Additive Implants Inc. 的作品 SureMAX 颈椎植入物

设计师 Additive Implants Inc. 的作品 SureMAX 颈椎植入物荣获了极具声望的 2020 A' Design Award 铜奖，竞赛类别为医疗器械与医疗设备设计。

铜医疗产品· 2020

SureMAX 颈椎植入物

设计师： Additive Implants Inc.

客户: Additive Implants Inc

医疗产品类别A' Design Award 铜奖获奖者

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关于 SureMAX 颈椎植入物

SureMAX是一款用于颈椎前路椎间盘切除融合手术的钛质颈椎植入物。SureMAX的刚度与患者骨骼的刚度相匹配，因此椎体不会受损，植入物也不会下沉。骨组织能够良好地长入钛材，但早期的钛制椎间融合器刚度过高。SureMAX采用钛粉末三维打印技术制造，从而实现了机械加工无法完成的几何结构。其表面经过多孔化与粗糙化处理，以促进骨组织生长。侧面视窗则便于在X射线影像中观察愈合情况。

荣誉认可

关于A' Design Award 铜奖

SureMAX 颈椎植入物是 A' Design Award 铜奖得主，这是授予以创造力、独创性和敏锐见长的杰出设计的极具声望的认可。铜奖得主是技艺娴熟、创意惊人的作品，印证了其设计师丰富的经验、想象力与机智。预计SureMAX 颈椎植入物将成为一件备受推崇、令人钦佩且被珍爱的物品，兼具显著的专业性与创新性。这件赢得 A' Design Award 铜奖的设计融入艺术、科学、设计和技术领域的最佳实践，并因注重细节而出类拔萃。SureMAX 颈椎植入物出色地满足需求，触动渴望，迷住情感，并吸引好奇心。

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媒体资料包

由设计师提供的致谢、团队成员及技术详情。

独特属性: SureMAX is the first Titanium spinal implant that has a stiffness that matches the individual's bone stiffness as not to damage it. Bone loves to grow into Titanium but Titanium cages have been limited because they are too stiff and damage the bone. SureMAX has solved this problem through using 3D print technology with geometries that are not machinable. It also has a porous roughen surface to encourage bone to grow into it.
尺寸与包装: There are 72 sizes for SureMAX. The height, the foot print and the angle of the implant are the 3 choices. The angles are 0, 7 and 14 degrees. The choice of the angle is used to correct any stenosis in the spine (this is when the spine has a deformity and the implant is used to fix it). The heights are 5,6,7,8,9,10,11 and 12 mm. The foot prints are 12x14 mm, 14x16 mm and 15x118mm. All units come in a sterile plastic package.
标签: spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
生产技术: 3D print technology has been used with Titanium powder (Ti6Al4) using porous surface technology to achieve designs that will encourage bone to grow into the spinal implant
设计挑战: To get result required- a high performance implants which is cost competitive, the team had to design a part that could both hand the stresses and forces required by the US government FDA while solving the patient challenges. The part had to be designed so minimal post processing would be required after 3D printing. Additionally, the rough porous surface which helps the healing process required advance software and new methodologies to manufacture. The diving boards had to share the spinal loads equally in order not to displace the implant in the spine. Side windows had to be designed that permits the loads to be distributed and have large have enough surface to see the bone healing. The hardest part of the design activity was to figure out how 8 independent platforms on both sides of the implant could function as a single unit and share the loads appropriately. The surface had to be porous and roughened Ti that could handle the appropriate loads. The teeth had to be the correct size and angle in order to assure stability, but not too big or small to them a ineffective.
研究: Titanium (Ti) has always been the material of choice for implants. But Ti is hard to machine and is very stiff. In the interface between Ti and bone, bone can be damaged and the implant subside ( or settle ) in the body. Plastic and Allograft bone material implants are used to address Ti's limitations. Additional, Ti is not X-ray translucent, so physicians can not see how the bone heals through and around the implant. Plastic implants also have the limitation that they remain inert in the body- they are never adsorbed. Bone however grows very well into Ti. The challenge was to create a Ti spinal cervical implant (cervical is for the neck) that had the same stiffness as bone as not to damage it, would not subside (it would stay on top of the bone and not settle), would remain in the position inserted (with the neck movement would not slip), X-ray could go through it (healing could be observed), would pass the stress test required by the FDA and would be cost effective.
灵感: The inspiration was the lack of a solution that took advantage of new geometries that can be created with Titanium which is the best material for bone to grow into by a spine surgeon who performs over 300 cervical surgeries a year. He wanted an implant made from Titanium that matched bone's hardness, not to damage the vertebra, was visible in X-rays, so healing could be seen through, and would not subside in the spine.
项目周期: The design started in 2015 and ended in October 2018 and FDA approval was received in February 2019 (3 year design and 4 month approval). The work was done in Phoenix Arizona USA.
操作流程: The implant is used in an Anterior Cervical Discectomy Fusion (ACDF) surgery where the front of the neck is opened, the damaged cartilage removed and an implant is inserted in order to fuse the vertebra. The implant comes in a sterile plastic package. The surgeon once the damage is observed and removed assesses the size required. The appropriate implant size, angle and foot print is selected and inserted into the spine. A plate is then used (not part of SureMAX) to attach the upper and lower vertebra. The bone then grows into the implant (called inter body fusion device IBFD) and the patient heals.
专利: Patented #10,299,938 Additive Implants Inc., May 2019, USA
5 additional patent pending and provisional patents
FDA #K182477 (2019), holder Additive Implants Inc. USA
Trademark #88115736 (2018), Additive Implants Inc. USA
团队成员: Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami