KR101489265B1 - Polymieric stent kit and method for manufacturing thereof - Google Patents

Abstract

The present invention relates to a polymer stent kit and a manufacturing method thereof and, more specifically, a blood vessel-inserted prosthesis, which is inserted in a blood vessel and is polymer, and a manufacturing method thereof. In the present invention, provided is a polymer stent kit, comprising a balloon; a polymer stent which is installed on the circumference of the balloon; and a cyclic-shaped metal member which is located on the circumference of the balloon and is formed on one end part or both end parts in a lengthwise direction of the polymer stent. According to the present invention, the position of the polymer stent inserted in the human body can be easily found by using radiation.

Description

[0001] POLYMERIC STENT KIT AND METHOD FOR MANUFACTURING THEREOF [0002]

The present invention relates to a polymer stent kit and a method of manufacturing a polymer stent kit, and more particularly, to a method of manufacturing a polymer stent kit and a polymer stent kit.

In general, stents are expandable medical prostheses and are used in body vessels for a variety of medical applications.

Examples include intravascular stents for the treatment of stenoses, urinary, biliary, tracheobronchial, oesophageal, renal tracts, There are stents to maintain the opening of the vein (inferior vena cava).

Typically, the stent is transported through a body tube to a treatment site using a transport device that maintains the stent in a compressed state.

In percutaneous transluminal angioplasty, an implantable endoprosthesis, i.e., a stent, is introduced through a delivery device and delivered to a treatment site through vessel conduits. After the stent approaches the treatment position, the stent is mechanically inflated with the aid of an inflatable balloon and inflated inside the tube. The transport device is then retreated from the stent and removed from the patient. The stent is within the tube of the treatment site as an implant.

Korean Patent No. 1231197

The present invention relates to a polymer stent kit and a method for manufacturing a polymer stent kit, and a method of manufacturing a polymer intraluminal implant and a method for manufacturing the same.

The present disclosure relates to balloons;

A polymer stent provided around the balloon; And

And an annular metal member located around the balloon and provided at one end or both end portions in the length direction of the polymer stent.

Further, the present specification provides a transportation device including the kit of the polymer stent.

The present invention also relates to a method of manufacturing a polymer stent implanted in a body,

Providing a polymeric stent around the balloon; And positioning the annular metal member around one end or both ends of the polymer stent in the longitudinal direction of the balloon.

One embodiment of the present invention is advantageous in that it is easy to grasp the position of the polymer stent implanted in the body by radiation.

One embodiment of the present disclosure has the advantage that the marker for locating the polymer stent is not detached from the polymer stent.

One embodiment of the present invention is advantageous in that an adhesive or melting process using an adhesive is not required when installing a marker for locating the polymer stent.

One embodiment of the present disclosure has the advantage that when the polymer stent is inflated due to inflation of the balloon, the mid-segment expansion of the polymer stent is first expanded in the longitudinal direction of the polymer stent.

The provision of the annular metal member at the end of the polymer stent in one embodiment of the present invention allows the polymer stent to inflate due to the inflation of the balloon so that both ends of the polymer stent are first inflated in the longitudinal direction of the polymer stent, bone inflation) can be prevented.

FIG. 1 is a state in which a radiation marker provided in a polymer stent is conventionally performed.
2 shows an embodiment of a pattern of a polymer stent according to the present invention.
3 is a view showing the strut width of the polymer stent.
4 shows one embodiment of a polymeric stent kit according to the present disclosure.
5 shows an embodiment of an annular metal member according to the present invention.

Hereinafter, the present invention will be described in detail.

The present disclosure relates to balloons; A polymer stent provided around the balloon; And an annular metal member located around the balloon and provided at one end or both end portions in the length direction of the polymer stent.

In this specification, a balloon means that a liquid, a gel or a gas is injected into an airtight bag to expand, and the liquid, gel or gas inside can be discharged and contracted. The balloon may be in the form of a rod or tubular shape so that the balloon may surround the polymer stent and the annular metal member. When the form of the balloon is rod-shaped or tubular, the balloon may be called a balloon catheter.

The material of the polymer stent may include a biodegradable polymer.

The biodegradable polymer is not particularly limited as long as it is a polymer capable of decomposing in the body.

For example, the biodegradable polymer may be a synthetic biodegradable polymer or a natural biodegradable polymer.

Examples of the synthetic biodegradable polymer include polyglycolide, polylactic acid, poly p-dioxanone, polycaprolactone, trimethylene carbonate, polyhydroxyalkanoate, But are not limited to, polyhydroxyalkanoates, polypropylene fumarates, polyortho esters, other polyesters, polyanhydrides, polyphosphazenes, Acrylate, poloxamers, and polyamino L-tyrosine, or a copolymer thereof, or a mixture thereof.

The natural biodegradable polymer may be one selected from the group consisting of polysaccharides modified polysaccharides, oxidized cellulose, gelatin, and collagen, or a mixture of one or more thereof.

When the polymer stent of the present invention is made of a biodegradable polymer, it is present inside the body of the treatment site, and after a certain time, it can be decomposed naturally. At this time, the decomposition time of the polymer stent of the present invention may be about 6 months to 3 years.

The polymer stent has a pattern formed therein, the engraved portion of the pattern penetrating the outer circumferential surface of the polymer stent, and the shape of the polymer stent can be maintained by the embossed portion of the pattern. Specifically, when one side of the embossed portion is referred to as a strut, a polymeric stent can be connected to a plurality of struts to maintain the shape of the polymeric stent.

The annular metal member may be provided at one end or both ends of the polymer stent in the longitudinal direction of the polymer stent. That is, one annular metal member may be provided at one end of the polymer stent, or two annular metal members may be provided at both ends of the polymer stent.

The annular metal member may be provided at the end of the polymer stent and may be compressed or deployed together when the polymer stent is compressed or deployed.

In the present specification, the annular shape refers to a shape in which the metal is bent so that both ends are in contact with each other. The above-mentioned annular type is merely an explanation of the form, and is not limited to a form in which both ends are bent and joined together. For example, the annulus of the present specification may actually be formed by bending and joining both ends, by laser processing, by stamping with a mold, or by melt extrusion.

The annular metal member may be formed in a pattern. In this case, the pattern is not particularly limited as long as it is provided at the end of the polymer stent and can be compressed or expanded together when the polymer stent is compressed or expanded.

In one embodiment of the present disclosure, the annular metal member may be the example shown in Fig. 5 (a) shows a zigzag ring-shaped metal member capable of shrinking and transferring together with the polymer stent, and FIG. 5 (b) shows a ring-shaped metal member having the same pattern as that of the polymer stent.

The pattern formed on the annular metal member may be the same as or different from the pattern formed on the polymer stent.

In this specification, when the pattern formed on the annular metal member is the same as the pattern formed on the polymer stent, it means that the repeating unit of the pattern formed on the annular metal member is the same as the repeating unit of the pattern formed on the polymer stent.

In the present specification, when the pattern is formed on the annular metal member provided at the end of the polymer stent, the pattern of the polymer stent and the pattern of the annular metal member may be connected to each other.

The pattern formed on the annular metal member may be at least 40% identical to the polymer stent.

In the present specification, the pattern of the polymer stent and the pattern of the annular metal member are not particularly limited as long as they are patterns that can be compressed or developed.

For example, the pattern of the polymer stent and the pattern of the annular metal member may each comprise a W-closed or V-closed shape.

Specifically, the pattern of the polymer stent and the pattern of the annular metal member are,

A unit cell having a shape of a V-shaped closed shape, the unit cell having a first hinge portion bent toward the inside of the unit cell and a second hinge portion facing the first hinge portion and bent outward of the unit cell; And a linker portion extending outward from the bent portion of the second hinge portion;

The repeating units are disposed such that the ends of the linker portions of any one of the repeating units are connected to the bent portions of the first hinge portion of another adjacent repeating unit,

The end of the first hinge portion and the end of the second hinge portion of any one of the repeating units may be connected to the end of the first hinge portion and the end of the second hinge portion, respectively, of another adjacent repeating unit.

According to one embodiment of the present invention, as shown in FIG. 2, the pattern is a unit cell 110 having a shape of a V-shaped closed shape, and includes a first hinge part 200 bent toward the inside of the unit cell, A unit cell (110) facing the first hinge unit and having a second hinge unit (250) bent to the outside of the unit cell; And

And a linker unit 130 extending outward from the bent portion of the second hinge unit.

The internal angle of the second hinge portion may be 90 [deg.] Or more and 160 [deg.] Or less.

The area of the repeating unit may be 1 mm ² or more and 7 mm ² or less. At this time, the area of the repeating unit means the width of the area occupied by one unit cell and its linker unit.

Wherein the repeating unit includes a strut of a unit cell, which is a line constituting a V-shaped closed diagram of the unit cell, and a strut which is a line constituting the linker unit, wherein in the polymer stent, And the area of the strut of the linker portion may be 5% or more and 40% or less. Here, the area of the repeating unit means the area of one unit cell and the area of the linker part thereof, and the area of the strut of one unit cell and the area of the strut of the ringer part means the area occupied by the lines of each strut.

All edges and ends of any one of the repeating units in the pattern are connected to edges and ends of other adjacent repeating units. That is, the repeating unit in the polymer stent does not have unconnected edges or ends.

Since the polymer stent has no unconnected edges or ends, the polymer stent has a relatively higher mechanical strength than a polymer stent formed of struts of the same width.

In the present specification, the annular metal member may be a metal stent.

In this specification, the annular metal member can be placed at the end of the polymeric stent and compressed and deployed with the polymeric stent without an adhesive or welding process. In this case, there is no need for an adhesive which can be harmful to the human body, and there is an advantage that the process is simplified since no separate bonding or welding process is required.

The material of the annular metal member is not particularly limited as long as it is a metal that is harmless to the human body while reflecting radiation.

For example, the material of the annular metal member may be at least selected from tantalum, cobalt, chromium, iridium, platinum, gold and silver. One metal or two or more alloys.

The polymer stent is generally a radiolucent that transmits radiation.

Generally, when the stent is inserted and is present in the body tube, the body is irradiated with X-ray or the like to find out the position of the polymer stent. However, since the polymer stent is generally a radiolucent that transmits radiation, it can not be grasped by radiation.

Thus, a radiomaker comprising a radiopaque material that reflects radiation to at least one strut of the polymeric stent is attached or fused. As shown in FIG. 1, at least one of the struts 1 of the polymer stent 10 may be attached or fused with a radiation marker 2 comprising a radiopharmaceutical material.

The radiation markers are likely to fall off due to defective junctions during the crimping or inflation of the polymer stent. In this case, there is a risk that an embolization or the like may be formed.

In addition, biocompatibility of the adhesive may be a problem when the radiation marker is attached to the polymer stent with an adhesive.

In the meantime, when the polymer stent having the annular metal member of the present specification is inserted into the body tube, the annular metal member can serve as a radiation marker because it is a radial element that reflects radiation. At this time, since the annular metal member is provided so as to be able to be compressed and deployed together with the polymer stent, there is little or no possibility that the polymer stent is separated from the polymer stent during compression or expansion of the polymer stent.

The outer diameter of the annular metal member may be 0.7 times or more and 1.3 times or less the outer diameter of the polymer stent.

In the present specification, the outer diameter of the annular metal member may be the same as the outer diameter of the polymer stent.

In this specification, the outer diameter of the annular metal member may be larger than the outer diameter of the polymer stent. In this case, the outer diameter of the annular metal member may be 1.1 times or more and 1.3 times or less the outer diameter of the polymer stent.

When the outer diameter of the annular metal member is larger than the outer diameter of the polymer stent, the ends of the polymer stent may be fitted and connected to the annular metal member.

In the present specification, the outer diameter of the annular metal member may be smaller than the outer diameter of the polymer stent. In this case, the outer diameter of the annular metal member may be 0.7 times or more and 0.9 times or less of the outer diameter of the polymer stent. When the outer diameter of the annular metal member is smaller than the outer diameter of the polymer stent, the balloon catheter can easily go toward the treatment position along the blood vessel, and when the polymer stent is inflated due to inflation of the balloon, Bone inflation in both ends of the polymer stent can be prevented.

The outer diameter of the polymer stent and the annular metal member may be 1 mm or more and 8 mm or less, respectively.

In one embodiment of the present invention, the outer diameter of the polymer stent and the annular metal member may be 1 mm or more and 1.8 mm or less, respectively. At this time, the polymer stent kit is in a state in which a balloon is inserted into the polymeric stent and the annular metal member provided in the longitudinal direction of the polymer stent and compressed to an outer diameter of 1 mm or more and 1.8 mm or less.

The line width of the annular metal member may be equal to the width of the strut of the polymeric stent or may be less than the width of the strut of the polymeric stent.

The line width of the annular metal member and the strut width of the polymer stent may be 40 μm or more and 200 μm or less, respectively.

In this case, the line width of the annular metal member and the strut width of the polymer stent mean the thickness (3) of the pattern on the circumferential surface as shown in FIG.

The ratio of the sum of the length of the polymer stent and the length of the annular metal member may be 1: 0.001 or more and 1: 0.5 or less. Specifically, it may be 1: 0.001 or more and 1: 0.3 or less.

The polymer stent may have a length of 10 mm or more and 40 mm or less.

The sum of the lengths of the annular metal members may be 0.1 mm or more and 10 mm or less.

In the present specification, the length of the annular metal member means A shown in Fig. 4, the length of the polymer stent means B shown in Fig. 4, and the lengths of the two or more annular metal members are equal to each other Or may be different.

One embodiment of the present invention is advantageous in that it is easy to grasp the position of the polymer stent implanted in the body by radiation.

One embodiment of the present disclosure has the advantage that the annular metal member, which is a marker for locating the polymer stent, is not detached from the polymer stent.

One embodiment of the present invention is advantageous in that an adhesive or melting process using an adhesive is not required when installing a marker for locating the polymer stent.

One embodiment of the present disclosure has the advantage that when the polymer stent is inflated due to inflation of the balloon, the mid-segment expansion of the polymer stent is first expanded in the longitudinal direction of the polymer stent.

The provision of the annular metal member at the end of the polymer stent in one embodiment of the present invention allows the polymer stent to inflate due to the inflation of the balloon so that both ends of the polymer stent are first inflated in the longitudinal direction of the polymer stent, bone inflation) can be prevented.

The apparatus may further include a housing having the polymer stent, the annular metal member, and the balloon.

Generally, after the compressed polymeric stent has been placed in a treatment position using a transporter, the polymeric stent is moved away from the transport device and the outer diameter of the polymeric stent is expanded by the inner diameter of the vessel at the treatment site. When the polymeric stent is expanded as described above, the end portion of the polymeric stent relatively receives a force for expanding the polymeric stent.

Since the polymer stent kit of the present disclosure is provided with the annular metal member that can be expanded together with the polymer stent located at the end of the polymer stent, when the polymer stent is expanded, the force applied to the end portion of the stent becomes the annular metal So that the polymer stent kit can be stably positioned in the body tube.

The present disclosure provides a transport device comprising the polymeric stent kit.

A balloon is inserted into the inside of the transportation device to store the polymer stent and the annular metal member in a compressed state, and the stent is transported to the treatment position through a body tube.

The present invention relates to a method of manufacturing a polymer stent implanted in a body,

Providing a polymeric stent around the balloon; And positioning the annular metal member around one end or both ends of the polymer stent in the longitudinal direction of the balloon.

Here, the description of the polymer stent and the annular metal member is the same as described above.

In the present specification, the step of positioning the annular metal member may be a step of locating the annular metal member on the outer surface of the balloon in the longitudinal direction adjacent to the end of the polymer stent. In this case, it may be that the annular metal member is compressed and deployed together in a compression process described below without attaching the annular metal member to the end portion of the polymer stent such as an adhesion process or a fusion process.

The present disclosure relates to a method of fixing an annular metal member to an end of a polymeric stent by means of a heated crimping head when the polymeric stent is compressed on the outer surface of the balloon, .

The present specification discloses that when a polymeric stent is compressed on the outer surface of a balloon, the polymeric stent is compressed into the annular metal member or the annular metal member is fitted into the polymeric stent without a separate step for connecting the annular metal member only An annular metal member may be secured to the end of the polymeric stent.

In the present specification, the method may further include forming a pattern on the polymer stent before or after the step of positioning the annular metal member.

In the present specification, the step of placing the annular metal member may further include forming a pattern on the polymer stent and the annular metal member provided at the end of the polymer stent.

In the step of forming the pattern on the polymer stent, a pattern may be formed on the polymer tube by using a laser.

In the step of forming the pattern on the annular metal member, a pattern may be formed on the metal tube by using a laser.

Preparing a polymer tube by extruding the molten polymer before forming a pattern on the polymer stent; And expanding the diameter of the extruded polymer tube.

The method may further include the step of pouring molten metal into a metal mold to form a metal tube before forming the pattern on the annular metal member.

And applying a composition for preventing vascular restenosis to the surface of the polymer stent having the annular metal member.

The method of applying the composition for preventing vascular restenosis on the surface of the polymer stent having the annular metal member is not particularly limited, and for example, the composition can be applied using an ultrasonic coater.

The composition for preventing vascular restenosis may be applied to some or all of the surfaces of the polymer stent having the annular metal member.

The composition for preventing vascular restenosis may be applied to at least the outer surface or the inner surface of the surface of the polymer stent having the annular metal member.

The composition for preventing vascular restenosis can be applied to all surfaces of the surface of a polymeric stent provided with an annular metal member.

The composition for preventing vascular restenosis is not particularly limited as long as it contains a compound capable of preventing vascular restenosis.

For example, the composition for preventing vascular restenosis may include a rapamycin-based compound. For example, the rapamycin compound may be Sirolimus, Everolimus, Biolimus, and Zotarolimus.

In one embodiment of the present disclosure, the composition for preventing vascular restenosis comprises at least one selected from the group consisting of Sirolimus, Everolimus, Biolimus and Zotarolimus .

The composition for preventing vascular restenosis may further comprise a polymer and a solvent.

The polymer is not particularly limited as long as it can impart adhesiveness to the surface of the polymer stent having the annular metal member.

The polymer may be the same as or similar to the polymer constituting the polymer stent. For example, when the material of the polymer stent includes a polylactic acid-based polymer, the polymer included in the composition for preventing vascular restenosis may include a polylactic acid-based polymer.

The solvent is not particularly limited and may be selected from those used in the art. For example, the solvent may include one or more of chloroform, acetic acid, acetone, methanol and ethanol.

The concentration of the solute excluding the solvent in the composition for preventing restenosis of blood vessels may be 0.15 wt% or more and 15 wt% or less.

And compressing the polymeric stent and the annular metal member provided at the end of the polymeric stent in the radial direction.

The compressing step compresses the polymer stent so that the cross-sectional shape of the circle of the polymer stent is maintained. Specifically, the compressing step compresses the polymeric stent having the annular metal member by applying a force in the radial direction of the polymeric stent. Here, the radial direction refers to a direction from the periphery of the circle to the center of the circle in a cross section perpendicular to the longitudinal direction of the polymer stent having the annular metal member.

The temperature of the compression step may be higher than body temperature and lower than the glass transition temperature of the polymeric stent. At this time, the body temperature may be the temperature of the intravascular blood into which the polymer stent is inserted, specifically, higher than 36 ° C and lower than 39 ° C. The glass transition temperature of the polymer stent is determined depending on the material of the polymer stent and is not particularly limited. For example, when the material of the polymer stent includes a polylactic acid-based polymer, Lt; RTI ID = 0.0 > 60 C. < / RTI >

The compressing step may compress the polymer stent having the annular metal member in all radial directions using a crimping head heated to a temperature higher than the body temperature and lower than the glass transition temperature of the polymer stent.

In the case where a balloon is inserted into the polymer stent before the compression step, the polymer stent having the compressed annular metal member is positioned at a treatment position using a transportation device, and then the polymer stent having the annular metal member With the aid of an inflatable balloon, it can be mechanically expanded inside the tube. The transport device is then separated from the polymeric stent with the annular metal member and the polymeric stent with the annular metal member is present as an implant within the body of the treatment site.

And inserting the compressed polymer stent and the annular metal member into the interior of the housing.

1: Strut 2: Radiation marker
10: polymer stent 20: balloon
30: annular metal member
110: unit cell 130: linker unit
200: first hinge part 250: second hinge part
300: repeat unit

Claims (20)

balloon;
A polymer stent provided around the balloon; And
And a metal stent disposed around the balloon and provided at one end or both ends of the polymer stent in the longitudinal direction thereof,
Wherein the repeating unit of the pattern formed on the metal stent is the same as the repeating unit of the pattern formed on the polymer stent. delete delete The method of claim 1, wherein the material of the metal stent is at least one selected from tantalum, cobalt, chromium, iridium, platinum, gold and silver. Or two or more alloys. The polymer stent kit according to claim 1, wherein the outer diameter of the metal stent is 0.7 times or more and 1.3 times or less of the outer diameter of the polymer stent. The polymer stent kit according to claim 1, wherein the polymer stent and the metal stent have outer diameters of 1 mm or more and 1.8 mm or less, respectively. The polymeric stent kit according to claim 1, wherein the line width of the metal stent is equal to or less than the width of the strut of the polymeric stent. The polymeric stent kit according to claim 1, wherein the line width of the metal stent and the strut width of the polymeric stent are each in the range of 40 탆 to 200 탆. The polymer stent kit according to claim 1, wherein the sum of the length of the polymer stent and the length of the metal stent is 1: 0.001 to 1: 0.5. The polymer stent kit according to claim 1, wherein the length of the polymer stent is 10 mm or more and 40 mm or less. The polymer stent kit according to claim 1, wherein the sum of the lengths of the metal stent is 0.1 mm or more and 10 mm or less. The kit of claim 1, further comprising a housing having the polymeric stent, the metal stent, and the balloon. A kit comprising a polymeric stent according to any one of claims 1 to 4. A method of manufacturing a polymer stent implanted in a body,
Forming a pattern in a polymeric stent and a metal stent; Providing a polymeric stent around the balloon; And positioning the metal stent at one end or both ends of the polymer stent in the longitudinal direction around the balloon,
Wherein the repeating unit of the pattern formed on the metal stent is the same as the repeating unit of the pattern formed on the polymer stent. delete delete [16] The method of claim 14, wherein the metal stent is made of at least one selected from the group consisting of tantalum, cobalt, chromium, iridium, platinum, gold, Or two or more alloys. ≪ RTI ID = 0.0 > 21. < / RTI > 15. The method of manufacturing a polymer stent kit according to claim 14, wherein the outer diameter of the metal stent is 0.7 times or more and 1.3 times or less of the outer diameter of the polymer stent. 15. The method of claim 14, further comprising compressing the polymer stent and the metal stent located at the end of the polymer stent in the radial direction. 21. The method of claim 19, further comprising inserting the compressed polymeric stent and the metal stent into the interior of the housing.

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