SureMAX Kev Cog Qhov Txha Caj Dab los ntawm Additive Implants Inc.

Qhov qauv tsim SureMAX Kev Cog Qhov Txha Caj Dab los ntawm Additive Implants Inc. yog tus yeej muaj nqis heev ntawm qhov khoom plig 2020 A' Design Award Tooj hauv Pawg Sib Tw Tsim Khoom Kho Mob thiab Khoom Siv Kho Mob.

ToojKhoom Kho Mob· 2020

SureMAX Kev Cog Qhov Txha Caj Dab

los ntawm Additive Implants Inc.

Tus Neeg Siv: Additive Implants Inc

Tus Yeej A' Design Award Tooj hauv Pawg Khoom Kho Mob

17,790

Tus Yeej Khoom Plig Tau Txheeb Xyuas

Txheeb Xyuas Qhov Xwm Txheej Khoom Plig rau #88502

Mus Saib Lub Vev Xaib Saib ntawm A' Design Award Tsab Xov Xwm Daim Phiaj Khoom Plig

Xim

Qhov Tsim

Txog SureMAX Kev Cog Qhov Txha Caj Dab

SureMAX yog ib qho cim titanium rau ntawm caj dab uas siv rau qhov kev ua phais anterior cervical discectomy thiab fusion. Qhov chov (stiffness) ntawm SureMAX raug kho kom sib xws nrog qhov chov ntawm tus neeg mob cov txha, yog li ntawd lub txha caj dab yuav tsis raug kub ntxhov thiab qhov khoom cog yuav tsis poob qis. Cov txha loj hlob zoo rau hauv titanium, txawm li ntawd los cov qhov cage titanium yav dhau los muaj qhov chov heev dhau. SureMAX raug tsim los ntawm kev luam ntaub qauv peb sab (three-dimensional printing) los ntawm cov paj txha titanium, uas pab tau kom muaj tau cov qauv tsim uas tsis tuaj yeem ua tau los ntawm cov cuab yeej machining. Sab nraud muaj qhov ntws (porous) thiab tsim kom nyeg heev los pab txhawb kev loj hlob ntawm txha. Cov qhov ib ce sab (side windows) pab kom pom tau qhov kho zoo los ntawm daim duab X-ray.

Qhov Lees Paub

Txog A' Design Award Tooj

SureMAX Kev Cog Qhov Txha Caj Dab yog tus yeej ntawm A' Design Award Tooj, ib qho kev lees paub muaj meej mom heev uas muab rau cov qauv tsim tshwj xeeb uas txawv los ntawm kev tsim tshiab, kev txawj tsim thiab kev ntse. Cov neeg yeej Tooj yog cov khoom muaj txuj ci heev thiab tsim tshiab heev uas ua pov thawj txog kev paub ntau, kev xav thiab kev txawj ua ntawm cov kws tsim qauv. SureMAX Kev Cog Qhov Txha Caj Dab xav tias yuav yog ib qho khoom uas neeg hwm, qhuas thiab hlub, uas tshaj lij heev thiab tsim tshiab. Cov qauv tsim yeej A' Design Award Tooj no siv cov kev coj ua zoo tshaj plaws ntawm kev kos duab, kev tshawb fawb, kev tsim qauv thiab thev naus laus zis thiab zoo heev vim nws saib xyuas cov ntsiab lus. SureMAX Kev Cog Qhov Txha Caj Dab ua tau raws li cov kev xav tau zoo kawg, kov cov kev xav, ntxias cov kev xav thiab txhawb kev xav paub.

Tom Qab Qhov Tsim

Pob Xov Xwm

Cov credit, cov neeg pab thiab cov ntsiab lus kev txawj ntse muab los ntawm tus tsim.

Yam Tshwj Xeeb: 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.
Qhov Loj & Ntim: 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.
Cov Ntsiab Lus: spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
Thev Naus Laus Zis Tsim Khoom: 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
Kev Sib Tw Tsim Qauv: 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.
Kev Tshawb Fawb: 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.
Kev Txhawb Siab: 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.
Lub Sij Hawm Ua Hauj Lwm: 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.
Txheej Txheem Ua Hauj Lwm: 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.
Cov Patent: 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
Cov Tswv Cuab Pab: Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami