SureMAX Implant Espinal Cervical de Additive Implants Inc.

El disseny SureMAX Implant Espinal Cervical de Additive Implants Inc. és un guanyador molt estimat del prestigiós 2020 A' Design Award de Bronze en la Categoria de Competició de Disseny de Dispositius Mèdics i Equipament Mèdic.

BronzeProducte Mèdic· 2020

SureMAX Implant Espinal Cervical

de Additive Implants Inc.

Client: Additive Implants Inc

Guanyador del A' Design Award de Bronze en la Categoria de Producte Mèdic

17,790

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El Disseny

Sobre SureMAX Implant Espinal Cervical

SureMAX és un implant espinal cervical de titani utilitzat en la cirurgia de discectomia i fusió cervical anterior. La rigidesa de SureMAX s'ajusta a la rigidesa de l'os del pacient, de manera que la vèrtebra no es danya i l'implant no s'enfonsa. L'os creix bé dins del titani, però les gàbies de titani anteriors eren massa rígides. SureMAX es produeix mitjançant impressió tridimensional a partir de pols de titani, la qual cosa permet obtenir geometries que no es poden mecanitzar. La superfície és porosa i rugosa per afavorir el creixement ossi. Les finestres laterals permeten observar el procés de curació en les imatges de raigs X.

El Reconeixement

Sobre el A' Design Award de Bronze

SureMAX Implant Espinal Cervical és un guanyador del guardó A' Design Award de Bronze, un reconeixement altament prestigiós concedit a dissenys sobresortints que es distingeixen per la creativitat, l'enginy i l'astúcia. Els guanyadors de Bronze són artefactes ampliament hàbils i sorprenentment creatius que autentiquen la vasta experiència, la imaginació i el recurs dels seus dissenyadors. Es preveu que SureMAX Implant Espinal Cervical sigui un objecte molt apreciat, admirat i estimat, notablement professional i innovador. Aquest disseny guanyador del guardó A' Design Award de Bronze incorpora les millors pràctiques de l'art, la ciència, el disseny i la tecnologia i és excel·lent per la seva atenció al detall. SureMAX Implant Espinal Cervical satisfà esplèndidament les necessitats, toca els desitjos, encisa els sentiments i crida la curiositat.

Darrere del Disseny

Dossier de Premsa

Crèdits, membres de l'equip i detalls tècnics proporcionats pel dissenyador.

Propietats Úniques: 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 i Embalatge: 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.
Etiquetes: spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
Tecnologia de Producció: 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
Repte de Disseny: 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.
Recerca: 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.
Inspiració: 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.
Durada del Projecte: 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.
Flux d'Operació: 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
Membres de l'Equip: Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami