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Absorbable macromolecule hemostatic clip

A hemostatic clip and polymer technology, applied in wound clips, medical science, surgery, etc., can solve the problem that the hemostatic titanium clip cannot be degraded, and achieve excellent degradability, firm structure, and good fixation effect

Pending Publication Date: 2020-12-25
东南大学泰州生物医药与医疗器械研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The object of the present invention is to solve the above-mentioned deficiencies in the prior art, and to provide an absorbable polymer hemostatic clip, which has a simple and delicate structure and a firm structure, and solves the problem that the existing laparoscopic disposable hemostatic titanium clip cannot be used in the human body. Degradation issues that do not interfere with radiographic examination distort the diagnosis of tissue in the clipped area

Method used

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preparation example Construction

[0032] The preparation method of described hemostatic clip, comprises the steps:

[0033] S1. Preparation of raw materials

[0034] (a) Preparation of polyglycolide:

[0035] Under vacuum or high pressure conditions, set the reaction temperature at 120-180°C, take a certain amount of glycolide in the reaction kettle, add 0.01-0.05% mass concentration of stannous octoate catalyst, the reaction time is 5-7h, and then reflux to purify and produce Granules to obtain polyglycolide, which should be stored in a refrigerator at low temperature and sealed;

[0036] (b) Preparation of polyglycolide-polytrimethylene carbonate-polydioxanone copolymer:

[0037] Under vacuum or high pressure conditions, set the reaction temperature at 110-200°C, take a certain amount of glycolide, trimethylene carbonate, and p-dioxanone in the reaction kettle, and add 0.01-0.05% mass concentration of stannous octoate Catalyst, glycolide: trimethylene carbonate: the weight ratio of dioxanone is (15:5:80)-...

Embodiment 1

[0046] Preparation of polyglycolide: take 200g glycolide in a reaction kettle, add 0.01% mass concentration of stannous octoate catalyst, then add a certain amount of acetone to adjust the viscosity of the system, and set the reaction temperature at 170°C under vacuum conditions. 6h to obtain polyglycolide product. The polyglycolide product is fed into an extruder, and the extruding temperature is 150° C. to obtain polyglycolide particles with a particle diameter of 1.5-2 mm and a length of 3 mm. The polyglycolide particles were vacuum dried at 40°C for 24 hours. The test condition was set at 230° C. / 2.16 kg by means of a melt index instrument, and the melt index of polyglycolide measured by ASTM D-1238 standard was 50 g / 10 min.

[0047] The polyglycolide prepared above is processed into the outer clip of the hemostatic clip through the injection molding process of the present invention, and the tensile strength of the outer clip is tested to be 70 MPa and the molecular weigh...

Embodiment 2

[0051] The preparation of polyglycolide-polytrimethylene carbonate-polydioxanone copolymer: in reactor, add 300g glycolide, trimethylene carbonate, p-dioxanone (by weight 15:25:60), adding 0.05% mass concentration of stannous octoate catalyst, reaction temperature 135 ° C, nitrogen protection, reaction time 6 h, and then reflux purification, at 170 ° C, the obtained polyglycolide-poly Sanya Methylcarbonate-polydioxanone copolymer product joins in extruder, obtains particle diameter and is 1.5-2mm, is long the particle of 3mm size, weighs and obtains pellet 280g, yield 93%, will The above pellets were dissolved in hexafluoroisopropanol solution, and the intrinsic viscosity of polyglycolide-polytrimethylene carbonate-polydioxanone copolymer was measured with an Ubbelohde viscometer in a constant temperature water bath at 25°C. The number is 3.60dL / g.

[0052] The polyglycolide-polytrimethylene carbonate-polydioxanone copolymer prepared above is processed into the inner layer cl...

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Abstract

The invention discloses an absorbable macromolecule hemostatic clip. The hemostatic clip comprises an outer-layer clip (1) and an inner-layer clip (2); the outer-layer clip (1) and the inner-layer clip (2) are both of a U-shaped opening structure; the outer-layer clip (1) and the inner-layer clip (2) are each provided with an anti-slip connector; the anti-slip connector comprises a clamping groove(3) and a guide strip (4); the clamping groove (3) is formed in the plane of the inner side of the outer-layer clamp; the guide strip (4) is arranged on the plane of the outer side of the inner-layerclamp and matched with the clamping groove; the clamping groove (3) is a mortise and tenon type wedge-shaped clamping groove; the guide strip (4) is a mortise and tenon type wedge-shaped guide strip;and the clamping groove (3) and the guide strip (4) are in wedge-shaped mortise and tenon connection. The absorbable macromolecule hemostatic clip in the invention is simple, exquisite and firm in structure; the problem that an existing disposable hemostatic titanium clip for a laparoscope cannot be degraded in a human body is solved; and diagnosis distortion of tissue in a clipping area of the hemostatic clip due to radiographic examination cannot be interfered.

Description

technical field [0001] The invention relates to the technical field of medical consumables for laparoscopic minimally invasive surgery, in particular to an absorbable polymer hemostatic clip. Background technique [0002] Laparoscopic surgery is a minimally invasive surgery. Compared with traditional surgery, laparoscopic surgery doctors cannot touch the surgical site, so blood vessel hemostasis is particularly important. In clinical practice, hemostatic clips are usually used to clamp ruptured blood vessels. At present, the most widely used hemostatic clips on the market are metal titanium hemostatic clips, which are metal hemostatic clips with low production cost and good stability. However, the use of metal titanium clips also brings hidden dangers to patients. On the one hand, the absorption capacity of titanium to X-rays is much higher than that of human tissues, which will interfere with radiographic examination and distort the diagnosis of the tissue in the clamped ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61B17/122A61L31/06A61L31/14B29C45/78B29C45/76B29C43/58
CPCA61B17/122A61L31/148A61L31/06B29C45/78B29C45/76B29C43/58A61B2017/00004B29C2945/76531B29C2945/76561B29C2043/5816
Inventor 顾兴中张玉成全祎
Owner 东南大学泰州生物医药与医疗器械研究院
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