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CN-122005930-A - Biomechanically-adapted injectable magnesium-based bone cement and application thereof

CN122005930ACN 122005930 ACN122005930 ACN 122005930ACN-122005930-A

Abstract

The invention relates to the technical field of orthopaedics endophytes, in particular to biomechanically-adaptive injectable magnesium-based bone cement and application thereof. The injectable magnesium-based bone cement is prepared from the following raw materials of solid-phase raw materials, liquid-phase raw materials and hydrogel microspheres, wherein the volume ratio of the mass of the solid-phase raw materials to the volume of the liquid-phase raw materials is 0.5-3 g/1 mL, the volume of the hydrogel microspheres is 0% or 10-60% of the total volume of the preparation raw materials, the solid-phase raw materials comprise Mg 3 (PO 4 ) 2 , the liquid-phase raw materials are aqueous solutions of hydrogen phosphate, the hydrogel microspheres are formed by crosslinking sodium alginate and other natural biopolymer materials, and the hydrogel microspheres contain or do not contain Li ions. The invention solves the problems that the mechanical property of the existing bone cement is not matched with that of the bone, the degradation of the bone cement is uncontrollable, the injection is convenient for minimally invasive surgery, and the magnesium-lithium ions promote the bone-blood vessel-nerve cooperative regeneration.

Inventors

  • Zhang Ningze
  • TONG WENXUE
  • Zu Haiyue
  • ZHANG YUANTAO
  • QIN LING

Assignees

  • 华镁至臻医疗科技(苏州)有限公司

Dates

Publication Date
20260512
Application Date
20260319

Claims (10)

  1. 1. The biomechanically-adaptive injectable magnesium-based bone cement is characterized in that the preparation raw materials comprise solid-phase raw materials, liquid-phase raw materials and hydrogel microspheres, wherein the volume ratio of the solid-phase raw materials to the liquid-phase raw materials is 0.5-3 g/1 mL, and the volume ratio of the hydrogel microspheres in the injectable magnesium-based bone cement is 0% or 10-60%; The solid phase raw material comprises Mg 3 (PO 4 ) 2 ; the liquid phase raw material is aqueous solution of hydrogen phosphate, and the concentration of the hydrogen phosphate in the aqueous solution of the hydrogen phosphate is 0.5-3M; the hydrogel microsphere is formed by crosslinking sodium alginate and other natural biopolymer materials, and the hydrogel microsphere contains or does not contain Li ions.
  2. 2. The injectable magnesium-based bone cement according to claim 1, wherein said solid phase raw material further comprises bioactive glass-ceramics.
  3. 3. An injectable magnesium-based bone cement according to claim 1, wherein said other natural biopolymer material comprises one or more of gelatin, chitosan and hyaluronic acid.
  4. 4. The injectable magnesium-based bone cement according to claim 1, wherein the preparation method of the hydrogel microspheres comprises the steps of: dissolving sodium alginate and other natural biological polymer materials in water to obtain a hydrogel solution, wherein when the hydrogel microsphere contains Li ions, the hydrogel solution also comprises lithium salt; Mixing the hydrogel solution, liquid paraffin and a dispersing agent, and stirring to form uncrosslinked hydrogel microspheres, thereby obtaining a solution containing uncrosslinked hydrogel microspheres; mixing the uncrosslinked hydrogel microsphere solution with crosslinking liquid, performing crosslinking reaction, solidifying the hydrogel microsphere after the crosslinking reaction is finished, and filtering the hydrogel microsphere by using a screen to obtain the hydrogel microsphere.
  5. 5. An injectable magnesium based bone cement according to claim 1, 3 or 4, wherein the mass ratio of sodium alginate to other natural biopolymer materials is 0.1-5:1.
  6. 6. An injectable magnesium based bone cement according to claim 1, 3 or 4, wherein said hydrogel microspheres have a diameter of 400-600 μm.
  7. 7. An injectable magnesium-based bone cement according to claim 1, wherein said hydrogen phosphate salt comprises mono-hydrogen phosphate and/or di-hydrogen phosphate.
  8. 8. The injectable magnesium-based bone cement according to claim 1 or 4, wherein when the hydrogel microspheres contain Li ions, the Li ion concentration is 5 to 30mM.
  9. 9. The injectable magnesium-based bone cement according to claim 1, wherein the injectable magnesium-based bone cement has a compressive strength of 4-60MPa and a setting time of 2-30min.
  10. 10. Use of the biomechanically adapted injectable magnesium-based bone cement according to claim 9 as 3D printing material or in the preparation of endosteal plants.

Description

Biomechanically-adapted injectable magnesium-based bone cement and application thereof Technical Field The invention relates to the technical field of orthopaedics endophytes, in particular to biomechanically-adaptive injectable magnesium-based bone cement and application thereof. Background Osteoporosis and osteonecrosis are both important and troublesome clinical conditions in orthopaedics. At present, osteoporosis has become the most common bone disease in the elderly and postmenopausal women worldwide, and osteonecrosis is more common in young and young people, bringing a great burden to society. Osteoporosis and osteonecrosis patients are both caused by deterioration of bone strength and bone microstructure, and are susceptible to microfracture or brittle fracture, while spontaneous regeneration of bone is greatly limited due to reduction of healing ability, resulting in significant deterioration of quality of life. The fixation of damaged bone using endophytes often requires open surgical treatment, and the structure and strength of the endophytes remains a major issue to be addressed. Thus, bone cement filling is considered an effective strategy that can reduce endophyte failure while promoting bone repair. Bone cements are also considered ideal substitutes for autologous/allogeneic bone graft reconstruction due to their excellent osseointegration ability. It can fill irregularly shaped damaged areas, provide permanent mechanical support to prevent collapse, or gradually degrade and be replaced as new bone in-growth occurs. Bone cements commonly used in clinic include polymethyl methacrylate (PMMA), calcium phosphate bone cements (CPC such as hydroxyapatite, hyaluronic acid and brushite), calcium sulfate bone cements (CSC), and the like. PMMA is a biologically inert material and is not degradable, CPC being the filler material of choice for enhancing bone healing due to its high affinity to natural bone (i.e. high similarity of mineral composition). However, under in vivo conditions, CPC degradation is very slow and is often only absorbed by a tiny portion of the human body, which can hinder bone recovery and even cause severe inflammation. Calcium sulfate cements degrade at a rate that is relatively fast and insufficient to support the formation of new bone. The magnesium (Mg) -containing bone cement shows more proper degradation behavior and better bone-joining performance, is hopeful to replace CPC, however, the mechanical property of the current magnesium-containing bone cement is not matched with that of bone, and meanwhile, the degradation performance is not easy to regulate and control, and cannot adapt to different clinical demands. In addition, bone-vascular-nerves act as a dense, inseparable complex, playing an important role in bone tissue regeneration. The bone provides mechanical support, the blood vessels provide nutrition to the bone and nerves, and transport metabolic waste products, and the nerves can regulate bone metabolism and angiogenesis. For patients with osteoporosis or osteonecrosis, severe damage has occurred to the bone-vascular-nervous system, and achieving bone-vascular-nerve cooperative regeneration is also an important challenge. With the development of accurate medical treatment, the reduction of damage to primary tissue during surgery, the performance of minimally invasive surgery and the promotion of rapid recovery of patients have gradually become a manifestation of technological progress. Therefore, in combination with the bone mass characteristics of patients suffering from osteoporosis or osteonecrosis, the development of an injectable biomechanically-adapted and degradable controllable magnesium-containing bone cement to achieve bone-vascular-nerve cooperative regeneration is an important development direction. Disclosure of Invention In view of the above, the invention aims to provide biomechanically-adaptive injectable magnesium-based bone cement and application thereof, which solve the problems that the mechanical properties of the existing bone cement are not matched with those of bones, the degradation of the bone cement is uncontrollable, and the injection is convenient for minimally invasive surgery and bone-blood vessel-nerve cooperative regeneration. In order to achieve the above object, the present invention provides the following technical solutions: The invention provides biomechanically-adaptive injectable magnesium-based bone cement, which is prepared from the following raw materials of solid phase raw materials, liquid phase raw materials and hydrogel microspheres, wherein the volume ratio of the solid phase raw materials to the liquid phase raw materials is 0.5-3 g/1 mL, and the volume ratio of the hydrogel microspheres in the injectable magnesium-based bone cement is 0% or 10-60%; The solid phase raw material comprises Mg 3(PO4)2; the liquid phase raw material is aqueous solution of hydrogen phosphate, and the concentration of the hydrogen phosp