SureMAX Cervicaal Wervelimplantaat door Additive Implants Inc.

Het ontwerp SureMAX Cervicaal Wervelimplantaat door Additive Implants Inc. is een hoog aangeschreven winnaar van de zeer prestigieuze 2020 A' Design Award in Brons in de competitiecategorie Medisch Product Ontwerp.

BronsMedisch Product· 2020

SureMAX Cervicaal Wervelimplantaat

door Additive Implants Inc.

Opdrachtgever: Additive Implants Inc

Winnaar van de A' Design Award in Brons in de categorie Medisch Product

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Het Ontwerp

Over SureMAX Cervicaal Wervelimplantaat

SureMAX is een titanium cervicaal wervelimplantaat dat wordt gebruikt bij anterieure cervicale discectomie- en fusiechirurgie. De stijfheid van SureMAX is afgestemd op de stijfheid van het patiëntbot, zodat de wervel niet wordt beschadigd en het implantaat niet inzakt. Bot groeit goed in titanium, maar eerdere titanium kooien waren te stijf. SureMAX wordt geproduceerd door middel van driedimensionaal printen van titaniumpoeder, wat geometrieën mogelijk maakt die niet machinaal bewerkt kunnen worden. Het oppervlak is poreus en opgeruwd om botgroei te ondersteunen. Zijvensters maken het mogelijk om genezing te zien op röntgenbeelden.

De Erkenning

Over de A' Design Award in Brons

SureMAX Cervicaal Wervelimplantaat is winnaar van de A' Design Award in Brons, een hoogst prestigieuze erkenning die wordt toegekend aan uitstekende ontwerpen die zich onderscheiden door creativiteit, vindingrijkheid en scherpzinnigheid. Winnaars in Brons zijn ruimschoots vaardige en opvallend creatieve artefacten die de grote ervaring, verbeelding en het vernuft van hun ontwerpers bevestigen. SureMAX Cervicaal Wervelimplantaat wordt verwacht een hooggewaardeerd, bewonderd en gekoesterd object te zijn dat opmerkelijk professioneel en innovatief is. Dit ontwerp dat de A' Design Award in Brons heeft gewonnen, verwerkt de beste praktijken in kunst, wetenschap, ontwerp en technologie en is uitstekend door zijn aandacht voor detail. SureMAX Cervicaal Wervelimplantaat bevredigt schitterend behoeften, raakt verlangens, charmeert gevoelens en spreekt de nieuwsgierigheid aan.

Achter het Ontwerp

Perskit

Credits, teamleden en technische details verstrekt door de ontwerper.

Unieke Eigenschappen: 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.
Afmetingen & Verpakking: 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
Productietechnologie: 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
Ontwerpuitdaging: 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.
Onderzoek: 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.
Inspiratie: 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.
Projectduur: 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.
Werkproces: 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.
Patenten: 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
Teamleden: Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami