Product Information 2020 - English - noras-mri
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In the picture from left to right : Manuel Noras, Daniel Gareis, Hubert Noras Dear Valued Customer, NORAS has been present internationally for over 30 years and has built a solid reputation due to its customer-oriented service. Besides our products, our slogan „we build your vision“ reflects exactly what we offer our customers: We are a competent partner with the planning and realiza- tion of your individual ideas and concepts. Our development and production is taking place mainly in Germany. The final assembly and final inspection is done manually by skilled employees, which provides an extra quality advantage. Within this catalog, you will find a summary of our products and the necessary order information. You will also learn more about our Research & Development area and customer-specific produc- tions. We look forward to working with you in the future and to fulfill your vision. Best Regards, Management of NORAS MRI products GmbH Hubert Noras Manuel Noras 3
COMPANY HISTORY 1986 the business sector MRI products. Founding of the NORAS Roentgen- und Medi- zintechnik GmbH. 2006 Initially, the company worked on improving Development of a Patient Rest for MR breast the MR imaging of surface coils. NORAS beca- examination and breast biopsy. me well known to MRI users thanks to its in- house development of an adjustable spine coil 2007 in cooperation with SIEMENS and the Institute Development of an 1.5T MR Breast Coil for inte- for Imaging Diagnostic in Wuerzburg, Germa- gration with the Patient Rest. ny (“Institut für bildgebende Diagnostik - Dr. Development of a positioning unit and fixation Wolfgang Keil”). This was followed by the de- device for MR biopsy with the GE 8Ch Breast velopment of 40 different surface coils. Coil. Development of the first adjustable spine coil. 2008 1990 Focus on the core competence MRI products NORAS MRI products GmbH Establishment of a branch office in Suhl, Ger- and therefore shutdown of the Suhl branch. many. Complete rebranding to NORAS MRI products Leibnizstraße 4 GmbH. 97204 Höchberg 1993 Development of a 3T Breast Coil for integration Germany General agent for MRI Devices Corporation, with the Patient Rest. USA. Tel.: +49 (0) 9 31-2 9927-0 2009 Fax: +49 (0) 9 31-2 99 27-20 1995 NORAS becomes vendor for the Siemens He- Start of developing a fixation unit and positio- althcare AG. Development of a transfer soluti- mri@noras.de ning system for MR-guided biopsy, which was on for the Philips Neurosurgery concept. Adap- www.noras.de patented 1996 under DE19626286C2. tion of the OR Head Coil to Philips 3T systems. 1998 2010 Development and production of a flexible OR Development of an improved OR Head Holder. head coil for the 0.2T Vertical Field Concerto Development of a 4Ch Dental Coil. from SIEMENS. Adaption of the OR Head Coil to Philips 1.5T systems. Hiring of a field representative for the 2001 U.S. market. Production of an OR Head Holder for integrati- on with a SIEMENS head coil. 2011/2012 Development of a 4Ch Orbit-Array and an 8Ch 2002 Elbow-Array. MRI Devices Europe GmbH (later Invivo) was Development of a new version of the OR Head established, for which Hubert NORAS was the Holder, MR guided prostate biopsy devices. managing director until 2005, besides admi- nistrating his own companies. 2013/2014 Development of the 16Ch Multipurpose-Array. 2003 Development of the 16Ch Uni-Belt and Uni-Lift Development and production of an OR Head for diagnostics, biopsy and therapy of the pro- Holder for SIEMENS, Erlangen, Germany, with state and other internal organs. an interface to Brainsuite® from the BrainLab AG, Munich, Germany. 2015/2016 Development of the Endocavity 2-Channel Coil 2004 and advanced USA market entry. Development of an 8Ch OR Head Coil 1.5T, to- Development of the Mandibula 15-Channel gether with RAPID Biomedical GmbH in Rimpar Dental Coil as well as project start of HYPMED. near Wuerzburg, Germany, for integration with the OR Head Holder. 2017 Relocation to a new office, including produc- Development of the Breast Biopsy 7-Channel tion facilities, in Hoechberg near Wuerzburg, Coil BI 7. Germany. 2018 2005 Development of the OR Head Holder LUCY. Development of an 8Ch (2x4) CPC coil, rotatab- le in 2 axes for parallel imaging. Internal restructuring and establishment of 4
IN SUMMARY MAMMA DIAGNOSTICS AND BIOPSY Biopsy Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Cranio-caudal Fixation Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Breast BI 7 MR Coil Set 1.5T & 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Breat Biopsy and Fixation Unit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Optional Components for Post&Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Optional Components for Grid Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Optional Components for cranio-caudal Fixation Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Breast Biopsy 4-Channel Coil BI 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Breast Biopsy and Fixation Unit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Optional Components for Post&Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Optional Components for Grid Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Optional Components for cranio-caudal Fixation Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Manual coordinate calculation for the Breast BI 7 MR Coil Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Manual coordinate calculation for the Post & Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Angulated, manual coordinate calculation for the Post & Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Manual coordinate calculation for the Grid Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 PROSTATE BIOPSY AND THERAPY Uni-Lift Prostate Intervention Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 UNIVERSAL DIAGNOSTICS AND INTERVENTION Uni-Belt 16-Channel Diagnostic & Intervention Coil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 DEDICATED MR RECEIVING COILS Variety 16-Channel Multipurpose Coil 1.5T & 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Typical Applications and Positioning Aids - Orthopedics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Typical Applications and Positioning Aids - Pediatrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Available Coil Packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Optional Components for the Variety 16-Channel Multipurpose Coil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Mandibula 15-Channel Dental Coil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 NEUROSURGERY Intraoperative Neurosurgery solution from NORAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 OR Head Holder LUCY & OR Head Coil 1.5T / 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Optional Components for NORAS OR Head Holder LUCY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 OR Head Holder FLEXIBILITY & OR Head Coil 1.5T / 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 OR Head Holder HEIDBERG & OR Head Coil 1.5T / 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Optional Components for OR Head Holder FLEXIBILITY and Upgrade Kit HEIDBERG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Development of the Noras OR Head Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 ADDITIONAL CONTENT Press Reports and Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 NORAS Corporate philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 NORAS Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 5
Biopsy Methods MAMMA Choose your preferred Breast Biopsy Method NORAS offers two different biopsy methods, each with its own advantages. Both methods are available for our Breast Biopsy Coils BI 4 and BI 7 and support MR-guided wire placement for 12, 14, 16, and 18 Gage, as well as Vacuum Gun Biopsies. The Post & Pillar Method High accuracy due to accurate coordinate 4 adjustment o il B I For Breast Biopsy 4 - C ha n n e l C Angular needle guidance 15 ° and 30 ° pos- terior and anterior Sterile disposable needle guide sleeves are available* For Breast BI 7 MR Coil Set * distributed by NORAS The Grid Method BI 4 el Coil For Breast Biopsy 4 - Chann Easy to use biopsy method Multiple biopsies in one process Sterile disposable grids are available* For Breast BI 7 MR Coil Set * distributed by NORAS Both methods are compatible with the following Vacuum Guns: C.R. Bard Vacora™ Suros Surgical ATEC™ Devicor Mammotome™ SenoRX Encor MRI™ 6
Cranio-caudal Fixation Units MAMMA With the NORAS Cranio-caudal Fixation Units you can optionally immobilize/fixate one or both breasts at the same time. Using this device, one can save up to 50% of scanning time, while reducing non-desired motion artifacts. l Coil BI 4 nn e ha -C 4 sy op For Brea s t Bi ilS et Co R I 7M For Breast B 7
Breast BI 7 MR Coil Set 1.5T & 3T NORAS product solutions for MAMMA Exclusively for the new Siemens MRI scanner generation Vida and Sola Please contact your SIEMENS The Noras Breast BI 7 MR Coil Set 1.5T & 3T is an innovative solution designed to representative for more information offer flexible use to meet the needs of the procedure to be performed in your clinic. Using the same set of comfort cushions, it can be combined with the Breast 18 You can obtain all components imaging coil from Siemens. The rigid coil frame forms a high element-density, 7-channel „phased array” con- Breast Biopsy and Fixation Unit di- figuration for high resolution imaging. One sided medial and up to two-sided rectly from NORAS. We will be plea- lateral biopsy access is possible. sed to give you personal advice. Patented lighting system integrated Post&Pillar and Grid Biopsy System The Post & Pillar biopsy system is designed for targeted needle guidance, which can be moved both left-right and anterior-pos- terior. Additionally, it supports angulated biopsies. As an alternative, disposable biopsy grids* can be used to perform biopsies also at numerous lesions at the same time. Disposable adapters* for all compatible biopsy needles and vacu- um guns are available directly from NORAS. * distributed by NORAS Fixation Units: medio-lateral and cranio-caudal Specially developed fixation units for medio-lateral or also cranio- caudal fixation of the breast are available as an option to avoid motion artifacts and reduce scan time. 8
Breat Biopsy and Fixation Unit Sets MAMMA for Breast BI 7 MR Coil Set 1.5T & 3T part number Breast Biopsy Set for Breast BI 7 on request Cranio-caudal fixation Breast BI 7 on request Optional Components for Post&Pillar Biopsy System for Breast BI 7 MR Coil Set 1.5T & 3T part number Post&Pillar Needle Guide Pillar Breast BI 7: autoclavable 118621 Post&Pillar Needle Guide Breast BI 7: autoclavable 118654 Post&Pillar Marker Breast BI 7: autoclavable 118946 Horizontal Slat Plate Breast BI 7 medial: autoclavable 118649 Horizontal Slat Plate Breast BI 7 lateral: autoclavable 118622 9
part number MAMMA 18G 118952 16G 118953 18G 16G Post&Pillar Needle Guide Sleeves disposable BI 7*: sterile; 5-pack 14G 118954 12G 118955 * distributed by NORAS 14G 12G C.R. Bard Vacora 118956 Post&Pillar Needle Guide Sleeves disposable BI 7*: for use with MR Suros Surgical ATEC 118957 compatible Vacuum Guns ; sterile; 5-pack SenoRX EnCor 10G 118958 * distributed by NORAS SenoRX EnCor 7G 118950 Optional Components for Grid Biopsy System for Breast BI 7 MR Coil Set 1.5T & 3T part number Grid Biopsy Unit disposable medial BI 7*: sterile; 5-pack 118979 * distributed by NORAS Grid Biopsy Unit disposable lateral BI 7*: sterile; 5-pack 118980 * distributed by NORAS Grid Marker Block: autoclavable 111251 18G 112660 16G 112143 18G 16G Grid Needle Blocks disposable*: sterile 14G 112659 12G 112731 * distributed by NORAS 14G 12G Breast Elevation Plate Breast BI 7 118761 10
Optional Components for cranio-caudal Fixation Unit MAMMA for Breast BI 7 MR Coil Set 1.5T & 3T part number Cranio-caudal fixation unit BI 7: single element 118719 CC-320-Plus Cushion Breast 118193 11
Breast Biopsy 4-Channel Coil BI 4 NORAS product solutions for MAMMA Exclusively for Siemens MRI Scanner Please contact your SIEMENS representative for more information The Patient Rest can be used for diagnostic imaging with the 4Ch coil and also with the optional Siemens 16Ch coil. This solution is only available through Siemens. SIEMENS 16-Channel Diagnostic Coil The NORAS Breast Biopsy 4-Channel Coil BI 4 was developed for the Siemens TIM system and serves with its 4Ch array coil for diagnostics as well as biopsy removal. The design of the whole setup is very open to ensure optimal access to the breast for interventions. Optionally, you can use the 16Ch coil* for optimized imaging (spectroscopy pos- sible) with the same Patient Rest. * distribution via Siemens Healthineers The Breast Biopsy Kit consists of a complete Post&Pillar positioning unit and two disposable grids for medial, lateral and cranio-caudal access. The biopsy set is compatible with the coordination software from Siemens, and therefore cannot be rotated by 360°. * distributed by NORAS The original components are available th- rough NORAS or through authorized re-sel- lers. Case The Breast Biopsy Kit consists of a steam ste- rilizable fixation unit including Post&Pillar po- sitioning unit. The sterile pieces* that are necessary for the biopsies are not part of the delivery content but can be ordered separately. Part of the biopsy kit is a 12G non-sterile trai- ning needle, including sleeve and cube, as well as two training grids (medial/CC and lateral). * distributed by NORAS 12
Breast Biopsy and Fixation Unit Sets MAMMA for Breast Biopsy 4-Channel Coil BI 4 part number Breast Biopsy Set Post&Pillar: autoclavable and reusable 118941 Breast Biopsy Set Grid disposable: autoclavable and reusable; with disposable grids in sterile packaging* 118943 * distributed by NORAS Breast Biopsy Set Grid reusable: autoclavable and reusable 118944 Cranio-caudal Fixation Unit CC-320-PLUS 118341 Optional Components for Post&Pillar Biopsy System for Breast Biopsy 4-Channel Coil BI 4 part number Post&Pillar positioning unit with telescope bar: autoclavable and reusable 111259 Post&Pillar Needle Guide: autoclavable and reusable; able to be angu- lated by 15° and 30° 111451 Post&Pillar marker: autoclavable and reusable; (remove marker liquid before autoclaving and refill afterwards) 111300 13
part number MAMMA 18G 112654 16G 112597 Post&Pillar needle guide sleeves*: disposable in sterile packaging 14G 112655 12G 112653 16G 18G 14G 12G * distributed by NORAS Base unit fixation plate: can be used laterally, medially and cranio-cau- dally and is used as adapter for slat plates and grids 111242 Base plate 111292 Slat plate horizontal: medial and cc 111212 Slat plate horizontal: lateral 111301 C.R. Bard Vacora MR10062-VAC Adapter Vacuum Guns for Post&Pillar System: Suros Surgical ATEC MR10062-AT autoclavable ; 2-pack SenoRX EnCor 10G MR10062-SE SenoRX EnCor 7G 113315 Guidance bracket for Invivo disposable needle guidance MR10062-MHA Disposable needle guidance (Multi Hub Assembly): not for 7G 113692 Adapter Vacuum Guns for Post&Pillar System Devicor Mammotome: autoclavable MR10062-ET2 14
Optional Components for Grid Biopsy System MAMMA for Breast Biopsy 4-Channel Coil BI 4 part number Grid Marker Block: autoclavable 111251 Grid biopsy unit: lateral, medial, CC; autoclavable and reusable 111252 Grid biopsy unit height adjustable: lateral; autoclavable and reusable 117143 Grid biopsy unit height adjustable*: lateral; disposable in sterile packaging; packaging consists of 5 grids 112235 * distributed by NORAS Grid biopsy unit height adjustable*: medial, CC; disposable in sterile packaging; packaging consists of 5 grids 112238 * distributed by NORAS 18G 112660 16G 112143 18G 16G Grid needle blocks*: disposable in sterile packaging 14G 112659 12G 112731 14G 12G * distributed by NORAS Optional Components for cranio-caudal Fixation Unit for Breast Biopsy 4-Channel Coil BI 4 part number Cranio-caudal fixation unit CC-320-PLUS: single element 118086 CC-320-Plus Cushion Breast 118193 15
MAMMA Manual coordinate calculation for the Breast BI 7 MR Coil Set On the following pages you will find instructions for the manual coordinate calculation of the BI 7 Post & Pillar and Grid Biopsy Method, which is located on the user interface of your Siemens MR-system. Besides the manual calculation of coordinates, additional solutions for software-supported coordinate calcu- lation are offered by third-party providers. Please contact NORAS or your Siemens representative directly if you have any questions regarding compatibi- lity and application. 16
Manual coordinate calculation for the Post & MAMMA Pillar Biopsy System 1 2 Perform a measurement with transversal slices and look for Start the „distance“ tool (menu, right center → „Extras“ → „di- the slice on which one you can see the marker. stance“ (ruler)). 3 4 Mark that line with a left-click and select the marked line with a right-click. In the context-menu, select „copy“. By doing so, Draw a line, straight through the pointer. the line is copied and can be pasted into other slices. 5 6 Select the „distance“ tool again and measure the distance between the lesion and the reference line that you inserted in step 5. Please note these measurements on a separate piece of paper. Scroll through the other slices until you find the lesion that In this example the Post & Pillar positioning unit has to be mo- you want to perform a biopsy on. Right-click on this slice und ved 31 mm from the starting position to anterior (because the select „Paste“. patient is lying in the prone position). 17
MAMMA 7 8 In order to determine the shift from head to feet (Post & Pillar positioning unit to the left or to the right), view the slice po- sition of the marker and lesion at the transversal slices. The The lesion you have chosen in step 5 is located in our example marker from step 1 is located on slice-position („SP“=Slice Po- on slice position H14.9. Hence, the difference is 14.9 mm – 0.5 sition) H0.5, therefore 0.5mm towards the head from the laser mm = 14.4 mm. In order to reach the lesion, you have to move positioning. the Post & Pillar positioning unit by 14mm towards the head. 9 10 Move the Post&Pillar unit with the marker according to the cal- culated coordinates (in our example 31mm downwards (ante- Perform a control scan in order to check that the marker is rior) and 14 mm towards the head). located in front of the lesion. 11 12 se the „distance” tool again in order to measure the pun- U cture depth from the surface of the skin to the middle of the lesion (in this case 31 mm). Subtract an offset, depending on the biopsy system (normally about 5-10 mm), in order to position the cannula lies in front of the lesion. Now puncture Perform a control scan in order to check that the end of the the breast with the trocar using this offset-corrected depth needle is positioned in front of (starting at skin surface). Afterwards pull the needle out of the lesion. the trocar and insert the plastic-bar into the cannula instead. The plastic-bar causes fewer artifacts than the needle and pre- The further biopsy may then be carried out by vents blood back-flow into the cannula. authorized personnel. 18
Angulated, manual coordinate calculation for MAMMA the Post & Pillar Biopsy System Perform the steps 1. to 10. from the user manual for the straight, manual calculation of coordinates. If you notice during the straight biopsy that, for example, one of the bars of the grid is in the way of the biopsy, or if you prefer to continue with an angulated biopsy for any other reason, you can also work with an angulation of 15 or 30 degrees toward the top or the bottom. 13 14 ow, an angle of 15 degrees (in this example) has to be dra- N wn to the original marker line. To do so, one needs to use the tool, which you find on the right hand side under „Extras” → Draw the first line, in this example from right to left, through „Angle“. the marker toward the lesion. 15 16 The second line has to have appropriate length toward the Draw the second line with an angle of 15 degrees from right left so it lasts at least underneath the pivot point of the Post & to left. This can also be done slightly underneath the first line. Pillar marker. You can also extend that line afterwards by pul- Please be aware that in this example, where we create the ang- ling its right endpoint. The new Marker design shows the pivot le counterclockwise, we will prepare an angle of 165 degrees. point as a black cross inside the marker. 17 18 Now, go ahead and move the second line (which forms an angle of 15 degrees with the first line) so that it has its left Choose the „distance” tool und draw a new line perpendicular endpoint in the center of the lesion. To do that, left-click the to the first line through the marker at the height of the pivot second line, hold down the left mouse key and move the line point, marked by the black cross inside the marker. It might with the mouse. help to start this line a little below the line through the marker. 19
MAMMA 19 Now move this new line, till the one ends reaches the referen- ce line through the marker and shorten it, so that is will touch the 15 degree line on the other end. You line now shows on the distance you need to move our needle guide in order to use a 15 degree angulation. In this example: 15mm up (posterior). 20 21 After movement (here 15 mm posterior) and angulation of the marker (here 15 degrees toward anterior, hence toward the After the puncture with the trocar, perform another control floor), perform a control scan in order to check that the marker scan in order to check that the end of the cannula lies right in points at the lesion. Now, determine similarly to step 11 the front of the lesion. puncture depth from the skin surface to the center of the The further biopsy may then be carried out by autho- lesion (here 30.5 mm without offset). rized personnel. 20
MAMMA Manual coordinate calculation for the Grid Biopsy System In the following the Grid localization process with medial/lateral access while using sagittal imaging slices is b riefly described. The grid pattern itself is used to locate the position of the lesion. The grid plate is mounted on the biopsy unit for the fixation of the breast. The pattern of this grid is visible on the sagittal MR-image at the edge of the breast. Therefore the grid position lying directly in line with the lesion can be identified manually. A needle block is inserted into that grid position. The lesion is marked by using the imaging tools on the scanner user interface, e.g. a circle or a cross. This marking is copied and pasted into the parallel sagittal slice, which shows the grid pattern. Now it can be easily seen, where the needle block and the needle need to be positioned. Additionally, a MR-visible marker block for better orienta- tion on the grid can be used (in this imaging example, the marker is sitting in the middle of the grid). With the knowledge of the number and thickness (plus a potential gap between slices) of the sagittal imaging slices from the surface of the grid to the lesion, the penetration depth can be easily calculated. 21
Uni-Lift Prostate Intervention Device for MR-guided interventions of the prostate Uni-Lift Prostate Intervention Device 118330 PROSTATE The Uni-Lift is designed as an arc in which the legs are mounted on brackets. The arc is adapted to the MR table and to the bore size, thereby preventing abutting of the legs while providing the maximum available space for intervention. The supine position allows transperineal access for biopsy and therapy of the prostate. As an application example a biopsy grid for transperineal access is shown. For MR-guided biopsies images can be taken by ordinary flex coils. The Uni-Lift Prostate Interventions Device from NORAS is compa- Transperineal Prostate Biopsy tible to the 70 cm Bore MR Systems (Siemens MAGNETOM Aera 1.5T, Skyra 3T & Espree 1,5T / GE Optima 450W 1.5T & Discovery For the transperineal access, the use of reusable sterilizable 750W 3T). grids made of biocompatible PEEK is provided. Height-adjustable grid biopsy unit for transperineal access. *NORAS is currently working on compatible solutions for other manufacturers of MR scanners. Kindly contact us in case you have any questions regarding the compatibility of the NORAS Uni-Lift Prostate Intervention Device for your scanner. 22
Uni-Belt 16-Channel Diagnostic & Intervention Coil Uni-Belt 16-Channel Diagnostics for diagnostic imaging and MR-guided interventions of and Intervention Coil 1.5T for SIE- On request MENS Scanner the prostate and other internal organs INTERVEN- in development TION The flexible 120 cm (47.24 in) long and 32 cm (12.6 in) wide coil is designed so that it can wrap around both hips, ab- domen and chest. The coil size is designed for optimal penetration depth to the body center. Due to a fixation system using two belts, the coil can be positi- oned very close and stable to the desired anatomy. The coil is designed for diagnostic images of the pro- state or internal organs (liver, kidney, etc), as well as MR-guided interventions, which can be performed th- rough integrated biopsy windows inside the coil plane. A biopsy unit with angulation possibility was specifically developed for the Uni-Belt coil. It can be easily attached inside the coils’ biopsy windows. Biopsies of prostate, liver, kidney, spinal cord etc. can be performed through the steam sterilizable and reusable biopsy unit made out of PEEK material. The advantage of the NORAS Uni-Belt is given by the arrangement of its single elements combined with the complete covering of the examination area. Futhermore, a better adapting to the anatomy has positive effects on the result of measurement. 23
Variety 16-Channel Multipurpose Coil 1.5T & 3T The Variety 16-Channel Multipurpose Coil enables high-resolution MR imaging in orthope- dics and pediatrics. Variety 16-Channel Multipurpose Coil 1.5T 117235 Variety 16-Channel Multipurpose Coil 3T 117234 Variety long 16-Channel Multipurpose Coil 3T 119722 The „Variety“ Coil is a 16-channel multipurpose array, which has been developed for high flexibility during examination of challenging anatomic regions. A good example for such areas is the imaging of musculoskeletal areas. VARIETY High signal quality based on a design with 8+8 array elements with high coil element density High resolution examinations of even small body regions with reduced scan durations High speed image acquisition due to the possibility of accele- rated imaging in all directions Application for diagnosis in orthopedics, pediatrics and in veterinary medicine Enables motion studies of all joints Enables mounting very close to anatomical region of interest through dedicated positioning aids (optimal image quality) • Compatibility with Siemens coil portfolio NEW: Siemens Coil File available* • No need to remove the spine coil anymore * Only applies for Siemens Skyra 3T and Aera 1.5T customers Each half of the coil is based on an 8-channel array, which can be used separately as a surface array for coverage of various body areas. The indivi- dual coil elements in each array have a small diameter of approximately 7 cm. This design results in a high signal quality, which allows for highest achievable resolutions. Based on the high mechanical FLEXIBILITY and on the small size of its array elements the “Variety“ covers a much larger field of applications for high resolution imaging in comparison to standard flexcoils. Through the use of Velcro® strips and dedicated positioning aids the “Variety“ Array can be adjusted very well to curved anatomical regions. The Variety 16-Channel Multipurpose Coil from NORAS MRI products is compatible to all Siemens Tim® systems. NORAS is currently working on compatible solutions for other manufacturers of MR-scanners. Kindly contact us in case you have any questions regarding the compatibility of the NORAS 16-Channel Multipurpose Array for your scanner. 24
Typical Applications and Positioning Aids - Orthopedics Hand and Wrist VARIETY The size of the coil halves enables imaging of the whole hand and wrist. A special positioning aid, in which the bottom coil half can be placed, creates a sta- ble and flat surface to put the hand on. If needed, the second coil half can be put on top of the hand. Alternatively, the hand can be positioned “standing up“ using our elbow positio- ning aid (see illustration below right). Elbow For smaller elbows (e.g. kids) a single coil half can be used to be wrapped around the elbow. This coil half can then be fixated using Velcro® strips. For bigger elbows, the size adjustable positioning aid can be used. 25
Shoulder A special sloped positioning device allows comfortable support on the lower coil half. For fixation of the upper coil half, you can use e.g. sandbags. VARIETY Knee, Foot and Ankle The stageless adjustment of the positioning device allows for proper support of pa- tients with a body size of up to 2.1 m and for knees with high or low volume. The flexible design also allows imaging in flexed and stretched position. Further- more, an optional supporting element for imaging in flexed position is available. We advise to use always the positioning aids in combination to enable support and less motion of the patient. 26
Typical Applications and Positioning Aids - Pediatrics Pediatrics small (0 - 6 months) VARIETY Pediatrics medium (6 - 36 months) Pediatrics large (4 - 8 years) 27
VARIETY Hand at 3T (Siemens Skyra) Hand at 3T (Siemens Skyra) Wrist at 3T (Siemens Skyra) Sequence parameters: 0.34 x 0.34 x 2 mm³; Sequence parameters: 0.29 x 0.29 x 1.5 mm³; Sequence parameters: 0.23 x 0.23 x 3 mm³; TR=3000ms; TE=58ms; TA=2:21; TR=34ms; TE=20ms; TA=2:44; TR=600ms; TE=14ms; TA=1:47; PAT-Factor: 2; FOV: 220 x 220. PAT-Factor: 3; FOV: 220 x 220. PAT-Factor: 2; FOV: 90 x 90. Shoulder at 3T (Siemens Skyra) Shoulder at 3T (Siemens Skyra) Knee at 3T (Siemens Skyra) Sequence parameters: 0.36 x 0.36 x 3 mm³; Sequence parameters: 0.41 x 0.41 x 3.2 mm³; Sequence parameters: 0.36 x 0.36 x 2.5 TR=600ms; TE=24ms; TA=3:34 min; TR=2500ms; TE=34ms; TA=2:40 min; mm³; TR=525ms; TE=11ms; TA=2:26 min; PAT-Factor: 2; FOV: 160 x 160. PAT-Factor: 2; FOV: 150 x 150. FOV: 150 x 150. Hip at 3T (Siemens Skyra) Hip at 3T (Siemens Skyra) Jaw joint at 3T (Siemens Skyra) Sequence parameters: 0.46 x 0.46 x 2 mm³; Sequence parameters: 0.43 x 0.43 x 1.2 mm³; Sequence parameters: 0.23 x 0.23 x 2 mm³; TR=600ms; TE=11ms; TA=3:48 min; TR=12.6ms; TE=5.1ms; TA=4:50 min; TR=3000ms; TE=95ms; TA=1:42 min; FOV: 119 x 119. PAT-Factor: 3; FOV: 199 x 220. FOV: 120 x 120. 28
VARIETY Elbow at 3T (Siemens Skyra) Elbow at 3T (Siemens Skyra) Foot at 3T (Siemens Skyra) Sequence parameters: 0.5 x 0.5 x 2 mm³; Sequence parameters: 0.6 x 0.6 x 3 mm³; Sequence parameters: 0.31 x 0.31 x 2 mm³; TR=729ms; TE=10ms; TA=2:54 min; TR=3000ms; TE=41ms; TA=4:33; TR=650ms; TE=11ms; TA=2:01 min; FOV: 89 x 260. PAT-Factor: 2; FOV: 200 x 200. PAT-Factor: 2; FOV: 120 x 120. Knee at 3T (Siemens Skyra) Ankle at 3T (Siemens Skyra) Ankle at 3T (Siemens Skyra) Sequence parameters: 0.31 x 0.31 x 3 mm³; Sequence parameters: 0.33 x 0.33 x 2 mm³; Sequence parameters: 0.39 x 0.39 x 3 mm³; TR=2500ms; TE=24ms; TA=2:27 min; TR=31ms; TE=18ms; TA=2:53 min; TR=3100ms; TE=34ms; TA=2:47 min; PAT-Factor: 2; FOV: 140 x 140. PAT-Factor: 3; FOV: 150 x 150. PAT-Factor: 2; FOV: 150 x 150. Child at 3T (Siemens Skyra) Child at 3T (Siemens Skyra) Child at 3T (Siemens Skyra) Sequence parameters: 0.35 x 0.35 x 4 mm³; Sequence parameters: 0.31 x 0.31 x 3.5 mm³; Sequence parameters: 0.34 x 0.34 x 3 mm³; TR=2410ms; TE=95ms; TA=5:39 min; TR=600ms; TE=20ms; TA=5:46 min; TR=633ms; TE=23ms; TA=7:32 min; PAT-Factor: 2; FOV: 181 x 223. PAT-Factor: 2; FOV: 181 x 200. PAT-Factor: 2; FOV: 165 x 220. 29
Technical Specifications Coverage Wrap Diameter Variety 16-Channel Multipurpose Coil (one coil half) 20 cm x 22 cm 5.5-8 cm VARIETY Variety 16-Channel Multipurpose Coil (both coil halves) 20 cm x 44 cm 11-17 cm Available Coil Packages part number Variety 16-Channel Multipurpose Coil 1.5T, Cable Length: 100 cm, consisting of: • Variety 16-Channel Multipurpose Coil 1.5T 2 pc. • Variety Clip 2 pc. 117235 • Variety Positioning Aid Multipurpose 2 pc. • Velcro® Fastener 300 4 pc. • Velcro® Fastener 500 4 pc. • Velcro® Fastener 500 back-to-back 4 pc. Variety 16-Channel Multipurpose Coil 3T, Cable Length: 100 cm, consisting of: • Variety 16-Channel Multipurpose Coil 3T 2 pc. • Variety Clip 2 pc. 117234 • Variety Positioning Aid Multipurpose 2 pc. • Velcro® Fastener 300 4 pc. • Velcro® Fastener 500 4 pc. • Velcro® Fastener 500 back-to-back 4 pc. Variety lang 6-Channel Multipurpose Coil 3T, Cable Length: 150 cm, consisting of: • Variety lang 16-Channel Multipurpose Coil 3T 2 pc. • Variety Clip 2 pc. 119722 • Variety Positioning Aid Multipurpose 2 pc. • Velcro® Fastener 300 4 pc. • Velcro® Fastener 500 4 pc. • Velcro® Fastener 500 back-to-back 4 pc 30
Optional Components for the Variety 16-Channel Multipurpose Coil part number Variety Positioning Aid Set Orthopedics 118353 (incl. Positioning Aids Elbow, Shoulder and Knee/Foot/Ankle) Variety Positioning Aid Set Pediatrics 118354 (incl. Positioning Aids Pediatrics small, medium and large) VARIETY Variety Positioning Aid Multipurpose 118398 Variety Positioning Aid Elbow 118468 Variety Positioning Aid Shoulder 118413 Variety Positioning Aid Knee, Foot and Ankle 118463 Variety Positioning Aid Pediatrics small 118465 Variety Positioning Aid Pediatrics medium 118467 Variety Positioning Aid Pediatrics large 118412 Variety Positioning Aid Inlay 118415 31
Mandibula 15-Channel Dental Coil Mandibula 15-Channel Dental Coil 1,5T for SIEMENS Scanner on request High-Resolution Imaging for Diagnostics in Orthodontics Mandibula 15-Channel Dental Coil 3T for SIEMENS Scanner 118871 Our Mandibula 15-Channel Dental Coil is a multi-element receive array and positioning system for three-dimensional (3D) high-resolution dental and maxillomandibular MRI images. Possible applications: • Orthodontia (instead of x-ray) • Diagnostics of the jaw joint • Imaging of periodontium and dental pulp • Implantology DENTAL • Imaging of nerves (foramen mentale) • Bone density (compacta, spongiosa) • Forensics (age estimation through wisdom tooth) • Maxifacially imaging (e.g. search for tumors) • Larynx • Inflammation Transversal view Advantages: High resolution dedicated MR imaging in dental area High resolution movement studies of the jaw joint Coil element underneath chin can be moved in and out for motion studies, e.g. on the jaw joint Easy to position and adjustable for most patients Excellent patient comfortability Optional mirror attachable for claustrophobic patients Minimized unwanted signal distortions (vibration, movement etc.) Sagittal view Panoramic teeth view 32
Intraoperative Neuro- surgery solution from NORAS As early as 2005, NORAS MRI products GmbH presented the first MR compatible head holder with receiving coils and was thus the pioneer in the field of intraoperative MRI imaging in the field of neurosurgery. With the innovative head holder NORAS was able to quickly establish a leading position in NEURO neurosurgery solutions. Based on a creative and respectful cooperation with leading neurosurgeons from Germany, Switzerland, the US and Ca- nada NORAS has created the head holders FLEXIBILITY and HEIDBERG in 2013. The head holder HEIDBERG became a strong alternative to older versions of NORAS head holders. Both head holder sys- tems convince besides excellent image quality with a unique sterile concept and an optimized workflow. The constant innovations are based on requirements, ideas and challenges that leading neurosurgeons experience in their everyday work. The increased reliability and high availability of the Head Holders FLEXIBILITY and HEIDBERG are proven in e.g. yearly more than 200 successfully completed cases in Europe using these advanced systems for MR-based neurosurgery. Thanks to ongoing enhancements and innovations, NORAS belongs to the drivers of intraoperative MR imaging. This was proven again in 2018: The new LUCY head holder combines years of experience in the field of MRI with new applications thanks to its CT compatibility. With constant innovation and new developments the NO- RAS MRI products Ltd is a reliable partner for MR-supported neurosurgery. 33
OR Head Holder LUCY & OR Head Coil 1.5T / 3T MR- and X-Ray compatible for multimodal applications for Siemens Magnetom Aera 1.5T & Skyra 3T/ Philips Ingenia 1.5T & 3T, Ingenia Ambition 1.5T & Ingenia Elition 3T* LUCY is an innovative neurosurgery solution that combines the functions of a head holder for secure fixation of the skull during interventions and a MR coil for intra-operative imaging. The head holder is compatible with the established 8-channel NORAS head coil setup. Thanks to the radiotranslucent material, the OR Head Holder LUCY (without the NORAS OR Head Coils) can also be used in the X-ray environment – CT and angiogra- phie – for intra-operative imaging. Besides tumor resections, „deep brain stimulations” (DBS) and minimally invasive pitu- itary surgery, the system also supports awake craniotomies. The NORAS OR Head Holder LUCY and the NORAS OR Head Coil 1.5T / 3T can be used with the MR systems Siemens Magnetom Aera / Skyra together with the Combi Dockable Table. Due to NEURO the compatibility to the new transferboard from Maquet our solution can be combined with the nexaris Angio-MR-CT and the Artis pheno Angiography System. Furthermore, the OP Head Holder LUCY and the NORAS OP Head Coils can be used with the Philips MR systems Ingenia 1.5T and 3T, Ingenia Ambition 1.5T and Ingenia Elition 3T. * Please contact us if you have any questions about the compatibility of the OR head holder LUCY and the head coil of NORAS. The design allows a positioning of the patient in prone, supine or lateral position on the OR table. The head frame of the NORAS OR Head Holder allows exact adaptation to the patient‘s head size. For optimal access to the area of intervention, the head frame can be pivoted, rotated, tilted and adjusted in height. A secure attachment of the patient‘s head is ensured by the three-point fixation. With the help of the integrated force indicator, the required clamping force can be checked exactly. The entire system is height-adjustable to achieve optimal patient positioning in 70 cm bores (Siemens/ Philips) as well as in Siemens CT scanners. In addition, the entire structure can be moved along the head-foot-axis and the horizontal axis. The NORAS 2x4 Ch coil concept, with the ability to position the both coils close to the head, provides excellent image quality. The OR Head Holder LUCY can be used in combination with the nexaris Angio-MR-CT and the Artis pheno Angiography System. LUCY is compatible with various surgical equipment (e.g. GREENBERG™, VarioGuide™, LEYLA retractors) and supports the navigation system of Brainlab. Thanks to a unique sterile concept, neither cables nor coils need to be sterilized! 34
Overview Collision check with bore gauge Brainlab AIR Support Optional components Excellent access to the intervention area Flexible patient positioning No sterilization of the coils and cables neces- NEURO sary 8-channel coil setup 1.5T / 3T Integrated force indicator 3-point fixation Radiotranslucent Removable and height material adjustable lower coil element 35
8-Channel Coil setup 1.5T / 3T Coil system The NORAS 8-channel coil system provides homoge- neous illumination and good imaging of the interven- tion area. The two-part construction of the coil system allows the removal of the coil halves in the preparation phase and during the intervention, which allows excellent access to the region of interest. The lower coil can be placed close to the patient‘s head due to the height adjustment possibility! NEURO height adjustable lower coil Sterile workspace: protection Sterile concept and time saving Thanks to a unique sterile concept, neither cables nor coils need to be sterilized! The sterile work area is delimited with two surgical di- sposable drapes. Thus, coils and cables as well as most of the components of the head-holder can be used in a non-sterile environment. The newly designed clamping mechanism ensures easy handling for optimum surgical drape protection! 36
3-point fixation with integra- Fixation ted force indicator Choose the right clamping force for a secure position of the patient‘s head! The integrated force indicator on the rear end of the one-point fixation allows you to control the tension be- fore and during the procedure. Optional Components for NORAS OR Head Holder LUCY part number All Purpose Arch Set LUCY: The All Purpose Arch can be attached in NEURO different angles to the toothing of the clamps in head-foot direction. If mounted in foot direction, the scalp can be sewed onto the arch or mounted with rubber bands or hooks. If mounted in the front, the 119672 arch serves as a hand rest. Additionally GREENBERG™ retractors can be mounted onto the arch by using various GREENBERG™ retractors. VarioGuide™ Adapter LUCY: With this adapter, the BrainLab VarioGui- de™ Biopsy Arm can be mounted on the left or right side of the Head 119671 Holder. GREENBERG™ Retractor Adapter: This additional adapter can be atta- ched to the All Purpose Arch and serves as an adapter of several GREEN- 114295 BERG™ and Budde® Halo retractors. It can be flexibly mounted on the All Purpose Arch. LEYLA Retractor Socket: The socket serves as mount of the various LEYLA® Retractors. The top part can be rotated horizontally in various 113243 angles. The bottom part is inserted into the dove tail of the Clamps (p/n 11937) or of the GREENBERG™ Retractor Adapter and locked tightly. Pediatrics Set LUCY: With the help of the „One-point Fixation with Force Indicator Pediatrics LUCY“ and the „Two-point Fixation Pediatrics LUCY“ it is possible to respond to the smaller head geometry of pedia- tric patients and to safely tension the head during surgery (and intra- 120368 operative imaging). The set is completed by 6 skull pins with small tips and a special strainer basket for small parts to store the sterile skull pins in the operating theatre. 37
OR Head Holder FLEXIBILITY & OR Head Coil 1.5T / 3T established Neurosurgery Solution for intraoperative MRI for Siemens Magnetom Aera 1.5T & Skyra 3T/ Philips Ingenia 1.5T & 3T/ Maquet Magnus OR Table & Alphamaquet Plus / Trumpf -TruSystem 7500 NEURO FLEXIBILITY is an established Neurosurgery Solution for intraoperative MRI. The head holder ensures safe immobilization of the head during an open skull surgery while also supporting the NORAS OR head coil system, already convinced with its excellent image quality. The Head Holder & OR Head Coils are available for Siemens and Philips 1.5T and 3T MR systems. The NORAS OR Head Holder FLEXIBILITY allows supine, prone, lateral positioning of the patient and supports awake cra- niotomies, DBS and minimally invasive pituitary surgery: FLEXIBILITY is is also suitable for pediatric applications. The Head Holder is designed as a three-point fixation in the lateral level. Furthermore, the surgeon has the option of using up to seven fixation points. For optimum access to the area of intervention, the head frame can be tilted, swiveled and rotated. The NORAS OR Head Holder FLEXIBILITY is height-adjustable, which enables excellent patient positioning in 70 cm bore systems Philips Ingenia and Siemens MAGNETOM Aera & Skyra. There is the possibility to move the setup along the head-feet-direction, which is very convenient when positioning the patient on the OR table. The NORAS OR Head Coils provide very good field homogeneity and excellent image quality. Due to a proven sterile concept, there is no need to sterilize the coils and cables. The Head Holder is compatible to various operating tools (e.g. GREENBERG™, VarioGuide™, LEYLA-Retractors) and sup- ports the navigation systems of Brainlab and Medtronic. 38
Brainlab AIR Support Overview Fixation with up to No sterilization seven points possible of the coils and cables necessary 8-channel coil setup 1.5T / 3T Removable lower coil element Flexible patient positioning NEURO NORAS MRI products has developed a “Sterile Concept” The sterile area is located between the two dra- Sterile Concept for the NORAS OR Head Holder and Head Coils. This was pes. Just the lower drape, in the picture turquoi- done in cooperation with the Neurosurgical University se, is getting perforated (the screws of the clamps Hospital of the University Clinical Center Heidelberg, penetrate the lower drape). The second drape, in the Neurosurgical Clinic of the University of Ulm at the picture violet, is not being penetrated at all. BKH Guenzburg and the Neurosurgery Center of the The coils and cables can stay non-sterile. ASKLEPIOS Clinic North – Hamburg/Heidberg. Due to this concept, there is no need to sterilize the co- ils and cables. During the development process, NORAS emphasized that the coils and cables as well as most components of the Head Holder can be used in an unsterile environ- ment. The basic concept is to create a sterile chamber in between the patient’s head and the top coil with two sterile OR drapes. A compatible version of the reference star and head holder adapter has been developed in collaboration with BrainLab AG. The reference star can now be tightly attached to the head holder without perforating the sterile OR drapes. This sterile concept is offered to all existing customers as an upgrade kit HEIDBERG. Left: Setup with All Purpose Arch, Multifunctional Bar System, VarioGuide™ Adapter and BrainLab Drape Link Reference Star. Right: Setup with two All Purpose Archs, VarioGui- de™ Adapter and BrainLab Drape Link Reference Star. 39
Flexible Pinning Possibilities Fixation Concept There are now three mounting points for height-adjus- table bottom pins. For the upper pins, a combination of one 2-point fixation and a 1-point fixation or two 2-point fixations can be mounted on each side of the head frame. This enables flexible pinning combinations in consideration of all patient positioning options. Clamping Device with Force Indicator The Clamping Device with Force Indicator allows the surgeon to apply a defined pinning force during fixati- on of the patient‘s head. Once the desired force is rea- ched, the fixation rod is tightened up by a lock lever and the clamping device can be removed. NEURO NORAS OR Head Holder FLEXIBILITY in the application 40
OR Head Holder HEIDBERG & OR Head Coil 1.5T / 3T Upgrade-Kit for our existing customers The Head Holder HEIDBERG is a further development of the older NORAS OR Head Holder versions for our existing customers. With the improved HEIDBERG model, several product features of our es- tablished neurosurgery solution FLEXIBILITY are available. The head holder ensures a secure stabilization of the head during the neurosurgical interventions. Thanks to the NORAS 8-channel OR Head Coils, excellent image quality can be achieved. We recommend all customers and users of older NORAS Head Holder versions – SI7000, SI7000-MQ, SI7300 or 113056 or 113066 (version 4) – to upgrade their systems with the HEIDBERG upgrade kit. The NORAS OR Head Holder HEIDBERG allows flexible and comfortable patient positioning and supports awake cranioto- mies, DBS and minimally invasive pituitary surgery. The OR Head Holder is suitable for use in pediatrics. The Head Holder is designed as a three-point fixation in the lateral level. Furthermore, the surgeon has the option of using up to seven fixation points. For optimum access to the area of intervention, the head frame can be swiveled and rotated. The NORAS OR Head Coils provide very good field homogeneity and excellent image quality. The OR Head Holder HEIDBERG is easy to clean. Furthermore, none of the cables nor any of the coils needs to be sterili- zed. The Head Holder is compatible to various operating tools (e.g. GREENBERG™, VarioGuide™, LEYLA-Retractors) and sup- ports the navigation systems of Brainlab and Medtronic. 41
Optional Components for OR Head Holder FLEXIBILITY and Upgrade Kit HEIDBERG part number Multifunctional Bar System: Through the modular setup of toothed joint parts and bars, the bar system can be adjusted ideally. GREEN- BERG™ retractors can be mounted onto the bars and Budde® Halo re- tractors can be clamped onto the joint parts. The ending of the joint 113217 parts is composed of a LEYLA Retractor Socket, which can be turned and locked vertically in various angles. VarioGuide™ Adapter: With this adapter, the BrainLab VarioGuide™ 111815 Biopsy Arm can be mounted on the left or right side of the Head Holder. NEURO All Purpose Arch: The All Purpose Arch can be attached in different angles to the toothing of the clamps in head-foot direction. If mounted in foot direction, the scalp can be sewed onto the arch or 113220 mounted with rubber bands or hooks. If mounted in the front, the arch serves as a hand rest. Additionally GREENBERG™ retractors can be mounted onto the arch by using various GREENBERG™ retractors. GREENBERG™ Retractor Adapter: This additional adapter can be atta- ched to the All Purpose Arch and serves as an adapter of several GREEN- 114295 BERG™ and Budde® Halo retractors. It can be flexibly mounted on the All Purpose Arch. LEYLA Retractor Socket: The socket serves as mount of the various LEYLA® Retractors. The top part can be rotated horizontally in various angles. The bottom part is inserted into the dove tail of the Clamps (p/n 113243 11937) or of the GREENBERG™ Retractor Adapter and locked tightly. Pediatric Set: The Pediatric Set has been developed in order to fulfill the requirements of pediatric demands. It includes a vacuum cushion, which effectively supports the child‘s head. Another component is a fixation force gauge with a hysteresis free cera- 114804 mic spring, which provides accuracy between 0N to 60N. A set of 6 tita- nium pins with small tips is included. 42
HISTORICAL OVERVIEW Development of the Noras OR Head Holder Head Holder SI7000 // Head Holder SI7000-MQ for Trumpf Miyabi Shell for Maquet bearing 1180-71A0 and 6042-01C0 The NORAS Head Holder SI7000 has been developed for the use with the Trumpf OR table Jupiter in combination with the Siemens Neuro Miyabi Shell for Siemens 1.5T and 3T MR systems (Espree, Symphony, Avanto, Verio, Trio). The NORAS Head Holder SI7000-MQ has been developed for the use with the Maquet bearing 1180-71A0 and 6042-01C0 for Philips Achieva 1.5T and 3T MR systems. NEURO Head Holder SI7300 For Siemens Magnetom Espree, Symphony and Verio with Rotating Table The NORAS Head Holder SI7300 has been exclusively developed for the Siemens MAGNETOM systems with rotating table. This combination allows lateral left or right patient positioning. Numerous variations of surgeries are possible, e.g. awake craniotomies in lateral position are feasible. Besides the standard components, further special components are available for the SI7300. 43
HISTORICAL OVERVIEW Head Holder 113056 // Head Holder 113066 (Version 4) for Trumpf Miyabi Shell for Maquet bearing 1180-71A0 and 6042-01C0 The NORAS Head Holder 113056 has been developed for the use with the Trumpf OR table Jupiter in combination with the Siemens Neuro Miyabi Shell for Siemens 1.5T and 3T MR systems (Espree, Symphony, Avanto, Verio, Trio). The NORAS Head Holder 113066 has been developed for use with the Maquet bearing 1180-71A0 and 6042-01C0 for Philips Achieva 1.5T and 3T MR systems. In contrast to the previous Head Holders SI7000 and SI7000-MQ, a new sterile concept has been realized. During the development process, NORAS emphasized that the coils and cables as well as most components of the Head Holder can be used in an unsterile environment. The basic concept is to create a sterile chamber in between the patient’s head and the top coil with two sterile OR drapes. For this reason, only one top array coil is required. Furthermore, the bottom array coil can now be removed for better access during the intervention. NEURO Locations of the NORAS Head Holder worldwide This map shows the locations of existing clients of our neurosurgery-solutions allover the world (Status July 2018). 44
NORAS Product Development NORAS has small administrative procedures due to the small size of the company. This results in development processes being able to be adjus- ted quickly and accurately per the customer’s re- quest. Nevertheless, all necessary departments for MR coils and MR equipment are located in one building. Starting with the mechanical development and the coil development department, continuing with the creation of a prototype and the stress tests up to the approval as a medical product, everything is being done in exceptional team collaboration. In the in-house coil R&D department new coil projects are being processed and already existing coils are being advanced according to the state of the art. 45
All of the mechanical develop- ments, from the phase of plan- ning up to series production are being edited on our 3D-CAD System (Solidworks). Mechanical adjustments and quick developments of proto- types are also being performed in the in-house department, besides the collaboration with different development partners. 46
PRESS REPORTS AND STUDIES HYPMED Innovative Breast-cancer research project HYPMED from NORAS MRI products GmbH gets EU funding over six million euros. Reviewers explicitly praise the scientific and clinical potential of the proposal. Würzburg/Brüssel, 07.09.2015 – The from NORAS supported and led by Uniklinik RWTH Aachen project proposal HYPMED (develop- ment of a hybrid MRT/PET-system for diagnostics of breast cancer) achieved top marks from the reviewers of the EU-program „Horizon 2020“ and unlimited funding recommendation. The innovative concept was praised by the reviewer commission: „The project has an extremely high potential. We expect, that the new approach of the HYPMED project will lead to earlier and better diagnosis of breast cancer by using determined MR/PET-imaging.“ „The HYPMED-project combines medical competence and physical-technical competence as well with engineering expertise in an ideal matter. It shows what potential the Uniklinik RWTH Aachen has in the field of medicine and technology “, highlights the project leader, Univ.-Prof. Dr. med. Christiane Kuhl, director of the clinic for diagnotic and interventionel radiology at Uniklinik RWTH Aachen. Together with the RWTH Aachen and other partners from all over europe NORAS will work on the HYPMED project. The Horizon MEDIA 2020-program is highly competetive; only two percent of the submitted proposals receive funding. It is extremely exceptional to score with full points from the reviewers in such a competition. Diagnose breast cancer earlier and improve treatment Breast cancer is still the leading cause of cancer related deaths among women. That’s why the search for new possibilities to diagnose the illness in an early state and to treat it is still in the focus of scientific research nowadays. The HYPMED-project aims to develop a new device for medical imaging based on the basic science of physics over the engineering implementation into the clinical test. The new device will deliver a so far not possible combination of breast-MRI and PET (positron emission tomography) thus pushing the frontiers globally in breast cancer research. “With the new device every conventional MR-system can be become a so called hybrid system if needed. It will allow us to recognize even the smallest changes and improve the assessment of tumor aggressiveness”, elabo- rates Prof. Kuhl. “Such imaging modalities are desperately needed for a targeted treatment”. This is not only true for breast cancer. The new concept will also allow for other diseases new diagnostic possibilities. “With the success of the HYPMED-project a new chapter in medical imaging will be written”, says Prof. Kuhl 47
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