Completely-biodegradable support capable of developing and preparation method thereof

A complete, stent rod technology, applied in the field of medical devices, can solve the problems of easy falling off and disappearance of the coating, weak bonding strength of the stent body, etc., achieving good biocompatibility and avoiding adverse reactions.

Active Publication Date: 2013-06-26
SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method also has its disadvantages: the bonding strength with the main body of the stent is weak, and it is easy to fall off during the subsequent stent crimping and opening, resulting in poor developing effect; secondly, the dipping/spraying of the stent takes a long time to dry. Remove the solvent; moreover, the developer layer coated on the outer layer of the stent will disappear prematurely with the degradation of the material...

Method used

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  • Completely-biodegradable support capable of developing and preparation method thereof
  • Completely-biodegradable support capable of developing and preparation method thereof
  • Completely-biodegradable support capable of developing and preparation method thereof

Examples

Experimental program
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Embodiment 1

[0050] The material of the stent body in the embodiment of the present invention is biodegradable polymer material PCL (polycaprolactone), and the overall schematic diagram of the stent is as follows Figure 6 shown. A hexagonal hole is centrally arranged in the length and width directions of all connecting straight rods 1 of the bracket, wherein each connecting straight rod has a hole, such as figure 1 and Figure 7 shown. The diagonal of the hexagonal hole is about 80 μm, which is about 2 / 5 of the width of the connecting straight rod. Among them, the degradable polymer used in the protective layer is PLLA (L-polylactic acid), with a weight average molecular weight of Mw=230,000 to 250,000, which can be dissolved in acetone to form a viscous solution with a mass fraction of 70% to 95%. The X-ray opaque contrast agent used in the developing layer is the purified crystal of diatrizoic acid, which is dissolved in ethanol to form a solution with a mass fraction of 60% to 95%. ...

Embodiment 2

[0053] The material of the stent body in the embodiment of the present invention is a copolymer of biodegradable polymer materials PLLA (poly-L-lactic acid) and PCL (polycaprolactone). The overall schematic diagram of the stent is as follows Figure 6 shown. A round hole is centrally arranged in the width direction of all connecting straight rods 1 of the bracket, wherein each connecting straight rod has 4 holes, and straight lines are evenly distributed on the connecting long straight rods, such as figure 2 shown. The pore diameter is about 90 μm, which is about 1 / 2 of the width of the stent rod. Among them, the degradable polymer PCL (polycaprolactone) used in the inner protective layer 5, the outer protective layer 3 is PLGA (polylactic acid-glycolic acid), the weight average molecular weight Mw = 170,000 to 190,000, and is soluble in acetone to form a mass Fraction 70%~95% viscous solution. The X-ray opaque contrast agent used in the developing layer is the purified cr...

Embodiment 3

[0056] The material of the stent body in the embodiment of the present invention is biodegradable polymer material PLLA (poly-L-lactic acid), and the overall schematic diagram of the stent is as follows Figure 6 shown. Round holes are provided on all connecting rods of the bracket, and each connecting rod has 3 holes, and a triangular arrangement is adopted on the connecting rods, such as image 3 shown. The diameter of the hole is about 50 μm, which is about 1 / 4 of the width of the connecting straight rod. Among them, the degradable polymer used in the protective layer is PLGA (polylactic acid-glycolic acid), with a weight average molecular weight of Mw=100,000 to 120,000, which can be dissolved in acetone to form a viscous solution with a mass fraction of 70% to 95%. The X-ray opaque contrast agent used in the developing layer is the purified crystal of iohexol, which is dissolved in ethanol to form a solution with a mass fraction of 60% to 95%.

[0057]First, a stainles...

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Abstract

The invention relates to the field of medical apparatuses and instruments and provides a completely-biodegradable support capable of developing and a preparation method thereof. A connecting rod of a support main body is provided with holes, markers which can develop in X-rays are filled in the holes, and each marker is composed of an outer protective layer, a developing layer and an inner protective layer. Both the support main body and the protective layers are made of biodegradable materials such as poly L lactic acid (PLLA), polycaprolactone (PCL) and poly lactic-co-glycolic acid (PLGA); the developing layers are made of contrast agents used for human bodies, and one or more than two of preferential amidotrizoic acid, diatrizoate, iohexol, iopromide and ioversol; and crystallization is carried out in advance through purification. The completely-biodegradable support can be clearly seen in the X-rays, the markers can be controlled to be completely degraded in 6 months to 2 years, developing time can be long, accordance can be achieved, and needs for support developing can be fundamentally met.

Description

technical field [0001] The invention relates to a medical device, in particular to a fully degradable polymer bracket that can be developed and a preparation method thereof. Background technique [0002] Traditionally used stents for the treatment of vascular stenosis are all made of metal materials, which can be clearly seen under X-rays, but because the materials cannot be degraded and absorbed by the human body, they will permanently stay in the human body after implantation, like a metal "vest". "It also restricts the normal contraction and pulsation of blood vessels, and in severe cases, it will cause late thrombosis of the stent and cause the death of the patient. Furthermore, the existence of metal implants will affect the subsequent MRI or CT images of blood vessels and interfere with the doctor's judgment. [0003] In view of the existence of such problems, degradable stents that can be degraded and absorbed by the human body have emerged as the times require. Aft...

Claims

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Application Information

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IPC IPC(8): A61F2/915
Inventor 袁新高康荣袁玲
Owner SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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