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Resorbable implantable devices

An implantable, silk fibroin technology, used in medical science, prosthesis, surgery, etc., can solve the problems of slow degradation of polyglycolic acid, increased risk of adverse reactions, and undetermined prion disease.

Inactive Publication Date: 2008-06-25
SUTUROX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Second, the nature of man-made non-absorbable substances and their need to remain in contact with tissues for an extended period of time increases the risk of adverse reactions
[0012] 2. Unpredictability of gut degradation is a problem
[0013] 3. The degradation rate of polyglycolic acid is slower than that of gut
[0016] 6. Bowel sutures appear to be more likely to become infected
[0017] 7. Collagen sutures have a potential, but so far unknown, risk of prion disease
[0021] 1. Subjectively think that the knotting strength is reduced and it is easier to slip off
[0022] 2. Braided synthetic sutures may be more likely to cut edematous or fragile tissue or solid organs, and more likely to cut doctors' gloves
[0023] 3. They can be significantly toxic
[0024] 4. In the study of a certain range of materials, it was found that poly-L-lactide / glycolate showed the highest incidence of granulation tissue and infection, while another suture material with long absorption time, polydioxanone Also results in some granulation tissue and significant infection rates
This patented protein is only suitable as a vehicle for suture surface adherents

Method used

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  • Resorbable implantable devices

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Example 1: Enhancement of suture strength and toughness by treatment with hot citric acid

[0078] The tensile properties of silk fibroin and sutures prepared from silk fibroin can be significantly improved by treatment with hot citric acid as follows: A. Prepare a 5% citric acid solution and adjust to pH 5.5 with concentrated or weak sodium hydroxide. Silk fibroin was treated with citric acid solution at 80°C for 1 hour. Silk fibroin was removed from the citric acid solution and rinsed thoroughly with distilled water (3*30 min) and then air dried.

[0079] The treatment was found to increase critical tensile strength by approximately 5% and increase elongation by 10-15% as measured on an Instron mechanical tester as described below.

[0080] Therefore, this treatment greatly increases the toughness of silk fibroin and sutures made of silk fibroin.

Embodiment 2

[0081] Example 2: Prolongation of suture absorption time

[0082] Process the silk fibroin of the present invention with formic acid and methanol to increase its resorption time in the following manner before or after the silk protein excipient is added: the silk fibroin (or the suture thread made of silk fibroin) is immersed in a 10-95 % formic acid solution or exposed to the vapor of formic acid solution at room temperature for 1-5 hours. The silk fibroin was washed and allowed to air dry. This treatment resulted in an increased degree of silk fibroin crystallinity, as determined by X-ray crystallography or by measuring the glass transition temperature of thoroughly dried fibers by various scanning calorimetry methods.

[0083] A further increase in crystallinity was achieved by additionally immersing the silk fibroin in a 30-100% methanol solution or exposing the silk fibroin to the vapors of this solution for 1 hour. The silk fibroin was air dried after washing. Better ...

Embodiment 3

[0087] Example 3: Binding peroxidase to silk protein

[0088] 1.16 mg horseradish peroxidase (HRP) was dissolved in 4 ml deionized water and 0.8 ml sodium periodate. The mixture was stirred at room temperature for 20 minutes. The mixture was added 6 drops of ethylene glycol and stirred at room temperature for 5 minutes to form an oxygenated HRP solution.

[0089] 2.25 mg silk fibroin was soaked in distilled water for 30 minutes and the pH was adjusted to 9.0-9.5 with 1M sodium carbonate solution. Oxygenated HRP solution was added and the resulting solution was stirred at room temperature for 2 hours.

[0090] 3. 0.4 ml of freshly prepared 0.4% w / v sodium tetraborate solution was added to the resulting solution, and then silk fibroin was incubated in the solution for 2 hours at 2-8°C.

[0091] 4. Finally the silk fibroin is washed thoroughly and air dried.

[0092] The efficiency of the binding reaction can be assessed by peroxidase staining with diaminobenzidine. An unbou...

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Abstract

A resorbable implantable device, such as a suture or prosthesis, comprising one or more silk elements made at least partially (poly)alanine Wild silk proteins of a saturnid moth or analogues thereof.

Description

technical field [0001] The present invention relates to poly(alanine) wild silk based resorbable implantable devices and methods of producing such devices as well as raw materials for the production of such devices. In particular, one embodiment of the present invention provides absorbable sutures. Background technique [0002] The ability to prepare absorbable materials and devices for implantation in the human or animal body has considerable advantages. First, the implanted substance or device can be slowly decomposed in the body and slowly replaced by normal tissue. The function and mechanical properties of this normal tissue in the callus are likely to be better than the implanted substance, which reduces the possibility of Risk of mechanical failure, which is a serious problem with non-absorbable orthopedic implants. Second, the nature of man-made non-absorbable substances and their need to remain in contact with tissues for prolonged periods of time increases the ris...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L17/08A61L27/48A61L27/58A61L27/22A61L27/36
Inventor 戴维・菲利普・科奈特克里斯蒂娜・奥尔特莱普尼古拉斯・斯克尔
Owner SUTUROX
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