Drug delivery balloon dilating catheter

A technology for dilating catheters and balloon catheters, which is applied in the field of medical devices, can solve problems such as unsuitable for large-scale industrial production, rupture of microporous permeable membranes, and complicated manufacturing processes, and achieve easy and rapid delivery, satisfying repeated expansion and contraction, The effect of simple production process

Active Publication Date: 2014-03-12
SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The use of laser drilling or etching technology to make microholes not only requires expensive instruments and equipment, but also has a complicated manufacturing process, which is not suitable for large-scale industrial production
Although the precision of laser drilling is high, microcracks are likely to occur around the micropores during the high-temperature laser thermal melting process, which may cause the potential risk of rupture of the microporous permeable membrane. As the porosity increases, the phenomenon of microcracks becomes more serious, and the mechanical strength decreases accordingly.
Due to the passage of charged particles in etching technology, the molecules around the micropores are ionized, so that the polymer chain is broken, and a new chain segment with high activity is formed at the fracture, which has poor chemical stability and is easy to be etched to expand the diameter of the micropore.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 Preparation of Nylon12 Drug Delivery Balloon Dilatation Catheter

[0046] Mix 1g of Nylon12 and 0.6g of PEG, melt at 220°C to form a homogeneous solution, and inject it into the mold (see attached figure 1 ), after cooling and solidifying at an appropriate temperature, extract PEG 3 to 4 times with acetone, about 6 hours each time; vacuum dry in a vacuum oven at 50°C for 14 hours, and then take out the microporous membrane balloon. Finally, (see attached figure 2 ) insert the prepared non-porous inner balloon 5 and the connected inflation catheter 3 into the microporous permeable membrane outer balloon 6, and use the microporous membrane balloon as the outer balloon 6 by laser welding And the non-porous balloon is used as the inner balloon 5, which is fused together to achieve a bonded state to form a double-layer balloon structure, and then the proximal part of the catheter is welded to form a balloon dilation catheter.

[0047] The porosity is 50.37%, and...

Embodiment 2

[0049] Example 2 Preparation of ethylene-acrylic acid drug delivery balloon dilatation catheter:

[0050] Mix 1 g of ethylene-acrylic acid (EEA) and 0.9 g of diphenyl ether (DPE), melt at 180 °C to form a homogeneous solution, and inject it into the mold (see attached figure 1 ); after cooling and solidifying at an appropriate temperature, extract the DPE with methanol 3 to 4 times, about 6 hours each time; vacuum dry in a vacuum oven at 50°C for 14 hours, and then take out the microporous membrane balloon. Finally, (see attached figure 2 ) insert the prepared non-porous inner balloon 5 and the connected inflation catheter 3 into the microporous permeable membrane outer balloon 6, and use the microporous membrane balloon as the outer balloon 6 by laser welding And the non-porous balloon is used as the inner balloon 5, which is fused together to achieve a bonded state to form a double-layer balloon structure, and then the proximal part of the catheter is welded to form a ball...

Embodiment 3

[0053] Example 3 Preparation of Ethylene-Vinyl Alcohol Drug Delivery Balloon Dilatation Catheter:

[0054] Mix 1g of ethylene-vinyl alcohol and 0.8g of PEG, melt at 220°C to form a homogeneous solution, and inject it into the mold (see attached figure 1 ); phase separation occurs after cooling, and the polymer phase and the diluent phase form an interphase structure; then the diluent PEG is removed with the extractant acetone, and the space occupied by the original diluent in the mixture becomes micropores, that is, a coherent microporous permeable membrane is formed structure of the balloon. Finally, (see attached figure 2 ) insert the prepared non-porous inner balloon 5 and the connected inflation catheter 3 into the microporous permeable membrane outer balloon 6, and use the microporous membrane balloon as the outer balloon 6 by laser welding And the non-porous balloon is used as the inner balloon 5, which is fused together to achieve a bonded state to form a double-laye...

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Abstract

The invention provides a drug delivery balloon dilating catheter of a double-layer balloon structure. The drug delivery balloon dilating catheter comprises a pressurizing hole-free inner balloon body and an outer balloon body with a drug-permeable micro-hole permeable membrane. Compared with the prior art, the hole diameter of the drug delivery balloon dilating catheter is even, and the high porosity and the high mechanical strength are achieved. The invention further discloses a manufacturing method of the drug delivery balloon dilating catheter of the double-layer balloon structure, the drug delivery balloon dilating catheter is made of materials such as polyethylene or nylon 12, the micro-hole permeable membrane is manufactured with a thermally induced phase separation method, and the drug delivery balloon dilating catheter has the advantages of being simple in manufacturing process, suitable for large-scale production, low in manufacturing cost and the like.

Description

technical field [0001] The invention relates to a medical device, in particular to a drug delivery balloon dilation catheter used for interventional treatment of vascular diseases. Background technique [0002] As an effective supplement to metal stent angioplasty, the traditional drug-eluting balloon has a good application in the process of vascular restenosis after the stent drug is completely released, and is gradually showing its superiority. However, the drug-coated balloon still has problems such as a large amount of loss of the drug on the surface of the balloon during the intervention process and a low drug transfer rate in the very short process of contacting the diseased tissue. [0003] In order to solve the above problems, those skilled in the art have made some improvements to the structure, composition and drug delivery methods of drug-eluting balloons. , CN200951251A discloses a double-layer balloon catheter, which is covered with a layer of microporous ballo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M29/02A61M31/00A61M1/00
Inventor 申峰袁玲常恩泽
Owner SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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