Pati­ent-spe­ci­fic
implants

All about
3di cra­nio­pla­s­tics

3di GmbH has deve­lo­ped its own pro­cess for manu­fac­tu­ring indi­vi­du­al CAD implants. Taking into account the sur­gi­cal aspects, it is pos­si­ble to manu­fac­tu­re pati­ent-spe­ci­fic implants within a very short peri­od of time. The main are­as of appli­ca­ti­on for our implants are: neu­ro­sur­gery, trau­ma sur­gery, tumour sur­gery, recon­s­truc­ti­ve and aes­the­tic pla­s­tic sur­gery, oral and maxillofacial sur­gery, and ear, nose and throat medi­ci­ne.

Are­as of appli­ca­ti­on

Neu­ro­sur­gery

After neu­ro­sur­gi­cal pro­ce­du­res (e. g., fol­lo­wing trau­ma, sur­gi­cal access, bone osteoly­sis, etc.), it is often neces­sa­ry to clo­se the pati­en­t’s skull again and achie­ve a satis­fac­to­ry result both neu­ro­lo­gi­cal­ly and cos­me­ti­cal­ly. This is whe­re our pati­ent-spe­ci­fic implants come in. To make the sur­ge­on’s work in the ope­ra­ting room easier and redu­ce the stress on the pati­ent, we manu­fac­tu­re indi­vi­du­al cra­nio­pla­sties that are pre­cis­e­ly adapt­ed to the pati­en­t’s defect in accordance with the neu­ro­sur­ge­on’s spe­ci­fi­ca­ti­ons. It is also pos­si­ble to pro­du­ce cor­re­spon­ding resec­tion tem­pla­tes so that tre­at­ment can be car­ri­ed out effi­ci­ent­ly and in a pati­ent-fri­end­ly man­ner in a one-stage sur­gery, saving the need for addi­tio­nal ope­ra­ti­on. On request, we can pro­vi­de the digi­tal data set in DICOM for­mat for use in the neu­ro­na­vi­ga­tio­nal device. In con­sul­ta­ti­on with our design engi­neers, various fas­tening opti­ons can be pro­vi­ded or indi­vi­du­al drill holes can be made to accom­mo­da­te medi­cal con­di­ti­ons. If neces­sa­ry, soft tis­sue defi­ci­ts can also be taken into account in implant plan­ning.

    Otorhi­no­la­ryn­go­lo­gy

    Given the par­ti­cu­lar­ly com­plex struc­tures of the jaw and facial area, pre­cis­e­ly fit­ting, cus­to­mi­zed implants signi­fi­cant­ly sim­pli­fy recon­s­truc­ti­ve sur­gery, for exam­p­le, after frac­tures, tumor ope­ra­ti­ons, or the cor­rec­tion of mis­a­lignments. 3di is able to manu­fac­tu­re pati­ent-spe­ci­fic implants and aug­men­ta­ti­ons that, depen­ding on your spe­ci­fi­ca­ti­ons [atten­ding phy­si­ci­an], may be very thin in order to fit opti­mal­ly into exis­ting ana­to­mic­al struc­tures. After con­sul­ta­ti­on bet­ween the trea­ting phy­si­ci­an and the respon­si­ble desi­gner, fas­tening opti­ons (tita­ni­um anchors) for epi­the­ses can also be incor­po­ra­ted into the implant, for exam­p­le.

      Oral and maxillofacial sur­gery

      Trea­ted dise­a­ses, inju­ries, or mal­for­ma­ti­ons in the area of the ears, nose, sinu­ses, fron­tal sinus, etc. some­ti­mes requi­re arti­fi­ci­al bone repla­ce­ment to impro­ve or res­to­re func­tion and aes­the­tics. We sup­port phy­si­ci­ans in the care of their pati­ents with our many years of expe­ri­ence in the design and manu­fac­tu­re of pati­ent-spe­ci­fic hard tis­sue repla­ce­ments. In addi­ti­on to health aspects, aes­the­tics also play an important role, espe­ci­al­ly in the head and face area, in order to enable pati­ents to enjoy a good qua­li­ty of life. It is also par­ti­cu­lar­ly important to us to pro­vi­de phy­si­ci­ans and pati­ents with fast and relia­ble, pre­cis­e­ly fit­ting CAD implants.

      Implant mate­ri­al used

      The mate­ri­al is sel­ec­ted based on medi­cal and manu­fac­tu­ring con­side­ra­ti­ons. Only medi­cal­ly appro­ved mate­ri­als are used.

      BIOVERIT®II

      is a den­se, non-out­gas­sing and non-resor­ba­ble mate­ri­al that can be machi­ned with con­ven­tio­nal tools with high manu­fac­tu­ring accu­ra­cy. BIOVERIT®II is a machinable glass cera­mic of the SiO2-Al2O3-MgO-Na2O‑K2O‑F sys­tem, con­sis­ting of a crys­tal pha­se (approx. 60 %) with main­ly phlo­go­pi­te crys­tals embedded in an alu­mi­no­si­li­ca­te glass matrix (approx. 40 %). No toxic effects are known.

      Pro­duct sheet BIOVERIT II

      PEEK

      Poly­ether­ether­ke­to­ne was deve­lo­ped as a non-resor­ba­ble high-per­for­mance ther­mo­pla­s­tic for long-term implan­ta­ti­on and is an aro­ma­tic poly­mer with a line­ar struc­tu­re belon­ging to the (poly)­aryletherketones (poly­mer group). PEEK is a semi-crystal­li­ne mate­ri­al that can be machi­ned with high manu­fac­tu­ring accu­ra­cy using con­ven­tio­nal tools. Sin­ce 2009, 3di GmbH has been pro­du­cing pati­ent-spe­ci­fic implants for the skull from this mate­ri­al.

      Pro­duct sheet PEEK

      TITANIUM

      is a non-resor­ba­ble, high­ly sta­ble metal for long-term implan­ta­ti­on and has alre­a­dy pro­ven its­elf in many are­as of the body. Due to this sta­bi­li­ty, it is pos­si­ble to design the implants to be very thin. Sub­se­quent machi­ning with sur­gi­cal tools is very dif­fi­cult or even impos­si­ble due to its high strength. Sin­ce pure tita­ni­um tends to wear down and is ben­da­ble, we use the tita­ni­um alloy Ti-6Al-4V for our implants.

      Pro­duct sheet Tita­ni­um

      Our pro­ce­du­re

      Data crea­ti­on and data trans­fer

      The neces­sa­ry data of the defect is recor­ded in the medi­cal faci­li­ty using com­pu­ter tomo­gra­phy ima­ging and then stored in DICOM for­mat.
      The data is sent to us secu­re­ly, encrypt­ed and quick­ly via our inter­net trans­fer por­tal. You can also pro­vi­de the data as a QR code by email or send it to us by post on a data car­ri­er (CD-ROM, DVD, USB stick).

      Plea­se enqui­re here for the desi­red CT scan para­me­ters and the link to the inter­net trans­fer por­tal.

      Data pre­pa­ra­ti­on

      We pro­cess and con­vert the data from the patient’s CT scan to crea­te a vir­tu­al 3D model of the patient’s head.

      Crea­ti­on of a 3D implant model

      An implant model is con­s­truc­ted on the basis of the vir­tu­al 3D pati­ent model. After con­sul­ta­ti­on bet­ween the atten­ding phy­si­ci­an and our design engi­neers, you [the phy­si­ci­an] deter­mi­ne the final implant shape. If requi­red, we will also send you phy­si­cal 3D models for implant plan­ning.

      Sen­ding appr­oval and com­mer­cial order to 3di

      In order to pro­du­ce the cra­nio­plasty, we requi­re two docu­ments in every case. The appr­oval of the design (“agree­ment pro­to­col”) by the atten­ding phy­si­ci­an, as well as a com­mer­cial order spe­ci­fy­ing the deli­very and bil­ling address.

      Manu­fac­tu­re and dis­patch of the implant

      Once the implant shape has been appro­ved, the design data is con­ver­ted into CNC con­trol data and then manu­fac­tu­red using com­pu­ter-aided pro­duc­tion in our in-house pro­duc­tion cent­re.
      Final­ly, the implant is ship­ped tog­e­ther with the neces­sa­ry paper­work and any neces­sa­ry access­ories, such as resec­tion tem­pla­tes or spe­cial screws for fix­a­ti­on.

      Fre­quent­ly asked ques­ti­ons

      How com­plex can the implants be?

      Almost any bone struc­tu­re of the human skull can be repli­ca­ted. The manu­fac­tu­ring accu­ra­cy is < 0.5 mm. The qua­li­ty of the CT data pro­vi­ded to us (age, lay­er spa­cing) is decisi­ve.

      What aspects are taken into account when desig­ning the shape?

      Func­tion­al pro­tec­tion is ensu­red and the patient’s exter­nal shape is res­to­red or signi­fi­cant­ly impro­ved in the case of gene­tic defects.

      Can soft tis­sue defi­ci­ts be com­pen­sa­ted for with the implant/augment?

      If the patient’s skin con­di­ti­on allows it, soft tis­sue defi­ci­ts can be com­pen­sa­ted for if neces­sa­ry. Howe­ver, this should defi­ni­te­ly be dis­cus­sed in advan­ce with the respon­si­ble desi­gner.

      How can the implants be ste­ri­li­sed?

      As the implants are deli­ver­ed non ste­ri­le, detail­ed clea­ning and ste­ri­li­sa­ti­on ins­truc­tions (steam ste­ri­li­sa­ti­on, 134 °C) are included with every CAD pla­s­tic sent. Our implants are sui­ta­ble for re-ste­ri­li­sa­ti­on (max. 2 repro­ces­sing cycles). Howe­ver, the decis­i­on on whe­ther to reu­se them on a pati­ent is always the respon­si­bi­li­ty of the trea­ting phy­si­ci­an.

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