A kind of drug delivery catheter and preparation method thereof

A technology for delivering catheters and drugs, applied in the field of medical devices, can solve the problems that anti-proliferative drugs cannot act on blood vessels, cannot effectively inhibit intimal hyperplasia for a long time, and the firmness of drug coatings is not good enough, so as to improve the long-term patency rate of blood vessels , Improve drug release, improve inhibitory effect

Active Publication Date: 2022-07-15
ACOTEC SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some problems inevitably exist in the current drug-coated delivery devices, such as: (1) The firmness of the drug coating is not good enough, most of the drugs are lost before reaching the target lesion blood vessels, and sufficient doses of anti-proliferative drugs cannot be acted on the blood vessels , the utilization rate is low; (2) The residence time of the drug coating in the target lesion is short, and it cannot effectively inhibit the intimal hyperplasia for a long time

Method used

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  • A kind of drug delivery catheter and preparation method thereof
  • A kind of drug delivery catheter and preparation method thereof
  • A kind of drug delivery catheter and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] In this embodiment, the inner tube is a guide wire tube body, the outer tube is an inflatable tube body, and the balloon handle is an inflatable handle; Figure 1-6 , a drug delivery catheter with a new structure, including a guide wire assembly 11, an inflatable assembly 12 and a protection assembly 13 nested in sequence from the inside out, wherein,

[0049] The guide wire assembly 11 includes a guide wire tube seat 111, a guide wire tube body 112 and a tip 114 that are connected in sequence. The outer surface of the distal end of the guide wire tube body 112 is fixedly provided with two developing identification rings 113, which are respectively aligned with the two ends of the straight section of the balloon 124 for displaying the balloon during the operation. The position of the balloon in the human body is to realize the positioning of the balloon 124; the distal end of the tip 114 is smoothed and tapered to reduce the damage to the blood vessel during the deliver...

Embodiment 2

[0057] In this embodiment, the inner layer of the wire guide tube body 112 is a PTFE liner, the middle layer is stainless steel braided wire, the braiding density is 130 PPI, and the outer layer is pebax63D; the inner layer of the inflatable tube body is a PTFE liner, and the middle layer is NiTi Winding wire, the pitch of the winding wire is 0.254mm, the outer layer is composed of Pebax72D, Pebax63D, Pebax55D, Pebax45D and Pebax33D; the inner layer of the protective tube body is a PTFE liner, the middle layer is a nickel-titanium winding wire, the pitch of the winding wire is 0.254mm, and the outer layer is a PTFE liner. The layer is Pebax72D; 200mg of the inflammation-suppressing drug methylprednisolone, 100mg of paclitaxel as an anti-proliferative drug, 10mg of polysorbate as an excipient, 2mg of tocopherol as a stabilizer, mixed with 23ml of ethanol, 19ml of n-heptane and 8ml of tetrahydrofuran into a drug coating solution; take the assembled inflatable assembly 12, in a cl...

Embodiment 3

[0060] In this embodiment, the inner layer of the wire guide tube body 112 is a PTFE liner, the middle layer is stainless steel braided wire, the braiding density is 80 PPI, and the outer layer is TPU80A; the inner layer of the inflatable tube body 123 is a PTFE liner, and the middle layer is nickel Titanium winding wire, the pitch of the winding wire is 0.508mm, and the outer layer is composed of Pebax72D, Pebax63D, Pebax55D, Pebax45D and Pebax33D; the inner layer of the protective tube body 132 is a PTFE liner, the middle layer is a nickel-titanium winding wire, and the pitch of the winding wire is 0.254mm , the outer layer is Pebax 72D; 200 mg of inflammatory suppressing drug dexamethasone, 200 mg of sirolimus as anti-proliferative drug, 4 mg of magnesium stearate as excipient, 2 mg of tocopherol as stabilizer, combined with 59 ml of acetone, 33 ml of n-heptane Alkane and 8 ml of tetrahydrofuran are mixed to prepare a drug coating solution; take the assembled inflatable comp...

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Abstract

The present invention provides a drug delivery catheter with a novel structure, comprising a balloon assembly and a protection assembly nested on the balloon assembly; the balloon assembly includes a balloon handle, an outer tube and a balloon connected in sequence, so that the The balloon assembly is provided with an inner tube, the outer tube is provided with a position indication mark, the distal end of the inner tube is fixedly connected with a tip, and the tip is a hollow structure; the outer surface of the balloon is coated with A drug microcapsule, the drug microcapsule is composed of a bioabsorbable surface coating material and a content drug, the content drug includes an anti-proliferative drug, an inflammation-suppressing drug, an excipient and a stabilizer; the protection component includes sequentially connected Protecting the handle and protecting the tube body; the invention transports the drug microcapsules to the target blood vessel through the balloon, significantly improves the drug delivery efficiency and utilization rate, and can release the drug to the target lesion for a long time, thereby maintaining the smooth blood vessel for a long time.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a drug delivery catheter with a novel structure and a preparation method thereof. Background technique [0002] Arterial disease of the lower extremities caused by atherosclerosis is an important part of the current global disease causing death and disability. There are an estimated 16-24 million patients with lower extremity arterial disease in the United States, and about 100,000 people need surgical treatment each year. The prevalence of lower extremity arterial disease is basically the same as that of coronary heart disease. With the increase of age, the incidence of lower extremity arterial disease will increase significantly, the incidence rate of 45 to 54 years old is 0.6%, the incidence rate of 55 to 64 years old is 2.5%, and the incidence rate of 65 to 74 years old is 8.8%. Lower extremity arterial disease seriously impairs the function of the affected extremity...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61M25/10A61M31/00
CPCA61M25/10A61M31/002A61M2025/105
Inventor 李亚泽代欢邢万里邱朋军赵宇
Owner ACOTEC SCI
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