| 人工牙根生物活性表面處理技術 |
人工牙根產品的主要功能在於加速骨整合(osteointegration)與有效縮短傷口癒合時間，使患者在植牙後三週內即可恢復咀嚼功能。由於人工牙根屬於class
II的醫療產品，因此製造的產品皆須符合規範，如美國的FDA、歐洲的CE與台灣的GMP。目前金屬中心在人工牙根的表面處理技術，強調於植體表面產生生物活性，如：噴砂酸蝕表面處理技術(Sand-blasted
Large-grift Acid-etched)、雙重酸蝕表面處理技術、中性溶液的電化學表面處理技術、高生物活性鹼熱表面處理技術與高親水性真空濺鍍之新製程的開發，並建立人工牙根試量產線。此五種極具生物活性的表面處理技術均可在鈦基材的人工牙根，形成1~5um的微米級孔洞，以利骨細胞的附著與生長，更加速骨整合時間。
The advantages of dental implant designing and manufacturing
are to facilitate osteointegration and to shorten the healing
over time of the damages. Patients can restore the chew function
after surgery by three weeks. Because the dental implants would
be inside the patients perpetually, the products should conform
to the FDA testing regulations. The current surface treating techniques
of dental implants in MIRDC focus on the developments of new process,
including SLA (Sand-blasted Large-grift Acid-etched) technique,
a dual-etching technique, an electrochemical surface treatment
with a neutral solution, a high-bio-active alkali-heat surface
treatment and a high-hydrophilic physical vapor deposition surface
treatment. At the same time, the facilities of mass production
are also building. All of the above five surface treatment technologies
could be applied to the Titanium-base dental implants, which are
formed 1~5um micro holes on the surface. The structures are beneficial
for cell adhesion, growth, and shortening the time of bone assimilation.
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| 整合臨床需求產生創新設計 |
臨床資訊平台結合醫師臨床需求，提供創新設計並讓產品快速試製，其中在該平台中於齒科/骨科領域，以齒科用固定釘上產出創新之產品設計概念，該技術是關於將齒科/骨科固定釘固定於組織之動力輔助手術器械商品化技術，固定釘釘入器械用以在齒槽骨上釘入固定釘，以固定再生膜，幫助骨再生。目前固定釘釘入器械設計，多以釘入器械從固定釘盛裝盤取出固定釘，將固定釘固持於釘入器械前端後，以敲槌輔助敲打釘入器械，以釘入固定釘。本技術包含一固定釘釘入器械，特定地具有釘入動力供應模組，以代替敲槌固持固定釘。進一步，透過本用於將齒科/骨科固定釘固定於組織之動力手術器械商品化技術包含上市規格設計、品質系統、符合上市需求之製程設計、臨床前及臨床試驗規畫移轉，縮短上市期程，幫助醫療器材產業快速升級。
The clinical information platform cooperates with doctor's
clinical demand, offers innovative designs and let the products
be trial-produced quickly. Within the platform, the innovative
design concept of nailing fixed on the tooth of orthopedics, technology
this about department tooth / dept. of orthopedics fixed to nail
power organized to affix to assist operation apparatus commercialized
technology, nail and enter the apparatus fixedly in order to nail
and enter nailing on the bone of tooth's socket fixedly, with
the membrane of fixed regeneration, help bone regeneration. Nail
and enter the apparatus to design fixedly at present, more in
order to nail and enter the apparatus from nailing the splendid
attire one to take out nailing fixedly, will nail holding it nailing
and entering the front of apparatus, assisting beating to nail
in order to strike the mallet into the apparatus fixedly firmly,
enter nailing in order to nail fixedly. This technology includes
nailing fixedly into the apparatus, nail and enter motive force
to supply the mould group particularly, hold nailing in order
to replace and strike the mallet firmly fixedly. Step forward,
through originally using for fixing the tooth department / dept.
of orthopedics to nail and affix the commercialized technology
of operation apparatus of motive force organized to include the
listing specification to design, quality system, accord with listing
demand make Cheng design, clinical, and the clinical trial rule
is drawn and transferred, shorten and is listed one Cheng, help
the medical apparatus industry to upgrade fast.
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研發動向