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Manufacturing method of developable inflatable balloon for kyphoplasty

A technology of kyphoplasty and kyphoplasty, which is applied in the field of medical devices, can solve the problems that affect the doctor's accurate judgment of inflatable balloons, limit the application of polyurethane imaging materials, and poor development of inflatable balloons, etc., and achieve excellent imaging effects , good cell compatibility, low price effect

Active Publication Date: 2013-01-23
EAST CHINA UNIV OF SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] This inflatable balloon has the following disadvantages: the inflatable balloon in the existing vertebral body balloon catheter only relies on two X-ray-opaque metal rings on the inflatable balloon inner tube to develop, while the vertebral body During the balloon inflation process, the position and size of the balloon cannot be seen, and there is a problem that the inflatable balloon of the vertebral body catheter balloon is poorly visualized, which affects the accurate judgment of the position of the inflatable balloon by the surgeon
The simplest method is to blend polymers with heavy metal inorganic salts, powders, etc., but this physical blending method can easily lead to material performance degradation, thus limiting the application of polyurethane developing materials

Method used

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  • Manufacturing method of developable inflatable balloon for kyphoplasty
  • Manufacturing method of developable inflatable balloon for kyphoplasty
  • Manufacturing method of developable inflatable balloon for kyphoplasty

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The pre-dehydration-treated poly(1,6-hexanediol) diol with a molecular weight of 1500 and 4'4-diphenylmethane diisocyanate are mixed in a molar ratio of 0.39:1, N 2 Stir and react at 80°C for 2.5 hours under protection to obtain a prepolymer, heat up to 90°C, add molten chain extender N,N-dihydroxyethyl-p-iodoaniline, the molar ratio of chain extender to diisocyanate is 0.3:1, Stir for 20 minutes, and plasticize at 75°C for 5 hours after discharge to obtain developable polyurethane with a hardness of 90A.

[0027] After vacuum-drying the developable polyurethane with a hardness of 90A at 50°C for 4-5 hours, add it to the extruder and extrude it into a transparent, smooth surface, and bubble-free wall thickness with an inner diameter of 2mm and an outer diameter of 3mm Uniform balloon tubing. The extrusion conditions are: the temperature of the feeding section of the extruder barrel is 175°C, the temperature of the compression section is 180°C, the temperature of the me...

Embodiment 2

[0030] The pre-dehydration-treated polytetrahydrofuran ether diol with a molecular weight of 2000 and 4'4-diphenylmethane diisocyanate are mixed in a molar ratio of 0.5:1, N 2 Stir and react at 80°C for 2 hours under protection to obtain a prepolymer, heat up to 85°C, add molten chain extender N,N-dihydroxyethyl p-iodoaniline, the molar ratio of chain extender to diisocyanate is 0.2:1, Stir for 10 minutes, and plasticize at 75°C for 5 hours after discharging to obtain developable polyurethane with a hardness of 80A.

[0031] The developable polyurethane with a hardness of 80A is vacuum-dried at 50°C for 4-5 hours, then added to the extruder, and extruded into a transparent, smooth surface and no bubbles with an inner diameter of 2.5mm and an outer diameter of 3.5mm Tubing for balloons with uniform wall thickness. The extrusion conditions are: the temperature of the feeding section of the extruder barrel is 185°C, the temperature of the compression section is 190°C, the temper...

Embodiment 3

[0034] Such as Figure 4 As shown, the RQ13 vertebral balloon catheter is composed of a Y-shaped head 3, a main catheter 2, a balloon 1, and a core tube 4. The specific assembly is as follows: the lower end of the balloon 1 is sealed with the lower end of the core tube 4 with an outer diameter of 1.9mm, The upper end of the balloon 1 with an inner diameter of 2.2 mm is sealed with the lower end of the main catheter 2 with an outer diameter of 2.1 mm. The upper end of the main catheter 2 is inserted into the sheath tube and connected to the Y-shaped head 3. The guide wire is placed in the Y-shaped head 3, and the assembly is completed.

[0035]During the operation, the patient lies prone, and the body surface projection of the pedicle of the diseased vertebra is monitored and determined by the C-arm X-ray machine. Expand enough for the inflatable balloon to pass through to establish a working channel; insert the visualized inflatable balloon of the RQ13 vertebral body catheter...

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Abstract

The invention relates to a developable inflatable balloon for kyphoplasty and a manufacturing method thereof. Developable polyurethanes are used as raw materials for the balloon, and developable polyurethane particles are fused and mixed and then are extruded to form a balloon tubing. Then the developable inflatable balloon is obtained by blow molding of the balloon tubing. The balloon of the invention not only has excellent biocompatibility and safety, but also can be developed in vivo. The developable inflatable balloon can be applied to vertebra balloon catheters and to treatment of vertebral compression fractures and osteoporosis, so as to enable surgeon doctors to accurately determine the location and the size of the balloon in the inflating process. Therefore, the vertebra height isrestored to the greatest extent, the problem of poor balloon development of vertebra balloon catheters during the surgery is solved, and the surgery quality is guaranteed. The developable inflatable balloon and the manufacturing method thereof of the invention have wide clinic application prospects.

Description

technical field [0001] The invention relates to a developable and inflatable balloon for kyphoplasty and a preparation method thereof, belonging to the field of medical devices. Background technique [0002] Kyphoplasty is a minimally invasive procedure. Under supervision, first insert the guide wire into the vertebral body, then insert the trocar with the wire, use the drill bit to expand the needle channel enough for the inflatable balloon to pass, and insert the inflatable balloon of the vertebral body catheter balloon to the affected vertebral body Below the side of the collapsed endplate, the inflatable balloon is inflated and expanded under pressure and X-ray monitoring, and the inflatable balloon is expanded to the edge of the cortical bone to stop inflating, so that the collapsed vertebral body can recover its height. Reconcile the bone cement, suck the bone cement into the injector, expel the air bubbles, slowly inject the bone cement into the vertebral body under ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61B17/56
Inventor 刘昌胜洪华
Owner EAST CHINA UNIV OF SCI & TECH
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