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Absorbable self-locking cervical vertebra fusion cage and production method thereof

A fusion device and self-locking technology, applied in medical science, tissue regeneration, prosthesis, etc., can solve the problems of poor anti-fatigue performance, achieve the effect of small surgical trauma, reduce diagnosis and treatment costs, and avoid subsidence and collapse

Inactive Publication Date: 2020-04-14
花沐医疗科技(上海)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since both polylactic acid and β-TCP are brittle materials, the current PLA / β-TCP fusion still has the problem of poor fatigue resistance.

Method used

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  • Absorbable self-locking cervical vertebra fusion cage and production method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] This embodiment provides an absorbable self-locking cervical fusion device, comprising a fusion device body and an anchor plate, the fusion device body is composited by polylactic acid, β-tricalcium phosphate (β-TCP) and a toughening agent; the anchor The number of anchoring plates is two, the anchoring plate is made of polylactic acid material, and an inclined through hole is opened on the main body of the fusion device, and the fusion device is fixed in the patient's body through the double locking structure of the anchoring plate; the fusion device For the structure of the main body and the anchor plate, refer to the content described in CN108938150A, and will not be described in detail here.

[0039] Among them, due to the absorbable elastic properties of polycaprolactone (PCL), polyethylene glycol-polylactic acid block copolymer (PEG-PLA), polyglyceryl sebacate (PGS) and polycitrate diol (PDC), etc. The body has good toughness, biocompatibility, and the degradation...

Embodiment 2

[0048] This embodiment provides a preparation method of an absorbable self-locking cervical fusion device, which includes the preparation method of the fusion device main body and the preparation method of the anchoring plate.

[0049] Wherein, the preparation method of the fuser main body comprises:

[0050] Dry PLDLLA, β-TCP and PCL separately, and then stir and mix the three according to a certain ratio (for example, the ratio in Implementation 1); melt and blend the uniformly mixed materials; precision injection molding to obtain the fuser body;

[0051] Wherein, the melt blending of the homogeneously mixed material comprises:

[0052] a. First, set the temperature of the melting zone (upper, middle and lower) of the blender to 160-230°C, the best is 195°C, the screw speed is set to 80-150 rpm, the best speed is 100 rpm, and then Slowly pour the mixed materials into the hopper;

[0053] b. Adjust the screw speed to the set value, and circulate and knead for 90 seconds; ...

Embodiment 3

[0063] This embodiment provides a method for preparing an absorbable self-locking cervical fusion device, which includes:

[0064] Weigh nano-scale β-TCP particles, PLDLLA and PCL according to the ratio of 30:60:10 by weight, that is, the weight percentage of nano-sized β-TCP is 30%, the weight percentage of polylactic acid is 60%, and the weight percentage of polycaprolactone The weight percentage is 10%.

[0065] Dry nano-sized β-TCP particles, PLDLLA and PCL separately, then stir and mix evenly, and finally put the uniformly mixed materials into a mixing extruder for melt blending and granulation to obtain PLA / nano-sized β -TCP / PCL biomedical composite particles. The composite material particles generated by the granulator are injected and molded by a micro-injection molding machine at a certain temperature, and processed into a fuser. In addition, the pure PLDLLA material is injection-molded by a micro-injection molding machine at a certain temperature, and processed int...

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Abstract

The invention discloses an absorbable self-locking cervical vertebra fusion cage and a production method thereof. The absorbable self-locking cervical vertebra fusion cage comprises a fusion cage mainbody and an anchoring plate, wherein the fusion cage main body is produced from polylactic acid, beta-tricalcium phosphate and a toughening agent; and the anchoring plate is made of a polylactic acidmaterial. The absorbable self-locking cervical vertebra fusion cage can meet the mechanical and anti-fatigue requirements of human interbody fusion, can become a qualified substitute of an existing interbody fusion cage, is smaller in operative wound, can effectively avoid the problems of sedimentation, collapse and incomplete biological bone healing, shortens the hospitalization time of a patient and reduces the diagnosis and treatment cost.

Description

technical field [0001] The invention relates to an absorbable self-locking cervical fusion device and a preparation method thereof, belonging to the technical field of medical equipment. Background technique [0002] As an effective surgical method for the treatment of cervical spondylosis, anterior cervical discectomy and bone graft fusion are widely used in the treatment of various cervical degenerative diseases. The medical device used in this procedure, the cervical intervertebral fusion cage, provides stability after implantation, and restores and maintains intervertebral height and cervical curvature. [0003] Cervical intervertebral fusions made of materials such as titanium alloy and polyether ether ketone (PEEK) are mainly used clinically at present. However, these non-absorbable fusers cause compression on the esophagus, muscles, and tissues, bringing foreign bodies and discomfort to patients. The high elastic modulus fusion cage is also easy to form a stress shi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/58A61L27/18A61L27/12A61L27/50
CPCA61L27/12A61L27/18A61L27/50A61L27/58A61L2430/38C08L67/04
Inventor 胡艳飞董超杰杨涛罗宇星
Owner 花沐医疗科技(上海)有限公司
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