SureMAX Mosebetsi o ka Sehloohong: Sekhahla sa Methapo ea Mokokotlo oa Molala ka Additive Implants Inc.

Moralo oa SureMAX Mosebetsi o ka Sehloohong: Sekhahla sa Methapo ea Mokokotlo oa Molala ka Additive Implants Inc. ke mohlodi oa khau e hlomphehang haholo ya 2020 Moputso oa Boronse oa A' Design Award Mokhahleong oa Tlhodisano oa Moralo wa Disebediswa le Thepa ya Bongaka.

BoronseSehlahiswa sa Bongaka· 2020

SureMAX Mosebetsi o ka Sehloohong: Sekhahla sa Methapo ea Mokokotlo oa Molala

ka Additive Implants Inc.

Moreki: Additive Implants Inc

Mohlodi oa Moputso oa Boronse oa A' Design Award Mokhahleong oa Sehlahiswa sa Bongaka

17,790

Mohlodi oa Khau ea Netefaditsweng

Netefatsa Boemo ba Khau bakeng sa #88502

Etela Sebaka Sheba ho A' Design Award Tokollo ya Boraditaba Baeche ya Moputso

Mebala

Moralo

Mabapi le SureMAX Mosebetsi o ka Sehloohong: Sekhahla sa Methapo ea Mokokotlo oa Molala

Mongolo oa Buka: SureMAX ke sekhahla sa mokokotlo oa molala se entsoeng ka titanium, se sebelisoang ts'ebetsong ea ho tlosa disk le ho kopanya mokokotlo (anterior cervical discectomy and fusion surgery). Thata ea SureMAX e lekantsoe ho lumellana le thata ea lesapo la mokuli, e le hore lesapo la mokokotlo (vertebra) le se ke la senyeha 'me sekhahla se se ke sa theoha. Masapo a hola hantle ho titanium, empa likeishe tsa titanium tsa khale li ne li le thata haholo. SureMAX e hlahisoa ka mokhoa oa ho hatisa ka meralo ea 3D ho tsoa lerōleng la titanium, e leng se lumellanang le meaho eo e ke keng ea sebetsoa ka mochine. Bokaholimo ba eona bo na le mekoallo 'me bo entsoe hore bo be bosoana ho tsehetsa ho hola ha lesapo. Lifensetere tse ka mahlakoreng li lumella ho bonoa ha phekolo e ntse e etsahala ka litšoantšo tsa X-ray.

Kamohelo

Mabapi le Moputso oa Boronse oa A' Design Award

SureMAX Mosebetsi o ka Sehloohong: Sekhahla sa Methapo ea Mokokotlo oa Molala ke mohapi oa Moputso oa Boronse oa A' Design Award, kananelo e hlomphehang haholo e fuoang meralo e ikhethang e tsejoang ka boqapi, bohlale ba ho qapa le bohlale. Bahapi ba Boronse ke lintho tse nang le bokhoni ka ho felletseng le boqapi bo hlollang tse tiisang boiphihlelo bo bongata, mohopolo le bokhoni ba ho iphumana ba baqapi ba tsona. SureMAX Mosebetsi o ka Sehloohong: Sekhahla sa Methapo ea Mokokotlo oa Molala e lebelletsoe ho ba ntho e hlomphuoang haholo, e ratoang le e ratehang, e nang le boprofeshenale bo bonahalang le mehopolo e mecha. Moralo ona o hapileng Moputso oa Boronse oa A' Design Award o kenyelletsa mekhoa e metle ka ho fetesisa bonong, mahlaleng, moralong le theknolojing mme o hlahella ka ho tsepamisa maikutlo lintlheng tse nyenyane. SureMAX Mosebetsi o ka Sehloohong: Sekhahla sa Methapo ea Mokokotlo oa Molala e kutloisisa litlhoko hantle, e ama litakatso, e hapa maikutlo mme e tsosa takatso ea ho tseba.

Ka Mora Moralo

Sete ya Boraditaba

Litlhaku, ditho tsa sehlopha le lintlha tsa botekgeniki tse fanoeng ke moetsi wa moralo.

Boleng bo Ikhethang: 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.
Boholo le Phuthelo: 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.
Lithegi: spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
Theknoloji ya Tlhahiso: 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
Phephetso ya Moralo: 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.
Dipatlisiso: 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.
Kgothaletso: 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.
Nako ya Projeke: 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.
Tsamaiso ya Mosebetsi: 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.
Diphatente: 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
Litho tsa Sehlopha: Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami