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SureMAX Príomhfheidhm Ionchlannán Snáithreach Céirbheacsach le Additive Implants Inc.

Tha SureMAX Príomhfheidhm Ionchlannán Snáithreach Céirbheacsach le Additive Implants Inc. na bhuannaiche air leth urramach anns an fharpais chliùitich 2020 Duais Umha A' Design Award ann an Roinn Farpais Dealbhadh Innealan agus Uidheamachd Meidigeach.


UmhaToradh Meidigeach· 2020

SureMAX Príomhfheidhm Ionchlannán Snáithreach Céirbheacsach

le Additive Implants Inc.

Neach-ceannach: Additive Implants Inc

Buannaiche Duais Umha A' Design Award ann an Roinn Toradh Meidigeach

18,477

Buannaiche Duais Dearbhaichte

Dearbhaich Inbhe na Duaise airson #88502

Dathan

An Dealbhadh

Mu dheidhinn SureMAX Príomhfheidhm Ionchlannán Snáithreach Céirbheacsach

Is ionchlannán céirbheacsach titeáiniam é SureMAX a úsáidtear i máinliacht discéiteachtaimí agus comhtháthaithe ceirbheacsaí tosaigh. Tá righneas SureMAX ag teacht le righneas chnámh an othair, ionas nach ndéantar dochar don veirteabra agus nach socraíonn an ionchlannán isteach. Fásann cnámh go maith isteach i dtiteáiniam, ach bhí na cásanna titeáiniam níos sine rórighin. Táirgtear SureMAX trí phriontáil trí-thoiseach ó phúdar titeáiniam, rud a cheadaíonn cruthanna geoiméadracha nach féidir a mheaisínú. Tá an dromchla poiriúil agus garbhaithe chun tacú le fás cnámh. Ceadaíonn fuinneoga taobhach cneasú a fheiceáil ar íomhánna X-gha.

An Aithneachadh

Mu dheidhinn Duais Umha A' Design Award

Tha SureMAX Príomhfheidhm Ionchlannán Snáithreach Céirbheacsach air Duais Umha A' Design Award a bhuannachadh, aithneachadh gu math urramach a bheirear do dhealbhaidhean sònraichte a tha air an comharrachadh le cruthachalachd, innleachd agus geurchuis. Tha buannaichean Umha nan obraichean gu math sgileil agus gu sònraichte cruthachail a dhearbhas eòlas farsaing, mac-meanmna agus tapachd an luchd-dealbhaidh. Thathar an dùil gum bi SureMAX Príomhfheidhm Ionchlannán Snáithreach Céirbheacsach na nì air a bheil mòran meas, ion-mholta agus gràdhach, a tha gu sònraichte proifeiseanta agus ùr-ghnàthach. Tha an dealbhadh seo a bhuannaich Duais Umha A' Design Award a' cur nan cleachdaidhean as fheàrr ann an ealain, saidheans, dealbhadh agus teicneolas an gnìomh, agus tha e sàr-mhath airson an aire do mhion-fhiosrachadh. Bidh SureMAX Príomhfheidhm Ionchlannán Snáithreach Céirbheacsach a' sàsachadh fheumalachdan gu h-iongantach, a' suathadh ri miannan, a' tàladh faireachdainnean agus a' togail fiosrachd.

Air Cùl an Dealbhaidh

Pasgan Naidheachd

Creideasan, buill sgioba agus fiosrachadh teicnigeach a chuir an dealbhaiche ri chèile.

Feartan Sònraichte
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.
Tomhasan & Pacadh
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.
Tagaichean
spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine
Teicneòlas Cinneasachaidh
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
Dùbhlan Dealbhaidh
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.
Rannsachadh
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.
Brosnachadh
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.
Faid a' Phròiseict
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.
Sruth Obrachaidh
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.
Peutantan
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
Buill na Sgioba
Dr. John Ehteshami MD
Robert Brosnehan
Matt Zoghi
JD Howell
Jeff Horn
Babak Ehteshami

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