骨科和脊柱植入物

用于植入物的生物相容性涂层。

Ionbond Medical Portrait
Hip Implant with ball

骨科和脊柱植入物涂层

骨科和脊柱植入物的预期使用寿命较长,这意味着植入物应具有优良的耐磨性,且不会对接受植入者造成有害影响。爱恩邦德 Medthin 涂层可实现符合这些要求的表面特性。

  • 防过敏。对于对金属过敏的患者,Medthin 涂层可减少由金属离子释放引起的过敏反应。我们的 Medthin 生物相容涂层可作为金属离子屏障,阻挡金属植入物释放的 98% 的 Co 或 Ni 离子。
  • 减少磨损。Medthin 涂层非常坚固,可减少植入物关节面之间多达 70% 的磨损和摩擦。这样不但可以减少来自 UHMWPE 和金属植入物的碎屑,亦可延长植入物的使用寿命。
Medical wrist implant

创伤创伤固定板、螺钉和锥形体涂层

例如在使用创伤固定板、螺钉和锥形体的情况下,金属部件之间的微动会导致微动腐蚀。在创伤植入物上采用 Medthin™ 涂层有助于防止这种情况发生。在存在腐蚀性体液的情况下,幅度 <250 微米的微动会除去不锈钢和钛制部件上的钝化氧化膜。这会导致微动腐蚀并使植入物释放离子,严重时还会产生大量被氧化的金属磨屑。第二代 Medthin™ 01 TiN 或第三代 Medthin™ 42 DLC 和 Medthin™ 53 SiN(爱恩邦德专利)等涂层有助于避免这些问题,从而延长涂层产品的使用寿命,提高其市场接受度。

Knee implant

Biocompatible Medthin™ coatings

  • 采用Medthin™ 01 TiN涂层的器械已获得多项引用爱恩邦德主文件 1413 的 FDA 510(k) 许可。目前,美国、瑞士和中国的爱恩邦德工厂正采用第二代氮化钛涂层沉积工艺加工各种骨科植入物,例如膝关节、肩关节和髋关节替换物
  • 众所周知,Medthin™ 11涂层可以减少植入物基底材料(如CoCr、SS或TAV)的离子释放。爱恩邦德目前可以从欧洲和亚洲使用大型涂层室以有吸引力的价格提供 "Medthin™ 11 TiNbN on Implants "的涂层服务。
Cell growth visualisation square

PEEK 和 PEKK 上的细胞生长表面和 Ti 涂层

将医用植入物整合或固定在骨骼中是提高植入物稳定性、减少对患者不利影响的重要方式。为此,可选择在 CoCrMo、不锈钢或 PEEK 上涂覆钛涂层,促进细胞附着和/或骨内生。对于由聚醚醚酮 (PEEK) 和聚醚酮酮 (PEKK) 制成的器械,Medthin™ 65 Ti(金属)涂层具备良好的细胞生长特性,可支持细胞附着。Medthin™ 65 涂层对于细胞黏附应用和 PEEK/PEKK 应用具有重要优势:

  • 细胞附着
  • 在 PEEK 和 PEKK 上具备良好的涂层附着力
  • 涂层粗糙度可调
  • 保留 PEEK/PEKK 结构

采用二代或三代 PVD 技术进行钛沉积,可实现优异的涂层附着强度(>20MPa,根据 ASTM F1147);同时,其沉积温度较低(<140°C),可完整保留 PEEK/PEKK 的结构特性。涂层工艺对 PEEK 结构的影响已通过差示扫描量热法 (DSC) 和傅里叶转换红外光谱 (FTIR) 得以验证。

采用 Medthin™ 65 Ti 涂层的 PEEK 脊柱融合器在 X 射线、CT 和 MRI 影像上是透明的,便于外科医生后续确认植入物的放置情况、位置和完整性。这种放射线透亮性使医生更容易确认治疗效果是否理想,有助于防止因植入物迁移引起脊柱融合,导致严重并发症。

我们为植入物提供的涂层解决方案

医疗
Knee implant

Medthin™ 01 - Implants

A reference coating for implants

Medthin™ 01 coating is particularly suitable for improving articulating joints such as those of “Coating on UHMWPE” where polyethylene wear and ion release from substrates (CoCr, SS, TAV, etc)  is strongly reduced. The coating is applied with thickness of about 5µm and it has adhesion strength to metal substrates higher than 1.5GPa leading to pristine abrasion resistance measured under knee and hip simulator tests compliant with ISO 14243 and ISO 14242 respectively. Titanium Nitride (TiN) is deposited with latest generation technologies showing a polycrystalline cubic structure with a fine and very dense structure,  roughness (Ra) values below 0.05µm, ideal for articulating zones. The coating coverage is rather uniform on external surfaces whereas for inner surfaces a Ionbond proprietary technology can be applied in some cases. Ionbond can currently deliver coating service of “Medthin™ 01 TiN on Implants” from America, Europe and Asia and the coating properties/characteristics have been filed in a FDA master file (MAF) number 1413. The MAF can be referred upon request and common agreement with Ionbond.

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医疗
Medical Knee Implant Gold

Medthin™ 11 - Implants

A possible alternative to TiN - in line with existing predicates

Medthin™ 11 coating is known to reduce ion release from implant substrates materials such as CoCr, SS or TAV. The coating is applied with thickness of about 5µm and it has adhesion strength to metal substrates higher than 1.0GPa leading to an  improved abrasion resistance when compared with uncoated CoCrMo. Titanium Niobium Nitride (TiNbN) is deposited with latest generation Ionbond technologies showing a polycrystalline cubic structure with a fine and very dense structure, roughness (Ra) values below 0.05µm, ideal for articulating zones.  The coating coverage is rather uniform on external surfaces whereas for inner surfaces a Ionbond proprietary technology can be applied in some cases.

Ionbond  can currently deliver coating service ”me too” of “Medthin™ 11 TiNbN on Implants” from Europe and Asia using large coating chambers at attractive prices.

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医疗
Medthin 42 acetabular insert

Medthin™ 42 - Implants

Probably the best (hard) coating for implants

Medthin™ 42 coating combines high adhesion strength with low UHMWPE wear and nearly no ion release from the implant substrate reaches the body fluids from the patient. The coating is applied with thickness of about 5µm and it has adhesion strength to metal substrates higher than 1.5GPa. Chromium Nitride + Diamond Like Carbon (top layer) for implants, is deposited with an hybrid system, a combination of PVD high energy sputtering and Plasma Assisted Chemical Vapor Deposition Technologies (PACVD). The top layer is amorphous and has excellent sliding characteristics with extremely low friction coefficients against many materials including ceramic.

The coating coverage is rather uniform on external surfaces.  Ionbond  can currently deliver coating service of “Medthin™ 42 DLC on Implants” from America, Europe and Asia.

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医疗
Medical disco cervical

Medthin™ 43 - Implants

The high class coating for implants

Medthin™ 43 coating is excellent to improve articulating joints such as those of “Coating on UHMWPE” where polyethylene wear and ion release from substrates (CoCr, SS, TAV, etc)  is reduced nearly to zero. The coating is applied with thickness of about 3 µm and it has adhesion strength to metal substrates higher than 0.8 GPa. Amorphous Diamond Like Carbon (ADLC) is deposited with latest generation Plasma Assisted Chemical Vapor Deposition Technologies (PACVD) showing an amorphous phase virtually with no pores and roughness (Ra) values below 0.02µm, ideal for articulating zones. The coating coverage is rather uniform on external surfaces whereas for inner surfaces a Ionbond proprietary technology can be applied in some cases.


Ionbond  can currently deliver coating service of “Medthin™ 43 ADLC on Implants” from Switzerland, France and UK and the coating properties/characteristics have been filed in a FDA master file (MAF) number 1647. The MAF can be referred upon request and common agreement with Ionbond.

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医疗
Knee prothesis gold

Medthin™ 60 - Implants

The high oxidation resistance coating

Medthin™ 60 coating is particularly suitable for improving articulating joints such as those of “Coating on UHMWPE” where polyethylene wear and ion release from substrates (CoCr, SS, TAV, etc)  is strongly reduced. The coating is applied with thickness of about 5 µm and it has adhesion strength to metal substrates in the GigaPascal range. The ZrN layer improves UHMWPE abrasion resistance >65% measured on knee simulator tests compliant with ISO 14243. Zirconium Nitride (ZrN) is deposited with latest generation technologies showing a polycrystalline cubic structure with a fine and very dense structure,  roughness (Ra) values below 0.05µm, ideal for articulating zones. The coating coverage is rather uniform on external surfaces while internal surfaces are difficult to coat.

Ionbond  can currently deliver coating service of “Medthin™ 60 ZrN on Implants” from multiple coating centers.

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Ton Hurkmans

Dr. Ton Hurkmans

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