Additive Implants Inc.によるSureMAX 頸椎インプラントは、医療機器・医療設備デザインコンペティションカテゴリーにおける非常に権威ある2020 A' Design Award 銅賞の優れた受賞作品です。
銅医療製品· 2020
SureMAX 頸椎インプラント
デザイナー： Additive Implants Inc.
クライアント: Additive Implants Inc
医療製品カテゴリーのA' Design Award 銅賞受賞者
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SureMAX 頸椎インプラント について
SureMAXは、前方頸椎椎間板切除術および固定術に用いられるチタン製頸椎インプラントです。SureMAXの剛性は患者の骨の剛性に合わせて設計されているため、椎体を損傷することなく、インプラントの沈み込みも生じません。骨はチタンによく癒合しますが、従来のチタン製ケージは剛性が高すぎるという課題がありました。SureMAXはチタン粉末による三次元プリンティングで製造されており、機械加工では実現できない形状を可能にしています。表面は多孔質かつ粗面化されており、骨の成長を促進します。側面の窓により、X線画像上で治癒の状態を確認することができます。
受賞
A' Design Award 銅賞 について
SureMAX 頸椎インプラントは、創造性、独創性、鋭い洞察力で際立つ傑出したデザインに授与される、高い権威をもつ評価である A' Design Award 銅賞の受賞作品です。銅賞の受賞作品は、十分に巧みで印象的なほど創造的な工芸品であり、デザイナーの豊富な経験、想像力、機知を裏づけています。SureMAX 頸椎インプラントは、高く評価され、称賛され、愛される品であり、顕著にプロフェッショナルで革新的であることが期待されます。この A' Design Award 銅賞を受賞したデザインは、芸術・科学・デザイン・技術のベストプラクティスを取り入れており、細部への配慮に優れています。SureMAX 頸椎インプラントは、ニーズを見事に満たし、欲求に触れ、感情を魅了し、好奇心を引きつけます。
デザインの裏側
プレスキット
デザイナーが提供するクレジット、チームメンバー、技術的な詳細。
- 独自の特性
- 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.
- 寸法とパッケージ
- 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.
- タグ
- spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
- 製造技術
- 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
- デザインの課題
- 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.
- リサーチ
- 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.
- インスピレーション
- 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.
- プロジェクト期間
- 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.
- オペレーションフロー
- 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.
- 特許
- 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 - チームメンバー
- Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami
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