EPM MUELLER® Modular Extractor System 2 - epm
Contents
1. 11 TECHNICAL DATA 11 1 EPM Mueller stem extractor S2 or AU2 Tapers 8 16 mm Striking weight 1 0 kg 2 2 Ib Total weight 2 2 kg 4 84 Ib 1 2 kg 2 4 Ib PN Variant Total length 550mm 21 7 inches Standard 620mm 25 inches long 350mm PN Hitting distance 205mm 8 1 inches standard 275mm 8 8 inches long 11 2 EPM Mueller modular stem extractor MO1 Inside modular neck 8 10mm 10 17mm Striking weight 1 0 kg 2 2 Ib Total weight 2 65 kg 5 83 Ib 1 35 kg 2 97 Ib PN Variant Total length 560mm 22 1 inches Standard 630mm 25 inches long 360mm PN Hitting distance 205mm 8 1 inches standard 275mm 8 8 inches long 11 3 EPM Mueller Knee Prosthesis extractor K2 Prosthesis dimensions 7 110mm Striking weight 1 0 kg 2 2 Ib Total weight 2 65 kg 5 83 Ib 1 35 kg 2 97 Ib PN Variant Total length 590mm 23 3 inches Standard 660mm 26 inches long 360mm PN Hitting distance 205mm 8 1 inches standard 275mm 8 8 inches long 11 4 EPM Mueller acetabular hemispheric and screw cup extractor C2 Cup outside dimension 38 74mm Striking weight 1 0 kg 2 2 Ib Total weight 2 65 kg 5 83 Ib 1 35 kg 2 97 Ib PN Variant Total length 590mm 23 3 inches Standard 660mm 26 inches long 360mm PN Hitting distance 205mm 8 1 inches standard 275mm 8 8 inches long 11 5 EPM Mueller2. 9 1 1 DESCRIPTION The universal extraction device for total hip replacement femoral components EPM Mueller Extractor is a modern surgical instrument which addresses problems arising through the increasing number of revision surgeries in total joint replacement lt ensures secure efficient low cost and correct handling Ergonomic aspects concerning the design of the grip and handling have been incorporated into manufacture as a result of ongoing feedback and development Key part of the instrument is the patented clamping mechanism and head with exceptional clamping force ensuring a secure connection between the instrument and almost all implant necks or tapers commercially available today The applied force is transferred to the prosthesis neck axially thereby avoiding dangerous eccentric leverage EPM hs Endo Plant M ller GmbH 9 1 2 COMPONENTS 1 Head of Tool 4 Striking Weight 7 Jamcase 10 Lever 2 Sliding Spacer 5 Pressure Rod 8 Pin with screw 3 Guiding Tube 6 Handpiece 9 Bolt with plasticinset al 6 Zon TO Ur a u I Ser d zc WU A d o Fig 1a Fig 1b Variant AE ABC extractor 9 1 3 HANDLING The EPM Mueller Extractor AU is delivered completely assembled and ready for use NON STERILE Sterilization is the responsibility of the User gt OPENING Fig 2 Open lever 1 and thread between jamcase and handpiece working thread with circular movements reverse clockwise
3. EPM Ms Endo Plant M ller GmbH Extraction Tools for Total Hip Replacements EPM Mueller Stem Extractor AU AU2 S S2 EPM Mueller Modular Extractor System 2 Knockout Tool for Joint Prosthesis CE ISO 13485 FDA Establishment Registration Number 3003759646 Patented in most countries USA Pat Nr 5 534 006 USA Pat Nr 8 603 100B2 EP 0 645 127 DE 43 32 872 C1 Technical Documentation Development of EDM Endo Plant Muller GmbH Copyright 1993 2014 All rights reserved EPM Endo Plant Muller GmbH Schleusen Str 8 63839 Kleinwallstadt Tel 49 0 6022 25419 Fax 49 0 6022 25419 e Mail epmmueller aol com Ust IdNr 180825097 Registered Aschaffenburg HRB 8276 manager E J M ller MD MDstom www epm mueller de _ EPM _ d Endo Plant M ller GmbH Technical Documentation Content 1 Introduction 2 Definition of medical tasks 3 Finite element model FEM analysis for revision with conventional extractors 3 1 Finite element FEM conditions and loads 3 2 Results and discussion 4 Principle and construction of the EPM Mueller Stem Extractor 5 Measurement of the functional Prototype 6 The EPM Mueller Extractor the EPM Mueller Modular Extractor System 2 6 1 EPM Mueller Stem Extractor 6 2 EPM Mueller Modular Extractor System 2 6 2 1 EPM Mueller Modular Extractor system 2 components 6 2 2 EPM Mueller Modular Extractor System 2 posibilities 7 FEM analysis for the revis
4. _ EPM _ Ms Endo Plant M ller GmbH 1 Introduction Since its inception in the early 60 s total hip replacement surgery has become enormously important today it is one of the most successful surgical interventions in orthopedics One of the problems in total hip replacement and joint replacement surgery in general is the limited survival time of the implants which have not reached the biomechanical qualities of the natural hip joint Today a survival time of 10 to 15 years is considered normal if no complications occur After years of implantation time the devices loosen aseptically This loosening is induced by wear particles A loose prosthesis causes pain which makes a revision operation necessary Fig 1 One of the problems during Revision Operations is the removal of the femoral component from the femora Even if the implant is loose and micro motion is possible they are still fixed by soft tissue and therefore hard to remove Fig 1 Fig 2 2 Definition of Medical and Technical Purposes 2 1 High accurately directed forces have to be applied to the femoral component for short periods of time so that the extraction impulse only acts upon the femoral component itself Fig 7 2 2 The energy of the extraction impulse has to be so high that the connection between implant and femora i e cement femora is terminated before the energy of the impulse is transferred to the femora Fig 5 2 3 To achieve this un
5. EPM Mueller stem extractor M6 Extractor M6 with 2 M6 extractor screws D 9 6 1 Components Extractor M6 attachment 1 M6 Extractor attachment 3 guiding tube 6 Handle 2 M6 screw 4 striking weight 9 6 2 Handling Turn the guide tube of the extractor with the handle and striking weight in the thread of the M6 Extractor attachment till stop Turn on the attachment screw one of the 2 M6 screws until they stop by damaging the thread at the extraction having to change only the M6 screw Now you can turn the extractor into the thread on the shaft or in the manufactured M6 thread with the thread maker Set TM on a broken shaft till stop and extract the shaft or the broken shaft part by striking movement of the hammer weight direction extractor handle 9 6 3 Disassembling The unit is disassembled by unscrewing the threaded connections without additional tools A complete separation from the Extractor attachment is performed in reverse order 16 EPM Ms Endo Plant M ller GmbH 9 7 EPM EPM Mueller thread maker set TM thread maker set TM M6 thread maker set 9 7 1 Components 1 M6 thread maker with T handle 3 Thread makers guide with handle 2 M5 drill 9 7 2 Handling Place the guide to the broken shaft site Bring the M5 drill in the guide tube up to the broken point The first mark on the drill is now on the edge of the guide tube Start now to drill up to the second mark reaches the edge The 2 mark
6. _ EPM _ d Endo Plant M ller GmbH The passive layer of brand new instruments is necessarily still thin and so these instruments tend to critical treatment conditions than are older used instruments Avoid long intervals between use and treatment for reuse For manual cleaning active non protein fixing cleaners with or withaut antimicrobial effect and or enzymes are to be used Regarding detergents and desinfectants the manufacturer s instruction concerning concentration temperature and exposure time should always be strictly followed Use soft lint free cloths or towels plastic brushes or cleaning guns for cleaning To prevent water spots spotting a final rinse using fully demineralised water is recommended After this the instrument must be dried carefully immediately By machine based cleaning only validated machine cleaning and desinfecting processes DIN EN ISO 156883 and national guidelines should be used 10 5 Check and care Instruments must be checked visually tactile and be macroscopically clean Maintance means targeted application of a lubricant milk to the joints threads or friction surfaces of instruments This prevents metal on metal friction and therefore constitutes a preventive measure against friction corrosion Requirements for care agents Paraffin white oil based in accordance with the current European or United States Pharmacopeia Biocompatible Suitable for steam sterilization and vap
7. 15 10 QPH CO 1001 15 10 QH Quick adaptor with plate IL 1001 15 2 10 QB Quick adaptor shaft 1001 15 2 10 QH Plate 1001 15 2 10 QC Quick adaptor cover 1001 15 2 10 QS Shaft spring 1001 15 2 10 CO44 Cup osteotom 44 1001 15 2 10 CO48 Cup osteotom 48 1001 15 2 10 CO52 Cup osteotom 52 1001 15 2 10 CO56 Cup osteotom 56 1001 15 2 10 CO60 Cup osteotom 60 1001 15 2 10 CO64 Cup osteotom 64 12 11 Hook attachment 1001 15 2 11 H Hook pointed r 12 12 Sterilization basket with lid and silicone holder 1001 15 12 BE Coated aluminum basket with lid 62 24 7cm 25 EPM d Endo Plant M ller GmbH 13 Warranty Service 24 months replacement warranty from date of invoice not granted for non compliance with the operating and maintenance or use instructions or consumption parts like drills screws sling osteotomes curettes chisel and hook International European German Sales hotline warranty service spare parts repair EPM Endo Plant Muller GmbH Schleusen Str 8 63839 Kleinwallstadt Tel 49 0 6022 25419 Fax 49 0 6022 25419 e mail epmmueller aol com www epm mueller de 26
8. 2 ATTENTION the threads at the guiding tube have to be always closed complete To enable clamping move the spacer back by putting pressure on spacer 3 Fig 2 gt APPLICATION and CLAMPING Fig 3 Slide 1 tool as far as possible over the neck of the prosthesis 10 EPM d Endo Plant M ller GmbH Note To use the instrument safely and effectively the orientation of the prosthesis has to be analyzed carefully and the EPM Mueller Extractor has to be APPLIED AXIALLY For clamping rotate 2 the handpiece with the opened lever at 90 to the axis at the distal end clockwise until resistance is felt Close 3 the lever to attain maximal clamping force ATTENTION USE NO ADDITIONAL TOOLS HAMMER Fig 3 gt EXPLANTATION Fig 4 The weight is placed at the end of the guidance tube closest to the prosthesis and is then moved forcefully towards the distal end of the tool impacting on the base of the handpiece sr sel e Ze We LR f un oz t th D A p nn CEA Ma enh Attention Do not use additional instruments with the EPM Mueller Extractor as HAMMER Fig 4 gt DETACHMENT Fig 5a 5b The extracted implant is removed from the tool with the same steps explained under OPENING of the instrument Fig 2 9 1 4 Disassembling To disassemble look at picture 1 5a and 5b e 1 Completely unscrew reverce clockwise lever assembly jamcase Fig 5a of handpiec
9. Pin and sling extractor PS2 Pin size 1 2 3 4 5 6mm Sling length 120 mm Striking weight 1 0 kg 2 2 Ib Total weight 1 9 kg 4 18 Ib 0 9 kg 2 Ib PN Variant Total length 550mm 21 7 inches Standard 620mm 25 inches long 350mm PN Hitting distance 205mm 8 1 inches standard 275mm 8 8 inches long 11 6 EPM Mueller Hook extractor H2 Striking weight 1 0 kg 2 2 Ib Total weight 1 65 kg 3 63 Ib 1 2 kg 2 64 Ib PN Variant Total length 530mm 20 9 inches Standard 600mm 23 7 inches long 360mm PN Hitting distance 205mm 8 1 inches standard 275mm 8 8 inches long 21 EPM hs Endo Plant M ller GmbH 12 Supply and Spare parts 1001 15 AU S2 PN KN2 C2 MO PS2 M6 TM SR QP CUC QH CO H2 BE 1001 7 AU S2 1001 5 AU2 1001 6 52 1001 8 PN AU PN S 1001 15 3 KN2 1001 15 4 C2 1001 15 5 MO 1001 15 6 PS2 1001 15 7 M6 1001 15 8 TM1 1001 15 9 DSR 1001 15 10 QP CUC 1001 15 10 QH CO 1001 15 11 H2 1015 15 12 BE EPM Mueller Modular extractor system 2 EPM Mueller Stem Extractor AU S2 EPM Mueller Stem Extractor AU2 EPM Mueller Stem Extractor S2 EPM Mueller Stem Extractor PN AU or PN S EPM Mueller Knee Extractor K2 EPM Mueller Hemispheric and Screw cup Extractor C2 EPM Mueller Modular Stem Extractor MO1 EPM Mueller Pin and sling Extractor PS2 EPM Mueller Extractor M6 EPM Mueller Thread maker TM EPM Muelle
10. chisel or osteotome into the recess of the quick adapter shaft and let the cover off The spring under the cover pushes it back to the closed position 9 9 3 Disassembling Remove the curette chisel or osteotome from the quick connector Pull then the cover completely until it stops then turn it to the right and slide off the sleeve from the shaft Now you can remove the spring At the other end of the shaft rotate the plate or the pneumatic coupling from the shaft 18 _ EPM _ d Endo Plant M ller GmbH 10 CLEANING and STERILIZATION The new instrument has to be cleaned up and disinfected before sterilisation 10 1 Preparation Brand new instruments and those returned from repair must be removed from their transportation packaging before storing and or inclusion in the instrument usage and processing cycle 10 2 Storage Store it at room temperature in dry rooms Condensate may cause subsequent corrosion damage Never store it near chemicals such as active chlorine which emit corrosive vapors To avoid mechanical damage during processing store it from the beginning in suitable racks or retainers Before using they must be sent through the entire processing cycle in the same manner as used instruments The reprocessing comprises Preparation pretreatment collecting precleaning and taking the instrument apart Cleaning disinfecting rinsing drying Visual inspection of clearness and acceptable condition
11. closed position gt Stem knocking out Adjust the spreading jaws to the prosthetic modular neck cavity and insert it till stops Turn the lever is in a vertical position to Extractor including jamcase until you pinch the prosthesis firmly finaly press the lever to the handle Now you can extract the prosthesis by striking movement of the hammer weight towards Extractor handle 9 2 3 Disassembling The unit is disassembled by unscrewing the threaded connections without additional tools excepting the jamcase and the jaws body which is further decomposed into parts using a supplied Allen key 12 EPM Ms Endo Plant M ller GmbH 9 3 EPM Mueller Knee extractor KN 9 3 1 Components 11b 12b 12c 12a 12e 12d EPM Mueller Knee Extractor KN2 with clamping and spreading jaws Option 2 chisels with quick adapter with plate or pneumatic coupling 1 jaws body 5 pressure rod 11a chisel R 1b body pin screws 6 handle 11b chisel Z 2a clamping jaws set 7 jamcase 12a Quick adapter shaft 2b spreading jaws set 8 pin screw 12b Quick adapter cover 3 guiding tube 9 bolt with plastic insert 12c Quick Adapter spring 4 striking weight 10 lever 12d Quick Adapter Plate 12e Quick Adapter pneumatic coupling 9 3 2 Handling Place the two pressure jaws into the opening of the housing and secure it with the 2 mounting screws using the Allen key No 3 Turn first the extractor jamcase from the handle almost completely out and then scre
12. is hard to remove The energy impulse is conveyed laterally to the femora Fractures of the trochantor or the shaft of the femora can occur ABC A misalignment between extraction vector and the longitudinal axis of the prosthesis can lead to injury of the bone surrounding the prosthesis to fractures and associated lengthening of the surgical time and anesthesia increasing of the risk of infection etc 4 Principle and Construction of the EPM Mueller Extractor Provide Axial force transfer and maximal clamping force Ensure the necessary clamping force is transferred to the neck of the prosthesis via a curved toolhead Fig 4 The size of the toolhead is minimized because of limited space during surgery The instrument is handled outside of the surgical field CAD picture Fig 4 5 Measurements of Functional Prototype The prototype was measured with a special trial set up and a Piezo force sensor The profile of force application was registered to monitor change of force over time and calculate the transferred impulse EPM Ms Endo Plant M ller GmbH A force was applied by hand via a weight against an infinitely hard base and registered by the Piezo sensor Data were acquired by an oscilloscope and stored The prototype of the extraction instrument is fixed and the weight 800g is accelerated to about 10m s During the whole time of the experiment the oscilloscope stores the strain delivered by the Pi
13. At the time of writing EPM Mueller Extractor has been used during over 600 total hip revision operations in the hospital A large number of femoral components have been successfully removed with only a few was extraction not possible These failures were primarily in the experimental phase using the prototypes AW3 4 the geometry of the instrument head has since been changed accordingly EPM Mueller Extractor AU has been in clinical use since 1999 The remaining failures were due to a maximal stability of the implant in the surrounding bone meaning an absence of loosening Stable implants cannot be removed by an extraction tool alone To date no complications for example bone fractures have been noted Handling has proven to be safe and easy The posture approach usually favored in GarmischPartenkirchen often leads to restricted available space at the operative site the limited size of the toolhead and the handling of the instrument outside of the surgical field have therefore proven extremely useful The surgical personnel have praised easy handling cleaning and sterilization of the EPM Mueller Extractor All parts of the EPM Mueller Extractor can be assembled and disassembled with ease and safety The space needed for storage is minimal and since the instrument can be used universally it is not necessary to maintain a large inventory of extraction devices 9 Use Instructions 9 1 EPM Mueller Stem Extractor AU AU2 S S2
14. aft 3 guide tube 1a cover 4 striking weight 2 pin chuck for 1 2 3 4 and 5 6mm diameter 6 Handle 2a metal sling 120mm 15 EPM Ms Endo Plant M ller GmbH 9 5 2 Handling Pin extractor Turn the guiding tube 3 together with striking weight and handle in the Extractor attachment 1 until it stops The cover 1a should be placed on the attachment with the unthreaded part forward and cover the pin chuck part First turn the cover tube back onto the shaft Then turn the pin chuck counterclockwise to the shaft end thread firmly Now turn forward the cover over the chuck Insert the chuck opening on the pin to be extracted and turn the cover so long until you catch firmly the pin Now you can extract the pin by hammer striking movement direction extractor handle Sling extractor The cover tube 1a should be placed with the thread free part to the attachment Turn the cover tube toward the shaft until the 2 recesses in the shaft are free Hook one end of the sling and cover it with the cover Now you can attach the other end of the sling around the part to be removed and hook it into the second recess and cover it with the cover Now you can extract the hooked part by hammer striking movement direction Extractor handle 9 5 3 Disassembling The unit is disassembled by unscrewing the threaded connections without additional tools A complete separation from the extractor attachment is performed in reverse order 9 6
15. aws and housing handle with option of cup osteotome and quick adapter and hook attachment EPM Ms Endo Plant M ller GmbH EPM Mueller stem Extractor M6 attachment Suitable for the extraction of stems with M6 threaded entry such as Zimmer shafts or broken long shafts after made of a M6 thread with M6 thread maker set a EPM Mueller M6 Thread maker Set TM EPM Mueller Ruined screw remover SR EPM Mueller Hook attachment a MONONHNMNZY XXXOZWMUO d SM wy IN Fig 7 The direction of force of the EPM Mueller Extractor normal case lies in the middle axis XY of the femora Fig 7 The strain distribution in the prosthesis during extraction with the EPM Mueller Extractor is homogenous which favors the detachment of the implant from spongiosa and soft tissue Strain in the cortical bone is low and shows no peaks Therefore the risk of fracture of the cortical bone is minimized The EPM Mueller Extractor is optimized for practical application The extraction forces are applied to the relevant sides the clamping force is extremely high and dependable and the device can universally be used for the most implant necks _ EPM _ d Endo Plant M ller GmbH 8 Surgical Use in Garmisch Partenkirchen Hospital of the EPM Mueller Stem Extractor The EPM Mueller Extractor has been in clinical use in Garmisch Partenkirchen Hospital since October of 1993
16. ctor AU S2 Pneumatic Shaft Extractor Extractor approach jaws for modular stems MO Knee stem Extractor approach KN2 Pan Extractor approach C2 Pin and Loop Extractor approach PS2 Screw Extractor approach M6 threaded makers Set Ruined screw remover set SR Quick adapter with curettes planing and pan osteotomes Chipping Extractor approach H2 Sterilization basket with silicone lid supports and instruments We developed 2014 EPM Mueller Modular Extractor System 2 based on the EPM Mueller hip stem Extractor Newly developed attachments allows the extraction of various prostheses such as modular neckless hip large head knee acetabular hemispherical or screw cups pins stuck drills and ruined screw Together with the EDM Mueller stem Extractor AU S2 the Modular Extractor system2 attachments provide a complete solution for prosthesis revision problems 6 2 2 EPM Mueller Modular Extractor System 2 use possibilities EPM Mueller stem Extractor S2 or AU EPM A d Endo Plant M ller GmbH EPM Mueller Modular stem Extractor MO1 EPM Mueller Knee shaft Extractor KN2 with extra spreading jaws with option of chisels with quick adapter Option The knee shaft extractor jaws can also be used for tibial component large head hip stems shoulder stems modular stocked heads and stocked drills EPM Mueller hemispherical and Screw cup Extractor C2 with extra spreading j
17. e e 2 Remove the pin screw with the Allan key 3 delivered than lever thereafter bolt with plasticinset with a narrow instrument presure rod can be used e 3 Extract presure rod e 4 Detach handpiece by unscrewing completely from the guiding tube e 5 Slide off the striking weight e 6 Remove sliding spacer through rectangular space at the instrument head e Remove guiding tube by unscrewing completely from the instrument head ATTENTION use the bolt always with the plasticinset together 11 EPM hs Endo Plant M ller GmbH Fig 5a ATTENTION NOTE CORRECT ORDER OF slider spacers A B C at the AE variant Fig 5b Fig 5b 9 2 EPM Mueller Modular stem extractor MO1 9 2 1 Components 2a2b2c 1 3 5 4 10 6 7 9 8 EPM Mueller Modular stem Extractor MO 1 body 4 stroke weight 8 pin with screw 1b body pin screws 5 pressure rod 9 bolt with plastic insert 2a 2b 2c Moveable Set 6 lever 10 handle 3 guiding tube 7 jamcase 9 2 2 Handling Place the spreading jaws set in the opening of the body and secure it with the 2 body pin screws using the Allen key No 3 Turn the Extractor jamcase from the handle first almost completely out and then screw the guiding tube of the extractor into the thread of the jaws body until it stops Now by turning the lever together with the jamcase the spreading jaws will get off and catch the modular stem The jaws are always hold by your hand on the body in the
18. e and soft tissue contacts remains on the cup to avoid bigger tissue damages gt Hemispherical cup knock out with spreading jaws Adjust the opening of the spreading jaws to the cup inside you have to place the jaws to catch favorable places Now turn the extractor lever in a vertical position including jamcase until you clamp the cup firmly then press the lever to the handle Now you can extract the cup by striking movement of the striking weight towards extractor handle In a press fit cup use after the mobilisation cup osteotome matching closely the size of the cup to remove bone and soft tissue contacts remains on the cup to avoid bigger tissue damages gt Screw cup knock out with spreading jaws First mount the body handle on the side of the body and turn the handle until it stops Adjust the opening of the spreading jaws to the cup inside Now turn the extractor lever in a vertical position including jamcase until you clamp the cup firmly you have to place the jaws to catch favorable places then press the lever to the handle Now you can unscrew the cup by turning it anti clockwise with the body handle 9 4 3 Disassembling The unit is disassembled by unscrewing the threaded connections without additional tools excepting the jamcase and the jaws body which is further decomposed into parts using a supplied Allen key 9 5 EPM Mueller Pin and sling extractor PS2 9 5 1 Components 1 Pin and sling extractor sh
19. ers are 10 mm apart After removal of the drill the guide tube and thorough rinsing you can make the M6 thread with the thread maker By twisting movements and repeated rinsing you create about 8 mm thread length Now you can screw the M6 extractor and extract the stem broken part 9 8 EPM Mueller hook extractor H2 Hook extractor H2 taa Hook extractor attachment H2 9 8 1 Components 1 hook attachment 3 guiding tube 4 striking weight 6 handle 9 8 2 Handling Turn the hook attachment to the extractor guiding tube with the handel and striking weight until it stops After hooking the item remove it by striking movement of the striking weight towards extractor handle Caution The hook tip can break off at to strong shocks 9 8 3 Disassembling The unit is disassembled by unscrewing the threaded connections without additional tools 17 E PM Ms Endo Plant M ller GmbH EPM Mueller Curette chisel cup osteotome with quick adaptor with plate and with pneumatic coupling 11c 12b 12c 12a 12d 12e EPM Mueller 2 curette 2 chisels and 6 cup osteotome quick adapter plate or pneumatic coupling for Woodpecker 9 9 1 Components lla chisel R 12a quick adapter shaft 11b chisel Z 12b quick adapter cover llc cup osteotome 12c quick adapter spring ld curette S 12d quick adapter plate l le curette L 12e quick adapter pneumatic coupling 9 9 2 Handling Pull the cover back and put the curette
20. ezo sensor strain proportional to force The impulse transfer time t is calculated from the strain time diagram Fig 5 Kraftsto verhalten Fumu Spannung in V 8 008 0 010 0 012 0 014 Zeit ins Fig 5 Results From the graph of force transfer time of t 500us can be derived A peak force of 50KN can be calculated for force transfer This peak force corresponds to a set up with an infinitely hard base In practical use an elastic fixation exists and consequently the measurements stated above will not be attained Duration of the force 0 5ms 0 0005s Amount of force 50Ns The impulse is high enough to overcome the holding forces inside of the bone and loosen the prosthesis The clamping mechanism reliably transfers the force to the implant Calculated clamping force at the neck of the prosthesis is 30KN 6 The EPM Mueller Stem Extractor EPM Mueller Extractor AU with open head on the side and one sliding spacer proper also for stems with fixed heads monobloks 4 Fig 6a EPM Mueller Extractor S with closed head and single sliding spacer Fig 6b EPM Mueller Extractor AU S with 2 exchangeable heads open AU closed S and one sliding spacer d r o Fig 6c EPM Mueller Extractor AE2 geschlossene Spannrahmen und drei Druckbacken A B C EPM Mueller Extractor PN AU PN S with adapter for pneumatic Ki e _ EPM _ Ms Endo Plant M ller GmbH EPM Muelle
21. iaxial force transfer is necessary as well as an extremely high connection force between instrument and femoral component Fig 4 2 4 The force vector has to be as close to the longitudinal axis of the femoral component as possible Fig 4 3 FEM Analysis of Revision with Conventional Extraction Tools To visualize the special relationships and magnitudes of force potentials and to compare the loads acting upon the cortical bone of the femora in revisions of the femoral component a finite element strain analysis of the femora while extracting a femoral component with different extraction devices was performed 3 1 Finite Element Modeling FEM Conditions and Loads For the Finite Element Analysis FEA two identical femora with two identical femoral components were modeled Fig 3 7 The femora were comprised of 3 D elements The femoral component outside of the bone and heads of the extraction instruments were compiled of 2 D elements For the calculations the near half symmetry of femora and femoral components were used At the ends of the heads of the extraction instruments a ramp force profile of F 0 N at time t 0s to F 10 kN at t 30 ms was imprinted in axial direction The axial direction is parallel to the middle axis of the femora in the FEM Therefore this represents a best case for the conventional extraction instruments Fig 3 The femora is imbedded in 2 D elements which represent the properties of the muscle surrounding
22. ing jaw right 12 5 Modular shaft Extractor spreading attachment 1001 15 5 23 EPM Ms Endo Plant M ller GmbH 1001 15 2 5 Modular shaft Extractor spreadingjaws set 1001 15 2 5 FJ Modular fix jaw 1001 15 2 5 MJ Modular mobile jaw 1001 15 2 5 MP Modular mobile piece 1001 15 2 5 5 jaw pin screw 12 6 Pin and sling attachment 1001 15 6 1001 15 2 6 B Attachment shaft 1001 15 2 6 C Shaft cover 1001 15 2 6 P2 Pin chuck 1 2mm 1001 15 2 6 P4 Pin chuck 3 4mm 1001 15 2 6 P6 Pin chuck 5 6mm 1001 15 2 6 S Metall sling 120mm 12 7 M6 Screw attachment with 2 M6 screws 1001 15 7 1001 15 2 7 M6A M6 Screw attachment m oc 1001 15 2 7 M6 M6 Screw 12 8 M6 Thread maker set 1001 15 8 1001 15 2 8 G Drill guide with handle 1001 15 2 8 D M5 drill 1001 15 2 8 TM M6 thread maker with T handle 12 9 Damaged screw remover set 1001 15 9 SR 1001 15 2 9 D M3 Drill 1001 15 2 9 R Reverse drill with T handle 12 10 1 Quick adapter with pneumatic coupling curetten and chisels 1001 15 10 QP CUC 1001 15 10 QP Quick adapter with pneumatic coupling 1001 15 2 10 QB Quick adapter shaft 1001 15 2 10 QP Pneumatic coupling EPM _ Ms Endo Plant M ller GmbH 1001 15 2 10 QC Shaft cover 1001 15 2 10 QS Shaft spring 1001 15 2 10 CUS Curette small 1001 15 2 10 CUL Curette big 1001 15 2 10 CR Chisel round 1001 15 2 10 CZ Chisel zak 12 10 2 Quick adaptor with plate and 6 cuo osteotome 1001
23. ion of the EPM Mueller Stem Extractor 8 Clinic use in Garmisch Partenkirchen KKH with the EPM Mueller Stem Extractor 9 User manual 9 1 EPM Mueller hip stem Extractor 9 1 1 short description 9 1 2 components 9 1 3 handling 9 1 4 detachment 9 2 EPM Mueller Modular hip stem Extractor MO 9 1 2 components 9 1 3 handling 9 1 4 ddetachment 9 3 EPM Mueller Knee prosthesis Extractor KN2 9 3 1 components 9 3 2 handling 9 3 3 ddetachment 9 4 EPM Mueller Acetabular hemispherical and Screw cup Extractor C2 9 4 1 components 9 4 2 handling 9 4 3 ddetachment 9 5 EPM Mueller Pin and sling Extractor PS2 9 5 1 components 9 5 2 handling 9 5 3 ddetachment 9 6 EPM Mueller M6 hip stem Extractor M6 9 6 1 components 9 6 2 handling 9 6 3 ddetachment 9 7 EPM Mueller Thread maker Set 9 7 2 components 9 7 3 handling 9 8 EPM Mueller hook Extractor H 9 8 1 components 9 8 2 handling 9 8 3 detachment 9 9 EPM Mueller Quick adapter with curettes osteotomes planing and pans 9 9 1 components 9 9 2 handling 9 9 3 detachment 9 10 maintenance 10 Cleaning and sterilization 10 1 Preparation 10 2 Recommended course of action for returned goods returns 10 3 Preparation for cleaning and disinfection 10 4 Manual and machine cleaning and disinfection 10 5 Checks and Care 10 6 sterilization 10 7 Storage of non sterile and sterile instruments 11 Technical data 12 Spare parts 13 Warranty Service
24. ody pin screw 6 Handle 12b quick adapter cover 1c body handle 7 jamcase 12c quick Adapter spring 2a clamping jaws 8 pin screw 12d quick adapter plate 2b spreading jaws 9 bolt with plastic insert 12e quick adapter pneumatic 3 guiding tube 10 lever 4 striking weight 11c cup osteotome 9 4 2 Handling Place the two pressure jaws into the opening of the body and secure it with the 2 body pin screws using the Allen key No 3 Turn the extractor jamcase from the handle first almost completely out and then screw the guiding tube of the extractor into the thread of the body until it stops Now you can compress or release the jaws as desired by turning the lever including jamcase into the handle The jaws are held by your hand on the body always in the wide open or at the spreading jaws in the closed position gt Cup knock out with clamping jaws Adjust the opening of the jaws to the cup outside dimension and set the jaw tips perpendicular to the plane of the cup Beat the jaws by the striking weight until the jaw step abut the acetabular rim Now turn the lever in a vertical position to extractor with the jamcase until you pinch the cup firmly then press the lever on the handle Now you can extract the cup by striking movement of the hammer weight towards extractor handle 14 _ EPM _ Ms Endo Plant M ller GmbH In a press fit cup use after the relaxation of the cup cup osteotome matching closely the size of the cup to remove bon
25. of material Care and repair where required Functional test Marking Packaging and sterilization approval for reuse and storage Validated cleaning disinfecting and sterilization processes supplemented by defined configurations for loading the washers disinfectors and sterilizers are an indispensable prerequisite for quality assurance Automated reprocessing with thermal disinfection and steam sterilization should be preferred Use correct water quality When using softened water especially when applying thermal disinfection in the final rinse anodized aluminium surfaces might be subject to attack due to an increased pH value Using demineralised water for steam sterilissation limit values for feed water quality conforming to EN 285 and ISO 17665 are required We recommend using demineralized water for the final rinse for the following reasons No spoting No increase in concentration of corrosive constituents e g chlorides No dried crystalline residues which could have a negative effect on the downstream Sterilization process Protection and stabilization of anodized aluminium surfaces 10 3 Returned instruments Only if the instruments have been cleaned disinfected dried and have been declarated hygienically safe 10 4 Cleaning and Disinfecting Any residues should be removed Never immerse stainless steel instruments in a physiological salt NaCl solution it leads to pitting and stress corrosion cracking 19
26. or permeable Instruments must not be treated with care agents containing silicone oil The proper functioning of the instruments must be assured by testing Apply instrument oil to tube rod and screws periodically to minimize wear friction 10 6 Packaging International standard EN ISO 11607 1 and 2 apply to packed items requiring sterilization It must be possible to mark and identify the package with information such as Sterilisation date Packer Expiry or use before date if date has been defined Contents 10 7 Sterilisation It is important to use only sterilisation methods and sterilizers that allow validated sterilization processes conform national guidelines Sterilisation accessories and packaging materials must be selected in accordance with the items to be sterilised as well as with the sterilisation method used Steam sterilization is the method of choice and is performed with saturated steam usually at 134 C Use validated steam sterilization processes in accordance with ISO 17665 EN 554 or DIN 58946 Part 6 in Germany 10 8 Sterile storing To guarantee the sterility of instruments until they are used on the patient germ tight packaging is absolutely essential Further requirements for the protected storage of sterile supplies and the prevention of corrosion damage include a dust free and dry environment and the prevention of temperature fluctuations 20 _ EPM _ d Endo Plant M ller GmbH
27. r Damaged screw remover DSR EPM Mueller Quick adaptor with pneumatic coupling curettes and chisels QP CUC EPM Mueller Quick adaptor with hammer plate and cup osteotomes QH CO EPM Mueller Hook extractor H2 Basket with lid and silicone holder 62 24 7 BE EPM Mueller Modular Extractor System 2 Item no 12 1 Slap hammer and pneumatic extractor shaft 1001 2 5 AU Head AU 1001 2 6 8 Head S 1001 2 04 U Slider spacer U 1001 2 17 ST2 Guiding tube ST2 1001 2 17 L2 Guiding tube L2 1001 2 15 ST Pressure rod ST 22 _ EPM Ms Endo Plant M ller GmbH 1001 2 15 PN Pressure rod PN 1001 2 09 N Striking weight 1000g 1001 2 11 ST2 Handel ST2 1001 2 11 PN2 Handel PN 1001 2 12 02 ST Jamcase ST2 1001 2 12 PN Jamcase PN 1001 2 07 2 Bolt with plasticinset 1001 2 13 2 Pin screw 1001 2 13 A2 5 3 Allan key 1001 2 14 Lever 12 3 Knee Extractor attachment 1001 15 3 1001 15 2 3 B Body 1001 15 2 3 S Pin screw 1001 15 2 3 L Knee clamping jaw left 1001 15 2 3 R Knee clamping jaw right 1001 15 2 3 4 L Knee and cup spreading jaw left 1001 15 2 3 4 R Knee and cup spreading jaw right 12 4 Hemispheric and screw cup Extractor attachment 1001 15 4 1001 15 2 3 B2 Body 2 1001 15 2 3 S Body pin screw 1001 15 2 3 G Body handle 1001 15 2 4 L Cup clamping jaw left 1001 15 2 4 R Cup clamping jaw right 1001 15 2 3 4 L Knee and cup spreading jaw left 1001 15 2 3 4 R Knee and cup spread
28. r Extractor SA for Antero access revisions with closed head single slider spacer and slider bar Fig 6e The EPM Mueller Extractor is characterized by axial force transfer and exceptional clamping mechanism The necessary clamping force is transferred to the implant neck by a curved toolhead The size of the tool head is adapted to space restrictions dictated by the surgical procedure The EPM Mueller Extractor is handled outside of the surgical field The EPM Mueller Extractor AW6 has been in clinical use since 1993 the EPM Mueller Extractor AE ABC Extractor the EPM Mueller Extractor AU since 1999 and the EPM Mueller Extractor S since 2004 the EPM Mueller Extractor PN since 2007 the EPM Mueller Modular Extractor System 1 since 2009 We launch 2014 the new EPM Mueller Extractor AS for Anterior approach revisions and the EPM Mueller Modular Extractor System 2 The EPM Mueller Extractor can be fixed to the exposed neck of the prosthesis with a few easy movements and the prosthesis can be removed with limited time and force requirements The EPM Mueller Extractor can be removed from the prosthesis after extraction via an easy snap lock mechanism without additional tools It can be disassembled and assembled easily and fits into a standard surgical tray Easy cleaning and sterilization are assured the instrument is fully autoclavable 6 2 1 EPM Mueller Modular Extractor System 2 components Hip Stem Extra
29. the bone A strain free condition is assumed at t O Fig 3 EPM _ d Endo Plant M ller GmbH d a PLOT NG S NODAT SCTITTON STEP 1 SUR 1 TIHE 03 mtr A DI z i Spe py A I UNI Perai T D 740 a En B y D A e TL btr Ju E D ed Te el Lol Ste See Fi 3 17 6603 IQ 3 2 Results and Discussion To depict the strains inside the femurs and femoral components the von Mises strains s EQV were used The FEA was performed in a transient mode The diagrams 3 and 7 show the von Mises strains at maximal extraction forces at t 30 ms One can notice the non homogenous distribution of strains inside the femoral component when conventional extraction tools are used Fig 3 One can deduct an asymmetrical transfer of forces to the femora from this which can only lead to a partial disconnection of the implant from the surrounding tissue Therefore multiple applications of the forces have to be performed Looking at the distribution of the strains in the cortical bone extraction with conventional tools causes high strains on the whole Fig 3 ABC and especially high maximal strains in the middle of the prosthesis and at the lower end of the prosthesis Fig 3 D With the conventional extraction tools the force vector is not directed along the longitudinal axis of the femoral component in the optimal case it is only parallel to this axis Xp the femoral component therefore jams and
30. w the guide tube of the extractor into the thread of the jaws body until it stops Now you can compress or release the jaws as desired by turning the lever including jamcase into the handpiece Your hand on the body holds the jaws always in the wide open position or at the spreading jaws in the closed position gt Prosthesis knock out Adjust the opening of the jaws to the prosthesis outside dimension to be extracted by the spreading jaws adjust to the inside dimension The adjustable clamping jaws can clamp objects of 5 110 mm at spreading jaws of 18 80 mm Turn the lever which is in a vertical position for Extractor to clamp firmly the prosthesis then press the lever to the handle Now you can extract the prosthesis by striking movement of the hammer weight towards Extractor handle 9 3 3 Disassembling The unit is disassembled by unscrewing the threaded connections without additional tools excepting the jamcase and the jaws body which is further decomposed into parts using a supplied Allen key 13 EPM Ms Endo Plant M ller GmbH 9 4 EPM Mueller Hemispherical and screw cup extractor C2 9 4 1 Components 2a 1b 1a 3 5 4 10 6 7 9 8 11c 11c 12b 12c 12a 12d 12e EPM Mueller Hemispherical and screw cup extractor C2 with clamping and spreading jaws Option 6 cup osteotome quick adapter with plate or pneumatic coupling for Woodpacker 1a body 5 pressure rod 12a quick adapter shaft 1b b
Download Pdf Manuals
Related Search