SureMAX 경추 척추 임플란트 by Additive Implants Inc.

SureMAX 경추 척추 임플란트 by Additive Implants Inc. is a highly esteemed winner of the very prestigious 2020 A' Design Award 동상 in 의료 기기 및 의료 장비 디자인 Competition Category.

동의료 제품· 2020

SureMAX 경추 척추 임플란트

by Additive Implants Inc.

Client: Additive Implants Inc

A' Design Award 동상 Winner in 의료 제품 Category

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The Design

About SureMAX 경추 척추 임플란트

SureMAX는 전방 경추 디스크 제거 및 유합술에 사용되는 티타늄 경추 척추 임플란트입니다. SureMAX의 강성은 환자의 뼈 강성에 맞춰 설계되어 척추뼈가 손상되지 않고 임플란트가 가라앉지 않습니다. 뼈는 티타늄 내부로 잘 자라 들어가지만, 기존의 티타늄 케이지는 지나치게 단단했습니다. SureMAX는 티타늄 분말을 이용한 3차원 프린팅 방식으로 제작되어 기계 가공으로는 구현할 수 없는 형상을 실현합니다. 표면은 다공성이며 거칠게 처리되어 골 성장을 촉진합니다. 측면 창을 통해 X선 영상에서 치유 과정을 확인할 수 있습니다.

The Recognition

About the A' Design Award 동상

SureMAX 경추 척추 임플란트, 이 작품은 A' Design Award 동상 수상작으로, 창의성, 독창성, 영민함으로 돋보이는 뛰어난 디자인에 수여되는 높은 권위의 인정입니다. 동상 수상작은 충분히 숙련되고 인상적으로 창의적인 작품으로, 디자이너의 폭넓은 경험, 상상력, 기지를 입증합니다. SureMAX 경추 척추 임플란트, 이 작품은 높이 평가받고 감탄과 사랑을 받는 사물로서 두드러지게 전문적이고 혁신적일 것으로 기대됩니다. 이 동상 수상 디자인은 예술, 과학, 디자인, 기술의 모범 사례를 담고 있으며 세부에 대한 주의로 훌륭합니다. SureMAX 경추 척추 임플란트, 이 작품은 필요를 훌륭하게 충족하고 욕망에 닿으며 감정을 매료하고 호기심을 불러일으킵니다.

Behind the Design

Press Kit

Credits, team members and technical details provided by the designer.

Unique Properties: 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.
Dimensions & Packaging: 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.
Tags: spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
Production Technology: 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
Design Challenge: 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.
Research: 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.
Inspiration: 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.
Project Duration: 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.
Operation Flow: 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.
Patents: 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
Team Members: Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami