10 years of cranioTOP®

A cordial welcome to the homepage of CLinstruments .
cranioTOP® -cranioplasty has been introduced to the neurosurgical community 10 years ago during the industrial exhibition of the 2007 annual convention of tne German Neorosurgical Society in Leipzig.
Since then we could supply a lot of your patients witn our customized cranioplasties. We thank all our colleagues for their support and confidence in our products which by this means have been crowned so much with success. We are looking forward to wecome you at our booth during the DGNC meeting in Magdeburg May 2017.

Yours sincerely,

K.D.Lerch

Craniotop

Unique concept for closure of skull defects:

Thin sheet of pure TITANIUM as implant material offers not only its well-known unsurpassable biocompatibility but also excellent compatibility with CT and MR imaging techniques.

European Patent No.: 1806113

Indications

Skull defects of all ethiologies, such as

  • Resorption or infection of reimplanted autologous bone
  • Bone destruction caused by tumor

cranioTOP® can be used as a template for the resection of osseous tumors e.g. osseus meningeomas, metastasis and so on.

CT-und MRI-compatibility

Titanium is characterized among other things by a low specific weight and low density, the substantial parameter for the absorption of X-rays. By the use of a small implant volume (0,5 mm pure titanium sheet metal) and by proper shaping, CT-artefacts are avoided or reduced to an absolute minimum. Brain tissue visualisation remains excellent in post-operative CT-assessment of the original disease.

Susceptibility is the measure for the induced magnetizability of metals, the effect of which in MRI is additionally dependant upon the metal implant size and respective volume. A high magnetizability produces the well-known metal susceptibility artefacts in MRI, which can at times lead to complete signal and picture extinction. Pure titanium, as used in cranioTop®, exhibits an extremely low susceptibility, being of nature a paramagnetic metal. Additionally cranioTop® utilises the lowest possible implant volume which reinforces titanium’s minimal artefact characteristics. In all clinically relevant MRI-Sequences cranioTOP® demonstrates extremely little artefact behavior with MRI-visualisation of underlying brain tissue remaining excellent and completely assessable.

Studies on patients with cranioTOP®-cranioplasties with a 3,0 Tesla magnet had been performed by A.Preuß et.al. at the Department of Neurosurgery, Technical University of Munich, Germany; the results had been presented during EANS Annual Meeting in Groningen,2010 .The authors conclude that no significant impairment of MR-imaging quality occured; a further evaluation concerning signal to noise ratio is in analyzing process.
A.Preuß, A.Förschler, A.Reinke, J.Lehmberg: “3-Tesla-MR-Imaging Quality With CAD-Titanium Cranioplasty And Outcome After Surgical Treatment”.The EANS Annual Meeting 2010,Groningen, The Netherlands

Hier finden Sie einige Fallbeispiele, bei denen Sie die MR_Kompatibilität erkennen können:

Characteristics of cranioTOP®

Only a minimum volume of implant material (pure titanium plate,thickness 0,5 mm) is required even in large cranioplasties.

In order to avoid “sinking flap” dislocation and to achieve high mechanical strength, the cranioTOP®-cranioplasty is placed with its edges overlapping the margins of the skull defect (and not into the defect), secured with minimally few screws (cranioDRIVE®) and positioned optimally through integrated spacer lugs.

Applying cranioplasty upon the upper margins of the defect avoids needing major and risky operative procedures, e.g. dissection of the bone edges and the dura mater as well as duraplasty can be avoided. The cortex remains spared from manipulation.

For example, osteolytic parts of the autologous bone can remain in place if additional dissection is too risky or time-consuming.

The minimal implant volume guaranties a local insensitivity against patient exposure to heat and cold, which otherwise commonly result in headaches when using more voluminous carbide and titanium cranioplasties manufactured by block-milling, casting or LASER procedures (LASER melting).

An accompanying 3-D-printed 1:1 scale model of the individual cranium and its defect is delivered along with each cranioTOP® implant – allowing a peri-operative “in-vitro” orientation of the implant first on the model, thereby ensuring the correct “in-vivo” placement.

Full loading capacity of cranioTOP® cranioplasties is already present immediately following implantation.

“MR-safe” and “MR-compatible”:  Full compatibility with CT and MR imaging techniques, particularly in all clinically relevant MRI sequences and up to a magnetic field strength of 3 Tesla.

Advantages of cranioTOP®

Applying the cranioplasty upon the edges of the defect achieves a full load capacity right from the beginninig – no “sinking flap”.  Fixation with mini-screws.  No sutures!

Minimum effort and lowest risk in operative dissection, for example: osteolytic, non infected rest bone can remain in situ and  be covered by cranioTOP®. No stepped shoulders at the edges of the cranioplasty. The lugs for positioning and fixation can  easily be adjusted intraoperatively – if necessary.

Absolute biocompatibility guaranteed by pure titanium. Electrochemically inert, non toxic, non allergenic, bactericidal 

Patients Insensitivity to heat and cold ensured by low volume of implant material

Outstanding cosmetic results

An optimum of CT and MRI compatibility in postoperative follow-up examinations, particularly in all clinically relevant MR sequence.  

Online assistance in the OR, via camera- assisted internet communication or telephone hot-line

Construction and fit is controlled during each step of manufacture by an experienced neurosurgeon. If desired, this neurosurgeon can offer consultative support and assistance.  

From CT to an individually tailored cranioplasty

01. Acquisition of data with CT

Stable and symmetric positioning of the patient in the centre of the scan field is essential. Helical CT-scan of the whole skull using a high-resolution matrix in thin slices (1mm, soft tissue and bone windows) with overlapping acquisition(pitch<1,0) particularly in the area of the defect.

Storage of data on CD-ROM in DICOM-standard.

02. Transfer CLinstruments

What we need from you:

  • Physicians prescription of a cranioplasty for the individual patient
  • High resoluting helical CT with thin slices (1-2mm), Gantry-Tilt= 0; (stored on CD-ROM in DICOM-standard)
  • Patients name; birthday and/or an other identifying code
  • preliminary CT (before craniotomy; independent of gantry-tilt and slice-thickness; very important in case of bifrontal or bilateral defects)
  • Short information about patients history

A check-list for the planning CT-examination can be downloaded from our Homepage.

CD-ROM can be transferred by general delivery services to CLinstruments but preferably via internet to our FTP-Server (ask us please for your personal access key!)

03. 3-dimensional reconstruction

3-dimensional data-reconstruction and manufacture of a 1:1 scale model with CNC-LASER-techniques or CNC-milling, as well as the manufacture of a negative mould for constructing the cranioplasty itself. Surface polishing and preparation of the lugs for positioning and fixation. Multiple boreholes distributed over the whole cranioplasty vault ensure an optimal contact between subcutis above and Dura mater below while furthermore serving to support possible dura stitches.

04. Implantation

cranioTOP® is delivered to the client neurosurgical department together with a segmental 1:1 scale model, as well as with documentation and an implant idendity card for the patient. If desired, coordinated mini-screws (cranioDRIVE®) may be ordered additionally.

After scalp opening and retraction of the skin flap, cranioTOP® is superpositioned upon the defect with fixation using commonly available neurosurgical mini-screws or with specially coordinated cranioDRIVE® titanium (Ti6Al4V), self-cutting micro-screws (Phillips-head) that fit firmly on the screwdriver tip during application.

Boring can be performed preferably with KIRSCHNER wire or – if desired – with a spiral bore. Screws, screwdriver, KIRSCHNER wire or spiral bore and a presevation box are delivered unsterile; can be sterilised by steam autoclaving.

Drawbacks of commonly implanted cranioplasties

Polymethylmethylacrylate PMMA:
Exothermal reaction while hardening in situ with production of crystallines. Toxic and allergic. High rate of infection and rejection. Often unsatisfying cosmetic results.

Carbides (so-called ceramics):
Heavy and voluminous. Have to be inserted into the defect with all resulting risks of additional dissection of bone edges,the dura, dura plasty, venous sinuses and so on.
In case of so-called osteomimetic apatite carbide only low strength; fixation only possible with sutures!

Titanium-CNC-milled, melted or LASER-generated:
Voluminous and has to be inserted into the defect, with the undesirable consequences known from the carbides i.e. the skull has to be made suitable for the cranioplaasty.

Additionally artifact impairment of image quality in postoperative CT-and MRI-examinations.

Patient sensivity with resulting headaches while exposed to heat and cold

PRODUCT GALLERY

CONTACT

If you have any questions left.

Address

CLinstruments GMBH
Nordwall 22-24
57439 Attendorn
Germany

Phone / Fax

Phone: +49 (0) 27 22 / 63 46 43-1
Fax: +49 (0) 27 22 / 63 46 43-3

E-mail

info@clinstruments.com

For any questions left

Please don’t hesitate to contact us via the contact form and we will get in touch with you as soon as possible.






    Our company history

    In 1987 the company was established as CLinstruments, Medical Technologies and EDP-Consulting Corporation, based in Witten in North-Rhine-Westphalia, Germany by the neurosurgeon Dr. med. Karl-Dieter Lerch.

    CLinstruments’ original activity was the production and distribution of the DORTMUNDER Microstereotaxis-System, developed by LERCH in 1985 . The essential aim of this system’s development was to re-integrate stereotaxis into the general and particulary minimal invasive and endoscopic practices of neurosurgery, enabling microsurgery by stereotaxis to become the direct forerunner to present day “navigation”, but still however surpassing navigation in targeted precision. Distributed by the ZEPPELIN Corporation the LERCH-DORTMUNDER system became in the years following the most often utilised Microstereotaxis-System in Germany.

    CLinstruments (directed by the developer himself) stands at your disposal for replacement parts and, of course, for new acquisitions of complete microstereotaxis systems. The design of a titanium ventricle-draining-system CranioDRAIN®, followed, as well as LERCH´s development of a novel aneurysm-clip-system RingLOC®.

    The best known of LERCH’s neurosurgical developments and patents is, of course, CranioFIX®, a rivet-like fastener to refix craniotomy bone flaps. (The brands RingLOC®, CranioFIX®, CranioFIXII® and CranioFIXresorb® are licenced to B.Braun-Aesculap, Inc..)

    CLinstruments’ first TITANIUM cranioplasties were made in 1996 using analog production techniques. After recruiting Dipl.-Ing. Jürgen Ortmann as technical chief of staff and co-partner, development began with CAD-production titanium thin sheet cranioTOP®-cranioplasties, including registration of relevant patent applications and trademark protections. Since then cranioTOP®-cranioplasties have been implanted in clinical practice by the Neurosurgical Clinic of the Municipal Hospital of the City of Dortmund, these having been first introduced generally at the industrial exhibition acompanying the 2007 annual convention of German Society of Neurosurgery (Deutsche Gesellschaft für Neurochirurgie – DGNC) in Leipzig. Distribution has also already begun of a dedicated TITANIUM-screw-system for the fixation of cranioTOP®-cranioplasties.

    European Patent No.:1806113