SureMAX Kakla skriemeļu spinālais implants — Additive Implants Inc.

Darbs SureMAX Kakla skriemeļu spinālais implants, kura autors ir Additive Implants Inc., ir augsti novērtēts un ļoti prestižās 2020 Bronzas balva A' Design Award ieguvējs kategorijā Medicīnas ierīču un medicīnas aprīkojuma dizains.

BronzasMedicīnas produkts· 2020

SureMAX Kakla skriemeļu spinālais implants

Autors: Additive Implants Inc.

Klients: Additive Implants Inc

Bronzas balva A' Design Award ieguvējs kategorijā Medicīnas produkts

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Dizains

Par SureMAX Kakla skriemeļu spinālais implants

SureMAX ir titāna kakla skriemeļu spinālais implants, ko izmanto priekšējās kakla diskektomijas un spondilodēzes operācijās. SureMAX stingums ir pielāgots pacienta kaula stingumam, tādēļ skriemelis netiek bojāts un implants neieziežas. Kauls labi ieaug titānā, taču agrākie titāna krātiņveida implanti bija pārāk stingri. SureMAX tiek ražots ar trīsdimensiju drukāšanas tehnoloģiju no titāna pulvera, kas ļauj radīt ģeometriskas formas, kuras nav iespējams izgatavot ar mehānisko apstrādi. Virsma ir poraina un raupjota, lai veicinātu kaula augšanu. Sānu lodziņi ļauj rentgena attēlos novērot dzīšanas procesu.

Atzinība

Par Bronzas balva A' Design Award

SureMAX Kakla skriemeļu spinālais implants ir Bronzas balvas A' Design Award ieguvējs, ļoti prestiža atzinība, ko piešķir izciliem dizainiem, kas izceļas ar radošumu, atjautību un viedumu. Bronzas ieguvēji ir pietiekami prasmīgi un pārsteidzoši radoši darbi, kas apliecina to dizaineru plašo pieredzi, iztēli un izdarību. Sagaidāms, ka SureMAX Kakla skriemeļu spinālais implants būs augsti vērtēts, apbrīnots un cienīts priekšmets, ievērojami profesionāls un inovatīvs. Šis ar Bronzas balvu apbalvotais dizains iekļauj labāko praksi mākslā, zinātnē, dizainā un tehnoloģijās un izceļas ar uzmanību detaļām. SureMAX Kakla skriemeļu spinālais implants lieliski apmierina vajadzības, skar vēlmes, valdzina jūtas un piesaista zinātkāri.

Aiz dizaina

Preses materiāli

Dizainera sniegtie autori, komandas dalībnieki un tehniskie dati.

Unikālās īpašības: 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.
Izmēri un iepakojums: 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.
Birkas: spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
Ražošanas tehnoloģija: 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
Dizaina izaicinājums: 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.
Pētījums: 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.
Iedvesma: 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.
Projekta ilgums: 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.
Darbības plūsma: 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.
Patenti: 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
Komandas dalībnieki: Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami