Skull bone cement_Changzhou Blon Minimally Invasive Medical Devices Technology Co. Ltd.

Language

ENGLISH

China

PMMA material introduction

Comparison of various repair materials

Product advantages

Product packaging and operation steps

PMMA material introduction

Polymethyl methacrylate (PMMA) is a polymer obtained from acrylic acid and its ester polymers and is collectively referred to as acrylic resin.

Test items

Test result

Test conclusion

Cytotoxicity test

Test results

	Proliferation rate	Reflect level
Negative control	105.0%	0
Positive control	5.7%	4
Leaching solution	86.8%	1

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Subchronic systemic toxicity test

test results:
Clinical observation: Clinical toxicity symptoms (local and systemic) were observed in all test animals.
Visual observation: There were no abnormal changes in the main cavity of the heart, lung, spleen, adrenal gland, intestine, and gonads of the control group.
Histopathological observation: Compared with the control group, there were no obvious pathological changes in 39 organs such as heart, liver, spleen, lung and kidney in the test group.
Hematology examination: Among the 12 blood routine indexes, compared with the control group, there was no statistical difference in the indexes of the test group. Among the 22 blood routine indicators, compared with the control group, the white ball ratio of the test group increased, but there was no obvious biological significance. There was no statistical difference in other indexes of the test article group.

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Bone implantation week (1, 4, 12, 26 weeks)

Histological observation

	Sample group	Control group	Difference	Degree of stimulation
	Average score	Average score
1 week	14.1	9.6	4.5	Slight irritation
4 weeks	1.8	1.2	0.6	No stimulation
12 weeks	0.5	0.7	0.2	No stimulation
26 weeks	0.5	0.5	0.0	No stimulation

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Test results

The inspected items of the tested samples meet the requirements of the Italian Tecres S.p.A. company bone cement YZB/IT-TEC01-46-2010 standard.

Comparison of various repair materials

	PMMA	Hydroxyapatite	Polyetheretherketone	Titanium mesh
Ductility	High	Low	Low	Low
Mechanical strength	High	Low	High	High
Histocompatibility	High	High	High	Low
Cost	Low	High	Moderate	Moderate

Product advantages

Good biocompatibility and high safety

PMMA materials have been used in clinical practice for more than 70 years. Compared with traditional bone cement materials, the total amount of plasticizers is less and the safety is higher.

Any shape, strong ductility

According to the defect area, the shape is personalized, thanks to the extremely ductility of PMMA, it can be accurately fitted and repaired at the defect.

Excellent mechanical properties

	Compressive strength	Bending strength
OEM standard	101±5	70±5	3000±150
ISO standard	>70MPa	>50MPa	>1800MPa

Comparison of compressive strength with other brands of repair materials: Mendec (100MP)> codman (82MP)> Biopex (8MP)

Preloaded with antibiotics to reduce the risk of infection

The infection rate related to skull repair has been from 2% to 20%. PMMA is the first bone defect repair material that can be preloaded with antibiotics (gentamicin or gentamicin + vancomycin), which greatly reduces postoperative Infection rate.

◇ The infection rate of the hydroxyapatite repair group of PMMA VS hydroxyapatite (33%) is much higher than that of the PMMA repair group (13%).

◇ The infection rate of the PMMA VS titanium mesh application titanium mesh repair group was 10.8%, and the PMMA repair group infection rate was 6.6%.

◇ PMMA was used to repair skull defects, and no postoperative infection occurred during the two-year follow-up.

Indications:

Repair of skull and jaw defects.

Product packaging and operation steps

Steps

a) Pour all the plasticizer and resin powder into the mixing bowl and mix evenly for 45 seconds;

b) Manual/mold shaping after standing for 3-4 minutes;

c) Before implantation, confirm that PMMA is cooled to room temperature and cleaned with sterile saline;

d) After PMMA is hardened, implant the defect and adjust the edge;

e) Use steel nails for fixing. The fixing holes should be ≥0.5 cm from the edge of PMMA.

*During in-situ skull formation, surgical wounds should be covered with sterile cotton gauze.	Repair sample

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Details