Degradable double-layer compound ureteral stent tube

Abstract

The invention discloses a ureteral stent tube made of a degradable material. The stent tube is a double-layer compound tube, the inner layer is constituted by a L-lactide / epsilon-caprolactone copolymer (PLLCA) elastomer material, and the weight average molecular weight of an L-lactide / epsilon-caprolactone copolymer is 0.1-0.8 million, wherein an epsilon-caprolactone unit accounts for 15%-25% in the copolymer, an L-lactide unit accounts for 75%-85%, and a layer of poly-1,4-dioxanone (PPDO) is uniformly covered on the outer layer of the ureteral stent tube. The viscosity average molecular weight is 0.1-0.5 million. The ureteral stent tube has the advantages of being good in biocompatibility, being capable of realizing self-degradation, being capable of being degraded and excreted from a body without drawing the tube, and reducing suffering and economic burden of a patient.

Description

Technical field [0001] The invention relates to a ureteral stent tube used in urology, in particular to a ureteral stent tube that can be completely degraded in the human body, and belongs to the field of biomedical materials. Background technique [0002] The ureteral stent tube (double pigtail catheter, or DJ tube) is widely used in urological surgery, suitable for upper urinary tract surgery such as kidney stones, ureteral stones, hydronephrosis, kidney transplantation, benign tumors of the kidney and ureter, and lithotripsy In the treatment of mechanical lithotripsy and dilation of ureteral stricture, it can play an important role in draining urine and preventing ureteral stricture and adhesion blockage after being implanted in the ureter. At present, most of the D-J tubes in clinical applications are made of silicone rubber or polyurethane polymer materials that cannot be degraded in the human body. There are some insurmountable defects in clinical applications: [0003] (1) ...

AI Technical Summary

Problems solved by technology

[0003] (1) It must be removed through an invasive operation, that is, through a cystoscope. Although this type of cystoscopic operation is not a major operation, the patient will suffer terribly. What is more serious is that the removal of the tube will cause varying degrees of damage to the urinary tract injury, which can lead to infection and edema, often requiring emergency treatment

[0004] (2) Due to various reasons, many patients will forget to extubate or delay extubation. When the non-absorbable stent tube is left in the body for a long time to form urinary stones, when it cannot be removed through the cavity, open surgery has to be taken out, which undoubtedly seriously increases the risk of extubation. Patient suffering and financial burden

[0006] (4) The surface friction coefficient of the silicone rubber stent tube is high, it is difficult to intubate during the operation, and it is easy to slide after being inserted into the body, which cannot well meet the requirements of clinical application

Foreign literature reports (Laaksovirta, S Laurila M.et al.Jurol, 167: 1527, 2002) use degradable lactide-glycolide copolymer (PLGA) as raw material to manufacture stent tube, the stent tube The disadvantage is that the molecular weight is too low, the degradation time is too fast, the supporting effect can only last for about a week, and the material is a typical plastic body, which is relatively hard and has poor elasticity, so it is difficult to be practically applied in the field of ureteral stent manufacturing

[0008] Chinese patent application CN101212937A discloses a fiber-reinforced composite absorbable ureteral stent. The absorbable material in this patent application can be made of L-lactide / ε-caprolactone. When implanted, the ureteral stent and ureter Wall friction is high, implantation is difficult, and the surface is hydrophobic and easy to form urinary stones

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