WO2011140973A1

WO2011140973A1 - Visualization marker capable of making polymeric stent clearly visible under x-ray

Info

Publication number: WO2011140973A1
Application number: PCT/CN2011/073894
Authority: WO
Inventors: 谢建; 魏征
Original assignee: 上海微特生物技术有限公司
Priority date: 2010-05-10
Filing date: 2011-05-10
Publication date: 2011-11-17
Also published as: CN202027751U

Abstract

A visualization marker capable of making a polymer stent clearly visible under X-ray is made of a marker body (1), and the material of the marker body (1) is gold, titanium, or platinum for medical use etc. The metallic marker body (1) is embedded in a prepared hole (3) of the stent from the outer surface of the polymer stent (2) in a manual manner, and at the side of the marker body (1) on the outer surface of the prepared hole (3) is formed a visualization marker (4) that is larger than the diameter of the outer surface of the prepared hole and protrudes from the outer surface of the stent, to form a "T" shaped marker(5) which is secured firmly in the prepared hole. The other side of the "T" shaped marker (5) does not protrude from the inner surface of the stent. After planting the stent, the marker is clamped firmly between the stent and the wall of blood vessel, so the marker can withstand long-term blood vessel movement and blood flow impaction but not fall off. The visualization marker has good visualization effect, and is safe for human body.

Description

Development marking for enabling polymer stents to be clearly visible under X-rays

The utility model relates to a development mark which can make a polymer stent clearly visible under X-rays, and belongs to the field of medical instruments. technical background

Minimally invasive placement of vascular stents is widely used as an effective intervention technique for the treatment of vascular stenosis. However, long-term retention of metal stents in blood vessels can cause chronic damage of blood vessels, which can cause atrophy of the middle layer of blood vessels and formation of aneurysms. And reactive intimal hyperplasia, ultimately leading to the occurrence of vascular restenosis (Rab ST, KiHgsB, Roubin GS, et al. Coronary aneurysms after stent Placement: a suggestion of altered vessel wall healing in the Presence of anti-inflammatory agents. J Am Coll Cardiol 1991, 18:1524). Since the stent is implanted into the blood vessel, it mainly plays a role in mechanical support of the blood vessel within a certain time of injury healing (for a coronary stent generally within half a year), so the ideal vascular stent should be given sufficient mechanical support and healing in the lesion segment. It is then gradually absorbed by the body (Colombo A, Karvouni E. Biodegradable stents: "fulilling the mission and stepping away". Circulation, 2000, 102: 371-373).

In recent years, many research institutes and vascular stent manufacturers have attempted to develop new biodegradable vascular stents. It is hoped that this stent can temporarily support the vessel wall, maintain vascular patency, and inhibit early thrombosis and advanced neointimal hyperplasia. It can also be used as a carrier for local drug delivery, effectively preventing the acute occlusion of the blood vessel after stent implantation and reducing the incidence of restenosis.

At present, biodegradable polymer scaffold materials that can be completely absorbed by the human body are all polymer plastic materials. The materials used for biodegradable vascular scaffolds are polylactic acid (PL), L-polylactic acid (PLLA or LP). LA) Polyglycolic acid/polylactic acid (PGLA), polycaprolactone (PCL), polyhydroxylbutyrate valerate (PHBV), polyacetylglutamic acid , PAGA), polyorthoesters (POE) and polyethylene oxide/polybutylene terephthalate (PEO/PBTP).

Unlike metal stents, transparent plastic-based stents evade X-ray detection during medical procedures and patient visits, making development difficult. Therefore, the difficulty of safely and accurately placing the stent in the lesion site during surgery is greatly increased, and the surgical failure rate is increased. Moreover, postoperative observation is difficult and cannot provide direct treatment and reoperation for different patients. in accordance with.

At present, many studies have done research on improving the imaging ability of various interventional stents under X-ray.

Patent 200620158386. X describes a method for increasing the development of a stent by coating a developing film with gold and silver powder on both ends of the stent. The adhesion of the coated developing film to the stent substrate may be due to the matrix material. Different and different. A developing film having poor adhesion has a great risk of falling off during and after implantation, resulting in an acute thrombus. Moreover, for a stent to which a drug coating is originally applied, a developing film having a different coating composition at both ends may cause an artificial coating unevenness, posing a risk to the treatment.

Patent 200920095643. 3 Describes a metal bracket using a two-layer material. The double-layer material has a thick wall, is difficult to manufacture and subsequent processing, is expensive, and can only be applied to a bracket of a metal matrix material.

It can be seen that there are still many defects in the development technique of the interventional stent, and no reports on the development technology of the degradable polymer stent have been reported.

The utility model aims to find a channel which is safely applied to the development of a degradable polymer stent. Utility model content

It is an object of the present invention to provide a development mark that can be safely applied to a degradable polymer scaffold.

This and other objects of the present invention will be further embodied and elucidated by the following detailed description and description. A development mark capable of making a polymer stent clearly visible under X-rays, wherein a reserved hole (3) is disposed on the polymer support (2), and a mark body (1) is embedded in the reserved hole (3). Forming a "T" mark (5), the mark (1) is a development mark (4) on the outer surface of the reserved hole (3), and the mark (1) does not protrude on the inner surface of the support at the other end of the reserved hole (3) . This radiopaque marker can be applied to any polymer stent to improve the development of X-rays.

The radiopaque marker capable of developing the polymer stent is to be embedded in the polymer holder to be embedded in the reserved hole (3). According to the length and diameter of the different brackets, any part of the bracket can be selected as needed. As the reserved hole position point and the number of reserved holes, the connecting ribs at both ends of the bracket are generally selected as the set points of the reserved holes. The shape of the reserved hole may be any suitable shape such as a circle, a plum shape, a star shape, a cross shape, a hexagon shape, or the like. The size of the outer hole of the bracket is between 0. 18~0. 24mm, and the diameter of the inner surface of the bracket is not larger than the diameter of the outer surface of the reserved hole.

〜1〜1〜1〜1〜1〜1〜1〜1 0毫米之间。 The diameter of the outer surface of the stent is 0. 01mm. Gold (or titanium, platinum, etc.) has minimal tensile strength and good ductility, and has good oxidation resistance. At the same time, this kind of precious metal has good biocompatibility and has been widely used for filling teeth and manufacturing human implants. A good material for radiopaque development marks. Thanks to the good ductility of the material, the metal pellets can be easily pressed into the reserved holes of the polymer holder, and the wells are well matched with the reserved holes, and the marking points are firm.

Further, the radiopaque marker capable of developing the polymer stent is to embed the marker body (1) from the outer surface of the polymer stent (2) into the bracket reserved hole (3), and to reserve the hole a developing mark (4) having a larger diameter than the outer surface of the reserved hole is formed on one side of the outer surface of the support, and the developing mark (4) is protruded from the outer surface 0. 01 0. 05 preferably 0. 03 The entire metal ball forms a metal "T" mark (5 ) Tightly fixed in the reserved hole, the other end of the "T" mark (5) does not protrude from the inner surface of the bracket (6). This design ensures that the outer surface of the stent is tightly attached to the inner wall of the blood vessel after implantation, and the marker is tightly sandwiched between the stent and the blood vessel wall, and can withstand long-term vasoconstriction and blood flow impact without falling off. After endothelialization, the whole stent is wrapped in the blood vessel wall by the new tissue. Over time, the degradable stent is completely absorbed, and the metal marker with excellent compatibility will be completely wrapped in the vessel wall. The blood flow is blocked.

The utility model can be used for X-ray development of any polymer-based stent, including but not limited to the above-mentioned polylactic acid (PLA), L-polylactic acid (PLLA or LPLA), Polyglycolic acid/polylactic acid (PGLA), polycaprolactone (PCL), polyhydroxylbutyrate valerate (PHBV), polyacetylglutamic acid (polyhydroxylbutyrate valerate, PHBV) Polyacetylglutamic acid, PLGA), polyorthoesters (POE) and polyethylene oxide/polybutylene terephthalate (PE0/PBTP). DRAWINGS

Figure 1 is a plan view showing the outer surface of the bracket connecting rib after a circular reserved hole is provided.

Figure 2 is a side view of the metal ball placed on the reserved hole of the bracket before being buried.

Figure 3 is a side view of the marker position bracket after the metal pellet is buried in the reserved hole.

Figure 4 is a top plan view of the outer surface of the marker position after the metal pellet is buried in the reserved hole.

Fig. 5 is a schematic view showing the shape of a "rivet" formed after the metal ball is buried in the reserved hole.

Figure 6 is a cross-sectional side view of the marker position bracket after the metal ball is buried in the reserved hole.

Fig. 7 is a plan view showing the outer surface of the bracket connecting rib after setting a plum-shaped reserved hole.

Fig. 8 is a plan view showing the outer surface of the bracket connecting rib after the provision of a cross-shaped reserved hole.

Figure 9 is a top plan view of the outer surface of the bracket connecting rib after setting a star-shaped reserved hole.

Fig. 10 is a plan view showing the outer surface of the bracket connecting rib after the hexagonal reserved hole is provided. detailed description

Referring to Figures 1-6, the present invention provides a development mark that enables a polymer stent to be clearly visible under X-rays. The recording body is a medical pure gold material, and the pure gold ball (1) is manually pressed into the reserved hole (3) of the polymer support by the outer surface of the polymer support (2), and a diameter larger than the reserved hole of the polymer is formed on the outer surface. The diameter, the mark of the shape of the development mark (4) that protrudes from the outer surface. The pure gold ball pressed into the reserved hole forms a "T" mark (5) under the action of an external force, and is firmly fixed in the reserved hole (3) of the polymer. The bracket material is PGLA, and the reserved holes are arranged on the connecting ribs at both ends of the bracket, which are round holes, and the reserved holes at both ends (3) are center-symmetrical, the size is 0.22 mm, and the diameter of the pure gold ball is 0.23 mm. After the pure gold ball (1) is pressed into the reserved hole (3), a development mark (4) larger than the outer surface diameter of the reserved hole is formed on the outer surface of the reserved hole holder, and the development mark (4) protrudes from the outer surface 0.03. The metal ball forms a pure gold "T" mark (5) that is tightly fixed in the reserved hole, and the other end of the "T" mark (5) does not protrude from the inner surface of the bracket (6).

Claims

Claim

A development mark capable of making a polymer support clearly visible under X-rays, characterized in that a reserved hole (3) is provided on the polymer support (2), and a metal mark is embedded in the reserved hole (3) The body (1) forms a "T" mark (5), the mark body (1) remains in the reserved hole (3), the outer surface portion is a development mark (4), and the mark body (1) is at a reserved hole (3) The inner portion does not protrude from the inner surface of the bracket.

2. The development mark according to claim 1, wherein the support hole (3) is disposed on the connecting rib at both ends of the support, and is a round hole. Or plum blossom holes or stars or crosses or hexagons.

3. The development mark according to claim 1 or 2, wherein the polymer support is clearly visible under X-rays, wherein the size of the support hole (3) is set according to a set point width. Its diameter is 0.18~0.24mm, and the diameter of the inner surface of the bracket is not larger than the diameter of the outer surface of the reserved hole.

4. The development mark according to claim 1, wherein the mark body (1) has a diameter of 0.19 to 0.25 mm, and the reserved hole is on the outer surface of the holder. A small ball with a diameter of 0.01 mm.

5. The development mark according to claim 1, wherein the development mark (4) protrudes from the outer surface by 0.01 to 0.05 mm, preferably 0.03 mm, and has a diameter. It is larger than the outer surface diameter of the reserved hole.

6. The development mark according to claim 1, wherein the mark (1) material is medical gold or titanium or platinum.