc Bioabsorbable stent and implantable medical device
US9352071B2 (en) * 2013-03-14 2016-05-31 Ethicon, Inc. Method of forming an implantable device
CN105395298A (zh) * 2014-09-04 2016-03-16 汤敬东 一种部分可降解血管支架及其制备方法
CN106333768B (zh) * 2016-10-21 2018-01-30 董念国 一种Fontan手术用的静脉血引流支架
CN107970081B (zh) * 2017-11-17 2023-06-23 上海利格泰生物科技股份有限公司 混合型人工韧带及制造方法
CN108014371A (zh) * 2017-12-29 2018-05-11 上海纽脉医疗科技有限公司 一种可再生心脏瓣膜及其制备装置、方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7704276B2 (en) * 2002-11-15 2010-04-27 Synecor, Llc Endoprostheses and methods of manufacture
CN101496754A (zh) * 2008-01-29 2009-08-05 太雄医疗器株式会社 可生物降解的双支架
CN102858280A (zh) * 2010-04-23 2013-01-02 美敦力瓦斯科尔勒公司 具有生物不可降解端部和用于增大的支架环绕强度的机构的生物可降解支架
CN105530895A (zh) * 2013-09-13 2016-04-27 雅培心血管系统有限公司 编制支撑架
CN106456309A (zh) * 2014-04-08 2017-02-22 波士顿科学国际有限公司 部分涂覆支架
CN109700581A (zh) * 2018-12-29 2019-05-03 先健科技(深圳)有限公司 支架及支架系统

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116212124A (zh) * 2023-05-09 2023-06-06 杭州糖吉医疗科技有限公司 一种胃内球囊可降解自封闭阀及其制备方法和应用
CN116212124B (zh) * 2023-05-09 2023-08-18 杭州糖吉医疗科技有限公司 一种胃内球囊可降解自封闭阀及其制备方法和应用

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