阅读说明：本技术 一种多功能医用管腔复合支架 (Multifunctional medical lumen composite stent ) 是由 赵晓辉 于 2020-12-04 设计创作，主要内容包括：本发明公开了一种多功能医用管腔复合支架,包括支架本体,以及设置于支架本体上的锚固件,所述支架本体的裸支架由金属丝材编制而成,具有轴向压缩和扩展两种构型,且至少具有两层结构,内层为支撑性结构,外层为覆膜结构,所述锚固件附接于外层覆膜结构,其特征在于：所述锚固件由从覆膜结构突出的线性连接体以及位于连接体顶端的一体成型的球状结构组成,所述连接体与球状结构可与覆膜结构材料相同,也可由与其不相同的材料组成。(The invention discloses a multifunctional medical lumen composite stent, which comprises a stent body and an anchoring part arranged on the stent body, wherein a bare stent of the stent body is woven by metal wires, has two configurations of axial compression and expansion, and at least has a two-layer structure, the inner layer is a supporting structure, the outer layer is a film covering structure, and the anchoring part is attached to the outer layer film covering structure, and is characterized in that: the anchoring piece is composed of a linear connecting body protruding from the film covering structure and an integrally formed spherical structure positioned at the top end of the connecting body, and the connecting body and the spherical structure can be made of the same material as the film covering structure or made of different materials.)

1. The utility model provides a multi-functional medical lumen composite stent, includes the support body to and set up the anchor assembly on the support body, the bare support of support body is worked out by the metal silk material, has two kinds of configurations of axial compression and expansion, and has two-layer structure at least, and the inlayer is the bearing nature structure, and the outer tectorial membrane structure that is, anchor assembly attaches to outer tectorial membrane structure, its characterized in that: the anchoring piece is composed of a linear connecting body protruding from the film covering structure and an integrally formed spherical structure positioned at the top end of the connecting body, and the connecting body and the spherical structure can be made of the same material as the film covering structure or made of different materials.

2. The multifunctional medical lumen composite stent of claim 1, further comprising an intermediate layer between the inner layer and the outer layer, wherein the intermediate layer is a drug-loaded layer or a sealing layer, if the intermediate layer is the drug-loaded layer, the outer layer membrane structure is a membrane made of degradable materials and having a microporous structure, and if the intermediate layer is the sealing layer, the outer layer membrane structure is a mixed drug coating consisting of the degradable materials and drugs.

3. The multifunctional composite medical luminal stent as described in claim 2, wherein the mixed drug coating contains bioactive substances, and the mixed drug is in the form of microspheres or clouds, and the microspheres or clouds are spaced from each other.

4. The multifunctional medical luminal composite stent of claim 2, wherein the drug-loaded layer has a plurality of different chambers for containing drugs and/or hydrophilic lubricating fluid, the chambers are communicated with each other by micropores, and drugs with different functions or therapeutic effects can be loaded in the different chambers.

5. The multifunctional medical luminal composite stent of any one of claims 1 to 4, wherein the stent body can also be 3D printed from a polymer material.

6. The multifunctional composite medical lumen stent as claimed in any one of claims 1 to 4, wherein the inner supporting structure is woven from metal wires, each metal wire forms a zigzag axial surrounding structure, the adjacent metal wires are connected by a connecting member, two metal wires at the axial middle position of the stent are connected by at least three sections of elastic expansion members, the left end of each elastic expansion member is fixedly connected with the zigzag metal wire at the corresponding side close to the wave crest, the right end of each elastic expansion member is fixedly connected with the wave trough of the zigzag metal wire at the other side, the left section of each elastic expansion member is a bent or spiral structure formed by cross weaving two or more elastic wire materials, the right section of each elastic expansion member is an elastic wire material, and the left and right sections of the connection are connected by welding or bonding.

7. The multifunctional composite stent for medical tube cavity as claimed in claim 6, wherein the elastic expansion pieces between the adjacent wave crests and wave troughs of the two metal wires have different arrangement modes, wherein the left section of one elastic expansion piece is of a bent or spiral structure, the right section of the adjacent elastic expansion piece is of a bent or spiral structure, the right section of one elastic expansion piece is an elastic wire material, and the left section of the adjacent elastic expansion piece is an elastic wire material.

Technical Field

The invention relates to the technical field of in-vivo lumen stents, in particular to a multifunctional medical lumen composite stent.

Background

Cardiovascular and cerebrovascular diseases are one of the important causes of human death, and compared with drug therapy and surgical treatment, interventional therapy has the advantages of small wound, obvious immediate effect, quick postoperative recovery, relatively good long-term effect and the like, and is a common method for clinically treating cardiovascular and cerebrovascular diseases at present. Since the first Bare Metal Stent (BMS) was placed into the human body in 1985, stent interventional therapy successfully solved the problem of high restenosis rate in the time of pure balloon dilatation, and became the main means of clinical treatment. In the past decades, researchers have adopted various techniques to improve the curative effect of the vascular stent, and particularly, clinical application of a drug eluting stent greatly reduces the incidence of restenosis in the stent. However, at present, late thrombosis and restenosis in stents are still two major complications limiting the clinical application of cardiovascular stents, and the design of an ideal vascular stent meeting the clinical requirements still needs to be continuously explored.

The stent of the invention can be applied to treating cardiovascular and cerebrovascular diseases, and can also be applied to cerebrovascular diseases or other lumen diseases, such as cerebral artery embolism, cerebral artery thrombosis, cerebral artery severe stenosis, cerebral aneurysm, trachea and bronchus stenosis, lower limb artery and vein, alimentary canal artery and vein, liver and lung blood vessel, and the like. In the prior art, the stent for interventional therapy is mostly woven by polymer or metal wires or carved and processed by metal pipes. In order to enhance the anti-restenosis ability of stents and to maximize the therapeutic duration of stents, various improvements have been made in the stent art. For example, the material and structural form of the bracket are improved; coating the stent with an antithrombotic drug; the surface of the bracket has radioactive action; development of a sheath-less stent, etc. However, most of the stents only delay the occurrence of restenosis, but cannot inhibit restenosis, have insufficient stability after implantation, are easy to cause thrombosis and restenosis at the middle and later stages after stent implantation, and some stents can realize axial compression but cannot realize radial compression, thus not well meeting the requirements of sheathing and releasing.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a multifunctional medical lumen composite stent, in particular to a stent which integrates a drug-loaded coating, an anchoring part, an elastic telescopic part and a laminated structure and takes metal or polymer as a base material.

In order to achieve the purpose, the invention provides the following technical scheme:

a multifunctional medical composite bracket for a lumen comprises a bracket body and an anchoring part arranged on the bracket body, wherein the bracket body is woven by metal wires, or is formed by 3D printing of polymer materials, has two configurations of axial compression and expansion, and at least has two-layer structure, the inner layer is a supporting structure, the outer layer is a film-coated structure, or has an intermediate layer between the inner layer and the outer layer, the intermediate layer is a drug-loaded layer or a sealing layer, if the middle layer is a drug-loading layer, the outer layer film structure is a film made of degradable materials and having a micropore structure, if the middle layer is a sealing layer, the outer layer film structure is a mixed drug coating layer consisting of degradable materials and drugs, the mixed drug coating layer contains bioactive substances, the mixed medicines are in a micro-sphere shape or a cloud shape, and the micro-sphere shape or the cloud shape mixed medicines are arranged at intervals; the drug-carrying layer is provided with a plurality of different cavities for containing drugs and/or hydrophilic lubricating liquid, the cavities are mutually communicated through micropores, and the different cavities can bear drugs with different functions or curative effects.

The degradable material comprises but is not limited to lactic acid-glycolic acid copolymer, polylactic acid, PEG-lactic acid-glycolic acid copolymer, and synthetic material prepared by taking glycolide, lactide, caprolactone, trimethylene carbonate and p-dioxane ketone as raw materials through homopolymerization or copolymerization; the medicine comprises one or more of rapamycin and derivatives thereof, paclitaxel and derivatives thereof, cyclosporine and derivatives thereof, and other medicines with the effect of inhibiting cell proliferation.

The anchoring part is attached to the outer-layer film covering structure, the anchoring part is composed of a linear connecting body protruding from the film covering structure and an integrally formed spherical structure positioned at the top end of the connecting body, the connecting body and the spherical structure can be made of the same material as the film covering structure and can also be made of different materials, the anchoring part can increase the friction force between the support and the wall of a human body lumen, and cannot cause puncture or stabbing pain to the wall of the lumen, so that the anchoring part has a good anchoring effect and is safe and reliable.

The inner supporting structure can be woven by metal wires, each metal wire forms a Z-shaped axial surrounding structure, connecting pieces are arranged between adjacent metal wires and connected, at least three sections of elastic expansion pieces are connected between two sections of metal wires in the axial middle position of the bracket, the left end of each elastic expansion piece is fixedly connected with the position, close to a wave crest, of the corresponding side Z-shaped metal wire, the right end of each elastic expansion piece is fixedly connected with the position, close to a wave trough, of the other side Z-shaped metal wire, the left section of each elastic expansion piece is a bent or spiral structure formed by cross weaving two or more elastic wire materials, the right section of each elastic expansion piece is an elastic wire material, the left and right sections of the connection positions are connected in a welding or bonding mode and the like, the elastic expansion pieces between the adjacent wave crests and wave troughs of the two sections of metal wires have different arrangement modes, and particularly, the left section of one elastic expansion piece is a bent, then adjacent elastic expansion spare right side section is the form of buckling or helical structure, and one of them elastic expansion spare right side section is an elasticity silk material, then adjacent elastic expansion spare left side section is an elasticity silk material, evenly increases the radial elasticity of support from this.

The elastic expansion piece can be arranged in the middle of the axial direction and also can be arranged between the adjacent metal wires at the two ends of the axial direction of the bracket.

The middle layer and/or the outer layer of the stent are provided with a laminated structure, different parts of the middle layer and/or the outer layer are connected into a whole through the laminated structure, the laminated structure is provided with an outer layer flange and an inner layer concave edge which are connected into a whole, the outer layer flange is inserted into the corresponding outer layer concave edge at the other end, the inner layer concave edge is inserted by the corresponding inner layer flange at the other end, the outer layer flange and the inner layer concave edge in the laminated structure are in concave-convex staggered arrangement or arranged in any form, such as local staggered arrangement or opposite staggered arrangement, and the like, in practical application, medical biological glue can be coated in each section of middle layer and/or outer layer or outside the bare stent, and then each section of the middle layer and/or the outer layer after processing is sleeved outside the bare stent, each section is tightly inserted, so that the independence, the sealing performance and the individuation of the middle layer and/or the outer layer are improved, and the storage difficulty and the processing difficulty are reduced.

Drawings

Fig. 1 is a schematic structural view of the multifunctional medical luminal composite stent of the present invention.

Fig. 2 is a top view of the multifunctional medical luminal composite stent of the present invention.

Fig. 3 is a schematic structural view of the elastic expansion piece of the present invention.

Fig. 4 is a schematic structural view of a laminated structure of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

As shown in fig. 1-4, a multifunctional medical composite lumen stent, the composite lumen stent 1 comprises a stent body 3 and an anchoring part 2 arranged on the stent body 3, the bare stent of the stent body 3 is woven by metal wires or is 3D printed by polymer materials, has two configurations of axial compression and expansion, and has at least two layers of structures, the inner layer is a supporting structure 111, the outer layer is a covering film structure 112, and can also have a middle layer between the inner layer and the outer layer, the middle layer is a drug-loaded layer or a sealing layer, if the middle layer is a drug-loaded layer, the outer covering film structure 112 is a covering film made of degradable materials and having a microporous structure, if the middle layer is a sealing layer, the outer covering film structure 112 is a mixed drug coating made of degradable materials and drugs, the mixed drug coating contains bioactive substances, the mixed medicines are in a micro-sphere shape or a cloud shape, and the micro-sphere shape or the cloud shape mixed medicines are arranged at intervals; the drug-carrying layer is provided with a plurality of different cavities for containing drugs and/or hydrophilic lubricating liquid, the cavities are mutually communicated through micropores, and the different cavities can bear drugs with different functions or curative effects.

The degradable material comprises but is not limited to lactic acid-glycolic acid copolymer, polylactic acid, PEG-lactic acid-glycolic acid copolymer, and synthetic material prepared by taking glycolide, lactide, caprolactone, trimethylene carbonate and p-dioxane ketone as raw materials through homopolymerization or copolymerization; the medicine comprises one or more of rapamycin and derivatives thereof, paclitaxel and derivatives thereof, cyclosporine and derivatives thereof, and other medicines with the effect of inhibiting cell proliferation.

The anchoring part 2 is attached to the outer-layer coating structure 112, the anchoring part 2 is composed of a linear connecting body protruding from the coating structure and an integrally formed spherical structure positioned at the top end of the connecting body, the connecting body and the spherical structure can be made of the same material as the coating structure and can also be made of different biocompatible materials, the anchoring part 2 can increase the friction force between the stent 1 and the wall of a human body lumen, and the wall of the lumen cannot be punctured or punctured, so that a good anchoring effect is achieved, and the anchoring part is safe and reliable.

The inner supporting structure 111 can be woven by metal wires 6, each metal wire 6 forms a Z-shaped axial surrounding structure, adjacent metal wires 6 are connected through a connecting piece, two sections of metal wires 6 in the axial middle position of the bracket are connected through at least three sections of elastic expansion pieces 7, the left end of each elastic expansion piece 7 is fixedly connected with the position, close to a wave crest, of the corresponding side Z-shaped metal wire, the right end of each elastic expansion piece 7 is fixedly connected with the wave trough of the other side Z-shaped metal wire, the left section of each elastic expansion piece 7 is a circuitous bent or spiral structure formed by cross weaving of two or more elastic wire materials, the right section of each elastic expansion piece 7 is an elastic wire material, the left and right sections of the connection positions are connected through welding or bonding and the like, and the elastic expansion pieces 7 between the adjacent wave crests and wave troughs of the two sections of metal wires 6 have different arrangement modes, specifically, the left section of one of the elastic extensible members 7 is of a bent shape or a spiral structure, the right section of the adjacent elastic extensible member 7 is of a bent shape or a spiral structure, the right section of one of the elastic extensible members 7 is an elastic wire, and the left section of the adjacent elastic extensible member 7 is an elastic wire, so that the radial flexibility of the stent is uniformly increased.

The elastic expansion piece 7 can be arranged at the axial middle position, and also can be arranged between the adjacent metal wires at the two axial ends of the bracket 1.

The middle layer and/or the outer layer of the stent are provided with a laminated structure, different parts of the middle layer and/or the outer layer are connected into a whole through the laminated structure, at one end of the connected part of the middle layer and/or the outer layer, the laminated structure is provided with an outer layer flange 4 and an inner layer concave edge 5 which are connected into a whole, the outer layer flange 4 is inserted into the outer layer concave edge corresponding to the other end, the inner layer concave edge 5 is inserted into the inner layer flange corresponding to the other end, the outer layer flange 4 and the inner layer concave edge 5 in the laminated structure are in concave-convex staggered arrangement or arranged in any form, such as local staggered arrangement or opposite staggered arrangement, and the like, in practical application, medical biological glue can be coated in each section of the middle layer and/or the outer layer or outside the bare stent, and then each section of the middle layer and/or the outer layer which is processed is sleeved outside the bare stent, each section is tightly inserted, so that the independence, the sealing performance and the individuation of the middle layer and/or the outer layer are improved, and the storage difficulty and the processing difficulty are reduced.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.