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Sterilization method for absorbable implant and matched instrument combined product

A technology for combining products and sterilization methods, applied in chemical instruments and methods, cleaning methods using liquids, cleaning methods and utensils, etc., can solve the problems of high sterilization cost, difficult operation, and the inability of supporting equipment to ensure sterilization effect.

Active Publication Date: 2021-06-22
厦门博创中安医疗技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to overcome the existing terminal sterilization method to sterilize aseptic absorbable implants and supporting equipment combination products. The performance of absorbing implant consumables is easily affected by sterilization, and the performance is reduced, and the supporting equipment with complex structure cannot guarantee the sterilization effect, or the sterilization cost is high and the operation is difficult. The performance of absorbable implant consumables is not affected, and the supporting equipment that is extremely challenging to kill microorganisms can achieve aseptic effect. The sterilization method for the combined product of absorbable implants and supporting equipment

Method used

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  • Sterilization method for absorbable implant and matched instrument combined product
  • Sterilization method for absorbable implant and matched instrument combined product
  • Sterilization method for absorbable implant and matched instrument combined product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Sterilization method of absorbable anchor system

[0027] S1. In a clean room with a cleanliness of 100,000, clean the non-absorbable device components (other accessories except absorbable anchors, including implants and non-absorbable sutures) with PWC-401 degreaser in sequence After degreasing and washing with purified water, assemble it into a non-absorbable accessory device.

[0028] S2. Put the non-absorbable supporting equipment into a single-layer medical tube (breathable packaging) and seal it, and then sterilize it with ethylene oxide. The sterilization conditions include a temperature of 50°C, a humidity of 80%RH, and a pressure of -70kPa , time 13h, ethylene oxide concentration is 420mg / L, obtains the sterilized non-absorbable supporting device.

[0029] S3. In a clean room with a cleanliness level of 100,000, tear open the package of the sterilized non-absorbable supporting device to take out the non-absorbable supporting device, and assemble the...

Embodiment 2

[0039] Example 2: Sterilization method of absorbable anchor system

[0040] S1. In a clean room with a cleanliness level of 10,000, the components of non-absorbable instruments (other accessories except absorbable anchors, including implants and non-absorbable sutures, etc.) are cleaned and degreased with PWC-401 degreaser in sequence. After washing with oil and purified water, it is assembled into a non-absorbable accessory device.

[0041] S2. Pack the non-absorbable accessory device into a single-layer PA composite film, vacuum pack, and then sterilize it by gamma ray irradiation with a sterilization dose of 27-32 kGy to obtain a sterilized non-absorbable accessory device.

[0042] S3. In a clean room with a cleanliness level of 10,000, tear open the packaging of the sterilized non-absorbable supporting device to take out the non-absorbable supporting device, and assemble the absorbable anchor onto the sterilized non-absorbable supporting device , to obtain the combined pr...

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Abstract

The invention belongs to the field of medical instrument sterilization, and relates to a sterilization method for an absorbable implant and matched instrument combined product. The method comprises the following steps: cleaning non-absorbable instrument sub-components in a clean room, assembling into a non-absorbable matched instrument, carrying out ethylene oxide sterilization or radiation sterilization on the non-absorbable matched instrument, assembling the absorbable implant consumables on the sterilized non-absorbable matched instrument in a clean room, and then performing ethylene oxide sterilization and desorption. By adopting the method provided by the invention, the contradictions that the absorbable implant consumables in the absorbable implant and the matched instrument combined product cannot be subjected to excessive sterilization due to the characteristic of easy degradation and the sterilization effect cannot be ensured due to the complex structure of the non-absorbable matched instrument can be effectively solved; and the method can guarantee that the absorbable implant consumables and matched instruments with complex structures can achieve the sterile effect at the same time, the performance of the absorbable implant consumables cannot be reduced, and important practical use value and significance are achieved.

Description

technical field [0001] The invention belongs to the field of sterilization of medical instruments, and in particular relates to a method for sterilizing a combined product of absorbable implants and matching instruments. Background technique [0002] Absorbable implants and supporting equipment combination products are mainly used in orthopedic consumables in the field of sports medicine. The common ones are absorbable anchor systems and absorbable interface nail systems, which are mainly used for clinical treatment of Achilles tendon rupture or ligament tear. . Combination products of absorbable implants and supporting devices include non-absorbable supporting devices and absorbable implant consumables (such as absorbable anchors, absorbable interface nails, etc.). Traditional non-absorbable implant consumables will permanently stay in the human body after completing the treatment task, so that the human body is always stimulated by foreign objects, which will weaken the p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/20A61L2/08A61L2/26B08B3/08A61L101/44
CPCA61L2/206A61L2/081A61L2/26B08B3/08A61L2202/24A61L2202/21A61L2202/17
Inventor 王老乌陈艳文曾达林超越杨问成陈淳淳罗永兴林清华
Owner 厦门博创中安医疗技术有限公司
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