Development of a magnetic intra-uterine manipulator

Doll, Stefan (Stellenbosch : Stellenbosch University, 2012-03)

Thesis

ENGLISH ABSTRACT: Uterine manipulation is integral to obtaining adequate access to the uterus during a laparoscopic procedure. A variety of mechanical manipulators have been developed to aid the surgeon with the dissection of the uterus during laparoscopic hysterectomies. Limitations of existing manipulators are that they require an additional assistant during surgery, are expensive and may cause tissue trauma to the vaginal or cervical canal. This study introduces the novel concept of a magnetic uterine manipulator, intended to overcome existing devices’ shortcomings and enabling non-invasive uterine manipulation. The first goal of the study was to investigate the strengths and weaknesses of existing mechanical manipulators and compare them to those of a magnetic device. Analysis showed that a magnetic manipulator would not be able to compete in terms of the range of motion of existing devices. A limited anteriorsagittal rotation range of 60 was seen in the magnetic manipulator compared to a range of 140 in mechanical devices. However, the magnetic manipulator could eliminate the need for an extra assistant, is reusable and thus also more economical. The second goal was to investigate which type of setup would be most successful at effective uterine manipulation. Through concept analysis a cart-on-arch system was deemed most effective. To lift an effective load of 1 N over an air-gap of 150 mm rare-earth N38 Neodymium (NdFeBr) magnets showed the most promise as magnetic actuators. FEA (Finite Element Analysis) simulations of the magnetic setup were validated experimentally which produced an acceptable MAE (mean absolute error) of 0.15 N. Furthermore, a comparative simulation study of shielded and unshielded magnets was done which concluded that shielded magnets produce a slightly higher attraction force and would be safer to use due to less magnetic flux fringing. Thirdly and lastly, potential safety hazards and risks of using magnetic actuators in surgical environments were identified. The literature research revealed that connections between magnetic fields and health risks to patients have not been conclusively proven in clinical studies to date, but nonetheless, great care should be taken in situations where the patient has a pace-maker or orthopaedic implants, as these might interact with the magnetic field. Recommendations for future work include further research into the geometry and scaling effects of magnetic shielding as well as electromagnetic actuator design. Electromagnetic actuators could replace rare-earth magnets, if coil and cooling systems are optimized, resulting in magnets that can be reversed or switched off and which are therefore easier to control and safer to handle.

AFRIKAANSE OPSOMMING: Ontwikkeling van ’n Magnetiese Intra-Uteriene Manipuleerder Baarmoedermanipulasie is van uiterste belang om sodoende voldoende toegang te kry tot die baarmoeder gedurende ’n laparoskopiese prosedure. Daar is reeds ’n verskeidenheid meganiese manipuleerders ontwikkel as hulpmiddel vir die chirurg in die ontleding van die uterus tydens laparoskopiese histerektomies. Beperkings van bestaande manipuleerders is dat ’n bykomende assistent tydens chirurgie benodig word. Die manipuleerders is ook duur en kan weefseltrauma veroorsaak aan die vaginale of servikale kanale. Die studie stel ’n nuwe konsep bekend: ’n magnetiese baarmoedermanipuleerder, gemik daarop om bestaande toestelle se tekortkominge te oorkom en nie-indringende baarmoedermanipulasie moontlik te maak. Die eerste doel van die studie was om die voordele en nadele van bestaande meganiese manipuleerders te ondersoek en dit te vergelyk met dié van die magnetiese toestel. Analise het getoon dat ’n magnetiese manipuleerder nie met bestaande toestelle sal kan kompeteer waar dit gaan om beweegruimte nie. Daar is ’n beperkte anterior-sagitale rotasiespeling van 60 in die magnetiese manipuleerder, terwyl die meganiese toestel ’n rotasiespeling van 140 het. Die magnetiese manipuleerder kan egter die nodigheid van ’n bykomende assistant uitskakel, is herbruikbaar en dus ook meer ekonomies. Die tweede doel van die studie was om die tipe opstelling wat meer suksesvol sal wees tydens doeltreffende baarmoeder manipulasie te ondersoek. Konsep-analise het getoon dat ’n "cart-on-arch"stelsel die beste sal werk. N38 Neodimium (NdFeBr) magnete het die beste vertoon as magnetiese aandrywer om ’n werklike belasting van 1 N oor ’n lugspasie van 150 mm te lig. EEA (Eindige Element Analise) simulasies van die magnetiese opstelling is eksperimenteel bekragtig en het ’n aanvaarbare gemene absolute fout (GAF) van 0.15 N gelewer. ’n Vergelykende simulasie studie het verder gewys dat beskutte magnete ’n effens hoër aantrekkingskrag oplewer en sal dus veiliger wees om te gebruik vanweë die verminderde magnetiese stromingsrand. Derdens en laastens is potensiële veiligheidsrisikos en gevare in die gebruik van magnetiese drywers in chirurgiese omgewings geïdentifiseer. Literatuurnavorsing het onthul dat die verband tussen magneetvelde en gesondheidsrisikos aan pasiënte nog nie voldoende bewys is in kliniese studies tot op datum nie. Gevalle waar pasiënte ’n pasaangeër of ortopediese inplantings het moet met groot sorg hanteer word aangesien dit dalk kan reageer met die magneetvelde. Aanbevelings vir toekomstige werk sluit verdere navorsing in in die rigting van die geometrie en die afskilferingseffek van magnetiese beskutting en ook elektromagnetiese drywer ontwerp. Elektromagnetiese drywers kan moontlik rou aarde magnete vervang indien winding en afkoelstelsels ge-optimeer word wat kan lei tot magnete wat omgekeer of afgeskakel kan word en dus makliker beheerbaar is en veiliger om te hanteer.

Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/19935
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