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Biological sleeve for accommodating implantable medical equipment as well as preparation method and application of biological sleeve

A medical device and biological technology, applied in the field of medical devices and biomedical materials, can solve the problems of reducing the quality of life of patients, failure of implanted devices, increasing the economic burden of patients, etc., to avoid suture breakage or premature degradation of suture, Avoiding the risk of suture breakage, the effect of good tissue repair capacity

Active Publication Date: 2022-01-11
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006](1) The shell of the equipment is often made of metal or polymer material, which is a foreign body to the human body, and rejection reaction will inevitably occur, thus causing infection, inflammation, etc.;
[0007] (2) Due to the size of the implanted device not fully fitting the cavity, or improper limb movement, the implanted device will continue to move, resulting in friction Hemorrhage, hematoma, blood clot formation after ulceration, etc.;
[0008](3) Due to the occurrence of diseases such as rejection and inflammation after the device is implanted, the tissue structure can change, the nearby tissue can be displaced, and finally the fistula can be formed ;
[0009](4) The wear and tear of the wire and the displacement of the device body may lead to premature failure of the implanted device, resulting in secondary surgery and more serious complications
[0010]The emergence of these complications not only increases the financial burden of patients, but also reduces the quality of life of patients, especially for those patients who rely on implanted medical devices such as CIED , but also increased the death rate

Method used

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  • Biological sleeve for accommodating implantable medical equipment as well as preparation method and application of biological sleeve
  • Biological sleeve for accommodating implantable medical equipment as well as preparation method and application of biological sleeve
  • Biological sleeve for accommodating implantable medical equipment as well as preparation method and application of biological sleeve

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0114] The preparation method of biological cover

[0115] The preparation method of the biological cover in the present disclosure comprises the following steps:

[0116] The preparation step of the biofilm layer 3: the biofilm layer 3 is formed from a sterilized and decellularized extracellular matrix material;

[0117] The coating step of the biofilm layer 3: alternately coating the biofilm layer 3 on the surfaces of both sides of the plate-shaped mold 2, so that the surfaces of the two sides are respectively coated with at least 2 layers of the biofilm layer 3; Wherein, the biofilm layer 3 of any layer includes a coating film layer 31 covering a partial area of ​​one side surface, and an extended film layer continuously extending to the other side surface corresponding to the partial area. 32;

[0118] Freeze-drying step: freeze-dry the biofilm layer 3 coated on the mold 2 in a non-pressing environment, so that at least two layers of the biofilm layer 3 are combined in...

Embodiment 1

[0152] This embodiment provides a method for preparing small intestinal submucosa material, which specifically includes the following steps:

[0153] (1) Primary treatment of raw materials

[0154] Take pig small intestinal submucosa tissue and divide it into specified size, remove lymphatic tissue, rinse until there is no stain on the surface, and drain the water; the specified size specifically refers to: width 2-10cm, length 2-20cm.

[0155] (2) Virus inactivation treatment

[0156] Adopt the virus inactivation solution that comprises 2% (v / v) peracetic acid, 20% (v / v) ethanol to soak pig small intestine submucosa tissue, carry out virus inactivation treatment; Virus inactivation solution and pig small intestine submucosa tissue The volume ratio is 40:1, the inactivation time is 4 hours, and the temperature range is 40°C.

[0157] (3) One time cleaning

[0158] Wash the porcine small intestinal submucosa tissue with cleaning solution until the detection conductivity is b...

Embodiment 2

[0164] The present embodiment provides the preparation method of biological cover, specifically comprises the following steps:

[0165] (1) fixed molding

[0166] The small intestinal submucosa material prepared in Example 1 was used as the biofilm layer. Carry out fixed molding on the mould, described mold is made up of stainless steel base plate of different sizes (type: 5.4*7; 15cm) of biofilm layer wraps around the bottom plate, and the remaining material at the bottom is about 5mm to 10mm, folded to one side, and scraped with a stainless steel scraper to complete the step of forward coating; in the opposite direction, wrap a new biofilm layer Make a circle around the base plate, with about 5mm to 10mm of material remaining at the bottom, fold it to the other side, scrape it flat, and complete the step of reverse coating. Repeat this process once, scrape it flat, and finally get a SIS biological cover with 2 sides and 4 layers, and the specification model is (5.4×5; 6.9×...

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Abstract

The invention belongs to the field of medical instruments and biomedical materials, and particularly relates to a biological sleeve for accommodating implantable medical equipment as well as a preparation method and application of the biological sleeve. According to the biological sleeve, the implantable medical equipment is placed in an accommodating cavity, a physical barrier can be provided for the implantable medical equipment, the implantable medical equipment is prevented from making direct contact with a machine body, and complications such as infection, inflammation, cicatrization and calcification after implantation are reduced. Besides, an integrally formed structure of the biological sleeve has high tensile strength, so that bad use conditions such as suture line breakage or premature degradation of the suture line in suture of the biological sleeve can be avoided, and stable physical isolation of the implantable equipment is realized.

Description

technical field [0001] The disclosure belongs to the field of medical devices and biomedical materials, and in particular, the disclosure relates to a biological cover for accommodating implanted medical devices, a preparation method and an application thereof. Background technique [0002] Implantable medical devices are one of the most effective means of treating cardiovascular and cerebrovascular diseases and orthopedic diseases. Among them, Cardiovascular Cardiac Implantable Electronic Device (CIED) includes cardiac pacemaker (Cardiac Pacemaker, PM), cardioverter defibrillator (Implantable CardioverterDefibrillator, ICD) and cardiac resynchronization therapy (Cardiac Resynchronization Therap, CRT) pacemaker and defibrillator, implantable cardiac event recorder (Insertable cardiac monitor, ICM) and implantable cardiovascular monitor are typical high-risk medical devices. In recent years, new treatment equipment such as subcutaneous ICD (Subcutaneous ICD, S-ICD), leadless...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/14A61L31/00
CPCA61L31/005A61L31/14
Inventor 赵博吴文跃门福民薛云霞
Owner BEIJING BIOSIS HEALING BIOLOGICAL TECH