WO2016010452A1

WO2016010452A1 - Multipurpose vascular implant

Info

Publication number: WO2016010452A1
Application number: PCT/RU2014/000717
Authority: WO
Inventors: Leonid Vitalyevich GLUSHCHENKO; Vladislav Aleksandrovich SHCHEPOCHKIN; Sergey Nikolaevich CHVALUN; Nikita Gennadyevich SEDUSH; Oleg Igorevich LEYBEL
Original assignee: Ic "Sovremennie Tehnologii", Ltd
Priority date: 2014-07-14
Filing date: 2014-09-24
Publication date: 2016-01-21
Also published as: RU2551938C1

Abstract

The invention relates to medicine, namely multipurpose vascular implants, and may be used in X-ray surgery for capturing blood clots or as a stent. The implant scaffold (1) formed by an assembly of non-crossing with each other longitudinal elements (2) made of bio-degradable material, whose ends on one side are joined together at one point (6), and at least by two transversal elements (3) made of bio-degradable material and made elastic, which enables contact at least between the central, part of each longitudinal element and the internal surface of vascular lumen sufficient for self-centering of the implant scaffold within the vessel, from when it is placed in vascular lumen until it is completely dissolved, and the ends on the other side of longitudinal elements are also joined together at one point (6) symmetrically to the opposite ends, at that the longitudinal elements are made elastic also. Technical result: increase of reliability of the implant fixation in a vessel together with an increase in its safety and scope of use.

Description

MULTIPURPOSE VASCULAR IMPLANT

TECHNICAL FIELD

The invention relates to medicine, namely to multipurpose vascular implants, and may be used in X-ray surgery for capturing blood clots or as a stent.

STATE OF ART

There is a known intravenous filter (Russian Federation patent No. 2000814, V. S. Savelyev et all., published October 15, 1993, A61M1/34) comprising a mesh formed by an assembly of non-crossing longitudinal fibers, whose ends on one side are joined together at one point, and on another side are fixed on fixing members equipped with hooks. The mesh is also formed by transversal fibers positioned symmetrically relative to each other and to the central longitudinal axis of the filter. The transversal fibers comprise two rings of different diameter connected with longitudinal mesh elements. Inclination of the ring plane to the central longitudinal axis of the filter is 90°. The mesh is made of polyglycolide-based material, e.g. Vicryl, ensuring resorption in the bloodstream. The filter is implanted percutaneously.

The design of the known filter has a number of disadvantages. First, the known design does not allow for filter placement from any access, including femoral access, but allows for placement only through jugular and subclavicular access, which is more unsafe for patients due to the risk of injury and bleeding. Second, because of the absence of a contact at least between the central part of each longitudinal mesh fiber and internal surface of vascular lumen, the thrombi "arriving" in the filter do not attach to the venous wall and move along the vasculature upon resorption of the device. Furthermore, there is an additional load upon the filter design due to a combination of hydrodynamic pressure and force of "venous wall compression" contributing to its fragmentation. Beside that, it may cause perforation of the vein by its base or migration in case of insufficiently experienced surgeon. Third, the filter has limited application, e.g. it cannot be used additionally as a venous stent at sites where veins are compressed by arteries. Moreover, Vicryl fibers, although they are fixed at the fiber fixing ring, are so thin that they will not maintain mesh scaffold strength. Again, these fibers are resorbable within 40 days, which, for example, does not allow for a full extent of PATE (pulmonary artery thromboembolism) prevention. It may occur within 90 days since the initial diagnosis of floating thrombus.

There is a known bio-degradable filter (US application No.

20100016881, COOK INCORPORATED, published January 21, 2010, A61M29/00) with a scaffold formed by an assembly of longitudinal elements, non-crossing with each other, made of bio-degradable polylactide- and polyglycolide-based material, whose ends on one side are joined together by means of biodegradable centralizer. Additionally, the filter scaffold is equipped with transversal zigzag elements in the shape of a ring, made of non-degradable material, e.g. stainless wire, Nitinol, etc. The rings of different diameter are positioned symmetrically relative to each other and to the central longitudinal axis of the filter and connected to the longitudinal scaffold elements. Inclination of the ring plane to the central longitudinal axis of the filter is 90°.

The design of the known filter has a number of disadvantages. First, only a part of the filter is made of biodegradable materials, hence upon resorption of the device there are remaining parts made of nitinol, steel, etc. subsequently resulting in thrombus formation and a need for chronic administration of anticoagulants. Partial resorbability is also associated with long-term complications, such as perforation and filter migration, because over time the material starts to change its form, and transversal filter elements may traumatize vascular wall even from the very beginning. Furthermore, after perforation of the vein transversal filter elements may cause fixation of the filter in a "tumbled state" due to the absence of uniform contact mainly between the central part of each longitudinal element and the internal surface of venous lumen, which may result in, e.g., PATE. An additional disadvantage is the degradation (resorption) time of 4-6 weeks, as the desired time is 90 days and more to avoid recurrences of the fatal illness .

There is a known plain interlacing stent (US application No.20140114389, BOARD OF REGENTA, THE UNIVERSITY OF TEXAS SYSTEM, published April 24, 2014, A61A2/07) with a scaffold formed by an assembly of longitudinal fibers made of biodegradable poly-L-lactide-based material, interlaced together with formation of volumetric mesh. Ends of each side of the fibers are interlaced together and fixed on a hook.

The disadvantage of the known invention is the multi-fiber design challenging the safety of the device as the fibers may change their position and the device may migrate. Furthermore, the above patent does not specify the material used and the time of its bio-degradation.

The closest analog (a prototype) of the present invention is a resorbable vascular filter (US application No.20120221040, Mitchell Donn Rggers, published August 30, 2012, A61F2/01) with a scaffold formed by an assembly of non-crossing with each other longitudinal plastic fibers made of bio-degradable material (e.g., PLGA-based 50/50), whose ends on one side are joined together at one point, and on another side are free. Additionally the filter has two fibriform transversal flexible crosspieces made of bio-degradable material in the shape of rings positioned symmetrically relative to each other and to the central longitudinal axis of the filter. Inclination of the ring plane to the central longitudinal axis is 90°.

The design of the known filter has a number of disadvantages. First, the fiber material is plastic used in order to form scaffolds presented in the above patent, which suggests insufficient strength and elasticity for fixation of the device in vena cava. Furthermore, during the resorption, hemodynamic load will fall upon several fibers resulting in break-off of pieces supporting the fibers. If the fibers are big, they will cause an occlusion of the vein and will result in venous thrombosis. In addition, because of the absence of contact between the central part of each longitudinal fiber and the internal surface of vascular lumen, there is no self- centering of the filter. Second, single transversal fibriform crosspieces between longitudinal fibers first of all will promote loss of mechanical elasticity of the device, loss of structural form and migration along vasculature, or loss of filter function. An additional disadvantage of the design is that bio-degradable material does not resolve within 90 to 180 days .

The present invention enables to avoid the abovementioned disadvantages of the analogs and the prototype.

DISCLOSURE OF THE INVENTION

The object of the invention is to create a new multipurpose vascular implant designed to provide appropriate fixation of the device in a vessel and secure thromboemboli filtration, and which may serve both as filter and stent, be placed from any access in persons of any age with PATE of any etiology without necessity in subsequent removal.

The technical result achieved by use of the invention consists in an increase of reliability of the implant fixation in a vessel together with an increase of its safety and scope of use.

The object of the invention and the required technical result are achieved by means of the following: the multipurpose vascular implant has a scaffold formed by an assembly of non- crossing with each other longitudinal elements made of biodegradable material, whose ends on one side are joined together at one point and at least by two transversal elements made of bio-degradable material, according to the invention, the transversal elements are made elastic, which enables contact at least between the central part of each longitudinal element and the internal surface of vascular lumen sufficient for self- centering of the implant scaffold within the vessel, from when it is placed in vascular lumen until when it is completely dissolved, and the ends on the other side of longitudinal elements are also joined together at one point symmetrically to the opposite ends, and the ratio between maximum distance between two external points of the scaffold aligned perpendicularly to the central longitudinal axis of the implant and the length of the implant when free is 2:3 to 4:5, ideally 3:4; notably, the longitudinal elements are also made elastic, and transversal elements are made as a unit with longitudinal elements or located over them, namely, the transversal elements are connected with the longitudinal elements inside and/or outside the scaffold, and the transversal elastic elements are positioned symmetrically relative to each other and to the central longitudinal axis of the filter and comprise fixing rings, each of which is connected with the longitudinal scaffold elements at at least two points, where inclination of the ring plane to the central longitudinal axis is 30° to 90°, or comprise fixing arches, each of which is connected with at least two longitudinal elements; in addition the elastic longitudinal elements, or elastic transversal elements, or elastic longitudinal and transversal elements are made of the same bio-degradable material or different bio-degradable materials, where copolymer of D,L-lactide and glycolide with molecular weight 75,000-200,000 Da with mole ratio 50.00- 99.99:0.01-50.00, or copolymer of trimethyl decarbonate and glycolide with molecular weight 75,000-200,000 Da with mole ratio 75.00-99.99:0.01-25.00, or copolymer of D,L-lactide and glycolide with molecular weight 75,000-200,000 Da with mole ratio 0.01-75.00:25.00-99.99, or copolymer of D,L-lactide, trimethyl decarbonate, and glycolide with molecular weight 75,000-200,000 Da with mole ratio 0.01-75.00:0.01-99.98:0.01- 24.99 are used as a bio-degradable material.

Essential feature of the present self-centering multipurpose implant is mutual arrangement and mutual connection of elastic longitudinal and elastic transversal elements providing increased and safe symmetrically distributed (at the same time relative to the central longitudinal axis of the scaffold and relative to the vein surface) contact area between the scaffold and venous walls. Arrangement of transversal elements enables at least the central part of each longitudinal element to contact simultaneously with the internal surface of vascular lumen. Because of that, in addition to the increased safe, symmetrically distributed area, the scaffold has mechanical elasticity and maintains the configuration, thus increasing reliability of the device and scope of its use. The increased vein contact area prevents possible perforation of vascular wall and adjacent organs and resulting bleeding, i.e. increases safety of the device. Symmetrical distribution of the contact area increases reliability of scaffold fixation and ensures uniform distribution of hemodynamic load upon the scaffold during the dissolution; as a result, the dissolution process is uniform, with no break-off or migration of both scaffold and its separate pieces, which also increases safety of the device. The device is not displaceable by blood flow and its position requires no adjustment. The scaffold maintains elastic properties, appropriate fixation in small and large vessels, and reliable blood filtration.

BRIEF DESCRIPTION OF DRAWINGS

Fig. 1 presents a three-dimensional picture of the implant (when free) with transversal elements made in the form of fixing rings angularly related to the longitudinal central axis of the scaffold.

Fig. 2 presents an elevational view of the implant shown in Fig. 1.

Fig. 3 presents a cross-section view of the implant shown in

Fig. 1 in a A-A line according to Fig. 2.

Fig. 4 presents a three-dimensional picture of the implant

(when free) with transversal elements made in the form of fixing ring angularly related to the longitudinal central axis of the scaffold and in the form of fixing arches (in combination) .

Fig. 5 presents an elevational view of the implant shown in Fig. 4.

Fig. 6 presents a cross-section view of the implant shown in Fig. in a B-B line according to Fig. 5.

Fig. 7 presents a three-dimensional picture of the implant (when free) with transversal elements made in the form of fixing arches.

Fig. 8 presents an elevational view of the implant shown in Fig. 7.

Fig. 9 presents a cross-section view of the implant shown in Fig. 7 in a B-B line according to Fig. 8.

EMBODIMENT

The multipurpose vascular implant has scaffold 1 formed by elastic longitudinal elements 2 and elastic transversal elements made in the form of fixing rings 3 (Fig. 1) or fixing arches 4 (Fig. 4) . In particular, use of fixing arches 4 should facilitate functioning of the implant in vena cava inferior. Non-crossing with each other longitudinal elements 2 are connected by both ends with each other in a line of the central longitudinal axis 5 of the implant, as well as with transversal elements 3, 4 (Fig. 1, 4, 7) made of the same or different biodegradable material. Elastic transversal elements 3, 4 may be made as a unit with longitudinal elements 2 (not shown in the drawings) or located over them (not shown in the drawings) , namely, the transversal elements 3, 4 may be connected with the longitudinal elements 2 inside (Fig. 2, 5, 8) and/or outside (not shown in the drawings) the implant scaffold 1. The transversal elastic elements 3, 4 should be positioned symmetrically relative to each other and to the central longitudinal axis 5 of the implant. There may be two or more elastic transversal elements 3, 4. The transversal elastic elements should be positioned in the scaffold and connected with the longitudinal elements in such a way that the diameter of the scaffold cross section decreases uniformly (symmetrically) from the scaffold center (midpoint of the line connecting the two clips) to the clips positioned symmetrically to each other.

As to the fixing rings 3, it is preferable to use two rings because if there are more rings the filter may not fit in the introducer catheter. Inclination of the fixing rings 3 plane to the central longitudinal axis 5 of the filter is 30-90°. The fixing rings 3 may have both same (Fig. 1) or different (not shown in the drawing) inclinations. If the inclination is less than 30°, the deployment of the structure is not ensured. If the inclination is more than 90°, the compression of the filter in the catheter is not ensured. Ideally, the fixing rings 3 plane is located in the implant cross section plane to ensure compression of the filter in order to insert it in the catheter. If the angle between the rings and the longitudinal axis is 70°, the fixing rings 3 plane should divide the central longitudinal axis into equal distances between the implant clips 6 (the ends) and the rings 3. With other angles, the distance between the rings 3 is the same, but the distance between the clips 6 decreases proportionally. The more the inclination, the more the distance between the rings 3 and the clips 6. E.g., if the inclination is 70°, the ratio between the rings 3 radius and the scaffold length when free will be 1:2 (not shown in the drawings) . In any case, the ratio between the maximum distance between the two external points (a) and (b) of the scaffold 1 positioned in a line perpendicular to the central longitudinal axis 5 and the scaffold 1 length (1) (Fig. 2) when free should be 2:3 to 4:5, ideally 3:4.

To ensure elasticity of the implant structure, the fixing rings 3 are connected with the longitudinal elements 2, ideally the opposite ones (Fig. 2, 5) by at least two points, as well as each fixing arch 4 is connected with at least two longitudinal elements 2, ideally the adjacent ones (Fig. 5, 8) . This allows for parallel rotation of both clips and folding of the scaffold 1 in the catheter during manufacture.

Fixation and self-centering of the scaffold 1 in a vessel (vein) is ensured by elastic force of the implant and the vein as a result of neoepithalization starting when the implant is placed into the body. The range of pressure upon venous wall accepted for bio-degradable materials is 2 to 7 N.

The bearing surface of the self-centering scaffold 1 in the vessel (vein) is created and maintained by all elastic transversal elements 3, 4 positioned in the vessel full-width because of their position crosswise of the vessel, as well as the central part of the longitudinal elements 2 between the clips 6 forming in that area almost cylindrical surface. The longitudinal elements 2 due to their curved geometric form, elasticity of the scaffold 1 material and connection with the clips 6 are also placed full-width. Increased number of the longitudinal elements 2 increases reliability of thromboemboli filtration and fixation of the self-centering scaffold 1 in the vessel. At the same time, the scaffold 1 should not create a resistance to blood flow. In order to meet these requirements it is reasonable to ensure linear dimension d of the meshes between the elements 2 and 3, 4 in deployed working position of the scaffold of 3-6 mm. A copolymer of D,L-lactide and glycolide with molecular weight 75,000-200,000 Da with mole ratio 50.00-99.99:0.01- 50.00, a copolymer of trimethyl decarbonate and glycolide with molecular weight 75,000-200,000 Da with mole ratio 75.00- 99.99:0.01-25.00, a copolymer of D,L-lactide and glycolide with molecular weight 75,000-200,000 Da with mole ratio 0.01- 75.00:25.00-99.99, a copolymer of D,L-lactide, trimethyl decarbonate, and glycolide with molecular weight 75,000-200,000 Da with mole ratio 0.01-75.00:0.01-99.98:0.01-24.99 may be used as a material for the scaffold 1 elements possessing the abovementioned elastic properties and sufficient absorption time of 90-180 days. The specified time of the filter self- resorption in vasculature is sufficient for completion of medical and preventive procedures. In addition, the listed polymers ensure recovery of volumetric structure of the scaffold 1, previously folded in the catheter, in the vessel.

E.g., poly (lactide-D, L-glycolide) is synthetized with subsequent manufacture of the elastic longitudinal elements as follows: Polymer L-lactide (LLA) is produced by polycondensation of L - lactic acid with subsequent thermal degradation and cyclization. Glycolide (GA) is produced from glycolic acid under the same conditions. Both monomers are purified five times by recrystallization from ethyl acetate. LLA and GA are vacuum-dried at room temperature for 72 hours. The monomers and copolymers are synthetized by opening of the ring during polymerization of corresponding monomer flows with use of SnOct₂ as a catalyzer. The mole ratio remains constant and equal to 2000/1. The monomers and catalyzer are loaded into silane polymerization tube. After degassing, the tube is sealed hermetically under vacuum, then polymerization is carried out at 130° C for 72 hours. The resulted polymers are reduced by dissolution in dichloromethane and the residuals — in methanol, and then are dried under vacuum at room temperature. Then the copolymer is used to obtain elastic longitudinal and transversal elements of the desired diameter. In order to do that, the copolymer is, e.g. extruded through the drawhole with use of single screw extruder (screw diameter = 3 mm) . The screw rate is maintained at 40 rpm. The drum temperature is 150 to 170 °C. Final dimensions of the elastic longitudinal elements are 1.0 - 2.0 mm (diameter) and 12.0 mm (length).

Possibility and time of the scaffold 1 material degradation in blood depend on the structure, morphology, and molecular weight of the copolymers.

Since most of enzyme-catalytic reactions take course in aqueous medium, the hydrophilic-hydrophobic nature of bonds in synthetic polymers markedly affects their bio-degradability. The present polymers and copolymer containing both hydrophilic and hydrophobic segments demonstrate higher bio-degradability compared to those containing only hydrophobic or only hydrophilic segment. As a result, degradation of the polymers starts as soon as they enter vasculature due to hydrolysis.

Synthetic bio-degradable polymers contain hydrolysable bonds along the full length of the polymeric chain. E.g. such bonds as amide, ether, carbonate, carbomide, and urethane bonds are susceptible to bio-degradation by microorganisms and hydrolytic enzymes. Thus during polymer degradation smaller parts of the material are taken up by neutrophillic granulocytes and monocytes possessing phagocytic activity, and the polymer undergoes hydrolytic dissolution by their enzymes.

Bio-degradation in biological environment, cells, tissues, and intercellular fluid differs from chemical degradation because the process involves enzymes and biological reagents present in cellular organelles and fluids. Crystalline regions degrade much faster under the action of enzymes than upon hydrolysis. Transverse dimension of crystallites markedly influences the degradation rate because due to the packing specificity degradation takes place exactly at the edge of the crystallite. Smaller transverse dimension results in larger surface of crystallite edges within the whole polymer volume and therefore leads to higher degradation rate.

Molecular weight affects hydrolysis rate because of constrained water access to high molecular weight polymeric materials.

Manufacture of the implant structure is performed by injection molding and subsequent welding of free ends of the longitudinal and/or transverse elements or with use of a 3D printer based on the abovementioned polymers. If a 3D printer is used, the structure is cleaned of the support material manually. The dimensions of longitudinal and transverse elements are 0.5 - 1.5 mm and more (diameter). Then the implant is inserted in 15 F (French) introducer catheter and the assembled device is sterilized. After sterilization, the device is packed in a sterile package.

Implantation of the multipurpose vascular implant is performed after diagnostic examination revealed pulmonary artery thromboembolism or floating thrombus of vena cava inferior, lower extremity deep veins, iliac or femoral veins, as well as in patients with recurrent pulmonary artery thromboembolism with undetected origin of the recurrence.

The implant is equipped by pusher catheter (not shown in the drawings) with radiopaque markers. The scaffold 1 is implanted under fluoroscopic control into vena cava inferior with catheter cap (not shown in the drawings) lumen down. The device may be implanted through any access, e.g. percutaneous catheterization of subclavicular, right internal jugular or femoral vein.

During pushing through the catheter the implant is compressed. After vena cava inferior is reached, the implant is advanced by the pusher (not shown in the drawings) through the cap lumen into vasculature where it deploys to have volumetric configuration, the longitudinal and transversal elements are positioned full-width within venous walls, and the scaffold is self-centering. Upon scaffold deployment in a vein the position of transversal elements may differ from the preferential one, in cross section plane, for up to a 30°, which has almost no effect on elasticity, volumetric configuration and self- centering of the scaffold. After placement of the scaffold 1 in a vein the catheter is removed. The scaffold 1 is reliably fixing and self-centering in a vessel because of increased and safe venous wall contact area. The increased vein contact area prevents possible perforation of vascular wall and adjacent organs and resulting bleeding. Experiments have shown that the implant scaffold 1 is not displaceable by blood flow and its position requires no adjustment. The implant scaffold maintains elastic properties, self-centering and appropriate fixation in small and large vessels, and reliable blood filtration. The self-resorbable implant has no metallic details of the scaffold 1 as it does not require use of robust hooks, loops, etc. required in the prototype to remove the filter after completion of the treatment; as a result, there is an increase both in safety of the present implant and scope of its use. Because of its new design, the multipurpose implant may be used, for example, as a stent in nutcracker syndrome when vein is compressed by an artery. Currently, nitinol venous stents are used to treat this disease.

The implant starts to lose its structure upon dissolution in 90-180 days after placement in patient's body. The clips dissolve first, then the filter changes to the stent form. Then the longitudinal elements start to dissolve, upon that they do not migrate in the blood flow, as during functioning in a vein these parts of the device epithelize. After that the vein recovers to the original state. Throughout resorption, the filter preserves its self-centering properties as it fuses with the vessel.

The present multipurpose vascular implant may be produced on the available equipment with use of medical grade materials. E.g. well-known manufacturers of polyglycolide-lactide surgical material: a) medical company Sitek Service LLC, Moscow produces the material under its own trade mark SITEK MED; PGLA synthetic resorbable sterile surgical material with elastic properties; PGLA fibers have antigenic and pyrogenic properties and upon dissolution cause mild tissue reaction. After implantation into tissues, the PGLA fibers lose 40% of the initial strength in two weeks, complete tissue absorption occurs in 90 days; b) production and technical organization MEDTECHNICA, Tatarstan, Kazan produces suture material with use of imported raw materials from UK, Germany, Korea, particularly polyglycolide lactide (PGLA) .

The present invention is not limited by the described embodiments, but vice versa covers different modifications and options within spirit and scope of the present claim.

Claims

1. Multipurpose vascular implant with scaffold formed by an assembly of non-crossing with each other longitudinal elements made of bio-degradable material, whose ends on one side are joined together at one point and at least by two transversal elements made of bio-degradable material, characterized in that the transversal elements are made elastic, which enables contact at least between the central part of each longitudinal element and the internal surface of vascular lumen sufficient for self-centering of the implant scaffold within the vessel, from when it is placed in vascular lumen until it is completely dissolved, and the ends on the other side of longitudinal elements are also joined together at one point symmetrically to the opposite ends, at that the longitudinal elements are made elastic as well.

2. Multipurpose vascular implant according to claim 1, characterized in that the ratio between maximum distance between two external points of the scaffold aligned perpendicularly to the central longitudinal axis of the implant and the length of the implant when free is 2:3 to 4:5, ideally 3:4.

3. Multipurpose vascular implant according to claim 1, characterized in that the transversal elements are made as a unit with longitudinal elements.

4. Multipurpose vascular implant according to claim 1, characterized in that the transversal elements are located over the longitudinal elements.

5. Multipurpose vascular implant according to claim 1, characterized in that the transversal elements are connected with the longitudinal elements inside and/or outside the scaffold.

6. Multipurpose vascular implant according to claim 1, characterized in that transversal elastic elements are positioned symmetrically relative to each other and to the central longitudinal axis of the filter.

7. Multipurpose vascular implant according to claim 1, characterized in that the transversal elastic elements comprise fixing rings, each of which is connected with the longitudinal scaffold elements at at least two points.

8. Multipurpose vascular implant according to claim 7, characterized in that inclination of the ring plane to the central longitudinal axis of the implant is 30° to 90°.

9. Multipurpose vascular implant according to claim 1, characterized in that the transversal elastic elements comprise fixing arches, each of which is connected with at least two longitudinal elements.

10. Multipurpose vascular implant according to claim 1, characterized in that the elastic longitudinal elements, or elastic transversal elements, or elastic longitudinal and transversal elements are made of the same bio-degradable material.

11. Multipurpose vascular implant according to claim 1, characterized in that the elastic longitudinal elements, or elastic transversal elements, or elastic longitudinal and transversal elements are made of different bio-degradable materials .

12. Multipurpose vascular implant according to claim 1, characterized in that copolymer of D,L-lactide and glycolide with molecular weight 75,000-200,000 Da with mole ratio 50.00- 99.99:0.01-50.00 is used as a bio-degradable material.

13. Multipurpose vascular implant according to claim 1, characterized in that copolymer of trimethyl decarbonate and glycolide with molecular weight 75,000-200,000 Da with mole ratio 75.00-99.99:0.01-25.00 is used as a bio-degradable material .

14. Multipurpose vascular implant according to claim 1, characterized in that copolymer of D,L-lactide and glycolide with molecular weight 75,000-200,000 Da with mole ratio 0.01- 75.00:25.00-99.99 is used as a bio-degradable material.

15. Multipurpose vascular implant according to claim 1, characterized in that copolymer of D,L-lactide, trimethyl decarbonate, and glycolide with molecular weight 75,000-200,000 Da with mole ratio 0.01-75.00:0.01-99.98:0.01-24.99 is used as a bio-degradable material.