Absorbable internally-fixed implantable iron-based alloy medical apparatus

Abstract

The invention provides an absorbable internally-fixed implantable iron-based alloy medical apparatus. A matrix of the absorbable internally-fixed implantable iron-based alloy medical apparatus comprises iron-based alloy and a degradable polymer, and is characterized in that the mass ratio of the iron-based alloy to the degradable polymer is 1: 4 to 4: 1; the weight average molecular weight of the degradable polymer is 150000-3000000; the polydispersity factor of the degradable polymer is 1-6. The absorbable internally-fixed implantable iron-based alloy medical apparatus provided by the invention further comprises an antioxidant. The iron-based alloy is used as a load-bearing framework or a reinforcing phase of the absorbable internally-fixed implantable iron-based alloy medical apparatus, so that the absorbable internally-fixed implantable iron-based alloy medical apparatus has good initial mechanical properties under the premise of reducing the using amount of the iron-based alloy matrix; through adjustment on the mass ratio and a combination mode of the iron-based alloy and the degradable polymer, the amount of an insoluble corrosion product of the iron-based alloy is reduced while the corrosion rate of the iron-based alloy in the later stage of implantation is increased, so that the corrosion product metabolizing burden of a tissue is reduced; through the addition of the antioxidant into the absorbable internally-fixed implantable iron-based alloy medical apparatus, the amount of the insoluble corrosion product of the iron-based alloy is further reduced.

Description

technical field [0001] The invention belongs to the field of absorbable implantable medical devices, in particular to an absorbable iron-based alloy internal fixation implantable medical device. Background technique [0002] The fracture healing time varies with the injury site, degree of injury and even the treatment method, usually 2 to 6 months, which requires the internal fixation and implantation of medical devices to have certain initial mechanical properties. For example, usually the initial bending strength of the bone nail needs to be over 350 MPa, and the tensile strength of the suture needs to be over 400 MPa. At present, the materials used to manufacture internal fixation and implanted medical devices for trauma repair mainly include permanent metals such as stainless steel, titanium-based alloys, and cobalt-based alloys, and absorbable materials such as polymers and magnesium-based alloys. Among them, the permanent metal has excellent mechanical properties and ...

AI Technical Summary

Problems solved by technology

[0004] Although the bending strength of absorbable bone nails made of high molecular weight polylactic acid can reach more than 150MPa, compared with traditional permanent metal materials, there are the following disadvantages: poor mechanical properties, usually only suitable for various non-load-bearing parts Fixation of cancellous bone, articular bone or bone with less activity to prevent failure of implanted medical devices due to excessive stress or frequent activities; degradation of polylactic acid will create an acidic environment, which can easily lead to serious inflammatory reactions at the implant site ; In addition, poor developability

In soft and hard tissues in the body, the time for these insoluble iron corrosion products to be metabolized and absorbed by the body may be as long as several years or even longer. metabolic burden

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