Atrial septal defect plugging device knitted by degradable material

A technology for atrial septal defect and degradable materials, which is applied in the field of atrial septal defect occluders, can solve the problems of verification, no detailed discussion of weaving materials and weaving processes, and achieve the effect of avoiding biological rejection

Inactive Publication Date: 2008-08-06
SHANGHAI JIAO TONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the above article, we did not discuss the weaving material and weaving proce

Method used

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  • Atrial septal defect plugging device knitted by degradable material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A double-umbrella occluder was braided with 0.2mm-diameter poly-L-lactic acid (PLLA) monofilament, the diameter of the large disk was 18mm, and the diameter of the small disk was 12mm. The film material among them is a polyester film with a thickness of 500nm. After molding, the occluder was tested in vitro.

[0020] The experimental device is made of plexiglass, and the two closed cavities in the middle are connected by small holes. The diameter of the small hole in the middle is slightly smaller than the diameter of the waist of the occluder, which can be compared with the diameter of the interatrial septum of the heart. Use the delivery device to deliver the occluder to the small hole, release the occluder, and then fix the occluder at the small hole after deployment. Build a model, the internal liquid temperature is about 37 degrees Celsius, simulating the internal environment of the human body.

[0021] The internal liquid is a phosphate buffer solution, which i...

Embodiment 2

[0024] A double-umbrella occluder was braided with 0.2mm-diameter poly-L-lactic acid (PLLA) monofilament, the diameter of the large disk was 14mm, and the diameter of the small disk was 9mm. The film material among them is a polyester film with a thickness of 700nm. After shaping, the occluder was introduced into the body of experimental dogs through the delivery device for animal experiments.

[0025] During the experiment, the dogs grew in good condition without systemic or local complications. The tissue has good compatibility with PLLA, and no severe acute tissue reaction and toxicological reaction occurred in dogs.

[0026] Regarding the degradability, after 30 days, the animals were observed with a scanning electron microscope, and it can be found that the occluder stent has been degraded to a certain extent in the SEM photos. After 6 months, the degree of degradation increased.

Embodiment 3

[0028]A double-umbrella occluder was braided by PBO monofilament with a diameter of 0.3 mm. The diameter of the large disc was 74 mm, and the diameter of the small disc was 66 mm. Add 3 nickel-titanium memory alloy wires with a diameter of 0.2mm on the outside, so that the quality of the memory alloy wires only accounts for 9.45% of the total mass of the occluder, less than 30%. Its role is to enhance resilience and grip. The film material among them is a polyester film with a thickness of 700nm. After heat setting, the occluder was introduced into the body of experimental dogs through the delivery device for animal experiments.

[0029] During the experiment, the dog's tissue had good compatibility with PBO, and no complications occurred. This kind of occluder is firmly clamped on the defect site and will not fall off easily.

[0030] After 30 days, the animals were observed under a scanning electron microscope, and it can be found that the PBO part of the occluder stent h...

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Abstract

The invention relates to an atrial septal defect occluder woven from degradable materials, which pertains to a medical apparatus technical field and comprises a bracket and membrane material inserted to the bracket and used for block blood from passing through; the bracket is made from degradable polymeric monofilament or degradable polymeric monofilaments together with shape memory alloy wires; the shape memory alloy wires are encircled outside a contour formed by the degradable polymeric monofilaments. In the atrial septal defect occluder, degradable polymeric material is adopted to completely or partially replace traditional Ni-Ti shape memory alloy. The atrial septal defect occluder of the invention is characterized by partial or complete biodegradability which means the atrial septal defect occluder can be partially or completely decomposed to small molecules innoxious to human body after being implanted in human body and then the small molecules are discharged from the human body so as to reduce reject reaction of human body and to improve the biocompatibility of interventional therapy materials.

Description

technical field [0001] The invention relates to a device in the technical field of medical devices, in particular to an atrial septal defect occluder woven with degradable materials. Background technique [0002] Congenital heart disease (hereinafter referred to as congenital heart disease) is a kind of cardiovascular disease that frequently occurs in children. Its lesion feature is that the septum between the left and right atrium cannot be closed normally after birth. Because the pressure of the left atrium is higher than that of the right atrium, under the action of pressure, the blood in the left atrium will flow to the right atrium through the defect, which will increase the burden on the right heart system and cause pathological changes. It is estimated that about 150,000 children with congenital heart disease are born in my country every year. At present, the treatment methods for congenital heart disease mainly include surgery and interventional therapy. However, s...

Claims

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Application Information

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IPC IPC(8): A61F2/02A61L27/50A61L27/58A61B17/00
Inventor 孙康窦红静王一涵李奋孙锟
Owner SHANGHAI JIAO TONG UNIV
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